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: 1711767
Sex: M
Age:
State: WA

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: atrial fibrillation; Systemic inflammation; headache; fatigue; stuffy nose; joint pain; nerve tingling; irregular heart rhythm; high blood pressure; diarrhea; nausea; insomnia; anxiety; stress; panic; This is a spontaneous report from a contactable consumer (Patient himself). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 01Sep2021 10:30 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 44 years). The patient's medical history included High blood pressure, atrial fibrillation, inflammation, sensitive to animal foods, gluten and dairy. The concomitant medications were not reported. It was reported that he did not took other vaccine in four weeks prior COVID vaccine. Other medications in two weeks included anti-Inflammatory supplements. He was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination. On 01Sep2021 at 20:00, the patient experienced atrial fibrillation, systemic inflammation, headache, fatigue, stuffy nose, joint pain, nerve tingling, irregular heart rhythm, high blood pressure, diarrhea, nausea, insomnia, anxiety, stress and panic. Patient did not receive any treatment as a result of events. the seriousness of the event atrial fibrillation was considered always serious and medically significant and for all the other events was non-serious. The outcome of the events was recovering. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1711768
Sex: F
Age:
State: FL

Vax Date: 03/27/2021
Onset Date: 03/28/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data: Test Date: 20210328; Test Name: hemoglobin dropped; Result Unstructured Data: Test Result:6.6; Comments: hemoglobin dropped to 6.6

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: shortness of breath; tachycardia; My hemoglobin dropped to 6.6; 24 hours after my second vaccine dose I started having a heavy period.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ep6955, Expiry date: unknown), via an unspecified route of administration, administered in arm left on 27Mar2021 16:00 (at the age of 43-years-old) as dose 2, single for covid-19 immunisation. Medical history included hyperthyroidism. Concomitant medications included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE); methimazole (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN), all for an unspecified indication and from an unspecified date and unknown if ongoing. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number En6199, Expiry date: unknown) via an unspecified route of administration, administered in Left arm on 05Mar2021 17:45 (at the age of 43-years-old) as dose 1 for covid-19 immunisation. No known allergies. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Mar2021 16:00 24 hours after my second vaccine dose the patient experienced a heavy period. Not normal with the birth control she was taking because she would only spot monthly. The bleeding became so heavy that she was passing large clots and soaking through sanitary pads every 2 hours. She visited her Obgyn, and he stopped her birth control and prescribed a medication to stop the bleeding. This did not work. She went to ER with shortness of breath and tachycardia 6 days later. She lost 2 litres of blood. She required a d and c procedure. Her haemoglobin dropped to 6.6 and she received a blood transfusion. She spent 4 days in the hospital. She never had anything like this prior. The patient was hospitalized for shortness of breath and tachycardia for 4 days. The patient underwent lab tests and procedures which included haemoglobin: 6.6 (haemoglobin dropped to 6.6) on 28Mar2021. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.

Other Meds: LO LOESTRIN FE; METHIMAZOLE

Current Illness:

ID: 1711769
Sex: U
Age:
State:

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/18/2021
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: chest pain and in my back; burping a lot; I got my third Pfizer booster shot; I got my third Pfizer booster shot; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received third dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) dose 3 via an unspecified route of administration on 31Aug2021 16:00 as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced I got my third Pfizer booster shot on 31Aug2021, chest pain and in my back on 01Sep2021, burping a lot on 01Sep2021. The outcome of the events chest pain, eructation, extra dose administered, off label use was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711770
Sex: F
Age:
State: WI

Vax Date: 09/03/2021
Onset Date: 09/03/2021
Rec V Date: 09/18/2021
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: Shortness of breath; Chest pain; Tongue swelled up; I started to lose my voice; my tongue swelled up and it was 'paining' very bad; Nausea; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: FF2587, patient was 39-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 03Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included asthma, bronchitis. The patient's concomitant medications were not reported. Historical vaccines included Flu shot and Pneumonia shot for immunization and experienced allergic with that. No prior vaccination within 4 weeks of COVID Vaccine, no family history for the same adverse event. On 03Sep2021, the patient experienced shortness of breath, chest pain, tongue swelled up, i started to lose my voice, my tongue swelled up and it was 'paining' very bad, on an unspecified date in 2021, the patient experienced nausea. AE resulted in to visit emergency for reported events. Therapeutic measures were taken for all events with Albuterol, I got Benadryl twice, and then they gave me Pepcid, they also gave me Methylprednisolone. It was reported that patient got the Pfizer Vaccine yesterday and told to wait for like 30 minutes and I waited for like '15' minutes and I feel like I was okay, so I pull it up and as I started driving, and experienced events, so I went to the emergency room, I was treated there, they gave me 2 doses Benadryl. I took my EpiPen (treatment) that I have in the car. They gave me steroid, and they gave me something else 'Pepcid'." Reported that same day patient came back from the emergency room. The outcome of event (Nausea) was not recovered, and outcomes of rest all reported events were recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711771
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: sick, terrible body ache, headache; Terrible body ache; Can't get well; Headache; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration in 2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced Sick; Terribly sick; I can't work, I cannot work now because all I am is sick, Terrible body ache, Headache, Can't get well. It was reported that she has been sick since the day injection the night she got sick, of the night of the injection on the 4th, after a month ago she have been sick like that sounding like a sick terrible body ache, headache, then severe med checked she have been to my family doctor, she have been to the emergency room. She don't know what else to do, no one is helping me they don't know what to, what do I do. She was terribly sick, and she was not getting the second one. Her pharmacist has known all this, she 'got all this checked in' and he has told me she need to call on Pfizer number on paper work and let you know that she sick and she can't get well, she don't know what's wrong she mean she have problems with getting sick easy and immune inefficiency (voice not clear), she should never got it, wish she would never got it, did not wanted to get it, pushed in to it by family because they think that it would make me (voice not clear) from the COVID (Voice not clear). she can't work, she cannot work now because all she was sick. Comment: Reporter type not probed hence captured by default as consumer or other non-health professional in tab. The outcome of events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711772
Sex: F
Age:
State: VA

Vax Date: 06/17/2021
Onset Date: 07/05/2021
Rec V Date: 09/18/2021
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: August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from 1-31Aug2021); Extremely irregular menstrual cycles; August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from 1-31Aug2021); This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 17Jun2021 11:00 (Lot Number: EW0180) as single dose (at the age of 23-years-old) for COVID-19 immunization (Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store). Medical history included none. The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included drospirenone, ethinylestradiol (LORYNA) and ethinylestradiol (NIKKI): both taken for contraception, start and stop dates were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 11:00 AM (Lot Number: EW0178) as single dose (at the age of 23-years-old) for COVID-19 immunization. On 05Jul2021, the patient experienced Extremely irregular menstrual cycles: July - cycle began 2 weeks early. August - cycle began 3 weeks early with spotting and bleeding that continued throughout the entire month (bled from August 1-31). The patient was not hospitalized. No treatment received. The outcome of the events was recovered on an unspecified date in 2021. The events were considered as non-serious. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.

Other Meds: LORYNA; NIKKI

Current Illness:

ID: 1711773
Sex: F
Age:
State: OK

Vax Date: 08/29/2021
Onset Date: 08/30/2021
Rec V Date: 09/18/2021
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: pain all over her body; pain that was hurting her so bad/achiness; cramping in her hands, feet and facehands were completely cramped up; Nausea; This is a spontaneous report from a contactable Nurse. A 27-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 29Aug2021 (at the age of 27-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for achiness. The patient medical history was not reported. There were no concomitant medications. Patient previously took first dose of bnt162b2 on an unspecified date in 2021 for covid-19 immunisation. On 30Aug2021, the patient experienced pain all over her body. Like out of ten she had stated then with pain that was hurting her so bad/achiness, she was hyperventilating so she had cramping in her hands, feet and face. Before they act they drew up and nausea (medically significant). It was reported that afterwards she experienced the little bit of the achiness she took Ibuprofen but it became, It got worse in the morning 30Aug2021. Nurse stated that we gave her treatment in response to adverse events which included steroid, Solu Medrol, gave her Benadryl. Norflox to relax her muscles cause her hands were completely cramped up. Zofran for Nausea. Solu Medrol, steroids, famotidine, fluids and then we gave her, she was given the steroid started taking the next day (on reporting date). The action taken in response to the events for ibuprofen was unknown. Outcome of all events were unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pain, Muscle spam, and Nausea and 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1711774
Sex: M
Age:
State: FL

Vax Date: 08/03/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data: Test Name: spinal test; Result Unstructured Data: Test Result:Guillain-Barre syndrome; Comments: they did a spinal test to confirm that was GBS; Test Name: vitalis test; Result Unstructured Data: Test Result:Unknown Results

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Couldn't walk; Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer, the patient. A 59-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FA6780), via an unspecified route of administration, administered in arm left on 03Aug2021 as dose number unknown, single (at the age of 59-years-old) for covid-19 immunization. Medical history included ongoing hypertension, neuropathy peripheral and ongoing skin cancer. Concomitant medications included amlodipine orotate;olmesartan medoxomil taken for hypertension, bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HYDROCHLOROTHIAZIDE) taken for hypertension and anastrozole. It was reported that the patient got the vaccine on 03Aug2021 and then on 08Aug2021, the patient could not walk. The patient had to go to the emergency room the following Sunday, on the 08, he had to go the hospital, could not walk. The patient was in hospital for 11 days and then went to a rehab for 5 days. The patient reported that when he was in hospital, they gave him 5 IVIG bags, 5 days in a row and did vitalis test and then spinal test to confirmed that was GBS (Guillain-Barre syndrome) given for. Consumer stated, "When patient was in hospital they gave me these bags, it was called IVIG, they gave patient 5 bags so they did a vitalis test then they did a spinal test to confirm that was GBS given for. They did a spinal test to confirm that and they confirm that's what I had and they treated me with the 'people' calls it IVIG, they were IV bag and they gave me 5, 5 days in a row they gave me a bag. The outcome of the events was unknown. Follow-up attempts were completed. No further information was expected. Follow-up (08Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds: AMLODIPINE OROTATE;OLMESARTAN MEDOXOMIL; BISOPROLOL HYDROCHLOROTHIAZIDE; ANASTROZOLE

Current Illness: Blood pressure high; Skin cancer

ID: 1711775
Sex: F
Age:
State: ID

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/18/2021
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: bloodwork; Result Unstructured Data: Test Result:Unknown; Test Name: EKG; Result Unstructured Data: Test Result:heart was fine; Comments: after COVID virus; Test Date: 20210901; Test Name: EKG; Result Unstructured Data: Test Result:irregular

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: COVID arm/great big huge lump; COVID arm/ she had a circle rash; red rash on her arm; sleeping a lot; she was weak; Myocarditis; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration in the arm on 18Aug2021 in the late afternoon or early evening (at the age of 64-year-old), dose 1, single for COVID-19 immunisation. Medical history included aneurysm in 2015 (it has not changed, it was diagnosed 6 years ago), obesity (weighed the same for over 20 years) and COVID (Feb2021) and got an infusion. The patient did not have diabetes. The patent did not have family history. The patient did not receive any concomitant medications. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. On 18Aug2021, the patient developed myocarditis right away after first shot. The patient did not know that was what it was. The patient thought it was normal and related to the shot. The patient had all symptoms of myocarditis. On 19Aug2021, the patient got COVID arm which started with a lump in her arm and then she had a circle rash from it at first. That was her biggest concern at first. She noticed it about 10:00 or 10:30. The patient got ready to take a shower and saw a red rash on her arm and she had great big huge lump. The was sleeping a lot and she was weak. The patient had to wait 90 days after to get her shot. The patient went to the doctor on 01Sep2021. The patient's doctor was referring the patient to a cardiologist and said for patient not to get second dose. The patient had an electrocardiogram (EKG) after COVID virus and her heart was fine. The EKG on 01Sep2021 showed irregular and she was going to the cardiologist. They did bloodwork and were sending her to a cardiologist because it was beyond what her primary care does. The patient could not have the second shot or a booster ever. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event myocarditis was not recovered. The outcome of the events sleeping a lot and 'she was weak' was unknown and outcome of other events was recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1711776
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Atrial fibrillation/ had atrial fibrillation 7/24; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient). A patient of unspecified age and gender 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) and dose 2 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 the patient's concomitant medications were not reported. The patient experienced atrial fibrillation for two days after the first dose and had atrial fibrillation 7/24 for four months after the second dose. This necessitated ablation surgery. The outcome of the event was reported as recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711777
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: I'm in unbearable pain in my lower back; feel like I am dragging my right leg; This is a spontaneous report from a Regulatory Authority. A female consumer (patient) of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. It was reported that, patient was in horrible reaction to the second dose of the COVID shot she was in unbearable pain in lower back and feel like she was dragging her right leg on an unspecified date. The outcome of both the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711778
Sex: F
Age:
State: NJ

Vax Date: 04/06/2021
Onset Date: 09/05/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210902; Test Name: SARS-COV-2 NAA/Nasal Swab; Test Result: Positive

Allergies:

Symptom List: Rash, Urticaria

Symptoms: COVID-19 positive; COVID-19 positive/symptoms: nasal congestion, fatigue, loss of taste and smell.; This is a spontaneous report from a contactable consumer. A 53-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EP7533, Expiry date was not reported), intramuscular, administered in Arm Right on 06Apr2021 15:30 (at the age of 53-years-old) as dose 2, single for covid-19 immunisation (Pharmacy or Drug Store). Medical history included hashimoto thyroiditis from an unknown date and unknown if ongoing and known allergies: penicillin, mycin/micin types of antibiotics, kiwi fruit. The patient's concomitant medications were not reported. Prior vaccination, the patient had not received any other vaccine within 4 weeks. The patient had been covid tested post vaccination. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6055, Expiry date was not reported), intramuscular, administered in arm right on 16Mar2021 13:00 as dose 1 for covid-19 immunisation. The patient had breakthrough COVID-19 positive case with these symptoms: nasal congestion, fatigue, loss of taste and smell. The patient tested positive. Symptoms began on Monday 30Aug2021 with congestion and then progressed with fatigue and loss of taste and smell on 31Aug2021. Took a nasal swab test on Thursday 02Sep2021 and learned positive result on Sunday 05Sep2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the adverse event. The patient underwent lab tests and procedures which included sars-cov-2 test/ nasal Swab: positive on 02Sep2021. The outcome of event was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711779
Sex: M
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Histopathology; Result Unstructured Data: Test Result:showed a superficial perivascular lymphohistiocyti; Comments: showed a superficial perivascular lymphohistiocytic infiltrate with scattered dermal erythrocytes, along with nonspecific chronic dermatitis, spongiosis, absent granular layer, and focal hyperkeratosis and parakeratosis.; Test Name: Physical exam; Result Unstructured Data: Test Result:revealed a 3-cm red-brown eczematous plaque on the; Comments: revealed a 3-cm red-brown eczematous plaque on the right flank and multiple two-toned papules with fine overlying scale, following skin cleavage lines in a Christmas tree distribution on the upper body (Figure 1(a,b)).

Allergies:

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

Symptoms: These findings were consistent with pityriasis rosea; This is a literature report, 2021, DOI: 10.1080/21645515.2021.1963173 entitled Pityriasis rosea after administration of Pfizer-BioNTech COVID-19 vaccine. A 66-year-old male with a history of mild hidradenitis suppurativa presented to his primary care physician due to the development of an ovoid eczematous plaque on his right flank. Over the next week, multiple similar slightly scaling patches and plaques appeared on his back, chest, and abdomen. The patient reported that approximately 1 week prior to the first lesion appearing, he had received the first dose of the PfizerBioNTech COVID-19 vaccine. His only other reported symptom was transient arm soreness. He denied any personal history of a similar rash or any generalized symptoms and reported no recent travel. Physical exam revealed a 3-cm red-brown eczematous plaque on the right flank and multiple two-toned papules with fine over lying scale, following skin cleavage lines in a "Christmas tree" distribution on the upper body (Pityriasis rosea (chest, flank, and axilla); pityriasis rosea (back)). There was no mucous membrane involvement. Histopathology showed a superficial perivascular lymphohistiocytic infiltrate with scattered dermal erythrocytes, along with nonspecific chronic dermatitis, spongiosis, absent granular layer, and focal hyperkeratosis and parakeratosis. These findings were consistent with pityriasis rosea. The patient was initially treated with triamcinolone 0.1% ointment as needed for itch, then transitioned to a bland emollient. Four weeks after initial presentation, the patient reported complete resolution of the rash. Discussion: To authors' knowledge, this is the first reported case of a COVID-19 vaccination being temporally associated with the development of PR. Their patient's clinical presentation and histopathologic findings were consistent with PR; the temporal association with the administration of the COVID-19 vaccine suggests that their patient's vaccination triggered development of PR. While PR most commonly presents spontaneously, with no known preceding trigger, neither this patient's age, nor the time of year, was typical of pityriasis rosea, making the antecedent vaccine the most likely cause. It is possible that the state of altered immunity due to his recent vaccination may have led to an endogenous reactivation of HHV-6 or HHV-7, which served as the viral trigger for this cutaneous eruption. Alternatively, as COVID-19 infection has also been reported to trigger PR, vaccination against this viral antigen may have served as a noninfectious trigger for the classic PR skin rash. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the reported event Pityriasis rosea is possibly related to BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 1711780
Sex: M
Age:
State: TX

Vax Date: 09/03/2021
Onset Date: 09/04/2021
Rec V Date: 09/18/2021
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:

Allergies:

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

Symptoms: he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine; he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine; pain started the next morning the vaccine shot; he had fever for few hours; stomachache; vomiting; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FC3181), second dose via an unspecified route of administration, administered in left arm on 03Sep2021 at 04:30 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. Medical history was reported as none. No concomitant medications were not reported. No known allergies were reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3180), first dose via an unspecified route of administration, administered in left arm on 10Aug2021 at 09:15 (at the age of 12-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received any other medication within 2 weeks was reported as none. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 04Sep2021 at 16:00,It was reported that he felt heavy heart pain for 5 or 6 times on and off since the 2nd dose of the vaccine(Friday 4pm) the paint started the next morning the vaccine shot. each times the pain last at least 5 minutes. beside heart pain, he had fever for few hours, stomachache, vomiting. all these symptoms stop on 3rd day (Monday morning). the symptom about the heart pain worry me that is one of the rare side effects that Inwould like it be tracked. Adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was reported as unknown.

Other Meds:

Current Illness:

ID: 1711781
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: Covid-19; Test Result: Positive

Allergies:

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

Symptoms: Breakthrough COVID-19; Breakthrough COVID-19; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were none. On an unspecified date, the patient experienced breakthrough COVID-19. The patient stated that event took place after use of product. The patient underwent lab tests and procedures which included Covid-19 test?positive on an unspecified date. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1711782
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: severe anaphylactic reaction; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sponsored program. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe anaphylactic reaction. The reporter wanted to know if she could get the ingredients of the COVID-19 vaccine and if the regulatory authority has approved the COVID-19 vaccine. The outcome of the event was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1711783
Sex: F
Age:
State:

Vax Date: 08/25/2021
Onset Date: 09/04/2021
Rec V Date: 09/18/2021
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: 20210904; Test Name: sars-Cov-2-Test; Test Result: Positive ; Comments: she tested positive on Saturday and her daughter tested positive today.

Allergies:

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

Symptoms: they are now testing positive for COVID 19; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 25Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient was received her first dose of the Pfizer COVID 19 vaccine on 25Aug2021. The patient states that they have not been exposed to anyone with COVID 19 and that they are now testing positive for COVID 19. The patient states that it has been 8-9 days and the patient tested positive on Saturday (04Sep2021). The patient would like to know if this is because of the vaccine and that they really don't have the virus. The patient makes an example of when people get the flu shot and then get sick with the flu. The patient states that it's the same because the vaccine is COVID that they put in their body. The patient was like to know if she can still get her second dose of the vaccine now since she has tested positive after the first dose. The patient states that this vaccine was the virus so that was why patient was testing positive right, patient states that the vaccine puts the virus in your body. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711784
Sex: U
Age:
State: ID

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Symptoms since Covid vaccines; Symptoms since Covid vaccines; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced symptoms since covid vaccines on an unspecified date. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711785
Sex: F
Age:
State: NJ

Vax Date: 05/01/2021
Onset Date: 05/03/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: abdomen pain; metrorrhagia; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EW0165, on 01May2021 at single dose in left arm (at the age of 34-year-old) for COVID-19 immunization. Medical history was none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received first dose of BNT162B2, Lot number EN6207, on 10Apr2021 11:00 in left arm forCovid-19 Immunization. After getting 2nd dose, the patient started to have metrorrhagia starting the 2 days after (03May2021). It lasted for 2 weeks. She never had a metrorrhagia in her entire life. She called hospital to report side effects, but they said she needed to see her doctor regarding this. She went to gynecology to see what's going on, and he said there wasn't any study regarding women's metrorrhagia side effect, but he had seen a lot of women suffering similar issue after getting vaccine, such as re-starting period after menopause. It's been almost 4 months since she got vaccinated, and she still had abdomen pain sometimes. Her biggest concern was that it would affect her body for not getting pregnant. They had been trying to get pregnant since 3 months and it's not happening. She was really worried. She was hearing similar side effects from a lot of people nowadays. No treatment was received. The outcome of the events was not resolved. The event metrorrhagia was serious with life-threatening.

Other Meds:

Current Illness:

ID: 1711786
Sex: F
Age:
State: MD

Vax Date: 04/12/2021
Onset Date: 07/26/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: Hair loss - Telogen Effluvium; This is a spontaneous report from a contactable Physician (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on 12Apr2021 at 12:00 (age at vaccination was 53-year-old) as dose number unknown, single for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history was reported as none. The concomitant medications were not reported. The patient was not allergic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications was received within 2 weeks of vaccination. On 26Jul2021, the patient experienced hair loss-telogen effluvium. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR) was negative on an unspecified date through nasal swab. Therapeutic measures were taken as a result of event. The treatment medication included over the conger medication for the event. No seriousness was reported for event. Outcome of the event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711787
Sex: F
Age:
State: MI

Vax Date: 09/02/2021
Onset Date: 09/03/2021
Rec V Date: 09/18/2021
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: Test Date: 20210903; Test Name: My temperature; Result Unstructured Data: Test Result:102.8; Comments: Units: degrees; Test Date: 20210903; Test Name: My temperature; Result Unstructured Data: Test Result:101.2; Comments: Units: degrees; Test Date: 20210903; Test Name: My temperature; Result Unstructured Data: Test Result:102.6; Comments: Units: degrees; Test Date: 20210904; Test Name: My temperature; Result Unstructured Data: Test Result:99.3; Comments: Units: degrees 1:30 in the morning my temperature was down

Allergies:

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

Symptoms: My temperature started rising, and reached 102.8 degrees; sore throat; severe chills; severe chills where I couldn't stop shaking.; This is a spontaneous report from a contactable consumer (patient herself). A 75-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Sep2021 at 14:30 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE (age at vaccination was 75 years old) for covid-19 immunization, administered at a Pharmacy or Drug Store. The patient medical history was not reported. No known allergies. Concomitant medications included carvedilol (strength: 3.125 mg) at 3.125 mg and methylprednisolone (strength: 8 mg) at 8 mg, both taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated, on 03Sep2021 at 2.30 pm, approximately 24 hours later "I started to get a sore throat, then I got severe chills where I couldn't stop shaking. My temperature started rising, and reached 102.8 degrees. My normal temperature is always 97.7 degrees. When my temp reached 101.2 degrees my husband gave me one Tylenol (extra strength). When it reached 102.6 he gave me another one. I slowly started to warm up and my temperature slowly started to come down. By about 1:30 in the morning my temperature was down to 99.3 and I was feeling good enough to finally go to sleep. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Lab data included body temperature: 102.8 degrees, 101.2 degrees and 102.6 degrees on 03Sep2021; body temperature: 99.3 on 04Sep2021. Patient received Tylenol as treatment for pyrexia and no treatment was given for any other events. At the time of this report, the outcome of all the events was resolving. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: CARVEDILOL; METHYLPREDNISOLONE

Current Illness:

ID: 1711788
Sex: F
Age:
State: GA

Vax Date: 09/04/2021
Onset Date: 09/04/2021
Rec V Date: 09/18/2021
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: Severe arm pain into the joints; Severe arm pain into the joints; Inability to lift arm; This is a spontaneous report from a contactable other hcp (patient). A 26-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in arm right on 04Sep2021 12:30 (Batch/Lot Number: Fc3184) (at the age of 26-years-old) as SINGLE for covid-19 immunization at Pharmacy or Drug Store. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Patient medical history included pre-hashimotos from an unknown date and unknown if ongoing. Patient concomitant medication(s) included dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) taken for an unspecified indication, start and stop date were not reported. On 04Sep2021 at 14:00, The patient experienced severe arm pain into the joints and had inability to lift her arm. The patient did not received any treatment for the events. The outcome of events was not recovered.

Other Meds: DAYQUIL

Current Illness:

ID: 1711789
Sex: M
Age:
State:

Vax Date: 09/05/2021
Onset Date: 09/06/2021
Rec V Date: 09/18/2021
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: 20210906; Test Name: Fever; Result Unstructured Data: Test Result:99.5; Comments: Had little bit of fever

Allergies:

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

Symptoms: Today he had little bit of fever 99.5; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FF2589) via an unspecified route of administration on 05Sep2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose on unspecified date (Lot number: FC3181) for covid-19 immunisation. On 06Sep2021, the patient had little bit of fever 99.5. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1711790
Sex: U
Age:
State:

Vax Date: 03/13/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: It started 12 hours after I got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over my body; It started 12 hours after I got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over my body; For some reason my tongue and my throat were really dry and irritated but my tongue is sore and my throat was kind of irritated; For some reason my tongue and my throat were really dry; my tongue is sore; tongue really dry and irritated; tongue really dry; Dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number not reported), dose 1 via an unspecified route of administration on 13Mar2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, 12 hours after getting the vaccine the patient experienced kind of itching, prick kind of a stinging nerve like sensation and that would be all over the body. Patient also reported that for some reason tongue and throat were really dry and irritated but tongue is sore and throat was kind of irritated, dry skin and this would not but it was not dry skin, it was something irritating the whole body from inside out. Patient appointment came and went to get the second shot and never got the second shot. Clinical course: It started 12 hours after patient got the vaccine and it was kind of itching, prick kind of a stinging nerve like sensation and that would be all over the body not at the same time, but it might go from nose to ankle, to elbow just one and it varied and the links of tiny twines but at times it is few seconds apart and patient does not know how to describe it. The other thing that patient had that for some reason, patient's tongue and throat were really dry and irritated but tongue was sore and throat was kind of irritated, but the thing about it was, that it lasted for 8 weeks. So, patient appointment came and went to get second shot because it was in a no way going to do that which is still going on. Patient did not know what it was or if it is going to get worse or will go away. So reason to say, patient never got the second shot but although. Patient primary care doctor treated the patient for dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out. Patient adverse reactions lasted for 8 weeks. Therapeutic measures were taken as a result of, dry skin and this would not but it was not dry skin, it was something irritating my whole body from inside out. Outcome for the events was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711791
Sex: F
Age:
State: WI

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 09/18/2021
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: Injection site pain, Menorrhagia

Symptoms: swollen lymph nodes/swollen lymph nodes in armpit of injection site; Nausea; Tired; Sore armpit of injection site; Nighttime cough; Sore arm of injection site; Mild headache; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself. A 35-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: FF2588), via an unspecified route in the left arm on 02Sep2021 at 12:45 (age at vaccination: 35-year-old), as a single dose for covid-19 immunization. Medical history included HBP, Obesity, Migraine Headaches, Asthma and Known allergies to Amoxicillin, Ragweed, Dogs and Cats. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) 10/12.5 mg QD; hydrochlorothiazide, lisinopril (ESTARLLYA) QD and cetrizine. It was unknown if prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Sep2021 at 20:00, patient experienced sore arm of injection site, Mild headache (day 1); on 03Sep2021 (day 2) sore arm of injection site, Mild headache, Nausea, Tired, Sore armpit of injection site, Nighttime cough; on 04Sep2021 (day 3) Sore arm of injection site, Nausea, Sore armpit of injection site (toward end of evening she could feel swollen lymph nodes), Nighttime cough and on 05Sep2021 (day 4) Sore/swollen lymph nodes in armpit of injection site - about marble size, tender with touch & movement, Nighttime cough. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: LISINOPRIL/HCTZ; ESTARYLLA; CETIRIZINE

Current Illness:

ID: 1711792
Sex: F
Age:
State: WA

Vax Date: 08/09/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Caller says her vertigo and Meniere's were worse than with the first dose after the second; Caller says her vertigo and Meniere's were worse than with the first dose after the second; Dizzy; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old female patient received bnt162b2 (BNT162B2) solution for injection, dose 2 (Lot Number: FC3181 expiry date was unknown) via an unspecified route of administration on 09Aug2021 (at the age of 83-years-old) as a single dose for covid-19 immunisation. Medical history included, meniere's disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical Vaccine dose 1 (LOT EW0168 expiry date was unknown) via an unspecified route of administration on 13Jul2021 as a single dose for covid-19 immunisation. Consumer said that she called because after she got her first shot on 13Jul2021, clarified to being Pfizer COVID-19 vaccine, she was a patient who has suffered with Meniere's and vertigo which she has had about 6 years off and on. She said she was very concerned about getting the Pfizer shot, then she got it and after that her Meniere's was coming back. She said she got concerned that if she got the second shot it would get worse so she put it off, and ended up getting her second shot 4 days later than she should have gotten it earlier. She says she called her Ear, Nose, and Throat doctor (ENT) and her primary care provider because she was so concerned, she would get vertigo and Meniere's back, but she got it because they said at her age, she needed to get the shot. She says she talked to 5 physicians and they all said same thing, so she got the shot. She says ever since that, her Meniere's has come back as a ringing and pounding in her ears is back, and it never goes away, and she was dizzy every day, this has changed her whole life. Report Type: Reporter says she has a case number called MJYLXKDQ. Follow up report. Caller said the reason she was calling back was if she help someone else, since when she called and asked if anyone reported Meniere's and vertigo, they had nothing on file. She said she would like to help someone else who suffers with these things since there is no cure for Meniere's or of vertigo, and if you have got it, you have to ride it out. She said after the shot, hers came back with a vengeance. Email Address: Caller declined to provide. Pfizer COVID-19 vaccine: She said no NDC/EXP were provided on her vaccine card for her doses. Reporter said her vertigo and Meniere's were worse than with the first dose after the second, it was not as much with the first. She said at her age she knew she should get it, she was very concerned, and all her doctors said she should get it, and her ENT really did, she went to them for her Meniere's and vertigo, and they said she needed the shot, to go get the shot, and they would give her Valium if she needs it. Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711793
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: She start today with coughing; she is coughing and coughing; this coughing is really bad; coughing too much; After the shot she feels tired then during in the night; Her heart; heartbeat go more faster; She feel weak; Headache; She is very down; She do not want to eat; she feel like nausea; This is a spontaneous report from a contactable consumer (Parent). A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated that Yesterday we went to Pharmacy and put their vaccine for my daughter 12-year-old. Yesterday she was prefect, but she started today with coughing and consumer didn't find anywhere, consumer read all the information about it was Pfizer vaccine. Consumer didn't find the coughing. She felt tired, her heart and this moment, it was like heartbeat go more faster and she was coughing and coughing, and she felt weak. But consumer read a cough was normal. But consumer didn't find the coughing. She was coughing. Yesterday she was perfect. After the vaccine, this morning she started coughing. Consumer wanted to know if this coughing could be normal for the vaccine or consumer have to take it her to doctor or consumer have to take it to hospital. Because she was coughing was really bad. She got a headache; she was very down. Her heart was got a like a fast, feel like a little bit faster. Consumer believed she was coughing too much consumer don't know. But yesterday she was perfect. After the shot she feels tired then during in the night. And this morning she start with the coughing. Consumer gave Tylenol (treatment) to her, she started with the headache. She did not want to eat. She felt like a nausea. The outcome of events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1711794
Sex: M
Age:
State: OH

Vax Date: 09/03/2021
Onset Date: 09/04/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: EKG; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: troponin blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: x-ray; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Headache; body/neck aches; body/neck aches; chest pain; difficulty breathing; lower back pain; This is a spontaneous report from a contactable consumer. This 16-year-old male consumer (patient) reported for himself that. A 16-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 03Sep2021 16:00 (Age at time of vaccination 16-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported) administered in Arm Right On Aug2021 15:30 for covid-19 immunization. The patient previously took amoxicillin and experienced drug hypersensitivity. The patient medical history, concomitant medications were not reported. No other medical history. He eats healthy and is muscular and physically fit. Ethnicity information is available. Device Date was 05Sep2021. COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient not received any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, Prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. On 2021 The patient underwent lab tests and procedures which included blood test: unknown results, electrocardiogram: unknown results, troponin: unknown results, x-ray: unknown results. On 04Sep2021 15:00 The patient experienced headache, body/neck aches, chest pain, difficulty breathing, lower back pain. Therapeutic measures were taken as a result of all events. AE resulted in Emergency room/department or urgent care. Events were consider as non serious. The outcome of events were resolving. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711795
Sex: F
Age:
State: NC

Vax Date: 09/03/2021
Onset Date:
Rec V Date: 09/18/2021
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: Test Name: fever; Result Unstructured Data: Test Result:Fever

Allergies:

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

Symptoms: Fever; Chills; Lots of night sweats; Nausea; Feels like been run over the train; Weakness; Low appetite; This is a spontaneous report from a contactable consumer (Patient, reported for herself). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: Unknown), via unspecified route of administration, on 03Sep2021 (at the age of 76-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history included lung cancer, emphysema, COPD, osteoporosis, aneurysm and blood pressure high. Patient reported that Lot number looks like an AN0187. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown) as a dose 1, single for COVID-19 immunization. The patient also reported that she had 3 IV bags of immunotherapy in the year like it was in 2017 and that bags killed her. Patient had 33 reactions (three treatments ended up in ER with it) from that on 3 IV bags of Immunotherapy and she had to stop it. The concomitant medication of the patient included nivolumab (OPDIVO), verapamil (VERAPAMIL), lisinopril (LISINOPRIL), lorazepam (LORAZEPAM) and meloxicam (MELOXICAM). Patient stated that she took verapamil as it was the blood pressure medicine, lisinopril 20mg, once a day, lorazepam 1mg, about she stated it was 8 hours, but she does not take it at all. Patient took occasionally meloxicam 15 mg, but it was not an ongoing thing and don't take to thin the blood. Patient don't need no thin blood with the aneurysm. Patient stated that lisinopril causes her to cough and took it for years. Patient took it for 15-18 years. Patient stated that she took two shots and it never bothers her other vaccine prior to 4 weeks of COVID vaccine. Patient wants to take the shot but not this year. On an unspecified the patient had some reaction to this second shot. Patient started of having in less than 24 hours after she had taken the shot fever, Chills, lots of night sweats and nausea and feel like been run over the train. Patient reported that three weeks back she had the first actually the couple of days over. Patient had it about 03:15 or something like that or 03:30 before that time the next day, she don't know maybe around 2'O clock 3'O clock the next day, Patient was sick and wanted to know how long this step was going to last, this fever and weakness and last night she had night sweats and have low appetite. The patient underwent lab tests and procedures for fever. Patient received the treatment of Tylenol. Outcome for all the reported events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: OPDIVO; VERAPAMIL; LISINOPRIL; LORAZEPAM; MELOXICAM

Current Illness:

ID: 1711796
Sex: F
Age:
State:

Vax Date: 08/01/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: kind of tired; arm hurt; started getting these little twitches; This is a spontaneous report from a contactable consumer (patient). A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient had experienced kind of tired, arm hurt and getting these little twitches. At the time of reporting, the outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711797
Sex: F
Age:
State:

Vax Date: 08/19/2021
Onset Date: 08/20/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data: Test Name: heart beat; Result Unstructured Data: Test Result:Rapid; Comments: SVT rapid heart beats over 200

Allergies:

Symptom List: Injection site pain

Symptoms: SVT rapid heart beats over 200. Hospitalized.; SVT rapid heart beats over 200. Hospitalized.; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number FA7485 and expiry date not reported), via an unspecified route of administration, on 19Aug2021 (at the age of 40-year-old), as dose 1, single, for COVID-19 immunisation in Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Aug2021, the patient experienced SVT rapid heartbeats over 200. Paint went to emergency room visit and was hospitalized. Patient was treated by cardiologist due to the events. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1711798
Sex: M
Age:
State: PA

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 09/18/2021
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: 2021; Test Name: Blood work; Result Unstructured Data: Test Result:unremarkable; Comments: all results are unremarkable; Test Date: 2021; Test Name: EMG; Result Unstructured Data: Test Result:confirmed peripheral neuropathy and carpal tunnel; Test Date: 2021; Test Name: COVID-19 antibody test; Test Result: Positive ; Comments: antibody test and did have antibodies, it was positive; Test Date: 2021; Test Name: COVID-19 antibody test; Test Result: Negative ; Comments: he was recently tested again for antibodies and it was negative

Allergies:

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

Symptoms: Heart attack; peripheral neuropathy continued and has gotten worse.; An outbreak of shingles on his left chest area and on his back on the scapula on the left side; it was carpal tunnel; he has sleep deprivation; The pain is worse when he sleeps; Inflammation in his hands; Within a month after the second vaccine he had an antibody test and did have antibodies, it was positive, but he was recently tested again for antibodies and it was negative; This is a spontaneous report from a contactable consumer (patient). A 71-years-old male patient of received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 12:30 (Age at vaccination 70-Years-old) (Batch/Lot Number: ER0730) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included polymyalgia rheumatica from an unknown date and unknown if ongoing His mother and brother both had polymyalgia rheumatica. Patient's medical history included Polymyalgia rheumatica. His mother and brother both had polymyalgia rheumatica. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Patient's family history included His father had everything and was overweight and diabetic, and died at 58 years old. His mother died at 91 years old from bone cancer. Concomitant medication included meloxicam taken for joint swelling from an unspecified start date and ongoing. The patient received BNT162B2 (PFIZER BIONTECH COVID VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:30 (age at vaccination 70-Years-old) (Batch/Lot Number: EN6201) as DOSE 1, SINGLE for covid-19 immunisation and experienced outbreak of shingles and after the shingles was treated and went away he was left with a frozen arm that turned into numbness and tingling in both arms and hands. It was reported that patient had polymyalgia rheumatica in the past but rheumatologist told him this wouldn't cause numbness and tingling in both hands, only one side so they don't think that was what was going on. Patient still had this in both hands and swelling and burning and had two rounds of steroids. It was reported that within a month after the second vaccine he had an antibody test and did had antibodies, it was positive, but he was recently tested again for antibodies and it was negative. Doctor told him that it was possible that it was because he was on a second round of steroids for inflammation in his hands, and he stopped taking steroids a week ago. He took a blood test at his annual physical and 4 or 5 months after the vaccine it was negative on antibodies. After 2nd dose he had an outbreak of shingles on his left chest area and on his back on the scapula on the left side. Stated that at first he thought he was having a heart attack, because of the heaviness on his chest and he also had frozen arm on right side, and he had a history of heart conditions. But stated that a heart attack normally affects the left arm. Stated that he always gets shots in left arm and didn't conclude that any of his symptoms had anything to do with the vaccine. He had not had the shingles vaccine yet, but if the covid vaccine was targeting his immune system then maybe it brought out the shingles virus. He stated that his frozen arm turned into numbness and tingling, and pretty soon was in both arms and hands, mostly in hands. His primary care doctor said that it was a side effect of the shingles and that it would go away in time. Within 3 weeks the shingles was gone. He had taken medications; it was never itchy but the peripheral neuropathy continued and has gotten worse. Now he had a team of neurologists and rheumatologists trying to determine the cause. His primary care doctor sent him to a neurologist because the neuropathy did not dissipate like he was told it would. The neurologist told him that it was carpal tunnel, but he did not had any repetitive motions or trauma. It happened at the time of the vaccine. The neurologist gave him steroids. Stated that he had Polymyalgia Rheumatica in the past, so the neurologist sent him to a rheumatologist before they started talking about doing surgery for carpal tunnel. The rheumatologist said that it is not Polymyalgia Rheumatica because the neuropathy is in both hands. It was reported that while he took the steroids his hands felt better, but as soon as the steroids ran out the symptoms returned due to the inflammation in his hands. Neuropathy was tingling and numbness but it's not as troubling as the swelling and burning that he had from the inflammation. He can't close his hands and make a fist. The neurologist did an EMG to check the conductivity of the nerves, which confirmed peripheral neuropathy and carpal tunnel, but they still don't understand where the inflammation came from, so they ran more tests. They have done a lot of blood work, but the results are all unremarkable; they have done every kind of blood test and all have been normal. They are going to do an EMG on his legs because the neurologist said if he had something super serious, like MS, he would also be having symptoms in his legs. He will also be having an MRI on his spine and vertebrae that will show the spinal column that holds the nerves that lead to his hands. Long story short, the doctors are stumped. He Stated that he had now taken 2nd round of steroids for the inflammation and burning. The pain was worse when he sleeps, which is typical of neuropathy, so he has sleep deprivation, his hands get stiff when he's not moving them. He has never had any of these problems before getting the vaccine. He has also learned at his annual physical that he no longer had any antibodies from the Covid vaccine. It was reported that he had antibodies about a month after getting the vaccine, but now he didn't had any antibodies 5 months after getting the vaccine, so now he was exposed again. He Stated that he stopped the steroids a week ago last Friday. Getting revaccinated was more important than taking the steroids. His doctors told him that the steroids may be the reason that he doesn't have antibodies anymore; when on steroids vaccines don't tend to work as well. Stated he had 3 neurologists, a rheumatologist, and a primary care doctor and no one has any answers. He stopped the steroids 1 week ago, from what he had read, he should not get a vaccine until 14 days post steroids. Event An outbreak of shingles on his left chest area and on his back on the scapula on the left side and peripheral neuropathy continued and has gotten worse led to Physician Office visit. The patient underwent lab tests and procedures which included blood test and showed unremarkable results in 2021, electromyogram confirmed peripheral neuropathy and carpal tunnel in 2021, sars-cov-2 antibody test positive on an unknown date in 2021 antibody test and did have antibodies, it was positive , sars-cov-2 antibody test and showed negative results in 2021 he was recently tested again for antibodies and it was negative. Therapeutic measures were taken as a result of an outbreak of shingles on his left chest area and on his back on the scapula on the left side, peripheral neuropathy continued and has gotten worse, it was carpal tunnel. At the time of this report, the outcome of events heart attack, within a month after the second vaccine he had an antibody test and did have antibodies, it was positive, but he was recently tested again for antibodies and it was negative, inflammation in his hands, it was carpal tunnel, he has sleep deprivation was unknown, an outbreak of shingles on his left chest area and on his back on the scapula on the left side recovered on an unknown date in 2021, peripheral neuropath

Other Meds: MELOXICAM

Current Illness:

ID: 1711799
Sex: F
Age:
State: VA

Vax Date: 08/27/2021
Onset Date: 08/30/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: body aches; headache; my supply has dropped; I also have been feeling like i took sedatives/I am having a hard time keeping awake during the day; I have hx of fatigue but the fatigue is really bothersome now.; heart has been fluttering; floating, my body felt very light; very sore arm; This is a spontaneous report from a contactable other hcp (patient). A 34-years-old female non pregnant patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 27Aug2021 14:45 as DOSE 2, SINGLE for covid-19 immunisation,(Age at vaccination-34yrs), Patient was not pregnant at the time of vaccination. Medical history included Hypertension, Premature Atrial Contractions, Asthma, Renal Artery Stenosis from an unknown date and unknown if ongoing, known allergies to Iodine, Contrast Dye, Shellfish, Morphine, Vicodin, Reaction to avocados from an unknown date and unknown if ongoing. Concomitant medication(s) included: PROCARDIA [NIFEDIPINE] 30 MG, Clopidogrel bisulfate (PLAVIX ) 75mg, Prenatal Vitamin (ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide) taken for an unspecified indication, start and stop date were not reported. The patient previously took past drugs iodine, morphine, vicodin and also took first dose bnt162b2(PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration administered in left arm on 06aug2021 at 12.00 pm for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. On 30Aug2021 the patient experienced Shortly after receiving the vaccine reported by patient itself as, she felt like she was floating, my body felt very light, very sore arm the next two days after that was on 01Sep2021 started experiencing body aches, headaches, and my heart has been fluttering. I also have been feeling like I took sedatives. I have hx of fatigue but the fatigue is really bothersome now. I am having a hard time keeping awake during the day and staying alert to do my job. I am breastfeeding and my supply has dropped. Patient was not diagnosed with COVID-19, prior to vaccination and also not been tested for COVID-19, since the vaccination. Patient received no treatment for the events. The clinical outcome of the events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.no further information is expected; 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 event Cardiac flutter cannot be totally excluded. The case will be reassessed if additional information becomes available.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.,Linked Report(s) : US-PFIZER INC-202101162607 Maternal/Child case

Other Meds: PROCARDIA [NIFEDIPINE]; PLAVIX; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1711800
Sex: F
Age:
State: TX

Vax Date: 03/01/2021
Onset Date: 03/10/2021
Rec V Date: 09/18/2021
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 Date: 20210817; Test Name: Covid test; Test Result: Positive ; Test Date: 20210817; Test Name: Covid test; Test Result: Negative

Allergies:

Symptom List: Tremor

Symptoms: One positive Covid test, one negative Covid test, doctor treating as if she has Covid, as she has a fever, after both vaccines; One positive Covid test, one negative Covid test, doctor treating as if she has Covid, as she has a fever, after both vaccines; One positive Covid test, one negative Covid test, doctor treating as if she has Covid, as she has a fever, after both vaccines; Aching pain in shoulder; This is a spontaneous report from a contactable reporter (Patient herself). A female patient of 32-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 19Jan2021 at 14:00 (Batch/Lot Number: EL9261, Expiry Date: Unknown) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on 01Mar2021 at 14:45 (Batch/Lot Number: EN6205, Expiry Date: Unknown) as DOSE 2, SINGLE both for covid-19 immunisation (at the age of 31-year-old) for the safety of her family. The patient's medical history and concomitant medications were not reported. Other products and patient History were reported as no. Vaccine was not administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): Pfizer, vaccine for Covid 19, dose one. No additional vaccines were administered on Same Date of the Pfizer Suspect. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine and events following prior vaccinations were none. Patient's Medical History (including any illness at time of vaccination) was none. Family Medical History Relevant to the event was not provided. On 18Aug2021, the patient had one positive covid test, one negative covid test, doctor treating as if she has covid, as she has a fever, after both vaccines. She had aching pain in shoulder (after second vaccine) on 10Mar2021 at 08:30. The patient underwent lab tests and procedures which included covid Blood Test, sars-cov-2 test that was positive on 17Aug2021 and sars-cov-2 test that was negative on 17Aug2021. Therapeutic measures were taken as a result of one positive covid test, one negative covid test, doctor treating as if she has covid, as she has a fever, after both vaccines (covid-19). Reporter stated she was reporting about the Pfizer, vaccine for Covid 19. She had some side effects from the vaccine, and she has some questions. Reporter stated she cannot tolerate the Covid nose swab test, and initially she went to the emergency room on 11Aug2021, to be tested for Covid. Reporter stated she refused the nose swab and was told to follow up with her doctor. Her doctor sent her for bloodwork to test her for Covid. The bloodwork was tested on 17Aug2021. Reporter reclarified that one test came back positive for Covid and a second test, came back negative. later in report, that her doctor is treating her as if she has Covid. Reporter asked how she could get those results, one positive and one negative? if she can get sick from Covid virus antibodies? her doctor was treating her, as if she has Covid. Reporter stated quarantined for 2 days, and since she was then negative, but her doctor treated her as if she had Covid. Reporter reads part of her doctor's notes and stated that she had symptoms, of a fever, and was fully vaccinated, and will quarantine according to her symptoms. Antipyretic Used (around the dates of Vaccination) included, Tylenol #3, given to Reporter by a friend. Strength was unknown to Reporter, by mouth on 02Mar2021 at 10:30 AM. A sample of the product was not available to be returned, if requested. Packaging sealed and intact was unknown. A notification generated from the gQTS system included, as part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and/or Q1252.Product Description (CR) reported as compound BNT162 Covid-19 Vaccine Suspension for Intramuscular 2ml multiple Dose vial x 1, Lot-# (CR): EL9261. Conclusion of Previously Completed Investigation (FCI/SI/OffCI) was, the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL9261was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EL9261, fill lot EL9252, and the formulated drug product lot EL9243. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. It was reported as, when more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. For (Root Parent) Complaint Number, Date Opened (GMT) on 30Mar2021, (Parent) Complaint Priority was normal. (Parent) Investigation was required. (Root Parent) was related to Potential AE. (Root Parent) Date of Contact (GMT) was 16Mar2021. Product Complaint Exchange Product Complaint Exchange, Initial item with PRD/SRD 16Mar2021[Got Covid], (BNT162B2). Pfizer-Biontech Covid-19 Vaccine injectable EL9261 - Lack of Effect. For (Root Parent) on 12Apr2021 at 11:39 AM (GMT-4:00) and 31Mar2021 at 09:06 AM (GMT-4:00) were added. Product quality investigation request LOE for Lot Number, EL9261 and EN6201, BNT162B2, QAEF COMPLAINT, FUP to PR ID. (Root Parent) G3 at 30Mar2021, no Rsnbly Suggest Device Malfunc. IDC - Level 1 was Quality, IDC - Level 2 was Product Complain, IDC - Level 3 was Complaint - Function / Therapeutic Properties. (Parent) Complaint Class was Product Use Attributes. (Parent) Complaint Sub-Class was Lack of Effect. (Parent) Brand/Trade Name was PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. (Parent) Product Family-API was BNT162B2. (Parent) Product-Description reported a COMPOUND BNT 162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1. (Parent) Product-Type reported as RX. (Parent) Product-Category was INJECTABLE. (Parent) was Sterile-Product. (Parent) was no combination-Product or Medical-Device (Parent) Lot-#, EL9261, Batch-Expiry 31May 2021. Fill Date (GMT) was 13Dec2020 and package Date (GMT) was 13Dec2020. Related Lot Type was Fill, for Related Lot # EL9252 and Related Lot Type, Bulk For Related Lot # EL9243. Due Date (GMT) was 14May2021 and original Due Date (GMT) was 14May2021. Reported as, yes manufacturing Site, Packaging Site, Finished Product Release Site and Investigating Site as Internal Pfizer Site/Department, Primary Op-U as. Pfizer reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number was valid, and an investigation will be performed. Repeat Investigation was not done. CAPA was Previously not Idented. Full Investigation was required. The complaint and its classification had been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This was a complaint for lack of effect of lot EL9261 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EL9261 pending review of lot genealogy. The investigation will include a review of the returned complaint sa

Other Meds:

Current Illness:

ID: 1711801
Sex: F
Age:
State:

Vax Date: 08/13/2021
Onset Date: 08/14/2021
Rec V Date: 09/18/2021
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: 20210814; Test Name: Temperature; Result Unstructured Data: Test Result:103; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:COVID-19; Comments: prior to vaccination; Test Name: Ultrasound; Result Unstructured Data: Test Result:complete miscarriage

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Miscarriage; Vomiting; 103 fever (2 consecutive); Pregnancy at time of Vaccination: Yes; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Aug2021 (at the age of 28-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported and concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient was pregnant at the time of vaccination and had maternal exposure during pregnancy. On 14Aug2021, the patient experienced 103 fever (2 consecutive), vomiting and had miscarriage. The patient received ultrasound-complete miscarriage and treatment for other events. The adverse events resulted in doctor or other health care professional office/clinic visit. The outcome of the events was recovered with sequel. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1711802
Sex: F
Age:
State:

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

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:

Allergies:

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

Symptoms: allergies; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program COVAX US Support via medical information team. A female patient of an unspecified age reported for herself that she received bnt162b2 (Comirnaty, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had first dose of Pfizer vaccine less than month ago. Pharmacist had told her not to get the second dose of covid vaccine because of her allergies. She did not have any issues from first dose. They told her it would be the 2nd dose that she would have an issue with. The patient wanted to know if she would be able to get second dose of vaccine. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711803
Sex: F
Age:
State: LA

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: A major flare up of general herpes; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown), dose 2 via an unspecified route of administration on 01Mar2021 (at the age of 50-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reported that after the second vaccination shot had a major recurrence. After the second dose of the vaccine, I had a major flare up of general herpes (01Mar2021) which I had not have a flare up of in over ten years so just wanna let you know that that will happen possibly and that was an adverse event part. The clinical outcome of event was unknown. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711804
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: pain in the right leg; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. The patient experienced pain in the right from the COVID-19 first shot. The outcome of the event was unknown. The lot number was not provided. Information on lot number has been requested during follow up.

Other Meds:

Current Illness:

ID: 1711805
Sex: F
Age:
State: NV

Vax Date: 07/02/2021
Onset Date: 07/02/2021
Rec V Date: 09/18/2021
Hospital:

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: fever; chills; sleepiness; pain in her right arm where she got the shot at.; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: SW0167) (at the age of 57-years-old), via an unspecified route of administration, right arm on 02Jul2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On01Jul2021, the patient had experienced severe pain in right arm. On 02Jul2021, the patient had experienced fever, chills and sleepiness. Additional Context: Stated that with the second shot that within three days she had severe chest pains, leg cramps, lightheadedness and swollen lymph nodes. Is for Pfizer Covid shot. Stated that she does not think that she should get the third shot because of the chest pain. No treatment was received in response to the adverse events. On 02Jul2021, the event sleepiness was recovered. On 07Jul2021, the events fever and chills was recovered. At the time of reporting, the event pain in her right arm where she got the shot at was not recovered. Product details: Stated that the second shot was on 01Aug2021 NDC unknown, expiration unknown and lot SH7485. Stated that it was in the right arm. Stated that the card was hard to read. No Follow-up attempts are possible. No information is expected further.

Other Meds:

Current Illness:

ID: 1711807
Sex: F
Age:
State: NV

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/18/2021
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:

Allergies:

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

Symptoms: severe chest pain; leg cramps; lightheadedness; swollen lymph nodes; headache; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: SH7485, Expiry Date: Unknown) via an unspecified route of administration, administered in arm right on 01Aug2021 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications reported. No investigation assessment was provided. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: SW0167) via an unspecified route of administration, administered in arm right on 02Jul2021 (at the age of 57-years-old) as dose 1, single for COVID-19 vaccination. The patient wanted to report her side effects. Stated with the first shot that she had fever, chills, sleepiness and pain in her right arm, headache where she got the shot on 02Jul2021. On unknown date in Aug2021, the patient stated that within three days of second shot, she had severe chest pain, leg cramps, lightheadedness and swollen lymph nodes. Stated that she does not think that she should get the third shot because of the chest pain. The patient stated that she was having chest pain 2-3 times a week but now she was having it once a week. Mentioned that she had a headache with the second shot in 2021. No treatment was reported for the reported events. The outcome of the events of severe chest pain was recovering; event of lightheadedness was recovered on an unknown date in 2021; and other events was not recovered at the time of reporting.

Other Meds:

Current Illness:

ID: 1711808
Sex: U
Age:
State:

Vax Date: 09/04/2021
Onset Date: 09/01/2021
Rec V Date: 09/18/2021
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: Pain in extremity

Symptoms: Itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FC3183; Expiration Date: Oct2021), dose 1 via an unspecified route of administration on 04Sep2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced itching on Sep2021. Reporter stated, " So, I have my vaccine yesterday actually, I got my first dose yesterday of the Pfizer and I wasn't sure whom to call all the pharmacy are closed and hospital are not giving me any answer so, I am not quite sure too I am having like itching, Is that normal? And itching everywhere. "Should I be worried about that I was reaction with itching? I am not having trouble in breathing, I am not having hives, I am just itching. Outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1711809
Sex: M
Age:
State: AZ

Vax Date: 08/27/2021
Onset Date: 08/28/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: When he coughs she can hear his chest; When he coughs she can hear his chest; He has got real bad runny nose; I get the other allergy reaction; This is a spontaneous report from a contactable consumer or other non HCP (Reporter's grandson). A 15-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 27Aug2021 at 16:30 (at the age of 15-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included ongoing asthma. The patient had no family medical history relevant to AE. Concomitant medication included salbutamol sulfate (PROAIR [SALBUTAMOL SULFATE]) taken for asthma and unspecified inhaler start and stop date were not reported. It was reported the patient received this concomitant medications since born. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any events prior vaccinations. The patient got real bad runny nose and get the other allergy reaction on 28Aug2021. On 03Sep2021 in the morning, the patient can breathe, when he coughs she can hear his chest. Like how boogers escape and where they go and that why he sounds like that. The patient not visited emergency room or physician office due to the events. It was reported that the patient born in incubator and there for a month or two diagnosed with asthma. The patient received Benadryl last night for the events. Therapeutic measures were taken as a result of events. The outcome of events was unknown and for event bad runny nose was not recovered The lot number for the vaccine [BNT162B2], was not provided and will be requested during follow up.

Other Meds: PROAIR [SALBUTAMOL SULFATE]

Current Illness: Asthma

ID: 1711810
Sex: M
Age:
State: CT

Vax Date: 03/04/2021
Onset Date: 08/30/2021
Rec V Date: 09/18/2021
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 Date: 20210901; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab

Allergies:

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

Symptoms: Positive covid test result, PCR, taken Wednesday 01Sep2021. First symptoms Monday 30Aug2021; Positive covid test result, PCR, taken Wednesday 01Sep2021. First symptoms Monday 30Aug2021; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: UNKNOWN), both doses via intramuscular administered in left arm as dose 2, single on 04Mar2021 and as dose 1, single on 11Feb2021 (at the age of 44-year-old) for covid-19 immunisation. The patient medical history was not reported. No concomitant medications were administered. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received no other medications within 2 weeks of vaccination. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination. On 30Aug2021, the patient experienced first symptoms and on 01sep2021, he was tested PCR nasal swab resulted positive. Lab tests and procedures which included SARS-COV-2 test: positive on 01Sep2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date in Sep2021. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711811
Sex: F
Age:
State: WA

Vax Date: 05/18/2021
Onset Date:
Rec V Date: 09/18/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: sore arm; her arm hurts but its getting worse; can feel a lump in that arm; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8735) dose 2 via an unspecified route of administration, administered in Arm Left on 18May2021 as DOSE 2, SINGLE (Age at vacciantion 41-years-old) was for covid-19 immunisation. Medical history included migraine (Migraine). The patient's concomitant medications were not reported. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8736) via an unspecified route of administration on 27Apr2021 as DOSE 1, SINGLE was for covid-19 immunisation. Patient does not received any vaccine prior to the vaccinations and did not visited emergency Room or physician Office. On an unspecified date, the patient experienced sore arm (pain in extremity), her arm hurts but its getting worse (condition aggravated) (non-serious) and feel a lump in that arm (mass). On an unspecified, date with outcome of unknown. The outcome of the event pain in extremity outcome of not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1711812
Sex: U
Age:
State:

Vax Date: 09/03/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: My hands will start falling in sleeping; my finger, index finger is numb, my hands is whole numb; I have numbness it won't go away; This is a spontaneous report from a contactable consumer (patient) reported for self. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 03Sep2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient regrets getting Pfizer shot, it was giving side effect right now. The patient got it on Friday 03Sep2021 and now the patient's hands would start falling in sleeping, the patient's finger, index finger was numb, the patient's hands was whole numb. The patient had numbness it won't go away. The patient wanted to know if the patient had to get the second shot because the second shot was due on 24Sep2021. The patient asked whether to go and get second one and get more side effects. The outcome of the event was not resolved. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711813
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/18/2021
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: I was having fluttering of my heart and I was feel like, It is been stuck; It's just 5 days or a week ago like, I am experiencing it.; This is a spontaneous report from a contactable consumer (patient herself). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0186, Expiry date, NDC number, UPC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had experienced i was having fluttering of my heart and i was feel like, it is been stuck; it's just 5 days or a week ago like, i am experiencing it. Caller stated, I don't see LOT# number on my card. It's my name, my date of birth, first dose. Oh Is the number in box on the card, Started with E. It has some letter in it. It is (#). That's what I see under the word Pfizer. Caller stated, do you have to document because I am asking a question, patient had the question about the Covid vaccine. Patient got the 1st shot and didn't show any reaction, but side effect, when came home, I was having fluttering of my heart and I was feel like, It is been stuck and Is it recommended that, You take the 2nd dose after experience that because the patient did not and had not this qualification so, patient's doctor knows about it. It's just 5 days or a week ago like, patient experiencing it. Caller stated, what is that, No. patient consulted the doctor and they didn't gave any medication. The patient did not receive treatment for the adverse event. The outcome of events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1711814
Sex: F
Age:
State:

Vax Date: 08/29/2021
Onset Date: 09/05/2021
Rec V Date: 09/18/2021
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: Test Date: 20210906; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:tested positive

Allergies:

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

Symptoms: they are now testing positive for COVID 19; her daughter began to feel bad yesterday; This is a spontaneous report from a contactable consumer (patient's mother) for the patient (daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 29Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter states that her daughter got her first dose of the vaccine on 29Aug2021. She states that they have not been exposed to anyone with COVID 19 and that they are now testing positive for COVID 19. She states that it has been 8-9 days and she tested positive on Saturday and her daughter tested positive today (06Sep2021). She would like to know if this is because of the vaccine and that they really don't have the virus? She makes an example of when people get the flu shot and then get sick with the flu. She states that it's the same because the vaccine is COVID that they put in their body. She states that her daughter began to feel bad yesterday (05Sep2021). The reporter would like to know if she can still get her second dose of the vaccine now since she has tested positive after the first dose. She also states that this vaccine is the virus so that is why she is testing positive right? She states that the vaccine puts the virus in your body. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive on 06Sep2021. The outcome of both the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1711815
Sex: F
Age:
State:

Vax Date: 09/04/2021
Onset Date: 09/05/2021
Rec V Date: 09/18/2021
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: 20210905; Test Name: Rapid Test; Test Result: Positive ; Comments: tested positive today for the rapid test

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: tested positive today for the rapid test; This is a spontaneous report from a Pfizer sponsored program. A Non-contactable consumer reported for a patient (reporter's wife) reported that: A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 04Sep2021 as dose 1, single for covid-19 immunization. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported. The caller wanted to know that if his wife take 2nd dose since his wife got covid-19 vaccine yesterday and she tested positive today (i.e. 05Sep2021) for the rapid test. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1711816
Sex: M
Age:
State:

Vax Date: 07/23/2021
Onset Date: 07/27/2021
Rec V Date: 09/18/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Lymphadenopathy of the left shoulder with pain, Lymphadenopathy of right shoulder.; Lymphadenopathy of the left shoulder with pain, Lymphadenopathy of right shoulder.; This is a spontaneous report from a non-contactable consumer. This 51-year-old male consumer (patient) reported. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FA7484), dose 2 via an unspecified route of administration, administered in Arm Left on 23Jul2021 (at the age of 51-years-old) as a single dose for covid-19 immunization. Medical history included hypertension, glucose tolerance impaired and pre-diabetic. Concomitant medication(s) included amlodipine besilate, hydrochlorothiazide, valsartan (AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE); losartan; simvastatin. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: PA6780), dose 1 via an unspecified route of administration, administered in Arm Left on 09Jul2021 (at the age of 51-years-old) as a single dose for covid-19 immunization. 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. On 27Jul2021, the patient experienced lymphadenopathy of the left shoulder with pain, lymphadenopathy of right shoulder. The patient was hospitalization for the event. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient did not receive any treatment. Outcome of the event was not recovered, at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE; LOSARTAN; SIMVASTATIN

Current Illness:

ID: 1711817
Sex: F
Age:
State: AR

Vax Date: 08/12/2021
Onset Date: 08/13/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Redness and swelling at the injection site; Redness and swelling at the injection site; Irregular non-period-related bleeding the day after the second dose; severe headaches; chills; fatigue; This is a spontaneous report from a non-contactable consumer (Patient). A 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FO8448, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 12Aug2021 09:30 (at the age of 49-year-old) as dose 2, single for COVID-19 immunization. The patient medical history was none. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (TAYTULLA) (birth control generic for Taytulla). The patient previously took oral minocycline for acne and experienced hypersensitivity (allergy). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0171, and Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 22Jul2021 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. The patient received no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID since vaccination. 0n 13Aug2021 01:00, the patient experienced irregular non-period-related bleeding the day after the second dose, severe headaches (Moderate to severe headaches), chills, and fatigue for 9 days starting the morning after the 2nd dose of the vaccine. On 14Aug2021, the patient experienced redness and swelling at the injection site for about 3 days. No treatment was given for the event. The outcome of the events was reported as resolved on an unspecified date in 2021. No follow-up attempts are possible, Information about Lot/Batch number cannot be obtained.

Other Meds: TAYTULLA

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am