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
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1276817
Sex: M
Age:
State: MA

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210216; Test Name: temperature; Result Unstructured Data: Test Result:97 Fahrenheit; Test Date: 20210215; Test Name: heart rate; Result Unstructured Data: Test Result:oscillating between 85 -110 BPM; Test Date: 20210215; Test Name: heart rate; Result Unstructured Data: Test Result:dropped back down

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; I had severe chills, fever and muscle cramps overnight. Was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours, the fever broke; elevated heart rate; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 15Feb2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE, dose 1 via an unspecified route of administration, administered in Arm Right on 25Jan2021 09:30 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Medical history included was none. The patient had no known allergies. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks after receiving COVID vaccine. The patient had no history of COVID prior to vaccination and did not test post vaccination. The patient also stated that on 15Feb2021 at 10:00 PM, he had severe chills, fever and muscle cramps overnight. He was unable to get the temperature of the fever as it was hard to get up and move to get thermometer. However, after 6 - 7 hours (on 16Feb2021), the fever broke and returned to 97F. The patient stated that on 15Feb2021 at 10:15 AM, about 30-45 minutes after vaccination, he experienced elevated heart rate. His Apple Watch alerted him asking if he was working out, and upon checking his heart rate, it was oscillating between 85 - 110 BPM. After about an hour, his heart rate dropped back down. The patient did not receive any treatment for the events. The outcome of the events chills, fever and muscle cramps was recovered on unspecified date in 2021. The outcome of the event heart rate increased was recovering.

Other Meds:

Current Illness:

ID: 1276818
Sex: F
Age:
State: NC

Vax Date: 01/28/2021
Onset Date: 01/30/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Name: shrunk height; Result Unstructured Data: Test Result:Height was about 5'2", she shrunk

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: shingles; This is a spontaneous report from a contactable Nurse (patient). A 91-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 intramuscular, administered in Deltoid Left on 28Jan2021 15:00 as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 30Jan2021, she began to see shingles starting under her breast, and it went into full blown shingles. She first noticed shingles barely under one breast, she noticed a little bit of a rash start and then it got worse and went all the way to her spine. It is kind of scabbing over now and she still has the deep pain. She did not have a problem with the itch, but she did have deep pain. She was not sure if it was coincidental. She was wondering if she should take the next shot. hcp gave her a medication, Valtrex, that he did not think would work since she was seen a week or two later after seeing the shingles and it should be taken when the shingles first starts. She took all of it. Patient does not think it was life threatening. she mentioned she had a problem with shakiness. Height was about 5'2", she shrunk. No prior vaccinations within 4 weeks and no AE prior vaccinations. The outcome of the event was recovering. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1276819
Sex: F
Age:
State: NC

Vax Date: 02/11/2021
Onset Date: 02/01/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling unwell; Weakness; light headed/weak when standing up; polymyalgia; sick; This is a spontaneous report from a contactable nurse (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9284; Expiration Date: 31May2021), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:30 as single dose for covid-19 immunisation. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 (Verbatim: Giant Cell Vasculitis, Reported she started taking Prednisone about a year ago for Giant Cell Vasculitis. She said she started at Prednisone 60mg a day, and now is down to Prednisone 10mg a day), Congestive Heart Failure, COPD, Hypertension, Pulmonary Hypertension. There were no concomitant medications.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1283, Expiry Date: 30Apr2021) on 21Jan2021 via Intramuscular, anatomical location was arm left, prednisone for Giant Cell Vasculitis (she started taking Prednisone (60mg a day)about a year ago for Giant Cell Vasculitis and was down to Prednisone 10mg a day.her side effects are not that bad. She said she just expected to feel better.), flu vaccine (She gets temperature 101 and sick from the flu vaccine, so she doesn't get the flu vaccine anymore and it had been quite a few years since she took the flu vaccine.), pneumonia vaccine (got a pneumonia vaccine about a year or so ago).On 12Feb2021, patient had been on the couch and watching television. She was fine laying down, but when she got up, she was lightheaded and didn't feel well and had weakness when she got up. Patient had a sore throat with swollen glands in her neck, her throat felt swollen and like it was closing up and glands started hurting on 15feb2021. She was sick when got up, but when lay down she was fine. she had polymyalgia was doing better before the vaccination. She was wondering if it was normal for the COVID-19 Vaccine side effects to last that long or were the COVID-19 Vaccine side effects expected to last that long. Wanted to know if because she was taking Prednisone, her COVID-19 Vaccine side effects were lasting longer. Patient stated she always thought she was 5'5", but the last time she was measured at the doctor she was told she was 5'. No further details provided. her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine. She took 1 Tylenol on 11Feb2021 and again on 15Feb2021 (Lot Number: 06V1489, Expiration Date: May2022). She said she took 2 Equate Brand Tylenol 500mg tablets because her throat felt swollen, and the throat swelling went away on 16Feb2021. Patient had severe pulmonary hypertension until she had a cardiac catheterization. She said she was told from the cardiac catheterization that she had the potential for pulmonary hypertension but did not have severe pulmonary hypertension. She said prior to the cardiac catheterization she had years of cardia echos performed, and the cardiac echos were not correct. The outcome of the event throat felt swollen was recovered on 16Feb2021, for feeling unwell, lightheadedness, weakness it was not recovered and sore throat, swollen glands it was recovering.

Other Meds:

Current Illness:

ID: 1276820
Sex: M
Age:
State: CT

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Fever; Chills; fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 52-Year-old male patient received second dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Batch/Lot Number: EL3247; Expiration Date: unknown), via an unknown route on 16Feb2021 at 11:00 am in the left arm, as a SINGLE DOSE for COVID-19 immunization. The patient's medical history included marginally high blood pressure. Patient's concomitant medications included (medications in two weeks) lisinopril. The patient received first dose of BNT162B2, Solution for injection, Lot number: Batch/Lot Number: EL3247), via an unknown route on 26Jan2021 at 09:30 am in the left arm, as a SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. On 16Feb2021 at around 10pm (on the same day of vaccination), the patient reported fatigue, fever, and chills. It was reported that, patient did not take any treatment medication for the events. The outcome of the events was resolving.

Other Meds: LISINOPRIL

Current Illness:

ID: 1276821
Sex: F
Age:
State: NY

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: pain on the back part of my shoulders. Excruciating, worst pain; she could sleep at all, she wasnt able to have food, she also had no motivation to do anything, not wanting to do anything, not wanting to leave her apartment; shooting pain on the right side into ear. It feels like her ear was being ripped off; shooting pain on the right side into ear. It feels like her ear was being ripped off; Lack of motivation; I had a terrible pain in my neck on both sides, I really couldn't move my neck; didn't have any appetite; body felt strange; This is a spontaneous report from a contactable consumer (patient). This 79-Year-old female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via unspecified route of administration, administered in Left arm on 04Feb2021 as a single dose for COVID-19 immunization. The patients past medical history and concomitant medications were not reported. On Friday 05Feb2021, the patient felt like her body didn't feel good, like she was not tired or exhausted but just a strange feeling. Then following Saturday Sunday Monday and Tuesday she was okay. Then on Wednesday 10Feb2021 almost a week later, she got up with excruciating pain in the neck, she did not have a temperature, and she did not lose sense of taste or smell, as well as she had no appetite. She had no Appetit on Wednesday 10Feb2021, Thursday 11Feb2021 and then on Friday 12Feb2021 she finally ate. Every time she would move her body its like the entire neck, shoulder, and shoulder blades were in excruciating pain. She could sleep at all, she wasnt able to have food, she also had no motivation to do anything, not wanting to do anything, not wanting to leave her apartment. A week later then on Saturday and Sunday, on Sunday her neck hurt. Both Sunday and Monday last night she was in excruciating pain, that was in the neck and was trying to sleep. She could not turn from one side to the other, because of the shooting pain on the right side into ear. It felt like her ear was being ripped off. Today her ear felt strange, she could hear but soft and that part of neck on the right side was not the same. She had no Tylenol or anything because she did not want it to effect the vaccine. On an unspecified date, she had lack of motivation. Her second dose was scheduled for 25Feb2021. Caller asks could she get side effects at any point. The patient was asking if her symptoms after her first dose were normal. The Clinical outcome for all the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276822
Sex: M
Age:
State: CT

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Tiredness the morning after 2nd vaccination; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 16Feb2021 at 11:15 AM (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, nasal polyps, chronic rhinitis and allergy to NSAID. Concomitant medication included 20mg olmesartan daily. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 (Lot Number: EL3247) on 26Jan2021 at 11:15 AM, as single dose in left arm for COVID-19 immunisation. On 16Feb2021, morning after second vaccination, the patient experienced tiredness. There was no treatment received for the adverse event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The outcome of the event was recovered.

Other Meds: OLMESARTAN

Current Illness:

ID: 1276823
Sex: F
Age:
State: NY

Vax Date: 02/14/2021
Onset Date: 02/14/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Lips felt funny; The arm that was a little sore; This is a spontaneous report from a contactable consumer (reporting herself). A 88-Years-old white female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266, expiration date: 31 May 2021), via intramuscularly in left arm on 14Feb2021 at a dose of 0.3ml as a single dose for COVID-19 immunisation. The patient's history included allergies to Penicillin, Cortisone, and she thinks also to Lidocaine, maybe. The patient did not have any NDC numbers, Lot numbers or expiry to provide for any of these products, as it was years ago. The patient did not receive any other medications. On 14Feb2021 about an hour after she got her vaccine; the patient had waited 40 minutes after getting the vaccine shot, and nothing happened, so she left, and while she was on her way home, she got a sensation in her nose, throat and upper chest like it was warm, and there was dryness. The patient previously used to get allergy shots because she was allergic to horse flies, and within 24 hours of being bitten, she would have hives the size of dinner plates. The patient went through allergy shots for 10 years and then she moved away and was no longer near water, so she did not think she needed the shots anymore. The patient had been getting the shots for 10 years, she would start to get where her lips felt funny and stuff after getting the shot, and her reaction to the COVID vaccine, felt similar to that, but it had dissipated within a half hour. This was probably respiratory and was not major, her nose did not close up, but it did get dry. The event resolved within an hour. The patient inquired with three physicians about if she should get the COVID vaccine, because she had an anaphylactic experience 40 years ago, before she was going to the allergist, and she had to go to the ER (emergency room), and they gave her whatever they did, Epinephrine or whatever it was, but that experience felt like she was being blown up like a straw was in her body. The patient inquired with these different physicians about told them about her experience from years ago, and what their suggestion would be, and they told the patient to go for it with getting the COVID vaccine, because it anything were to happen, it would be within 15 minutes of getting the shot, but the patient's was more than 15 minutes after getting it. The patient got the hives to the horse flies, it was usually within 24 hours. The patient did take an EPIPen with her when she went to get the COVID vaccine, because she was concerned she would have a reaction, but did not end up needing to use it. The outcome of the events was recovered.

Other Meds:

Current Illness:

ID: 1276824
Sex: M
Age:
State: CT

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Headache; tiredness; Arm pain at injection site; Some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via unspecified route of administration at arm left on 16Feb2021 02:45 PM at single dose for COVID-19 immunization. The patient's medical history included asthma. There was no COVID prior vaccination. The patient was not tested for COVID post vaccination. There were no known allergies. There were no other vaccines in four weeks. The patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration at arm left on 29Jan2021 09:00 AM at single dose for COVID-19 immunization. Concomitant medication included within two weeks was flecainide one time 2 weeks prior to second dose. On 16Feb2021 at 03:15 PM, the patient had some left ear pain (4-5 quick pulsing feelings) approximately 30 mins after dose. On 16Feb2021 at 08:45 PM, the patient had arm pain at injection site approximately 6 hours after dose that subsided by 24 hours after dose. On 17Feb2021 at 08:45, the patient had headache which started about 18 hours after dose and lasted for a few hours and on the same day the patient had general tiredness the day following dose. The patient did not receive any treatment for the events. The outcome of the events was recovered in 2021.

Other Meds: FLECAINIDE

Current Illness:

ID: 1276825
Sex: F
Age:
State: FL

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210218; Test Name: Qualitative PCR; Test Result: Positive

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: rash under armpits; it was my back went out; This is a spontaneous report from a contactable consumer. This 42-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 1, administered in Arm Left on 05Feb2021 08:00 PM as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks. On 05Feb2021, After going home and rest around 8 pm, the patient could not get out of sofa , her back went out and she had to crawl to bed and lay flat until Sunday. Then patient felt little better and then she had a rash under armpits.The patient underwent lab tests and procedures which included Nasal Swab: Positive on 18Feb2021. The patient did not receive any treatment for adverse event. The clinical outcome of the events was recovered. Information on lot number/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276826
Sex: F
Age:
State: NY

Vax Date: 02/05/2021
Onset Date: 02/01/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: ataxia; not able to think straight; extremely dizzy; Lethargic; headache to the back of her neck to her head; This is a spontaneous report from a contactable other health care professional. A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration at left arm on 05Feb2021 11:00 as single dose for COVID-19 immunization. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246). Medical history included high functioning autism; reporter mentioned that this was diagnosed when her daughter was 16, but she suspected it since she was a child, polio; reporter mentioned that her daughter had polio as a baby, she was adopted from out of the country and got polio, high cholesterol; reporter mentioned that this was diagnosed when she was a baby, she came to this country when she was 16 months old and had it then and ADD; reporter mentioned that this was diagnosed when she was 16, but started before that somewhere in her teenager years. Patient concomitant medications were not reported. On an unspecified date in Feb2021, patient has been extremely dizzy, lethargic, and has a headache to the back of her neck to her head, not able to think straight and not be able to move around. Reporter said that patient said that the dizziness is getting worse, and patient did try to work one day last week, then tried again, and couldn't, reporter would say it is getting worse. Reporter mentioned that she gave her daughter a 24 hours allergy pill, nasal spray, and some over the counter Bonine, but all it did was put her to sleep. 24 hours allergy pill was clarified to being generic Value Med Allergy Relief, the ingredient Cetirizine 10mg. UPC: 68925-3, LOT S200197, EXP Oct2021. Reporter also mentioned that Bonine was also over the counter, with LOT 173146C, EXP August 2019. Dosage: 25mg took one last night and one this morning, the product other name is Meclizine. Reporter mentioned that the generic nasal spray is over the counter Mometasone furoate made by Apotex Corporation. LOT: RG4324, EXP: June 2021. Reporter mentioned that she doesn't know what to do for her, and she was supposed to see her doctor today, but due to the snowstorm her appointment was cancelled until tomorrow, the ENT. Reporter mentioned that the doctor said that there was nothing they could do for dizziness. Reporter also mentioned that her daughter got both doses of the vaccine, and it was the second one that really made her sick. Reporter thought that it is serious because her daughter was not getting better and she was in tears because patient does not feel good, and she did not know what was wrong with patient. Reporter wanted to know whether this is something that has been reported or that they had heard of happening before. Outcome of the events was unknown. Reporter thought that it is serious because her daughter was not getting better and she was in tears because patient does not feel good, and she did not know what was wrong with patient. Reporter wanted to know whether this is something that has been reported or that they had heard of happening before. Outcome of the events was unknown. Reporter thought that it is serious because her daughter was not getting better and she was in tears because patient does not feel good, and she did not know what was wrong with patient. Reporter wanted to know whether this is something that has been reported or that they had heard of happening before. Outcome of the events was unknown.; 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 reported events cannot be excluded. However, the concomitant medication of allergy pill may provide a plausible alternative explanation for the events. 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: 1276827
Sex: U
Age:
State: FL

Vax Date: 02/14/2021
Onset Date: 02/22/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: Large red, itchy, warm patch right below injection sight.; Large red, itchy, warm patch right below injection sight; Large red, itchy, warm patch right below injection sight; This is a spontaneous report from a contactable consumer (patient). A 68-years-old patient of an unknown gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN9581) administered in left arm via an unknown route of administration, on 14Feb2021 at 16:15 pm ((at the age of 68-years-old) as SINGLE DOSE for covid-19 immunization. Medical history included mixed connective tissue. The patient previously administered first dose of bnt162b2 (Lot number: EL1283) via unspecified route, administered in left arm on 24Jan2021 at 07:15am. There were no known allergies. Concomitant medications (other medications in two weeks) included Methotrexate, Hydroxychloroquine, Phenytoin, Prednisone. Prior to vaccination the patient was not tested for covid-19. Patient did not test COVID post vaccination. On 22Feb2021, 8 days after second dose, the patient experienced large red, itchy, warm patch right below injection sight about 3 inches in diameter. The patient did not receive any treatment for adverse events. The patient had no other vaccine in four weeks. The outcome of the events was unknown.

Other Meds: METHOTREXATE; HYDROXYCHLOROQUINE; DILANTIN [PHENYTOIN]; PREDNISONE

Current Illness:

ID: 1276828
Sex: F
Age:
State: FL

Vax Date: 02/16/2021
Onset Date: 02/18/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: injection site soreness, red rash, itching; injection site soreness, red rash, itching; Injection site soreness; This is a spontaneous report from a contactable Healthcare professional (Patient herself). A 62-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9263, Expiration date: Not reported), via an unspecified route of administration on 16Feb2021 03:15 PM at a single dose at her left arm for COVID-19 immunisation. Medical history included high blood pressure. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included losartan, tocopherol (VITAMIN E), ascorbic acid (VITAMIN C), cyanocobalamin (VITAMIN B12), estradiol (YUVAFEM) and replens iron, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced injection site soreness, red rash, itching on 18Feb2021. No treatment received for the adverse event. The patient had not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information about batch number has been requested.

Other Meds: LOSARTAN; VITAMIN E [TOCOPHEROL]; VITAMIN C [ASCORBIC ACID]; VITAMIN B12 [CYANOCOBALAMIN]; YUVAFEM

Current Illness:

ID: 1276829
Sex: F
Age:
State: FL

Vax Date: 02/16/2021
Onset Date: 02/18/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: stomach ache/terrible stomach ache; pain; This is a spontaneous report from a contactable consumer (patient's husband). This is report 4 of 4 for the reporter's wife. A 68-year-old female patient (wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6201, Expiry Date: 30Jun2021), via an unspecified route of administration in left upper arm on 16Feb2021 at 3:45PM as single dose for COVID-19 immunization. Medical history included immune deficient and has additional issues and spinal surgical pain. Concomitant medication included oxycodone (XTAMPZA ER) at 18mg for spinal surgical pain. No additional vaccines administered on the same date of the Pfizer suspect. No prior vaccinations within 4 weeks. She does not get a lot of vaccines and this is something he has to get on her about. Reporter was concerned about his wife getting the second dose of the COVID Vaccine. She was due to get second shot on 09Mar2021. She was adamant about getting it. He was worried because she has more health issues. 24 hours later she got a terrible stomachache and pain which started in the afternoon of 18Feb2021. It lasted 3-4 days almost five days before it went away. The pain is gone now. It was low abdominal pain. It went away on 22Feb2021 (today as reported). His wife does not want to ask about her getting the 2nd dose. She would rather go in blind and not know anything. A visit to emergency room and physician's office was not required for events. The outcome of events was recovered on 22Feb2021. No follow-up attempts are possible. No further information is expected.

Other Meds: XTAMPZA ER

Current Illness:

ID: 1276830
Sex: F
Age:
State: RI

Vax Date: 02/18/2021
Onset Date: 02/19/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 20210219; Test Name: low grade fever; Result Unstructured Data: Test Result:99.8

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: muscle aches all over my body; chills; Fatigue; a low grade fever of 99.8; headache; mild nausea; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 18Feb2021 14:45 as SINGLE DOSE in Arm Left for covid-19 immunization. Medical history included asthma and anemia. The patient previously took amoxicillin, ibuprofen and Advil and experienced known allergies. Historical vaccine included: the patient received first dose of bnt162b2 (Lot Number: EL3247), via an unspecified route of administration on 28Jan2021 10:15 as SINGLE DOSE in Arm Left for covid-19 immunization. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine in four weeks. Concomitant medications included: unspecified birth control medications. On 19Feb2021 at 5:30, the day after second dose of the COVID-19 vaccine, she experienced muscle aches all over my body, chills, fatigue, a low-grade fever of 99.8, a headache, and mild nausea. The patient did not receive any treatment for adverse events. Since the vaccination the patient had not been tested for COVID-19. The outcome of events was recovering.

Other Meds:

Current Illness:

ID: 1276831
Sex: F
Age:
State: NC

Vax Date: 02/17/2021
Onset Date: 02/18/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210218; Test Name: fever; Result Unstructured Data: Test Result:102.1

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: fever of 102.1; chills; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in right arm on 17Feb2021 at 14:45 at single dose for COVID-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 27Jan2021 at 10:45 AM at single dose for COVID-19 immunization. Medical history included allergic to sulfa and penicillin. Concomitant medications included levothyroxine. Patient was not pregnant at the time of vaccination. 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. Since the vaccination, the patient had not been tested for COVID-19. On 18Feb2021 at 07:00, Patient had a fever of 102.1 and the chills on the next morning. Fever kept going down the next day and fine now. No treatment was received for the adverse events. The outcome of the events was recovered.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1276832
Sex: F
Age:
State: NY

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: general itchiness; throat tightening; dizziness; This is a spontaneous report from a contactable Physician reported for a consumer (patient). A 40-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiry date was not reported) intramuscular at left arm on 25Feb2021 at 09:30 am (age at vaccination was 40 years) at a single dose for COVID-19 immunization. Medical history included HTN. The patient had known allergies to Penicillin and vancomycin. Concomitant medication patient received within 2 weeks of vaccination included duloxetine (DULOXETINE), gabapentin (NEURONTIN), verapamil (VERAPAMIL) and naproxen (NAPROXEN). The patient received shot and shortly after on 25Feb2021 at 09:45 am, the patient felt general itchiness and throat tightening and dizziness. The facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received Epinephrine x2 steroids, Benadryl, famotidine now sxs improved. The reporter evaluated the patient in the emergency room. The outcome of all the events was recovering.

Other Meds: DULOXETINE; NEURONTIN; VERAPAMIL; NAPROXEN

Current Illness:

ID: 1276833
Sex: M
Age:
State: CA

Vax Date: 02/16/2021
Onset Date: 02/24/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Date: 20210224; Test Name: COVID; Test Result: Positive

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: Tested positive for COVID/experiencing difficulty of breathing, disoriented a lot, feels horrible, 2 days ago experienced high fever, sore muscles, and headache/felt bad, 6 days after he felt pain and soreness; Breathing difficult; Disorientation; This is a spontaneous report from a Pfizer-sponsored program through a contactable consumers (one was patient), physician. A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201) via an unspecified route of administration on 16Feb2021 at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. It was reported that patient got the 1st dose of the vaccine on 16Feb2021 and tested positive for COVID on 24Feb2021. He was experiencing difficulty of breathing, disoriented a lot, was suffering, and felt horrible in 2021. He says he was sorry he was so disoriented. He confirmed it was the Pfizer COVID 19 vaccine. patient stated 2 days ago he started experiencing high fever, sore muscles, and headache and 5 days later felt bad after vaccine shot. He says after 6 days from having the vaccine he felt pain and soreness and he called his administration health provider and they said for him to get a COVID test and on 24Feb2021 he tested positive for COVID. he was told to quarantine 10 days and take Tylenol, that was all they said. He was scheduled to get the second vaccine on 09Mar2021 at 12:30. The outcome for the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1276834
Sex: F
Age:
State: KY

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Name: heartbeat; Result Unstructured Data: Test Result:irregular

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: A Fib; irregular heartbeat; dizziness; This is a spontaneous report received from a contactable consumer (patient) from Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported) via an unspecified route of administration on 16Feb2021, at a single dose for COVID-19 immunisation. The patient's medical history included pre-existing condition related to her heart. Concomitant medications was not reported. On 16Feb2021, the patient experienced an irregular heartbeat and dizziness after the 1st shot, she was not sure if that was related to the vaccine as she mentioned she has a pre-existing condition related to her heart. She wants to check if she can take the vaccine on 09Mar2021 since she has AFib after going to her heart doctor. The patient underwent lab tests and procedures which includes heartbeat irregular. Outcome of the events were reported as unknown.

Other Meds:

Current Illness:

ID: 1276835
Sex: F
Age:
State: MO

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result:102 Fahrenheit

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: flu like symptoms; fever of 102 F; This is a spontaneous report from a contactable consumer or other non hcp. A 46-years-old female patient received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On Feb2021, The patient experienced flu like symptoms, fever of 102. Patient did not receive any treatment for events. The patient underwent lab tests and procedures which included body temperature: 102 Fahrenheit. The patient does not receive any vaccine prior to covid vaccine and post covid vaccination. The outcome of the events was unknown. Information about Lot/Batch has been requested.

Other Meds:

Current Illness:

ID: 1276836
Sex: F
Age:
State: PA

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

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: had reaction after the second dose; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown); Expiry date: Unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had reaction after the second dose and she was wondering if she needed, that can she get another dose like they need to in future or was she considered allergic to it. Product details (asked that would be on the card they gave her), causality, treatment and other details were unknown (Limited information was available over the call).The outcome of event allergic reaction after immunization was unknown. Follow up attempts were completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1276837
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. 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: 1276838
Sex: F
Age:
State: NY

Vax Date: 02/27/2021
Onset Date: 02/27/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Significant gerd immediately following administrationsing; left arm and shoulder pain; left arm and shoulder pain; This is a spontaneous report from a contactable consumer, the patient. A 51-Year-old (non-pregnant) female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiration date: unknown), via an unspecified route of administration in left arm on 27Feb2021 14:30 (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient medical history included colitis ulcerative, fibromyalgia, premenstrual dysphoric disorder all from an unknown date and unknown if ongoing. Known allergies includes food allergy (lobster), contrast media allergy (contrast dye). Allergies to medications includes, drug hypersensitivity with ZIPACK, BACTRIM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medications were not reported. No COVID prior vaccination. Prior to vaccination, the patient has not been tested for COVID-19. On 27Feb2021 14:45 (at 02:45 PM) the patient experienced Significant GERD immediately following administration and left arm and shoulder pain within a couple of hours. The GERD was surprising not the arm and shoulder pain. The patient did not receive treatment for the adverse event. Since the vaccination, the patient has not been tested for COVID. Seriousness of the event was reported as non-serious. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1276839
Sex: F
Age:
State: MO

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Negative; Test Name: EKG; Result Unstructured Data: Test Result:Negative; Test Name: ultrasound of her abdomen; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Nauseous and lightheaded; Nauseous and lightheaded; Left arm sore; Horrible reflux and belching; made her reflux worse; Horrible reflux and belching; Not sleeping as well because she does not feel as good; Not sleeping as well because she does not feel as good; Weakness; burning into her esophagus; She does not hardly have any appetite; She has been sick ever since she got the shot; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein (PREVNAR 13, Solution for injection in pre-filled syringe) via unspecified route of administration on 05Jan2021 at single dose in upper left arm for Routine vaccination at Doctor's office. Medical history included ongoing reflux in the past in 1998. Prior Vaccinations (within 4 weeks) was none. Patient previously got shingles shot. She did not have any problem with that. Family medical history was none. Concomitant medications were not reported. It was reported that patient had been sick ever since she got the shot in 2021. Her symptoms appeared as soon as she got into car. She had blood drawn after the shot, so it was probably 30 minutes after she got the shot. She started feeling nauseous and lightheaded on 05Jan2021. This progressed into reflux in Jan2021 and she was still lightheaded and cannot drive. She tried Omeprazole and it might have made her reflux worse in Jan2021. She has been to the doctor three times since then. She stopped taking it because it did not make her better. It was 20 mg. She may have thrown it away. It was in a pharmacy vial. The light-headedness was worse and nausea was about the same. It has gone into this horrible reflux and she has tons of belching. She does not hardly have any appetite in Jan2021. The horrible reflux and belching started in Jan2021. It has gone into burning into her esophagus and she has had tons of reflux in Jan2021. Not sleeping as well because she does not feel as good started end of Jan2021. Weakness probably started about the same time she could not sleep, which would be towards the end of Jan2021 for the last month. She then stated her left arm was sore for 3 days started on 05Jan2021. She noticed it more on 06Jan2021, and after a couple of days, it was not very noticeable. She has fought some reflux in the past. She was not on anything for it. It was just occasional. She has had this since 1998 mildly off and on. The patient underwent labs and procedures included blood test the second time, EKG (Electrocardiogram) to double check and ordered an ultrasound of her abdomen with result negative for all on unknown date. The outcome of sickness was unknown, pain in arm was recovered on 08Jan2021, while for other events was not recovered. No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.

Other Meds:

Current Illness: Reflux esophagitis

ID: 1276840
Sex: F
Age:
State: FL

Vax Date: 02/24/2021
Onset Date: 02/24/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210226; Test Name: Nasal Swab/ Rapid covid test; Result Unstructured Data: Test Result:Negative; Test Date: 20210301; Test Name: Nasal Swab/ Rapid covid test; Result Unstructured Data: Test Result:Negative; Test Date: 20210226; Test Name: PCR; Result Unstructured Data: Test Result:Negative; Test Date: 20210301; Test Name: PCR; Result Unstructured Data: Test Result:Pending

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: 2 white blisters in the back of throat; sore throat.; cough; fatigue; head congestion; body aches; couldn't move my left arm; This is a spontaneous report from a contactable Other HCP (patient). A 37-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198), via an unspecified route of administration in the left arm on 24Feb2021 at 14:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient medical history included Hashimotto's. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient concomitant medication included levothyroxine sodium (UNITHROID), liothyronine and venlafaxine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On24Feb2021, the patient experienced, patient couldn't move left arm without assistance. on 25Feb2021, at 06:00, the patient experienced fatigue, head congestion, and body aches progressively got worse as the day continued. On 26Feb2021, (second night after vaccination) patient developed a severe cough and sore throat. It was reported that patient not been sick or even had a mild cold since 2009. The patient had undergone rapid covid and PCR covid test on 26Feb2021 and resulted in negative. It was reported that the symptoms continued getting worse. The patient did not have fever. The fatigue was the worst by Saturday (as reported). The patient throat still causing a lot of pain and the coughing had gotten progressively worse by Monday (as reported). On 01Mar2021, the patient undergone Nasal Swab/ Rapid covid test which resulted in negative and PCR test results were pending. On 02Mar2021 the patient woke up with 2 white blisters in the back of throat. It was reported that patient haven't been around anyone with strep recently and haven't had strep as an adult. The patient visited physician office and emergency room. The patient received counter cough medicine, Zpak and lozenges as a treatment for the events. The outcome of all the events was not resolved.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event throat blister and the suspect drug. 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: UNITHROID; LIOTHYRONINE; VENLAFAXINE

Current Illness:

ID: 1276841
Sex: M
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 202101; Test Name: Covid-19 test; Test Result: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: he tested positive for Covid-19; he tested positive for Covid-19; This is a spontaneous report from a contactable physician (Patient) from a Pfizer-sponsored program. A male patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Jan2021, as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Dec2020, as a single dose for COVID-19 immunization. Reporter stated that he received his first dose of the vaccine in Dec2020 and his second dose in Jan2021 but did not remember the dates. 24 hours after the second dose (in Jan2021), he tested positive for COVID-19 and he thought it was just a reaction to the vaccine. Another 36 hours later he received monoclonal antibodies. He asked if it is recommended that the vaccine be repeated given the timing of the monoclonal antibody therapy. It was also reported that patient received both dose of COVID vaccine 18 or 19 days apart. Right after 2nd dose of COVID vaccine, came down with COVID virus. Outcome of the event was unknown. Information on about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the second vaccine dose and the event onset.

Other Meds:

Current Illness:

ID: 1276842
Sex: F
Age:
State: NY

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data: Test Date: 20210209; Test Name: Body Temperature; Result Unstructured Data: Test Result:100.6 Degree

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: body ache; fever 100.6; Chills; Muscle ache; This is a spontaneous report from a contactable consumer. A 69-year-old Female consumer reported in response to Non-HCP letter sent in cross-referenced case which included that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, in arm left on 09Feb2021 12:45 (at the age of 69-year-old) as single dose for COVID-19 immunization. The patient medical history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, in arm left on 19Jan2021 12:30 as single dose for COVID-19 immunization and experienced headache, chills, fever and muscle ache. Patient concomitant medications were not reported. No other product(s) were taken together with the COVID-19 vaccine. illness at time of vaccination was None. On 09Feb2021 at 20:00, patient experienced body ache, fever 100.6, chills, muscle ache lasted about 24 hrs. The patient underwent lab tests and procedures which included body temperature: 100.6 on 09Feb2021. Adverse events did not require visit to Emergency room nor Physician Office. Seriousness of the event was reported as non-serious. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1276843
Sex: F
Age:
State: MI

Vax Date: 02/19/2021
Onset Date: 03/02/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210302; Test Name: Blood work; Result Unstructured Data: Test Result:nothing standing out to support; Comments: nothing standing out to support symptoms; Test Date: 20210302; Test Name: Head CT; Result Unstructured Data: Test Result:nothing standing out to support; Comments: nothing standing out to support symptoms; Test Date: 20210302; Test Name: Neck CT; Result Unstructured Data: Test Result:nothing standing out to support; Comments: nothing standing out to support symptoms; Test Date: 20210204; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210302; Test Name: Nasal Swab; Test Result: Negative ; Test Date: 20210204; Test Name: Rapid COVID Test; Test Result: Negative ; Test Date: 20210302; Test Name: Rapid COVID Test; Test Result: Negative

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: cold sweats; lethargic; fever; chills; stiff, painful neck (back of neck) (turning radius without more pain was very small); painful neck (back of neck) (turning radius without more pain was very small); headache; large swollen lymph node in neck (right side); Pain in neck irradiates more when coughing; 1 week after 2nd dose nose infection very prominent again (same nostril); This is spontaneous report from a contactable consumer (patient herself). A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration in right arm on 19Feb2021 at 13:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included panic disorder. Patient (self) has no underlying medical issues outside of panic disorder. No known allergies. Concomitant medications included sertraline hydrochloride (ZOLOFT), trazodone, doxycycline, sulfamethoxazole, trimethoprim (BACTRIM); All received in two weeks within the vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 28Jan2021 as a single dose for COVID-19 immunisation and presented with a nose infection (left nostril, suspected MRSA), prescribed doxycycline for 7 days. Infection reduced (but not completely resolved). The patient did not receive other vaccine in four weeks. Prior vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has been tested for COVID-19. It was reported that, second dose 19Feb2021 approx. 1 week after 2nd dose (on an unspecified date in 2021) nose infection very prominent again (same nostril), prescribed Bactrim for 10 days. On 02Mar2021, patient experienced lethargic, fever, chills, stiff, painful neck (back of neck) (turning radius without more pain was very small), headache, large swollen lymph node in neck (right side). Pain in neck irradiates more when coughing. On 03March2021, patient experienced fever, chills, and cold sweats in addition to the same issues as 02March2021 with no resolve or progress on symptoms reducing. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included rapid COVID test: Negative, nasal swab: Negative on 04Feb2021 (performed one week after 1st dose), blood work: Nothing standing out to support symptoms, heat CT: Nothing standing out to support symptoms, neck CT: Nothing standing out to support symptoms completed in the ER, nasal swab: Negative, rapid COVID test: Negative on 02Mar2021. The events were considered as non-serious by the consumer. The patient was treated with Bactrim, fluids. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021235826 Similar report from same reporter

Other Meds: ZOLOFT; TRAZODONE; DOXYCYCLINE; BACTRIM

Current Illness:

ID: 1276844
Sex: F
Age:
State: CT

Vax Date: 01/20/2021
Onset Date: 02/16/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Both times like mini version of covid which I had a year ago.; Both times like mini version of covid which I had a year ago. Now right side of my neck hurts and still inflamed. Feeling extremely fatigued. Headaches. Exhaustion; This is a spontaneous report from a contactable other HCP(patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9262 and expiration date was not reported) via unspecified route at right arm on 20Jan2021 at 09:15 AM as single dose for covid-19 immunization. Medical history included arthritis, joint issues, chronic pain in knees and back. The patient's concomitant medications include aspirin or tylenol occasionally. The patient was sensitive to augmentin and allergic to insect stings. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 16Feb2021, at 03:00 AM, both times the patient had like mini version of covid which she had a year ago. Now right side of her neck hurts and still inflamed, feeling extremely fatigued, headaches and exhaustion. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of drug ineffective, suspected Covid-19 and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.

Other Meds: ASPIRIN (E.C.); TYLENOL

Current Illness:

ID: 1276845
Sex: F
Age:
State: WA

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: I was freezing.Went to bed had terrible chills for 2-3hrs.; I had pain on the left side of my head above the ear; I was very tired for over a day; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer Covid vaccine, Solution for injection, Lot number: PAA156051) via unspecified route of administration at arm right on 10Feb2021 at a single dose for COVID-19 immunisation. Patient medical history was not reported. Concomitant medications included Atenolol at 50mg twice daily. No covid prior vaccination and no covid tested post vaccination. It was reported that on an unknown date in 2021, patient was very tired for over a day. 2 nd shot received at arm left on 05Mar2021. Stated that within 6 hrs patient had pain on the left side of head above the ear. Patient was freezing, went to bed had terrible chills for 2-3 hrs. Had to be covered with several blankets. She did warm up, but completely exhausted into Sunday AM. Her stomach hurt, couldn't eat, lost 2 1/2 lbs. Patient was known with unspecified allergies. The outcome of the events was unknown.

Other Meds: ATENOLOL

Current Illness:

ID: 1276846
Sex: F
Age:
State: NJ

Vax Date: 01/09/2021
Onset Date: 01/18/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Comments: assuming it's third Nerve Palsy at this point; Test Date: 2021; Test Name: CT; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: MRI; Test Result: Negative ; Comments: it was not Aneurysm or brain tumor; Test Date: 20210118; Test Name: tested; Test Result: Positive

Allergies:

Symptom List: Nausea

Symptoms: Fever; sick; I developed Covid symptoms; I was tested Positive; This is a spontaneous report from a contactable consumer(patient). A 58-years-old female patient (weight (kg): 90.72, height (cm): 155) received bnt162b2 (BNT162B2, solution for injection, batch/Lot number not reported), first dose via an unspecified route of administration on 09Jan2021 as SINGLE DOSE, for covid-19 immunization. Patient was 58 years old at the time of vaccination. Medical history included thyroid disorder and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID), both taken for an unspecified indication, start and stop date were not reported. On 12Jan2021, patient developed Covid symptoms and on 18Jan2021, she was tested Positive. She had fever and became sick from all. The patient was not hospitalized and was seen in the emergency room. Her fever stopped at the end. The patient underwent lab tests and procedures which included blood test: unknown results on 2021 assuming its third Nerve Palsy at this point , computerised tomogram which was normal on 2021 , magnetic resonance imaging was negative on 2021 it was not Aneurysm or brain tumor, Sars-cov-2 test: positive on 18Jan2021. The outcome of the event fever was recovering and for other events it was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: SINGULAIR; SYNTHROID

Current Illness:

ID: 1276847
Sex: F
Age:
State: TN

Vax Date: 02/10/2021
Onset Date: 02/13/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Chilblains/Covid Toes; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL9261, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 10Feb2021 at 16:00 (at the age of 71 years old) as a single dose for COVID-19 immunisation in a hospital. Medical history included Raynaud's Syndrome (self-diagnosed because fingers turn white when cold/discussed with dermatologist) from an unknown date. The patient was not pregnant and was not diagnosed with COVID-19 prior the vaccination. The patient's concomitant medications were not reported. It was reported that patient did not have other vaccine in four weeks. On 13Feb2021, 3 days after being vaccinated, the patient developed very swollen, red toes on one foot (right) and was diagnosed as Chilblains/Covid Toes. Events resulted in doctor or other healthcare professional office/clinic visit wherein therapeutic measure was given in response with the events which included Clobetasol Propionate Ointment. The patient was not tested for COVID-19 after vaccination. The patient was recovering from the event.

Other Meds:

Current Illness:

ID: 1276848
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Throwing up for almost a week, she's violently throwing up, can't hold anything down liquid or food; Severe pain; If you just touch her, her whole body is like on fire; Headache; Senses are magnified, her sense of smell is overwhelming. Her hearing, she is in tears because just somebody talking to her in a normal voice is like they are screaming at her; Can't taste anything; This is a spontaneous report from a contactable consumer, reporting on behalf of a friend (Patient) via India Call Centre. A female patient (Friend) of an unspecified age received second dose bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The Patient's Medical history included Blood cancer, Heart problems and concomitant medications included unspecified heart medications. The Patient received first dose of historical vaccine, bnt162b2 on an unspecified date for covid-19 immunisation. It was reported that the patient has been throwing up for almost a week, she was violently throwing up. She cannot hold anything down liquid or food. She has had severe pain like if you just touch her, her whole body was like on fire, have a horrible headache, her senses are magnified, her sense of smell was overwhelming. Her hearing, she was in tears because just somebody talking to her in a normal voice was like they were screaming at her. Taste, well she cannot taste anything because has not been eating anything on an unspecified date around 23Feb2021 (Reporter was not sure about the date). Reporter stated, "That they don't have. She has been throwing up for a week and she has had vaccine probably 3 days prior to that 2 or 3 days prior to that." Reporter stated, When probed if still experiencing events (event not specified), "Yes it continues to get worse." It was also reported that that patient was in the hospital right now. They believe that she has had a reaction to her Pfizer vaccine, the hospital there doesn't seem to know what to do, they were kind of just given up on her and we don't know who to contact for help. The Clinical outcome of the events was unknown. Information about batch number has been requested.

Other Meds:

Current Illness:

ID: 1276849
Sex: F
Age:
State: IL

Vax Date: 02/12/2021
Onset Date:
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 2021; Test Name: COVID; Test Result: Positive

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable consumer (patient) via pfizer sponsored program. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number and expiry date: unknown), on an unspecified route of administration on 12Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The patient received the first dose of vaccine on 12Feb2021. On an unknown date in 2021, the patient tested positive for COVID. The patient had scheduled her second dose of vaccine on 06Mar2021 and was worried if she can continue for second dose. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1276850
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/04/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: sars-cov-2 antibody test; Result Unstructured Data: Test Result:Positive

Allergies:

Symptom List: Tremor

Symptoms: received 1st dose of Covid vaccine and then found out the next day that he had Covid; the next day that he had Covid; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (son) reported that. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was that reporters son received 1st dose of Covid vaccine and then found out the next day that he had Covid. Wondering what to do about 2nd dose. Caller also wants to know if there was any more information available about pregnant women and the Covid vaccine. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive on unspecified date. Outcome of the events were unknown. Information about Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1276851
Sex: F
Age:
State: SC

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: covid-19 test; Result Unstructured Data: Test Result:positive

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Drug ineffective; had her first dose and tested positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that (reporting for herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was vaccinated with the first dose and tested positive. She was scheduled to have 2nd dose on 09Mar2021 and based on the information given to her, there should be a 30days interval before getting the 2nd shot if someone tested positive for Covid (drug ineffective and covid-19). She would like to confirm if that information is correct. The patient underwent lab tests and procedures which included sars-cov-2 antibody test and was positive on unspecified date. Case considered as serious (medically significant). Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1276852
Sex: U
Age:
State: CA

Vax Date: 02/16/2021
Onset Date: 02/01/2021
Rec V Date: 05/01/2021
Hospital: Y

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data: Test Name: Tests; Result Unstructured Data: Test Result:all the tests were negative

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: unconscious about 2 minutes; moderate headache; I had a general unwell feeling; nauseated; incontinent; I became faint; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received first dose of COVID-19 vaccine previously. The patient stated that they had their second Covid-19 vaccine on 16Feb2021. Approximately 10 hours (on 16Feb2021) afterward the patient developed a moderate headache, which 400 mg of ibuprofen eased. The patient had a general unwell feeling much of the following day (16Feb2021), so the patient rested and napped. About 36 hours after the injection the patient became faint, nauseated, and incontinent. The patient was unconscious about 2 minutes. The patient was taken by ambulance to the hospital and remained through the night for observation for the event loss of consciousness. To date, all the tests were negative. The patient received treatment for the event headache. The outcome of the event headache was recovering. The outcome of the events loss of consciousness, syncope, malaise and nausea was unknown. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1276853
Sex: F
Age:
State: MI

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: IgG; Result Unstructured Data: Test Result:300; Comments: Units not provided

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: when they gave me the vaccination I was in the bed the whole time almost 2 weeks; had Meniere's disease and made worse; hard to breath; did not feel good; could taste sodium in her mouth; felt tired for two days; She felt very dizzy immediately after receiving the vaccine; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The patient medical history included Meniere's' disease, ongoing Allergies, ongoing Asthma and sulfa deadly to me. The patient concomitant medication was not reported. The patient reported I was in the bed the whole time almost 2 weeks. The felt tired for two days, she felt very dizzy immediately after receiving the vaccine and could taste sodium in her mouth and it was hard to breath. The patient did not feel good and felt tired for two days. The patient had Meniere's disease and made worse. The patient took Prednisone and rescue inhalers as a treatment medication to all the events. The patient also questioned about the ingredients of vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Other Meds:

Current Illness: Allergy; Asthma

ID: 1276854
Sex: F
Age:
State: MA

Vax Date: 02/17/2021
Onset Date: 02/19/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Auto-immune flare up; Lichen Sclerosus and had a flare up 2 days following shot; This is a spontaneous report received from a non-contactable other HCP (patient herself). A 38-year-old female patient received second dose of BNT162B2 (Solution for injection, lot number: unknown, Expiration date: Unknown) on 17Feb2021 18:30 via unspecified route of administration as SINGLE DOSE for covid-19 immunisation. The patient medical history included Lichen Sclerosus ongoing from an unknown date. The patient has not allergies. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Solution for injection, lot number: unknown, Expiration date: Unknown) on 27Jan2021 18:30 via unspecified route of administration as SINGLE DOSE for covid-19 immunisation. The patient had no other vaccine within four weeks. The patient was not tested for COVID-19 prior to vaccination and not post vaccination. Two days after her second dose of vaccination, on 19Feb2021, the patient had flare up of Lichen Sclerosus over the weekend and had a flare up 2 days following shot. Treatment medication was given Clobetesol. The outcome of the events was recovered. Follow up Information on batch/lot number was requested.

Other Meds:

Current Illness: Lichen sclerosus

ID: 1276855
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: I am fine except these little red bumps come up; rash; red spots /blotches; This is a spontaneous report received from a contactable consumer (patient himself). An 89-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included cancer sores and History of cancer. The patient's concomitant medications were not reported. Patient previously took first dose of COVID-19 vaccine for COVID-19 immunization and he states that he has red spots/blotches on his ankles, hips, back and chest. The patient experienced fine except little red bumps come up on an unspecified date and was hospitalized. He also experienced rash on an unspecified date. Therapeutic measures for the rash included he had an unspecified cream two times a day. The outcome for the both the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276856
Sex: M
Age:
State: TX

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

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

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: tested positive after the 1st dose; tested positive after the 1st dose; This is a spontaneous from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was tested positive after his 1st dose of vaccine. The consumer already received 2 doses of the vaccine; she received her 2nd dose last Saturday (unspecified date). She inquired if she needed to be quarantined from the patient or if she could go to work. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276857
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Unknown results; Test Name: adherence score; Result Unstructured Data: Test Result:8+; Comments: low; Test Name: ARMS; Result Unstructured Data: Test Result:7; Comments: high risk

Allergies:

Symptom List: Pain in extremity

Symptoms: Diarrhea; Gray stools; Tiredness/feel moderately tired; Right hand pain stiffness in joints and fingers; Right hand pain stiffness in joints and fingers; Right hand pain stiffness in joints and fingers; Her right hand continues to feel stiff; Not sure if this has helped. She still has significant pain; This is a spontaneous report from a Pfizer-sponsored program, received from a non-contactable consumer (patient) and subsequently from a contactable nurse and a contactable physician. A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from Feb2021 (Batch/Lot Number: DL0309) to an unspecified date, at 11 mg, daily, oral from an unspecified date (Batch/Lot Number: DD9555) to an unspecified date, at 11 mg, via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) and ongoing, at 11 mg, daily for Erosive inflammatory arthritis, psoriatic arthropathy, of the hands, feet, as pine and spine. . Medical history included : Diagnosis: Arthropathic psoriasis, unspecified. The patient's concomitant medications were not reported. . On unspecified date the patient experienced right hand pain stiffness in joints and fingers, tiredness, one or two missed doses due to diarrhea and gray stools. Patient stated that she started probably around 07Feb2021. Patient stated she had not refilled because she thought it was on auto refill. Patient stated having had diarrhea after starting XELJANZ and missed one or two days due to symptoms, and gray color stool. Patient also stated being tired moderately. Patient also stated that she had still pain and used MOBIC for right hand fingers and joints. Patient's ARMS (Adherence to Refills and Medications Scale) 7 high risk, low adherence score (8+), discussed importance of taking medication and setting refills on time, she denied missed doses. Patient wanted to know about the COVID vaccine, she was advised patient to speak to medical doctor (reported as MDO). Patient verbalized understanding, she agreed to adherence calls, and she had no questions. Nurse advised patient to contact pharmacy for any questions and refills.Subsequently the Patient indicated she continues to feel moderately tired but is not sure if its because she had the Covid-19 vaccine. Symptoms of diarrhea and gray stool that were previously reported on 08Mar2021 have resolved. Additionally, she confirmed she missed one dose of Xeljanz on the day she received her COVID-19 vaccine. Patient confirmed Her right hand continues to feel stiff, she has three days of Xeljanz on hand.The patient Continued on Xeljanz. Not sure if this has helped. She still has significant pain. Treatment received for Right hand pain stiffness in joints and fingers.Lab data included also blood work :unknown results on unknown date.The patient recovered from Diarrhea and Gray stools , not recovered from Tiredness/feel moderately tired.The outcome of the other events was unknown. Follow-up (07Apr2021,08Apr2021 and 09Apr2021): This is a follow-up report combining information from duplicate reports 2021389939 and 2021269483. The current and all subsequent information will be reported under manufacturer report number 2021269483.New information recevied from a Pfizer Sponsored Program and another Pfizer Sponsored Program from a contactable nurse and non-contactable consumer rand a contactable physician includes: Adding of suspect drug (bnt162b2) , suspect drug details, clinical course, new adverse reaction, treatment , outcome and additonal lab data. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1276858
Sex: M
Age:
State: FL

Vax Date: 01/18/2021
Onset Date: 01/20/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data: Test Date: 20200707; Test Name: Covid 19 test; Test Result: Negative

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: noticed cut on my head, stopped bleeding with gentle pressure; noticed cut on my head, stopped bleeding with gentle pressure; Fell in my bedroom; felt dizzy for a few seconds; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: EL3302) via Intramuscular in deltoid muscle on 18Jan2021 at 10 AM as single dose for COVID-19 immunisation in nursing home/senior living facility. Patient's medical history included high cholesterol, acid reflux, both ongoing. Concomitant medications included ongoing simvastatin oral for high cholesterol (for years), oral generic acid reducer for acid reflux (for years). On Wednesday 20Jan2021 at 11 AM he fell in bedroom in narrow area between bed, bookcase, and file cabinet. Did not lose consciousness but felt dizzy for a few seconds. Got up quickly; noticed cut on his head; stopped bleeding with gentle pressure. The patient underwent lab test which included Covid 19 test on 07Jul2020: Negative. Initiation of new medication / other treatment / procedure was not required for event. The outcome of event cut on his head was unknown, for other events was recovered in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds: SIMVASTATIN

Current Illness: Acid reflux (oesophageal); High cholesterol

ID: 1276859
Sex: F
Age:
State: PA

Vax Date: 04/15/2020
Onset Date: 03/16/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: tiredness/chill; tiredness/chill; left lymph node in jaw swollen; couldnt bite or chew on left side; This is a spontaneous report from a contactable consumer. This 62-year-old female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) intramuscularly on left arm on 12Mar2021 15:00 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8734) intramuscularly on left arm on 02Apr2021 15:50 as single dose for COVID-19 immunisation. The patient medical history included history included anticoagulant therapy, gastro oesophageal reflux disease, blood cholesterol abnormal and blood pressure abnormal. The patient concomitant medications included Eliquis for blood thinner from 15Apr2020 (ongoing), Omeprazole-DR 20mg for acid reflux from 12Dec2020 (ongoing), Atorvastatin for cholesterol from 15Apr2020 (ongoing), Lisinopril for blood pressure from 2018 (ongoing). On 16Mar2021 at about 07:00 hours, she had her left lymph node in jaw swollen and could not bite or chew on left side. On 03Apr2021 about at about 14:00 hours, she had tiredness/chill. She states that she was on blood thinners and takes Eliquis and no one asked her at the vaccination site. She did not know if that was a complicated adverse event and did not tell them and would like to know why it was mentioned in the factsheet and if there was something she should be looking out for. Treated with Tylenol and clod compress had eased. No relevant tests were done. No Adverse reaction to vaccine from Eliquis. No prior vaccinations. Outcome was recovering for left lymph node in jaw swollen and could not bite or chew on left side and recovered for tiredness/chill. Follow-up (12Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored program. Information on lot number/batch number has been requested. Follow up (13Apr2021): This is a follow-up spontaneous report from a contactable consumer which included information on dose, start dates, route of administration, concomitant medications and adverse events. No follow-up attempts are possible. No further information is expected.

Other Meds: OMEPRAZOLE; ATORVASTATIN; LISINOPRIL

Current Illness:

ID: 1276860
Sex: F
Age:
State: KY

Vax Date: 02/09/2021
Onset Date: 02/28/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 202008; Test Name: exam; Result Unstructured Data: Test Result:normal

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Other vaccine same date details/other vaccine same date product; mild visual acuity decrease/slight decrease Visual Acuity and depth perception; Neuromyelitis optica exacerbation; This is a spontaneous report from a contactable Physician. A 68-years-old (non-pregnant) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265, expiration date was not provided), via intramuscular route of administration at right arm on 09Feb2021 14:00 (at the age of 68-years-old) as single dose for COVID-19 immunization. Medical history included Addisons Ds, hypertension, Post Hysterectomy, Optic Neuritis type symptoms and Minor visual symptom. Concomitant medications included amlodipine for hypertension, estradiol for hysterectomy, fludrocortisone for addisons disease, hydrocortisone for addison's disease, metoprolol hypertension olmesartan hypertension. On 28Feb2021, the patient awoke with slight decrease visual acuity and depth perception and neuromyelitis Optica exacerbation and required visit to physician office. Other vaccine same date details/other vaccine same date product. The patient was treated with solumedrol high dose iv starting Rituxan Infusions for event neuromyelitis Optica exacerbation. The seriousness of the event neuromyelitis Optica exacerbation was considered as medically significant. The patient was not pregnant at the time of vaccination. The patient did not have any known allergies. The patient had no other vaccine within four weeks. 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 provided information to you regarding the reported adverse event(s) with the use of the product as consider the Pfizer product had a casual effect to the adverse event. The outcome of the event was event neuromyelitis Optica exacerbation was recovering on 03Mar2021, and outcome of other events was unknown. No follow-up attempts are needed. No further Information is expected.; Sender's Comments: Based on medical history and concurrent disease the event neuromylitis optica progression and visual acuity decreased mostly represented intercurrent condition in this patient unrelated to Bnt162b2. 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: AMLODIPINE; ESTRADIOL; FLUDROCORTISONE; HYDROCORTISONE; METOPROLOL; OLMESARTAN

Current Illness: Addison's disease

ID: 1276861
Sex: M
Age:
State:

Vax Date: 02/23/2021
Onset Date: 03/01/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210301; Test Name: COVID TEST; Test Result: Positive

Allergies:

Symptom List: Vomiting

Symptoms: tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male consumer reported for himself that he received the first dose of the Pfizer COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number/expiry date: unknown) via an unspecified route of administration as a single dose for COVID-19 immunization on 23Feb2021. The patients past medical history and concomitant medications were not reported. The patient reported that he received the first dose of the Pfizer COVID-19 and was tested positive for COVID on 01Mar2021." He received monoclonal antibodies via IV. Patient was scheduled to receive the second dose tomorrow. He wants to know if he can still receive the second dose as scheduled. E-transmitting AE due to long hold time, requested a call back. Information regarding lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1276862
Sex: M
Age:
State: NC

Vax Date: 02/18/2021
Onset Date:
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: my first dose I had in my right shoulder I hardly felt the pain, I waited for an hour before leaving I had no side effects at all, little soreness in shoulder; I am feeling so weak; Severe chills; waves of chills; shaking; Headache; Feeling tired; Nausea; Feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) on 18Feb2021 14:30 as single dose and was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. Patient was 75-years-old at the time of vaccination. Patient medical history and concomitant medications were not reported. The patient had his second dose and his first dose he had in his right shoulder he hardly felt the pain, he waited for an hour before leaving, he had no side effects at all, little soreness in shoulder, he had no complaint about it but he had the second vaccine at 2:30 afternoon (statement incomplete). Patient experienced little soreness in shoulder, was feeling so weak, had waves of chills, shaking, he shook for about an hour, it went away for a while, in half an hour or 45 minutes it returned again. He never had shaking with chills in his entire life, he was surprised with the reaction, by 2:30 this afternoon after 24 hours of that he was back to hundred percent again, he was recovering very nicely but he does have injection site pain in shoulder but that's not a big deal. Patient visited hospital because he had severe chills accompanied with headache, feeling tired, some nausea, there was unwell feeling, little bit of fever was not actual fever but the injection site pain (reason of hospitalization was not clarified). The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021210764 similar report from same reporter

Other Meds:

Current Illness:

ID: 1276863
Sex: M
Age:
State: MA

Vax Date: 02/22/2021
Onset Date: 02/25/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Been to ER a bunch of times due to crohn's related pain.; Inflectra (Infliximab) was given at 600 mg every 5-6 weeks for Crohn's/weight: 194lbs; Inflectra (Infliximab) was given at 600 mg every 5-6 weeks for Crohn's/weight: 194lbs; I got an inflectra infusion 3 days after my 1st vaccine dose and felt horrible for 2 days; The initial safety information received was reporting only non-serious adverse drug reaction, upon receipt of follow-up information on [16Apr2021], this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 38-year-old, via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; infliximab (INFLECTRA), via an unspecified route of administration from 25Feb2021 (Batch/Lot number was not reported) and ongoing, at 600 mg (600 mg every 5-6 weeks) for Crohn's. Medical history included partial blockage in 2018 and being immunosuppressed since 2003. Concomitant medications included paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took infliximab (REMICADE) for Crohn's from 2003 to an unspecified date. The patient reported that he was an immunosuppressed person who has received two doses of COVID 19 vaccine. He received dose 1 on 22Feb2021 and dose 2 on 15Mar2021. He also received an infusion of Inflectra on 25Feb2021. Prior to his 25Feb2021 infusion, he had received either Inflectra or Remicade infusions bi-monthly for over a decade. The patient stated that if he can participate in any study of the Covid vaccine's efficacy on immunosuppressed people, please let him know how he can help. The patient reported that he has been to ER a bunch of times due to Crohn's-related pain on an unspecified date. He got an Inflectra infusion 3 days after his 1st vaccine dose and felt horrible for 2 days. The patient was asking if getting an Inflectra infusion so closely to a 1st vaccine dose reduce his antibody production. The action taken in response to the events for infliximab was unknown. The outcome of the events was unknown. Information on the lot/ batch number has been requested. Follow-up (23Apr2021): This is a follow-up spontaneous report based on the information received by Pfizer. A contactable consumer (patient) reported that: This follow-up serious report was received from other study by a consumer in on 16 Apr 2021. This is a non-Celltrion sponsored study. Added patient's age reported as 38 (unit not provided). Added patient's weight of 194 lbs and height of 5'8". Previously reported event "I am an immunosuppressed person" (coded as Immunosuppression) was removed as an event and was added as historical condition which started on 2003 and reportedly that patient is fine now. It was further reported that patient was admitted to hospital due to being immunosuppressed. Added historical drug Remicade started on 2003 for Crohn's. On unspecified date, the patient experienced additional events described as "Been to ER a bunch of times due to Crohn's related pain" and "Admitted for partial blockage in 2018" (coded to unevaluable event) and "I got an Inflectra infusion 3 days after my 1st vaccine dose and felt horrible for 2 days" (coded to Feeling bad). Corrective treatment for the events and outcome of events were not reported. Added regimen for Inflectra (Infliximab) to include dose and frequency of 600 mg every 5-6 weeks and start date of 2021. Additional concomitant medications included Tylenol at 1g given before infusion and Benadryl at 25 mg given before infusion, both given via unspecified route for unspecified indication. Additional co-suspect drug BTN162B2 was added, for vaccination, 2 doses in Q1 2021, date started on Feb 2021. Additionally, event Overdose was captured as Inflectra (Infliximab) was given at 600 mg dose for Crohn's for patient with weight of 194 lbs. Event Off label dosing frequency was also captured as Inflectra (Infliximab) was given at 600 mg every 5-6 weeks for Crohn's. The reporter did not provide seriousness for event pain while serious (hospitalization) for event Admitted for partial blockage. Reporter's causality for event pain was not related (reported as Crohn's-related pain) and causality was not reported for event Admitted for partial blockage. The reporter did not describe events overdose and off label use. Case comment for follow-up dated 16 APR 2021: Updates to case details (additional events, historical drug) noted. Causality of event partial blockage-Unevaluable event (Unlisted, Serious) is Not assessable in the absence of necessary details for a meaningful assessment. Causality of event Feeling abnormal (Unlisted, Non-serious) is Related based on the temporal relationship between therapy and event. Known history of immunosuppression and recent vaccination are confounders to the assessment. Causality of event Pain (Listed, Non-serious) is Not related and attributed to the underlying condition. Causality of events Overdose and Off label dosing frequency (both Unlisted, Non-serious) is Not applicable and dependent on the prescribing practice of the HCP.

Other Meds: TYLENOL; BENADRYL

Current Illness:

ID: 1276864
Sex: M
Age:
State:

Vax Date: 03/09/2021
Onset Date: 03/17/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210317; Test Name: COVID; Test Result: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: he received the first dose of Pfizer COVID vaccine on 09Mar2021.On 17Mar2021, he tested positive for COVID and is wondering if he is still able to get his second dose on 30Mar2021 as scheduled.; This is a spontaneous report from a contactable consumer or other non-HCP via Medical Information Team. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 09Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Mar2021, patient underwent lab tests and procedures which included sars-cov-2 test which patient got positive for covid and was wondering if he could still be able to get his second dose on 30mar2021 as scheduled. The outcome of the event was unknown. No Follow-up attempts are possible. Information about lot/batch cannot be obtained.

Other Meds:

Current Illness:

ID: 1276865
Sex: F
Age:
State: CT

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Name: x-ray; Result Unstructured Data: Test Result:Sacroiliitis; Comments: diagnosed with Sacroiliitis

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: sacroiliitis; pain in her thigh; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unspecified date it was reported that patient was due for her 2nd dose and wanted to know if she can take the vaccine. She was diagnosed with sacroiliitis by her doctor upon her X-Ray. She did not experience any side effects after the first dose but had pain in her thigh. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1276866
Sex: U
Age:
State: IL

Vax Date: 01/01/2021
Onset Date: 03/13/2021
Rec V Date: 05/01/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data: Test Date: 20210313; Test Name: Tested positive for virus; Test Result: Positive

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received both doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on and unspecified dates in Dec2020 and Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 13Mar2021, the patient tested positive for the virus. Fortunately, the patient had a mild case. The seriousness of the event was considered as medically significant. Outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am