VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1707711
Sex: U
Age:
State:

Vax Date: 07/29/2021
Onset Date: 07/30/2021
Rec V Date: 09/17/2021
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: I felt bad; Chills; Headache; Arms were like really hurting a lot and I can barely move it; Arms were like really hurting a lot and I can barely move it; Had little bit of nausea; Two three different areas were just like red, its looks like I would have an allergy or something; Two three different areas were just like red, its looks like I would have an allergy or something; My body feels weird like I have catch a cold or something; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7485, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 29Jul2021 08:15 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that, the patient went on Thursday like 08:15 for vaccination and then the next day on 30Jul2021 at 20:15 the patient got the reaction, "I felt bad", chills, the patient went to the bed and had headache. On the same day, the patient had little bit of nausea too and patient reported "arms were like really hurting a lot and I can barely move it". Then the following day, on Sunday is when the patient was able to get up and felt little bit better but when the patient came to work (today in the morning, because the patient did vaccination in left hand and not in right hand), the patient did not realize and when someone sat next and they said, what's wrong. In the arm where they gave the shot not around it, like "two three different areas were just like red, its looks like I would have an allergy or something" on an unspecified date in 2021. The patient got to work yesterday feeling bad and just have to go home, "I really felt bad". "My body feels weird like I have catch a cold or something" on an unspecified date in 2021. The patient started to have a headache, the patient needed to go home and the patient went home and then started feeling really bad like in the afternoon may be like 2 o' clock or something like that. The patient did not know if it is normal. The patient was concerned and wanted to make sure that it was okay, that what the patient was seeing on arm. The patient took Tylenol (extra strength, maybe 500 or something) as treatment for the events. The patient reported that product details said that the patient had to go back on 19Aug2021. The little sticker was put at the site of vaccination. The call was hung up abruptly by the patient hence, limited information was available over the call. The outcome of the events was unknown. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds:

Current Illness:

ID: 1707712
Sex: F
Age:
State: NJ

Vax Date: 08/01/2021
Onset Date: 08/02/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210731; Test Name: Sars-CoV2 Real Time PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Body and joint pain; lump under armpit; chest pain; heart racing; Body and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old non pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FC3180) via an unspecified route of administration in arm left on 01Aug2021 10:30 dose 2, single (age at vaccination: 48 years) for COVID-19 immunisation. Medical history included asthma, allergies: shellfish, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took iodine and experienced allergy. Historical vaccine includes bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number FA7485) via an unspecified route of administration in arm left on 11Jul2021 12:00 dose 1, single for COVID-19 immunisation. No other vaccine in four weeks and no other medications in two weeks. No covid prior vaccination and covid was tested post vaccination. On 02Aug2021 at 02:00 PM, the patient experienced lump under armpit, had chest pain and heart racing, body and joint pain. No treatment was received. The patient underwent lab tests and procedures which included sars-cov-2 real time PCR test resulted as negative on 31Jul2021 nasal swab. The clinical outcome of the events was not resolved. No follow attempts are possible; no further information is expected

Other Meds:

Current Illness:

ID: 1707713
Sex: F
Age:
State: MO

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 09/17/2021
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: Shoulder hurts; muscle pain; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Mar2021 as a dose 1, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 15Apr2021 as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the caller named (withheld), already got the first and second dose of the Pfizer vaccine. Stated that, she received the first dose last on 25Mar2021 and got the second dose last on 15Apr2021. (Withheld) told that, she lost her vaccination card and wanted to get a copy of it. (Withheld) also mentioned that, on an unspecified date in 2021, her shoulder hurts after getting the first and second dose, she cannot straight her arm up and whenever she's trying to straighten her arm she's having muscle pain on an unspecified date in 2021. Stated that, the call was not transferred as the call got disconnected. Any medical questions addressed by this program forwarded/referred to Medical Information (live operators only) was reported as no: customer and/or medical inquiry was not forwarded or referred to MI. 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: 1707714
Sex: F
Age:
State:

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: Blood works; Result Unstructured Data: Test Result:Unknown results; Test Name: CT Scan; Result Unstructured Data: Test Result:Unknown results; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: She had an on and off fever after that up until May.; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 67-year-old at the time of vaccination), via an unspecified route of administration on 23Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced she had an on and off fever after that up until May. Reported that she went to infectious disease doctors and ran test, CT scan, blood works, X-rays. She already discussed this concern with her HCP and said she might need to get the 1st shot again, then she also spoke with her Pharmacist and said she needs to get the 2nd dose. The patient underwent lab tests and procedures which included blood test, CT Scan, x-ray all with unknown results. The outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. 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: 1707715
Sex: M
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: his 2 adolescent daughters became ill with covid-like sxs/reported same illness days there after; This is a spontaneous report from a contactable other hcp. A adult male (age appx 40-year-old) patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 intramuscular on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. Medical history included moderately obese/apparent high BMI from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Not known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. The patient previously received first dose of bnt162b2 via intramuscular route on an unspecified date for covid-19 immunisation. Consumer stated his 2 adolescent daughters became ill with covid-like SXS, patient reported same illness days thereafter, since recovered. Unknown sequalae. Appeared healthy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment. The outcome of the events was recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707716
Sex: U
Age:
State: FL

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 2 shots in Feb; 2 shots in Feb; I have problems; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Company Information. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 3 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 3, single, and dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jan2021 as single for COVID-19 immunisation. The patient experienced as, i have problems on 2021, 2 shots in feb on Feb2021. Reported as, patient was veteran. Patient took covid 19 vaccine in Jan and 2 shots in Feb. Patient have problems. Outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1707717
Sex: U
Age:
State:

Vax Date: 07/26/2021
Onset Date:
Rec V Date: 09/17/2021
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: A lot of rash; Itching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 26Jul2021 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had Pfizer vaccine done on last Monday and patient getting a lot of rash and itching and patient wanted to see, Is that something normal. The outcome of the events was unknown. Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].

Other Meds:

Current Illness:

ID: 1707718
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Sick; Coughing; I can't sleep; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 81-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration on 05Mar2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9269) via an unknown route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. Patient stated, I need to talk to somebody in Pfizer who knows about the vaccine and what kind of ingredients they use. Consumer stated, patient received first injected in February 15 and then I had the second one, and that was injected on 05Mar2021 and since then, on unknown date I have been very sick. I need to call before but I did not and I am coughing and I can't sleep its 3 o clock in the morning its 6 o clock in the morning and I am still up. I went to doctor, my pulmonary doctor and they did all kinds of test and gave all kinds of medicines (Unspecified Medications) and I am not getting better. So, I would like to talk to somebody who will be able to tell me something. I am not coughing in this 3 minutes because patient received codeine treatment and I had taken a lot of stuff since then. Consumer sated, patient heard that they were giving the third shot. Is that true. Do you think I can get it. The outcome of the events was reported as unknown. Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1707719
Sex: U
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: I slept for 2 day; Had months of inflamation after first dose.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced months of inflammation after first dose and eventually slept for 2 days. Patient stated that had a weird situation in regards to the MRNA vaccine. After the first dose, within 30 mins had an adverse reaction. My doctor advised me to not get it as did ER physician. That being said months later with Delta starting to dominate cases and my mother being high risk. I just got my second dose 59 days later. 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: 1707720
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: asthma; pre-diabetes; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old patient of an unspecified gender received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation.The patient medical history and concomitant medications were not reported.patient previously received first dose bnt162b2 (BNT162B2, Solution for injection,Batch/Lot Number: not reported)via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation.On an unspecified date the patient experienced asthma, pre-diabetes. The outcome of the events asthma, glucose tolerance impaired was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be re-quested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1707721
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: on my legs I am getting really itchy and like red, I want to say like small red bumps; on my legs I am getting really itchy and like red, I want to say like small red bumps; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: FA7484) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient's legs getting really itchy and red like small red bumps. Consumer was informed safety report will be filed and contact the doctor for emergency. The outcome of the events was unknown. No further information was reported.

Other Meds:

Current Illness:

ID: 1707722
Sex: F
Age:
State:

Vax Date: 07/29/2021
Onset Date:
Rec V Date: 09/17/2021
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: Since getting the vaccine is having trouble breathing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 29Jul2021 as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received Pfizer Covid vaccine last week on Thursday and since getting the vaccine was having trouble breathing on an unspecified date in 2021. The reporter seriousness for the event was reported as unspecified. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707723
Sex: F
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: arm ballooned up the size of a small apple; arm turned bright red / got three dark red like something between a rash and blood blister; arm was burning hot to the touch; got three dark red like something between a rash and blood blister; got three dark red like something between a rash and blood blister; At the beginning it was light brown dots on her arm; This is a spontaneous report from a contactable consumer.This female consumer (patient) reported for herself that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm ballooned up the size of a small apple, arm turned bright red / got three dark red like something between a rash and blood blister, arm was burning hot to the touch, got three dark red like something between a rash and blood blister, got three dark red like something between a rash and blood blister, at the beginning it was light brown dots on her arm. The clinical outcome of 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: 1707724
Sex: M
Age:
State: CA

Vax Date: 07/31/2021
Onset Date: 07/31/2021
Rec V Date: 09/17/2021
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: Radial Nerve tingling; pain in right hand; This is a spontaneous case received from a contactable consumer (patient himself). A 21-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/batch number was not reported), via an unspecified route of administration in left arm on 31Jul2021 at 15:30 (age at vaccination 21-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Jul2021 16:15, the patient experienced radial nerve tingling and pain in right hand. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment taken for the events was unknown. The outcome of the events was recovering. Follow-up attempts are completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1707725
Sex: U
Age:
State: MT

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Fever; Ache; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE for covid-19 immunisation. No reactions, with the second time. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced fever, ache. The outcomes of events were unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. 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: 1707726
Sex: F
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself. A female patient, of an unspecified age, received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient medical history and concomitant medications not reported. Patient had severe anxiety on an unspecified date. She wanted to know more information on getting the booster shot for the COVID-19 vaccine and the availability. The outcome of the event reported as unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1707727
Sex: F
Age:
State: ND

Vax Date: 08/02/2021
Onset Date: 08/03/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration on Aug 2, 2021, at 10:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. She stated she had every side effect listed and more. She was okay after getting the shot, but at night in bed, (Aug 2021) she experienced chills, fever, aches until midnight. Repeatedly, she tried to get up yesterday (Aug 3, 2021) and she had vertigo, dizziness, nausea and diarrhea. She took Tylenol and left her feel so weak. She experienced shortness of breath and she had chills again yesterday. All day, she wondered if the shortness of breath was related to the vaccine. Therapeutic measures were taken as a result of chills, fever, aches, vertigo, dizziness, nausea and diarrhea. At the time of this report, the outcome of shortness of breath and felt so weak: unknown; other events: recovering. The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1707728
Sex: F
Age:
State: FL

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: States that it was worse the second day; States that her wife is afraid to take the second dose of the Pfizer Covid 19 Vaccine; Experiencing pain in her arm after receiving the 1st dose; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a female (patient). A 28-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot number: Unknown, Expiry date: Unknown, NDC number: Unknown) dose 1 via an unspecified route of administration, administered in the left arm on 17Jul2021 16:45 (at the age of 28 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing oesophageal achalasia, ongoing cardiac murmur functional, diabetes (aunt with diabetes). The patient concomitant medication was not reported. No PQC was present. Vaccine was not administered at military facility. No other vaccines were given 4 weeks. Additional vaccines were not administered on same date of the pfizer suspect. On 17Jul2021 the patient experienced experiencing pain in her arm after receiving the 1st dose. On an unspecified date Patient states that it was worse the second day, states that her wife is afraid to take the second dose of the pfizer covid 19 vaccine. Reporter states that the caller's wife's second dose of the vaccine is scheduled for 07Aug2021. The caller would like to know if this side effect was normal and if her wife can still take the second dose when she is still having pain; mentions the pain is not as bad now as it was in the first days. Caller comes onto the line and verifies information received from the transferring agent. States that her wife is afraid to take the second dose of the Pfizer Covid 19 Vaccine. Says her wife has heard that sometimes the second dose was worse than the first one. State's wife was worried because she was still feeling the arm pain from the first one. Caller mentions that her wife has a condition called Achalasia. States that are causes difficulty swallowing and was a rare disease with no cure. Caller states her wife was diagnosed with this about 2 months ago. States her wife was diagnosed before she received the first dose of the vaccine. Caller mentions that the vaccine was the same for her. She also had pain in her arm. States she had this with her first and second dose. With the second dose she states she also had fever and pain all over her body. Caller states she knew this was normal. Caller states that she is good and declines to complete a safety report for herself currently. Caller states she has no questions regarding her own experience. AE had not result to emergency and physician room visit. The clinical outcome of the event experiencing pain in her arm after receiving the 1st dose was reported as not recovered and states that it was worse the second day, states that her wife is afraid to take the second dose of the pfizer covid 19 vaccine was reported as unknown.

Other Meds:

Current Illness: Achalasia; Murmur functional

ID: 1707729
Sex: F
Age:
State: NC

Vax Date: 03/11/2021
Onset Date: 03/01/2021
Rec V Date: 09/17/2021
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: lip swelling; heart racing; raspy voice; panic; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 11Mar2021 (at the age of 54-year-old) as dose 1, single for covid-19 immunisation. Medical history included known allergy to mosquito bites from an unknown date and unknown if ongoing, she knows of mosquito bites she gets a big reaction on her skin sets her off. The patient's concomitant medications were not reported. On 11Mar2021 within 90 seconds felt an impending doom with complaints that she had lip swelling, heart racing, raspy voice, Her vaccination provider kept her at the site for 30 minutes then let her go afterwards. For five days after received the first dose of the Pfizer Covid-19 vaccine, till had complaints and on an unspecified date in Mar2021 she was panic, dizzy, nauseous. She read on Medscape that a small study was done with subjects who had side effects with the first dose of the Pfizer Covid-19 vaccine and did well with the second dose. Patient asked that if there was any information about receiving the second dose after having side effects with the first dose of the Pfizer Covid-19 vaccine. Agent relays that the callers healthcare provider advised her not to get the 2nd dose. Stated that yesterday she read an article that says it's ok to get the 2nd dose. she didn't took anything as she didn't want to mask anything and left it at that. Stated she was fine after 5 days, it went away. She tried to went for the 2nd shot and they asked her how did it go with the 1st shot and told her no for the 2nd. Has spoken to her immunology clinic, health department, and two pharmacist who have told her not to receive the second dose of the Pfizer Covid-19 vaccine. Outcome of the events were unknown. Information about lot/batch number cannot be obtained. No further information expected.

Other Meds:

Current Illness:

ID: 1707730
Sex: M
Age:
State:

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 09/17/2021
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: 202106; Test Name: Antibody test; Result Unstructured Data: Test Result:antibodies; Comments: he got tested in June and had antibodies; Test Name: Covid test; Test Result: Negative ; Comments: he tested negative for COVID SAR 2

Allergies:

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

Symptoms: Bad case of diarrhea for one day; Sore arm; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported, expiry date: not reported) via an unspecified route of administration on 19Jul2021 as dose 1, single for COVID-19 immunization. The patient's medical history included COVID from Dec2020, constipation. He has taken medicine before and after but he has never had that happen before. One of the medications that he is taking causes constipation and he has to usually take prunes or something to keep going, but this was the opposite. Concomitant medications were not reported. On 23Jul2021, patient experienced a bad case of diarrhea for one day and on 20Jul2021, experienced, sore arm. Patient also stated he experienced a bad case of diarrhea for one day that occurred two days after receiving the vaccine. Caller states he did not experience anything else with the first dose other than a sore arm. Sore arm wasn't severe, it was just sore. He could use it but it was just sore. It wasn't bad, it was just there. But two days later he had a severe case of diarrhea that lasted one day and then it was gone. He had the COVID vaccine on 19Jul2021 and he had a sore arm for about 2 1/2 to 3 days and then it was gone and he had diarrhea on the second day afterwards. His arm was sore starting on 20Jul2021 and it was gone by 23Jul2021 probably. The diarrhea started on 23Jul2021 and lasted all day and then it was gone. He confirms he has recovered completely from both side effects. He had to drink a lot of water to stay hydrated. Lab test included antibody test: had antibodies on an unspecified date in Jun2021, Covid test: negative on an unspecified date. The outcome of events was recovered on 23Jul2021. Follow up (04Aug2021): New follow-up information received from a contactable consumer (patient) included: event information, vaccine information, outcome of event added. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707731
Sex: M
Age:
State: MO

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported with the first dose of the Pfizer Covid 19 vaccine he initially thought he had bruising but then clarified he did not experience bruising and only just a sore arm. Consumer clarified that he was mistaken, there was no bruising noted. Caller explained that his second dose was early in the morning and he experienced this "burst of energy" as if he had drunk caffeinated beverage or a red bull. It was unusual, felt totally energetic but did not have any weird side effects of being over caffeinated. This lasted from 7-8 hours. It was amazing and a nice feeling. He did house and yard chores. Then at 7pm he just "petered out" no more energy and was tired. He did not feel sick and felt normal the next day and that was it. Patient questioned, Any data on autoimmune disorders in regard to long term efficacy of Pfizer Covid 19 vaccine? Consumer further explains he has read from multiple sources 39-59% efficacy rate. What does that percentage mean? Any further conclusions? "Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine." In closing call, consumer stated to agent, "Thanks a lot (Withheld) I had to say you did a great job in helping us and giving us info and Kudos to you and Pfizer what you were doing, I really appreciate that." The clinical outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707732
Sex: F
Age:
State: CA

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 09/17/2021
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: blazing headache; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported for herself. A female patient with an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown), via unknown route of administration on 25Mar2021 as DOSE 1 SINGLE for covid-19 immunisation. The patient medical history and concomitant medication were not reported. On an unknown date, the patient experienced blazing headache. she had her first dose 25Mar2021, about 4 months ago, a little over that. She said she hasn't had her second dose yet so she wanted to see if it was still recommended or ok to get it. At the time of this report 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: 1707733
Sex: M
Age:
State: FL

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 09/17/2021
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: chest pain; rash on his neck and all over the body; itchiness/ rash developing on his skin and is itchy; pain in the injection site (right upper arm); This is a spontaneous report from a contactable Nurse. This Nurse reported for 12-year-old male patient (Reporter's son). A 12-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in right arm on Aug2021 (at the age of 12-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient has side effects of chest pain, rash on his neck and all over the body, itchiness/ rash developing on his skin and is itchy, pain in the injection site (right upper arm). The reporter wants to know what to do to alleviate itching and how long will it take to go away. The reporter questioned whether the Pfizer was like neurotoxins, like any of the chemicals that go inside the brain and was asking whether the vaccine was tested on animals, like mice. The clinical outcome for 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: 1707734
Sex: F
Age:
State: UT

Vax Date: 07/08/2021
Onset Date: 07/09/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 2020; Test Name: cholesterol; Result Unstructured Data: Test Result:extremely high; Comments: sodium chloride was on the low side which she had that happen last year; Test Date: 20210726; Test Name: complete blood count; Result Unstructured Data: Test Result:Sodium Chloride low; Comments: high cholesterol prior to receiving the COVID vaccine.; Test Date: 20210726; Test Name: Lab work; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 77-years old female patient received first dose of bnt162b2(COMIRNATY, formulation: solution for injection, lot number: FA6780, Expiration Date: 30Sep2021) via an unspecified route of administration on 08Jul2021 at 11:00 (at the age of 77-year-old) in left arm as dose 1, single for COVID-19 immunisation. The patient medical history included fatigue from 1993 to ongoing, fibromyalgia from 1993 to ongoing , pneumonia bacterial from 1988 to an unknown date had severe bacterial pneumonia and was in the hospital for 2 weeks , blood cholesterol increased, it was genetic, blood cholesterol increased, it was genetic , drug hypersensitivity from 2020, allergies to Penicillin, Codeine, Latex Penicillin and Codeine she was allergic to this was years ago rubber sensitivity, seasonal allergy and she has some seasonal allergies. She stated that she never had a breathing problem or lung issue, she had no rash. The concomitant medications were not reported. The patient previously took Fluzone high dose and experienced illness, codeine and experienced drug hypersensitivity, Fluzone high dose and experienced fatigue and rhinorrhoea. On 09Jul2021, the patient experienced felt like bad case of the flu, felt very sick, tiredness/just exhaustion, headache, muscle pain, chills, joint, the injection site was a little tender, nausea, diarrhea, like her nose ran constantly, it was ongoing, it was like she kept getting a cold and she did not usually get colds. She confirmed that the symptoms began the next day after her firAst shot (09Jul2021). The patient underwent lab tests and procedures which included blood cholesterol increased: extremely high on 2020 sodium chloride was on the low side which she had that happen last year, full blood count: sodium chloride low on 26Jul2021 high cholesterol prior to receiving the COVID vaccine, laboratory test: unknown results on 26Jul2021. The patient not visited Emergency Room and Physician Office. The outcome of the events were not recovered (She was on the only one that still has ongoing symptoms). Follow-up attempts are completed. No further information was expected.

Other Meds:

Current Illness: Chronic fatigue; Fibromyalgia

ID: 1707735
Sex: M
Age:
State: NC

Vax Date: 06/05/2021
Onset Date: 06/05/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Fever; chest pain; swollen arm; tired; swollen node; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 14-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0217 and Expiry date: Unknown), dose 2 intramuscular, administered in Arm Left on 05Jun2021 12:30 at the age of 14-years-old as DOSE 2, SINGLE for covid-19 immunization. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing Other medical history: ADD , drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Penicillin. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient received other medications of vaccination. The patient was not diagnosed with Covid 19 and has not been tested for Covid-19 Since the vaccination. Concomitant medication included methylphenidate taken for an unspecified indication, start and stop date were not reported.On 05Jun2021 23:45 the patient experienced fever, chest pain, swollen arm, tired, swollen node. Therapeutic measures were taken as a result of fever , chest pain , swollen arm, tired , swollen node. Treatment included Antibiotic and prevacid and ibuprofen and Tylenol.On an unspecified date in 2021, the patient had recovered from the events. No follow-up attempts are needed. No further information is expected.

Other Meds: METHYLPHENIDATE

Current Illness:

ID: 1707736
Sex: F
Age:
State: CT

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Mammography; Test Result: Negative ; Test Date: 2021; Test Name: ultrasound; Test Result: Negative

Allergies:

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

Symptoms: Breast and nipple soreness; Breast and nipple soreness; sick; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) via a Pfizer sponsored program. A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced breast and nipple soreness and sick. The treatment was received for the adverse event with antibiotic therapy for 10 days. It was further stated that she said that she did not get the 2nd dose of the vaccine that was scheduled last 23Apr because a few days after the 1st dose she was sick and experienced breast and nipple soreness and she went to antibiotic therapy for 10 days. She was asking if it is safe for her to take the 2nd dose of the Covid-19 vaccine. The patient underwent lab tests and procedures which included mammogram: negative, ultrasound breast: negative on an unspecified date in 2021. She added that she sought help from a cancer doctor then underwent mammography and ultrasound procedure and it was negative. The clinical outcome for all the events was reported as unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707737
Sex: U
Age:
State: MN

Vax Date: 02/19/2021
Onset Date: 02/01/2021
Rec V Date: 09/17/2021
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: mild fatigue; This is a spontaneous report from a contactable consumer, the patient. A 67-years-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) dose via an unspecified route on 19Feb2021 at single dose (at the age of 67 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown) dose via an unspecified route on 29Jan2021 at single dose (at the age of 67 years) for covid-19 immunisation and had no adverse event. The patient experienced mild fatigue on an unknown date in Feb2021. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707738
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: She also had pain in her arm; 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, dose 1 (Lot number expiry date was not reported) via an unspecified route of administration at arm on an unspecified date as a single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. While calling to report adverse event for her wife and her wife's pain in arm after the Pfizer Covid 19 Vaccine the reporter mentioned that the vaccine was the same for her. She also had pain in her arm. Stated she had this with her first and second dose. With the second dose she states she also had fever and pain all over her body. Reporter stated she knew this was normal. Reporter stated that she is good and declines to complete a safety report for herself at this time. Reporter stated she has no questions regarding her own experience. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707739
Sex: M
Age:
State: MO

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 09/17/2021
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: Burst of energy; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical Vaccine BNT162B2 first dose for COVID-19 Immunization (Experienced Sore arm). Consumer clarified that he was mistaken, there was no bruising noted. Caller explained that his second dose was early in the morning and he experienced this "burst of energy" as if he had drank caffeinated beverage or a red bull. It was unusual, felt totally energetic but did not have any weird side effects of being over caffeinated. This lasted from 7-8 hours. It was amazing and a nice feeling. He did house and yard chores. Then at 7pm he just "petered out" no more energy and was tired. He did not feel sick and felt normal the next day and that was it. on 2021 the patient experienced burst of energy, tired. 'The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.1 In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.1 At this time, a booster dose (an extra or third dose after receiving the two-dose series) is not recommended or authorized. If you have any further questions on the use of Pfizer-BioNTech COVID-19 Vaccine, ask your healthcare professional. 'The Companies anticipate the clinical studies to begin in August, subject to regulatory approvals. Question: Any data on autoimmune disorders in regard to long term efficacy of Pfizer Covid 19 vaccine? Consumer further explains he has read from multiple sources 39-59% efficacy rate. What does that percentage mean? Any further conclusions? Participants who were healthy or had stable chronic medical conditions were eligible. An active immunocompromising condition or recent immunosuppressive therapy were exclusion criteria. The study excluded participants who were immunocompromised. Outcome of the events was recovered on unspecified date of 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1707740
Sex: M
Age:
State: TX

Vax Date: 05/27/2021
Onset Date: 06/01/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Severe itching under my stomach/hips and on both legs; sleepless nights for almost 2 months; Black spots on both of my legs like chicken pox; This is a spontaneous report from a contactable consumer. A 62-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 at 15:00 (at the age of 62 year) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. The patient medical history was not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. On 01Jun2021 at 22:00, patient experienced severe itching under stomach/hips and on both legs, had sleepless nights for almost 2 months and now have black spots on both of legs like chicken pox. It was reported that no therapeutic measures were taken for the events experienced. The adverse events did not result in emergency room and physician office. The outcome of event sleeplessness was recovered on an unspecified date in 2021 while for rest events was recovering. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1707741
Sex: F
Age:
State: WI

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210802; Test Name: Covid-19; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Injection site pain

Symptoms: severe headache; I have pretty significant and persistent pain in the back of my neck; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 42 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 20:00 (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included crohn's disease from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication(s) included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOPRAZOLE) taken for an unspecified indication, start and stop date were not reported; hydroxyzine (HYDROXYZINE) taken for an unspecified indication, start and stop date were not reported; mesalamine (MESALAMINE) taken for an unspecified indication, start and stop date were not reported; ondansetron (ZOFRAN [ONDANSETRON]) taken for an unspecified indication, start and stop date were not reported; baclofen (BACLOFEN) taken for an unspecified indication, start and stop date were not reported; naproxen sodium (ALEVE) taken for an unspecified indication, start and stop date were not reported. The patient previously took levaquin and experienced hypersensitivity, flexeril [cefixime] and experienced hypersensitivity. The patient experienced severe headache on 30Jul2021 22:00 with outcome of not recovered. Also, significant and persistent pain in the back of her neck on 30Jul2021 22:00 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021. No follow-up attempts are possible. No further information is expected.

Other Meds: SUBOXONE; PANTOPRAZOLE; HYDROXYZINE; MESALAMINE; ZOFRAN [ONDANSETRON]; BACLOFEN; ALEVE

Current Illness:

ID: 1707742
Sex: F
Age:
State: TX

Vax Date: 05/27/2021
Onset Date: 06/01/2021
Rec V Date: 09/17/2021
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: Severe Itching Under Stomach/Hips/Legs; Severe Itching Under Stomach/Hips/Legs; Sleepless Nights For More Than 45 Days; Black Spots On The Legs. Like Chicken Pox.; This is a spontaneous report from a contactable consumer. This 58-year-old Female consumer (patient) reported. A 58-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration, administered in Arm Left on 27May2021 15:00 (at the age of 58-years-old) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not have any allergies. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021 22:00, the patient experienced severe itching under stomach/hips/legs. Sleepless nights for more than 45 days. Black spots on the legs like chicken pox. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. Device time stamp was 04Aug2021. Information on the Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1707743
Sex: F
Age:
State: AR

Vax Date: 03/08/2021
Onset Date: 03/08/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Throat feeling swollen; generalized flush; This is a spontaneous report from a contactable other healthcare professional. A 31-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0167, Expiry date: not reported), via intramuscular route of administration in left arm on 08Mar2021 14:19 (at age of 31-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy to medications, food or other products: multiple, multiple drug allergies including anaphylaxis to IV antibiotic of some kind. Other illnesses at the time of vaccination and up to one month prior were unknown. The patient's concomitant medications were not reported. Prescriptions, over-counter medications taken were unknown. Chronic or long-standing health conditions were unknown. The patient never had an adverse event following any previous vaccine. On 08Mar2021 at 14:25, the patient experienced throat feeling swollen and generalized flush. The patient received first dose of bnt162b2 vaccine at 14:19. At 14:25, complained of (c/o) throat feeling swollen and noticeable generalized flush. No SOB or wheezing, able to maintain conversation with nurse. Vital signs were stable. Notified EMS per adverse drug reaction chart. EMS arrived and transported patient to the hospital. The events resulted in emergency room visit. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1707744
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Tremor

Symptoms: She also had pain in her arm; the second dose she states she also had fever; pain all over her body; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced pain in arm. On an unspecified date after second dose of vaccination, patient experienced pain in her arm, also had fever and pain all over her body. Caller stated she knew this was normal. 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: 1707745
Sex: F
Age:
State: GA

Vax Date: 03/01/2021
Onset Date: 06/01/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: My shoulder, it begin to hurt, it is sore and I can't lay on that side; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. (at the age of 75 years) Medical history included diabetes, Kidney problem, Asthma Bronchitis, High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included glipizide (GLIPIZIDE) taken for diabetes mellitus, start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure measurement, start and stop date were not reported; Lasix (Unclear and not clarified hence not captured in tab) for diabetes one shot a week. Patient may take some over the counter Tylenol for the pain but nothing else (Further not clarified hence not captured in tab). On an unspecified date of Jun2021 Consumer stated my shoulder, it begins to hurt, it is sore, and I can't lay on that side. Consumer stated, Well, I have been feeling for a while but now that I have started doing a lot of stuff it is been hurts bad for the last couple of weeks and I cannot lay on it because I took the shot it was in the March now, I can't lay on it at all. I cannot lay on that side on the arm it hurts bad. Oh god I want to say I do not know what date it is. Maybe it is the 1st of July it started hurting some but June, July last July around middle July it starts hurting bad and now it is hurting even if I take a nap. I don't know what day it was. It was the middle of June. The outcome of the event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: GLIPIZIDE; LISINOPRIL

Current Illness:

ID: 1707746
Sex: U
Age:
State:

Vax Date: 08/03/2021
Onset Date: 08/01/2021
Rec V Date: 09/17/2021
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: My whole body broke out in to a rash; I am breaking out in to hives; My neck is just swelling, like my throat closing up; My neck is just swelling, like my throat closing up; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced whole body broke out in to a rash, breaking out in to hives causing urticaria, had the neck swelling, like the throat closing up and throat tightness on Aug2021 with outcome of unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707747
Sex: F
Age:
State: NY

Vax Date: 07/22/2021
Onset Date: 07/23/2021
Rec V Date: 09/17/2021
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: 20210729; Test Name: Nasal Swab; Test Result: Negative

Allergies:

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

Symptoms: pain in arm; Severe headache; malaise; nausea; projectile vomiting; diarrhea; severe abdominal cramping for more than 1 week; This is a spontaneous report from a contactable Physician. This 41-year-old female Physician (patient). A 41-year-old (non-pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 22Jul2021 08:30 AM (at the age of 41-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Penicillin allergy from an unknown onset and unknown ongoing and concomitant medications were not reported. On 23Jul2021, after the vaccination, the patient experienced pain in arm, Severe headache, malaise, nausea, and projectile vomiting and diarrhoea for multiple days and severe abdominal cramping for more than 1 week. Treatment was given with fluids, CT scan, Tylenol/Motrin. No other vaccines were taken in four weeks and no other medications were taken in two weeks. Patient was not diagnosed with covid prior vaccination. The patient lab data includes SARS-CoV-2 test on 29Jul2021, and the result was found to be negative. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness:

ID: 1707748
Sex: M
Age:
State:

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 09/17/2021
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: couldn't stand for a day or 2; This is a spontaneous report from a non-contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 14Jan2021 (at the age of 62-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included inguinal hernia and concurrent condition included prostate too large. Concomitant medications included tamsulosin hydrochloride (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), oxybutynin (OXYBUTYNIN), and ocrelizumab (OCREVUS). The patient reported he "couldn't stand for a day or 2", on an unspecified date in 2021. The patient reported that he did not have the second dose. No further information was reported. The outcome of the event was reported as resolved on an unspecified date in 2021. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds: FLOMAX [TAMSULOSIN HYDROCHLORIDE]; OXYBUTYNIN; OCREVUS

Current Illness: Enlarged prostate (Patient's concurrent condition included: Prostate too large)

ID: 1707749
Sex: F
Age:
State: KY

Vax Date: 08/02/2021
Onset Date: 08/03/2021
Rec V Date: 09/17/2021
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: I fell down on the ramp.; I feel this is weird; This is a spontaneous report from a contactable consumer (Retired Nurse) reported for herself. A 59-year-old female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Batch/Lot number: Unknown, Expiry date: unknown), via an unspecified route in the left arm on 02Aug2021 as a single dose for covid-19 immunization. Medical history included blood pressure since she was in her 30s, multiple sclerosis, CNS disease, well-kind of syndrome (not clear) and Mason's (Not clarified hence not captured in tab) and had it diagnosed in 2008. Concomitant medications included carvedilol 12.5 milligrams once a day and amlodipine 5 milligrams once a day. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Aug2021, patient experienced several incidences and day after day. Her first one was that she was in a blur blur saying she was moving and so coming out on the ramp, she fell down on the ramp. she sits, feeling this rolled down ramp or right into the grass then her husband and her daughter helped get her to sit in a chair and they blame her shoes she has, so they got me another pair of shoes. So, throughout the day she kept noticing she kept trying of fall, her legs like since you know didn't work or they were, she has this in almost time like she was they see me, her legs were doing the work, but her brain was telling (Unclear and not clarified). Was that make sense and she guess she was falling again like six times more and she kept blame my shoes that she kept after like six times again she told her husband she said she don't know what is going on but she was trying to fall so much today and reason why she was, we got there and got into my big bath tub and then almost felt again after that and she feel this is weird? She was not dizzy, she doesnt have a headache, anything. She was not off balance, none of those things and she must add and say she do have MS she has multiple sclerosis that was you know, the CNS disease and she do have well kind of syndrome she was dizzy, and she was off balance (Further clarification unknown hence not captured in tab) and all that concept, but she had none of that today she was fine. She talks to the pharmacist that you had her injection and just tell someone about that because its just like hit was the different hell like a quick stand or something. Is that make sense. She didn't know maybe didn't get well as much as in it you know its like her inner after she didn't go handy hand roller, any idea. Patient do have a Mason's (Not clarified hence not captured in tab) and have had it diagnosed in 2008 and it feels its just the intermediate that I had it then goes away and it comes on and it goes away. She doesnt have it like all the time. After the receiving the shot. She must be bore. Her husband is here. She was sorry her husband had a heart attack last year and everything and this time he was and so he has not, he hasn't as in she can't do without that on you it. She thought, you know this year on actually on each you know. So, she will have on her mind because new words every in time on she had broadly bad days and everything and she had loved and far better your idea. Patient did not receive any treatment for the events. No lab tests were performed. The clinical outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: CARVEDILOL; AMLODIPINE

Current Illness:

ID: 1707750
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Knot under arm; Could not lift arm up after first vaccine; it hurt to lift her arm; This is a spontaneous report received from a contactable consumer for female patient (reporter's daughter) that. A 15-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller states after her first shot, her daughter had a knot under her arm, and it hurt to lift her arm and a week after the vaccine on an unspecified date. The event outcome was unknown. The lot number for the vaccine, [Pfizer-BioNTech Covid-19 Vaccine], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707751
Sex: F
Age:
State:

Vax Date: 08/03/2021
Onset Date:
Rec V Date: 09/17/2021
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: had a restless night; had pain at the site of injection; headache; low grade fever; does not feel well; arm pain, when she lifts her arm up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 15-year) on 03Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on an unspecified date for COVID-19 immunization; after the first shot the patient experienced, knot under arm, could not lift arm up a week after the vaccine. On an unspecified date in 2021 the patient experienced headache, had a restless night, had pain at the site of injection, low grade fever, does not feel well, arm pain, when she lifts her arm up. Caller stated her daughter got her second shot yesterday. The clinical outcome of the events was unknown. Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.

Other Meds:

Current Illness:

ID: 1707752
Sex: F
Age:
State: OH

Vax Date: 03/05/2021
Onset Date: 04/21/2021
Rec V Date: 09/17/2021
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: Since her second covid vaccine, she has spotting starting the day after ovulation until her period begins. This has happened every month since her second vaccine.; Patient has spotting (abnormal vaginal bleeding) starting the day after ovulation until her period begins; Since her second covid vaccine, she has spotting starting the day after ovulation until her period begins. This has happened every month since her second vaccine.; This is a spontaneous report from a contactable consumer (reported for herself). A 30-years old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6205/Batch number was not reported), dose 2 via an unspecified route of administration on 05Mar2021 (at the age of 29-years-old) as dose 2, single for covid-19 immunisation at student health clinic. The patient medical history was not reported. Concomitant medication(s) included progesterone (PROGESTERONE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3 VITAMIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9267/Batch number was not reported), dose 1 via an unspecified route of administration right arm on 12Feb2021 at 12:00 PM as dose 1, single for covid-19 immunisation at student health clinic. On 21Apr2021, consumer reported that Since her second covid vaccine, she has spotting (abnormal vaginal bleeding) starting the day after ovulation until her period begins. This has happened every month since her second vaccine. Before the vaccine, she could spot a week after ovulation until her period. She could start progesterone 200 mg nightly around 4 days after ovulation to avoid this spotting. There was a strong correlation between her second vaccine and now starting to bleed consistently the day after ovulation until her period. She needs to start progesterone the day of ovulation in order to not spot during the luteal phase. Her and her husband are actively trying to conceive. The reporter stated the events result in doctor or other healthcare professional office/clinic visit. It was unknown if patient receive treatment for the events. The outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds: PROGESTERONE; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS ; D3 VITAMIN

Current Illness:

ID: 1707753
Sex: F
Age:
State: NY

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Antibody test; Result Unstructured Data: Test Result:High titer

Allergies:

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

Symptoms: ear ache; inflammatory response; This is a spontaneous report from contactable pharmacist. A 34-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 01Jul2021 as dose 1, single for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (she also revealed that, prior to taking the 1st dose of the Pfizer covid vaccine, she was diagnosed with Covid-19, date is unknown). The patient's concomitant medications were not reported. The patient experienced earache and inflammatory response in 2021 and caller wants to know if this might be related to her body's immune response, because of the high antibodies. Caller stated patient returned last week for the second and revealed that she had an antibody test that resulted in a high titer results, she also revealed that, prior to taking the 1st dose of the Pfizer covid vaccine, she was diagnosed with Covid-19, date is unknown. Caller inquired should the patient receive the second dose of the Pfizer Covid vaccine since her antibodies came back high. Antibody testing was not currently recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. Antibody tests currently authorized under an EUA icon have variable sensitivity, specificity, as well as positive and negative predictive values, and were not authorized for the assessment of immune response in vaccinated people. Furthermore, the serologic correlates of protection have not been established, and antibody testing does not evaluate the cellular immune response, which might also play a role in vaccine-mediated protection. Finally, antibody testing against nucleocapsid would not detect immune responses resulting from vaccination, but patients might not always know what type of antibody test was used. If antibody testing was performed following vaccination, additional doses of the same or different COVID-19 vaccines were not recommended based on antibody test results at this time. If antibody testing was done after the first dose of an mRNA vaccine, the vaccination series should be completed regardless of the antibody test result. She does not have number for her titers. She was having earache and inflammatory response after the first dose and went to her PCP and he consulted back to them. They cannot figure out what is causing earache and inflammation. The other pharmacist got all the information yesterday and did not have time to contact Pfizer and only contacted VAER's last night. The patient underwent lab tests and procedures which included antibody test: high titer in 2021. 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: 1707754
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: High fevers; Swelling and pain under his left armpit.; Swelling and pain under his left armpit.; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient reported for himself). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, on an unspecified date as dose as dose 1, single for COVID-19 immunisation. Caller states that patient received his 2nd dose of the Pfizer COVID-19 vaccination on Tuesday morning. The day after he experienced on unknown date high fevers that have since resolved. His concern today is after receiving the vaccine in his left arm, he now has swelling and pain under his left armpit. Caller would like to know how long to expect the side effects to last. The outcome of the event pyrexia was reported as recovered on unknown date and while other events was unknown. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1707755
Sex: F
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: flares ups; face gets a little puffy; swollen; welts; a lot of cosmetics; lips get cracked; This is a spontaneous report from a sponsored program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as UNKNOWN, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient stated that "she has an allergy to gallates (cant really spell it) something like propyl gallates and like doxyoxy. not really sure, it's like a bunch of gallates they put in preservatives, propeloxidal, like oxyitol?? doxyotol. Patient has seen a list of ingredients, what was says is it that like if you are allergic to PEG, propylene gallates and all that do not get the Pfizer vaccine, the CDC has that list do not get the vaccine if you are allergic to what I am allergic to". Patient Stated that, she has been to a few HCP and no one would tell her not to get it no one would tell her to get it. On an unspecified date, she not had severe reactions but gets flares ups all the time, like an internal, lips get cracked and puffed, face gets a little puffy, swollen sometimes and had welts, usually from a lot of cosmetics and it could be food but over the past year, year and a half has been having a lot more flare ups, so when she has gone to the doctors she said maybe in some of her food it was effecting her a little more. 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: 1707756
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Sick; This is a spontaneous report from a sponsored program . A contactable consumer (Patient's mother) reported for a patient (Reporter's daughter). A female patient of an unspecified age received first dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that her daughter got the first dose 4 months ago. She was not able to get the 2nd dose because she was sick. Caller wanted to know if her daughter can take the second dose or does she have to go all over again with the first dose. The outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707757
Sex: M
Age:
State: NY

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 09/17/2021
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 have been having a pain in same section, in same area where the needle was inserted; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), dose 2 via an unspecified route of administration on 31Mar2021 (at the age of 63-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (at the age of 62-year-old) on an unspecified date in 2021 for COVID-19 immunization. Patient stated, I had been having some side effects I believe from the vaccine. I received it from, four months ago but almost every night after a month of it, I had been having a pain in same section, in same area where the needle was inserted on an unspecified date in 2021. It became more intense right now it more intense, every evening when I came home, I was having that serious pain when I go to bed. Patient stated date of first shot "It was 3 weeks before that" and further not clarified. Consumer stated date of adverse event "May be a month after the vaccine (Confirmed as second dose) was administered." Patient again stated, "No, I had not taking any medication for it, I was just concerned every night same problem, we are right now speaking, I was still feeling the same." Patient stated I went to a hospital. It was general hospital, government facility. Patient stated I know persons who are facing the same thing, but they are not family, but they are friends have the same problem. There was no investigation assessment. The clinical outcome of event was not recovered. Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2].

Other Meds:

Current Illness:

ID: 1707758
Sex: U
Age:
State: CA

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Name: testing myself several times a week (qPCR); Test Result: Negative

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: petechial rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 28Apr2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced petechial rash on an unspecified date in 2021. The patient said that, was currently working on Covid diagnostics. I received my first Covid vaccine on 28Apr2021. Right after, my arm displayed a severe 'petechial rash', as diagnosed by my PCP, and I was recommended not to take the booster shot. Three months later, my whole family got sick with Covid (all of them symptomatic with fever, vomit and lethargic), probably with delta variant because of the RNA amplification display. And I stayed confined at home with all three of them, taking care of them, for two weeks. And against all odds, I did NOT get the disease. Patient said, I keep testing myself several times a week (qPCR), and I always come back negative. The patient underwent lab tests and procedures which included sars-cov-2 test that was negative on an unspecified date. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1707759
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: she is breaking out hives; This is a spontaneous report from a contactable Consumer or other non-HCP (mother of patient) reported for a female patient (daughter). A 15-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Lot Number: UNKNOWN) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced breaking out hives. Reported stated that her daughter who is fifteen and half just got her first Pfizer Covid shot(Further not clarified hence captured as Unspecified vaccine) and she was breaking out hives. It did not seem to wear and was asking if she could put her daughter on Benadryl. The patient outcome of the event was unknown at the time of this report. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1707760
Sex: F
Age:
State:

Vax Date: 08/04/2021
Onset Date: 08/01/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: fever of 103; Result Unstructured Data: Test Result:103

Allergies:

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

Symptoms: fever of 103; every muscle and joint in her body is hurting; every muscle and joint in her body is hurting; difficult to walk with the pain; coughing; sneezing; no appetite; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 04Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fever of 103, every muscle and joint in her body is hurting, difficult to walk with the pain, coughing, sneezing and no appetite. Patient took vaccine yesterday 04Aug2021. Stated everything that she read basically said after the first dose you will get a headache and a sore arm. She was sitting there now with a fever of 103, it had been going up; every muscle and joint in her body is hurting; and it was difficult to walk with the pain; she was coughing and sneezing and has no appetite. She asked should she take the second does? that was three weeks from now and this was just the first dose, asking with these side effects. Call sound was broken but sounds like caller asked if these are side effects? Another voice was heard stating, he already reported and she should go to the emergency room. Patient then stated looks like she should go to the emergency room. The patient underwent lab tests and procedures which included body temperature: 103 on Aug2021. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am