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: 0929096
Sex: F
Age: 66
State: CA

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: All vital signs stable

Allergies: none

Symptoms: Pt stated that she began to feel light headed after receiving vaccination VSS, she rested on cot for 30 min and left

Other Meds: baby asa

Current Illness: none

ID: 0929097
Sex: F
Age:
State:

Vax Date: 12/30/2020
Onset Date: 01/01/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Hives; This is a spontaneous report from a contactable other health professional. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021, NDC number: 5926710001), via an unspecified route of administration on 30Dec2020 08:11 at a single dose in right bicep (right arm) for COVID-19 immunisation. Medical history included urinary tract infection from 21Dec2020 to Dec2020 which was resolved and fine after the antibiotic, ongoing eczema (had this condition basically her entire life), ongoing sensitive skin (always had pretty sensitive skin). Concomitant medication not reported. The patient previously took nitrofurantoin (MACROBID [NITROFURANTOIN]) from 24Dec2020 to 28Dec2020. The patient experienced hives on 01Jan2021 09:00 (also reported as "got it last Wednesday morning and broke out in hives the next day"). Patient stated, "I have a question to you. I got the Covid Vaccine, the Pfizer Vaccine on Wednesday morning like around 8 o' clock and this morning I woke up and I broke out hives. I didn't know if in two days, I just want to report my symptoms just to make sure everything is okay." The hives were bad on Friday and took Benadryl and Cortisone cream and it is better now. The hives are not worse; not as bad as it was on the first day. She took about 5 Benadryl throughout the first day: 01Jan2021. Over the last few days she has continued to get small breakouts of hives on pretty much every single spot on her body except for her face; the hives seem to kind of take turns in different areas of the body but have not gone away. She has used Hydrocortisone, lotion and Benadryl for the hives. The outcome of the event was recovering. She is both a sonogram technologist as well as the patient. She asked if she should or should not receive the second dose of Pfizer COVID- 19 Vaccine in response to the hives. She is supposed to get second dose on 19Jan2021; unknown if she will or will not change dose scheduling in response to event at this time.

Other Meds:

Current Illness: Eczema (Had this condition basically her entire life.); Sensitive skin (She has always had pretty sensitive skin.)

ID: 0929098
Sex: M
Age: 47
State: NV

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: 3 hours after I felt hot in the face and mild head ache started. also felt disoriented and weak. after 2 hours I felt normal. The day after I woke up feeling very tired and weak. I called in sick and rested that day.

Other Meds:

Current Illness:

ID: 0929099
Sex: F
Age:
State: WV

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201231; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptoms: left arm and shoulder pain persisted; generalized itching; localized reaction distal to injection site (4 cm in circumference); Nearly debilitating joint, muscle and body aches and pain; Nearly debilitating joint, muscle and body aches and pain; severe headache; chills; night sweats; weakness; dizziness; lethargy; fever; body aches; nausea; Muscle soreness at injection site; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK9231), intramuscularly in the left arm, on 23Dec2020 at 14:30 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension, depression, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included atenolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), and simvastatin (MANUFACTURER UNKNOWN). The patient previously took bupropion hydrochloride (WELLBUTRIN) and experienced allergy. The patient did not receive other vaccines within four weeks prior to vaccination. The patient experienced fever, body aches, nausea, and muscle soreness at injection site on 24Dec2020 at 16:00; generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches, severe headache, chills, night sweats, weakness, dizziness, and lethargy on 26Dec2020; and left arm and shoulder pain persisted on 03Jan2021. All of the events were reported as non-serious. The events were described as: Within 24 hours (as reported), fever, body aches, nausea, and muscle soreness at injection site occurred. Then within 72 hours (as reported), generalized itching, localized reaction distal to injection site (4 cm in circumference), nearly debilitating joint, muscle and body aches and pain for three days with onset of severe headache, fever, chills, night sweats, weakness, dizziness, and lethargy. On Day 11 (as reported), left arm and shoulder joint pain persisted. The patient underwent lab tests and procedures which included nasal swab: negative on 31Dec2020. The patient did not receive any treatment for any of the events. The clinical outcome of all of the events was recovering.

Other Meds: ; HCTZ; ZOLOFT;

Current Illness:

ID: 0929100
Sex: F
Age: 64
State: ID

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: none

Allergies: Sea food

Symptoms: extreme sore arm - mild fever 99 degrees- fatigue- severe headache

Other Meds: none

Current Illness: none

ID: 0929101
Sex: F
Age:
State: IL

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: neck pain; fatigue; possible low grade fever; muscle ache; injection site pain; heart pounding and shakiness; heart pounding and shakiness; This is a spontaneous report from a contactable nurse, the patient. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the right arm on 29Dec2020 at 14:30 (at the age of 53-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies and prior Covid diagnosis. Concomitant medications were unknown. The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. On 30Dec2020 at 06:30, the patient experienced neck pain, fatigue, possible low grade fever, muscle ache, injection site pain within 16 hours of vaccination; heart pounding and shakiness within an hour of vaccination (29Dec2020 15:30). Treatment was provided for the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness included acetaminophen (TYLENOL) and ibuprofen. The outcome of the events neck pain, fatigue, possible low grade fever, muscle ache, injection site pain, heart pounding and shakiness was recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0929102
Sex: F
Age:
State: TX

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

Lab Data:

Allergies:

Symptoms: Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection in the left arm on 02Jan2021 at 15:15 (at the age of 31-years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. Concomitant medications were unknown. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Jan2021 at 19:00, the patient experienced tiredness, headache and muscle pain. No treatment was provided for the events tiredness, headache and muscle pain. The outcome of the events tiredness, headache and muscle pain was not recovered. Since the vaccination, the patient has not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0929103
Sex: F
Age:
State: CA

Vax Date: 12/22/2020
Onset Date: 12/25/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20200912; Test Name: covid; Test Result: Negative ; Test Date: 20201228; Test Name: PCR test; Test Result: Positive ; Test Date: 20201221; Test Name: rapid test/Nasal Swabs; Test Result: Negative ; Test Date: 20201222; Test Name: rapid test/Nasal Swabs; Test Result: Negative ; Test Date: 20201225; Test Name: rapid test/Nasal Swabs; Test Result: Positive

Allergies:

Symptoms: When she went back to work on 25Dec2020 it was positive/On the weekend she had to come back to do a PCR test on28Dec2020 and it was positive.; When she went back to work on 25Dec2020 it was positive/On the weekend she had to come back to do a PCR test on28Dec2020 and it was positive.; This is a spontaneous report from a contactable nurse. A 43-year-old female patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration given in the left arm on 22Dec2020 at a single dose for covid-19 immunization. The patient medical history included "patient's a blood donor" reported as, she donated blood on 12Sep2020 and it was negative for covid. The patient's concomitant medications were not reported. The patient experienced "when she went back to work on 25Dec2020 it was positive/on the weekend she had to come back to do a pcr test on28dec2020 and it was positive" on 25Dec2020 with an unknown outcome. It was further reported that the patient was a registered nurse that works night shift. She clarified that the rapid test was taken each time she goes to work. When she went to work on the night of 21Dec2020 the rapid test was negative.Then she got the Covid vaccine in the morning of 22Dec2020. When she went back to work the night of 22Dec2020 the rapid test was negative. When she went back to work on 25Dec2020 it was positive. On the weekend she had to come back to do a PCR test on28Dec2020 and it was positive. Caller clarifies that the rapid tests were Nasal Swabs. The patient's latest test was on 28Dec2020, she was told that when she comes back, they do not have to do the rapid test daily anymore, it will now be every 90 days. The patient did not have a test before the vaccine. She has had no issues with Vaccines in the past.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive for corona virus infection based on the known safety profile. However given the short duration of 3 days since the vaccine first dose, it is unlikely patient would have fully developed immunity.

Other Meds:

Current Illness:

ID: 0929104
Sex: M
Age:
State: AR

Vax Date: 12/18/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: monoclonal antibodies; Test Result: Negative ; Test Date: 20201228; Test Name: monoclonal antibodies; Test Result: Positive ; Test Date: 20201228; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptoms: positive COVID-19 test with symptoms/had like a head cold and cold like symptoms/he tested positive for COVID.; positive COVID-19 test with symptoms/had like a head cold and cold like symptoms/he tested positive for COVID.; This is a spontaneous report from a contactable nurse. A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular on left deltoid on 18Dec2020 at single dose for COVID prevention. The patient had no medical history. There were no concomitant medications. The patient got his first dose of the COVID Vaccine on 18Dec2020, and he states that he did fine and had no problems. But on 28Dec2020, when he was going to work, he noticed that he had like a head cold and cold like symptoms. He was swabbed and tested for COVID PCR on that day, and he tested positive for COVID. After his positive COVID test, he was tested for monoclonal antibodies, and at first, he was told that test came back positive, but then about 12 hours later, he was told that the staff had misread it, and he was actually negative for monoclonal antibodies, so the caller was given monoclonal antibody therapy and he did fine with that, and he is recovered now. He is scheduled to go back to work this Thursday, and he is supposed to receive the second dose of the vaccine, on Friday. He checked the schedule for getting the second dose, and he was not on the list, so he called the infection control nurse, and she told the caller that because he received the monoclonal antibody therapy, he now has to wait 90 days to receive the second dose of the vaccine. Caller states that he looked for that information, and he did not see that anywhere, so he is wondering if that is correct, because it almost seems to him that if he waits 90 days, he would have to start the series again. The outcome of the event was recovered on an unspecified date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The case will be reassessed if additional information becomes available.

Other Meds:

Current Illness:

ID: 0929105
Sex: M
Age: 0
State: IL

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: None

Allergies: None

Symptoms: Generalized hives

Other Meds: None

Current Illness: None

ID: 0929106
Sex: F
Age: 49
State: OH

Vax Date: 12/18/2020
Onset Date: 12/19/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: N/a

Allergies: N/a

Symptoms: Pain in left side/lower back that has persisted from 12/18/2020 til 2nd dose on 01/08/2021

Other Meds: N/a

Current Illness: N/a

ID: 0929107
Sex: F
Age:
State:

Vax Date: 12/31/2020
Onset Date: 01/01/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: low grade temp; Result Unstructured Data: Test Result:100

Allergies:

Symptoms: soreness/pain at injection site (had a very hard time utilizing that arm); headache (probably a migraine); nausea; general body aches; chills; low grade temp 100; tired; general feeling unwell; This is a spontaneous report from a contactable health care professional nurse, the patient. A 34-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), intramuscular in the left arm on 31Dec2020 16:15 as a single dose, for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing and Know Allergy to Latex. Concomitant medication included budesonide (PULMICORT), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]), magnesium (MAGNESIUM), cyanocobalamin (VIT B12). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 01Jan2021 04:30, the patient experienced soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell. No treatment was given for the event. Laboratory test include Body Temperature 100 on an unspecified date. The clinical outcome of Soreness/pain at injection site (had a very hard time utilizing that arm), headache (probably a migraine), nausea, general body aches, chills, low grade temp 100, tired, general feeling unwell recovered Jan2021. .

Other Meds: PULMICORT; ALBUTEROL [SALBUTAMOL]; ; VIT B12

Current Illness:

ID: 0929108
Sex: U
Age:
State: KS

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high; Test Name: Pulse; Result Unstructured Data: Test Result:120; Comments: My pulse is like a 120

Allergies:

Symptoms: High blood pressure; My pulse is like a 120; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 01Jan2021 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced "high blood pressure" and "my pulse is like a 120", both on unspecified dates. It was reported that the consumer stated "I got the shot today and I have been having really bad high blood pressure since I have got the immunization. How long do you think that side effect will last, or should I be going to the ER (emergency room)? My pulse is like a 120." The consumer stated that they "just got the COVID shot at their job today". The consumer was informed about the Information department, to which the consumer inquired "will that be a just a Pfizer rep or will that be an actual doctor?" The consumer was informed that there would be a live agent and that department had the information regarding the side effects of the vaccine. The consumer then asked, "for the side effects I have, I need to go to the ER then?". The consumer was suggested to visit the nearest ER if needed or can call an alternate number that was provided as the department was closed. Limited information was available over the call. The clinical outcome of the events "high blood pressure" and "my pulse is like a 120" were both unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0929109
Sex: F
Age:
State: IL

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201230; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptoms: Arm pain at injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A 54-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: unknown, unspecified route on 28DEC2020 12:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient did not have allergies to medications, food, or other products. Concomitant medication included ergocalciferol (VIT D), calcium (CALCIUM). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28DEC2020 03:45, the patient experienced arm pain at injection site. The event arm pain at injection site did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. No treatment was received for the event. Outcome of the event arm pain at injection site was recovered. Since the vaccination, the patient had been tested for COVID-19. Covid test type post vaccination = Nasal Swab, Covid test date on 30Dec2020 and result was negative. Information on lot/batch number has been requested.

Other Meds: VIT D;

Current Illness:

ID: 0929110
Sex: F
Age: 27
State: WV

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: None

Allergies: Sulfa

Symptoms: Body Aches, Chills, Vomiting, Extreme tiredness, Swelling at the injection site.

Other Meds: Latuda 40mg daily

Current Illness: no

ID: 0929111
Sex: F
Age:
State: CA

Vax Date: 12/21/2020
Onset Date: 12/23/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Her period came one week earlier than planned. It's was more painful and heavier.; Her period came one week earlier than planned. It's was more painful and heavier.; Her period came one week earlier than planned. It's was more painful and heavier.; Chills; Sore throat; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for COVID-19 immunization. Medical history included ongoing chronic migraines. Concomitant medications included ascorbic acid (VIT C), and ergocalciferol (VIT D). On 21Dec2020, the patient received the vaccine. After 48 hours (23Dec2020), she had chills, and a sore throat but no fever. It was mentioned that the chills and sore throat just lasted for one day. On 03Jan2021, the patient mentioned that her period came one week earlier than planned. It's was more painful and heavier. She mentioned that she always had a difficult period, but this this one seems more intensified (10 times) and was very painful. It was mentioned that the patient was getting the second one next week. The patient recovered from chills and sore throat on 24Dec2020 while not recovered for the remaining events

Other Meds: VIT C; VIT D

Current Illness: Chronic migraine

ID: 0929112
Sex: M
Age:
State: IL

Vax Date: 12/30/2020
Onset Date: 01/02/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210102; Test Name: Body temperature; Result Unstructured Data: Test Result:103

Allergies:

Symptoms: low grade fever/low grade fever of 103; chills; dry cough; lethargy; This is a spontaneous report from a contactable nurse. A 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 with expiry date Mar2021), via an unspecified route of administration in left deltoid on 30Dec2020 14:30 at a single dose for COVID-19 immunization. The administration was one in a local pharmacy. There were no relevant medical history and concomitant medications. On Saturday night, 02Jan2021, the patient started getting a low grade fever of 103, had chills, lethargy and an intermittent dry cough. The outcome of the events was not recovered. The events were considered medically significant events.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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:

Current Illness:

ID: 0929113
Sex: F
Age:
State: WA

Vax Date: 12/22/2020
Onset Date: 12/01/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: experienced like a "red welt" that was "hot to touch" and that was "itchy" for 3 days; experienced like a "red welt" that was "hot to touch" and that was "itchy" for 3 days; experienced like a "red welt" that was "hot to touch" and that was "itchy" for 3 days; This is a spontaneous report from a contactable consumer reporting for self. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. After she received the vaccine on 22Dec2020, the reporter experienced "like a red welt" that was hot to touch and that was itchy for 3 days (onset Dec2020). Then it came back in a similar fashion on 29Dec2020. She consulted her doctor who prescribed a steroid cream and Benadryl. It then improved the next day, as it was less red and no longer hot to touch. The final clinical outcome of the events red welt, hot to touch, and itchy was resolving. The events were reported as non-serious. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 0929114
Sex: F
Age: 65
State: CT

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: none

Allergies: penecillin

Symptoms: after 11 days, I still have a large (1/2 dollar size, red mark at the injection site that is warm to the touch and at times itchy. I had no other symptoms or reactions to the vaccine.

Other Meds: none

Current Illness: none

ID: 0929115
Sex: F
Age:
State: CA

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

Lab Data:

Allergies:

Symptoms: Experienced swelling at the injection site; experienced redness at the injection site; experienced tenderness, and pain at the injection site; Her arm was very tense; Felt itchy; itchy at the site; A large red hive appeared; discomfort; This is a spontaneous report from a contactable consumer (patient's husband). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose (dose 1, arm) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient is a physician who received the shot at work. Reporter stated patient had a localized reaction to the COVID-19 Vaccine. On the first day after receiving the vaccine, she experienced swelling, redness, tenderness, and pain at the injection site for 24 to 48 hours, and her arm was very tense. After 3 days, the discomfort disappeared but her arm was still tight. 8 days after the injection patient felt itchy and itchy at the site and a large red hive appeared, the injection site was again tender and swollen, the next day the hive was gone but patient's arm was still tight and swollen at the site of the injection. 13 days after the vaccination she returned to normal. Reporter wanted to know if the only contraindication to not receiving the second dose of the vaccine is if someone experienced anaphylaxis after the first dose. Information on the Batch/Lot number has been requested.

Other Meds:

Current Illness:

ID: 0929116
Sex: F
Age:
State: CT

Vax Date: 12/16/2020
Onset Date: 12/01/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Felt like her thyroid was off/could not function well; Felt exhausted; Feeling out of it, like she was drugged/felt foggy; Feeling out of it, like she was drugged; Feeling restless at night; She hasn't been able to sleep at night; This is a spontaneous report from a consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 on the left arm at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital (not a military facility). Medical history included ongoing Grave's disease from 2007. There were no concomitant medications. On 16Dec2020 (19:00), the patient was feeling out of it, like she was drugged, and felt foggy. On 17Dec2020, the patient had felt exhausted. In Dec2020, the patient was feeling restless at night; and has not been able to sleep at night. On an unspecified date, the patient had felt like her thyroid was off and could not function well. The outcome of the events was recovered in Dec2020 for 'feeling out of it, like she was drugged, and felt foggy'; was not recovered for 'feeling restless at night' and 'has not been able to sleep at night'; and was unknown for all the other events. The patient was leery about receiving the second COVID-19 vaccine dose.

Other Meds:

Current Illness: Graves' disease

ID: 0929117
Sex: F
Age: 62
State: OR

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

Lab Data: unknown

Allergies: Pears- Hives Codeine- Hallucinations Lisinopril- Cough

Symptoms: patient has a hx of anaphylaxis to pears. Within 5 minutes of vaccine developed tingling and numbness to lips and tongue. patient escorted to the emergency department for further evaluation and treatment.

Other Meds: unknown

Current Illness: unknown

ID: 0929119
Sex: F
Age:
State:

Vax Date: 12/18/2020
Onset Date: 12/18/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: tongue started tingling and then went completely numb, in which lasted several hours; tongue started tingling and then went completely numb, in which lasted several hours; headache; muscle pain; chills; mild allergic reaction; This is a spontaneous report from a contactable healthcare professional reporting on herself. A 45 (Unit: Unspecified) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 18Dec2020 as a single dose for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. On 18Dec2020, 45 minutes later after receiving the vaccine, the patient experienced her tongue started tingling and then went completely numb, in which lasted several hours. Then she experienced a headache, muscle pain, and chills. The patient inquired if she should receive the second dose of the Covid vaccine after experiencing side effects or a mild allergic reaction. The outcome of the events tongue started tingling and then went completely numb, headache, muscle pain, chills and allergic reaction was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 0929120
Sex: F
Age: 44
State: IN

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: none

Allergies: none

Symptoms: moderate myalgias, fatigue, back pain, extremity pain and weakness

Other Meds: wellbutrin XL, Mirena IUD, Dexilant, probiotics

Current Illness: none

ID: 0929121
Sex: F
Age:
State:

Vax Date: 12/22/2020
Onset Date: 12/27/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: bloodwork; Result Unstructured Data: Test Result:Unknown result; Comments: prior vaccine

Allergies:

Symptoms: hives; face swelling; itching; rash; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), intramuscular in left arm on 22Dec2020 11:08 at single dose for COVID-19 vaccination. Medical history included ongoing blood pressure high, ongoing cholesterol, ongoing depression. Concomitant medication included atenolol (tablet, strength 50 mg) from an unknown date and ongoing for blood pressure high, simvastatin (tablet, strength 20 mg) from an unknown date and ongoing for cholesterol, paroxetine hydrochloride (PAXIL, tablet, strength 40 mg) from an unknown date and ongoing for depression. The patient experienced hives, face swelling, itching and rash on 27Dec2020. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccination within 4 weeks was none. She got the first Covid 19 dose on 22Dec2020 and was fine, then on 27Dec2020 she had hives, itching, and face swelling for several days. Caller stated her lungs were clear and she was okay other than the extreme itching. The face swelling was what worried her. The hives and itching went away within about 36 hours. The face swelling kind of got worse for a couple of days before it went away. Caller verifies she recovered from the hives/rash/itching within 36 hours. She got a steroid shot and things like that and it went away pretty quickly. The face swelling was completely gone but did last for a good 5 days. She didn't know if this reaction was related to the vaccine. She wanted to call and let Pfizer know and see if there was any reports of anything else like that or similar to that type of reaction. She was not sure if that really matters or not except she was not sure about taking the booster. She was kind of leaning towards taking the second vaccine. She didn't have any breathing issues. She asked as far as the second dose after those side affects, was it recommended? Her doctor said she could get the second one and prescribed her an Epi pen and would give a dose of Benadryl at the time of the second vaccine. She may take some Benadryl before getting the second vaccine and have her EpiPen with her just in case. She hadn't seen her doctor about this experience with the COVID-19 vaccine. She only went to an urgent care. The caller stated she went to urgent care twice. She received a steroid shot but doesn't have any name, NDC/UPC, Lot number or expiration date for any of the medication she received. She probably threw that paperwork out. She knew she wasn't given anything the second time she went to the urgent care. The second time she went back was because the face swelling was getting worse. She was prescribed an EpiPen and was told to take Zyrtec which did help. Everything had gone away. She would consider these events to be medically significant because of the face swelling, it kind of scared her. She made the comment she was taking high blood pressure medicine and cholesterol medicine, but other than that she was very healthy. She was not really an allergic person. She had not had any testing done since she received the vaccine. She did have bloodwork done prior but not since the vaccine. The patient underwent lab tests and procedures which included blood work prior vaccine with unknown result. The outcome of hives, rash and itching was recovered on an unspecified date of Dec2020 (within about 36 hours); face swelling was recovered on 01Jan2021.; Sender's Comments: Based on the time gap between the vaccine and the events there is not a reasonable possibility that the reported events were related to the suspect product, events are most likely due to patient underlying contributory factors 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: ; ; PAXIL [PAROXETINE HYDROCHLORIDE]

Current Illness: Blood pressure high; Cholesterol; Depression

ID: 0929122
Sex: F
Age:
State: WI

Vax Date: 12/16/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Developed full body rash; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. On 28Dec2020, the patient had developed full body rash. The rash was further described as mild. The patient had no change in any personal care products, and felt like the rash was due to the vaccine. The outcome of the event was unknown. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 0929123
Sex: F
Age: 67
State: TX

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

Lab Data:

Allergies:

Symptoms: Patient complained of feeling like she "swallowed a feather or a cat hair" - her lungs were tickling. She said she felt fine, but wanted to be sure to report the "strange feeling". Patient said she feels well, but wanted to contribute to research. Patient advised to call 911 or go to the nearest emergency room for any further issues.

Other Meds:

Current Illness:

ID: 0929124
Sex: F
Age:
State:

Vax Date: 01/03/2021
Onset Date: 01/04/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: Blood pressure; Result Unstructured Data: Test Result:drop

Allergies:

Symptoms: drop in blood pressure resulting in fainting; drop in blood pressure resulting in fainting; Severe headache; fever; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unspecified route of administration on 03Jan2021 at single dose at left arm for immunization. Medical history included allergies to Penicillins. The patient's concomitant medications within 2 weeks of vaccination included birth control pill, prenatal vitamin. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced severe headache, fever, and drop in blood pressure resulting in fainting the morning following receiving the vaccine on 04Jan2021 with outcome of recovering. Patient didn't receive treatment for events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. This report is considered non-serious. No follow-up attempts are possible. Information about Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the close temporal relationship, the association between the event fainting with BNT162b2 can not be completely 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:

Current Illness:

ID: 0929125
Sex: F
Age: 37
State: TX

Vax Date: 12/24/2020
Onset Date: 01/05/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: None.

Allergies: None.

Symptoms: On the morning of Wednesday, January 6th, I woke up with a red splotch on the arm that I received the vaccination on. The splotch was located about 5 inches away from the injection site. It was raised and itchy. I didn't take anything in hopes that it would dissipate on it's own. On the morning of Thursday, January 7th, I woke up with a splotchy circle directly around the injection site. It was also raised and itchy. I went to work that day and one of the RN's looked at it, they stated that it could be an allergic reaction to the shot and suggested I take Benadryl to see if it would dissipate. I took some last night (Thursday, January 7th) and woke up this morning to find the splotches a little faded. They aren't as raised however they are still itchy. I will continue to take Benadryl for the next few days to see if it completely dissipates.

Other Meds: TRI-SPRINTEC TABLETS 28'S Buproprion XL 450mg 1st Phormula Supplements: Thyro-Drive and 1Db Goddess Costo Brand Zyrtec (Daily) Flo-Nase Mist (Daily)

Current Illness: Early onset of strep in the first week of December however I took a 7 day supply of Penicillin VK 500mg (2x daily)

ID: 0929126
Sex: M
Age:
State: WV

Vax Date: 12/15/2020
Onset Date: 12/26/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201228; Test Name: COVID-19 PCR test; Test Result: Positive

Allergies:

Symptoms: Test positive for COVID-19/have symptoms on 26, 27 and 28Dec2020; Test positive for COVID-19/have symptoms on 26, 27 and 28Dec2020; This is a spontaneous report from a contactable physician (patient). A 59-year-old male patient started to receive first dose of BNT162B2 (Batch/lot number: EH9899) intramuscular into left deltoid on 15Dec2020 at single dose for covid-19 immunisation. Medical history included hypertension and the patient was on blood pressure (BP) medications. The patient received no other vaccines on the same day as the COVID Vaccine. The patient received first dose on 15Dec2020 and was exposed to someone with COVID on 24Dec2020 and tested positive for COVID 28Dec2020. The patient stated that he was wondering what the recommendations are for receiving the second dose of the product, if someone contracted COVID-19 after receiving the first dose. He tested Positive for COVID-19 on 28Dec2020 and he does not know if it is ongoing or not, as he does not re-test for COVID-19 until Wednesday (30Dec2020), but he currently has no symptoms. The patient stated that he did have symptoms on 26, 27 and 28Dec2020. The lab tests and included COVID-19 PCR test: positive on 28Dec2020. The outcome of events was unknown.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be completely excluded.

Other Meds:

Current Illness:

ID: 0929127
Sex: M
Age:
State: NY

Vax Date: 12/21/2020
Onset Date: 12/01/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201222; Test Name: Fever; Result Unstructured Data: Test Result:101.4 to 101.6 degrees Fahrenheit; Test Date: 20201223; Test Name: Fever; Result Unstructured Data: Test Result:98.8 to 99.9 Fahrenheit

Allergies:

Symptoms: Fever; He sweated the whole night; He slept for 24 hours and that is abnormal; This is a spontaneous report from a contactable physician (patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO140; Batch number: 20201221E; Expiration date was not reported) on 21Dec2020 at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included previously having COVID-19 from Oct2020 to an unspecified date; abnormal cholesterol; and abnormal blood pressure. Concomitant medications included acyclovir [aciclovir] (ACYCLOVIR); atorvastatin for abnormal cholesterol; hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS) for abnormal blood pressure; and vitamin D NOS. On 22Dec2020, the patient had fever. In Dec2020, the patient had sweated the whole night; and had slept for 24 hours and that was abnormal. The patient had body temperature values of 101.4 to 101.6 degrees Fahrenheit on 22Dec2020; and 98.8 to 99.9 degrees Fahrenheit on 23Dec2020. The patient had received ibuprofen (MOTRIN) and paracetamol (TYLENOL) as treatment for the fever. The patient considered his adverse reaction "mildish". The outcome of the events was recovered on 22Dec2020 (21:00) for 'fever'; and was recovered in Dec2020 for 'sweated the whole night' and 'slept for 24 hours and that was abnormal'. The reporter's assessment on the causal relationship between the vaccine and the event was related.

Other Meds: ACYCLOVIR [ACICLOVIR]; ; LOSARTAN HYDROCHLOROTHIAZIDE ACTAVIS; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 0929128
Sex: F
Age: 27
State:

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

Lab Data:

Allergies:

Symptoms: Patient was given second Pfizer vaccine at 8:19. About 11 minutes after receiving the vaccine patient complained of chest pain. 911 was called, nasal 02 was administered. BP 150/90, P103. Patient was taken by ambulance to the ED. She stated her chest pain was an 8 out of 10.

Other Meds:

Current Illness:

ID: 0929129
Sex: F
Age:
State: MI

Vax Date: 01/03/2021
Onset Date: 01/03/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills; fever; headache; lots of body aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 20-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the left arm on 03Jan2021 at 08:00 AM (at the age of 20 years-old) as a single dose for COVID-19 vaccination. Medical history was unknown. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 03Jan2021, the patient experienced chills, fever, headache, and lots of body aches. The report was reported as non-serious. It was unknown if the patient was treated for chills, fever, headache, and lots of body aches. The clinical outcome of chills, fever, headache, and lots of body aches was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 0929130
Sex: F
Age:
State: PA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: chills; fatigue; small rash on left arm (size of half dollar); 1 pinpoint spot "hive": under chin, on right arm, under left foot; This is a spontaneous report from a contactable nurse (patient). A 60-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL1284), via intramuscular route of administration in the right arm on 28Dec2020 at 05:30 AM (at the age of 60 years-old) as a single dose for COVID-19 vaccination. Medical history included diabetic and asthma. The patient's allergies included sulfa, iodine, shellfish and latex/rubber. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported; however, there were other medications the patient received within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020 at 06:30 AM, the patient experienced chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The report was reported as non-serious. The patient was not treated for chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot. The clinical outcome of chills, fatigue, small rash on left arm (size of half dollar, 1 pinpoint spot "hive" under chin, on right arm and under left foot was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0929131
Sex: F
Age:
State: KY

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; Tiredness, headache, chills, nausea, and feeling unwell.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), via intramuscular route of administration in the right arm on 30Dec2020 at 12:30 PM (at the age of 27 years-old) as a single dose for COVID-19 vaccination. There was no relevant medical history. The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 31Dec2020, the patient experienced tiredness, headache, chills, nausea, and feeling unwell. The report was reported as non-serious. The patient was not treated for tiredness, headache, chills, nausea, and feeling unwell. The clinical outcome of tiredness, headache, chills, nausea, and feeling unwell was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are Possible; Information about batch number cannot be obtained. No further information is expected

Other Meds:

Current Illness:

ID: 0929132
Sex: M
Age:
State: NJ

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201224; Test Name: BP; Result Unstructured Data: Test Result:50/30; Test Date: 20201224; Test Name: HR; Result Unstructured Data: Test Result:45

Allergies:

Symptoms: Patient fainted in the ICU setting.; dizziness; hypotension; This is a spontaneous report from a contactable Other HCP. A 25-year-old male patient received BNT162B2 (Lot number: eh9899) via an unspecified route of administration on 24Dec2020 13:00 at single dose for covid-19 immunisation. The patient did not have any known allergies or medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. On 24Dec2020, patient experienced dizziness and hypotension. Patient's blood pressure (BP) was 50/30 and heart rate (HR) 45. Patient fainted in the intensive care unit (ICU) setting. This happened during work hours while treating a patient. Patient was treated in the emergency department (ED). The adverse events resulted in emergency room/department or urgent care. It was unknown if treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was recovered.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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:

Current Illness:

ID: 0929134
Sex: F
Age: 36
State: OH

Vax Date: 12/22/2020
Onset Date: 12/23/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: PCN, Macrobid, Cipro

Symptoms: numbness to lips day after vaccine tingling and numbness to left arm, progressively getting worse no drooping to face hives injection site pain

Other Meds:

Current Illness: n/a

ID: 0929135
Sex: F
Age: 20
State: IL

Vax Date: 01/05/2021
Onset Date: 01/06/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: None

Allergies: No allergies to medications, food or other products.

Symptoms: Side Effects included: headache, body aches (back pain), low-grade fever, chills, soreness in arm after injection and throughout the next 24-48 hours, overall fatigue/tired. Most went away after the 24 hour mark. After the 24 hour mark -- soreness in arm continued and same with the headache.

Other Meds: Birth Control, Magnesium (200 mg), Vitamin D, Vitamin B2, Elderberry supplement, Cranberry supplement, Vitamin C

Current Illness: None.

ID: 0929136
Sex: F
Age:
State: KY

Vax Date: 01/03/2021
Onset Date: 01/04/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20210104; Test Name: Body Temp; Result Unstructured Data: Test Result:101 Fahrenheit; Test Date: 202101; Test Name: Body Temp; Result Unstructured Data: Test Result:99 Fahrenheit; Test Date: 20201223; Test Name: COVID test; Result Unstructured Data: Test Result:negative

Allergies:

Symptoms: temperature of 101 ?F; body aches; headache; nausea; chills; This is a spontaneous report from a contactable Other HCP (patient). A 26-year-old female patient started to receive BNT162B2 (Batch/lot number: EK9231) at right deltoid via an unspecified route of administration on 03Jan2021 12:20 at single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. The patient experienced temperature of 101 ?F, chills, body aches, headache and nausea on 04Jan2021 02:00. Patient stated for the second one, she was hoping for the best, but she got the vaccine yesterday (03Jan2021), at 12:20, and today (04Jan2021), at 2 AM, she had a temperature of 101, and chills, body aches, headaches, and nausea. She was out of it today, she was not feeling good, and was told to do this. Caller got the vaccine at Employee Health. After 4 hours of Tylenol (expiry is May2021, lot is P115252), her temperature went right back up. It was about 99 when she had Tylenol. Chills started late this morning (04Jan2021) and were ongoing when she was not on Tylenol, but her body aches were ongoing. 9AM was when her headache started, and she was intermittently on Tylenol, but if past the 4 hour mark, they were as bad as they were this morning, but with Tylenol they were better. Nausea was mostly this morning, and had gotten better. Patient stated that due to her current symptoms her employer had required her to be tested for COVID-19. She had not yet received the results of that test. Seriousness for events temperature of 101 ?F, chills, body aches, headache and nausea was Medically significant. Lab data included COVID test on 23Dec2020 was negative. The outcome of temperature of 101 ?F, headache and nausea was recovering; of body aches was not recovered; of chills was unknown. Primary Source Reporter (Method of assessment was Global Introspection) considered the events were related to BNT162B2.; Sender's Comments: There is a reasonable possibility that the events reported were related to BNT162b2 based on known drug safety profile and close temporal relationship. 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:

Current Illness:

ID: 0929137
Sex: F
Age:
State: IL

Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; just shy of 24hrs after the vaccine, I developed bone/ joint pain in hips and shoulders, myalgias and a fever. Pain in my hips affected my ability to walk/gait. Pain was 8/10, constant, achy and throb; myalgia; fever; Pain in my hips affected my ability to walk/gait; Pain was 8/10, constant, achy and throbbing; This is a spontaneous report from a contactable physician. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685 expiration date unknown), intramuscularly, on an unspecified date in Dec2020 at 17:00 (at the age of 32-years-old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history was not provided. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Just shy of twenty-four hours after receiving the vaccine, the patient developed bone/ joint pain in hips and shoulders, myalgias, a fever and pain in her hips which affected her ability to walk/gait. Her pain was 8/10, constant, achy and throbbing. Movement and sitting in the same position exacerbated the symptoms. The patient specified that she did not receive any treatment for the events. She did mention, however, that a hot shower and sleep eased her symptoms. The clinical outcome of bone pain, joint pain, myalgia, fever, pain and difficulty in walking was reported as self-limited and resolved completely within 12-14 hours. It was also reported that since the vaccination the patient had not been tested for COVID-19.

Other Meds:

Current Illness:

ID: 0929138
Sex: F
Age: 40
State:

Vax Date: 12/28/2020
Onset Date: 01/05/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data: none

Allergies:

Symptoms: Patient received vaccine the 28th of December 2020. Physical exam show erythema, warm to touch, itching, slightly raised area and blanching to palpation. Circle drawn around redness previous night (2inx1.5in approx) and redness has progressed to larger diameter . Denies pain at sight. Patient has long painted nails. Patient given oral antibiotics, cephalexin 500mg taken 4 times a day for 10 days as well as topical steroid cream, triamcin acet 0.025% to be applied to area twice a day for 2 days. Instructed to follow up in two days to evaluation. During follow up, area noted to be improving. Instructed to continue current treatment and return if worsening of symptoms or development of new symptoms, fever/chills.

Other Meds:

Current Illness:

ID: 0929139
Sex: F
Age:
State: NV

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Date: 20201230; Test Name: blood pressure; Result Unstructured Data: Test Result:Elevated; Comments: elevated heart rate and blood pressure; Test Date: 20201230; Test Name: heart rate; Result Unstructured Data: Test Result:Elevated; Comments: elevated heart rate and blood pressure

Allergies:

Symptoms: Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Itching and redness over whole body/I turned all red and was itching all over my body by about 10:30- 10:45 am/I still have mild itching; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Had an allergic reaction; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2) lot no: EK9231, via an unspecified route of administration in left arm on 30Dec2020 09:00 at a single dose for COVID-19 immunization. Medical history HTN and exercise-induced asthma, both from an unspecified date and unknown if ongoing. The patient was not pregnant at the time of vaccination. The patient had no covid prior to vaccination and was not covid tested post vaccination. Concomitant medication included colecalciferol (VITAMIN D), montelukast sodium (SINGULAIR), and biotin. No other vaccines were administered in four weeks. Known allergies include tapendalol (NUCYNTA) and trimethoprim/sulfamethoxazole (BACTRIM). On 30Dec2020 09:30, the patient experienced itching and redness over whole body, elevated heart rate, and blood pressure. The patient was given IV diphenhydramine (BENADRYL) 50 mg, IV famotidine (PEPCID), IV methylprednisolone (SOLU MEDROL), "flui" as treatment for AEs. The patient further clarified that she received the COVID 19 vaccine on 30Dec2020 at 9:00 and she had an allergic reaction. She turned all red and was itching all over her body by about 10:30- 10:45 am and was at the ER by about 11am. She started on prednisone 40mg for 3 days and diphenhydramine every 6 hours, as needed on 30Dec2020. On Sunday (03Jan2021), she was still severely itching and turning red so prednisone was continued for an additional 3 days and was switched to cetirizine (ZYRTEC) because she can't function on diphenhydramine. Cetirizine was not helping so she had to take diphenhydramine yesterday morning (04Jan2021). Last night (04Jan2021), she was ok without any diphenhydramine but this morning (05Jan2021), she still have mild itching, and no redness. The redness comes and goes; it is on the face, chest, arms, legs. When it first started, it was whole body redness. Then it moved to different areas on different days; she don't have a rash or hives, just redness. She had a 4 inch band of redness on both arms one day. The events were reported as non-serious. The patient had not recovered from the events.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of allergic reactions cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies to multiple materials may put the patient at high risk of allergic reactions. 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: VITAMIN D [COLECALCIFEROL]; SINGULAIR;

Current Illness:

ID: 0929140
Sex: F
Age:
State:

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

Lab Data: Test Name: Sars-Cov-2; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptoms: contracted Sars-Cov-2 in between her two doses; contracted Sars-Cov-2 in between her two doses; This is a spontaneous report from a Contactable Other HCP. A female patient of an unspecified age started to receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient was due for her 2nd dose of Pfizer-Biontech Covid19 vaccine on 06Jan2020. She contracted Sars-Cov-2 in between her two doses, want to know if she should receive her second dose as scheduled. Patient had COVID-19 test with unknown result. Outcome of events was unknown. Information about lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (contracted SARS CoV 2) with BNT162b2 cannot be completely excluded.

Other Meds:

Current Illness:

ID: 0929141
Sex: M
Age: 33
State: MI

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: very bad dizziness that lasted over an hour

Other Meds:

Current Illness:

ID: 0929142
Sex: M
Age: 38
State: NY

Vax Date: 01/04/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: NKA

Symptoms: I run twice a week. One 6-8 mile and one 10-12 mile run. I breathe through my nose mostly and I'm in very good pulmonary and cardiovascular condition. I went for a run and 1 mile in I started drooling a lot! Spitting out mouthfuls every 15-30 seconds and I never spit. Then my chest got tight and hurt and got irritated. The feeling was identical to Bronchitis. I started walking home and my breathing rate increased with wheezing. I got nauseous and was bent over with saliva poring out of my mouth. Walking up one flight of stairs was difficult. I have a finger pulse oximeter and it was at 84! Breathing was very rapid and difficult. After 5 minutes it went up to 94 and then up to 98-99 after 1 more minute (when my pulse fell back under 100bpm. Chest tightness continued for about 1 hour before I was back to normal for the most part. by today I feel 100% again.

Other Meds: Omeprazole 40 mg od, Zyrtec 10 mg od, multivitamin od, vitamin d 7500 units daily, colase od, 2 senna od, probiotic od, calcium citrate 2000mg od. zinc 50mg od. Cosamin DS (3) od.

Current Illness: None

ID: 0929143
Sex: F
Age:
State: VA

Vax Date: 01/04/2021
Onset Date: 01/04/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; Ocular migraine, onset at 14:00, took 1 dose of Imitrex at 14:15. Vision began to improve at 14:40.; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of bnt162b2 (BNT162B2, PFIZER, Lot number: EL1284, expiry date not reported), via an unspecified route of administration on 04Jan2021 09:00 at a single dose on Left arm for COVID-19 immunisation. Medical history included Migraine, asthma, seasonal allergies, RLS (Restless legs syndrome). Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), sumatriptan succinate (IMITREX), fluticasone propionate (FLONASE ALLERGY RELIEF). The patient previously took Amoxicillin, codeine and experienced allergies. The patient experienced ocular migraine, onset at 14:00, took 1 dose of Imitrex (25 mg) at 14:15. Vision began to improve at 14:40. The outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at the Hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were considered as non-serious.

Other Meds: NEXIUM [ESOMEPRAZOLE MAGNESIUM]; ADVAIR; SINGULAIR; IMITREX; FLONASE ALLERGY RELIEF

Current Illness:

ID: 0929144
Sex: M
Age:
State: NJ

Vax Date: 12/23/2020
Onset Date:
Rec V Date: 01/08/2021
Hospital:

Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:Normal

Allergies:

Symptoms: Joint pain; I started feelings like I am having flu like symptoms like chills; Body fatigue; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported ), via an unspecified route of administration on the upper arm on 23Dec2020 at a single dose for COvid-19 immunization. Medical history included triglycerides (abnormal). Concomitant medication included eicosapentaenoic acid ethyl ester (VASCEPA) for triglycerides. The patient is a dialysis technician in a dialysis Unit. The vaccine was given in a facility. The patient got the Covid Vaccine on 23Dec2020 and its like more than a week now, on an unspecified date, he felt joint pain, body fatigue and two nights ago, he started feelings like he was having flu like symptoms like chills he took his temperature and its normal so he doesnt know if there is a reported reactions like this that he was feeling and he would like to know what does he needs to do, to know anything and an advice. He was scheduled for the blood work done at this month. The patient was taking only paracetamol (TYLENOL) for his joint pain, and chills and that's the only thing that he is experiencing right now. The consumer did not undergo emergency room or physician office. Outcome of the event chills was not recovered, while for the other events was recovered on an unspecified date. Information on the lot/batch number has been requested.

Other Meds: VASCEPA

Current Illness:

ID: 0929145
Sex: F
Age: 51
State: OH

Vax Date: 12/31/2020
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies: PNC Bee stings

Symptoms: Itching and swelling at injection site

Other Meds: Amlodipine 5 mg Lisinopril 20mg Omeprazole 20mg B12 5000 Iron 18 mg D3 Ameran menopausal supplements

Current Illness: None

ID: 0929146
Sex: U
Age:
State:

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

Lab Data: Test Name: COVID-19; Result Unstructured Data: Test Result:tested positive

Allergies:

Symptoms: tested positive for COVID-19 more than a week after receiving our COVID-19 vaccine; tested positive for COVID-19 more than a week after receiving our COVID-19 vaccine; This is a spontaneous report from a non-contactable consumer. A 45-years-old patient of an unspecified gender started received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for COVID-19 more than a week after receiving COVID-19 vaccine. Outcome of the event was unknown. No follow up attempts are possible. Information on lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information

Other Meds:

Current Illness:

ID: 0929147
Sex: F
Age: 49
State: NY

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 01/08/2021
Hospital:

Lab Data:

Allergies:

Symptoms: Reported Temp 100.6F, difficulty sleeping, dizzy, lightheaded, flushed , nausea with diarrhea for 12 hours. All symptoms resolved. Patient Included the following information: 1 st dose Phizer EH 9899 2nd Dose Phizer EK 9231

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 134,999

Page last modified: 14 December 2021 10:42pm