VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
92,076
AK1,880
AL6,345
AR4,151
AS46
AZ14,991
CA66,887
CO12,550
CT8,943
DC1,795
DE2,009
FL42,724
FM4
GA17,031
GU124
HI2,580
IA4,919
ID2,892
IL22,128
IN24,197
KS5,047
KY9,111
LA5,500
MA15,718
MD13,434
ME3,351
MH8
MI20,971
MN13,585
MO10,747
MP30
MS3,198
MT2,477
NC18,051
ND1,501
NE3,109
NH3,218
NJ20,216
NM4,218
NV4,728
NY37,667
OH20,793
OK6,692
OR9,244
PA25,607
PR2,588
QM2
RI2,163
SC7,261
SD1,282
TN10,445
TX39,890
UT4,618
VA15,980
VI67
VT1,830
WA16,071
WI12,042
WV2,571
WY926
XB5
XL1
XV2

ID: 1521924
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 07/29/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: ADMINISTERED A DOSE OF VACCINE THAT WAS OPENED FOR 18 HOURS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced administered a dose of vaccine that was opened for 18 hours. On 29-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered a dose of vaccine that was opened for 18 hours and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1521925
Sex: M
Age:
State: MA

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

Vax Type:
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Symptoms: NUMBNESS AND TINGLING IN HANDS AND FEET WHICH WAS GETTING WORSE; This spontaneous report received from a pharmacist concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced numbness and tingling in hands and feet which was getting worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness and tingling in hands and feet which was getting worse. This report was non-serious.

Other Meds:

Current Illness:

ID: 1521926
Sex: U
Age:
State:

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

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Symptoms: SWEATS; EXTREMELY SLEEPY; HUNGRY; CHILLS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sweats, extremely sleepy, hungry, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweats, chills, extremely sleepy and hungry was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1521927
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 07/27/2021
Rec V Date: 08/03/2021
Hospital:

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Symptoms: MILD ACHINESS IN SHOULDERS; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight was 135 pounds, and height was 62 inches. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient was not pregnant at the time of report. The patient is allergic to certain antibiotics. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, the subject experienced mild achiness in shoulders. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild achiness in shoulders on 27-JUL-2021. This report was non-serious.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1521928
Sex: F
Age:
State:

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

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Symptoms: REALLY BAD CHILLS; FELT A BIT RUN DOWN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced really bad chills, and felt a bit run down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really bad chills, and felt a bit run down. This report was non-serious.

Other Meds:

Current Illness:

ID: 1521929
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
Manufacturer:
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Symptoms: SHARP CHEST PAIN; TINGLING SENSATION ON THE VACCINATED ARM; NUMBNESS ON THE VACCINATED ARM; This spontaneous report received from a consumer concerned a 57 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included pinch spinal nerves.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced sharp chest pain. On JUN-2021, the subject experienced tingling sensation on the vaccinated arm. On JUN-2021, the subject experienced numbness on the vaccinated arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness on the vaccinated arm, and tingling sensation on the vaccinated arm, and the outcome of sharp chest pain was not reported. This report was non-serious.

Other Meds:

Current Illness: Nerve compression

ID: 1521930
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 07/31/2021
Rec V Date: 08/03/2021
Hospital:

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Symptoms: TACHYCARDIA; LOW GRADE FEVER; INJECTION SITE SORENESS; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the subject experienced tachycardia. On 31-JUL-2021, the subject experienced low grade fever. On 31-JUL-2021, the subject experienced injection site soreness. Laboratory data included: Body temperature (NR: not provided) 101 F, and Heart rate (NR: not provided) greater than 110 beats per minute (BPM). On 01-AUG-2021 14:00, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from injection site soreness, and had not recovered from low grade fever, and tachycardia. This report was non-serious.

Other Meds:

Current Illness: Non-smoker; Social alcohol drinker (once in a month)

ID: 1521931
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 07/28/2021
Rec V Date: 08/03/2021
Hospital:

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Symptoms: ADMINISTERED VACCINE TO PATIENT BY 9 MINUTES (VIAL PUNCTURED AT 8:33 AM SYRINGE WAS DRAWN UP AND IMMUNIZATION WAS GIVEN 2:42 PM); This spontaneous report received from a health care professional concerned a 35 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies no medical history. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820095, and expiry: 18-AUG-2021) dose was not reported, administered on 28-JUL-2021 14:42 for prophylactic vaccination. No concomitant medications were reported. On 28-JUL-2021, the subject experienced administered vaccine to subject by 9 minutes (vial punctured at 8:33 am syringe was drawn up and immunization was given 2:42 pm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered vaccine to patient by 9 minutes (vial punctured at 8:33 am syringe was drawn up and immunization was given 2:42 pm) was not reported. This report was non-serious.

Other Meds:

Current Illness: Non-smoker

ID: 1521932
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
Manufacturer:
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Symptoms: NUMBNESS IN ELBOW DOWN, FOREARM, HANDS AND FEET; TINGLING SENSATION FROM ELBOW DOWN FOREARM,HANDS AND FEET/PRICKLY FEELING AFTER GET FROM STANDING ON FEET FOR LONG TIME BUT FEELING FROM THE ELBOW DOWN; FEELS ACHY; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight was 170 pounds, and height was 72 inches. The patient's concurrent conditions included non smoker, and non alcoholic, and other pre-existing medical conditions included patient had no known drug allergies and did not had any history of drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced numbness in elbow down, forearm, hands and feet. On JUL-2021, the subject experienced tingling sensation from elbow down forearm, hands and feet/prickly feeling after get from standing on feet for long time but feeling from the elbow down. On JUL-2021, the subject experienced feels achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness in elbow down, forearm, hands and feet, tingling sensation from elbow down forearm,hands and feet/prickly feeling after get from standing on feet for long time but feeling from the elbow down and feels achy was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1521933
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 07/26/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
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Vax Name:
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Lab Data:

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Symptom List:

Symptoms: PERSISTENT TINGLING SENSATION ON BOTH SIDES OF FACE (MORE ON RIGHT SIDE) AND ON BOTH ARMS (MORE ON RIGHT ARM) GOING UP AND DOWN AND GETTING WORSE; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. The patient's past medical history included back surgery, and knee replacement surgery, and concurrent conditions included arthritis, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient have no history of drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 210A21A, expiry: 21-SEP-2021) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, the subject experienced persistent tingling sensation on both sides of face (more on right side) and on both arms (more on right arm) going up and down and getting worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent tingling sensation on both sides of face (more on right side) and on both arms (more on right arm) going up and down and getting worse. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (3 drinks per week); Arthritis; Non-smoker

ID: 1521934
Sex: F
Age:
State: GA

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

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Symptom List:

Symptoms: ADMINISTERED SOME OF THE VACCINE (PARTIALLY ADMINISTERED); This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced administered some of the vaccine (partially administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered some of the vaccine (partially administered) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1521935
Sex: F
Age: 77
State: RI

Vax Date: 02/25/2021
Onset Date: 02/26/2021
Rec V Date: 08/03/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

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Symptom List:

Symptoms: heart wasn't working right; has been weak; red patch on her arm; swelling; itching; feels like the vaccine has given her the COVID-19 virus; anxiety; Infected right eye; felt terrible; dry cough; Unable to sleep; big raised oval rash which was hot to the touch; slight temperature; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (heart wasn't working right) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pacemaker insertion (cardiac) from 18-Mar-2021 to 19-Mar-2021. Concomitant products included HYDROCHLOROTHIAZIDE for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (slight temperature) and FATIGUE (fatigue). On 04-Mar-2021, the patient experienced INSOMNIA (Unable to sleep) and RASH (big raised oval rash which was hot to the touch). On 08-Mar-2021, the patient experienced VACCINATION COMPLICATION (felt terrible) and COUGH (dry cough). On 17-Mar-2021, the patient experienced EYE INFECTION (Infected right eye). On an unknown date, the patient experienced CARDIAC DISCOMFORT (heart wasn't working right) (seriousness criterion hospitalization), ASTHENIA (has been weak), ERYTHEMA (red patch on her arm), SWELLING (swelling), PRURITUS (itching), SUSPECTED COVID-19 (feels like the vaccine has given her the COVID-19 virus) and ANXIETY (anxiety). The patient was hospitalized from 18-Mar-2021 to 19-Mar-2021 due to CARDIAC DISCOMFORT. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CARDIAC DISCOMFORT (heart wasn't working right), EYE INFECTION (Infected right eye), VACCINATION COMPLICATION (felt terrible), COUGH (dry cough), ASTHENIA (has been weak), INSOMNIA (Unable to sleep), ERYTHEMA (red patch on her arm), SWELLING (swelling), PRURITUS (itching), SUSPECTED COVID-19 (feels like the vaccine has given her the COVID-19 virus), ANXIETY (anxiety), RASH (big raised oval rash which was hot to the touch), PYREXIA (slight temperature) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Heart rate: 33 (Low) low. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Pacemaker insertion (cardiac) could be a contributory factor. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Added new events (infected right eye and heart wasn't working right), procedure, lab and hospitalization.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Pacemaker insertion (cardiac) could be a contributory factor.

Other Meds: HYDROCHLOROTHIAZIDE

Current Illness:

ID: 1521936
Sex: M
Age:
State: NM

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

Vax Type:
Manufacturer:
Vax Name:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Some sort of blood formation in his ankle/Like a blood clot; Not feeling well; Rash on his arm; Felt tired; Bleeding at the back of his neck at his cervical area of his spine; Back of his neck at his cervical area of spine has laceration; Dizzy; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's medical history was not provided. Concomitant products included LORAZEPAM and MIRTAZAPINE for an unknown indication. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced SKIN HAEMORRHAGE (Bleeding at the back of his neck at his cervical area of his spine), SKIN LACERATION (Back of his neck at his cervical area of spine has laceration), DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu like symptoms), RASH (Rash on his arm) and FATIGUE (Felt tired). On an unknown date, the patient experienced THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot) (seriousness criterion medically significant) and MALAISE (Not feeling well). The patient was treated with Wound care (Bandage) for Skin haemorrhage and Wound care (Bandage) for Skin laceration. At the time of the report, THROMBOSIS (Some sort of blood formation in his ankle/Like a blood clot), SKIN HAEMORRHAGE (Bleeding at the back of his neck at his cervical area of his spine), SKIN LACERATION (Back of his neck at his cervical area of spine has laceration), DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu like symptoms), MALAISE (Not feeling well), RASH (Rash on his arm) and FATIGUE (Felt tired) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. 81-year-old male patient who experienced a serious, unlisted event of THROMBOSIS among other non-serious events. Very limited information regarding this event has been provided at this time. Details including the exact diagnosis, treatment received, outcome are required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received include the new adverse events (Not feeling well and blood clot).; Sender's Comments: 81-year-old male patient who experienced a serious, unlisted event of THROMBOSIS among other non-serious events. Very limited information regarding this event has been provided at this time. Details including the exact diagnosis, treatment received, outcome are required for further assessment.

Other Meds: LORAZEPAM; MIRTAZAPINE

Current Illness:

ID: 1521937
Sex: F
Age: 24
State: WA

Vax Date: 05/17/2021
Onset Date: 05/25/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Erythema Multiforme; Red dots on torso; Itching; diarrhea; abdominal cramping; redness; itchy eyes; runny nose; feeling hot; tingling sensation; Hypersensitivity reaction; Hard to touch; Itchiness; Pain at injection site; nausea; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA MULTIFORME (Erythema Multiforme) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Vomiting on 01-May-2002. Previously administered products included for an unreported indication: Z-PAK. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced ERYTHEMA MULTIFORME (Erythema Multiforme) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Red dots on torso), PRURITUS (Itching), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), ERYTHEMA (redness), EYE PRURITUS (itchy eyes), RHINORRHOEA (runny nose), FEELING HOT (feeling hot), PARAESTHESIA (tingling sensation), HYPERSENSITIVITY (Hypersensitivity reaction), VACCINATION SITE INDURATION (Hard to touch), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Pain at injection site), NAUSEA (nausea) and CHILLS (chills). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse reaction, at a dose of 1 dosage form. On 27-Jun-2021, ERYTHEMA MULTIFORME (Erythema Multiforme), PRURITUS (Itching), DIARRHOEA (diarrhea), ABDOMINAL PAIN (abdominal cramping), ERYTHEMA (redness), EYE PRURITUS (itchy eyes), RHINORRHOEA (runny nose), FEELING HOT (feeling hot), PARAESTHESIA (tingling sensation), HYPERSENSITIVITY (Hypersensitivity reaction), NAUSEA (nausea) and CHILLS (chills) had resolved. At the time of the report, RASH ERYTHEMATOUS (Red dots on torso), VACCINATION SITE INDURATION (Hard to touch), VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE PAIN (Pain at injection site) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The concomitant medications were not reported. It was reported that the patient seek medical care at Doctor's office and date of hospitalization was reported as 27-MAY-2021. It was reported that the adverse events are most likely caused by mRNA-1273. The consumer mentioned that she contacted an ER doctor identified the rash she developed as Erythema Multiforme. She mentioned that she asked if she should get the second dose and the ER doctor talked with a few other doctors and a derm and they all agreed that she should not get anymore shots. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Event added, contact info updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1521938
Sex: F
Age: 59
State: TN

Vax Date: 06/02/2021
Onset Date: 06/02/2021
Rec V Date: 08/03/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Could not use Left Hand; numbness to their left arm and hand, and their left foot.; Heart Palpitations; Feel Sick; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Could not use Left Hand) and HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Penicillin allergy and Mitral valve prolapse (Heart) since 1993. Concomitant products included CARVEDILOL, LOSARTAN POTASSIUM and ALPRAZOLAM (XANAX) for an unknown indication. On 02-Jun-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) (seriousness criterion hospitalization) and ILLNESS (Feel Sick). On 07-Jun-2021, the patient experienced PALPITATIONS (Heart Palpitations). On an unknown date, the patient experienced LIMB DISCOMFORT (Could not use Left Hand) (seriousness criterion hospitalization). On 10-Jun-2021, PALPITATIONS (Heart Palpitations) had resolved. At the time of the report, LIMB DISCOMFORT (Could not use Left Hand) had not resolved and HYPOAESTHESIA (numbness to their left arm and hand, and their left foot.) and ILLNESS (Feel Sick) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, Magnetic resonance imaging: unknown Inconclusive. On an unknown date, Chest scan: unknown Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: the follow up document received contains no significant information(NNI).; Reporter's Comments: Patient took water pills as treatment medication. On day 5 the patient felt sick on 02 Jun 2021, she went to emergency room with her chest hunting and left side numbness of the body. She also had Magnetic resonance imaging (MRI) and shown to several doctors. Then went to post-exposure prophylaxis (PEP)on 10 Jun 2021. On 10 Jun 2021 she took off work on medical leave for a week. She could not able to use her left hand good and still waiting to see neurologist. The patient had not ever tested positive for COVID-19, and had not taken any prescriptions, over the counter medication, dietary supplement or herbal remedies at the time of vaccination. The patient had not experienced similar adverse event in the past and other potential causes for the event was unknown.

Other Meds: CARVEDILOL; LOSARTAN POTASSIUM; XANAX

Current Illness: Mitral valve prolapse (Heart); Penicillin allergy

ID: 1521939
Sex: M
Age: 71
State: CA

Vax Date: 02/27/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: catarac in r eye; Deficiency in vitamin B12; leg started to heal and look so much better and the last scab was finally gone; This spontaneous case was reported by a consumer and describes the occurrence of CATARACT (catarac in r eye) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Have skin cancer and had two surgeries in the past to help. It has been a few years since the last surgery.). Concurrent medical conditions included Skin cancer and Wound oozing (3-4 inch bumpy non-healing area in right knee constantly oozing a bloody to pinkish fluid.). Concomitant products included METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZIDE), CARVEDILOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN B12 NOS for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CATARACT (catarac in r eye) (seriousness criterion medically significant), VITAMIN B12 DEFICIENCY (Deficiency in vitamin B12) and THERAPEUTIC RESPONSE UNEXPECTED (leg started to heal and look so much better and the last scab was finally gone). The patient was treated with IBUPROFEN for Throbbing pain, at a dose of 400 mg three times a day. At the time of the report, CATARACT (catarac in r eye) and VITAMIN B12 DEFICIENCY (Deficiency in vitamin B12) outcome was unknown and THERAPEUTIC RESPONSE UNEXPECTED (leg started to heal and look so much better and the last scab was finally gone) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Significant follow up was received. New event- cataract added. Case was upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: METFORMIN; LISINOPRIL/HYDROCHLOROTHIAZIDE; CARVEDILOL; BABY ASPIRIN; VITAMIN B12 NOS

Current Illness: Skin cancer; Wound oozing (3-4 inch bumpy non-healing area in right knee constantly oozing a bloody to pinkish fluid.)

ID: 1521940
Sex: M
Age:
State: PA

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Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: Worsening LV function; Non-sustained ventricular tachycardia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Worsening LV function) and VENTRICULAR TACHYCARDIA (Non-sustained ventricular tachycardia) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Worsening LV function) (seriousness criteria hospitalization and medically significant) and VENTRICULAR TACHYCARDIA (Non-sustained ventricular tachycardia) (seriousness criteria hospitalization and medically significant). The patient was treated with METOPROLOL SUCCINATE for Adverse event, at an unspecified dose and frequency; COLCHICINE for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, MYOCARDITIS (Worsening LV function) and VENTRICULAR TACHYCARDIA (Non-sustained ventricular tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 110/59 mmHg (Inconclusive) 110/59 mmHg. On an unknown date, Body temperature: 101 ?F (High) 101 ?F on presentation to hospital. On an unknown date, C-reactive protein: 74.2 (High) 74.2 mg/L (reference range: <10 mg/L). On an unknown date, Computerised tomogram coronary artery: normal (normal) normal; No coronary artery disease or anomalies. On an unknown date, Echocardiogram: lv systolic function was normal (normal) LV systolic function was normal (initial) and mild reduction in lvef to 50% (abnormal) mild reduction in LVEF to 50% (subsequent). On an unknown date, Ejection fraction: 59-50 (Inconclusive) 59-50 percent, 53 (Inconclusive) 53 percent and 49 (Inconclusive) 49 percent. On an unknown date, Electrocardiogram: demonstrated diffuse st elevations (abnormal) demonstrated diffuse ST elevations. On an unknown date, HIV test: negative (Negative) Negative. On an unknown date, Heart rate: 120 (Inconclusive) 120 beats per minute. On an unknown date, Influenza virus test: negative (Negative) Negative. On an unknown date, Laboratory test: elevated high-sensitivity troponin (abnormal) elevated high-sensitivity troponin. On an unknown date, Magnetic resonance imaging heart: mild hypokinesis of the mid lateral wall (abnormal) mild hypokinesis of the mid lateral wall; sub epicardial delayed enhancement in the lateral wall, sub epicardial enhancements (abnormal) sub epicardial enhancements in the same areas of T1 and T2 elevations, 1089-1097 (High) High and 64-72 (High) High. On an unknown date, Physical examination: unremarkable (normal) unremarkable. On an unknown date, Red blood cell sedimentation rate: 29 (High) (reference range: <15 mm/hour). On an unknown date, Respiratory syncytial virus test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Troponin: 7,206 - 32,140 (High) 7,206 - 32,140 ng/L (reference range: <15 ng/L). On an unknown date, Ventricular internal diameter: 4.8 (normal) Normal RV size and function; No valvular disease. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Worsening LV function) and VENTRICULAR TACHYCARDIA (Non-sustained ventricular tachycardia) to be possibly related. On an unknown date lab test included were LVEDVi: 101 mL/m 2 ; RVEDVi: 118 mL/m 2 Concomitant medications were not provided by the reporter. Action taken with the mRNA-1273 in response to the event is not applicable. The patient's hospital course was complicated by brief episodes of non-sustained ventricular tachycardia. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Myocarditis is an AESI which is included in the acute cardiac injury for mRNA vaccine. Continuous monitoring of this event is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Myocarditis is an AESI which is included in the acute cardiac injury for mRNA vaccine. Continuous monitoring of this event is expected.

Other Meds:

Current Illness:

ID: 1521941
Sex: M
Age: 61
State: TX

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 08/03/2021
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Symptoms: Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high and Hypercholesterolemia. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy) had not resolved. The patient was given steroids as treatment medication. The patient was on blood pressure and cholesterol medicine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Blood pressure high; Hypercholesterolemia

ID: 1521943
Sex: F
Age: 29
State: FL

Vax Date: 04/17/2021
Onset Date: 07/04/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: Diagnosed with small Pericardial Effusion/1 week later diagnosed with large Pericardial Effusion; 1 week later diagnosed with Pleural Effusion; Feeling sick; Feeling tiredness; Coughing blood; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (Diagnosed with small Pericardial Effusion/1 week later diagnosed with large Pericardial Effusion), HAEMOPTYSIS (Coughing blood), PLEURAL EFFUSION (1 week later diagnosed with Pleural Effusion), MALAISE (Feeling sick) and FATIGUE (Feeling tiredness) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jul-2021, the patient experienced HAEMOPTYSIS (Coughing blood) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERICARDIAL EFFUSION (Diagnosed with small Pericardial Effusion/1 week later diagnosed with large Pericardial Effusion) (seriousness criteria hospitalization and medically significant), PLEURAL EFFUSION (1 week later diagnosed with Pleural Effusion) (seriousness criterion hospitalization), MALAISE (Feeling sick) (seriousness criterion hospitalization) and FATIGUE (Feeling tiredness) (seriousness criterion hospitalization). The patient was treated with AZITHROMYCIN (ZITHROMAX) for Adverse event, at an unspecified dose and frequency; LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency and IVERMECTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, PERICARDIAL EFFUSION (Diagnosed with small Pericardial Effusion/1 week later diagnosed with large Pericardial Effusion), PLEURAL EFFUSION (1 week later diagnosed with Pleural Effusion), MALAISE (Feeling sick) and FATIGUE (Feeling tiredness) outcome was unknown and HAEMOPTYSIS (Coughing blood) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not reported. Treatment medication also include Zithromax, Levaquin, Ivermectin, and methozine. Patient had difficulty in breathing due to her allergies. She was diagnosed with small Pericardial Effusion and was discharge. Then 1 week later she was re-admitted into hospital with Pericardial Effusion but this time it was large in size and also diagnosed with Pleural Effusion(fluid around the lungs). Company Comment: This is a 29-year-old female patient who experienced hemoptysis, pleural effusion, and pericardial effusion among others after 1st dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Details including date of vaccination of 2nd dose, diagnosis/discharge summary is required for further assessment.; Sender's Comments: This is a 29-year-old female patient who experienced hemoptysis, pleural effusion, and pericardial effusion among others after 1st dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Details including date of vaccination of 2nd dose, diagnosis/discharge summary is required for further assessment.

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Current Illness:

ID: 1521944
Sex: F
Age: 44
State: OH

Vax Date: 02/10/2021
Onset Date: 03/11/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: Went to ER on 11Mar2021, where they ran few test and diagnosed her with Pulmonary Embolism in the middle and lower lib of the right lung; Felt very high pulse rate; Short of breath/felt like she couldn't catch her breath under the mask; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Went to ER on 11Mar2021, where they ran few test and diagnosed her with Pulmonary Embolism in the middle and lower lib of the right lung), HEART RATE INCREASED (Felt very high pulse rate) and DYSPNOEA (Short of breath/felt like she couldn't catch her breath under the mask) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. Concomitant products included METOPROLOL for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PULMONARY EMBOLISM (Went to ER on 11Mar2021, where they ran few test and diagnosed her with Pulmonary Embolism in the middle and lower lib of the right lung) (seriousness criteria hospitalization, medically significant and life threatening), HEART RATE INCREASED (Felt very high pulse rate) (seriousness criteria hospitalization and life threatening) and DYSPNOEA (Short of breath/felt like she couldn't catch her breath under the mask) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 11-Mar-2021 due to DYSPNOEA, HEART RATE INCREASED and PULMONARY EMBOLISM. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for prduct used for unknown indication, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Went to ER on 11Mar2021, where they ran few test and diagnosed her with Pulmonary Embolism in the middle and lower lib of the right lung), HEART RATE INCREASED (Felt very high pulse rate) and DYSPNOEA (Short of breath/felt like she couldn't catch her breath under the mask) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 150 - 159 (Inconclusive) between 150 - 159. It was reported that, after vaccination, the next day morning before going to work she was felt very high pulse rate, short of breath. Later, she went to work to school to teach but felt like she couldn't catch her breath under the mask. Her pulse was between 150-159, so she was asked to see her physician. She went to ER on 11-Mar-2021, and few tests were run and she was diagnosed with pulmonary embolism in the middle and lower lib of the right lung. She was hospitalized for 1 night and discharged on following day. The patient was also prescribed Eliquis (blood thinner) and was also taking lower dose of aspirin. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: METOPROLOL

Current Illness:

ID: 1521945
Sex: M
Age: 51
State: CA

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 08/03/2021
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Symptoms: Atrial fibrillation; hurts when puts out laterally; numbness left side of face; blood pressure dropped; stomach(muscle) pains; weakness in the left arm; to whole left side of body being in pain; pain in arm went through arm to neck; burst of pain to neck; pain left side of face; alopecia spot/hair fell out; feeling lightheaded; sever vertigo.; headache; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. Concomitant products included CARVEDILOL for Hypertension. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DIZZINESS (feeling lightheaded), VERTIGO (sever vertigo.) and HEADACHE (headache). On 14-Apr-2021, the patient experienced ALOPECIA (alopecia spot/hair fell out). On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in arm went through arm to neck), NECK PAIN (burst of pain to neck) and FACIAL PAIN (pain left side of face). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), PAIN (hurts when puts out laterally), HYPOAESTHESIA (numbness left side of face), BLOOD PRESSURE DECREASED (blood pressure dropped), MYALGIA (stomach(muscle) pains), ASTHENIA (weakness in the left arm) and MYALGIA (to whole left side of body being in pain). The patient was treated with METOPROLOL for Atrial fibrillation, at an unspecified dose and frequency and APIXABAN (ELIQUIS) for Atrial fibrillation, at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), DIZZINESS (feeling lightheaded), VERTIGO (sever vertigo.), ALOPECIA (alopecia spot/hair fell out), PAIN IN EXTREMITY (pain in arm went through arm to neck), NECK PAIN (burst of pain to neck), FACIAL PAIN (pain left side of face), PAIN (hurts when puts out laterally), HYPOAESTHESIA (numbness left side of face), BLOOD PRESSURE DECREASED (blood pressure dropped), MYALGIA (stomach(muscle) pains), ASTHENIA (weakness in the left arm), HEADACHE (headache) and MYALGIA (to whole left side of body being in pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was advised not to receive the second dose because of all the symptoms had after getting the first dose of vaccination. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of hypertension and use of concomitant medication carvedilol are confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, underlying medical history of hypertension and use of concomitant medication carvedilol are confounder.

Other Meds: CARVEDILOL

Current Illness: Hypertension

Date Died: 05/13/2021

ID: 1521946
Sex: M
Age:
State: KY

Vax Date: 01/01/2021
Onset Date: 05/13/2021
Rec V Date: 08/03/2021
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Symptoms: Strokes; Blood clots; Died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died), CEREBROVASCULAR ACCIDENT (Strokes) and THROMBOSIS (Blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Aneurysm. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Strokes) (seriousness criteria death and medically significant) and THROMBOSIS (Blood clots) (seriousness criteria death and medically significant). The patient died on 13-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter Patient had multiple medical issues , got vaccine after and aneurysm. Very limited information regarding this events has been provided at this time. Further information can't be requested. Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information can't be requested.; Reported Cause(s) of Death: Unknown cause of death

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Current Illness:

ID: 1521947
Sex: M
Age: 63
State: FL

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: he couldn't go back for his 2nd dose; his hand went numb; he had a nerve entrapment in his left elbow; could not receive his 2nd dose of the COVID-19 vaccine as scheduled due to an emergency surgery done to relieve the nerve entrapment; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (his hand went numb), NERVE COMPRESSION (he had a nerve entrapment in his left elbow), INTENTIONAL PRODUCT USE ISSUE (could not receive his 2nd dose of the COVID-19 vaccine as scheduled due to an emergency surgery done to relieve the nerve entrapment) and PRODUCT DOSE OMISSION ISSUE (he couldn't go back for his 2nd dose) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (could not receive his 2nd dose of the COVID-19 vaccine as scheduled due to an emergency surgery done to relieve the nerve entrapment) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (he couldn't go back for his 2nd dose) (seriousness criterion hospitalization). On an unknown date, the patient experienced HYPOAESTHESIA (his hand went numb) (seriousness criterion hospitalization) and NERVE COMPRESSION (he had a nerve entrapment in his left elbow) (seriousness criterion hospitalization). The patient was hospitalized on 26-May-2021 due to HYPOAESTHESIA, INTENTIONAL PRODUCT USE ISSUE and NERVE COMPRESSION, and then on 26-May-2021 due to PRODUCT DOSE OMISSION ISSUE. On 29-May-2021, INTENTIONAL PRODUCT USE ISSUE (could not receive his 2nd dose of the COVID-19 vaccine as scheduled due to an emergency surgery done to relieve the nerve entrapment) had resolved. At the time of the report, HYPOAESTHESIA (his hand went numb) and NERVE COMPRESSION (he had a nerve entrapment in his left elbow) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (he couldn't go back for his 2nd dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant medications reported by investigator No treatment medications provided by the reporter. Patient had to go for an emergency surgery for relieve of the nerve entrapment. He was in the hospital for about 3 days, the surgery happened a month after receiving the 1st dose of the vaccine, around 26MAY2021. Company Comment: This case concerns a 63-year-old male hospitalized with serious unexpected events of hypoaesthesia, nerve compression, intentional product use issue and product dose omission issue. Event onset approximately one month after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 63-year-old male hospitalized with serious unexpected events of hypoaesthesia, nerve compression, intentional product use issue and product dose omission issue. Event onset approximately one month after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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Current Illness:

ID: 1521948
Sex: U
Age:
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Rec V Date: 08/03/2021
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Symptoms: modernashotgivemeheartattack; Modernashotgivemeashortofbreath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (modernashotgivemeheartattack) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (modernashotgivemeheartattack) (seriousness criterion medically significant) and DYSPNOEA (Modernashotgivemeashortofbreath). At the time of the report, MYOCARDIAL INFARCTION (modernashotgivemeheartattack) and DYSPNOEA (Modernashotgivemeashortofbreath) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Very limited information regarding the events has been provided at this time. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Regulatory Authority follow up received. On 28-Jul-2021:Regulatory Authority follow up received.; Sender's Comments: Very limited information regarding the events has been provided at this time.

Other Meds:

Current Illness:

ID: 1521949
Sex: F
Age: 53
State: CA

Vax Date: 02/24/2021
Onset Date: 03/01/2021
Rec V Date: 08/03/2021
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Allergies: Allergy to Reglan

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Symptoms: Developed moderate tinnitus about 10 days after my 2nd Pfizer vaccination. Almost 5 months later, the tinnitus persists and disrupts my daily life and sleep. I saw an Ear, Nose, Throat doctor who said they have seen multiple patients who developed tinnitus from the vaccine.

Other Meds: Qvar, Gabapentin, Lexapro, Edarbi

Current Illness: None

ID: 1521950
Sex: F
Age: 36
State: FL

Vax Date: 03/29/2021
Onset Date: 03/31/2021
Rec V Date: 08/03/2021
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Symptoms: Non stop Tinnitus in both ears

Other Meds: None

Current Illness: None

ID: 1521951
Sex: M
Age: 1
State: GU

Vax Date: 07/12/2021
Onset Date: 07/29/2021
Rec V Date: 08/03/2021
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Allergies: No known allergies

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Symptoms: Patient in for red pimple like lesions on his abdomen and back noticed since 4 days now. Parents state the older papular rashes are drying up but new ones are noted on the face, left shoulder, left axilla, right arm, 3 on the right thigh and one on the right leg. Rashes start as red papules which become crusted. He had his Varicella Vaccine #1 given on July 12, 2021. No new soap, lotion used. No new food eaten. They have dogs outside the house. Nobody else has it at home. He also has a runny nose with clear nasal discharges but is getting better. No fever or cough. No fast or labored breathing. He is active and eating well. No sick contacts at home but goes day care. DIAGNOSIS: Parents were advised since he was noted with new red papules over the weekend and had old ones which are drying up now with history of Varicella vaccine on 7/12/2021, rashes likely from the Varicella vaccine. he has no exposure to active Tuberculosis, none reproted from daycare and nobody at home has it. Parents were advised not to bring him back to daycare until all the lesions are dried up. Advised he is contagious too though it is from the vaccine. Will report to VAERS.

Other Meds: NO

Current Illness: NO

ID: 1521952
Sex: M
Age: 68
State: FL

Vax Date: 06/01/2021
Onset Date: 06/06/2021
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: I began to hemorrhage severely and lost 6 pints of blood. This was 3 days after a colonoscopy where two polyps were removed. There was no bleeding after this, it started three days later after I had received the vaccine I also was severely short of breath for two weeks afterwards

Other Meds: Zinc 50 mg

Current Illness: no

ID: 1521953
Sex: F
Age: 28
State: PA

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 08/03/2021
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Allergies: Sulfa antibiotics

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Symptoms: Uterine cramping, intense vaginal bleeding similar to a menstrual period. Soaking pads every 2 hours for first 2 days, then moderate bleeding for the next 3 days. Completely unexpected, not listed on the vaccine data sheet as a possible side effect. It was not my normal time for menstruation.

Other Meds: None

Current Illness: None

ID: 1521954
Sex: M
Age:
State: NY

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Rec V Date: 08/03/2021
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Symptoms: bullous drug eruption with features of Stevens-Johnson syndrome; bullous drug eruption with features of Stevens-Johnson syndrome; painful rash; blisters; persistent skin lesions; myalgia; fever; This literature-non-study case was reported in a literature article and describes the occurrence of DERMATITIS BULLOUS (bullous drug eruption with features of Stevens-Johnson syndrome), STEVENS-JOHNSON SYNDROME (bullous drug eruption with features of Stevens-Johnson syndrome), RASH (painful rash), BLISTER (blisters) and SKIN LESION (persistent skin lesions) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension, Hyperlipidemia, Diabetes mellitus, Chronic kidney disease, Coronary artery disease and Hypothyroidism congenital. Family history included Myasthenia gravis (Patient's sibling, who died of complications of myasthenia gravis). Concurrent medical conditions included Obesity and Alcohol use. Concomitant products included AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRIN 81), BRIMONIDINE, CLOPIDOGREL, FAMOTIDINE, FUROSEMIDE, GABAPENTIN, INSULIN ASPART, INSULIN GLARGINE, LEVOTHYROXINE, LISINOPRIL, METOPROLOL, PRAVASTATIN and TAMSULOSIN for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DERMATITIS BULLOUS (bullous drug eruption with features of Stevens-Johnson syndrome) (seriousness criteria hospitalization prolonged and medically significant), STEVENS-JOHNSON SYNDROME (bullous drug eruption with features of Stevens-Johnson syndrome) (seriousness criteria hospitalization prolonged and medically significant), RASH (painful rash) (seriousness criterion hospitalization prolonged), BLISTER (blisters) (seriousness criterion hospitalization prolonged), SKIN LESION (persistent skin lesions) (seriousness criterion hospitalization prolonged), MYALGIA (myalgia) and PYREXIA (fever). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to BLISTER, DERMATITIS BULLOUS, RASH, SKIN LESION and STEVENS-JOHNSON SYNDROME. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PREDNISONE (oral) for Adverse event, at an unspecified dose and frequency; MUPIROCIN for Adverse event, at an unspecified dose and frequency and Wound care (bullae were drained) for Dermatitis bullous. At the time of the report, DERMATITIS BULLOUS (bullous drug eruption with features of Stevens-Johnson syndrome), STEVENS-JOHNSON SYNDROME (bullous drug eruption with features of Stevens-Johnson syndrome), RASH (painful rash), BLISTER (blisters), SKIN LESION (persistent skin lesions), MYALGIA (myalgia) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: positive (Positive) serum antibodies to bullous pemphigoid (BP), BP 180 and BP 230, were 8 and <2 respectively (within the normal limit with range <20). In 2021, Biopsy: abnormal (abnormal) The histopathology showed full-thickness epidermal necrosis and a very sparse lymphocytic inflammatory infiltrate.. In 2021, Blood creatine phosphokinase: high (High) 347 and an incidental findings of mild Acute Kidney Injury on Chronic Kidney Disease.. In 2021, Blood glucose: high (High) hyperglycemia. In 2021, Blood potassium: high (High) hyperkalemia. In 2021, Body mass index: 31.65 (High) high. In 2021, Physical examination: abnormal (abnormal) extensive areas of painful violaceous patches on his abdomen, buttocks and lower extremities, many of which developed into large flaccid bullae. Patient had no involvement in his mucous membranes, palms, soles, joints or targetoid lesions. Significant lower extremity muscle tenderness, stiffness with preserved strength. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Transaminases: high (High) mild transaminitis. In 2021, Vital signs measurement: normal (normal) normal. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered DERMATITIS BULLOUS (bullous drug eruption with features of Stevens-Johnson syndrome), STEVENS-JOHNSON SYNDROME (bullous drug eruption with features of Stevens-Johnson syndrome), RASH (painful rash), BLISTER (blisters), SKIN LESION (persistent skin lesions), MYALGIA (myalgia) and PYREXIA (fever) to be possibly related. Patient has no known drug or food allergy or rheumatological disease. Patient denied smoking or recreational drug use. This is a 66-year-old male patient who experienced dermatitis bullous and Stevens-Jonson syndrome among others on an unspecified date after mRNA1273 administration. Very limited information regarding this event has been provided at this time. Date of vaccination, date of event onset and discharge summary is required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received by safety on 28-Jul-2021 included a nonsignificant ICSR abstract.; Sender's Comments: This is a 66-year-old male patient who experienced dermatitis bullous and Stevens-Jonson syndrome among others on an unspecified date after mRNA1273 administration. Very limited information regarding this event has been provided at this time. Date of vaccination, date of event onset and discharge summary is required for further assessment.

Other Meds: AMLODIPINE; ASPIRIN 81; BRIMONIDINE; CLOPIDOGREL; FAMOTIDINE; FUROSEMIDE; GABAPENTIN; INSULIN ASPART; INSULIN GLARGINE; LEVOTHYROXINE; LISINOPRIL; METOPROLOL; PRAVASTATIN; TAMSULOSIN

Current Illness: Alcohol use; Obesity

ID: 1521955
Sex: F
Age:
State: OH

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Rec V Date: 08/03/2021
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Symptoms: The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.; This literature-non-study case was reported in a literature article and describes the occurrence of CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) (seriousness criterion hospitalization). The patient was treated with CORTICOSTEROIDS (oral) for Chilblains, at an unspecified dose and frequency. At the time of the report, CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy skin: superficial and mid-dermal perivascular cuffed lym (Inconclusive) Superficial and mid-dermal perivascular cuffed lymphocytic infiltrate. Mild superficial dermal edema is present. No interface changes are present. There is no evidence of vasculitis or vasculopathy. Initial and multiple deeper sections were examined. Direct immunofluorescence of the skin showed no specific immunoreactants detected. In 2021, Blood immunoglobulin G: positive (Positive) Present one month post-vaccine. In 2021, Blood test: normal (normal) normal. negative inflammatory markers and autoimmune serologies. In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) to be possibly related. It was reported that the patient will not get the second COVID-19 vaccine dose. Furthermore, it was made known that the chilblains-like lesions suggest an antibody response from either 1 vaccine dose or a previous PCR-negative COVID-19 infection. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Asthma

ID: 1521956
Sex: M
Age:
State: NY

Vax Date: 01/08/2021
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Rec V Date: 08/03/2021
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Symptoms: Laryngal malacia; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGOMALACIA (Laryngal malacia) in a male patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 012l20a) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): 17-Dec-2020- Hypothyrodism. MEDICAL HISTORY (Patient): The patient's past medical history included No adverse event. On 08-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The mother's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 22-May-2021. On an unknown date, the patient was diagnosed with LARYNGOMALACIA (Laryngal malacia) (seriousness criterion medically significant). The patient was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. The vaginal delivery occurred on 24-May-2021, which was reported as Full-term. For neonate 1, with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. At the time of the report, LARYNGOMALACIA (Laryngal malacia) outcome was unknown. No concomitant and treatment medications were provided. Company comment: This is a child case whose mother was a case of maternal exposure during pregnancy and with associated adverse event of Laryngomalacia on the child. Very limited information regarding these events have been provided at this time. Further information has been requested. This case was linked to MOD-2021-052207 (Parent-Child Link). See case MOD-2021-052207 for details regarding the Parent case.; Sender's Comments: This is a child case whose mother was a case of maternal exposure during pregnancy and with associated adverse event of Laryngomalacia on the child. Very limited information regarding these events have been provided at this time. Further information has been requested.

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ID: 1521957
Sex: F
Age:
State: FL

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Symptoms: Neuropathy in arm for 3 weeks; pins and needles sensation; This spontaneous case was reported by a non-health professional and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) (seriousness criterion medically significant) and PARAESTHESIA (pins and needles sensation). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in arm for 3 weeks) and PARAESTHESIA (pins and needles sensation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product information was not provided by reporter. No treatment information was provided. Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.

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Date Died:

ID: 1521958
Sex: F
Age:
State: MI

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Symptoms: Lost her mother after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Lost her mother after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information was provided. No relevant concomitant medications were reported. Very limited information regarding the events has been provided at this time; Sender's Comments: Very limited information regarding the events has been provided at this time; Reported Cause(s) of Death: unknown cause of death

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ID: 1521959
Sex: F
Age: 65
State: AR

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 08/03/2021
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Symptoms: Seizures; High blood pressure; Patient was not strong enough to take the phone; Patient couldn't use hands and arms; Patient didn't speak coherently; Violent chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizures) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SEIZURE (Seizures) (seriousness criterion medically significant), HYPERTENSION (High blood pressure), ASTHENIA (Patient was not strong enough to take the phone), HYPOKINESIA (Patient couldn't use hands and arms), SPEECH DISORDER (Patient didn't speak coherently) and CHILLS (Violent chills). At the time of the report, SEIZURE (Seizures), HYPERTENSION (High blood pressure), ASTHENIA (Patient was not strong enough to take the phone), HYPOKINESIA (Patient couldn't use hands and arms), SPEECH DISORDER (Patient didn't speak coherently) and CHILLS (Violent chills) outcome was unknown. No adverse events were experienced after the first dose of COVID-19 vaccine, which was "all ok". No information provided about the first dose of the vaccine. No concomitant medication, treatment received or medical history was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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ID: 1521960
Sex: M
Age:
State: MN

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Symptoms: Could not walk, hospitalized for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could not walk, hospitalized for 4 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Could not walk, hospitalized for 4 days) (seriousness criterion hospitalization). The patient was hospitalized for 4 days due to GAIT INABILITY. At the time of the report, GAIT INABILITY (Could not walk, hospitalized for 4 days) had resolved. No concomitant medication was reported. It was reported the patient could not walk after receiving the second vaccine dose. He was hospitalized 4 days, treated with steroids and got better. Company Comment Very limited information regarding this event has been provided at this time. Further information has been requested. Cross linked with case MOD21-124652; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

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ID: 1521961
Sex: F
Age: 80
State: MN

Vax Date: 02/25/2021
Onset Date: 02/01/2021
Rec V Date: 08/03/2021
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Symptoms: Feels like she injured it, like a sprain; Sometimes has no strength in her left shoulder; when she coughs, it sometimes hurts her stomach and chest; Cough; Hurts in the area the injection was administered; Arm sore for 5 months; Viral pneumonia/ was very sick; was very sick; Arm aching and sore; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA VIRAL (Viral pneumonia/ was very sick) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Automobile accident and Fractured sternum. Concurrent medical conditions included Chest pain (non-cardiac). Concomitant products included DULOXETINE and CLONAZEPAM for an unknown indication. On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Arm aching and sore). On an unknown date, the patient experienced PNEUMONIA VIRAL (Viral pneumonia/ was very sick) (seriousness criterion medically significant), ILLNESS (was very sick), LIGAMENT SPRAIN (Feels like she injured it, like a sprain), MUSCULAR WEAKNESS (Sometimes has no strength in her left shoulder), ABDOMINAL PAIN UPPER (when she coughs, it sometimes hurts her stomach and chest), COUGH (Cough), INJECTION SITE PAIN (Hurts in the area the injection was administered) and MYALGIA (Arm sore for 5 months). The patient was treated with AMOXICILLIN for Viral pneumonia, at an unspecified dose and frequency. At the time of the report, PNEUMONIA VIRAL (Viral pneumonia/ was very sick), ILLNESS (was very sick), MUSCULAR WEAKNESS (Sometimes has no strength in her left shoulder), ABDOMINAL PAIN UPPER (when she coughs, it sometimes hurts her stomach and chest), COUGH (Cough), INJECTION SITE PAIN (Hurts in the area the injection was administered) and MYALGIA (Arm sore for 5 months) outcome was unknown and PAIN IN EXTREMITY (Arm aching and sore) and LIGAMENT SPRAIN (Feels like she injured it, like a sprain) had not resolved. After receiving her second dose of the vaccine on 25 Feb 2021, the patient's arm had been aching and sore for about 5 months at the time of report. She was not doing anything that would make the aching worse. The aching was continuous and not going away. It hurt in the area where the injection was administered. It felt like she injured it, like a sprain. She sometime had no strength in her left shoulder. The vaccine was administered in her left arm, which is her non dominant arm. The patient was exposed to her daughter, who had a bad cold, which turned into viral pneumonia. She was quarantined and took amoxicillin, but she still had a cough from it at the time of this report. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Automobile accident and Fractured sternum could be a contributory factor. Treatment included amoxicillin for viral pneumonia.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Automobile accident and Fractured sternum could be a contributory factor.

Other Meds: DULOXETINE; CLONAZEPAM

Current Illness: Chest pain (non-cardiac)

ID: 1521962
Sex: U
Age:
State: CO

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Symptoms: They have vials in a regular freezer which will be 4 weeks in a couple of days; The case was considered invalid as other info, not qualifying for reporting- CEP. It was not confirmed if patient was administered the vaccination or not. This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist reported that: Is the Reporter a Healthcare Professional (HCP)?: Yes; Occupation/ Specialty: Pharmacist Is the reporter the prescribing HCP?: No; Name: Unknown, Address; Unknown; Occupation/ Specialty: Unknown Is the reporter's contact information available to you or a sub-contracted party?: Unknown Suspect Product(s): Pfizer Covid-19 Vaccine Start date: Unknown Stop date: Unknown Verbatim and Event Description: The Caller, Withheld is a Pharmacist, asking regarding the storage of the Pfizer Covid-19 vaccine. They have vials in a regular freezer which will be 4 weeks in a couple of days. Asked if they can still use the vaccine. Provided PMI contact number and HOO. Warm transferred to PMI (Withheld) and created Manual PC form. Created and submitted CITI form #. Medical Information: Were any medical questions addressed by this program forwarded/referred to Medical Information: Yes Information on lot/batch number has been requested. Amendment: This follow up is being submitted to amend previously reported information: event recoded to no adverse effect.

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Current Illness:

ID: 1521963
Sex: M
Age:
State: FL

Vax Date: 03/17/2021
Onset Date: 04/30/2021
Rec V Date: 08/03/2021
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Symptoms: Having trouble breathing when talking; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 65-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208) via an unspecified route of administration in right arm on 17Mar2021 13:15 as dose 1, single (at the age of 64-years-old) for COVID-19 immunization and received unspecified Pfizer vaccine (Lot Number- Er8737) via an unspecified route of administration in left arm on 17Mar2021 as dose 2, single for unspecified indication. Patient did not receive any other vaccine in four weeks. Patient did not had COVID-19, prior to vaccination. Patient underwent COVID-19 (nasal swab) test with result as negative. Patient medical history included Multiple Sclerosis. The concomitant medications were not reported. On 30Apr2021, the patient experienced trouble breathing when talking. The pulmonologist inhaler prescriptions did not alleviate any symptoms. The adverse events resulted in doctor or other healthcare professional office/clinic visit emergency room/department or urgent care. The patient received treatment as pulmonologist tests with unknown results and medications. The outcome of the event was not recovered.

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Current Illness:

ID: 1521964
Sex: M
Age:
State: PA

Vax Date: 04/25/2021
Onset Date: 06/01/2021
Rec V Date: 08/03/2021
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Symptom List:

Symptoms: I have had several heart attacks which I didn't know I had and I didn't feel; It (EKG) came back bad funky and I had my first EKG done and they said it was funky; After the second shot I went into the EKG and I found heart problems; I had a heart catheterization that came back funky; I have blockages in heart and arteries; I am only at 30 percent of the pump volume which I don't feel; I have blockages in heart and arteries; I am only at 30 percent of the pump volume which I don't feel; I have heart issues; There is a gene that's been activated and is causing this ailment; It (COVID Vaccine) triggered the gene/ Illness; That the only destruction in my body has been adding the Pfizer vaccines; stomach; sodium level after night; control blood glucose; This is a spontaneous report from a contactable consumer (patient himself). A 55-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8735) intramuscularly in deltoid on 25Apr2021 as dose 2, single (at the age of 55-years-old) for COVID-19 immunization. Vaccination facility type was reported as clinic. Patient did not receive any vaccination 4 weeks prior to the COVID-19 shot. Patient medical history was reported as none. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER8730) intramuscularly in deltoid on 03Apr2021 as dose 1, single for COVID-19 immunization. Patient had the Pfizer vaccine in April the first shot and then in June he had a pre-admission test EKG, never had one before his life, he never got sick and it (EKG) came back bad funky and he never had one before his life. He had a perfect health and checked his blood panel twice a year, it was not even more self, he had two different doctors look at it, have multiple therapist that he worked with to monitor his health and chances and he had his first EKG done and they said it was funky. So he had an Echo cardiogram next that came back funky. Then he had a heart catheterization that came back funky and they said that he had several heart attacks which he did not know he had and he did not feel and that he had blockages in heart and arteries and what not, which he did not feel and he was only at 30 percent of the pump volume which he did not feel and then he currently there was a gene that was being activated and was causing this ailment, illness and it was a previous condition to some type of a heart condition certainly (further clarification unknown). He had never been sick in his whole entire life, he did not get sick, he had a gentle health and good overall health and now suddenly he had heart issues and he was on heart medicine and he was suspecting the only thing that changed in recent history was getting the Pfizer vaccine which he did not wanted to get and he got it because he was pressured into it by family and doctors and everybody in the community and surely afterwards he developed a heart condition and he thought there was a link. When confirmed the name of the medication as Pfizer COVID Vaccine, he stated, he thought it (Covid Vaccine) triggered the gene. When probed that the side effects started after the first shot, he stated, after the second shot he went into the EKG and he found heart problems. When probed that the consumer was looking for a solution for the same, he stated, he wanted to notify Pfizer and he wanted to be contacted just to know if there was any cardio or heart related issues with the Pfizer vaccine that had been experienced by other people especially people like himself who are healthy otherwise in their 50s. It did not make sense to him and that was the only thing that he could conclude that the only destruction in his body had been adding the Pfizer vaccines. He stated, the start date of the event was in June, say it was on 28Jun2021, no 27Jun2021. No, it had to be earlier than that, it was on Sunday because he was in doctor office, a week earlier 22Jun2021. Treatment medications included a bunch of medicines for because of the heart condition. He stated Entresto, Jardiance, Metformin, he had more, Lipitor and also Metoprolol and then also Atorvastatin and then he was also on Pantoprazole and then also an Aspirin. He took Entresto and Jardiance for his heart. He took metformin to help with glucose level to keep them low so his heart improves to function. Patient was taking atorvastatin and metoprolol one was form of Lipitor and he thought the other one is for his stomach. No he thought the Metoprolol, he thought that was for his heart or for his poor Lipitor, like one of them was generic form of Lipitor, Entresto was for his heart and Metformin was for glucose to control the levels for heart. He was on Aspirin for heart clotting (block). For pantoprazole patient was not sure, but told it was for his stomach the rest were for his heart and for the Lipitor type of drugs and also to control blood glucose also for his heart sodium level after night so that his heart pumps and worked efficiently and after 30 percent which was ridiculously low. The outcome of the events was unknown. Follow-Up (23Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1521965
Sex: F
Age:
State: KY

Vax Date: 07/16/2021
Onset Date: 07/16/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; Around 30 minutes after receiving first shot of Pfizer, my throat started to feel "funny" my mouth and throat had a tingling sensation and a metallic taste in my mouth. Within 5 minutes my throat bega; This is a spontaneous report from a contactable consumer. This 30-year-old female consumer (patient). A 30-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198, Expiration date: unknown), via unspecified route, administered in arm right on 16Jul2021 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history includes Penicillin allergy and covid-19. Concomitant medications include vitamin e, cyanocobalamin (VITAMIN B-12), folic acid, omeprazole (PROTONIX). No other vaccines received 4 weeks prior to vaccination. Prior to vaccination patient was diagnosed with covid and since the vaccination the patient has been tested for covid. On 16Jul2021 12 :45 AM, after the vaccination, the patient throat started to feel "funny" her mouth and throat had a tingling sensation and a metallic taste in her mouth. Within 5 minutes her throat began to feel tight. It progressively got tighter. she went straight to the ER. her blood pressure was 160/95 and heart rate was 150. her throat did not close all the way off thankfully but closed enough for her to not be able to swallow. Patient received steroid pack and steroid shot as treatment for the observed events. The patient underwent lab tests and procedures on 16Jul2021 which include Blood pressure 160/95, heart rate 150 and SARS-CoV-2 test which showed a negative result. The outcome of the events are recovering. No follow-up attempts possible. No further information expected

Other Meds: VITAMIN E [TOCOPHEROL]; VITAMIN B-12; FOLIC ACID; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1521966
Sex: M
Age:
State: AR

Vax Date: 05/11/2021
Onset Date: 07/18/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
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Lab Data:

Allergies:

Symptom List:

Symptoms: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received the second dose of bnt162b2 (BNT162B2, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left/ Left shoulder area on 11May2021 at 01:00 PM (Batch/Lot Number: EW0164; Expiration Date: 31Aug2021) as a single dose and the first dose via an unspecified route of administration, administered in Arm Left/ Left shoulder area on 03Apr2021 (Batch/Lot Number: ER8737; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunization. Medical history included ongoing gastro reflux (has silent reflux and the doctor put him on a generic form of Prilosec). The patient did not have any family history. The patient's concomitant medications were not reported. Age at time of vaccination was 45 years. The patient had tested positive for rapid COVID antibody test for COVID-19 on 18Jul2021. Patient has had both doses of the Covid vaccines and took a rapid test 2 months afterwards and it came back positive. He wants to know if Pfizer has heard of anything like this before. Patient would like to know if there have been any other reports of people testing positive for COVID-19 after receiving both doses. Patient would like to know if there was any information regarding someone showing a false positive test result on a rapid test for COVID-19. Patient stated he will be going for a blood test to confirm the test result. Patient would like to know if the efficacy of the Pfizer COVID vaccine is 94.8 percent. Stated he was going to have a blood test, since it was more accurate. Thinks his appointment for that was at 11am today. He thought he should go ahead and have the antibody test as well, but then decided to call the source since Pfizer should have this information available, so he decided to call and ask Pfizer if this was something heard of. No further details provided. Got the shots around his birthday. Had the first Covid dose on 03Apr2021 in the left shoulder area at 11am. Unable to provide the NDC, expiry, or dose, but provides Lot number of ER8737. Had the second dose on 11May2021 in the left shoulder area. Unable to provide the NDC, expiry, or dose, but does provide lot number details. No problems with vaccines in past. Had the rapid test yesterday. He went to the (pharmacy name) and got a test kit, but wasn't comfortable about the result since he works in food service and this affects his work. It was the Covid antibody rapid test and it had a 5 digit number behind it. Does not provide any further details. States he does not know if this matters, but he has silent reflux and the doctor put him on a generic form of Prilosec for gastro reflux. No further details provided. The outcome of the event tested positive for COVID-19 was not recovered. Conclusion of Previously Completed Investigation stated that the complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE INJECTABLE lot EW0164 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0164, fill lot EP8696, and the formulated drug product lot EP8593. A complaint sample was not returned. No related quality issues were identified. QA Review and Rationale stated that the complaint and it was classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect related to lot ER8737 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot ER8737 pending review of lot genealogy. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (site name) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There is no impact to the quality of the lot. It is unknown how the product was handled, stored, or administered after it left the (site name) site. Pfizer (site name) o Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch meets potency specifications. It is unknown how the product was handled, stored, or administered after it left the Pfizer (site name) site. Impact Analysis stated based on the final scope of the investigation, which was limited to the reported finished goods lot and associated fill and formulated drug product lots, and that a root cause related to the production process was not identified, the reported issue is not representative of the lot and does not indicate a negative impact on product quality. No regulatory notification is required. Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion stated the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8737 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot EP8586. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The scope of this investigation included the reported finished goods lot ER8737, fill lot EW3426, and the formulated drug product lot

Other Meds:

Current Illness: Gastroesophageal reflux

ID: 1521967
Sex: M
Age:
State: IL

Vax Date: 06/23/2021
Onset Date:
Rec V Date: 08/03/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: myocarditis/inflammation of the heart or the lining of the heart.; pericarditis/inflammation of the heart or the lining of the heart.; could not work a full 8 hour shift after getting the vaccine; first dose of the Pfizer BionTech COVID19 vaccine on March/then received the second dose on June.; This is a spontaneous report from a contactable consumer or other non-health care professional (parent). A 32-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 23Jun2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 on an unknown date in Mar2021 as dose1, single for COVID-19 immunization and experienced got COVID on the end of March and beginning of April, fever, sore arm, pale and fatigued. On an unknown date, the patient experienced myocarditis/inflammation of the heart or the lining of the heart, pericarditis/inflammation of the heart or the lining of the heart, could not work a full 8 hour shift after getting the vaccine and first dose of the pfizer biontech covid19 vaccine on march/then received the second dose on June. The patient underwent lab tests and procedures which included blood test: normal result and electrocardiogram: normal result on unknown date, sars-cov-2 test: positive on Mar2021. Reporter reported on behalf of her two sons (32 and 33 years old) who got myocarditis and pericarditis after receiving the vaccine. They received the first dose of the Pfizer BionTech COVID19 vaccine on March then got COVID on the end of March and beginning of April then received the second dose on June. She said that it was after the second dose, they started having problems. She did call the clinic but was "clueless." A nurse told her that the symptoms his sons are having is because the vaccine can cause myocarditis and pericarditis and explained it was the inflammation of the heart or the lining of the heart. The next day after reporting that, CDC and Pfizer came up with it but was too late for that. They went to the doctor and got EKG and blood work and something else which the results were normal, but still has it. She told them to do an ECHO to find out what happened. She said that normal people got sore arms. His other son got fever, shortness of breath and a little chest heaviness so the doctor put him on Prednisone again. His one son could not work a full 8 hour shift after getting the vaccine. His other son's work was very considerate for allowing him to sit down for 10-15 minutes. She said that his son was a normal full grown man and he has migraine that was treated and controlled. His other son who the 1st vaccine experienced shortness of breath and can't even work a full day. She thought that the vaccine should help people. They have received 2 forms (manufacturer report) from Safety for her son on Saturday (17Jul2021) and it has two different dates and different numbers (# for (Initials) and # for (Initials)) which says 9Jul and 13Jul. She wants them to be accurate for both of his son because they are not going to pay for this and that Pfizer should pay for this. She called back and she said no follow up after waiting for EKG for 4 days and that the clinic is "clueless. She thinks that Pfizer should be responsible for all the co-pay to pay here. The medical information which was booked in as initial report of case and processed as 2nd dose BNT162b2 for the 32 year-old son named (Initials). As per the narrative information "Reporter was calling on behalf of her two sons (32 and 33 years old) who got myocarditis and pericarditis after receiving the vaccine. They received the first dose of the Pfizer BionTech COVID19 vaccine on March then got COVID on the end of March and beginning of April then received the second dose on June, both son received 1st dose Pfizer BionTech COVID19 vaccine on March and 2nd dose on June. And both sons got COVID after the 1st dose (on the end of March and beginning of April). While in another medical information source 00325605 (PRD 07Jul2021, booked in as initial, with the same reporter information as #), it was reported that reporter calling for her 33 y/o son, he received his 1st Pfizer vaccine Mar2021 then had contracted COVID- 19 around 04Apr2021. He then received his 2nd Pfizer Covid vaccine on 23Jun21. She stated that her other son, who was 31y/o, had a fever, sore arm, pale and fatigued after he got his 1st Pfizer vaccine dose on 23Jun2021. He still has SOB and chest heaviness from having Covid-19 in April, and was due to get his 2nd Pfizer vaccine and he may not because of what his brother was going through. As per the information in report the son supposed to be the same person as in report #) only received the 1st dose on 23Jun21 and by the time of reporting (07Jul2021) has not yet received the 2nd dose. Hence Please help to confirm below questions for report #: Did the 32 year-old son named (Initials) receive the 2nd dose or not? Which time for 1st dose is correct for the 32 year-old son named (Initials), on March or on 23Jun2021? Response received: Based on the call recordings for INT-#, INT-#, INT-#, all 3 recordings have conflicting information from the caller regarding (Initials) 1st and 2nd dose. INT-# does not specifically speak on any dates that (Initials) has received which dose, INT-# specifically states (Initials) received the 1st dose when (Initials) received the 2nd dose on 23Jun2021 and (Initials) has not received the 2nd dose yet, and INT-# states that (Initials) received the 2nd dose the same day (Initials) received the 2nd dose. The clinical outcome of the events was reported as unknown. Information on lot/ batch number has been requested.

Other Meds:

Current Illness:

ID: 1521968
Sex: F
Age:
State: SC

Vax Date: 01/22/2021
Onset Date: 07/13/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

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Symptom List:

Symptoms: she does not have an amazing immune system; left with what feels like to be fatigue and a bad cold; tested positive for Covid 19 after receiving both doses of the vaccine in Jan and Feb of this year. Both a rapid and a PCR test were positive for Covid 19 on 15 July; tested positive for Covid 19 after receiving both doses of the vaccine in Jan and Feb of this year. Both a rapid and a PCR test were positive for Covid 19 on 15 July; fever; constant chills; a high heart rate; just felt terrible like she had the flu; cough; having symptoms on 13Jul2021. It seemed to sinus related; had sinus pressure and a very light ticklish cough the first day, 13Jul2021; left with what feels like to be fatigue and a bad cold; This is a spontaneous report from a contactable other HCP (Nurse). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200; Expiration Date: 20Jun2021), dose 1 intramuscular, administered in Arm Left (Deltoid Left) on 22Jan2021 19:00 (at the age of 57-years-old) as Dose 1, Single, and dose 2 intramuscular, administered in Arm Left (Deltoid Left) on 13Feb2021, at around 11:00 or 12:00 (at the age of 57-years-old) (Batch/Lot Number: EN6200; Expiration Date: 20Jun2021) as Dose 2, Single for covid-19 immunization. The patient had no medical history. The patient had no family medical history relevant to adverse event. The patient's concomitant medications were not reported. The patient had no other products. No additional vaccines administered on same date of the Pfizer. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The patient started having symptoms on 13Jul2021. It seemed to sinus related, nothing made her think COVID. She explains she had sinus pressure and a very light ticklish cough the first day, 13Jul2021. The second day on 14Jul2021, she had more sinus pressure and frequent cough. On 15Jul2021 (Thursday), she had fever, constant chills, a high heart rate and just felt terrible like she had the flu. She believes her testing positive for COVID-19 and the symptoms she experienced on Thursday are medically significant but did not require hospitalization. The caller verifies her symptoms have improved some. The fever and chills were gone after 24 hours. She was left with what feels like to be fatigue and a bad cold. The physician didn't order any treatment. The place she went to get tested was an urgent care with a physician. A physician saw her and ordered the test. It was reported that, the patient was shocked that she tested positive since she was not working in direct patient care. She asked why, she was breaking through. Wouldn't Pfizer want to know so we can track, why this happening. The patient tested positive for Covid 19 after receiving both doses of the vaccine in Jan2021 and Feb2021 of this year. Both a rapid and a polymerase chain reaction (PCR) test were positive for Covid 19 on 15Jul2021, just a few days ago. When she went to get tested for Covid, she asked if they could tell if it was a variant. She was told a special Blood test was needed. Does Pfizer recommend getting that test to see which variant she was infected with, does Pfizer track it. The one vial expired Jun2021 so that was just when it has to be used and it was given in Feb2021. She asked was Pfizer interested in getting a blood sample, she was willing to give a blood sample so Pfizer can test it. She wanted to report this information but also check with Pfizer in regard to a special blood test. She explains she asked when she got tested if they could tell if it was a variant of COVID or not and was told that it takes a special kind of blood test to determine this. The caller assumed Pfizer would want that blood test done to be able to track where the issue was. The patient does not have an amazing immune system. She hasn't had a cold in 6 or 8 years, so she was not really matching up to the other people breaking through. she was actually tested in (place name) on 15Jul2021. She flew from (place name). She was just on one flight from (place name) and then she drove from (place name). She states she went straight from the airport to an urgent care in (place name). She confirms she was deemed positive for COVID in the state of (place name). The adverse event did not required visit to emergency Room. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (site name) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6200was 5706482 5705159 investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified. When more than one investigation was found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion was blank in the table above, then the investigation record was likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6200was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6200, fill lot EN5332, and the formulated drug product lot EN5321. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There was no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. Reporter seriousness for vaccination failure, covid 19, fever, chills, a high heart rate, just felt terrible like she had the flu was reported as medically significant. The outcome of the events chills and fever was resolved in Jul2021 and outcome of all other events was unknown.

Other Meds:

Current Illness:

ID: 1521969
Sex: F
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: The patient then got COVID-19 and never got the 2nd dose; The patient then got COVID-19 and never got the 2nd dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (BNT162B2, BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included immunodeficiency from an unknown date and unknown if ongoing did go through immunotherapy. The patient's concomitant medications were not reported. On an unspecified date patient experienced the patient then got covid-19 and never got the 2nd dose with, Caller states that she has a patient who was "involved in home health back in Jan and received the 1st dose of the Pfizer COVID-19 Vaccine. The patient then got COVID-19 and never got the 2nd dose. The caller wants to know if the patient can get her 2nd dose or if they need to restart the series over. Caller would also like to know if there are any contraindications for the patient getting the 2nd dose of the Pfizer COVID-19 Vaccine after having had immunotherapy treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome for all events was unknown. Follow-up(19Jul2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a patient that: Caller declined to proceed with report stating she doesn't have all of her information and she will let her son know that they can report and requested transfer to regulatory authority. Full report details not obtained. Information on the lot/batch number has been requested.; Sender's Comments: The reported event Covid 19 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.

Other Meds:

Current Illness:

ID: 1521971
Sex: F
Age:
State: NJ

Vax Date: 03/24/2021
Onset Date: 07/01/2021
Rec V Date: 08/03/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: if she does anything slightly laborious, she will start sweating profusely; lost her sense of smell; pressure in her sinuses and ears/constant pressure and blockage; pressure in her sinuses and ears/constant pressure and blockage; congestion in her sinuses; congestion in her ears; congestion in her nose; congestion in her head; PCR Covid nasal swab, Tested positive; PCR Covid nasal swab, Tested positive; constant tickle in her throat; sneezing; coughing; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number ER8727, expiration date 31Jul2021), via an unspecified route of administration, administered in Arm Left on 24Mar2021 around 17:30-18:00 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6205, expiration date unspecified), via an unspecified route of administration, administered in Arm right on 02Mar2021 as DOSE 1, SINGLE for covid-19 immunization (32 year when vaccinated). On an unknown date in Jul2021, the patient presented with fatigue. On 13Jul2021, the patient developed constant tickle in her throat along with coughing. On 14Jul2021, the patient was tested positive for covid-19 via PCR covid-19 nasal swab. On 16Jul2021, the patient started experiencing congestion in her sinuses, congestion in her ears, congestion in her nose, congestion in her head accompanied by pressure in her sinuses and ears/constant pressure and blockage. On 17Jul2021, the patient lost her sense of smell. On an unknown date the patient also reported that if she does anything slightly laborious, she will start sweating profusely. The patient also informed that it has been a long time since she has weighed herself. The patient did not hospitalize for the events. The outcome of the events was reported as resolving for congestion in her sinuses, congestion in her ears, congestion in her nose, congestion in her head, pressure in her sinuses and ears/constant pressure and blockage, fatigue while it was reported as resolved for constant tickle in her throat, coughing and not recovered for Loss of smell and unknown for PCR Covid nasal swab, tested positive, sneezing, and if she does anything slightly laborious, she will start sweating profusely This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): [Truncated Conclusion - See PR ID of Previously Completed Inv for full text] The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot ER8727 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. A complaint sample was not returned, and photographs were not received. There were no deviations that may. When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely an Offline Contractor Investigation and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. Description of complaint: Caller reporting her experience with the Pfizer COVID 19 vaccine. While reporting she says her fever began 25Mar it was 99.3 and that is ongoing, its gotten higher. She took Tylenol about 2 hours ago when it was 101.7. She would say the fever has worsened because it went up to 101.7. No further information provided. Investigation decision: (Parent) Evaluation Comment: This is a complaint for Lack Of Effect of lot ER8727 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. Pfizer (site name withheld) reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid, and an investigation will be performed. QA Review & Rationale: This is a complaint for Lack Of Effect of lot ER8727 of product PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate The initial scope of this investigation is limited to ER8727 pending review of lot genealogy to determine other in-scope lots. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. A full investigation will be performed. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot ER8727, fill lot EP8679, and the formulated drug product lot EP8566. Manufacturing and packaging batch records were reviewed for the reported complaint lot. (site name withheld) did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. It is unknown how the product was handled, stored, or administered after it left the Pfizer site. Root Cause Analysis/Identif: (site name withheld) Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch continues to meet potency specifications. It is unknown how the product was handled, stored, or administered after it left the (site name withheld). Impact Analysis: Based on the scope of this investigation, the manufacturing and packaging batches remain acceptable and the reported complaint is not representative of the lot. No regulatory notification is needed. Improve/Control: Corrective / Preventive Action: There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot ER8727 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot ER8727, fi

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ID: 1521972
Sex: M
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Rec V Date: 08/03/2021
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Symptoms: Guillian Barre syndrome; High inflammatory markers; This is a spontaneous report from a non-contactable consumer or other non-HCP. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose number unknown single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Events took place after use of product. On an unspecified date in 2021, the patient experienced high inflammatory markers, suspected Guillian Barre syndrome. The symptoms began around 40 days after vaccine, he had reported to Pfizer and another regulatory authority. 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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Current Illness:

ID: 1521973
Sex: U
Age:
State:

Vax Date: 06/30/2021
Onset Date: 07/01/2021
Rec V Date: 08/03/2021
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Symptoms: Affected my arm; My elbow and around elbow too, it seems like when I grip my fist together, it hurts there and if I lift something, grips my fist and pull up, it hurts; It seems like my joint or like straight out to it, it hurts; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: EWO185), via an unspecified route of administration, administered on 30Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: unknown), via unspecified route of administration, administered on unspecified date as dose 1, single for COVID-19 immunisation and experienced ache. It was reported that on an unspecified date in Jul2021, the patient had a vaccine shot, the second one, patient affected arm, elbow and around elbow too, it seems like when patient grip fist together, it hurts there and if lift something, grips patient fist and pull up, it hurts and it has been three weeks that is why (sentence incomplete). Patient looked online and it says it is for couple of days, it is not couple of days, it is three weeks. Patient just wanted to know what (sentence incomplete). On an unspecified date in 2021, it seems like joint or like straight out to it, it hurts, it's a kind of (sentence incomplete), it was not worse, but it was not better, it was just the same amount." Patient stated as, "I have got EWO185, I don't know if it is O or 0, let me read it again, it is EW and then I think it is 0185 or it is O, I am not sure if it is O or 0." and just wanted to know about the side effect why it was not going away. The outcome of event was not recovered.

Other Meds:

Current Illness:

ID: 1521974
Sex: M
Age:
State: NC

Vax Date: 04/09/2021
Onset Date: 04/22/2021
Rec V Date: 08/03/2021
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Symptoms: I woke up on 22Apr2021 at around 2 a.m. with very severe pain in my chest region; I also had some difficulty breathing as this tended to make the pain worse; I was not able to go back to sleep; I still feel pain in that area of my body and extending to my back.; thought I was suffering from pericarditis; This is a spontaneous report from a contactable other Hcp(patient). A 52-year-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0150), via an unspecified route of administration on 09Apr2021 at 11:00 am (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration on 19Mar2021 at 11:00 am (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin taken for diabetes mellitus, start and stop date were not reported. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Apr2021 at around 2:00 a.m, the patient experienced very severe pain in my chest region. He was not able to go back to sleep and had some difficulty breathing as this tended to make the pain worse. He literally stayed up until daybreak when he went in to see my doctor. The doctor performed electrocardiogram test and found my heart to be functioning well despite the severe pain that he was experiencing. She thought he was suffering from pericarditis. She decided to go the nearest ER for further tests. He stayed in the ER for about 5 hours during which I was subjected to a bunch of tests which turned out negative, patients primary care doctor then prescribed for me colchicine BID and ibuprofen 600 mg TID for 3 months. He still feels pain in that area of my body and extending to my back. The patient was visited to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care for the events. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unspecified date 2021 found my heart to be functioning well. The outcome of the events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pericarditis and the suspect drug BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds: METFORMIN

Current Illness:

ID: 1521975
Sex: M
Age:
State:

Vax Date: 05/14/2021
Onset Date:
Rec V Date: 08/03/2021
Hospital: Y

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Symptoms: Caller said his son suffered an autoimmune response; This is a spontaneous report from a contactable consumer (Mother) reported for patient (son). A 13-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on 14May2021 (at the age of 13-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. The concomitant medications of the patient were not reported. The reporter said that after receiving one dose and got tested for antibody, the result was negative. She wanted to know if that was normal and if it happened and wanted to know if her son was protected while testing negative for the antibody. She called on behalf of her son who received the 1st dose of the Pfizer Biontech COVID19 vaccine on 14May2021 and was supposed to receive the 2nd dose on 08Jun2021, but missed it due to hospitalization. She said her son suffered an autoimmune response 2 days after. Her son also tested negative for the antibody after first dose. She wanted recommendation on getting the 2nd dose of the vaccine beyond the 21-day window. The event led to hospitalization. The patient underwent lab tests and procedures which included antibody test: negative on an unspecified date. The outcome of the events was reported as unknown. Information on the lot/batch number has been requested.

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Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm