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: 1681866
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Her face has been swollen her eyes actually; Her face has been swollen her eyes actually; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: FC3183) as single dose for covid-19 immunisation. The patient medical history and the patient's concomitant medications were not reported. The patient experienced her face has been swollen her eyes actually (non-serious) on an unspecified date with outcome of unknown.

Other Meds:

Current Illness:

ID: 1681867
Sex: F
Age:
State: NJ

Vax Date: 08/21/2021
Onset Date: 08/21/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Chills; Fever; body aches; headache; muscle aches; joint pain; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot. FC3181) on 21Aug2021, at 03:45 PM, in the left arm, at single dose, for COVID-19 immunisation. Relevant medical history included Penicillin allergy. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 21Aug2021, at 07:45 PM, the patient experienced chills, fever, body aches, headache, muscle aches and joint pain. No treatment was received. Clinical outcome of the adverse events was recovering at time of this report. Post the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681868
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: My feet and my hand started burning; Back of my legs started cramping; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received first dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ER8729, Expiration date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single and also received second dose via an unspecified route of administration on 21Jul2021 as dose 2, single (COMIRNATY, Solution for injection, Batch/Lot Number: EW0172, Expiration date: unknown) for covid-19 immunisation (at the age of 51 years). The patient medical history and concomitant medications were not reported. On an unknown date in 2021, The patient experienced burning in feet and hand, and back of legs started cramping. Patient did not visit the doctor and received no treatment for the events. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1681869
Sex: U
Age:
State:

Vax Date: 08/21/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Two, Three front teeth, My upper lip and then, My whole nose went numb after, I got the shot yesterday.; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2 Solution for injection, Lot Number: not reported), via an unspecified route of administration on 21Aug2021 as Dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. On unspecified date in Aug2021 patient experienced two, three front teeth, my upper lip and then, my whole nose went numb after, consumer got the shot yesterday. The outcome of the event was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up. FUP (PRD/SRD 02Sep2021): Follow-up activities closed. Batch/lot number not available.

Other Meds:

Current Illness:

ID: 1681870
Sex: U
Age:
State:

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

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

Lab Data: Test Date: 20210821; Test Name: Body Temperature; Result Unstructured Data: Test Result:101.4 Centigrade

Allergies:

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

Symptoms: Low grade fever; 101.4 Centigrade; Feeling sick; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 20Aug2021, the patient was feeling sick and on 21Aug2021, the patient experienced low grade fever, 101.4 Centigrade. Clinical outcome of the adverse events was unknown at time of this report. The lot number for BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681871
Sex: M
Age:
State:

Vax Date: 07/21/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: weighs; Result Unstructured Data: Test Result:about 209 lbs

Allergies:

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

Symptoms: His voice started go; His voice completely went out, You can barely understand him; This is a spontaneous report from a contactable consumer (patient's wife). A 63-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: ER8729, Expiry date: Unknown) via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his voice started go, his voice completely went out, you can barely understand him. Patient went to walk-in clinic and they gave him a 'z-pack' (not clarified). The patient underwent lab tests and procedures which included weight: about 209 lbs on an unspecified date. It was reported that patient didn't receive any treatment for the events. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1681872
Sex: U
Age:
State:

Vax Date: 08/21/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: 202108; Test Name: Temperature; Result Unstructured Data: Test Result:Slight temp

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: I have a slight and running, Just a very slight temp not very much.; Little bit of chills, Off and on.; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 21Aug2021 10:00 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had second Covid shot yesterday morning (21Aug2021) at 10 O'clock and was taking elderly mother to an appointment today (22Aug2021) and patient was having just a couple side-effects. It was nothing bad. Just need to know, if should be around other people. Had a slight and running, just a very slight temperature (slight fever) not very much and a little bit of chills, off and on, that was it on an unspecified date in Aug2021. 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: 1681873
Sex: U
Age:
State:

Vax Date: 08/16/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: 202108; Test Name: Body temperature; Result Unstructured Data: Test Result:a 101 for like 2 hours; Comments: I had a temperature twice, just a little bit, a 101 for like 2 hours and went away and never came back

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Headache; I am feeling down always like I want to be sleeping everyday; I am not hungry; I had a temperature twice; I am feeling down; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Aug2021 as dose 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Aug2021, patient experienced headache, feeling down always like want to be sleeping everyday, not hungry and had a temperature twice. The patient got first vaccine last Monday and was good till Tuesday, like maybe, the patient would say 15, it was 12 hours after I put it on, the patient started having like headache, felt down and not hungry. The patient stated nothing like that, but the worst thing was got headache. The patient had a temperature twice, just a little bit, a 101 for like 2 hours and went away and never came back but right now felt a lot of headache and not hungry and feeling down always like wanted to be sleeping every day. The patient was wondering was that normal. On an unspecified date in Aug 2021, the patient underwent lab tests body temperature with results a 101 for like 2 hours. The outcome of the event body temperature increased was recovered on an unspecified date in Aug 2021. Outcome of the other events were unknown. The lot number for the vaccine [bnt162b2] was not provided and would be requested during follow up.

Other Meds:

Current Illness:

ID: 1681874
Sex: F
Age:
State: NY

Vax Date: 02/27/2021
Onset Date: 03/05/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 202004; Test Name: PCR/Nasal Swab; Test Result: Negative ; Test Date: 202105; Test Name: PCR/Nasal Swab; Test Result: Negative ; Test Date: 20210820; Test Name: PCR/Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: felt fainting / lightheadedness; stiff neck; back pain; dry mouth; heart palpitation; weak; tingling of limbs; shortness of breath; chest tightness; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm left on 27Feb2021 at 15:45 (Batch/Lot Number: EN 6205) for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No other vaccine in four weeks and no other medications in two weeks were taken. The patient experienced stiff neck, back pain, felt fainting, weak, dry mouth, heart palpitation, tingling of limbs, shortness of breath, chest tightness, lightheadedness on 05Mar2021. The patient had covid tests PCR (Nasal Swab) in Apr2020, May2021 and 20Aug2021 were negative. No treatment received for the events. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681875
Sex: U
Age:
State:

Vax Date: 08/22/2021
Onset Date: 08/22/2021
Rec V Date: 09/08/2021
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: My stomach is cramping; Throwing up; Nauseous; Light headedness/Dizzy; This is a spontaneous report from a contactable consumer or other non hcp(patient). A patient of unspecified age and gender received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Lot number-not reported), via an unspecified route of administration on 22Aug2021earlier at 1:30 as DOSE 1, SINGLE for covid-19 immunisation .The patient's medical history and concomitant medications were not reported.It was reported that the patient received the first dose of Covid-19 vaccine today 22Aug2021 earlier at 1:30.On 22Aug2021 the patient experienced stomach cramping, throwing up ,nauseous, Light headedness,dizzy after patient took first dose of Covid-19 vaccine.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: 1681876
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient experienced extreme fatigue, lost all sense of smell, muscle and joint pain. The outcome of the events: unknown. The patient stated as follows: "I was vaccinated two weeks ago yesterday with the Pfizer first dose. Within 7 days I started feeling (you know it seems to be normal side effect) fatigue, extreme fatigue. Then I started getting muscle and joint pain, which lasted most of the week until Thursday, this last Thursday, today Sunday. Friday it was still there. It got better yesterday and today I am feeling much better. One of the things I noticed was on Thursday I lost all sense of smell. " The lot number for the vaccine, BNT162B2, not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1681877
Sex: F
Age:
State:

Vax Date: 08/18/2021
Onset Date: 08/22/2021
Rec V Date: 09/08/2021
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: Top lip was little swollen; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 18Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced top lip was little swollen on 22Aug2021 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: 1681878
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: my son (consumer) needs "new Heart and Lung"; my son (consumer) needs "new Heart and Lung"; This is a spontaneous report from a contactable consumer (mother) reported for a male patient that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter stated, "We both (mother and son) got our Pfizer (first dose) shots and we did really good but for my son (patient) needs "new Heart and Lung" (further not clarified) we had (first dose) received in the Hospital about 3 weeks ago (Covid vaccination). Now we just had Vaccine second dose yesterday. Asking if there anything you can tell me about any help (treatment)". The outcome of both the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681879
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: right hip was really sore; it's painful to walk; This a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration, on an unspecified route of administration as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unknown date, 2 days after receiving the bnt162b2 vaccine, she said that her "right hip was really sore, it's painful to walk". She added that she was never had hip problems before. The outcome of the events was unknown. 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: 1681880
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: I am experiencing pain in my shoulder where I got the shot; This is a spontaneous report from a contactable consumer (the patient). A 9-decade-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Aug2021 (Batch/Lot Number: EW0181) as single dose for covid-19 immunisation . Medical history included anticoagulant therapy. The patient's concomitant medications were not reported. The patient experienced pain in my shoulder where i got the shot (non-serious) on 19Aug2021 with outcome of unknown. The patient still has pain in the muscle three days after the shot. Follow up information has been requested.

Other Meds:

Current Illness:

ID: 1681881
Sex: F
Age:
State: NC

Vax Date: 08/18/2021
Onset Date: 08/18/2021
Rec V Date: 09/08/2021
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: Third dose last Wednesday on 18Aug2021; sore throat; Third dose last Wednesday on 18Aug2021; This is a spontaneous report from a contactable consumer (patient herself) via Pfizer Sponsored. This female patient (age unknown) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unknown route, on 18Aug2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient stated that she received her third dose last Wednesday on 18Aug2021 and has a sore throat. The patient had an appointment to get swabbed for COVID and wanted to know if this will affect the result of the COVID test because her Pharmacist explained that she may test positive because she just had the booster. 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: 1681882
Sex: F
Age:
State: SC

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

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

Lab Data: Test Name: MRI of her brain; Result Unstructured Data: Test Result:extensive demyelination (Multiple Sclerosis)

Allergies:

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

Symptoms: an MRI of her brain that shows extensive demyelination; her doctor thinks she has Multiple Sclerosis; This is a spontaneous report from a contactable Nurse (patient). A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. Family history included sarcoidosis from an unknown date and unknown if ongoing (daughter is 40 years old). The patient medical history and concomitant medications were not reported. Since the patient was vaccinated, she had an MRI of her brain that showed extensive demyelination and her doctor thinks she has multiple sclerosis. They don't know for sure if she has it, but they are pretty sure she does. They are doing extensive test work. The patient is scheduled for a spinal tap next week to confirm the Multiple Sclerosis (patient had no history of Multiple sclerosis). Outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1681883
Sex: F
Age:
State: FL

Vax Date: 08/09/2021
Onset Date: 08/10/2021
Rec V Date: 09/08/2021
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: heart pounding very hard; it pounds more than it use to and she has a racing feeling; arm hurt; itching; not feeling well; This is a spontaneous report received from a contactable consumer. This 70-Year-old female consumer (patient) reported for herself that: A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FC3181), via an unspecified route of administration, administered in Right arm on 09Aug2021 (around 2 o'clock) (70-years-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included only takes supplements. She is not on heart medicine. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient had not received prior vaccinations within 4 weeks. On 10Aug2021, heart pounding very hard, it pounds more than it use to and she has a racing feeling. On an unspecified date on 2021, the patient's arm was hurt, itching and not feeling well. Later that night, on 10Aug2021, around 2-3 am she felt her heart pounding very hard. That went away but her heart isn't the same. she reported that it pounds more than it use to and she has a racing feeling. She is due for her second dose of the vaccine on Monday 30AUG and wants to know if she should get the vaccine. She also reported that her arm hurt after the vaccine and a few days later she experienced some itching. The patient reported that if she feels this way when her second vaccine is due, she will probably not get the second dose. At first she do not realize what it was. She had it as bad since then. Her heart had not been the same since that night. It is pounding more than it used to. She is supposed to take the second dose next week. If she felt this same way then she do not want to take it. She was not feeling well. Should she take the next shot feeling this way. The reporter do not have a prescribing doctor. She did report with Vsafe a couple days afterwards did put her heart was slightly pounding after Wednesday (01Sep2021) when really pounding. The pounding was not as hard as it was that one night. She only takes supplements. She is not on heart medicine. Time the vaccination was given (24 hour clock)-around 2 o'clock. The clinical outcome of events heart pounding very hard, it pounds more than it use to and she has a racing feeling were recovering and other events were unknown.

Other Meds:

Current Illness:

ID: 1681884
Sex: M
Age:
State: AR

Vax Date: 08/11/2021
Onset Date: 08/19/2021
Rec V Date: 09/08/2021
Hospital: Y

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: Large blood clot in right leg(DVT). Currently on blood thinners; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 11Aug2021 13:00 (Lot Number: FC3180) as single dose (at age of 58-year-old) for covid-19 immunisation. Medical history was reported as none. He had no known allergies. Concomitant medications were not reported. Facility type vaccine: pharmacy or drug store. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Aug2021 06:00 patient experienced large blood clot in right leg, deep vein thrombosis (DVT). Currently on blood thinners. Event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was admitted for the event on unknown date. Patient was treated with Coumadin and Lovenox. Patient did not have COVID prior vaccination. No COVID tested post vaccination. Patient had not recovered, at the time of the report.

Other Meds:

Current Illness:

ID: 1681885
Sex: F
Age:
State: OR

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 09/08/2021
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: 20210730; Test Name: heartbeat; Result Unstructured Data: Test Result:elevated

Allergies:

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

Symptoms: she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); she had a severe allergic reaction, which included swelling of face and throat (could still breathe); fast heartbeat lasted approximately 3 minutes; dizziness; Weakness; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0217), via an unspecified route of administration, administered in right deltoid on 30Jul2021 as single dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes on an unspecified date in 1994 and Hashimoto's disease on an unspecified date in 1997. The patient's concomitant medications were not reported. The vaccination facility type was pharmacy/drug store. Prior to vaccinations (within 4 weeks), the patient did not received any other vaccinations. The patient reported that she received her first dose of the vaccine 30Jul2021, and had a reaction within 15 minutes. She is concerned about getting the second dose, which is coming up. The patient reported that she had a severe allergic reaction, which included swelling of face and throat (could still breathe), fast heartbeat, dizziness and weakness, all on 30Jul2021. The patient confirmed her reaction was pretty much exactly 15 minutes after she got the injection on 30Jul2021. She stated it was relatively short lived but came on very quickly and all at once. She stated that the swelling of her face and throat lasted probably 6 hours. She could breathe just fine, she just looked in mirror and was like whoa. The fast heartbeat lasted approximately 3 minutes, it was not very long. She stated that the pharmacist did come out and confirmed she had an elevated heartbeat. The dizziness and weakness was worse for the first hour after she had the vaccine. She experienced dizziness the duration of the rest of the day, so she would say probably 12 hours. The patient underwent lab tests and procedures which included heartbeat: elevated on 30Jul2021. The outcome of the events allergic reaction, swelling of face, throat swelling and heartbeats increased was recovered on 30Jul2021; and the outcome of the events dizziness and weakness was recovered on Jul2021.

Other Meds:

Current Illness:

ID: 1681886
Sex: F
Age:
State:

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/08/2021
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: Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; Tinnitus one hour after vaccination, hearing loss in both ears feels like pressure but can't clear; This is a spontaneous report from a contactable nurse (patient). A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0176), via an unspecified route of administration on 23Aug2021 at 15:45 (at the age of 25-years-old) at dose number unknown, single for COVID-19 immunization. Medical history included known allergies to shellfish and COVID. Concomitant medications were reported as none. There were no other vaccines in four weeks. Vaccination facility type was reported as hospital. She was not tested for COVID post vaccination. On 23Aug2021 at 16:45, 1 hour after vaccination, the patient experienced tinnitus and hearing loss in both ears which felt like a pressure but couldn't clear (as reported). She did not receive any treatment in response to the events. The outcome of the events was not recovered.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event deafness bilateral and the administration of the vaccine cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1681887
Sex: F
Age:
State: NJ

Vax Date: 05/20/2021
Onset Date: 06/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210607; Test Name: Nasal Swab; Test Result: Positive

Allergies:

Symptom List: Unevaluable event

Symptoms: Covid test type post vaccination=Nasal Swab/covid test result=Positive; Covid test type post vaccination=Nasal Swab/covid test result=Positive; my breasts started to be sore; I got my period - a bit heavier and longer then it had been as it was waning with menopause; I got my period - a bit heavier and longer then it had been as it was waning with menopause; I had been in menopause for about 14 months. About 2 weeks after the first dose/ I got my period - a bit heavier and longer then it had been as it was waning with menopause; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;Lot Number: EW0185),via an unspecified route of administration in Left arm on 20May2021 (at 58 years) as single dose for covid-19 immunisation. The patient medical history included menopause from 2020. No known allergy. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported. No other vaccines given in four weeks. Patient was in menopause for about 14 months. About 2 weeks after the first dose (on 03Jun2021), her breasts started to be sore and a few days later (Jun2021), she got her period, a bit heavier and longer then it had been as it was waning with menopause.No treatment given and patient recovered on an unknown date in 2021.Later, on 07Jun2021, the patient had nasal swab that resulted positive (Drug ineffective, COVID-19) with outcome unknown.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1681888
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: I have been sick.; Light-headed/ Dizzy; Vomiting; Diarrhea; I had a really bad headache, Had it for 4 days.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, consumer stated, got the Pfizer shot Sunday. Sunday was fine but ever since Monday, consumer have been sick. Went to the doctor and to urgent care and did not know what else to do. Consumer also stated, lightheaded, vomiting., diarrhea and had a really bad headache had it for 4 days. The outcome for the event headache was recovered on an unspecified date whereas outcome for the other events were unknown. Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].

Other Meds:

Current Illness:

ID: 1681889
Sex: F
Age:
State: IN

Vax Date: 08/21/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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: 202011; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result: Positive.

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: The injection site pain that hurt all day; It is really really hot from like my shoulder almost to my elbow; I was running a fever; Tiredness; Headache; I have muscle pain; Joint pain so bad; Chills; Nauseous; Pain in arm; I can't eat; I couldn't get out of my bed; This is a spontaneous report received from a contactable consumer(patient). A 48-years-old female patient received bnt162b2 (BNT162B2) dose 1, via an unspecified route of administration on 21Aug2021 (Batch/Lot Number: FC3182; Expiration Date: 31Oct2021) as single dose for covid-19 immunisation . Medical history included coagulopathy, breast cancer , covid-19 on Nov2020. Concomitant medications included boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken for menopause, start and stop date were not reported. The patient experienced injection site pain that hurt all day (non-serious) on Aug2021 with outcome of unknown , it is really really hot from like my shoulder almost to my elbow (non-serious) on Aug2021 with outcome of unknown , I was running a fever (non-serious) on Aug2021 with outcome of unknown , tiredness (non-serious) on Aug2021 with outcome of unknown , headache (non-serious) on Aug2021 with outcome of unknown , i have muscle pain (non-serious) on Aug2021 with outcome of unknown , joint pain so bad (non-serious) on Aug2021 with outcome of unknown , chills (non-serious) on Aug2021 with outcome of unknown , nauseous (non-serious) on Aug2021 with outcome of unknown , pain in arm (non-serious) on Aug2021 with outcome of unknown , i can't eat (non-serious) on Aug2021 with outcome of unknown , i couldn't get out of my bed (non-serious) on Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on Nov2020 . Follow-up attempts are completed. No further information is expected.

Other Meds: Estroven

Current Illness:

ID: 1681890
Sex: F
Age:
State: CA

Vax Date: 12/23/2020
Onset Date: 01/11/2021
Rec V Date: 09/08/2021
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: Obliteration of menses; This is a spontaneous report from a contactable nurse (patient). A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), on 23Dec2020 at 16:15 (at the age of 47-years-old), administered in the left arm, at dose 1, single for COVID-19 immunisation. Medical history was reported as none; the patient had not known allergies; prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient obliteration of menses on 11Jan2021. The event was reported as serious as resulted in disability or permanent damage; no treatment was received in response to the event. The patient had not recovered from the event.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1681891
Sex: M
Age:
State:

Vax Date: 08/20/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
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 Name: Blood; Result Unstructured Data: Test Result:Unknown results; Test Name: urine; Result Unstructured Data: Test Result:Unknown results

Allergies:

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

Symptoms: Pain in the injection site; Fever; Chills; Joint pain; Body pain; Fatigue/sleepy like tired; Loss of appetite but at the same time you are hungry; Loss of appetite but at the same time you are hungry; Cannot walk too much because I tend to fall; Nightmares; Thirsty; Diarrhea; Nausea; sleepy like tired; I got the first one, the second one and then I got a new one, a third one; I got the first one, the second one and then I got a new one, a third one; This is a spontaneous report from a contactable consumer (patient). A 25-years-old male patient received third dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: EW0175, expiration date: 31Aug2021) (age at the time of vaccination was 25 years) via an unspecified route of administration on 20Aug2021 in arm left as DOSE 3, SINGLE for COVID-19 immunisation. The patient's medical history included recently diagnosed with HIV in Aug2021. Concomitant medication was not reported. The patient previously received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) (age at the time of vaccination was 25 years) via an unspecified route of administration on 05Jan2021 in arm left as DOSE 2, SINGLE for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number: unknown) (age at the time of vaccination was 24 years) via an unspecified route of administration in Dec2021 in arm left as DOSE 1, SINGLE for COVID-19 immunisation. Consumer stated, I am having side effects from my shot 3, from Covid-19 Vaccine (Pfizer Covid-19 Vaccine). It was not too bad. I just wanted to report what I am feeling. Consumer stated, Well, pain in the injection site which was normal, a bit of fever, chills like I am cold, joint pain, body pain, like if I touch my body it kind of hurts a little bit, fatigue, I guess, loss of appetite but at the same time you are hungry and I guess like I cannot walk too much because I tend to fall like obviously my joints kind of like bother me and I think, I guess it was nightmares, sleepy like tired, I get thirsty. It was like relaxing away. I think that my immune system and I think that is like overall what it is, it is more off this Covid shot. So, it was I think that the second shot was like way worse. This was not too bad. When clarified if the consumer receive the third dose of Pfizer Covid-19 Vaccine, in response Consumer stated, I got the first one, the second one and then I got a new one, a third one. That was the new booster that was happening. I think so approximately I would say 8 hours after the shot. When probed for the safety report, Consumer stated, And also that the symptoms are less severe than the second shot, if that helps. So, the first one was kind of, I am feeling kind of like the same effects that I got from the first one. But not entirely. So, it is like it was like alright and then it was like really bad for the second one and now it was like not too much. I was having a little bit of nausea that is the only thing. But that is the only medication (Unspecified Medication) I just started. So, I think that was because I have not eaten anything. Start date of events: Consumer stated, the first shot, let me think about it. So, the first shot. It was in December and I started having, I remember being, I think the symptoms were kind of same. I take the vaccine; I was off for two days after and I was like sleepy and I have just a little bit of fever and stuff like that. It was like the same that I am having right now. But not bad. The second dose, three hours after I got it I was feeling sleepy. I slept, I believe like 20 hours. But like symptoms were like I would sleep that much. But then I was like waking up. I normally play in a video game & I was feeling like that something is happening and also like my body was burning, my nostrils were hurting, my joints felt like, the same symptoms and I was like waking up, just drinking water and going to the bathroom. Drinking water- going to the bathroom, drinking water- going to the bathroom and then just like sleeping. At the same time sleeping- water- bathroom. Consumer stated, My left arm. All of them have been in my left arm. Consumer stated, No, I was recently diagnosed with HIV. So, that is why I got my first shot. So, I was recently diagnosed with HIV for my shot no.3. So, that is why it was this past Monday. I guess you can say 16Aug or Aug17. Consumer stated, I just started the HIV medication. I mean I take the other ones. But I do take any other medication when I took the vaccine. I have the medication. But I just started it yesterday. After you like always after my shot. So, the medication is not showing any side effects yet like this. This is how my immune response reacts usually. So, does not have to do anything to do with it. Laboratory work: Consumer stated, Yes, I got blood and I got urine. Blood & urine. I am sorry I just had another thing to add, I had an antibacterial injection like antibiotic, I mean, and I got an antibiotic injection. But it should not be that. Only it is like side effect of and many medication, it was just like may be like diarrhea. But it is still nothing to do with my immune system. The patient did not receive any treatment for the events. The outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1681892
Sex: F
Age:
State: NY

Vax Date: 05/09/2021
Onset Date: 05/16/2021
Rec V Date: 09/08/2021
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: erythematous reticular patches on the upper back bilaterally/spread to beneath breasts and upper chests and arms; hand and lip swelling; hand and lip swelling; Pruritus started; previous areas turned into post inflammatory hyperpigmentation; rash became bullous at the edges, which were very sensitive to touch; rash became bullous at the edges, which were very sensitive to touch; This is a spontaneous report from a contactable other healthcare professional. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, in the left arm, on 09May2021 (at the age of 17-years-old) at dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any medication within 2 weeks of vaccination. The patient received the first dose of BNT162B2 via intramuscular route, in the left arm, on 18Apr2021 (at the age of 17-years-old) for COVID-19 immunisation. The events occurred over a period of 2 months since vaccination. Started on 16May2021, as erythematous reticular patches on the upper back bilaterally. It was not pruritic at this point. Spread to beneath breasts and upper chests and arms. At this point, in 2021, patient also developed hand and lip swelling. Pruritus started in 2021. Additionally, in 2021 rash became bullous at the edges, which were very sensitive to touch, and the previous areas turned into post-inflammatory hyperpigmentation. The events were reported as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Prednisone was administered in response to the events. The patient was recovering from the events. The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1681893
Sex: U
Age:
State:

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/08/2021
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: I never had this intense Runny nose in my whole life; that is not the common side effect of the vaccine and I feel so bad; it may be I have Covid; I feel so bad after my 2nd shot; Fatigue; Pain and body ache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot/Batch No: KC3182, expiry date not provided), via an unknown route of administration, administered on 20Aug2021 12:00, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, Dose 1 for covid-19 immunisation. On 20Aug2021 after the second shot of the vaccine beginning at night, the patient experienced like a common side effect of fatigue, pain/body ache. After 24 hours of second shot on 21Aug2021, the patient experienced intense runny nose. The patient reported that when the patient looked online, it said the runny nose that did not mean it might be covid because that was not the common side effect. The patient also felt so bad after second shot. The patient wanted to report about common side effect of the runny nose. The patient reported that it never had this intense runny nose in whole life. The outcome of the events was unknown. Follow-up attempts completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681894
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Graft vs. Host disease, after both vaccines; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included acute myeloid leukaemia (AML) and stem cell transplant. The patient's concomitant medications were not reported. Previously on an unknown date, the patient received the first dose of the vaccine for covid-19 immunisation.The patient experienced Graft vs. Host disease, after both vaccines on an unspecified date with outcome of unknown. The reporter stated was trying to get the patient Rapamune/Sirolimus, she would like to secure Sirolimus for a stem cell transplant patient.The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681895
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: Excruciating pain in right knee; This is a spontaneous report from a contactable physician (neighbor). The contactable physician reported similar events for three patients (this is the third of three reports). This case is non-serious. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (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 excruciating pain in right knee on an unspecified date with outcome of unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101030082 Same reporter/drug, similar event, different patient;US-PFIZER INC-202101032200 Same reporter/drug, similar event, different patient

Other Meds:

Current Illness:

ID: 1681896
Sex: M
Age:
State:

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: Blood; Result Unstructured Data: Test Result:Unknown results; Test Name: Urine; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Injection site pain

Symptoms: my joints felt like, the same symptoms; feeling sleepy; my body was burning; my nostrils were hurting; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old male received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EW0175) via unspecified route of administration, administered in left arm on 05Jan2021 (age at the time of vaccination was 25-year-old) as a single dose for COVID-19 immunization. Medical history included HIV since an unspecified date in Aug2021. I was recently diagnosed with HIV. So, that was why I got my first shot. Concomitant Medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, in left arm on Dec2020 (age at the time of vaccination was 24-year-old) as a single dose for COVID-19 immunization experienced a little bit fever and was like sleepy. On an unspecified date, the patient experienced my joints felt like, the same symptoms, feeling sleepy, my body was burning, and my nostrils were hurting. It was reported that Consumer stated, The first shot, let me think about it. So, the first shot. It was in December and I started having, I remember being, I think the symptoms were kind of same. I take the vaccine; I was off for two days after and I was like sleepy and I have just a little bit of fever and stuff like that. It was like the same that I am having right now. But not bad. The second dose, three hours after I got it, I was feeling sleepy. I slept, I believe like 20 hours. But like symptoms were like I would sleep that much. But then I was like waking up. I normally play in a video game & I was feeling like that something was happening and also like my body was burning, my nostrils were hurting, my joints felt like, the same symptoms and I was like waking up, just drinking water and going to the bathroom. Drinking water going to the bathroom, drinking water going to the bathroom and then just like sleeping. At the same time sleeping water bathroom. The patient underwent lab test and medical procedure which included Blood test on an unspecified date, which result was unknown and Urine analysis which result was unknown on an unspecified date. The clinical outcome of all the events was unknown. Information on the lot batch number has been requested.

Other Meds:

Current Illness:

ID: 1681897
Sex: M
Age:
State:

Vax Date: 12/01/2020
Onset Date:
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Name: Blood; Result Unstructured Data: Test Result:Unknown; Test Name: Urine; Result Unstructured Data: Test Result:Unknown

Allergies:

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

Symptoms: was like sleepy; A little bit of fever; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on Dec2020 (at the age of 24-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included HIV infection recently diagnosed. The patient's concomitant medications were not reported. The patient reported that it was in December and started having, the symptoms were kind of same. I take the vaccine; I was off for two days after and I was like sleepy and I had just a little bit of fever and stuff like that. But not bad. The patient underwent lab tests and procedures which included blood test: result unknown on an unspecified date and urine analysis: result unknown an unspecified date. The outcome of the event were recovered on an unspecified date. Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2

Other Meds:

Current Illness:

ID: 1681898
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: First dose: sore left arm/Second dose: sore left arm; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support by a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Batch/Lot Number: EN6206) as dose 1, single (at the age of 60 year) for covid-19 immunisation, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single (at the age of 60 year) for covid-19 immunisation. The consumer reported no medical history that was relevant, but she does take thyroid medication and has taken that for years. The patient did not have vaccine in four weeks. With the Covid 19 vaccine she had a sore left arm with the first Covid 19 vaccine. It was an extremely painful left arm. She put ice on her arm after her injection. It was extremely painful. When she went to get her second Covid 19 vaccine she brought ice with her. The second Covid 19 vaccine was not as bad as the first Covid 19 vaccine but was still sore in her left arm. She received both Covid 19 vaccines in her left arm. With the first Covid 19 vaccine her sore arm lasted about 2 days and on the third day the pain started subsiding. She did not have to go to the doctor or hospital for treatment for her sore arm after receiving the Covid 19 vaccine. She states she and her husband have the same primary care doctor. When probing adverse events with other vaccines she reports she gets her other vaccines like she's supposed to and has never had any problems. Therapeutic measures were taken as a result of first dose: sore left arm/second dose: sore left arm. The outcome of the event was not recovered.

Other Meds:

Current Illness:

ID: 1681899
Sex: F
Age:
State: CA

Vax Date: 08/19/2021
Onset Date:
Rec V Date: 09/08/2021
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: Horrible headache; Tired; could not get out of bed and slept for like 15 hours; Joint pain, her joint in her legs fingers back and spine; Swollen lymph nodes; felt like throwing up; She said that under her arm and breast were hurting on the left side where she got the shot; They were burning like the shot burned in her arm. It was a burning sensation; She was literally feeling like the blood was rushing through her veins, literally; she still has not been feeling ok/she still feels a little sick and does not want to pass out; She has not been able to walk her normal walks or lift weights; She does not have the strength to do it yet; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in Left arm on 19Aug2021 (77-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were none. Historical vaccine included the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jul2021 (77-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. On an unspecified date on 2021, the patient experienced Horrible headache, Tired, could not get out of bed and slept for like 15 hours, joint pain, Swollen lymph nodes, felt like throwing up, She said that under her arm and breast were hurting on the left side where she got the shot, burning like the shot burned in her arm. It was a burning sensation, She was literally feeling like the blood was rushing through her veins, literally, she still has not been feeling ok, She has not been able to walk her normal walks or lift weights, she still feels a little sick and does not want to pass out, She does not have the strength to do it yet. It was reported that the patient had some horrible symptoms after her second dose. The patient reported that she got home and was ok for the first half of the day, but afterwards experienced a horrible headache like she had never had in her life. She was tired, could not get out of bed and slept for like 15 hours. The patient had joint pain, in her legs fingers back and spine. She had swollen lymph nodes under her arms that got really swollen and that were still swollen, but not as much and they were still hurting. She felt like throwing up. The patient reported that under her arm and breast were hurting on the left side where she got the shot and they were burning like the shot burned in her arm. The patient further reported that it was a burning sensation. She said that she did not go to the doctor very often. She was literally feeling like the blood was rushing through her veins, literally. The patient had not gone to the physician yet. If her symptoms do not go away in a week or so, she will see the doctor. The patient reported that she did not do well with shots and had a lot of trouble as a little girl with it. The patient did not want to get sick with this and her lymph nodes. The patient was still not been feeling ok. She had not been able to walk her normal walks or lift weights, because she was still little sick and did not want to pass out. The patient had no strength to do it yet. The patient will see how she feels next week. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681900
Sex: F
Age:
State:

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

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

Lab Data: Test Name: clotting platelet elevated after she got the vaccine; Result Unstructured Data: Test Result:Platelet count increased; Comments: clotting platelet elevated after she got the vaccine

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: shooting pain in the head; brain fog; fatigue; clammy feet; hollow sound in the stomach; clotting platelet elevated after she got the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a 87-years-old female patient (reporter's mother) that: A 87 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at an (Age at the vaccination 87years old) dose number unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient had experienced strange side effects - shooting pain in the head, brain fog, fatigue, clammy feet , hollow sound in the stomach (you can hear its amplification) - Her mother takes chemotherapy every night for 5 years now because of lung cancer - She is 115 pounds and asking if the booster dose will be the same amount as the initial 2 doses- Asking if the booster dose is highly advised for her mother and if she needs it - She confirmed that her mother is not immunocompromised according to her doctor. Patient mentioned that she had a normal platelet count in February and all of a sudden her clotting platelet elevated after she got the vaccine. At the time of reporting, the outcome of the events were unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness: Chemotherapy (Her mother takes chemotherapy every night for 5 years now because of lung cancer)

ID: 1681901
Sex: F
Age:
State: TN

Vax Date: 04/05/2021
Onset Date: 08/14/2021
Rec V Date: 09/08/2021
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: I have developed an abscess in my arm pit that requires draining; This is a spontaneous report from a contactable other healthcare professional (patient). A 46-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 05Apr2021 (at the age of 46-years-old) as dose number unknown, single for COVID-19 immunisation. The medical history and concomitant medications of the patient were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient not been tested with covid-19. The patient stated that she had developed an abscess in her arm pit that requires draining on 14Aug2021. The event led to the physician office visit. Therapeutic measures were taken as a result of event that included had to have it drained and now another apt drain. The outcome of the event was reported as not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Subcutaneous abscess and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1681902
Sex: F
Age:
State: GA

Vax Date: 08/20/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: her left hand middle finger was numb and it was moving to her first fingers; really bad headache; muscle aches; fatigue; freezing cold, with chills; freezing cold, with chills; sweating; nasal congestion; couldn't breathe; lightheaded; slight cough; mild sore throat; was really bad and she didn't sleep/feels very drained; was really bad and she didn't sleep; hot flashes; sinus congestion; like a vasovagal response; received her third dose booster shot; received her third dose booster shot; still pretty sick; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FC3180, and Expiration date: Unknown), dose 3 via an unspecified route of administration, administered in left arm on 20Aug2021 11:30 (at the age of 41-year-old) as dose 3, single for COVID-19 immunisation. Medical history reported none. There were no concomitant medications. Previously the patient received first dose of BNT162B2 on 23Dec2020 (Lot Number: EL0142, Expiration Date: Unknown) and second dose on 11Jan2021 (Lot Number: EL0142, Expiration Date: Unknown) (both at the age of 41-year-old). The patient had zero side effects after her first shot, only a sore arm. After her second dose for the first 24-36 hours she had slight chills, muscle pain, and fatigue. The patient said being a physical therapist who had to work with COVID patients. She said she "received her third dose booster shot", clarified to being Pfizer COVID-19 vaccine. She said she got the third dose booster because her "son is immunocompromised" and she and her husband wanted to get the booster. The patient did not have any primary care provider. The reported that the third dose kicked her butt, it felt like a full on flu response was going on. She said she got it at 11:30AM on 20Aug2021(Friday), then at 09:30AM on the 21Aug2021 (Saturday) she had a really bad headache, muscle aches, and fatigue. Later in the same day she was freezing cold, with chills, and would periodically break out in a sweat (sweating). She said she would lay down through the day and rest, then that night she was congested (nasal congestion) and couldn't breathe through her nose, and when she would get up to do anything, she would feel lightheaded like a vasovagal response. She took Advil as treatment, around the clock. She clarified that she was not short of breath, that was not accurate, she "couldn't breathe" out of her nose, she was very congested in her nose. She had no chest pain. The patient took Advil 600mg probably three times a day. She said her congestion had gotten better, it started getting better Sunday morning when she woke up on the 22Aug2021. She said her muscle aches and fatigue were better, but she still did not go to work today because she did not think she can take care of patients. She said that "she is sweating right now actually", and she took a shower earlier because she was freezing cold and put on sweatpants and a sweatshirt and had to take the sweatshirt off. The patient said that she felt like she was missing some things that she wanted to tell call handler. She said on 21Aug2021, Saturday evening she started having a slight cough, not like she was very congested, just coughing, she felt the need to cough. She said she had a mild sore throat. She took more Ibuprofen when things were happening then. On Saturday night it "was really bad and she didn't sleep" the whole night and finally got up at 04:30AM and took over the counter Advil Cold and Sinus medication and used a nasal spray, an Afrin-type nasal spray then went to sleep around 05:00AM then at 08:00AM she woke up on 22Aug2021, Sunday and did not have sinus congestion anymore. She said on Sunday she felt better than she did all day Saturday. She said she started coughing more and having more episodes of periodic sweating and freezing cold and all that. She said last night she slept pretty good and stayed asleep all night, and she took another Advil Cold and Sinus last night and used another puff of nasal spray. The patient said on 23Aug2021, (today) she felt fatigued still and could not go to work, she "feels very drained". She said then something really weird happened (this) 23Aug2021, morning, that was why she called. She said this morning she was very relaxed, she was watching TV, and she felt freezing cold, about 09:30AM. She clarified she was eating and watching TV and all of a sudden, the middle finger on her right hand nail bed and the tip of her finger were completely numb. She said she tried to warm her hand up and then "her left hand middle finger was numb and it was moving to her first fingers". She said she took a hot shower which did relieve her fingers being numb. She went to go lay down for 30 minutes after the shower and then taking Acetaminophen because she had hot flashes and sweating again. The patient reported that she was still home and "still pretty sick". There was no investigation assessment. She said that she did not need attention, she just wanted to recommend staggering it, because she did not want people to hear about negative side effects for a bunch of people and not get it, she would like Pfizer to be ahead of it and not behind it, to better encourage people to get the vaccine. The outcome of the events "was really bad and she didn't sleep (insomnia)" and sinus congestion was reported as resolved on 22Aug2021. The outcome of the event "her left hand middle finger was numb and it was moving to her first fingers" was reported as resolved on 23Aug2021. The outcome of the events muscle aches and nasal congestion was resolving. The outcome of the events fatigue, freezing cold, with chills (feeling cold), sweating, slight cough, "was really bad and she didn't sleep/feels very drained", hot flashes, and "still pretty sick" was not resolved. The outcome of the events really bad headache, freezing cold, with chills (chills), "couldn't breathe", lightheaded, like a vasovagal response, and mild sore throat was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1681903
Sex: M
Age:
State: FL

Vax Date: 08/19/2021
Onset Date: 08/01/2021
Rec V Date: 09/08/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Pneumonia; 3rd single dose of BNT162b2; 3rd single dose of BNT162b2; And then went to the A-Fibrillation; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular injection in the left arm, on 19Aug2021, at around 10:30 - 11:00 AM (Batch/Lot Number: FC3182), at the age of 84 years old, as 3rd single dose, for COVID-19 immunisation. Medical history included Crohn's disease, pneumonia approximately 10 years prior to the initial reporting (approximately in 2011), or maybe more. Concomitant medication included vedolizumab (ENTYVIO) every 6 weeks 2-6 weeks, for Crohn's disease. Prior vaccinations included flu vaccine yearly, but not received in 2021 at the time of the initial reporting. The patient received the 1st single dose of BNT162b2 (lot number: EL3246) on 03Jan2021, and the 2nd single dose (lot number: EL9262) on 26Jan2021, all as intramuscular injections in the arm, at the age of 84 years old. The patient had very, very minor reactions to the 1st and 2nd doses. The patient's wife stated that on 20Aug2021, within a day from having the 3rd single dose, her husband who was 100% well, developed pneumonia, for which he was hospitalized on 21Aug2021, and then went to the A-Fibrillation (as reported). She thought this was directly related to the booster shot. The reporter had no information regarding the treatment received due to pneumonia. The patient had not recovered from pneumonia at the time of the reporting, while the outcome of atrial fibrillation was not provided. Follow-up attempts are completed. No further information is expected.

Other Meds: ENTYVIO

Current Illness:

ID: 1681904
Sex: M
Age:
State: NJ

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

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

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

Allergies:

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

Symptoms: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer reported for 5 patients. This report refers to the male (other guest's husband) she was at dinner with. A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. In Aug2021, after vaccination, the patient was tested positive for COVID. This consumer reported stated she was with three people on 24Jul2021, inside at dinner. She was with person who was coughing their brains out but had a mask on, another person who wasn't wearing a mask, and the third person who only had one shot. All three tested positive for COVID and she was the only one who didn't. She clarified she still has immunity obviously, and she doesn't want to get another shot. The consumer clarifies the female person who was coughing her brains but was wearing a mask and was sitting across from the reporting consumer. This person's husband had COVID and didn't know it but was cured. His symptoms resolved in 2 days but was shedding the virus apparently. She clarifies this person's husband was not wearing a mask and was talking a mile a minute, he had just gotten over COVID that week and was fine. He had gone back to work and everything. Apparently, the male that had COVID that week was still shedding the virus because the other male guest at the dinner was in the hospital for 2 weeks. The reporting consumer confirms they all three people at the dinner with her tested positive for COVID. The patient had recovered from the event on unknown date in 2021. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1681905
Sex: F
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: biopsied; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: Bloodwork; Result Unstructured Data: Test Result:elevation in antibodies for allergic reaction; Test Date: 2021; Test Name: lab work; Result Unstructured Data: Test Result:unknown conclusion

Allergies:

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

Symptoms: broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; broke out in horrible itchy rash along with blistering and oozing spots all over the entire body; first dose on 01Apr2021/second dose on 15Apr2021; showed some kind of elevation in antibodies for allergic reaction; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 15Apr2021 at 12:00 (Batch/Lot number was not reported; at the age of 54 years old) as dose 2, single for COVID-19 immunisation. Medical history included vitamin B deficiency controlled with monthly shot, anemic, and high BP. Concomitant medications included ibuprofen (MOTRIN) and losartan potassium (LOSARTIN). The patient previously took Vicodin and experienced allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; at the age of 54 years old) in the left arm on 01Apr2021 at 12:00pm for COVID-19 immunisation. The patient reported that she broke out in horrible itchy rash along with blistering and oozing spots all over the entire body on 19Apr2021. The only place it did not appear was on her face. The patient went to urgent care twice within two-week span because got worse and worse. The patient was sent for bloodwork after visit in 2021, and doctor said the patient showed some kind of elevation in antibodies for allergic reaction. In 2021, the primary care doctor referred the patient to a dermatologist and was biopsied newest spot on the knee, sent it to pathology for review, also more lab work was done for third time showing an unknown conclusion. At that point of 3rd round of steroids, antibiotics, creams, ointments, the patient was referred to (University name). At visit, doctors said they never seen a severe reaction like the patient has. The patient showed pictures of the progression of her awful reaction to this and brought all the past results from other doctors which had no clue how to diagnose because vaccine being too new. In summary, the patient was one of the unlucky few, a guinea pig. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The events resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. Other treatments included drugs, anti-itch pills, steroids, creme, and ointments. The patient is recovering from the events. The events were assessed as serious (Disability or permanent damage). Information on the lot/batch number has been requested.

Other Meds: MOTRIN [IBUPROFEN]; LOSARTIN

Current Illness:

ID: 1681906
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Weight; Result Unstructured Data: Test Result:Decreased

Allergies:

Symptom List: Pain in extremity

Symptoms: lost weight; I am exhausted/I am very tired; I was really sick; not feeling great; extra dose administered; This is a spontaneous report from a contactable consumer (patient, self-reported). A patient of unspecified age and gender received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 18Aug2021, as a single dose for COVID-19 immunization, second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an un-specified route of administration, on an unspecified date, as a single dose for COVID-19 immunization and after second shot had a reaction and you know it felt, flu like symptoms, and first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that the patient had third shot (further clarification unknown hence not captured in tab) and after second shot the patient had a reaction and you know it felt, flu like symptoms whatever and the patient was anticipating the same type of thing when the patient had the shot last Wednesday and today on Monday was the first day actually feel somewhat decent and other than fact that the patient was exhausted, lost weight, everything on 23Aug2021. The patient wanted to know like has this happened before the people the patient like felt like the patient was really sick and had it for so long, was that something that has happened before. The patient stated that the patient was concerned the patient mean it was possible to get sick at same time that seems strange and was perfectly fine you know when got it and right now the patient felt like the patient didn't have fever today (further not clarified hence not captured in tab), it was the first time the patient was very tired and all wanted to know was if you supposed to documenting this all but I also wanted to know the patient was sure you have heard many thousands of peoples and the patient wanted to know if this was that something unusual obviously it was not the usual thing ok you wanna connect me to with them. The patient stated that the patient was not feeling great so did not feel like doing that. The patient underwent lab test and procedure included weight which was decreased on an unspecified date. Outcome of the events was unknown. The lot number for the vaccine, BNT162B2 was not provided and will be re-quested during follow up.

Other Meds:

Current Illness:

ID: 1681907
Sex: F
Age:
State:

Vax Date: 03/10/2021
Onset Date: 08/14/2021
Rec V Date: 09/08/2021
Hospital:

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

Lab Data: Test Date: 20210820; Test Name: got tested with the PCR test and its positive for SARS Covid-2; Result Unstructured Data: Test Result:Positive

Allergies:

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

Symptoms: I had a break through; got tested with the PCR test and its positive for SARS Covid-2; I had a break through; got tested with the PCR test and its positive for SARS Covid-2; Cold/ I thought like I had a pretty bad cold coming on; Congestion; Runny nose; Sneezing; kind of feeling achy; Tired; sinus; bad cold sinus infection; Sweaty; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 59 years), dose 1 via an unspecified route of administration on 18Feb2021 as dose 1, single, and dose 2 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 59 years),via an unspecified route of administration on 10Mar2021 as dose 2, single for COVID-19 immunisation. The medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID). The patient received first dose on 18Feb of this year and second dose on 10Mar of this year at the and she recently returned from travel exactly about a week ago on the 14th of August. She thought like she had a bad cold coming on you know sinus, congestion, runny nose often sneezing just kind of feeling achy and it just continued throughout the week and then on, when was that, about 5 days and with it persisting she went and got tested with the PCR test and its positive for SARS Covid-2. So, she was like it was very mild and concerns consistently most of that was 10 days before it was off. It just felt like a very bad, bad cold sinus infection, never any fever just sweaty, tired but she was symptoms free more or less for about 2 days now but it definitely a breakthrough case but mild in severity. The events started on 14Aug2021. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained, no further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1681908
Sex: F
Age:
State: NC

Vax Date: 04/12/2021
Onset Date: 04/13/2021
Rec V Date: 09/08/2021
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: 20210413; Test Name: heart rate; Result Unstructured Data: Test Result:about 45; Comments: 11:00

Allergies:

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

Symptoms: Low heart rate / about 45; vasovagal syncope; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:00 (Batch/Lot number was not reported) (at the age of 20 years old) as single dose for covid-19 immunisation. Medical history included allergy to latex. The patient was not pregnant at the time of vaccination. Patient did not have COVID-19 prior to vaccination. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 02Mar2021 at 3pm, via an unspecified route of administration, administered in left arm (lot number: unknown) (at the age of 20 years old) for covid-19 immunisation. Concomitant medication included etonogestrel (NEXPLANON) taken for an unspecified indication, start and stop date were not reported. On 13Apr2021 at 11:00, the patient experienced low heart rate and vasovagal syncope. Heart rate at about 45. Heart rate remained under 60 for 48 hours post vaccine. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was treated with IV (as reported). Patient was not tested for COVID-19 post vaccination. The patient underwent lab tests which included heart rate: about 45 on 13Apr2021 11:00. Outcome of the events was recovered. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds: NEXPLANON

Current Illness:

ID: 1681909
Sex: F
Age:
State: NC

Vax Date: 02/10/2021
Onset Date: 02/18/2021
Rec V Date: 09/08/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Myocarditis; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via unspecified route of administration in right arm on 10Feb2021 02:00 PM (at the age of 48-year-old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included atrial fibrillation (AFiB). The patient did not have COVID prior vaccination. The patient's concomitant medications received within two weeks included multiple vitamin (unspecified), vitamin D, escitalopram oxalate (LEXAPRO) and flecainide, all from unspecified date. The patient previously received amoxicillin sodium/clavulanate potassium (AUGMENTIN), sertraline (ZOLOFT), ceftriaxone/beta-lactamase inhibitor (BACTRUM), IVP dye (as reported) and they were reported as known allergies. No other vaccines were administered within four weeks. On 18Feb2021 the patient experienced myocarditis. The event resulted in emergency room/department or urgent care visit and patient was hospitalized for 2 days. Treatment received due to the event included heart catherization, steroids and fluids. The patient was not tested for COVID post vaccination. The outcome of the event was unknown.

Other Meds: VITAMIN D [VITAMIN D NOS]; LEXAPRO; FLECAINIDE

Current Illness:

ID: 1681910
Sex: F
Age:
State: OK

Vax Date: 08/07/2021
Onset Date:
Rec V Date: 09/08/2021
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: Sweating more; Chest flutters around heart; Runny nose; This is a spontaneous report from a contactable consumer(patient) or other non-healthcare professional. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186) as dose 1 single, administered in left arm on 07Aug2021 (at the age of 58-year-old) for COVID-19 immunization. The patient medical history included an allergic reaction to when she had the Tuberculosis shot, and there were two medications in one shot. The patient had a bad reaction in her left arm and it was hot to touch. She got the shot when she turned 50 or something as reported. NDC/LOT/EXP Unknown. The concomitant medications were not reported. About a week after she had the first dose the patient experienced chest flutters around the heart, sweating more, and a runny nose. The patient said that she does not know if that was normal or not. The patient said that she was not a sickly person. Never had a flu shot in her life. Patient was sweating more. It began about a week later and has perspiration on her forehead and gets so hot that she must turn the AC up and then she gets too hot. It was up and down. She could feel sweat on her face and not the whole body, just in the head and forehead she was feeling so hot. The runny nose was at the same time as sweating. She did not have a cold or runny nose before the shot. The chest flutter was not constant, comes and goes. Sometimes when it happened, there was a little pinch. The patient's second dose of COVID 19 immunization was due on 28Aug2021. Outcome: It is starting to taper off, it's not as much. The event outcome for sweating more and chest flutter was not recovered, and runny nose was unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1681911
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: I received my third dose of Pfizer Covid vaccine on 19Aug2021; I received my third dose of Pfizer Covid vaccine on 19Aug2021; just to the side of injection site on my arm it's kind of swollen like a two inch swollen area and it was red and sore; has a little swelling; just to the side of injection site on my arm it's kind of swollen like a two inch swollen area and it was red and sore; has a little swelling; just to the side of injection site on my arm it's kind of swollen like a two inch swollen area and it was red and sore; has a little swelling; This spontaneous report from contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, on 19Aug2021, as a dose 3, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Batch/Lot number: not reported), via an unspecified route of administration, on unspecified date at, as a dose 1, single and dose 2, single for COVID-19 immunization. It was reported that patients first two doses were uneventful. On unspecified date patient experienced injection site on patient arm it was kind of swollen like a two inch swollen area and it was red and sore and now it's not sore but it was still had a little swelling. Patient was wondering how many days patient can expect that to last. 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: 1681912
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/08/2021
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: lymph node and my neck under my jaw is swollen up so if I swallow it hurts; lymph node and my neck under my jaw is swollen up so if I swallow it hurts; This is 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: FC3180), via an unspecified route of administration, as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient past drug includes remicade for rheumatoid disease (I have rheumatoid disease so I am on immune depressant infusion once a month I take Remicade, they put that IV for 3 hours once a month it lowers my immune system). The patient stated that patient calling and was doing by the time to saw and was anywhere to get to the patient's doctors but the patient got the first shot the first of the week of this month and due for the second one today and the day after that the patient got the shot and had lymph node, the Covid vaccine (Captured as per verbatim) shot, the Pfizer. The patient got the shot the 1st of the month, the first one and due for the second one today but the patient lymph node and neck under and the jaw was swollen up so if it swallow it hurts and it was swollen but the patient had rheumatoid disease so on immune depressant infusion once a month the patient took Remicade and they put that IV for 3 hours once a month it lowers the patient's immune system. The patient did not know if they should get the second shot again while it was still swollen and also neck was. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1681913
Sex: F
Age:
State: SC

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

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

Lab Data: Test Date: 20210408; Test Name: heart rate; Result Unstructured Data: Test Result:Rise to 150-160; Comments: After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days.; Test Date: 202106; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; After 30 minutes, My heart rate would rise to 150-160 frequently for 3 days. It started my menstrual cycle back that had been gone for 2 years and restarted menopause.; This is a spontaneous report from a contactable nurse. A 52-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (age at vaccination 52-years-old) (Batch/Lot Number: ER8729) as dose 1, single for covid-19 immunisation. Medical history included hyperthyroidism, meniere's disease, cardiac disorder and covid-19. Concomitant medication included levothyroxine sodium, hydrochlorothiazide, triamterene (DYAZIDE), magnesium and potassium. Patient had COVID prior to vaccination. Patient was tested for COVID-19 post vaccination. Patient did not receive any vaccines in 4 weeks. On 08Apr2021 10:00, after 30 minutes heart rate would rise to 150-160 frequently for 3 days. It started her menstrual cycle back that had been gone for 2 years and restarted menopause. The patient underwent lab tests and procedures which included heart rate rise to 150-160 on 08Apr2021. On an unspecified date in Jun2021, patient was tested for sars-cov-2 with nasal swab and showed negative results. Patient did not receive any treatment for events. At the time of this report, the outcome of event was recovering.; Sender's Comments: Based on plausible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: LEVOTHYROXINE SODIUM; DYAZIDE; MAGNESIUM; POTASSIUM

Current Illness:

ID: 1681914
Sex: M
Age:
State: NH

Vax Date: 02/24/2021
Onset Date: 03/03/2021
Rec V Date: 09/08/2021
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: redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; This is a spontaneous report from a contactable consumer (patient). This 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) on 24Feb2021, at the age of 71 years, as the second single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history was none. The patient received the first dose of BNT162B2 vaccine on 03Feb2021 (lot EN5318), at the age of 71 years, in right arm. The patient did not have COVID prior vaccination. Concomitant medication included morniflumate (FLOMAX). On 03Mar2021 the patient experienced redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area. COVID was not tested after vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit, required treatment (cortisone shot) and had not yet resolved.

Other Meds: FLOMAX [MORNIFLUMATE]

Current Illness:

ID: 1681915
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about my day without wheezing and having tightness in chest and induced cough due to the tightness.; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Aug2021 18:00 (at the age of 40-years-old) (Batch/Lot Number: FA7485) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, hypoglycaemia, arthritis, Allergy: Latex, Known Allergies: oral steroids. Concomitant medications included ibuprofen (IBUPROFEN); paracetamol (TYLENOL); rimegepant sulfate (NURTEC ODT). The patient has Known Allergies: morphine, and external iodine. On 20Aug2021 21:00, the patient experienced Severe sore arm; asthmatic flare-ups for past 4 days (not improving with inhalers). Not severe enough to go to ER, but not able to go about her day without wheezing and having tightness in chest and induced cough due to the tightness. Therapeutic measures were taken as a result of the events. The outcome of the events was not recovered. The patient did not have COVID prior vaccination, and was not COVID tested post vaccination. Follow-up attempts are completed. No further information is expected.

Other Meds: IBUPROFEN; TYLENOL; NURTEC ODT

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am