Vaccine Adverse Event Reporting System

(VAERS)

Reports from March 6, 2001- March 5, 2005

Received by Illinois Vaccine Awareness Coalition (IVAC), through Freedom of Information Act (FOIA) requests, from Food & Drug Administration (FDA).

TYPE

Adverse Reaction Reports 3/6/01-3/5/02

Deaths 3/6/02- 3/5/03

Adverse Reaction Reports 3/6/03-3/5/04

6VAX-F
DTAP+IPV+HEPB+HIB -Hexavax- Aventis Pasteur
5
0
3
1
30
1
7
0
45
2
ADEN
Adenovirus Live
7
0
-
-
-
-
-
-
7
0
ANTH
Anthrax Adsorbed Biothrax Bioport
-
-
519
1
860
6
738
3
2117
10
ANTH
Anthrax Adsorbed Michigan Dept Pub Health
-
-
35
0
52
0
35
0
122
0
ANTH
Anthrax–Unknown Manufacture (Unk Mfr)
2030
7
-
-
1
-
-
-
2031
7
BCG
Mycobax Adventis Pasteur
-
-
4
0
3
0
6
0
13
0
BCG
Tice Organon-Teknika
-
-
4
0
-
-
41
0
45
0
BCG
Unk Mfr
46
3
3
0
74
31
3
0
126
34
CHOL
Cholera-USP Unk Mfr
98
0
1
0
1
0
3
0
103
0
CHOL
Cholera -USP Lederle/Wyeth
-
-
2
0
-
-
-
-
2
0
DPP
DiphtheriaToxoid/Pertussis/Polio Inact-Unk Mfr
46
0
1
0
18
1
18
0
83
1
DT
DiphtheriaTetanus Adsorbed BSI
-
-
6
0
17
0
24
1
47
1
DT
DiphtheriaTetanus Adsorbed PED-Ditranix-SmithKline
-
-
7
0
11
0
21
1
39
1
DT
DiphtheriaTetanus Adsorbed PED- Aventis Pasteur/Connaught
-
-
57
0
60
0
56
0
173
0
DT
DiphtheriaTetanus Adsorbed PED- Bioport
-
-
2
0
-
-
-
-
2
0
DT
DiphtheriaTetanus Adsorbed PED – Lederle
-
-
7
0
-
-
-
-
7
0
DT
DiphtheriaTetanus Adsorbed PED – Mass Public Health Dept
-
-
4
0
8
0
6
0
18
0
DT
DiphtheriaTetanus Adsorbed PED – Unk Mfr
1716
18
11
0
17
0
14
0
1758
18
DTAP
Acel-Imune, Lederle
-
-
114
2
49
0
45
1
208
3
DTAP
Certiva, Baxter
-
-
1
0
-
-
1
0
2
0
DTAP
Daptacel, Aventis Pasteur
-
-
260
5
1004
20
1362
17
2626
42
DTAP
Infanrix, GlaxoSmithKline
-
-
2865
50
2081
30
1652
97
6598
177
DTAP
Tripedia,Adventis PasteurConnaught
-
-
1586
25
1788
17
1362
15
4736
57
DTAP
Unk Mfr
18745
450
209
5
208
12
274
10
19436
477
DTAPH
DTAP+HIB Trihibit, Aventis Pasteur
-
-
69
0
79
1
58
1
206
2
DTAPH
Unk Mfr
111
1
7
1
13
0
15
1
146
3
DTAPHE
DTAP HepB IPV-Pediarix,GlaxoSmithKline
-
-
3
0
325
12
643
31
971
43
DTAPIP
Unk Mfr
1
1
-
-
-
-
-
-
1
1
DTOX
Diphtheria Toxoids – Unk Mfr.
26
0
1
0
-
-
-
-
27
0
DTP
Aventis Pasteur (Connaught)
-
-
32
1
28
8
42
1
102
10
DTP
Mass. Pub Hlth Biol Lab
-
-
-
-
1
0
2
0
3
0
DTP
Wyeth
-
-
2
0
-
-
-
-
2
0
DTP
Tri-Immunol, Lederle Lab.
-
-
24
0
6
0
5
0
35
0
DTP
Unk Mfr
20487
728
118
3
56
1
100
2
20761
734
DTPHEPB
DTP+HepB Tritanrix,SmithKlineBeecham
24
3
6
2
10
1
3
0
43
6
DTPHIB
DTP+ACTHIB Aventis Pasteur
5
0
6
0
49
27
23
3
83
30
DTPHIB
DTP+HIB Tetramune, Lederle
5943
223
40
1
8
0
7
0
5998
224
DTPHIB
Unk Mfr
108
4
6
0
9
0
13
1
136
5
DTPHIP
Unk Mfr
2
0
-
-
-
-
-
-
2
0
DTPIHI
DT+IVP+HIB+HepB, Pentacoq
32
5
12
0
8
0
3
0
55
5
DTPIPV
Unk Mfr
39
1
4
0
2
0
3
1
48
2
DTPIPV
Connaught
-
-
-
-
2
0
-
-
2
0
DTPPHI
DTP+IPV+ACT-HIB Unk Mfr.
12
0
5
0
23
1
7
0
47
1
FLU
Flu-Imune Lederle
94
7
21
0
26
0
15
1
156
8
FLU
Fluogen, Parkdale
318
1
3
0
-
-
6
0
327
1
FLU
Flushield, Wyeth
432
5
334
2
63
1
2
0
831
8
FLU
Fluvirin, Medeva Pharma - Evans
331
8
262
5
629
11
1172
0
2394
24
FLU
Fluzone, Aventis Pasteur /Connaught
1603
10
1106
7
1317
48
1462
38
5488
103
FLU
Flumist, Medimmune/Wyeth
-
-
-
-
188
0
246
0
434
0
FLU
Unk Mfr
1930
32
304
7
465
5
343
5
3042
49
HBHEPB
HIB+HepB Comvax, Merck
2848
608
843
30
649
20
493
37
4833
695
HBPV
HIB Hibimune, Lederle
-
-
37
0
26
1
21
2
84
3
HBPV
HIB Polysaccharide, Unk Mfr
160
6
1
0
2
1
-
-
163
7
HBVC
Merck
2
0
-
-
-
-
3
0
5
0
HEP
HepB Enerix-B, GlaxoSmithKline
-
-
1276
19
1037
24
673
33
2986
76
HEP
HepB Heptavax, Merck
-
-
41
0
180
1
94
0
315
1
HEP
HepB Recombivax HB, Merck
-
-
845
9
495
21
505
23
1845
53
HEP
HepB GenhevacB, Pasteur Merieux
-
-
4
0
7
0
15
1
26
1
HEP
Unk Mfr
35553
688
190
8
228
16
201
8
36172
720
HEPA
HepA-Havrix,GlaxoSmithKline
-
-
494
2
492
2
424
1
1410
5
HEPA
VAQTA, Merck
-
-
261
0
388
1
344
0
993
1
HEPA
Unk Mfr
3507
18
66
0
83
3
86
1
3742
22
HEPAB
HepA+HepB Twinrix GlaxoSmithKline
946
1
132
1
164
1
202
0
1444
3
HIBV
HIB ACTHIB, Aventis Pasteur
-
-
894
32
854
36
1036
39
2784
107
HIBV
Hiberix
-
-
26
1
66
2
88
9
180
12
HIBV
Hibtiter, Lederle
-
-
446
15
93
5
82
17
621
37
HIBV
Omnihib, Aventis Pasteur
-
-
3
0
9
0
6
0
18
0
HIBV
Pedvaxhib – Merck
-
-
277
3
355
10
546
25
1178
38
HIBV
Prohibit -Aventis Pasteur-Connaught
-
-
16
1
228
0
12
0
256
1
HIBV
Unk Mfr
24172
933
120
1
145
10
187
9
24624
953
IPV
PolioVirus Inactive – IPOL Aventis Pasteur
-
-
3212
54
2445
60
3080
81
8737
195
IPV
Poliovax–Aventis Pasteur /Connaught
-
-
325
22
1175
7
160
31
1660
60
IPV
PolioVirus Inactive – Lederle
-
-
5
0
30
0
31
1
66
1
IPV
Unk Mfr
11585
423
230
8
227
11
365
21
12407
463
JEV
Japanese Enceph–J-VAX Aventis Pasteur Connaught
-
-
42
0
27
0
25
0
94
0
JEV
Unk Mfr
259
6
-
-
-
-
-
-
259
6
LYME
Lymerix-GlaxoSmithKline discont'd 2-26-02
1772
8
293
2
164
0
44
0
2273
10
M-RV
Measles – Rubeovax
3
0
-
-
-
-
-
-
3
0
MEA
Measles -Attenuvax-Merck
-
-
30
2
19
0
23
0
72
2
MEA
Unk Mfr
434
8
1
0
7
1
4
0
446
9
MEN
Meningococcal-Menomune Aventis Pasteur
-
-
155
1
143
3
122
0
420
4
MEN
Meningococcal Polysaccharide - Unk Mfr
-
-
1
0
-
-
1
1
2
1
MEN
Meningococcal – Unk Mfr
802
16
21
2
38
0
30
1
891
19
MER
Measles+Rubella–MR-VaxII Merck
-
-
3
0
8
0
9
0
20
0
MER
Measles+Rubella -Unk Mfr
128
0
1
0
-
-
-
-
129
0
MM
Measles-Mumps, MM-VAX, Merck
38
2
5
0
24
1
4
0
71
3
MMR
Measles-Mumps-Rubella, Priorix GlaxoSmithKline
-
-
6
0
18
0
20
0
44
0
MMR
Virivac – Merck
-
-
14
0
626
0
367
0
1007
0
MMR
MMR-II – Merck
-
-
3975
15
3553
9
3720
16
11248
40
MMR
Unk Mfr
27934
168
76
0
155
0
175
1
28340
169
MMRV
Measles-Mumps-Rubella-Varicella Proquad
-
-
-
-
-
-
1
0
1
0
MNC
Mennigococcal-Meningitec, Wyeth
-
-
6
1
11
0
4
0
21
1
MNC
Mennigococcal, Unk Mfr
24
3
1
0
25
1
41
1
91
5
MU
Mumps-MumpsVax II – Merck
63
2
10
1
13
2
4
0
90
5
MUR
Mumps+Rubella-Bivax II, Merck
15
0
1
0
1
0
1
0
18
0
NULL
Unk Mfr
76
1
-
-
-
-
-
-
76
1
OPV
ORAL Polio Virus - Lederle
23908
885
162
11
104
27
106
11
24280
934
P
Pertussis
22
2
-
-
-
-
-
-
22
2
PLAGUE
Plague
23
3
-
-
-
-
-
-
23
3
PNC
Pneumo,7-Valent Prevnar, Lederle
5381
162
1712
70
2120
74
1908
127
11121
433
PPV
Pneumo,23-Valent Pneumovax, Merck
-
-
965
8
1304
14
1147
13
3416
35
PPV
Pneumo,23-Valent PNU-Imune Lederle
-
-
72
0
32
0
19
0
123
0
PPV
Pneumo,23-Valent, Unk Mfr
7628
113
92
3
91
1
68
2
7879
119
RAB
Rabies-Imovax,Aventis Pasteur Connaught
-
-
126
4
106
1
72
1
304
6
RAB
Rabies -Rabavert, Chiron
-
-
49
6
53
1
165
0
267
7
RAB
Rabies-RabieVax,Adventis Pasteur
-
-
2
0
10
1
3
0
15
1
RAB
Rabies-Rabipur, Chiron
-
-
3
1
8
2
14
2
25
5
RAB
Rabies-Rabivac, Chiron
-
-
1
0
3
0
-
-
4
0
RAB
Rabies, Unk Mfr
1733
25
18
0
14
0
17
0
1782
25
RABA
Rabies - Bioport
-
-
-
-
-
-
2
0
2
0
RUB
Rubella-MeruvaxII, Merck
-
-
34
0
29
0
19
0
82
0
RUB
Rubella-Rudivax, Pasteur Merieux
-
-
-
-
2
0
-
-
2
0
RUB
Rubella – Unk Mfr
724
1
1
0
6
1
1
0
732
2
RV
Rotavirus, Rotoshield, Wyeth
720
10
13
1
2
1
1
0
736
12
SEV
Unk Mfr
1
0
-
-
1
0
-
-
2
0
SMALL
Smallpox-Dryvax, Wyeth
70
0
363
0
1730
10
395
2
2558
12
TBE
Tick-Borne Enceph, Unk Mfr
30
0
3
0
2
0
-
-
35
0
TD
Tetanus/Diphtheria, TD-Adsorbed Adult, Ditanrix -GlaxoSmithKline
12
0
4
0
7
0
11
0
34
0
TD
Tetanus/Diphtheria, TD-Adsorbed Adult - Aventis Pasteur Connaught
-
-
766
2
916
5
779
2
2461
9
TD
Tetanus/Diphtheria, TD-Adsorbed Adult, Mass Pub Hlth
-
-
46
0
59
0
79
0
184
0
TD
Tetanus/Diphtheria, TD-Adsorbed Adult, Mich Dept of Pub Hlth
-
-
2
0
-
-
4
0
6
0
TD
Tetanus/Diphtheria, TD-Adsorbed Adult, SCLAVO
-
-
2
0
-
-
-
-
2
0
TD
Tetanus/Diphtheria, TD-Adsorbed Adult, Wyeth - Lederle
-
-
10
0
4
0
4
0
18
0
TD
Tetanus/Diphtheria, TD-Adsorbed Adult, TD-RX, GlaxoSmithKline
17
0
4
0
8
0
5
0
34
0
TD
Tetanus/Diphtheria, TD-Adsorbed Adult, Unk Mfr
10738
16
78
1
82
1
98
0
10996
18
TTOX
Tetanus Toxoid,Aventis Pasteur Connaught
-
-
59
0
66
1
79
0
204
1
TTOX
Tetanus Toxoid- Wyeth Lederle
-
-
3
0
2
0
1
0
6
0
TTOX
Tetanus Toxoid- TVAX-GlaxoSmithKline
-
-
4
0
3
0
4
0
11
0
TTOX
Tetanus Toxoid -Unk Mfr
1447
5
45
2
57
1
58
0
1607
8
TTOX
Tetanus Toxoid Adsorbed, Adventis Pasteur Connaught
-
-
54
0
73
0
22
0
149
0
TTOX
Tetanus Toxoid Adsorbed- Bioport
-
-
2
0
2
0
-
-
4
0
TTOX
Tetanus Toxoid Adsorbed -Wyeth Lederle
-
-
3
0
-
-
-
-
3
0
TTOX
Tetanus Toxoid Adsorbed – Mass Dept PH
-
-
3
0
6
0
3
0
12
0
TTOX
Tetanus Toxoid Adsorbed – Mich Dept PH
-
-
1
0
-
-
-
-
1
0
TTOX
Tetanus Toxoid Adsorbed – SwissSerumBerna
-
-
-
-
1
0
-
-
1
0
TTOX
Tetanus Toxoid Adsorbed – Unk Mfr
3
0
2
0
5
0
7
0
17
0
TYP
Typhoid-TyphimVI, Aventis Pasteur Connaught
-
-
166
1
173
1
190
0
529
2
TYP
Typhoid-Vivotif Berna, SwissSerumBerna
-
-
29
1
31
0
45
1
105
2
TYP
Typhoid-USP Wyeth
-
-
1
0
5
0
1
0
7
0
TYP
Typhoid-Unk Mfr
1911
12
58
2
83
2
79
0
2131
16
UNK
Unknown Vaccine
592
17
147
3
123
5
166
0
1028
25
VARCEL
Varcella-Varilrix, GlaxoSmithKline
-
-
9
0
4
0
6
0
19
0
VARCEL
Varcella-Varivax, Merck
-
-
2751
0
1779
7
2684
10
7214
17
VARCEL
Varcella – Unk Man
17789
45
42
0
65
0
89
0
17985
45
YF
Yellow Fever -YF-VAX- Aventis Pasteur Connaught
-
-
153
5
129
1
117
1
399
7
YF
Yellow fever – Unk Mfr
773
12
11
0
29
0
32
2
845
14
                       
FLU
(1988-2001)**
13235
275
-
-
-
-
-
-
-
-

 

Total Adverse Reaction Reports
(as given to IVAC by the FDA)
3/6/01
TO
3/5/02:
250,482
Total Deaths Reports
(as given to IVAC by the FDA)
3/6/01
TO
3/5/02:
5,495

TOTAL ADVERSE REACTION REPORTS – 333,271

TOTAL DEATH REPORTS - 7,578

*Statistics for 3/6/01-3/5/02 were provided by the FDA without sorting by manufacturer.

** Statistics for FLU vaccine 1988-2001 were provided by the FDA.

***February 23, 2004 phone message: To: Barbara Alexander Mullarkey, president of IVAC From: Ed Castilla, Access Litigation and Freedom of Information Branch (HFM-48), Center for Biologics Evaluation and Research, FDA

“Hello. This message is for Barbara Mullarkey. This is Ed Castilla from Food and Drug Administration. Barbara, the numbers 250,482 are the total number of reports for March 6, 2001 to 2002. Any questions, you can call me.”

VAERS is a passive system in which the FDA requires reporting of vaccines' adverse reactions/deaths. There is no penalty for doctors, nurses or pharmacists who fail to report vaccine's adverse reactions.
Only 1% of serious drug reactions are reported to the FDA – Journal of American Medical Association, 6/2/93.


Important Information from the FDA about the Vaccine Adverse Event Reporting System (VAERS), January 23, 2004:

FDA states: “About 85% of vaccine adverse event reports concern relatively minor events, such as ordinary fevers or redness and swelling at the injection site. The remaining 15% describe serious events, such as seizures, high fevers, life-threatening illnesses, or deaths..."

The report of an adverse event to VAERS is not a documentation that a vaccine caused the event...over ten million vaccinations per year are given to children less than one year old, usually between 2 months and 6 months of age...infants are at greater risk for...high fevers, seizures, and sudden infant death syndrome (SIDS). Some infants will by coincidence experience such an event shortly after a vaccination...it is usually not possible to be sure whether a particular adverse event resulted from a concurrent condition or from a vaccination, even when it occurred soon afterward...Since it is difficult to distinguish a coincidental event from one truly caused by a vaccine, the VAERS database will contain events of both types.”


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Copyright 2006 Illinois Vaccine Awareness Coalition.