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VAERS Catalog by Vaccine
List of Pages


Table of Contents

1. Vaccine Type • Vaccine Name • Page No.
2. Page No. + 1st Record (Vaccine Type, Name • Event/Outcome • Description)

Each Page: 10,000 Records.
All Records Sorted A-Z.


Vaccine Type • Vaccine Name • Page No.:

6VAX-F • DTAP+IPV+HEPB+HIB (HEXAVAC) • Page 1
6VAX-F • DTAP+IPV+HEPB+HIB (INFANRIX HEXA) • Page 1
6VAX-F • DTAP+IPV+HEPB+HIB (INFANRIX HEXA) • Page 2
6VAX-F • DTAP+IPV+HEPB+HIB (INFANRIX HEXA) • Page 3
6VAX-F • DTAP+IPV+HEPB+HIB (INFANRIX HEXA) • Page 4
6VAX-F • DTAP+IPV+HEPB+HIB (INFANRIX HEXA) • Page 1
6VAX-F • DTAP+IPV+HEPB+HIB (NO BRAND NAME) • Page 4
6VAX-F • DTAP+IPV+HEPB+HIB (NO BRAND NAME) • Page 5
6VAX-F • DTAP+IPV+HEPB+HIB (NO BRAND NAME) • Page 4
ADEN • ADENOVIRUS (NO BRAND NAME) • Page 5
ADEN • ADENOVIRUS (NO BRAND NAME) • Page 5
ADEN • ADENOVIRUS (TYPE 4, NO BRAND NAME) • Page 5
ADEN • ADENOVIRUS (TYPE 4, NO BRAND NAME) • Page 5
ADEN • ADENOVIRUS (TYPE 7, NO BRAND NAME) • Page 5
ADEN • ADENOVIRUS (TYPE 7, NO BRAND NAME) • Page 5
ADEN_4_7 • ADENOVIRUS TYPES 4 & 7, LIVE, ORAL (NO BRAND NAME) • Page 5
ADEN_4_7 • ADENOVIRUS TYPES 4 & 7, LIVE, ORAL (NO BRAND NAME) • Page 5
ANTH • ANTHRAX (BIOTHRAX) • Page 5
ANTH • ANTHRAX (BIOTHRAX) • Page 6
ANTH • ANTHRAX (BIOTHRAX) • Page 7
ANTH • ANTHRAX (BIOTHRAX) • Page 8
ANTH • ANTHRAX (BIOTHRAX) • Page 9
ANTH • ANTHRAX (BIOTHRAX) • Page 5
ANTH • ANTHRAX (NO BRAND NAME) • Page 10
ANTH • ANTHRAX (NO BRAND NAME) • Page 11
ANTH • ANTHRAX (NO BRAND NAME) • Page 10
ANTH • ANTHRAX (NO BRAND NAME) • Page 9
BCG • BCG (MYCOBAX) • Page 11
BCG • BCG (MYCOBAX) • Page 12
BCG • BCG (MYCOBAX) • Page 11
BCG • BCG (NO BRAND NAME) • Page 12
BCG • BCG (NO BRAND NAME) • Page 12
BCG • BCG (TICE) • Page 12
BCG • BCG (TICE) • Page 12
CEE • FSME-IMMUN. (NO BRAND NAME) • Page 12
CEE • FSME-IMMUN. (NO BRAND NAME) • Page 12
CHOL • CHOLERA (NO BRAND NAME) • Page 12
CHOL • CHOLERA (NO BRAND NAME) • Page 12
CHOL • CHOLERA (USP) • Page 12
CHOL • CHOLERA (USP) • Page 12
CHOL • CHOLERA (VAXCHORA) • Page 12
CHOL • CHOLERA (VAXCHORA) • Page 12
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 17
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 18
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 19
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 20
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 21
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 22
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 23
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 24
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 25
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 26
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 27
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 28
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 29
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 30
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 31
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 32
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 33
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 34
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 35
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 36
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 37
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 38
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 39
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 40
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 41
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 42
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 12
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 13
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 14
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 15
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 16
COVID19 • COVID19 (COVID19 (JANSSEN)) • Page 17
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 100
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 101
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 102
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 103
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 104
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 105
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 106
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 107
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 108
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 109
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 110
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 111
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 112
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 113
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 114
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 115
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 116
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 117
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 118
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 119
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 120
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 121
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 122
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 123
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COVID19 • COVID19 (COVID19 (MODERNA)) • Page 125
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 126
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 127
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 128
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 129
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 130
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 131
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COVID19 • COVID19 (COVID19 (MODERNA)) • Page 133
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 134
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 135
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COVID19 • COVID19 (COVID19 (MODERNA)) • Page 137
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 138
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 139
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COVID19 • COVID19 (COVID19 (MODERNA)) • Page 146
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 147
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 148
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COVID19 • COVID19 (COVID19 (MODERNA)) • Page 150
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COVID19 • COVID19 (COVID19 (MODERNA)) • Page 165
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 62
COVID19 • COVID19 (COVID19 (MODERNA)) • Page 63
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COVID19 • COVID19 (COVID19 (MODERNA)) • Page 62
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 192
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 193
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 194
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 195
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 196
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 197
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 199
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 202
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 209
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 211
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 214
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 215
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 216
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 217
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 218
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 224
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 225
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 226
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 227
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 228
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 229
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 230
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 231
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 232
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 233
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 234
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 235
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 236
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 237
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 238
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 239
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 240
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 241
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 242
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 243
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 244
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 245
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 246
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 247
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 248
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 249
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 250
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 251
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 252
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 253
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 254
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 255
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 256
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 257
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 258
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 259
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 260
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 261
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 262
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 263
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 264
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 265
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 266
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 267
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 268
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 269
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 270
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 271
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 272
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 325
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 326
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 327
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 328
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 329
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 330
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 331
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 332
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 333
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 335
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 338
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 165
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COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 170
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 171
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 172
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 173
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 174
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 175
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 176
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 177
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 178
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 179
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 180
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 181
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 182
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 183
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 184
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 185
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 186
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 187
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 188
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 189
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 190
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 191
COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Page 192
COVID19 • COVID19 (COVID19 (UNKNOWN)) • Page 339
COVID19 • COVID19 (COVID19 (UNKNOWN)) • Page 338
COVID19 • COVID19 (COVID19 (UNKNOWN)) • Page 339
DF • DENGUE TETRAVALENT (DENGVAXIA) • Page 339
DF • DENGUE TETRAVALENT (DENGVAXIA) • Page 339
DPIPV • DP+IPV (NO BRAND NAME) • Page 339
DPIPV • DP+IPV (NO BRAND NAME) • Page 339
DPP • DIPHTHERIA TOXOID+PERTUSSIS+IPV (NO BRAND NAME) • Page 339
DPP • DIPHTHERIA TOXOID+PERTUSSIS+IPV (NO BRAND NAME) • Page 339
DPP • DIPHTHERIA TOXOID+PERTUSSIS+IPV (QUATRO VIRELON) • Page 339
DPP • DIPHTHERIA TOXOID+PERTUSSIS+IPV (QUATRO VIRELON) • Page 339
DT • DT ADSORBED (DECAVAC) • Page 339
DT • DT ADSORBED (DECAVAC) • Page 340
DT • DT ADSORBED (DECAVAC) • Page 339
DT • DT ADSORBED (DITANRIX) • Page 340
DT • DT ADSORBED (DITANRIX) • Page 340
DT • DT ADSORBED (NO BRAND NAME) • Page 340
DT • DT ADSORBED (NO BRAND NAME) • Page 341
DT • DT ADSORBED (NO BRAND NAME) • Page 340
DTAP • DTAP (ACEL-IMUNE) • Page 341
DTAP • DTAP (ACEL-IMUNE) • Page 342
DTAP • DTAP (ACEL-IMUNE) • Page 343
DTAP • DTAP (ACEL-IMUNE) • Page 341
DTAP • DTAP (CERTIVA) • Page 343
DTAP • DTAP (CERTIVA) • Page 343
DTAP • DTAP (DAPTACEL) • Page 344
DTAP • DTAP (DAPTACEL) • Page 345
DTAP • DTAP (DAPTACEL) • Page 346
DTAP • DTAP (DAPTACEL) • Page 347
DTAP • DTAP (DAPTACEL) • Page 348
DTAP • DTAP (DAPTACEL) • Page 349
DTAP • DTAP (DAPTACEL) • Page 350
DTAP • DTAP (DAPTACEL) • Page 351
DTAP • DTAP (DAPTACEL) • Page 343
DTAP • DTAP (DAPTACEL) • Page 344
DTAP • DTAP (INFANRIX) • Page 353
DTAP • DTAP (INFANRIX) • Page 354
DTAP • DTAP (INFANRIX) • Page 355
DTAP • DTAP (INFANRIX) • Page 356
DTAP • DTAP (INFANRIX) • Page 357
DTAP • DTAP (INFANRIX) • Page 358
DTAP • DTAP (INFANRIX) • Page 359
DTAP • DTAP (INFANRIX) • Page 360
DTAP • DTAP (INFANRIX) • Page 361
DTAP • DTAP (INFANRIX) • Page 362
DTAP • DTAP (INFANRIX) • Page 363
DTAP • DTAP (INFANRIX) • Page 364
DTAP • DTAP (INFANRIX) • Page 351
DTAP • DTAP (INFANRIX) • Page 352
DTAP • DTAP (INFANRIX) • Page 353
DTAP • DTAP (NO BRAND NAME) • Page 364
DTAP • DTAP (NO BRAND NAME) • Page 365
DTAP • DTAP (NO BRAND NAME) • Page 366
DTAP • DTAP (NO BRAND NAME) • Page 367
DTAP • DTAP (NO BRAND NAME) • Page 364
DTAP • DTAP (TRIPEDIA) • Page 369
DTAP • DTAP (TRIPEDIA) • Page 370
DTAP • DTAP (TRIPEDIA) • Page 371
DTAP • DTAP (TRIPEDIA) • Page 372
DTAP • DTAP (TRIPEDIA) • Page 373
DTAP • DTAP (TRIPEDIA) • Page 374
DTAP • DTAP (TRIPEDIA) • Page 375
DTAP • DTAP (TRIPEDIA) • Page 367
DTAP • DTAP (TRIPEDIA) • Page 368
DTAP • DTAP (TRIPEDIA) • Page 369
DTAPH • DTAP+HIB (NO BRAND NAME) • Page 375
DTAPH • DTAP+HIB (NO BRAND NAME) • Page 375
DTAPH • DTAP+HIB (TRIHIBIT) • Page 375
DTAPH • DTAP+HIB (TRIHIBIT) • Page 375
DTAPHEPBIP • DTAP+HEPB+IPV (INFANRIX PENTA) • Page 375
DTAPHEPBIP • DTAP+HEPB+IPV (INFANRIX PENTA) • Page 375
DTAPHEPBIP • DTAP+HEPB+IPV (NO BRAND NAME) • Page 376
DTAPHEPBIP • DTAP+HEPB+IPV (NO BRAND NAME) • Page 375
DTAPHEPBIP • DTAP+HEPB+IPV (NO BRAND NAME) • Page 376
DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Page 377
DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Page 378
DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Page 379
DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Page 380
DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Page 381
DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Page 382
DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Page 376
DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Page 377
DTAPIPV • DTAP+IPV (INFANRIX TETRA) • Page 382
DTAPIPV • DTAP+IPV (INFANRIX TETRA) • Page 383
DTAPIPV • DTAP+IPV (INFANRIX TETRA) • Page 382
DTAPIPV • DTAP+IPV (KINRIX) • Page 383
DTAPIPV • DTAP+IPV (KINRIX) • Page 384
DTAPIPV • DTAP+IPV (KINRIX) • Page 385
DTAPIPV • DTAP+IPV (KINRIX) • Page 386
DTAPIPV • DTAP+IPV (KINRIX) • Page 383
DTAPIPV • DTAP+IPV (QUADRACEL) • Page 386
DTAPIPV • DTAP+IPV (QUADRACEL) • Page 387
DTAPIPV • DTAP+IPV (QUADRACEL) • Page 386
DTAPIPV • DTAP+IPV (UNKNOWN) • Page 387
DTAPIPV • DTAP+IPV (UNKNOWN) • Page 388
DTAPIPV • DTAP+IPV (UNKNOWN) • Page 387
DTAPIPVHIB • DTAP+IPV+HIB (INFANRIX QUINTA) • Page 388
DTAPIPVHIB • DTAP+IPV+HIB (INFANRIX QUINTA) • Page 389
DTAPIPVHIB • DTAP+IPV+HIB (INFANRIX QUINTA) • Page 388
DTAPIPVHIB • DTAP+IPV+HIB (NO BRAND NAME) • Page 389
DTAPIPVHIB • DTAP+IPV+HIB (NO BRAND NAME) • Page 389
DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Page 390
DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Page 391
DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Page 392
DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Page 393
DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Page 394
DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Page 389
DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Page 390
DTAPIPVHIB • DTAP+IPV+HIB (UNKNOWN) • Page 394
DTAPIPVHIB • DTAP+IPV+HIB (UNKNOWN) • Page 394
DTIPV • DT+IPV (FOREIGN) • Page 394
DTIPV • DT+IPV (FOREIGN) • Page 394
DTIPV • DT+IPV (NO BRAND NAME) • Page 394
DTIPV • DT+IPV (NO BRAND NAME) • Page 395
DTIPV • DT+IPV (NO BRAND NAME) • Page 394
DTOX • DIPHTHERIA TOXOIDS (NO BRAND NAME) • Page 395
DTOX • DIPHTHERIA TOXOIDS (NO BRAND NAME) • Page 395
DTP • DTP (NO BRAND NAME) • Page 396
DTP • DTP (NO BRAND NAME) • Page 397
DTP • DTP (NO BRAND NAME) • Page 398
DTP • DTP (NO BRAND NAME) • Page 399
DTP • DTP (NO BRAND NAME) • Page 400
DTP • DTP (NO BRAND NAME) • Page 401
DTP • DTP (NO BRAND NAME) • Page 402
DTP • DTP (NO BRAND NAME) • Page 403
DTP • DTP (NO BRAND NAME) • Page 404
DTP • DTP (NO BRAND NAME) • Page 395
DTP • DTP (NO BRAND NAME) • Page 396
DTP • DTP (TRI-IMMUNOL) • Page 405
DTP • DTP (TRI-IMMUNOL) • Page 406
DTP • DTP (TRI-IMMUNOL) • Page 407
DTP • DTP (TRI-IMMUNOL) • Page 408
DTP • DTP (TRI-IMMUNOL) • Page 409
DTP • DTP (TRI-IMMUNOL) • Page 404
DTP • DTP (TRI-IMMUNOL) • Page 405
DTP • TD+PERTUSSIS (NO BRAND NAME) • Page 409
DTP • TD+PERTUSSIS (NO BRAND NAME) • Page 409
DTPHEP • DTP+HEP B (NO BRAND NAME) • Page 409
DTPHEP • DTP+HEP B (NO BRAND NAME) • Page 409
DTPHEP • DTP+HEP B (TRITANRIX) • Page 409
DTPHEP • DTP+HEP B (TRITANRIX) • Page 409
DTPHIB • DTP+HIB (DTP+ACTHIB) • Page 409
DTPHIB • DTP+HIB (DTP+ACTHIB) • Page 409
DTPHIB • DTP+HIB (NO BRAND NAME) • Page 409
DTPHIB • DTP+HIB (NO BRAND NAME) • Page 409
DTPHIB • DTP+HIB (TETRAMUNE) • Page 410
DTPHIB • DTP+HIB (TETRAMUNE) • Page 411
DTPHIB • DTP+HIB (TETRAMUNE) • Page 412
DTPHIB • DTP+HIB (TETRAMUNE) • Page 413
DTPHIB • DTP+HIB (TETRAMUNE) • Page 409
DTPHIB • DTP+HIB (TETRAMUNE) • Page 410
DTPIHI • DT+IPV+HIB+HEPB (NO BRAND NAME) • Page 413
DTPIHI • DT+IPV+HIB+HEPB (NO BRAND NAME) • Page 413
DTPIPV • DTP+IPV (NO BRAND NAME) • Page 413
DTPIPV • DTP+IPV (NO BRAND NAME) • Page 413
DTPPHIB • DTP+IPV+ACT-HIB (NO BRAND NAME) • Page 413
DTPPHIB • DTP+IPV+ACT-HIB (NO BRAND NAME) • Page 413
EBZR • EBOLA ZAIRE (ERVEBO) • Page 413
EBZR • EBOLA ZAIRE (ERVEBO) • Page 413
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) • Page 413
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) • Page 414
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) • Page 413
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) • Page 414
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (GSK)) • Page 414
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) • Page 414
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) • Page 415
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) • Page 416
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) • Page 414
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) • Page 416
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) • Page 417
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) • Page 418
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) • Page 419
FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) • Page 416
FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Page 420
FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Page 421
FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Page 422
FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Page 423
FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Page 419
FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Page 420
FLU3 • INFLUENZA (SEASONAL) (AGRIFLU) • Page 423
FLU3 • INFLUENZA (SEASONAL) (AGRIFLU) • Page 423
FLU3 • INFLUENZA (SEASONAL) (ENZIRA) • Page 423
FLU3 • INFLUENZA (SEASONAL) (ENZIRA) • Page 423
FLU3 • INFLUENZA (SEASONAL) (FLU-IMUNE) • Page 423
FLU3 • INFLUENZA (SEASONAL) (FLU-IMUNE) • Page 424
FLU3 • INFLUENZA (SEASONAL) (FLU-IMUNE) • Page 423
FLU3 • INFLUENZA (SEASONAL) (FLUARIX) • Page 424
FLU3 • INFLUENZA (SEASONAL) (FLUARIX) • Page 425
FLU3 • INFLUENZA (SEASONAL) (FLUARIX) • Page 426
FLU3 • INFLUENZA (SEASONAL) (FLUARIX) • Page 427
FLU3 • INFLUENZA (SEASONAL) (FLUARIX) • Page 424
FLU3 • INFLUENZA (SEASONAL) (FLULAVAL) • Page 428
FLU3 • INFLUENZA (SEASONAL) (FLULAVAL) • Page 429
FLU3 • INFLUENZA (SEASONAL) (FLULAVAL) • Page 427
FLU3 • INFLUENZA (SEASONAL) (FLULAVAL) • Page 428
FLU3 • INFLUENZA (SEASONAL) (FLUOGEN) • Page 429
FLU3 • INFLUENZA (SEASONAL) (FLUOGEN) • Page 430
FLU3 • INFLUENZA (SEASONAL) (FLUOGEN) • Page 429
FLU3 • INFLUENZA (SEASONAL) (FLUSHIELD) • Page 431
FLU3 • INFLUENZA (SEASONAL) (FLUSHIELD) • Page 432
FLU3 • INFLUENZA (SEASONAL) (FLUSHIELD) • Page 433
FLU3 • INFLUENZA (SEASONAL) (FLUSHIELD) • Page 430
FLU3 • INFLUENZA (SEASONAL) (FLUSHIELD) • Page 431
FLU3 • INFLUENZA (SEASONAL) (FLUVAX) • Page 433
FLU3 • INFLUENZA (SEASONAL) (FLUVAX) • Page 433
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 435
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 436
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 437
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 438
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 439
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 440
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 441
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 442
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 433
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 434
FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Page 435
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 444
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 445
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 446
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 447
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 448
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 449
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 450
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 451
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 442
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 443
FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Page 444
FLU3 • INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL) • Page 452
FLU3 • INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL) • Page 451
FLU3 • INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL) • Page 452
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 456
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 457
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 458
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 459
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 460
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 461
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 462
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 463
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 464
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 465
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 466
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 467
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 468
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 469
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 470
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 471
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 472
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 473
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 474
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 452
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 453
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 454
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 455
FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Page 456
FLU3 • INFLUENZA (SEASONAL) (NILGRIP) • Page 474
FLU3 • INFLUENZA (SEASONAL) (NILGRIP) • Page 474
FLU3 • INFLUENZA (SEASONAL) (TIV DRESDEN) • Page 474
FLU3 • INFLUENZA (SEASONAL) (TIV DRESDEN) • Page 475
FLU3 • INFLUENZA (SEASONAL) (TIV DRESDEN) • Page 474
FLU3 • INFLUENZA (SEASONAL) (TIV QUEBEC) • Page 475
FLU3 • INFLUENZA (SEASONAL) (TIV QUEBEC) • Page 475
FLU4 • INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) • Page 475
FLU4 • INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) • Page 476
FLU4 • INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) • Page 477
FLU4 • INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) • Page 475
FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Page 478
FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Page 479
FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Page 480
FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Page 481
FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Page 482
FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Page 477
FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Page 478
FLU4 • INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) • Page 482
FLU4 • INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) • Page 483
FLU4 • INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) • Page 484
FLU4 • INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) • Page 482
FLU4 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) • Page 484
FLU4 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) • Page 485
FLU4 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) • Page 484
FLU4 • INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL QUADRIVALENT) • Page 485
FLU4 • INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL QUADRIVALENT) • Page 485
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 486
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 487
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 488
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 489
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 490
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 491
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 492
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 485
FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Page 486
FLU4 • INFLUENZA (SEASONAL) (QIV DRESDEN) • Page 492
FLU4 • INFLUENZA (SEASONAL) (QIV DRESDEN) • Page 492
FLU4 • INFLUENZA (SEASONAL) (QIV QUEBEC) • Page 492
FLU4 • INFLUENZA (SEASONAL) (QIV QUEBEC) • Page 492
FLUA3 • INFLUENZA (SEASONAL) (CHIROMAS) • Page 492
FLUA3 • INFLUENZA (SEASONAL) (CHIROMAS) • Page 493
FLUA3 • INFLUENZA (SEASONAL) (CHIROMAS) • Page 492
FLUA3 • INFLUENZA (SEASONAL) (FLUAD) • Page 493
FLUA3 • INFLUENZA (SEASONAL) (FLUAD) • Page 494
FLUA3 • INFLUENZA (SEASONAL) (FLUAD) • Page 493
FLUA4 • INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) • Page 494
FLUA4 • INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) • Page 495
FLUA4 • INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) • Page 494
FLUC3 • INFLUENZA (SEASONAL) (FLUCELVAX) • Page 495
FLUC3 • INFLUENZA (SEASONAL) (FLUCELVAX) • Page 495
FLUC3 • INFLUENZA (SEASONAL) (OPTAFLU) • Page 495
FLUC3 • INFLUENZA (SEASONAL) (OPTAFLU) • Page 495
FLUC4 • INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) • Page 496
FLUC4 • INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) • Page 497
FLUC4 • INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) • Page 495
FLUC4 • INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) • Page 496
FLUN(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) • Page 498
FLUN(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) • Page 499
FLUN(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) • Page 497
FLUN(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) • Page 498
FLUN3 • INFLUENZA (SEASONAL) (FLUENZ) • Page 499
FLUN3 • INFLUENZA (SEASONAL) (FLUENZ) • Page 499
FLUN3 • INFLUENZA (SEASONAL) (FLUMIST) • Page 500
FLUN3 • INFLUENZA (SEASONAL) (FLUMIST) • Page 501
FLUN3 • INFLUENZA (SEASONAL) (FLUMIST) • Page 502
FLUN3 • INFLUENZA (SEASONAL) (FLUMIST) • Page 499
FLUN3 • INFLUENZA (SEASONAL) (FLUMIST) • Page 500
FLUN4 • INFLUENZA (SEASONAL) (FLUENZ TETRA) • Page 502
FLUN4 • INFLUENZA (SEASONAL) (FLUENZ TETRA) • Page 503
FLUN4 • INFLUENZA (SEASONAL) (FLUENZ TETRA) • Page 502
FLUN4 • INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) • Page 503
FLUN4 • INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) • Page 504
FLUN4 • INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) • Page 503
FLUR3 • INFLUENZA (SEASONAL) (FLUBLOK) • Page 504
FLUR3 • INFLUENZA (SEASONAL) (FLUBLOK) • Page 504
FLUR4 • INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) • Page 504
FLUR4 • INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) • Page 505
FLUR4 • INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) • Page 504
FLUX • INFLUENZA (SEASONAL) (FOREIGN) • Page 505
FLUX • INFLUENZA (SEASONAL) (FOREIGN) • Page 506
FLUX • INFLUENZA (SEASONAL) (FOREIGN) • Page 505
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 509
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 510
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 511
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 512
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 513
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 514
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 515
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 516
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 517
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 518
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 519
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 520
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 521
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 522
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 523
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 506
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 507
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 508
FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Page 509
FLUX(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) • Page 523
FLUX(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) • Page 524
FLUX(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) • Page 523
H5N1 • INFLUENZA (SEASONAL) (PANDEMIC FLU VACCINE (H5N1)) • Page 524
H5N1 • INFLUENZA (SEASONAL) (PANDEMIC FLU VACCINE (H5N1)) • Page 524
HBHEPB • HIB+HEP B (COMVAX) • Page 525
HBHEPB • HIB+HEP B (COMVAX) • Page 526
HBHEPB • HIB+HEP B (COMVAX) • Page 527
HBHEPB • HIB+HEP B (COMVAX) • Page 524
HBHEPB • HIB+HEP B (COMVAX) • Page 525
HBHEPB • HIB+HEP B (NO BRAND NAME) • Page 527
HBHEPB • HIB+HEP B (NO BRAND NAME) • Page 527
HBPV • HIB POLYSACCHARIDE (HIBIMUNE) • Page 528
HBPV • HIB POLYSACCHARIDE (HIBIMUNE) • Page 527
HBPV • HIB POLYSACCHARIDE (HIBIMUNE) • Page 528
HBPV • HIB POLYSACCHARIDE (NO BRAND NAME) • Page 528
HBPV • HIB POLYSACCHARIDE (NO BRAND NAME) • Page 528
HEP • HEP B (ENGERIX-B) • Page 531
HEP • HEP B (ENGERIX-B) • Page 532
HEP • HEP B (ENGERIX-B) • Page 533
HEP • HEP B (ENGERIX-B) • Page 534
HEP • HEP B (ENGERIX-B) • Page 535
HEP • HEP B (ENGERIX-B) • Page 536
HEP • HEP B (ENGERIX-B) • Page 537
HEP • HEP B (ENGERIX-B) • Page 538
HEP • HEP B (ENGERIX-B) • Page 539
HEP • HEP B (ENGERIX-B) • Page 540
HEP • HEP B (ENGERIX-B) • Page 541
HEP • HEP B (ENGERIX-B) • Page 542
HEP • HEP B (ENGERIX-B) • Page 543
HEP • HEP B (ENGERIX-B) • Page 544
HEP • HEP B (ENGERIX-B) • Page 545
HEP • HEP B (ENGERIX-B) • Page 546
HEP • HEP B (ENGERIX-B) • Page 547
HEP • HEP B (ENGERIX-B) • Page 528
HEP • HEP B (ENGERIX-B) • Page 529
HEP • HEP B (ENGERIX-B) • Page 530
HEP • HEP B (ENGERIX-B) • Page 531
HEP • HEP B (FOREIGN) • Page 547
HEP • HEP B (FOREIGN) • Page 548
HEP • HEP B (FOREIGN) • Page 547
HEP • HEP B (GENHEVAC B) • Page 548
HEP • HEP B (GENHEVAC B) • Page 548
HEP • HEP B (HEPLISAV-B) • Page 548
HEP • HEP B (HEPLISAV-B) • Page 548
HEP • HEP B (NO BRAND NAME) • Page 549
HEP • HEP B (NO BRAND NAME) • Page 550
HEP • HEP B (NO BRAND NAME) • Page 551
HEP • HEP B (NO BRAND NAME) • Page 552
HEP • HEP B (NO BRAND NAME) • Page 553
HEP • HEP B (NO BRAND NAME) • Page 548
HEP • HEP B (NO BRAND NAME) • Page 549
HEP • HEP B (RECOMBIVAX HB) • Page 556
HEP • HEP B (RECOMBIVAX HB) • Page 557
HEP • HEP B (RECOMBIVAX HB) • Page 558
HEP • HEP B (RECOMBIVAX HB) • Page 559
HEP • HEP B (RECOMBIVAX HB) • Page 560
HEP • HEP B (RECOMBIVAX HB) • Page 561
HEP • HEP B (RECOMBIVAX HB) • Page 562
HEP • HEP B (RECOMBIVAX HB) • Page 563
HEP • HEP B (RECOMBIVAX HB) • Page 564
HEP • HEP B (RECOMBIVAX HB) • Page 565
HEP • HEP B (RECOMBIVAX HB) • Page 566
HEP • HEP B (RECOMBIVAX HB) • Page 567
HEP • HEP B (RECOMBIVAX HB) • Page 553
HEP • HEP B (RECOMBIVAX HB) • Page 554
HEP • HEP B (RECOMBIVAX HB) • Page 555
HEP • HEP B (RECOMBIVAX HB) • Page 556
HEPA • HEP A (HAVRIX) • Page 569
HEPA • HEP A (HAVRIX) • Page 570
HEPA • HEP A (HAVRIX) • Page 571
HEPA • HEP A (HAVRIX) • Page 572
HEPA • HEP A (HAVRIX) • Page 573
HEPA • HEP A (HAVRIX) • Page 574
HEPA • HEP A (HAVRIX) • Page 575
HEPA • HEP A (HAVRIX) • Page 576
HEPA • HEP A (HAVRIX) • Page 577
HEPA • HEP A (HAVRIX) • Page 578
HEPA • HEP A (HAVRIX) • Page 579
HEPA • HEP A (HAVRIX) • Page 567
HEPA • HEP A (HAVRIX) • Page 568
HEPA • HEP A (HAVRIX) • Page 569
HEPA • HEP A (NO BRAND NAME) • Page 579
HEPA • HEP A (NO BRAND NAME) • Page 580
HEPA • HEP A (NO BRAND NAME) • Page 581
HEPA • HEP A (NO BRAND NAME) • Page 579
HEPA • HEP A (VAQTA) • Page 583
HEPA • HEP A (VAQTA) • Page 584
HEPA • HEP A (VAQTA) • Page 585
HEPA • HEP A (VAQTA) • Page 586
HEPA • HEP A (VAQTA) • Page 587
HEPA • HEP A (VAQTA) • Page 588
HEPA • HEP A (VAQTA) • Page 581
HEPA • HEP A (VAQTA) • Page 582
HEPA • HEP A (VAQTA) • Page 583
HEPAB • HEP A+HEP B (NO BRAND NAME) • Page 588
HEPAB • HEP A+HEP B (NO BRAND NAME) • Page 588
HEPAB • HEP A+HEP B (TWINRIX) • Page 589
HEPAB • HEP A+HEP B (TWINRIX) • Page 590
HEPAB • HEP A+HEP B (TWINRIX) • Page 591
HEPAB • HEP A+HEP B (TWINRIX) • Page 592
HEPAB • HEP A+HEP B (TWINRIX) • Page 588
HEPAB • HEP A+HEP B (TWINRIX) • Page 589
HEPATYP • HEP A+TYP (HEPATYRIX) • Page 592
HEPATYP • HEP A+TYP (HEPATYRIX) • Page 592
HIBV • HIB (ACTHIB) • Page 594
HIBV • HIB (ACTHIB) • Page 595
HIBV • HIB (ACTHIB) • Page 596
HIBV • HIB (ACTHIB) • Page 597
HIBV • HIB (ACTHIB) • Page 598
HIBV • HIB (ACTHIB) • Page 599
HIBV • HIB (ACTHIB) • Page 600
HIBV • HIB (ACTHIB) • Page 601
HIBV • HIB (ACTHIB) • Page 602
HIBV • HIB (ACTHIB) • Page 603
HIBV • HIB (ACTHIB) • Page 604
HIBV • HIB (ACTHIB) • Page 605
HIBV • HIB (ACTHIB) • Page 592
HIBV • HIB (ACTHIB) • Page 593
HIBV • HIB (ACTHIB) • Page 594
HIBV • HIB (HIBERIX) • Page 605
HIBV • HIB (HIBERIX) • Page 606
HIBV • HIB (HIBERIX) • Page 605
HIBV • HIB (HIBTITER) • Page 608
HIBV • HIB (HIBTITER) • Page 609
HIBV • HIB (HIBTITER) • Page 610
HIBV • HIB (HIBTITER) • Page 611
HIBV • HIB (HIBTITER) • Page 612
HIBV • HIB (HIBTITER) • Page 613
HIBV • HIB (HIBTITER) • Page 614
HIBV • HIB (HIBTITER) • Page 606
HIBV • HIB (HIBTITER) • Page 607
HIBV • HIB (HIBTITER) • Page 608
HIBV • HIB (NO BRAND NAME) • Page 615
HIBV • HIB (NO BRAND NAME) • Page 616
HIBV • HIB (NO BRAND NAME) • Page 617
HIBV • HIB (NO BRAND NAME) • Page 614
HIBV • HIB (NO BRAND NAME) • Page 615
HIBV • HIB (OMNIHIB) • Page 617
HIBV • HIB (OMNIHIB) • Page 618
HIBV • HIB (OMNIHIB) • Page 617
HIBV • HIB (PEDVAXHIB) • Page 619
HIBV • HIB (PEDVAXHIB) • Page 620
HIBV • HIB (PEDVAXHIB) • Page 621
HIBV • HIB (PEDVAXHIB) • Page 622
HIBV • HIB (PEDVAXHIB) • Page 623
HIBV • HIB (PEDVAXHIB) • Page 624
HIBV • HIB (PEDVAXHIB) • Page 618
HIBV • HIB (PEDVAXHIB) • Page 619
HIBV • HIB (PROHIBIT) • Page 624
HIBV • HIB (PROHIBIT) • Page 625
HIBV • HIB (PROHIBIT) • Page 624
HIBV • HIB (TETRACOQ) • Page 625
HIBV • HIB (TETRACOQ) • Page 625
HIBV • HIB POLYSACCHARIDE (FOREIGN) • Page 625
HIBV • HIB POLYSACCHARIDE (FOREIGN) • Page 625
HPV2 • HPV (CERVARIX) • Page 625
HPV2 • HPV (CERVARIX) • Page 626
HPV2 • HPV (CERVARIX) • Page 627
HPV2 • HPV (CERVARIX) • Page 628
HPV2 • HPV (CERVARIX) • Page 629
HPV2 • HPV (CERVARIX) • Page 625
HPV4 • HPV (GARDASIL) • Page 633
HPV4 • HPV (GARDASIL) • Page 634
HPV4 • HPV (GARDASIL) • Page 635
HPV4 • HPV (GARDASIL) • Page 636
HPV4 • HPV (GARDASIL) • Page 637
HPV4 • HPV (GARDASIL) • Page 638
HPV4 • HPV (GARDASIL) • Page 639
HPV4 • HPV (GARDASIL) • Page 640
HPV4 • HPV (GARDASIL) • Page 641
HPV4 • HPV (GARDASIL) • Page 642
HPV4 • HPV (GARDASIL) • Page 643
HPV4 • HPV (GARDASIL) • Page 644
HPV4 • HPV (GARDASIL) • Page 645
HPV4 • HPV (GARDASIL) • Page 646
HPV4 • HPV (GARDASIL) • Page 647
HPV4 • HPV (GARDASIL) • Page 648
HPV4 • HPV (GARDASIL) • Page 649
HPV4 • HPV (GARDASIL) • Page 650
HPV4 • HPV (GARDASIL) • Page 651
HPV4 • HPV (GARDASIL) • Page 652
HPV4 • HPV (GARDASIL) • Page 653
HPV4 • HPV (GARDASIL) • Page 654
HPV4 • HPV (GARDASIL) • Page 655
HPV4 • HPV (GARDASIL) • Page 656
HPV4 • HPV (GARDASIL) • Page 629
HPV4 • HPV (GARDASIL) • Page 630
HPV4 • HPV (GARDASIL) • Page 631
HPV4 • HPV (GARDASIL) • Page 632
HPV4 • HPV (GARDASIL) • Page 633
HPV9 • HPV (GARDASIL 9) • Page 658
HPV9 • HPV (GARDASIL 9) • Page 659
HPV9 • HPV (GARDASIL 9) • Page 660
HPV9 • HPV (GARDASIL 9) • Page 661
HPV9 • HPV (GARDASIL 9) • Page 662
HPV9 • HPV (GARDASIL 9) • Page 663
HPV9 • HPV (GARDASIL 9) • Page 656
HPV9 • HPV (GARDASIL 9) • Page 657
HPV9 • HPV (GARDASIL 9) • Page 658
HPVX • HPV (NO BRAND NAME) • Page 663
HPVX • HPV (NO BRAND NAME) • Page 664
HPVX • HPV (NO BRAND NAME) • Page 665
HPVX • HPV (NO BRAND NAME) • Page 663
IPV • POLIO VIRUS, INACT. (IPOL) • Page 667
IPV • POLIO VIRUS, INACT. (IPOL) • Page 668
IPV • POLIO VIRUS, INACT. (IPOL) • Page 669
IPV • POLIO VIRUS, INACT. (IPOL) • Page 670
IPV • POLIO VIRUS, INACT. (IPOL) • Page 671
IPV • POLIO VIRUS, INACT. (IPOL) • Page 672
IPV • POLIO VIRUS, INACT. (IPOL) • Page 673
IPV • POLIO VIRUS, INACT. (IPOL) • Page 674
IPV • POLIO VIRUS, INACT. (IPOL) • Page 675
IPV • POLIO VIRUS, INACT. (IPOL) • Page 676
IPV • POLIO VIRUS, INACT. (IPOL) • Page 677
IPV • POLIO VIRUS, INACT. (IPOL) • Page 678
IPV • POLIO VIRUS, INACT. (IPOL) • Page 665
IPV • POLIO VIRUS, INACT. (IPOL) • Page 666
IPV • POLIO VIRUS, INACT. (IPOL) • Page 667
IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Page 679
IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Page 680
IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Page 681
IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Page 682
IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Page 683
IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Page 678
IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Page 679
IPV • POLIO VIRUS, INACT. (POLIOVAX) • Page 684
IPV • POLIO VIRUS, INACT. (POLIOVAX) • Page 685
IPV • POLIO VIRUS, INACT. (POLIOVAX) • Page 686
IPV • POLIO VIRUS, INACT. (POLIOVAX) • Page 687
IPV • POLIO VIRUS, INACT. (POLIOVAX) • Page 688
IPV • POLIO VIRUS, INACT. (POLIOVAX) • Page 689
IPV • POLIO VIRUS, INACT. (POLIOVAX) • Page 683
IPV • POLIO VIRUS, INACT. (POLIOVAX) • Page 684
JEV • JAPANESE ENCEPHALITIS (J-VAX) • Page 689
JEV • JAPANESE ENCEPHALITIS (J-VAX) • Page 689
JEV • JAPANESE ENCEPHALITIS (JE-VAX) • Page 689
JEV • JAPANESE ENCEPHALITIS (JE-VAX) • Page 689
JEV1 • JAPANESE ENCEPHALITIS (IXIARO) • Page 689
JEV1 • JAPANESE ENCEPHALITIS (IXIARO) • Page 690
JEV1 • JAPANESE ENCEPHALITIS (IXIARO) • Page 689
JEVX • JAPANESE ENCEPHALITIS (NO BRAND NAME) • Page 690
JEVX • JAPANESE ENCEPHALITIS (NO BRAND NAME) • Page 690
LYME • LYME (LYMERIX) • Page 690
LYME • LYME (LYMERIX) • Page 691
LYME • LYME (LYMERIX) • Page 690
LYME • LYME (NO BRAND NAME) • Page 691
LYME • LYME (NO BRAND NAME) • Page 691
MEA • MEASLES (ATTENUVAX) • Page 692
MEA • MEASLES (ATTENUVAX) • Page 691
MEA • MEASLES (ATTENUVAX) • Page 692
MEA • MEASLES (FOREIGN) • Page 692
MEA • MEASLES (FOREIGN) • Page 692
MEA • MEASLES (MORATEN) • Page 692
MEA • MEASLES (MORATEN) • Page 692
MEA • MEASLES (NO BRAND NAME) • Page 692
MEA • MEASLES (NO BRAND NAME) • Page 692
MEN • MENINGOCOCCAL (MENOMUNE) • Page 692
MEN • MENINGOCOCCAL (MENOMUNE) • Page 693
MEN • MENINGOCOCCAL (MENOMUNE) • Page 692
MEN • MENINGOCOCCAL (MENOMUNE-A-C) • Page 693
MEN • MENINGOCOCCAL (MENOMUNE-A-C) • Page 693
MEN • MENINGOCOCCAL (NO BRAND NAME) • Page 693
MEN • MENINGOCOCCAL (NO BRAND NAME) • Page 694
MEN • MENINGOCOCCAL (NO BRAND NAME) • Page 695
MEN • MENINGOCOCCAL (NO BRAND NAME) • Page 693
MENB • MENINGOCOCCAL B (BEXSERO) • Page 696
MENB • MENINGOCOCCAL B (BEXSERO) • Page 697
MENB • MENINGOCOCCAL B (BEXSERO) • Page 698
MENB • MENINGOCOCCAL B (BEXSERO) • Page 699
MENB • MENINGOCOCCAL B (BEXSERO) • Page 695
MENB • MENINGOCOCCAL B (BEXSERO) • Page 696
MENB • MENINGOCOCCAL B (TRUMENBA) • Page 700
MENB • MENINGOCOCCAL B (TRUMENBA) • Page 701
MENB • MENINGOCOCCAL B (TRUMENBA) • Page 699
MENB • MENINGOCOCCAL B (TRUMENBA) • Page 700
MENHIB • MENINGOCOCCAL CONJUGATE+HIB (MENITORIX) • Page 701
MENHIB • MENINGOCOCCAL CONJUGATE+HIB (MENITORIX) • Page 701
MENHIB • MENINGOCOCCAL CONJUGATE+HIB (UNKNOWN) • Page 701
MENHIB • MENINGOCOCCAL CONJUGATE+HIB (UNKNOWN) • Page 701
MER • MEASLES+RUBELLA (MR-VAX II) • Page 701
MER • MEASLES+RUBELLA (MR-VAX II) • Page 701
MER • MEASLES+RUBELLA (NO BRAND NAME) • Page 701
MER • MEASLES+RUBELLA (NO BRAND NAME) • Page 701
MM • MEASLES+MUMPS (MM-VAX) • Page 701
MM • MEASLES+MUMPS (MM-VAX) • Page 701
MM • MEASLES+MUMPS (NO BRAND NAME) • Page 701
MM • MEASLES+MUMPS (NO BRAND NAME) • Page 701
MMR • MEASLES+MUMPS+RUBELLA (MMR I) • Page 702
MMR • MEASLES+MUMPS+RUBELLA (MMR I) • Page 701
MMR • MEASLES+MUMPS+RUBELLA (MMR I) • Page 702
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 709
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 710
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 711
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 712
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 713
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 714
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 715
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 716
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 717
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 718
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 719
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 720
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 721
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 722
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 723
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 724
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 725
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 726
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 727
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 728
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 729
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 730
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 731
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 732
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 733
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 734
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 735
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 736
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 737
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 738
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 739
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 740
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 741
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 742
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 702
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 703
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 704
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 705
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 706
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 707
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 708
MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Page 709
MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Page 743
MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Page 744
MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Page 745
MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Page 746
MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Page 742
MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Page 743
MMR • MEASLES+MUMPS+RUBELLA (PRIORIX) • Page 746
MMR • MEASLES+MUMPS+RUBELLA (PRIORIX) • Page 747
MMR • MEASLES+MUMPS+RUBELLA (PRIORIX) • Page 746
MMR • MEASLES+MUMPS+RUBELLA (VIRIVAC) • Page 747
MMR • MEASLES+MUMPS+RUBELLA (VIRIVAC) • Page 748
MMR • MEASLES+MUMPS+RUBELLA (VIRIVAC) • Page 747
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (NO BRAND NAME) • Page 748
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (NO BRAND NAME) • Page 748
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 750
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 751
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 752
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 753
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 754
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 755
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 748
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 749
MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Page 750
MNC • MENINGOCOCCAL (MENINGITEC) • Page 755
MNC • MENINGOCOCCAL (MENINGITEC) • Page 755
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 757
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 758
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 759
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 760
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 761
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 762
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 763
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 764
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 765
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 766
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 755
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 756
MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Page 757
MNQ • MENINGOCOCCAL CONJUGATE (MENVEO) • Page 766
MNQ • MENINGOCOCCAL CONJUGATE (MENVEO) • Page 767
MNQ • MENINGOCOCCAL CONJUGATE (MENVEO) • Page 768
MNQ • MENINGOCOCCAL CONJUGATE (MENVEO) • Page 769
MNQ • MENINGOCOCCAL CONJUGATE (MENVEO) • Page 766
MNQ • MENINGOCOCCAL CONJUGATE (NO BRAND NAME) • Page 769
MNQ • MENINGOCOCCAL CONJUGATE (NO BRAND NAME) • Page 769
MNQHIB • MENINGOCOCCAL C & Y+HIB (MENHIBRIX) • Page 769
MNQHIB • MENINGOCOCCAL C & Y+HIB (MENHIBRIX) • Page 769
MU • MUMPS (MUMPSVAX I) • Page 769
MU • MUMPS (MUMPSVAX I) • Page 769
MU • MUMPS (MUMPSVAX II) • Page 769
MU • MUMPS (MUMPSVAX II) • Page 769
MU • MUMPS (NO BRAND NAME) • Page 769
MU • MUMPS (NO BRAND NAME) • Page 769
MUR • MUMPS+RUBELLA (FOREIGN) • Page 769
MUR • MUMPS+RUBELLA (FOREIGN) • Page 769
MUR • MUMPS+RUBELLA (NO BRAND NAME) • Page 769
MUR • MUMPS+RUBELLA (NO BRAND NAME) • Page 769
OPV • POLIO VIRUS, ORAL (NO BRAND NAME) • Page 770
OPV • POLIO VIRUS, ORAL (NO BRAND NAME) • Page 771
OPV • POLIO VIRUS, ORAL (NO BRAND NAME) • Page 769
OPV • POLIO VIRUS, ORAL (NO BRAND NAME) • Page 770
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 773
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 774
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 775
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 776
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 777
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 778
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 779
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 780
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 781
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 782
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 783
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 784
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 771
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 772
OPV • POLIO VIRUS, ORAL (ORIMUNE) • Page 773
PER • PERTUSSIS (NO BRAND NAME) • Page 784
PER • PERTUSSIS (NO BRAND NAME) • Page 784
PLAGUE • PLAGUE (NO BRAND NAME) • Page 784
PLAGUE • PLAGUE (NO BRAND NAME) • Page 784
PLAGUE • PLAGUE (USP) • Page 784
PLAGUE • PLAGUE (USP) • Page 784
PNC • PNEUMO (PREVNAR) • Page 787
PNC • PNEUMO (PREVNAR) • Page 788
PNC • PNEUMO (PREVNAR) • Page 789
PNC • PNEUMO (PREVNAR) • Page 790
PNC • PNEUMO (PREVNAR) • Page 791
PNC • PNEUMO (PREVNAR) • Page 792
PNC • PNEUMO (PREVNAR) • Page 793
PNC • PNEUMO (PREVNAR) • Page 794
PNC • PNEUMO (PREVNAR) • Page 795
PNC • PNEUMO (PREVNAR) • Page 796
PNC • PNEUMO (PREVNAR) • Page 797
PNC • PNEUMO (PREVNAR) • Page 798
PNC • PNEUMO (PREVNAR) • Page 799
PNC • PNEUMO (PREVNAR) • Page 800
PNC • PNEUMO (PREVNAR) • Page 784
PNC • PNEUMO (PREVNAR) • Page 785
PNC • PNEUMO (PREVNAR) • Page 786
PNC • PNEUMO (PREVNAR) • Page 787
PNC10 • PNEUMO (SYNFLORIX) • Page 800
PNC10 • PNEUMO (SYNFLORIX) • Page 801
PNC10 • PNEUMO (SYNFLORIX) • Page 800
PNC13 • PNEUMO (PREVNAR13) • Page 805
PNC13 • PNEUMO (PREVNAR13) • Page 806
PNC13 • PNEUMO (PREVNAR13) • Page 807
PNC13 • PNEUMO (PREVNAR13) • Page 808
PNC13 • PNEUMO (PREVNAR13) • Page 809
PNC13 • PNEUMO (PREVNAR13) • Page 810
PNC13 • PNEUMO (PREVNAR13) • Page 811
PNC13 • PNEUMO (PREVNAR13) • Page 812
PNC13 • PNEUMO (PREVNAR13) • Page 813
PNC13 • PNEUMO (PREVNAR13) • Page 814
PNC13 • PNEUMO (PREVNAR13) • Page 815
PNC13 • PNEUMO (PREVNAR13) • Page 816
PNC13 • PNEUMO (PREVNAR13) • Page 817
PNC13 • PNEUMO (PREVNAR13) • Page 818
PNC13 • PNEUMO (PREVNAR13) • Page 819
PNC13 • PNEUMO (PREVNAR13) • Page 820
PNC13 • PNEUMO (PREVNAR13) • Page 821
PNC13 • PNEUMO (PREVNAR13) • Page 822
PNC13 • PNEUMO (PREVNAR13) • Page 823
PNC13 • PNEUMO (PREVNAR13) • Page 824
PNC13 • PNEUMO (PREVNAR13) • Page 801
PNC13 • PNEUMO (PREVNAR13) • Page 802
PNC13 • PNEUMO (PREVNAR13) • Page 803
PNC13 • PNEUMO (PREVNAR13) • Page 804
PNC13 • PNEUMO (PREVNAR13) • Page 805
PPV • PNEUMO (NO BRAND NAME) • Page 825
PPV • PNEUMO (NO BRAND NAME) • Page 826
PPV • PNEUMO (NO BRAND NAME) • Page 827
PPV • PNEUMO (NO BRAND NAME) • Page 828
PPV • PNEUMO (NO BRAND NAME) • Page 824
PPV • PNEUMO (NO BRAND NAME) • Page 825
PPV • PNEUMO (PNEUMOVAX) • Page 834
PPV • PNEUMO (PNEUMOVAX) • Page 835
PPV • PNEUMO (PNEUMOVAX) • Page 836
PPV • PNEUMO (PNEUMOVAX) • Page 837
PPV • PNEUMO (PNEUMOVAX) • Page 838
PPV • PNEUMO (PNEUMOVAX) • Page 839
PPV • PNEUMO (PNEUMOVAX) • Page 840
PPV • PNEUMO (PNEUMOVAX) • Page 841
PPV • PNEUMO (PNEUMOVAX) • Page 842
PPV • PNEUMO (PNEUMOVAX) • Page 843
PPV • PNEUMO (PNEUMOVAX) • Page 844
PPV • PNEUMO (PNEUMOVAX) • Page 845
PPV • PNEUMO (PNEUMOVAX) • Page 846
PPV • PNEUMO (PNEUMOVAX) • Page 847
PPV • PNEUMO (PNEUMOVAX) • Page 848
PPV • PNEUMO (PNEUMOVAX) • Page 849
PPV • PNEUMO (PNEUMOVAX) • Page 850
PPV • PNEUMO (PNEUMOVAX) • Page 851
PPV • PNEUMO (PNEUMOVAX) • Page 852
PPV • PNEUMO (PNEUMOVAX) • Page 853
PPV • PNEUMO (PNEUMOVAX) • Page 854
PPV • PNEUMO (PNEUMOVAX) • Page 855
PPV • PNEUMO (PNEUMOVAX) • Page 856
PPV • PNEUMO (PNEUMOVAX) • Page 857
PPV • PNEUMO (PNEUMOVAX) • Page 858
PPV • PNEUMO (PNEUMOVAX) • Page 859
PPV • PNEUMO (PNEUMOVAX) • Page 860
PPV • PNEUMO (PNEUMOVAX) • Page 861
PPV • PNEUMO (PNEUMOVAX) • Page 862
PPV • PNEUMO (PNEUMOVAX) • Page 828
PPV • PNEUMO (PNEUMOVAX) • Page 829
PPV • PNEUMO (PNEUMOVAX) • Page 830
PPV • PNEUMO (PNEUMOVAX) • Page 831
PPV • PNEUMO (PNEUMOVAX) • Page 832
PPV • PNEUMO (PNEUMOVAX) • Page 833
PPV • PNEUMO (PNEUMOVAX) • Page 834
PPV • PNEUMO (PNU-IMUNE) • Page 862
PPV • PNEUMO (PNU-IMUNE) • Page 863
PPV • PNEUMO (PNU-IMUNE) • Page 864
PPV • PNEUMO (PNU-IMUNE) • Page 862
RAB • RABIES (IMOVAX ID) • Page 864
RAB • RABIES (IMOVAX ID) • Page 864
RAB • RABIES (IMOVAX) • Page 864
RAB • RABIES (IMOVAX) • Page 865
RAB • RABIES (IMOVAX) • Page 864
RAB • RABIES (NO BRAND NAME) • Page 865
RAB • RABIES (NO BRAND NAME) • Page 866
RAB • RABIES (NO BRAND NAME) • Page 865
RAB • RABIES (RABAVERT) • Page 866
RAB • RABIES (RABAVERT) • Page 867
RAB • RABIES (RABAVERT) • Page 866
RAB • RABIES (RABIE-VAX) • Page 867
RAB • RABIES (RABIE-VAX) • Page 867
RAB • RABIES (RABIPUR) • Page 867
RAB • RABIES (RABIPUR) • Page 867
RAB • RABIES (RABIVAC) • Page 867
RAB • RABIES (RABIVAC) • Page 867
RUB • RUBELLA (MERUVAX I) • Page 867
RUB • RUBELLA (MERUVAX I) • Page 867
RUB • RUBELLA (MERUVAX II) • Page 867
RUB • RUBELLA (MERUVAX II) • Page 868
RUB • RUBELLA (MERUVAX II) • Page 867
RUB • RUBELLA (NO BRAND NAME) • Page 868
RUB • RUBELLA (NO BRAND NAME) • Page 868
RUB • RUBELLA (RUDIVAX) • Page 868
RUB • RUBELLA (RUDIVAX) • Page 868
RV • ROTAVIRUS (ROTASHIELD) • Page 868
RV • ROTAVIRUS (ROTASHIELD) • Page 868
RV1 • ROTAVIRUS (ROTARIX) • Page 869
RV1 • ROTAVIRUS (ROTARIX) • Page 870
RV1 • ROTAVIRUS (ROTARIX) • Page 871
RV1 • ROTAVIRUS (ROTARIX) • Page 872
RV1 • ROTAVIRUS (ROTARIX) • Page 873
RV1 • ROTAVIRUS (ROTARIX) • Page 874
RV1 • ROTAVIRUS (ROTARIX) • Page 875
RV1 • ROTAVIRUS (ROTARIX) • Page 868
RV1 • ROTAVIRUS (ROTARIX) • Page 869
RV5 • ROTAVIRUS (ROTATEQ) • Page 877
RV5 • ROTAVIRUS (ROTATEQ) • Page 878
RV5 • ROTAVIRUS (ROTATEQ) • Page 879
RV5 • ROTAVIRUS (ROTATEQ) • Page 880
RV5 • ROTAVIRUS (ROTATEQ) • Page 881
RV5 • ROTAVIRUS (ROTATEQ) • Page 882
RV5 • ROTAVIRUS (ROTATEQ) • Page 883
RV5 • ROTAVIRUS (ROTATEQ) • Page 884
RV5 • ROTAVIRUS (ROTATEQ) • Page 885
RV5 • ROTAVIRUS (ROTATEQ) • Page 886
RV5 • ROTAVIRUS (ROTATEQ) • Page 875
RV5 • ROTAVIRUS (ROTATEQ) • Page 876
RV5 • ROTAVIRUS (ROTATEQ) • Page 877
RVX • ROTAVIRUS (NO BRAND NAME) • Page 886
RVX • ROTAVIRUS (NO BRAND NAME) • Page 887
RVX • ROTAVIRUS (NO BRAND NAME) • Page 886
SMALL • SMALLPOX (ACAM2000) • Page 888
SMALL • SMALLPOX (ACAM2000) • Page 889
SMALL • SMALLPOX (ACAM2000) • Page 887
SMALL • SMALLPOX (ACAM2000) • Page 888
SMALL • SMALLPOX (DRYVAX) • Page 889
SMALL • SMALLPOX (DRYVAX) • Page 890
SMALL • SMALLPOX (DRYVAX) • Page 891
SMALL • SMALLPOX (DRYVAX) • Page 889
SMALL • SMALLPOX (NO BRAND NAME) • Page 891
SMALL • SMALLPOX (NO BRAND NAME) • Page 891
SSEV • SUMMER-SPRING ENCEPH (NO BRAND NAME) • Page 891
SSEV • SUMMER-SPRING ENCEPH (NO BRAND NAME) • Page 891
TBE • TICK-BORNE ENCEPH (NO BRAND NAME) • Page 891
TBE • TICK-BORNE ENCEPH (NO BRAND NAME) • Page 892
TBE • TICK-BORNE ENCEPH (NO BRAND NAME) • Page 891
TD • TD ADSORBED (DITANRIX) • Page 892
TD • TD ADSORBED (DITANRIX) • Page 892
TD • TD ADSORBED (NO BRAND NAME) • Page 893
TD • TD ADSORBED (NO BRAND NAME) • Page 894
TD • TD ADSORBED (NO BRAND NAME) • Page 895
TD • TD ADSORBED (NO BRAND NAME) • Page 896
TD • TD ADSORBED (NO BRAND NAME) • Page 897
TD • TD ADSORBED (NO BRAND NAME) • Page 898
TD • TD ADSORBED (NO BRAND NAME) • Page 899
TD • TD ADSORBED (NO BRAND NAME) • Page 900
TD • TD ADSORBED (NO BRAND NAME) • Page 892
TD • TD ADSORBED (NO BRAND NAME) • Page 893
TD • TD ADSORBED (TD-RIX) • Page 900
TD • TD ADSORBED (TD-RIX) • Page 900
TD • TD ADSORBED (TDVAX) • Page 900
TD • TD ADSORBED (TDVAX) • Page 901
TD • TD ADSORBED (TDVAX) • Page 900
TD • TD ADSORBED (TENIVAC) • Page 901
TD • TD ADSORBED (TENIVAC) • Page 901
TD • TETANUS DIPHTHERIA (NO BRAND NAME) • Page 901
TD • TETANUS DIPHTHERIA (NO BRAND NAME) • Page 902
TD • TETANUS DIPHTHERIA (NO BRAND NAME) • Page 903
TD • TETANUS DIPHTHERIA (NO BRAND NAME) • Page 901
TDAP • TDAP (ADACEL) • Page 905
TDAP • TDAP (ADACEL) • Page 906
TDAP • TDAP (ADACEL) • Page 907
TDAP • TDAP (ADACEL) • Page 908
TDAP • TDAP (ADACEL) • Page 909
TDAP • TDAP (ADACEL) • Page 910
TDAP • TDAP (ADACEL) • Page 911
TDAP • TDAP (ADACEL) • Page 912
TDAP • TDAP (ADACEL) • Page 913
TDAP • TDAP (ADACEL) • Page 914
TDAP • TDAP (ADACEL) • Page 915
TDAP • TDAP (ADACEL) • Page 916
TDAP • TDAP (ADACEL) • Page 903
TDAP • TDAP (ADACEL) • Page 904
TDAP • TDAP (ADACEL) • Page 905
TDAP • TDAP (BOOSTRIX) • Page 918
TDAP • TDAP (BOOSTRIX) • Page 919
TDAP • TDAP (BOOSTRIX) • Page 920
TDAP • TDAP (BOOSTRIX) • Page 921
TDAP • TDAP (BOOSTRIX) • Page 922
TDAP • TDAP (BOOSTRIX) • Page 923
TDAP • TDAP (BOOSTRIX) • Page 924
TDAP • TDAP (BOOSTRIX) • Page 925
TDAP • TDAP (BOOSTRIX) • Page 916
TDAP • TDAP (BOOSTRIX) • Page 917
TDAP • TDAP (BOOSTRIX) • Page 918
TDAP • TDAP (NO BRAND NAME) • Page 925
TDAP • TDAP (NO BRAND NAME) • Page 926
TDAP • TDAP (NO BRAND NAME) • Page 927
TDAP • TDAP (NO BRAND NAME) • Page 925
TDAPIPV • TDAP+IPV (FOREIGN) • Page 927
TDAPIPV • TDAP+IPV (FOREIGN) • Page 927
TTOX • TETANUS TOXOID (NO BRAND NAME) • Page 927
TTOX • TETANUS TOXOID (NO BRAND NAME) • Page 928
TTOX • TETANUS TOXOID (NO BRAND NAME) • Page 929
TTOX • TETANUS TOXOID (NO BRAND NAME) • Page 927
TTOX • TETANUS TOXOID (TEVAX) • Page 929
TTOX • TETANUS TOXOID (TEVAX) • Page 929
TTOX • TETANUS TOXOID, ADSORBED (NO BRAND NAME) • Page 929
TTOX • TETANUS TOXOID, ADSORBED (NO BRAND NAME) • Page 929
TYP • TYPHOID LIVE ORAL TY21A (NO BRAND NAME) • Page 929
TYP • TYPHOID LIVE ORAL TY21A (NO BRAND NAME) • Page 929
TYP • TYPHOID LIVE ORAL TY21A (VIVOTIF) • Page 929
TYP • TYPHOID LIVE ORAL TY21A (VIVOTIF) • Page 930
TYP • TYPHOID LIVE ORAL TY21A (VIVOTIF) • Page 929
TYP • TYPHOID VI POLYSACCHARIDE (ACETONE INACTIVATED DRIED) • Page 930
TYP • TYPHOID VI POLYSACCHARIDE (ACETONE INACTIVATED DRIED) • Page 931
TYP • TYPHOID VI POLYSACCHARIDE (ACETONE INACTIVATED DRIED) • Page 930
TYP • TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) • Page 931
TYP • TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) • Page 932
TYP • TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) • Page 931
TYP • TYPHOID VI POLYSACCHARIDE (TYPHIM VI) • Page 932
TYP • TYPHOID VI POLYSACCHARIDE (TYPHIM VI) • Page 933
TYP • TYPHOID VI POLYSACCHARIDE (TYPHIM VI) • Page 934
TYP • TYPHOID VI POLYSACCHARIDE (TYPHIM VI) • Page 935
TYP • TYPHOID VI POLYSACCHARIDE (TYPHIM VI) • Page 932
UNK • VACCINE NOT SPECIFIED (FOREIGN) • Page 935
UNK • VACCINE NOT SPECIFIED (FOREIGN) • Page 935
UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Page 936
UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Page 937
UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Page 938
UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Page 939
UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Page 940
UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Page 941
UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Page 935
UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Page 936
UNK • VACCINE NOT SPECIFIED (OTHER) • Page 941
UNK • VACCINE NOT SPECIFIED (OTHER) • Page 942
UNK • VACCINE NOT SPECIFIED (OTHER) • Page 941
VARCEL • VARICELLA (NO BRAND NAME) • Page 942
VARCEL • VARICELLA (NO BRAND NAME) • Page 943
VARCEL • VARICELLA (NO BRAND NAME) • Page 944
VARCEL • VARICELLA (NO BRAND NAME) • Page 942
VARCEL • VARICELLA (VARILRIX) • Page 944
VARCEL • VARICELLA (VARILRIX) • Page 944
VARCEL • VARICELLA (VARIVAX) • Page 951
VARCEL • VARICELLA (VARIVAX) • Page 952
VARCEL • VARICELLA (VARIVAX) • Page 953
VARCEL • VARICELLA (VARIVAX) • Page 954
VARCEL • VARICELLA (VARIVAX) • Page 955
VARCEL • VARICELLA (VARIVAX) • Page 956
VARCEL • VARICELLA (VARIVAX) • Page 957
VARCEL • VARICELLA (VARIVAX) • Page 958
VARCEL • VARICELLA (VARIVAX) • Page 959
VARCEL • VARICELLA (VARIVAX) • Page 960
VARCEL • VARICELLA (VARIVAX) • Page 961
VARCEL • VARICELLA (VARIVAX) • Page 962
VARCEL • VARICELLA (VARIVAX) • Page 963
VARCEL • VARICELLA (VARIVAX) • Page 964
VARCEL • VARICELLA (VARIVAX) • Page 965
VARCEL • VARICELLA (VARIVAX) • Page 966
VARCEL • VARICELLA (VARIVAX) • Page 967
VARCEL • VARICELLA (VARIVAX) • Page 968
VARCEL • VARICELLA (VARIVAX) • Page 969
VARCEL • VARICELLA (VARIVAX) • Page 970
VARCEL • VARICELLA (VARIVAX) • Page 971
VARCEL • VARICELLA (VARIVAX) • Page 972
VARCEL • VARICELLA (VARIVAX) • Page 973
VARCEL • VARICELLA (VARIVAX) • Page 974
VARCEL • VARICELLA (VARIVAX) • Page 975
VARCEL • VARICELLA (VARIVAX) • Page 976
VARCEL • VARICELLA (VARIVAX) • Page 977
VARCEL • VARICELLA (VARIVAX) • Page 978
VARCEL • VARICELLA (VARIVAX) • Page 979
VARCEL • VARICELLA (VARIVAX) • Page 980
VARCEL • VARICELLA (VARIVAX) • Page 944
VARCEL • VARICELLA (VARIVAX) • Page 945
VARCEL • VARICELLA (VARIVAX) • Page 946
VARCEL • VARICELLA (VARIVAX) • Page 947
VARCEL • VARICELLA (VARIVAX) • Page 948
VARCEL • VARICELLA (VARIVAX) • Page 949
VARCEL • VARICELLA (VARIVAX) • Page 950
VARCEL • VARICELLA (VARIVAX) • Page 951
VARZOS • ZOSTER (NO BRAND NAME) • Page 980
VARZOS • ZOSTER (NO BRAND NAME) • Page 981
VARZOS • ZOSTER (NO BRAND NAME) • Page 980
VARZOS • ZOSTER (SHINGRIX) • Page 1000
VARZOS • ZOSTER (SHINGRIX) • Page 1001
VARZOS • ZOSTER (SHINGRIX) • Page 1002
VARZOS • ZOSTER (SHINGRIX) • Page 1003
VARZOS • ZOSTER (SHINGRIX) • Page 1004
VARZOS • ZOSTER (SHINGRIX) • Page 1005
VARZOS • ZOSTER (SHINGRIX) • Page 1006
VARZOS • ZOSTER (SHINGRIX) • Page 985
VARZOS • ZOSTER (SHINGRIX) • Page 986
VARZOS • ZOSTER (SHINGRIX) • Page 987
VARZOS • ZOSTER (SHINGRIX) • Page 988
VARZOS • ZOSTER (SHINGRIX) • Page 989
VARZOS • ZOSTER (SHINGRIX) • Page 990
VARZOS • ZOSTER (SHINGRIX) • Page 991
VARZOS • ZOSTER (SHINGRIX) • Page 992
VARZOS • ZOSTER (SHINGRIX) • Page 993
VARZOS • ZOSTER (SHINGRIX) • Page 994
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Page No. + 1st Record (Vaccine Type, Name • Event/Outcome • Description):

Page 1: 6VAX-F • DTAP+IPV+HEPB+HIB (HEXAVAC) • Event/Outcome: See Description Patient received HEXYON and PREVENAR 13 shots. After an afternoon with few naps, but successful feedings, at night patient couldn't sleep, had gas and would vomit after feedings. Symptoms continued until 6:30 AM 03/11/2017 at which point baby paracetamol was provided. Patient then slept 4 hours and ...

Page 2: 6VAX-F • DTAP+IPV+HEPB+HIB (INFANRIX HEXA) • Event: Crying This is a spontaneous report received from the foreign Regulatory Authority. Regulatory Authority report number 171775. A physician (contactable through Regulatory Authority only) referred that a 5-months-old male patient received the second dose of PREVENAR 13 (Lot # F59867) at 0.5 ml single dose, ...

Page 3: 6VAX-F • DTAP+IPV+HEPB+HIB (INFANRIX HEXA) • Event: Monocyte percentage decreased Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 8-month-old male patient who experienced weight loss, breathing irregularities, appetite lost, anaemia, pro B acute lymphatic leukaemia, respiratory syncytial virus infection, neutropeni ...

Page 4: 6VAX-F • DTAP+IPV+HEPB+HIB (INFANRIX HEXA) • Outcome: Death This is a spontaneous report from a contactable lawyer via legal division. A 23-month-old male patient of an unspecified ethnicity had received four doses of PREVENAR on unknown dates when the patient was an unspecified age for immunization and ""two vaccinations against meningitis"" on unspecified ...

Page 5: 6VAX-F • DTAP+IPV+HEPB+HIB (NO BRAND NAME) • Event: Seizure seizures/ convulsions; respiratory arrest/stopped breathing; blue skin; Cramps; grey face; sad; staring,; unable to contact; cried; This case was reported by a physician via call center representative and described the occurrence of seizure in a 3-month-old female patient who received Rota (Rotarix ...

Page 6: ANTH • ANTHRAX (BIOTHRAX) • Event: Acne Immunizations were given starting the left arm then rotating to the left then the right etc. Five immunizations were given total. All 5 shots were given in 1 year 4 months time span from 03/28/2003 until the last was given 7/13/2004. Symptoms include burning for 24 hours in each arm for a full 24 ho ...

Page 7: ANTH • ANTHRAX (BIOTHRAX) • Event: Full blood count normal Description: 11/10/98. Received anthrax vaccine #1- denies problems. 11/24/98. Received anthrax vaccine #2- denies problems. 12/11/98. Received anthrax vaccine #3- pt. states 4 wks after receiving the vaccine, noticed that he was ""tripping over repeatedly over right foot""- occurred once a week- no ...

Page 8: ANTH • ANTHRAX (BIOTHRAX) • Event: Myalgia fatigue, muscle aches, joint aches, appetite loss, body cramps. Currently on medication hold. ...

Page 9: ANTH • ANTHRAX (BIOTHRAX) • Event: Tongue disorder Noted tongue swollen, bumps both side, tongue white and sides if tongue numb on 4/12/06. Patient reports feeling feverish 4/12/06 and 4/13/06, putting cold water on face to cool off. On 4/15/06 tip of tongue also numb. Seen in ER ON 4/15/06. Given Prednisone (oral) and Pepcid. On 4/16/06 took Benadr ...

Page 10: ANTH • ANTHRAX (NO BRAND NAME) • Event/Outcome: See Description Approximately 2 - 3 hours after receiving injection for deployment, pt experienced onset of abdominal pain, nausea, chills, and headache. ...

Page 11: ANTH • ANTHRAX (NO BRAND NAME) • Event: Lymphadenopathy Patient complained of rash on left shoulder and across left pectoral, swollen lymph nodes, chills. Patient temp at 99.1 F at 0940 2 Feb 08, all other vital signs normal. Patient was instructed to continue tylenol and sent home with 48 hours quarters. Patient returned 4 Feb 08 with BP 138/76, temp 98 ...

Page 12: BCG • BCG (MYCOBAX) • Event: Serum ferritin normal Initial unsolicited report received from a pediatrician on 26-May-2016. This case involves an 08-month-old female patient who was vaccinated with 0.5 ml subcutaneous dose of ACTHIB (batch number and site of administration was not reported) on an unspecified date. Patient's medical history and concom ...

Page 13: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event/Outcome: See Description MASSIVE STROKE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported ...

Page 14: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event/Outcome: See Description 24 hours after rec' the vaccine she had started her cycle with blood clots. Her cycle did not come on that day. She had to use the bathroom no matter what time for it to come on. Doctor office, Doctor perfomed a series of lab test. Doctor states that she is getting blood clots and think it may be fr ...

Page 15: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event/Outcome: See Description Woke up at midnight with chills, fatigue and nausea. I took 3 Advil (generic version) and after one hour symptoms subsided. ...

Page 16: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event/Outcome: See Description patient fainted ...

Page 17: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event/Outcome: See Description Severe headache, dizziness, neck pain, inability to turn neck ...

Page 18: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Arthralgia Roughly 25-30 minutes following receiving the shot, I became extremely dizzy and weak. A few minutes later I felt difficulty breathing and realized that my throat was swelling. My heart began to race, but I cannot say if that was a result of the other symptoms I was experiencing. The dizziness and w ...

Page 19: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Blood test About six hours after the vaccine I had a headache. I woke up during the night with all over body aches that were very painful. I also had a headache and fever of 100-102 degrees. I was in bed for three days and I was still very fatigued for a whole week. My hands and legs were swelling off and on. ...

Page 20: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Chills night chills, fever, headache, body aches, loss of taste, swollen discolored (whiteish) tongue with bumps along the perimeter ...

Page 21: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Computerised tomogram abnormal She developed a large pulmonary embolus, and she died on 3/17 at Hospital. She developed symptoms of SOB on 3/11, and was admitted to the hospital. She was initially stable and not requiring oxygen and was sent home on anticoagulation. However she returned the same day with worsening symptoms, tropo ...

Page 22: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Diarrhoea D1 to D2: Nausea, Fever (High: 102.9F), Stomach Pain, Diarrhea, Headache D3 to D7: Stomach Pain, Nausea ...

Page 23: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Dyspnoea fever, chills, myalgias, SOB, increase in baseline cough. Some symptoms improving after 24 hours of onset but SOB and increase in cough still present at 72 hours post-vaccination. ...

Page 24: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Fatigue LOSS OF APPETITE; PERIOD DELAYED A WEEK; WORSE CRAMPS THAN USUAL; CHILLS; NAUSEA; FEVER; FATIGUE; HEADACHES; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were repor ...

Page 25: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Feeling abnormal Severe headache, body aches, fever 104.8 at highest and lowest for 3 days was 102, brain fog, fatigue, shortness of breath ...

Page 26: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Headache LEG NUMBNESS; LEG THROBBING / SORE ARM; CHILLS; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection ...

Page 27: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Headache HEART PALPITATION; BODY ACHES; CHILLS; HEADACHE; CHEST TIGHTNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included digestive problem, anxiety, penicillin allergy, an ...

Page 28: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Hypotension Vagal, Tremors, hypotension, seizures, ...

Page 29: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Insomnia RAPID HEARTBEAT; FEELING ANXIOUS; LOSS OF SLEEP; NAUSEA; SKIN FELT HOT; COLD; ACHYNESS; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism. The patient receive ...

Page 30: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Malaise Having lunch on 04/29/21, around 11:30 am. Talking with co-worker started noticing by vision went blurry. My hands & feet started tingling. I turned very pale in facial color. Had co worker call 911, paramedics to me to ER. All my vitals showed normal, ekg, blood work, platlet count all good !! Went ...

Page 31: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Myalgia BLOODY STOOL; INFLAMED BURSA OF LEFT HIP, RADIATING TOWARDS SPINE; ARTHRALGIA; MYALGIA; SLIGHTLY LOW KIDNEY FUNCTION; FATIGUE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions inclu ...

Page 32: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: No adverse event No adverse reaction note at this time. Vaccine medication error- Administered different manufacturer COVID vaccine on second dose ...

Page 33: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Pain Headache, Fatigue within an hour, 8 hours after Achiness all over, Chills, Fever, Racing Heartbeat, Headache comes and goes, sleepiness, then too hot can't sleep Took 2 Ibuprofen, 2 x 30 suedo-effedrin , ate bagel and cream cheese, 1/2 a banana 3x2000 D3 vitamin Trying to sleep now ...

Page 34: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Parosmia Sense of smell and taste altered horribly. Constantly smelling things that are not there or complete change in the way things taste and smell. Constantly smeeling things that are rotting or dirty feet or chemical smell. ...

Page 35: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Pyrexia NUMB ARM; HEADACHE; CHILLS; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient stated having no medical problems and have no known allergies. ...

Page 36: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Rash ON LOWER LEFT ARM, PATIENT STARTED HAVING WELTS ALL OVER ARM. NO ITCHING, NO ISSUES BREATHING, NO PAIN. STARTED AFTER ABOUT AN HOUR AFTER ADMINISTRATION OF VACCINE. OFFERED TO CALL PARAMEDICS, AND OFFERED BENADRYL, PATIENT DECLINE. INFLAMMATION OF WELTS STARTED SUBSIDING, SO PATIENT DECIDED TO LEAVE ...

Page 37: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Supraventricular tachycardia Heart rate 186, shortness of breath, profuse sweating. Successfully treated with IV adenosine [ADENOCARD]. Diagnosed as SVT (supra ventricular tachycardia), AKI (acute kidney injury), and dehydration. ...

Page 38: COVID19 • COVID19 (COVID19 (JANSSEN)) • Event: Ultrasound scan Venous blood clot in leg, and lunnv ...

Page 39: COVID19 • COVID19 (COVID19 (JANSSEN)) • Outcome: Death Symptom onset was 12/26/2020, with nausea, fever, chills, rigors, fatigue, cough, & myalgia. ...

Page 40: COVID19 • COVID19 (COVID19 (JANSSEN)) • Outcome: Recovery J&J COVID Vaccine EUA J&J Vaccine 4/10/2021 4/13/21: Believes she is having a reaction to her Johnson and Johnson COVID-19 vaccination. This vaccination was given on 04/10/2021. Patient is 39-year-old female with a past medical history significant for ulcerative colitis that has been in remission si ...

Page 41: COVID19 • COVID19 (COVID19 (JANSSEN)) • Outcome: Visit to Hospital or Doctor (Emergency) PLATELETS DECREASED; This spontaneous report received from a consumer concerned of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune deficiency. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, rou ...

Page 42: COVID19 • COVID19 (COVID19 (JANSSEN)) • Outcome: Visit to Hospital or Doctor (NonEmergency) I had the normal arm soreness. I had rapid heart rate and it continued for about 24 hours. I had a fever of 103 and every part of my body was hurting. I had severe chest pains, severe migraines for abut a month and muscles aches for about 2 months. ...

Page 43: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Headache, Myalgia, Fever, painful lump in armpit on injection side Narrative: ...

Page 44: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description 1/13/21 4:00PM arm pain, advil for relief. Next day 1/14/21 04:30 AM dizzy, chills, fever temp 99.8, hives on stomach, neck tightness all day. All symptoms have resolved today 1/15/2021, hives still present some ...

Page 45: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Aprox 4-5 hours later had burning painful urination. Next day aches, chills, pain, 101 temp., diarhea. Became very dehydrated. Sore arm at injection sight. Lasted 3 days or until Saturday evening. ...

Page 46: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Patient received Pfizer for her 1st dose. Her second dose (administered 04/28/21) was given as Moderna. ...

Page 47: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Patient presents to orthopedic clinic after several months of shoulder pain beginning soon after immunization. Pain occurs with movement, not at rest, and patient is not able to put on clothing normally. Six weeks after immunization patient fell and had a pulling injury to affected shoulder. Pain is ...

Page 48: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Injection site on left arm started itching about 2 or 3 hours after injection. Injection site became swollen and hot to the touch. A round red rash appeared. Site is very sensitive and painful to touch. ...

Page 49: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Redusert allmenntilstand/reduced general condition; Influensafølelse/flu-like symptoms; Feber/fever; Muskelsmerter/mylagia; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Redusert al ...

Page 50: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description 3x days pain at injection site 3x days headaches 3x days loss of appetite 2x days fever 2x days debilitating neck pain fully recovered 4 days after injection ...

Page 51: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Headache, brain fog, extremely tired, body aches ...

Page 52: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description 6 hours after first vaccination patient developed generalized itching over the face, hair line, ears, feet and hands with an associated red rash in these locations. ...

Page 53: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Rash all over body. Reported to Primary Care Physician, prescribed a Antihistamine & topical Hydrocortisone Cream. Treatment for 5 days. ...

Page 54: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Faintness followed by sweating, chills, tightness in chest, labored breathing. All symptoms arose within 5 minutes of the dose and subsided within 30-45 minutes. Pharmacy called 911 and EMTs came and said my vitals were good. ...

Page 55: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description After my 1st Moderna Vaccine, I had symptoms consistent with ""Covid Arm."" The large red circle appeared, a full week after my initial injection. It was itchy at times, sore at others, and mostly gone within 5-6 days. Immediately after my 2nd Moderna Vaccine, I had a small bump, with a bruise. By t ...

Page 56: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description After 7 days from the vaccine, I experienced pain underarm and I feel a swollen lymph node that hurts. The following day, the vaccine site became red about 6 inches, and itchy, and feels warm. The swelling lasted about 4 days and I still have the redness on the arm and itchiness until now that is da ...

Page 57: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description At 5:30 the day following vaccine, I was nauseated and had emesis x 1. I had cold flash throuh my body. Headache, chills, body aches and tired. Temp 99.5 ...

Page 58: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Sweaty and hot and arm numb in 15 minutes ...

Page 59: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Shot was administered on 1/20/2021. By that Friday, my upper right arm (over my bicep) developed a red patch, which I had attributed to dermatographia. Over the weekend, it began to raise up a bit from my skin and swell, and became warm to the touch. By Monday, 1/24/2021, the swelling had stopped, b ...

Page 60: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description nauseous that night (thurs) and off / on following day (fri), slightly nauseous on sat, rash at injection site since thurs. low grade fever in afternoon on Friday. Sore arm late Saturday. Chills on thurs night and Friday afternoon ...

Page 61: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Patient was nervous about getting the shot. After getting she said she felt like her heart was racing and she had nausea. She also felt like her body was cold. ...

Page 62: COVID19 • COVID19 (COVID19 (MODERNA)) • Event/Outcome: See Description Rash patient saw PCP and went to the ER. ...

Page 63: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Acute sinusitis 10 days s/p vaccination, I developed severe headache. Seen in urgent care and diagnosed with bilateral ear infection and acute sinusitis. Treated with antibiotics and medrol dose pack. Sxs persisted Upon completion. Seen by ENT today and thought to be migraine triggered by vaccine. No history of mig ...

Page 64: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Aphthous ulcer Canker sores, red/injection site pain, headaches o 01/24/2021 ...

Page 65: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Arthralgia Flu like symptoms for 4 days, 102 degree fever for two days, nauseous, severe diarea for 4 days. Several days after I was feeling better my right knee swelled up and became very painful. An orthopedic doctor diagnosed it as gout. I was given a gout med and prednisone. It is a week later now and stil ...

Page 66: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Asthenia First 8 hrs tired weak temperature 102.7, back tight like it was fused and unable to move Nauseated like I had COVID all over again I was in bed Thursday through the weekend. I ended up with excruciating pain that landed me in the hospital for two weeks for extreme nerve pain to the point I can?t wa ...

Page 67: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Balance disorder 2 weeks after shot developed peripheral neuropathies, balance issues, weakness/shuffling of feet (like parkinsons/autoimmune). All symptoms are similar to Guillain-Barre Syndrome (patient has not been diagnosed, symptoms are similar) ...

Page 68: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Blood pressure decreased PATIENT PASSED OUT AND APPEARED TO BE HAVING A SIEZURE WITH EYES ROLLING BACK IN HEAD. HE WAS SLUMPED IN CHAIR. NON- RESPONSIVE. wAS ABOUT TO ADMINISTER EPINEPHRINE , WHEN HE CAME TO. HIS VOICE WAS WEAK AND SAID NO TO EPI. HE WAS DIAPHORETIC AND VERY PALE. EMS CAME ONTO SCENE AND TOOK OVER. BLOOD PR ...

Page 69: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Body temperature increased Just slightly sore injection site first 24 hours. At 30 hours, developed chills and a temperature of 103. The following two days, still running a temperature of over 103. In addition, had headache and neck stiffness that could not be relieved by Acetaminphen. ...

Page 70: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Cardiac monitoring heart palpitations starting 3 days later, continued 1X/daily; on day 21 had tachycardia HR 136-148 for 3 hours; on day 23 had tachycardia HR > 170 -- lasted about 30 minutes, seen at ER but had already started to come down. After that, have not had strong palpitations or tachycardia. ...

Page 71: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Chest pain Pt developed chest pain/shortness of breath by 4/20, proceeded to local Hospital ER by 4/21 w/ N-STEMI on EKG w/ elevated troponin >8000, ECHO with global hypokinesis and mod-severe AR,, Chest CTA neg for PA/PNA. Emergent cardiac catheterization negative for CAD, Transferred to another Hospital 4/22 ...

Page 72: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Chills nausea, chills, lightheadedness/near-syncope, tremors, myalgias, fever, diarrhea ...

Page 73: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Chills Vomit no stop cold chills stomach pain cramping , diarrhea.headache . ...

Page 74: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Chills I experienced chills and fever with 8 hours after the vaccine, which I expected as a side effect. Then 36 hours after the vaccine a rash broke out on my arms, neck, stomach, back, and chest - which was unexpected. I took a Benadryl, and the rash cleared in about 24 hours. ...

Page 75: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Computerised tomogram head Edema, muscle ache, swelling in hands and feet. Joint swelling, inflammatory arthritis. ...

Page 76: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Cough variant asthma Severe hives, itching, asthmatic cough, shortness of breath ...

Page 77: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Death Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician, hospice, and family were ...

Page 78: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Diarrhoea Stomach pain and cramps. Frequent loose bowel movements, 15-20 per day. Excessive gas (burping) and farting constantly. Fatigue and weak. Lack of sleep due to having to go to rest room frequently. Hemorrhoids pain and some bleeding due to frequent bowel movements. Functioning daily activities diffic ...

Page 79: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Dizziness Been having rapid heart rate and elevated blood pressure on and off for four days. Ten min after the first and ONLY shot, it felt like a rush and they brought me to the next room, checked my BP and HR. 177/111 and 115 bpm. Got better after a bit, and went home. 28 hours later, my heart started racin ...

Page 80: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Dizziness 28 year-old-male with no past medical history presented with episode of vasovagal syncope. Patient states he feels ""dizzy, blurry vision, and lightheaded"" immediately after receiving the vaccination. The patient was placed on the floor by the nurse who administered the vaccine and his lower extrem ...

Page 81: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Dysgeusia Within 15 minutes of injection, I had a strong metallic taste in my mouth, hot sweaty palms, heart rate and blood pressure seriously elevated ...

Page 82: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Dyspnoea At about 9:30 pm on 3/25, left arm started getting sore and felt a rush of warmth in the crook of my elbow on the same arm. Went to bed. During the night felt ill, but didn't do anything about it. On 3/26 at around 7:00 am, when I usually awake, I couldn't really get out of bed because of fatigue, s ...

Page 83: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Electrocardiogram T wave inversion A few minutes after receiving the shot I noticed extreme tiredness and light headedness. I got up to notify staff and my vision went and I began to feel nauseated. They helped me to a seat and I began sweating profusely and the nausea intensified. After several minutes the nausea and vision changes ...

Page 84: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Erythema Started noticing soreness in my left arm late on 2/25/2021, similar to what I had the next day after my shot. It got worse during the night, couldn't lay on that arm all night, and on awakening my arm was very painful, red, hot with a large lump. ...

Page 85: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Eye pain Typicial symptoms started about 12 hours after the injection. Very bad body aches, severe headache, eye ball pain (weird), chills. About 2 days after the vaccination, all of my previous respiratory symptoms that I have had well managed and under control have returned. I am wheezing, congested, ringi ...

Page 86: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Fatigue First 3 days after injection on 1/14/21, there was soreness and slight swelling with a bit of redness. It went away after 3 days and no other symptoms. 10 days later, small rash consisting of lots of red spots near site of injection. Day 11, the red bumps are no longer visible but a large singular p ...

Page 87: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Fatigue The morning after my vaccination I awoke with bodily aches (primarily back and hip), severe headache, neck pain (stiff and sore) fatigue, some achiness at injection site. These were somewhat alleviated with acetaminophen but returned just as severe when medicine wore off. The second morning I still ...

Page 88: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Fatigue 1/21/21: Immediate swelling at injection site, hot to touch and arm soreness 1/22/21: I woke up at 7:30am with a sore throat and right ear pain. This is typical for me when I am starting to fight something off. I was managing okay until around 1pm when I started to low grade fever at 99.8. By around ...

Page 89: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Feeling abnormal Severe Fatigue in first week - lengthy sleep and actually slack-jawed at times. Fatigue has lingered, with brain fog - difficulty finding words, difficulty staying awake, difficulty staying focused. Feeling of slight numbness/fatigue from shoulders up. Similar feeling to jet lag. It's been 4 weeks. ...

Page 90: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Flushing Approximately 5 minutes after receiving the Moderna vaccine patient became flushed and states that he ""doesn't feel well"". pt appears very anxious, pale, diaphoretic, and breathing fast. blood pressure was 210/98. HR 99. Oxygen saturation was 99%. When attempting to calm patient he states he ""nee ...

Page 91: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Glossitis Itchy peeling eyelids Itchy peeling lips, worsening to include area @mouth. Blister-like redness and irritation on tongue. Lips and tongue tingly. ...

Page 92: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Headache Day 1: headache and chills, no fever. Day 2: fatigue and chills, no fever Day 3-4 : fatigue and chills, no fever Day 5: Strong heart palpitations, chills and fatigue . Day 6-7 Heart pain, palpitations, chills and fatigue/ Had to rest constantly. Began taking ibuprofen to calm the inflammation. Day 8 ...

Page 93: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Headache Chest pain / tightness; nausea; extreme fatigue; pain in left / right rib cages; headache; 48 hours to date ...

Page 94: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Headache Slight fever of 100.2, nausea (I did vomit), major body aches, migraine, uncontrollable shaking, soreness at the injection site and lack of sleep (due to the pain in my arm and body aching) all from 1/4 to 1/5 early morning. During the daytime hours of the 1/5, took Tylenol (1,000mg) every 5 hours ( ...

Page 95: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Headache Severe pain in lower back/kidneys, excessive thirst and dehydration, swelling of face, joint and muscle pain, rash of white bumps on entire body, chills, headache, fatigue ...

Page 96: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Herpes zoster I developed shingles on my lower right stomach, side, and back 3 weeks after second Moderna vaccine ...

Page 97: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Hypersomnia Immediate reaction; tingling from deltoid to ear on left, which last about 2 hrs. Injection site became red, swollen, and was sore to touch and felt like a deep muscle ache which lasted until 1/17/21. Then on 1/18/21, injection site became itchy and very red - worse than at time of injection; very h ...

Page 98: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Hypokalaemia This patient received the Covid shot and has a primary coded discharge of U07.1 Covid-19. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation. Other diagnoses E87.6 - Hypokalemia ...

Page 99: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Incorrect dose administered needle hub was loose, when provider went to inject, the dose spilled out onto individual. Individual was not able to stay for 2nd redose. Individual returned the following day for a full booster dose with no issues. ...

Page 100: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site erythema Fatigue, chills, weakness, red itchy spots near injection site ...

Page 101: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site erythema Pain, swelling, redness in spot where shot was given. ...

Page 102: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site haemorrhage Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: Patient felt queasy shortly after shot. Per patient, proceeded to restroom and experienced vomiting. Patient stayed whole 15 minutes for observation. Pt stated dizziness and that she was a l ...

Page 103: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site pain There were no immediate adverse affects after the vaccine. Arm tenderness near the injection site became very noticeable the morning after the shot. About a day after the vaccine, I developed flu-like symptoms: joint tenderness, body aches, chills, and a low-grade fever of 99 - 100.1 degrees. These ...

Page 104: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site pain Covid arm Hard, warm, red lump at injection site which appeared a week later. Lump is warm and slightly painful to the touch. The area is sore and slightly itchy ...

Page 105: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site pruritus COVID Arm - 5 inch red swollen bump around injection site. Sore, hot and slightly itchy ...

Page 106: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site pruritus Fever chills, sweeting, slept for over 24 hours, swelling at the injection spot, achy diarrhea it has been over 2 weeks now I I have a itchy rash on my arm the site of the injection just appeared ...

Page 107: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site rash Covid arm, A rash around the injection site, started about 9 days after the shot. ...

Page 108: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site swelling My left arm is swelling greatly around injunction site ...

Page 109: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site swelling About 45 minutes after injection, my lips started to tingle and my face was blotchy. This did not last long ( subside as I was driving back to the injection site).Approximately 8 days after administration of 1st vaccine my arm started itching and the air of infection became hard, swollen and hot to ...

Page 110: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Injection site warmth Redness, moderate swelling, warm and itchy at the site of injection 7 days after administration ...

Page 111: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Laboratory test normal patient did well during administration of vaccine however 27-28 hours post vaccine she experienced sever headache accompanied by right thigh pain and then developed right and left thigh/muscle pain and weakness with persistent bilateral frontal headache that would come and go but get worse when she ...

Page 112: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Loss of consciousness THE PATIENT SLID OUT OF HIS CHAIR TO A SITTING POSITION. HE BLACKED OUT FOR A SECOND, BUT CAUGHT HIMSELF BEFORE FALLING OVER. HE FELT LIGHT HEADED. HIS BLOOD PRESURE WAS 140/86 AND A HEART RATE OF 73. AFTER 20 MINUTES HE WAS FEELING FINE AND WAS BACK TO NORMAL. HE REFUSED A CALL TO 911 STATING HE WA ...

Page 113: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Lymphadenopathy Swollen limp nodes in arm pit and collar bone. ...

Page 114: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Malaise 11 hours after the shot i spiked a fever of 102.8, very tired. Then had extreme pain in my joints that evening. Then the following morning i was short of breath and had burning pain between the breast that went through to the back that only lasted about 2 minutes and went away. at 1:30 pm i was on m ...

Page 115: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Mobility decreased MYSTERY ""STROKE"": The patient remembers receiving the MODERNA COVID vaccination and feeling nothing immediately after shot, took off work a few days later and then on following Monday remembered getting up and preparing for day with shave and shower. Remembers blood sugar being in normal range. We ...

Page 116: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Musculoskeletal stiffness migraine, jaw pain, body aches, shoulder & neck tight. Site of injection is swollen, red, hot to the touch, hurts to move arm. Discomfort goes shoulder down to injection site. Complains of being tired. ...

Page 117: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Myalgia 2/5/2021 extreme exhaustion, dizziness, weakness, extreme sweat lightheaded passed out at work, fever, body aches, red irritated swollen extreme pain at injection site. 2/6/2021 fatigue, dizziness, weakness, muscle joint pain slight fever, red irritated swollen pain tingling arm electric shock like ...

Page 118: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Nausea Headache, nausea >10 days ...

Page 119: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Nausea Swelling, soreness of the injection site...the injection area a week later is still hot to the touch and has increased in area size. It itches and has been dispersing in that area into patch like hive. The itches has moved to thigh area on left and right sides of body. I have also had a dull burning ...

Page 120: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Neck pain Dose 1 Extreme pain and swelling at injection site and then moving down arm and underneath arm down right side of body. Right leg hot an painful in front thigh area. This whole effect lasted 10 days Fever up to 101 approximately 3 hours later lasting 2 days (up and down fever) Chills lasting 2 days ...

Page 121: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Oedema Erythema and edema approx. 4cm distal to injection site. Lesion is approx. 5-6cm x 8 cm, ovoid. It is pruritic and muscle tissue below is tender. First noticed 4/10 first thing in morning. Not sure when it actually started, but pruritus not noticed prior to 4/10. No treatment. Time course unknown, s ...

Page 122: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pain in extremity My arm starting absolutely killing me the night of the second vaccine which was on Wednesday. Today is Saturday and my arm is still as painful. There is no rash, not itchy, didn?t seem to be swollen or red but I have a high pain tolerance living with migraines and I can barely use my arm. I?m starti ...

Page 123: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pain in extremity Intermittent flushing in ears, fingers and toes for 3-4 hours after shot shooting pain from L elbow to L wrist and knuckles that lasted about a minute ...

Page 124: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pain Shortness of breathe after day 3-11 Nausea after day 5-11 Dizziness after day 3-11 All over body pain after day 2-10 Extreme tiredness after day 5-11 Rash at injection site after day 2-8 Redness at injection site day 1-11 ...

Page 125: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pain Right arm sore, swollen and warm to the touch right after shot. Still a tad sore but getting better two days later. A little over 24 hours (Friday evening), had chills, felt hot but no fever, and had body aches. Felt good next morning after 800mg ibuprofen. ...

Page 126: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pain Immediately after receiving the shot, I experienced quite a bit of pain in my left arm. After 5 minutes of receiving vaccination, I started to experience shortness of breath followed by rapid heart rate (which was confirmed by the nurse,) and lightheadedness. I also found that I was shaking if I hel ...

Page 127: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Palpitations 5 minutes post vaccine administration I started to feel palpitations, numbness on both arms and went up the nape/head, flushing, tingling in both arms dizziness, then dysphagia but able to talk. Hives at torso after 10 minutes. I was assessed by to physicians working at the site. Epi pen was given t ...

Page 128: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Paralysis Two hours after injection I got very cold and got uncontrollable trembles with total loss of muscle use . ...

Page 129: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pharyngeal swelling Reported that within 2 minutes of receiving vaccine,began to experience a swelling feeling in his throat. ...

Page 130: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Product administered to patient of inappropriate age Not old enough for Moderna vaccine ...

Page 131: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pruritus LEFT ARM STARTED TO BECOME VERY ITCHY AND RED STARTING ON FEBRUARY 3, 2021, 9 DAYS AFTER THE INJECTION. IT CONTINUES TO BE ITCHY AND RED AS OF TODAY, FEBRUARY 5, 2021. ...

Page 132: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pulmonary embolism A few days after the second vaccination, patient started feeling poorly. Shortness of breath, tiredness and could not shake it. Ended up at hospital and after multiple tests he was flown to another hospital with a pulmonary embolism. He is currently in hospital being treated for PE and multiple clot ...

Page 133: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pyrexia Fever, chills, weakness, fatigue, diarrhea, nausea, headache, joint pains, muscle pain. ...

Page 134: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pyrexia Patient presents today with his wife and son. He was recently hospitalized having developed a fever the day after his Covid vaccine 1 with associated confusion and some ataxia. He was admitted to the hospital overnight where an MRI scan suggested no acute change showing only moderate cerebral atroph ...

Page 135: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Pyrexia Fever of 101 Chills Body aches Nausea ...

Page 136: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Rash erythematous Swelling in mouth, bottom lip, and tongue, sore throat Itching on entire body and head Rash on entire body --looks like sunburn PCP prescribed-- Prednisone 10mg tab--12 day course on 04/5/21 Betamethasone valerate 0.1% ointment on 03/25/21 Patient claims to be recovering ...

Page 137: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Rash No rash on injection site. However rash on both legs and one arm had rash on elbow. The rash became dark purple and very large. I was taking Benedryl, Hydrocortisone and Calamile lotion over the counter with no improvement. I went to the doctors, he prescribed a steroid, the rash lightened however b ...

Page 138: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Rash Later on in that evening, started having body aches that became server overnight. Had a low-grade fever of 100.2. Had server chills that lasted for 3 days. On the second day arm (left) swelled up and had a rash. Seen the doctor, she thinks I was having allergic reaction to the vaccine. Doctor though ...

Page 139: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: SARS-CoV-2 test negative Nausea after 10 minutes of receiving vaccine. Fatigue, fever, chills (my body felt like it was pulsing-like I was receiving electric shock therapy). Abdominal cramping (felt like I was having labor contractions), loose stool from 6/16/2021 night through morning of 6/21/2021. ...

Page 140: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Skin discomfort Day 2-arm soreness and fatigue Day 14- red raised rash on left arm (warm to touch, slight discomfort with itching) ...

Page 141: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Sleep disorder Got the vaccine, and later noticed pain in her neck, knees, head. She had dizziness, chills, shakes, nausea and a slight fever. She went to bed that evening and everything was hurting, and felt very nauseous. She had a very bad nights rest, but when she woke up her temp was over 100, normal is 97. S ...

Page 142: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Swelling i was fine before leaving the pharmacy they held me for additional time to see if i had any swelling. Literally felt well, did have arm soreness the next few days. On April 7, I noticed some swelling but I just thought it was because I had a ton of sweets that day. The next morning I woke up, I was ...

Page 143: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Tachycardia Started with fatigue and headache about 3 hours after receiving vaccine. Slept for 14 hours straight. Woke up the next morning with fatigue, muscle/joint pain and extreme irritability. Later that evening, began shaking violently. Immediately took 400mg Motrin. Unable to walk or speak. Only able to m ...

Page 144: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Tinnitus Increased tinnitus and increased hearing loss, no treatment ...

Page 145: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Troponin Had DVT and PE after the first dose of the Moderna Covid vaccine administered at First Health. This resulted in a two day hospitalization and was previously reported to VAERS. Pulmonary and hematology specialists were consulted and recommended that the second dose of the Moderna vaccine be given bec ...

Page 146: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Urticaria Hives, diarrhea. ...

Page 147: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Vaccination site reaction Swelling/ redness/ soreness/warmth on the site of vaccination which started the next day(12/31/2020) up to current day (1/07/2021), also I noticed it is slightly itchy and less sore. I don't have fever or any other reaction, just this one. It has been 8 days and it has not gone away yet, but it is n ...

Page 148: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: Vomiting Chills, shaking, nausea, vomiting, dizziness/light headedness, tired, extremely sore arm, achy, extreme headache ...

Page 149: COVID19 • COVID19 (COVID19 (MODERNA)) • Event: White blood cell count Pancreatitis; Upper abdominal discomfort; Fever; This case was received via an unknown source (no reference has been entered for a health authority) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021. This regulatory authority case was reported by a physician and describes the occurrence of ...

Page 150: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Hospitalization 02/27/2021 -received vaccine #1. 03/01/2021 - began to have chest tightness. All through March I felt bad with symptoms of muscle aches, headaches, shortness of breath, loss of appetite, nausea. By the middle of March I felt so bad that on the 17th I had a covid test, which turned out negative. On t ...

Page 151: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Life-Threatening IVC thrombus w/wedge-shaped R-sided pulmonary infarct, suspect PE. Pt initially on Lovenox 100mg subQ bid., started on Apixaban 10mg PO bid for 5 days followed by Apixaban 5mg PO bid for 5 days. Pt continued to demonstrate need for supplemental O2 w/O2Sat 86% on room air at rest, d/c from hospital w ...

Page 152: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Recovery her lymphedema on her right arm became a cellulitis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CELLULITIS (her lymphedema on her right arm became a cellulitis) in a 76-year-old female patient who received mRNA-1273 (Moderna CO ...

Page 153: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Recovery Had the Moderna vaccine on Tuesday, 3/16/21. Had a major heart attach on Friday 3/19/21. ...

Page 154: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Recovery As with the first shot, I was very fatigued and achy. A day or two after the shot I began having pain in the left side of my chest. It was a tight feeling that made it difficult to breathe. The pain only got worse and after a couple of days, I decided to go to the emergency room as I feared I was ha ...

Page 155: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Recovery Was perfectly fine and felt great before but around 2100 about 12 hours after i received the vaccine i started to get flu like symptoms where my body kept shivering, shaking uncontrollably, cold sweats, 100.7 fever, headache like no other, and arm hurt like a tetanus shot. ...

Page 156: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Recovery Not approved for age...patient only 17. No adverse reactions. ...

Page 157: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Recovery Mini seizure; Diarrhea; Slight temperature; Vomiting; A spontaneous report was received from a consumer concerning an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of slight temperature/fever, vomiting, diarrhea and short seizure early in the mor ...

Page 158: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Recovery Hypertension, tachycardia, and shortness of breath for one hour. Burning sensation on the injection site. ...

Page 159: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Visit to Hospital or Doctor (Emergency) itching, tongue numbness ...

Page 160: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Visit to Hospital or Doctor (Emergency) Patient experience acute altered mental status on Friday 5/21; seen in ER on Sat 5/22 and Mon 5/24 ...

Page 161: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Visit to Hospital or Doctor (Emergency) Back pain day 0-3 and 6. Abdominal pain day 3-4 and 6. Vomiting and blood in stool day 6. Visited ER day 6 due to unsubsiding abdominal pain and listed symptoms. Toradol given by IV elevated pain symptoms. Surgeon decided to release me but if symptoms reoccur, more tests will be done. Had never had ...

Page 162: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Visit to Hospital or Doctor (NonEmergency) Tinnitus started the day after the 2nd shot. As of this writing (6/8/21), the condition still exists ...

Page 163: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Visit to Hospital or Doctor (NonEmergency) Soreness, chills and neuropathy constantly for 16 days ...

Page 164: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Visit to Hospital or Doctor (NonEmergency) Numbness that started between about 1/10/2021 and 1/15/2021. It started in the great toe of one foot and then within about 1 week was noticeable in the great toe of the other foot. Then within 1 month, it was noticeable in the fingers of both hands as well. It seems to have improved somewhat , but s ...

Page 165: COVID19 • COVID19 (COVID19 (MODERNA)) • Outcome: Visit to Hospital or Doctor (NonEmergency) Nine minutes after receiving the vaccine, I began to feel ""weird"", then hot. I asked the nurse to take my temperature, but it was normal. I was thirsty, then extremely weak and light-headed. While sitting, I started tilting over to the side and thought I would pass out. They called EMTs who took m ...

Page 166: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Headache, Left arm and shoulder pain ...

Page 167: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Received 2nd dose Pfizer lot EL0142 in right arm on 1-13-2021. Employee is experiencing body aches and cramping all over. ...

Page 168: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description 20 minutes post injection started to feel clammy, increased heart rate and rash appearance on both arms and hands. Reported to doctor at site and EMS was called. Heart rate was 98, BP 218/110 taken three times by EMS. Administered Benadryl liquid by EMS and monitored for thirty minutes. Rash stopped ...

Page 169: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Dr took her off work because of swollen lymph nodes and neurological things. Really sick all weekend long. Swollen lymph nodes in clavicle ,neck, cheek. Dr. prescribed muscle relaxants ...

Page 170: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description right breast pain/swelling and right axillary tender lymphadenopathy right arm pain ...

Page 171: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description The headache was present after the first dose; This is a spontaneous report from a contactable consumer (patient self-reported). A 30-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, l ...

Page 172: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Sudden severe vertigo upon waking up on 4/14, Had to lay on back and was ok, took 2hrs to go away. Have similar but much less severity every morning for short time. Throughout day still feel ""off"" and not perfect. Also noticed tinnitus seems worse since all day long. Blood Pressure, O2 level and p ...

Page 173: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description blood in the left eye; then squeezing her fingers, a bruise appeared in the palm; Dizziness; weakness; 100 beats per minute; This is a spontaneous report from a contactable consumer (another person), downloaded from the regulatory authority-WEB. The regulatory authority number is LT-SMCA-4114. A 69- ...

Page 174: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Diffuse heat, asthenia, enlargement of the left submandibular lymph nodes, major hypertensive crisis with fainting in a normally hypotensive subject. On the occasion of the first widespread hypertensive crisis; Diffuse heat, asthenia, enlargement of the left submandibular lymph nodes, major hyperten ...

Page 175: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Four days post vaccine onset of severe symptoms, chest pain, chest tightness, synthscope, vertigo, fatigue, feelings of arrhythmia, tachycardia, shortness of breath (unresolved by inhalers). From onset, severe symptoms were constant for the first two weeks, after which point symptoms come on in epis ...

Page 176: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Itching; low blood pressure 105/62; low heart rate ( 47 ); continually faint; Heart racing; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority, report number GB-MHRA-WEBCOVID-202103251758277250, Safety Report Unique Identifier ...

Page 177: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Pain in limb/ aching limbs; flu like; extreme fatigue; headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202103191112030990. Safety Report Unique Identifier GB-MHRA-ADR 24976183. A 67-year-old ma ...

Page 178: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Shingles rash; Shingles rash; pain in jaw; pain in neck; pain in ear; abdominal pain; diarrhoea; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number (GB-MHRA-WEBCOVID 202102101541190010), Safety Report Uni ...

Page 179: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description This is a spontaneous report from a contactable physician from the UK-MHRA. The regulatory authority report number is GB-MHRA-TPP6936449C999990YC1612882975569, Safety Report Unique Identifier GB-MHRA-ADR 24780482. A 72-year-old female patient received BNT162B2 (reported as COVID-19 MRNA VACCINE BION ...

Page 180: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description I received my 2nd Pfizer COVID 19 vaccine on May 4th. 6 hours after the shot, I had severe pain in my lower back, left side with some queasiness when not lying down. Tuesday night and Wednesday were the worst. Tylenol helped alleviate the pain quite a bit, but I was only comfortable when laying on m ...

Page 181: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Patient reports right upper quadrant abdominal pain at end of 15 minute observation. vitals obtained @ 2:25 134/65, HR 72, Spo2 98%, RR 16. No acute signs of distress. Patient denies any adverse symptoms. (2:34) Vitals 122/84, HR 79, SpO2 98%, RR 16. Patient states RUQ abdominal pain is ""better. ...

Page 182: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Started with itching, swelling and burning of lips the day of.took benadryl then all day the 13th. That evening I started feeling it in my tongue and throat I did benadryl and epi went to emergency room and was given steroid ...

Page 183: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Syncope; headache; body aches; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; intermittent fevers with flushing/chills; nausea night of 2nd inj and next day; Severe fatigue; joint pain; I felt very ill; akin to the flu; This is a spontaneous report from a contact ...

Page 184: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Roughly six (6) hours after I received my second dose I became extremely agitated and angered what I would call a homicidal rage that lasted for about an hour which then morphed into a visual hallucinations those lasted for about an hour and those turned into racing heart with heart palpitations and ...

Page 185: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description - day after vaccine developed cough productive of white mucus, dyspnea on exertion. Finally sought care 3/17 due to progression of symptoms and was found to have bilateral pulmonary emboli. No DVTs. No risk factors for PE. No prolonged immobilization, travel, surgeries, obesity, active cancer. - COV ...

Page 186: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description my left ankle was lightly swollen yesterday and it's still swollen today; This is a spontaneous report from a contactable consumer (reported for himself). A 65-year-old male patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Batch/lot number and Expiration dat ...

Page 187: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Itchy vesicular rash on lower right back 3 days after first vaccine dose. Redness and blistering. Itching resolved after treatment with topical steroid for ~7 days. Bumps have remained till now. ...

Page 188: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Started Tuesday evening with light headed, dizziness, headache, in the early morning hours pt said she felt as if her right side was going numb & asked to go to the hospital. Later in the afternoon she got worse along with bad chest pain & stomach & started vomitting ...

Page 189: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description Metallic taste in mouth, cotton mouth, woke me up out of completely asleep at 12;15 a.m. drank carbonated soda , realized it was exactly 84 hours later after receiving second vaccine. Looked up side effects online. Then read some people saying they felt like the had a mouth full of nickles in mouth ...

Page 190: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description soreness in arm, bad headache, nausea, itching on head, face and upper body. ...

Page 191: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description left side bell's palsy symptoms ...

Page 192: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event/Outcome: See Description The morning following my vaccination, I began experiencing gross hematuria. This condition has continued for 24 hours now. ...

Page 193: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Abdominal pain upper Stomach pain ...

Page 194: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Adult failure to thrive Date of Admission 06/04/2021 Date of Discharge 06/05/2021 Reason for Hospitalization - Fatigue Hospital Course - Patient is a 67 YoF with a PMH significant for stage IV mantle cell lymphoma, antiphospholipid antibody syndrome on Xarelto, last received rituximab on 5/7 with recent hospital admission ...

Page 195: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Angioedema Angioedema; Diarrhoea; headache; lethargy; Myalgia; vomiting; wheezing; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority report number is 548219. A 46 (unspecified unit) old female patient received BNT162B2 (COMIRNATY), via an ...

Page 196: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Aphasia Not sleeping well at night due to pressure feeling in her chest up; Not sleeping well at night due to pressure feeling in her chest up; shivers; jaw got paralyzed; she got shaky; feeling bad/ brain fog; burning sensation in her body; She couldn't talk; slight elevated temp (99.7F max); She has been ...

Page 197: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Arthralgia Muscular weakness; Musculoskeletal stiffness; Arthralgia/Joint pain; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20212698. A 72-year-old male patient received BNT162B2 (COMIRNATY, solution for i ...

Page 198: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Arthralgia Feeling febrile, headache, severe body aches, fatigue, joint pain and weakness in arm shot was given (lasted the longest) ...

Page 199: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Asthenia Immediate: severe nausea/dizziness (room spinning) and a strong constant metallic taste 1 hour following: neck swelling, jaw pain/tingling, face numbness, arm numbness (Right arm) - patient took 25 mg Benadryl po 2 hours after: weakness (difficulty ambulating) and foot itchiness/tingling 8 hours aft ...

Page 200: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Axillary pain Swelling in my nodes. Pain in my armpit on the side I got my first shot. Achy joints. ...

Page 201: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Barium swallow Received first dose Pfizer/BioNTech vaccine 4/14. One day after vaccination began feeling abdominal pain, associated with nausea. Described as starting near the umbilicus, then to bilateral sides. Presented to medical attention on 4/16 (2 days after vaccination.) Initial concern was for appendicitis ...

Page 202: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Blood creatine phosphokinase Urticaria after 22 hours; diagnosed grade 1 allergic reaction with urticaria and angioedema (of the eye and right lip); feeling hot and cold; Vomiting after 24 hours; dizziness with presyncope (after 30 hours); dizziness with presyncope (after 30 hours); 38,2°C; angioedema (of the eye and right lip)...

Page 203: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Blood pressure decreased Lightheadedness, rapid breathing, tingling sensation all over the body, sudden drop in blood pressure to 80/50. Lasted about 20 minutes and then gradually subsided without medical treatment . ...

Page 204: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Blood pressure measurement Muscle spasms; This is a spontaneous report received from a contactable consumer (patient) from the United Kingdom's Medicines and Healthcare products Regulatory Authority. The regulatory authority report number is , Safety Report Unique Identifier . A 47-year-old male patient received the first dos ...

Page 205: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Blood test tiny blood clots under her skin/they looked like a circle of a bruise/Colored dark blue; tiny blood clots under her skin/they looked like a circle of a bruise/Colored dark blue; arrhythmias 3 times per night/Increased frequency of arrhythmias; arrhythmias 3 times per night/Increased frequency of arr ...

Page 206: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Body temperature kidney was not functioning properly; GFR was 41 (stage 3)/ low GFR; Stage 3B Kidney disease; 100.2°F fever; whole body was aching; tired; right kidney started aching and then the left kidney; leucocytes in her urine; high creatinine; bladder symptoms; oil bubbles in my pee/bubbles in her pee; I don' ...

Page 207: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Body temperature Fever of 101; body aches like the flu; headache; like the flu; This is a spontaneous report from a contactable health care professional, the patient. A 53-years-old female non-pregnant female patient (health care professional) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN ...

Page 208: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: C-reactive protein increased C-reactive protein: 97.8mg/l; Red blood cell sedimentation rate: 35mm; Pulmonary artery embolus bilateral; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100031367. A 36-year-old female patient ...

Page 209: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Cerebral artery occlusion global aphasia and right hemiplegia; Sopor; global aphasia and right hemiplegia; Glasgow Coma Scale - 8; Middle cerebral artery occlusion; This is a spontaneous report received from a contactable physician downloaded from the European Medicine Agency (EMA) EudraVigilance-WEB. The regulatory authorit ...

Page 210: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Chest pain According to patient, he received the COVID vaccine on 1/18 and endorsed typical vaccine symptoms (myalgias, fatigue, lymphedema on right axillary, sweats and chills). He was taking ibuprofen for prophylactic symptom relief and was able to attend work the following day. The patient stated to still e ...

Page 211: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Chest X-ray normal 4/1/2021 odd tickling cough, brief. Biked anyway, 60 min hard ride. But just in case started 81mg ASA qd. 4/2 odd tickling cough brief. Biked anyway, 60 min, good hard ride. not feeling ill, no fever, cough did not continue, not productive, no URI symptoms. Cough was different. 4/3 woke with pain up ...

Page 212: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Chills Fever, Chills, Heart Palpitations - Heart rate was 126 Joint Pain Pain in Chest when taking Breaths More Pain when lying down, cant turn on the side Eye Pain with Headaches ...

Page 213: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Chills Extreme tiredness Headache Muscle pain Chills Nausea Feeling unwell ...

Page 214: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Chills Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Injection site redness; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCI ...

Page 215: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Computerised tomogram abdomen normal Dizziness, tachycardia, bells palsy, neck pains, fainting,, fainting after eating, trouble speaking, swollen lymph nodes, dysautonomia , chest pain, anxiety, weird stretchy feeling in the neck, diarrhea like morning sickness, nausea, spasms in throat while speaking ...

Page 216: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Condition aggravated I had a flare up of what I believe to be Leprosy, specifically in my left hand.; I had a flare up of what I believe to be Leprosy, specifically in my left hand.; vaccine caused my immune system to flare up, and once my immune system returned to normal I suspect that a pre-existing bacterial infectio ...

Page 217: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Cough No adverse side effects from vaccine. Just that after 5 days of receiving vaccine, I became infected with Covid-19. Started with symptoms Tuesday Dec. 29 2020 at 6am (Chills, severe body aches) I currently work in a jail setting with active covid-19 cases. Exposure to covid-19 at work high. Covid sy ...

Page 218: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: COVID-19 Breakthrough infection; positive COVID-19 test with clinical symptoms (respiratory symptoms of inflammation of the upper airways, rhinitis, sore throat, headache, and fatigue); Breakthrough infection; positive COVID-19 test with clinical symptoms (respiratory symptoms of inflammation of the upper ai ...

Page 219: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Deafness neurosensory Patient had tinnitus for 3 days following Pfizer vaccine, and then sudden sensorineural hearing loss ~ 4 days after the Pfizer vaccine. ...

Page 220: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Deep vein thrombosis Popliteal vein thrombosis/deep vein thrombosis on the femoral superopoplitus of recent appearance on the right; superficial venous thrombosis of the right small saphenous vein/saphenous vein thrombosis; red leg, painful and hot; red leg, painful and hot; red leg, painful and hot; This is a spontaneo ...

Page 221: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Diarrhoea Suspected COVID-19; Suspected COVID-19; Diarrhea; Taking other treatments or medicines, known to lower the immune response; Taking other treatments or medicines, known to lower the immune response; weakness; tiredness; This is a spontaneous report from a contactable consumer. This is a report receiv ...

Page 222: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Disturbance in attention extremely strong menstrual cramping and bleeding; extremely strong menstrual cramping and bleeding; Throbbing pains in the side of head; Extremely cloudy in the head; Attention span is limited; Migraines longer than 4 days; This is a spontaneous report from a contactable consumer (patient). A 21-yea ...

Page 223: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Dizziness 51 yo black female c/o itching and dizziness 15 minutes after receiving her 1st dose of the Pfizer vaccine. Patient stated to staff member she started to itch all over 10 minutes after sitting in the observation area. Patient was escorted to the triage area where she was evaluated by on-site EMS and ...

Page 224: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Dizziness PATIENT COMPLAINED OF FEELING DIZZY AND WARM. TINGLING IN RIGHT HAND AND BACK OF THROAT. RED AND BLOTCHY AROUND NECK. FEELING NAUSEA. BENADRYL 50MG IM GIVEN RT DELTOID. ...

Page 225: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Dizziness Vaccine given at 1845 @ 1851 Raven describes feeling dizzy, hot, and ringing in her ears Was in standing position , encouraged to sit, denied nausea- offered juice, applied pox/HR monitor HR 78 , pox 98% on RA 1855 ringing in ears subsided, verbalized feeling better drank full offering of apple juic ...

Page 226: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Dry throat Dry mouth; Upper back pain; Weakness; Tiredness; Dizzy spells; Low back pain; Ear ache; Water retention; Abdominal bloating; Dry throat; Headache; Out of body experience; Bloating; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority ...

Page 227: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Dyspnoea Dizziness & NauseaVomiting Narrative: Employee reported immediate side effects of dizziness, nausea, and shortness of breath to 2nd dose of COVID-19 vaccine. Vital signs taken and were within normal limits. Reported continued nausea at 1345 while other symptoms resolved. Multiple nurses offered to c ...

Page 228: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Dyspnoea Throat swelling; Face swelling; Flush Face; headache; fast heart beat; difficult breathing; chills; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) first d ...

Page 229: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Ear pain Sickness; feeling very cold; pain in left ear; feeling unsteady; very tired; This is a spontaneous report from a contactable consumer. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202101170706576640, Safety Report Unique Identifier GB-MHRA-ADR 24604667 ...

Page 230: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Electrocardiogram Nausea; Dizziness and room spinning; room was spinning; her white blood cell count was elevated; Kidney failure and allergic reaction; Allergic Reaction; still wasn't feeling normal; Could not keep head up and was in bed; breathless; extreme fatigue; exhausted and weak; Heart was banging fiercely; T ...

Page 231: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Epistaxis Sneezing bout of 10-15 minutes following injection. Fine until after dinner when I felt a liqiud draining in my right nostril. I suspected it to be mucous but was surprised when I wiped and blew my nose, red blood was on the tissue. It stopped bleeding and no longer bled. No other symptoms occurred. ...

Page 232: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Exposure to SARS-CoV-2 Contact with and (suspected) exposure to covid-19 Suspected COVID-19 virus infection Clinical Support 4/13/2021 COVID-19 virus infection Dx Encounter Notes All notes COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide MAB Infusion Treatment Team: Primary Care Physician: The physician ...

Page 233: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Facial paralysis Her left arm and face were numb; mass/swelling on her face; The left side of her face is drooping; face became swollen; face became swollen and inflamed; face was still swollen and sore; This is a spontaneous report from a contactable consumer (patient) and a contactable nurse. This 68-year-old fema ...

Page 234: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Fatigue I received 1st dose of Pfizer covid-19 vaccine on 12/26/2020 w/ no side FX. I received 2nd dose of Pfizer covid-19 vaccine on 1/16/2021 with no immediate side effects. On 1/26/2020 at 10:AM I started experiencing cold chills with uncontrollable shaking and fatigue. I took ibuprofen 800 mg and went t ...

Page 235: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Fatigue insomnia; muscle cramps; Tiredness; Maternal exposure during pregnancy; Hallucinations; Muscle soreness; YELLOW CARD VACCINE MONITOR This is a Non-interventional study report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA ...

Page 236: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Fatigue Some fatigue; This is a spontaneous report received from a contactable consumer, the patient. This patient reported different events with two vaccine doses: This is the second of two doses. This 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mR ...

Page 237: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Fatigue Brain fog; memory problems; slower thinking and movements; general fatigue ...

Page 238: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Feeling abnormal sore throat; coughing; felt quite poorly; fatigued; shoulder which was tense; Pain; upper arm; hurting; jaw line; hurting; across back; hurting; spine; hurting; shoulder blade muscle; hurting; Feeling hot/shoulder; warm; shoulder pain; vaccination site warmth; severe headaches; gastrointestinal bloa ...

Page 239: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Feeling hot Pain to left breast into right leg then left leg and shot back up into her heart area, then would shoot into her head; Shoulders and back achy and tense; Shoulders and back achy and tense; Stiffness; Arm swollen and red from site of injection to elbow for a week; Arm itching; Arm heated; This is a s ...

Page 240: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Flushing Patient presented with flushing and rash on face within 3 minutes of vaccination. Her throat started to itch and she was experienced difficulty swallowing without dyspnea. EMS was contacted and obtained vitals upon arrival. Patient was stable with BP of 185/95 and 02 sat of 98% on room air. Vitals r ...

Page 241: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Gastrooesophageal reflux disease hard time breathing; heart attack; minor chest pain which he thought was indigestion and heart burn; had clot arteries based in blood clots; 1 artery was 99% blocked; cold sweats; afraid to eat because he was so bloated/acid reflux; could not hold food down; out of energy; fatigued, totally out of e ...

Page 242: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Hallucination, auditory auditory hallucination; This is a spontaneous report from a contactable physician (patient herself). A 42-year-old female patient (non-pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 28Dec2020 in left ...

Page 243: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Headache Headache (akin to a tension headache, forehead location) almost instantly after injection that has persisted but lessened in severity since injection over the course of one week. ...

Page 244: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Headache flu-like aching; generally under the weather; injection site warmth; pain at the injection site; injection site itching; headache; injection site lump; This is a spontaneous report received from a contactable consumer (patient) by Pfizer from the Regulatory Agency. The regulatory authority report nu ...

Page 245: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Headache Vertigo; Tachycardia; Hypotension; Asthenia; Pain; Sensitivity; Edema; Inflammation; Dizziness; Vomiting; Nausea; Headache; Fatigue; This is a Spontaneous report from a non-contactable Other Health Professional. This is a report received from Health Authority . Regulatory authority report number is ...

Page 246: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Headache under arm started to burn, went and looked and glands had swollen up to golf ball size; under arm started to burn; Pain in joints; headache on right side; This is a spontaneous report from a contactable other health care professional (patient). A 52-years-old non-pregnant female patient received sec ...

Page 247: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Headache Becoming acutely dizzy, light headed, nausea, head ache, diaphoretic, feeling like about to faint ...

Page 248: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Heart rate increased About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl. ...

Page 249: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Hepatitis C virus test During the night following vaccine administration, fever (peak 38.1°C), swelling and pain in the feet and hands, enlarged submandibular lymph nodes with pain, swollen axillary and clavicular cavity lymph nodes; During the night following vaccine administration, fever (peak 38.1°C), swelling and pain ...

Page 250: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Hyperhidrosis I had the ""normal"" aches and tiredness starting many hours after 2nd shot (1st shot only had the very sore arm/unable to lift left arm straight up on the second and third day). Went to bed around 10pm. Slept hard and woke up at 12:05am the next morning with EXTREME convulsing chills and clearly ha ...

Page 251: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Hypersensitivity I have severe allergies now because from the shot I almost died; shot made my allergies like ten times worse; I have severe allergies now because from the shot I almost died; shot made my allergies like ten times worse; I can't hear you my allergies are horrible today; Light-headed; Cough; This is a ...

Page 252: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Hypoaesthesia oral On 1/24/2021 states on that Sunday his tongue became numb and developed pain behind right ear. Took ibuprofen, went to bed that even. When he awoke the next morning, Monday, 1/25/2021, the right side of his face was disfigured, puffy, and his mouth was drawn down. He drove to family member approxima ...

Page 253: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Hypomenorrhoea Monthly Period during normal scheduled time was only 1 day and very small. 2 weeks later it is a normal flow and massive pain/cramps. This is above normal. I have a Paraguard IUD to help control flow and was not off until after this shot. According to my tracker between dose 1 and dose 2, my period ...

Page 254: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Impaired work ability I received the first COVID vaccine from Pfizer. At first I experienced only mild side effects such as headache and fatigue and dizziness. That night I awake with severe stabbing abdominal pain. I couldn't sleep much of the night due to pain. The pain continued until the following day. I had to take ...

Page 255: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Influenza B virus test Inpatient Discharge Summary Admission Date: 3/22/2021 Discharge Date: 3/27/2021 Principal Problem: COVID-19 virus infection Hospital Course s a 79 y.o. male who presented to the hospital with a complaint of 1 week of shortness of breath and fever. He was managed for- COVID19 pneumonia with acute hyp ...

Page 256: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Injection site hypoaesthesia Day 1: limited mobility in the left shoulder join, pain at the injection site Day 3,4,5: numbness of the arm and fingers on the left arm, unable to hold fingers together, whole left arm numbness occasionally, limited control of movements ...

Page 257: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Injection site pain At 9:00 PM on the day of vaccination (8 hours after vaccination) I felt achy and tired and needed to lay down. I also had chills and soreness & swelling at the injection site. I went to bed at 10:30pm. At 1:45 AM (13 hours after vaccination) I woke up with low grade fever, chills, muscle/body aches, ...

Page 258: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Insomnia Second dose received Thursday 1/21/21 Evening of Friday 1/22/21- arm pain, hands and feet chilled, achy ankles, back pain, low grade temperature Saturday (1/23)- backpain, night sweats Sunday (1/24)- night sweats, backpain, pain around ribcage in the front, felt sucker punched, feeling chest tightne ...

Page 259: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Joint range of motion decreased Cannot raise arm for two days., it is ok on the third day and forward. ...

Page 260: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Leukocytosis Inflammatory reaction; Leukocytosis; Renal failure aggravated; Rhabdomyolysis; pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21111376. A 82-years-old male patient (reported as 82-year and 4-month-old) ...

Page 261: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Loss of consciousness Got sick; Headache; Shortness of breath; Passed out; Dizzy/ Dizziness; Tightness in her chest; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, first dose, intramuscula ...

Page 262: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Lymphadenopathy Increase in size of lymph nodes. This was detected the day before my second shot based on self exam suggested by my spouse. ...

Page 263: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Magnetic resonance imaging head abnormal Multiple blood clots, bleeding, hematoma, bleeding events after heparin, swelling in lower body, gangrene in both feet, double below knee amputation, situation ongoing, still in hospital. ...

Page 264: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Malaise Headache; Tiredness; Feeling sick; Hot flush; Chills; This is a spontaneous report. A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21May2021 (Lot Number: ET8885) as SINGLE DOSE for COVID-19 immunisation. ...

Page 265: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Mean platelet volume normal Admitted on 6/18 with fever, pain at injection site and chest pain. Evaluated at local ED, found to have an elevated troponin to 12 and ST elevation in anterolat leads by report on EKG. An ECHO was obtained and revealed decreased EF to 47% and he was transferred to our hospital, initially monitored ...

Page 266: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Migraine Dizziness at time of injection, migraine the rest of the day. Nausea and slight dizziness throughout the week. Left work early 1/20/21 with nausea and vertigo, began short term disability. Contacted PCP for antibiotics thinking I had an ear infection; upon completion of antibiotic and continued symp ...

Page 267: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Muscle spasms feels like there are little tiny baby hands pinching his internal organs throughout his abdomen; Eyes swollen and his vision was diminished; Eyes swollen and his vision was diminished; On his injection arm- 2 inches away from the injection site appeared a size of a gigantic golf ball/A huge lump app ...

Page 268: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Myalgia Dizziness, Headache, Myalgia, Nausea Vomiting, hot flash, right side chest heaviness x 1 day ...

Page 269: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Myalgia suspected myocardial infarction; Muscle pain in the chest symptom of myocardial infarction swollen Adam's apple jaw pain and between shoulders; Muscle pain in the upper body; stuffed Adam's apple; jaw pain; pain and between shoulders; This is a spontaneous report from a contactable consumer, downloa ...

Page 270: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Myocardial oedema 16-year-old male with no significant past medical history, now presenting with chest pain. Patient had 2 episodes of left-sided mid-chest pain. The initial episode was at ~ 3 am on 5/18 when the pain woke him up from sleep, lasted for ~ 20 minutes and he was able to fall back to sleep, he did not me ...

Page 271: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Nausea Initial nausea and vomiting two weeks after administration, followed by progressive dementia-like symptoms, including fatigue, muscular weakness and tremor, confusion, memory problems, lack of concentration. Abandonment of previously routine household and personal tasks. Inattentiveness to personal ...

Page 272: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Nausea she blacked out (fainted) on her way to the bathroom; sore arm; nausea; feeling very unwell; hit her head on the bathroom door; chills; extreme sweating; She is still having dizziness; chills, extreme sweating, clam hands, sweating.; This is a spontaneous report from a contactable consumer (patient) ...

Page 273: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Nausea his liver panel showed issues; Graves' disease; white blood cells came down; loss of appetite; weak; Diarrhea; he would get tired very quickly.; spiking fevers; Increased blood pressure; high resting heart rate; baseline heart rate was over 105/his heart rate from 60 to about 80 in the month of Apri ...

Page 274: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Neck pain Sharp pain in my upper arm, wrapping around to my triceps, into my left trapezius and up into the left side of my neck. At about that same time, I developed pain in my left wrist and in the pinky and ring fingers of my left hand. Pain has continued for more than two months now despite regular stretc ...

Page 275: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Nodule syncope; dyspnoea; respiratory distress; Headache; Fever greater than or equal to 38 Celsius degrees; Asthenia/ Fatigue/Adynamia; Asthenia/ Fatigue/Adynamia; chills; induration; nodule; pain; sensitive skin; vaccination site erythema; edema; inflammation; pruritus/itching; exanthema; Body temperatur ...

Page 276: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Oropharyngeal pain Splitting headache, sinus pressure, 102.3 degree fever, body aches, chills, sore throat, runny nose, sore arm, fatigue. Took Advil at 7:00 PM on 2/14/21 because I couldn?t tolerate the pain anymore. It is 11:30 AM on 2/15/21 and still fatigued, aches, chills, and headache. ...

Page 277: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Oxygen saturation slight COVID-19 infection despite 2x vaccination/ mild COVID-19 infection without lung involvement (Ct 19); slight COVID-19 infection despite 2x vaccination/ mild COVID-19 infection without lung involvement (Ct 19); This is a spontaneous report from contactable physician downloaded from a regulatory ...

Page 278: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Pain in extremity Light periods; Painful arm; YELLOW CARD VACCINE MONITOR This is a Non-Interventional Study report received from a contactable consumer received from the regulatory authority report number is GB-MHRA-YCVM-202105192021230410-EGXO1. Safety Report Unique Identifier GB-MHRA-ADR 25324357. A 41-year-old no ...

Page 279: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Pain in extremity Pt was at work, laying tile, and developed sudden onset of chest, back, neck and left arm pain, with associated dizziness around 10:15AM 5/10/21. He sat down for bit and symptoms persisted. He vomited x1 and went home, assuming he had developed the same ""24 GI bug"" his daughter had over the weeken ...

Page 280: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Pain An hour after I had the vaccine, I started having headaches, followed by slight vertigo. I took Tylenol as soon as I got home due to symptoms getting worse. That night I went to bed at 10pm and didn?t wake up till 7:45am (I was dead tired, I didn?t even hear my alarm). Jan/19/21. Soon as I got up, I ...

Page 281: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Pain Large rash at site. Pain, swelling. extreme fatigue. ...

Page 282: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Pain achy, ""just don't feel good"", facial swelling, shortness of breath, slight headache ...

Page 283: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Palpitations Client reports that 5 minutes after her dose she felt lightheaded, palpitations, flushing of her face and feeling hot. ...

Page 284: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Paraesthesia oral All day Saturday the right side of my face felt tingly and when pressed hurt. Was able to smile, talk and move my face. Tongue tingled a little, and lips (right edge of mouth) off and on until it finally stopped Sunday morning. Haven?t had any issues with it since then. Never had that happen before, ...

Page 285: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Paraesthesia began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face ...

Page 286: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Peripheral swelling My leg and foot swelled on Thursday. We elevated and treated with heating pad & Advil. The swelling went down, so we started for home, drove 4hrs. My leg & foot swelled back up. We went to the ER they gave me an ultrasound, and said I had 2 blood clots in my leg. They prescribed, Eliquis. ...

Page 287: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Platelet count purpura on the tongue, mouth, face and upper limbs; This is as spontaneous report received from a contactable pharmacist downloaded from the regulatory authority report number is FR-AFSSAPS-RE20211006, Safety report unique identifier FR-AFSSAPS-2021035364. A 94-year-old patient of an unspecified gen ...

Page 288: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Product administered to patient of inappropriate age pt became very fatigued and has bouts of confusion. She has episodes where she doesnt know where she is or who she is with. She has had one episode that she didnt know who she was that lasted a few seconds. Most episodes last a couple of minutes. Her parents took her to Hospital ER i. They did an EK ...

Page 307: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Throat irritation 2 mins after the vaccine I got a burning sensation in throat and chest area my heart beat elevated to 160 the burning sensation lasted about 5 mins elevated heat rate lasted about an hour but in 10 mins I was feeling better and heart rate went to 107 got cramping in stomach which lasted about an hou ...

Page 308: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Tinnitus I have constant tinnitus since about a day after receiving the first dose to the Covid-19 vaccine. It got worse over the New Year's weekend, and now seems to be stabilized as a constant ringing. I will be making an appointment this coming week to have it investigated, but wanted to get the prelimina ...

Page 309: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Tremor Headache right forehead with impaired sensation of this; Headache right forehead with impaired sensation of this; Feeling unwell with coldness, tremors and confusion; pain and weakness of the legs; Feeling unwell with coldness, tremors and confusion; Feeling unwell with coldness, tremors and confusi ...

Page 310: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Ultrasound Doppler two weeks after vaccination, pt developed significant DVT throughout venous system of leg. Had been extremely sedentary from msk injury sustained 3 days prior to vaccine ...

Page 311: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Urine analysis On 4/18/21 the day after receiving my second Pfizer vaccine. I awoke fatigued and with a sore right arm and fever of about 99. The fatigue increased, and then included extreme thirst despite drinking plain water throughout the morning and early afternoon, then I experienced slight nausea, then synco ...

Page 312: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Vaccination failure Vaccination failure; asymptomatic COVID-19; This is a spontaneous report from a contactable other hcp downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IT-MINISAL02-713261. A 93-years-old female patient received bnt162b2 (COMIRNATY, solution for injection) first dose on 28J ...

Page 313: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Vaccination site pain temperature rise 37.7 ° C, headache, bone pain, pain at the injection site that cannot be controlled with drugs; temperature rise 37.7 ° C, headache, bone pain, pain at the injection site that cannot be controlled with drugs; temperature rise 37.7 ° C, headache, bone pain, pain at the injection site ...

Page 314: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Ventricular extrasystoles PVCs with compensatory pauses, postural orthostatic hypotension associated with chest tightness, shortness of breath, dizziness and blurry vision ...

Page 315: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Vital signs measurement Systemic: tachycardic and uncontrollable shaking-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: 30-35 min post injection...patient complained of feeling strange and her heart was pounding. Measured BP at 160/95 and P at 117. Had patient sit in armed chair and d ...

Page 316: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: Vomiting 3 hours following vaccine experienced vomiting, loss of balance and throat tightening resulting in shortness of breath. Was seen in same day care within 20 minutes of symptom onset. Given Kenalog 80mg intramuscular and Zofran 4mg intramuscular with improvement of symptoms ...

Page 317: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Event: X-ray normal Day 1. Had numbness in left hands. Nausea as well that day. Day 3 had a headache and couldn?t sleep from it. Day 4 stiff neck started early morning but night couldn?t sleep from pain and not able to find a comfortable spot. Day 5. Neck pain significantly increased. Couldn?t turn my head right or lef ...

Page 318: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Death death- unexplained cause ...

Page 319: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Hospitalization Death Cardiac arrest Hyperkalemia NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) ESRD needing dialysis (CMS/HCC) ...

Page 320: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Hospitalization Guillain Barre syndrome; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202104051047074320, Safety Report Unique Identifier GB-MHRA-ADR 25080126. A female patient of an unspecif ...

Page 321: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Hospitalization Heart attack; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 24Mar2021 (at the age of 37-years-old) at single dose for COVID-19 immunisation. Medical history and concomitant medi ...

Page 322: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Life-Threatening STROKE; facial paralysis; could not stand; could not walk; unconsciousness; short-term memory disappeared; This is a spontaneous report from a contactable consumer (patient) downloaded from the WEB, regulatory authority number SE-MPA-2021-042567. An 83-year-old female patient received BNT162B2 (COMI ...

Page 323: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery Fever, headache, chills. ...

Page 324: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery Approximately 5-10 minutes after 1st dose of vaccine, patient complained of feeling sweaty, nauseous, and not feeling right. She was tachycardic and bradycardic soon after. She was transported to the ED for evaluation. She endorsed lightheadedness, chest pain, and trouble swallowing upon ED triage. ...

Page 325: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery Embolism pulmonary; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Agency WEB, Regulatory authority number ES-AEMPS-869098. A 71-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 26Apr2021 (Lot Number: EW6326) as 1st dose, single ...

Page 326: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery shingles; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority EudraVigilance-WEB CZ-CZSUKL-21003582. A 71-year-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 15Mar2021 (Lot Number: ET3620) as single dose for COVID-19 immun ...

Page 327: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery Within 5 minutes of injection, client became flushed and diaphoretic. She felt extremely nauseated and vomited x1. Client had not eaten breakfast before injection. Client monitored for over 1 hour in dark quiet room where client was able to recline and relax. Vital signs were stable. No difficulty b ...

Page 328: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery COUGH, TOUNGE TINGLING , SCRATCHY THROAT 15 MIN POST VACCINE. EPI AND BENADRLY GIVEN IN CLINIC EMERGENCY DEPT GAVE DECADRON ...

Page 329: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery Aches and chills, fatigue, fever of 101.4 and headaches. Treated with Ibuprofen and Acetaminophen. Lasted 2 days. ...

Page 330: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery Started with fever, chills, sweating, headache, body aches and extreme fatigue about 14 hours after vaccine, symptoms subsided about 48 hours after onset. ...

Page 331: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Recovery Headache ...

Page 332: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Visit to Hospital or Doctor (Emergency) After receiving the vaccination, when I stood up I felt a rush to my head. I went to sit in the waiting area to be monitored and my tongue and lip started itching. I then started w/ a red rash to the R side of my neck. My body started to itch all over. I was brought into a treatment room and my vita ...

Page 333: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Visit to Hospital or Doctor (Emergency) Ramsay Hunt syndrome 3 days after second vaccine shot; This is a spontaneous report from a contactable consumer(patient). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12May2021 (at age 25-years-old) (Batch/Lot Number ...

Page 334: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Visit to Hospital or Doctor (Emergency) Acute Myocarditis ...

Page 335: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Visit to Hospital or Doctor (NonEmergency) 20 minutes after shot, I experienced a warm sensation move across my chest. I began having a headache in the right temple. These two effects lasted 30-40 minutes. I began to feel a little better so I returned to work. On Friday 3-26-2021 I began feeling extremely weak and muscle aches. My heart rate ... Page 336: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Visit to Hospital or Doctor (NonEmergency) collapse; Syncope; symptoms of anaphylactic shock; WBC 15.7 thou/ ul; Glucose: 110 mg/dl; This is a spontaneous report from a contactable consumer (patient) received by post. A 46-year-old male patient received his first dose of bnt16b2 (COMIRNATY) via an unspecified route of administration as a sin ... Page 337: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Visit to Hospital or Doctor (NonEmergency) L jaw tingling. scratchy throat, globus sensation in throat 20 min s/p vaccine. globus sensation resolved following benadryl. tingling still present at 14 hours but has improved. ...

Page 338: COVID19 • COVID19 (COVID19 (PFIZER-BIONTECH)) • Outcome: Visit to Hospital or Doctor (NonEmergency) After each dose I had a very heavy menstrual period that I was not due for within 24 hours ...

Page 339: COVID19 • COVID19 (COVID19 (UNKNOWN)) • Event/Outcome: See Description I have been having episodes of tinnitus for about 30 years. After the first vaccine, tinnitus was 24/7 with increased in sound. After 2nd vaccine, unnerving - loud, constant, losing sleep. Still loud, constant but must be getting used to it - able to sleep. However, if I wake up early, cannot get ba ...

Page 340: DT • DT ADSORBED (DECAVAC) • Outcome: Visit to Hospital or Doctor (Emergency) Redness swelling and itching of R arm and legs, (-) SOB, syncopy (-) wheezing warm now spreading down her arm. ...

Page 341: DT • DT ADSORBED (NO BRAND NAME) • Event: Rash maculo-papular This 34-year-old was activated November 2003 and later discharged. During this month of activation, she received Anthrax #1, Typhoid, Hepatitis A #1, Influenza, IPV, Diphtheria, and a Tuberculin test. She states the shot was given to the upper backside of her right arm. That evening her arm became s ...

Page 342: DTAP • DTAP (ACEL-IMUNE) • Event: Ear disorder 12JAN97 @ 2AM pt woke up w/fever 100;dx ear infect by phone & ordered cofactor;14JAN97 5PM pt woke up from nap felt warm;mom held pt & eyes rolled back;started shaking all over;mom called 911;t105;taken to ER; ...

Page 343: DTAP • DTAP (ACEL-IMUNE) • Outcome: Recovery following day p/vax pt exp crying for 2hr or more, sl fever, dec appetite;TO ER;21OCT98 T101.2;diagnosis possible adverse reaction (crying/fever), poss esophagitis d/t thrust, ?acid reflux; ...

Page 344: DTAP • DTAP (DAPTACEL) • Event/Outcome: See Description Pt. received vaccinations 3/14/12. Mom reported reaction 3/16/12. Pt. evaluated by MD. (1) Right deltoid 3x2 cm erythematous rash, tender/warm indurated. (2) Left deltoid 5x5 cm erythematous rash, tender warm indurated - treated with BACTRIM antibiotic x 10 D. ...

Page 345: DTAP • DTAP (DAPTACEL) • Event: Blister On left arm where client received Dtap 5 and polio 4, arm was red and swollen approx 7""x5"". In the center of the redness was a large blister 1""x 1/2"" with small blisters surrounding approx 3""x3"". Mother states he gets this reaction when he gets mosquito bites. Referred to physician. ...

Page 346: DTAP • DTAP (DAPTACEL) • Event: Eyelid oedema Eyelids and facial swelling, cough, wheezing. ...

Page 347: DTAP • DTAP (DAPTACEL) • Event: Injection site induration Started on evening of day vaccine given arm swollen, erythematous, indurated upper arm (same arm vaccine given in). Treated with Tylenol, compress and Benadryl. ...

Page 348: DTAP • DTAP (DAPTACEL) • Event: Listless Vaccines given at approximately 12:39pm, shortly thereafter, patient became listless and diaphoretic. Mom immediately notified MA who in turn notified RN. Patient was returned to exam table, legs elevated, vitals taken, oxygen administered. MD at bedside monitoring treatment. Eventually, she was sat ...

Page 349: DTAP • DTAP (DAPTACEL) • Event: Rash papular Multiple papules, vesicles, trunk, neck, arms. ...

Page 350: DTAP • DTAP (DAPTACEL) • Outcome: Hospitalization Intussusception 5/15/07 Received vax records from reporter. Lot numbers corrected in VAERS database. RO lot number & dose confirmed by vax records. 5/25/07 Received medical records from hospital which reveal patient experienced emesis, bloody stools, abdominal pain & lethargy. IS at right hepatic fl ...

Page 351: DTAP • DTAP (DAPTACEL) • Outcome: Recovery Low grade fever, right arm swelling at site of injection, hard, by hospital had cellulitis. ...

Page 352: DTAP • DTAP (INFANRIX) • Event/Outcome: See Description Swelling and pain of right bicep after vaccination. CL Mid biceps circumference = 22 cm, R = 26 cm. Small bullas surrounding vesicles at site of injection. ...

Page 353: DTAP • DTAP (INFANRIX) • Event/Outcome: See Description Noticed hives at injection site of dtap, left thigh. Area swelling and hot to touch. Given 25 mg of benadryl and notification clinic of reactio, 1:15 pm. Hives subsided with benadryl but 2 hours later they reappeared. complained of her head hurting a lot and stomach pain. RN from clinic called and I ...

Page 354: DTAP • DTAP (INFANRIX) • Event: Angioedema This case was reported by a physician and described the occurrence of laryngeal edema in an infant subject of unspecified gender who was vaccinated with Infanrix, GlaxoSmithKline for prophylaxis. In 2004 the subject received unspecified dose of Infanrix (unknown) lot number not provided. In 2004, 15 ...

Page 355: DTAP • DTAP (INFANRIX) • Event: Dermatitis bullous Erythema and rash bullous; Erythema and rash bullous; This is a spontaneous report from a contactable Physician via regulatory authority downloaded from the regulatory authority-WEB: IT-MINISAL02-545533. A 5-month-old male patient received on 09Apr2019 pneumococcal 13-val conj vac (dipht crm197 prot ...

Page 356: DTAP • DTAP (INFANRIX) • Event: Haemoglobin normal This is a spontaneous report from a contactable physician received from Agency. Regulatory authority report number NO-NOMAADVRE-FHI-2016-21824. A 5-month-old male patient received second dose of PREVNAR 13 (batch number J74504), at 0.5ml single dose and second dose of INFANRIX (batch number A20CB185 ...

Page 357: DTAP • DTAP (INFANRIX) • Event: Injection site hypersensitivity Pt c/o red/swollen area with itching to LMT where DTPA injection given 4 x 4 area ...

Page 358: DTAP • DTAP (INFANRIX) • Event: Injection site swelling This case was reported by a regulatory authority (Regulatory Authority (clinical) # 616739235) and described the occurrence of arm cellulitis in a 6-year-old male subject who was vaccinated with (Infanrix, GlaxoSmithKline) for prophylaxis. On 4 October 2007 the subject received unspecified dose of I ...

Page 359: DTAP • DTAP (INFANRIX) • Event: No adverse event No adverse events. ...

Page 360: DTAP • DTAP (INFANRIX) • Event: Pyrexia Pt was administered IPV, DTaP, Hib/HepB, and PCV7 on 7/20/05 at around 3:00 p.m. Pt was given Tylenol at the clinic and every 4-6 hrs at home. At around 6:00 a.m., pt was noted to feel warm. At 7:00 a.m. she was noted to have a temp of 102 and over the next hour she became ""listless, grey, and limp ...

Page 361: DTAP • DTAP (INFANRIX) • Event: Tenderness Pt has edema almost an erysipelas over the injection site, tender and hot, improved with warm packs and antibiotics. ...

Page 362: DTAP • DTAP (INFANRIX) • Outcome: Recovery Injection reaction of left leg 3 cm and crying X 8 hours. ...

Page 363: DTAP • DTAP (INFANRIX) • Outcome: Recovery Local red cutaneous reaction without infection. Imyculin-maximum dimension approx. 8cm -9cm. ...

Page 364: DTAP • DTAP (INFANRIX) • Outcome: Visit to Hospital or Doctor (Emergency) Per mom after having immunization five days later hive tye rash appeared. Child was seen at ER and told she was having a reaction to one of the immunizations and given Keflex. Was seen by her doctor next day. Rx fill for Keflex and started at approx 3 mos meds given on 3 mo later original rash began ...

Page 365: DTAP • DTAP (NO BRAND NAME) • Event: C-reactive protein normal 9 hours after receiving routine 2 month immunizations (DTaP, Hib, rotavirus, inactivated polio) this pt became first drowsy then lethargic and pale. Pt was brought to ER were he had episodes of bradycardia with desaturations. Events continued hourly for 24 hours and lethargy slowly finished over the ...

Page 366: DTAP • DTAP (NO BRAND NAME) • Event: Injection site swelling LUE swelling, pruritus, pain, diffuse erythema, large hard nodule, low grade fever, nausea, vomiting, diffuse body aches, chills, malaise after medical assistant administered DTaP subcutaneously. ...

Page 367: DTAP • DTAP (NO BRAND NAME) • Event: Tic About 1 1/2 weeks after receiving immunizations, the patient had a seizure while riding in a car. He was taken to the ER and had another seizure. He stayed in the hospital about 4 or 5 days. Tests were done and he was put on medicine, which seemed to help lessen the seizures for a while, but would t ...

Page 368: DTAP • DTAP (TRIPEDIA) • Event/Outcome: See Description Patient came in with red, wetly, raised area of skin right where shot was administered. ...

Page 369: DTAP • DTAP (TRIPEDIA) • Event/Outcome: See Description 14 1/2 x 12cm area of erythema noted on Left upper ventral leg with 1 x 1.5cm black border around white center with injection site centrally. Sx 36-48 after injection. Cold compress and benedryl Q-6hrs. ...

Page 370: DTAP • DTAP (TRIPEDIA) • Event: Erythema Spotty, slight rash (pink in color) to belly and lower back. ...

Page 371: DTAP • DTAP (TRIPEDIA) • Event: Injection site induration Approximately 4 hours post vaccine, patient developed redness, induration and warmth in upper arm which spread to involve entire outer aspect of upper arm by 4/27/01. Patient was given Keflex for rule out cellulitis. Telephone call to patient's mother on 4/28/01 revealed the redness had lessened. ...

Page 372: DTAP • DTAP (TRIPEDIA) • Event: Malaise pt became ill, acted lethargic & started running fever about 1hr p/vax;was taken to ER, T105 R MD on call found no evidence of ear, throat, chest or other infect;site of inj (lt thigh) sore & swollen;mom was told fever probably d/t immun ...

Page 373: DTAP • DTAP (TRIPEDIA) • Event: Respiratory disorder Large area of redness on lft thigh reaching to hip area @ approx 5:30pm. No increase in temp, but child fussy. Took to ER where was told it was reaction to dtap. Injection given & prescription for Benadryl. ER records to be req'd. ...

Page 374: DTAP • DTAP (TRIPEDIA) • Outcome: Recovery Red tender swollen in area that TRIPEDIA DTaP/Hib was given. ...

Page 375: DTAP • DTAP (TRIPEDIA) • Outcome: Visit to Hospital or Doctor (Emergency) Pt experienced elevated fever of up to 103 within four hours of vax. ...

Page 376: DTAPHEPBIP • DTAP+HEPB+IPV (NO BRAND NAME) • Event/Outcome: See Description During her last feeding of the night, she started arching her back. I thought she just wanted out of my lap and to be burped. I sat her up and she started having spasms where she would throw her hands behind her head and turn her head from side to side while her whole body would jerk. She had cluste ...

Page 377: DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Event/Outcome: See Description no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported). No information regarding the patient's medical history, concur ...

Page 378: DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Event: Diarrhoea haemorrhagic Mother reports pt developed significant flatus and subsequent diarrhea (>8 times daily) beginning three days after being vaccinated (5/14/07). Diarrhea has been watery and explosive and at times there has been blood and mucous streaking. This has continued for 2 weeks. ...

Page 379: DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Event: Injection site rash On Monday, 8/27/18, at 9:00 AM I spoke with the child's grandmother, who had left 2 voicemails on our clinic phone over the weekend. She told me the child was found to have a red and swollen right upper arm on Saturday. She stated that the child complained of his right arm feeling hot and having ras ...

Page 380: DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Event: Pyrexia Fever 1/2 day following immunizations 2 days after immunization - redness, swelling, pain on right arm at site of MMR. Spontaneous resolution of symptoms by 3 days following immunization. ...

Page 381: DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Event: White blood cell count normal Redness, induration, swelling on R thigh where Hib and PREVNAR were given. Later developed into a localized abcess. Had recurrence of similar symptoms with 12 mo shots in Aug of 2006. Abscess in L leg with 12 month shots where Hib & MMR were given. Symptom: Erythema Start: 04/2006; Swelling Start 04 ...

Page 382: DTAPHEPBIP • DTAP+HEPB+IPV (PEDIARIX) • Outcome: Recovery Simple febrile seizure- Seen in ER for febrile seizure (simple), that occurred 24 hours after the vaccines were administered. The seizure was not witnessed in the ER but mother reported 1.5 minutes of seizure activity before calling EMS. No other significant signs of infection on ER workup. Was disc ...

Page 383: DTAPIPV • DTAP+IPV (INFANRIX TETRA) • Outcome: Hospitalization This case was reported by the MHRA (GB-MHRA-ADR 21404991) and described the occurrence of injection site cellulitis in a 4-year-old female subject who was vaccinated with INFANRIX-IPV. On 9 November 2011 the subject received unspecified dose of INFANRIX-IPV (0.5 ml, intramuscular). On 10 November 20 ...

Page 384: DTAPIPV • DTAP+IPV (KINRIX) • Event: Drug administered at inappropriate site This case was reported by a healthcare professional and describe the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included varicella virus vaccine (non-gsk); manufacturer unspecified; unknown given on 17 ...

Page 385: DTAPIPV • DTAP+IPV (KINRIX) • Event: Injection site swelling Woke up in AM of March 29 with injections sites with minimal Redness, Warm, induration, Swelling and pain. Mother was given Home comfort measures and to return March 30 for follow up. Child returned and injection sites symptoms have gotton worse throughout the night. Dr. examined child and treated h ...

Page 386: DTAPIPV • DTAP+IPV (KINRIX) • Event: Unevaluable event None stated. ...

Page 387: DTAPIPV • DTAP+IPV (QUADRACEL) • Event: Blood test normal 7/20/19 Febrile seizure - seen in ER. Also had vomiting + h/o recent diarrhea. Bloodwork, urine normal. Abd sono with mesenteric adenitis. T 100.3 in ER. ...

Page 388: DTAPIPV • DTAP+IPV (UNKNOWN) • Event: White blood cell count Initial unsolicited report received from a pharmacist via Health Authority, (under the reference number: 115101249) on 09 July 2015. This case is a cluster of two cases and is linked to 2015SA101488 (same reporter, same vaccine). A male patient had received a third dose of 0.5 ml of ACTHIB, second d ...

Page 389: DTAPIPVHIB • DTAP+IPV+HIB (INFANRIX QUINTA) • Event: Resuscitation This case was reported by a regulatory authority (# NO-NOMAADVRE-FHI-2011-12033) and described the occurrence of loss of consciousness in a 5-month-old male subject who was vaccinated with INFANRIX-POLIO-HIB (GlaxoSmithKline), (non-gsk) PREVENAR. The subject's medical history included torticollis. O ...

Page 390: DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Event/Outcome: See Description Information has been received from a physician concerning a patient who on unknown date, was vaccinated with a first dose of ROTATEQ (dose, route and lot number not reported). On an unknown date, the patient developed intussusception. The patient was hospitalized. The physician considered intussusce ...

Page 391: DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Event: Cyanosis Information has been received from a nurse practitioner concerning a 16 week old patient who ""last Thursday"" on 07-OCT-2010 was vaccinated with a dose of ROTATEQ (Lot# unknown) along with 2 other vaccines which were unspecified. The nurse reported that ""the next day"" on 08-OCT-2010, the patient ...

Page 392: DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Event: Irritability Mom reports after vaccines at 4 mos pt was fussy, in pain, decrease appetite, cried when touched for 1 week after. No treatment. ...

Page 393: DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Event: Sleep disorder Initial report received on 11 February 2013 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electron ...

Page 394: DTAPIPVHIB • DTAP+IPV+HIB (PENTACEL) • Outcome: Recovery My son had a generalized tonic clonic seizure that lasted 14 minutes and required 2 doses of medication to stop it. ...

Page 395: DTIPV • DT+IPV (NO BRAND NAME) • Event: Cough Initial report received from SPMSD (E2014-01355). Case report retrieved from the literature on 07 February 2014. A 23-year-old healthy male took part in a clinical trial and took chloroquine chemoprophylaxis and received three intradermal doses at four-week intervals of aseptic, purified Plasmodium ...

Page 396: DTP • DTP (NO BRAND NAME) • Event/Outcome: See Description mom called couple hr p/vax & stated pt was shaking the hands & head for mins.- called ambulance, but when they arrived pt was OK ...

Page 397: DTP • DTP (NO BRAND NAME) • Event: Agitation 17DEC93 pt let out cry; dad picked up-pt head fell back, eyes crossed & went upward-went limp & was pale-seemed to quit breathing; eyes glazed; ...

Page 398: DTP • DTP (NO BRAND NAME) • Event: Crying Initial unsolicited report received from a physician via partner company (LG LIFE SCIENCES, Manufacturer control number: PL-LGLS-EVX6461) via Health Authority (case ID, under the reference number: PL-URPL-N248/2017) on 10-MAR-2017 and transmitted to Sanofi on 10-MAR-2017. Follow-up information was r ...

Page 399: DTP • DTP (NO BRAND NAME) • Event: Hypotonia Case received from the Health Authorities through the local affiliate in a foreign country on 08 May 2012 under the reference number PL-URPL-OCR-20120412002 (local reference number 2012/0134). A 17-month-old male patient, with no reported medical history, had received his dose of IMOVAX POLIO, batch ...

Page 400: DTP • DTP (NO BRAND NAME) • Event: Metal poisoning This case was reported by a lawyer and described the occurrence of autism in a 18-month-old male subject who was vaccinated with DTP vaccine (A or W not known), (manufacturer unspecified), OPV vaccine, HIB vaccine, MMR, new strain vaccine, Meningoccocal vaccine and Hepatitis B vaccine. This case is ...

Page 401: DTP • DTP (NO BRAND NAME) • Event: Pyrexia irritability, low grade fever day of immun 3DEC93; fever of 103 on 4DEC93 not controlled by APAP; 5DEC93 fever 101-102; 6DEC93 MD visit, placed on antiviral med; 7DEC93 fever gone; ...

Page 402: DTP • DTP (NO BRAND NAME) • Event: Stupor episode of lethargy, unresponsive staring & eyes rolling for 30min, thigh swollen tender;seen @ hosp ...

Page 403: DTP • DTP (NO BRAND NAME) • Outcome: Hospitalization 2OCT AM irritability progessing to lethargy; approx 9PM became unresponsive; shoulders, hands & forehead twitching, fever 106F; Brought to ER by EMS; treated w/meds; ...

Page 404: DTP • DTP (NO BRAND NAME) • Outcome: Recovery pt recvd vax;began screaming high pitched 4 hrs p/ vax;unable to comfort pt,lasted 2-2 1/2 hrs;had rapid breathing & t;apap given q/ 4 hrs;contacted MD via telephone;8sep problem resolved; ...

Page 405: DTP • DTP (TRI-IMMUNOL) • Event/Outcome: See Description 15 minutes p/inject, pt started screaming; had high pitched cry almost continuously for 24 hrs; given APAP every 4 hrs & used ice pack per MD; poor appetite; vomited every time took a bottle; unable to move lt leg for over 24 hrs; t100.0; ...

Page 406: DTP • DTP (TRI-IMMUNOL) • Event: Cough Pt recvd vax @ 11AM & mom reports that approx 15 mins later pt began coughing (which lasted about 15 mins) then c/o itching all over & feeling sleepy; pt slept a while & mom noted swellng of face; pt taken to clinic w/hives; ...

Page 407: DTP • DTP (TRI-IMMUNOL) • Event: Pallor 2 days following 2nd set of immun awakened from nap @ 1130AM limp, colorless & lethargic lasted approx 30 to 60 min; ...

Page 408: DTP • DTP (TRI-IMMUNOL) • Event: Vasodilatation Shot given lt leg 27DEC91; redness slight & swelling (large area to the knee) developed; 24-48 hrs; small hardened area @ shot site; no streaking w/warmth per hx; swelling resolving 30DEC91 w/warm soaks; otherwise infant fine; ...

Page 409: DTP • DTP (TRI-IMMUNOL) • Outcome: Visit to Hospital or Doctor (Emergency) 30 wk premature doing well; 15hrs post vax had sudden onset of hypotonia/apnea x 2 recvd mouth to mouth resus by father; Other cause ruled out; ...

Page 410: DTPHIB • DTP+HIB (TETRAMUNE) • Event/Outcome: See Description pt recv vax 29APR98 10AM;awoke 5PM tactile fever, w/in 5min found to be bluish, foaming @ mouth & stiff;lasted 3-5min dx in ER w/sz; ...

Page 411: DTPHIB • DTP+HIB (TETRAMUNE) • Event: Glycosuria pt recvd vax 9OCT95 @ 10AM; nl exam @ that time;10hrs later temp sl elevated & irritable;26hrs still irritable-t101, not eating as well;sleepy;34hrs very lethargic, resp rapid;adm to hosp;dx diabetes mellitus-acidotic-re insulin ...

Page 412: DTPHIB • DTP+HIB (TETRAMUNE) • Event: Skin nodule diarrhea, lump on the leg;ER doesn't specify rt or lt; ...

Page 413: DTPHIB • DTP+HIB (TETRAMUNE) • Outcome: Visit to Hospital or Doctor (Emergency) vesicle rash in various stages of healing more dense in diaper area & back scattered lesions on scalp & trunk;high pitched irritated cry;MD recommends DPH cream; ...

Page 414: FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (CSL)) • Event: Arthritis reactive Report received from a foreign Regulator (no: 262530) on 10-Jun-2010. A 67 year old female patient received a single subcutaneous dose of PANVAX H1N1 influenza Vaccine injection (batch: 090200701) on 14-OCT-2010. Medical history and concomitant medication history was not specified. On 19-Jan-2010, 6 ...

Page 415: FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) • Event: Chest discomfort Vaccine (H1N1) administered 10-29-09. Approx 2 weeks later red bumps on chest then generalized. Sometimes the rash would be bumps, sometimes hives, some chest tightness. Took BENADRYL at night, ZYRTEC in the morning. Was seen by doctor. Lips, eyes started swelling, put on steroids with no relief tha ...

Page 416: FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (NOVARTIS)) • Event: Stress Numb and slightly tingling upper lip (as if affected by Novocain). Lower forehead was slightly numb at the surface level. Arm that received shot had more pain than ever felt from a flu shot. Later that afternoon the numbness, then decreased moved to the the lower lip. ...

Page 417: FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) • Event: Angioedema Day after vaccine developed hives and angioedema of hands, forearms, feet and ankles and facial flushing - symptoms persist despite steroid therapy that began on 11-2-09 and seen again 11-5-09. 11/13/09: Primary Care Records received from dates of service 11/2/09 to 11/5/09. Angioedema, hives, possi ...

Page 418: FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) • Event: Laboratory test Received the H1N1 shot in office on 10-21-09. Several hours later around 6 PM she had onset of chest pain, SOB, and gasping for air. Felt like her throat was closing up. She was taken to Emergency Room and treated for allergic reaction. 11/17 and 11/20 medical records received for DOS 10/21/09-10/23 ...

Page 419: FLU(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (SANOFI)) • Outcome: Life-Threatening Reported to ER with Acute Liver Failure. ...

Page 420: FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Event/Outcome: See Description Chronic Guillain-Barre syndrome - unknown diagnosis date. Patient undergoing ongoing treatment. ...

Page 421: FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Event: Flushing Dizzy, flushed, diaphoretic. ...

Page 422: FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Event: Musculoskeletal stiffness AFLURIA immunization 10/6/14. Patient experienced pain and stiffness immediately. Pain has not decreased since 10/6/14. ...

Page 423: FLU3 • INFLUENZA (SEASONAL) (AFLURIA) • Event: Underdose On 9/30, DOH was notified by an out-of-state health services company that a nurse had reused syringes for multiple persons earlier that day at an employee influenza vaccination clinic where the health services company had been contracted. The nurse contracted by the health services company brought t ...

Page 424: FLU3 • INFLUENZA (SEASONAL) (FLU-IMUNE) • Event: Rash Very sore at injection area, unable to lift arm without a lot of pain, which is still going on. Then on the 9th the rash started. ...

Page 425: FLU3 • INFLUENZA (SEASONAL) (FLUARIX) • Event: Computerised tomogram This case was reported by a regulatory authority (131743) and described the occurrence of polyneuritis in a 60-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 19 October 2010, the subject received unspecified dose of FLUARIX (intramuscular, unknown injection site). On 1 ...

Page 426: FLU3 • INFLUENZA (SEASONAL) (FLUARIX) • Event: Insomnia Nov 3rd 2008 rec'd flu shot pt sore for 1st couple of days. Ok until Nov. 15 pain (L) shoulder just below acromion #3. Nov 20 call Dr. & used Alleve, Tylenol. Nov 19 pain increased #8 no sleeping. Nov-22 went to ER walkin clinic. Nov 22 pain. #10. Couldn't lift her own arm- someone had to lift arm. ...

Page 427: FLU3 • INFLUENZA (SEASONAL) (FLUARIX) • Event: Tenderness Given a flu shot on Tuesday. Called Thursday afternoon to report that it was sore & the pain has been on into her shoulder & neck. She also developed some bumps in her neck. It sounded to me like these were probably lymph nodes but I asked her to please come in for me to view what she was talking ab ...

Page 428: FLU3 • INFLUENZA (SEASONAL) (FLULAVAL) • Event/Outcome: See Description Developed rash on arms and itching, progressed to shortness of breath and to feeling of throat closing. EMS called. ...

Page 429: FLU3 • INFLUENZA (SEASONAL) (FLULAVAL) • Event: Oedema peripheral Pain, redness, swelling in arm; can't lift arm. Went to doctor; received antibiotics to ward off abscess formation. ...

Page 430: FLU3 • INFLUENZA (SEASONAL) (FLUOGEN) • Event: Chills 12OCT chills, t101 & vomiting throughout noc ...

Page 431: FLU3 • INFLUENZA (SEASONAL) (FLUSHIELD) • Event/Outcome: See Description pt devel muscle soreness 1 to 2 days p/vax;then devel muscle pain, numbness in extremities & lips, diff swallowing;pt hosp 17OCT96 & on 18OCT96 neurologist dx GBS;pt being treated w/albumin plasma exchange; ...

Page 432: FLU3 • INFLUENZA (SEASONAL) (FLUSHIELD) • Event: Livedo reticularis On 11/5/99, the pt developed a rash under her breasts and arms. The pt was seen by the physician on 11/10/99 and reportedly a dx of sinus infection and fungal rash were made. She was prescribed Zithromax and a topical cream. By 11/22/99, her rash extended to her hair and eyes and completely covered ...

Page 433: FLU3 • INFLUENZA (SEASONAL) (FLUSHIELD) • Outcome: Visit to Hospital or Doctor (Emergency) pt states p/vax 6OCT97 that evening arm became red, sl swollen & warm to touch, just under inj site on lt arm;pt was seen @ hosp 9OCt97; dx local rxn to Td vax;tx w/cold compresses to lt upper arm, prescription for keflex; ...

Page 434: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Event/Outcome: See Description Day after vaccination, pneumonia injection site, very sore developed red line around site to post chest call. Stated ""it even hurt to lift up my arm"". ...

Page 435: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Event/Outcome: See Description Pt. complains of a sore left shoulder- Received injection (FLUVARIN) 9/1/09 still having problems as of 9/17/09. Pt. called 9/8 saying she had a problem with her arm (see back) ...

Page 436: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Event: Dizziness Panic attack like symptoms. Tightness in chest. Wheezing, dizziness, nausea. ...

Page 437: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Event: Hypertrophy A report was received from a health care professional on 11/06/03, concerning a 2 year old male vaccinee who received Fluvirin on 11/06/03. On 11/06/03, the vaccinee received a single of dose of Fluvirin intramuscularly. At the time of reporting the vaccinee did not exhibit any adverse symptoms from ...

Page 438: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Event: Injection site pruritus Case number PHEH2013US025328 is an initial, report received from a pharmacist on 04 DEC 2013. This report refers to a patient of an unknown age and gender. The patient was vaccinated with FLUVIRIN (batch number: 1308401; expiry date: not reported) subcutaneously on an unspecified date as it was mist ...

Page 439: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Event: Myelitis transverse Painful left arm within 45 minutes of shot. Numbness and tingling started later that evening and was especially bothersome and painful the next morning, 10/10/08. I said to my co-workers that I thought I was having a stroke. Numbness in chest is significant. Cannot feel collarbone area on left side. ...

Page 440: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Event: Paraesthesia Burning pain in anterior thighs and proximal arms, increased weakness. 3 weeks later had paresthesias and numbness in arms, left leg began to drag, trouble with ADL ...

Page 441: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Event: Tendon injury Patient received vaccine on 10/28/14, called 2 wks later complaining of arm pain. Told to call MD about complaint. Pt called 11/22/14 saying MD says a tendon may have been ""hit"" during vaccination. ...

Page 442: FLU3 • INFLUENZA (SEASONAL) (FLUVIRIN) • Outcome: Recovery The patient felt dizziness come on about 10 minutes after administration of flu shot. Emergency personnel were called and he was taken away in ambulance for precautionary reasons. ...

Page 443: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Event/Outcome: See Description pushed down the fluid leaked out of the syringe around the hub and onto the patient's arm / no AE; pushed down the fluid leaked out of the syringe around the hub and onto the patient's arm / no AE; plunger was pushed down the fluid leaked out of syringe / no AE; Initial information received on 04-No ...

Page 444: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Event/Outcome: See Description Shaking, chills, rigor, high fever, couldn't sleep, no appetite. ...

Page 445: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Event: Cellulitis Pt. reported arm swelling. Neighbor was a doctor; recommended treatment. Pt. subsequently saw Dr. who prescribed Doxycycline 100mg for cellulitis. ...

Page 446: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Event: Extra dose administered Patient did not experience any adverse reactions. ...

Page 447: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Event: Injection site erythema Red, swollen, hot injection site. Itchy later. Symptoms resolved in 3-4 days. ...

Page 448: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Event: Malaise PT IS NOT FEELING WELL AND HAD 1' BIG ROUND RED SPOT ON LEFT ARM. ...

Page 449: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Event: Pain 3:30pm chills/fever/aches/pain/ringing in ears/headache/shortness of breath. ...

Page 450: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Event: Sneezing Pt describes onset of nausea and vomiting, with cough, sneezing, belching and fever. Worse x2 days and progressively better since yesterday 10/6/14. ...

Page 451: FLU3 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) • Outcome: Recovery Patient experienced lower back pain, sharp pain in arms, hands, and thighs, plus nausea and vomiting. ...

Page 452: FLU3 • INFLUENZA (SEASONAL) (FLUZONE INTRADERMAL) • Event/Outcome: See Description Per patient's email - I got my vaccine on Thursday 10/31/13 in the right deltoid while at work. Within 15-20 minutes I felt a ""little funny"" and a tingling sensation in my throat. My tongue started to swell and I could feel it in the throat as well. I did take OTC Benadryl and that helped. After a ...

Page 453: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event/Outcome: See Description Rash, starting evening of administration, about 1 inch above and growing to about 6 inches below site. Pt states it happens every year, no egg, latex or neomycin allergy. ...

Page 454: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event/Outcome: See Description pt recv vax 5NOV97 & w/in 1 to 2hr pt exp pain @ the inj site;pt also exp a sore throat & earache that subsided p/24hr; ...

Page 455: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event/Outcome: See Description Shots given 12/15/10 child's arm was warm, red and causing pain 2 days after vaccine was administered. Mother states child had fever of 101.3 at home and vomiting. Fever and vomiting began the night vaccines were given and continued the day after. Child temp now 97.1 oral. Called on 12/20/10 child i ...

Page 456: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event/Outcome: See Description Patient felt dizzy, eyes were burning, and he had mild respiratory distress. Patient was seen 2 hours later, and was feeling much better. His blood pressure was normal. ...

Page 457: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Blood immunoglobulin M increased GUILLAIN-BARRE Syndrome - lost ability to crawl, dysphagia, back pain. Also had URI, patchy airspace opacities on CXR, mycoplasma IgM positive. Discharged on Zithromax. ...

Page 458: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Convulsion Focal seizure, (right-sided) for about 5 minutes following influenza vaccine. Parent reports EEG done at hospital. ...

Page 459: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Dyspnoea Began with a horrible coughing spell that lasted about 30 minutes. My voice changed, got hoarse, then throat and windpipe began closing up and felt like I couldn't breathe. I began to feel dizzy, like I was going to pass out, weak, and nauseous. Nausea has yet to go away, 24 hours after shot. ...

Page 460: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Febrile convulsion Febrile seizure 10/9/04. URI symptoms began the day prior. ...

Page 461: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Hypertension Patient received flu and pneumonia vaccines on 01/21/05. On 01/25/05 her blood pressure was high and today it is 200/100 and she has dizziness. She called her doctor that manages her HTN, who instructed her to take additional medication. I explained to the patient that my knowledge the flu and pneum ...

Page 462: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Injection site erythema Swelling of leg with some redness, but more edema. Was seen in Emergency Room and had ultrasound because of the degree of swelling. Put on Benadryl. Returned to clinic on 11/08 with continued diffuse swelling of left leg. No discreet nodule. Min. rash. ...

Page 463: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Injection site pruritus Itching at injection site - inflamed - c/o itching nose. ...

Page 464: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Lip swelling 10/17/14 Pt reports 5:30 - 6P - couldn't clear her throat, drank water, sx did not change. Eyes became ""bright red"", itchy, ""felt like sand in them."" ""Pus-like"" D/C running from eyes."" 7P hives on face and arms. 10 mins later, inside of mouth swelled lip ""Curved"" (swollen), 8P - called phar ...

Page 465: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Nausea Received vaccine, 3.5 min later fainted, hitting head. Regain consciousness, reported nausea, vomited. Ambulance called, vitals stable. IV started, pt transported to hospital. CT revealed a sub cranial bleed, craniotomy performed at hospital. ...

Page 466: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Pain This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number not provided) on 04-OCT-2012. Other suspect therapies included FLUZONE which was also vaccinated on 04-OCT-2012. No concom ...

Page 467: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Pruritus Erythema multiforme. Covered head to toe with erythematous wheals with dusky centers, dryness & itching. ...

Page 468: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Rash pruritic Red raised rash to chest, trunk, buttocks, and upper arms. 9/25/11 Rash developed later that day. Went to ER & Dr gave her BENADRYL. Required visit to NP & received steroid Rx. Red, itchy rash to chest, trunk, buttocks & upper arms. Few spots to lower inner arms. ...

Page 469: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Swollen tongue Approx. 12 hrs after receiving flu shot tongue started ""tasting metallic"" & swelling. ER visit hoarse/sore throat, received injection of BENADRYL. Today c/o hoarseness & aching. Pt states would like to know what additive/preservative is so she can list as allergy in future - pkg insert given to pt ...

Page 470: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Event: Viral infection Patient received a influenza shot 10/18/04, Fluzone U1427AA, .05ml, IM. Patient nausea, low grade fever and chills and seen 10/25/04. She had sudden death 10/27/04. Medical Record received on 11/22/2004 states pt experienced viral syndrome, Baker's Cyst, and calf pain. ...

Page 471: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Outcome: Recovery From initial information received on 12/9/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that an 11 month old female patient received her first dose of FLUZONE, lot number U1468AA, administered in the left thigh, a dose of MMR, lot number 0313P, a ...

Page 472: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Outcome: Recovery Possible allergic reaction: dizziness and nausea, then difficulty breathing with wheezing and chest tightness. No hives or edema, 911 called, gave Albuterol tx. ...

Page 473: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Outcome: Recovery c/o itching & difficulty breathing; ...

Page 474: FLU3 • INFLUENZA (SEASONAL) (FLUZONE) • Outcome: Visit to Hospital or Doctor (Emergency) SOB, Cough, Rash (Diffuse erythema), Pruritis, Urticaria, Mild Tachycardia (122). NS 1,000 sec at wide open rate then 200 sec/hr. Solumedral 125mg IV, Discharge Meds: Prednisone 20mg twice each day for 4 days, Benadryl 50mg ever 6 hr today then if needed. Final diagnosis: allergic reaction to Flu va ...

Page 475: FLU3 • INFLUENZA (SEASONAL) (TIV DRESDEN) • Event: Respiratory tract infection acute respiratory infection; new onset of cough or worsening of a chronic cough; This case was reported in a literature article and described the occurrence of acute respiratory tract infection in a elderly male subject who received trivalent inactivated influenza vaccine for prophylaxis. Concurrent ...

Page 476: FLU4 • INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) • Event: Herpes zoster Aggitated, shingles out break. Welts around left arm injection site and right side of neck. Confussion, eyes blurry. Pain in joints, muscles and back, nsomnia, Random bursts of pain everywhere, sensitivity to light, nueropathy in hands and feet. ...

Page 477: FLU4 • INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) • Event: X-ray limb Arm has hurt since shot. The pain is progressively worse. It hurts almost all of the time. ...

Page 478: FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Event/Outcome: See Description 3 minutes after flu vaccination, the patient reported lightheadedness and the feeling she was going to pass out in the pharmacy lobby. The patient then experienced a short episode of syncope with spasms that lasted less than 30 seconds in duration. She was supported by her father to the floor until ...

Page 479: FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Event: Fatigue This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 7-year-old male patient who received FLUARIX QUADRIVALENT (batch number A2Z34, expiry date 30th June 2017). Concurrent medical conditions included allergic reaction. On 3rd No ...

Page 480: FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Event: Injection site warmth Red, swollen and warm to touch at injection site. Swelling size about the size of baseball shadow. Advised to use BENADRYL and cool packs. ...

Page 481: FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Event: Pyrexia fever of 101F; body aches; sore throat; runny nose; cough; This case was reported by a nurse via call center representative and described the occurrence of fever in a 61-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number NA23N, expiry ...

Page 482: FLU4 • INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) • Outcome: Recovery Patient was administered lot 5D4H4 exp 6/30/21 and experienced lightheadedness right after the vaccine was given. This resolved in approximately 5 minutes. Prior to receiving this, it was attempted to administer her vaccination with same vaccine lot 373H3 exp 6/30/21; however, there was an issue wit ...

Page 483: FLU4 • INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) • Event: Dysphagia About 7 hours following the vaccine, my throat started getting very sore. It hurt a lot when I swallowed. It felt like there was a big lump in my throat that i could not swollow. I also noticed ulcers/bumps on the back of my throat. Also, my mouth felt itchy/tingly. My eyes got red, and i had a slig ...

Page 484: FLU4 • INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) • Event: Tremor Received flu shot during shift at hospital. Started with prickly feeling in face and arms less than 1 minute after injection. Notified coworker. Lost awareness. When regaining awareness, was surrounded by coworkers who asked me to get into the gurney and gave me water. Per my coworkers, my skin flus ...

Page 485: FLU4 • INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE QUADRIVALENT) • Event: Injection site urticaria Patient noticed arm soreness later in the day, got progressively worse throughout the evening. next morning notice swelling and hives local to the injection site. Hives then spread across the body and patient noticed lip swelling as well. Patient proceeded to local quick care office to be evaluated, ...

Page 486: FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Event/Outcome: See Description Patient had onset of 102-105 deg fever with lethargy at 11PM after vaccine, Tylenol did not bring fever down and did not improve patient affect, at 11AM started having myoclonic seizures (muscle twitches every 30-60 seconds that lasted for 1-2 sec at a time for 7 hours). Patient getting Tylenol ever ...

Page 487: FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Event: Anxiety I received the vaccine around 8:00am at my workplace health clinic after my work shift. Around 8:20, I suddenly felt very nauseous, faint, dizzy, light-headed and dazed. A minute or two later I felt tingling over my entire face and tongue and anxiety. About 5-10 minutes after that, I had severe abdo ...

Page 488: FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Event: Fatigue About 4 hours after receiving vaccine, client developed a bad headache and felt tired. Around 7:30pm had pain, swelling, redness, heat @ injection site and developed a stiff neck. Pt. called physician. 10/28/14 symptoms continued with development of dizziness & fatigue. Redness was about 4.5 inches ...

Page 489: FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Event: Injection site pruritus GROSS SWELLING, PAIN, REDNESS, PRURITUS WITH INDURATION WITH 7CM DERMACATION LOCALLY ON LEFT DELTOID. TREATED WITH COLD COMPRESS FOR 1st 48HRS AND TYLENOL FOR PAIN. ...

Page 490: FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Event: Pain in extremity Pt describes pain and soreness to her left arm post vaccination. While she expected this as she has received vaccinations in the past, the pain and soreness has continued and increased to today (12/15/2016). Per pt she is taking anti-inflammatory's and is having difficulties lifting her arm above 90 ...

Page 491: FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Event: Skin warm Child has swollen arm, warm to touch. No fever. Give TYLENOL and ice affected area as needed. ...

Page 492: FLU4 • INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) • Outcome: Recovery Initial unsolicited report received from a nurse on 28 October 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer: unknown, batch number, expiry date, route and site of administration were not reported) on an unspecified dat ...

Page 493: FLUA3 • INFLUENZA (SEASONAL) (CHIROMAS) • Outcome: Death COVID-19; This is a spontaneous case initially received from other health professional on 24-Jul-2020, concerning an elderly patient of unspecified gender. The aim of this study was to analyse coronavirus pandemic from pharmacoepidemiology and pharmacovigilance point of view. The patient was one of ...

Page 494: FLUA3 • INFLUENZA (SEASONAL) (FLUAD) • Event: Nausea This spontaneous case, reported by other non-health professional to regulatory authority and initially retreived on 29-Oct-2018 by Seqirus from regulatory authority (regulatory reference number: GB-MHRA-EYC 00187591), concerns a 77-year-old, elderly female patient of weight 62.13 kg and height 159 c ...

Page 495: FLUA4 • INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) • Outcome: Recovery Patient came and informed that she an adversed reaction with Fluad Quadrivalent which was given on 10/15/20. There was redness on the injection site at her left deltoid on the night of 10/15/20. She had fever, chills, and pain on her upper left arm and doubled in size. She went to Urgent Care on 10/ ...

Page 496: FLUC4 • INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) • Event/Outcome: See Description Lump under injection site ...

Page 497: FLUC4 • INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT) • Event: No adverse event Case number PHEH2016US029224, is a spontaneous report initially received from nurse on 04 Nov 2016. This report refers to 31 year old female patient. Medical history and concomitant medications were not reported. This breast feeding patient was inadvertently vaccinated with a single dose of FLUCELVA ...

Page 498: FLUN(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) • Event/Outcome: See Description RIGHT THIGH SWELLING AND REDNESS. TYLENOL PRESCRIBED 1 1/2 TSP 4-6 HRS ...

Page 499: FLUN(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (MEDIMMUNE)) • Event: Pyrexia Patient complained of cough, runny nose, fever, sore throat. ...

Page 500: FLUN3 • INFLUENZA (SEASONAL) (FLUMIST) • Event/Outcome: See Description A non-serious report of administration of expired FluMist has been received from a nurse concerning a 28-month-old female. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for Fl ...

Page 501: FLUN3 • INFLUENZA (SEASONAL) (FLUMIST) • Event: Helicobacter test negative Numerous bruises and petechaie over patient's body. Taken to pediatrician on 10/5/11. Blood platelet count was 1,000 (normal count is 250,000). Diagnosed with ITP. Referred to Hematologist same day. Started prednisone treatment and continued for 3 weeks. No long term results. On 10/25/11 patient was ...

Page 502: FLUN3 • INFLUENZA (SEASONAL) (FLUMIST) • Event: Rhinorrhoea Pt returned to clinic on 9/21/12 with runny nose x 3 days, fever (101) and congested cough onset 9/20/12 worsening. MD assessment found (+) wheezes, clear runny nose, and resp rate 25. Dx with pneumonitis and Rx albuterol sulfate 0.083% neb tx q 4-6 hrs. and Children's BENADRYL. ...

Page 503: FLUN4 • INFLUENZA (SEASONAL) (FLUENZ TETRA) • Event: Fatigue RASH; HEADACHE; ITCHING; Itching both hands; TIREDNESS; A report has been received from the consumer through Agency via regulatory authority concerning a male patient of unknown ethnic origin. No medical history was reported. Concomitant medication included solifenacin. On 04-Nov-2019, the patient r ...

Page 504: FLUN4 • INFLUENZA (SEASONAL) (FLUMIST QUADRIVALENT) • Event: Influenza A virus test positive A report has been received from a health professional concerning a female patient. Medical history and concomitant medications of the patient was not reported. The patient had received FLUMIST (intranasal) on 05-Nov-2013. It was reported that the patient was tested positive for Flu A. Patient was no ...

Page 505: FLUR4 • INFLUENZA (SEASONAL) (FLUBLOK QUADRIVALENT) • Event: Arthralgia continuing shoulder pain and reduced range of motion lasting 8 weeks, pt has yet to seek treatment ...

Page 506: FLUX • INFLUENZA (SEASONAL) (FOREIGN) • Event: Febrile convulsion Report received from a foreign Regulator on 14-MAY-2010. A 20 month old female patient received one dose of FLUVAX injection (batch number 090627102) on 26-MAR-2010 for inoculation and vaccination. Medical history and concomitant medications were unknown. On 26-MAR-2010, 8 hours after receiving FLUV ...

Page 507: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event/Outcome: See Description Extremely Sore. Pain radiating down entire arm, under arm, armpit, front & back of arm & across & under shoulder blade. Slightly warm to touch & whelps appeared on upper arm the next day 11/08/2011. Took ibuprofen, Benadryl & used Arthritis Cool Blue Alcohol on upper arm. This date 07/09/11 still ex ...

Page 508: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event/Outcome: See Description Injection site high on shoulder, shooting pain down arm and to neck. Now experiencing intense shoulder pain. ...

Page 509: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event/Outcome: See Description Very sore throat, chills, muscle aches, fatigue, cough ...

Page 510: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Biopsy skin abnormal Case number PHHY2011JP68029 is an initial spontaneous literature report received on 27 Jul 2011. The authors presented a case of microscopic polyangiitis and giant cell arteritis after influenza vaccination. This report refers to a 67 year old female patient. Her medical history included chronic kid ...

Page 511: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Condition aggravated A 58 year old female pt was hospitalized in Nov 2005 with a 2 day history of high fever spikes. She had been diagnosed with RA (rheumatoid arthritis) in 1997. Several disease modifying anti rheumatic drugs, including Bucillamine, Mizoribine, Salazosulfapyridine, had not been effective, and bilateral ...

Page 512: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Dysphonia Case number PHFR2016GB004842, is an initial spontaneous report received from a health care professional via regulatory authority (GB-MHRA ADR 23511644) on 09 Jun 2016. This report refers to a 42 year old female patient. Medical history and concomitant medications were not reported. The patient was v ...

Page 513: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Full blood count normal Influenza-associated encephalopathy/encephalitis (IAE); Influenza B virus infection; status epilepticus; acute respiratory failure; fever/tactile fever; runny nose; generalised fatigue; bowel and bladder incontinence; bowel and bladder incontinence; recurrent, prolonged generalised tonic clonic seiz ...

Page 514: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Hypotonia This case report is part of a batch of reports associated with several products that was received on 13 November 2014 by our partner who received the report from the Ministry of Health. Partner forwarded the batch of cases to Sanofi Pasteur affiliate on 14 November 2014. A male patient, age reported ...

Page 515: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Injection site pain Case received from the Health Authorities in a foreign country on 27-Jun-2013 under the reference number MA20131088. Case medically confirmed. The Health Authorities received this spontaneous case report from the Health Department of the military under the reference 308-2013. A 24-year-old male pati ...

Page 516: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Malaise Drug allergy for medications that she is allergic/becomes ill because the flu shot is made with a chicken protein ended with pneumonia; could not breathe; becomes ill; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 70-year-old femal ...

Page 517: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Neck pain This case was reported by the foreign regulatory authority and described the occurrence of neuralgia in a 49-year-old female subject who was vaccinated with Influenza vaccine. On 3 October 2011 the subject received unspecified dose of Influenza vaccine. On 3 October 2011, the same day as the vaccina ...

Page 518: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Pain pt recvd vax & exp shoulder pain which has persisted to date; ...

Page 519: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Pyrexia Patient complained of being cold and tired throughout the evening. Developed fever after going to bed around 8PM. Fever lasted 24 -36 hours. ...

Page 520: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Staring Patient had a major personality change a day or two after 18 month shots and flu shot. He acted as though intoxicated, had no balence, started chasing and biting parents. He started staring off into space and could not be redirected back to his surroundings. He was later diagnosed with Autism. All o ...

Page 521: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Event: Vomiting High fever 102.7 for 24 hrs then started to break. Chills almost to conuations for 6 hrs Elevated heart beat-burning ears and eyes vomiting and weakness ...

Page 522: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Outcome: Recovery Information has been received from a registered nurse concerning a 72 year old female patient with multiple allergies who on 10/10/02 was vaccinated in the left arm with a dose of pneumococcal vaccine 23 polyvalent (lot # 643249/0358M). Concomitant vaccination included a dose of influenza virus vacc ...

Page 523: FLUX • INFLUENZA (SEASONAL) (NO BRAND NAME) • Outcome: Visit to Hospital or Doctor (Emergency) Initial reaction was swelling, lightheaded, and pain at injection site. Within 48 hrs had feeling of burning throughout body and lost consciousness and had to be taken by ambulance. Within the next week began experiencing abdominal pain and swelling, fatigue, and memory problems. Within the year beg ...

Page 524: FLUX(H1N1) • INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) • Event: Gamma-glutamyltransferase normal Initial information regarding this unsolicited case downloaded from database without narrative (level 2A), was received on 26-Mar-2018 from physician via consumer via health authority (under the reference number: IE-IMB-2011-008741). The following narrative is based on the information retrieved from ... Page 525: HBHEPB • HIB+HEP B (COMVAX) • Event/Outcome: See Description This report concerns a 24 month old male who on 01-DEC-2000 was vaccinated with a dose of Comvax. Concomitant therapy included a dose of Infanrix. On 01-DEC-2001 the pt experienced moderately severe pain at an unspecified site and fever. The next day, he recovered, with out treatment. the reporter c ...

Page 526: HBHEPB • HIB+HEP B (COMVAX) • Event: Faeces discoloured Three days post vax the pt developed a fever up to 102F. No other symptoms. The pt was taken to the ER and it was noted that the pt had red/brown diarrhea like stools. A stool guaiac was positive for the occult blood. The pt was noted to have anemia. A rule out sepsis work-up was done which revealed ...

Page 527: HBHEPB • HIB+HEP B (COMVAX) • Event: Sepsis seizure like event on way home from receiving 2 ml vaccine (Rota, DTaP, Prevnar, IPV, Comvax) 12/26/07-records received for DOS 11/17-11/19/07-C/O abnormal movements and fever. Temp 38.4. Eyes deviated right, bilaterally and up. Arms flexed. ...

Page 528: HBPV • HIB POLYSACCHARIDE (HIBIMUNE) • Event/Outcome: See Description Rash and swelling day after injection, no fever, no SOB, no treatment. ...

Page 529: HEP • HEP B (ENGERIX-B) • Event/Outcome: See Description pt recv vax JUN96 & exp malaise w/loss of urine;no abn movements were observed & the pt was not hosp;CT scan was nl;electroencephalogram showed signals in hyperpnoea;pt recovered w/o sequelae; ...

Page 530: HEP • HEP B (ENGERIX-B) • Event/Outcome: See Description 4/21/04: developed eye infection and has been seen by 2-3 doctors for treatment of infection. At present, mom states it is resolved. Took 6 weeks of eye meds. (All info per mother). ...

Page 531: HEP • HEP B (ENGERIX-B) • Event/Outcome: See Description On 04/08/2003, pt started having irritability, low grade fever, then rash began on upper thighs and quickly spread (apprx. 6 hours) over rest of body. At time of presentation, macular-papular rash without vesicules or pustules. ...

Page 532: HEP • HEP B (ENGERIX-B) • Event: Arthralgia Pt states 48hrs after 1st Hep (9/19/08) felt nauseous & achy but thought it was stress. 48hrs after 2nd Hepatitis B nausea was worse, had severe muscle aches & joint aches, severe headache, ulcers on roof of mouth & tongue felt swollen. ...

Page 533: HEP • HEP B (ENGERIX-B) • Event: Chest pain pt recv vax & w/in 1hr exp wheezing, severe swelling, heat, pain & tenderness @ the inj site, diff breathing & chest tightness;tx in ER w/DPH & Solu-Medrol; ...

Page 534: HEP • HEP B (ENGERIX-B) • Event: Dizziness pt recvd vax; 2 hrs later exp v, n, warmth & dizziness; resolved p/ 48 hrs; ...

Page 535: HEP • HEP B (ENGERIX-B) • Event: Eye disorder pt recvd vax & 16hrs p/vax pt noted lt facial palsy w/drooling, paralysis of facial nerve, hyperacusis of lt ear, dec taste;dx bell's palsy;BP 160/112;c/o lt eye irritation & dec vision;poss bell's palsy w/keratitis 2ndary to exposure; ...

Page 536: HEP • HEP B (ENGERIX-B) • Event: Hepatitis B antigen positive This case was reported by a healthcare professional and described the occurrence of positive hepatitis B serology in a 89-year-old female subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis. The subject suffers from renal impairment and undergoes hemodialysis three times a we ...

Page 537: HEP • HEP B (ENGERIX-B) • Event: Injection site erythema Patient called 5 days after given Hep B & A vaccines. Patient reported red welt below Hep B injection site on left arm. Pt also reported some itching, pain at injection site and tingling sensation in left hand. ...

Page 538: HEP • HEP B (ENGERIX-B) • Event: Laboratory test abnormal This case was reported by manufacturer legal dept. and described the occurrence of a multiple sclerosis in a 32 year old female who received Engerix B for prophylaxis. Medical and drug histories are unknown in this subject. In 1995 and early 1996 the subject received three injections of Engerix B at ...

Page 539: HEP • HEP B (ENGERIX-B) • Event: Mydriasis This case was reported by a regulatory authority and described the occurrence of nystagmus in a 14-year-old male subject who was vaccinated with Engerix B for prophylaxis. On 26 March 2007 the subject received unspecified dose of Engerix B (unknown, lot number not provided). On 29 March 2007, 3 days ...

Page 540: HEP • HEP B (ENGERIX-B) • Event: Pain pt recvd vax & exp sudden pain in rt shoulder w/inj;pt went home used ice/heat/motrin w/o relief;18JAN96 awoke w/severe rt shoulder pain & unable to move d/t pain;mild swelling rt hand & gen discomfort rt arm;no evidence nerve damage ...

Page 541: HEP • HEP B (ENGERIX-B) • Event: Pyrexia pt recvd vax & was instructed to take apap q 4 hrs;par didn't give apap,awake w/ high pitched scream;purple lips; limp; hard time breathing; purple under eyes & moaning;given apap;pt taken to ER & adm for observ; t 103;lethargic ...

Page 542: HEP • HEP B (ENGERIX-B) • Event: Rhinorrhoea 6-10 Red, raised, very itchy bumps. One on neck, all others on torso. General malaise, sore throat, runny nose. ...

Page 543: HEP • HEP B (ENGERIX-B) • Event: Unevaluable event pt became pregnant a/the scheduled 2nd dose; 2nd & 3rd doses deferred until post pregnancy; ...

Page 544: HEP • HEP B (ENGERIX-B) • Outcome: Disability On 4/25/94 and 5/30/94, the pt was vaccinated with Engerix-B at a dose of 20mcg. On 7/2/94 and 5/15/95, the pt was vaccinated with GenHevac B. On 11/23/96, approx. 2 1/2 years after the 2nd injection of Engerix-B, the pt developed dysphonia, swallowing disorder and general fatigue. Unspecified check ...

Page 545: HEP • HEP B (ENGERIX-B) • Outcome: Recovery On 6/9/00 a dose of Engerix and Havrix were given. On 6/10/00, 1 day post vax, this male subject developed Guillain Barre like syndrome with weakness and paralysis of both legs and left arm. He was not hospitalized. ON 6/16/00, he had completely recovered. The reporting physician considers the event ...

Page 546: HEP • HEP B (ENGERIX-B) • Outcome: Recovery Patient reports watery eyes and itchy throat following immunization with AVA # 1, Hep B 1, and typhoid # 3 on 3 Jun 08. He subsequently received Hep B # 2 in July without any problems. Patient reported that he has a history of latex allergy and felt that this reaction was due to latex. After a neg I ...

Page 547: HEP • HEP B (ENGERIX-B) • Outcome: Visit to Hospital or Doctor (Emergency) Per MD's office; face and arm was red and complaining of feeling hot. BP 140/98 and MD gave shot of Benadryl and prednisone in office and sent home with prescription for Benadryl and prednisone. Per pt; she started experiencing nausea, seeing spots (black, red, orange). Face was red, felt really hot ...

Page 548: HEP • HEP B (FOREIGN) • Event: Somnolence 17MAR93 sluggish, started to vomit; to MD; 18MAR93 sleepy; MD stated no more Hep B shots due to allergic reaction; ...

Page 549: HEP • HEP B (NO BRAND NAME) • Event/Outcome: See Description This case was reported in a literature article and described the occurrence of vaccination failure in a 24-year-old male subject who received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Concurrent medical conditions included hep ...

Page 550: HEP • HEP B (NO BRAND NAME) • Event: Crying Case received from the Health Authorities through the local affiliate on 29 May 2012 under the reference number PL-URPL-OCR-20120514002 (local reference number 2012/0163). An 01-month-old patient (gender not specified), with no reported medical history, had received an intramuscular dose of ACT-HIB, ...

Page 551: HEP • HEP B (NO BRAND NAME) • Event: Hypothyroidism This case was reported and described the occurrence of type I diabetes mellitus in 31 month old male subject who was vaccinated with combined measles, mumps and rubella vaccine, live, attenuated (new stain) Priorix, hepatitis B vaccine HBvaxPRO, combined diphtheria, tetanus, acellular pertussis and ...

Page 552: HEP • HEP B (NO BRAND NAME) • Event: Pruritus Case retrieved from the literature on 21-OCT-2013 via SPMSD under SPMSD reference number: E2013-8356. Case medically confirmed. This case is linked with the case E2013-08376 (case mentioned in the article, with same adverse event, same vaccine). This case concerns the patient number 3 of the article ...

Page 553: HEP • HEP B (NO BRAND NAME) • Outcome: Hospitalization Initial unsolicited report received from a healthcare professional via Health Authority through partner company LG LIFE SCIENCES, (Manufacturer control number UA-LGLS-EVX6322) on 26-JAN-2017 and transmitted to Sanofi 02-FEB-2017. This case involves a nine-month-old female patient who was vaccinated ...

Page 554: HEP • HEP B (RECOMBIVAX HB) • Event/Outcome: See Description 3/22/04 Interpreter for mother called office. Said child began experiencing some eyelid paralysis on L about 1 week ago (3/15/04). Says it is steadily getting worse & now L side of face is visibly different from the R, especially noticeable when she smiles. Child went to family friend (chiropractor) ...

Page 555: HEP • HEP B (RECOMBIVAX HB) • Event/Outcome: See Description Patient was given her first Hepatitis B shot on her right arm. Within 1 or 2 minutes, I administered a seasonal flu shot in her left arm. Immediately after the patient slumped over and started to shake and passed out for 5 seconds. When she came too, the first thing that she asked was how long she w ...

Page 556: HEP • HEP B (RECOMBIVAX HB) • Event/Outcome: See Description Pt recvd vax 27OCT92 & on 29OCT92 pt devel fever of 104, myalgia, lymphadenopathy, headache, sore throat; temp lasted for 3 days; @ the time of report the pt had sl sore throat & lymphadenopathy; ...

Page 557: HEP • HEP B (RECOMBIVAX HB) • Event: Autism Initial and follow up information has been received regarding a case in litigation concerning a male child who, for the first two years of his life was vaccinated with injections containing the dangerous and highly toxic mercury based preservative thimerosal. The alleged result of these vaccinations ...

Page 558: HEP • HEP B (RECOMBIVAX HB) • Event: Dizziness pt recvd vax & exp nausea, general weakness, pain at inject site & lightheadness; pt continue to feel very weak; ...

Page 559: HEP • HEP B (RECOMBIVAX HB) • Event: Hepatic function abnormal Pt recv vax on 4/20/98; on 4/22/98 pt exp fatigue, nausea, bloating, hepatic function abnormality ...

Page 560: HEP • HEP B (RECOMBIVAX HB) • Event: Influenza pt recv vax SEP96 & pt exp diarrhea; ...

Page 561: HEP • HEP B (RECOMBIVAX HB) • Event: Malaise mom states pt had no sx until 14MAR97 in AM;pt was crying, irritable, cried w/eyes closed & just didn't act as usual;fed well but cont crying;no fever was like that for 2 days & began to act like old self;20MAR97 pt had apnea; ...

Page 562: HEP • HEP B (RECOMBIVAX HB) • Event: No adverse event Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and r ...

Page 563: HEP • HEP B (RECOMBIVAX HB) • Event: Pyrexia chills, nausea, vomiting, pallor, fever;supportive care given @ home;resolution over approx 1 day; ...

Page 564: HEP • HEP B (RECOMBIVAX HB) • Event: Skin disorder pt recvd vax JUL89 & devel hives & welts w/bluish/purple scarring on hands & feet; No further details were provided; ...

Page 565: HEP • HEP B (RECOMBIVAX HB) • Event: Vomiting Post vax, pt started coughing, then started vomiting. Pt turned blue on the way to the car. Pt was retracting, wheezing and having a very difficult time breathing. Pt brought back to office and given treatment and sent to ED and given Solu-Medrol and Benadryl. Pt needed to be admitted to the hospita ...

Page 566: HEP • HEP B (RECOMBIVAX HB) • Outcome: Recovery Pt developed itching on way home after receiving vaccine. At 10:44 PM on the night of receiving vax, pt presented to ER with hives. He was treated with Benadryl and Pediapred. He was discharged from ER at 11:15 the same night. ...

Page 567: HEP • HEP B (RECOMBIVAX HB) • Outcome: Visit to Hospital or Doctor (Emergency) 28MAY94 & 29JUN94 low grade temp/fussy; 30JUN94 130AM-430AM awake & fussy; 8AM screaming like cry that lasted all day & until about 8-9PM; t100.5; ...

Page 568: HEPA • HEP A (HAVRIX) • Event/Outcome: See Description Pt's mother states 1 week after receiving vaccination the child experienced diarrhea, a fever of 99-100 and a rash beginning at his ears and spreading all over the child's body. Pt's mother state this lasted for 3-4 days. ...

Page 569: HEPA • HEP A (HAVRIX) • Event/Outcome: See Description Pt received vaccines and reported feeling light headed. He was placed in a reclining position. BP was taken; 156/98. Pt was left with family to rest. Family agreed to watch him to prevent any falls from table. His blood pressure was again checked in 5 minutes and found to have gone down to 140/86. H ...

Page 570: HEPA • HEP A (HAVRIX) • Event: Aspartate aminotransferase increased This case was reported by a practice nurse and described the occurrence of hepatic function abnormal in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). Previous vaccination included HAVRIX (GlaxoSmithKline) given in September 1998. In September 2003 the subj ...

Page 571: HEPA • HEP A (HAVRIX) • Event: Dizziness 12-7 2019 in the morning by ambulance (support for trauma helicopter) a kind of epileptic attack occurred, resulting in a coma. This took more than 48 hours; confusion / after a week of gibberish; nausea; suspected inflammation balancing organ; throwing up; headache. Looked like flu phenomena; tired ...

Page 572: HEPA • HEP A (HAVRIX) • Event: Haemoglobin normal Acute hepatic failure. Patient became jaundiced within a few hours of administration of varivax/hepatitis A/prevnar/MMR vaccines on 07/09/07. Stools were white-colored for several days. Patient was taken to emergency room for jaundice on 07/15/07. At the time, liver enzymes were elevated (SGPT 6303, ...

Page 573: HEPA • HEP A (HAVRIX) • Event: Injection site hypoaesthesia Pt c/o Numbness in Left arm at deltoid radiating down arm. Sharp, pain when raising arm. Only able to raise arm shoulder-high. Also pain in triceps when she bends arm. Pt states problem hasn't resolved since administration of vaccine. Has not sought medical care. Has taken OTC ASA for s/sx with some ...

Page 574: HEPA • HEP A (HAVRIX) • Event: Loss of consciousness Patient received HEP A #1 and Varivax #2 in office. Complained of arm soreness. Driving home in car with MOC passed out. Paramedics were called and patient taken to hospital. ...

Page 575: HEPA • HEP A (HAVRIX) • Event: Pallor 13 yo received HPV #1, then hep A; within 1 minute c/o headache, then head drooped (placed supine) looked glassy-eyed to RN, extended (L) arm x 1. Responsiveness pale but all VSS = Syncopal episode ...

Page 576: HEPA • HEP A (HAVRIX) • Event: Rash Vaccines administered 3/12/13. 1-2 hours after pt began to notice soreness in area. In AM of 3/13/13, area was red, inflames, swollen, painful, with possible mild fever, (L) tricep area of upper arm. Has taken 400mg ibuprofen 3x on 3/14/13 inflamed area. 12 cm x 10 cm with 3.5 cm x 2 cm area having ...

Page 577: HEPA • HEP A (HAVRIX) • Event: Urticaria This infant developed urticaria approximately 24 hours after vaccines were administered. ...

Page 578: HEPA • HEP A (HAVRIX) • Outcome: Recovery On 8/4/14 child woke up with hives all over his body. A few days ago had mild fever, no other symptoms other than rash, not ichy. No coughing, no rhin. no diarrhea. Good appetite. No new foods eaten, no meds currently. ...

Page 579: HEPA • HEP A (HAVRIX) • Outcome: Visit to Hospital or Doctor (Emergency) DYSPNEA, RHINORRHEA, WHEEZES APPROX 30-40 MINS AFTER MULTIPLE INJECTIONS. TREATED SUCCESSFULLY WITH ALBUTERAL/IPRATROPIUM, PREDNISONE, O2 AND BENADRYL. SHE THEN DEVELOPED A RASH BUT NEVER HAD ANY RASH OR ERYTHEMA AT INJECTION SITES. SHE WAS DISCHARGED WITH FLOVENT, RANITIDINE,ZYRTEC,ALBUTERAL MDI RX ...

Page 580: HEPA • HEP A (NO BRAND NAME) • Event: Activities of daily living impaired Case received from a health care professional, via a company representative on 13-FEB-2012 and on 15-FEB-2012. Case medically confirmed. a 47-year-old male patient had received an injection of STAMARIL (batch number G5343-5) on 28-Nov-2011 and later on he developed redness and pain around the inject ...

Page 581: HEPA • HEP A (NO BRAND NAME) • Event: Pyrexia Unsolicited case received from agency through the Health Authorities which forwarded it to Sanofi's local partner on 01 March 2016. This case is part of a line listing containing hundreds of cases. This case involves 24-month-old male patient who was vaccinated with first dose of Fluzone (batch numb ...

Page 582: HEPA • HEP A (VAQTA) • Event/Outcome: See Description Subjective fever, generalized myalgia, malaise the following morning/day. ...

Page 583: HEPA • HEP A (VAQTA) • Event/Outcome: See Description Information has been received from a physician concerning an 1 month old male who on an unspecified date was vaccinated with a dose of VAQTA (Lot #666030/1397Y) instead of hepatitis B vaccine. No information was provided as to how the patient was presently doing. No further information was provided. ...

Page 584: HEPA • HEP A (VAQTA) • Event: Febrile convulsion Febrile seizure-45 secs of blank stare and bilateral upper extremity shaking-no treatment. ...

Page 585: HEPA • HEP A (VAQTA) • Event: Injection site papule 8/7/15 at well child visit received MMR, VARIVAX and Hep A, after shots small amount of redness and swelling at (R) thigh injection site. 2 days ago (8/15/15) developed new redness (R) thigh, pink dots, papules. 8/16/15 hives off and on arms and legs. Went to ER for eval, fever to 102. Hives resolve ...

Page 586: HEPA • HEP A (VAQTA) • Event: No adverse event This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. From 01-MAY-2018 to 31-MAY-2018, the patients were vaccinated with improperly stored ROTATEQ lot # R002052, expiration date 22-MAY-2019; GARDASIL 9 lot # N022583, expir ...

Page 587: HEPA • HEP A (VAQTA) • Event: Streptococcal identification test negative Severe rash from head to toe. ...

Page 588: HEPA • HEP A (VAQTA) • Outcome: Recovery Post vax, redness that night. Wed. 17:30 pm light rash all over in spots, 10:00 pm after shower, itching and bright red rash all over body with some swelling.Taken to hospital by mom. Given Benadryl, no difficulty breathing. ...

Page 589: HEPAB • HEP A+HEP B (TWINRIX) • Event/Outcome: See Description This spontaneous report was received from a consumer and refers to a currently 7 years old male patient. The patient had blood tests for allergies in spring 2016 with negative result (the patient did not have any allergies) and he did not have any hypersensitivities. Vaccines for the influenza have ...

Page 590: HEPAB • HEP A+HEP B (TWINRIX) • Event: Exposure via skin contact Allergic reaction; Exposure via skin contact; Occupational exposure to drug. 22-NOV-2016. 2016-006626 (0.0) ...

Page 591: HEPAB • HEP A+HEP B (TWINRIX) • Event: No reaction on previous exposure to drug This case was reported by another health care professional and described the occurrence of retrobulbar neuritis in a 43-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline). The subject works in the dialysis unit of a hospital as a dialysis nurse. On 30 January 2009 the subject ...

Page 592: HEPAB • HEP A+HEP B (TWINRIX) • Outcome: Recovery Patient was underage for vaccine given - reported sore arm. ...

Page 593: HIBV • HIB (ACTHIB) • Event/Outcome: See Description Initial unsolicited report received from a Health Authority (under the reference number PL-URPL-N552/2017) on 24-APR-2017. This case involves a 1-month-old male patient who was vaccinated with first 0.5 ml dose of ACT-HIB (batch number: L5480, expiry date: Sep 2017) vi intramuscular route in right t ...

Page 594: HIBV • HIB (ACTHIB) • Event/Outcome: See Description pt recv vax; crying 1hr p/ vax, lasting x 4 hr;no soreness or swelling or redness;to MD 4may95, less irritable;back to nl behavior 5may;no further pertussis vax per MD; ...

Page 595: HIBV • HIB (ACTHIB) • Event: Blood creatinine increased dermatitis; At the same day, the child appeared fever; vaccination site red and swelling (redness and swelling, about 15*10 cm); vaccination site red and swelling of 15*10 cm. (This area felt hard with high skin temperature and pressing pain); vaccination site red and swelling of 15*10 cm. (This are ...

Page 596: HIBV • HIB (ACTHIB) • Event: Cyanosis Grandmother reports patient began having trouble breathing, eyes rolled back, foamed at the mouth, and her lips turned blue. Symptoms occurred at about 4:00PM on 1/9/03, while patient was riding in the car. Patient was seen in the emergency room and admitted to the hospital for further evaluation. N ...

Page 597: HIBV • HIB (ACTHIB) • Event: Gait disturbance Initial unsolicited report received from a Patient Compensation Association (PCA) lawyer (Reference number- 18-6052) via Partner Company on 19-Sep-2018 and transmitted to Sanofi on 19-Sep-2018. This case involves Infant female patient (age not reported), who experienced pneumonia, bronchitis, granul ...

Page 598: HIBV • HIB (ACTHIB) • Event: Injection site mass Patient received 2 month vaccines and PEDIARIX given on left thigh. Developed bump/lump to area 3 cm x 3.5 cm, no erythema, non tender. ...

Page 599: HIBV • HIB (ACTHIB) • Event: Meningitis It was reported that an 8 month old patient who received 3 doses of ActHIB developed meningitis (possibly H Influenza type B). Final Lab report confirmed H Influenza type B. Further information is requested. From mailed follow-up contact on 06/06/2001, it was stated the female pt received an ActHIB ...

Page 600: HIBV • HIB (ACTHIB) • Event: Pyrexia Case received from the Health Authorities through the local affiliate in a foreign country on 01 May 2012 under the reference number HIB-365 (local reference number A201200128). A 17-month-old male patient, with no medical history (including allergy) and no concomitant therapy, had received his 1st ...

Page 601: HIBV • HIB (ACTHIB) • Event: Scratch Initial unsolicited report received from a Lawyer through Agency via our partner company on 17-Aug-2018 and transmitted to Sanofi on same date. This case involves Infant female patient who experienced pneumonia, allergy to aluminum, ear infection, common cold, scarlatina, chickenpox, granuloma, itch ...

Page 602: HIBV • HIB (ACTHIB) • Event: Vasodilatation rt leg swollen et bright red from groin to knee, hot to touch;used cold compresses;improved next high pitched cry for 45mins, episode of not breathing;grandma flicked pt on feet; ...

Page 603: HIBV • HIB (ACTHIB) • Outcome: Recovery fever of 105 w/in 24hrs p/shot; taken to ER;no other sxs x/fussiness; all other illness r/o; pt was given inj & fever med as stated by MOC ...

Page 604: HIBV • HIB (ACTHIB) • Outcome: Recovery None. ...

Page 605: HIBV • HIB (ACTHIB) • Outcome: Visit to Hospital or Doctor (NonEmergency) Initial unsolicited report received from the Lawyer via Partner Company (AJ vaccines) on 27 Sep 2017 and transmitted to Sanofi on 27 Sep 2017. This case involves a female patient (age not reported) who was vaccinated with primary first, second and third doses of ACT-HIB, DITEKIPOL and PREVENAR 13 (b ...

Page 606: HIBV • HIB (HIBERIX) • Event: Musculoskeletal stiffness THis case was reported by a regulatory authority and described the occurrence of convulsion in an approximately 2 month old male subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and haemophilus influenzae type B vaccine for prophylaxis. On ...

Page 607: HIBV • HIB (HIBTITER) • Event/Outcome: See Description pt dx w/HIB meningitis 30OCT92; date of vax administration is unk @ this time; ...

Page 608: HIBV • HIB (HIBTITER) • Event/Outcome: See Description Mom states that pt woke up from nap @ approx 11AM p/immun given that AM & was shaky & skin appeared purplish blotchy color & lips appeared same; Was shaking & crying was taken to MD for eval; No sz occurred; temp unk Mom had given APAP; ...

Page 609: HIBV • HIB (HIBTITER) • Event: Cough Pt has t105, severe tremors, rash on back, stuffy nose, hacking cough, very lethargic will drink water & juice; Refuses food & milk; has only 1/2 dose of APAP; referred to ER STAT; pt has ear infect given ATB; ...

Page 610: HIBV • HIB (HIBTITER) • Event: Injection site haemorrhage Pt experienced injection site reaction characterized by redness, swelling to the size of silver dollar, warm to touch, and ecchymotic at site. ...

Page 611: HIBV • HIB (HIBTITER) • Event: Pyrexia On 11JAN93 pt was seen @ ER due to a convuls, tonic, 2 min w/eyes rolling back; had low grade fever on 9 & 10JAN93; ...

Page 612: HIBV • HIB (HIBTITER) • Event: Screaming 22MAR93 recvd vax 230-3PM approx 4PM started screaming w/cont screaming/crying for next 4 1/2 hrs; 23MAR93 9AM till 330PM went into deep sleep uanble to awaken; p/that was limp & sleepy but would respond; no fever @ any time; ...

Page 613: HIBV • HIB (HIBTITER) • Outcome: Hospitalization 5 hrs p/DTP/HIB injects jerking arms/legs, w/abormal eye, breathing for 30seconds; (-) fever ...

Page 614: HIBV • HIB (HIBTITER) • Outcome: Recovery Cried constantly for 2-2 1/2 hrs, inconsolable-mom called MD & was instructed to given APAP as directed; ...

Page 615: HIBV • HIB (NO BRAND NAME) • Event/Outcome: See Description Fever for three days, lumps under vaccine site. ...

Page 616: HIBV • HIB (NO BRAND NAME) • Event: Enterovirus test negative This is a spontaneous report from a contactable unspecified Healthcare professional received from the Ministry of Health. Regulatory authority report number not provided. A 2-month-old female patient receive first single dose of PREVENAR 13, (lot number M40810) on 01Feb2016 for immunization. The pat ...

Page 617: HIBV • HIB (NO BRAND NAME) • Event: Rash maculo-papular pt recv vax 19JUL96 & 29JUL96 pt exp a measles-type rash w/a few red spots on scalp, trunk & lower extremities;pt recovered w/in 2-3 days; ...

Page 618: HIBV • HIB (OMNIHIB) • Event: Pyrexia Fever NOS on 2013-01-16, clinician comment: Fever less than 24 hrs after vaccination, no focus, no sign of illness. ...

Page 619: HIBV • HIB (PEDVAXHIB) • Event/Outcome: See Description T/C received from mom: states, immunization site red, hot to touch, no temp, afebrile, okay to use OTC. Return if worsens ...

Page 620: HIBV • HIB (PEDVAXHIB) • Event: Drug administered to patient of inappropriate age MICR was not available. RN tried to accommodate a walk in appointment for an immunizations update. Assessment of immunizations due was incorrect by RN. The 3rd dose of Rotavirus was given to client who has since aged out and it no longer eligible to receive the 3rd and final dose. HIB #3 was also ad ...

Page 621: HIBV • HIB (PEDVAXHIB) • Event: Injection site pain The mother of this child reported that her child woke up with redness, hard area and clear drainage from injection site. Mother stated the child cried when the site was touched. Mother was instructed to take child to the ER. ...

Page 622: HIBV • HIB (PEDVAXHIB) • Event: Product storage error No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug ...

Page 623: HIBV • HIB (PEDVAXHIB) • Event: Varicella Patient mother calls office complaining patient had vaccinations 1 week ago and complain of spots on patient back and stomach. Patient mom states looks like chickenpox. ...

Page 624: HIBV • HIB (PEDVAXHIB) • Outcome: Visit to Hospital or Doctor (Emergency) Varicella, MMR, HIB, PCV-13 given on 8/20/10. Developed rash on 8/31/10. Accompanied by bilateral ear infection with fever. ...

Page 625: HIBV • HIB (PROHIBIT) • Event: Vasodilatation 4AUG96 sl red rash on arms, legs, elevated temp;was given DPH by mom;5AUG96 cleared p/DPH, few lesions on legs;no fever; ...

Page 626: HPV2 • HPV (CERVARIX) • Event: Balance disorder This case was reported by a physician via regulatory authority and described the occurrence of difficulty in walking in a female subject who received CERVARIX (batch number AHPVA138BA, expiry date unknown), (batch number AHPVA143BA, expiry date unknown) and (batch number AHPVA149CA, expiry date unkn ...

Page 627: HPV2 • HPV (CERVARIX) • Event: Hepatic enzyme increased This case was reported by a physician and described the occurrence of liver function disorder in a 29-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. In August 2010 and September 2010, the subject received 1st and 2 ...

Page 628: HPV2 • HPV (CERVARIX) • Event: Paraesthesia oral This case was reported by a consumer and described the occurrence of tingling sensation on tongue in a 41-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 10 October 2012, the subject received u ...

Page 629: HPV2 • HPV (CERVARIX) • Outcome: Recovery This case was reported by a physician via a regulatory authority (# 157963) and described the occurrence of aggression in a 11-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). On 14 September 2011, the subject received 1st dose of CERVARIX (.5 ml, intramuscular, unknown in ...

Page 630: HPV4 • HPV (GARDASIL) • Event/Outcome: See Description This spontaneous report was received from a nurse and refers to a 2-year-old patient of an unknown age and gender. No information about concomitant medication, pertinent medical history and drug reactions or allergies was provided. On 17-JUN-2015, the patient was administered GARDASIL (0.5ml/once, i ...

Page 631: HPV4 • HPV (GARDASIL) • Event/Outcome: See Description Information has been received from a health professional concerning an approximately 24 year old female who in approximately August 2008, was vaccinated with GARDASIL second dose. In approximately August 2008, the patient experienced syncope and seizure for a few seconds. Subsequently, the patient r ...

Page 632: HPV4 • HPV (GARDASIL) • Event/Outcome: See Description This spontaneous report was received from a patient mother refers to her daughter as a female patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot # were not reported). On an unknown date, the patient experi ...

Page 633: HPV4 • HPV (GARDASIL) • Event/Outcome: See Description Developed posterior shoulder pain within 3 days of administration. No injection site reaction. ...

Page 634: HPV4 • HPV (GARDASIL) • Event: Abortion Information has been received from an female patient (KOR-2012-08-018), for GARDASIL, a Pregnancy Registry product who was vaccinated with GARDASIL. The patient reported that she was vaccinated with the first dose of GARDASIL in February, but was not vaccinated with the second dose, which had been p ...

Page 635: HPV4 • HPV (GARDASIL) • Event: Autonomic nervous system imbalance Information has been received from a physician concerning a 10 year old female with a history of drug intolerance to UNASYN, unilateral small kidney and vesicoureteric reflux who on 15-JAN-2009 was vaccinated with GARDASIL (lot # 0719X), there was no concomitant therapy and there was no preexisting ...

Page 636: HPV4 • HPV (GARDASIL) • Event: Cervical dysplasia Information has been received from a physician concerning a 26 year old female with papilloma viral infection (Type 16, 58) who in November 2007, was vaccinated with GARDASIL vaccine. In May 2006, the type 16 and 58 of human papilloma virus were detected in the Pap smear result. The patient was vacc ...

Page 637: HPV4 • HPV (GARDASIL) • Event: Cystitis Information has been received from SPMSD (manufacturer control # DK-1577272925-E2015-03496) on 14-APR-2015. Case was received from a consumer via the Health Authorities on 07-Apr-2015 under the references DK-DKMA-ADR 22929849 and DK-DKMA-EFO11530. The primary reporter was the patient. Case is not me ...

Page 638: HPV4 • HPV (GARDASIL) • Event: Drowning Information received regarding a case in litigation from a lawyer, an Agency, a nurse, physician, patient's (Pte) mother and news report concerning a 14 year old healthy female with occasional and well controlled migraine and acne who on 09-OCT-2008, was vaccinated with the first dose of GARDASIL, l ...

Page 639: HPV4 • HPV (GARDASIL) • Event: Erythema Red soreness at time of vaccine, extreme fatigue, numbness tingling in hands & feet, severe nausea still to this date, lightheadedness, lack of premenstruation. Bowel issues possible blockage in March/2008. Healthy child is now so very ill!! 12/02/2008 Reviewed PCP office records which consisted onl ...

Page 640: HPV4 • HPV (GARDASIL) • Event: Full blood count seizure, lasting approximately 2 minutes, no medications given, 911 called, fu in physician's office same day ...

Page 641: HPV4 • HPV (GARDASIL) • Event: Helicobacter infection Information has been received from Sanofi Pasteur MSD (Sender case report number: FR-1577272925-E2015-00016) on 08-JAN-2015. Case received from the Health Authorities on 05-Jan-2015 under the reference number PV20140448. A 21-year-old female patient (weight: 41 kg, size: 150 cm, BMI: 18.22) had rece ...

Page 642: HPV4 • HPV (GARDASIL) • Event: Inappropriate schedule of drug administration Information has been received from a Health Authority (HA) concerning a 43 year old female with a positive history of extrinsic asthma and atopy who on 27-JUN-2007 was vaccinated with Gardasil (lot# unknown) IM, injection site unspecified. On 04-JUL-2007 the patient was presented with pain and sting ...

Page 643: HPV4 • HPV (GARDASIL) • Event: Injection site oedema Client reported redness onto LDT with numerous 3-4 raised areas measuring totaling 40 mm-60 mm. No open areas noted. No itching presented. Vital Signs: 9:25 AM-107/70;75,20-no c/o SOB. No c/o laryngospasm. A/O x3. Skin color-pink/skin-warm & dry. ARNP informed with recommendation of Benadryl IM; Dep ...

Page 644: HPV4 • HPV (GARDASIL) • Event: Local swelling Pt c/o pain after vaccination, swelling, redness, tingling and radiating pain traveling down arm to hand. Pt saw neurology - R/O'd nerve involvement. DX: by provider as prob muscle tear vs. hematoma with nerve pressure. ...

Page 645: HPV4 • HPV (GARDASIL) • Event: Multiple sclerosis Information has been downloaded from Agency (DE-PEI-PEI2018000812). This spontaneous report has been received from a physician, concerning a 15 year old female patient. The patient's historical drug included vaccination with GARDASIL received on 14-NOV-2016 and 16-JAN-2017. Concurrent conditions, me ...

Page 646: HPV4 • HPV (GARDASIL) • Event: Nervousness Information has been received from Sanofi Pasteour (MSD) (case report number DK-1577272925-E2015-12969) as a part of a business agreement on 17-NOV-2015. Case received from Non-Health Care Professional via Health Authorities on 13-Nov-2015 under the reference number DK-DKMA-ADR 23227615 and DK-DKMA- ...

Page 647: HPV4 • HPV (GARDASIL) • Event: Obesity Information has been received from a physician concerning a 17 year old female patient who on 14-AUG-2009, 26-JUL-2010 and 06-DEC-2010 were vaccinated subcutaneously with the first, second and third doses of GARDASIL, respectively. In December 2010, the patient was diagnosed with ""Evans syndrome"". ...

Page 648: HPV4 • HPV (GARDASIL) • Event: Paraesthesia Information has been received from a physician concerning a 15 year old female who on 29-FEB-2008 was vaccinated with GARDASIL (lot number not specified). Concomitant therapy included MENACTRA given in one arm and PEDIARIX given in the same arm as the GARDASIL. The patient had a reaction in the arm ...

Page 649: HPV4 • HPV (GARDASIL) • Event: Pyrexia Information was obtained on a request by the Company from the agency (agency # 424588) via a Public Case Detail concerning a 13 years old male patient. The patient's medical history, concomitant therapy and concurrent condition were not reported. On 06-NOV-2017, the patient was vaccinated with GARDA ...

Page 650: HPV4 • HPV (GARDASIL) • Event: Sleep disorder Within a half an hour from the time of the injection, my arms and hands began to go numb. Both hands were so numb, and my whole body was shaking so badly I had difficulty holding on to the steering wheel trying to drive home. Then severe dizziness set in, and difficulty swallowing and breathing. My ...

Page 651: HPV4 • HPV (GARDASIL) • Event: Temperature regulation disorder This case was received from the health authority on 17-Oct-2013. GB-MHRA-ADR 22271078. This case is not medically confirmed as it was reported by a consumer. A female patient (age not reported), with no medical history reported, received in 2009 an injection of GARDASIL (batch number not reported), ...

Page 652: HPV4 • HPV (GARDASIL) • Event: Vaginal haemorrhage Pt saw PCP on 2/4/09 for GYN/PAP and received #1 GARDASIL that day. Urine HCG on 2/4/09 was negative. Pt subsequently had (+) pg test 2/16/09. Pt had onset of vaginal bleeding 3/25/09 - presented to ER and was found to have a sub chorionic hemorrhage with viable fetus - pt- had episodes of vag. bldg ...

Page 653: HPV4 • HPV (GARDASIL) • Outcome: Hospitalization Information has been received from a nurse practitioner concerning a 26 year old female who in January 2008, and February 2008 was vaccinated with the first and second doses of GARDASIL (lot#, route and dose not reported). Concomitant therapy included (oral) hormonal contraceptives (unspecified). In ...

Page 654: HPV4 • HPV (GARDASIL) • Outcome: Recovery Information has been received from a nurse practitioner concerning her 17 year old sister who on approximately 17-AUG-2008 was vaccinated with a first dose of GARDASIL. The patient received a 0.5 mL third dose of GARDASIL while she was pregnant. Her last menstrual period was in December 2008 and her ...

Page 655: HPV4 • HPV (GARDASIL) • Outcome: Recovery Patient passed out. No injury. Decreased BP. ...

Page 656: HPV4 • HPV (GARDASIL) • Outcome: Visit to Hospital or Doctor (Emergency) Information has been received from a physician concerning a 16 year old female patient who on unspecified dates was vaccinated with 3 doses of GARDASIL (no lot number given). The physician reported that the patient experienced injection site reactions after all 3 doses with the third dose being the ...

Page 657: HPV9 • HPV (GARDASIL 9) • Event/Outcome: See Description Headache, neck pain, nausea, malaise and local pain and redness (left deltoid). ...

Page 658: HPV9 • HPV (GARDASIL 9) • Event/Outcome: See Description PT HAD A SYNCOPE EPISODE WHEN ADMINISTER HPV VACCINE. PT HAD TDAP/ MCV ON RT ARM PT WAS FINE ONLY COMPLAIN WAS (IT HURTS). WHEN NURSE WAS ADMINISTRATING HPV PT HAD THE SYNCOPE EPISODE. NURSE HOLD PT LAY HER DOWN ON EXAM TABLE. MOM CALL DR. RECHECK PT'S VITALS. LAY DOWN PT FOR 15-30 MIN. ON THE EXAM ...

Page 659: HPV9 • HPV (GARDASIL 9) • Event: Erythema Patient given immunization on right deltoid with immediate reaction, with a wheal with redness and splotchy rash. Patient was told to wait 15 minutes after being inspected by a provider and given an ice pack. Measurement of spot was 1.5 inches. Provider told to patient to wait 15 minutes and I re me ...

Page 660: HPV9 • HPV (GARDASIL 9) • Event: Influenza A virus test negative Patient had fever of 102, 4cm erythema at injection site on right arm, nausea, chills, myalgia and headache. Treatment plan for patient included supportive care to get through the next couple of days. Recommended doses of Tylenol and Motrin and staying hydrated. ...

Page 661: HPV9 • HPV (GARDASIL 9) • Event: No adverse event This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 21-JUL-2015 and on 19-NOV-2015, the patient was vaccinated with a dose of G ...

Page 662: HPV9 • HPV (GARDASIL 9) • Event: Pyrexia This spontaneous report was received from a physician referring to his 16 year old male patient son. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 20-JUN-2018 (reported as ""two days ago""), the patient was vaccinated with G ...

Page 663: HPV9 • HPV (GARDASIL 9) • Outcome: Recovery Patient passed out for about 15 seconds as the patient reports that she had nothing to eat or drink before the vaccine was administered. Patient came to and reports to feel fine after, as she was not light headed, dizzy, etc. Patient stayed in office for about 20 mins after and left feeling fine. On ...

Page 664: HPVX • HPV (NO BRAND NAME) • Event: Antibody test This case was reported in a literature article and described the occurrence of central nervous system disorder in a 15-year-old female subject who received Human papilloma type 16 + 18 vaccine + AS04D. On an unknown date, less than a year after receiving Human papilloma type 16 +18 vaccine + AS04D, ...

Page 665: HPVX • HPV (NO BRAND NAME) • Event: Urinary incontinence Intense pain and then fainting with some jolting, lost bladder control. Chills, headache, nausea, intense stomach pain the next night. ...

Page 666: IPV • POLIO VIRUS, INACT. (IPOL) • Event/Outcome: See Description Cellulitis right arm (Deltoid region). ...

Page 667: IPV • POLIO VIRUS, INACT. (IPOL) • Event/Outcome: See Description Had DTAP-IPV yesterday. Starting during the night, vomiting and temperature 101 degrees. Vomited x1 this AM, placed on BRAT diet. ...

Page 668: IPV • POLIO VIRUS, INACT. (IPOL) • Event: Blood creatinine normal She states that she was seen for travel here at our clinic on March 14th for pre-travel in preparation to a trip (see records). She received yellow fever, typhoid, hep B, polio and meningitis vaccines at that time. She states she had a sore arm for two days. Then approximately on 03/21 she developed ...

Page 669: IPV • POLIO VIRUS, INACT. (IPOL) • Event: Erythema TC from father states he noticed swelling and redness in her right arm the following morning around 8AM (11/18/04). He took her to MD at medical clinic and she ""was given"" antibiotics"" (type unknown). He states decreased swelling today 11/19/04. Pt not in for observation. Parent states pt doing b ...

Page 670: IPV • POLIO VIRUS, INACT. (IPOL) • Event: Hypoaesthesia Numbness, tingling and weakness in calves, ankles and feet which progressed to diagnosis of GUILLAIN BARRE syndrome. Neuropathy Calves. Sensation, increase Calves and feet. Paresthesia Feet. 03/30/07-records received with report. Numbness, tingling and weakness in calves, ankles and feet which progr ...

Page 671: IPV • POLIO VIRUS, INACT. (IPOL) • Event: Injection site induration Approximately 24 hours after receiving kindergarten boosters, left arm started to get red, swollen, warm and hard to the touch. She may have had a slight fever, but her temperature was not taken. The swelling went from the elbow to the shoulder with the deltoid having a red hard induration 2+ inches ...

Page 672: IPV • POLIO VIRUS, INACT. (IPOL) • Event: Injection site swelling Swelling, redness, vesicles tenderness over 8""x5"" area right upper arm. Treated with cold compress and 2 pack pediapred. ...

Page 673: IPV • POLIO VIRUS, INACT. (IPOL) • Event: No adverse event No adverse events. I gave a Hepatitis A inj instead of DTAP. ...

Page 674: IPV • POLIO VIRUS, INACT. (IPOL) • Event: Pyrexia Pt seen in ER on 3/16/03 due to increased fever over the entire weekend. On 3/16/03, had blood and urine cultures done. Temperature of 104.8F (rectally) at ER. ...

Page 675: IPV • POLIO VIRUS, INACT. (IPOL) • Event: Syncope Syncope event within 5 minutes after administration. Full recovery. No intervention needed. ...

Page 676: IPV • POLIO VIRUS, INACT. (IPOL) • Outcome: Recovery Urticaria and rash around injection site, site also warm to touch. ...

Page 677: IPV • POLIO VIRUS, INACT. (IPOL) • Outcome: Recovery 5 YO with history of afebrile seizure x1 10/04 cm no reds, neg EEG, CT. No further seizures. 9/1/05 received Dapt, MMR, IPV 4PM less than 1 hr, later had staring, generalized seizure. EEG +. No fever, 9/3/05 reported erythema swelling at Dapt site. Discharge summary states personal distress, vomitin ...

Page 678: IPV • POLIO VIRUS, INACT. (IPOL) • Outcome: Visit to Hospital or Doctor (Emergency) Parent called immunizations 9/1/04 @ 1200. Child came into Immunizations @ 1500 on 8/31/04 for his preschool immunizations. Mom stated he was well, no fever in the last 7 days,never had any problem with his previous immunizations was premedicated with Motrin at 1300 on 8/31/04. Immunizations were gi ...

Page 679: IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Event/Outcome: See Description Administered DTAP, IPV and MMR given. Noticed while placing Bandaids on that left arm at site of MMR reddened. Pt complained of nothing being wrong except arms sore from injections. Also noticed few red areas on other arm and chest. Notified MD immediately. Benadryl 15mg given and Prelone ttsp po as ...

Page 680: IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Event: Decreased appetite This case was reported by a healthcare professional via a regulatory authority (# NO-NOMAADVRE-FHI-2012-13797) and described the occurrence of abdominal pain in a 29-year-old male subject who was vaccinated with BOOSTRIX-POLIO (GlaxoSmithKline), TWINRIX adult. The subject was previously healthy. On ...

Page 681: IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Event: Injection site pain Injection site reaction on left upper arm with pain and redness. Began 2 days after shot was given. Treatment: Elidel Cream bid to rash and Zithromax suspension 250 mg 1/2 tsp po qd for 7 days. ...

Page 682: IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Event: Pyrexia Low energy, muscle weakness, pain, increased stomach pain, high fever 102, no appetite, chills, sleeping all day, glazed eyes, body pain all over, excessive crying. Two days later continuing for a week-Sore throat and runny nose over all feeling sick. ...

Page 683: IPV • POLIO VIRUS, INACT. (NO BRAND NAME) • Outcome: Hospitalization This case was reported by a regulatory authority and described the occurrence of tonic convulsion in a 5 month old female subject who was vaccinated with combined diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type B vaccine for prophylaxis. Family his ...

Page 684: IPV • POLIO VIRUS, INACT. (POLIOVAX) • Event/Outcome: See Description Initial information regarding this unsolicited case downloaded from regulatory authority database without narrative (level 2A), was received on 18-Jun-2018 from a Physician via health authority (under the reference number: PL-URPL-N217/2016). The following narrative is based on the information retri ...

Page 685: IPV • POLIO VIRUS, INACT. (POLIOVAX) • Event: Blood urea normal Initial report received from a healthcare professional (patient's parent) on 15 April 2014. A 03-month-old female patient, whose concomitant medications were not reported, had received 0.5 ml intramuscular second dose of IMOVAX Polio, (batch number J0359-1) in arm on 12 February 2014. The patient's ...

Page 686: IPV • POLIO VIRUS, INACT. (POLIOVAX) • Event: Injection site erythema This patient came to my home at 10:30 PM on 04/11/01. The grandmother states that her daughter noticed redness in the Am on 04/11/01 with progression that evening. Unk fever. Assessment revealed erythema and induration of approximately 12 cm on the right and left thigh. The area was hot to touch. Th ...

Page 687: IPV • POLIO VIRUS, INACT. (POLIOVAX) • Event: Pallor over 2wk period, became pale, was fussy, dec appetite;7/16/99 pt was hosp, transferred to ER T103 & fussiness, had fast heart beat, wheezing, rash, fever lasted 4 days;pt still has cramping stomach; ...

Page 688: IPV • POLIO VIRUS, INACT. (POLIOVAX) • Event: Vaccination site reaction Vaccination site reaction : greater than 10 cm lasting over 3 days; This case was reported by a physician via regulatory authority and described the occurrence of vaccination site reaction in a 2-year-old male patient who received DTPa (Infanrix DTPa) (batch number AC14B187AA, expiry date September ...

Page 689: IPV • POLIO VIRUS, INACT. (POLIOVAX) • Outcome: Recovery father states about 2hr p/vax pt vomited then immed turned white then green & went limp for a period less than 1min duration;pt was real quiet & showed slow responsiveness;temp was nl;breast fed nl ;30min later appeared tired;no MD eval ...

Page 690: JEV1 • JAPANESE ENCEPHALITIS (IXIARO) • Event: Rash Gluteal rash, right side, appeared 10 minutes after vaccine administration. Patient showed no sighs of NVD, difficulty breathing, swelling, or wheezing. No treatment needed, per provider. Patient told to follow up if symptoms worsen. ...

Page 691: LYME • LYME (LYMERIX) • Event: Hot flush This is a spontaneous report from a RN referring to a 41 year old male. On 5/26/99, the pt received is 1st dose of Lymerix. Approximately 10 days later, on 6/7/99, the pt experienced generalized rash, itching, shortness of breath, dizziness and hot/cold flashes. She was seen twice by a physician and ...

Page 692: MEA • MEASLES (ATTENUVAX) • Event/Outcome: See Description pt recvd vax;devel discolored grayish front teeth;pharm reported that vax not MFRed by MSD; ...

Page 693: MEN • MENINGOCOCCAL (MENOMUNE) • Event: Pruritus Swelling of upper lip and itchy on lip and right side of neck. ...

Page 694: MEN • MENINGOCOCCAL (NO BRAND NAME) • Event: Cyanosis This case was reported by a regulatory authority (266135) via other manufacturer (CSL) and described the occurrence of cyanosis in a 17-month-old female subject who was vaccinated with HIBERIX (GlaxoSmithKline), PRIORIX, NEISVAC-C and FLUVAX (non-gsk). On 12 April 2010, the subject received unspecif ...

Page 695: MEN • MENINGOCOCCAL (NO BRAND NAME) • Event: Rash generalised Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 1 year old female patient. The reporter type was the State/Territory Health Department. On 22-JAN-2014 the patient was vaccinated with the first dose of MMR II (HSA) (Lot# unspecified), intramu ...

Page 696: MENB • MENINGOCOCCAL B (BEXSERO) • Event/Outcome: See Description This case was reported by a physician via regulatory authority and described the occurrence of hyperpyrexia in a 2-year-old male patient who received BEXSERO (batch number 146901, expiry date 30th April 2016. On 1st December 2015, the patient received the 1st dose of BEXSERO (intramuscular). On 1st ...

Page 697: MENB • MENINGOCOCCAL B (BEXSERO) • Event: Eye movement disorder After checking out and leaving the doctor's office after a routine well-child exam, we got in our car. Right after my son closed the door and fastened his seat belt, he reclined his seat slightly. I jokingly asked if he was already feeling lethargic. We were warned that he might be lethargic for abo ...

Page 698: MENB • MENINGOCOCCAL B (BEXSERO) • Event: Musculoskeletal stiffness Vaqta and Gardasil administered in left deltoid without incident. Bexsero administered in right deltoid. Immediately patient stated he didn't feel well, approximately 5 seconds later his eyes rolled up, he stiffened. Nurse attempted to restrain patient in chair, but patient jerked very hard away fro ...

Page 699: MENB • MENINGOCOCCAL B (BEXSERO) • Event: Vaccination complication About 2 min from the summit. 1 dose of Bexsero i.m. : episode of sudden loss of consciousness + diffuse stiffness of the trunk and shocks of the right hemisome. Spontaneous shooting in 10 seconds.PA 1; About 2 min from the summit. 1 dose of Bexsero i.m. : episode of sudden loss of consciousness + di ...

Page 700: MENB • MENINGOCOCCAL B (TRUMENBA) • Event/Outcome: See Description Redness, pain, warmth to R) deltoid. Rash to neck and R) deltoid. ...

Page 701: MENB • MENINGOCOCCAL B (TRUMENBA) • Event: Pain Severe migraine onset around 2:45 PM. Patient was screaming and crying. He said he couldn't see. His face and lips were swelling. He vomited 3 times. His behavior changed and he became erratic and confused. Left side of his body was in pain down due his thigh. ...

Page 702: MMR • MEASLES+MUMPS+RUBELLA (MMR I) • Event/Outcome: See Description Pt recv vax on 2/15/99; on 3/2/99 pt exp rash atypical of pox vesicles or fine papules ...

Page 703: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event/Outcome: See Description Child received MMR and VARIVAX on 8-5-09. 8-11-09. Child started with a rash on 8-12-09 child was brought into Health Dept with rash on face, head, arms, chest. He had fever Friday, Saturday, Sunday - 99-103. ...

Page 704: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event/Outcome: See Description 25 - 50 lesions. exposed to active chicken pox ...

Page 705: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event/Outcome: See Description 2/8/17 Pt stated her neck started to feel sore but not on the inside. Denies SOB and difficulty swallowing but neck is tender to touch and uncomfortable when she moves and looks up. 2/9/2017 spoke to pt again approx. 1130 and she states there is now a palable tender lump at the base of her throat. ...

Page 706: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event/Outcome: See Description Chicken pox more than 25 ...

Page 707: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event/Outcome: See Description Red welt/hive on lateral left thigh. ...

Page 708: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event/Outcome: See Description Patient is a 12 m.o. male who presents with seizure-like activity. Pt was in his crib crying and standing when his back arched and his eyes rolled back and he began twitching. Mother reports that the twitching lasted for about a minute. Afterwards, the pt was sleepy, but still crying. Pt was given h ...

Page 709: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event/Outcome: See Description skin rash, itching, redness and swelling, red indurated area 1""x2"" area, excoriation, local reaction from varicella to L thigh ...

Page 710: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Agitation pt recv vax & cried out, mom went to pick pt up & was jerking & eyes were rolled back into head & was unresponsive & blue around the lips;911 called;911 dispatcher said it was a sz;t104, unresponsive, not acting nl;dx pneumonia; ...

Page 711: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Autism It was reported in a published article, title as stated above that on an unspecified date a male child was vaccinated with a first dose of MMR (manufacturer unknown). The patient's mother reported that immediately following the immunization the patient experienced deterioration. The child was subseq ...

Page 712: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Chronic pigmented purpura Red patches on right leg. From the sole of feet up to butt cheek. The discoloration patches spread and darkened over a few months period. Also mood swings. ...

Page 713: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Cyanosis pt recv vax & exp fever 102.6 given APAP;had runny nose & cough 1wk prior to vax;exp t103 pt refused APAP;mom put in bath tub pt fell backwards;mom picked up seizured & turned blue;called 911 & taken to ER ...

Page 714: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Dysphemia Speech. Abnormal stuttering. Follow up: Change to non-serious, disregard report-parents don't want to pursue; normal boy. ...

Page 715: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Excoriation 12/29/10 Symptoms began within 24 hours, had itching,urticaria, excoriations diffusely, significant amount of hives, seen in office, given DEPO-MEDROL injection & oral steroids by ER. Plan to do allergy testing near future. ...

Page 716: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Food allergy Food allergies of some sort - haven't pin pointed the food yet... Hives on face, swelling of eyes, hives on torso. ...

Page 717: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Hypertonia c/o stiffness & pain to lt arm x 2 days noticed rash-redden from elbow down to wrist; felt warm to touch; no fever recommended to go to MD or ER & refused; applied warm compress w/good result; ...

Page 718: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Infection pt recvd MMR vax 3NOV88 & 25FEB91 devel congestion & a cough; dx OM; 13MAR92 it was found that ear infect had not resolved; 22MAR91 temp, cough dx clinicial strep; pos conjunctivitis, Koplik's spot, mac pap rash, red tongue; ...

Page 719: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Injection site erythema Erythema measuring approximately 5 inches by 3 inches and indurated approximately 2 inches by 2 inches. Running fever at the site and forehead, hard at the site and sore. Guardian took child to Urgent Care and they stated it was an adverse reaction and put the child on Cefadroxil 250/5 Susp twice a ...

Page 720: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Injection site mass Lt inject site hard, red, painful 2"" in size; 18JUN91 fa says all right now; no residual swelling, redness or tenderness; ...

Page 721: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Injection site reaction Vaccinated 9/19/02. Sent to ER 9/21 with cellulitis left upper arm, central bullous lesion. Put on Keflex. Induration about 4cmx5cm on 9/25/02. ...

Page 722: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Injection site warmth Right deltoid area erythematous, swollen area 6""x6""in. Warm, slightly tender. (local reaction only) Pt in no acute distress and reaction slowly evolved on 2-3 days. Benadryl 25mg PO given and also started on oral steroids. ...

Page 723: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Lymphadenopathy Pt recvd MMR vax & w/in 24 hrs to 48 hrs following vax pt devel t013 w/enlargement of the occipital lymph nodes; sx resolved the next day; 10 to 14 days following vax devel small pinpoint rash primarily on chest & trunk; ...

Page 724: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Nausea Approximately 36 days after receiving MMR, Varicella, OPV, 13 month infant spiked high temperature, projectile vomiting and tonic/clonic grand mal seizure 2.5 minutes with loss of consciousness about 30 seconds. Rescue 911 called during seizure. To ER. CPH, Lab work. Postical state muscle weakness. ...

Page 725: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Oedema peripheral pt recv vax 19APR95 & pt struggled during vax procedure on 20APR95 lt arm swollen-pt saw MD who stated swelling-hematoma from struggling; gave pt Augmentin & DPH; swelling improved-soreness less intense; moving arm more fully ...

Page 726: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Parotid gland enlargement Pt recvd MMR vax in 1982 & in DEC91 devel clinical mumps w/swollen parotid glands, trisums, low-grade fever, & anorexia; ...

Page 727: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Pruritus Right thigh-softball sized area of pruritic erythema, induration, swelling, pruritis ...

Page 728: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Pyrexia fever 102.2R;lesions on trunk, neck & cheek non on arms & legs; 14 days p/shot, very irritable; ...

Page 729: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Rash erythematous Day 1 of reaction - Fever of 104 degrees. Rash, beginning on back. Small, slightly raised pink bumps. Not fluid-filled. Day 2 of reaction - Fever of 104 degrees. Rash from Day 1 still present. Also developed raised, inflamed pimples - approximately 6 on the back and about 4-6 on the chest/stomach. N ...

Page 730: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Rash Developed high fever (102) on 8FEB followed a few days later 14FEB w/rash which started on his face & spread to the body; Seen by MD 18FEB tx DPH for a ""poss rxn to MMR 2 wks later chid was well w/no rash; F/U 7MAR91 ...

Page 731: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Rhinitis pt recv vax;17jul94 pt exp rhinitis, HA,fever of 103; general malaise,joint aches & a rash on abd & back area;presented to MD on 20jul,was instructed to rest;acetaminophen to start; recovered; ...

Page 732: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Staring Within 3 1/2 weeks of receiving his MMR, the pt lost all speech, no longer looked at his family and frequently, threw screaming tantrums whenever we would try to interact with him. He began to exhibit odd behavior, such as walking on tiptoe, flapping his hands and endlessly spinning the wheels on to ...

Page 733: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Unevaluable event 3AUG95 mom who asked for school certificate & stated pt had rxn past MMR & was seen @ MD ofc; ...

Page 734: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Event: Viral infection On 04/19/2002 9pm fever started. On 04/20, rash started on face, few on neck and legs. Temp max 102.7 deg. F. On 04/22, went to doctor's and chicken pox was diagnosed. On 04/23/2002 fever subsided and treated with Tylenol and Motrin. ...

Page 735: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Outcome: Hospitalization Information has been received from the health authority concerning a 15 month old male with no reported medical history who on 4/30/04 was vaccinated with MMR (lot # not reported) IM. On 5/4/04, two days before hospitalization, the child was fussy. The child eventually developed a high fever on 5/6/ ...

Page 736: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Outcome: Recovery redness, swelling right deltoid 2 days after shots. ...

Page 737: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Outcome: Recovery High fever (up to 104 degrees F) for 3 days, gave constant fever reducers (ibuprofen, acetaminophen), resolved on 4th day. ...

Page 738: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Outcome: Recovery 8/17/05 Dtap/ IPV given right arm. Call from parent, swollen right arm, hot to touch, discussed instruction, for Tylenol and ice. Checked on Friday, better, gone by Saturday via mother. ...

Page 739: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Outcome: Recovery pt had difficulty in breathing & swallowing within 30 min of vax ...

Page 740: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Outcome: Visit to Hospital or Doctor (Emergency) Eating dinner, then sudden onset seizure with head turning to left, eyes fixed, drooling, became stiff and twitching noted. Lethargic afterward and vomited once. Temperature 99.4-101. Taken by EMS to hospital. Became more alert after 30 minutes- vomited again. ...

Page 741: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Outcome: Visit to Hospital or Doctor (Emergency) Mom states took pt to ER 8 days post vax; fever was 106; Test run & MD said probably rxn to MMR; ...

Page 742: MMR • MEASLES+MUMPS+RUBELLA (MMR II) • Outcome: Visit to Hospital or Doctor (Emergency) rash neck, arms, & chest;swelling of both arms;was determined to have bronchitis as well;hx asthma; ...

Page 743: MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Event/Outcome: See Description Injection site - swollen, red, soreness, fever (at the injection site) left leg where DTAP + Polio were given. ...

Page 744: MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Event: Foetal disorder Information has been received from Sanofi Pasteur MSD (SPM) (manufacturer control # GB-1577272925-E2015-08076) on 10-JUL-2015. Serious case received from the agency on 09-JUL-2015. This case is linked to E2015-06677 (mother case) and E2015-08104 (twin baby). This case is medically confirmed. One out ...

Page 745: MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Event: Petechiae Information has been received from Sanofi Pasteur (MSD) (SPM) (manufacturer control # IT-1577272925-E2015-08147) on 17-JUL-2015. Case received from Health Authority (case n. 317773) on 14-JUL-2015 through SPMSD. Case initially reported by a physician (specialist). This case is linked to the case E20 ...

Page 746: MMR • MEASLES+MUMPS+RUBELLA (NO BRAND NAME) • Event: Vaccination failure Suspected Vaccination failure; Measles; Information has been downloaded (BE-GLAXOSMITHKLINE-BE2019GSK089262). This spontaneous report was received from a physician regarding a 20-year-old female patient. No information was reported regarding the patient's medical history, concurrent condition and co ...

Page 747: MMR • MEASLES+MUMPS+RUBELLA (PRIORIX) • Event: Culture urine negative This case was reported by a regulatory authority (# DHH-N2012-57736) and described the occurrence of acute disseminated encephalomyelitis in a 36-year-old male subject who was vaccinated with PRIORIX (GlaxoSmithKline), BOOSTRIX, MENCEVAX. The subject's medical history included staphylococcal epiduri ...

Page 748: MMR • MEASLES+MUMPS+RUBELLA (VIRIVAC) • Event: Pyrexia High fever and chills running for 4.0 days now. Fever as high as 104 at times. ...

Page 749: MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Event/Outcome: See Description 5 YO female had a physical exam within normal limit, received 4 YO vaccines KINRIX, PROQUAD, Influenza, 3 minutes after vaccines were given the mom called out for help and the patient was on the floor with arm stiffness and then crying. Lock rolled patient to left side, checked pupils they were equa ...

Page 750: MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Event/Outcome: See Description Child's arm was swollen, red and warm to the touch. Mom was told to treat with Hydrocortisone cream, Benadryl, and Ibuprofen as needed. ...

Page 751: MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Event: Feeling hot Swollen, redness and warmth, 1-3 days after injection. BENADRYL. TYLENOL. ...

Page 752: MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Event: Injection site pruritus Pt's mother called to report that patient's left leg at injection became progressively red, itchy, painful, and warm to touch shortly after injection of Kinrix and Proquad. Also the size of redness continued to increase in size. Pt's mother took pt to hospital where pt was diagnosed with suspected i ...

Page 753: MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Event: No adverse event Immunizations were given early. No known adverse reaction. ...

Page 754: MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Event: Rash Information has been received from a physician and a woman in a physician's office concerning a female who on 08-Aug-2006 at 10:50 am was vaccinated in the left thigh a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lo ...

Page 755: MMRV • MEASLES+MUMPS+RUBELLA+VARICELLA (PROQUAD) • Outcome: Recovery Seizure vs sleep apneic episode 5/3/16 while napping at daycare. Seen at ED immed after. ...

Page 756: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event/Outcome: See Description Appendicitis developed the morning after vaccination requiring appendectomy. ...

Page 757: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event/Outcome: See Description FATIGUE, NAUSEA, VOMITING, RASH, WEAK, LOW GRADE FEVER, CHILLS, SWEATS. SEEN ON 05/07/12 BY DR. Skin: Diffuse maculo-papular erythematous almost purple in spots rash across arms trunk and legs. CLASSIC DRUG LIKE RASH. RX PREDNISONE AND BENADRYL. ...

Page 758: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event: Cellulitis Information has been received from a RN concerning a male pt (18 to 20 yrs of age) who on 25Jan06 was vaccinated SC in the left tricep with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649696/0490P). Concomitant therapy included influenza virus 3v reassortant vaccine live intranasal ...

Page 759: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event: Erythema Behind Lt ear red, swollen. Bil eyes swelled, red. Felt weird given BENADRYL. Woke up not as swollen. ...

Page 760: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event: Immediate post-injection reaction Vascular headache probably secondary to MENACTRA vaccine. Severe headache onset within minutes of vaccination. Vomited once. Treated with Ibuprofen 800 mg every 4-6 hrs. ...

Page 761: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event: Injection site warmth The initial case was missing the following minimum criteria: unspecified adverse event. Upon receipt of follow-up information on 30Jun2017, this case now contains all required information to be considered valid. This is a spontaneous report from two contactable consumers, received via a sales repres ...

Page 762: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event: Nuclear magnetic resonance imaging brain abnormal 10 days following the vaccine, pt began to have pain and progressive weakness of her left arm and left leg. She was evaluated at hospital and found on MRI to have areas of demyelination of her brain and spine. 3/16/09-records received-Admitted 1/25/09 via ED with C/O left-sided weakness over last se ... Page 763: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event: Pyrexia Pneumovax and Menactra given in left deltoid on 7/29/2008 about 1:30pm. That evening he began to have pain in shoulder, fever to 102, and chills. He was seen in the office and found to have marked tenderness, swelling and warmth of the left deltoid. WBC was 13.7K. The following day he was seen with ...

Page 764: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Event: Urticaria Extensive local swelling including entire arm and proximal forearm with localized pain and urticaria. ...

Page 765: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Outcome: Recovery 11/17/07 considerable swelling, erythema, warmth & pain in the right upper arm. Overall fever & malaise. Reports arm pain, inability to use arm & weakness. Needs help with all activities. ...

Page 766: MNQ • MENINGOCOCCAL CONJUGATE (MENACTRA) • Outcome: Visit to Hospital or Doctor (Emergency) Information has been received from a licensed visiting nurse through the Merck pregnancy registry concerning a 17 year old female patient with no history or allergies to medication, who on 09-APR-2007 was vaccinated intramuscularly into the right deltoid, with a dose of GARDASIL (Lot# 654885/1424F). ...

Page 767: MNQ • MENINGOCOCCAL CONJUGATE (MENVEO) • Event: Computerised tomogram normal This case was reported by a consumer and described the occurrence of optic neuritis in a 14-year-old female patient who received MENVEO (batch number X14033, expiry date January 2017). Concurrent medical conditions included myopia (since the age of 8 years). Concomitant products included FSME IMMUN. ...

Page 768: MNQ • MENINGOCOCCAL CONJUGATE (MENVEO) • Event: Local swelling Redness, mild swelling on (L) arm, warm to touch. Area measures 4 inch circum. No breathing problems noted. Gave 25mg BENADRYL at office exam and to take 25mg BENADRYL tonight and apply ice. ...

Page 769: MNQ • MENINGOCOCCAL CONJUGATE (MENVEO) • Outcome: Hospitalization Case number PHHY2011AT60468 is an initial spontaneous report received from a physician on 06 Jul 2011: This report refers to a female patient of unknown age group. Her medical history was not reported. She was vaccinated with MENVEO (batch number: A/X 10099) on 30 Jun 2011. No other vaccines were ad ...

Page 770: OPV • POLIO VIRUS, ORAL (NO BRAND NAME) • Event/Outcome: See Description Lung cancer developed in early 50's. He did not smoke. Died of cancer treatment. Suspect connection to Rhesus polio vaccine ...

Page 771: OPV • POLIO VIRUS, ORAL (NO BRAND NAME) • Event: Screaming Pt t102.4, vomiting 2 days p/2nd shot; pt had to go in hosp started having sz, blind cannot roll over, stand up, crawl, hold anything in hands, poor head control; pt almost brain dead, fed w/feeding tube; continuous crying; high-pitched cry ...

Page 772: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event/Outcome: See Description Pt vaccinated with DTP/OPV experienced prolonged crying greater than 3 hrs after injection. ...

Page 773: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event/Outcome: See Description pt had hives on trunk area on the morning of 28JUN94; pt didn't have nay hives around inject, fever; appeared healthy x/hives; immun div recommended that pt see pvt MD; ...

Page 774: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event: Agitation 28FEB92 pt irritable but consolable p/DTP yesterday; Today dec PO, especially last bottle; less smiling seems pale now better; rxn lt thigh; t100.6; ...

Page 775: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event: Crying about 45mins to 1 hr p/vax pt lifted from car seat was pale, limp looked @ mom but not moving or responsive; then had 2 episodes of screaming, tensing fists, staring off with unusual scream x 5-10seconds, limp x 1 min then repeat of stiff ...

Page 776: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event: Hypokinesia 4NOV97 lt leg unable to move, swollen, crying cont > than 3hr;no temp, leg swollen, sore for 24hr; ...

Page 777: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event: Injection site oedema local rxn of lt upper arm swelling & pain; ...

Page 778: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event: Pharyngitis 29MAR94 1AM t101; no other sx APAP administered every 4 hrs; no localized react 29MAR94-12noon; t101 cont APAP; 29MAR94 730PM sz taken to hosp t105.4 in ER; Motrin administered; dx as ear infect; 31MAR93 cold sx; ...

Page 779: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event: Pyrexia had shots 8MAR95 & 10MAR95 ran low grade fever 101; on 11MAR95 fever to 104 w/vomiting; temp WNL p/day 4; ...

Page 780: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Event: Somnolence mom called triage nurse stating pt w/unconsolable crying-high pitched x 2hrs;afeb;pt listless ...

Page 781: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Outcome: Disability Pt had to be held all day; didn't move or cry if held, screamed if laid down; pt given APAP & slept 12 hrs that noc even p/3 hr nap; pauses between breaths were so long that I would shake her & muscles go inc weaker; motor skills of 4 mons; ...

Page 782: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Outcome: Recovery 1 of 2 pts vaxed from the same lots exp urticarial rash following vax w/Tetramune/OPV; pt recovered; ...

Page 783: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Outcome: Recovery Hands, feet & head mottled, seizure; t106 R; ...

Page 784: OPV • POLIO VIRUS, ORAL (ORIMUNE) • Outcome: Visit to Hospital or Doctor (Emergency) pt recvd vax 19NOV03 & became pale-limp p/left clinic; pt brought to clinic again assessment VS done; refer red pt to hosp ER for evual ...

Page 785: PNC • PNEUMO (PREVNAR) • Event/Outcome: See Description Information regarding PREVENAR was received from a healthcare professional via a regulatory authority regarding a 7-month-old male patient who experienced muscle stiffness, non-convulsive movements involuntary of muscle, trismus and muscle spasms. The patient received a dose on 17-Feb-2009. Addition ...

Page 786: PNC • PNEUMO (PREVNAR) • Event/Outcome: See Description Pt developed generalized vesicular, varicella rash over head, neck, trunk and arms, 2-3 days following varicella vaccination. No fever, but had 3-4 days of malaise and decreased appetite. Lesions would pop and crust over in typical chicken-pox fashion with lesions in multiple stages of healing. ...

Page 787: PNC • PNEUMO (PREVNAR) • Event/Outcome: See Description 1 day post injection of DTaP & MMR (both in right deltoid) redness 10cm, warmth, mild pain with movement all at injection site. ...

Page 788: PNC • PNEUMO (PREVNAR) • Event: Body temperature increased Temp of 102.7, Treated with Motrin in ER and given script for Motrin and Tylenol ...

Page 789: PNC • PNEUMO (PREVNAR) • Event: CSF white blood cell count negative This is a spontaneous report received from a contactable physician via the foreign institute, report number NL-RIVM-2010-00.761. An 11-month-old female patient received the fourth doses of PREVENAR and DTaP+IPV+Hib on 12Feb2010, The patient had no relevant medical history, Past drug events included ...

Page 790: PNC • PNEUMO (PREVNAR) • Event: Erythema Patient developed a possible cellulitis 10/15/08 two days after receiving DTaP. Temp 103 started in the afternoon after injection 10/13/08 with subsequent red area developing over two days. Remained febrile at the time of the appointment to evaluate the possible cellulitis. Treated with Keflex for 1 ...

Page 791: PNC • PNEUMO (PREVNAR) • Event: Hypotonic-hyporesponsive episode The child received his second immunization with DTAP/HIB/IPB on February 9 at about 10 AM. He did well after the vaccine unto about about 1:45 PM, he suddenly became pale, limp, and hyporesponsive. The epidose lasted about 15-20 minutes, after which his color and muscle tone improved and he began re ...

Page 792: PNC • PNEUMO (PREVNAR) • Event: Injection site swelling A nurse reported that a 3 year old male received an injection of Prevnar on 11/9/00 and within 2 to 3 hours, he developed an injection site reaction characterized by an area a ""quarter in size"" of redness, swelling and tenderness. He also had the chills. On 11/10/00, the child was not feeling well ...

Page 793: PNC • PNEUMO (PREVNAR) • Event: Medication error Patient was given combined DTAP/HIB vaccine (this should not have been administered combined until 15 months). ...

Page 794: PNC • PNEUMO (PREVNAR) • Event: Postictal state Possible febrile seizure on 7/26/06 @ 10am versus blank staring spell vs. post-ictal state. Self resolved in ~2 minutes. Has had history of febrile seizure back in January 06.8/24/06 Received medical records from PCP which reveal patient seen in ER January, 2006 for febrile seizure & diarrhea. In Ma ...

Page 795: PNC • PNEUMO (PREVNAR) • Event: Rash generalised Excessive crying fever, rash all over, Tylenol every 4-6 hours, fluids. ...

Page 796: PNC • PNEUMO (PREVNAR) • Event: Somnolence Within 24 hrs, pt became lethargic and almost unresponsive, slept thru feedings-hardly arousable for next feed. Afebrile throughout episode. 36hrs after went to ER-sepsis work-up negative. Lethargy and low arousability continued for total of 48 hrs. In am of 04/21/2002 more alert and playful, acting ...

Page 797: PNC • PNEUMO (PREVNAR) • Event: Vomiting Mother reported at approximately 3:30pm 02/12/04 that child vomited during night. Denied fever or rash. Said baby felt hot but was given Tylenol regularly. Stated she was better after having been sick. Reports baby sitter called--reported infant vomited a lot of mucusy vomit. Denied fever or rash. C ...

Page 798: PNC • PNEUMO (PREVNAR) • Outcome: Hospitalization 12-10-07 Rc'd Rotateq and other IZ's. Diarrhea started 12-16-07, also vomiting. Seen in office 12-17-07 with dehydration, sent to medical center. + Rotavirus PCR stool culture. No fevers. 1/17/08-records received for DOS-12/17-12/22/07-DC DX: Gastroenteritis. Dehydration. Presented with 3 day histor ...

Page 799: PNC • PNEUMO (PREVNAR) • Outcome: Recovery Patient had a temperature of 101.7 ax on Wednesday night. Had seen the doctor earlier in the day for his 4 month checkup. Doctor advised to give Tylenol to patient and come in on 2/15/08. ...

Page 800: PNC • PNEUMO (PREVNAR) • Outcome: Visit to Hospital or Doctor (Emergency) Fever 105 degrees F 11-/-09 10:30 PM - Brought to hospital ER and admitted for fever 11-5-09 - Fever started 11-1-09 102 degrees F. Currently hospitalized. 11/24/09 ER records received for date 11/5/09. DX: dehydration, febrile illness. Presenting SX: fever, irritable x24hrs. Assessment: pt received ...

Page 801: PNC10 • PNEUMO (SYNFLORIX) • Event: Conjunctivitis hospitalization; Acute bronchospasm; Acute bronchiolitis; enteritis; acute bronchiolitis; intrinsic asthma with acute exacerbation; acute bronchospasm; non specified viral disease; herpetic gingivostomatitis; viral non specified exanthema; colitis; gastroenteritis of infectious origin; asthma; non s ...

Page 802: PNC13 • PNEUMO (PREVNAR13) • Event/Outcome: See Description Pt. was walking dog, felt hot, dizzy, nauseous, sob. Went to Urgent Care and received an injection of a steroid, symptoms improved within 10-20 minutes. Pt received Prevnar 13 in right deltoid and Fluzone High-dose in left arm. Has had flu injection in past with no adverse reaction. ...

Page 803: PNC13 • PNEUMO (PREVNAR13) • Event/Outcome: See Description This is a spontaneous report received from a contactable pediatrician participating in the meeting of Agency For Medical Research and Development through a Pfizer employee (not sales representative). A 17-month-old male patient of an unspecified ethnicity received the 4th dose of PREVENAR 13 subcuta ...

Page 804: PNC13 • PNEUMO (PREVNAR13) • Event/Outcome: See Description Increase redness and pain on the injection site 5 days after administration. ...

Page 805: PNC13 • PNEUMO (PREVNAR13) • Event/Outcome: See Description Resident had developed a small bruises (approx. 2 cm diameter) after receiving PREVNAR injection around 3-15-16. This brownish colored bruise remains on arm. Resident also has c/o right upper arm and shoulder pain on and off since injection, which is severe at time and affects her range of motion to ...

Page 806: PNC13 • PNEUMO (PREVNAR13) • Event: Blood culture negative Febrile seizure with apnea. In the course of the afternoon following the vaccines patient developed high tactile fever and in early evening, eyes rolled up and he started to shake. Per parents, he stopped breathing for 3-5 minutes and turned pale, maybe slightly blue. 911 called. ...

Page 807: PNC13 • PNEUMO (PREVNAR13) • Event: Coagulation test Nausea, vomiting, diarrhea, chills, sweats, vertigo, heart palpitations, tachycardia. Severe HYPERTENSION. ...

Page 808: PNC13 • PNEUMO (PREVNAR13) • Event: Decreased eye contact After vaccine started noticing twitching movements which were random. Very lethargic for 2-3 days. Difficult to arouse. Decreased neck control and eye contact. Cried for 8 hours - fussy/irritable. ...

Page 809: PNC13 • PNEUMO (PREVNAR13) • Event: Erythema This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female (age: 87; units unknown) patient of unknown ethnicity received PREVNAR 13 at single dose on an unspecified date. After vaccination, her arm turned red and was swollen and hot. She went to the emerge ...

Page 810: PNC13 • PNEUMO (PREVNAR13) • Event: Gastrointestinal surgery Pt given ROTATEQ #1 on 7/20/11 at 2 mo old checkup. Developed vomiting on 8/15/11. Seen at urgent care on 8/16/11. Returned to urgent care on 8/18/11 and was admitted for bloody stool. Developed bilious vomiting on 8/19/11. UGI study abnormal. Transferred to another Hospital on 8/19/11 and had surge ...

Page 811: PNC13 • PNEUMO (PREVNAR13) • Event: Incorrect product storage This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 2 month old male patient. Patient had no history of chickenpox. On 01-OCT-2014, the patient was vaccinated with first dose of ROTATEQ (dose: 2 ml, orally) (lot #J013589, expiration date: 06-JUN-2015) which was inc ...

Page 812: PNC13 • PNEUMO (PREVNAR13) • Event: Injection site macule Multiple small erythematous target like spots on legs with one larger macular spot on (L) leg. 2 tiny blister like lesions on (R) hand. Close monitoring, resolution with 1 week expected outcome. ...

Page 813: PNC13 • PNEUMO (PREVNAR13) • Event: Injection site swelling 12/20/2018 approximately 1hour after receiving this vaccine PREVNAR 13 I felt off balance/dizzy; later in the evening I felt achey and tired and used 400 mg Ibuprofen every 6 hours. Right arm extremely tender hurt to move or touch, had zingy pain down right arm into right hand wrist hurt, forearm hu ...

Page 814: PNC13 • PNEUMO (PREVNAR13) • Event: Lumbar puncture normal About 48 hours after 2 month imms. patient developed grunting, turned limp, foaming at mouth, and unresponsiveness that lasted approximately 2 hours. Admitted underwent sepsis work up which was negative. EEG normal and normal MRI. Recovered without intervention. No fever documented at or around even ...

Page 815: PNC13 • PNEUMO (PREVNAR13) • Event: No adverse event ROTATEQ given after 14 weeks-6 days. In 15th week. No reaction - nothing but given 4 days late. ...

Page 816: PNC13 • PNEUMO (PREVNAR13) • Event: Petechiae Information has been received for a direct report from the regulatory authority (V18100246) on 27-JUN-2018, regarding a case provided by the physician. Information has been received from a physician concerning a 2-month-old male patient through the regulatory authority. The points to note (underlyin ...

Page 817: PNC13 • PNEUMO (PREVNAR13) • Event: Pyrexia This is a spontaneous report received from the Regulatory Authority. Regulatory Authority report number 169190. A nurse (contactable through Regulatory Authority only) referred that a 12-months-old female patient received a dose of PREVENAR 13 (lot number F59867) intramuscular on 17Mar2012 and a dos ...

Page 818: PNC13 • PNEUMO (PREVNAR13) • Event: Renal failure acute This is a spontaneous report from a contactable other health professional. A 24-month-old female patient received 3 doses of PREVENAR 13 via an unspecified route of administration as follows: The first dose (Batch Number E39936) on 10Nov2010 when she was 8 weeks old (reported as 56 days old); the se ...

Page 819: PNC13 • PNEUMO (PREVNAR13) • Event: Streptococcus test positive This is a spontaneous report from a contactable physician. A 3-month-old male patient was administered the first dose of PREVENAR 13 for vaccination on an unknown date. The route of administration was not reported. The patient was not a premature baby and was a healthy infant. At 5-months-old, the p ...

Page 820: PNC13 • PNEUMO (PREVNAR13) • Event: Vaccination site induration DEVELOPMENT AND WORSENING OF RED RASH AND A HARD LUMP AT VACCINATION SITE. PAINFUL AND RASH SPREAD. FOLLOWING DAY FELT NAUSEOUS. BEGAN TREATMENT WITH CEPHALEXIN 500MG TID. RASH STILL SPREAD, REPEAT TRIP TO WALK IN CLINIC, RECEIVED CEFTRIAXONE INJECTION AND INCREASED CEPHALEXIN TO 500MG QID. RASH IMP ...

Page 821: PNC13 • PNEUMO (PREVNAR13) • Outcome: Hospitalization disorders in vigilance; This case was reported by a physician via regulatory authority and described the occurrence of depressed level of consciousness in a 9-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included DTPa (Infanrix) for prophylaxis, PNEUMOC ...

Page 822: PNC13 • PNEUMO (PREVNAR13) • Outcome: Recovery Vaccinated 2/6/12. Mother called on 2/7/12 that child had fever, was lethargic and EMS was called. Kept in hospital for observation x 24 hours. ...

Page 823: PNC13 • PNEUMO (PREVNAR13) • Outcome: Recovery 7:30 pm the same night, hive bilateral upper arms - responded to BENADRYL, but next am hives again present. ...

Page 824: PNC13 • PNEUMO (PREVNAR13) • Outcome: Visit to Hospital or Doctor (Emergency) Red sore swollen leg at the injection site with uncontrollable crying. ...

Page 825: PPV • PNEUMO (NO BRAND NAME) • Event/Outcome: See Description arm was so swollen; it was swollen, it was red, it had a big red area on it; arm was so swollen; it was swollen, it was red, it had a big red area on it; Nauseated; patient had her second pneumonia shot; This is a spontaneous report from a contactable consumer. This consumer reported similar events ...

Page 826: PPV • PNEUMO (NO BRAND NAME) • Event: Gait disturbance Red hard lump on the leg that was hot to the touch. He also developed hives during the following two weeks. Walked with a limp for 4-5 days. ...

Page 827: PPV • PNEUMO (NO BRAND NAME) • Event: Neck pain pt recvd vax;local irritation;rubor ,dolor,neck pain and shoulder pain; ...

Page 828: PPV • PNEUMO (NO BRAND NAME) • Event: Vasodilatation lt arm swelling, reddened, warm to touch & throbbing from 4PM to this AM 5NOV96 1130AM;took ASA last noc;encouraged no more ASA;took APAP or Ibuprofen;warm moist pack to site; ...

Page 829: PPV • PNEUMO (PNEUMOVAX) • Event/Outcome: See Description This spontaneous report as received from a certified nurse practitioner refers to a 20 month old male child. On 03-MAR-2014 the patient was inadvertently vaccinated with PNEUMOVAX 23 instead of PREVNAR 13. Lot number, expiry date, route of administration and anatomical location of the vaccination we ...

Page 830: PPV • PNEUMO (PNEUMOVAX) • Event/Outcome: See Description Pt went septic. ...

Page 831: PPV • PNEUMO (PNEUMOVAX) • Event/Outcome: See Description This spontaneous report was received from a pharmacist and refers to a 17-year-old female patient with penicillin allergy. The patient's medical history included kidney transplantation on 02-DEC-2016. Concomitant therapies included calcitriol, cholecalciferol (reported as vitamin D3), ferrous sulfat ...

Page 832: PPV • PNEUMO (PNEUMOVAX) • Event/Outcome: See Description Red, puffy, purple around injection site. abx given. ...

Page 833: PPV • PNEUMO (PNEUMOVAX) • Event/Outcome: See Description This spontaneous report was received from a physician via a company representative refers to a 63-year-old female patient. Current conditions included chronic bronchitis/asthma, GERD (Gastro oesophageal reflux disease), hypothyroidism, fibromyalgia and allergy to sulfa drugs. On 22-MAY-2013 the pati ...

Page 834: PPV • PNEUMO (PNEUMOVAX) • Event/Outcome: See Description Next day post vax, the pt presented with cellulitis from injection site on down, a red swollen arm, and a slightly elevated temperature. The pt was treated with Keflex, warm compresses, and told to keep the affected area elevated. ...

Page 835: PPV • PNEUMO (PNEUMOVAX) • Event: Autopsy Admitted to hospital on 2/24/15 sepsis. Varicella verified on PCR with subsequent progressive multi-organ failure. Autopsy: Cause of death 3/5/15 – disseminated varicella - final histology pending as of 4/6/15. ...

Page 836: PPV • PNEUMO (PNEUMOVAX) • Event: Cellulitis Patient experienced an injection site cellulitis -like reaction when given the vaccine. ...

Page 837: PPV • PNEUMO (PNEUMOVAX) • Event: Cough Initial and follow-up information has been received from a physician concerning a 67 year old female patient with no known drug reactions/allergies and pertinent medical history who on 06-MAR-2009 at 14:00 was vaccinated intramuscularly into the deltoid area with the first dose of PNEUMOVAX 23. Ther ...

Page 838: PPV • PNEUMO (PNEUMOVAX) • Event: Erythema Left sided (facial, arm, leg) parasthesias; Left arm erythema; dysphagia ...

Page 839: PPV • PNEUMO (PNEUMOVAX) • Event: Expired product administered This spontaneous report as received from a Nurse refers to a 65 year old male patient. On 20-FEB-2015 the patient was vaccinated with an expired PNEUMOVAX 23 (lot number J009689, expiry date 29-JAN-2015) 0.5 ml, intramuscularly in the right deltoid. No concomitant medications were reported. No adver ...

Page 840: PPV • PNEUMO (PNEUMOVAX) • Event: Headache Body aches, headaches, swollen lymph nodes and high body temperature the day after receiving the vaccine. The patient went to the doctor and was diagnosed with having cellulitis. ...

Page 841: PPV • PNEUMO (PNEUMOVAX) • Event: Incorrect storage of drug This spontaneous report as received from a nurse refers to a 75 year old patient. Medical history and concurrent conditions were not reported. On 12-MAR-2014, the patient was vaccinated with PNEMOVAX 23 lot #J005067; expiration date: 17-JAN-2015 (dose, strength and route were not reported). Secondar ...

Page 842: PPV • PNEUMO (PNEUMOVAX) • Event: Injection site erythema Patient was given the Pneumonia vaccine Friday 8/2/10 afternoon around 12:45. At the time of injection she had no reaction. Patient came into the office Monday with complaints of redness,swelling and heat at the injection site that traveled around the bottom of her arm that was present over the week ...

Page 843: PPV • PNEUMO (PNEUMOVAX) • Event: Injection site erythema Left arm pain. This is a 66 yo male, came to ER with: being 1 day s/p PNEUMOVAX in left arm, (flu in right) with some pain and swelling shortly after immunization, and awoke this morning with increased pain, swelling & redness distal to site of vaccination. No itching, no constitutional sx. Allergie ...

Page 844: PPV • PNEUMO (PNEUMOVAX) • Event: Injection site pain PT SAID SHE HAD SEVERE PAIN AT INJECTION SITE THAT STARTED THE DAY OF AND EVENTHOUGH SHE HAS BEEN TAKING TYLENOL, IT HAS NOT GONE AWAY. SHE SAID PAIN IS SO BAD THAT SHE CAN NOT MOVE HER ARM. ABOUT 10 INCH AWAYB FROM SITE SHE HAD SOME REDNESS AND SHE WAS WOONDERING IF THAT HAS SOMETHING TO DO WITH VA ...

Page 845: PPV • PNEUMO (PNEUMOVAX) • Event: Injection site pruritus Patient was given pneumococcal vaccine in L Deltoid on 3/14/09 @ 1722. Patient noted that her arm was very sore. On 3/15/09 @ 2038 RN noted that ""deltoid areas of arms painful. L deltoid erythematous."" Patient's L arm is red, swollen hot and itchy from L deltoid to 2-3"" below L elbow. Patient rec ...

Page 846: PPV • PNEUMO (PNEUMOVAX) • Event: Injection site swelling WELTS, REDNESS, AND SWELLING TO INJECTION UPPER ARM. ...

Page 847: PPV • PNEUMO (PNEUMOVAX) • Event: Injection site warmth Moderate edema, redness, pain, and warmth at injection site. Symptoms also included fever, chills, and congestion with cough. ...

Page 848: PPV • PNEUMO (PNEUMOVAX) • Event: Mean cell haemoglobin concentration Information has been received from a dermatologist and hospital pharmacist concerning a 71 female patient (it was also reported as in her 70's) with rectal cancer from August 2005, pharnygitis and insomnia and a history of Large intestine carcinoma who on 21-OCT-2010 was subcutaneously vaccinated wi ...

Page 849: PPV • PNEUMO (PNEUMOVAX) • Event: Nausea Arm very very red swelled down to his elbow, 102 fever with nausea vomited 2 days and now diarrhea. ...

Page 850: PPV • PNEUMO (PNEUMOVAX) • Event: Oedema peripheral Information has been received from a Nurse Practitioner (N.P.) concerning a 69 year old female with no Drug reactions/allergies and no pertinent medical history who on 21-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot#665924/0930Z; Exp: 17-JUL-2011). On 22-SEP-2010 the patient developed cellulitis. ...

Page 851: PPV • PNEUMO (PNEUMOVAX) • Event: Pain in extremity L deltoid swelling, redness, pain. Onset 12/31/07. Tx: ice, muscle relaxer. ...

Page 852: PPV • PNEUMO (PNEUMOVAX) • Event: Peripheral swelling Headache red body swollen Rt arm fever. ER I.V. antibiotics, short of breath. Started feeling better Sat 10-15-16. ...

Page 853: PPV • PNEUMO (PNEUMOVAX) • Event: Pyrexia This spontaneous report as received from a pharmacist refers to a 15 year old male patient with asthma. There was no drug reactions/allergies. On 11-NOV-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot# as reported J007060, expiration date not reported, 0.5 ml, Intramuscularly). Conco ...

Page 854: PPV • PNEUMO (PNEUMOVAX) • Event: Pyrexia Information has been received from a healthcare worker concerning a 68 year old female patient with no pertinent medical history and no known drug allergies who on 21-MAR-2011 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667914/1067Z, expire date 28-FEB-2012), 0.5 ml, intramuscularly. T ...

Page 855: PPV • PNEUMO (PNEUMOVAX) • Event: Skin warm Patient is experiencing pain at the injection site. She also mentioned the injection itself was painful. Her arm is very sore and it is also red and warm to the touch. I (the pharmacist) recommend she try ibuprofen and ice therapy. She said she has tried that already with minimal benefit. She had on ...

Page 856: PPV • PNEUMO (PNEUMOVAX) • Event: Tenderness Information has been received from a registered nurse concerning a 71 year old white female patient with allergies to erythromycin and alprazolam (Xanax) who on Jul 08 2004 at 3:23 pm was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647636/0944N), intramuscularly in the rig ...

Page 857: PPV • PNEUMO (PNEUMOVAX) • Event: White blood cell count decreased Initial and follow-up information has been received from a physician concerning a 73 year old male who on 26-SEP-2008 was vaccinated with PNEUMOVAX vaccine (Lot # 658074/0961U) (Lot # originally reported by physician as 660685/0619X) IM in his right arm (dose not reported), the patient had COPD exac ...

Page 858: PPV • PNEUMO (PNEUMOVAX) • Outcome: Life-Threatening Information has been received from a Certified Medical Assistant and a Nurse Practitioner concerning a 19 year old male student with asthma, seasonal allergies, iodine allergy and a history of repeated pneumonias and supraventricular tachycardia (SVT) s/p ablation and no illness at the time of vacci ...

Page 859: PPV • PNEUMO (PNEUMOVAX) • Outcome: Recovery Pt received in (L) arm FLUZONE HD and PNEUMOVAX 23 and in (R) arm ZOSTAVAX. Pt reported on 10/21 that her arm on 10/18 (day after immunization in (L) arm was swollen from shoulder to wrist w/water hanging down that she could hold. She also reported that she thought she had shingles on both lower ext ...

Page 860: PPV • PNEUMO (PNEUMOVAX) • Outcome: Recovery Information has been received from a certain MA concerning a 54 year old male who on 10OCT2003 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polysaccharide vaccine. On 12OCT2003, about two days later, the pt developed a fine, red rash on his trunk, facial swelling and vom ...

Page 861: PPV • PNEUMO (PNEUMOVAX) • Outcome: Visit to Hospital or Doctor (Emergency) Local reaction 4in diameter, redness heat, pain. ...

Page 862: PPV • PNEUMO (PNEUMOVAX) • Outcome: Visit to Hospital or Doctor (Emergency) Information has been received from a certified medical assistant concerning a 59 year old male who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The reporter indicated that the pt developed an erythematous site reaction and a fever after vaccination. The reporter also asked if th ...

Page 863: PPV • PNEUMO (PNU-IMUNE) • Event: Erythema 24 hours post vax, the pt felt as though she had the flu, her left arm had some swelling and by 3:30 pm the arm was red and swollen to elbow and felt like it was going to fall off. She experienced hard chill, high fever, no appetite which lasted 3 days. She took Tylenol. ...

Page 864: PPV • PNEUMO (PNU-IMUNE) • Outcome: Recovery pt revaxed 9JUN92 & w/in 1 day exp a local reaction which included swelling & erythema; w/in 2-3 days had fever of 99; fever peristed for 6 wks then 102; hospitalized 15JUl; appetite loss; tests neg; local reaction resolved; fever persiste; ...

Page 865: RAB • RABIES (IMOVAX) • Event: Injection site hypersensitivity pt recvd vax;rash on torso;red,blotchy;not itchy;""major ha for a wk p/ dose;sl redness w/ induration at site;had 3 doses series 10 yrs ago;will see dermatologist because uncertain w/ vax;has had pre dx skin condition in past; ...

Page 866: RAB • RABIES (NO BRAND NAME) • Event: Mydriasis This case was reported in a literature article and described the occurrence of rabies in a 48-year-old male patient who received Rabies Vaccine. Concurrent medical conditions included dog bite (at 2 pm bitten by a dog on the forehead on the right side of left eyebrow). Concomitant products included ...

Page 867: RAB • RABIES (RABAVERT) • Outcome: Recovery Within one hour of administration of Day 7 rabies vaccination, patient reports that his lips swelled with associated numbness. Denies any other symptoms. Symptoms resolved within several hours without any medication. ...

Page 868: RUB • RUBELLA (MERUVAX II) • Event: Pyrexia Information has been received from a health professional concerning a 13 year old female who on 5/11/01 was vaccinated with rubella virus vaccine live. There was no concomitant medications. On 5/20/01, the pt experienced a fever and pathologic plasma biochemistry with elevated liver enzymes. She was ...

Page 869: RV1 • ROTAVIRUS (ROTARIX) • Event/Outcome: See Description This case was reported by a physician and described the occurrence of rotavirus infection in a 3-month-old subject of unspecified gender who was vaccinated with Rotarix (GlaxoSmithKline). On 15 January 2008 and 21 February 2008 the subject received 1st dose and 2nd dose of Rotarix (oral). Approximat ...

Page 870: RV1 • ROTAVIRUS (ROTARIX) • Event: Blood test normal Parents tried to wake up baby to feed and would not arouse. EMS called and taken to a hospital. Baby was awake and alert when EMS arrived and remained so during hospital observation. ...

Page 871: RV1 • ROTAVIRUS (ROTARIX) • Event: Faeces discoloured This case was reported by a physician via sales rep and described the occurrence of acute gastroenteritis in a infant patient who received ROTARIX for prophylaxis. On an unknown date, the patient received the 1st dose of ROTARIX. On an unknown date, less than a day after receiving ROTARIX, the patie ...

Page 872: RV1 • ROTAVIRUS (ROTARIX) • Event: Kawasaki's disease This case was reported in a literature article and described the occurrence of Kawasaki's disease in a 3-month-old male patient who received ROTARIX. On an unknown date, the patient received the 1st dose of ROTARIX (oral). On an unknown date, 1 day after receiving ROTARIX, the patient experienced Ka ...

Page 873: RV1 • ROTAVIRUS (ROTARIX) • Event: Rotavirus infection This case was reported by a healthcare professional and described the occurrence of rotavirus in a 13-month-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccination included 1st doses of PENTACEL (Sanofi Pasteur) and PREVNAR 7 (Wyeth) both given on 3 November 2009 ...

Page 874: RV1 • ROTAVIRUS (ROTARIX) • Event: White blood cell count increased This case was reported by a physician via Sanofi Pasteur and described the occurrence of idiopathic thrombocytopenic purpura in a 6-year-old female subject who was vaccinated with INFANRIX HEXA (GlaxoSmithKline), ROTARIX, ROUVAX (non-gsk), AVAXIM (non-gsk), PENTAXIM (non-gsk) and VAXIGRIP (non-gsk). ...

Page 875: RV1 • ROTAVIRUS (ROTARIX) • Outcome: Recovery This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 6-month-old female patient who became pale, unconsciousness, cyanotic around mouth, went limp and experienced unconsciousness. The patient received a dose on 18-Jan-201 ...

Page 876: RV5 • ROTAVIRUS (ROTATEQ) • Event/Outcome: See Description Information has been received from a physician concerning a 10 month old female who in 2009 was vaccinated with 3 doses of ROTATEQ. On 15-SEP-2009 the patient received the third dose of vaccine. In December 2009, the patient was hospitalized (cause and outcome was not reported). The stool analysis p ...

Page 877: RV5 • ROTAVIRUS (ROTATEQ) • Event/Outcome: See Description Information has been received from a licensed practical nurse concerning an 8 week old female with no pre-existing medical history of allergies who on 27-NOV-2007 at 11:00 and on 29-JAN-2008 at 14:15 was vaccinated PO with her first and second doses of Rotateq (lot# 657671/0902U, 657986/1205U). Ther ...

Page 878: RV5 • ROTAVIRUS (ROTATEQ) • Event: C-reactive protein increased Developed fever up to 102 degrees along with bulging of anterior fontanelle. Was seen in ER next day where labs done and L.P. done. Was admitted on antibiotics pending cultures. Did well at the hospital, culture negative. ...

Page 879: RV5 • ROTAVIRUS (ROTATEQ) • Event: Drug administered to patient of inappropriate age This spontaneous report as received from a registered nurse refers to a 4 month old patient of unknown gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with the first dose of ROTATEQ (orall...

Page 880: RV5 • ROTAVIRUS (ROTATEQ) • Event: Hyporesponsive to stimuli This spontaneous report as received from a regulatory authority (agency # was not provided) on 01-DEC-2014 refers to a 3 month old patient of unknown gender. On 29-MAY-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # J004868, expiration date: 31-DEC-2014) (strength and dose were ...

Page 881: RV5 • ROTAVIRUS (ROTATEQ) • Event: Intussusception Information has been received from an investigator concerning a 25 week male who entered a study, title as stated above. On 12/22/2005 the patient was vaccinated with rotavirus G1 G2 G3 G4 P1 reassortant vaccine vaccine live (human bovine), dose 2 of rotavirus G1 G2 G3 G4 P1 reassortant vaccine vacc ...

Page 882: RV5 • ROTAVIRUS (ROTATEQ) • Event: No adverse event This spontaneous report was received from a healthcare worker referring to a 3 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 23-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unkno ...

Page 883: RV5 • ROTAVIRUS (ROTATEQ) • Event: Pyrexia Case of misuse (inappropriate schedule of vaccine administered - 1st dose of ROTATEQ given at week 13) was received from a healthcare professional (paediatrician) on 19-SEP-2011. Case was medically confirmed. A 13-week-old male patient (weight: 7.1 kg; height: 63.5 cm) received a first dose of PENTA ...

Page 884: RV5 • ROTAVIRUS (ROTATEQ) • Event: Ultrasound abdomen abnormal Mother reported that soon after the administration of the immunizations infant began to have fever, increased respiratory rate and some abdominal distention. Mom started to give Tylenol at that time. The symptoms worsened and mom brought the infant to the emergency room on 7/18/10 for evaluation and ...

Page 885: RV5 • ROTAVIRUS (ROTATEQ) • Outcome: Hospitalization Information was obtained on a request by the Company from the agency via a Public Case Detail concerning a 4 month old female patient who on 04-JAN-2013 received second dose of ROTATEQ via oral (Lot number 0592AE) 1 dose unspecified 1 time. Secondary suspect vaccine given on the same day included se ...

Page 886: RV5 • ROTAVIRUS (ROTATEQ) • Outcome: Recovery Information has been received from a nurse practitioner (NP) concerning a 2 month old male who was vaccinated PO, at 2 months old, with the first 2.0 mL dose of Rotateq. The NP reported that in 2007, the patient developed diarrhea for 10 days. The patient was seen in the Emergency Room (ER), but was ...

Page 887: RVX • ROTAVIRUS (NO BRAND NAME) • Event: Abnormal behaviour Localized redness at injection site with hard palpable mass/swelling under the skin and under area of redness. Extreme fussiness and change in usual behavior. ...

Page 888: SMALL • SMALLPOX (ACAM2000) • Event/Outcome: See Description Patient described pain and redness to injection site. No other information obtained as medical documents not obtained up to this reporting date. Patient discharged and has recovered. ...

Page 889: SMALL • SMALLPOX (ACAM2000) • Event: Troponin I increased This report was received from the investigator on 07 June 2010. A 20 year-old male subject with no significant medical history received the following vaccines on 13 March 2010: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Sixteen days afte ...

Page 890: SMALL • SMALLPOX (DRYVAX) • Event: Enzyme abnormality DEVELOPED ACUTE LEFT SIDED CHEST PAIN ON THE MORNING OF FEBRUARY 28, 2006. THE PATIENT WAS ASLEEP AT THE TIME THE PAIN DEVELOPED. THE PAIN WAS ASSOCIATED WITH NAUSEA AND DIAPHORESIS BUT NO VOMITING. THE PATIENT WAS TAKEN TO SICK CALL BY THE SICK CALL VAN AND SEEN BY THE PHYSICIAN'S ASSISTANT. THE PA ...

Page 891: SMALL • SMALLPOX (DRYVAX) • Event: Thirst Patient diagnosed with Type I diabetes. He believes the illness is due to smallpox vaccine and anthrax vaccine. 31-year-old male who contacted the Vaccine Healthcare Centers (VHC) Network at the request of someone who also developed type 1 diabetes. Both service members have concerns regarding vacci ...

Page 892: TBE • TICK-BORNE ENCEPH (NO BRAND NAME) • Event: Arthritis This case was reported by a physician and described the occurrence of arthritic signs in a 7 year old female subject who was vaccinated with hepatitis A vaccine and tick-borne encephalitis vaccine for prophylaxis. Concurrent medical conditions included Gaucher's disease which was treated with Imiglu ...

Page 893: TD • TD ADSORBED (NO BRAND NAME) • Event/Outcome: See Description pt recv vax; swelling, throbbing approx 24 hr p/ vax; ...

Page 894: TD • TD ADSORBED (NO BRAND NAME) • Event: Cellulitis Pt recv vax & devel cellulitis. Pt seen in ER & tx w/antibiotic therapy. ...

Page 895: TD • TD ADSORBED (NO BRAND NAME) • Event: Hypoaesthesia The pt experienced soreness to the left arm for several weeks, then soreness with deep pain. The pt experienced numbness in Index and thumb. Was seen by a doctor on 2/27/01 and one more time since. Pain medication provided no relief. Placed on steroids with little relief. Appointment on 4/23/01. ...

Page 896: TD • TD ADSORBED (NO BRAND NAME) • Event: Injection site oedema 26JUN95 itchy eyes, weak, tightness in throat, runny nose; visited primary MD 27JUN95 & recvd inj Aristocrat; inject site on 30JUN95 still edematous & red; ...

Page 897: TD • TD ADSORBED (NO BRAND NAME) • Event: Myasthenic syndrome pt recvd vax; redness & heat to site Lt deltoid; noted fatigue; muscle weakness; achiness of joints; pt felt warm; slight erythema; ...

Page 898: TD • TD ADSORBED (NO BRAND NAME) • Event: Pyrexia 11JUN91 pt recvd TD; 12JUN91 fever upon awakening; ...

Page 899: TD • TD ADSORBED (NO BRAND NAME) • Event: Vomiting 10 days p/vax pt exp cerebral deficit & was hosp;Dx= brain stem encephalitis ...

Page 900: TD • TD ADSORBED (NO BRAND NAME) • Outcome: Visit to Hospital or Doctor (Emergency) Right arm cellulitis; tx w/ antibiotics and anti-inflammatory medication. ...

Page 901: TD • TD ADSORBED (TDVAX) • Event: Pain in extremity Patient stepped on glass and received TD on 4/30/10. The next day (5/1/10) the injection site was hard and swollen. On 5/3/10, she was zoned out, tired, depressed, wanted to cry, obsessive with thoughts, and couldn't ""get connections with her thought form"", and couldn't function. On 5/4/10, patien ...

Page 902: TD • TETANUS DIPHTHERIA (NO BRAND NAME) • Event: Diplopia This is a spontaneous report from a contactable physician received from the Drug Agency. Regulatory authority report number ES-AGEMED-005362334. A 61-year-old male patent of an unspecified ethnicity received PREVENAR 13 (lot# N16502, exp date May2018), at 0.5 ml, and DIFTAVAX (Lot# L7136-5, exp date ...

Page 903: TD • TETANUS DIPHTHERIA (NO BRAND NAME) • Outcome: Visit to Hospital or Doctor (Emergency) Severe pain- swelling- redness at site of injection and upper arm. Decreased movement of left arm. Treatment- Ice to area as needed & Atarax 25 mg three times daily. ...

Page 904: TDAP • TDAP (ADACEL) • Event/Outcome: See Description After receiving the last vaccine Varicella, patient had what appeared to be a seizure - symptoms observed were slight loss of consciousness, slight muscle stiffing, and slight muscle jerking with lasted for less than 1 minute. Patient was then conscious and speaking, verbalizing nausea and sleepines ...

Page 905: TDAP • TDAP (ADACEL) • Event/Outcome: See Description Received Tdap & Varicella on 8 Nov in (R) arm. On Monday 14 Nov, (R) arm was red and tender and swollen. Wen to doctor. Dx w/ cellulitis Temp 98.4 B/P 100/72 P: 90. Given CLEOCIN 600 mg IM & Tramadol for pain Rx Clindamycin 150 mg x 80 tabs. ...

Page 906: TDAP • TDAP (ADACEL) • Event: Cellulitis Redness, swelling and pain (RT) upper arm. Treated w/doxycycline for cellulitis. ...

Page 907: TDAP • TDAP (ADACEL) • Event: Erythema 1-11 Wed AM had vaccines-soreness. Wed PM very sore, hard to walk (R) leg. 1-12 Thurs-increased soreness, swollen and red-BENADRYL given. 1-13 Friday-knee to hip red, swollen, itching BENADRYL given. Office visit-BENADRYL and ORAPRED given, also Rx for cephalexin for 10 days. ...

Page 908: TDAP • TDAP (ADACEL) • Event: Heart rate increased Initial report received on 20 April 2011 from a consumer, who is the patient. A 55 year old female patient, with an allergy to thimerosal, received a left deltoid intramuscular injection of ADACEL (lot number unknown) on 10 January 2011. The patient had no illness at the time of vaccination. Concomi ...

Page 909: TDAP • TDAP (ADACEL) • Event: Injection site haematoma Left deltoid, erythematous raised patch below site. Contusion above site. Large amt swelling into upper forearm. Lymphadenopathy, axilla and tonsillar. ...

Page 910: TDAP • TDAP (ADACEL) • Event: Injection site swelling Patient received a Tdap injection on Wed. 10/31/2012 in the left deltoid area. Left arm and Tdap vial were both cleansed with alcohol. Patient tolerated the procedure well. She reported (via an email several days later) that her arm did have some Increased soreness later that day but she did not fee ...

Page 911: TDAP • TDAP (ADACEL) • Event: Musculoskeletal pain Extreme soreness in arm and shoulder. Extreme difficulty in movement of arm e.g. when dressing/undressing. Strong pain and discomfort when sleeping. Pain peaked a few days after vaccination. Slowly subsiding; however still quite relevant after 12 days, and some rotational movement of arms are not fe ...

Page 912: TDAP • TDAP (ADACEL) • Event: Pain 7/29 pt reports headache began. Pain was in head, neck, upper back and shoulders. General body aches with joint pain. by 8/15/07 pt still reporting headaches not relieved by Tylenol or Motrin. Also decreased sleeping, increased urination and dark urine. Pt reports has been to MD and awaiting follow ...

Page 913: TDAP • TDAP (ADACEL) • Event: Pyrexia Woke up in morning and noticed burning pain to shot area and quarter size ""hive"" type red area. Red area slowly got bigger on 7/16 and 7/17 and ran a fever (101.6) approx 3:00 am and went to Emergency Department. Was told to take Benadryl and Ibuprofen. The fever over 101 lasted from 7/17 to 7/19. ...

Page 914: TDAP • TDAP (ADACEL) • Event: Tinnitus Patient states that several hours after receiving her travel immunizations on 3-11-08 she began to notice ringing in her ears. After 2 weeks she sought medical care. Various tests were run and diagnosis of ""tinnitis"" was given. She presented herself again in our clinic today to state these facts a ...

Page 915: TDAP • TDAP (ADACEL) • Outcome: Recovery Post Vaccination Syncope ...

Page 916: TDAP • TDAP (ADACEL) • Outcome: Visit to Hospital or Doctor (Emergency) Severe (L) arm/shoulder pain 6 days after vaccine. Decreased ROM. No relief with warm compresses, anti-inflammatories. Treated w/T#3, percocet, steroid injection at clinic. Then given DILANDID and TORADOL at ER. Now 90% improved 1 month after. ...

Page 917: TDAP • TDAP (BOOSTRIX) • Event/Outcome: See Description 101.5 temperature, strong aches in joints muscles and bones- it felt like severe arthritis, loss of strength, heart pains. ...

Page 918: TDAP • TDAP (BOOSTRIX) • Event/Outcome: See Description Redness, warmth, induration 2""x 2 1/2"" to injection site. Pt. reports site is painful to touch. ...

Page 919: TDAP • TDAP (BOOSTRIX) • Event: Decreased appetite Nausea, fever, severe weakness, lost of appetite, fast heart beating, sensitivity to light, insomnia. Next day: Headache, strong muscle ache, severe weakness, no appetite, must be in bed. ...

Page 920: TDAP • TDAP (BOOSTRIX) • Event: Headache Rec'd vaccine approx. 12:00 noon on 5/22/06. Remained at HD X 15 min. Approx. 13:30, began having mild to moderate H/A over forehead. Took ibuprofen last night. H/A relieved. Other associated symptoms were lightheadedness, weakness and loss of appetite. No longer lightheaded but weakness and loss of ...

Page 921: TDAP • TDAP (BOOSTRIX) • Event: Injection site swelling Marked swelling to area of injections. ...

Page 922: TDAP • TDAP (BOOSTRIX) • Event: No adverse event Physician ordered a TDAP instead of an HPV, patient had a TDAP last year. The TDAP was administered as part of the orders. No harm done. Just an honest mistake. ...

Page 923: TDAP • TDAP (BOOSTRIX) • Event: Rash macular On 6/2/10 around 4PM, client noticed redness ""blotchy"" on (L) arm where received TDAP & VZV vaccines. On 6/3/10 upon wakening at 9AM, client noticed hardness and swollen (L) deltoid area, continued redness, warm to touch. Back of upper (L) arm (where VZV given) is redness and small knot under the ...

Page 924: TDAP • TDAP (BOOSTRIX) • Event: Wrist fracture Seen 9/7/2016 - open fx (L) wrist. To OR for repair. Discharge same day. ...

Page 925: TDAP • TDAP (BOOSTRIX) • Outcome: Visit to Hospital or Doctor (Emergency) PATEINT REPORTED HAVING FEVER, RASH ON FACE, CHEST, AND ABDOMEN AREA. ITCHING, HEADACHE. AFTER THE SECOND DAY WITH THE SYMPTOMS, RECEIVE TREATMENT IN HOSPITAL, ZYRTEC 10 MG 1 TAB DAILY. SHE RECOVERED 3 DAYS LATER. ...

Page 926: TDAP • TDAP (NO BRAND NAME) • Event: Double stranded DNA antibody Case number PHHY2012US058747, is an initial literature report received on 09 Jul 2012. The authors reported a case of post vaccination acute myopericarditis in an adolescent. This case refers to 17-years-old male patient. He had no history of angina pectoris, cocaine abuse, hyperlipidemia or congeni ...

Page 927: TDAP • TDAP (NO BRAND NAME) • Event: Swelling Fever, upset stomach, diarrhea, muscle tightness, extreme muscle soreness. Three days after, new symptoms of red streaking and swelling, further red skin and warmth to touch four days after. Went to urgent care clinic and was treated for infection caused by vaccine injection. ...

Page 928: TTOX • TETANUS TOXOID (NO BRAND NAME) • Event: Headache High fever, accelerated heart rate, muscle aches over whole body, swelling under arm, vomiting, headache, some diarrhea. Felt better after 3 1/2 days. ...

Page 929: TTOX • TETANUS TOXOID (NO BRAND NAME) • Outcome: Visit to Hospital or Doctor (Emergency) severe h/a, extreme muscle pain, muscle spasm, dry mouth, dizziness, lack of energy-temp of 101-102;could not dress or walk on own;rx APAP, valium; ...

Page 930: TYP • TYPHOID LIVE ORAL TY21A (VIVOTIF) • Event: Abdominal tenderness 8/15/17 @630pm-Received three injection vaccines: Polio, Meningitis, Yellow Fever; 8/16/17 @500am-first dose of oral typhoid vaccine with glass of cold water; 8/17/17 @800pm-vomited after attending wine tasting event (did not drink enough wine to cause that); 8/18/17 @500am-second dose of oral typho ...

Page 931: TYP • TYPHOID VI POLYSACCHARIDE (ACETONE INACTIVATED DRIED) • Event: Anaphylactoid reaction pt recvd Typhoid vax & exp an anaphylactoid reaction, accompanied by seizures; pt was admitted to ICU & is recovering; ...

Page 932: TYP • TYPHOID VI POLYSACCHARIDE (NO BRAND NAME) • Event: Rash Started with oral typhoid 1/3/07 became nausea. On 1/5/07 took pill #2 vomited pill up, felt very nauseous after 7 hours and then on 1/06/07 noticed rash on lower lip itchy red and raised went to ER. ...

Page 933: TYP • TYPHOID VI POLYSACCHARIDE (TYPHIM VI) • Event: Blood creatine phosphokinase MB increased Patient had chest pain which was non-radiating and presented to the ED on August 7, 2011. Patient was admitted and referred to cardiology who diagnosed him with Myopericarditis on August 9, 2011. ...

Page 934: TYP • TYPHOID VI POLYSACCHARIDE (TYPHIM VI) • Event: Lip swelling Called clinic 11/2 hr after receiving vaccine complaint of allergic reaction -felt like her lips and tongue swelling, generally not feeling well. Sent to local ER. Stable in ER. VSS. No swelling noted anywhere, no hives or rash, no SOB, no nausea or vomiting, no lightheadedness. Treated for subjecti ...

Page 935: TYP • TYPHOID VI POLYSACCHARIDE (TYPHIM VI) • Event: Vomiting Patient developed sudden onset of myalgias, nausea, vomiting, abdominal pain, fever, RLQ pain and chills on afternoon of 2/23/05. Yellow fever vaccine was administered on 2/22/05. Patient hospitalized on 2/24/05 and an appendectomy was performed. Patient discharged next day without complications. ...

Page 936: UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Event/Outcome: See Description Strong muscular problems; Herpes on her lips; Severe insomnia, sleep only 2.5 hours per 24 h; Feeling that she does not have enough energy after a few steps; Xeljanz 5 mg once a day for psoriatic arthritis; Arm was red; High fever; Infection with serratia marcescens; This case was reported by a cons ...

Page 937: UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Event: Blood test Acute generalised exanthematous pustulosis; confluent pruritic maculopapular rash; fever < 38°C; Herpes zoster ophthalmic; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TS20212214. A 78-years-old male pa ...

Page 938: UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Event: Fatigue Very painful injection site. Cold, chills, fatigue, overall unwell feeling, exhaustion ...

Page 939: UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Event: Livedo reticularis Information has been downloaded from database (NL-LRB-00264001). This spontaneous report as received from a consumer refers to a 14 month old female patient. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 04-JAN-2018, the patient was vaccinated wit ...

Page 940: UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Event: Pruritus 6 hours after shot, broke into big hives on face. Took Zyrtec and Claritin and went away in 30 mins. Some itchiness on body but not hives. ...

Page 941: UNK • VACCINE NOT SPECIFIED (NO BRAND NAME) • Event: Vomiting Stomach pain diarrhea nausea vomiting headache ...

Page 942: UNK • VACCINE NOT SPECIFIED (OTHER) • Event: Chills About 12 hours after the injection (around 10:30 PM Friday 3/39) I had chills for 3 hours, plus fever, aches, pains, nausea, headache, general malaise until approximately 6 PM Saturday 3/30. ...

Page 943: VARCEL • VARICELLA (NO BRAND NAME) • Event: Headache Nausea and headache at 12:00 Dizzy,headache,shaky, itchy,difficulty breathing, pain in the chest, and out of body feeling starting at 3:00 PM ...

Page 944: VARCEL • VARICELLA (NO BRAND NAME) • Outcome: Visit to Hospital or Doctor (Emergency) Loss of eye contact, words, repetitive odd behaviors, crying, sick, diarrhea. Pt was given 18 vaccines until 18 months. Pt was born with a twin-his sister is NT. At birth swallowed fluid-mild pneumonia- given antibiotics and Hep B- another Hep B 2 months later- more vaccines- MMR, Flu, chicken pox a ...

Page 945: VARCEL • VARICELLA (VARIVAX) • Event/Outcome: See Description This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was inadvertently administered an expir ...

Page 946: VARCEL • VARICELLA (VARIVAX) • Event/Outcome: See Description This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown dates, the patients were vaccinated with improperly stored dos ...

Page 947: VARCEL • VARICELLA (VARIVAX) • Event/Outcome: See Description pt recvd vax 28SEP95 & 7OCT95 pt exp soreness @ inj site that lasted until 8OCT95;9OCT95 pt exp sore throat, fever, adenopathy, stiff neck & otitis;f/u the pt's MD reported that no further info was available as the pt did not contact ofc; ...

Page 948: VARCEL • VARICELLA (VARIVAX) • Event/Outcome: See Description Red, warm, itchy, swelling. ...

Page 949: VARCEL • VARICELLA (VARIVAX) • Event/Outcome: See Description This spontaneous report was received from a registered nurse and refers to a 1 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were reported as none. On 16-FEB-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot numbe ...

Page 950: VARCEL • VARICELLA (VARIVAX) • Event/Outcome: See Description Vaccines given 5/26/2009. Left leg appeared red, warm to touch and painful when touched. Mom noticed this on 6/9/09. Subsequent appt. 6/6/09. On 6/5 area involved = 1 1/2 inches 6/6 area 3 cm X 3 cm child also had temp on 6/5 - 6/6 : (101. degree) ax. 6/6/09 started on axb. for 10 days ...

Page 951: VARCEL • VARICELLA (VARIVAX) • Event/Outcome: See Description Information has been received from a physician concerning a male between the ages of 4 & 5 who in approximately OCT-2007 (month and half ago) was vaccinated subcutaneous with a second 0.5 ml dose of VARIVAX (Oka/Merck). In approximately OCT-2007 (after receiving his second dose) the patient develope ...

Page 952: VARCEL • VARICELLA (VARIVAX) • Event: Abnormal behaviour On Thursday, September 27th we began to notice our son was seeking for more deep pressure sensory than what is normal for him. His autism sensory processing problem causes him to seek sensory and he needs deep pressure to satisfy his body's needs thru the day and even at night with a weighted blanke ...

Page 953: VARCEL • VARICELLA (VARIVAX) • Event: Body temperature Initial and follow-up information has been received from a medical assistant concerning a 12 month old male with no relevant medical history or allergies who on 18-JUL-2008, also reported as 10 days ago, was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number 659457/1913U) subcutaneously in th ...

Page 954: VARCEL • VARICELLA (VARIVAX) • Event: Dermatitis bullous pt recv vax 16APR98 945AM & devel erythematous patches on forehead p/crying ?rxn to vax-probably not; ...

Page 955: VARCEL • VARICELLA (VARIVAX) • Event: Drug ineffective pt recvd vax 12JUN95 & 9 days later pt devel chicken pox described as microvesicles on a pink base & very small lesions primarily on back; seen in ER: ...

Page 956: VARCEL • VARICELLA (VARIVAX) • Event: Erythema Noticed fever 9-6-07. Noticed red-itchy bumps all over body 9-7-07. ...

Page 957: VARCEL • VARICELLA (VARIVAX) • Event: Full blood count normal 6/24/09 redness, swelling, warmth, soreness below sight of varicella immu Dx ""Mild Superficial Cellulitis"". Rx KEFLEX 500 mg po BID x 10d. 6/25/09 increased redness c/o painful thigh no streaking. Rx ROCEPHIN 1 Gm L buttocks D/C KEFLEX CBC WNL. 6/26/09 leg looking much better she is feeling better ...

Page 958: VARCEL • VARICELLA (VARIVAX) • Event: Inappropriate schedule of drug administration Information has been received from a health professional concerning a 6-year-old female with reactive airways disease, with no history of drug reactions or allergies, who on 17-JUL-2001 (Lot # 635451/1143K) and 23-AUG-2003 was vaccinated intramuscularly with the first and second doses of Varivax. Co ...

Page 959: VARCEL • VARICELLA (VARIVAX) • Event: Infection pt recv vax 16SEP95 & 31MAY96 pt devel a severe rash described as a natural case of chickenpox; ...

Page 960: VARCEL • VARICELLA (VARIVAX) • Event: Injection site erythema Left upper arm- mild redness, tenderness at injection site. Pt noticed area 1 day ago. ...

Page 961: VARCEL • VARICELLA (VARIVAX) • Event: Injection site induration Localized induration and erythema on rt arm - HPV and VAR. Diameter of 2in. Warm compress 20min TID and IB. May last for 1wk. ...

Page 962: VARCEL • VARICELLA (VARIVAX) • Event: Injection site reaction Pt. arrived today for an appt. Pt. explained that her (R) deltoid (upper extremity) had a reaction from vaccine. Area noted to be 50mm x 50mm (round and circular). Pt. denies pain. No fever/chills. Area noted to be pink, no evidence of cellulitis. ...

Page 963: VARCEL • VARICELLA (VARIVAX) • Event: Injection site warmth On 5/29/10 Injection site red, hot and swollen. Patient treated with Amoxicillin. ...

Page 964: VARCEL • VARICELLA (VARIVAX) • Event: Medication error Information has been received from a registered nurse concerning a 10 year old patient who was vaccinated SC with 0.5 ml dose of Zostavax (Lot # 657675/0618U) instead of Varivax. It was reported that the office was expecting an order of Varivax and an order of Zostavax and the Zostavax vaccine arriv ...

Page 965: VARCEL • VARICELLA (VARIVAX) • Event: No adverse event no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medi ...

Page 966: VARCEL • VARICELLA (VARIVAX) • Event: Pain in extremity Redness at injection site to back side of left arm approximately 2in long and 1.5 in wide. Injection site warm to touch. Left upper arm swollen. Client states arm hurts and burns. Clients also states that she applied ice to site for a few minutes while at work. ...

Page 967: VARCEL • VARICELLA (VARIVAX) • Event: Pruritus Sweating, itching, rash, heat wave. ...

Page 968: VARCEL • VARICELLA (VARIVAX) • Event: Pyrexia pt recvd vax 14NOV95 & 27NOV95 pt devel a fever & 28 blisters located on abd & back (range not recorded);no further details were provided; ...

Page 969: VARCEL • VARICELLA (VARIVAX) • Event: Rash maculo-papular approx 2yrs p/ vax pt exp approx 50 scattered papules as well as itchiness. rpt felt events were not related to therapy w/varicella ...

Page 970: VARCEL • VARICELLA (VARIVAX) • Event: Rash Information has been received from a physician concerning a 6 year old female with no pertinent medical history or allergies who in approximately 2004 (2 to 3 years ago) was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In approximat ...

Page 971: VARCEL • VARICELLA (VARIVAX) • Event: Skin ulcer The pt experienced outbreak of less than 50 lesions. Onset 10/29/00 and was itchy. ...

Page 972: VARCEL • VARICELLA (VARIVAX) • Event: Tuberculin test positive Right upper arm with diffuse erythema. ...

Page 973: VARCEL • VARICELLA (VARIVAX) • Event: Varicella Information has been received from a physician concerning a six year old female patient who was vaccianted with varicella virus vaccine live (lot 622752/0183B). The physician reported that last week. On 5/3/2005 the patient came into the office with a very mild breakthrough case of chicken pox. No t ...

Page 974: VARCEL • VARICELLA (VARIVAX) • Outcome: Hospitalization Post vax, the pt experienced a very bad reaction (no details provided) and was hospitalized. A 15-day follow up report received 01/10/2001 adds: Info has been received from a pharmacist concerning a female with monosodium gluconate (No details provided) allergy who was vaccinated with varicella viru ...

Page 975: VARCEL • VARICELLA (VARIVAX) • Outcome: Recovery Pt. feels nauseated, headache is ongoing, sensitive to light, fever of 102.0, pain in arm & leg (injection sites). ...

Page 976: VARCEL • VARICELLA (VARIVAX) • Outcome: Recovery Noticed pimple rash on L arm at injection site. Small cluster few red pimple areas on face and stomach and back couple on legs. ...

Page 977: VARCEL • VARICELLA (VARIVAX) • Outcome: Recovery Pt had gotten chickenpox 12/27/97. ...

Page 978: VARCEL • VARICELLA (VARIVAX) • Outcome: Visit to Hospital or Doctor (Emergency) 4-26-08 Mother noticed ""little red dot"" on L leg where varicella had been given on 4-19-08. The red area became larger & tender & more red as time went by. Came to clinic where shots were given. Area was approx 7 cm diameter. Was advised to see her MD which she was. No treatment recommended. Area ...

Page 979: VARCEL • VARICELLA (VARIVAX) • Outcome: Visit to Hospital or Doctor (Emergency) Several months post vax, pt developed acute lymphoblastic leukemia. The pt has been on maintenance chemotherapy since the diagnosis. In recent weeks, pt has been exposed to varicella. On approximately 6/26/01, pt developed chickenpox and was hospitalized. MD noted the child's rash was very atypical ...

Page 980: VARCEL • VARICELLA (VARIVAX) • Outcome: Visit to Hospital or Doctor (Emergency) Information has been received from a physician concerning a child with no reactions after the first dose of VARIVAX (Oka/Merck) who on approximately 10-JUL-2008, two weeks ago, was vaccinated with the second dose of VARIVAX (Oka/Merck). The patient experienced severe swelling under the arm, redness ...

Page 981: VARZOS • ZOSTER (NO BRAND NAME) • Event: Oropharyngeal pain Clogged Sinuses, Sore Throat, Lack of Energy. ...

Page 982: VARZOS • ZOSTER (SHINGRIX) • Event/Outcome: See Description Pain, rash. ...

Page 983: VARZOS • ZOSTER (SHINGRIX) • Event/Outcome: See Description severe rash , pain and warm area around injection site ...

Page 984: VARZOS • ZOSTER (SHINGRIX) • Event/Outcome: See Description About 24 hours after vaccination, patient experienced diarrhea, vomiting and severe chills (hands were shaking uncontrollably) with about 103 fever. Pt took 3 tablets of ADVIL 200 mg and went to bed. All the symptoms were resolved by morning. ...

Page 985: VARZOS • ZOSTER (SHINGRIX) • Event/Outcome: See Description PATIENT ROPORTED NEXT DAY SHE HAD SEVERE DIARRHEA - LOST A LOT OF FLUID AND DEHYDRATION. DID HAVE SOME SORENESS DUE TO INJECTION. ...

Page 986: VARZOS • ZOSTER (SHINGRIX) • Event: Arteriogram carotid normal Non-intractable vomiting, nausea, non-intractable headache, chills, full body aches. Symptoms were sever enough that Patient went to the Emergency Room for care. Patient was given toradol, solumedrol, Compazine, Benadryl and fluids. Patient fully recovered and went home that night. It is unknown wha ...

Page 987: VARZOS • ZOSTER (SHINGRIX) • Event: Burning sensation Patient developed a red, burning rash on head around temple area and over head. ...

Page 988: VARZOS • ZOSTER (SHINGRIX) • Event: Chills Patient complained of fatigue, shivering, myalgia starting about 8 hours after vaccination. Patient treated with TYLENOL and hydration and condition improved over the next 24 hours. ...

Page 989: VARZOS • ZOSTER (SHINGRIX) • Event: Dysuria Numbness in groin and rectal area / Numbness in feet; Dfficulty urinating; difficulty defecating; feel numbness in rectal area; Skin became sensitive to touch; Skin was painful to the touch; rash; Difficulty walking; Flu like symptoms; Chills; Achy all over; Headache; May have multiple sclerosis; Th ...

Page 990: VARZOS • ZOSTER (SHINGRIX) • Event: Fatigue Rash on arm, 101.3 Temperature 04/27/2019, Laryngitis 04/30/2019, Sore throat, white sores and inflammation at back of throat, Tired, chronic cough 04/30/2019. Symptoms lasted until 05/14/2019 ...

Page 991: VARZOS • ZOSTER (SHINGRIX) • Event: Headache This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (30 years ago). Concurrent medical conditions included chronic lymphocytic leukem ...

Page 992: VARZOS • ZOSTER (SHINGRIX) • Event: Hot flush chills, hot flashes, headache, head congestion, general malaise ...

Page 993: VARZOS • ZOSTER (SHINGRIX) • Event: Injected limb mobility decreased This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received at the age of 60 years). On 26th May 2018, the patient receiv ...

Page 994: VARZOS • ZOSTER (SHINGRIX) • Event: Injection site pain Redness, swelling around injection site pain, tenderness ongoing for 4 days ...

Page 995: VARZOS • ZOSTER (SHINGRIX) • Event: Injection site swelling swollen, painful, elevated in the area surrounding injection site ...

Page 996: VARZOS • ZOSTER (SHINGRIX) • Event: Lipase Patient received SHINGRIX vaccine date she reported of 3/20/2019 and 3/28/2019 started to experience myalgias and arthralgias and severe pain in all her joints of the body and muscles to the extent that she was unable to turn herself and her husband had to lift her and which point she went to urgent ...

Page 997: VARZOS • ZOSTER (SHINGRIX) • Event: Myalgia This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received SHINGRIX. In April 2018, the patient received SHINGRIX. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever, heada ...

Page 998: VARZOS • ZOSTER (SHINGRIX) • Event: Neck pain This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 53-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included surgery (had many surgeries in life and prior to getting SHINGRIX). Concomi ...

Page 999: VARZOS • ZOSTER (SHINGRIX) • Event: Pain fever; achiness; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (1st dose received on an unknown date). On an unknown ...

Page 1000: VARZOS • ZOSTER (SHINGRIX) • Event: Periorbital swelling swelling under left eye ...

Page 1001: VARZOS • ZOSTER (SHINGRIX) • Event: Pyrexia Onset of symptoms experienced approximately 4.5 hrs subsequent to injection: discomfort/slight rubor/warmth at injection site; generalized myalgia, arthralgia (joint pain most pronounced at base of neck; low spine and bilateral hips); fever; malaise; diminished appetite; somnolence. It should be not ...

Page 1002: VARZOS • ZOSTER (SHINGRIX) • Event: Rash The patient developed a rash on her scalp and on her cheeks. She had an itchy scalp and back of neck. ...

Page 1003: VARZOS • ZOSTER (SHINGRIX) • Event: Swelling She experienced swelling, soreness, redness, and burning sensation the night when she had a shot. She couldn't lift her left arm. Her symptoms have been getting better. ...

Page 1004: VARZOS • ZOSTER (SHINGRIX) • Outcome: Death Large B Cell Lymphoma; vaccine overloaded his already stressed lymphatic system and progressed aggressively; vaccine overloaded his already stressed lymphatic system and progressed aggressively; he died after two weeeks in the hospital; This case was reported by a consumer via interactive digital me ...

Page 1005: VARZOS • ZOSTER (SHINGRIX) • Outcome: Recovery Patient started feeling severe fatigue and stomach pain within 4 hours of receiving vaccine, proceeded to vomit 3 times and develop low grade fever (99.6) and body aches/chills. Most of the symptoms resolved within 3 days, however severe fatigue and cold sweats lasted 7 days. After 7 days, all side ...

Page 1006: VARZOS • ZOSTER (SHINGRIX) • Outcome: Visit to Hospital or Doctor (Emergency) This case was reported by a physician via call center representative and described the occurrence of focal seizures in a 74-year-old female patient who received SHINGRIX for prophylaxis. In December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHIN ...

Page 1007: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event/Outcome: See Description Information has been received from a registered nurse referring to unknown number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stor ...

Page 1008: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event/Outcome: See Description post herpetic neuralgia; issues with her vision; congestive heart failure; heart attack; bacterial infection; herpes zoster; Information has been received from a lawyer regarding a case in litigation and refers to a female patient (pt) of unknown age. No information was provided regarding medical hi ...

Page 1009: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event/Outcome: See Description Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. During 2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and rout ...

Page 1010: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event/Outcome: See Description post herpetic neuralgia; outbreak of herpes zoster; Information has been received from a lawyer regarding a case in litigation, regarding a female patient of unknown age (the patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not pro ...

Page 1011: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Abdominal discomfort I got a shingles shot at Pharmacy about 11:45 AM I have never had a reaction to a vaccine before this. I got a large red welt about 3 inches by 4 inches at injection site, flushing, rapid heart beat, throat closing up, burning sensation in lungs, trouble breathing, upset stomach, headache, dizzy, am ...

Page 1012: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Chest X-ray normal Patient received PNEUMOVAX 23 and ZOSTAVAX on RIGHT deltoid area on 7/2/2010. Seen in E.D. on 7/05/2010 for fever 104 degrees with mild erythema to RIGHT deltoid only-no abscess. Had headaches and myalgias by 7/3/2010- No other symptoms or findings. Treated with ceftriaxone IV and Vancomycin in E.D. ...

Page 1013: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Erythema Red sores first a few than massive. Doctor issued presc. I presently being treated by my doc. Still in pain been on meds for 2 1/2 month. Have difficulty in walking am using cane to prevent a fall. ...

Page 1014: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Herpes zoster shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-OCT-2013, the patient was vacci ...

Page 1015: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Hypersensitivity Information has been received from a consumer concerning her husband, a 69 year old male with blood pressure high, sulfonamide allergy and WELLBUTRIN allergy who on 29-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included omeprazole, oxybutynin ER, naproxen, NIFEDIAC ...

Page 1016: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Injection site erythema 3/6/16 noticed soreness... looked at area and noticed a reddened area around injection site. 3/7/16 noticed the reddened area had grown. 12:20pm 3/7/16 area is red about 2 inches by 3 inches and feels swollen. No treatment has been attempted at this time. ...

Page 1017: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Injection site pruritus This spontaneous report was received from a pharmacist refers to a 74 year old female patient. The patient has high cholesterol, hypertension, anxiety, history of heart attack, allergy to iodine, trimethoprim, sulfa drugs, statins, tetanus toxoids, had reaction to TDap before and CELEBREX. The patie ...

Page 1018: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Injection site urticaria Tuesday AM had red raised welts around where shot was given, soreness, pain in area. Continued thru Wed. night. Saw RPh recommended ice and Ibuprofen. Stopped in Thurs AM was better. Continued treatment. Called Friday night was back to normal. ...

Page 1019: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Nausea Sub normal temperature, Headache, Nauseous, abdominal discomfort, loose bowels, dizzyness/lightheadedness. ER Visit per primary physican. Fever next AM ...

Page 1020: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Pain Reeived Shingles Shot July 21, 2008. Thought I had had no reaction to shot; however, two weeks later I had severe intermittent pains on left side behind ear and going forward toward face. It began August 5th. The night of Aug. 6 woke up at 2:30 a.m. with severe pain again and again every minute or s ...

Page 1021: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Pyrexia This spontaneous report as received from a 57 years old female consumer with allergy to Sulfa and cortisone, no pain medications or anti-inflammatories. The patient's concurrent condition included heart flutters and asthma, medical history ""last July"" (July, 2012), she had a rash on her ribs on on ...

Page 1022: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Rash 2 1/2 x 1 in lateral raised rash on tricep found 5 days after shingles injection. Warm to touch but no pain associated. ...

Page 1023: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Event: Urticaria 5-23-13 Patient has red, itchy, welt size of 50 cents piece told to do BENADRYL, TYLENOL and ice to area. 5-24-13 Patient came into clinic 4.5 x 4 inch red area surrounding inj site c/o itching. Doxy called to pharmacy. ...

Page 1024: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Outcome: Recovery This spontaneous report was received from a nurse via field representative and refers to a patient of unspecified age. The patient's medical history included unspecified breakouts and no concurrent condition. On an unspecified date, the patient was vaccinated with ZOSTAVAX (dosing information not re ...

Page 1025: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Outcome: Visit to Hospital or Doctor (Emergency) This spontaneous report was received from physician assistant (who was also the stepdaughter of the patient) via field representative regarding a male patient of unknown age. The patient's medical history included urinary blockage. The patient was immunocompromised. On an unknown date the patient wa ...

Page 1026: VARZOS • ZOSTER LIVE (ZOSTAVAX) • Outcome: Visit to Hospital or Doctor (NonEmergency) middle cerebral artery territory ischemic stroke; systolic congestive heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditio ...

Page 1027: YF • YELLOW FEVER (STAMARIL) • Outcome: Recovery Large, red, slightly painful, raised area at site of injection appeared 2 days after vaccination. Was about 2 inches long and 1 inch wide. Lasted about 2 days and very slowly went away on its own. No medication taken or applied topically. ...

Page 1028: YF • YELLOW FEVER (YF-VAX) • Event: Injection site oedema Yellow fever vaccine site R/A SC site. Immediately noticed redness at injection site (dime-sized) which increased over 1 week to a huge hive, raised, red, swollen area approx 1 1/2"" x 4"", warm to touch, itchy, applied Benadryl cream. Symptoms subsiding 5/3-5/6/05. No further MD treatment, no visit ...

Page 1029: YF • YELLOW FEVER (YF-VAX) • Outcome: Recovery Member states 3 days after vaccination, experienced chest pains throughout chest & back. Continued for 3 days. Member seen by Dr on 11/28/2011. ...

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