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: 1810505
Sex: F
Age:
State: TN

Vax Date: 10/06/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: shingles; pain deep within inside your body; burning gnawing pain deep within inside your body; irritation; blister; itching; This is a spontaneous report from a contactable consumer. This 43-year-old consumer (patient) reported for self that. A 43-years-old female patient received third dose (booster) of BNT162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: 301458A), via an unspecified route of administration, administered in Arm Left on 06Oct2021 16:45 (age at vaccine 43-years-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history included ongoing mitral valve prolapse she was Stated diagnosed when she was 10 years old, herpes zoster from an unknown date and unknown if ongoing she Stated got shingles for the first time when she was 19 years old. There were no concomitant medications. The patient previously received Historical vaccine BNT162B2 (formulation: Solution for injection, Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on an 23Jan2021 as DOSE 1, SINGLE, received second dose BNT162B2 (formulation: Solution for injection, Lot Number: EL9266), via an unspecified route of administration, administered in Arm Left on an 13Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Received MMR Vaccine (Bach/lot number was not reported) on unspecified date Immunization on rash, only knows that she was 18 months old and heard about her reaction from her mother. It was reported has she earlier and reported what she said was a side effect of the covid vaccine, but she was running around trying to pick up prescriptions for myself so she is calling back. She has taken third dose the booster a few days back on 6Oct2021, and for the second, and now third does she have broken out with shingles, after she have taken each one of those. she wants to know if this is an effect that has been reported in other people she went to my primary care, it has been diagnosed as shingles twice. the hives she understand, she was hoping to find out the percentage of people who have shingles she was afraid if she have to get boosters in the future, she don not want keep getting shingles every time either, she was looking at another two three weeks of this. the last time it lasted a whole month of shingles, and this is no fun". this is my third round with shingles. She called she provider this morning and informed them that she have the same pain, and he called Acyclovir. Shingles a burning gnawing pain deep within inside your body, pulling at every nerve is attached to. The blister, and the itching and irritation, is similar to chicken pox, but the deep internal pain that feels like your nerves are being pulled from your spine, is not like the chicken pox. There is no way to get comfortable, whether you sit, stand, lay, its constant nagging pain Like a hot burning poker deep in your soul, pulling your nerves out. she spoke to my doctor after my second dose about the shingles vaccine, and he said she was too young, she have gotten shingles three times. hope you never get shingles. A review of the Prescribing Information for Pfizer-Biontech Covid Vaccine did not find information regarding Shingles as a side effect, however, itching, hives, and a rash have been reported as side effects of the vaccine. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. She stated that she is calling about the Pfizer Product: Covid Vaccine. States that she got the booster dose of the vaccine this week. States that each shot itself was fine. With the second and third doses she got shingles each time. States she got shingles for the first time in her life when she was 19 years old. Says that 8 days after the second dose of the Pfizer Covid Vaccine she got shingles also. Now she is 43 years old; she took her third dose earlier this week, and has shingles today. States she feels it important to mention that she has no underlying medical conditions, besides mitral valve prolapse. States she is healthy as a horse and wears a mask daily. She stated that she did visit her doctor with the shingles she had after the second dose of the Covid Vaccine; with this current shingles she called her doctor and he called her in a prescription. The patient is wondering if other people have called in with similar situations States that she heard a rumor about a co-workers sister who was in an identical situation to the callers. States that the co-workers sister got shingles after her second dose of the Covid Vaccine; and is now worried about getting the third dose. States the co-workers sister recently lost her father to Covid 19. She declines to provide information for report on the co-workers sister; states she does not know enough about her to give the information. States that all she knows is her co-workers sister works as a dental hygienist. She declines transfer to hospital at this time. States she has to go and pick up her prescription. The patient experienced shingles on 07Oct2021, pain deep within inside your body, burning gnawing pain deep within inside your body, irritation, blister and itching on Oct2021. The clinical outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness: Mitral valve prolapse (10 years old)

ID: 1810506
Sex: F
Age:
State: AZ

Vax Date: 09/02/2021
Onset Date: 09/01/2021
Rec V Date: 10/23/2021
Hospital: Y

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

Lab Data: Test Date: 20210913; Test Name: E.coli; Result Unstructured Data: Test Result:had E.coli; Test Date: 202109; Test Name: Lab test; Result Unstructured Data: Test Result:unknown results; Test Date: 20210913; Test Name: salmonella; Result Unstructured Data: Test Result:salmonella; Test Date: 202109; Test Name: Brain scan; Result Unstructured Data: Test Result:unknown results; Test Date: 202109; Test Name: Troponins level; Result Unstructured Data: Test Result:high; Test Date: 202109; Test Name: Body Scan; Result Unstructured Data: Test Result:unknown results

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: got tested and had E.coli and salmonella; got tested and had E.coli and salmonella; ill; ill with food poisonings; bacterial infection; didn't feel good; brain bleed; broken nose; pulmonary embolism; broken knee cap; troponins were high; dehydrated; fell; blood clots in her lungs; it was thought might have had infarction; diarrhea; blood pressure was low; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received the 3rd dose of BNT162B2 (COMIRNATY, lot number: R3181) via an unspecified route of administration in the right arm on 02Sep2021 in the afternoon at 79 years old as single dose for COVID-19 immunization. Medical history included ongoing A-Fib diagnosed with in 2002-2003 (had 5 ablations related to the A-fib). Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) for A-fib, dronedarone hydrochloride (MULTAQ) for A-fib. The patient previously received BNT162B2 with the 1st dose (lot number: EL1283) on 28Jan2021 in the morning, the 2nd dose (lot number: EN6202) on 23Feb2021; both via an unspecified route of administration in the right arm at 79 years old for COVID-19 Immunization. It was explained that she was on Eliquis for her A-fib but it was stopped 2-3 weeks before the booster shot, her cardiologist said she didn't need it anymore. She was moved to a baby aspirin in place of the Eliquis. The patient had food poisoning. She was ill on Saturday night the 12Sep2021. She went to the medical center on Sunday morning. She got tested and had E.coli and salmonella on 13Sep2021. She was on antibiotics for 3 days (Erythromycin 500mg). She was still ill with diarrhea nothing worked. She was dehydrated and her blood pressure was low. She fell right on her brick patio. They found blood clots in her lungs and the doctor seems to think she fell because of the blood clot. It was encapsulated blood clot in her lungs. She was curious because she read somewhere it could be a side effect of the vaccine. She had no issues like that before. She was on a baby aspirin. Seemed like a whole bunch of junk that happened at once. Afterward she became ill with food poisonings, around the 12Sep2021. She went down hill after this and had bacterial infection that she tried to cure. She ended up in the hospital on her birthday. She noted she was watering her plants and didn't feel good. She fell down on her face, had brain bleed, broken nose, and pulmonary embolism, and broken knee cap on Sep2021. The doctor told her she probably fell because she had blood clots in her lungs. The patient stated she knew there were a few people who had had blood clots after the shot and she wanted to know what was the time line for this to occur after getting the shot. While in the hospital they did lab work. The patient remarked she normally took Multaq for A-fib but she did not have this product in the hospital. Also, she didn't have any episodes in the hospitals of A-fib so that was good. Her cardiologist was surprised. It was noted that her troponins were high and it was thought might have had infarction Sep2021 but they didn't know for sure. She had a brain scan and body scan looking for blood clots. Results for these labs and procedures were not provided. AE(s) require a visit to Emergency Room. Outcome of the events was unknown.

Other Meds: BABY ASPIRIN; MULTAQ

Current Illness: Atrial fibrillation (diagnosed with in 2002-2003; had 5 ablations related to the A-fib)

ID: 1810507
Sex: F
Age:
State: FL

Vax Date: 02/24/2021
Onset Date: 10/05/2021
Rec V Date: 10/23/2021
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: heart aches; flu like symptoms; fever; aches; headaches; back aches; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the 2nd dose (lot number: EN6200) on 24Feb2021 at age of 76 years old, at the 3rd dose (lot number: FF2588) on 05Oct2021 at 02: 30 AM at age of 77 years old; both via an unspecified route of administration in the left arm as single dose for COVID-19 immunization. Medical history included heart issues. Concomitant medications were unknown. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously receive the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) on 03Feb2021 via an unspecified route of administration in the left arm at age of 76 years old as single dose for COVID-19 immunization. The patient had flu like symptoms, fever, aches, headaches after both the second and third injections, also heart aches and back aches too, on 05Oct2021. No treatment was received for the events. No hospitalization prolonged. Outcome of the events was recovered on Oct2021. This report was reported as non-serious. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810508
Sex: F
Age:
State: KS

Vax Date: 10/07/2021
Onset Date: 10/07/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: COVID-19; Result Unstructured Data: Test Result:diagnosed with COVID-19; Comments: Prior to vaccination

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: get a rash all over; swelling of the extremities; very itchy; DOSE 3 (BOOSTER) SINGLE; DOSE 3 (BOOSTER) SINGLE; This is a spontaneous report from a contactable other hcp (patient). A 19-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2), dose 3 intramuscular, administered in Arm Right on 07Oct2021 10:00 (Batch/Lot Number: 301308A) at the 19-years-old as DOSE 3 (BOOSTER) SINGLE, for covid-19 immunisation. Medical history included Covid-19. Concomitant medication included influenza vaccine (FLU) taken for immunisation on 27Sep2021; medroxyprogesterone acetate (DEPO PROVERA) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included BNT162B2 on 05Feb2021 at the age of 19-year-old for Covid-19 Immunization (Dose Number: 2, Batch/Lot No: EN5318, Location of injection: Right Arm, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular); and BNT162B2 on 15Jan2021 at the age of 19-year-old for Covid-19 Immunization (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Right Arm, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular). The most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. The patient experienced get a rash all over, swelling of the extremities, very itchy on 07Oct2021 10:30 with outcome of not recovered. The patient underwent lab tests and procedures which included COVID-19: diagnosed with covid-19 on an unknown date (Prior to vaccination). The patient started to get a rash all over and had swelling of the extremities. The patient became very itchy, was given 25mg of Benadryl to try and reverse the itching and rash. She was still feeling itchy and have some. No hospitalization Prolonged. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Rash, Peripheral swelling, Pruritus and the suspect drug BNT162B2 cannot be excluded. The case will be re-assessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: DEPO PROVERA

Current Illness:

ID: 1810509
Sex: F
Age:
State: NY

Vax Date: 10/07/2021
Onset Date: 10/08/2021
Rec V Date: 10/23/2021
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: rheumatoid like pain (extreme) in all joints; shakes; swollen hands/ swelling under left arm; weakness in the legs; muscle spasm; Stomach upset; unable to walk with body upright; chills; fever; extreme headache; Pain in muscles and joints; nausea; extreme muscle pain/ pain in muscles and joints; This is a spontaneous report from a contactable pharmacist. This pharmacist (patient) reported for herself that a 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ff2589) at the age of 45-years, via an unspecified route of administration in left arm on 07Oct2021 at 18:00 at single dose for COVID-19 immunization, at pharmacy/drug store. Medical history included high blood pressure. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Concomitant medications included olmesartan medoxomil (BENICAR) and gabapentin (GRALISE). The patient historically received first single dose of BNT162B2 (lot number: 301308a) at the age of 45-years via an unspecified route of administration in left arm on 15Sep2021 at 12:00 PM for COVID-19 immunization. On 08Oct2021 at 12:00, the patient had extreme muscle pain, shakes, chills and fever, swollen hands, weakness in the legs, extreme headache, muscle spasm that feels like she was beaten. Swelling under left arm. Pain in muscles and joints. Stomach upset and nausea. Unable to walk with her body upright and rheumatoid like pain (extreme) in all joints. AE treatment included paracetamol (TYLENOL) 500 mg. Outcome of the events was recovered with lasting effects. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event rheumatic disorder and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: BENICAR; GRALISE

Current Illness:

ID: 1810510
Sex: F
Age:
State: CA

Vax Date: 09/26/2021
Onset Date: 09/29/2021
Rec V Date: 10/23/2021
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: DVT in left leg; antiphospholipid syndrome; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the of 74-years, dose 3 via an unspecified route of administration, administered in arm left on 26Sep2021 (lot number: FF2587) as dose 3 (booster), single for COVID-19 immunisation. Medical history included antiphospholipid syndrome. The patient was not pregnant at time of vaccination. No COVID-19 prior vaccination. Concomitant medications included propranolol; acetylsalicylic acid, caffeine, paracetamol, salicylamide (EXCEDRIN); calcium carbonate (TUMS). No other vaccine in four weeks. The patient historically received BNT162B2 for COVID-19 immunisation at the age of 74-years, first single dose in left arm on 30Jan2021 (lot number: EI3248), second single dose in left arm on 20Feb2021 (lot number: EN6201). The patient previously received iodine, nitrofurantoin (MACRODANTIN), nitrofurantoin (FURADANTIN), metronidazole (FLAGYL) and Radi-opaque dye, all experienced allergies. On 29Sep2021, the patient experienced DVT in left leg, beginning 3 days after vaccination; diagnosed in ER. Have antiphospholipid syndrome. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. AE treatment included blood thinners. Outcome of the events was recovering. No COVID-19 tested post vaccination. Follow-up attempts are completed. No further information is expected.

Other Meds: PROPRANOLOL; EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]; TUMS [CALCIUM CARBONATE]

Current Illness:

ID: 1810511
Sex: M
Age:
State: CA

Vax Date: 02/16/2021
Onset Date: 03/26/2021
Rec V Date: 10/23/2021
Hospital: Y

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: Guillen-Barre Syndrome (GBS); This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 57-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) at the age of 57-years, via an unspecified route of administration on 16Feb2021 as dose 2, single for COVID-19 immunization. Medical history was not reported. No known allergies. No COVID-19 prior vaccination. No other vaccine in four weeks. No other medications in two weeks. The patient historically received first single dose of BNT162B2 (lot number: EL3247) on 25Jan2021 for COVID-19 immunisation (at the age of 57-years). The patient experienced Guillen-Barre Syndrome (GBS) on 26Mar2021. AE resulted in emergency room/department or urgent care, hospitalization for 21 days, disability or permanent damage. AE treatment included medical and rehabilitation. Outcome of the event was not recovered. No COVID-19 tested post vaccination.

Other Meds:

Current Illness:

ID: 1810512
Sex: M
Age:
State: OR

Vax Date: 10/05/2021
Onset Date: 10/06/2021
Rec V Date: 10/23/2021
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: 20211007; Test Name: heartbeat; Result Unstructured Data: Test Result:irregular heartbeat

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: heart fluttering; chest discomfort; irregular heartbeat; Severe headache; joint pain; nausea; fatigue; pain and redness at injection site lasting two days; pain and redness at injection site lasting two days; This is a spontaneous report from contactable consumer (patient). A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via an unspecified route of administration, administered in Arm Left on 05Oct2021 13:00 (Lot Number: FE3592) as dose 3 (booster), single (at age of 78-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included MGUS, Barritts, Ventricular Fibrillation. No known allergies. Concomitant medications included apixaban (ELIQUIS); omeprazole; atorvastatin. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL9262, Location of injection: Arm Left) on 19Feb2021 10:00 AM (at age of 77-years-old) for COVID-19 Immunization; the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot No: EL9269, Location of injection: Arm Left) on 09Mar2021 09:30 AM (at age of 77-years-old) for COVID-19 Immunization. On 06Oct2021 03:30, the patient experienced Severe headache, joint pain, nausea, fatigue, pain and redness at injection site lasting two days. On 07Oct2021 (third day), he experienced heart fluttering, chest discomfort, and irregular heartbeat. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment received. Outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds: ELIQUIS; OMEPRAZOLE; ATORVASTATIN

Current Illness:

ID: 1810513
Sex: F
Age:
State: CO

Vax Date: 10/08/2021
Onset Date: 10/08/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: loss of consciousness; severe hypotension; two episodes of emesis and LOC; severe chills; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER BIONTECH COVID 19) via intramuscular on the left arm on 08Oct2021 at 09:00 AM (Lot Number: EW0183) at the age of 32-year-old as single dose for COVID-19 immunization. Medical history was none. The patient didn't received other vaccines within 4 weeks prior to the COVID vaccine. Known allergy was none. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Concomitant medication was none. The patient previously received the first dose and the second dose of BNT162B2, the second dose on 15Jan2021 at 12:00 PM (Lot Number: EL1283) on the left arm, the first dose on 24Dec2020 at 01:15 PM (Lot Number: EK5730) on the right arm, both via intramuscular at the age of 31-year-old as single dose for COVID-19 immunization. On 09Oct2021 at 12:15 PM, the patient experienced severe hypotension and loss of consciousness. Hypotension lasting about 60 min with two episodes of emesis and LOC. followed by severe chills. No treatment was received. The outcome of booster and off label use was unknown. The outcome of other events was recovered with sequel in 2021.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development loss of consciousness cannot be totally excluded.

Other Meds:

Current Illness:

ID: 1810514
Sex: F
Age:
State: NY

Vax Date: 09/27/2021
Onset Date: 09/27/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20211007; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: my right eye felt droopy lid; severe chills; felt so cold despite blankets and sweater; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient (not pregnant) received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 27Sep2021 at 13:30 at the age of 53-year-old as single dose for COVID-19 immunization. Medical history included lupus, HX antiphospholipid antibodies, pulmonic stenosis and sjogren's. The patient didn't receive other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (Nasal Swab) on 07Oct2021 and result was negative. Concomitant medication included warfarin and hydroxychloroquine. The patient previously received dilaudid and experienced allergy. On 27Sep2021 at 18:30, the patient experienced severe chills, felt so cold despite blankets and sweater. Then about 6hrs later the right eye felt droopy lid. Since patient was feeling to cold he stayed under covers for hours until I felt warm. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received included steroid eye drops. The outcome of events was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds: WARFARIN; HYDROXYCHLOROQUINE

Current Illness:

ID: 1810515
Sex: F
Age:
State: MI

Vax Date: 10/03/2021
Onset Date: 10/05/2021
Rec V Date: 10/23/2021
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: Forearm of injection arm developed two small bruises with nerve type discomfort; Forearm of injection arm developed two small bruises with nerve type discomfort. At times it feels like there is tearing or pulling apart inside.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FF8841), via an unspecified route of administration in left arm on 03Oct2021 at 15:00 (at the age of 61 years old, not pregnant at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included patient had known allergies pennecilin. Concomitant medication in two weeks included levothyroxine sodium. Other vaccine within 4 weeks included influenza vaccine as DOSE NUMBER UNKNOWN, SINGLE from 08Sep2021 to 08Sep2021. Historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injectio n, Lot number: FC3183), via an unspecified route of administration in left arm on 12Sep2021 at 03:00 PM (at the age of 61 years old,) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 05Oct2021 patient experienced forearm of injection arm developed two small bruises with nerve type discomfort. At times it feels like there was tearing or pulling apart inside. Bruises did not appear at same time but few days apart. This happened approx. 2 days after 2nd dose injection. It was not going away. No hospitalization required. The patient did not received treatment due to the events. Reporter considered events as non-serious. The outcome of events was not recovered. Follow up attempts completed. No further information is expected.

Other Meds: LEVOTHYROXINE SODIUM

Current Illness:

ID: 1810516
Sex: F
Age:
State: CA

Vax Date: 10/08/2021
Onset Date: 10/09/2021
Rec V Date: 10/23/2021
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: Lump/swelling at injection site; Lump/swelling at injection site; swollen tender left clavicular lymph node; swollen tender left clavicular lymph node; This is a spontaneous report from a contactable nurse. This 32-year-old female nurse (patient) reported for herself. A 32-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 intramuscular, administered in Arm Left on 08Oct2021 11:45 (at the age of 32 years) (Batch/Lot Number: EW018S) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation at hospital. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) dose 1, administered in Arm Left on 26Dec2020 (at the age of 31 years) (Batch/Lot Number: EK5730) and dose 2, administered in left leg on 14Jan2021 (at the age of 31 years) (Batch/Lot Number: EL8982) for COVID-19 Immunization. On 09Oct2021 12:00 the patient experienced Lump/swelling at injection site, swollen tender left clavicular lymph node. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovering at the time of report. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810517
Sex: F
Age:
State: AZ

Vax Date: 04/02/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
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: Antibody test; Result Unstructured Data: Test Result:EBV Antibodies; Test Date: 202104; Test Name: Biopsy; Result Unstructured Data: Test Result:Granulome Annulare

Allergies:

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

Symptoms: rash; Granuloma annulare; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW015D), via an unspecified route of administration in Arm Right on 02Apr2021 at 16:00 (at 60 years) as single dose for covid-19 immunisation. Medical history included low thyroid, high cholesterol, menopause, overweight (30 lbs), Mono (at the age of 26 years) and she was told had EBV antibodies, mild Shingles (at the age of 51 years) and had known allergy to bee stings (not been stung since she was a teenager). Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.Concomitant medications were not reported.Previously the patient received two doses of Shingles Vaccine for immunization, on 15Oct2019 (first dose; at 58 years old) and on 11Mar2020 (second dose;at 59 years old); patient also get flu shot every year for immunization and last one was on 16Oct2021 (at 59 years old). On 12Mar2021 at 16:45 (at 60 years) the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6206), in left arm for covid-19 immunisation. On an unspecified date in Apr2021 at 12:00 the patient experienced rash and granuloma annulare, that resulted in Doctor or other healthcare professional office/clinic visit.Clinical course was as follows: when the patient got the shots, hardly felt it at the injection site - no side effects, no fever, no nausea. Not much discomfort from either dose. Then 2-3 weeks following the second shot she started to develop a rash, it started on upper arms, near the vaccine site and spread quite a bit. Primary doc initially thought it was an allergic reaction, eventually did biopsy and lab result was Granulome annulare. Now seeing a dermatologist. Prednisone and Elidel not very effective. Rash was extensive. Now she was trying Plaquenil. Patient stated never had any reaction to a vaccination, ever, other than the normal expected discomfort as the vaccine did its job creating antibodies. Final outcome of the events was not recovered.

Other Meds:

Current Illness:

ID: 1810518
Sex: M
Age:
State: TX

Vax Date: 10/07/2021
Onset Date: 10/08/2021
Rec V Date: 10/23/2021
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: Everytime i have a bowel movement i bleed; This is a spontaneous report received from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FF2588), administered in left arm on 07Oct2021 at 05:45 PM (at the age of 26-year-old) as dose 2, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. The patient's medical history was reported as none. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications included other unspecified vaccine (lot number Wag4161) administered in left arm on 07Oct2021 as dose number 2 (as reported). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number Ff2587), administered in left arm on 15Sep2021 at 01:00 PM as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine (as reported). On 08Oct2021 at 09:15 AM the patient experienced that every time she had a bowel movement she bled. The event was reported as non-serious, and no treatment was received due to the event. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event was not resolved. Follow-up (13Oct2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810519
Sex: M
Age:
State: NV

Vax Date: 09/20/2021
Onset Date: 09/20/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Feelings of having a fast beating, fluttering, pounding heart; Thought I was having an heart attack.; pounding heart; injection site pain/really bad arm pain on arm that injection was given; Feelings of having a fast beating; tiredness; severe headaches; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot Number: Ff2587 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 20Sep2021 (at the age of 49-years-old) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took morphine and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. The patient had feelings of having a fast beating, fluttering, pounding heart, thought he was having an heart attack, had injection site pain/really bad arm pain on arm that injection was given, tiredness, severe headaches, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, feeling unwell on 20Sep2021. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. No treatment was given for the events. The outcome of the event feeling unwell was recovered and outcome of rest of the events was recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810520
Sex: M
Age:
State: NC

Vax Date: 10/08/2021
Onset Date: 10/08/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20211009; Test Name: Heart rate; Result Unstructured Data: Test Result:elevated; Test Date: 20210331; Test Name: Nasal Swab; Test Result: Negative ; Comments: COVID 19 Antigen/Rapid.

Allergies:

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

Symptoms: swollen armpit (lymph nodes?); overnight sweats; elevated heartrate; chest pain; burning sensation throughout the day; fatigue; overnight chills; injection-site pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 33-years-old male patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF8841), via an unspecified route of administration, administered in left arm on 08Oct2021 at 10:20 (at the age of 33-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection, lot number: EL3247) on 14Jan2021 and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution injection, lot number: EL3247) on 04Feb2021 for COVID-19 immunization. Medical history included cholesterol, hypothyroidism and Hashimoto's Thyroiditis. Concomitant medications included levothyroxine sodium (LEVOXYL), colecalciferol, fish oil (OMEGASAN 3) and Multi-vitamins. On 08Oct2021 10:20 the patient experienced overnight chills and injection-site pain. On 09Oct2021 13:00 the patient experienced fatigue, elevated heartrate, chest pain, burning sensation throughout the day, overnight sweats. On 09Oct2021 19:00 the patient noticed swollen armpit (lymph nodes?). Facility type vaccine mentioned as Workplace clinic. No other vaccine in four weeks has been administered. Other medications in two weeks mentioned as Levoxyl, Omegas, Multi-vitamins, Other medical history: Cholesterol, Hypothyroidism, Hashimoto's Thyroiditis. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. No known allergies reported for the patient. The patient underwent lab tests and procedures which included Nasal Swab (SARS-CoV-2 test): Negative on 31Mar2021 COVID 19 Antigen/Rapid; heart rate: elevated on 09Oct2021. Therapeutic measures were taken as a result of overnight chills, injection-site pain, fatigue, elevated heartrate, chest pain, burning sensation throughout the day, swollen armpit (lymph nodes), overnight sweats. On 08Oct2021 at around 20:00 took two Tylenol PM tablets. On 09Oct2021 at around 9am took two Tylenol Gelcaps. May plan to visit Primary Care Physician this coming week reporter stated. The outcome of event overnight chills, injection-site pain was recovered on an unspecified date of Oct2021 while outcome of event fatigue recovered on 09Oct2021. The events were reported non-serious. The outcome of event overnight sweats was outcome of recovering while outcome of rest all event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds: LEVOXYL; OMEGASAN 3

Current Illness:

ID: 1810521
Sex: U
Age:
State:

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
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: Salivary gland to abscess; swollen lymph nodes around my jaw; It is swollen and sore; they are on my jaw more so then my neck/ Jaw was swollen, sore and tender; Jaw was swollen; couldn't eat; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 20Oct2021, this case now contains serious adverse reaction(s). Information processed together. This is a spontaneous report from a contactable consumer (reporting or self). A patient of unspecified age and gender received BNT162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Oct2021 (Batch/Lot Number: FF8839) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162b2 (COMIRNATY), Lot # FF2588, on an unspecified date for COVID-19 immunization and experienced foggy brain. The patient reported having had their second COVID vaccine "on this last Wednesday" (Oct2021). The patient reported swollen lymph nodes, which seem to be around the patient's jaw. It was swollen and sore. The reporter clarified they were on the patient's jaw moreso than neck. Jaw was swollen, sore and tender. Salivary gland to abscess. There was a lot of swelling and pain, and she couldn't eat. When it burst, it all went down. Swelling and pain 6 hours after her shot. Following Monday, around five days. The patient received ibuprofen for treatment. The patient recovered from the events on an unspecified date in Oct2021.

Other Meds:

Current Illness:

ID: 1810522
Sex: F
Age:
State: MI

Vax Date: 08/01/2021
Onset Date: 09/04/2021
Rec V Date: 10/23/2021
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: having hot flash things; she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot; maybe on 04Sep2021, she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 3 via an unspecified route of administration, administered in Arm Left on Aug2021 (Lot Number: FC3181) as dose 3 (booster), single (at age of 40-years-old) for covid-19 immunisation. Medical history included Lupus; pain associated with severe back spine issues, immune compromised. Concomitant medications included hydroxychloroquine taken for Lupus; duloxetine hydrochloride (CYMBALTA) taken for pain associated with severe back spine issues. Historical Vaccine included the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation on an unspecified date. The patient got the booster vaccine (Covid-19 Vaccine) probably 6 weeks ago and after a week, maybe on 04Sep2021, she started her period little bit, and it didn't stop since then. It's been still going on and on 08Oct2021 she started bleeding a lot, she was having hot flash things. The patient will call her OB-GYN (further not clarified) on Monday. She was assuring if it was all brought on by booster vaccine. Which happened about 5 weeks ago, maybe 04Sep2021. The event was not worsening. When probed if any doctor prescribed the vaccine, the patient stated doctor didn't prescribe her. She got vaccine because she was immune compromised (further not clarified the word). No treatment received. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: HYDROXYCHLOROQUINE; CYMBALTA

Current Illness:

ID: 1810523
Sex: F
Age:
State: NC

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20211006; Test Name: BP; Result Unstructured Data: Test Result:218/92; Test Date: 20211006; Test Name: BP; Result Unstructured Data: Test Result:201/81; Test Date: 20211006; Test Name: BP; Result Unstructured Data: Test Result:172/66; Test Date: 20211006; Test Name: BP; Result Unstructured Data: Test Result:185/78; Test Date: 20211006; Test Name: BP; Result Unstructured Data: Test Result:192/80; Test Date: 20211006; Test Name: BP; Result Unstructured Data: Test Result:180/73; Test Date: 20211006; Test Name: BP; Result Unstructured Data: Test Result:174/78; Test Date: 20211007; Test Name: BP; Result Unstructured Data: Test Result:117/69; Test Date: 20211006; Test Name: heart; Result Unstructured Data: Test Result:pounding rapidly

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Very tired; She took my bp and it was 218/92./Kept me for about an hour re-checking bp readings of 201/81, 186/78 & 172/66/My bp was 185/78, 192/80,180/73 & 174/78; My heart suddenly started pounding rapidly and would not slow down.; Headache; Dizziness; This is a spontaneous report from a contactable consumer. A 59-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FF2588), via an unspecified route on 06Oct2021 at 16:00 (at the age of 59-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included Hypertension, Carotid stenosis, Hyperlipidemia & spasmodic dysphonia and had known allergies: Naproxen, Ezetimibe, Benzonatate & NSAID. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received other prescribed medications in two weeks. The patient experienced and stated within 10 minutes after receiving injection my heart suddenly started pounding rapidly and would not slow down. I told nurse, she took my bp and it was 218/92. They quickly took me to an exam room with a doctor following me in. Kept me for about an hour re-checking bp readings of 201/81, 186/78 & 172/66 then discharging me at 5:10 pm. Later that evening had headache and dizziness. My bp was 185/78, 192/80,180/73 & 174/78. Next day was very tired but bp was normal at 117/69 on 06Oct2021 at 16:30. AE resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on unspecified date of 2021. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810524
Sex: M
Age:
State: FL

Vax Date: 03/19/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: cholesterol; Result Unstructured Data: Test Result:Normal; Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result:Normal; Comments: including his A1C; Test Date: 2021; Test Name: triglycerides; Result Unstructured Data: Test Result:Normal

Allergies:

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

Symptoms: two months after the 2nd dose he had a heart attack; really strong angina pain and it was really sharp; felt really sharp pain in his chest; he was walking and then all of a sudden, he could not walk anymore; Obstructive sleep apnea; mouth was dry; throat got too dry; sometimes if it was not too humid or the air flow through his mouth was dry it caused discomfort; Dizzy; numbness in his fingers; Felt like he might faint; This is a spontaneous report from a Pfizer sponsored program a regulatory authority received by a contactable consumer (patient). A 46-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 19Mar2021 08:30 (Lot Number: EP7534) as dose 2, single (at age of 45-years-old) for covid-19 immunisation. Prior Vaccinations within 4 weeks was none. Medical history was none. Family medical history relevant to events was none. There were no concomitant medications. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6205, Location: left shoulder) on 26Feb2021 (at age of 45-years-old) for COVID-19 immunization. The patient experienced two months after the 2nd dose he had a heart attack on May2021, really strong angina pain and it was really sharp on Apr2021, felt really sharp pain in his chest on Apr2021, he was walking and then all of a sudden, he could not walk anymore on Apr2021, obstructive sleep apnea in 2021, mouth was dry in 2021, throat got too dry in 2021, sometimes if it was not too humid or the air flow through his mouth was dry it caused discomfort in 2021, dizzy in 2021, felt like he might faint in 2021, numbness in his fingers in 2021. The patient went to the hospital was on 27Jun2021 and two months prior to going to the hospital he had really strong angina pain and it was really sharp, and he was walking and then all of a sudden, he could not walk anymore; stated he felt really sharp pain in his chest and at the time he did not associate that with a heart attack. He had to stop walking at that time and after 2 minutes he could continue walking again and then the pain came back, and he had to stop walking again. He was on a diet and exercise and the pain happened all of a sudden and at that time that he had the 2nd dose of the vaccine, his cholesterol and triglycerides and all of his blood work including his A1C was pretty normal. He did not go to the hospital because he was having the chest pain that he had but because he felt a little dizzy and felt like he might faint and had some numbness in his fingers. The doctors were shocked because he did not have a history of cardiovascular disease at that time and no one in his family has a history of that. He suffered from obstructive sleep apnea and his throat got too dry and when he breathes with the CPAP every night and sometimes if it was not too humid or the air flow through his mouth was dry it caused discomfort and he thought the reported event was that. His heart attack was a non-STEMI heart attack. All events resulted in emergency room visit and physician office visit. The patient was hospitalized for all events from 27Jun2021 to 04Jul2021. The patient underwent lab tests and procedures which included cholesterol: normal in 2021, blood work: normal including his A1C in 2021, triglycerides: normal in 2021. Outcome of the events was unknown.

Other Meds:

Current Illness:

ID: 1810525
Sex: M
Age:
State: MA

Vax Date: 05/23/2021
Onset Date: 09/28/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210930; Test Name: PCR (Nasal Swab); Test Result: Positive

Allergies:

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

Symptoms: Tested positive on 30-Sep-2021 by PCR.; Tested positive on 30-Sep-2021 by PCR.; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers not reported), on 02May2021 (first dose, at 17 years) and on 23May2021 (second dose, at 17 years), both at single doses for covid-19 immunisation . The patient medical history included allergy. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. Symptoms initiated on 28Sep2021 and included nasal congestion, cough. He was tested positive on 30Sep2021 by PCR (Nasal Swab). Symptoms began to subside about "2Sep2021" (as reported). Patient attended on 25Sep2021 (as reported). No treatment given. Patient recovered on an unknown date in 2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1810526
Sex: F
Age:
State: MA

Vax Date: 06/12/2021
Onset Date: 10/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20211003; Test Name: home test; Test Result: Positive

Allergies:

Symptom List: Unevaluable event

Symptoms: Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021; Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021; This is a spontaneous report from a contactable consumer. A 15-year-old female patient (not pregnant) received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers not reported), on 20May2021 (first dose, at 15 years) and on 12Jun2021 (second dose, at 15 years) , both as single doses for covid-19 immunisation . The patient medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19.Patient's brother tested positive via PCR test on 30Sep2021. Patient started symptoms on 01Oct2021, tested positive via home test on 03Oct2021. Symptoms of nasal congestion and headache subsided within a few days. No treatment given. Patient recovered on an unknown date in Oct2021. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up

Other Meds:

Current Illness:

ID: 1810527
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: covid; Test Result: Positive

Allergies:

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

Symptoms: That night she went to go to bed and fell to the floor.; 3 days later she caught covid in the hospital after taking the Pfizer shot.; 3 days later she caught covid in the hospital after taking the Pfizer shot.; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date in 2021 (at the age of 69 years old) as dose number unknown, single, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter said that the patient (girlfriend's mother) took the Pfizer Covid vaccine in 2021 and that night she went to go to bed and fell to the floor. They rushed her to the hospital and 3 days later she caught covid (2021) in the hospital after taking the Pfizer shot. She was covid positive. The patient was hospitalized from an unspecified date in 2021 due to the events 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:

Current Illness:

ID: 1810528
Sex: M
Age:
State: NM

Vax Date: 09/18/2021
Onset Date: 09/18/2021
Rec V Date: 10/23/2021
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: HA; brain fog; short term memory issues; This is a spontaneous report from a non-contactable nurse (patient). A 28-year-old male patient received BNT162B2, via an unspecified route of administration, administered in deltoid left on 18Sep2021 (Batch/Lot number was not reported) at the age of 28 years old, as dose 1, single for COVID-19 immunisation. There were no other medical history nor concomitant medications. No known allergies. No other vaccine in four weeks nor other medications in two weeks. No covid prior vaccination; not covid tested post vaccination. Got shot 2 weeks ago. The patient experienced headache (HA), brain fog and short term memory issues on 18Sep2021, every day since including the day of the injection. The reporter assessed adverse events as serious, resulted in disability or permanent damage. No treatment was provided. Outcome of events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Headache, Feeling abnormal, Memory impairment and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1810529
Sex: U
Age:
State:

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 10/23/2021
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: think it gave her/him a heart attack; real weak; right arm still swelled up; feel sick; face turned deep red; wrecked health; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced think it gave her/him a heart attack, real weak, right arm still swelled up, feel sick, face turned deep red, wrecked health on an unspecified date. Time she/he got back to the house she/he almost died. The patient mean it almost killed her/him. Her/his face turned deep red and think it gave her/him a heart attack (clarification unknown). She/he almost died right here at own home (further clarification was unknown) and she/he had a bad reaction, it literally gave 'bumps' in her/his body. The patient called about a month ago and was in 'normalization'. Outcome of the events was unknown. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810530
Sex: F
Age:
State: NY

Vax Date: 12/18/2020
Onset Date: 01/04/2021
Rec V Date: 10/23/2021
Hospital: Y

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

Lab Data: Test Name: ct scans; Result Unstructured Data: Test Result:unknown result; Test Name: Blood work; Result Unstructured Data: Test Result:unknown result

Allergies:

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

Symptoms: acute pancreatitis; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19, Lot Number: EK5730), via an unspecified route of administration, administered in arm right on 18Dec2020 (at the age of 41-years-old) as dose 1, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included acute pancreatitis from an unknown date. There were no concomitant medications. The patient previously took Reglan [metoclopramide hydrochloride], and experienced drug allergy. Within a week and a half from getting the 1st of 2 Pfizer vaccines, the patient had acute pancreatitis on 04Jan2021. The acute pancreatitis would resolve for a short time and then come back within days for several reoccurrences. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The patient was hospitalized for 5 days within the month of Jan/Feb of 2021. The patient received IV fluids, pain/nausea meds, CT scans, blood work as treatment. The outcome of the event was recovered.; Sender's Comments: Based on the currently available information the causal association between the event acute pancreatitis and the suspect drug BNT162B2 is assessed unrelated and more likely due to underlying medical condition of acute pancreatitis.

Other Meds:

Current Illness:

ID: 1810531
Sex: F
Age:
State: NH

Vax Date: 07/31/2021
Onset Date: 07/31/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: Test Result:plummeted

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: passed out and kept going in and out of consciousness; passed out and kept going in and out of consciousness; blood pressure plummeted; This is a spontaneous report from a contactable consumer (patient's parent). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA6780), via an unspecified route of administration in left arm on 31Jul2021 14:14 (at the age of 16-years-old) as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not having any known allergies. The patient was not pregnant. The patient experienced passed out and kept going in and out of consciousness and blood pressure plummeted on 31Jul2021 14:15. The events resulted in emergency room/department or urgent care. Patient was treated with two bags of electrolytes; heart monitored. It was reported that a minute or so after the first vaccination, patient passed out and kept going in and out of consciousness. After seeing that her blood pressure plummeted, the ambulance transported her to hospital where she remained for a few hours until stabilized. Since the vaccination, patient has not been tested for COVID-19. Outcome of events was resolved on the same day. Patient wanted to be fully vaccinated, so when it was time for the second shot, she had it administered at hospital while she was lying down. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0202), via an unspecified route of administration in left arm on 25Aug2021 09:00 as dose 2, single for COVID-19 immunization. She did not have an adverse reaction to the second shot.

Other Meds:

Current Illness:

ID: 1810532
Sex: F
Age:
State: IN

Vax Date: 10/07/2021
Onset Date: 10/08/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20210927; Test Name: blood work for hormones level; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210927; Test Name: testosterone; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210927; Test Name: Vitamin B12; Result Unstructured Data: Test Result:Unknown results

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: started her period although like she had a week ago finished it; really very heavier than the normal period; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 07Oct2021 (Batch/Lot Number: 301458A) at the age of 46 years as single dose for covid-19 immunisation. Medical history included Blood pressure high. Concomitant medications included beta blockers for high blood pressure. Patient got the first dose of the Pfizer vaccine on Thursday 07Oct2021 and she started her period although like she had a week ago finished it, so it was really very heavier than the normal period, so patient was concerning. Event start date was 08Oct2021. Patient had blood work for hormones level, testosterone and Vitamin B12 and patient guessed on 27Sep2021. Events were worsening. No treatment was received for the event. Outcome of events were not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810533
Sex: F
Age:
State: MD

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 10/23/2021
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: rash on right arm from elbow to wrist that spread to left arm; Blotches; Severe itching; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (COVID 19), dose 1 via an unspecified route of administration, administered in right arm in May2021 07:00 (Batch/Lot number was not reported) as dose 1, single at the age of 52-year-old for COVID-19 immunization. The patient was not pregnant. Medical history included high bop, sleep apnea, obesity. No other vaccine in four weeks. Concomitant medications included lisinopril; linaclotide (LINZESS); levothyroxine; fluoxetine; vitamin d taken in two weeks. The patient previously took biaxin, claritin [loratadine] and experienced allergy. The patient experienced rash on right arm from elbow to wrist that spread to left arm. Blotches all over top of both legs. Severe itching to where she wanted to tear her skin off. No treatment received. No Covid prior vaccination. No Covid tested post vaccination. The outcome of event was not recovered. The lot number for bnt162b2, was not provided and will be requested during follow up.

Other Meds: LISINOPRIL; LINZESS; LEVOTHYROXINE; FLUOXETINE; VIT D [VITAMIN D NOS]

Current Illness:

ID: 1810534
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: kind of unconscious; his heart is barely working; water in the lungs; he got so sick; This is a spontaneous report from a contactable physician. A male patient of (33 or 34 years old) received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration (Lot number: Not reported) on an unspecified date as dose 1, single and via intramuscular on an unspecified route of administration (Lot number: Not reported) on an unspecified date as dose 2, single for COVID-19 immunization. On an unspecified date in 2021 patient experienced kind of unconscious, his heart was barely working, water in the lungs and he got so sick. It was reported that after the patient received the third dose he got so sick he was hospitalized. The patient had been in the hospital for 6-7 days. What does Pfizer recommend. Had anything happened with the safety of the Pfizer covid booster vaccine. Had one had a severe reaction like this. was there an antidote. The caller understood the doctors in Australia were giving good care to the patient as the patient was in Australia. was there someone in Australia from Pfizer who could help the caller's sister. Caller was asking what Pfizer recommends for anaphylactic shock. Seriousness of the kind of unconscious, his heart was barely working was hospitalization and medically significant and events water in the lungs, he got so sick was medically significant. It was reported that as soon as the patient had the third dose he slept and then they took him to the emergency room. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the limited information provided the causal association between the events loss of consciousness, heart failure, pleural effusion and illness with the usage of the vaccine BNT162B2 cannot be completely excluded. The case will be reassessed once detailed information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1810535
Sex: F
Age:
State: NH

Vax Date: 09/01/2021
Onset Date: 09/02/2021
Rec V Date: 10/23/2021
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: 20210927; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Injection site pain

Symptoms: swollen lymph node in left arm pit; extreme pain; hot; bruising; This is a spontaneous report from a contactable consumer (patient). A 15-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 01Sep2021 09:00 (Batch/Lot number was not reported) at the age of 15 years as single dose for covid-19 immunisation. Medical history included asthma and known allergies: tree nuts. Patient had no COVID prior vaccination. There were no concomitant medications. Historical vaccine included the first dose of bnt162b2, via an unspecified route of administration, administered in left arm on 10Aug2021 06:00 PM at the age of 15 years as single dose for covid-19 immunisation and experienced hives on face and neck for 7 days, swollen lymph node in left arm pit for 7 days. Patient was not pregnant. Patient experienced swollen lymph node in left arm pit after second dose. Still swollen, extreme pain, hot, bruising. Not resolved. Adverse event start date was 02Sep2021. Ae resulted in: doctor or other healthcare professional office/clinic visit. Treatment: antibiotics was received. Covid (Nasal Swab) tested post vaccination on 27Sep2021 was negative. Outcome of events were not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810536
Sex: U
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: seizures; Had bad reaction; I had the wicked reaction; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in left arm, on an unspecified date, at dose 2, single for covid-19 immunization. Medical history included asthma; did not use the inhaler every day, migraine and the patient was immunocompromised (ongoing). Concomitant medications included cefaclor; fluticasone; oxcarbazepine; quetiapine fumarate (SEROQUEL) and amitriptyline hydrochloride (TRIPTA). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, on an unspecified date, at dose 1, single for covid-19 immunization. The patient experienced seizures and had a bad reaction/wicked reaction on an unspecified date. The patient had booster dose of bnt162b2 on an unspecified date. 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: CEFACLOR; FLUTICASONE; OXCARBAZEPINE; SEROQUEL; TRIPTA

Current Illness: Immunocompromised

ID: 1810537
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/23/2021
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: 10 day after the first shot contracted Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included gout from 2019. 10 day after the first shot the patient contracted covid. Concomitant medications included unspecified gout medication from 2019. The outcome of event was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810538
Sex: F
Age:
State: CA

Vax Date: 10/08/2021
Onset Date: 10/08/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20211008; Test Name: Fever; Result Unstructured Data: Test Result:102.5; Comments: Fever of 102.5.; Test Date: 20210311; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Test Date: 20210627; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Test Date: 20210818; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative

Allergies:

Symptom List: Tremor

Symptoms: Severe body and head aches.; Severe body and head aches; Chills; Nausea; Diarrhea; Intense face pain in sinus zone and red splotches in these areas.; Intense face pain in sinus zone and red splotches in these areas.; Hives in armpit, under breasts, down sides, and in groin area; Fever of 102.5; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female consumer reported for herself that she received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number 30155BA) via an unspecified route of administration in left arm on 08Oct2021 at 09:00AM (at the age of 68-year-old) at single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 16Jan2021 at 09:30AM and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL8982) in left arm on 06Feb2021 at 01:00PM, both for COVID-19 immunisation. Age at first and second vaccination was 67-year-old. Other relevant medical history was none. The patient did not receive any other vaccines withing 4 weeks prior to the COVID vaccine. The patient had allergy to Levaquin, Macrobid and Morphine. Concomitant medications included colesevelam, cetirizine hydrochloride (ZYRTEC), multivitamin and multimineral. On 08Oct2021 at 06:30PM the patient experienced fever of 102.5, severe body and head aches, chills, nausea, diarrhea, intense face pain in sinus zone and red splotches in these areas, hives in armpit, under breasts, down sides, and in groin area. The patient was told to go to ER if it got worse, but she did not go. The events required physician office visit and were treated with Benadryl, Tylenol and Ibuprofen. The patient was not diagnosed with COVID-19 prior to vaccination and has been tested for COVID-19 since the vaccination. Nasal swab was negative on 11Mar2021, 27Jun2021 and 18Aug2021. The events were resolving at the time of report.

Other Meds: COLESEVELAM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness:

ID: 1810539
Sex: M
Age:
State:

Vax Date: 10/09/2021
Onset Date:
Rec V Date: 10/23/2021
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: Experiencing headache; Feels like he is tired/ He is feeling tired; This is a spontaneous report from a contactable consumer or other non hcp (mother) reporting for a patient (son). A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on 09Oct2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccination included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on unknown date as dose 1, single for covid-19 immunization. On an unspecified date in 2021, the patient reported experiencing headache, feels like he is tired/ he is feeling tired. Reporter stated her son had the second dose of vaccine yesterday but he was complaining he had a headache and he felt like he was tired. Reporter asked what kind of medicine that she needed to give. Her concern was could she give him a medicine just like over the counter medicine like Tylenol or Advil or Motrin or pain reliever. Reporter further stated she was going to ask somebody and she was not going to go to the doctor because that's only the side effect, it was not the fever, feeling right now. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1810540
Sex: F
Age:
State: TX

Vax Date: 08/28/2021
Onset Date:
Rec V Date: 10/23/2021
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: Had severe panic attack, I thought I am having a heart attack; My shoulder within the right arm, it was sore for 3 weeks; Joints still hurt; had severe panic attack; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Aug2021 (Lot Number: EE2588) at the age of 54 years as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID). Patient wanted to report an adverse event that patient had from getting the vaccine. The first shot that she received, her shoulder within the right arm, it was sore for 3 weeks and the joints still hurt. Patient had had severe panic attack, she thought she was having a heart attack (Further clarification was unknown) and patient got passed that, so she got her second shot. Outcome of joints still hurt was not recovered and the other events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1810541
Sex: M
Age:
State:

Vax Date: 04/05/2021
Onset Date: 10/04/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 20211007; Test Name: Nasal Swab; Test Result: Positive.

Allergies:

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

Symptoms: This is a spontaneous report received from a non-contactable consumer (patient). A 25-year-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: ER8737) via an unspecified route of administration on 15Mar2021 (At the age of 25-year-old) as single dose and second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6208) via an unspecified route of administration on 05Apr2021 (At the age of 25-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. Since the vaccination, the patient had been tested for COVID-19. On 04Oct2021 the patient experienced breakthrough covid case, covid. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 07Oct2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event breakthrough covid case was unknown, and other event covid was recovering. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1810542
Sex: F
Age:
State: TX

Vax Date: 09/20/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: blood work; Result Unstructured Data: Test Result: Unknown results.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: heart hurt; her arms swelled up; itchy; headache; nerve pain; big red spot on the arm; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Sep2021 (Batch/Lot Number: FC3181) at the age of 54 years as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID). Historical vaccine included the first dose of bnt162b2 on 28Aug2021 at the age of 54 years for COVID-19 immunisation and experienced shoulder within the right arm, it was sore for 3 weeks and the joints still hurt, had severe panic attack, thought she was having a heart attack. Patient got her second shot and then her arms swelled up and it was red for 3 weeks and it was still red but swelling had gone down and itchy and patient had a headache every single day and then she felt like her heart hurt and then she had from her hips down to her knee a nerve pain and so it was going on after the second shot from her hip to her knee. When they gave her her second shot, it immediately 'shot' up to her brain, patient felt like immediate headache. So, she did not know if it was the muscle or what but her arm was swollen for 3 weeks and red and now the swelling was going down but it was still big red spot on the arm. They drew blood work yesterday and for her symptoms that she had reaction to the COVID Vaccine. Outcome of arms swelled was recovered in 2021 and the other events were unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: SYNTHROID

Current Illness:

ID: 1810543
Sex: F
Age:
State: AZ

Vax Date: 03/01/2021
Onset Date: 04/01/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; This is a spontaneous report from a contactable physician. A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 at the age of 69 years as single dose for covid-19 immunisation. Medical history included hyperlipidemia, DDD (Degenerative disc disease), past drug history: allergy, covid-19. Concomitant medications included pravastatin. Historical vaccine included the first dose of bnt162b2, intramuscular in Mar2021 at the age of 69 years as single dose for covid-19 immunisation. Patient was not pregnant. Developed muscle pain in back of thighs and groins 2 weeks after covid vaccine, moved to neck and shoulders and then to radiating down arms Medrol dose pack helped - but pain recurred when she stopped. Date of start of reaction/event was Apr2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment Kenalog shot, Ibuprofen, Amitriptyline, Rheumatology referral, Prednisone were received. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were recovering. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events Myalgia, pain in extremity, groin pain, neck pain, arthralgia and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: Pravastatin

Current Illness:

ID: 1810544
Sex: F
Age:
State: PA

Vax Date: 10/05/2021
Onset Date: 10/05/2021
Rec V Date: 10/23/2021
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: rash/It's on my entire body's but mostly my arms and wrists; Severe itching; swelled on hands and feet; My finger tips on right hand are still numb; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 05Oct2021 12:00 (Lot Number: 30130BA), at the age of 47-year-old, as dose 2, single for COVID-19 immunisation. The patient's medical history included allergy to an unspecified drug. The patient received no concomitant medications. The patient was not pregnant at time of vaccination. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 14Sep2021 at 12:00 PM (Lot Number: EE3592), at the age of 47-year-old, as dose 1, single for COVID-19 immunisation. The patient reported she experienced rash that comes and goes. Seemed to be bad in the evening for some reason. It was on her entire body but mostly her arms and wrists. She had severe itching (she could't take it). First two days after second dose she swelled on hands and feet; that seemed to have stopped. Her fingertips on right hand were still numb. The events started on 05Oct2021 at 16:00. She never had a problem with breathing (Benadryl helped). As of 10Oct2021 she had been taking Benadryl for 5 days and she was going to go to doctor the next day because she couldn't take it anymore. The events were reported as non serious. The event 'swelled on hands and feet' was resolved on 08Oct2021, while other events had not resolved. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810545
Sex: U
Age:
State: CA

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 10/23/2021
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: Tongue throat tingled; Tongue throat tingled; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 22Apr2021 15:45 (Batch/Lot Number: EW0175) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took the dose 1 of bnt162b2 (Batch/Lot number: ER8733) intramuscular in left arm on 30Mar2021 01:15 (at age of 35 years old, as reported) for COVID-19 immunization. On an unspecified date, the patient experienced tongue throat tingled. The doctor talked to the patient, took Benadryl (as reported). The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810546
Sex: F
Age:
State: GA

Vax Date: 10/08/2021
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: flutterings in my chest periodically; Right arm injection site pain; This is a spontaneous report from a contactable other HCP. A 29-year-old female patient received second dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 08Oct2021 at 08:30 (Batch/Lot Number: FF2589) as DOSE 2, SINGLE for Covid-19 immunization. Medical history included obesity, known allergies: raw fruits and known allergies: vegetables. The patient received initial dose of BNT162B2 on 17Sep2021 (Dose number: 1, Lot number: FF2588, Administration time: 08:30 AM, location: Right arm) and reported Muscle/body aches from the bottom of my ribcage to the base of my neck and Chest pain- my heart was pounding hard against my chest like it was about to beat out of my chest. Concomitant medication included dextroamphetamine hydrochloride (DEXTROAMPHETAMINE HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took sodium benzoate and experienced drug hypersensitivity (Known allergies: sodium benzoate). The patient experienced fluttering in my chest periodically and right arm injection site pain on unspecified dates. The patient reported Right arm injection site pain was present to date of 2nd dose/ 3 weeks and I experience fluttering in my chest periodically which were not present prior to receiving this vaccine. No treatments was received for the events. Outcome of the events was recovered with sequelae.; Sender's Comments: Based on the available information,. the contributory role of the suspect product BNT162B2 (BNT162B2) to reported Cardiac flutter is possibly related. Case will be reassessed upon receipt of follow-up information.,Linked Report(s) : US-PFIZER INC-202101346039 same patient/reporter/drug, different dose/Event

Other Meds: Dextroamphetamine Hydrochloride

Current Illness:

ID: 1810547
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: anti-spike antibody; Result Unstructured Data: Test Result: Positive - 15.7; Test Name: AST; Result Unstructured Data: Test Result:1007; Test Name: AST; Result Unstructured Data: Test Result:98; Test Name: Bone marrow biopsy; Result Unstructured Data: Test Result: hemophagocytosis; Test Name: Fibrinogen; Test Result: 435 mg/dl; Test Name: Triglycerides; Result Unstructured Data: Test Result:263; Test Name: Fever; Result Unstructured Data: Test Result:39.6 Centigrade; Test Name: Soluble CD25; Result Unstructured Data: Test Result:18100 pg/mL; Test Name: Hemoglobin; Result Unstructured Data: Test Result:11.5 g/mL; Test Name: Hemophagocytosis; Result Unstructured Data: Test Result: Yes; Test Name: hyperferritinaemia; Result Unstructured Data: Test Result:84848 ng/ml; Test Name: EBV blood PCR; Result Unstructured Data: Test Result:10275 IU/ml; Test Name: H-Score; Result Unstructured Data: Test Result:213; Test Name: Platelet; Result Unstructured Data: Test Result:11.5; Test Name: Rheumatologic work-up; Result Unstructured Data: Test Result: positive anti-Ro/La and U1-RNP autoantibodies; Comments: positive anti-Ro/La and U1-RNP autoantibodies; Test Name: Ferritin; Result Unstructured Data: Test Result:75249 ng/ml; Test Name: White blood count; Result Unstructured Data: Test Result:3.0; Comments: K/uL.

Allergies:

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

Symptoms: This is a spontaneous report from an unpublished manuscript. A contactable physician reported for a 53-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. Medical history included ILD with autoimmune features. The patient's concomitant medications were not reported. The rapid generation of safe and effective mRNA vaccines has been an unprecedented success of the SARS-CoV-2 pandemic. Adverse events are extremely uncommon even in large population-database analyses. However, exacerbations of underlying hematologic and autoimmune diseases have been reported post-vaccination. Rare cases of possible vaccine-related HLH have also been reported after other SARS-CoV-2 vaccines. Given the widespread administration of these vaccines, it is essential to continue to monitor for rare adverse events and specific patient populations at-risk for them. In this case series, we describe five cases reported across the unknown locations over the last year of hyperinflammatory reactions including HLH with temporal associations to mRNA vaccination in people with underlying immune dysregulation. A 53-year-old man developed interstitial lung disease (ILD) seven-months before presentation. Biopsy showed non-specific interstitial pneumonia. Rheumatologic work-up showed positive anti-Ro/La and U1-RNP autoantibodies. He had no other autoimmune signs or symptoms. Prednisone and mycophenolate were trialed without improvement over four-months. Rituximab was planned, so he received BNT162b2 mRNA-vaccine. Four-days after vaccination, he developed fever and worsening hypoxia. Antibiotics were started, but his symptoms progressed requiring mechanical ventilation. Labs demonstrated new onset pancytopenia, hyperferritinaemia (84848ng/mL), and increased Soluble CD25 (18100U/mL). Bone marrow biopsy showed hemophagocytosis. Infectious evaluation revealed only an EBV viremia (10275-IU/mL) of unknown duration. He was started on dexamethasone, anakinra, and intravenous immunoglobulin. On transfer to the Institute of Health, he was consented onto study (unknown) #. His condition improved over eight-weeks but was complicated by Pseudomonas bacteremia and autoimmune hemolytic anemia (AIHA). Ventilatory support was weaned after three-months, and he was discharged to a rehabilitation facility. The patient was 53-year-old man with Underlying Condition ILD with autoimmune features. Lab test included: Temperature (Celsius): 39.6, Ferritin (ng/mL): 75249, White blood count (K/uL): 3.0, Hemoglobin (g/dL): 11.5, Platelet (K/uL): 11.5, Triglycerides (mg/dL): 263, Fibrinogen (mg/dL): 435, AST (U/L): 98, 1007. Soluble CD25 (pg/mL): 18,100, Hemophagocytosis: Yes, H-Score: 213. EBV blood PCR (IU/mL): 10275. Vaccine Response- anti-spike antibody (U/mL): Positive-15.7. Organomegaly: Hepatomegaly. Treatment included: Dexamethasone, IVIG, anakinra. The Outcome of the events worsening hypoxia, fever was recovering, for other events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal relationship, the association between the events autoimmune hemolytic anemia, bacterimia, hemophagocytic lymphohistiocytosis, hypoxia, AST increased, and pancytopenia with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1810548
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
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: AST; Result Unstructured Data: Test Result:36; Comments: U/L; Test Name: Bone marrow biopsy; Result Unstructured Data: Test Result: myelodysplastic syndrome (MDS) with excess blasts; Test Name: Fibrinogen; Test Result: 561 mg/dl; Test Name: Triglycerides; Test Result: 106 mg/dl; Test Name: Fever; Result Unstructured Data: Test Result:40.1 Centigrade; Comments: High grade fevers; Test Name: Soluble CD25; Result Unstructured Data: Test Result:4,907; Comments: pg/mL; Test Name: Bone marrow culture; Result Unstructured Data: Test Result: MAC, developed pulmonary aspergillosis.; Test Name: Hemoglobin; Result Unstructured Data: Test Result:6.8 g/dl; Test Name: EBV blood PCR; Result Unstructured Data: Test Result:1,000; Comments: IU/mL; Test Name: H-Score; Result Unstructured Data: Test Result:208; Test Name: anti-spike antibody; Result Unstructured Data: Test Result:2.1; Comments: U/mL; Test Name: Platelet; Result Unstructured Data: Test Result:106; Comments: K/uL; Test Name: Ferritin; Result Unstructured Data: Test Result:7,724 ng/ml; Comments: Ferritin increased from 2,642 to 7,724ng/mL; Test Name: White blood count; Result Unstructured Data: Test Result:2.6; Comments: K/uL.

Allergies:

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

Symptoms: worsening cytopenias; worsening cytopenias; anemia; Ferritin increased; hyperferritinemia; high-grade fevers (40.1?C); This is a spontaneous report from an unpublished manuscript via a contactable physician. A 55-year-old female patient received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included GATA-2 deficiency, MDS (blasts 6-8%), MAC, pulmonary aspergillus and adult-onset Still's disease (AoSD). Concomitant medications included unspecified steroids. Patient presented with four-months of fevers, cytopenias, and hyperferritinemia. She had received steroids for presumed adult-onset Still's disease (AoSD). Her symptoms initially improved but then returned. Bone marrow culture grew MAC, and she developed pulmonary aspergillosis. Bone marrow biopsy revealed myelodysplastic syndrome (MDS) with excess blasts. She was diagnosed with GATA2 deficiency based on uniallelic GATA2 expression and was consented onto a natural history protocol at NIH (#). Her symptoms stabilized with antibiotics, but intermittent fevers persisted. She received the BNT162b2 mRNA-vaccine in preparation for chemotherapy and developed high-grade fevers (40.1 centigrade) three-days after vaccination. Ferritin increased from 2,642 to 7,724ng/mL, and she had worsening cytopenias. Due to pulmonary aspergillosis, steroids were avoided. Anakinra was trialed but not tolerated. Fevers continued but her labs stabilized over two-weeks, although she continued to need blood transfusions for anemia. Her condition then returned to baseline, and her MAC and aspergillus improved with treatment. Underlying Condition: Temperature (Celsius): 40.1; Ferritin (ng/mL): 7,724; White blood count (K/uL): 2.6; Hemoglobin (g/dL): 6.8; Platelet (K/uL): 106; Triglycerides (mg/dL): 106; Fibrinogen (mg/dL): 561; AST (U/L): 36; Organomegaly: Hepatosplenomegaly; Soluble CD25 (pg/mL): 4,907; Hemophagocytosis: ND - Not determined; H-Score: 208; EBV blood PCR (IU/mL): 1000; Treatment: Ketorolac, anakinra (not tolerated); Vaccine Response - anti-spike antibody (U/mL): Positive - 2.1. Outcome: Alive - pending chemotherapy, transplant. Outcome of the events was unknown. The rapid generation of safe and effective mRNA vaccines has been an unprecedented success of the SARS-CoV-2 pandemic. Adverse events are extremely uncommon even in large population-database analyses. However, exacerbations of underlying hematologic and autoimmune diseases have been reported post-vaccination. Rare cases of possible vaccine-related HLH have also been reported after other SARS-CoV-2 vaccines. Given the widespread administration of these vaccines, it is essential to continue to monitor for rare adverse events and specific patient populations at-risk for them. In this case series, we describe five cases reported across the Unknown locations over the last year of hyperinflammatory reactions including HLH with temporal associations to mRNA vaccination in people with underlying immune dysregulation. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1810549
Sex: M
Age:
State:

Vax Date: 06/01/2021
Onset Date: 07/01/2021
Rec V Date: 10/23/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: Myocarditis; Test Result: Negative; Comments: tested for myocarditis which came back negative.

Allergies:

Symptom List: Vomiting

Symptoms: suffered a seizure then cardiac arrest; Cardiac arrest; Nauseous; dizzy; will never play sports again; This is a spontaneous report from a contactable consumer (patient's mother). An adolescent male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Jun2021 (Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient had no prior health issues. He was an active athlete; worked out at the gym and had made the varsity football team prior to the events. The patient's concomitant medications were not reported. The reporter stated that her son, almost 16 years of age, received the Pfizer vaccine in May/Jun of 2021 - he received both doses through a pop-up event that the school district was offering. With his final dose being the first week of Jun2021, he did not have any initial side effects from the vaccine. Both she and her husband were also vaccinated, but they received Moderna. The patient was a healthy, active, loving boy who was loved by everyone. On 19Jul2021, upon arriving to a friend's house, patient suffered a seizure then cardiac arrest. He was resuscitated 3x prior to arriving at the hospital, after getting his pulse back. The house he was at was able to administer CPR (cardiopulmonary resuscitation). He was airlifted to a hospital where testing began to try to find out what happened. It was ruled his event was cardiac related, not neurological. Prior to the event he was nauseous, and dizzy in Jul2021. He was tested for myocarditis in 2021 which came back negative. A defibrillator was now in his chest, and the patient could never play sports again. Reporter stated for a 14-year-old, this was a huge hit mentally. As a parent, she worries for him, but she was grateful he was here. However, the time leading up to bringing him home was a nightmare for them emotionally, a mental pain no parent should go through, no child either. The reporter stated they still had no answers as to what caused their son's issues. They were in the process of genetic counseling which may present some answers although she was not hopeful on this. They have been working with the best of the best when it came to doctors for his ongoing treatment. She read so much about the effects of the vaccine, the nausea, the dizziness, the cardiac arrest. All signs point to that a child would have had chest pains, and that these symptoms occurred a certain amount of time after vaccination. The fact that patient was working out after the vaccine too, and an athlete by nature, just made her even more curious. With the patient, it happened about 5 weeks post vaccination and no myocarditis that they have seen to date. The signs and symptoms are so spot on for what happened to him, and she was wondering if there are other reported cases that do not present the myocarditis. Patient could have died, in fact on paper, he did die and was resuscitated. The reporter was simply reaching for awareness because there was no one that can tell her this was not a cause of the vaccine. She was more curious as a concerned parent if any research to date notes that this could happen to kids, even if they do not have the classic myocarditis. He had all the warning signs. The outcome of the events was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810550
Sex: M
Age:
State: IL

Vax Date: 03/22/2021
Onset Date: 10/09/2021
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: Nasal Swab; Test Result: Negative.

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (Lot Number: EJ1685) at the age of 29 years as single dose and the first dose of bnt162b2, via an unspecified route of administration on 01Mar2021 (Lot Number: EK5730) at the age of 29 years as single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Household family member was positive for COVID. Pfizer colleague wellness labeled patient as presumed positive. Patient was experiencing the following symptoms: fever, chills, sweats, headache, and a cough. Adverse event start date was 09Oct2021. No treatment was received. Covid (Nasal Swab) tested post vaccination was negative. Outcome of events were recovering. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1810551
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/23/2021
Hospital:

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

Lab Data: Test Name: Covid-19 test; Test Result: Positive.

Allergies:

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

Symptoms: specific patient that have gotten both doses of the Pfizer vaccine and have come down with covid; specific patient that have gotten both doses of the Pfizer vaccine and have come down with covid; This is a spontaneous report from a Pfizer sponsored program with Regulatory Authority support, received from a contactable other healthcare professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single, and 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's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the reporter has patients that have gotten both doses of the Pfizer vaccine and have come down with COVID. The reporter wants to know if she gives the booster shot do the patients have to isolate for 2 weeks. She would also like to get the booster so she wants to get an answer if she would have to isolate as well. The reporter added that there is a specific patient that have gotten both doses of the Pfizer vaccine and have come down with COVID. The reporter has firsthand knowledge of the patient and was reporting on a specific patient. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: A contributory role of BNT162B2 to event have gotten both doses of the Pfizer vaccine and have come down with COVID cannot be excluded based on temporal association and available information.

Other Meds:

Current Illness:

ID: 1810552
Sex: F
Age:
State:

Vax Date: 06/01/2020
Onset Date: 09/11/2021
Rec V Date: 10/23/2021
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: She was diagnosed with covid-19 on 11Sep2021; She was diagnosed with covid-19 on 11Sep2021; This is a solicited report from Regulatory Authority based on information received by Pfizer from the RA (manufacturer control number: 21K-163-4105766-00). A contactable consumer (patient) reported that a 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 45-years-old), dose 1 intramuscular on 20Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 intramuscular on 10Sep2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation; and Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous in Jun2020 (Batch/Lot number was not reported), at unspecified dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient had received Pfizer covid-19 vaccination on 20Aug2021 and 10Sep2021. She was diagnosed with covid-19 on 11Sep2021. On 20Aug2021, she received first dose of COVID-19 vaccine manufactured by Pfizer Biontech. On 10Sep2021 she had received second dose of COVID-19 vaccine manufactured by Pfizer Biontech. The action taken in response to the events for Risankizumab was unknown. Causality for Skyrizi (Risankizumab): The reporter's causality for the event(s) of COVID-19 was not provided. Causality for COVID-19 vaccine per reporter was not reported. The reporter's assessment of the causal relationship of the events with the BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported event COVID-19 with suspected vaccine BNT162B2 cannot be completely excluded.

Other Meds: SKYRIZI [RISANKIZUMAB]

Current Illness:

ID: 1810553
Sex: F
Age:
State: VT

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/23/2021
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: severe pain; severe headache.; Skin crawling / painful; This is a spontaneous report from a contactable consumer via Pfizer colleague. A 60-year-old female patient (not pregnant) received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number unknown), via an unknown route, on 06Oct2021 (at the age of 60-year-old) at single dose for COVID-19 immunisation. The patient received the first and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date for COVID-19 immunisation. On 06Oct2021, the patient developed severe pain, severe headache and skin crawling / painful. No seriousness criteria were provided. The patient was not treated for the events. The patient had recovered from the events on unknown date in 2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1810554
Sex: F
Age:
State:

Vax Date: 06/12/2021
Onset Date: 06/01/2021
Rec V Date: 10/23/2021
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: Felt fatigued; High amounts of Inflammation; Crohn's disease flare up; This is a solicited report based on information by Pfizer from Regulatory Authority, manufacturer control number: 21K-163-4110252-00. A contactable female consumer (patient) reported a patient of an unspecified age received BNT162B2, intramuscular on 12Jun2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunization and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at UNK (Citrate free) for moderate to severe adult Crohn's disease. Medical history included moderate to severe adult Crohn's disease. There was no reported medical history. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient's concomitant medications were not reported. The patient previously took BNT162B2 via Intramuscular route on 12May2021 as DOSE 1, SINGLE for COVID-19 immunization. On unknown date in 2021, the patient experienced Crohn's disease flare up and high amounts of inflammation. In Jun2021, the patient experienced felt fatigued after second Covid vaccine. The action taken in response to the events for adalimumab was dose not changed. The outcome of Crohn's disease flare up was not recovered while the other events was unknown. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Crohn's disease flare up with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of felt fatigued after second covid vaccine with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of high amounts of inflammation was not provided. Causality for BNT162B2: Crohn's disease aggravated: Causality as per reporter (Drug/Vaccine): Not Related; Fatigue: Causality as per reporter (Drug/Vaccine): Possible; Inflammation: Causality as per reporter (Drug/Vaccine): Not Related. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible dose- event relationship post-vaccination the causal role of BNT162B2 vaccine cannot be excluded for the reported events. Case will be further reviewed on follow up information The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: HUMIRA

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am