VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
46,870MODERNA
532GLAXOSMITHKLINE BIOLOGICALS
353PFIZER\BIONTECH
231MERCK & CO. INC.
221UNKNOWN MANUFACTURER
62SEQIRUS, INC.
25DYNAVAX TECHNOLOGIES CORPORATION
13EMERGENT BIOSOLUTIONS
12SANOFI PASTEUR
9NOVARTIS VACCINES AND DIAGNOSTICS
5PFIZER\WYETH
5PAXVAX
2TEVA PHARMACEUTICALS
2PROTEIN SCIENCES CORPORATION
1BERNA BIOTECH, LTD.
1INTERCELL AG
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL1,906
1,575
289
IMM209286
252
236
229
s029456178
171
UT7065MA166
155
149
145
S034636133
107
U62828AA103
100
98
P10025327596
U6737AA85
UJ446AA79
78
78
59
57
4BH3254
4F47253
52
27656352
50
PP9L548
49TM346
42
40
38
MENVEO38
4F47237
R1B252M36
34
C5763AA30
93362229
25
300057A24
UNK24
22
CW311621
18
17
15
UH894AB15
3Y7NL12
R1B743M12
EJ168611
el128410
10
10
10
9
ARBA141A9
UNK9
8
UNK8
8
1F4EB8
Unknown7
7
No batch number6
5
5
UJ090AA5
5
5
4
4
4
UNK4
JEV18K95E4
UNK3
A115A3
Z127A3
3
3333324181073
2
2
2
TAR352
1
1
1
1
1
A739081
1
1
1
1
1
037K20A68,542
EL128447,700
133

Incidents per State

State Total
15,185
CA14,096
NY7,507
TX7,196
FL6,939
IN5,527
PA4,560
IL4,179
OH4,054
AZ3,856
MI3,771
NJ3,411
MA3,278
VA3,208
NC3,114
WA3,034
GA2,864
MD2,652
MN2,534
CO2,532
WI2,457
MO2,029
OR1,943
TN1,715
CT1,693
KY1,603
OK1,226
AL1,201
KS1,162
IA1,157
SC1,106
NM1,065
UT973
AR951
LA945
NE829
NV797
ME795
MT789
NH756
ID674
AK661
WV661
PR650
MS585
HI536
RI510
VT441
SD361
ND356
DE350
DC239
WY209
GU32
AS16
VI13
MP9
MH3
FM2
QM1
XB1

ID: 1022103
Sex: F
Age:
State: GA

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: temperature; Result Unstructured Data: Test Result:101.7; Test Date: 20210125; Test Name: temperature; Result Unstructured Data: Test Result:102

Allergies:

Symptoms: got real sick; fever; Nauseous; chills and was freezing to death; chills and was freezing to death; her hands and feet were cold; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 25Jan2021 12:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that while on the way home, the patient got real sick, she had a 102 fever, had chills and was freezing to death, and was nauseous. She is feeling a lot better than she did earlier. The husband put a heating pad on her feet, her hands were cold, she had chills, she was cold all over, when you touched her, her hands and feet were cold. The first time he checked, her temperature when she was first home was 101.7, then went up to 102, and stayed there for a while, but she feels like it came down. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022104
Sex: F
Age:
State: NC

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: Nasal Swab; Test Result: Negative ; Comments:Test Date: 20210119; Test Name: Nasal Swab; Test Result: Negative; Test Date: 20210121; Test Name: Nasal Swab; Test Result: Negative ; Comments: Test Date: 20210125; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: pain, redness, itching at site; pain, redness, itching at site; pain, redness, itching at site; Muscle ache; heaviness to arm; overall malaise; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number Ek9231), via an unspecified route of administration, on 13Jan2021 10:30 AM, in right arm as single dose for COVID-19 immunisation. The patient was vaccinated at workplace clinic. Patient age at vaccination was 56 years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. Concomitant medications were not reported. On 13Jan2021 at 10:30 AM the patient experienced pain, redness, itching at site, muscle ache and heaviness to arm plus overall malaise as well lasting 2 weeks (clarification requested). No treatment was received for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has been tested for COVID-19 (Nasal Swabs, on 14Jan2021; 19Jan2021; 21Jan2021; 25Jan2021, all with negative result).

Other Meds:

Current Illness:

ID: 1022105
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: tested; Test Result: Positive

Allergies:

Symptoms: Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; Patient received 1st dose of covid vaccine Friday. Monday patient had tested positive Monday.; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A patient of an unspecified age and gender received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received 1st dose of covid vaccine on Friday. Monday patient had tested positive. Called would like to know if and when patient can get 2 dose of covid vaccine. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022106
Sex: F
Age:
State: SC

Vax Date: 01/01/2021
Onset Date: 01/27/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210127; Test Name: covid; Test Result: Positive

Allergies:

Symptoms: Her sister was diagnosed with covid today 27Jan2021/Positive with covid after the first dose; Positive with covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable nurse (patient's sister). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on unknown date in Jan2021 at single dose on right arm for preventative. Medical history and concomitant medications were not reported. Reporter's sister had gotten COVID in between the two vaccine doses. She clarified that her sister only had the first dose of the vaccine. Her sister was diagnosed with COVID today 27Jan2021. Lab data included SARS-CoV-2 test positive on 27Jan2021. Her sister will be done with quarantine the day before she gets her second dose. She was calling to ask if her sister can get the second dose. She read all the information and she thought it should be ok for her sister to get the second dose. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1022107
Sex: F
Age:
State:

Vax Date: 01/31/2021
Onset Date: 01/31/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Pregnant at the time of vaccination: Yes; She is pregnant at time of vaccination; She is pregnant at time of vaccination; first, covid 19; first, covid 19; This is a spontaneous report from a non-contactable consumer A 33-year-old pregnant female patient received bnt162b2 (BNT162B2; Solution for injection) via an unspecified route of administration on 31Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had last menstrual on 31Jan2021. She is pregnant at time of vaccination while taking bnt162b2. On an unknown date in 2021, patient had first, covid 19. The mother was due to deliver on 07Nov2021. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. There was no treatment for the event covid 19. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1022108
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 01/12/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210112; Test Name: COVID-19 test; Test Result: Positive

Allergies:

Symptoms: covid positive; covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was covid positive on 12Jan2021 with outcome of unknown. The patient underwent lab tests included covid-19 virus test: positive on 12Jan2021. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022109
Sex: F
Age:
State: FL

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: she had quite a rash, it was red, right where the injection was made; it was warm; her arm was hurting a bit; slight headache; This is a spontaneous report from a contactable consumer (patient) and contactable physician. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration at arm left on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history included COVID-19 (with symptoms: terrible headache, cough, shortness of breath for good 6 weeks and fatigue) from Nov2020 to an unknown date. The patient experienced slight headache on 23Jan2021, her arm was hurting a bit on 25Jan2021. On 26Jan2021, her arm was still sore, it was warm, she had quite a rash, it was red, right where the injection was made, the rest was more pink. The patient outcome of headache was recovered on 24Jan2021, the outcome of the other events was not recovered.

Other Meds:

Current Illness:

ID: 1022110
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: COVID-19; Test Result: Positive ; Test Name: COVID-19; Test Result: Negative

Allergies:

Symptoms: positive for the COVID-19 Virus; positive for the COVID-19 Virus; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (Covid-19 Vaccine), via an unspecified route of administration at single dose for covid-19 immunisation. Medical history included congestion. Concomitant medications were unknown. She said she didn't realize she was asymptomatic, and tested positive for the COVID-19 Virus. She said she had already received her first COVID-19 Vaccine dose before she was told she was positive for the COVID-19 Virus. Consumer asked if she should delay getting the second dose of the COVID-19 Vaccine, or does she need to start from scratch. She asked if Pfizer has any specific COVID-19 Vaccine protocol for someone who has tested positive for the COVID-19 Virus after already receiving a COVID-19 Vaccine dose. Reported she had been experiencing some congestion, so she decided on a Monday to get tested for the COVID-19 Virus. She said her COVID-19 Virus test was negative. She said on that Friday she was still congested. She said she had her first COVID-19 Vaccine dose earlier on that Friday. She said after she had received the COVID-19 Vaccine on that Friday, someone who she had been in close contact with tested positive for the COVID-19 Virus. She said since her congestion started, she had developed other symptoms, so she retested for the COVID-19 Virus later in the day that Friday. She said she received a positive COVID-19 Virus test result on Monday. She said she was guessing that the was positive for the COVID-19 Virus at the time she received her first COVID-19 Vaccine dose on that Friday. Reported she looked at Pfizer's Medical Information website to see if she needed to repeat her first COVID-19 Vaccine dose, and didn't find any information directly related to her situation. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number could not be requested.

Other Meds:

Current Illness:

ID: 1022111
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive; Comments: rapid antigen test kit

Allergies:

Symptoms: tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; 4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 2nd of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has tested positive for covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1022112
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Positive; Comments: rapid antigen test kit

Allergies:

Symptoms: tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; tested positive for Covid/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test after receiving the whole series; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 4 patients, calling on behalf of another office. This report is for 3rd of 4 patient. A patient of unspecified age and gender received the 1st and 2nd doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tested positive for Covid after receiving the 2nd dose over 15 days before this report/4 people at a doctor's office (2 doctors and 2 office managers) tested positive on an rapid-antigen test 15 days after receiving the whole series on an unspecified date. The patient had no Covid symptoms, feeling fine after both doses. The patient underwent lab tests and procedures which included Sars-cov-2 test (rapid antigen test kit): positive. The outcome of events was unknown. Reporter was wondering if it was a false positive. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021076785 same reporter/drug/event, different patient

Other Meds:

Current Illness:

ID: 1022113
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Name: antibodies; Result Unstructured Data: Test Result:none

Allergies:

Symptoms: checked for antibodies and had none; This is a spontaneous report from a contactable physician via a sales representative. A female patient of an unspecified age received first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she completed her two dose series of the Pfizer vaccine, waited a week and checked for antibodies and had none. Outcome of event was not recovered. information about lot and batch number has been requested.

Other Meds:

Current Illness:

ID: 1022114
Sex: F
Age:
State: FL

Vax Date: 01/07/2021
Onset Date: 01/17/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210122; Test Name: COVID; Test Result: Positive

Allergies:

Symptoms: Tested positive for COVID; Tested positive for COVID; Lost taste and smell; Lost taste and smell; cold like symptoms; Fever; chills; nausea; vomiting; felt cold; runny nose; This is a spontaneous report from a contactable consumer (patient). This 69-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) via intramuscularly at left arm on 07Jan2021 at single dose for prevention. Medical history included allergic to Penicillin, quite a bit of discomfort with two shingles shots, exposed to COVID-19. Concomitant medications were none. The patient experienced cold like symptoms, Fever, chills, nausea, vomiting, felt cold, runny nose, all on 17Jan2021 10:00; lost taste and smell on 21Jan2021; tested positive for COVID on 22Jan2021 10:20. The patient received the first inoculation 07Jan2021, she had symptoms. The patient was tested for COVID on 22Jan2021 and both tested positive. The patient was scheduled to have their second dose on 28Jan2021, and she wanted to know if she should get it or not. She did not feel it was a result of the vaccination. She felt it was because she got exposed to COVID-19. Her symptoms were more severe on that one day. She felt like she was getting a cold that day. She was a compassionate care giver for her mother and wanted to get tested before they went to see her in a facility. She was surprised when she got a positive result. She still had a cough, runny nose and cold like symptoms. Her loss of taste and smell started about 4-5 days ago. Outcome of the event tested positive for COVID was unknown, of the event Lost taste and smell was not recovered, of other events was recovering.

Other Meds:

Current Illness:

ID: 1022115
Sex: F
Age:
State: AR

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Ringing in ears; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3246) at single dose, in the left arm, on 25Jan2021, at 04:45 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included metoprolol, gabapentin, triamcinolone acetonide (SYMCORT), chlorthalidone and doxepin. On 26Jan2021, the patient experienced ringing in ears. No treatment was received. Clinical outcome of the adverse event was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.

Other Meds: METOPROLOL; GABAPENTIN; SYMCORT; CHLORTHALIDON; DOXEPIN

Current Illness:

ID: 1022116
Sex: M
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Lower extremity myalgia; Right hip pain; Fever; This is a spontaneous report from a non-contactable physician. A 26-year-old male patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, lot number: EL324), intramuscular on 01Feb2021 07:00 at single dose for covid-19 immunisation. No other medical history, allergies to medications, food, or other products and concomitant medications were reported. Prior to vaccination the patient diagnosed with COVID-19 was unknown. The past medication included first dose of BNT162B2 (COVID 19, Pfizer, lot number: EK4176), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation. The patient experienced lower extremity myalgia, right hip pain and fever on 02Feb2021 07:00. The patient received acetaminophen as therapeutic measures of events. The outcome was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1022117
Sex: F
Age:
State: NY

Vax Date: 01/16/2021
Onset Date: 01/31/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Ache in the lower left rib cage and left side; This is a spontaneous report received from a contactable other healthcare professional (patient herself). A 43-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL32Y6), via an unspecified route of administration on left arm on 16Jan2021 14:30 at single dose for COVID-19 immunization. Medical history included congenital heart defect and dairy sensitivity. The patient's concomitant medications were not reported. The patient experienced ache in the lower left rib cage and left side on 31Jan2021 12:00. The adverse event result in doctor or other healthcare professional office/ clinic visit. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not been tested for COVID-19. The event was assessed as non-serious by the reporter. The outcome of the event was reported as not recovered.

Other Meds:

Current Illness:

ID: 1022118
Sex: M
Age:
State: CA

Vax Date: 01/24/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: blood pressure; Result Unstructured Data: Test Result:high

Allergies:

Symptoms: high blood pressure; headache; body aches; joint pain; fatigue; lack of appetite; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: e79263), via an unspecified route of administration on 24Jan2021 at single dose for COVID-19 immunization. The patient medical history included high cholesterol and high blood pressure (controlled with medication), both from an unknown date and unknown if ongoing. The patient's concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX) on 30Dec2020 at single dose for immunization, paracetamol (TYLENOL), atorvastatin and olmesartan medoxomil (BENICAR). On 25Jan2021, the patient experienced high blood pressure, headache, body aches, joint pain, fatigue and lack of appetite. No therapeutic measures were taken in response to the events. The patient outcome of the events was not recovered.

Other Meds: TYLENOL; ATORVASTATIN; BENICAR

Current Illness:

ID: 1022119
Sex: F
Age:
State: MO

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210124; Test Name: Temperature; Result Unstructured Data: Test Result:102.5 Fahrenheit

Allergies:

Symptoms: Fever; Headache; Chills; Feeling like a heavy weight on her body; Back pain; This is a spontaneous report from a contactable nurse, the patient. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EZ3247), via an unspecified route of administration in the left arm on 23Jan2021 at 15:20 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history included gestational diabetes (first pregnancy) from an unknown date to an unknown date and two pregnancies on unknown dates. Concomitant medications included unspecified post-natal multivitamins and paracetamol (TYLENOL; Lot Number: SBA22; Expiration Date: Jan2023) taken before getting the vaccine on 23Jan2021 to prevent soreness. The patient previously received the first dose of BNT162B2 on 03Jan2021 (at the age of 34-years-old; Lot Number: EL0142) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 24Jan2021 at 04:00, the patient experienced chills and had a feeling like a heavy weight on her body. On 24Jan2021 at 07:00, the patient had a fever and headache. On 24Jan2021, she also had back pain. The clinical course was as follows: On 23Jan2021, the patient took paracetamol before getting the vaccine as she heard one can feel sore after getting it. The patient received the second dose on 23Jan2021 at 15:20. The patient was okay after she got the vaccine. However, early the next morning (24Jan2021), she had shivering without any fever (later referred to as chills). The chills were something she never experienced in her life. It was like she was in the cold. She could not move, it was that bad. She felt a heavy weight on her whole body. She could not get out of bed. A few hours later at 07:00, she checked her temperature and it was 102.5 degrees Fahrenheit. She took paracetamol. The headache started with the fever around 07:00. She stated she kept taking paracetamol. She did try to stop using paracetamol, but without it, the headache was still there. The back pain was also severe on 25Jan2021. The chills recovered on 25Jan2021 and the fever was recovered on 26Jan2021. The clinical outcomes of the headache and felt like a heavy weight on the body were unknown; while that of the back pain was not recovered. The events of chills, fever, headache, and back pain were reported as serious by the patient (nurse) for being medically significant. The patient (nurse) assessed the events of chills, fever, headache, back pain, and felt like a heavy weight on her body were related to the vaccine.; Sender's Comments: Based on a compatible temporal association and known BNT162B2 vaccine safety profile causality between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: TYLENOL

Current Illness:

ID: 1022120
Sex: F
Age:
State: TX

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Severe chills; joint pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received bnt162b2, via an unspecified route of administration on 30Jan2021 at 04:45, single dose in the Left arm for covid-19 immunization. Medical history included Hashimotos Thyroiditis. Concomitant medication included thyroid (ARMOUR THYROID). The patient previously took Levoquine and experienced allergies. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. In Feb2021, the patient experienced severe chills and joint pain still 4 days later. The patient did not receive treatment for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Other Meds: ARMOUR THYROID

Current Illness:

ID: 1022121
Sex: M
Age:
State: WA

Vax Date: 01/21/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Dizziness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021at a single dose in left upper arm for Covid-19 immunisation at the age of 73-year-old. Lot number was EL9262. Medical history and concomitant medications were none. On 26Jan2021, the patient experienced Dizziness, it started in the morning, when he got out of bed, the first time he woke was at 5 AM and right at the time of report it was going on 11 AM and he was taking it easy, sitting back and relaxing, he fell asleep. The patient did not recover from the event.

Other Meds:

Current Illness:

ID: 1022122
Sex: M
Age:
State: NJ

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210125; Test Name: PCR nasal swab; Result Unstructured Data: Test Result:positive

Allergies:

Symptoms: On 25Jan2021 tested positive for COVID; On 25Jan2021 tested positive for COVID; Headache; Loss of appetite; Dry skin patches; This is a spontaneous report from a Contactable Consumer (patient) via a Pfizer-sponsored program. A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 18:00 at single dose in left arm for COVID-19 immunization. Medical history and concomitant medications were none. The patient had no Prior Vaccinations within 4 weeks. The patient took the first dose of the COVID vaccine on 08Jan2021 and was due to get his second dose but on 25Jan2021 tested positive for COVID. The patient wanted to know if he was allowed to take the second dose. He had a PCR nasal swab that showed the positive COVID diagnosis. He took headache medication after, Tylenol. He had a headache starting on 21Jan2021 and it was lingering on and off but has resolved at this point. He noticed about 8-9 pm the night he got the shot, 08Jan2021, on both feet he had dry skin patches and this lasted about 2 hours; it resolved as this point. He also had a loss of appetite the next day though he ate anyway. That lasted about 8 hours. The outcome of Loss of appetite, Dry skin patches, Headache was resolved. The outcome of other events was unknown. Information about Lot/ Batch has been requested.

Other Meds:

Current Illness:

ID: 1022123
Sex: M
Age:
State: TX

Vax Date: 01/08/2021
Onset Date: 01/14/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210114; Test Name: Covid; Test Result: Positive

Allergies:

Symptoms: tested positive for Covid after receiving the vaccine; tested positive for Covid after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose (with a syringe) on the right arm for protection of COVID 19. The patient medical history and concomitant medications were not reported. Patient stated that he had got the vaccination on 08Jan2021 and ended up testing positive for COVID/tested positive for COVID after receiving the vaccine on 14Jan2021. He was supposed to get the second dose this week. Treatment was none. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022124
Sex: M
Age:
State: CA

Vax Date: 01/25/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 202101; Test Name: Covid19; Test Result: Positive

Allergies:

Symptoms: Tested positive with Covid19; Tested positive with Covid19; Fever; Loss of smell; Muscular pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tested positive with covid19, fever, loss of smell, muscular pain in Jan2021. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022125
Sex: M
Age:
State: CO

Vax Date: 12/22/2020
Onset Date: 12/22/2020
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination; nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination; This is a spontaneous report from contactable other HCP. (mother) This other HCP reported information for both mother and baby. This is the baby report. An infant male patient started to received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EK5730, transmammary route of administration, on 22Dec2020 18:15 as a SINGLE DOSE for COVID-19 immunization. Medical history was not reported. Concomitant medication included levothyroxine (LEVOTHYROXINE), biotin (BIOTIN), ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), ergocalciferol (VIT D) and lactobacillus acidophilus (PROBIO). The patient experienced vaccine exposure via breastmilk on 22Dec2020. The mother reported nursing my infant and he developed fever for 3 days without any other symptoms on unspecified date following my vaccination. Outcome of the nursing my infant and he developed fever for 3 days without any other symptoms following my vaccination was unknown.; Sender's Comments: Linked Report(s) :-PFIZER INC-2021098666 Infant case (dose 1)

Other Meds: LEVOTHYROXINE; BIOTIN; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; VIT D; PROBIO

Current Illness:

ID: 1022126
Sex: F
Age:
State: MI

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: This is a spontaneous report received from a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 29Jan2021 11:45 (at the age of 66-years-old) as a single dose for COVID-19 immunization. The patient's medical history included high cholesterol, and allergies to medications, food, or other products (unspecified). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 12:15, the first 8 hours, the patient experienced nausea, dizziness, and slight headache. The patient did not receive any treatment for the events. The clinical outcome of nausea, dizziness, and slight headache was recovered on 29Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Date Died: 01/19/2021

ID: 1022127
Sex: M
Age:
State: AK

Vax Date: 01/12/2021
Onset Date: 01/19/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: One week to the day after patient's first vaccine he died of a heart attack; This is a spontaneous report from a contactable consumer and from a contactable physician. A 71-year-old male patient (husband) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at single dose on the right arm for COVID-19 immunization. The patient medical history included past heart conditions. No known allergies. Patient took other medications in two weeks. Facility type vaccine was doctor's office/urgent care. No other vaccine received in four weeks. One week to the day after patient's first vaccine he died of a heart attack on 19Jan2021 18:30. Cause of death was heart attack. No COVID prior vaccination. No COVID tested post vaccination. It was unknown if an autopsy was performed. The physician reported that the patient arrived DOA. Physician signed the death certificate based on the patient's prior diagnosis. Physician would not provide additional cause of death medical background without consent. He was not aware of any adverse events experienced from the time of vaccination to the date of death. Follow-up (05Feb2021): This is a follow up spontaneous report from a contactable physician. This physician reported in response to HCP telephonic follow up activity which the following: patient death and cause of death were confirmed. Follow-up attempts are completed. No further information is expected. Information about Lot number is not available.; Sender's Comments: Based on the temporal relationship, the association between the event fatal heart attack with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: One week to the day after patient's first vaccine he died of a heart attack

Other Meds:

Current Illness:

ID: 1022128
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: received 2nd vaccine booster/ experience brief tingling but no other symptoms; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, Expiry Date: 31Mar2021), via an unspecified route of administration on 17Dec2020 10:00 at a single dose for COVID-19 immunization and experienced numbness to right hand, weakness in legs, right hand felt cold, "heaviness in my legs", Dry mouth, and "within less than 10 minutes I had a warm tingling feeling." The patient had since received 2nd vaccine booster and did experience brief tingling but no other symptoms on an unspecified date with outcome of unknown. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1022129
Sex: F
Age:
State: CA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Swelling of hands, fingers; rash and redness on forearms/red rash; Face swollen; Very hot.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Feb2021 at 03:15 (at the age of 40-years-old) as a single dose for COVID-19 immunization. Medical history included obesity from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took amoxicillin/clavulanic acid (AUGMENTIN) and dextropropoxyphene napsilate/paracetamol (DARVOCET); both from unknown dates to unknown dates for unknown indications and experienced allergy. On 02Feb2021 at 15:45, the patient experienced swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot; all reported as serious of being life-threatening. The events required a visit to the urgent care (physician's office). The patient was treated with epinephrine (EPIPEN) and unspecified medications at the urgent care after emergency medical services were called. The clinical outcomes of swelling of hands/fingers, rash and redness on forearms/red rash, face swollen, and very hot were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]

Current Illness:

ID: 1022130
Sex: F
Age:
State: PA

Vax Date: 01/09/2021
Onset Date: 01/01/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20201227; Test Name: PCR; Test Result: Negative ; Test Date: 20201228; Test Name: PCR; Test Result: Negative ; Test Date: 20201229; Test Name: PCR; Test Result: Positive

Allergies:

Symptoms: headache; This is a spontaneous report from a contactable healthcare professional (hcp) (patient). A 39-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine) second dose (lot number: EK9231) on 09Jan2021 in left deltoid, intramuscularly at a single dose for prophylaxis. Medical history included Heart Disease (VSD asymptomatic). The patient previously took first dose of bnt162b2 (lot number: EH 9899) on 18Dec2020 for COVID-19 prophylaxis. The patient's concomitant medications were not reported. The patient had a test for SARS - CoV2: 27Dec2020: negative, none of symptoms; 28Dec2020: negative; 29Dec2020: positive: all PCRS. On 28Dec2020, the patient also had headache + cough. The patient was diagnosed positive COVID by PCR on 29Dec2020. The patient experienced 30 degree of severe symptoms headache on an unspecified date in Jan2021 continued daily as of 19Jan2021. The reported issue occurred after use of the product. No treatment received for headache. The outcome of event headache was not recovered.

Other Meds:

Current Illness:

ID: 1022131
Sex: F
Age:
State: GA

Vax Date: 12/19/2020
Onset Date: 12/19/2020
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 202009; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown Result

Allergies:

Symptoms: She had no side effects after the first vaccine and was tender on the first day, which went away; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 19Dec2020 10:30 at single dose for Covid-19 immunization. The patient's medical history included hypertension. The patient had an X-ray back in Sep2020 (unknown result). The patient's concomitant medications were not reported. On 19Dec2020, the patient had the first dose and stated that she had no side effects after first vaccine and was tender on the first day which went away. The outcome of the event was recovered on 20Dec2020. The event was treated with unspecified treatment. The reporter assesses the event as non-serious.

Other Meds:

Current Illness:

ID: 1022132
Sex: M
Age:
State: CA

Vax Date: 01/11/2021
Onset Date: 01/16/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data: Test Date: 20210105; Test Name: Covid 19 Ab; Result Unstructured Data: Test Result:+ (positive) result, comments: (+) for antibody

Allergies:

Symptoms: Headache; Fatigue; Feeling unwell; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 MRNA VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 MRNA VACCINE number: EK5730), intramuscularly right deltoid on 21Dec2020 at a single dose for COVID-19 immunization but had tired, feeling unwell, lethargy, headache, and Covid 19 Ab on 05Jan2021 with + (positive) result, comments: (+) for antibody. The patient received the vaccine from a hospital that is not a facility. The patient reported that he was positive (+) for headache, fatigue and feeling unwell on the second dose with the "best & time" [pending clarification] of 5 days (16Jan2021). The outcome of the events was unknown. The reported considered the Pfizer product had a causal effect to the adverse events. The following information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1022133
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: anaphylaxis to influenza vaccination less than two months ago; Initial information received on 28-Jan-2021 regarding an unsolicited valid serious courtesy case from a physician. This case involves a patient of an unknown age and gender who experienced anaphylaxis (anaphylactic reaction), after receiving INFLUENZA VACCINE. Past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiration date not reported) via an unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious anaphylaxis (anaphylactic reaction) (unknown latency, medically significant) after vaccination with influenza, less than two months ago. Also reported: physician allergist stated, that the question was regarding the PEG (Polyethylene glycol) that's in the Pfizer Covid (coronavirus disease) (PFIZERBIONTECH COVID-19 VACCINE) vaccine, question was whether there is a polysorbate in the vaccine that he received, which was the fluzone quadrivalent and wondering if that is going to cross react with the PEG in the Pfizer vaccine. The chemical name that was given in the descriptions of the fluzone quadrivalent was ethyleneoxide, and need to know from someone who is closer to chemistry than physician is, if that was polysorbate. Caller is in the vaccination clinic and has a potential vaccine recipient (who is scheduled to receive the vaccine today) in which had anaphylaxis to influenza vaccination less than two months ago Adverse Event involving Influenza vaccination The patient did not experience any additional symptoms/events. Medication Details and reason for taking the medicine: Prophylactic Vaccination . It is unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome was unknown for the event anaphylactic reaction. Information on the batch number to be requested for this case.; Sender's Comments: This case involves patient who had anaphylactic reaction, after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.

Other Meds:

Current Illness:

ID: 1022134
Sex: F
Age: 4
State: TX

Vax Date: 12/15/2020
Onset Date: 12/15/2020
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a patient received a dose of Fluzone which was stored at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from the other health care professional (medical assistant) via agency (Reference number: 00444852). This case involves a 4 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] that was stored at 0.7 Celsius for 25 hours and 24 minutes lot UJ477AA, Expiry date: 30-Jun-2021 via intramuscular route in unknown administration site on 15-Dec-2020 for prophylactic vaccination (Product storage error). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. It was an actual medication error due to incorrect product storage (latency: same day). Reporter can be contacted by Sanofi: Yes, Potential Product technical complaint (PTC): No, Description: Call received from medical assistant (MA) reporting a temperature excursion of unknown cause. Caller reporting PENTACEL, IPOL, FLUZONE QUADRIVALENT Multi Dose Vials (MDVs) AND PREFILLED SYRINGES, MENACTRA, ADACEL, and DAPTACEL at 0.7C for 25 hours and 24 minutes. Caller reported opened IPOL MDVs and opened Fluzone Quadrivalent MDVs. Caller reporting excursion occurring in December 2020. Caller reporting 11 doses of Fluzone Quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines post excursion. Product used: Not Applicable. At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1022135
Sex: F
Age: 1
State: TX

Vax Date: 12/01/2020
Onset Date: 01/20/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: A temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 1 years old male patient for whom reported temperature excursion of unknown cause at 0.7 Celsius for 25 hours and 24 minutes (Product storage error), while he received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], ,MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], IPV (VERO) [IPOL], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] [lot UJ477AA and expiry date: 30-Jun-2021] via an intramuscular route at an unknown administration site for prophylactic vaccination on 20-JAN-2021. Medical history, medical treatment, vaccination, concomitant medication and family history were not provided. It was a case of actual medication error due to product storage error temperature too low. [Latency: at the same time of vaccination]. Details of laboratory data not reported. It was reported that, caller reported opened Ipol Multi dose vials and opened Fluzone quadrivalent MDVs. Caller reporting excursion occurring in Dece-2020. Caller reported 11 doses of Fluzone quadrivalent MDVs were administered post excursion. Caller with question on viability of administered vaccines. It was not reported if the patient received a corrective treatment. At the time of report, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1022141
Sex: U
Age:
State: MI

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional adverse event reported.; Nurse gave expired PROQUAD to patient, expired on 19-JAN-2021; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drug and concomitant therapies was not provided. On 20-JAN-2021, the patient was vaccinated with one dose Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number F022916 Expiration date 19-JAN-2021 (dosage regimen and route of administration were not provided) for prophylaxis. Lot number F022916 is invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD). Lot number F022916 does not match any company product as confirmed by lot verification team.

Other Meds:

Current Illness:

ID: 1022142
Sex: U
Age:
State: IN

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: No additional adverse event; Unknown 4 month old patient was administered first ROTATEQ dose; This spontaneous report was received from a medical assistant concerning a 4-month-old patient. Information regarding the patient's concurrent conditions, medical history, historical drug and concomitant therapies was not provided. On 13-JAN-2021, the patient was vaccinated with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral route, lot #1688832 and expiration date 24-JUN-2021, for prophylaxis. No additional adverse event was reported.

Other Meds:

Current Illness:

ID: 1022143
Sex: U
Age:
State: IL

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: improperly stored vaccine was administered; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 25-JAN-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status: recombinant Human albumin (rHA)) (M-M-R II) lot # S035354 has been verified to be a valid lot number, expiration date was reported as 04-NOV-2021, but upon internal validation, it was established as 05-NOV-2021, 1 injection for prophylaxis (exact doses, dose #, route of administration and anatomical location were not reported). The temperature excursion was above 9 Celsius degrees (13.4 Celsius degrees) for 2 hours and 9 minutes. There were no previous excursions reported. The digital data logger was involved.

Other Meds:

Current Illness:

ID: 1022144
Sex: F
Age: 63
State: MI

Vax Date: 12/08/2020
Onset Date: 12/09/2020
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Shingles on the right side, near the breast; itching; This case was reported by a consumer and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 4BA4A, expiry date 31st January 2022) for prophylaxis. The patient's past medical history included shingles (eight separate occasions). On 8th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th December 2020, 1 days after receiving Shingrix, the patient experienced shingles and pruritus. The patient was treated with benadryl (nos) (Benadryl) and hydrocortisone. On an unknown date, the outcome of the shingles and pruritus were not recovered/not resolved. It was unknown if the reporter considered the shingles and pruritus to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced shingles on the right side, near the breast and itching. The patient was using Benadryl and 1 percent hydrocortisone cream to help alleviate symptoms. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1022145
Sex: M
Age: 24
State: TN

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: soreness in the thumb joint; patient received 1 ml instead of 0.5 ml of the vaccine; A spontaneous report was received from a pharmacist concerning a 24-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced accidental overdose ? patient received 1 milliliter instead of 0.5 milliliter of the vaccine and arthralgia ? soreness in the thumb joint. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the right arm intramuscularly for prophylaxis of COVID-19 infection. On 12 Jan 2021, the patient received 1 milliliter of the Moderna COVID-19 vaccine instead of the recommended 0.5 milliliters. On 15 Jan 2021, the patient reported he had soreness in the right thumb. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, accidental overdose ? patient received 1 milliliter instead of 0.5 milliliter of the vaccine, was considered resolved on 12 Jan 2021. The outcome of the event, arthralgia ? soreness in the thumb joint, was considered unknown.; Reporter's Comments: This case concerns a 24 year old male patient who experienced a unexpected events of Accidental overdose and Arthralgia. The latter event occurred 3 days after first dose of the study medication administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1022146
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital: Y

Lab Data:

Allergies:

Symptoms: Severe Vomiting; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe vomiting. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced severe vomiting and was hospitalized for two weeks. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, severe vomiting, was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced a serious event of severe vomiting. The event of occurred on an unknown date after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-Unknown). Treatment and outcome are unknown. There is not enough information of assess the causal association between he reported event and the administration of mRNA-1273 vaccine as critical details such as the date of treatment, onset of the event, patient's medical history including exclusion of other triggers cannot be established. Main field defaults to ?possibly related'

Other Meds:

Current Illness:

ID: 1022147
Sex: U
Age: 55
State: TN

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: some of the vaccine trickled down arm; A spontaneous report was received from a consumer concerning a 55-year-old patient who received Moderna's COVID-19 vaccine and experienced "some of the vaccine trickled down arm". The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, on the same date of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M2OA) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021 patient received first dose of vaccine but wasn't sure if the full dosage was administered because some trickled down their arm. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event "some of the vaccine trickled down arm" was considered resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 011M2OA. There were no reported AEs associated with this case of Incorrect dose administered.

Other Meds:

Current Illness:

ID: 1022148
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: a patient receives 0.3mL on their first administration of the moderna vaccine for covid; A spontaneous report was received from a healthcare professional concerning a patient, of unknown gender and age, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and administered 0.3mL of the mRNA-1273 vaccine, an underdose. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection. The patient was administered 0.3mL of the mRNA-1273 vaccine, an underdose. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event, vaccine underdose, was considered resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender who received received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of Covid-19 infection and administered 0.3mL of the mRNA-1273 vaccine, an underdose. There were no reported adverse events in this case of underdose.

Other Meds:

Current Illness:

ID: 1022149
Sex: F
Age: 16
State: PA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: vaccine administered to a 16-year old patient; A spontaneous report was received from a nurse concerning a 16-year-old female who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to a 16-year old patient. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, the Moderna COVID vaccine was given to a 16- year- old patient at their facility. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, vaccine given to a 16-year old patient, was considered resolved on 29 Jan 2021.; Reporter's Comments: This case concerns a 16 year old female who received her first of two planned doses of mRNA-1273 (Batch number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.

Other Meds:

Current Illness:

ID: 1022150
Sex: F
Age: 38
State: KY

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient did not receive more than half of the dose, maybe got a fraction of it; faulty syringe; A spontaneous report ) was received from a nurse concerning a 38-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) had a faulty syringe and did not receive more than half of the dose, maybe got a fraction of it. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number not provided). On 04 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 007M20A) on her right arm, intramuscularly for prophylaxis of Covid-19 infection. The patient was administered the mRNA-1273 vaccine with a faulty syringe and therefore, she did not receive more than half of the dose, maybe got a fraction of it. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with mRNA-1273 in response to the events were considered not applicable. The events did not receive more than half of the dose, maybe got a fraction of it and faulty syringe use, were considered resolved on 04 Feb 2021.; Reporter's Comments: This case concerns a 38-year-old female patient who received their second of two planned doses of mRNA-1273 (Lot# 007M20A), reporting Underdose and Syringe issue.

Other Meds:

Current Illness:

ID: 1022151
Sex: U
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 17- year old received the vaccine; A spontaneous report was received from a pharmacist assistant concerning a 17-year-old patient (gender unknown), who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 17- year old received the vaccine. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number not provided) for prophylaxis of COVID-19 infection. On 04 Feb 2021, the pharmacist assistant reported a 17-year old had received one dose of the Moderna's COVID vaccine. No adverse event was reported by the patient after being given the vaccine. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The event, 17- year old received the vaccine was considered resolved on an unknown date.; Reporter's Comments: This report refers to a case of Product administration error for mRNA-1273 (Lot number not provided). This event of inappropriate age at vaccine administration had no associated AEs.

Other Meds:

Current Illness:

ID: 1022152
Sex: F
Age: 76
State: VA

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: When she was given the shot, part of it escaped the syringe and ran down her arm; When she was given the shot, part of it escaped the syringe and ran down her arm; When she was given the shot, part of it escaped the syringe and ran down her arm; A spontaneous report was received from a consumer who was also a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and when she was given the shot, part of it escaped the syringe and ran down her arm/ device connection issue and underdose. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Jan 2021, the patient presented to the pharmacy for their first of two planned doses of mRNA-1273 (Lot number: 007M20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Jan 2021, during vaccination, part of it escaped the syringe and ran down her arm. The patient was concerned by how much vaccine escaped the needle and reported that it was "like a gush". She did not experience any symptoms. No treatment information was provided. Action taken with mRNA-1273 in response to the event(s) was not reported. The event, when she was given the shot part of it escaped the syringe and ran down her arm, was considered resolved.; Reporter's Comments: This report refers to a case of Device connection issue and Underdose for mRNA-1273, (Lot number: 007M20A) with no associated adverse events.

Other Meds:

Current Illness:

ID: 1022153
Sex: F
Age: 68
State: NY

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Arm started to leak a clear liquid; Arm started to leak a clear liquid; Arm was sore; Arm was red; A spontaneous report was received from a consumer who was also a 68-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced sore arm (injection site pain), redness (injection site erythema) and her arm leaked a clear liquid right after getting the vaccine (vaccination site discharge/ incorrect dose administered). The patient's medical history was not provided. No concomitant medications were reported. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) in the left arm for prophylaxis of COVID-19 infection. After the injection, the patient's arm started to leak a clear liquid. Her arm was also sore and red. No treatment information was provided. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of the event, arm leaked a clear liquid, was considered as resolved on 20 Jan 2021. The outcome of the events, sore arm and redness, was unknown.; Reporter's Comments: This concerns a 68-year old female patient who experienced injection site pain, redness, and her arm leaked clear liquid after mRNA-1273 administration.Based on the current available information and temporal association between the use of the product and the start date of the events (redness, site pain), a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1022154
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: bad reaction to the first one painful hives all over one side of his face; bad reaction to the first one painful hives all over one side of his face; Initial information was received on 18-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient's mother or father) via social media. This case involves adult male patient (age not specified) who had bad reaction to the first one painful hives all over one side of his face (urticaria and pain), while he received INFLUENZA VACCINE. Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history or risk factor were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious bad reaction to the first one painful hives all over one side of his face (urticarial and pain) (unknown latency) following the administration of INFLUENZA VACCINE. It is unknown if the patient experienced any additional symptoms/events. Laboratory data was not provided. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of events were unknown for both events. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1022155
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: sore arm; Initial information received on 19-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer or non-healthcare professional in the . This case involves patient (unknown demographics) who experienced sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE. The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor. Patient concomitant medication include vitamins as he took since decades. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE. Patient was saying as your age, you'll find out you've been having a mild case of the flu. It's easy to transmit the flu to others. The 1918 flu was delay for people with good immune systems which killed them. Most employers prefer it, some require it. But he do it because some of his friends are vulnerable. Why kill a buddy over a day. It is unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine not provided. There were no lab data/results available. It was not reported if the patient received a corrective treatment. The event outcome was unknown for pain in extremity. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1022156
Sex: F
Age: 22
State: MI

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 22 year old patient received FLUZONE HD/ NO AE; 22 year old patient received FLUZONE HD/ NO AE; a patient received FLUZONE QUAD and FLUZONE HD on same day/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Agency(Reference number- 00438020) via call-center and transmitted to Sanofi on 20-Jan-2021. This case involves a 22-years-old female patient who received 0.5 mL INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number and expiry date not reported) in right deltoid and INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (batch number: UJ507AA and expiry date: 30-Jun-2021) in left deltoid on same day 20-Jan-2021 for prophylactic vaccination (extra dose administered, product administered to patient of inappropriate age and overdose). The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. It was an actual medication error case due to extra dose administered, overdose and inappropriate age at vaccine administration (latency: same day). Patient received no other vaccines or medications. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for FLUZONE HIGH-DOSE QUADRIVALENT for this case.

Other Meds:

Current Illness:

ID: 1022157
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 01/25/2021
Rec V Date: 02/11/2021
Hospital:

Lab Data:

Allergies:

Symptoms: patient inadvertently receive a Pentacel vaccine at 7 months of age with no AE; Initial information received on 25-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare Professional. This case involves a 7 month old male patient who receive 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ384AAA and expiry date 09-Oct-2021) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (not produced by Sanofi Pasteur) ( lot number and expiry date not reported), patient inadvertently receive a pentacel vaccine at 7 months of age (accidental exposure to product). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEP [HEPATITIS B VACCINE]) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE SHANTHA) for prophylactic vaccination. It was a potential medication error case due to accidental exposure to product. The caller stated that a patient inadvertently receive a pentacel vaccine at 7 months of age. See the additional event details field for more info. Additional Description of event Adverse events :The patient was given a pentacel vaccination at 7 months of age. Staff person SH administered 0.5 ml of penticacel in the patient's right thigh. He also received prevnar, Hep B and the Roto virus vaccines on this visit. NP wrote the orders. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds: HEP [HEPATITIS B VACCINE]; ROTAVIRUS VACCINE

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm