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: 1712821
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: sore arm; rashes all over the body; This is a spontaneous report from a Pfizer sponsored program Covax US Support. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number, and Expiration Date: Not Reported) via unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm and rashes all over the body on an unspecified date. Patient wanted to know what to do with her experience. The outcome of events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1712822
Sex: F
Age:
State: IL

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 09/18/2021
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: fatigue; body ache; fever; super sweating the night; just laying down it feels like he was laying on brick; arm still hurts like crazy; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 04Mar2021 (at the age of 35 years old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19 from Jul2020 to an unknown date. Concomitant medication included Multi Vitamins , taken for an unspecified indication, start and stop date were not reported. On the same day of vaccination, on 04Mar2021, the patient reported that all of the virus-like symptoms came back specifically fatigue, body ache and she woke up and broke fever. The patient was super sweating the night before the report, on 04Mar2021 and in early morning of the report. The patient thought the symptoms did not changed much and he was just laying down it feels like he was laying on brick on 04Mar2021. The patient's arm still hurts like crazy also on 04Mar2021. Outcome of all events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1712823
Sex: F
Age:
State: WA

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: had Covid shot on left arm and they are to be sore but gone into the lymph node; had Covid shot on left arm and they are to be sore but gone into the lymph node; little bit pain into the chest; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6198, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 02Mar2021 (at the age of 65-years-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included "Glucop" (as reported) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021, the patient had COVID shot on left arm and they are to be sore but gone into the lymph node and little bit pain into the chest. It was reported that on third day still it was getting worsen not "bad". It was in the left lymph node on which received the shot and seems to be, the pain was getting worsen not better and she was getting nervous about it. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.

Other Meds:

Current Illness:

ID: 1712824
Sex: F
Age:
State: CA

Vax Date: 02/23/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Her neck on the left side is swollen; Her neck on the left side is swollen and she is having severe pain; whole body aches; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration Date: 24Feb2021), via an unspecified route of administration on 23Feb2021 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetic for 5-6 years, a heart patient and has a pacemaker - all from an unknown date. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient reported that her neck on the left side was swollen and she was having severe pain. The patient was having severe pain on that side, the left side and it was swollen. The pain, the severe pain was ongoing and it was severe and has stayed about the same intensity the whole time. The patient was also having whole body aches on an unspecified date in Mar2021. All of this began around the same time, and the patient confirmed around the same time as the swelling. The patient's whole body aches are off and on but the one in her neck on the left side where the swelling was, it stayed there. The patient was asking if should she go to nearest clinic or go to the doctor, her primary care. The next dosage of the patient was reported to be on 16Mar2021. Outcome of all events was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712825
Sex: F
Age:
State: OK

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

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

Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:has a temperature

Allergies:

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

Symptoms: very sick; has a temperature; Swelling; throwing up; arm is real sore; This is a spontaneous report from a non-contactable consumer (daughter). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient goes to a couple different doctors and she was fine, healthy, everything until she got her second shot. The patient experienced very sick, has a temperature, was swelling, was throwing up, her arm was real sore and she can't get up on an unspecified date. The patient was still swelling and the reporter wanted to know what to do to counteract side effects. The outcome of the events was unknown. The reporter said that she needed to know what she needed to do to try to help the patient. The reporter said that she was going to take her mother into the hospital, she didn't like these shots in the first place, she was not for them at all, she doesn't trust them, they don't have enough information to be giving them to people. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1712826
Sex: F
Age:
State: NY

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

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

Lab Data: Test Date: 20210218; Test Name: Blood pressure; Result Unstructured Data: Test Result:153/93; Comments: High

Allergies:

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

Symptoms: face felt hot/burning/on fire; face was red/chest red; chest red/flushed; numbness and tingly on face- right side of face and neck/head/right side; numbness and tingly on face-right side of face and neck/head/right side/some tingling under neck; slightly itchy face; high blood pressure 153/93 - high bp for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; extreme gerd which resulted in not being able to sleep for 4 days; heart racing; have tingly hypersensitive feeling in face 2 weeks later; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer reported for herself that: A 48-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EI.9266), via an unspecified route of administration, administered in Arm Left on 18Feb2021 at 11:30 (at the age of 48-year-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included hashimotos thyroid, GERD (Gastroesophageal reflux disease), ana positive -connective tissue disorder, raynauds, fibromyalgia and right eye proptosis from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]); liothyronine (LIOTHYRONINE); omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took benadryl and experienced drug allergy (side effect can't go to the bathroom). Patient was not received any other vaccine four weeks prior vaccination. On 18Feb2021 at 11:45 the patient experienced face felt hot/burning/on fire, face was red, chest red/flushed, numbness and tingly on face-right side of face and neck/head/right side, slightly itchy face, some tingling under neck, high blood pressure 153/93 - high bp for 4 days, extreme GERD which resulted in not being able to sleep for 4 days would wake up to heart racing, still have tingly hypersensitive feeling in face 2 weeks later. Since vaccination patient not tested for covid-19. Event resulted to visit Doctor or other healthcare professional office/clinic. Therapeutic measures were taken as a result of the events with Pepcid, Claritin and ice packs on face. The patient underwent lab tests and procedures which included blood pressure measurement: 153/93 on 18Feb2021 High. The outcome of the event still has tingly hypersensitive feeling in face 2 weeks later was not recovered and all other events were recovered with lasting effects. No follow up attempts are possible. No further information is expected.

Other Meds: SYNTHROID; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; LIOTHYRONINE; OMEPRAZOLE

Current Illness:

ID: 1712827
Sex: F
Age:
State: TN

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: There are red spots, about 4 of them on her leg/4 more on the opposite leg/they are slightly raised but they don't itch/red dots under the skin/She started breaking out/breaking out on her legs; She had an allergy before and it is acting like that; Her arm swelled up got real red and sore; Her arm swelled up got real red and sore; Her arm swelled up got real red and sore; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Lot number: EL9266, Expiration Date: Not Reported) via unspecified route of administration on 25Feb2021 (at the age of 74-years-old), as dose 1, single for COVID-19 immunisation. Medical history included had an allergy before and allergic reaction to a drug, Penicillin (reported as She didn't think much about it but she had one allergic reaction to a drug, Penicillin and she had taken it for 2 months before). There were no concomitant medications. The patient experienced there are red spots, about 4 of them on her leg/4 more on the opposite leg/they are slightly raised but they don't itch/red dots under the skin/she started breaking out/breaking out on her legs, She had an allergy before and it is acting like that, and her arm swelled up got real red and sore on an unspecified date. It was reported that patient noticed, on the first week on an unspecified date, that there were red spots, about 4 of them on her leg and she didn't think that much about it then later on she noticed like 4 more on the opposite leg then last night there was one more on that leg and she got up this morning and there are 3 on the original leg it started on. They were in a cluster of 3-4, they were slightly raised but they don't itch. It was also reported that patient noticed that her arm swelled up got real red and sore and she said that was not a bad reaction but that was the first thing she noticed and the other thing gradually she started breaking out. Patient also reported that she has been taking the same medicine for years so that makes her think the reason why she would be breaking out on her legs was probably related to the vaccine. Patient was also inquiring if she can take diphenhydramine (BENADRYL) because of the events. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712828
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Allergic reaction; This is a spontaneous report from a non-contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction to the first time around and it wasn't serious. The outcome of the event was unknown. The patient was querying if the second shot that they were getting is a little bit lighter or a heavier one. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1712829
Sex: M
Age:
State:

Vax Date: 02/27/2021
Onset Date: 03/05/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Rash on whole entire body, front and back and all over the place; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Lot number: EN6205, Expiration Date: Not Reported) via an unspecified route of administration on 27Feb2021, as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash on whole entire body, front and back and all over the place on the morning of 05Mar2021, 6 days after the vaccination. Reporter was asking if this was a side effect of the vaccine. The outcome of event was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712830
Sex: F
Age:
State: ME

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: body rash; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6198, Expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 (at the age of 66-years-old) as dose 1, single for COVID-19 immunisation. Medical history included asthma and acid reflux both from an unknown date. Concomitant medications included simvastatin; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), and benzonatate all taken for an unspecified indication and potassium bicarbonate , sodium alginate (GAVISCON ADVANCED) taken for acid reflux; start and stop date were not reported. On an unspecified date in Mar2021 about 8 o'clock, the patient had a body rash, no other reactions, and felt fine. She went to bed and the body rash was gone. She just wanted to make sure she can go ahead and get her second dose scheduled on 25Mar2021. No treatment was received for the event. The outcome of the event was recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information expected.

Other Meds: SIMVASTATIN; BREO ELLIPTA; BENZONATATE; GAVISCON ADVANCED

Current Illness:

ID: 1712831
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Bad headache; Joint ache; Left arm swelling; Red rash; first dose given on 17Feb2021, second dose on 03Mar2021; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 03Mar2021 at 10:30 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. Medical history included multiple sclerosis and penicillin allergy both from an unknown date. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications included ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 17Feb2021 at 10:30 (at the age of 67-years-old) for COVID-19 immunisation. On 03Mar2021 at 21:00, the patient experienced bad headache, joint ache, left arm swelling, and red rash. The patient was administered with first dose of BNT162B2 on 17Feb2021 and second dose of BNT162B2 on 03Mar2021 which was an inappropriate schedule of vaccine administered. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: OCREVUS

Current Illness:

ID: 1712832
Sex: M
Age:
State: MS

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

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

Lab Data: Test Date: 20210304; Test Name: body temperature; Result Unstructured Data: Test Result:99.3; Comments: fever (hour 13); Test Date: 20210304; Test Name: body temperature; Result Unstructured Data: Test Result:99.5; Comments: hour 14; Test Date: 20210304; Test Name: body temperature; Result Unstructured Data: Test Result:101.6; Comments: hour 14; changed in exactly 20 minutes; Test Date: 20210304; Test Name: body temperature; Result Unstructured Data: Test Result:103; Comments: hour 14; changed in 34 minutes; Test Date: 20210304; Test Name: body temperature; Result Unstructured Data: Test Result:101.3; Comments: between hour 15 and 18 fever fluctuated; Test Date: 20210304; Test Name: body temperature; Result Unstructured Data: Test Result:102.7; Comments: between hour 15 and 18 fever fluctuated; Test Name: heart rate; Result Unstructured Data: Test Result:105; Comments: bpm Normal rest rate; Test Date: 20210304; Test Name: heart rate; Result Unstructured Data: Test Result:120; Comments: bpm (resting) Increased; hour 12

Allergies:

Symptom List: Rash, Urticaria

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EM9809) via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:45 (age at vaccination was 32-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included some SVT (supraventricular tachycardia) in heart. The patient's concomitant medications (within 2 weeks) were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The facility type where the vaccine was administered was reported as doctor's office/urgent care. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: PAA156051) via an unspecified route of administration, administered in left arm on 10Feb2021 at 13:30 (age at vaccination was 32-year-old), as dose 1, single for COVID-19 immunization and experienced slight metallic taste and became energetic over the next two days. On 04Mar2021, the patient experienced super hot / increased heat / extremely hot, back pain, increased heat and sweating, headache, chills / strong waves of chills / cold chills, left side of face feeling weird, fever/ 99.3 fever with shakes / from 99.5 to 101.6 in exactly 20 minutes / 101.6 to about 103 in 34 minutes / fever fluctuated between 101.3 to 102.7, muscle aches, joint aches, and increased heart rate (120 bpm resting). It was reported that the patient experienced super hot for 10 minutes on 11:30 (hour 1) and hour 4; major back pain, hot but no fever on hour 8; back pain with increased heat and sweating on hour 9; trace headache, chills and left side of face feeling weird but nothing physically noticeable on hour 10; patient was the same (but not as much), with fever, headache (feeling), muscle aches and joint aches on hour 11; more and more strong waves of chills, increased heart rate (120bpm resting), no headache while back pain and aches continue on hour 12; extremely hot with super cold chills, and 99.3 fever with shakes on hour 13; and on hour 14, the patient went from 99.5 to 101.6 in exactly 20 minutes and in the same hour the patient went from 101.6 to about 103 in 34 minutes. It was reported that between hour 15 and 18, the patient's fever fluctuated between 101.3 to 102.7. The patient underwent lab tests and procedures which included body temperature of 99.3 (fever; hour 13), 99.5 (hour 14), 101.6 (hour 14; changed in exactly in 20 minutes), 103 (hour 14; changed in 34 minutes), 101.3 (between hour 15 and 18 fever fluctuated), and 102.7 (between hour 15 and 18 fever fluctuated); all on 04Mar2021; and heart rate of 105 bpm (normal rest rate) on an unspecified date and 120 bpm (resting; increased; hour 12) on 04Mar2021. There was no therapeutic measures were taken as a result of the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712833
Sex: F
Age:
State: CA

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

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

Lab Data: Test Date: 20210303; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:150/110; Comments: Her blood pressure the morning of 03Mar2021 was 150-something over 110.; Test Date: 20210305; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:144/88; Comments: Took her blood pressure this morning, 05Mar2021 and it was 144/88.

Allergies:

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

Symptoms: the headache was more intense; Pain on the right breast; Blood pressure was way too high.; Chills; Axilla area of right arm is swollen and burning; Axilla area of right arm is swollen and burning; Cannot wear a bra due to swelling close to right breast; Achy all over; Tired; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN9810 and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 01Mar2021 (at the age of 56-year-old), as dose 2, single, for COVID-19 immunisation. Left-handed patient. Medical history included: the patient had an accident three to four years ago on her left arm. Patient had horrible pain from the beginning. From her accident she doesn't take therapy or nothing. She was ok and stated it was like the Flu. She started getting achy and felt the pain. From the accident everything was ok. She was feeling it all over her body. She had a plate in the left arm. Patient had white coat syndrome. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9264 and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 08Feb2021 (at the age of 56-year-old), as dose 1, single, for COVID-19 immunisation and felt weird, arm was going to hurt/couldn't elevate her arm and terrible headache off and on. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. On 01Mar2021 (Monday evening), she just felt like with the first dose of COVID Vaccine. She was very tired and went to bed early and thought it was fine and everything was ok. But on 02Mar2021, the patient experienced terrible side effects. It was clarified worst side effect was the one on the vaccinated arm. Under the arm, in the axilla area and close to the breast, was swollen and burning. She cannot wear a bra. The patient experienced chills and achy all over. The patient expected that her arm was going to hurt like after first dose where she couldn't elevate her arm, but this was so different. The swelling was still there. Burning went down a little bit but was still painful. Chills disappeared after one day. It was reported that pain on the right breast was not supposed to happen. With the second COVID Vaccine, the headache was more intense. Stated the headache felt much lighter now than what she had. On 03Mar2021, the blood pressure was way too high. She doesn't have high blood pressure and stated she needed to be at the doctors to be monitored. Her blood pressure was not going down. She was scared when she goes to the doctor and had white coat syndrome. But with this COVID vaccine, her blood pressure when whacko. Her blood pressure the morning of 03Mar2021 was 150-something over 110 and that made her got to the doctor. The doctor didn't want to put her on blood pressure medication because she doesn't have high blood pressure usually. Took her blood pressure on 05Mar2021 and it was 144/88. The patient went to the doctor due to the events and was still dealing with them. The patient was told to take ibuprofen 800 and prednisone. The outcome for hypertension, axilla area of right arm was swollen and burning was not recovered, the outcome for headache was recovering, the outcome for chills was recovered on 03Mar2021 and the outcome for other events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712834
Sex: F
Age:
State: OK

Vax Date: 03/02/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore throat; sore neck / whole neck was swollen and is tender to touch; swollen on the side of her injection from the base of her neck to her skull / whole neck was swollen; swollen lymph node; Chills; she was just frozen; slept most of the day; uncomfortable; lump; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6203) via an unspecified route of administration, administered in left arm on 02Mar2021 at 09:30 (age at vaccination was 70-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included thyroidectomy (about 8 years ago) and patient has no thyroid (as reported). Concomitant medications included levothyroxine sodium (SYNTHROID, 0.5 mg) from unspecified date and was taken since she has no thyroid (as reported). The patient's historical vaccine included flu shot (INFLUENZA VACCINE) on Sep2020 for unknown indication; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN9581, Expiration date: May2021) via an unspecified route of administration, administered in left arm on 09Feb2021 (age at vaccination was 70-year-old), as dose 1, single for COVID-19 immunization and experienced sore arm. The patient previously took paracetamol (TYLENOL) on Sep2020 (before her flu shot) for unknown indication. It was reported that the vaccination facility type was vaccination clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was reported that the family's medical history relevant to adverse reactions and relevant tests were none. On 03Mar2021 (second day), the patient woke up with chills (like she was in a meat locker), she was just frozen (that she piled up with blankets) and slept most of the day. On 04Mar2021 (third day), the patient experienced a sore neck and it was swollen on the side of her injection from the base of her neck to her skull; and noticed a swollen lymph node while her chills were gone. On 05Mar2021, she had a bad sore throat. On Mar2021, she stated that it still swollen and was uncomfortable and has no redness or heat. On Mar2021, she felt the whole neck was swollen and is tender to touch; and there was a lump (toward the right of her collar bone and up about half an inch). It was reported that after the second dose, she did fine on the first day (vaccination day) and she did great. At first, the patient thought she slept wrong and did not think anything about it then she thought it was maybe because she had her thyroid removed before. She said that she does not know if the combination of all of these was causing her the symptoms. Also, she does have a doctor appointment on an unspecified date (Monday) and she thought about taking a paracetamol (TYLENOL) or ibuprofen (ADVIL), but she did not because everyone she has told said her not to. Therapeutic measures were taken for the event sore throat including gargles of some salt water while for other events were none. Outcome of the events chills and she was just frozen was recovered on 04Mar2021; a sore neck, it was swollen on the side of her injection from the base of her neck to her skull, swollen lymph node, whole neck was swollen and is tender to touch, sore throat and uncomfortable was not recovered while slept most of the day and lump was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: SYNTHROID.

Current Illness:

ID: 1712835
Sex: F
Age:
State: AZ

Vax Date: 02/24/2021
Onset Date: 02/26/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash came again but worse, covering more of the tops of her hands; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN5318, Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 at 15:45 (at the age of 47 years old) as dose 2, single for COVID-19 immunisation. No medical history was reported. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included zinc; elderberry [sambucus nigra], vitamin c [ascorbic acid] and turmeric - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (lot number: EL9263), via an unspecified route of administration, administered in left arm on 04Feb2021 at 04:45PM (at the age of 47 years old) as dose 1, single for COVID-19 immunisation and experienced rash on top of both hands, extending to a couple fingers and itchy rash. On 26Feb2021, the patient reported that the rash came again but worse, covering more of the tops of her hands. It was same as before, but it didn't show up until about 2 days after the second shot. At 9 days after the shot, it was still here and was not any better. The patient was using hydricortizone cream as treatment. The patient haven't seen a doctor about it, but have taken pictures. Since vaccination, the patient has not been tested for COVID-19. The patient did not recover from the event. No follow-up attempts are possible. No further information is expected.

Other Meds: ZINC; ELDERBERRY [SAMBUCUS NIGRA]; VITAMIN C [ASCORBIC ACID]

Current Illness:

ID: 1712836
Sex: F
Age:
State: CA

Vax Date: 02/19/2021
Onset Date: 02/28/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210112; Test Name: basic chem panel; Result Unstructured Data: Test Result:normal; Test Name: body temperature; Result Unstructured Data: Test Result:96.7 degrees Fahrenheit; Test Name: body temperature; Result Unstructured Data: Test Result:99.6 degrees Fahrenheit; Test Date: 20210112; Test Name: EKG; Result Unstructured Data: Test Result:normal

Allergies:

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

Symptoms: chills; fever; total pain throughout the body; muscular pain; profound weakness; diminished appetite; nausea; dry cough; The important thing was her temperature temperature ally runs around 96.7 degrees Fahrenheit was 99.6 degrees Fahrenheit.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 19Feb2021 at 12:30 (at the age of 82-years-old) (Lot Number: EN6200; Expiration Date: 30Jun2021) as dose 2, single for COVID-19 immunisation. Medical history included open heart surgery from 30Apr2019 to 30Apr2019, rectal adenocarcinoma from 2016 to 2016, embolic strokes, chronic edema, coronary artery disease, AFib (atrial fibrillation), bilateral carotid artery surgery from 2016 to 2016, and congestive heart failure. Concomitant medications included rivaroxaban (XARELTO, strength: 15 mg) (also reported strength: 20 mg before) taken for an unspecified indication from 2013 and ongoing; diltiazem hydrochloride (CARDIZEM CD, strength: 120 mg) taken for coronary artery disease from an unspecified start date and ongoing; metoprolol tartrate (strength: 100 mg) taken for coronary artery disease from an unspecified start date and ongoing; potassium canrenoate (ALDACTONE, strength: 25 mg), and torasemide (TORSEMIDE, strength: 50 mg) taken for coronary artery disease, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (Lot Number: EL9263; Expiration Date: 31May2021) on 29Jan2021 for COVID-19 immunisation. On 28Feb2021, the patient experienced chills, fever, total pain throughout the body, muscular pain, profound weakness, diminished appetite, nausea, dry cough, and the important thing was her temperature ally runs around 96.7 degrees Fahrenheit was 99.6 degrees Fahrenheit. The patient asked is it possible that she could have had these symptoms as a delayed reaction to the vaccine. The clinical course was reported as follows: symptoms: further described to include chills; fever; total pain throughout her body; muscular pain; profound weakness. In addition to that she had diminished appetite of course. The important thing was her temperature which normally runs around 96.7 degrees Fahrenheit was 99.6 degrees Fahrenheit. She has been coughing and it is a dry cough, it does not produce any mucus or anything from her, does not bring up anything from that cough. She has not seen her primary care provider about event. Patient called her office and they instructed her to call back if she was not feeling better in 2-3 days. She has not called back because she seems to not have the acute symptoms that she did have any longer. The one thing that stands out is relative to her cardiac history and open-heart surgery historically and she has limits as to how much activity she can feel comfortable doing without being exhausted. What she noticed with symptoms during this event starting about 28Feb2021 is she feels more exhausted in this time frame. It really caught her late Sunday, 28Feb2021: she was chilling so she got into bed early around 21:00-21:30 and woke up at about 03:30 01Mar2021 and she was in a very negative state; she had difficulty navigating; she needed to find her way to the bathroom and she had to hang onto everything around her to keep her from tipping over and then found her way out to the kitchen to get a glass of water; that was about 50 footsteps and took an Extra strength Tylenol at that time and she had a glass of water which she was able to keep down. She did have low grade nausea. So she found her way back to bed and she fell asleep and did not wake up until noon on 01Mar2021 which is highly unusual for her; even if she wakes in the middle of the night she is usually up by 07:00-07:30. Symptoms are definitely less and improved dramatically from Monday, 01Mar2021 which was her low point. Tuesday, 02Mar2021 and Wednesday, 03Mar2021 she stayed close to home. She did not go out, had lots of chores to do and she could not muster up the energy. On Thursday, 04Mar2021 she finally got it together and went got in her car and drove to the bank, pharmacy and grocery store and then came home; so, she was out doing errands for about 2 hours. By the time she got home she was really low on body fuel; But she was happy that she was able to get out there and do what she needed to do. Regarding relevant testing/investigations she reported none since prior to vaccines; the last time she had lab work done was 12Jan2021 when she had a repeat of her EKG and a basic chem panel. The doctor said everything was within normal limits; and her EKG was consistent with her medical history and issues. The outcome of the events was recovering/resolving. No follow-up attempts are needed. No further information is expected.

Other Meds: XARELTO; CARDIZEM CD; METOPROLOL TARTRATE; ALDACTONE [POTASSIUM CANRENOATE]; TORSEMIDE

Current Illness:

ID: 1712837
Sex: M
Age:
State:

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: body temperature; Result Unstructured Data: Test Result:never got over 99.9; Comments: fever

Allergies:

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

Symptoms: Weakness; Arm is still very sore; Extremely tired/Fatigue; Headache; Muscle pain; Chills; Joint pain; Fever never got over 99.9; unwell; Nausea; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Feb2021 (Lot Number: EN6198) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified dates in 2021, the patient experienced weakness, arm is still very sore, extremely tired/fatigue, headache, muscle pain, chills, joint pain, fever never got over 99.9, unwell, and nausea. The patient still had weakness, arm was still very sore, extremely tired and fatigued, feels very unwell and weak. The patient's headache, muscle pain, chills, joint pain, fever, and nausea went away. The outcome of headache, nausea, muscle pain, chills, joint pain, and fever never got over 99.9 were recovered on unspecified dates in 2021 while the remaining events were not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712838
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: half of lower lip was swollen to about twice normal size; 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, solution for injection; Batch/Lot number and expiration date were not reported), via unspecified route of administration on 01Mar2021 (reported as Monday) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced half of lower lip was swollen to about twice normal size (about half of the lower lip) on 05Mar2021. The patient does not know if this was a possible side effect. It does not hurt but it's swollen up as if it was a huge blister and the patient have never had anything like this before. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1712839
Sex: F
Age:
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: had a horrible rash; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot number, and Expiration Date: Not Reported) via unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced had a horrible rash on an unspecified date. Patient took diphenhydramine (BENADRYL) as a result of the event. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1712840
Sex: F
Age:
State: IN

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itchiness at the shot site; This is a spontaneous report from a contactable consumer (patient reported for himself). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, strength 0.3ml (reported as 30mcg/0.3 ml), Lot Number: EL9262, expiry date not reported), via an unspecified route of administration on 05Feb2021 (at the age of 76 years old) as dose 1, single for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Patient had no problems with the first shot, she had the first shot 05Feb2021 and she had no problems other than the band aid left some glue behind, she left it on for 10 minutes then she yanked it off, that was because she had a coat on and could not get to it but the glue on the band aid was enough that she had itchiness at the shot site (05Feb2021) but that was not because of the shot other than that she had no problem with the first shot. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and reporter assessment, there is no possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Vaccination site pruritus which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1712841
Sex: F
Age:
State: UT

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

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:101.8 degrees Fahrenheit

Allergies:

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

Symptoms: aches; fever of 101.8 degrees F; This is a spontaneous report from a contactable consumer (patient) received via Pfizer-sponsored program regulatory authority Support. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, 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 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced aches and fever of 101.8 degrees F. 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:

Current Illness:

ID: 1712842
Sex: F
Age:
State: WA

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: light headedness; sore arm; chills; headache; nausea; fever; This is a spontaneous report from a Regulatory Authority via contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that she experienced side effects after the vaccination. On an unspecified date, the patient experienced light headedness on the next day of vaccination, sore arm on the second day of vaccination and the events chills, headache, nausea and fever on the third day. The outcome of the events was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1712843
Sex: F
Age:
State:

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 at 12:00 pm (at the age of-29 year) as a single dose for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sore arm on 10Mar2021 at 16:00 pm. No treatment was received for the adverse event. The outcome of event was unknown. No follow up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712844
Sex: F
Age:
State: OK

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: This is a spontaneous report from a Pfizer sponsored program COVAX US support via contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; 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 experienced chilling and little fever in Mar2021. The outcome of the events was unknown at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1712845
Sex: F
Age:
State: IN

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210311; Test Name: BP; Result Unstructured Data: Test Result:elevated; Comments: 168/58; Test Date: 20210311; Test Name: heart rate; Result Unstructured Data: Test Result:135 to 145

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Throat swelling; chills; muscle tremors; weak; dizzy; high resting heart rate 135 to 145; elevated BP 168/58; BP fluctuated; heart and BP fluctuated; head ache; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 at 10:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. Medical history of the patient included GERD, allergy from Oxy family which causes significant respiratory depression. Concomitant/other medications in two weeks included Omeprazole 20 mg, famotidine [PEPCID AC], cannabidiol [CBD oil] taken for unspecified indication. Patient did not receive any other vaccine within four weeks of COVID-19 vaccine. It was unknown if patient had COVID prior vaccination. On 11Mar2021, at 10:45 patient experienced Throat swelling, chills, muscle tremors, weak, dizzy, high resting heart rate 135 to 145, elevated BP 168/58. Both heart and BP fluctuated, headache. AE resulted in: Emergency room/department or urgent care. Patient was not for COVID tested post vaccination. Treatment in response to the events were unknown. Outcome of the events were recovering. No follow-up attempts are possible. No further information is expected.

Other Meds: OMEPRAZOLE; PEPCID AC; CBD OIL

Current Illness:

ID: 1712846
Sex: F
Age:
State: CO

Vax Date: 02/28/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: fever; Result Unstructured Data: Test Result:99; Comments: fever of 99

Allergies:

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

Symptoms: 14 days after vaccine I started severe diarrhea; severe joint aches; Coughing; 4 Days after I had a strange headache for 2 days; then felt fatigue; fever of 99 for an afternoon; noticed lungs seemed different as breathless, which progressed to a little pressure which I have never had before; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6203) via an unspecified route of administration (age at vaccination 76-year) in right arm on 28Feb2021 at 01:15 PM as dose 1, single for COVID-19 immunization. Medical history included diverticulitis; SOD; emphysema; Known allergies: several drugs, bee/wasp stings, msg, most preservatives; all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); tiotropium bromide (SPIRIVA RESPIMAT); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d nos (VITAMIN D NOS); all taken in two weeks of COVID vaccination, for an unspecified indication, start and stop date were not reported. The patient received no COVID prior vaccination. The patient not tested COVID post vaccination. Patient received no other vaccine in four weeks. Reported facility type vaccine was Doctor's office/urgent care. The patient experienced 4 days after she had a strange headache on 04Mar2021 for 2 days; then felt fatigue, fever of 99 for an afternoon, noticed lungs seemed different as breathless, which progressed to a little pressure which she never had before, on an unspecified date in Mar2021; 14 days after vaccine she started severe diarrhea, severe joint aches, coughing, on 14Mar2021. It was reported that "She never had before though, she had emphysema. Called her physician and she said to not take scheduled second shot when scheduled on 14Mar2021. Then she was concerned of what's next." AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on an unspecified date which included body temperature: 99 (fever of 99). The patient received no treatment for the adverse events. The clinical outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.

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

Current Illness:

ID: 1712847
Sex: M
Age:
State: NY

Vax Date: 03/06/2021
Onset Date: 03/07/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: blood; Result Unstructured Data: Test Result:Unknown results; Comments: Stated that they take his blood out every three months because it is heavy.; Test Name: test; Result Unstructured Data: Test Result:Covid; Comments: Stated that when they did the test that he had already had Covid.

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: boil under his right arm; boil under his right arm was reported as worsened; redness on his right arm; fever; This is a spontaneous report from a contactable consumer. This consumer reported for a 62-Year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration, administered in arm right on 06Mar2021 as dose number unknown, single for COVID-19 immunization (age at vaccination: 62-Year-old). Medical history included COVID-19 from on an unspecified date in Mar2020. The patient's concomitant medications were not reported. On 07Mar2021, the patient had big red boil on his arm and fever. Stated that it has gotten worst, and it is next to the breast. Also stated that when they did the test that he had already had COVID and that he thought he had the flu, and it was COVID. It was reported that he found out two months later when he had the test. Timeframe between vaccination and starting of symptoms was 01 day. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included blood test: unknown results (stated that they take his blood out every three months because it is heavy) and test included: COVID (stated that when they did the test that he had already had COVID). The patient recovered from fever on 07Mar2021. The outcome of events boil under his right arm, boil under his right arm was reported as worsened and redness on his right arm was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712848
Sex: M
Age:
State: IL

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210222; Test Name: Heartbeat; Result Unstructured Data: Test Result:Rapid

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Dizziness; Rapid Heartbeat; tremors; vertigo; inability to walk well; cold sores around nose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 11:00 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included heart disease, neurological vascular, EPI, degenative disc disease from an unknown date and unknown if ongoing, known allergy: Penicillin, Iodine dye from an unknown date and unknown if ongoing. Concomitant medication(s) included clonazepam (KLONOPIN); atorvastatin (LIPITOR [ATORVASTATIN]); warfarin sodium (COUMADIN); omeprazole (PROTONIX [OMEPRAZOLE]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Facility where COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Post vaccination, the patient had not been tested for COVID-19. On 22Feb2021 11:15, patient experienced dizziness, rapid heartbeat, tremors, vertigo, inability to walk well, cold sores around nose. Patient visited doctor or other healthcare professional office/clinic, emergency room/department or urgent care for adverse events. The patient underwent lab tests and procedures which included heartbeat: rapid on 22Feb2021. The clinical outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds: KLONOPIN; LIPITOR [ATORVASTATIN]; COUMADIN; PROTONIX [OMEPRAZOLE]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1712849
Sex: F
Age:
State: TX

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itchy red rash on my chest and arms; very red, hot face; very red, hot face; This is a spontaneous case received from a contactable consumer (patient herself). A 34-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6205) via an unspecified route of administration in left arm on 11Mar2021 17:40 (age at vaccination 34-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included thrombocytopenia and 3 months postpartum/breastfeeding. Concomitant medications included aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX [AMINOBENZOIC ACID, BIOTIN, CALCIUM PANTOTHENATE, CHOLINE BITARTRATE, CYANOCOBALAMIN, FOLIC ACID, INOSITOL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE]), SELENIUM, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, ZINC, GoatsRue, Shatavari. The patient had known allergies with sulfa drugs, apple/pear and diary. Other vaccine administered in four weeks was reported as none. COVID prior vaccination and COVID tested post vaccination was reported as none. On 12Mar2021 09:10, the patient stated that she received the vaccine at 5:45 PM on Thursday, at Friday morning at 9:10 AM had a very red, hot face. Ten minutes later she had an itchy red rash on her chest and arms. No fever, she could breath find and it went away after an hour or so. No treatment was taken for the events. Outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are possible. No further information was expected.

Other Meds: B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACI; SELENIUM; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; ZINC

Current Illness:

ID: 1712850
Sex: F
Age:
State: NM

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Patient received vaccine and felt neck swelling and chest tightness.; Patient received vaccine and felt neck swelling and chest tightness.; This is a spontaneous report from a contactable Health Care Professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6203), dose 1 intramuscularly on 26Feb2021 at 15:30 (at the age of 60-years-old) as a DOSE 1, SINGLE for covid-19 immunisation at Health Clinic facility. The patient medical history included rhinitis allergic, hypersensitivity, glucose tolerance impaired, headache, hyperlipidaemia, food allergy (fish and seeds/nuts) and gastroesophageal reflux disease all from an unknown date and unknown if ongoing. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) 90 ug, TID (Three times a day) (albuterol 90 mcg/inh inhalation aerosol) 4 puff), fexofenadine hydrochloride (ALLEGRA), naproxen sodium (ALEVE) 220 mg, once a day orally, biotin (BIOTIN) as needed orally, colecalciferol (VITAMIN D 3) once a day, epinephrine (EPINEPHRINE) (EpiPen 2-Pak 0.3 mg injectable kit) 1 each (0.3 mg) Intramuscularly, garlic [allium sativum] (GARLIC [ALLIUM SATIVUM]) orally (garlic oral capsule), lisinopril (LISINOPRIL) (lisinopril 10 mg oral tablet; 1 tab 10 mg) orally, lysine (LYSINE) 1000 mg, once a day orally and probiotics (PROBIOTICS) once a day (3-10 billion CFUs) orally, all were taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccine in four weeks. It was unknown If patient had covid prior vaccination and If tested for covid post vaccination. The patient received vaccine and felt neck swelling and chest tightness on 26Feb2021 at 15:45. It was reported that, 1538 Patient received vaccine and felt neck swelling and chest tightness. Patient received treatment for the event which was reported as, patient refused Benadryl and stated it knocks her out. Patient took 2 puffs of her prescribed Albut. Outcome of the event was resolved in 2021. No follow-up attempts are possible. No further information is expected.

Other Meds: ALBUTEROL [SALBUTAMOL]; ALLEGRA; ALEVE; BIOTIN; VITAMIN D 3; EPINEPHRINE; GARLIC [ALLIUM SATIVUM]; LISINOPRIL; LYSINE; PROBIOTICS

Current Illness:

ID: 1712851
Sex: M
Age:
State: TX

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

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

Lab Data: Test Date: 20210309; Test Name: low grade fever; Result Unstructured Data: Test Result:100.7 Fahrenheit; Comments: developed low grade fever (100.7); Test Date: 20210309; Test Name: Chest X-ray; Test Result: Negative ; Comments: Chest X-rays negative

Allergies:

Symptom List: Injection site pain

Symptoms: Woke up this morning with debilitating pain across middle of back; Every breath caused severe pain; low grade fever (100.7); chills; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 10:30 (age at vaccination 42 years old) (Batch/Lot Number: EN6203) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical Vaccine BNT162B2 product=COVID 19, lot unknown=False, dose number=1 age at vaccination 42 years old, for COVID-19 immunisation. on 09Mar2021 01:00 The patient experienced woke up this morning with debilitating pain across middle of back Every breath caused severe pain. Went to ER and received Toradol. Came home and developed low grade fever (100.7) and chills. AE treatment with Toradol and Tylenol. The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on 09Mar2021 developed low grade fever (100.7), chest x-ray: negative on 09Mar2021 Chest X-rays negative. Therapeutic measures were taken as a result of woke up this morning with debilitating pain across middle of back (back pain), every breath caused severe pain (chest pain), low grade fever (100.7) (pyrexia), chills (chills). Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1712852
Sex: F
Age:
State: WA

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 12Mar2021 08:30 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization, at other facility. The patient medical history included fibromyalgia. Concomitant medications included gabapentin (GABAPENTIN), spironolactone (SPIRONOLACTONE), and duloxetine hydrochloride (CYMBALTA). The patient had no known allergies. The patient received no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 12Mar2021 08:30, the patient experienced chest and throat tightness along with dizziness. No treatment was given for the events. The outcome of the events was reported as not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds: GABAPENTIN; SPIRONOLACTONE; CYMBALTA

Current Illness:

ID: 1712853
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; This is a spontaneous report from a non-contactable other hcp (patient). A 27-year-old (non-pregnant) female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 14:30 (at the age of 27-year-old) at dose number unknown, single for covid-19 immunisation. Medical history included Chronic migraines, GERD. Patient had no known allergies. Patient did not have covid prior vaccination. Patient has not tested for covid-19 post vaccination. Patient did not have other vaccine in four weeks. Concomitant medications were not reported. On 05Mar2021 the patient experienced Extreme fatigue, weakness, drowsiness, joint pains, Myalgia's, GERD, sweats, ABD pain. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse events. Outcome of the events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1712854
Sex: F
Age:
State: TN

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: right arm soreness; This is a spontaneous report from a contactable consumer (Patient). A 42-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot Number: EL9269; Expiration Date: 31May2021), via an unspecified route of administration on 15Feb2021(at the age of 42-years-old) administered in Arm Right as a single dose for COVID-19 immunisation. Medical history included using 4-year-old eyeglasses from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 15Feb2021, the patient experienced right arm soreness. It was reported that Caller is a 42-year-old female who received the second dose of the Pfizer Covid 19 vaccine and is reporting the following side effects that have worsened each day: "Friday night sore arm same as first dose. Next day body aches, slight headache, tired. Yesterday body pain, like the most intense workout of my life. I couldn't get up. No energy and horrible headache. I've been taking Tylenol since Friday. Saturday slight chills, burning up and then cold chills. Yesterday could not get warm- freezing all day. Temperature was normal but I've been taking Tylenol. Hurting and headache and dizziness this morning. it seems like each day something adds on. Is this normal? Reported she got her second Pfizer COVID-19 Vaccine shot on Friday (12Mar2021). She said she heard nothing bad happens after getting the Pfizer COVID-19 Vaccine, and if there are side effects, the side effects would only be a day or two. She said she was on day 3 of having side effects after her second COVID-19 Vaccine. She said she maybe fine, but wanted to make sure what she was experiencing were expected side effects for the COVID-19 Vaccine. She said she was a school teacher, and didn't want to go to school today because of how she was feeling. She said her arm (left) was hurting after her second COVID-19 Vaccine, but she was OK with her arm hurting. She said her arm (right) hurt, too, after her first COVID-19 Vaccine. She clarified after her first COVID-19 Vaccine, she had only right arm soreness. She said the right arm soreness was bad. She said she wasn't used to that type of arm soreness after a vaccine, though she was expecting some type of arm soreness. She said her right arm soreness went away after a couple of days. She said her arm hurting was an expected side effect of the COVID-19 Vaccine. She said her body ached, as well, after the second COVID-19 Vaccine. She said she anticipated body aches, and took Tylenol, and rested a bit. She said she was extremely tired, too. She said each day she had something additional she was experiencing. She said she had no energy yesterday (14Mar2021), and her body aches had progressed to her body being in pain. She said her body pain hurts worse than the pain she would experience from working out. She said she had a light headache yesterday (14Mar2021), and when she got up this morning, she became dizzy. She said she each day she was getting more side effects. She said she was still taking Tylenol. She said she doesn't have a fever, but wasn't sure if that was because she had been taking Tylenol for her pain. She said she read it was OK to take Tylenol with the COVID-19 Vaccine, so she took Tylenol on her way to get her second COVID-19 Vaccine on Friday (12Mar2021). She said the next day (13Mar2021), she took a shower in the morning, and took Tylenol again. She clarified she had been taking Tylenol every day since she received her second COVID-19 Vaccine. She said today (15Mar2021), she had no energy. Caller was advised she would be transferred to Pfizer Medical Information for further assistance with her question about COVID-19 Vaccine side effects. Reported she had her first COVID-19 Vaccine administered on 15Feb2021 in her right arm, providing Pfizer Lot Number: EL9269, and Expiration Date: May2021. She said her second COVID-19 Vaccine was administered on Friday, 12Mar2021, at 1:08PM in her left arm because she had gone through a "drive-thru" COVID-19 Vaccination site. She said she normally would have had the vaccine administered in her non-dominant right arm. She provided the second COVID-19 Vaccine Pfizer Lot Number as EN6204, and the Expiration Date as Unknown. She said there was no NDC Number listed for her first and second COVID-19 Vaccine doses. Reported she was as healthy as a horse. Reported she had been taking 2 Extra Strength Tylenol 500mg at time since 12Mar2021,She stated she would have to "pray about the numbers", when asked for the Extra Strength Tylenol NDC Number. She stated her vision was not the best, and she had to put on glasses to make the Extra Strength Tylenol 500mg product label bigger, so she could read the NDC Number. She said she had vision issues her whole life, and was using 4 year old eyeglasses to read the Extra Strength Tylenol product label. She clarified she could hardly move her left arm after getting the second COVID-19 Vaccine. She said her left arm became sore around 10:00PM on 12Feb2021 but was better now. She said her body aches started on Saturday (13Mar2021) morning and were tolerable. She said she the Tylenol wasn't helping her body aches. She said she wasn't sure if her feeling tired was a side effect of the second COVID-19 Vaccine, or her just "sleeping-in" on Saturday morning. She said she got up on Saturday (13Mar2021) morning and made her kids breakfast. She said she noticed she was really tired around 9:30AM-10:00AM. She said her headache was pretty bad today (15Mar2021). She said she noticed when she was sitting around on Saturday (13Mar2021) her body ached, but on Sunday (14Mar2021) she immediately felt pain in her body. She said she couldn't get up out of bed on Sunday, and when she tried to move, her whole body was in pain. She said she was very dizzy this morning (15Mar2021), and the whole room was spinning. She said as long as she was sitting, or didn't move too quickly, she was good for a period of time. She said her dizziness settled down, as long as, she didn't switch positions too quickly. She said her energy level was different today than from yesterday. She said today she felt she had no energy. She said she laid down over the weekend when she was tired, but today, she had no option to lay down, and feels her lack of energy a lot more. Therapeutic measures were taken as a result of right arm soreness and treatment included tynelol. The outcome of the event was recovered on an unknown date Feb2021. Information on Lot/Batch number was available. Additional information has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712856
Sex: F
Age:
State: AZ

Vax Date: 03/13/2021
Onset Date: 03/14/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: I noticed a lump closer to my neck than my shoulder; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:30 (Batch/Lot Number: EN6206) as DOSE 2 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The History of all previous immunization with the Pfizer vaccine First dose of the product was administered on 14Feb2021. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient Received her second dosage on Saturday morning and states she has developed a lump near my neck, left, between my shoulder and her neck, closer to her neck on 14Mar2021. It's real swollen and it's tender to the touch and it's on the same side she had her shot. Caller wants to know if that is one of the side effects, could it possibly be one, has anyone else had one, or is it something else. Caller states she tried contacting her doctor first, but he is completely booked for the week. The event outcome was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712857
Sex: F
Age:
State: KS

Vax Date: 03/14/2021
Onset Date: 03/14/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; having an allergic reaction; This is a spontaneous report from a contactable consumer. This 43-year-adult female consumer reported that. A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 14Mar2021 11:45 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Peanuts allergy from an unspecified date and unknown ongoing and concomitant medications includes Metronidazole and Minerals Nos, Quercetin, Thioctic Acid, Vitamins Nos (EMERGEN-C). On 14Mar2021, 4 hours after the vaccination, the patient experienced cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling. When patient woke up in the morning, face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes. ER DR confirmed was having an allergic reaction. Received a few shots and medication to take as treatment. Patient was not diagnosed with covid prior vaccination and covid was not tested post vaccination. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.

Other Meds: METRONIDAZOLE; EMERGEN-C

Current Illness:

ID: 1712858
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: The nerve on the backside of my leg was inflamed to the back of my knee; Outbreak of herpes; Tenderness in the nerve on the left side of my face; Occasional pain in my left ear; Sore arm; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 69-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:15 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included lumbar discectomy, low back pain with bilateral sciatica, degenerative disc from an unknown date and unknown if ongoing degenerative disc. The patient concomitant medications were not reported. Patient not had Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, did not patient been tested for COVID-19. The patient did not receive other medications in two weeks of vaccination. Other than a sore arm on 05Mar2021, I had no reaction on the Friday that I received the shot. I also have herpes which breaks out in the hairline of my forehead and on the back side of my right buttocks. The day after the vaccine on Saturday, On 06Mar2021 the nerve on the backside of my leg was inflamed to the back of my knee, I also had an outbreak of herpes in both areas and tenderness in the nerve on the left side of my face with occasional pain in my left ear. The nerve pain in my leg and face subsided by Monday, the bilateral sciatic pain thru my buttocks area on both sides has not dissipated as of yet. Patient visited doctor or other healthcare professional office/clinic visit. Treatment was received for the events (recommendation to hear, stretch and elevate). The outcome of the events was reported as recovering. The lot number for [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1712859
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Mildly sore arm after the first and second shot; This is a spontaneous report from a contactable consumer. A contactable consumer (patient) reported for a himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced mildly sore arm after the first and second shot on an unspecified date. No medical questions about side effects at this time. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712860
Sex: F
Age:
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: I got my shot 2 weeks ago today and i have metallic taste in my mouth.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 76-years-old female patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced I got my shot 2 weeks ago today and i have metallic taste in my mouth. It started about 1 week ago. Is that a side effect. The clinical outcome of the events was reported as unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712861
Sex: F
Age:
State: IL

Vax Date: 03/10/2021
Onset Date: 03/10/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient herself). A 84-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 (at the age of 84-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller mentioned that she received the 1st dose of the vaccine on 10Mar2021 and had a lot of problems since she got that shot. She mentioned that on the day she received it, she was okay and just had a sore arm. She mentioned that a day after, she had a headache for 6 days, was tired that she was on and off her couch, had chills, and could not eat because her mandibular joint on the right side of her jaw hurt. She could not chew, not even toast, so she resulted to drinking coffee and sipping soup. She had no good sleep because of it. She did not had a temperature or any dental problems. She said that her mouth was still hurting, she still had a sore throat. It was so bad that she would not wish it on her worst enemy. Because of this, she was very worried about the 2nd dose. She was asking what to expect of it and would it be similar. she was due for it on 31Mar2021. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712862
Sex: F
Age:
State:

Vax Date: 02/22/2021
Onset Date: 03/04/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: She reports a swollen lymph node on the same side as injection; This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 22Feb2021, as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient reported noticing a swollen lymph node on her collar bone on the same side that she received the vaccine on 04Mar2021. She was due for her second shot, today, but her HCP told her to wait another week to see if the swelling in her lymph node will go down. Do we have information about duration of swollen lymph nodes? Lymphadenopathy is a commonly reported AE in the clinical trials, but the frequencies we have reported are from the 7 days post either dose. No information for duration. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712863
Sex: F
Age:
State: NJ

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

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

Lab Data:

Allergies:

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

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, she felt "really sick, kidney damage, blood in her urine, her stomach is "really bad on 2021. Reported as, Patient got the first dose of Pfizer vaccine 2 weeks ago, does not remember exact day. She felt "really sick", it looks like she had kidney damage, she had blood in her urine, she had a "very bad" reaction. The last two weeks she has been to 5 different hospitals, because they know nothing about the vaccine o how to help her. She was prescribed antibiotics, her stomach was "really bad", she still has kidney problems. On Wednesday, she was scheduled for the second dose. Treatment were given for the adverse event. Outcome of the event kidney damage was not recovered and unknown for other events. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1712864
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: he had a sore arm for a couple of days; This is a spontaneous report from a contactable consumer (patient). This male consumer reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included skin ulcer from an unknown date and unknown if ongoing ulcer on his leg. Concomitant medication included valaciclovir hydrochloride (VALTREX) taken for skin ulcer (for an ulcer on his leg) start and stop date were not reported. The patient experienced a sore arm for a couple of days. Patient wanted to know, patient took Valtrex daily and prophylactically, for an ulcer on leg, and it will affect the efficacy of the vaccine. Response: no drug interactions listed in the fact sheet (Sect 10). Provided the two classes of medication that are contraindicated in the attached document. The outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds: VALTREX

Current Illness:

ID: 1712865
Sex: M
Age:
State: OH

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

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

Lab Data:

Allergies:

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

Symptoms: sore arm for 2-3 days; This is a spontaneous report from a contactable consumer reported for a 86-year-old male consumer (patient) that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for 2-3 days. What were the titer cut off levels during the trial. Caller got an antibody test with a reference point of .8 and a measurement of 250. What does this mean. Caller received second dose of Pfizer vaccine on 10Feb2021 and experienced no side effects. The clinical outcome of event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1712866
Sex: F
Age:
State: TX

Vax Date: 03/12/2021
Onset Date: 03/15/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: dizziness/very dizzy; vomiting; having cold sweats; This is a spontaneous report received from a contactable Consumer or other non-HCP (patient reported for herself). The report was not related to a study or programme. A 21-year-old adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6204, Expiration date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 12Mar2021 at 18:00 (at the age of 21-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Patient medical history was None. Family Medical History Relevant to AEs was none. The patient concomitant medications were not reported. Prior Vaccinations within 4 weeks was none. On 15Mar2021, the patient experienced dizziness/very dizzy, vomiting and having cold sweats. The clinical details of the events as follows: caller stated she was calling about the Pfizer COVID vaccine and stated she had a few questions stated she had her 1st dose of the Pfizer COVID Vaccine on Friday evening on 12Mar2021 and today she had a pretty adverse event of being very dizzy having cold sweats and vomiting that began today 15Mar2021. Caller stated she did not believe the dizziness. cold sweats and vomiting are ongoing and stated she did not have treatment. Caller stated the symptoms were not pleasant and was asking if those were typical side effects with the Pfizer COVID Vaccine. Caller stated her 2nd question was that she was asking if it is safe to get the 2nd dose of the Pfizer COVID Vaccine in regard to the symptoms she has reported. Caller aware that Pfizer unable to offer treatment recommendations or medical advice; caller referred to her HCP. The AEs did not require a visit to Emergency Room and Physician Office. The events did not Result in death, Life threatening, caused prolonged hospitalization, Disabling Incapacitating and Congenital anomaly or birth defect. Relevant Tests were None. There was no Investigation Assessment provided. The case was reported as non-serious. The patient outcome of the events vomiting and having cold sweats was not resolved and the outcome of other event was unknown at the time of this report. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712867
Sex: F
Age:
State: MA

Vax Date: 03/11/2021
Onset Date: 03/13/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: she is on a blood thinner and received the first dose of the Pfizer-BioNTech COVID-19 vaccine; Severe Diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient reported for herself). A 74-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in right arm on 11Mar2021 at 11:00 (at the age of 74-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history included hypertension from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications within 2 weeks of vaccination included blood pressure (BP) medications and blood thinner. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 13Mar2021 at 13:00, the patient experienced severe diarrhea. It was reported that the patient stated she was on a blood thinner and received the first dose of the Pfizer-BioNTech COVID-19 vaccine. She explained she was told after the fact that she should tell the vaccination provider about being on a blood thinner. The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. No treatment was received for the event. Not allowed to contact healthcare professional. No product quality complaint was present. Expiration date has been requested. The outcome of the event was reported as resolving. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1712868
Sex: F
Age:
State: NY

Vax Date: 02/25/2021
Onset Date: 03/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Date: 20210310; Test Name: Covid test PCR; Test Result: Negative ; Comments: Nasal Swab

Allergies:

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

Symptoms: Mild headache around sinuses and back of head; cold symptoms (very mild congestion, mild eyes burning); cold symptoms (very mild congestion, mild eyes burning); cold symptoms (very mild congestion, mild eyes burning); mild chest discomfort (similar to acid reflux/GERD which I have a history of).; chest pain (thought was related to my GERD condition); This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 25Feb2021 13:45 (Lot number was not reported) (at the age of 54-years-old) as dose 1, single for covid-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), mild mitral valve prolapse. There were no concomitant medications received within two weeks of vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient did not have covid-19 prior to vaccination and was tested for covid-19 post vaccination. On 04Mar2021, the patient experienced mild headache around sinuses and back of head and cold symptoms, very mild congestion, mild eyes burning and mild chest discomfort similar to acid reflux/GERD which she had a history of. The symptoms began about a week after first vaccine dose and were present 1.5 weeks later. The patient was preoccupied with possibly having caught COVID during that time and the chest pain in Mar2021, she thought was related to her GERD condition. The patient had polymerase chain reaction (PCR) test by nasal swab on 10Mar2021 and the result was negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The outcome of chest pain was unknown and outcome of all other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Other Meds:

Current Illness:

ID: 1712869
Sex: F
Age:
State: FL

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: swollen; little tumor on the eyelid; pain in her eye; eye was irritated; left eye tumor red and itching; left eye tumor red and itching; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route on 11Mar2021 at 09:30 (at the age of 80-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included anxiety diagnosed a long time ago, diabetes from 1958 to ongoing, blood pressure high diagnosed 10 or 13 years ago, high cholesterol diagnosed since the caller was in her 40's and got the shingles vaccine before, family history her mother had glaucoma. The patient concomitant medications were not reported. The patient historical vaccine included BNT162b2 Covid 19 shot (Batch/lot number: EN9267) and experienced eye was very red and itchy and swollen, very dry tongue and mouth and used refresh eye drops for her eyes but she stopped using them and got a Flu shot last Sep. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced left eye tumour red and itching. Patient received the first shot and she got strong side effects in her right eye, she doesn't know if it's the shot. The patient eye was very red and itchy and swollen. The patient also had a very dry tongue and mouth. The patient was planning on going to the pharmacy in a little while to ask for something for her eye. The patient first shot was 17Feb2021 and then on the right eye it looked like a small tumour, that is severe. Today 11Mar2021 the patient went for her second shot and on the other eye, her left eye, it's like a little tumour on the eyelid, red and very itchy and has to keep from scratching it all the time. The patient was going to the pharmacy right now to get something for her eye. The patient other eye, the right eye, was clear already, she's hoping her left eye will clear up like this. After the second dose the side effect is her left eye, sometimes she feels pain in her eye and sometimes she doesn't, if she closes it or applies pressure she feels pain. The itch is worse, than when the patient got the shot she didn't have the itch and now it started itching when she got home. The patient eye was irritated. The patient got blood test about 2.5 months ago but that was before she received the vaccines. Patient did not visit to Emergency room or Physician's office. Lately the patient had been suffering from her eyes, she had some condition where she thought her eyes were closed but they weren't but this was from a medication which she stopped taking and it hadn't happened since, she was given the wrong medication for her illness. The outcome of the events left eye tumour red and itching was not recovered and other events was unknown. No follow up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Anxiety (Verbatim: Anxiety); Blood pressure high (Verbatim: Blood pressure high); Diabetes (Verbatim: Diabetes); High cholesterol (Verbatim: High cholesterol)

ID: 1712870
Sex: F
Age:
State:

Vax Date: 02/22/2021
Onset Date: 02/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient was given the first Moderna COVID-19 vaccine on 25/JAN/2021 and 0n 22/FEB/2021, the patient got her second COVID-19 vaccine.; Patient was given the first Moderna COVID-19 vaccine on 25/JAN/2021 and 0n 22/FEB/2021, the patient got her second COVID-19 vaccine.; had no reaction to the COVID-19 vaccine injections except for a little soreness in the arm; This is a spontaneous report based on information received from a non-Pfizer sponsored program (marketing program name not available) by Pfizer (manufacturer control number: US-AMGEN-USASL2019000533), license party for etanercept (ENBREL). A contactable consumer reported a 76-years-old female patient received bnt162b2 (PFIZE-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Feb2021 as dose 2 (initial Pfizer dose), single for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took gold and prednisone for unknown indication and also took moderna covid-19 vaccine on 25Jan2021 for covid-19 immunisation and experienced a little bruise and soreness. The patient was given the first Moderna COVID-19 vaccine on 25Jan2021 and on 22Feb2021, she got her second COVID-19 vaccine. She had completed two COVID-19 vaccine injections. On unknown date in feb2021, she had no reaction to the COVID-19 vaccine injections except for a little soreness in the arm. Patient had no fever and no headache with the COVID-19 vaccine either. Subsequently, the patient took Tylenol (paracetamol) as a treatment right after she got the COVID-19 vaccine, and she did. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1712871
Sex: F
Age:
State: FL

Vax Date: 01/29/2021
Onset Date: 01/01/2021
Rec V Date: 09/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: wife was injected by the needle in the right arm, but "screamed out" because the needle was put in a bad spot; keeps her awake at night; Right arm is still hurting her and is getting Worse; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9263), via an unspecified route on 29Jan2021 (at the age of 76-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Jan2021, the patient experienced was injected by the needle in the right arm, but "screamed out" because the needle was put in a bad spot. The vaccine provider then administered dose in left arm. Reporter says his wife is still having right arm pain. Reporter was unsure if wife had vaccine dose injected into right arm or just needle insertion. Reporter says 2nd dose was given in left arm because right arm was still hurting at the time of 2nd dose. She had 2 of them, the first was on 29Jan2021 and the second was on 26Feb2021. Reporter asking what he and his wife should do about the arm pain. Reporter stated that his wife had severe pain in the right arm from the first shot and it keeps her awake at night. What his wife said was at the site, for the first dose they initially put the shot in the right arm and then the person administering the shot said they had a problem, and so then they put the shot on the left arm. Reporter stated that he thinks the needle broke in the arm. He again confirms that they made an attempt to administer the vaccine on the right arm, but because they had a problem administered the vaccine in the left arm. After his wife was done he saw that the patch was placed on her left arm. Her Right arm is still hurting her at the moment. He asks is this normal and how to deal with it. He confirms it was her right arm still hurting her and getting Worse. The outcome of the event keeps her awake at night was unknown and other events was not recovered. Information on Lot/Batch number was available. Additional information has been requested Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am