VAERS 2021 Database www.vaers.hhs.gov

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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: 1646053
Sex: F
Age:
State: PA

Vax Date: 07/24/2021
Onset Date: 07/26/2021
Rec V Date: 08/28/2021
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: swelling of throat; Severe hives; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0198, Expiry date was not reported), via intramuscular route of administration on 24Jul2021 11:00 (at the age of 31-years-old) in Arm right as dose 2, single for COVID-19 immunization. The patient Medical history included irritable bowel syndrome from an unknown date and unknown if ongoing, cat scan dye from an unknown date and unknown if ongoing, honey bee venom from an unknown date and unknown if ongoing. Concomitant medication(s) included eluxadoline (VIBERZI); omeprazole (OMEPRAZOLE); lamotrigine (LAMICTAL); pancreatin (CREON); dicyclomine (DICYCLOMINE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took Latuda medication. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0176 and Expiry date was not reported), via intramuscular route of administration on 03Jul2021 12:00pm (at the age of 31-years-old) in Arm left as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination patient was not tested for COVID-19. On 26JUL2021 10:40, the patient experienced severe hives, On 27Jul2021 the patient experienced swelling of throat. Therapeutic measures were taken as a result of severe hives, swelling of throat with Prednisone, Benedryl , hydroxyzine, Zyrtec, steroid cream. The outcome for the events was not recovered.

Other Meds: VIBERZI; OMEPRAZOLE; LAMICTAL; CREON; DICYCLOMINE

Current Illness:

ID: 1646054
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: rheumatoid arthritis flare up; experienced inability to get out of bed; sickness; FACILITATED COLLECT This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer. A 62-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in 2021 at dose 1, single and the second dose intramuscularly in 2021 at dose 2, single for COVID-19 immunisation; patient started to receive adalimumab (HUMIRA solution for injection in pre-filled pen, citrate free) subcutaneously for moderate to rheumatoid arthritis; prednisone for unspecified indication. Medical history included moderate to rheumatoid arthritis. It was unknown if patient was enrolled in a COVID-19 vaccine trial. Concomitant medications were not reported. In 2021, the patient experienced inability to get out of bed, sickness and rheumatoid arthritis flare up. The patient also experienced prednisone with no effect. The events were reported as follows: patient experienced events of non-serious inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up with adalimumab. In 2021, the patient experienced inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up. Prednisone and BNT162b2 were also considered suspect. The action taken with adalimumab and prednisone was unknown. The patient was recovering from the events. Causality for adalimumab: the reporter's causality for the event(s) of inability to get out of bed, prednisone with no effect, sickness and rheumatoid arthritis flare up was not provided. The reporter's assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. 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 Rheumatoid arthritis, Mobility decreased, and Illness and the suspect drugs. 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: 1646055
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: I noticed a few hours ago that I have a very light swelling at my left arm that in my armpit area, I am assuming that would be the lymph node area, that it's on the same site of vaccine; Swelling at my left arm; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 2, SINGLE for an unspecified indication. The patient medical history was not reported. Patient took first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) on an unspecified date for covid-19 immunization. The patient's concomitant medications were not reported. On an unspecified date the patient experienced i noticed a few hours ago that i have a very light swelling at my left arm that in my armpit area, i am assuming that would be the lymph node area, that it's on the same site of vaccine, swelling at my left arm. 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: 1646056
Sex: M
Age:
State:

Vax Date: 07/23/2021
Onset Date: 07/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210729; Test Name: Heart rate; Result Unstructured Data: Test Result:113; Test Date: 20210729; Test Name: Saturation; Result Unstructured Data: Test Result:Fine

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Heart rate, 113; Feel on and off like I can not feeling like too well; Mild headache that comes and go; Muscle ache; Sensation in my stomach, like my stomach burn, sort of like heart burn sensation sort off; Sense of anxiety; This is a spontaneous report received from a contactable consumer. This 36-year-old male consumer (patient) reported for himself. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection lot number was not reported) via an unspecified route of administration in arm right on 23Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing I had asthma as a child, but I think I cured out of it as a guy as I grow older. Concomitant medications were not reported. On 23Jul2021, it was reported by the patient that that I had symptoms that still kind off lingering around that mild headache that comes and go, sort of like muscle aches and then I had been through like sensation in my stomach, like my stomach burn, sort of like heart burn sensation sort off, I did not had any of that I was so, feeling a sense of anxiety and checked saturation and heart rate last night when I got home from work and wanted to check my heart rate, 113 for my heart rate and my saturation was fine, I can just feel on and off like I cannot feeling like too well. Treatment received was Tylenol and Ibuprofen, use for muscle ache. The patient underwent lab tests and procedures which included heart rate resulted as 113 on 29Jul2021, saturation resulted as fine on 29Jul2021. The clinical outcome of the events 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: 1646057
Sex: U
Age:
State:

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
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: I feel not so good in my heart area; I feel like a pressure in the chest area; I do not feel good; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 29Jul2021 as dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated I got the vaccine couple of hours ago (Like two hours ago) and i feel not so good in my heart area, i feel like a pressure in the chest area, i do not feel good on 29Jul2021. Patient stated tell me if it is normal or if it could be bad you know because I was afraid to get the vaccine and now I feel bad you know. Consumer wanted to know what to do if it would get worse whether to go to the hospital or something. The clinical outcome of 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: 1646058
Sex: M
Age:
State: KY

Vax Date: 06/14/2021
Onset Date: 06/14/2021
Rec V Date: 08/28/2021
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: Test Date: 2021; Test Name: Antibody test; Result Unstructured Data: Test Result:0; Comments: Did not have antibodies in his system after the first dose; Test Date: 2021; Test Name: Antibody test; Result Unstructured Data: Test Result:0; Comments: Did not have antibodies in his system after the second dose; Test Date: 20210726; Test Name: Antibody test; Result Unstructured Data: Test Result:1000; Comments: Antibodies went from zero to 1000 after receiving a third dose; Test Name: WBC count; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: A little soreness; Antibodies went from zero to 1000 after receiving a third dose; Antibodies went from zero to 1000 after receiving a third dose; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Vaccine Lot Number was unknown; vaccine lot expire date was unknown), dose 3 via an unspecified route of administration, administered in the left arm on 14Jun2021 (age at vaccination was 77-year-old) as a dose 3, single for covid-19 immunisation at Pharmacy/Drug Store. The patient medical history included chronic lymphocytic leukaemia from an unknown date and unknown if ongoing Diagnosed 6 years ago; they just monitor his white blood cell count up to 60,000. He had immunodeficiency from an unknown date and unknown if ongoing He does have a Compromised immune system as far as his Chronic lymphocytic leukemia (CLL). He did have a Compromised immune system as far as his Chronic lymphocytic leukemia (CLL). There were no concomitant medications. The patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Expiry Date: Unknown), dose 1 via an unspecified route of administration, administered in the left arm on Jan2021 around 11am (age at the time of vaccination 76-year-old) as a dose 1, single and dose 2 via an unspecified route of administration, administered in the left arm on 05Feb2021 around 11am (at the age of 76-years-old) as a DOSE 2, SINGLE both for covid-19 immunisation at Hospital. Other Products reported as No. The reporter believed he was administered all three doses in his left arm. He had no effects, just a little soreness the next day. 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) included First dose of the COVID Vaccine; Second dose of the COVID Vaccine (Lot Number / Expiry Date: Unknown). Additional Vaccines Administered on Same Date of the Pfizer Suspect considered as suspect were none. Prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s) were None. The patient experienced antibodies went from zero to 1000 after receiving a third dose on 14Jun2021 and a little soreness on 15Jun2021. Patient did not have antibodies in his system after the first and second dose. The Reporter was reporting, this experience with the COVID vaccine. he reported that, first of all, he was 77 years old, and he had a condition called Chronic lymphocytic leukemia (CLL). He had his first 2 vaccines back in Jan and beginning of Feb. Then, somewhere like 4 months later, he got tested for antibodies twice, about a month apart. Both tests revealed he did not have any antibodies in his system. He states the tests and blood work were through withheld. He confirmed he did not have any antibodies. Recently, back in the beginning of Jun, he got a third vaccine. Nobody told him to do it, he just walked in and got a third shot. He got another antibody testing done after receiving the third vaccine and his antibodies went from zero to 1000. Reporter stated when he initially received the first two vaccines, he was 76 years old; he had a birthday in June and was now 77. His doctor (Oncologist/Hematologist) treated his Leukemia is separate. The reporter verified he did not have his vaccine record card with him to provide any details regarding the three doses he received. He believed he received his second dose on 05Feb2021, so if you count back 3 weeks prior to that date, that was about the time he received his first dose. The third dose he received on 14Jun2021. The reporter believed he was administered all three doses in his left arm. He had no effects, just a little soreness the next day. He doesn't take any other medications at all. He knew he got the third dose on 14Jun2021 and wanted to wait a month or a little longer after getting the third vaccine. He didn't want to be tested right after the third shot. He got his lab work done around 26Jul2021 where his antibodies were at 1,000. He had his first 2 COVID vaccines back in Jan and beginning of Feb. Then, somewhere like 4 months later, he got tested for antibodies twice, about a month apart. Both tests revealed he did not have any antibodies in his system. Back in the beginning of Jun, he got a third vaccine. Nobody told him to do it, he just walked in and got a third shot. He got another antibody testing done after receiving the third vaccine and his antibodies went from zero to 1000. The reporter verified he does not have his vaccine record card with him to provide any details regarding the three doses he received. Antibodies test, he had the lab results, but doesn't have the dates of his test with him. The patient underwent lab tests and procedures which included sars-cov-2 antibody test that was 0 on 2021 and did not have antibodies in his system after the first dose, sars-cov-2 antibody test that was 0 on 2021 did not have antibodies in his system after the second dose, sars-cov-2 antibody test that were 1000 on 26Jul2021 antibodies went from zero to 1000 after receiving a third dose and white blood cell count that was unknown on an unspecified date. Reporter seriousness for the event was unspecified. Outcome of 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: 1646059
Sex: F
Age:
State: FL

Vax Date: 03/31/2021
Onset Date: 04/05/2021
Rec V Date: 08/28/2021
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: Basal cell carcinoma in nose; Alopecia Areata; Telugen effluvium; Lost lots of hair, eventually noticed it started to fall in patches.; This is a spontaneous report received from a contactable consumer. A 39-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, in Arm Left on 31Mar2021 14:30 (Batch/Lot Number: Ep 1533) (at the age of 39 years-old) as single dose for covid-19 immunisation . The patient had received the first dose of vaccine on 31Mar2021 at 02:30 PM (Lot Ep 1533) in Left arm. The patient medical history was not reported. The patient's 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. Patient was not pregnant. Drug history included drug allergy to bactrim. On 05Apr2021 the patient experienced lost lots of hair, eventually noticed it started to fall in patches. She saw 2 doctors and both diagnosed alopecia areata and Telogen effluvium in May2021. At the same time while going through the process she was also diagnosed with a basal cell carcinoma in her nose. The adverse events resulted in the Doctor or other healthcare professional office/clinic visit . Treatment received for the adverse events inclued steroid shots, steroid topical creams, uv light tr. The outcome of the events was recovering.

Other Meds:

Current Illness:

ID: 1646060
Sex: F
Age:
State:

Vax Date: 02/01/2021
Onset Date: 12/01/2020
Rec V Date: 08/28/2021
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 Date: 20210318; Test Name: Blood Works; Result Unstructured Data: Test Result: Normal; Test Date: 20210318; Test Name: Computerized Tomography; Result Unstructured Data: Test Result: Normal; Test Date: 20210318; Test Name: Electroencephalogram; Result Unstructured Data: Test Result: Normal; Test Date: 20210318; Test Name: Magnetic Resonance Imaging; Result Unstructured Data: Test Result: Normal; Test Date: 202102; Test Name: Physical Examination of Throat; Result Unstructured Data: Test Result: Infected Tonsils.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Stroke; Tonsillitis; Confusion; This is a solicited report from the marketing program 'Facilitated Collect' received from a contactable consumer (patient) based on information received by Pfizer from via (Manufacturer Control Number: 21K-163-3999881-00). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via intramuscular, on 17Mar2021 at single dose for COVID-19 immunisation. Co-suspect drug includes adalimumab (HUMIRA), via subcutaneous, at dose of 40 mg cyclic (1 in 2 weeks) from 2016 to an unspecified date on Feb2021 and then restarted in Feb2021 at same dose and regimen for moderate to severe rheumatoid arthritis. The patient is a non-smoker and abstains from alcohol. Relevant medical history included back problems, rheumatoid arthritis, high blood pressure, depression, anxiety, acid reflux, patent foramen ovale, weight loss, fluid retention, allergies, chronic pain in back and legs, insomnia and anti-inflammatory therapy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Past drug history included allergy manifested by hives to acetylsalicylic acid (ASPIRIN), naproxen sodium (ALEVE), ibuprofen, benzylpenicillin potassium (PENICILLIN), and naproxen. Relevant concomitant medications included paracetamol (TYLENOL), cefixime (FLEXERIL) for back problems, gabapentin (NEURONTIN) as anti-inflammatory therapy, prednisone for rheumatoid arthritis, methotrexate for rheumatoid arthritis, folic acid for rheumatoid arthritis, amlodipine besilate (NORVASC) for high blood pressure, escitalopram oxalate (LEXAPRO) for depression, buspirone hydrochloride (BUSPAR) for anxiety, alprazolam (XANAX) for anxiety, aluminum hydroxide gel, dried, magnesium carbonate (PEPCID) for acid reflux, clopidogrel bisulfate (PLAVIX) for patent foramen ovale, phentermine for weight loss, furosemide sodium (LASIX) for fluid retention, colecalciferol (VITAMIN D), ascorbic acid (VITAMIN C), cetirizine for allergies, oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) for chronic pain in back and legs, trazodone for insomnia, losartan potassium (COZAAR) for high blood pressure, and multivitamin. In Dec2020 the patient had tonsillitis. In Feb2021, physical examination of throat revealed tonsils infected and on 04Feb2021, the patient underwent removal of her tonsils because it was infected and was hospitalized overnight. She was prescribed antibiotics (unspecified) for two weeks. She stopped taking HUMIRA when she was taking her antibiotics as advised by her physician. On 18Mar2021, the patient had stroke for which she was hospitalized for 3 days. The event stroke was also considered medically significant. She was given tissue plasminogen activator to stop her stroke. She believed that she had her stroke when she received her COVID 19 Vaccine because it was her vaccinations a day before she had her stoke. She was kicked by her student which was autistic in the head. On unknown date, the patient presented confusional state. On 18Mar2021, blood test, computerized tomogram and electroencephalogram were normal. The patient had recovered from stroke in 2021; she was recovering from confusion; and she had recovered from tonsillitis in 2021. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via intramuscular, on 05Apr2021 to complete COVID-19 immunisation. Pfizer's statement: The reporter's assessment of the causal relationship of the events with BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for the events of stroke, tonsillitis and confusion with adalimumab (HUMIRA) was no reasonable possibility. Manufacturer opinion is that there is no reasonable possibility that the events of stroke, and confusion are related to adalimumab (HUMIRA). Manufacturer opinion is that there is a reasonable possibility that the event of tonsillitis (infected tonsils) is related to adalimumab (HUMIRA). No follow-up attempts are possible; information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: The events are considered intercurrent conditions and unrelated to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown).

Other Meds: Tylenol; Flexeril [Cefixime]; Neurontin; Prednisone; Methotrexate; Folic Acid; Norvasc; Lexapro; Buspar; Xanax; Pepcid [Aluminum Hydroxide Gel, Dried; Magnesium Carbonate]; Plavix; Phentermine; Lasix [Furosemide Sodium]; Vitamin D [Colecalc

Current Illness:

ID: 1646061
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: High blood pressure; Result Unstructured Data: Test Result:High

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: going to die from your vaccine; nausea; vomiting; high blood pressure; This is a spontaneous report from contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as a dose number unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that, going to die from your vaccine, nausea, vomiting and high blood pressure. Patient asked, me how long after the vaccine can be nausea, vomiting last. I am already 2 weeks here with nausea, vomiting with the high blood pressure. I am going to die from your vaccine, I am going to die. The patient underwent lab tests and procedures which included blood pressure measurement which was high on an unspecified date. 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: 1646062
Sex: F
Age:
State: NJ

Vax Date: 07/28/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: hard lump where I got the vaccination; just lost 35 pounds; This is a spontaneous report from a contactable consumer reported for herself. A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 28Jul2021 (at the age of 29-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history, concomitant medications, investigation assessment and prior vaccinations within 4 weeks included none. he patient experienced hard lump where she got the vaccination, just lost 35 pounds on Jul2021. Patient had my vaccination (confirmed as Pfizer Covid vaccine) on Wednesday and had a very hard lump where she got the vaccination. And asked if that was normal. In response to weight, patient stated as 380, just lost 35 pounds (further clarification unknown). No treatment taken for event and stated she just didn't find it normal. Her friend just told to call and double check as how hard it was. Clinical outcome of events was unknown. Information about lot/batch number will be obtained during follow-up.

Other Meds:

Current Illness:

ID: 1646063
Sex: U
Age:
State: TN

Vax Date: 07/28/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
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: Metallic taste in my mouth; Right eye started to twitch/ Eye twitching; This is a spontaneous report from a contactable consumer (patient). A 61-year-old patient of an unspecified gender received first dose of BNT162b2 (COVID-19 Vaccine-Manufacturer Unknown, solution for injection), at an unknown route of administration at right arm on 28Jul2021 (lot Number: EW0161, expiry date: unknown), (at the age of 61-year-old), first dose, single for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient experienced metallic taste in the mouth and right eye started to twitch/eye twitching on 28Jul2021. The patient did not received treatment to the events. The event right eye started to twitch/eye twitching was not recovered. The event metallic taste in the mouth was recovered on 28Jul2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646064
Sex: F
Age:
State: WI

Vax Date: 06/29/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: left hand fingers went to sleep for about 7-8 hours; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181 and expiration date was not reported), first dose via an unspecified route of administration, administered in the left arm on 29Jun2021 (at the age of 62-year-old) as single for covid-19 immunization. The patient's medical history included drug hypersensitivity for septra and bactrim. The patient's concomitant medications were not reported. Patient did not had any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. On unspecified date in 2021, the patient experienced left hand fingers went to sleep for about 7-8 hours. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646065
Sex: F
Age:
State: TN

Vax Date: 07/25/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: 202107; Test Name: complete blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID; Test Result: Positive ; Test Name: ultrasound; Result Unstructured Data: Test Result:fibroids are real tiny; Test Date: 202107; Test Name: ultrasound; Result Unstructured Data: Test Result:fibroids were small

Allergies:

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

Symptoms: Bleeding; Pink tissue is gushing out of her; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in Left arm on 25Jul2021 (48-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included fibroids from Feb2012 to an unknown date Diagnosed while pregnant, covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) 500 mg daily from feb2020 which is ongoing for covid, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) from feb2020, 2000 iU, daily which was ongoing, Multivitamin taken all for covid-19 from Feb2020 and ongoing. The patient previously took BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EWD181 or EW0181), via an unspecified route of administration, administered in Arm Left on 03Jul2021 (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient received the second dose of the Pfizer Covid 19 vaccine on 25Jul2021. She received the first dose on 03Jul2021. She was calling to report a side effect. She was bleeding on 26Jul2021. Pink tissue was gushing out of her on unspecified date of Jul2021. She went to the emergency room. They ran a complete blood test and she had an ultrasound on unspecified date in Jul2021. She was told to follow up with her doctor. They said she needs to see a gynecologist. The clinic does not accept her insurance. The doctor said it was coming from the shot. She has had fibroids in the past. An ultrasound in the past showed that the fibroids are real tiny. The patient underwent lab tests and procedures which included blood test: unknown results on Jul2021, sars-cov-2 test: positive, ultrasound scan: fibroids are real tiny on an unspecified date on 2021. The ultrasound at the emergency room indicated that the fibroids were small on unspecified date on Jul2021. The clinical outcome of event bleeding was not recovered, and pink tissue is gushing out of her was unknown.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1646066
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: like my arm pit is kind of swollen and it hurts little bit; like my arm pit is kind of swollen and it hurts little bit; 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, Formulation: Solution for injection, Lot number: Unknown), 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 got the Shot (Pfizer Covid Vaccine) in left arm and slept on the arm on day the patient gets shot, the patient slept on arm and only need arm, when the knees, like arm pit was kind of swollen and it hurts little bit, so tried to figure out was it normal in arm or the patient do not know. The reporter reported "What number do you want? It's on the Vaccination card on the back of the Vaccination card. Okay on the Vaccination card I don't see a number on here, I just see my name". Consumer stated, "I am calling just to find out, I have swelling on my arm, I want to know if it's come from the shot. That's all I want to know. I don't need the address that's all I want to know where all this came to my arm, that's all I want to know. I don't want to need all this address all I want to know where this come did from the shot. Where did this come from the shot all I want to know because if this came from the shot, I won't be taking the second one. I didn't even know, could you send to the people I want to talk". The outcome of 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: 1646067
Sex: F
Age:
State:

Vax Date: 07/31/2021
Onset Date:
Rec V Date: 08/28/2021
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: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: I feel a little tired; Did not sleep well; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer sponsored program. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 31Jul2021 at 09:30 am (Batch/Lot Number: EW0182) as dose 1, single for covid-19 immunization (at the age of 62-years-old). The patient medical and concomitant medications were not reported. It was reported that after receiving the first dose of vaccine on an unspecified date in 2021, the patient felt a little tired and did not sleep well. The patient further stated she was calling also because she wants to know if ever she will feel headache or something and fever, what does she need to take as a medication. She was scheduled for the second dose on 21Aug2021 at 9:30am. She further stated that she was feeling okay and she felt a little tired because she did not sleep well last night and it might be from that and she was not sure. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1646068
Sex: F
Age:
State: MD

Vax Date: 07/29/2021
Onset Date: 07/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:110; Test Name: heart rate; Result Unstructured Data: Test Result:120; Test Name: heart rate; Result Unstructured Data: Test Result:125

Allergies:

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

Symptoms: Increased heart rate; Facial swelling; some swelling in my neck right underneath my chin; Shortness of breath and difficulty in breathing when my heart rate spikes; Numbness down my right arm; This is a spontaneous report from a contactable consumer. This 36-years old female consumer (patient) reported for herself. A 36-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0180, Expiration date: unknown), via unspecified route, administered in right arm on 29Jul2021 (at the age of 36-year-old) as dose 2, single for COVID-19 immunization. The patient medical history includes Coeliac disease from an unspecified date to unknown ongoing and concomitant medications includes loratadine, pseudoephedrine sulphate (CLARITIN-D) for an unknown indication, cyanocobalamin (B-12) for unknown indication, cholecalciferol, menaquinone-7, Phyto menadione, retinol palmitate, tocopherol, tocotrienols nos (VITAMIN D COMPLEX) for unknown indication. No vaccine was taken within four weeks prior to vaccinations. On 29Jul2021, immediately after the vaccination, the patient experienced increased heart rate that went down on its own within 15-to-20-minute, patient noticed that her heart rate was experiencing spikes even when she was sitting completely still. Her heart rate was increased to 110, 120 and 125. she wears a heart monitor, a watch that monitors her heart rate. Patient also experienced facial swelling and some swelling in the neck right underneath her chin, which was noticeable externally. Patient also started to experience some shortness of breath and difficulty in breathing when her heart rate spikes. patient also experienced numbness down the right arm, the same arm that she got the shot, not at the injection site its down the higher length of her arm. The patient lab data includes heart rate readings on unspecified dates which showed 110, 120, and 125. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.

Other Meds: CLARITIN-D; B-12; VITAMIN D COMPLEX

Current Illness:

ID: 1646069
Sex: F
Age:
State:

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 08/28/2021
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: 20210410; Test Name: Body Temperature; Result Unstructured Data: Test Result:Unknown results; Comments: Low Grade Fever

Allergies:

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

Symptoms: Psoriatic arthritis aggravated/ psoriatic arthritis flare; Ankle deformity/ deformed in feet, ankles, fingers; Foot deformity/ deformed in feet, ankles, fingers; Finger deformity/ deformed in feet, ankles, fingers; Raynaud's disease; Sleep unwell/ not sleeping well; Pain; Central nervous system inflammation/ neurological inflammation; Low grade fever; Sagging eyelid skin/ facial and eyelid sagging; Skin laxity; Feeling of warmth/ felt gentle warmth; Nail psoriasis; Vaccination site pain/ injection site hurt in arm; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-3861806-00). A non-contactable 53-year-old adult female consumer (patient) reported for herself. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE (tozinameran), Solution for injection. Batch/Lot number was not reported), dose 1 intramuscular, administered in Deltoid Left (Left shoulder) on 10Apr2021 (at the age of 53-years-old) as DOSE 1, SINGLE for COVID-19 immunization, adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for psoriatic arthropathy. The patient had a relevant medical history of sjogren's syndrome, raynaud's syndrome, postural orthostatic tachycardia syndrome, allergy, hypermobility syndrome, arthritis, nocturnal seizures, rem sleep behavior disorder, thrombocytopenia, hypothyroidism and endometriosis. Concomitant medication included levothyroxine sodium (SYNTHROID). It was unknown if patient was enrolled in a COVID-19 vaccine trial. On unknown dates, the patient experienced raynaud's disease, deformed in feet, ankles, fingers, not sleeping well, psoriatic arthritis flare and humira had no effect. In 2021, the patient experienced nail psoriasis and COVID vaccine injection site hurt in arm. On 10Apr2021, the patient experienced facial and eyelid sagging, neurological inflammation, felt gentle warmth, low grade fever and pain. In 2021, the COVID vaccine injection site hurt in arm and low grade fever resolved. On unknown dates, facial and eyelid sagging, neurological inflammation, felt gentle warmth and pain resolved. Pfizer biontech COVID-19 vaccine (tozinameran) was also considered suspect. Causality for humira(adalimumab). The reporter's causality for the events of facial and eyelid sagging onset 10Apr2021, facial and eyelid sagging onset 10Apr2021, neurological inflammation, felt gentle warmth, nail psoriasis, raynaud's disease, COVID vaccine injection site hurt in arm, deformed in feet, ankles, fingers unknown onset, deformed in feet, ankles, fingers unknown onset, deformed in feet, ankles, fingers unknown onset, low grade fever, not sleeping well, psoriatic arthritis flare, pain and humira had no effect was not provided. On 22Jul2021, received updates to study information, event information, reporter opinion of causality, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of nail psoriasis, raynaud's disease, COVID vaccine injection site hurt in arm, deformed in feet, ankles, fingers, not sleeping well and psoriatic arthritis flare were added. Causality as per reporter (Drug/Vaccine) for all the events not reported. The patient underwent lab tests and procedures which included body temperature: unknown results on 10Apr2021 Low Grade Fever. The outcome of the event psoriatic arthropathy was not recovered, nail psoriasis, raynaud's phenomenon, ankle deformity, foot deformity and finger deformity were unknown while other events were recovered on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided in narrative, The causal relation between the events of Vaccination site reaction, pain, fever, feeling of hot, Raynaud 'syndrome and suspected vaccine BNT162B2 cannot be totally excluded. The reported event of psoriatic arthropathy ,nail psoriasis, deformity in feet, deformity in ankles, deformity in fingers are consider not related to suspected vaccine and more likely due to ongoing medical history of Psoriasis .Reported event of sleeping unwell was considered unrelated to suspected vaccine more likely due to ongoing rem sleep behavior disorder. Event Neurological inflammation is consider unrelated to suspected vaccine and likely due to Sjogren's disease. 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) : 21K-163-3861806-00

Other Meds: SYNTHROID

Current Illness:

ID: 1646070
Sex: M
Age:
State: NC

Vax Date: 07/26/2021
Onset Date: 07/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210726; Test Name: Resting Heart Rate; Result Unstructured Data: Test Result:~+20 BPM

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Increased Resting Heart rate (~+20BPM); Sharp chest Pains on 3 occasions; Difficulty Breathing; This is a spontaneous report from a contactable consumer reporting for himself. This 37-year-old male patient received on 26Jul2021 16:00 at the age of 37-years first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ew0186) as single dose in the arm left for Covid-19 immunization. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 26Jul2021 21:00, the patient had Increased Resting Heart rate (~+20BPM), Sharp chest Pains on 3 occasions, Difficulty Breathing. No treatment was provided. Outcome was recovering. The case was reported as non serious.

Other Meds:

Current Illness:

ID: 1646071
Sex: F
Age:
State: MO

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 08/28/2021
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: fainted; seizure; heart racing; head still hurts to touch; sweating; shaking; extremely confused; This is a spontaneous report received from a contactable consumer (patient). A 23-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198), via an unspecified route of administration, administered in left arm on 16Jul2021 at 16:00 (at the age of 23-years-old) as dose 2, single for COVID-19 immunisation. The patient previously received the first dose of bnt162b2 (Lot no: EW1198) on 24Jun2021. The patient medical history was not reported. The patient was not COVID tested post vaccination. The patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE) taken for attention deficit hyperactivity disorder (ADHD), start and stop date were not reported, and unspecified birth control. The patient reported that after receiving her 2nd vaccination dose, she fainted and had a seizure in the pharmacy. Initially after receiving the shot, she felt normal for 30 seconds. She was browsing because they instructed her to wait 10 mins. She started to feel her heart racing as if she just sprinted, and she felt confused. She was worried she was going to be sick, so she went to sit back down in the patient area. That was all she remembered. She woke up to pharmacists and bystanders helping her. She was told that she landed on her head and had a seizure in the fetal position. Her head still hurts to touch that area the day of reporting. She was shaking and sweating after waking up and was extremely confused. Her head hurt so badly. There was a very nice pharmacist and bystander who helped keep her calm until the EMS arrived. Nothing like this has ever happened to her before and she did not have allergies. She was completely fine after her first dose. The events were treated with EMS care. The outcome of events was recovering.

Other Meds: VYVANSE

Current Illness:

ID: 1646072
Sex: F
Age:
State: NY

Vax Date: 07/20/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: blood pressure; Result Unstructured Data: Test Result:85/56; Test Date: 202107; Test Name: Pulse; Result Unstructured Data: Test Result:39; Test Date: 202107; Test Name: Pulse; Result Unstructured Data: Test Result:120; Test Date: 202107; Test Name: oxygen; Result Unstructured Data: Test Result:84%

Allergies:

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

Symptoms: Bradycardia; tachycardia; Extreme fatigue; oxygen was 84%; multiple fainting episodes; pulse was 39; pulse was 120; blood pressure was 85/56; she felt hot and sweaty; she felt hot and sweaty; Bruises all over her body from the fainting; it was like she was swimming through syrup and then she went down, the following day it happened again; She was still sore for quite awhile; This is a spontaneous report from a contactable nurse (patient). A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0198, Expiration date not reported), via an unspecified route of administration, administered in Deltoid Left on 20Jul2021 14:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation (reported as almost died from 1st interaction with Covid). Medical history included in 2017 she was in bad car accident that caused a brainstem injury and resulted in most of her current medical conditions, ongoing adrenal insufficiency (HPA access damage; Cortisol average is 2), narcolepsy from 2017 and ongoing, ongoing asthma (Born with it), migraine from 2017 and ongoing (treated with Botox), Velopharyngeal insuffiency from an unknown date (dysphagia, so she chokes frequently when she tries to eat and drink), ongoing Partially blind (no left vision in either eye. Wears glasses), ongoing vertigo (when she tips her head back/ posterior), ongoing 8 Herniated disc (8 discs in her back), ongoing dizziness, ongoing nausea, ongoing cardiac issues, COVID-19 from Oct2020 (She was very ill and had to have multiple steroid treatments to recover). Family history included father died from heart attack at 65 years old. She has allergies to preservatives (Stated she has tremendous allergies to sulfites, sulfa, thimerosal, basically all preservatives). Concomitant medication(s) included hydrocortisone (MANUFACTURER UNKNOWN) taken for adrenal insufficiency from an unspecified start date and ongoing; lisdexamfetamine mesilate (VYVANSE) taken for narcolepsy from an unspecified start date and ongoing; salbutamol (VENTOLIN [SALBUTAMOL]) taken for asthma from an unspecified start date and ongoing; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from an unspecified start date and ongoing; gabapentin (GABAPENTIN) taken for intervertebral disc protrusion from an unspecified start date and ongoing; topiramate (TOPAMAX) taken for migraine from an unspecified start date and ongoing; oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) taken for pain from an unspecified start date and ongoing; hyoscyamine taken for muscle spasms, start and stop date were not reported; meclizine hcl taken for dizziness, vertigo from an unspecified start date and ongoing; ondansetron (ZOFRAN [ONDANSETRON]) taken for nausea from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0198, Expiration date not reported), via an unspecified route of administration, administered in anterior Deltoid Left on 29Jun2021 14:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation and experienced sore arm, felt like she had a mild case of COVID for about 5 days, headache, fever, very dizzy and light headed, and almost fainted it may have been a vasovagal reaction. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Other historical vaccines included Flu vaccine and TDAP. On an unspecified date in Jul2021, the patient experienced oxygen was 84%, multiple fainting episodes, pulse was 39, pulse was 120, blood pressure was 85/56, she felt hot and sweaty, bruises all over her body from the fainting, it was like she was swimming through syrup and then she went down, the following day it happened again, she was still sore for quite a while. On an unspecified date, she experienced tachycardia, bradycardia and extreme fatigue. The consumer stated that she got her 2nd dose of the Pfizer Covid Vaccine on 20Jul2021. Since then, she has had all the other symptoms, and had a fainting episode at the time of the vaccine and multiple other fainting episodes since. Clarifies that the first fainting episode occurred the night after she got the shot, that night when she got up to get some Advil, it was like she was swimming through syrup and then she went down. The following day it happened again. Stated that she had a PulseOx and a blood pressure machine at her house, and her pulse was 39, and oxygen was 84%, which was what it was when she was sick with Covid; but her pulse and oxygen were not staying like that constantly. Stated that the day before, she felt hot and sweaty so she checked her pulse and it was 120. Caller stated that she was small, and typically her blood pressure was low normally, but it was 85/56 the two days before, so she had been all over the place since getting the 2nd dose of the vaccine. She was still sore for quite a while. She believed all her symptoms were directly related to the Covid vaccine, especially since the fainting episode started the day she got the 2nd dose. States she dose feel like she was improving; she's not falling on the ground fainting every day. Stated she has fainted about 6-7 times already; her dog took a hit for her, she fell on the dog instead of hitting the fireplace. Stated that it happened so fast, she tried to stop it, but there's just not always anything she can do. Sometimes she tried to cough to see if that will help, like forcing a vasovagal reaction. Stated that she had bruises all over her body from the fainting. Stated that the fainting could be an interaction with one of her medications, but at least she was alive. Most people with a brainstem injury didn't live. Stated this might be putting more stress on her heart which may not have been fully recovered from her experience with Covid. Stated after having Covid she had some cardiac issues that she was still recovering from. Stated that she did contact her physician, but they haven't contacted her back. She would like to see a Cardiologist, but she needs a referral. Stated that she had tremendous allergies to sulfites, sulfa, thimerosal, basically all preservatives; she has an EpiPen in case she needs it. Stated she can't take nitrates. No further details provided. Adverse events did not required visit to Emergency Room or Physician Office. She did read that some kids had experienced some mild myocarditis, so might be she was experiencing some of that. Caller states that her symptoms are definitely cardiac related; she is having tachycardia, bradycardia, and she knows the symptoms, and has extreme fatigue. She still feels the shots were worthwhile. Stated she was sure she just needs to rest, especially if it is myocarditis because there really isn't a treatment for it. On an unspecified date in Jul2021, the patient underwent lab tests and procedures which included blood pressure: 85/56, pulse: 39, pulse: 120, oxygen: 84%. Verbatim event relatedness: Pfizer Covid Vaccine: 2nd dose: multiple fainting episodes, pulse was 39, and oxygen was 84%, pulse was 120, blood pressure was 85/56 - Related. The outcome of event multiple fainting episodes was resolving whereas outcome of all other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events oxygen saturation decreased, syncope, bradycardia and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, E

Other Meds: HYDROCORTISONE; VYVANSE; VENTOLIN [SALBUTAMOL]; BREO ELLIPTA; GABAPENTIN; TOPAMAX; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; HYOSCYAMINE; MECLIZINE HCL; ZOFRAN [ONDANSETRON]

Current Illness: Adrenal insufficiency (HPA access damage; Cortisol average is 2.); Asthma (Born with it); Blindness unilateral (no left vision in either eye. Wears glasses); Cardiac disorder (after having Covid she had some cardiac issues that she was still recovering from); Dizziness; Herniated disc (8 discs in her back); Migraine (Treated with Botox); Narcolepsy; Nausea; Vertigo (When she tips her head back/ posterior)

ID: 1646073
Sex: F
Age:
State: NY

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: soreness in the leftcalf; slight fever; occasional pressure inthe head; muscle twitches in theleft calf; strange tinglingsensations in the face; numbness spread across the left side of the body. Through the arm, shoulder, neck, face and down the leg; minor swelling in the throat; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Jul2021 at 17:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medication within two weeks of COVID-19 vaccine. On 27Jul2021 at 17:45, the patient experienced minor swelling in her throat but nothing alarming. On the same day at 18:00, the patient experienced strange tingling sensations in face, and after that a numbness spread across her left side of the body, Through her arm, shoulder, neck, face and down her leg. On the same day at 18:15, the patient experienced soreness in her left calf. Even her tongue was divided in two sides, numbness was slight but feeling sense was different on one each side. This had now persisted for 72 hours, and she had a slight fever, she experienced occasional pressure in her head and muscle twitches in her left calf. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events minor swelling in her throat, strange tingling sensations in face, and after that a numbness spread across her left side of the body, through her arm, shoulder, neck, face and down her leg, soreness in her left calf. Even her tongue was divided in two sides, numbness was slight but feeling sense was different on one each side, a slight fever, occasional pressure in her head and muscle twitches in her left calf was not recovered at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1646074
Sex: F
Age:
State: PA

Vax Date: 04/19/2021
Onset Date: 05/24/2021
Rec V Date: 08/28/2021
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: Ulcerative Colitis within 2 weeks of the second shot of Pfizer ER8731; This is a spontaneous report from a contactable other health professional (patient). A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 19Apr2021 (Lot Number: ER8731) (at the age of 55-year-old) as single dose for COVID-19 immunisation. The patient did not experienced COVID-19 before or after vaccination. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included losartan; potassium; hydrochlorothiazide and amlodipine besylate, all concomitants were taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on an unspecified date (Lot Number: EW0168) as single dose for COVID-19 immunisation, the patient previously took propranolol and experienced allergy. The patient experienced ulcerative colitis within 2 weeks of the second shot of Pfizer ER8731 (as reported) on 24May2021. The event was serious, disabling. The event required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of ulcerative colitis and included treatment with mesalamine. The patient outcome of the event was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of ulcerative colitis due to temporal relationship. Case will be re-assessed upon the additional information provided. 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: LOSARTAN; POTASSIUM; HYDROCHLORZIDE; AMLODIPINE BESYLATE

Current Illness:

ID: 1646075
Sex: F
Age:
State:

Vax Date: 07/07/2021
Onset Date: 07/09/2021
Rec V Date: 08/28/2021
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: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Swollen node on top of collar bone; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Jul2021, the patient experienced swollen node on top of collar bone. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen node on top of collar bone was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646076
Sex: F
Age:
State: NJ

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
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: Light headed immediately afterwards; Loss of body function; Disoriented; Sleepy; This is a spontaneous report from a contactable healthcare professional, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 30Jul2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin, sulfur and latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not receive any concomitant medications. On 30Jul2021 at 16:30, the patient felt light headed immediately afterwards. She also experienced loss of body function, felt disoriented and sleepy. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light headed immediately afterwards, loss of body function, disoriented and sleepy were resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646077
Sex: F
Age:
State:

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Antibody; Result Unstructured Data: Test Result:UNKNOWN RESULTS

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Injection site pain immediately after receiving vaccine; This is a spontaneous report from a non-contactable nurse, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration on 30Jul2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021, immediately after receiving the vaccine, the patient experienced injection site pain. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent antibody test and the result was unknown. The clinical outcome of the event injection site pain was resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646078
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: lip feels little bit tingling; Lip or tongue reaction; This is a spontaneous report from a contactable consumer. This consumer (patient) of unknown age and gender reported that he/she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced lip feels little bit tingling and Lip or tongue reaction (Unspecified condition of the tongue). The event outcome was unknown. Consumer stated that he/she got ready to get my get my second shot after 3 weeks and had side effect which was lip feels little bit tingling and lip or tongue reaction. Consumer hung up the call abruptly. Hence further probing could not be done. Limited information available over the call. Report Comment: Reporter type could not probed, hence captured as Consumer or other non-health professional in tab by default. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646079
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: I am not functioning well at all; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA 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 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced i am not functioning well at all. I went to the Doctor like 5 times they cannot find anything wrong it is all because I have to get the second vaccine. Consumer was informed about Pfizer Medical Information Department. As consumer abruptly hung up the call. Product details, Pharmacy details and further probing could not be done. Limited information available over the call and appropriate response could not be provided. The 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: 1646080
Sex: F
Age:
State: CA

Vax Date: 07/27/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Fever; Body aches; Ankles pain; Knees pain; Hip pain; Unable to lift injected site arm; Face swelling; Tingling of feet and hands; Throwing up; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 27Jul2021 at 09:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to hay fever, opioids and some fruit. Concomitant medications included vitamins. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jun2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Jul2021 at 06:00, the patient experienced fever, body aches, ankles, knees pain, hip pain, unable to lift injected site arm, face swelling, tingling of feet, hands and throwing up. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, ankles, knees pain, hip pain, unable to lift injected site arm, face swelling, tingling of feet, hands and throwing up was recovering at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646081
Sex: F
Age:
State: FL

Vax Date: 07/25/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Jul2021 at 10:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 28Jul2021, the patient experienced painful and large swelling of lymph nodes (especially around neck, underarms and chest), swelling of lips and numbness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of the events painful and large swelling of lymph nodes (especially around neck, underarms and chest), swelling of lips and numbness were not recovered at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646082
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Name: Lactic dehydrogenase; Result Unstructured Data: Test Result:2871; Test Date: 202106; Test Name: Fever; Result Unstructured Data: Test Result:40.8 Centigrade; Test Name: CRP; Result Unstructured Data: Test Result:173.0; Test Name: Ddlmer; Result Unstructured Data: Test Result:>1000; Test Date: 202105; Test Name: Covid19 antibody; Result Unstructured Data: Test Result:>2500; Test Name: covid19 test; Test Result: Negative ; Test Name: Ferritin; Result Unstructured Data: Test Result:35114; Test Name: WBC; Result Unstructured Data: Test Result:35.56

Allergies:

Symptom List: Nausea

Symptoms: Cytokine storm; fever; short of breath; ground-glass opacities with the lung; This is a spontaneous report from a contactable consumer (husband) reported for a female patient A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on Apr2021 as single dose for covid-19 immunisation. First dose was administered in an unknown date in 2021. The patient medical history was not reported. The patient's concomitant medications were not reported. A month later, in the end of May, she started to have fever, and it lasted over 5 weeks. On the week five, she was admitted to withheld and after ruling out all infectious reasons, she was diagnosed as cytokine storm (onset in an unspecified date in 2021) related with the Covid vaccine. Her Covid19 antibody is >2500. She has been taking steroids (prednisone 50mg) since then, all metrics and cytokine storm are getting better. But in week nine, all of a sudden, the fever came back at 40.8 degree, and had short of breath symptom. She had to go ER at 2am on Sat and was transferred to ICU then, the doctor said many metrics and symptoms were very similar to Covid19 patients, but her covid19 test result was still negative. The symptoms she had including short of breath, fever, ground-glass opacities with the lung, and some metrics including WBC:35.56, Ferritin: 35114, CRP: 173.0, Lactic dehydrogenase: 2871, Ddimer>1000. Reporter said his wife is suffering from Cytokine storm which is very likely causing by the Covid19 vaccine, and she is having symptoms very similar to Covid19 patients. Her current doctors do not have much knowledge about the vaccine, so they cannot provide good solution for this issue. The outcome of Cytokine storm was recovering. The outcome of fever was not recovered. The outcome of short of breath and ground-glass opacities with the lung was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646083
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: facial swelling on the left side of the face; facial swelling on the left side of the face; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on an unknown date in Jul2021 at 10:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) for unknown indication and birth control (MANUFACTURER UNKNOWN) both from unknown dates and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 at 05:00 the patient experienced facial and lip swelling on the left side of the face. It was reported that the patient had filler on both the left and right side of the face but only the left side was swollen. Therapeutic measures were not taken as a result of the events. The event resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event facial and lip swelling on the left side of the face was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: ADDERALL

Current Illness:

ID: 1646084
Sex: M
Age:
State: LA

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Fever; Chills; Body ache; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in left arm on 30Jul2021 at 17:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient had no allergies to medications, food and other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jul2021 at 21:00, the patient experienced fever, chills and body ache. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit or emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events, fever, chills and body ache was recovering at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646085
Sex: F
Age:
State: NY

Vax Date: 07/28/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: estrogene level; Result Unstructured Data: Test Result: Low; Test Name: vitamin D level; Result Unstructured Data: Test Result: Low.

Allergies:

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

Symptoms: Blisters; Hives extreme itchiness on left arm and toes , ankles and bottom of feet/ hives; Hives extreme itchiness on left arm and toes, ankles and bottom of feet./ Itchiness; This is a spontaneous report from a contactable consumer (patient). An adult female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 28Jul2021 at 18:00 (Lot Number: FA7484) as single dose for COVID-19 immunisation. Medical history included low vitamin D and estrogen levels. The patient reported known allergies to FLAGYL and as a child to raw shrimp shells. There were no concomitant medications. The patient reported hives, extreme itchiness on left arm and toes, ankles and bottom of feet. The shot was Wednesday evening. Hives, blisters, itchiness Saturday (on 31Jul2021 at 8:00). Saturday night took BENADRYL because itchiness was so bad. Since the vaccination the patient has not been tested for COVID-19. The patient outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646086
Sex: M
Age:
State: MN

Vax Date: 05/25/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: 2021; Test Name: final tap; Result Unstructured Data: Test Result:abnormal; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:abnormalities; Comments: may be suggestive of multiple sclerosis and enhancing bilateral wide regions of brain, cervical and thoracic cords, suggesting multiple sclerosis or the other ideologies are possible

Allergies:

Symptom List: Tremor

Symptoms: it is like multiple sclerosis presentation; lower extremities weakness; he is undergoing plasmapheresis to try to restore his neurological functions; This is a spontaneous report from a contactable physician. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 at the age of 41-years-old via an unspecified route of administration on 25May2021 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included anxiety from an unknown date. Concomitant medications included escitalopram oxalate (LEXAPRO) and escitalopram (ESCITALOPRAM) taken for anxiety, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 41-years-old on 04May2021 (Lot No: EW0173) for covid-19 immunisation. The physician reported that on an unspecified date in 2021 (reported as half a month ago; for further clarification), the patient came in with lower extremities weakness, he had MRI, which shows abnormalities, may be suggestive of multiple sclerosis and enhancing bilateral wide regions of brain, cervical and thoracic cords, suggesting multiple sclerosis or the other ideologies are possible. He had a final tap that was also abnormal. And he is undergoing plasmapheresis to try to restore his neurological functions. The patient was hospitalized due to the events on 22Jul2021. The outcome of the events was unknown.; Sender's Comments: The events most likely an intercurrent conditions and unrelated to suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Case will be reassessed when additional information is received.

Other Meds: LEXAPRO; ESCITALOPRAM

Current Illness:

ID: 1646087
Sex: F
Age:
State:

Vax Date: 07/18/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: 202107; Test Name: blood pressure; Result Unstructured Data: Test Result:very high

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: I am going to die/ I am killing myself because of this vaccine/ I almost died; Vomiting; Very high blood pressure; I have a crazy headache; I am very sick after this Vaccine; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FA7484), via an unspecified route of administration on 18Jul2021 at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jul2021, the patient experienced vomiting, very high blood pressure, and a crazy headache. She was very sick after this vaccine. She was really going to die and mentioned "You are really killing people with this vaccine." The patient felt very bad until now, it was already 2 weeks. She was currently not able to work and was only going to hospitals, to doctors, and spending so much money. A lot of people already died from this vaccine, so the patient reported but nobody cared. She was killing herself because of this vaccine and nobody was helping the patient, not even a call back. The patient almost died. She has a very high blood pressure and was very sick. She stated that she will never do the second shot because she almost died from the first shot. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646088
Sex: U
Age:
State:

Vax Date: 07/29/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: left leg I have like almost tingling; left leg I have like almost tingling and (numbness) things; This is a spontaneous report from a contactable consumer (Patient). An unspecified age and gender 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 29Jul2021 into left arm as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date Jul2021, the patient experienced left leg have like almost tingling and (numbness) things.The outcome of 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: 1646089
Sex: F
Age:
State: TX

Vax Date: 05/09/2021
Onset Date: 05/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210114; Test Name: Covid-19; Test Result: Negative

Allergies:

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

Symptoms: Tingly sensation on right leg; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 25-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09May2021 17:15 (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was reported that 24May2021, patient experienced tingly sensation on right leg. Would not want to walk at times. Regarding reaction stop date it was mentioned as it was not a regular thing anymore. It was every now and then. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Jan2021. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected

Other Meds:

Current Illness:

ID: 1646090
Sex: U
Age:
State:

Vax Date: 07/31/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
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: While I was administering the vaccine, some of it leaked from the syringe. So, I had the needle into the muscle the same time the syringe leaked from the site; While I was injecting it to the patient it leaked at the same time from the site.; While I was administering the vaccine, some of it leaked from the syringe; It was not fully administered.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0196 (not clarified appropriately), NDC number, UPC number, expiry date was reported as unknown) via an unspecified route of administration on 31Jul2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that while injecting the vaccine with the needle into the muscle, some of it leaked from the syringe at the same time from the site. The vaccine was not fully administered to the patient. The reporter wanted to know what to be done in the situation. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646092
Sex: M
Age:
State:

Vax Date: 07/25/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: Patient has been tired; Patient don't have more energy; This is a spontaneous report from a contactable consumer (reported for himself). An 80-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0175/Batch number was not reported), dose 1 via an unspecified route of administration, administered in deltoid left on 25Jul2021 (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jul2021, the consumer stated patient has been tired, and patient don't have more energy. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1646093
Sex: F
Age:
State:

Vax Date: 07/01/2021
Onset Date: 07/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Nasal Swab; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: hand has also weakened.; bruise the day after. It is currently a week exactly and the bruise has gotten worse. Its a bruise surrounding the injection point; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in Jul2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 24Jul2021, the patient experienced bruise the day after receiving the vaccine, after a week the bruise gotten worse. It's a bruise surrounding the injection point and her hand was also weakened. The event resulted in doctor or other healthcare professional office/clinic visit. On an unknown date in Jul2021, the patient underwent nasal swab, SARS CoV-2 test and the result was not unknown (not reported). Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events hand has weakened and vaccination site bruise was not resolved at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1646094
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: She got pain in left hip bone; This is a spontaneous report from a contactable pharmacist. A 12-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FA74E4), via an unspecified route of administration in arm left on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, when probed for concern, stated that, the reporter was a pharmacist from # pharmacy. Stated that, a young lady was there, she just got the second dose of the Pfizer and 2 minutes after getting the second dose, she felt pain in the left hip bone and she got the shot left shoulder. She was walking and the pain in not preventing her to walk normally and the mom said her daughter was having the pain. We don't know what it was. Stated that, she has never had any issue, any medical conditions. She wanted to speak to you guys to see whether it was a side effect that happen for this patient and what do you recommend we do. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1646095
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: She is having some headache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient experienced she is having some headache on 2021. Reporter wanted to know her daughter can receive Tylenol or not for the event. The outcome of the event headache was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646096
Sex: M
Age:
State:

Vax Date: 02/23/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Got kind of sick, first one was the worst one; Nightmares; This is a spontaneous report received from a contactable consumer. This male consumer (patient) reported. A 68-year-old male patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 23Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history includes asthma from an unspecified date and unknown ongoing and concomitant medications includes Salbutamol [ALBUTEROL]. On an unspecified date, after the vaccination, the patient experienced nightmares and Got kind of sick, first one was the worst one. The events assessed as non-serious. The outcome of the events was unknown. No follow-up attempts possible. No further information expected. Follow-up (23Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1646097
Sex: M
Age:
State: AZ

Vax Date: 05/02/2021
Onset Date: 05/03/2021
Rec V Date: 08/28/2021
Hospital: Y

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: Dystonia; This is a spontaneous report from a contactable consumer (patient). A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02May2021 (Lot Number: EW0170) as single dose (at the age of 21-years-old) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 (Lot Number: EW0151) as single dose (at the age of 21-years-old) for COVID-19 immunization. He also received the Pneumococcal vaccine in 2020 (Further clarification unknow, suspect captured as per Verbatim) for immunization and experienced swelling up of the arm and high fever. The patient experienced dystonia on 03May2021. The patient stated, "I was just trying to find out information about people having a weird side effect with the second vaccine. About a couple of months ago I was administered to the hospital, they say a weird side effect dystonia that's what they called it? Which in general was basically the body no longer responding to inputs from brain and just a causing like major weird muscular effect were similar to cramps it set up all around body so you can't step in the board and that was exact and I was waiting to see if I was going to have it again in case it wasn't the Pfizer vaccine but over the course of three months (Further clarification unknown) and for long its been and had the vaccine the second one I haven't had any effects from it. I haven't had no other signs of 'handback' (Further clarification unknown) issue so I feel like it might be the vaccine." The patient was hospitalized for dystonia from 03May2021 to 03May2021. The outcome of the event was recovered in 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646098
Sex: M
Age:
State: IN

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: stroke after taking your two vaccine shots for covid; right side is totally paralyzed; speech is slurred; very hard to even talk; This is a spontaneous report from contactable consumer (patient, self-reporting). A 79-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown; Expiry Date: Unknown), dose 2 via an unspecified route of administration in 2021 (at the age of 79-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown; Expiry Date: Unknown) dose 1 via an unspecified route of administration on 13May2021 as single dose for COVID-19 immunisation. The patient did not know about receive any vaccines within four weeks prior to the vaccination. Consumer sated, first vaccine date was 13May. In 2021, the patient had a stroke after taking two vaccine shots for Covid. Consumer further stated, he wanted to talk about, his right side was totally paralyzed. He had such, speech was slurred and he truly, he was only supported by disability and all his money was gone, he cannot get any bathtub or toilet in the house and his home therapists was running out of insurance and he need help. Consumer stated, he had a stroke, he was not a doctor. This was hard for him; it was very hard to even talk. Consumer stated, he did not remember start date of event, it was just a couple of weeks after he took the shot. He did not like giving his medical history. He was explaining that he got a stroke. Now, he had got all kinds of stroke medicines, he was taking (not clarified further). Consumer stated, He had a lot of lab tests, but he did not know what they were. He had been in a hospital, 8 weeks. He did not need to get on case book, this was ridiculous. He did not question for the stroke. Consumer stated, He did not remember anatomical site of administration, He thought it was in his left but he was not sure. Reporter seriousness for events was unspecified. Outcome of all 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: 1646099
Sex: M
Age:
State: PR

Vax Date: 07/17/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
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: Develop sort of a rash all over his body; Body is break out all over; This is a spontaneous report from a contactable consumer (patient's wife). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 17Jul2021 (Batch/Lot Number: EW0198) (at age 45-years-old) as dose 1, single for covid-19 immunisation. Medical history included diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 27July2021, it's like 9-10 days after, patient developed sort of a rash all over his body. Reporter was calling to see if this could be associated with the vaccine because that never happened to him before and reporter was reading about the vaccine rash but don't know if it's applicable because it was like 9 or 10 days after the first shot. The patient was received Benadryl and a lot of cream because his body was break out all over. Outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1646100
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I just notice my teeth gotten to rot after my second shot but I also haven't brush in two years; I just feel like ever since I got the vaccine my life is actually gone down hell; I just feel like ever since I got the vaccine my life is actually gone down hell; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 56-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date the patient just noticed patient's teeth gotten to rot after the second shot, but patient also haven't brush in two years; the patient just feels like ever since got the vaccine patient's life was actually gone down hell. Consumer stated, "I just notice my teeth gotten to rot after my second shot, but I also have not brush in two years so, I am not really sure I was just wondering if it is like a co-relation that you aware of. Oh, my teeth just rotted kind of rot, but I also have not brush my teeth in two years; I just feel like ever since I got the vaccine my life is actually gone down hell." The clinical outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. Follow up (23Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1646101
Sex: F
Age:
State: GA

Vax Date: 07/07/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: It was the needle it was "intravenous" (not clarified) I don't know when they bring it in; Left arm is swelled up like a big knot; Developed hives; developed rash in my left arm where I took the vaccine; huge inflamed lump in my left arm where I took the vaccine; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer(patient) reported for herself. A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0180, Expiration date: unknown) in left arm on 07Jul2021 at 11:30 am (at the age of 69-year-old) as dose 1, single for COVID-19 immunisation. Medical history of the patient included high Blood Pressure and acid Reflux Disease. Concomitant medication included Bisoprolol for High Blood Pressure and Omeprazole for unspecified indication. On an unspecified date in Jul2021, the patient experienced Left arm is swelled up like a big knot and developed some tube rash, hives and it itches hardly bad, small amount of rash was inside the vaccination area; when broke up with hives it was like broken out on hand and in arm and then huge inflamed lump in my left arm where took the vaccine. Patient reported that" it was the needle it was "intravenous" (not clarified) I don't know when they bring it in" and "I had first dose on 7th July but Pharmacy says they have batches that went bad and have to get new batches of vaccine; I am scheduled to take second vaccine in August on coming Monday". Patient was concerned if there was any reason for her not to take the vaccine or still it is safe to take the vaccine. It was reported that "Last year I had an extreme itching and adding at the hive make "popular" (not clarified) but it wasn't severe rash and I also use Isopropyl and the antiseptic I put it on that". Treatment was taken as benadryl and Tylenol then warm compress on arm and used warm compress the arm and it was best thing happened and it helped a lot. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: BISOPROLOL; OMEPRAZOLE

Current Illness:

ID: 1646102
Sex: U
Age:
State: FL

Vax Date: 07/14/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: body weight; Result Unstructured Data: Test Result:235 punds; Comments: at the time of shots; Test Name: body weight; Result Unstructured Data: Test Result:212; Comments: after shots

Allergies:

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

Symptoms: 14 days later I got the second one, 14 days after the first one; weight was 212 pounds at time reporting and it was 235 when he/she got both the shots, hopefully going down; No hearing in my left ear/otal deafness on the left ear; I could not tell where the phone was ringing because I can tell directions hardly; This is a spontaneous report from a contactable consumer (patient). A 64-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 14Jul2021 (12Jul2021 maybe, as reported) (at the age of 64-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included deafness, back operation in Mar202. The patient's concomitant medications were not reported. The received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 24Jun2021 (at the age of 64-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient experienced no hearing in my left ear/total deafness on the left ear; I could not tell where the phone was ringing because I can tell directions hardly (deafness) (disability, medically significant) in 2021 with outcome of unknown, 14 days after the first shot she got the second shot (non-serious) on 14Jul2021 with outcome of unknown, weight was 212 pounds at time reporting and it was 235 when he/she got both the shots hopefully going down (non-serious) in Jul2021 with outcome of unknown. Therapeutic measures were taken as a result of deafness. The course of events was as follows: It appeared as though when patient got the second shot in the left arm, patient woke up in the next morning with no hearing in his/her left ear. The doctors have already given the patient Prednisolone (treatment) and what have you called and its coming back somewhat but not all the way back but its coming back. Patient was probed if the hearing problem was coming back and he/She stated "Yes with Prednisolone, Methylprednisolone." It was about half back (half hearing back), patient was afraid that it was going to be gone forever so even its half way back (half hearing back). Patient got some. Patient had total deafness, at first he/she waited couple of days because patient did not even tied of two together and when patient went to saw a doctor and told the doctor about it: they said well "this sometimes happen with the flu shot" (Further clarification was unknown) and they said "we will get you on Prednisolone" and hopefully it recovers that all way or at least somewhat so like patient said he/she did not think it was all the way back because when patient used the phone in that ear it still sounds weird, it did not sound like it used to. At least patient said its partially back and patient was glad because before when it was total deafness on the left ear, patient could not tell where the phone was ringing because patient can tell directions hardly, his/her ear was very odd, it was very odd thing to experience. Treatment: Patient took the last pill of Methylprednisolone 4mg yesterday (29Jul2021), it was regimen like it was 6 pills, 5 pills, 4 pills, 3 pills, 2 pills, 1 pills you know in corresponding days over 6 days. Patient just took the last one like patient said and he/she saw the ear, nose and throat next Wednesday to see how the hearing have come back, like how much. Patient weight was 212 pounds at time reporting in Jul2021 and it was 235 when he/she got both the shots, hopefully going down. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1646103
Sex: M
Age:
State: NJ

Vax Date: 07/27/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Allergy test; Result Unstructured Data: Test Result:Allergic; Comments: allergic to was like dust and you know stuff like that because he was tested already couple of years ago

Allergies:

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

Symptoms: Had some reactions that's itching,scratching all over the body;Itchiness and it felt hot/started itching and it got so bad that I actually still have like scratch marks on my chest my belly itching; Had some reactions that's itching, scratching all over the body; Itchiness and it felt hot; little itchy and it was little sore; It was the worst feeling I have ever had; my eyes got pink red and I felt like I was on fire; my tongue felt very strange the upper part of my mouth felt like was numb; Nervous; possibility of having an allergy from the vaccine; my tongue felt very strange the upper part of my mouth felt like was numb; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient, patient care technician) reported that a 61-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (not really sure, guess it was muscular but he was not sure) on 27Jul2021 at 61-years-old (Batch/Lot Number: EW0171) as dose 1, single on Left arm for COVID-19 immunization. Medical history included hypertension, allergic to like dust and stuff like that because he was tested already a couple of years ago. Concomitant medication included bisoprolol fumarate and hydrochlorothiazide (Ziac but he took the generic brand) taken for hypertension. Transferring agent stated, "He got the first dose of the COVID 19 Vaccine last July 27 and last night he had some reactions that's itching, scratching all over the body. There is no difficulty in breathing only itchiness and it felt hot. He took Benadryl 25 mg (treatment) and after that it went away. He wanted to know if t his is because of the shot or if there is the possibility that he had sorry, if t his is the possibility of having an allergy from the vaccine?". Consumer stated if they wouldn't be able to tell him whether or not it was from the shot? They would be able to clarify, so like he explained to her he did work for hospital and so he was asking the nurse that he work with as a matter of fact there were 2 nurse there, one of those were supervisor because she had to tell the supervisor what he was experiencing and the supervisor said she doesn't think that it was a reaction because of what he probably had once sooner than that, so she really does think that's from the shot. But he just wanted to touch face and call up Pfizer just to be on the safe side to find out. So he can call that number on Monday and he can probably get more information from them because he was scheduled to get the second dose on 16th of August. So before he get the second dose he wanted to make sure that it's okay. Consumer stated, he received the Pfizer shot on the 27Jul2021 which was Tuesday of last week and so on Friday he work night at the Medical Centre in (withheld). So, on Friday night he had lunch around at around 2 O' Clock in morning. he didn't have any allergies he was not allergic to any kind of food and all he was allergic to was like dust and you know stuff like that because he was tested already couple of years ago. He had some orange juice when he was having sandwich probably like chicken carver sandwich that was around 2 O' Clock at around 3, he wanted to say moving ahead once to 2:30 at around 3 O' Clock he started itching and it got so bad that he actually still have like scratch marks on my chest my belly was itching, his tongue felt very strange the upper part of my mouth felt like was numb my eyes got pink red and he felt like he was on fire so after that he immediately told his charge nurse, he said something was not right and she said what's wrong how do you feel? he said he was just itching he can't control it and she said okay you know go ahead and see how you feel. So, she waited for 2 minutes then he said (withheld) and he came back to her and he said no you need to get me a Benadryl right away first there is something not right she went and called pharmacy and got me 25 mg of Benadryl, so probably it had been half hours after that may be 45 minutes it went away but it was the worst feeling he have ever had he has never had this experience before and he didn't know whether was from something that he eat which never happened before never happen the food allergies or was it a reaction was it a delayed action from the shot so she called her supervisor up and supervisor said she doesn't think that was a reaction from the shot because it shouldn't have happen because he did stay 15 minutes afterwards to make sure you know nothing went wrong and he head my home and he was okay and subsided it was little itchy and it was little sore so he took Tylenol he took some Tylenol and so that was that and then all of a sudden it happens and he was saying wow this has never happened to him before so he wanted to just report it to Pfizer the first part gave him this number to call just to report it on Monday morning which he did so he don't force to step he should take after bit. It was also reported that Tylenol was taken the first day when he received the shot so he receive the shot on 27th so he took the Tylenol (LOT number SPPA0722 and expiration is Oct2024) on the 27th it was a little. No other vaccines 4 weeks prior to first dose of COVID Vaccine. When asked for any help: Consumer stated, "I am just wondering as far as the second the second dose which would be on Aug 16th he am just concern what gonna you can give me an answer the question for me will he experience the same thing after the second dose what should he experience or what? Cause he am little Nervous he am nervous because its mandatory so he can't get out of it well he just need to know well he experience the same thing and you know what should he do if this happens again? " The outcome of the events "experienced had some reactions that's itching, scratching all over the body; itchiness and it felt hot/started itching and it got so bad that i actually still have like scratch marks on my chest my belly was itching" and "had some reactions that's itching, scratching all over the body; itchiness and it felt hot" was recovered; while other events was unknown. No follow-up attempts are possible. No further information expected.; Reporter's Comments: '

Other Meds: BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am