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: 1284713
Sex: M
Age:
State: TN

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/04/2021
Hospital:

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Symptoms: ITCHY EYES; EYE SWELLING; This spontaneous report received from a health care professional concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: unknown) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the subject experienced eye swelling. On 29-APR-2021, the subject experienced itchy eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from eye swelling, and itchy eyes. This report was non-serious.

Other Meds:

Current Illness:

ID: 1284714
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 05/04/2021
Hospital:

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Symptoms: HEART SENSATION OF TURNING INSIDE OUT; WEIRD FEELING; SORE ARM; FATIGUE; painful injection site; HEADACHE; NUMBNESS AND TINGLING IN RIGHT SIDE OF FACE; NUMBNESS AND TINGLING IN RIGHT SIDE OF CHEST AND RIBCAGE; DISORIENTED; TROUBLE GRASPING REFLEX; PAIN IN EARS; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, hypothyroid, pollen allergy, alcoholic, 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: 041A21A, expiry: 21-JUN-2021) dose was not reported, administered on 28-APR-2021 14:45 for prophylactic vaccination. Concomitant medications included salbutamol for asthma, levothyroxine sodium for hypothyroid, and liothyronine sodium for hypothyroid. On 28-APR-2021, the subject experienced numbness and tingling in right side of face. On 28-APR-2021, the subject experienced numbness and tingling in right side of chest and ribcage. On 28-APR-2021, the subject experienced disoriented. On 28-APR-2021, the subject experienced trouble grasping reflex. On 28-APR-2021, the subject experienced pain in ears. On 28-APR-2021, the subject experienced weird feeling. On 28-APR-2021, the subject experienced sore arm. On 28-APR-2021, the subject experienced fatigue. On 28-APR-2021, the subject experienced painful injection site. On 28-APR-2021, the subject experienced headache. On 29-APR-2021, the subject experienced heart sensation of turning inside out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness and tingling in right side of face, numbness and tingling in right side of chest and ribcage, disoriented, trouble grasping reflex, pain in ears, weird feeling, sore arm, and painful injection site on 28-APR-2021, and heart sensation of turning inside out, and headache on 29-APR-2021, and was recovering from fatigue. This report was non-serious.

Other Meds: SYNTHROID; CYTOMEL; VENTOLIN [SALBUTAMOL]

Current Illness: Alcohol use (Occasional use. Patient reported that not had any alcohol in the past 3 weeks.); Asthma (Ventolin x 1 puff as needed for tightness in chest); Hypothyroidism (Synthroid 75mcg and Cytomel (liothyronine) 5mcg x 1/2 tab once daily. Patient took usual thyroid medication morning of injection and the day after); Non-smoker; Pollen allergy

ID: 1284715
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/04/2021
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Symptoms: HIVES ON THE UNDER SIDE OF BOTH ARMS AND LOWER LEGS; This spontaneous report received from a patient concerned a 39 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (form of admin and route of admin were not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 25-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the subject experienced hives on the under side of both arms and lower legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives on the under side of both arms and lower legs. This report was non-serious.

Other Meds:

Current Illness:

ID: 1284716
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/04/2021
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Symptoms: SORENESS IN ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (subcutaneous, batch number: UNKNOWN expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the subject experienced soreness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of soreness in arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1284717
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 04/18/2021
Rec V Date: 05/04/2021
Hospital:

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Symptoms: DROWSINESS; FEELING PAIN IN ARM; TIREDNESS; FEVER; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of known drug allergies and no drug abuse or drug illicit use.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 18-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-APR-2021, the subject experienced feeling pain in arm. On 18-APR-2021, the subject experienced tiredness. On 18-APR-2021, the subject experienced fever. On 01-MAY-2021, the subject experienced drowsiness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling pain in arm, and tiredness, and had not recovered from fever, and drowsiness. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1284718
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/04/2021
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Symptoms: TINNITUS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 tinnitus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus. This report was non-serious.

Other Meds:

Current Illness:

ID: 1284719
Sex: F
Age: 71
State: CA

Vax Date: 01/29/2021
Onset Date: 02/06/2021
Rec V Date: 05/04/2021
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Symptoms: Left ear hearing loss; unilateral vision loss; Brain fog; Hot; Swelling in her arm that is the size of a baseball; COVID Arm; Itchy; Red circle around injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Left ear hearing loss) and BLINDNESS UNILATERAL (unilateral vision loss) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dairy intolerance. Concomitant products included DOXYCYCLINE from 01-Jan-2020 to an unknown date for Rosacea, DEXLANSOPRAZOLE (DEXILANT) and FAMOTIDINE for Stomach discomfort, ROSUVASTATIN for Stroke, LEVOTHYROXINE for Thyroid disorder NOS, CLOPIDOGREL, CALCIUM, ACETYLSALICYLIC ACID (BABY ASPIRIN), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and MAGNESIUM OXIDE for an unknown indication. On 29-Jan-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE REACTION (COVID Arm), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Left ear hearing loss) (seriousness criterion medically significant) and BLINDNESS UNILATERAL (unilateral vision loss) (seriousness criterion medically significant). On 13-Feb-2021, VACCINATION SITE REACTION (COVID Arm) had resolved. At the time of the report, DEAFNESS UNILATERAL (Left ear hearing loss), FEELING ABNORMAL (Brain fog), VACCINATION SITE WARMTH (Hot), PERIPHERAL SWELLING (Swelling in her arm that is the size of a baseball), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red circle around injection site) and FATIGUE (Tired) outcome was unknown. Treatment information not provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. 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 21-Apr-2021: Case upgraded to serious based on event update. Con meds added. Prior event outcome updated. Medical history updated based on information; 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: DOXYCYCLINE; LEVOTHYROXINE; DEXILANT; FAMOTIDINE; ROSUVASTATIN; CLOPIDOGREL; CALCIUM; BABY ASPIRIN; XYZAL; MAGNESIUM OXIDE

Current Illness: Dairy intolerance

ID: 1284720
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 05/04/2021
Hospital: Y

Vax Type:
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Symptoms: Bronchitis; Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy) in a 78-year-old female 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy). At the time of the report, RASH PRURITIC (Rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area, rash is very itchy) outcome was unknown. Information about concomitant medication was not reported. Follow up information was received on 29-APR-2021, regarding the patients second vaccine. The patient was hospitalized for 5 days after receiving the second vaccine. Her primary care doctor does not have any information regarding her symptoms yet. The patient was admitted with shortness of breath and was diagnosed with bronchitis. The patient also developed a rash that would appear on various parts of her body like her arms, legs, and back, but it would go away and then appear in a new area. The rash was very itchy. No treatment information 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. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant Follow up, Case 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:

Current Illness:

ID: 1284721
Sex: M
Age: 58
State: MA

Vax Date: 03/25/2021
Onset Date: 04/23/2021
Rec V Date: 05/04/2021
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Symptoms: Superficial blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Superficial blood clot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Superficial blood clot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Ultrasound scan: abnormal (abnormal) Ultrasound of left arm was done and determined a blood clot in that arm.. Patient went to the emergency room on 24 Apr 2021, approximately 7 pm. The patient was a healthy individual and used to do bike ride 11 miles per day with average speed 16mph. He did bike ride the evening of his second covid shot. No relevant concomitant medications were reported. Treatment information included anti-inflammatory medicine. Action taken with mRNA-1273 in response to the events was not applicable. 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 26-Apr-2021: Additional information was received on 26 Apr 2021. Added lab data and treatment; 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: 1284722
Sex: F
Age:
State: IL

Vax Date: 04/11/2021
Onset Date: 04/11/2021
Rec V Date: 05/04/2021
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Symptoms: went through a miscarriage on 23APR2021, after receiving the first dose; feeling abdomen pain lightly two to three days later; could not left her arm after the injection; injection site was sore,could not lift her arm after the injection; found pregnant on 07MAR2021,first vaccine dose 11APR2021; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Feb-2021 and the estimated date of delivery was 20-Nov-2021. On 11-Apr-2021, the patient experienced EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021). On 13-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection). On 14-Apr-2021, the patient experienced ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later). On 23-Apr-2021, the patient experienced ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the eighth week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, miscarriage on 23-Apr-2021. On 11-Apr-2021, EXPOSURE DURING PREGNANCY (found pregnant on 07MAR2021,first vaccine dose 11APR2021) had resolved. On 23-Apr-2021, ABORTION SPONTANEOUS (went through a miscarriage on 23APR2021, after receiving the first dose) had resolved. At the time of the report, ABDOMINAL PAIN (feeling abdomen pain lightly two to three days later), VACCINATION SITE MOVEMENT IMPAIRMENT (could not left her arm after the injection) and VACCINATION SITE PAIN (injection site was sore,could not lift her arm after the injection) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter stated that his wife was found pregnant on 07Mar2021. She had normal back pain and normal pregnancy pain during her pregnancy. My wife could not left her arm after the injection and the injection site was sore on 13-Apr-2021. After taking the Moderna vaccine she started to have abdomen pain lightly for two to three days on 14-Apr-2021. On 22-Apr-2021, she started to feel unbearable pain. On Friday 23-Apr-2021 she had a miscarriage. No treatment product information was not provided Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow-up had NNI; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1284723
Sex: M
Age: 67
State: IN

Vax Date: 03/19/2021
Onset Date: 04/23/2021
Rec V Date: 05/04/2021
Hospital:

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Symptom List:

Symptoms: he couldn't pee; low appetite; he thought he may pass out; Chills; severe headache every time he got up; feel sick to his stomach but never vomited; low grade fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (he couldn't pee) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 030A2L1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced URINARY RETENTION (he couldn't pee) (seriousness criterion medically significant), DECREASED APPETITE (low appetite), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired). On 23-Apr-2021, DECREASED APPETITE (low appetite) had resolved. On 25-Apr-2021, URINARY RETENTION (he couldn't pee), PRESYNCOPE (he thought he may pass out), CHILLS (Chills), HEADACHE (severe headache every time he got up), NAUSEA (feel sick to his stomach but never vomited), PYREXIA (low grade fever) and FATIGUE (tired) had resolved. The reporter stated, the patient had similar side effect from what he had from the 1st dose. Additional concomitant medications included Blood pressure pills, Cholesterol pills and maybe back pain pill. Treatment medication included Tylenol. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: An additional document received on 26 Apr 2021 has information Upgraded case to serious, updated suspect product details, concomitant medication, treatment medication and event details.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. Chills, headache, pyrexia, fatigue and nausea are consistent with the product safety profile.

Other Meds: PROZAC

Current Illness:

ID: 1284724
Sex: M
Age: 56
State: OR

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 05/04/2021
Hospital:

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Symptoms: passing out; blood pressure of 70/40; Feeling hot; Sweaty; Dizziness; Lethargy; Sore arm; Achy all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passing out) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passing out) (seriousness criterion medically significant), BLOOD PRESSURE DECREASED (blood pressure of 70/40), FEELING HOT (Feeling hot), HYPERHIDROSIS (Sweaty), DIZZINESS (Dizziness), LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy all over). On 21-Apr-2021, LOSS OF CONSCIOUSNESS (passing out) had resolved. At the time of the report, BLOOD PRESSURE DECREASED (blood pressure of 70/40), FEELING HOT (Feeling hot), HYPERHIDROSIS (Sweaty), DIZZINESS (Dizziness), LETHARGY (Lethargy), PAIN IN EXTREMITY (Sore arm) and MYALGIA (Achy all over) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Patient reports that paramedics had to come after he passed out. Treatment of the events included acetaminophen. Company comment: This case concerns a 56-year-old male with a serious unexpected event of loss of consciousness, and nonserious unexpected blood pressure decreased, feeling hot, hyperhidrosis, dizziness, lethargy and expected pain in extremity. Event onset the same day as first dose mRNA-1273. Events resolved. 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.

Other Meds:

Current Illness:

ID: 1284725
Sex: M
Age: 69
State: TN

Vax Date: 03/03/2021
Onset Date: 03/07/2021
Rec V Date: 05/04/2021
Hospital:

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Symptoms: Diagnosed Two Pulmonary Embolism; DVT on left leg; Coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism), DEEP VEIN THROMBOSIS (DVT on left leg) and COUGH (Coughing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (DVT on left leg) (seriousness criterion medically significant) and COUGH (Coughing) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism), DEEP VEIN THROMBOSIS (DVT on left leg) and COUGH (Coughing) outcome was unknown. After his 2nd dose of Moderna vaccine on 01-Apr-2021, the patient's coughing become worst again. His pulmonologist prescribed prednisone and his family physician prescribed him Azithromycin. No concomitant medications were not provided. Treatment included as Eliquis, Azithromycin, cough medicine, prednisone. 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. This case was linked to (Patient Link).

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Current Illness:

ID: 1284726
Sex: M
Age: 63
State: FL

Vax Date: 03/10/2021
Onset Date: 03/12/2021
Rec V Date: 05/04/2021
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Symptoms: bleeding from rectum; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding from rectum) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 039A21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced RECTAL HAEMORRHAGE (bleeding from rectum) (seriousness criterion medically significant). At the time of the report, RECTAL HAEMORRHAGE (bleeding from rectum) had resolved. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant product use was not provided by the reporter. No treatment information was provided. The colonoscopy was scheduled for May. 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.

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Current Illness:

Date Died: 03/23/2021

ID: 1284727
Sex: F
Age: 67
State: IL

Vax Date: 03/18/2021
Onset Date: 03/23/2021
Rec V Date: 05/04/2021
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Symptoms: heart attack; Bood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and THROMBOSIS (Bood clot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria death and medically significant) and THROMBOSIS (Bood clot) (seriousness criterion death). The patient died on 23-Mar-2021. The reported cause of death was Heart attack and Clot blood. It is unknown if an autopsy was performed. Not Provided No concomitant medication were reported. No treatment information was provided.; Reported Cause(s) of Death: Heart attack; Clot blood

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Current Illness:

ID: 1284728
Sex: F
Age: 66
State: LA

Vax Date: 03/02/2021
Onset Date: 04/02/2021
Rec V Date: 05/04/2021
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Symptoms: shingles; Eyes swells a lot; headache; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported. Concurrent medical conditions included Drug allergy. Concomitant products included HYDRALAZINE, LOSARTAN, ATENOLOL, AMLODIPINE, OXYCODONE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) and Ibuprofen for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced HEADACHE (headache). On 05-Apr-2021, the patient experienced HERPES ZOSTER (shingles) (seriousness criterion medically significant) and EYE SWELLING (Eyes swells a lot). At the time of the report, HERPES ZOSTER (shingles) had not resolved and EYE SWELLING (Eyes swells a lot) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient could not see good due to swelling of eyes. Her face was itching, had rash and bumps on her face due to shingles. Treatment details include acyclovir tablet 800mg 5 times a day, acyclovir ointment. Company Comment:Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, a causal relationship cannot be excluded. Some vaccines have been known to exacerbate latent herpes zoster. Patient has a history of shingles/. Headache is consistent with the product known safety profile. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.

Other Meds: HYDRALAZINE; LOSARTAN; ATENOLOL; AMLODIPINE; OXYCODONE; ALLEGRA; NEXIUM [ESOMEPRAZOLE MAGNESIUM]; Ibuprofen

Current Illness: Drug allergy

ID: 1284729
Sex: M
Age: 59
State: CA

Vax Date: 04/03/2021
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Rec V Date: 05/04/2021
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Symptoms: TIA Stroke (transient ischemic attack); loss of memory for 15 minues could not spell the word "side" nor "effect"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) in a 60-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. No relevant medical history was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) (seriousness criterion medically significant) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect"). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication included vitamin-c and fish oil 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.

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Date Died:

ID: 1284730
Sex: M
Age: 68
State: FL

Vax Date: 03/18/2021
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Rec V Date: 05/04/2021
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Symptoms: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first 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 concomitant medication was provided.; Sender's Comments: This is a 68-year-old, male patient who received mRNA-1273 vaccine (batch no. unknown) who died, on an unknown date after receiving first dose of vaccine. No medical history or conmeds were provided. Existing comorbidities probably could have been the causative factor in his death. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: unknown cause of death

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Current Illness:

Date Died:

ID: 1284731
Sex: M
Age:
State: NY

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Rec V Date: 05/04/2021
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Symptoms: Died due to his many medical conditions; could not administer second vaccine; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of GENERAL PHYSICAL HEALTH DETERIORATION (Died due to his many medical conditions) in a male 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. The patient's past medical history included Rehabilitation therapy (Patient was in rehabilitation center) and General physical health deterioration (It is reported that patient had history of many medical conditions, unspecified.). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Died due to his many medical conditions) (seriousness criterion death) and PRODUCT DOSE OMISSION ISSUE (could not administer second vaccine). The patient died on an unknown date. The reported cause of death was medical conditions. It is unknown if an autopsy was performed. At the time of death, PRODUCT DOSE OMISSION ISSUE (could not administer second vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: This is a male patient of unknown age who received mRNA-1273 vaccine (batch no. unknown) who died on an unknown date after receiving first dose of vaccine. Patient had history of many medical conditions. No conmeds were given. Reporter could not administer second vaccine. Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: medical conditions

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ID: 1284733
Sex: M
Age:
State: MO

Vax Date: 01/14/2021
Onset Date: 01/01/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: prostate cancer; Had some pain 1st and 2nd at injection site; some joint pain next 3 to 9 days; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 19Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Vaccination facility type was hospital. Patient received the first dose of the vaccine and is due to receive the second dose on 04Feb2021. On 03Feb2021, he is due to receive a steroid injection in his back and was wondering if the two are compatible. He will have his injection shot at his lower back the day before his 2nd dose vaccine. It was further reported that on 14Jan2021, the patient received his first covid vaccine and had some pain 1st and 2nd (day) at injection site (14Jan2021) and some joint pain next 3 to 9 days (Jan2021), went into hospital for prostate cancer on 02Feb2021. The patient experienced prostate cancer on an unspecified date. The patient was hospitalized for prostate cancer from 02Feb2021 to an unknown date. They would not give him 2nd vaccine at hospital. 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: 1284734
Sex: F
Age:
State: GA

Vax Date: 01/06/2021
Onset Date: 02/15/2021
Rec V Date: 05/04/2021
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Symptoms: I am currently 26 weeks pregnant and already completed both doses; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable other health care professional(patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on 06Jan2021) as single dose, dose 1 via an unspecified route of administration, administered in Arm Left on 20Dec2020 09:30 as single dose for covid-19 immunisation. Medical history included Asthma, GERD, anxiety/depression.Concomitant medications included lansoprazole (PREVACID) duloxetine hydrochloride (CYMBALTA); fluticasone propionate (FLOVENT); ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT). Patient was 26 weeks pregnant and already completed both doses of COVID-19 vaccine. On 15Feb2021, patient tested positive for COVID-19 and have been sick. Patient had not covid prior vaccination, Patient had nasal swab test on 15Feb2021with positive result and had known allergies. Patient used azithromycin, zinc, steroids and melatonin as treatment.The patient delivered the pregnancy on 25May2021. The outcome of event covid-19 and drug ineffective was recovering and exposure during pregnancy was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is a reasonable possibility of causal association between the events drug ineffective and COVID 19 and the suspect drug.

Other Meds: PREVACID; CYMBALTA; FLOVENT; MULTI VIT

Current Illness:

ID: 1284735
Sex: F
Age:
State: NY

Vax Date: 03/04/2021
Onset Date: 03/06/2021
Rec V Date: 05/04/2021
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Symptoms: Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering. Follow up attempts are completed. No further information is expected. Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious. Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: RITALIN; IMIPRAMINE; BACLOFEN; ATENOLOL; CRESTOR; ZETIA; TOFRANIL; SINGULAIR; BABY ASPIRIN; CLONIDINE

Current Illness:

ID: 1284736
Sex: F
Age:
State: VA

Vax Date: 03/03/2021
Onset Date: 03/05/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: throbbing headache; exhausted; muscle aches; sick; fatigue; hands had tremors; body aches; This is a spontaneous report from a contactable consumer. This 68-years-old Female consumer reported herself that: Country: Report about covid vaccine: Yes. Reporting type: AE. Reporter type: Non-healthcare Professional reporting for a patient. Patient name: (name). DOB: ## Age group: Elderly (65+ Years). Current age: 68. Current age unit: Years. Gender: Female. Is pregnant: No. Race: (race). Address street: (address). City: (city). State: (state). Zipcode: ### Phone no.: ## Email: (mail id). Covid vaccine details: Product=COVID 19 Brand=Prizer. Lot number= EN6198. Lot unknown= False Administration date=03Mar2021 Administration time=10:15 AM Vaccine location= Right arm. Dose number=1 Facility type vaccine: (name) Facility name: (name) Facility address street: (address) Facility city: (city) Facility state: (state) Facility zipcode: ### Facility country: If other vaccine in four weeks: No. Other medications in two weeks: Albuterol Inhaler. Adverse event: I had a throbbing headache in the back of my head that has lasted 12 days. It was the worst headache I have ever had and had terrible fatigue. My hands had tremors and I had body aches for 3 days. Headache so bad I had to get a CT scan Adverse event start date: 05Mar2021 Adverse event start time: 12:00 AM Adverse event country: Ae resulted in: Doctor or other healthcare professional office/clinic visit. If patient recovered: Recovering If treatment ae: Yes. Ae treatment: CT scan, Blood work. If covid prior vaccination: No. If Covid tested post vaccination: Yes. Covid test post vaccination: Covid test type post vaccination=Nasal Swab Covid test name post vaccination=Rapid Test Covid test date=12Mar2021 Covid test result=Negative. Known allergies: No. Other medical history: Cancer in remission for 6 years. Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included: Patient Details: Initials: (name). Sex: Female. Is the patient also the reporter? Yes Date of birth: ### Country of Incidence: Reporter Details: Reporter type: Consumer or other non health professional. Reporter type details: self. First name: (name). Surname: (name). Address line: (address). Town / City: (city). County / State: (state). Post code / ZIP code: ## Country: Telephone: ## Email address: (mail). Primary / Prescribing Healthcare Professional Info: Country: Event Details: Company aware date: 23Mar2021 Report type: Follow-up Report no new event Products: Suspect products: COVID Vaccine: NDC number: Not Provided. Lot Number: Not Provided. Reason for no lot number: Other: follow up report and she previously provided it. Expiry date: Not Provided. History: Concomitant Products: Other Products Not Provided. Other conditions: Other Conditions Not Provided. Investigations: Investigations Not Provided. Additional Context: Other Reference(s): No Transfer to agency Required. Additional Context: She had her first shot three weeks ago tomorrow. She is scheduled to get second one tomorrow. She was sick for 13 days after the first one. She was so sick. The headache was so bad the doctor sent her for a CT scan of her head. The headache was at the crown of the head and down into the back of the head. She never had a headache in the back of her head like that before. Her doctor wanted to make sure no bleed. It started lightly for two days and got worse and worse. It was 13 days before it went away. On top of that she had muscle aches in the beginning, but those went away. She was exhausted. She has already sent this in to Pfizer. She is questioning if she should get the second dose. She did get a COVID test and that was negative. She has done what she was supposed to do. Reference Number: she doesn't have a reference number. She has been on hold for two hours. She held because she feels this is very important. She really don't want to end up in trouble because she gets the second vaccine. Her doctor said it is a tough call. When she has to go get a shot and walk in with an EpiPen it gives her an ugly feeling. Her doctor is really not thrilled. She is darned if she does and darned if she doesn't. She knows one lady that died two days later and another one that died a couple of days later. They were both in another place. One was the wife of a surgeon. She thinks it has been reported. One was a community leader. They are waiting on the autopsies. Caller declined to proceed with a report for the two women that died after receiving the COVID vaccine. One died in the bathroom on the second day. The other is a doctor's wife and she passed one to two days after the shot. Neither was expected. Caller doesn't have their health records. She doesn't live in the same town. She is sure they are aware at Pfizer that this happened. She can't find anything. She didn't get a reference number from Pfizer. She gave the lot number when she reported it before because she remembered she had to get the card. She also reported it through (name). (name) gave her a confirmation number of ## on 13Mar2021. She think she would have filed them at the same time, so she probably reported it to Pfizer on 13Mar2021. Caller is going to delay the second shot. She knows she has up to 42 days. to get it. Is there a product complaint to report: No. Is there a medical information request: Yes. Please describe the medical information request: She is questioning if she should get the second dose. Is this an Other report: No Site: Call Centre # Contact Centre Ref: ##, ## Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that included: Primary source(s) of information: Reporter title: (title). Reporter given name: (name). Reporter family name: (name). Reporter's postcode: ### Reporter country code: Qualification: Consumer or other professional. Reporter Phone Number: ### Patient characteristics: Patient: PRIVACY. Sex: male. Patient First Name: (name). Patient Last Name: (name). Drug(s) Information: Characterization of drug role: suspect. Proprietary medicinal product name: Pfizer-Biotech COVID-19 Vaccine. Identification of the country where the drug was obtained: Country of authorization/application: Active Substance Information: Active Drug substance names: Pfizer-Biotech COVID-19 Vaccine. Narrative case summary and further information: Case narrative: Originating AE Request: REQ-# Attachments: 1 Reporter Subtype: Patient. PQC Present: No. AE Present: Yes. PQC Details: Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Potential Duplicate case: Caller stated she reported this online to Pfizer safety on 13Mar. Caller received the first dose of the Pfizer covid vaccine on 03Mar and it made her sick for 13 days. She had a really bad headache for 9 days and had a CT scan done for the headache, she was in the hospital, was exhausted. Caller is scheduled for second dose tomorrow. caller wanted to know if the side effects lasted that long after the first dose with other people. caller is a 68 years old female. Caller stated she is not sure about if the 2 females who received the covid vaccine were Pfizer covid vaccine or not but they died in (place name). Caller refused to provide any other information including age of the patients. Caller stated that one of them was a Doctor's wife. Request Name: REQ-# Product: Pfizer-Biotech COVID-19 Vaccine. Question: Question: Caller wanted to know how many people experienced severe headache and were they given the second dose.

Other Meds: ALBUTEROL [SALBUTAMOL]

Current Illness:

ID: 1284737
Sex: M
Age:
State: KY

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: dizziness/dizzy/almost felt like fainting; felt like fainting; racing heart; sweating; This is a spontaneous report from contactable consumers (one is the patient). A 37-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 19Feb2021 13:00 [also reported as 26Feb2021 12:45 PM] (Lot Number: EL9267; Expiration Date: May2021) as a single dose for covid-19 immunisation. Medical history included drug penicillin allergies and low testosterone ongoing since 2018. Concomitant medication included testosterone cipionate (TESTOSTERONE CYPIONATE) for low testosterone, start and stop date were not reported. The patient previously took amoxicillin but had allergies. The patient reported that a few minutes after his first vaccination (19Feb2021), he experienced a racing heart, dizziness, sweating, and almost felt like fainting. A couple waves of this hit him and subsided after 10-15 minutes. The events required emergency room visit. The patient has not been covid tested post vaccination. The patient was not diagnosed with covid prior vaccination. The patient has his blood checked twice/year all normal levels (unspecified date). The patient mentioned that he became slightly dizzy after receiving his first COVID-19 vaccine and he was not nervous or scared prior to or following receiving the vaccine. He also does not have history or problems receiving other vaccines or blood draws when he received the second vaccine, he felt normal for a couple minutes although he would feel "something" thought his body immediately after the injection. A few minutes went suddenly, he became very dizzy or short of breath, EMS was on standby at this site, so they advised him to sit on the floor. They connected heart /02 monitor to him (2021), and his heart rate was very highly (around 130 BPM) or then it would swing widely to less than 50 BPM. During these swings, he would get very dizzy or faint. This happened multiple times starting from less severe to severe with fainting, to finally going away, unfortunately after 30 minutes or so when the heart rate swings were observed, EMS administered Epinephrine and Benadryl in IV form. He was taken to a hospital via ambulance where he was later discharged after no issue in observation. The events tachycardia, dizziness and fainting were considered serious with seriousness criterion of hospitalization/prolongation of hospitalization and important medical event. The outcome of the events was recovering.

Other Meds: TESTOSTERONE CYPIONATE

Current Illness: Testosterone low

ID: 1284738
Sex: F
Age:
State: AL

Vax Date: 02/26/2021
Onset Date: 03/07/2021
Rec V Date: 05/04/2021
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Symptoms: symptoms of covid 19 starting 07Mar2021 and tested positive for covid 19 last 11Mar2021; symptoms of covid 19 starting 07Mar2021 and tested positive for covid 19 last 11Mar2021; This is a spontaneous report from a Pfizer-sponsored program by contactable consumer (patient). A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 26Feb2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient had the symptoms of covid 19 starting 07Mar2021 and tested positive for covid 19 on 11Mar2021. The patient was scheduled for her second dose on 19Mar2021and wanted to know that whether she could attend her appointment for her second of the covid vaccine. The outcome of the events was unknown. Information on about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1284739
Sex: M
Age:
State: PA

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Rec V Date: 05/04/2021
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Symptoms: tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A male patient of an unspecified age received First dose bnt162b2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and Concomitant medication were not re-ported. On an unspecified date, patient reported that he tested positive for covid after he got the 1st dose. Outcome for events was unknown.

Other Meds:

Current Illness:

ID: 1284740
Sex: M
Age:
State: CO

Vax Date: 03/23/2021
Onset Date: 03/29/2021
Rec V Date: 05/04/2021
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Symptoms: chalky taste in my mouth; bad breath; stuffy and thus breathing issues; This is a spontaneous report received from a contactable Consumer reporting for herself. A 61-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:45 (Batch/Lot Number: EP6955) as single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient experienced chalky taste in my mouth on 29Mar2021 with outcome of not recovered , bad breath on 29Mar2021 with outcome of not recovered , stuffy and thus breathing issues on 29Mar2021 with outcome of not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1284741
Sex: M
Age:
State: PA

Vax Date: 03/16/2021
Onset Date: 03/18/2021
Rec V Date: 05/04/2021
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Symptoms: had a rash underneath his injection site; experienced strong muscle aches mid-chest up, arms, back, hands, & jaw two nights in a row; This is a spontaneous report from a contactable consumer (the patient) . A 75-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:00 (Batch/Lot Number: EN6200) as single dose for covid-19 immunisation . Medical history included hypertension (Takes high blood pressure medicine). In the past the patient received an unknown vaccine against hay fever and experienced rash. On 23Feb2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced experienced strong muscle aches mid-chest up, arms, back, hands, & jaw two nights in a row on 18Mar2021 01:30 with outcome of not recovered , had a rash underneath his injection site on an unspecified date with outcome of unknown. Course of the event: After 2nd shot, the patient experienced strong muscle aches mid-chest up, arms, back, hands and jaw two nights in a row. Took Tylenol. Since then, once almost every day, usually weight training or fast walking, the patient experienced the same ache, maybe not as severe as the first two nights but it sure does get his attention. The patient been checked out at the ER to insure it's not a heart issue per primary care physician. The emergency room doctor told the patient his EKG was fine and his bloodwork didn't show anything. No follow-up attempts are needed; No further information is expected.

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Current Illness:

ID: 1284742
Sex: F
Age:
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Rec V Date: 05/04/2021
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Symptoms: a light nose bleed that lasted about 15 minutes; This is a spontaneous report received from a Pfizer sponsored program from a contactable consumer (patient) . A 27-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 on an unknown date. The patient experienced a light nose bleed that lasted about 15 minutes on an unspecified date with outcome of recovered. Course of the event. Caller stated one hour after receiving the second dose she experienced a light nose bleed that lasted about 15 minutes. Caller stated she just used a Kleenex and only had to switch it out once. Caller states it was not severe and she didn't have to use a washcloth or anything and has not happened since.

Other Meds:

Current Illness:

ID: 1284743
Sex: M
Age:
State:

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 05/04/2021
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Symptoms: extreme tiredness; nauseated; night sweats; felt weak; light-headed; brief rapid breathing; This is a spontaneous report from a contactable consumer reported for himself. A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 16:30, at the age of 34 years, as single dose for covid-19 immunisation. Medical history included drug hypersensitivity to penicillin. The patient's concomitant medications were not reported. The vaccine was administered at the hospital. On 31Mar2021 17:00 the patient experienced extreme tiredness, nauseated, night sweats, felt weak, light-headed, brief rapid breathing all with outcome of recovering. The patient didn't receive any treatment for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1284744
Sex: F
Age:
State: IL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/04/2021
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Symptoms: fever; body and muscle pain; headache; body and muscle pain; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 01Apr2021 at 7 pm after her 2nd dose, the patient experienced fever, body and muscle pain and headache. She said she still had these symptoms on the day of the report, on 03Apr2021. The patient had not recovered from the events. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1284745
Sex: M
Age:
State: FL

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 05/04/2021
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Symptoms: Multiple rashes that began 24 hours later. The rash is on one lower part of arm upper area near wrist, another on leg above the knee, and on the middle area of calf.; This is a spontaneous report from a contactable consumer. A 59-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 12:30 at the age of 59 years-old (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation . Medical history included an allergy to shellfish and high cholesterol. There were no other vaccines in the past 4 weeks. There were no concomitant medications. On 15Apr2021, at 0700, the patient experienced multiple rashes that began 24 hours later (after vaccination received during an unspecified hospitalization). The rash was on one lower part of arm upper area near wrist, another on leg above the knee, and on the middle area of calf. The outcome of the event was not recovered.

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Current Illness:

ID: 1284746
Sex: F
Age:
State: TX

Vax Date: 03/19/2021
Onset Date: 04/10/2021
Rec V Date: 05/04/2021
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Symptoms: Sudden hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 13:30 (Lot Number: EN6198) at a single dose, and the second dose via an unspecified route of administration in left arm on 19Mar2021 13:30 (Lot Number: EN6199) at a single dose for covid-19 immunization at the age of 53 years old. Medical history included hypertension and known allergies to sulfa, both from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included irbesartan taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden hearing loss in right ear on 10Apr2021 12:00. The event resulted in doctor or other healthcare professional office/clinic visit, and cased disability or permanent damage. The patient underwent lab tests and procedures which included covid-19 virus test (nasal swab): negative on 14Apr2021. Therapeutic measures were taken as a result of sudden hearing loss in right ear included steroid injection series into eardrum. The outcome of the event was not recovered.

Other Meds: IRBESARTAN

Current Illness:

ID: 1284747
Sex: M
Age:
State: PA

Vax Date: 01/25/2021
Onset Date: 01/27/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: appendicitis/had his appendix removed; This is a spontaneous report from a contactable consumer (patient). A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 25Jan2021 (lot number: EL3249) at the age of 35 years old, as single dose for COVID-19 immunisation. Medical history reported as none. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. No other vaccines received in four weeks. No other medications taken in two weeks. On unspecified date, after first vaccination, the patient had appendicitis and had his appendix removed. The event resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab): negative. The patient was given dose 2 of BNT162b2 on 15Feb2021 (lot number: EL9267), administered in left arm. Outcome of the event appendicitis was recovered with sequelae.

Other Meds:

Current Illness:

ID: 1284748
Sex: F
Age:
State: NY

Vax Date: 02/23/2021
Onset Date: 03/03/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: Cervical insufficiency in pregnancy resulting in loss of pregnancy; Cervical insufficiency in pregnancy resulting in loss of pregnancy; This is a spontaneous report from a contactable healthcare professional (patient). A 31-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) at the age of 31-years-old, via an unspecified route of administration in left arm on 23Feb2021 at 08:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. She has no COVID prior to vaccination, no other vaccines in four weeks, and no other medications in two weeks. The patient was pregnant. Her last menstrual date was on 11Oct2020. Her delivery date is on 18Jul2021. The patient received her COVID-19 vaccine in a hospital. She experienced cervical insufficiency in pregnancy resulting in loss of pregnancy on 03Mar2021 at 15:00. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization from 2021 to 2021 for 1 day. There was no treatment given in response to the events. She was not tested got COVID post vaccination. She received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) at the age of 31-years-old, via an unspecified route of administration in right arm on 16Mar2021 at single dose for COVID-19 immunization. The outcome of the events was unknown.; Sender's Comments: The information available is limited. The etiology for the reported events could be multifactorial in nature. However until more information is available the contributory role of the suspect product BNT162B2 cannot be completely ruled out based on the potential temporal association noted. This case will be updated when more information is available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

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Current Illness:

ID: 1284749
Sex: F
Age:
State: CA

Vax Date: 03/30/2021
Onset Date: 04/11/2021
Rec V Date: 05/04/2021
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Symptoms: left-side facial drop with left mouth corner; stroke symptoms; transient mild headache; blurry vision; left side of tongue affected; slurring speech; felt confused; drowsy; This is a spontaneous report from a contactable consumer (patient). This 17-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8734), via an unspecified route of administration in the right arm at 17 years old on 30Mar2021 at single dose for COVID-19 immunization. Medical history included acquired brain injury (C-PVL) from pneumococcal strep infection, hypoxic ischemic encephalopathy, premature birth, quadriplegic dyskinetic cerebral palsy. Concomitant medications were none. The patient was not pregnant at time of vaccination. The patient previously received T-Dap vaccine at 10 years old and had prolonged migraine reaction. 12 days after, the patient developed stroke symptoms with transient mild headache, blurry vision, and left-side facial drop with left mouth corner and left side of tongue affected causing slurring speech also felt confused and drowsy which lasted for 8 hours. Events were started on 11Apr2021 at 03:30 PM. Events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient went to ER, they did stroke work-up. No evidence of stroke. The patient received treatment including CT scan, MRI, EKG, labs. The patient had no covid prior vaccination, no covid tested post vaccination. Outcome of the events was recovering.

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Current Illness:

ID: 1284750
Sex: F
Age:
State: NH

Vax Date: 03/28/2021
Onset Date: 03/28/2021
Rec V Date: 05/04/2021
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Symptoms: chronic lyme disease; could not breath/shortness of breath; knees swelled up; eyes burned; significant fatigue; increase in body pain; my knees are still damaged, especially in the back; knees still damaged, especially in the back; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 73-year-old via an unspecified route of administration, administered in Arm Right on 28Mar2021 14:00 (Lot Number: ER8733) as single dose for covid-19 immunisation. Medical history included hepatitis c, persistent lyme disease (ongoing), Known allergies: some antibiotics and foods. There was no other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. There were no concomitant medications. The patient experienced could not breath, had to walk around for 20 minutes, she had chronic lyme disease. Her knees swelled up, her eyes burned, she had shortness of breath. Now three weeks later her knees were still damaged, especially in the back and she still had significant fatigue and increase in body pain, but the shortness of breath upon walking had improved. The back of her knees had never been this bad. She -would never have another shot-think it would kill her. The events start date was 28Mar2021. No treatment was received. The outcome of event Dyspnoea was recovering, of knees still damaged, especially in the back, fatigue and increase in body pain was not recovered, of other events was recovered with sequel.

Other Meds:

Current Illness: Lyme disease

ID: 1284751
Sex: F
Age:
State: MD

Vax Date: 03/04/2021
Onset Date: 03/06/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: started to speak gibberish and was taken to the emergency room; out of it; combative; started to speak gibberish and was taken to the emergency room; out of it; combative; She can't remember anything after the emergency room/She has no recollection; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 81-year-old via an unspecified route of administration, administered in the left arm on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, blood pressure abnormal. There was no other vaccinations within four weeks prior to the first administration. Concomitant medications included ongoing metformin taken for diabetes mellitus; lisinopril taken for blood pressure abnormal, both taking for quite a while; at least a few years. The patient previous took first dose of BNT162B2 at the age of 81-year-old via an unspecified route of administration, administered in the left arm on an unspecified date as single dose for covid-19 immunisation. The patient experienced started to speak gibberish and was taken to the emergency room; out of it; combative on 06Mar2021. Caller stated she was perfectly fine and healthy prior and up to that time and the day after. Caller stated on Saturday she got up in the morning and was talking to a friend when all of a sudden something was going wrong. Caller thanked God she was at a friend's because if she had been home she would have died. Caller stated she was rushed to the ER and after 3 MRIs that confirmed that she was not having a stroke or something similar. Caller stated she spent 6 days in ICU and 2 weeks in a rehab center, went back to friends house for another week, before she went home because she was not comfortable being home by herself because she was to take her blood pressure often. Caller stated she was perfectly fine after the first shot and after the second one. It was 2 days and she had this terrible reaction and it was the only thing it can be put down to so everything else had come up normal. On 06Mar2021, caller explained she was actually getting ready to groom one of her dogs. She got up and felt fine and she was talking to her friend and another one of her friends and all of a sudden she started to talk gibberish, so her friend asked if she was having a stroke. Her friend took the caller's blood pressure and said they were going to the hospital and her friend took her to the emergency room. Caller stated that was all she can recall. She can't remember anything after the emergency room. According to her friend, caller was out of it, getting combative, and all kinds of stuff going on. She had no recollection, she remembered getting in the car to go to the hospital, but then had no recollection. Caller stated she just went to see the doctor a week ago and got a good bill of health. The doctor said she was pretty much good; she's improved. Caller stated her doctor told her she did not have a stroke and they did not definitively know what happened; the only thing she can put it down to was a reaction to the Pfizer COVID-19 vaccine. The outcome was recovering. Information about the Lot/batch number has been requested.

Other Meds: METFORMIN; LISINOPRIL

Current Illness:

ID: 1284753
Sex: M
Age:
State: NY

Vax Date: 03/25/2021
Onset Date: 03/29/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: TIA ( mini stroke) on fourth day after dose two.; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208 and expiration date not provided), via an unspecified route of administration, administered in Arm Right second dose on 25Mar2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included Hypertension and Penicillin allergy. The patient's concomitant medications included lamotrigine (LAMICTAL) and bupropion hydrochloride (WELLBUTRIN). The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201 and expiration date not provided) via an unspecified route of administration administered in Arm Right first dose on 04Mar2021 administration time: 04:00 PM for covid-19 immunisation. On 29Mar2021 10:00, the patient experienced TIA (mini stroke) on fourth day after dose two. The event resulted in physician office visit, Emergency room visit, and hospitalization for 1 day. The patient was treated and was placed on three medication (unspecified). The patient underwent lab tests and procedures which included Spectrum DNA test: negative on 15Apr2021. The outcome of the event was recovering.

Other Meds: LAMICTAL; WELLBUTRIN

Current Illness:

ID: 1284754
Sex: M
Age:
State: CO

Vax Date: 12/18/2020
Onset Date: 12/20/2020
Rec V Date: 05/04/2021
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Symptoms: posterior vitreous detachment; This is a spontaneous report from a contactable physician. A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EL-3302), intramuscular, administered in Arm Right on 18Dec2020 08:00 (at 50-years-old) as single dose for COVID-19 immunization. Medical history included HTN (hypertension). Patient had no known allergies. Facility type vaccine was Hospital. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. Concomitant medications included amlodipine; chlorthalidone. The patient experienced posterior vitreous detachment on 20Dec2020 with outcome of not recovered. Ae resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of posterior vitreous detachment (also reported that "treatment: exam, there is no treatment", pending confirmation).; Sender's Comments: Based on the information provided, the event "Posterior vitreous detachment" is likely to be an intercurrent event unrelated to the use of suspect product bnt162b2 in this 50-year-old male patient. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Other Meds: AMLODIPINE; CHLORTHALIDONE

Current Illness:

ID: 1284755
Sex: F
Age:
State: NY

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: light headed; heat inside her left arm then her chest; heart palpitations rapid; high blood pressure around 180/123mmhg; Neck stiffness; throat becoming stiff; Very difficult breathing; tightness in her chest; This is a spontaneous report from a contactable other health professional (patient). A 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0161), via an unspecified route of administration, administered in left arm on 18Apr2021 11:45 am (at 49-year-old, not pregnant at the time of vaccination) at single dose for COVID-19 immunisation. Medical history included hypertension, Covid-19 from 09Jan2021. Tested positive for COVID on 09Jan2021 and have antibodies after infection. Patient took vaccine under 100 days after COVID infection. No known allergies. Concomitant medications included metoprolol; paracetamol (TYLENOL extra strength), and multi vitamin. No other vaccine in four weeks. On 18Apr2021 11:52 (reported as 7 minutes after BNT162B2 1st dose), the patient experienced light headed, heat inside her left arm then her chest, tightness in her chest, felt heart palpitations rapid, high blood pressure around 180/123 mmhg. Neck stiffness and throat becoming stiff. Very difficult breathing after all symptoms were present. The events resulted in emergency room/department or urgent care, hospitalization. The days of hospitalization was 1 day. Therapeutic measures were taken as a result of the events, which included aspirin/ 2 bags of 1000 ml Sodium chloride. The outcome of the events was recovering. No COVID tested post vaccination.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: METOPROLOL; TYLENOL

Current Illness:

ID: 1284756
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/04/2021
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Symptoms: Positive for SARs-COV-2; Positive for SARs-COV-2; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, expiry date and lot number not reported), via an unspecified route of administration On an unknown date in Apr2021(reported as last Wednesday), as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Apr2021(reported as last Wednesday), patient received first dose and tested positive for SARs-COV-2. The event was considered serious (medically significant). It was reported that the patient had scheduled for second dose. The outcome of the event was unknown. Information related to batch/Lot no. was requested.

Other Meds:

Current Illness:

ID: 1284757
Sex: F
Age:
State: CT

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 05/04/2021
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Symptoms: feeling unwell, not healthy; headache; sore throat; chest cough; she tested positive for covid after the first injection; she has had increased resting pulse rate from 90 to between 122-125/very high, elevated, resting pulse at 94 beats per minute/her pulse has been over 100 beats per minute continuously; arm hurt but not very much, arm was just tender; ran a fever of 101 to 104 for seven days/high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (Patient). A (Age: 54; Unit: Unknown) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. EP7534, expiry date not reported) via unspecified route in left arm on 26Mar2021 at 14:40 PM as single dose for COVID-19 immunization. Medical history included anxiety disorder (ongoing), bipolar disorder (ongoing) and bipolar with panic disorder. Concomitant medication included unspecified medication (When probing concomitant medications, she reports she'd been taking psychiatric medications since she was in her 20's. She'd been on all her current medication for at least 3 months or more). No other vaccine in four weeks. The patient experienced feeling unwell, not healthy, arm hurt but not very much, arm was just tender, headache, sore throat, chest cough on an unknown date, ran a fever of 101 to 104 for seven days/high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit, she has had increased resting pulse rate from 90 to between 122-125/very high, elevated, resting pulse at 94 beats per minute/her pulse has been over 100 beats per minute continuously on 26Mar2021 and she tested positive for covid after the first injection on 01Apr2021. Caller stated she caller to report an experience to the pfizer covid 19 vaccine. Caller stated she had the first dose of the Pfizer covid 19 vaccine on 26Mar2021. Caller stated she tested positive for covid after the first injection and ran a fever of 101 to 104 for seven days. Caller stated she has had increased resting pulse rate from 90 to between 122-125. Caller stated her pulse rate is usually in the 60's mostly 64. Caller stated she was feeling unwell, not healthy. Caller stated she was bipolar with panic disorder and is very scared at this point to get the second dose. Caller wanted to confirm that her increased resting pulse could be a severe allergic reaction. Caller wanted guidance about if or when to receive the second dose. Caller already reported to safety. Caller confirmed her concern was about the increased resting pulse. Caller asked since she had covid, was she protected for 90 days. She was calling about the Covid 19 vaccine. She had her first dose on 26Mar2021, and she immediately had a reaction to it. She had a very high, elevated, resting pulse, it was 94bpm. Since she had received the Covid 19 vaccine her pulse has been over 100 beats per minute continuously. The other thing that was peculiar was that she tested positive for the Covid 19 virus after receiving the Covid 19 vaccine. She had concerned that her pulse has not returned to normal. She has a question about when and if she should get the second Covid 19 vaccine. She was currently scheduled to receive her Covid 19 vaccine on 26Apr2021. She does suffer from an anxiety disorder and bipolar disorder so her pulse rate has been especially frightening for her. She is relieved because her husband has been reading and he's seen some stuff online that people have mental symptoms after the Covid 19 vaccine. She felt better knowing that her medication was still working. Meaning her medication for her anxiety disorder and bipolar disorder is still working. She has no further information on the people online. She reports her arm hurt but not very much. That started the same day that she received the vaccine. Her arm was just tender, she was aware of her arm. Her arm was only tender about 4-5 days. Her arm isn't bothering her now. She did suffer with a high fever from 101 degrees Fahrenheit to 104 degrees Fahrenheit starting on the day she received the Covid 19 vaccine. She's had no fever at all for the last 2 weeks. The only symptom that remains is her increased pulse. She got the Covid 19 virus test on 01Apr2021. She's not sure if was the rapid or the longer Covid 19 test. She received her results in about 24 hours. She also went to the emergency room on the night of 01Apr2021 because her fever was 104 degrees Fahrenheit even taking the Tylenol. When the Tylenol could no longer manage her fever, she went to the emergency room. She was on her second bottle of Tylenol. She reports the first bottle was the brand name of Tylenol, but she has discarded the bottle. It was the 4-hour kind. NDC/Lot/Expiry not known. The second bottle of Tylenol was the (Company name) Tylenol knock off brand of Acetaminophen. Each tablet was 650mg take 2 tablets every 8 hours as needed. Lot# unknown, NDC 0363-0336-01, Expiry Sep2022. She had to get her glasses to read the print on the (Company name) Tylenol knock off brand. She went to the emergency room because the Tylenol was no longer keeping her fever down and she got frightened. She did not have the Covid 19 test at the emergency room, she had the Covid 19 test. She was sent home from the emergency department. She was not admitted to the hospital. She reports the Covid 19 virus definitely moved through her body starting with a headache, sore throat, and a chest cough. She reports her symptoms lasted a bit longer than her fever. She reports the chest cough lasted the longest. She reports that some people think the Covid 19 vaccine would give you the Covid 19 virus. She believes she had the Covid 19 virus before she received the Covid 19 vaccine. She reports she might have remained asymptomatic until she received the Covid 19 vaccine. The event high fever, elevated heart rate resulted in emergency Room. The outcome of event Pulse rate increased was not recovered, Pain in arm was recovered, whereas unknown for all other events. Description of complaint: PC 1: Tested positive for the Covid 19 virus after receiving the Covid 19 vaccine. Received Covid 19 vaccine on 26Mar2021, tested positive on 01Apr2021. Lot# EP7534 in the left arm NDC/Expiry not known PC 2: She also went to the emergency room on the night of 01Apr2021 because her fever was 104 degrees Fahrenheit even taking the Tylenol. When the Tylenol could no longer manage her fever she went to the emergency room. She reports the first bottle was the brand name of Tylenol but she has discarded the bottle. It was the 4 hour kind. NDC/Lot/Expiry not known. The second bottle of Tylenol is the (Company name) Tylenol knock off brand. Acetaminophen. Each tablet is 650mg take 2 tablets every 8 hours as needed. Lot# unknown NDC 0363-0336-01, Expiry Sep2022 PC 3: She has to get her glasses to read the NDC/Expiry from the (Company name) Tylenol knock off brand. NDC 0363-0336-01 Expiry Sep2022, Lot # unknown No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness: Anxiety disorder (Anxiety disorder); Bipolar disorder (Verbatim: Bipolar disorder/bipolar with panic disorder)

ID: 1284758
Sex: M
Age:
State: OR

Vax Date: 04/18/2021
Onset Date: 04/19/2021
Rec V Date: 05/04/2021
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Symptoms: passed out; extreme nausea; hit the bathroom floor; have a cut lip; extreme chills; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left arm on 18Apr2021 10:45 (Lot Number: EW0164) as single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and allergy. Concomitant medications included chlordiazepoxide, clidinium bromide (LIBRAX), Multi-Vitamin, colecalciferol (D3), ascorbic acid (VIT C), fish oil. No other vaccine was received in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient received first dose of BNT162B2 (lot# ER2613) in left arm on 27Mar2021 12:00 PM for COVID-19 immunization. The patient experienced extreme nausea 19Apr2021 00:30, then he passed out and hit the bathroom floor. The patient woke up a few moments later, when her wife found him. The patient had a cut lip. The patient then had extreme chills for 30-60 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. It's unknown if treatment was received. The outcome of events was recovering.

Other Meds: LIBRAX [CHLORDIAZEPOXIDE;CLIDINIUM BROMIDE]; OMEPRAZOLE; D3; VIT C; FISH OIL

Current Illness:

ID: 1284759
Sex: F
Age:
State:

Vax Date: 04/01/2021
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Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: I don't feel good; rash all over the body, spots, in a couple of spots; shaking; throwing up; sick; This is a spontaneous report from a non-contactable consumer reporting for herself. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Apr2021 at single dose for COVID-19 immunisation. Relevant medical history included that she had Stevens-Johnson syndrome and was in the hospital for a month because she had a reaction to vancomycin and almost had a liver transplant. Concomitant medications were not reported. The patient reported that on an unspecified date she did not feel good, woke up with breaking a rash all over the body, spots, in a couple of spots, shaking, throwing up, sick. She have been through urgent care and nobody had any idea. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

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Current Illness:

ID: 1284760
Sex: M
Age:
State: NJ

Vax Date: 03/31/2021
Onset Date: 04/01/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: pneumonia; temperature going up to 103 degrees/fever; tested positive for COVID19/COVID 19 positive; sore throat; cough; diarrhea; very bad headache; a little tired; high blood pressure; His Legs were a little wobbly from not using the muscles while in the hospital; get dehydrated; This is a spontaneous report from a contactable consumer(patient). A 66-year-old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number ERO727), via an unspecified route of administration at Arm Right on 31-MAR-2021 09:30 at the 66 years old at single dose for COVID-19 immunisation. The medical history was none. The concomitant medications were none. On 07Apr2021, he started to develop symptoms: sore throat and cough. On 08Apr2021, he got a PCR and rapid test, and he tested positive for COVID19. On the weekend of 10Apr2021 and 11Apr2021, it started getting more severe. He had a very bad headache on the left side of his head, right next to his left eyeball on 07-APR-2021. The patient stated that he could not get any relief, tried to take Tylenol but nothing helped. He also had diarrhea on 07-APR-2021, "couldn't hold anything in", and started to get dehydrated in APR2021. The reporter states that then that weekend on the 10Apr2021 at night getting a high temperature going up to 103 degrees/fever. On 13Apr2021, his son told him that he better get to the ER. At the ER, he did a chest X-ray and another PCR test to confirm the COVID19 diagnosis. On the chest X-ray they found something unusual in his chest so they did a "contrast cat scan" and found pneumonia on 13-APR-2021. He was admitted the hospital on 13Apr2021 and was discharged on 16Apr2021. He is now scheduled for his second dose of the vaccine one 21Apr2021. He went to a clinic yesterday for a PCR test and it came out positive. He's getting conflicting information as to what needs to be done, some people are telling him he has to wait for 3 months, other are telling him to notify his PCP. He's wondering if he can get his second dose as planned on 21Apr2021. The patient stated that while he was in the hospital, they did a CAT scan. Caller reports that first they did an X-ray of his lungs and found something in lungs. The patient stated that they scheduled a CAT scan with contrast and was told he had pneumonia on top of having the COVID virus. The patient stayed in the hospital and they pumped him with fluids because he was pretty dehydrated because he couldn't hold anything in. The patient stated that he had diarrhea and everything else. The patient stated he had high blood pressure in APR-2021 and he just didn't want to take a risk of any fatalities. The patient stated that they gave him some type of medication to fight the COVID virus, "Repar" or something like that. 16Apr2021 in the afternoon, they released caller back home. The patient stated that his temperature went down, his blood pressure went down and everything seemed to be ready for him to go home. The patient stated that yesterday on 18Apr2021 he decided to get another PCR test because he wanted to see if he still had the COVID virus. The patient stated that he didn't have a follow up PCR at the hospital because the hospital doesn't normally do it. PCR test still came out positive yesterday 18Apr2021. Caller states that his big question is that he is scheduled to get the 2nd Pfizer COVID vaccine on 21Apr2021 and since he is still testing positive for the COVID virus, is he still required to get the second Pfizer COVID vaccine or does caller have to wait. The patient stated that he is getting conflicting answers, some say you can't get the second shot for at least 3 months but the caller doesn't know how true that is. The patient stated that he tested positive for the COVID virus on 8Apr2021, caller went to a testing center. The patient stated that it was getting annoying, it was not the COVID symptoms. The patient stated that he thinks only thing is he was feeling was a little tired and tired from being in the hospital for so many days in APR-2021, In APR-2021 his Legs were a little wobbly from not using the muscles while in the hospital. The patient stated he was walking around in the apartment to help build up the leg muscles. The patient stated that he does have an appetite and is drinking liquids. The patient stated that he was diagnosed with pneumonia on 13Apr2021 and he is not sure if it is ongoing or not. He asked the hospital before discharge about if they were going to check again for the pneumonia the answer was we normally don't test and that caller needs to go to his PCP doctor to see if the PCP will order another test for the pneumonia. The patient stated that it would have been easier for them to check again while caller was still in the hospital already. The events sore throat, fever, cough require a visit to Emergency Room. If applicable, there was not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The outcome of event COVID-19 was Not recovered, the events Pneumonia, Dehydration, Tiredness , Muscle weakness was unknown, the events Sore throat, Cough, Diarrhea, Fever, Headache was recovered on 16-APR-2021, the event Blood pressure high was recovering.

Other Meds:

Current Illness:

ID: 1284762
Sex: F
Age:
State: FL

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: I had an allergic reaction to the Pfizer Covid vaccine; I fell; Passed Out Without Warning and Hit her Face on the Tile Floor; Busted Mouth; Stitches in Mouth; Right Knee Very Sore /Left Shoulder Very Sore and Can't Use It; Black Left Eye; states it was black, blue, purple, green and yellow; Tiredness; Left Hand Pinky Sore; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 14:00 at age of 80-year-old (Batch/lot Number: EN6205) at single dose for COVID-19 immunization. The vaccine was not administered at Military Facility. Medical history included she has hearing aides but it is hard to hear or understand sometimes. There were no concomitant medications. Prior Vaccinations (within 4 weeks) was the first dose of Pfizer COVID Vaccine (Batch/lot number: EL9267) on 18Feb2021 at age of 80-year-old administered in right arm and no adverse events following prior vaccinations. The patient reported she had an allergic reaction to the Pfizer COVID vaccine, she fell on 11Mar2021, not fainted. On 11Mar2021, the patient passed out without warning and hit her face on the tile floor, experienced busted mouth/stitches in mouth, right knee and left shoulder were very sore, black left eye/it was black, blue, purple, green and yellow, tiredness, left hand pinky sore. The patient was calling about the Pfizer COVID Second Shot; verified Pfizer COVID Vaccine. Her second shot was on 11Mar2021 and on the same day she passed out without any warning whatsoever, and she hit the tile floor and ended up in the hospital for five days. She passed out and didn't remember falling or feeling anything before falling. The patient also has a primary physician, but she had been seeing the plastic surgeon for this. The patient asked what does she do if she needs to get a booster. It scared her to death if she would have to take another shot. The patient asked (name) to hand her a pair of glasses to read the plastic surgeons name. She stated the printing is so small on there. She was supposed to see the doctor on 19Apr2021, but she didn't feel good enough to go see the doctor. For busted Mouth, they put in 3 layers of stitches. The stiches have been giving her a fit because sometimes they come undone and hang down. She had to go back into him and get them cut out twice, and she had another one from last night (18Apr2021). It is very sore. States the stiches inside the lip have not resolved and it was still hard. One part of her lip is soft and one part is hard. It was all hard in the beginning. The stitches on the inside are supposed to dissolve. For right Knee it was very sore and she can't hardly use it. For left shoulder it is very sore and she can't hardly use it. It made it awkward to get in and out of bed when she can't use her left arm or her right knee. Her left shoulder was really bothering her and she may have to go have some more work done. It has been popping and went in and out of the joint. That would be back with her primary doctor. Sore pinky on left hand had recovered it didn't stay that long. Black left eye, it was black and blue purple green and yellow. It cleared up in the last couple of days. She was lucky she didn't break the bone around her eye. Treatment included stitches, hospitalization, given antibiotics and blood clotting shots so she didn't get blood clots, she had 3 of those in her belly. She wasn't allowed to get out of the bed when she was in the hospital. She had a terrible experience in the hospital. For the event onset time, it was at 20:00, they drove home from (place name), which is an hour and something, and they stopped at (place name), came home and set outside and she said she had to go lay down because she was tired. She woke up an hour and half to 2 hours later, got out of bed, sat on side, stood up and got herself together and walked to bottom of bed and went out flat. The events required a visit to emergency room and physician office. For emergency room visit, it was reported on 11Mar2021 at (hospital name); the patient should've called redacted number but didn't, they drove in. The patient was hospitalized from 11Mar2021 to 16Mar2021 at (hospital name). The outcome of passed out, tiredness were resolved on 11Mar2021, outcome of 'black left eye/it was black, blue, purple, green and yellow' was resolved on 17Apr2021, outcome of left hand pinky sore was resolved in 2021, the outcome of fell, allergic reaction to the Pfizer COVID vaccine were unknow, outcome of busted mouth, right knee/left shoulder very sore were not resolved.

Other Meds:

Current Illness: Hearing aid user

ID: 1284763
Sex: M
Age:
State: TX

Vax Date: 03/30/2021
Onset Date: 04/02/2021
Rec V Date: 05/04/2021
Hospital: Y

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Symptoms: acute appendicitis; I had severe abdominal pain beginning on 02Apr; This is a spontaneous report from a contactable consumer. A 43-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, administered on the left arm, at the age of 43 years, on 30Mar2021 10:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included surgery from 03Apr2021 to an unknown date. Concomitant medications included paracetamol (TYLENOL) and nystatin (STATIN [NYSTATIN]), both taken for an unspecified indication, start and stop date were not reported. The patient received first dose of COVID vaccine BNT162B2, at the age of 43 years, on 09Mar2021 in the left arm at single dose for COVID-19 immunization. The patient stated, "I had severe abdominal pain beginning on 02Apr2021; I went to the emergency room at 3am on 03Apr2021 and was diagnosed with acute appendicitis". The patient was hospitalized for the events. The outcome of the events was recovered on an unspecified date. Information about Batch/Lot number has been requested.

Other Meds: TYLENOL; STATIN [NYSTATIN]

Current Illness:

ID: 1284764
Sex: F
Age:
State: CA

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 05/04/2021
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Symptoms: with right leg, severe pain and had DVT diagnosed/ diagnose with DVT (deep vein blood clot) in my leg; This is a spontaneous report from a contactable consumer (patient). A female patient (Age: 60; Unit: Unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included COVID-19 from 02Oct2020 to an unknown date. Concomitant medications were not reported. The patient experienced with right leg, severe pain and had dvt diagnosed/ diagnose with dvt (deep vein blood clot) in my leg on an unspecified date in 2021 with outcome of unknown. Patient states she had COVID-19 on 02Oct2020. She received her first Pfizer vaccine dose in her left arm on 17Mar2021. On 01Apr2021, she went to the hospital ED with right leg, severe pain and had DVT diagnosed. She was sent home from the ED with Xarelto. On 07Apr2021, 2nd vaccine dose received by patient. Consumer stated, "I called the health department and I just wanted you to record that I called you guys back on 17Mar I've had my first COVID shot and then 01Apr, I went to the hospital (further details for the hospitalization not available hence not checked as seriousness criteria) and diagnose with DVT (deep vein blood clot) in my leg. I just felt, I just know that what going on right now with Johnson and Johnson but I am just trying to kind of understand that 2 weeks to the day that I had my first COVID shot I came down with the blood clot in my leg. So I just wanted to see if that's anything that I need to concerned, it's very painful, fortunately I have been able to work from home but it's very painful and I did get my second round because level one I need to think about it. So, with everything going on. I never had blood clot now before that I have now." Information on the lot/batch number has been requested.

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Current Illness:

ID: 1284765
Sex: F
Age:
State: MA

Vax Date: 04/18/2021
Onset Date: 04/18/2021
Rec V Date: 05/04/2021
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Symptoms: fainting; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; hot burning sensation down left arm from injection site to wrist; dry throat; intense thirst; difficulty swallowing; vertigo; cloudy vision; waves of nausea; weak/numb hands; weak/numb hands; uncontrollable shaking; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 18Apr2021 at 09:45 (Batch/Lot Number: EW0164) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took pneumococcal vaccine for immunisation and experienced allergy, tylenol and experienced allergy, codeine and experienced allergy. The patient experienced fainting, hot burning sensation down left arm from injection site to wrist, dry throat, intense thirst, difficulty swallowing, vertigo, cloudy vision, waves of nausea, weak/numb hands, uncontrollable shaking; all on 18Apr2021 with outcome of recovered in Apr2021. No treatment received for the events. All events resulted in doctor or other healthcare professional office/clinic visit.

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Current Illness:

Total 2021 VAERS Injuries: 704,237

Page last modified: 03 October 2021 5:28pm