VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1390929
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/22/2021
Rec V Date: 06/11/2021
Hospital: Y

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Symptoms: hallucinations; left sided temporal seizures; fevers; This is a spontaneous report received from a contactable other-HCP. A 66 years old male patient received BNT162B2 (lot number unknown) at single dose for COVID-19 immunisation on unknow date. Relevant medical history included: Type I Diabetes, CKD III (Chronic kidney disease stage 3), Hypertension and Heart failure. Relevant concomitant drug was unknown. Patient reported of fevers since 22May2021 two days after the vaccine. Two weeks later he reported to have hallucinations per son and also left sided temporal seizures, both since 22May2021. The patient was independent and living alone before this episode. Antiepileptic medication was received as treatment. The patient was hospitalized due to the events. The outcome of event was resolving. The patient had Covid-19 NAAT (Nasal swab) test on 22May2021 with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19.; Sender's Comments: Based on temporal association and profile of the product, the events were considered related to suspect product BNT162B2 (lot number unknown).

Other Meds:

Current Illness:

ID: 1390930
Sex: M
Age:
State: WA

Vax Date: 04/13/2021
Onset Date: 04/14/2021
Rec V Date: 06/11/2021
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Symptoms: fever every night, of just over 100; body aches; massive joint pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received second of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 13Apr2021, at the age of 34-years-old, (Lot Number: EW0153) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Historical vaccine includes first dose of BNT162B2, on 23Mar2021 left arm (Lot number: EP7534). On 14Apr2021, the day after the second shot, the patient had fever every night, of just over 100, has body aches and massive joint pain for over 30days. The adverse event required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events was assessed as serious, disability. Since the vaccination, the patient been tested for COVID-19, test: Nasal Swab on 20May2021 with negative result. The outcome of the events was recovering. Treatment received for the adverse event includes prednisone.

Other Meds:

Current Illness:

ID: 1390931
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
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Symptoms: had an allergic, anaphylaxis, reaction to the pfizer vaccine; had an allergic, anaphylaxis, reaction to the pfizer vaccine; This is a spontaneous report from a non-contactable consumer (pateint). A patient of unspecified age and gender received (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNK, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported 'I had an allergic, anaphylaxis, reaction to the pfizer vaccine. ' The outcome of event was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1390932
Sex: F
Age:
State:

Vax Date: 05/26/2021
Onset Date: 05/01/2021
Rec V Date: 06/11/2021
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Symptoms: ocular swelling; allergic reaction; This is a spontaneous report from a non-contactable pharmacist. A 16-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 16 years old on 26May2021 on left arm at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced ocular swelling and allergic reaction in May2021. The events were resulted in Emergency room/department or urgent care. Treatment was received for the events. Since the vaccination, the had patient been tested for COVID-19 with unknown results in 2021. The outcome of the events were not resolved. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, the events are considered related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).

Other Meds:

Current Illness:

ID: 1390933
Sex: F
Age:
State: VA

Vax Date: 05/06/2021
Onset Date: 05/09/2021
Rec V Date: 06/11/2021
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Symptoms: She had 2 blood clots in her right leg, and she was now on Eliquis; she had right leg swelling; she had right leg pain; flu; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 06May2021 (Batch/Lot Number: Not Provided) as a single dose, for covid-19 immunisation, with first dose given 15Apr2021. Medical history and concomitant medications were not reported. The patient said she had the flu 3 days after getting her second COVID-19 Vaccine, had right leg swelling, right leg pain, and had 2 blood clots in her right leg. The patient said she was now on apixaban (ELIQUIS), and financial assistance, due to being on unemployment. The outcome of the events was not reported.

Other Meds:

Current Illness:

ID: 1390934
Sex: F
Age:
State:

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Rec V Date: 06/11/2021
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Symptoms: she may have myocarditis; symptomatic ventricular ectopy; fatigue; headache; This is a spontaneous report received from a contactable consumer for a female patient (our young, female physician) of unspecified age 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 2ND DOSE, SINGLE for covid-19 immunisation . The patient medical history was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 1ST DOSE, SINGLE DOSE for covid-19 immunisation on unknown date. The patient's concomitant medications were not reported. The patient who was with no major medical problems developed symptomatic ventricular ectopy that she stated to begin 10 days after her second vaccine dose (Pfizer). She is currently under the care of a cardiologist who believed she might have myocarditis. She also experienced fatigue and headache with her second vaccine dose. She was started on ibuprofen and is feeling "a little better". She denied fever or other systemic manifestations. The outcome of the events was unknown. Therapeutic measures were taken as a result of she may have myocarditis (myocarditis). Information on the batch number has been requested.

Other Meds:

Current Illness:

ID: 1390935
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 06/11/2021
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Symptoms: Bleeding rectally for three days; couldn't think; Headache; Intestinal issues; Felt almost like she had COVID; Diarrhea; Nauseated; Felt like she was smothering; Felt foggy in her head like she couldn't think; Weak; Eye felt not right, blurry; Confused; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Provided) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bleeding rectally for three days, headache, intestinal issues, felt almost like she had covid, diarrhea, nauseated, felt like she was smothering, felt foggy in her head like she couldn't think, weak, didn't feel right, just not herself, eye felt not right, blurry and confused on an unspecified date. The outcome of bleeding rectally, headache, intestinal issues, felt almost like she had covid, diarrhea, nauseated, felt like she was smothering, felt foggy in her head like she couldn't think, weak, didn't feel right, just not herself, eye felt not right, blurry and confused was unknown. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1390936
Sex: F
Age:
State: MD

Vax Date: 04/16/2021
Onset Date: 05/08/2021
Rec V Date: 06/11/2021
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Symptoms: Bell's Palsy on the right side of her face; This is a spontaneous report from a contactable consumer (patient herself). A 54-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 16Apr2021 10:45 as single dose for covid-19 immunisation at pharmacy or drug store. The patient had no medical history and no known allergies. The patient's concomitant medication included vitamin D3 taken for an unspecified indication. 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 has not been tested for COVID-19. It was reported that, the patient took her first Pfizer shot on 16Apr2021 and on 08May2021 symptoms started and on 09May2021 she was diagnosed with having Bell's Palsy on the right side of her face. Doctor advised not to take her second Pfizer shot on 11May2021 until recovery which could take up to 8 weeks or longer. The adverse event resulted Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the unspecified medicine as treatment for the event and was still taking. The outcome of the event was reported as recovering. No follow-up attempts are possible. No further information expected. Information about lot/batch number cannot be obtained.

Other Meds: VITAMIN D3

Current Illness:

ID: 1390937
Sex: F
Age:
State: PA

Vax Date: 03/24/2021
Onset Date: 03/28/2021
Rec V Date: 06/11/2021
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Symptoms: Hard swelling at injection site; pain started that went from shoulder blade, down the left arm, to my fingers; pain started that went from shoulder blade, down the left arm, to my fingers; pain started that went from shoulder blade, down the left arm, to my fingers; All 5 fingers became numb; This is a spontaneous report received from a contactable consumer (patient) reporting for herself received via COVAES. A 70 year-old female (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number er8730 and expiration date 24Mar2021) (at 70 years old), via an unspecified route of administration, on 14Apr2021 at 15:00 as a single dose for COVID-19 vaccination (anatomical location: arm left), administered at Pharmacy or Drug Store. Medical history included: arthritis. Concomitant medications included: Diclophenac. On 28Mar2021, the patient experienced hard swelling at injection site. Within 3 days a pain started that went from shoulder blade, down the left arm, to my fingers. All 5 fingers became numb. Over the next 6 weeks the pain decreased and is now gone, but 2 of my ringers remain numb from the tip to the 1st knuckle. The outcome of the events was recovered/resolved with sequel. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.The reporter classified the event(s) as serious.

Other Meds: DICLOPHENAC

Current Illness:

ID: 1390938
Sex: F
Age:
State: NY

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 06/11/2021
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Symptoms: Pneumonia; My body aches; I am feeling chills all the time; flue like symptoms; I am very puzzled because how I feel/I am not feeling right; I don't have energy; Cough; Headache; arms were hurting quite a bit and whole body was aching; I cannot breath; getting very frustrated; I am not feeling well; my body is requiring quite a bit of water; I felt like I am in freezer; This is a spontaneous report from a contactable consumer. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6199) via an unspecified route of administration, on 05Mar2021 as a single dose in the right arm and received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN8727) via an unspecified route of administration, on an unspecified date in Mar2021 as a single dose in the right arm for COVID-19 immunization. Medical history included diabetes mellitus, blood cholesterol increased, High cholesterol and neoplasm malignant all from an unknown dates and unknown if ongoing. Concomitant medication included telmisartan (MICARDIS) taken for blood pressure measurement, start and stop date were not reported; simvastatin (ZOCOR) taken for blood cholesterol, start and stop date were not reported; colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; insulin detemir (LEVEMIR) taken for an unspecified indication, start and stop date were not reported. The patient experienced pneumonia on an unspecified date with outcome of unknown, body aches on an unspecified date with outcome of unknown, chills all the time on an unspecified date with outcome of unknown, flu like symptoms on an unspecified date with outcome of unknown, lack of energy on an unspecified date with outcome of unknown, cough on an unspecified date with outcome of unknown, headache on an unspecified date with outcome of unknown, arms were hurting quite a bit and whole body was aching on an unspecified date with outcome of unknown, sensation of not being able to breath on an unspecified date with outcome of unknown, getting very frustrated on an unspecified date with outcome of unknown, not feeling well on an unspecified date with outcome of unknown, body is requiring quite a bit of water on an unspecified date with outcome of unknown, feeling cold like she is in a freezer on an unspecified date with outcome of unknown, and the patient is very puzzled because of how she feesl/she is not feeling right on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included computerised tomogram thorax: inconclusive, sars-cov-2 test: negative on an unspecified date. Therapeutic measures were taken as a result of my body aches which included Tylenol which is reported as "not helping." and cough (unspecified). The patient was also given Albuterol and Buterol ("has not doing anything") and "Hydrochloride."

Other Meds: MICARDIS; ZOCOR; VITAMIN D 3; MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THI; LEVEMIR

Current Illness:

ID: 1390939
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 06/11/2021
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Symptoms: I am fully vaccinated; I have COVID; I am fully vaccinated; I have COVID; This is a spontaneous report received from a non-contactable consumer (patient). A patient of unspecified age and gender received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Numbers: Unknown) both via an unspecified route of administration on unspecified dates in Feb2021 (dose 1) and Mar2021 (dose 2), both as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she was fully vaccinated and had COVID, on an unspecified date. The patient called to report that she received the Pfizer vaccine and was fully vaccinated. The first shot was in February and the second one was in March, and now the patient had COVID. The patient wanted to know how long this would last before they got over it. The clinical outcome of the event I am fully vaccinated; I have COVID was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.

Other Meds:

Current Illness:

ID: 1390940
Sex: F
Age:
State: OR

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 06/11/2021
Hospital: Y

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Symptoms: Legs Wouldn't Work; she couldn't walk; Slurred speech; Really sharp pains inside her head; Lymph Node Abnormal; Confused; foggy; This is a spontaneous report received from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EW0150) at the age of 76 years, as a single dose, for COVID-19 immunisation. Medical history included cerebrovascular accident (Mini Strokes), TIAs ( states she has had a few of them; the last one was years ago), Car Wreck with head pain on the side of the head. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 (Lot Number: EN6208). The patient did not receive any other vaccines within four weeks prior to the vaccination On 01Apr2021 the patient experienced legs wouldn't work; she couldn't walk, she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy. In April2021 she had lymph node abnormal. The patient was hospitalized from 01Apr2021 to 05Apr2021 (4 days). The patient had lab tests and procedures on unspecified date, which included computerized tomogram with Contrast: normal; electroencephalogram (EEG): abnormal; x-ray: abnormal lymph node. The verbatim chronological clinical course was reported as follows: the patient stated she received her second shot on 31Mar2021 and on 01Apr2021, she ended up in the ER and admitted to the hospital because her legs wouldn't work, she couldn't walk and she had slurred speech. The patient thinks the time of onset of the events was in the afternoon but stated it is foggy because she was a little confused at the time. Patient stated she also had a x-ray and it showed that her lymph node was abnormal. She also had really sharp pains inside her head. Patient stated that the event legs wouldn't work, couldn't walks, it was ongoing but she was doing Physical Therapy and she is starting to get back to her normal. In terms of the really sharp pain inside her Head, the patient stated that she was in a car wreck and had some head stuff and this really brought it out really sharp which she has never had before. The patient stated she thinks the vaccine just brought out her TIAs and she has had headaches in the side of her head but these were a lot sharper. The patient reported that she goes to her Neuro Doctor next week. The patient stated she went back to the doctor and he did a computerized tomogram (CT) with contrast. She stated that when she was in the hospital, her EEG was abnormal. She stated per the report of the x-ray guy, he said that the abnormal lymph node was caused from the shot, the Covid shot. She stated tomorrow she has an ultrasound or some kind of test to see if she needs to have a biopsy of the lymph node. The clinical outcome of she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy was recovered. The clinical outcome of experienced legs wouldn't work; she couldn't walk, was recovering. The outcome of the remaining event was unknown.

Other Meds:

Current Illness:

ID: 1390941
Sex: F
Age:
State: DC

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 06/11/2021
Hospital: Y

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Symptoms: Diverticulitis; Sore arm; Fatigued/ very tired; sluggish; pain with getting up and walking; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8731), via an unspecified route of administration on 24Apr2021 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727) on 01Apr2021 (at the age of 55-years-old) for COVID-19 immunisation. On 24Apr2021, the patient experienced sore arm that lasted for about 3 days; felt fatigued and sluggish for the first couple of days post vaccination which started to taper off by 27Apr2021. It was in and out now. On an unspecified date in 2021, after the second vaccination, the patient was fatigued and very tired, had pain with getting up and walking. On 08May2021, the patient ended up in the hospital and was diagnosed with diverticulitis from eating a lot of nuts (as of an unspecified date in 2021). She was hospitalized from 08May2021 to 10May2021. The clinical outcome of sore arm was resolved on Apr2021 (reported as 27Apr2021 or 28Apr2021), of diverticulitis and pain with getting up and walking was unknown, of "Fatigued/ very tired" and sluggish was not resolved.

Other Meds:

Current Illness:

ID: 1390942
Sex: F
Age:
State: PA

Vax Date: 05/21/2021
Onset Date: 05/21/2021
Rec V Date: 06/11/2021
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Symptoms: swollen arm; 2 days later hives under chin on left side/ hives on left cheek/ hives on her left trunk, face, and arm; throat started to close; mouth started to itch; swollen itchy eyes; swollen itchy eyes; sneezing; swollen lump in shoulder immediately; This is a spontaneous report from a contactable consumer (the patient). A 54-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0167), via an unspecified route of administration in the left arm on 21May2021 17:00 (at the age of 54-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma, allergies, leaky heart valve, fusion feet, cholesterol, triglycerides, ulcers, and allergy to sulfa and bananas. The patient had a negative COVID-19 nasal swab in Jan2021, and twice in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: montelukast sodium (SINGULAIR), fexofenadine hydrochloride/ pseudoephedrine hydrochloride (ALLEGRA D), diphenhydramine hydrochloride (BENADRYL), citalopram hydrobromide (CELEXA), eicosapentaenoic acid ethyl ester (VASCEPA), budesonide/ formoterol fumarate (SYMBICORT), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021 19:00, within 2 hours of vaccination, the patient experienced swollen itchy eyes, mouth started to itch, sneezing, throat started to close; swollen lump in shoulder immediately. Two days later (23May2021), hives under chin on left side. The next day (unspecified date) she got hives on left cheek, then a few days later (unspecified date), hives on her left trunk. It was also reported she had hives on left side of trunk, face, and arm, and had a swollen arm. For treatment, the patient took 3 BENADRYL and 20 mg of prednisone. The outcome of the events was recovering. Since the vaccination, the patient has been tested for COVID-19 on an unspecified date (unknown results).

Other Meds: SINGULAIR; ALLEGRA D; BENADRYL; CELEXA [CITALOPRAM HYDROBROMIDE]; VASCEPA; SYMBICORT

Current Illness:

ID: 1390943
Sex: M
Age:
State: CA

Vax Date: 05/09/2021
Onset Date: 05/09/2021
Rec V Date: 06/11/2021
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Symptoms: Lost his vision; Breathing almost completely shut down; Severe fever and sweats that night; Ringing in his ears; Cold sweat; Severe fever and sweats that night; Could not get up from the chair or move to 40 minutes; Achy; Arm severely sore; This is a spontaneous report from a contactable consumer (parent of the patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration on 09May2021 (Batch/Lot Number: ER8735, at the age of 30 years) as a single dose for COVID-19 immunization at a pharmacy drug store. Medical history included allergies to antibiotics (penicillin and all cross over drugs). The patient has no prior no health issues. The patient was not diagnosed with COVID-19 prior to vaccination. Historical vaccine included the patient received the first dose of the BNT162B2 vaccine (Batch/Lot Number: EW0151) on 09Apr2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was reported as none. The patient was not taking any other medications within 2 weeks of receiving the vaccination. On 09May2021, the patient received the second dose of the BNT162B2 vaccine. On 09May2021, the patient had a immediate reaction to the vaccination where his breathing almost completely shut down. He experienced ringing in his ears, lost his vision and had cold sweats. He could not get up from the chair or move for 40 minutes. It was reported that the patient meditates, and he kept his breathing going on his own. The pharmacist assisted him. That night he was achy and had severe fever and sweats. He had to rest for many days. His arm was severely sore and took many days to recover. It was reported that the patient has a very high threshold for pain, but this was severe. The patient has not been tested for COVID-19 after receiving the vaccination. The consumer inquired if the patient should avoid all COVID booster shots next year. The consumer inquired if it possibly this was a polyethylene glycol reaction. No treatment was received for the events. The outcome of event arm was severely sore was recovered in May2021. The outcome of the events loss of vision, breathing almost completely shut down, severe fever, ringing in his ears, night sweats, cold sweats, could not get up from the chair or move and achey was reported as recovering.

Other Meds:

Current Illness:

ID: 1390944
Sex: F
Age:
State: MD

Vax Date: 04/27/2021
Onset Date: 05/14/2021
Rec V Date: 06/11/2021
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Symptoms: This is a spontaneous report from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received a dose (unspecified dose number) of BNT162B2 (solution for injection; Lot unknown and expiry not provided) as a single dose via unspecified route in the left arm on 27Apr2021 at 12:30 (at 55-years-old), for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medications sans indication, posology and therapy dates included fluoxetine hydrochloride (PROZAC), and bupropion hydrochloride (WELLBUTRIN SR). The patient denied any COVID diagnosis prior to vaccination. The patient was not pregnant at the time of vaccination and denied receiving any other vaccine within four weeks of this vaccine. On 14May2021 the patient began to experience smelling cigarette smoke when none was there. The patient stated that sometimes it makes her choke a little. The patient also began to experience extremely painful and swollen breasts since 14May2021. The patient has not been tested for COVID since the vaccine. The outcome of the events smelling cigarette smoke when none was there, makes her choke a little, and extremely painful, swollen breasts was not recovered. Information on the Batch/Lot number has been requested.

Other Meds: PROZAC; WELLBUTRIN SR

Current Illness:

ID: 1390945
Sex: M
Age:
State: IN

Vax Date: 04/21/2021
Onset Date: 05/16/2021
Rec V Date: 06/11/2021
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Symptoms: Blood clotting; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), via an unspecified route of administration, administered in arm left on 21Apr2021 at 09:00 (at the age of 44-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included desvenlafaxine succinate (PRISTIQ) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (Batch/Lot Number: FR2613), administered in arm left on 25Mar2021 at 09:30 AM, for COVID-19 immunisation. The patient experienced blood clotting on 16May2021 at 22:00. The patient underwent lab tests and procedures which included sars-cov-1 test: positive on an unspecified date (prior to vaccination). There was no treatment received for the event. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.

Other Meds: PRISTIQ

Current Illness:

ID: 1390946
Sex: M
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 05/13/2021
Rec V Date: 06/11/2021
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Symptoms: Acute pericarditis; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0162), via an unknown route in the left arm, on 15Apr2021 (at the age of 45-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8730) administered in Mar2021 for COVID-19 immunisation. No relevant medical history was provided. The patient was not diagnosed with COVID-19 before vaccination. The patient did not have concomitant medications. No other vaccine was received in four weeks. On 13May2021 at 13:00, the patient was found to have acute pericarditis. The event was assessed serious because requiring hospitalization. An angiogram was done, and results were not provided. On 14May2021, a Nasal Swab was done and resulted negative. The patient was recovering from the event.

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Current Illness:

ID: 1390947
Sex: F
Age:
State: CO

Vax Date: 04/13/2021
Onset Date: 04/15/2021
Rec V Date: 06/11/2021
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Symptoms: fainting from heavier menstruation; Sore arm; body aches; low grade fever 99.1; menstruation 3 days early; Heavy menstruation; Lethargic; fatigue for 4 days; Headache; dry throat; thirsty; This is a spontaneous report from a contactable consumer. A 24-years-old non-pregnant female patient received bnt162b2 (BNT162B2) dose 2 via an unspecified route of administration, administered in left arm on 13Apr2021 09:45 (Batch/Lot Number: EW0161) at the age of 24 years old as a single dose for covid-19 immunisation and dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021 at 09:45 (Batch/Lot Number: EP6955) at the age of 24 years old Medical history and concomitant medications were not reported. The patient previously took amoxicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021 at 1500 the patient experienced Sore arm, body aches, low grade fever 99.1, menstruation 3 days early, Heavy menstruation, Lethargic, fainting from heavier menstruation, fatigue for 4 days, Headache, dry throat, thirsty. The patient was not hospitalized for the events. The outcome of the events was recovered with sequelae. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.

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ID: 1390948
Sex: F
Age:
State: TN

Vax Date: 05/13/2021
Onset Date: 05/14/2021
Rec V Date: 06/11/2021
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Symptoms: seizure; This is a spontaneous report from a contactable nurse (parent of the patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in the right arm on 13May2021 at 11:00 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE (at the age of 27 years old) for covid-19 immunisation. Medical history included depression from an unknown date and unknown if ongoing. Concomitant medication included bupropion hydrochloride (WELLBUTRIN) taken for depression at 150mg once a day from Apr2021 (reported as 2 weeks prior to vaccination date) to May2021 (stopped after she had the seizure). The patient experienced seizure on 14May2021 at 13:00 with outcome of unknown. She had no history of seizure activity. No family history of seizures. The patient underwent lab tests and procedures which included blood test: normal on an unspecified date, computerised tomogram: normal on an unspecified date, electrocardiogram: normal on an unspecified date, and electroencephalogram: normal on an unspecified date. The event required emergency room visit and physician office visit. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of seizure due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head MRI, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021605934 Same reporter/drug/event, different patient.

Other Meds: WELLBUTRIN

Current Illness:

ID: 1390949
Sex: F
Age:
State: SC

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 06/11/2021
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Symptoms: Feet started to hurt, she couldn't put weight on her feet and they were turning black; Legs and feet were hurting so bad; Legs and feet were hurting so bad; She couldn't put weight on her feet and they were turning black; She couldn't put weight on her feet and they were turning black; Legs and feet were starting to swell; Legs and feet were starting to swell; Her hands were black; Hands were starting to swell up; This is a spontaneous report from a contactable consumer (the patient). A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 07Apr2021 at 17:00 (Lot Number: EW0151), at the age of 52 years, as a single dose for COVID-19 immunisation. Medical history included crohn's disease (Crohn's disease Diagnosed at age 25), thyroid disorder (thyroid Diagnosed in her 30's). Concomitant medication taken within two weeks of vaccination included vitamin b12, zinc, potassium, tocopheryl acetate (E-VITAMIN), cyanocobalamin (B12), and vitamin b complex (VITAMIN B), all taken for crohn's disease; levothyroxine taken for thyroid disorder, dicycloverine (DICYCLOMINE) taken for abdominal pain, and omeprazole (PRILOSEC). The patient experienced feet started to hurt, she couldn't put weight on her feet and they were turning black on 10Apr2021, hands were starting to swell up on 07Apr2021, her hands were black on 08Apr2021, legs and feet were starting to swell on 09Apr2021, legs and feet were hurting so bad on 10Apr2021. She couldn't put weight on her feet and they were turning black on 10Apr2021. The patient was hospitalized for feet started to hurt, she couldn't put weight on her feet and they were turning black on 10Apr2021. The patient received treatment. The verbatim clinical course was reporter as follows: The patient is calling about the Pfizer covid vaccine. The patient had the first dose on 07Apr2021. By 10Apr2021 the patient was in the hospital, they thought at first the patient had blood clots. The patient is still not back to work yet. They keep having the patient have tests done. The patients hands and feet turned black and were swollen up after she received the vaccine. The patient got the vaccine at 5:00pm on 07Apr2021, and that night her hands were starting to swell up. The patient thought it was because of her Crohns. Then the vessels in the patients fingers started busting, is what it looked like, and her hands were black and she couldn't hardly move them on 08Apr2021. Then the next day, 09Apr2021, the patient noticed her legs and feet were starting to swell. The next day, 10Apr2021, the patient was starting to look down and her legs and feet were hurting so bad she had to sit down when she was vacuuming. The patient thought she stepped on the vacuum cord when her feet started to hurt, she couldn't put weight on her feet and they were turning black. The patient propped her legs up and then soaked them in Epson salt and hot water and that made them worse. The patient went to healthcare facility on10Apr2021 and they said it looks like she has blood clots so they sent her to emergency room. In the emergency room they admitted the patient and did test after test. They gave the patient morphine for the pain that was shooting down her legs, it felt like needles were sticking in her legs. The patient was out of it for a couple of days because when she got that morphine she didn't know she was in the world. Morphine- unknown lot, NDC , and expiration dates for doses involved. They gave the patient gabapentin and that helped some. They were giving the patient so much Gabapentin during the day she couldn't function so they cut it back to giving it to at night. The patient was taking the Gabapentin 3 times a day, at the time, and she couldn't function on it. Gabapentin- unknown lot, NDC, and expiration date for the doses given in the hospital. The night of 07Apr2021 the patient couldn't really move her fingers and took it easy. 09Apr2021 is when this started in her feet. Then on 10Apr2021 the patient went to the hospital because the pain was so bad. By the end of the day the patient is still swollen. One leg was swollen more than the other but they are not black and blue like they were and they said its from nerve damage. The patient was so drugged up in the hospital, she didn't know her name. The patient has an EMG test scheduled on 04Jun2021. The patient was scheduled for the second shot on 28Apr2021 and didn't get it because she was told not to by her doctor and the hospital doctors. Test in the hospital was as follows: 10Apr2021: US venous leg bilateral, chest x-ray with one vw portable, CBC with differential, CMP, d-dimer, EFR, INR, active particle thromboplastin time, EKG. On 11Apr2021: TSH, TR3, CK, Magnesium, sars-cov-2antigenfia with reflux to covid rapid test- negative, aorta angiogram runoff with contrast, x-ray of the foot lateral and oblique. On 12Apr2021: Magnesium, CBC, BMP, ANA, ANA titer. On 13Apr2021: CBC,BMP, and a urinalysis with reflex. On 19May2021: MRI lumbar and spine with and without contrast was ordered by the neurologist. The patient reported that she thought that the hospital reported this so she went back to her paperwork and called today to report this event. The clinical outcome of She couldn't put weight on her feet and they were turning black, Legs and feet were hurting so bad, and Legs and feet were starting to swell was unknown. The patient was recovering from the remaining events. Additional information has been requested.

Other Meds: VITAMIN B12 [VITAMIN B12 NOS]; ZINC; POTASSIUM; E-VITAMIN; B12 [CYANOCOBALAMIN]; VITAMIN B; LEVOTHYROXINE; DICYCLOMINE; PRILOSEC [OMEPRAZOLE]

Current Illness:

ID: 1390950
Sex: F
Age:
State: ID

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 06/11/2021
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Symptoms: Bell's palsy affecting right half of face; dose number 2 administered on 21Apr2021; dose number 2 administered on 21Apr2021; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received second dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 21Apr2021 12:00 as 2nd dose, single dose for COVID-19 immunisation. Medical history included asthma, eczema and known allergies included beef. Patient was not pregnant at time of vaccination. Concomitant medications included epinephrine and melatonin. No other vaccine was given in four weeks. The patient previously took first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), administered in right arm on 07Apr2021 10:00 (at age of 21-year-old) as single dose for COVID-19 immunisation. On 21Apr2021, the patient received dose number 2 and experienced bell's palsy affecting right half of face on 18May2021 12:00. The event bell's palsy resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy affecting right half of face with 60mg Prednisone daily for 7 days. No covid prior vaccination. No covid tested post vaccination. Outcome was not recovered for bell's palsy affecting right half of face and for remaining events was unknown. No Follow-up attempts are Possible. Information on lot/batch number cannot be obtained.

Other Meds: EPINEPHRINE; MELATONIN

Current Illness:

ID: 1390951
Sex: F
Age:
State: IL

Vax Date: 03/26/2021
Onset Date: 04/14/2021
Rec V Date: 06/11/2021
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Symptoms: my body developed an elevated inflamation event in my neck, shoulders and hands. It has since been diagnosed as Polymyalgia Rhuematica.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot unknown), via an unspecified route of administration in the left arm on 26Mar2021 10:00 as second dose, single for Covid-19 immunisation. Medical history included osteoarthritis, allergic to penicillin and shrimp. She had her first dose of bnt162b2 on 05Mar2021 (lot unknown) at 10:00am in the left arm. The patient's concomitant medications were not reported. On 14Apr2021 (also reported as within a week of last dose), the patient informed her body developed an elevated inflammation event in her neck, shoulders and hands and diagnosed as Polymyalgia Rhuematica in which she had a clinic visit to a doctor or other healthcare professional office. This was treated with prednisone. The outcome of event was recovering. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1390952
Sex: F
Age:
State: MI

Vax Date: 04/21/2021
Onset Date: 05/01/2021
Rec V Date: 06/11/2021
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Symptoms: after an accident, which she broke multiple bones; after an accident, which she broke multiple bones; she fell; has some soreness at the site of injection; This is a spontaneous report from a contactable consumer (reporting about sister, patient). A 57-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot Number: Pfizer 9810) as single dose for covid-19 immunisation at the age of 57-year-old. Medical history included ongoing diabetes. There were no concomitant medications. The patient experienced soreness at the site of the injection on unspecified date in 2021. In May2021, the patient had an accident, broke multiple bones, she fell, was in hospital. The outcome of events was unknown. The consumer reported the patient just has some soreness at the site of injection, but after she fell, she has described many indications, indications that are going to affect her, those indications are not related to COVID at all, they are related to her injury and diabetes. Information about batch/ lot number has been requested. Follow-up (27May2021): New information received from the same contactable consumer included: Lot number, medical history, new events (accident, broke multiple bones, fell, soreness at the site of the injection). The case was upgraded from non-serious to serious. Follow-up attempts are needed. further information is expected.

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Current Illness: Diabetes

Date Died: 05/09/2021

ID: 1390953
Sex: M
Age:
State: MD

Vax Date: 03/17/2021
Onset Date: 05/01/2021
Rec V Date: 06/11/2021
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Symptoms: ITP; Brain dead; Brain hemorrhage; Blood in the mouth; Patches on legs; Back pain; D Dimer Very high; Her husband couldn't talk; bruise on arm; This is a spontaneous report from a contactable Nurse (patient's wife). A 72-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm on 17Mar2021 16:00 (Batch/Lot Number: EL3247; Expiration Date: 31May2021) as 2ND DOSE, SINGLE (at the age of 72 years) for covid-19 immunisation . The patient received the first dose of BNT162B2 (Lot number: EL3246, Expiration date: Unknown) on 25Feb2021 16:30 in Arm (side not specified) as single dose (at the age of 72 years) for Covid-19 immunisation. Medical history included blood cholesterol from an unknown date and unknown if ongoing, vascular graft from 2013 to an unknown date. Had flu shot and pneumonia shot. No problems. The patient received no other vaccine other than BNT162B2 within 4 weeks. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for vascular graft from 2013 to an unspecified stop date; metoprolol (METOPROLOL) taken for vascular graft, start and stop date were not reported. 6 weeks after the second vaccine, he had patches on legs and back pain. He went to hospital. They found generalized bleeding and ITP, and he passed away immediately. The patient experienced brain dead (death, hospitalization) on 09May2021 , brain hemorrhage (death, hospitalization) on 04May2021 , ITP (immune thrombocytopenia) (death, hospitalization) on an unspecified date , blood in the mouth (death, hospitalization) on 03May2021 , back pain (death, hospitalization) on 2021 , patches on legs (death, hospitalization) on May2021 , D Dimer very high (death, medically significant) on an unspecified date , her husband couldn't talk (Her husband couldn't talk. She was calling his name. She asked him why he was not talking. She squeezed his hand and he squeezed back. He couldn't talk.) (death) on an unspecified date, bruise on arm (death) on 2021. The patient was hospitalized from 03May2021 to 09May2021. The patient underwent lab tests and procedures which included computerised tomogram abdomen: no active bleeding, no mass on 03May2021, computerised tomogram head: hemorrhage on 04May2021, fibrin D Dimer: very high on unspecified date. Therapeutic measures were taken as a result of ITP, back pain. With ITP, they started to do plasmapheresis. Wife stated that the doctor gave him medication Aleve, for back pain. He took 5 tablets only. Then she saw the spots. She told her husband not to take anymore and he did not. The patient died on 09May2021. An autopsy was not performed. Wife said that the doctor was not sure if they were related. The wife stated that she did feel that they were related. The reporter stated events back pain, ITP, blood in the mouth, brain Hemorrhage, Patches on legs, were related to the suspect product. Wife stated that before this, her husband did 2 miles running every other day or twice a week. He was healthy. He ate healthy foods. Her husband's cholesterol was always under 200. He had no issues. His bloodwork was done, and all was OK. He constantly went to the doctor. This case is not related to a study.; Sender's Comments: Based on the information currently available, the reported events are attributed to intercurrent or underlying medical conditions that were unlikely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.; Reported Cause(s) of Death: Brain dead; Brain hemorrhage; ITP; Blood in the mouth; Back pain; Patches on legs; bruise on arm; Her husband couldn't talk; D Dimer Very high

Other Meds: LIPITOR [ATORVASTATIN]; ASPIRIN (E.C.); METOPROLOL

Current Illness:

ID: 1390954
Sex: F
Age:
State: TX

Vax Date: 02/22/2021
Onset Date: 02/24/2021
Rec V Date: 06/11/2021
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Symptoms: Myocarditis; abnormal heartbeat; intense chest pain; Shortness of breath; The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 22Feb2021 16:30 (Batch/Lot Number: EL9266) as single dose for covid-19 immunisation at the age of 22-year-old. Medical history included covid-19 prior to the vaccination. No known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID) and levonorgestrel (KYLEENA) (reported as Kyleena IUD). No other vaccine received in four weeks. It was reported that I woke up with intense chest pain two days after the first dose. Thought I was having a heart attack. Now realizing it was Myocarditis. Intense pain when moving and lifting heavy objects. Apple watch detected an abnormal heartbeat which fixed itself later on in the day. I experienced shortness of breath. The pain in my chest felt like intense bruising. I still feel a sharp bruising pain when I lift something too heavy or turn quickly. The events stated on 24Feb2021 08:00. No treatment received, and outcome of events was recovered with sequelae on unspecified date in 2021. The patient hasn't been tested post vaccination.

Other Meds: SYNTHROID; KYLEENA

Current Illness:

ID: 1390955
Sex: M
Age:
State: MI

Vax Date: 05/12/2021
Onset Date: 05/15/2021
Rec V Date: 06/11/2021
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Symptoms: Spontaneous Pneumothorax; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12May2021 09:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Apr2021 at 17:15 (age: 30-years) in the right arm for COVID-19 immunization. On 15May2021 06:00, the patient experienced spontaneous pneumothorax. The patient was hospitalized for the event for 9 days. Therapeutic measure was taken as a result of the event which included chest drain. The patient underwent Nasal swab test with negative result on 18May2021. The outcome of the event was not recovered. Information about lot/batch number has been requested.

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Current Illness:

ID: 1390956
Sex: M
Age:
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Vax Date: 05/15/2021
Onset Date: 05/18/2021
Rec V Date: 06/11/2021
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Symptoms: Shortness of breath started getting severe/ diagnosed with CHF/ unable to breathe when laying back in a chair; This is a spontaneous report from a contactable consumer (patient himself). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization and experienced intermittent SOB 5 days after. He received the second dose on Saturday, 15May2021. Shortness of breath started getting severe on the following Monday (18May2021), worsened on Tuesday, and went to ED on Wednesday. He was diagnosed with CHF. He has experienced being unable to breathe when laying back in a chair and having to stop 5-6 times during a 1 mile walk due to the shortness of breath. He has been referred to a Cardiologist. Outcome of the event was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1390957
Sex: M
Age:
State: IN

Vax Date: 05/19/2021
Onset Date: 05/01/2021
Rec V Date: 06/11/2021
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Symptoms: This is a spontaneous report from a contactable consumer (Patient). A 35-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 19May2021 22:30 (Batch/Lot Number: EW0177) as single dose for covid-19 immunisation at the age of 35-year-old. Medical history included allergies to Penicillin, Cipro. There were no concomitant medications. On 14May2021 18:00 (as reported), the patient experienced Sleepwalking for 6 hours straight. Hallucinations. Severe sweating, heart racing, hot flash. The events were recovered without treatment. The patient was not COVID prior vaccination and hasn't been tested post vaccination.

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Current Illness:

ID: 1390958
Sex: M
Age:
State: FL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 06/11/2021
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Symptoms: when I spit up, there was blood; couldn't breathe; tired; Caller stated he is as sick as a dog; fever; my stomach feels like push ups; first shot in Jan2021/he didn't get his second shot until 01Apr2021; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 (at the age of 66-year-old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on Jan2021 and experienced back injury. The patient received Pfizer-BioNTech COVID-19 Vaccine first dose in January, and he was supposed to go back for second dose on 08Feb2021. However he was not able to attend second dose appointment and did receive second dose until 01Apr2021: yesterday morning (26May2021) he couldn't breathe he was tired and was down, he had a fever, he had 5 blankets on him. His stomach felt like push ups and he had a spit, when he spit up, there was blood. He was as sick as a dog. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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Current Illness:

ID: 1390959
Sex: M
Age:
State: CT

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 06/11/2021
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Symptoms: sever sore throat; difficult to swallow; headache; chills; sweats; light head/woozy; fever 100.7--101.0; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 16:30 at single dose in left arm (at the age of 68-year-old) for COVID-19 immunization. Medical history was none. He had no Known allergies. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.)), simvastatin and metoprolol. The patient did not receive other vaccine in four weeks. On 27Apr2021 16:30, the patient experienced headache, fever 100.7-101.0, chills, sweats, light head, woozy, severe sore throat, difficult to swallow, lasted up to 6 days slowly got better each day. His primary is concerned about and so was he about the throat, he prescribed an epipen for him to have. He had many reservations about his 2nd shot. He had lived a very healthy life very rarely being sick. No treatment was received for the events. The outcome of all events was resolved on 03May2021. Information on the lot/batch number has been requested.

Other Meds: ASPIRIN (E.C.); SIMVASTATIN; METOPROLOL

Current Illness:

ID: 1390960
Sex: M
Age:
State: NH

Vax Date: 05/01/2021
Onset Date: 05/21/2021
Rec V Date: 06/11/2021
Hospital: Y

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Symptoms: mini stroke (TIA); small carotid dissection in neck artery; This is a spontaneous report from a non-contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 01May2021 10:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included hypertension. The patient had no known allergies. Concomitant medications included lisinopril (LISINOPRIL), amlodipine besilate (AMLODIPINE BESILATE) and lactulose (LIS) all taken for an unspecified indications and therapy dates. On 21May2021 (also reported as 2 weeks after 1st vaccine), the patient went to the emergency room department with a mini stroke (TIA). CT of neck on that same day of 21May2021 showed a small carotid dissection in neck artery. The patient also had nasal swab COVID test on that day with unknown results. It was reported that TIA possibly caused by dissection being blocked for a short time. The patient went 3 days in hospital (since May2021) running test. It was stated that the events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient had prescriptions (unspecified medications) and follow up care as treatment. The patient recovered from the events in May2021. The patient then received the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE on 26May2021 16:45 ((Batch/Lot number was not reported) on the left arm. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Other Meds: LISINOPRIL; AMLODIPINE BESILATE; LIS

Current Illness:

ID: 1390961
Sex: M
Age:
State: CA

Vax Date: 04/12/2021
Onset Date: 04/01/2021
Rec V Date: 06/11/2021
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Symptoms: not able to function; sleeps all day; lost 14 pounds since the second dose of the vaccine/lost another 4 pounds over the weekend; chest hurt; Shortness of breath; fatigued and very weak; fatigued and very weak; Headache; cannot focus on school online; blood pressure goes up and down; heart rate goes up and down; Dizziness; muscle mass depleting; This is a spontaneous report from a contactable consumer (patient's parent). A 17-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in the right arm, at age 17 years, on 12Apr2021 (Batch/Lot Number: EW0158) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included pressure in his eye from an injury, asthma (diagnosed when the patient was about 2) and has family members with asthma and heart conditions. Patient is in perfect health, he works out 6 days a week, and does football conditioning 5 days a week. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Concomitant medication included timolol taken for pressure in his eye from an injury from an unspecified start date to 20May2021. Additional vaccines administered on same date of the Pfizer Suspect was none. The patient historically received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EP7534) at the left arm at age 17 years on 22Mar2021 for COVID-19 immunization. The patient got his second dose of the vaccine on 12Apr2021 and shorty after on 19Apr2021, he became very fatigued, very weak, his chest hurt, and he had shortness of breath. On Apr2021, patient had dizziness. The patient used to have bulky arms and now you can see his muscle mass depleting in Apr2021. The patient cannot focus on school online because of the headaches from 19Apr2021. The patient's blood pressure goes up and down from 19Apr2021. For days from 19Apr2021, the patient's heart rate will be fine in the 60s and it goes up to 120 or 130 with chest pain, it fluctuates depending on the day. The patient visited the emergency room on 05May2021, but was not admitted and no one knows what was going on with the vaccine. It was also reported that the patient lost 14 pounds on 25Apr2021 since the second dose of the vaccine. They knew the patient has already lost 10 pounds and then yesterday, 25May2021, the patient weighed himself and noticed he has lost another 4 pounds over the weekend. Patient had bloodwork on 20May2021 and it was all negative. The primary care provider was concerned about the weight loss so she ran a bunch of blood work. The patient is negative for COVID test and chest x-ray on 21May2021 and he has had multiple tests done. The patient went to his primary care provider on 25May2021 (yesterday from the time off reporting) and the reporter mentioned that maybe can they look at this as being a side effect from the vaccine. The patient's doctor laughed and said nothing has been proven yet about this. The reporter felt that this is a reaction to the vaccine. At the time of reporting on 26May2021, the patient was not able to function and sleeps all day. The patient also underwent lab tests and procedures that includes being tested negative for mono twice now (on unspecified dates). Clarified that they have not filed a safety report with Pfizer on the patient's events. The outcome of the events 'dizziness', 'lost 14 pounds since the second dose of the vaccine/lost another 4 pounds over the weekend', 'muscle mass depleting', 'cannot focus on school online', 'not able to function' and 'sleeps all day' was unknown; while for the other events, it was not recovered.

Other Meds: TIMOLOL

Current Illness:

ID: 1390962
Sex: F
Age:
State: NJ

Vax Date: 02/01/2021
Onset Date: 05/01/2021
Rec V Date: 06/11/2021
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Symptoms: swollen Lymph nodes in left neck/clavicle area; This is a spontaneous report from a contactable pharmacist. A 52-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown), via intramuscular route of administration in the right arm on 01Feb2021 (at the age of 52-year-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Medical history included breast cancer (CA) female "13 years post breast CA, chemotherapy and mastectomy". The patient's concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. on 01May2021, the patient developed swollen lymph nodes in left neck/clavicle area. CT scan done (unspecified date in May2021 with unknown results). When visited oncologist for evaluation (unspecified date in May2021), node was negative but the oncologist noted they were seeing this in post -CA patients. He acknowledged it was a bit farther out than usual, the vaccine was a possible reason. The clinical outcome of the swollen lymph nodes in left neck/clavicle area was resolving. 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, a possible contributory role of the suspect drug to the reported event "swollen Lymph nodes in left neck/clavicle area" cannot be completely excluded based on temporal association. 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1390963
Sex: F
Age:
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Vax Date: 03/01/2021
Onset Date: 04/01/2021
Rec V Date: 06/11/2021
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Symptoms: This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 36-year-old female patient received BNT162B2, via an unspecified route of administration in Mar2021 (Batch/Lot number and expiry date were not reported) as 2nd dose, single for COVID-19 immunization. Medical history included migraines (treated with Relpax and Botox) and not tolerating medication, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 in Feb2021 for COVID-19 immunisation; eletriptan (RELPAX) and botox, both for migraine. The office manager told the physician about her daughter who got the Pfizer COVID vaccine shots in February and March. She did not have any immediate adverse events. However, in April she started having underlying chest pains for 13 days and her rheumatologist diagnosed her with lupus and said it was caused by the COVID vaccine. The patient has a history of not tolerating medication very well. She also has migraines treated with Relpax and Botox. The outcome of the other events was unknown. The following information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of lupus and chest pains 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.

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Current Illness:

ID: 1390964
Sex: F
Age:
State: NY

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Symptoms: suicidal thoughts; allergic reaction; a rash; throat swelling; erratic moods; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 29-year-old on an unspecified date at single dose for covid-19 immunisation. Medical history included allergies to Sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included calcium; bifidobacterium lactis (PROBIOTIC); magnesium, all received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The allergic reaction included a rash and throat swelling. Psychological/neurological effects included suicidal thoughts and erratic moods. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were serious for being disability. Facility where the most recent COVID-19 vaccine was administered in Doctor's office/urgent care. Since the vaccination, the patient has not been tested for COVID-19. The patient received the medication for events. The outcome of events was not recovered. Follow-up attempts are needed. Further information is expected.

Other Meds: CALCIUM; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; MAGNESIUM

Current Illness:

ID: 1390965
Sex: U
Age:
State: CA

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Rec V Date: 06/11/2021
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Symptoms: Another employee that he works with got fully vaccinated in January, and then got covid a few months later.; Another employee that he works with got fully vaccinated in January, and then got covid a few months later; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, and dose 2 via an unspecified route of administration, administered in Arm Left on Jan2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that another employee that he works with got fully vaccinated in January, and then got Covid a few months later on an unspecified date. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021614562 same drug, different patient/event

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Current Illness:

ID: 1390966
Sex: F
Age:
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Symptoms: Pemphigus; This is a spontaneous report from a contactable pharmacist. This reporter reported for 9 patients. A 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. The event was assessed as non-serious by the reporter. Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of BNT162B2 to the development of pemphigus 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.c,Linked Report(s) : US-PFIZER INC-2021615628 same reporter and drug, different patient and AE

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Current Illness:

ID: 1390967
Sex: M
Age:
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Symptoms: episode of pericarditis; episode of pericarditis; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included pericarditis. The patient's concomitant medications were not reported. Patient who had medical history of pericarditis had another episode of pericarditis and was brought to the hospital after receiving the COVID vaccine. He received ketorolac (TORADOL) and was discharged. Outcome of the event was recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a causal association between the reported event pericarditis and BNT162B2 cannot 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 RAs, Ethics Committees, and investigators, as appropriate.

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Current Illness:

ID: 1390968
Sex: M
Age:
State: AL

Vax Date: 04/23/2021
Onset Date: 04/01/2021
Rec V Date: 06/11/2021
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Symptoms: pain; pain was causing blood pressure to be elevated/blood pressure elevation; Headache; injection pain/injection site extreme pain; pain was so bad could not sleep at night/sometimes he is not going to sleep until 02:00 the next mor; This is a spontaneous report received from a contactable consumer (patient's spouse) via a Pfizer-sponsored program. A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 23Apr2021 (lot number: EN0170), as 2nd dose, single dose, at age 52 years old, for COVID-19 immunisation, at a pharmacy/drug store. Medical history and concomitant medications were not reported. Historical vaccine included the first dose BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), administered in the left arm, on 24Mar2021 (lot number: EP6955), at age 52 years old, for COVID-19 immunisation. The patient did not have prior vaccinations within four weeks of BNT162B2. On 23Apr2021, the patient received his second dose of BNT162B2. On 23Apr2021 at 19:30, the patient experienced injection pain/injection site extreme pain. The patient did not act on it because he knew the injection site may be sore for a week. On 24Apr2021, the injection site was hurting bad but again he did not act on it because he knew it may sore but it had been a whole month and it was concerning. The reporter stated that the pain was causing the patient's blood pressure to be elevated. The reporter noticed the blood pressure elevation about 2 weeks after the second injection in the morning time (May2021). The patient also experienced headache at the same time as when the patient's blood pressure was elevated around the morning time, about 2 weeks after the second injection (May2021). It was reported that the pain was so bad that the patient could not sleep at night within a week of the second injection (Apr2021), time of onset was reported as "around 15:00 or 16:00 and as it goes over to the night 190:0 or 20:00, sometimes he is not going to sleep until 02:00 the next morning"). The events required physician's office visit on an unspecified date (reported as "the other day") and the reporter brought the events to the doctor's attention and stated that the patient was in pain throughout the day. The reporter was thinking of taking the patient to urgent care. Treatment for the event "injection pain/injection site extreme pain" and "pain" included heating pads, ice packs, lidocaine patches, unspecified cream and rubbing lotion to try and ease the pain. The reporter was thinking about Advil and asked every how many hours should the patient take the Advil. The outcome of the events was not recovered. Follow-up attempts are needed. Further information is expected.

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Current Illness:

ID: 1390969
Sex: M
Age:
State: IN

Vax Date: 05/14/2021
Onset Date: 05/16/2021
Rec V Date: 06/11/2021
Hospital: Y

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Symptoms: inflammation in his intestines and his stomach; petechial rash on his legs, which is still getting a little bit worse; HSP; stomach pain/extreme stomach pain started again and so on/intermittent stomach pain/lower left abdominal pain; lower left abdominal pain and he doubled over in pain and started vomiting; Caller states again he had intermittent pain throughout the day; vomited about three times in total, it wasn't like excessive vomiting; didn't feel well/feel sick again; This is a spontaneous report from a contactable consumer (patient's parent). A 13-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0164, expiration date: 31Aug2021), at the age of 13 years old, in left arm on 14May2021 16:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was a normal 13 years old, he doesn't take anything, he's active. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The vaccines administered on same date with BNT162B2 was none. The previous immunization with the Pfizer vaccine was none. The patient previously received the flu shot every year and experienced no adverse event. On 16May2021, about 48 hours after the vaccination, the patient started having stomach pain in the middle of the night. It began 16May2021 in the evening and into 17May2021, the patient was having stomach pain and not feeling well. Reporter stated the patient woke her up. Reporter stated they thought it was some food he ate. Reporter stated they tested his covid antibodies and they also personally at home on 17May2021 night, they tested him with a home kit for covid just to double check because nobody really brought it up and it was negative also. Reporter confirmed the home covid test was done on 17May2021. Reporter stated there was no known exposure, they just did it to make sure he didn't have covid. The patient was taken to the emergency room on 18May2021. Reporter stated they were waiting because patient felt good during the day and they thought nothing was wrong, but then the extreme stomach pain started again and so on 18May2021, she took him to the local emergency room. Reporter stated they didn't do much other than push on his stomach, she was worried about appendicitis. Reporter stated they didn't worry too much, but she thought maybe it was his appendix. The doctor examined him and said he had a stomach issue and released him with medicine and that was the 18May2021. On 19May2021 and 20May2021, the patient would get intermittent stomach pain, again thinking it was a stomach bug or something. On 20May2021, the patient experienced petechial rash on his legs. Reporter called the pediatrician and again the patient was having intermittent stomach pain and kept having it intermittently. The patient would feel fine then feel sick again then on the 22May2021, the patient had more bad stomach pain and some vomiting so he wound up back in the emergency department, it was a different one than the first on 22May2021. The patient did a lot of blood work, his labs came back good, but he did not do a CAT scan, but reporter tried to do everything else, tested patient for covid, antibodies and everything and they sent him home again on the 22May2021. The patient had intermittent pain again throughout 23May2021 then on 24May2021, he went to visit the pediatrician just for a visit and they were thinking its Henoch-Schonlein purpura (HSP) which is an autoimmune response and they still didn't have a diagnosis for his stomach. Reporter stated patient was perfectly fine at the pediatrician, then when they got home, he started having lower left abdominal pain and he doubled over in pain and started vomiting. The patient vomited about three times in total, it wasn't like excessive vomiting. Reporter stated the pain would bring it on, he does have a rash, which is still getting a little bit worse. Reporter stated they took him back to the emergency room, they did a CAT scan and that showed he had inflammation in his intestines and his stomach so they kept him in the hospital. The patient was admitted on 24May2021 when he visited the emergency room for the third time. Reporter stated because patient was in pain, they admitted him to watch him. Reporter stated they were worried about the patient having intussusception with the bowel, where his bowel can go inside each other and can create a blockage, so they wanted to admit him to make sure that didn't happen. Reporter stated the worst of the stomach pain was on 25May2021, which would have been at 19:00. The patient had not had an episode since then, he hadn't had an attack like that since. The whole week before from 17May2021, or the 16May2021 when it started through 25May2021, it was very intermittent of a lot of pain. So far, knock on wood, the patient hadn't had it since 25May2021 at 19:00 and hopefully tonight it won't happen. Reporter stated it will be about 48 hours of not having the bad pain. Reporter stated he still has some pain, but not like where she had to rush him to the emergency room. The patient's vomiting ended on 24May2021 or 25May2021. He had recovered completely from vomiting so far. The patient was released on 26May2021 with a diagnosis of HSP, which was an auto immune response, and he'd never had this happen before. Reporter stated if she googled HSP, it said it can still get worse, but it was not the worst case of HSP. Reporter stated the patient has never had anything like this before, he was perfectly fine, they made it through covid and didn't get covid and he is a healthy kid so she thought Pfizer should know. The outcome of the events HSP, stomach pain, petechial rash was not recovered. The outcome of vomiting was recovered on 24May2021 or 25May2021. The outcome of the events inflammation in intestines and stomach, didn't feel well/feel sick, intermittent pain and lower left abdominal pain was unknown. No follow-up attempts are needed. No further information is expected.

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Current Illness:

ID: 1390970
Sex: F
Age:
State: PA

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Rec V Date: 06/11/2021
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Symptoms: tested positive for Covid virus; tested positive for Covid virus; This is a spontaneous report received via a Pfizer-sponsored program, from a contactable consumer (parent). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned there were also 2 children and 2 adults who were positive. Clarified later in call that they were all at a dinner party together with 4 adults vaccinated and 2 unvaccinated children, one being her daughter (adult) and niece and they both also tested positive for Covid virus, which she finds profound. Stated her daughter received the Pfizer Covid vaccine, but her niece was not vaccinated and was just positive for Covid virus. Mentioned she just read that the CDC is only interested in post vaccination serious cases. The outcome of the events was unknown. Information on the lot/batch number has been requested. Further information is expected.

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Current Illness:

ID: 1390971
Sex: F
Age:
State: PA

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 06/11/2021
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Symptoms: kidney stones; severe left flank pain; extreme thirst; This is a spontaneous report from contactable consumer (patient). A 19-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10May2021 14:00 (Lot Number: EW0168) as single dose (at the age of 19-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cefalexin monohydrate (LEXIPRON), ethinylestradiol, levonorgestrel (VIENVA), all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Apr2021 02:00 PM (Lot Number: EW0162) as single dose (at the age of 19-years-old) for COVID-19 immunization and experienced Heavy period off schedule from pill pack. The patient experienced extreme thirst since second dose (10May2021). Then, on 27May2021, had severe left flank pain causing an emergency room visit. Preliminary diagnosis is kidney stones. At ER, patient received pain medication, saline hydration drip. The outcome of the events was recovering. The event kidney stones was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are possible; further information has been requested.

Other Meds: VYVANSE; LEXIPRON; VIENVA

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ID: 1390972
Sex: U
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Vax Date: 05/11/2021
Onset Date: 05/01/2021
Rec V Date: 06/11/2021
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Symptoms: I feel like to commit suicide, I feel that terrible; I have lost all of my appetite; Have been sleeping 14 hours a day since I had that second dose of vaccine; can't eat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 11May2021 (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 20Apr2021 for COVID-19 Immunization. In May2021, the patient had lost all of appetite and had been sleeping 14 hours a day since having the second dose of vaccine. This got the patient, felt like to commit suicide, the patient felt that terrible (not clarified further, event captured as per verbatim) and the patient can't eat. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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ID: 1390973
Sex: F
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Symptoms: Two strokes; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced two strokes on an unspecified date within a week of receiving the first dose. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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ID: 1390974
Sex: F
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Symptoms: seizures; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for Covid-19 immunization. The patient received the first dose of BNT162B2 on an unspecified date for Covid-19 immunization and experienced two strokes (within a week of receiving first dose). The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced two seizures after receiving second dose. The outcome of event was unknown. Information about Lot/Batch number has been requested.

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ID: 1390975
Sex: M
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Vax Date: 12/29/2020
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Rec V Date: 06/11/2021
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Symptoms: cytokine release syndrome in a patient who received the Pfizer/BNT vaccine; This is a Literature-Spontaneous report from Journal of Nature Medicine, 2021; entitled "Cytokine release syndrome in a patient with colorectal cancer after vaccination with BNT162b2." Patients with cancer are currently prioritized in coronavirus disease 2019 (COVID-19) vaccination programs globally, which includes administration of mRNA vaccines. Cytokine release syndrome (CRS) has not been reported with mRNA vaccines and is an extremely rare immune-related adverse event of immune checkpoint inhibitors. We present a case of CRS that occurred 5 d after vaccination with BTN162b2 (tozinameran)-the Pfizer-BioNTech mRNA COVID-19 vaccine-in a patient with colorectal cancer on long-standing anti-PD-1 monotherapy. The CRS was evidenced by raised inflammatory markers, thrombocytopenia, elevated cytokine levels (IFN-y/IL-2R/IL-18/IL-16/IL-10) and steroid responsiveness. The close temporal association of vaccination and diagnosis of CRS in this case suggests that CRS was a vaccine-related adverse event; with anti-PD1 blockade as a potential contributor. Overall, further prospective pharmacovigillence data are needed in patients with cancer, but the benefit-risk profile remains strongly in favor of COVID-19 vaccination in this population. CRS/cytokine storm is a systemic inflammatory response, characterized by excessive cytokine release (that is, elevated INF-y, IL-6, IL-10 and IL-2R) #. CRS might develop after infection (including COVID-19) or due to iatrogenic causes, most notably chimeric antigen receptor T cell (CAR-T) therapy and, less frequently, cytotoxic chemotherapy or stem cell transplantation#. Extremely rarely, it occurs after immune checkpoint inhibitor (ICI) therapy#, and, to our knowledge, it has not been reported after administration of any vaccine. Here the authors report a case of CRS after vaccination with BNT162b2 (tozinameran), an mRNA COVID-19 vaccine. A 58-year-old male commenced anti-PD-1 monotherapy (an investigational ICI within an ongoing interventional clinical trial; NCT02715284)) in Feb2019 for the treatment of mismatch repair-deficient colorectal cancer (MMRd CRC) metastatic to mesentry and rectus muscle. Two months after treatment initiation, he experienced a neurological immune-related adverse event (irAE) with worsening ataxia (grade 1 to grade 2, and magnetic resonance imaging changes in pons, medulla and cerebellum) on the background of pre-existing spinocerebellar ataxia of unknown etiology. ICI was suspended, and he was commenced on 1 mg kg-1 prednisolone (tapered over 1 month), and ataxia returned to grade 1 (baseline). Anti-PD-1 therapy was re-started in Jun2019, with stable disease as per immune-related Response Evaluation Criteria in Solid Tumors. In Mar2020 (13 months after commencing ICI), he developed an endocrine irAE (grade 1 hypocortisolemia from adrenocorticotropic hormone deficiency) and was commenced on physiological corticosteroid replacement (prednisolone, 3 mg daily). Disease control was maintained, and the last ICI dose was administered in 27Dec2020 d before BNT162b2. The patient had no history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and had negative SARS-CoV-2 serological tests in Jun2020 and Oct2020. He received the first dose of BNT162b2 vaccine on 29Dec2020 without immediate adverse events, except for grade 1 inflammation at the vaccination site. Five days later (32 d after the last anti-PD-1 dose), he presented with myalgia, 2-d history of diarrhea (grade 1) and 1-d history of fever (38.4 degree C) despite anti-pyretics (ibuprofen) use. On admission to the hospital, his vital signs were as follows: oxygen saturation, 100% on room air; respiratory rate, 18 breaths per minute; blood pressure, 111/71 mmHg; heart rate, 86 beats per minute (Normal); and temperature, 36.7 degree C. Laboratory investigations revealed elevated inflammatory markers (C-reactive protein (CRP)), 125 mg L-1 (normal, <6 mg L-1); serum lactate dehydrogenase (LDH), 184 U L-1 (normal range, 120-246 U L-1); and thrombocytopenia (68 x 109 cells per liter (normal range, 150-410 cells per liter)), confirmed on microscopy. Empirical treatment with broad-spectrum intravenous antibiotics was commenced; however, blood and urine cultures were negative, as was SARS-CoV-2 RT-PCR of serial nasopharyngeal swabs. There were no clinical signs or symptoms during admission or follow-up to suspect a thrombotic event in this patient. Computed tomography of thorax, abdomen and pelvis revealed no nidus of infection or thrombosis and showed stable disease with respect to cancer. The patient was not heparinized. Over the next 5 d, fevers up to 39.8 degree C continued, with worsening thrombocytopenia (28 x 109 cells per liter) and increasing inflammatory markers (CRP, 317 mg L-1; LDH, 849 U L-1), including significantly elevated ferritin (6,010 ug L-1 (normal range, 18-464 ug L-1)). At this point (5 d after admission), CRS was suspected (grade 3), and he was commenced on 1 mg kg-1 of intravenous methylprednisolone (IVMP), and antibiotics were ceased 3 d later. Biochemical and hematological indices normalized within 7 d of IVMP initiation, and the patient was afebrile and asymptomatic upon discharge home with a weaning corticosteroid regimen. He remained well and was re-challenged with anti-PD-1 on 8Feb2021 (36 d after initial presentation) without any adverse events. He did not receive the second dose of BNT162b2. Other lab data included MCP-1: Elevated (Test: Macrophage, Results: increased). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported cytokine release syndrome. 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.

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Current Illness: Colorectal cancer

ID: 1390976
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Symptoms: Three strokes; Two seizures; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Caller complaining about Vaccine, she wanted to report Pfizer for the vaccine causing her three strokes, two seizures within a week of receiving first dose (unspecified date). Caller Disconnected shortly after being taken off hold to be referred to a facility. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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ID: 1390977
Sex: F
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State: FL

Vax Date: 04/24/2021
Onset Date: 05/26/2021
Rec V Date: 06/11/2021
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Symptoms: 32 day after vaccination I developed Bell's Palsy.; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0158; Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 24Apr2021 13:30 as 2nd dose, single dose for covid-19 immunisation. Medical history included diabetes. Patient had known allergies to penicillin. Concomitant medication included metformin. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: unknown, Formulation: solution for injection), via an unspecified route of administration, administered in arm right on 03Apr2021 at 13:15 as single dose for covid-19 immunisation with no adverse effect. Patient developed bell's palsy 32 day after vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received metformin within 2 weeks of vaccination. Patient developed bell's palsy 32 day after vaccination. These adverse event result in emergency room/department or urgent care. Patient was treated with anti viral prescription. Patient was not diagnosed with covid-19 prior to vaccination and since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not recovered. Follow up needed, further information has been requested.

Other Meds: METFORMIN

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ID: 1390978
Sex: U
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Symptoms: anaphylactic reaction; This is a spontaneous report from a non-contactable consumer received from other company, Mylan (Case ID: GI-2021-5625). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date. The outcome of the event was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

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Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm