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: 1652882
Sex: M
Age:
State: KY

Vax Date: 05/06/2021
Onset Date: 06/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210611; Test Name: CK elevations; Result Unstructured Data: Test Result:476; Test Date: 20210611; Test Name: creatinine; Result Unstructured Data: Test Result:1.7; Test Date: 20210615; Test Name: creatinine; Result Unstructured Data: Test Result:1; Test Date: 20210611; Test Name: Mild AKI's and transients; Result Unstructured Data: Test Result:Unknown result; Comments: Mild AKI's and transients

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: some possible increase in heat exhaustion; kind of like a heat stroke; Unable to get through military exercises after receiving the Pfizer Covid Vaccine; This is a spontaneous report from a contactable physician. A 20-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Deltoid Right on 06May2021 06:54 (at 19-years age) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) for covid-19 immunisation. The patient experienced some possible increase in heat exhaustion on an unspecified date, unable to get through military exercises after receiving the pfizer covid vaccine on 11Jun2021 and, kind of like a heat stroke on an unspecified date. The patient underwent lab tests and procedures which included blood creatine phosphokinase: 476 on 11Jun2021, blood creatinine: 1.7 on 11Jun2021, blood creatinine: 1 on 15Jun2021, blood test: unknown result on 11Jun2021 Mild AKI's and transients. Reporter was a military physician and had reported some of his men (referring to military people) were actually experiencing some difficulty in carrying out there usual military exercises as compared to before. Reporter mentioned some possible increase in heat exhaustion but he is not positive that it is caused by the vaccine. In line with this, he would like to have some information in regards precaution that may be aware of regarding an increase in heat exhaustion after an amount of days after getting the vaccine. Over-all there were 28 people reporting this side effect after getting their second dose on 06Jun2021. There are adverse events that may not have occurred in the clinical trial but may have occurred in the 'real-world' post-authorizaiton setting. Pfizer cannot provide treatment recommendations. However, the CDC has established a project comprised of a team of vaccine safety experts who can be consulted on complex COVID-19 vaccine safety questions. You can also use the search terms, 'CDC and CISA' on your search engine to find this website. Be sure to follow the CDC's instructions on making a request (either online or phone) to consult the CISA team. A bunch of other factors probably played a role. Kind of chasing a wild goose. The caller wants to make sure. The caller reports he was not seen anything else in his research other than a couple reports of pericarditis in young men. The caller wanted to make sure there is no reason to be concerned. The 12 mile mark was only a one time kind of thing. Other physical activity and physical fitness has occurred as usual without any problems. This was a onetime thing just a red herring. Causality: The caller states the event was probably heat and humidity related issue, peoples conditioning. The caller is the officer assigned to investigate the situation. The caller wants to make sure he is not missing anything. The caller would like to know any recommendations, the caller states he has not seen taking it easy for longer than a week or two after receiving the Pfizer Covid Vaccine. Causality: The caller states the event is not a direct correlation, more of an indirect kind of thing that just popped up. Whether the event is a thing or more of like, a bunch of other reasons the caller can think of that this could happen including heat and humidity. The reporter wanted to make sure as the investigation medical officer the caller is not missing anything and is doing his due diligence.The patient went to the emergency room for further stabilization. The patient was not hospitalized. The patient stayed in the emergency room for 2-3 hours for observation and fluids. The outcome of the events was unknown. Information on batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021757388 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757389 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757390 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757537 Same reporter/ drug/ AE, different patient

Other Meds:

Current Illness:

ID: 1652883
Sex: F
Age:
State: DE

Vax Date: 06/17/2021
Onset Date: 06/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Neuropsychiatric; OCD; Crying; Withholding food; Headbanging the same she has had after infections; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181), via an unspecified route of administration on 17Jun2021 at 14:00 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, paediatric acute onset neuropsychiatric syndrome and mast cell activation syndrome. The patient had known allergies to red dye. Concomitant medications included ivabradine hydrochloride (CORLANOR), pyridostigmine bromide (MESTINON), cromoglicate sodium (GASTROCROM), escitalopram oxalate (LEXAPRO) and clonidine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), via an unspecified route of administration on 27May2021 at 14:00 (at the age of 14-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Jun2021 at 20:00, the patient experienced neuropsychiatric, obsessive-compulsive disorder (OCD), crying, withholding food and headbanging, the same she has had after infections. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with NSAIDS and antihistamines. The clinical outcome of the events neuropsychiatric, obsessive-compulsive disorder (OCD), crying, withholding food and headbanging were resolving at the time of this report.

Other Meds: CORLANOR; MESTINON; GASTROCROM; LEXAPRO; CLONIDINE

Current Illness:

ID: 1652884
Sex: F
Age:
State:

Vax Date: 06/18/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Asthma/almost every night she has attacks; This is a spontaneous report from a contactable consumer (patient's father). A 13-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 18Jun2021 (last Friday) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included history of genetic asthma which she got from caller and has not had any recent attacks. No concomitant medications were reported. Caller stated since the second dose, almost every night she has attacks and the medicines Advair she is using daily and Albuterol does not seem to help, the attacks are more constant. Caller stated he does not hear hissing when he listens to her back/chest. Caller wanted to know if this is a reported side effect. Therapeutic measures were taken as a result of Asthma. Outcome of the event was not recovered. Information about lot/batch number has been requested. Additional information has been requested. Follow-up (20Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1652885
Sex: M
Age:
State: GA

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, coronary heart disease, lactose intolerant, IBD. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took other medication in two weeks, but unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 22Mar2021 at 15:15 as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 the patient experienced tinnitus - ringing in both ears with high pitch which prolonged for 24 hours per day/ 7 days per week. No therapeutic measures were taken as a result of the event tinnitus. The clinical outcome of the event tinnitus was not resolved, at the time of this report.

Other Meds:

Current Illness:

ID: 1652886
Sex: F
Age:
State: NY

Vax Date: 06/21/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hives on scalp area; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Jun2021 at 10:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included unspecified off the counter pills for migraine from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31May2021 at 10:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have any allergies to medications, food or other products. On 22Jun2021 at 06:00, the patient experienced hives on scalp area, 20 hours after the second vaccine shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event hives on scalp area was recovering at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1652887
Sex: M
Age:
State: CA

Vax Date: 05/17/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I am having numbness and tingling effect in my left arm where I had the shot. But only happen about 5 days ago. Its more than a month since the shot.; I am having numbness and tingling effect in my left arm where I had the shot. But only happen about 5 days ago. Its more than a month since the shot.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 17May2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On 15Jun2021, the patient was having numbness and tingling effect in his left arm where he had the shot. But only happened about five days before the report. It was more than a month since the shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events having numbness and tingling effect in left arm where the patient had the shot was not resolved at the time of this report.

Other Meds:

Current Illness:

ID: 1652888
Sex: M
Age:
State: MA

Vax Date: 03/22/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: his left arm under the forearm, like the tendon that runs from his wrist to elbow on the inside, he had pain; Starting on 01May2021 he experienced pain in shoulder, the right shoulder under his arm pit; It is also in the joints, knees, tendons and muscles; on 03May2021 or 04May2021 the other arm was doing the same thing.; It is also in the joints, knees, tendons and muscles; pain in the shoulder, joints, back area that changes locations and pain comes and goes - It started 4 weeks after getting the 2nd dose; pain in the shoulder, joints, back area that changes locations and pain comes and goes - It started 4 weeks after getting the 2nd dose; Pain legs; It is also in the joints, knees, tendons and muscles; it was just a needle in arm and hurt a little bit but that is fine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 22Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 01Mar2021 10:00 as dose 1, single for covid-19 immunisation and experienced vaccination site pain. Starting on 01May2021 he experienced pain in shoulder, the right shoulder under his arm pit. He exercises and run 4-6 miles so he thought might be from running. On 02May2021 his left arm under the forearm, like the tendon that runs from his wrist to elbow on the inside, he had pain. Then on 03May2021 or 04May2021 the other arm was doing the same thing. Subsequently, the top of his right shoulder, started having pain. Then the top of his back, the deltoid muscle he would say, was sore. The pain has gone to his legs, both of them. He has pain in his left hip in the back. He can feel it in his joints and knees, especially the left. Right now, the left elbow, if she presses against it is a little tender. Reported pain in the shoulder, joints, back area that changes locations and pain comes and goes. After the first and second dose he was fine, it was just a needle in arm and hurt a little bit but that is fine. At first the pain was a 1 out of 10, just enough that he knew it there. Now it is a little bit worse, a 2 out of 10 since starting but the pain the comes and goes, but he would say getting worse. Therapeutic measures were taken as a result of pain in the shoulder, joints, back area that changes locations and pain comes and goes - it started 4 weeks after getting the 2nd dose, pain legs, it is also in the joints, knees, tendons and muscles, starting on 01may2021 he experienced pain in shoulder, the right shoulder under his arm pit his left arm under the forearm, like the tendon that runs from his wrist to elbow on the inside, he had pain, on 03may2021 or 04may2021 the other arm was doing the same thing included ibuprofen. It has been 5 weeks and he has used ice and the Ibuprofen but it doesn't work. Patient was recommended Physical therapy. The events resulted in ER visit in Jun2021. The outcome of the event vaccination site pain was unknown, remaining events were not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1652889
Sex: M
Age:
State:

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

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

Lab Data: Test Date: 202106; Test Name: Spike test; Test Result: Negative.

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: One week after the second dose he had surgery for a "really bad issue" with his back; received two days of IV Decadron and a 10 day course of oral Decadron post surgery for inflammation; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on Jan2021 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced one week after the second dose he had surgery for a "really bad issue" with his back, received two days of iv Decadron and a 10-day course of oral Decadron post-surgery for inflammation. The patient underwent lab tests and procedures which included antibody test was negative on Jun2021. Therapeutic measures were taken as a result of one week after the second dose he had surgery for a "really bad issue" with his back (back disorder), received two days of iv Decadron and a 10-day course of oral Decadron post-surgery for inflammation (inflammation). The outcome of the events was unknown.

Other Meds: ASPIRIN

Current Illness:

ID: 1652890
Sex: F
Age:
State: OH

Vax Date: 06/21/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Fever; Result Unstructured Data: Test Result: 100 Fahrenheit.

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: running a little fever; This is a spontaneous report from a contactable female consumer. This 86-Year-old female patient reported for herself. An 86-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified rout on 21Jun2021 at 11:00 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported and concomitant medications included warfarin. On 22Jun2021, the patient was running a little fever. It was reported that "yesterday she got her vaccine, the Pfizer, and today she is running a little fever. Caller states she sees that's a little side effect, but they didn't say what to take. The fever is 100, it has decreased she believed a little bit. The patient was just concerned because she took the vaccine and saw that's one of the side effects. She wanted to know should she take Tylenol, it wasn't on the sheet they gave her. She doesn't see where they suggest any kind of medication and also reported that she is also on warfarin a blood thinner and she is allowed to take Tylenol but not ibuprofen. The patient underwent laboratory test included fever resulted 100 F. The outcome of the event was not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds: WARFARIN

Current Illness:

ID: 1652891
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Caller states after her and her dad received the vaccine they could no longer speak in a high tone.; This is a spontaneous report from a contactable consumer or other non hcp. An 83-years-old male patient received bnt162b2 dose 1 via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient reported that after she and her dad received the vaccine they could no longer speak in a high tone (dysphonia). The outcome of event unknown. Follow-up (22Jun2021): This is a follow-up spontaneous report from a contactable consumer. The consumer reported for a 83-year-old male patient that. Additional note: The report is cross referenced to report ID: We all got it in January and February and then she got to march and we couldnt hit high notes. Her dad is the same way. Follow-up attempts are completed. Information regarding the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758858 same reporter/drug/AE, different patient.

Other Meds:

Current Illness:

ID: 1652892
Sex: F
Age:
State: FL

Vax Date: 06/15/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Extreme fatigue; Headache; Severe joint pain; severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0187) via an unspecified route of administration in the right arm on 15Jun2021 at 18:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included Takayasu arteritis. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (MANUFACTURER UNKNOWN), calcium/ colecalciferol (CALCIUM D), multi-vitamins and vitamin d nos (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date taken within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0176) via an unspecified route of administration in the right arm on 25May2021 at 18:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jun2021 at 21:00 Within 3 hours of vaccination experienced severe nausea that needed medication. Approx. 24 hours post injection, on 16Jun2021 experienced extreme fatigue, headache, and severe joint pain that was so intense that she was unable to move without being in excoriating pain. Since the vaccination the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events nausea, fatigue, headache and severe joint pain with zofran 8 mg and ibuprofen 500mg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe nausea and headache was recovered on unknown date in Jun2021. The clinical outcome of the event extreme fatigue was recovered on 19Jun2021, 72 hours post onset. The clinical outcome of the event severe joint pain was recovered on 17Jun2021, 24 hours post onset.

Other Meds: BABY ASPIRIN; CALCIUM D [CALCIUM;COLECALCIFEROL]; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1652893
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: ringing in ears; anxiety; depression; been detrimental to her mental health; hasn't been able to do anything, very inactive, and his getting worse; hasn't been able to do anything, very inactive, and his getting worse; This is a spontaneous report from a Contactable consumer (Patients husband). A 60-year-old female patient received first dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration around 06Mar2021 (reporter was unsure of the exact date patient received the first dose, but he says it was around 06Mar2021) at the age of 60-year-old, Time the Vaccination Was Given: in the early morning around 9AM, as dose 1, single for Covid-19 immunization. The patient did not have any medical history and concomitant medications. She had No other history with this product. It was stated that 2 days after first dose, the patient experienced ringing in her ears it was a reaction and it hasn't gone away. It has been detrimental to her mental health. She has had anxiety and depression, the ringing doesn't go away. She has been going to therapy but it doesn't go away. She has been taking medication to calm her down but it still doesn't. No further information provided. Reporter wanted to know if they know anything about it, if there is anyway to undo the vaccine or if Pfizer has found anything that is useful because at this point she is going through a lot and he is going to have to take her to the hospital. The patient didn't take the second dose because of the ringing in the ears. It was stated that she had not just ringing in her ears but anxiety and depression". She hasn't been able to do any-thing, very inactive, and getting worse. They have the potential of going to the hospital emergency. Reporter stated they "will continue to work with the physicians, trying to manage how we can handle this". Reporter also stated that the patient have talked with people (privacy) and they have experienced similar symptoms. The patient did not undergo any investigation assessment. There was not any additional Vaccines Administered on Same Date of the Pfizer Suspect: None, Prior Vaccinations (within four weeks prior to the first administration date of the suspect vaccine). The event did not lead to Emergency Room visit however lead to visit to a Physician Office. The outcome of the events was unknown. Additional Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1652894
Sex: M
Age:
State: KS

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

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

Lab Data:

Allergies:

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

Symptoms: Got hiccups for a few days after each dose; Loss of sleep; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 74-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), via an unspecified route of administration in left upper arm on 01Apr2021 (Age at vaccination: 74-years-old) as single dose and first dose via an unspecified route of administration on 11Mar2021 (Age at vaccination: 74-years-old) (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Vaccination facility: Indoor Athletic Facility put on by county health department. No medical history and no concomitant medications was reported. vaccine was not Vaccine Administered at Military Facility. Did not receive Additional Vaccines on Same Date of the Pfizer Suspect. Did not receive any other vaccine within 4 weeks of covid-19 vaccine. It was reported that patient got both doses of the Pfizer BioNTech Covid-19 vaccine and he got hiccups for a few days after each dose. he was wondering if that has been reported. He shared that a friend had asked him if he had any side effects from vaccine, and he said no. Then said her brother had hiccups and is in his mid 80s, was bedridden for awhile. He had gotten the Moderna vaccine, though. Stated that there are reports on TV about a booster in the fall. Would he possibly have the same effects if he got a booster. Upon date 22Jun2021 it was reported that About 5 to 6 days after first dose he got the hiccups which lasted for 3 or 4 days. After second dose, something similar happened (hiccups), and he did not think much about it. Reports a loss of sleep since hiccups did not stop. Hiccups ended after the second dose around 08Apr2021 or 09Apr2021. The outcome for the event got hiccups for a few days after each dose was resolved on 2021 and for event loss of sleep outcome was reported as unknown at the time of this report. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1652895
Sex: F
Age:
State: NJ

Vax Date: 05/10/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swelling and small lump on the neck; lump pains; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 10May2021 at 10:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:- EW0171) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced swelling and small lump on the neck. It appeared after vaccine dose 2, taken on 10th May 2021. The lump had been on the neck for more than 4 weeks then and not reducing. The lump pains when pressed hard. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swelling and small lump on the neck and lump pains was not recovered at the time of report.

Other Meds:

Current Illness:

ID: 1652896
Sex: M
Age:
State: MD

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

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

Lab Data: Test Name: Covid-19 positive; Result Unstructured Data: Test Result:POSITIVE; Comments: Caller confirmed he tested positive prior to receiving vaccine.

Allergies:

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

Symptoms: severly ill; nauseaous; feeling bad; This is a spontaneous report received from contactable consumer (patient) or other non-health care professional via Pfizer-sponsored program. A 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch number/LOT: unknown), via unspecified route of administration on unspecified date on left arm at a DOSE 1, SINGLE for COVID-19 immunization. Concomitant medications include betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL), Vitamin D NOS (reports he started taking Vitamin D in March or April), Metformin, simvastatin, Aspirin all drugs received on unspecified date. Patient had medical history of diabetes, High blood pressure (years ago), high cholesterol (years ago), patient was tested positive for the disease. It was confirmed that he tested positive prior to receiving vaccine. patient stated that he has had surgeries he doesnt know if that was relevant to anything. Prior Vaccinations (within 4 weeks) patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient stated that he had gotten his first shot and second shot and then lost his card. He went back to the vaccine site and they only have the first shot on record. He had a trip planned and needs the verification that he had received the vaccines. He was wondering if her should get a third vaccine or not, even though his doctor recommended that he did not. He reports after his first vaccine he got severely ill (night, patient was in bed. he woke up bc of natural causes. on the way back to bed he got ill. patient got to feeling bad), he was nauseous (he never threw up but was nauseous) and sick but was able to go back to sleep and the next morning he was fine. Caller confirms above but clarifies they only had the second shot on record. He states you cant get the second shot until you get the first shot. He was wanting to know if he should get a third vaccine or not even though his doctor requested that he couldn't. He reports he just wants to find out if he should get a third shot or not. He was not going to report his symptoms to this department because he felt fine the next morning. He reports that after the second shot he was perfectly fine. Caller states his symptoms started the second day after he got the shot but he does not know what that day was. He thought he had recorded it but guesses he didn't. it was reported that he can't think of the names of the medications he takes. Caller states he does not have the Lot number, or expiration date for his medications. He reports he takes medication for diabetes, high blood pressure, and high cholesterol, he also takes a multivitamin and vitamin D. later he clarified that he takes metformin and Simvastatin. Patient received 2nd shot was given on 11Mar2021. Outcome of events was recovered on unspecified date. Information on the lot/batch, further information has been requested.

Other Meds: MULTIVITAMIN & MINERAL; VITAMIN D NOS; METFORMIN; SIMVASTATIN; ASPIRIN (E.C.)

Current Illness:

ID: 1652897
Sex: M
Age:
State: PA

Vax Date: 06/07/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: flu symptoms; fever; headache; This is a spontaneous report from a contactable consumer. This male consumer (patient) of unspecified age reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) dose unspecified, via an unspecified route of administration on 07Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, he patient experienced flu symptoms, fever and headache. He had his Covid Vaccine Pfizer on 07Jun2021 and has had flu symptoms, fever, headache for 5 days. Outcome was resolved on an unspecified date in Jun2021 for all the events. No additional information was provided and if you require additional information, please contact the reporter directly. Information on Lot/Batch information has been requested.

Other Meds:

Current Illness:

ID: 1652898
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: After the first dose the caller got sick and really mean and irritable and out of character; After the first dose the caller got sick and really mean and irritable and out of character; This is a spontaneous report from a contactable other hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included regular aging stuff like sore shoulders and sore hips from an unknown date and unknown if ongoing, arthralgia from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. The patient experienced after the first dose got sick and really mean and irritable and out of character on an unspecified date in Apr2021. This happened 2 or 3 days after the first dose which was on 01Apr2021. Patient could not be around people because she was so sick. It went away within a couple of days. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652899
Sex: F
Age:
State: PA

Vax Date: 03/24/2021
Onset Date: 03/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: sore arm; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's husband) reported for a 77-year-old female patient that: A 77-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 24Mar2021 09:00 am (at the age of 77-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing 15 years ago, breast conserving surgery from an unknown date and unknown if ongoing, Is seen yearly and has been clean, metabolic surgery from an unknown date and unknown if ongoing, 10 years ago, diabetes mellitus from an unknown date and unknown if ongoing, caller is unsure if she still is since having gastric bypass surgery, tobacco user from an unknown date and unknown if ongoing. She quit 25 years ago. She is a cancer survivor. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 03Mar2021 (at the age of 77-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. None any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). AE(s) did not require a visit to emergency room and physician office. The patient experienced sore arm on 24Mar2021. The clinical course as follows, while reporting on self caller mentioned that his wife also got the vaccine and experienced a sore arm. Caller is not sure which arm his wife received the vaccine in. His wife received the second dose on 24Mar2021. Her arm was sore on 24Mar2021 lasting until 25Mar2021. She recovered completely. Caller states he and his wife went together to get the vaccine. None relevant test reported. The outcome of event recovered on 25Mar2021 This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds:

Current Illness:

ID: 1652900
Sex: F
Age:
State: TX

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

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

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:UNKNOWN

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Heart felt like it was out of her body; Heart felt like it was low and then high; she felt like she had all the symptoms of COVID after the shot.; she was not feeling 100%; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 49-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heart felt like it was out of her body, heart felt like it was low and then high, she felt like she had all the symptoms of covid after the shot, she was not feeling 100% (non-serious) on an unspecified date with outcome of unknown. Additional Context: Warm transfer from Representative with Pfizer: Caller on the line calling about the COVID Vaccine, the Pfizer COVID Vaccine. She mentioned she had a very bad experience and had a bad reaction regarding the shot. It scared her to death. She had a feeling as if she was dying. She was in emotional distress in regard to crying and having to take test with her health care provider. Transfer agent clarified reaction to be she felt like her heart was out of her body. After transfer attempted to confirm details provided from agent. However, caller went in to explain she had never experienced this before. She stated she had not been to the hospital since she had her son 29 years ago. She lives a pretty healthy life and is proud about it. She is a pretty preventative person. When she went to go get the COVID shot she was scared to death. She was scared already due to the different things going around about. However, she was trying to do the right thing and get the shot. She got the shot, and then it felt like her heart felt like it was low and then high. She thought at first, she was okay and just went on with it. She later sated she felt like she had all the symptoms of COVID after the shot. Date of birth and age of onset captured as provided. While attempting to capture demographic details, caller stated she just wants to go ahead and give a brief detail about what happened and then we can ask the additional questions later. She stated she was really calling because she wants to know what happens. She has a stack of bills due to having to the doctor after the shot. Caller stated she felt so, like was, did not feel like she would make it much longer. She felt like something was wrong. She went to an urgent care and then was directed to go the Emergency Room, withheld Emergency. She also had an EKG done. She was directed to the Emergency Room, because at the urgent care felt like could not do the blood work. Caller mentioned she was not feeling 100% and would not have the test back in a timely manner. Caller explained the doctor was saying he would hate for something to happen while waiting for the result so she was sent to the Emergency Room. This was on 22May2021. Comission: Provided caller with the legal department address due to request for compensation. Informed would have to submit a written request looking for compensation. After providing address caller stated it sounds like she needs to get an attorney. Stated whenever have to contact a legal department would need a legal advisor since it's starting to get legal. Stated they probably won't respond to little 'ole her. Stated they will blow her to the back of the street unless she has an attorney. She then stated there is no need to continue with report in providing the fine details regarding the event. She will need to go through with it through an attorney. Since caller declined to continue with report unable to clarify information provided further or capture additional details. At times throughout the report caller would not complete sentence in describing details. Unable to clarify statements further. Information on batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1652901
Sex: U
Age:
State:

Vax Date: 06/06/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: some possible increase in heat exhaustion; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 06Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Jun2021, patient experienced some possible increase in heat exhaustion. Patient experienced some difficulty in carrying out usual military exercises as compared to before. Physician mentioned some possible increase in heat exhaustion, but he was not positive that it was caused by the vaccine. Physician would like to have some information in regards to precaution that may be aware of regarding an increase in heat exhaustion after "x" amount of days after getting the vaccine. The outcome of the event was unknown. Follow-up attempts are needed. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021757388 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757389 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757390 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021755866 Same reporter/ drug/ AE, different patient

Other Meds:

Current Illness:

ID: 1652902
Sex: F
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 04/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Not able to work/function past 03 PM; Ruptured Achilles tendon; Severe nausea; Extreme Fatigue/ exhaustion; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 03Aug2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer, the patient. This 42-year-old female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via intramuscular route in the left shoulder on 15Apr2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history included likely had COVID in Feb2020. The patient had no known allergies, no relevant family history, and no concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via intramuscular route in the left shoulder on 17Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunization. On 16Apr2021, the patient experienced extreme nausea and extreme fatigue, both reported as serious for disability. Patient had severe nausea and exhaustion for 13 days. Patient further described extreme nausea & fatigue resulting in inability to work functionally or care for children for 2 weeks; she was rendered useless by 3 pm each day, earlier on others. On 19Apr2021, patient had a ruptured Achilles tendon and experienced exhaustion. There was no treatment received for the events. The clinical outcome of extreme nausea and extreme fatigue/exhaustion was recovered on 30Apr2021, of ruptured Achilles tendon was not recovered, of not able to work/function past 3 PM was unknown. The patient was not COVID tested post vaccination. The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Other Meds:

Current Illness:

ID: 1652903
Sex: F
Age:
State: FL

Vax Date: 06/15/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Breasts extremely sore and enlarged.; Breasts extremely sore and enlarged.; This is a spontaneous report from a contactable consumer (patient). An 18-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number and expiration date: Not reported), via an unspecified route of administration on 15Jun2021 (age at vaccination: 18-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unknown date in Jun2021, the patient breasts extremely sore and enlarged. It was going on day 7 of pain and treated with Ice packs and Tylenol. Outcome of the events was recovering. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1652904
Sex: M
Age:
State: CA

Vax Date: 06/17/2021
Onset Date: 06/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Development of a rash on and around genitals; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 17Jun2021 at 10:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medial history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was unknown if the patient had allergies to medications, food, or other products. On 18Jun2021 at 01:00, the patient had development of a rash on and around genitals. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event development of a rash on and around genitals was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1652905
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Numbness and pain in entire right arm, right side of head; Pain in entire right arm,; Pain right side of head,; Severe exhaustion for 3 days post vaccination; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Apr2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown weather the patient had received any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced numbness and pain at entire right arm, right side of head, and severe exhaustion for three days post vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events numbness and pain in entire right arm, right side of head, and severe exhaustion for three days post vaccination was recovered on unknown date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652906
Sex: F
Age:
State: OR

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Very hurtful arm, barely moving; Throwing up; Chills; Teeth were chattering; Feeling very weak; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced very hurtful arm, barely moving leading to limb injury, vomiting, chills, teeth were chattering and feeling very weak on an unspecified date with outcome of unknown. She had the shot at 12:20 in the morning and 09:30 at night it start getting very hurtful arm, barely moving and she started throwing up about every 20 minutes she was throwing up until 6 am. she had chills, very big chills, like 97 degrees, she had the blanket like in the winter, she had jacket and was with chills and her teeth was chattering. she was feeling very weak and every 20-30 minutes she was puking and then there was nothing to puke after a while. It lasted until 6 am, she was extremely weak and the chills went away and the stomach was not throwing up and for a whole day she only had 2 cans of sprite sipping because water would not stay down, anything could not stay down, she was extremely weak and that about it and was in pain, Her daughter and husband with the second vaccine were even worse. They had all the symptoms but had but for 4 days. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758769 Same reporter/drug/AE, different patient;US-PFIZER INC-2021758768 Same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1652907
Sex: M
Age:
State: NC

Vax Date: 06/21/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Chills; Fever; Sweats; Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0196) via an unspecified route of administration in the left arm on 21Jun2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0191) via an unspecified route of administration in the left arm on 01Jun2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jun2021, the patient experienced chills, fever, sweats, severe headache. The clinical outcome of the events chills, fever, sweats, severe headache was not resolved at the time of report. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1652908
Sex: M
Age:
State: OR

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Very hurtful arm, barely moving; Throwing up; Teeth were chattering/Chills; Feeling very weak; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This case is for reporter's husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced very hurtful arm, barely moving, throwing up, chills/teeth were chattering and feeling very weak. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758715 Same reporter/drug/AE, different patient;US-PFIZER INC-2021758769 Same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1652909
Sex: F
Age:
State: OR

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

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Very hurtful arm, barely moving; Throwing up; Chills/Teeth were chattering; Feeling very weak; This is a spontaneous report from a contactable consumer. This case is for reporter's daughter. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and experienced no adverse event. On an unspecified date, the patient experienced very hurtful arm, barely moving, throwing up, chills/teeth were chattering and feeling very weak. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758768 Same reporter/drug/AE, different patient;US-PFIZER INC-2021758715 Same reporter/drug/AE, different patient

Other Meds:

Current Illness:

ID: 1652910
Sex: F
Age:
State: IL

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

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

Lab Data:

Allergies:

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

Symptoms: Tinnitus in both ears in the form of ringing.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO180) in the left arm on 24May2021 at 18:30 (at the age of 40-years-old) as a dose for COVID-19 immunisation and patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO217) in the left arm on 14Jun2021 at 18:45 (at the age of 40-years-old) as a dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included mefenamic acid (ADVIL); for unknown indication from unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021 at 21:00, the patient experienced tinnitus in both ears in the form of ringing. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event tinnitus in both ears in the form of ringing was not recovered at the time of this report.

Other Meds: ADVIL [MEFENAMIC ACID]

Current Illness:

ID: 1652911
Sex: F
Age:
State: CA

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: EKG; Result Unstructured Data: Test Result:EKG abnormality; Test Name: EKG; Result Unstructured Data: Test Result:Upright P wave; Test Name: EKG; Result Unstructured Data: Test Result:flipped p wave

Allergies:

Symptom List: Nausea

Symptoms: her eyes are repaired/ I wonder if it has somehow repaired my cones/rods. Also wondering if it has helped my blood pressure; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (COMIRNATY;,Solution for injection,), dose 1 via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: EN6198) as dose 1 (at the age of 70 year), single, dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 70 year) for COVID-19 immunisation. Medical history included myocardial infarction. The patient's concomitant medications were not reported. On an unspecified date in 2021, Patient had the Pfizer covid shot and now patient seeing colors brilliantly. Patient knew that's not something you're concerned with, but patient wonder if it has somehow repaired my cones/rods. Also wondering if it has helped my blood pressure, of it was having started using progesterone. Prior to this, Patient had very negative side effects from cardiac meds, so patient started progesterone and it seems to be helping. But patient wonder if the shot was somehow fixing things. Patient had an EKG abnormality, and it was now good after patient received the vaccine. Patient said all her arteries were normal. Patient added her eyes are repaired. Patient said she's sensitive to blue lights and they seem a little yellow to her now. Patient sated in the 1990s, patient had no melanin and things were pale. Patient sated that she noticed back then in exercise class, after 30 minutes patient stated could see dark and light but now this time the colors were all light and bright. Patient sated she was not sure if it fixed the rods and cones that were responsible for perception of color or what. Patient sated that she didn't know if it was the Covid vaccine or if it was because she stopped taking her blood pressure medication because it can cause stiffness and difficulty walking. Patient sated she read progesterone cream helps with blood pressure and it does for her. Patient sated it could reversed heart damage from the Covid vaccine, but she had a flipped p wave and they said she had a heart attack many years ago. Patient sated after both doses of the Covid vaccines, patient has an upright p wave. Patient sated she didn't know if the EKG was just positional or what. Patient sated she wonders if this stuff was repairing, not just like a vaccine like the polio, chicken pox, or mumps. Patient sated she was not positive but she doesn't think she was as photosensitive, so that was beneficial. Patient sated she knew so many people who were so anti Covid vaccine and if she touched them they freak out and say she was going to get metal in their body.

Other Meds:

Current Illness:

ID: 1652912
Sex: U
Age:
State: NJ

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: had blood spew out of the injection site; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This consumer reported for 3 patients, this is 2 of the 3 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine, Solution for injection), dose 2, via an unspecified route of administration on 23Jan2021 (Batch/Lot number: E19126 and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced had blood spew out of the injection site. It was explained that the bleeding lasted about an hour, it was not a lot but shot right out of the puncture, where the jab was at the injection site. The reporter wanted to know if he should get a third dose of the vaccine. It was reported that when he received the 2nd dose the patient lost a lot of blood, there was excess bleeding at the injection site. The caller stated that the tech put the needle in and afterward states that he was the 3rd patient that had blood spew out of the injection site. No other information provided for this statement as the caller declined to complete the report. The clinical outcome of the event was unknown. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021760093 same reporter/product/event, different patient

Other Meds:

Current Illness:

ID: 1652913
Sex: M
Age:
State: WI

Vax Date: 06/17/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sore in the arm; This is a spontaneous report from a contactable consumer or other non hcp (parent) from a Pfizer-sponsored program Covax US Support. A contactable consumer reported for 19-Year-old patient (reporter's son). A 19-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Jun2021 (at the age of 19-year-old) at dose 1, single for covid-19 immunisation. Medical history included autism, lyme disease and allergic to gluten and silica related compound. Concomitant medications were not reported. On an unspecified date the patient experienced sore in the arm. Verbatim and Event Description: The reporter reported who has autism and lyme disease and is about to get his first dose of the covid-19 vaccine today, 22Jun2021but wanted to ask and clarify about the ingredients of the vaccine if containing any gluten and silica related compound which she suspected withheld to be allergic to. While getting information regarding withheld mentioned about her other son named withheld who she stated, got his first dose of the Pfizer covid-19 vaccine last Thursday, 17June2021 who had a sore in the arm. Created and submitted a manual AE form: due to concern mentioned related to the Caller's other son, who had an adverse event after getting the first dose of the vaccine but was not the main reason for the call. Outcome of the event was unknown. Follow-up attempts are needed. Information on Lot/Batch number been requested. Follow up (20Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652914
Sex: F
Age:
State: FL

Vax Date: 03/29/2021
Onset Date: 03/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swollen lymph nodes on collarbone; Arm pain; Fever; Nausea; Neck pain; This is a spontaneous report from a contactable other healthcare professional, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 29Mar2021 at 11:45 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS). The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 15:00, the patient experienced swollen lymph nodes on collarbone, arm pain, fever and nausea, still had swollen lymph nodes and arm/neck pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph nodes on collarbone, arm pain, neck pain, fever and nausea were resolved with sequelae. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1652915
Sex: F
Age:
State: NY

Vax Date: 05/28/2021
Onset Date: 06/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Sick and couldn't walk so missed second dose of vaccine; Sick and couldn't walk so missed second dose of vaccine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 28May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 83-years-old). The patient medical history and concomitant medications were not reported. It was reported that on 28May2021 the patient received the first dose of vaccine and stated that she was supposed to go to get her vaccine, but she was sick and couldn't walk on 18Jun2021, so missed second dose of vaccine. She called and they gave her another date. She can't remember the date when she was supposed to get the vaccine. She wanted to know if we could help her get the date. The outcome of the events was unknown. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1652916
Sex: F
Age:
State: WA

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: I got headache; I have been throwing out; I am having chills, just kind of swell everywhere; My arm hurts and I was, have diarrhea, just feeling really bad; I got headache; I have been throwing out; I am having chills, just kind of swell everywhere; My arm hurts and I was, have diarrhea, just feeling really bad; I got headache; I have been throwing out; I am having chills, just kind of swell everywhere; My arm hurts and I was, have diarrhea, just feeling really bad; I got headache; I have been throwing out; I am having chills, just kind of swell everywhere; My arm hurts and I was, have diarrhea, just feeling really bad; I got headache; I have been throwing out; I am having chills, just kind of swell everywhere; My arm hurts and I was, have diarrhea, just feeling really bad; I got headache; I have been throwing out; I am having chills, just kind of swell everywhere; My arm hurts and I was, have diarrhea, just feeling really bad; I got headache; I have been throwing out; I am having chills, just kind of swell everywhere; My arm hurts and I was, have diarrhea, just feeling really bad; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown) via intramuscular route, administered in Right Arm (in her muscle) on Jun2021 as a Dose 1, single for COVID-19 immunization. The patient's medical history included blood pressure high, heart disease, depression, anxiety, Chronic obstructive pulmonary disease. The patient's concomitant medication(s) included metoprolol, furosemide, aripiprazole (ARPIZOL), acetylsalicylic acid (ASPIRIN), bupropion, clarithromycin (CLARITIN), losartan, atorvastatin, glyceryl trinitrate (NITROGLYCERIN), montelukast, cetirizine. The patient had not received any other vaccine within 4 weeks prior to vaccination. On an unknown date in 2021, the reported stated that, she was on blood thinner, she had got a lot of bad symptoms, got headache, she had been throwing out but, she had been week now, having chills, just kind of swell everywhere, her arm hurts, had diarrhea, just felt really bad. She informed that she was doing the paperwork, she got from the pharmacist after she got her shot, and they didn't tell her or give her the paperwork about it after they have the shot and then she told them that she was on blood thinner. She asked the lady at counter when she check in and she said they would know that because they would check it on internet and on the compute that she was registered about her medications. She stated her age as 59 (units unspecified). She confirmed that she started to have these reactions yesterday, like a few hours on 18th after she got shot. She stated Pfizer, it said QW0Z17 she though (batch number was not clarified). She stated that, she had not got those symptoms from her medicines. She didn't know what to take for it. No investigation assessment was reported. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: METOPROLOL; FUROSEMIDE; ARPIZOL; ASPIRIN [ACETYLSALICYLIC ACID]; BUPROPION; CLARITIN [CLARITHROMYCIN]; LOSARTAN; ATORVASTATIN; NITROGLYCERIN; MONTELUKAST; CETIRIZINE

Current Illness:

ID: 1652917
Sex: F
Age:
State:

Vax Date: 06/21/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: weak; hot and cold; Chills; Throat sore; Fatigue; Flu like symptoms; head is hurting; swollen at the site of the injection; Flu like symptoms; head is hurting; weak; hot and cold; Chills; Throat sore; Fatigue was reported as worsened.; a little heat around the injection site area; This is a spontaneous report from a contactable consumer (patient). A 44-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 in Arm Right on 21Jun2021 (at the age of 44 years old) as dose 1, single for COVID-19 immunisation. Medical history included stroke (additional information for other conditions: in 2010 and one in Jan2021), blood pressure measurement (has blood pressure problems and had a stroke in January). The patient's concomitant medications were not reported. The patient experienced head is hurting, swollen at the site of the injection on 21Jun2021, flu like symptoms, weak, hot and cold, chills, throat sore, fatigue on 22Jun2021, flu like symptoms; head is hurting; weak; hot and cold; chills; throat sore; fatigue was reported as worsened, a little heat around the injection site area on an unspecified date on Jun2021. Event reported as, "the patient took the vaccine on monday and then 30 minutes afterwards her head started hurting. Then yesterday the patient symptoms were way worse and today it was worse. Today there was still a little heat around the injection site area. The caller's arm is still swollen a little bit but when the caller moves her arm it is not good, she can feel it still. The caller's throat is sore and she is fatigued. Tuesday is when everything started going down hill. Today the patient is in the bed and missing work because she can't work like this". Outcome of the event flu like symptoms, head is hurting, weak, hot and cold, chills, throat sore, fatigue was not recovered, recovering for swollen at the site of the injection, and unknown for flu like symptoms; head is hurting; weak; hot and cold; chills; throat sore; fatigue was reported as worsened, a little heat around the injection site area. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1652918
Sex: M
Age:
State: KY

Vax Date: 06/13/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Swelling and pain in calf; Pain in calf; Joint pain; This is a spontaneous report from a contactable healthcare professional. A 35-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13Jun2021 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Other medical history reported as none. The patient had no known allergies to medications, food and other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications were not reported. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 15Jun2021, the patient experienced swelling and pain in calf and joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events swelling and pain in calf and joint pain was not recovered at the time of this report. The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1652919
Sex: F
Age:
State: VA

Vax Date: 04/11/2021
Onset Date: 04/18/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Severe tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 11Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Mitral Valve Prolapse (MVP). The patient was allergic to penicillin. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 21Mar2021 at 09:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021, the patient experienced severe tinnitus. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event severe tinnitus was not resolved at the time of report.

Other Meds:

Current Illness:

ID: 1652920
Sex: F
Age:
State: MO

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

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

Lab Data: Test Date: 20210622; Test Name: Rapid test; Test Result: Negative; Comments: Nasal Swab.

Allergies:

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

Symptoms: Discomfort at injection site with small lump present, more noticable with pressure (IE following side sleeping); Discomfort at injection site with small lump present, more noticable with pressure (IE following side sleeping); Pain throughout arm for 2-3 days; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, scoliosis, pain, headache and chronic sinus. The patient had known allergies to wasp sting and codeine. Concomitant medications included PRN for pain and headache, taken on an unknown date, unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 06Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, for second dose, the patient experienced pain throughout arm for 2-3 days, discomfort at injection site with small lump present, more noticeable with pressure (IE following side sleeping). It was reported that for first dose no adverse reactions. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. On 22Jun2021, the patient underwent rapid test (nasal Swab) and the result was negative. The clinical outcome of the events pain throughout arm for 2-3 days, discomfort at injection site with small lump present, more noticeable with pressure (IE following side sleeping) were resolving at the time of report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1652921
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: One of her daughters has been fully vaccinated with Pfizer Covid19 vaccine and experienced "chills and stuff and just couldn't get warm"; One of her daughters has been fully vaccinated with Pfizer Covid19 vaccine and experienced "chills and stuff and just couldn't get warm"; This is a spontaneous report from a contactable consumer or other non hcp (parent) from a Pfizer sponsored program. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 2, single and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced one of her daughters has been fully vaccinated with pfizer covid19 vaccine and experienced chills and stuff and just could not get warm. Reporter is a consumer with many concerns regarding her college-aged daughters receiving the Pfizer-Biontech Covid19 vaccine. She indicated she was trying to get medical exemptions before they returned to school in the fall. She reported a letter to parents indicated an exemption could be acquired (for medical or religious reasons) because the product is not FDA-approved. She has 3 daughters, total: 2 with asthma, 1 that is allergic to peanuts, and 1 takes specific birth control pills due to her migraine with aura. One of her daughters has been fully vaccinated with Pfizer Covid19 vaccine and experienced chills and stuff and just could not get warm but continued to go to work. The youngest (19 y/o female) has asthma and is allergic to peanuts. Mom discussed vaccination exemption with the allergist, who indicated it would be more beneficial for her to receive vaccination; no medical exemption indicated. This child also has dermographism and reports she felt the liquid go in her arm when she received a flu shot, previously, and later fainted after that flu shot. She also has a daughter who has migraine with aura that is managed with birth control pills. Will the vaccine affect her cycle. She additionally called for someone else who has been fully vaccinated with the Pfizer-Biontech Covid19 vaccine series in May and has since been prescribed valacyclovir. For menstrual changes question: answered Per FAQ-: The authorized EUA Prescribing Information for the Pfizer-BioNTech COVID-19 Vaccine does not list menstrual changes as adverse reaction from clinical studies and post authorization experience. Reporter is a consumer, calling on behalf of someone else. She reports the patient has received both doses of the Pfizer-Biontech covid19 vaccine, finishing the series sometime in May, but is now being prescribed valacyclovir. Will the antiviral interact with the vaccine. Question: reporter is a consumer with many concerns regarding her college-aged daughters receiving the Pfizer-Biontech Covid19 vaccine. She indicated she was trying to get medical exemption, since the product has not been FDA approved. Outcome of the events was unknown. Information regarding the lot/batch number has been requested. Follow up (20Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652922
Sex: F
Age:
State: KY

Vax Date: 06/18/2021
Onset Date: 06/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Her right hand was experiencing tremors. The tremors have persisted since then and progressed to the rest of her body as of today.; This is a spontaneous report from a contactable other healthcare professional. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0172) via intramuscular route of administration in the left arm on 18Jun2021 at 14:15 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient had reported any other health issues. It was unknown whether the patient had any known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0172) via intramuscular route of administration in the left arm on 28May2021 at 14:00 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. On 20Jun2021, three days after receiving her second vaccine, the patient experienced tremors in right hand. The tremors had persisted since then and progressed to the rest of the body. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event tremors in right hand and progressed to the rest of the body was not recovered at the time of this report.

Other Meds:

Current Illness:

ID: 1652923
Sex: M
Age:
State: PA

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

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

Lab Data: Test Date: 20210528; Test Name: heart rate; Result Unstructured Data: Test Result:persistent increased (90 bpm)

Allergies:

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

Symptoms: persistent increased heart rate at rest. (90 bpm); This is a spontaneous report received from a contactable consumer (patient). A 14-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unknown), via an unknown route of administration on an unknown date as dose 1, single and second dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine , solution for injection, batch/lot number: unknown), via an unknown route of administration in right arm on an unknown date as dose 2, single for COVID-19 immunisation at public health clinic/veterans administration facility. The patient's medical history was not reported. Concomitant medications included sertraline hydrochloride (ZOLOFT) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); both were taken foran unknown indication from an unknown date and take multivitamin. No other vaccine in four weeks. On 28May2021, the patient persistent increased heart rate at rest. (90 bpm); identified as "not looking well" at school and sent home resolved over time. did not seek additional medical support beyond school nurse. Event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination and no covid tested post vaccination. No treatment received. The outcome of the events was recovered on an unspecified date in 2021. Information on the lot/batch number has been requested.

Other Meds: ZOLOFT; ADDERALL

Current Illness:

ID: 1652924
Sex: M
Age:
State: WA

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Stomach cramps; Gas; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Er8737) via an unspecified route of administration on 17Apr2021 at 10:00 (at the age of 61-years-old) in left arm as a single dose for covid-19 immunization. Medical history included anxiety, hypertension, and penicillin allergy all from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications included lisinopril (LISINOPRIL) and propranolol (PROPRANOLOL) both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot number=Ep6955) on 27Mar2021 at 10:00 in left arm for covid-19 immunization. The patient experienced stomach cramps, gas, and diarrhoea on 17Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated, and he was seeking treatment appt next Thursday. The outcome of all the events was not resolved. No follow-up attempts are possible. No further information is expected.

Other Meds: LISINOPRIL; PROPRANOLOL

Current Illness:

ID: 1652925
Sex: F
Age:
State: ME

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:abnormally fast heart rate; Comments: abnormally fast heart rate (if I moved or stood up).(my resting heart rate is mid 50s bpm); Test Date: 20210524; Test Name: Covid Test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab 3x/wk (ended 24May2021) testing PCR, covid test result=Negative

Allergies:

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

Symptoms: Tachycardia/My resting heart rate is mid 50s bpm. After the second vaccine, I was hitting 100+ bpm even during minimal motion.; abnormally fast heart rate (if I moved or stood up); tightness in chest; This is a spontaneous report from a contactable consumer or other non hcp. A 56-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 14Apr2021 09:45 (Batch/Lot Number: EW0158) as DOSE 2 (Age at vaccination: 56-years-old), SINGLE for COVID-19 immunisation. Patients Medical history: ongoing insomnia and ongoing seasonal allergy. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) taken via oral route for seasonal allergy from an unspecified start date and ongoing; ibuprofen taken for an unspecified indication, start and stop date were not reported and zolpidem taken via oral route of administration for insomnia from an unspecified start date and ongoing. The patient was not pregnant at vaccination. Historical vaccine included as bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm left on 24Mar2021 at 04:15 AM (Batch/Lot Number: EW0158) as DOSE 1, SINGLE for COVID-19 immunisation. The patient had no Covid prior vaccination and not tested for COVID post vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced abnormally fast heart rate (if I moved or stood up) and tightness in chest. Her resting heart rate was mid 50s bpm. On 14Apr2021 06:30 PM, After the second vaccine, she was hitting 100+ bpm even during minimal motion. Tachycardia symptoms started in the afternoon following second covid-19 vaccine dose in the morning if she moved from bed/resting position. my heart rate shot up to over 100bpm. the high heart rate was sustained until complete physical in action. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021 Nasal Swab 3x/wk (ended 24May2021) testing PCR,covid test result=Negative,heart rate: abnormally fast heart rate on abnormally fast heart rate (if I moved or stood up). The outcome of the event (tachycardia, chest discomfort and heart rate increased) was recovered on Apr2021. Follow-up attempts are completed. No further information is expected.

Other Meds: ALLEGRA; IBUPROFEN; ZOLPIDEM

Current Illness: Insomnia; Seasonal allergy

ID: 1652926
Sex: M
Age:
State: NE

Vax Date: 06/10/2021
Onset Date: 06/17/2021
Rec V Date: 08/28/2021
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: Feeling pain on left side below the nipples; Sometimes would feel a bit dizzy; Feel uncomfortable on left side; Left arm would give pain mixed with a lot of discomfort; Left arm would give pain mixed with a lot of discomfort; Feeling weak in legs; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Jun2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or any other products. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Jun2021, the patient started feeling pain on left side below the nipples, felt uncomfortable on his left side and sometimes would feel a bit dizzy. The patient's left arm would give him pain mixed with a lot of discomfort and this would prevent him from focusing on what he was doing. Patient did not know what to do about this, and went to the gym to see if that would help and it helped for a day and came back the next day. Most of the time, this issue happened when patient woke up and was getting ready for work. He started feeling weak in his legs and started having pain on his left side. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events feeling pain on left side below the nipples, feel uncomfortable on left side, left arm would give pain mixed with a lot of discomfort and feeling weak in legs which included treatment with ibuprofen (MANUFACTURER UNKNOWN) and it seemed to help the patient so far. It was unknown whether any therapeutic measures were taken as a result of the event sometimes would feel a bit dizzy. The clinical outcome of the events feeling pain on left side below the nipples, feel uncomfortable on left side, sometimes would feel a bit dizzy, left arm would give pain mixed with a lot of discomfort and feeling weak in legs were resolving at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1652927
Sex: F
Age:
State: KY

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

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: numbness to her tongue; numbness under her lip; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 65-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numbness to her tongue, numbness under her lip on an unspecified date. Reporter is a pharmacist who is calling to report a patient who received the Pfizer Covid vaccine today and is 15 minutes after the dose is experiencing numbness to her tongue. Reporter wants to know if this has been reported and is a side effect of the vaccine. After hanging up with caller document found that was specific to Paresthesia. Called provider back and informed her of updated information. As of 31Dec2020, a search of our safety surveillance database for Pfizer-BioNTech COVID-19 vaccine revealed that we have received spontaneous reports of dental paresthesia, paresthesia, paresthesia oral, paresthesia mucosal, intranasal paresthesia, pharyngeal paresthesia, paresthesia ear and vaccination site paresthesia since the market introduction (including emergency use authorization) of Pfizer-BioNTech COVID-19 vaccine. Calling about Pfizer COVID vaccine. She just gave the vaccine to a patient and within 15 minutes started having numbness under her lip, is that normal. Outcome of the events was unknown. Information regarding the Lot/Batch number has been requested. Follow-Up (PRD/SRD 20Aug2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1652928
Sex: M
Age:
State: FL

Vax Date: 06/22/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: In a constant mental fog; I have no short-term memory; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0180) via an unspecified route of administration in the arm left on 22Jun2021 at 16:00 as a single dose(at the age of 47-years-old) for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient had no known allergies. Prior to the vaccination the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID. On 22Jun2021, the patient reported that he was in a constant mental fog and had no short-term memory. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event in a constant mental fog and short term memory loss was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1652929
Sex: F
Age:
State: DC

Vax Date: 06/23/2021
Onset Date: 06/23/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Swelling in arm; sleeping more than 4 hours; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 23Jun2021 at 12:15 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 13:00, the patient experienced swelling in arm and was sleeping more than four hours. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events swelling in arm and sleeping more than 4 hours was resolving at the time of this report.

Other Meds:

Current Illness:

ID: 1652930
Sex: F
Age:
State:

Vax Date: 06/22/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hoarse throat; can barely speak; Pregnancy, 14 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 22Jun2021 at 11:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient delivery date is on 22Dec2021. She was 14weeks pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included doxylamine succinate (UNISOM), prenatal vitamins (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN) and pyridoxine hydrochloride (MANUFACTURER UNKNOWN) from an unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jun2021 at 17:30, the patient experienced hoarse throat and barely speak. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hoarse throat and can barely speak were not resolved at the time of the report. No follow-up attempts are possible. No further information is expected

Other Meds: UNISOM [DOXYLAMINE SUCCINATE]; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; MAGNESIUM; VITAMIN B6

Current Illness:

ID: 1652931
Sex: F
Age:
State: CA

Vax Date: 05/05/2021
Onset Date: 06/12/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itching all over; series of rashes on my torso; blister type itchy bumps; my skin is crawling; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ;Lot Number: EW0178) via an unspecified route of administration in the left arm on 05May2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included severe reaction to H1N1 vaccination (allergy to vaccine) in 2010. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient was allergic to fluoroquinolones and clobetasol (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on an unknown date at 08:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Jun2021 at 08:00 the patient experienced itching all over, series of rashes on torso, blister type itchy bumps, skin crawling . The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the reported events. The clinical outcome of the event itching all over, series of rashes on torso, blister type itchy bumps, skin crawling were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am