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
38,878
AK1,239
AL2,904
AR1,891
AS34
AZ8,770
CA36,271
CO6,944
CT4,712
DC960
DE956
FL19,668
FM3
GA7,689
GU56
HI1,304
IA2,897
ID1,548
IL11,628
IN17,864
KS2,811
KY3,643
LA2,737
MA8,738
MD7,542
ME1,996
MH6
MI10,613
MN7,153
MO5,447
MP12
MS1,450
MT1,464
NC9,126
ND808
NE1,773
NH1,971
NJ9,455
NM2,305
NV2,252
NY19,387
OH11,324
OK2,924
OR4,944
PA13,367
PR1,303
QM1
RI1,319
SC3,375
SD767
TN4,966
TX19,047
UT2,627
VA8,887
VI29
VT1,144
WA8,443
WI6,686
WV1,424
WY510
XB4
XL1
XV2

ID: 1304988
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/11/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: FEVER BLISTER/ COLD SORES; LIPS EXFOLIATING/ PEELING; This spontaneous report received from a patient concerned a 56 year old female. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced fever blister/ cold sores, and lips exfoliating/ peeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever blister/ cold sores and lips exfoliating/ peeling was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304989
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 05/05/2021
Rec V Date: 05/11/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: EXTRA DOSE ADMINISTERED; This spontaneous report received from a physician concerned a 63 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: Unknown) dose was not reported, administered on 09-APR-2021, and dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAY-2021, the subject experienced extra dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extra dose administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304990
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/11/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Symptom List:

Symptoms: INJECTION BURNED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to pine trees and other pollen producing trees and grass, runny nose, cough, and watery eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included diphenhydramine hydrochloride for seasonal allergies. On 2021, the subject experienced injection burned. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection burned was not reported. This report was non-serious.

Other Meds: BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Cough; Runny nose; Watering eyes

ID: 1304991
Sex: M
Age:
State: TX

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

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

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Symptom List:

Symptoms: BODY ACHES; CHILLS; FEVER; HEADACHE; This spontaneous report received from a health care professional concerned an elderly 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: Unknown) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, headache and body aches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304992
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 05/11/2021
Hospital:

Vax Type:
Manufacturer:
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Lot:
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Lab Data:

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Symptom List:

Symptoms: HEADACHES; MUSCLE PAIN/MUSCLES ACHES IN LEGS; 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced headaches. On 06-APR-2021, the subject experienced muscle pain/muscles aches in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headaches and muscle pain/muscle pain/muscles aches in leg was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304993
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 04/13/2021
Rec V Date: 05/11/2021
Hospital:

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

Allergies:

Symptom List:

Symptoms: PALPITATIONS; RIGHT CALF CRAMPS; DYSGEUSIA; TINNITUS; DIARRHEA; DIZZINESS; CHILLS; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was 225 pounds, and height was 62 inches. The patient's concurrent conditions included chronic kidney disease, meniere's disease, anxiety, occasional drinker, non smoker, allergic to keflex, and environmental allergies, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 13-APR-2021 for prophylactic vaccination. Concomitant medications included lisinopril for chronic kidney disease, and spironolactone for chronic kidney disease. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced tinnitus. On 14-APR-2021, the subject experienced diarrhea. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced chills. On 14-APR-2021, the subject experienced fever. On 15-APR-2021, the subject experienced dysgeusia. On 03-MAY-2021, the subject experienced palpitations. On 03-MAY-2021, the subject experienced right calf cramps. On 05-MAY-2021, Laboratory data included: Doppler scan (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Normal. On 07-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown, and Urinalysis (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dysgeusia on 24-APR-2021, diarrhea on 14-APR-2021, right calf cramps on 04-MAY-2021, chills, and fever on 15-APR-2021, and nausea on 16-APR-2021, and was recovering from dizziness, tinnitus, palpitations, and fatigue. This report was non-serious.

Other Meds: ALDACTONE [SPIRONOLACTONE]; LISINOPRIL

Current Illness: Allergic reaction to antibiotics (not true allergy-patient states she gets headaches from Keflex.); Anxiety; Chronic kidney disease; Environmental allergy; Meniere's disease; Non-smoker; Social alcohol drinker

ID: 1304994
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/11/2021
Hospital:

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

Allergies:

Symptom List:

Symptoms: SORE AND ACHY; FREEZING COLD; MILD HEADACHE; This spontaneous report received from a patient concerned a male 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 sore and achy, freezing cold, and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from freezing cold, and was recovering from sore and achy, and mild headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304995
Sex: F
Age:
State: WA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/11/2021
Hospital:

Vax Type:
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Vax Name:
Lot:
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Lab Data:

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Symptoms: NEUROLOGICAL SYMPTOMS; This spontaneous report received from a consumer 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 was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced neurological symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of neurological symptoms was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304996
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/11/2021
Hospital:

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

Allergies:

Symptom List:

Symptoms: HEAVY BREATHING EVEN IF JUST TALKING/SHORTNESS OF BREATH; HEADACHES; HEAVINESS IN CHEST/FEELS LIKE SOMEONE IS SITTING ON MY CHEST; This spontaneous report received from a patient concerned a 60 year old female. 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: Unk) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in chest/feels like someone is sitting on my chest. On 02-APR-2021, the subject experienced heavy breathing even if im just talking/shortness of breath. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy breathing even if just talking/shortness of breath, and the outcome of headaches and heaviness in chest/feels like someone is sitting on my chest was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304997
Sex: M
Age:
State: TX

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

Vax Type:
Manufacturer:
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Lot:
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Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: CARDIAC EVENT; This spontaneous report received from a patient via a company representative concerned a 42 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced cardiac event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac event on 08-MAY-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304998
Sex: M
Age:
State:

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

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

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Symptom List:

Symptoms: GONE THROUGH HELL TODAY; This spontaneous report received from a patient via a company representative concerned a male 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: Unk) dose was not reported, administered on 07-MAY-2021 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 08-MAY-2021, the subject experienced gone through hell today. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gone through hell today was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1304999
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: DEBILITATING DAILY MIGRAINES; LOSS OF FEELING ON LEFT SIDE; This spontaneous report received from a patient via a company representative concerned a 33 year old female. 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 debilitating daily migraines, and loss of feeling on left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the debilitating daily migraines and loss of feeling on left side was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1305000
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: EXTREMELY TIRED; This spontaneous report received from a patient via a company representative 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 30-APR-2021 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 06-MAY-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extremely tired was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1305001
Sex: F
Age:
State: AZ

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: ACHE; FEVER; HEADACHE; NAUSEOUS; BURNING SENSATION ON RIGHT ARM DOWN TO WRIST; This spontaneous report received from a patient concerned an adult female. 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: 207A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.7 F. On 07-MAY-2021, the subject experienced burning sensation on right arm down to wrist. On 08-MAY-2021, the subject experienced ache. On 08-MAY-2021, the subject experienced fever. On 08-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning sensation on right arm down to wrist on 07-MAY-2021, had not recovered from fever, headache, and nauseous, and the outcome of ache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1305002
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient via a company representative 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, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 17:00 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 01-APR-2021 21:00, the subject experienced body aches. On 01-APR-2021 21:00, the subject experienced fatigue. On 01-APR-2021 21:00, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fatigue, and headache on 03-APR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1305003
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: unusual side effects; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced unusual side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unusual side effects was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1305004
Sex: M
Age: 69
State: TX

Vax Date: 12/30/2020
Onset Date: 01/04/2021
Rec V Date: 05/11/2021
Hospital:

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

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Symptom List:

Symptoms: Fast Heart Beat; Lightheadedness; Shortness of breath; arrythmia; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrythmia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stent placement (Patient had a stent inserted in him 9 months ago) in May 2020. Concomitant products included PRAVASTATIN from 12-Sep-2014 to an unknown date for Cholesterol, ALLOPURINOL from 12-Mar-1999 to an unknown date for Gout, METFORMIN from 12-Jan-2008 to an unknown date for Prediabetes, TICAGRELOR (BRILINTA) from 12-May-2020 to 28-Dec-2020 for blood thinner, ACETYLSALICYLIC ACID (ASPRIN) from 12-May-2020 to an unknown date. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced ARRHYTHMIA (arrythmia) (seriousness criterion medically significant). On 03-Feb-2021, the patient experienced DIZZINESS (Lightheadedness) and DYSPNOEA (Shortness of breath). On 03-Feb-2021 at 5:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Fast Heart Beat). On 05-Jan-2021, ARRHYTHMIA (arrythmia) outcome was unknown. On 04-Feb-2021, HEART RATE INCREASED (Fast Heart Beat) had resolved. At the time of the report, DIZZINESS (Lightheadedness) and DYSPNOEA (Shortness of breath) had resolved. Treatment information not provided. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded This case was linked to MOD-2021-043170 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: New events added includes arrythmia, light headedness, dizziness and shortness of breath.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded

Other Meds: ALLOPURINOL; METFORMIN; PRAVASTATIN; BRILINTA; ASPRIN

Current Illness:

ID: 1305005
Sex: F
Age: 30
State: IL

Vax Date: 11/28/2017
Onset Date:
Rec V Date: 05/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Colon fistula drainage due to infection on the site; Gastrintestinal infection; Chills; Fever; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COLONIC FISTULA (Colon fistula drainage due to infection on the site), GASTROINTESTINAL INFECTION (Gastrintestinal infection), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. The patient's past medical history included Intestinal fistula repair (Colonic Fistula surgery) on 01-Sep-2017 and Fistula repair (colonic fistula drainage insertion surgery) on 28-Sep-2017. Concurrent medical conditions included Crohn's disease. On 28-Nov-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLONIC FISTULA (Colon fistula drainage due to infection on the site) (seriousness criterion medically significant), GASTROINTESTINAL INFECTION (Gastrintestinal infection), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, COLONIC FISTULA (Colon fistula drainage due to infection on the site) was resolving, GASTROINTESTINAL INFECTION (Gastrintestinal infection), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and PYREXIA (Fever) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator. On 02-MAR-2021, patient had a surgery to remove the colon fistula drainage due to infection on the site. She was doing better with colon fistula but still had some draining. No other treatment information was provided by the reporter for symptoms like chills, fever, headache. This case concerns a 34-year-old female with PMH of Crohn's disease on adalimumab, who had serious unexpected events of gastrointestinal infection, colonic fistula, pyrexia, chills, and headache. Event onset with unknown latency after second 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. Action taken with mRNA-1273 in response to events was not applicable. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received included patient demographics, medical history, dose unit and therapy start date of co-suspect drug, vaccine second dose , adverse event Fistula drainage was deleted as per intial and gastrointestinal infection was added and outcome was unknown. Treatment surgery added in narrative description.; Sender's Comments: This case concerns a 34-year-old female with PMH of Crohn's disease on adalimumab, who had serious unexpected events of gastrointestinal infection, colonic fistula, pyrexia, chills, and headache. Event onset with unknown latency after second 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: Crohn's disease

ID: 1305006
Sex: F
Age:
State: NY

Vax Date: 01/21/2021
Onset Date: 02/19/2021
Rec V Date: 05/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced MYALGIA (flulike muscle aches). On 19-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested postive for SARS-CoV-2 RNA). On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). On 20-Feb-2021, MYALGIA (flulike muscle aches) had resolved. At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) and COVID-19 (tested postive for SARS-CoV-2 RNA) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The patient's symptoms included oropharyngeal pain, nasal congestion, anosmia and headache. 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 event (myalgia) a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (myalgia) a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1305007
Sex: M
Age:
State: FL

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

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

Symptom List:

Symptoms: This literature-non-study case was reported in a literature article and describes the occurrence of VACCINATION FAILURE (vaccine response impaired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Non-ischaemic cardiomyopathy (cause or organ failure) and Solid organ transplant since an unknown date. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression. 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 VACCINATION FAILURE (vaccine response impaired) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to VACCINATION FAILURE. At the time of the report, VACCINATION FAILURE (vaccine response impaired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: positive (Positive) Diagnosis of COVID-19 was confirmed in all patients with polymerase chain reaction (PCR) of nasal swabs.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION FAILURE (vaccine response impaired) to be possibly related. Baseline immunosuppression for solid organ transplantation was achieved with basiliximab. Patient was hospitalized for 5 days and treated with Remdesivir and Convalescent Plasma. The patient was discharged on 2 Liters of oxygen. "The clinical presentation and course of these patients were comparable to those of SOTs who had COVID-19 infection and have not been vaccinated. This finding suggests that SOTs are still at risk of acquiring COVID-19 infection even after vaccination..." 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. This case was linked to MOD-2021-094284, MOD-2021-094289, MOD-2021-094295 (E2B Linked Report). This case was linked to MOD-2021-094325 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD-2021-094284:Same literature article_Patient 3 MOD-2021-094289:Same literature article_Patient 3 MOD-2021-094295:Same literature article_Patient 5

Other Meds: TACROLIMUS; MYCOPHENOLATE MOFETIL; PREDNISONE

Current Illness: Solid organ transplant

ID: 1305008
Sex: M
Age: 85
State: KS

Vax Date: 03/24/2021
Onset Date: 04/22/2021
Rec V Date: 05/11/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Fainted; Left rib cage injured; Aches in the bones; Ill; Fell face first into the floor, fell on my hands; Bruised his hand; Face injured; Left hip and knee is injured; Nausea; Aches in the joints; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) and CHEST INJURY (Left rib cage injured) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042821A and 003821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Patient spent 50 days in the hospital) from October 2020 to 04-Dec-2020. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CHEST INJURY (Left rib cage injured) (seriousness criterion medically significant), BONE PAIN (Aches in the bones), ILLNESS (Ill), FALL (Fell face first into the floor, fell on my hands), CONTUSION (Bruised his hand), FACE INJURY (Face injured), JOINT INJURY (Left hip and knee is injured), NAUSEA (Nausea) and ARTHRALGIA (Aches in the joints). At the time of the report, SYNCOPE (Fainted), CHEST INJURY (Left rib cage injured), BONE PAIN (Aches in the bones), ILLNESS (Ill), FALL (Fell face first into the floor, fell on my hands), CONTUSION (Bruised his hand), FACE INJURY (Face injured), JOINT INJURY (Left hip and knee is injured), NAUSEA (Nausea) and ARTHRALGIA (Aches in the joints) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac function test: normal (normal) normal (heart was ok). No relevant concomitant medications were provided. On 22 Apr 2021, patient experienced aches in his joints and bones, he was becoming ill and had nausea which triggered emergency and needing to go to bathroom. He was heading to the bathroom, he fainted and fell face first into the floor. He injured his face, fell on his hands. He had bruised his hand. His left rib cage and left hip and knee was injured. He went to the Emergency Department where he was told his heart was ok, he was not delirious and consciousness was ok. He stated, it has now been a week and the bruising is still there and the stiches will be coming off tomorrow. No treatment information was provided. Action taken with mRNA in respect 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. However, the events face injury, contusion, fall, chest injury and joint injury is unlikely related to m-RNA 1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the events face injury, contusion, fall, chest injury and joint injury is unlikely related to m-RNA 1273.

Other Meds:

Current Illness:

ID: 1305009
Sex: M
Age: 63
State: MI

Vax Date: 03/06/2021
Onset Date: 03/28/2021
Rec V Date: 05/11/2021
Hospital:

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Symptoms: headache; Pneumonia; covid-19; difficulty breathing from copd; Achey; tired; high fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (covid-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired) and PYREXIA (high fever). On 12-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (covid-19), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired), HEADACHE (headache) and PYREXIA (high fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Apr-2021, Computerised tomogram: positive (Positive) positive for pneumonia.. On 12-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient finished treatment with antibiotics and was tested positive for antibodies. Patient took Levofloxacin, inhaler (albuterol) and steroid dexamethasone medications as a treatment. There are no concomitant medication reported. 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. Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 This case was linked to MOD-2021-095577 (E2B Linked Report).; 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. Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 MOD-2021-095577:

Other Meds:

Current Illness:

ID: 1305010
Sex: U
Age:
State: NY

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

Vax Type:
Manufacturer:
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Lot:
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Symptom List:

Symptoms: secondary immune thrombocytopenia; Based on the current case data, this case has been classified as invalid. This literature-non-study case was reported in a literature article and describes the occurrence of IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) (seriousness criterion hospitalization). At the time of the report, IMMUNE THROMBOCYTOPENIA (secondary immune thrombocytopenia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Platelet count: unknown 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. The case pertains to 11 patients from a literature article review. Concomitant medication use was not reported Treatment information was not reported. Very limited information regarding the event has been provided at this time. Very limited information regarding the event has been provided at this time. This case was linked to MOD-2021-096709 (E2B Linked Report).; Sender's Comments: Very limited information regarding the event has been provided at this time. MOD-2021-096709:Same literature article (37-yo male)

Other Meds:

Current Illness:

ID: 1305011
Sex: F
Age: 89
State: GA

Vax Date: 01/16/2021
Onset Date: 02/17/2021
Rec V Date: 05/11/2021
Hospital: Y

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

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Symptom List:

Symptoms: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation), PULMONARY EMBOLISM (blood clots in her lungs) and THROMBOSIS (blood clots everywhere) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIARRHOEA (diarrhea), BLOOD PRESSURE ABNORMAL (no blood pressure), VACCINATION SITE PAIN (arm still hurts from time to time) and FATIGUE (felt tired). On 03-Mar-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion hospitalization), PULMONARY EMBOLISM (blood clots in her lungs) (seriousness criterion hospitalization) and THROMBOSIS (blood clots everywhere) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PULMONARY EMBOLISM (blood clots in her lungs), THROMBOSIS (blood clots everywhere), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), BLOOD PRESSURE ABNORMAL (no blood pressure) and FATIGUE (felt tired) outcome was unknown and DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (arm still hurts from time to time) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) haven't found anything. On an unknown date, Endoscopy: normal (normal) haven't found anything. Treatment medication included apixaban. Action taken with mRNA-1273 in response to the events was not Applicable. The patient had an endoscopy and CAT scan where they haven't found anything at when she was at the clinic. Consumer was vaccinated with first dose on 16JAN2021 (was not able to locate lot/expiration on vaccination card). She got her second dose on 17FEB2021 (was not able to locate lot/expiration on vaccination card) and she felt like she was getting the flu, felt tired and on 3MAR2021, she was rushed to the hospital because she had "no blood pressure" and presented atrial fibrillation and blood clots in her lungs and everywhere. Her arm still hurts from time to time and continues to have diarrhea. She states she is a fairly healthy person does not take any medications, only Centrum vitamins. Since then she has gone to the clinic, had an endoscopy and CAT scan where they haven't found anything. She is now on Eliquis. 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 MOD-2021-101609 (Patient Link).; 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: VITAMINS NOS

Current Illness:

ID: 1305012
Sex: F
Age: 40
State: FL

Vax Date: 03/31/2021
Onset Date: 04/29/2021
Rec V Date: 05/11/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was reported.). On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, CONJUNCTIVAL HYPERAEMIA (Burst blood vessels in the left eye extending from iris to the outer edge of the eye ball) and FATIGUE (Fatigue) outcome was unknown. Concomitant medications were not reported. The patient reported that she experienced the adverse event in the left eye, 12 hours after the administration of the second dose of the vaccine. The right eye was completely fine. 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. Treatment medication included Tylenol (acetaminophen). This case was linked to US-MODERNATX, INC.-MOD-2021-102880 (E2B Linked Report).; 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: 1305013
Sex: F
Age: 62
State: NM

Vax Date: 04/01/2021
Onset Date: 04/11/2021
Rec V Date: 05/11/2021
Hospital:

Vax Type:
Manufacturer:
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Symptom List:

Symptoms: My feet were swollen last week; Headache; Bell's palsy; Could not open an eye on left side; Can't talk great; Can't blink; Mouth was crooked.; Feeling something wrong; Mouth still numb and twisted; Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bell's palsy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's palsy) (seriousness criterion medically significant), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted) and INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping). On an unknown date, the patient experienced PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache). At the time of the report, FACIAL PARALYSIS (Bell's palsy), EYE MOVEMENT DISORDER (Could not open an eye on left side), SPEECH DISORDER (Can't talk great), EYE DISORDER (Can't blink), DYSKINESIA (Mouth was crooked.), FEELING ABNORMAL (Feeling something wrong), HYPOAESTHESIA ORAL (Mouth still numb and twisted), INSOMNIA (Can't close the eye and has to put a patch at night in order to sleep and wasn't sleeping), PERIPHERAL SWELLING (My feet were swollen last week) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Lab details were not provided. Treatment medication for the symptoms included. prednisone 20 mg for 7 days valacyclovir 500 mg for 7 days white petrolatum to lubricate under the patch muscle relaxant for sleep - described as effective 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.; 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: 1305014
Sex: F
Age: 50
State: NJ

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 05/11/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Liver enzymes increased; Iron level increased; Constipation; Could not move my left arm for 4 days; Blood pressure was very low; arm Pain at the injection site; Exhaustion; Massive headaches; Felt a sensation going up the left side of my neck and face; Tingling in my feet and hands; felt dizzy; Slept for several hours; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEPATIC ENZYME INCREASED (Liver enzymes increased), BLOOD IRON INCREASED (Iron level increased) and CONSTIPATION (Constipation) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Carcinoid syndrome in 2012, Neuroendocrine carcinoma in 2012 and Tumor excision (Tumors removed from liver and pancreas) in 2014. Concomitant products included TELOTRISTAT ETIPRATE (XERMELO), OCTREOTIDE ACETATE (SANDOSTATIN), LANREOTIDE, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D [VITAMIN D NOS], FISH OIL, LEVOTHYROXINE, FOLIC ACID, IRON, VITAMIN B COMPLEX, PANCRELIPASE (ZENPEP), DEXLANSOPRAZOLE (DEXILANT), FAMOTIDINE (PEPCID [FAMOTIDINE]), SUCRALFATE, HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HCL), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), MAGNESIUM CITRATE and MACROGOL 3350 (MIRALAX) for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced SENSORY DISTURBANCE (Felt a sensation going up the left side of my neck and face), PARAESTHESIA (Tingling in my feet and hands), DIZZINESS (felt dizzy) and HYPERSOMNIA (Slept for several hours). On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (Liver enzymes increased) (seriousness criterion medically significant), BLOOD IRON INCREASED (Iron level increased) (seriousness criterion medically significant), CONSTIPATION (Constipation) (seriousness criterion medically significant), INJECTED LIMB MOBILITY DECREASED (Could not move my left arm for 4 days), HYPOTENSION (Blood pressure was very low), VACCINATION SITE PAIN (arm Pain at the injection site), FATIGUE (Exhaustion) and HEADACHE (Massive headaches). At the time of the report, HEPATIC ENZYME INCREASED (Liver enzymes increased) had not resolved, BLOOD IRON INCREASED (Iron level increased), SENSORY DISTURBANCE (Felt a sensation going up the left side of my neck and face), PARAESTHESIA (Tingling in my feet and hands), DIZZINESS (felt dizzy), HYPERSOMNIA (Slept for several hours), INJECTED LIMB MOBILITY DECREASED (Could not move my left arm for 4 days), HYPOTENSION (Blood pressure was very low), VACCINATION SITE PAIN (arm Pain at the injection site), FATIGUE (Exhaustion) and HEADACHE (Massive headaches) outcome was unknown and CONSTIPATION (Constipation) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood iron: increased (High) increased. On an unknown date, Blood pressure measurement: very low (Low) Very Low. On an unknown date, Liver function test: increased (High) increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Because of reactions to the first vaccine the patient's oncologist recommended to take a rescue shot of Octreotide 1 hour before the second vaccination. No treatment details were provided. Action taken with mRNA-1273 in response to the events was not Applicable. There is not enough information to assess the causal association between the event of hepatic enzyme increased and blood iron increased and the administration of mRNA-1273 as the onset of the event was not provided, Events are confounded by the medical history and concomitant medication. Based on temporality, the causal relationship between the other events and the product use cannot be excluded. Vaccination site pain, fatigue and headache are consistent with the product safety profile. This case was linked to MOD-2021-100644 (E2B Linked Report). This case was linked to MOD-2021-104568 (Patient Link).; Sender's Comments: There is not enough information to assess the causal association between the event of hepatic enzyme increased and blood iron increased and the administration of mRNA-1273 as the onset of the event was not provided, Events are confounded by the medical history and concomitant medication. Based on temporality, the causal relationship between the other events and the product use cannot be excluded. Vaccination site pain, fatigue and headache are consistent with the product safety profile. MOD-2021-100644:Reporter's friend

Other Meds: XERMELO; SANDOSTATIN; LANREOTIDE; VITAMIN B12 [VITAMIN B12 NOS]; VITAMIN D [VITAMIN D NOS]; FISH OIL; LEVOTHYROXINE; FOLIC ACID; IRON; VITAMIN B COMPLEX; ZENPEP; DEXILANT; PEPCID [FAMOTIDINE]; SUCRALFATE; HYDROXYZINE HCL; ZYRTEC [CETIRIZINE

Current Illness:

ID: 1305015
Sex: F
Age:
State: NJ

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

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

Allergies:

Symptom List:

Symptoms: Had a reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Had a reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Endocrine disorder (Unspecified neuroendocrine condition.). 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 VACCINATION COMPLICATION (Had a reaction) (seriousness criterion hospitalization). At the time of the report, VACCINATION COMPLICATION (Had a reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided by the reporter. Reporter states patient was rushed to the hospital due a reaction to the vaccine and was treated with ctreotide (unknown dose) for 24 hours and received 3 shots of epinephrine. Very limited information regarding this event has been provided at this time. Further information has been requested. This case was linked to MOD-2021-100633, MOD-2021-104568 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. MOD-2021-100633:Reporter's First Dose MOD-2021-104568:Reporter's Second Dose

Other Meds:

Current Illness: Endocrine disorder (Unspecified neuroendocrine condition.)

ID: 1305016
Sex: F
Age: 47
State: FL

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 05/11/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: Having heart arrhythmia every day; Rapid Heart Beat; Flu-like symptoms; Migraines; Iitchy throat; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Having heart arrhythmia every day) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arrhythmia (Heart arrhythmias was reported.). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced ARRHYTHMIA (Having heart arrhythmia every day) (seriousness criterion medically significant), HEART RATE INCREASED (Rapid Heart Beat), INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIGRAINE (Migraines) and THROAT IRRITATION (Iitchy throat). On 11-Apr-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MIGRAINE (Migraines) and THROAT IRRITATION (Iitchy throat) had resolved. At the time of the report, ARRHYTHMIA (Having heart arrhythmia every day) and HEART RATE INCREASED (Rapid Heart Beat) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: rapid heart beat (High) Rapid Heart Beat. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included for the events were ibuprofen, acetaminophen and diphenhydramine. The patient had recently relocated so she does not have a primary care physician at this time. 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.; 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: ALLEGRA

Current Illness: Arrhythmia (Heart arrhythmias was reported.)

ID: 1305017
Sex: F
Age: 61
State: CA

Vax Date: 02/12/2021
Onset Date: 03/22/2021
Rec V Date: 05/11/2021
Hospital: Y

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Symptoms: Immune thrombocytopenia (ITP); Blisters in the mouth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) in a 61-year-old female patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Medical history has not been reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) (seriousness criterion hospitalization) and ORAL MUCOSAL BLISTERING (Blisters in the mouth). The patient was hospitalized on 22-Mar-2021 due to IMMUNE THROMBOCYTOPENIA. At the time of the report, IMMUNE THROMBOCYTOPENIA (Immune thrombocytopenia (ITP)) had not resolved and ORAL MUCOSAL BLISTERING (Blisters in the mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Platelet count decreased: (Low) Admitted to the hospital with NO platelet counts. Patient was not on any concomitant medications before being admitted into the hospital. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1305018
Sex: M
Age: 78
State: MA

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 05/11/2021
Hospital: Y

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Symptoms: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROSTOMY (nephrostomy bleeding) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Urostomy, Nephrostomy and Colostomy. Concurrent medical conditions included Lymphoma (stage 4 lymphoma cancer), Renal failure (stage 4 renal failure) and Neuropathy NOS (chemo related neuropathy). On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), FATIGUE (fatigue) and CHILLS (he had chills). On 27-Apr-2021, the patient experienced NEPHROSTOMY (nephrostomy bleeding) (seriousness criterion hospitalization prolonged) and DEHYDRATION (he was dehydrated). On an unknown date, the patient experienced MYALGIA (hurting all over). The patient was hospitalized on 28-Apr-2021 due to NEPHROSTOMY. At the time of the report, NEPHROSTOMY (nephrostomy bleeding), DEHYDRATION (he was dehydrated), PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), MYALGIA (hurting all over), FATIGUE (fatigue) and CHILLS (he had chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. After the patient got the vaccine, he was very fatigue for a few days. He had a lot of arm pain. The doctors noticed that he got rash on both of his forearms. He complained of headaches and it was hurting all over. He was very weak and had chills. He had labored breathing. His nephrostomy was bleeding a lot in the tubes so they had to hospitalize him. He went to hospital on 27-Apr-2021 and was currently in the hospital. He had blood transfusions and he was very dehydrated. He was put on IV saline. He took Eliquis but doctors wanted to stop it because his kidneys were not in good shape. Company comment: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as the event is common local complication from nephrostomy tube placement, The other events are temporarily associated with the product use and a causal relationship cannot be excluded.; Sender's Comments: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as the event is common local complication from nephrostomy tube placement, The other events are temporarily associated with the product use and a causal relationship cannot be excluded.

Other Meds:

Current Illness: Lymphoma (stage 4 lymphoma cancer); Neuropathy NOS (chemo related neuropathy); Renal failure (stage 4 renal failure)

ID: 1305019
Sex: F
Age:
State: DE

Vax Date: 03/19/2021
Onset Date: 04/13/2021
Rec V Date: 05/11/2021
Hospital: Y

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Symptoms: mini stroke prior to second dose; Second dose outside 42 day window; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Second dose outside 42 day window). The patient was hospitalized on 13-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini stroke prior to second dose) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Second dose outside 42 day window) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date. No concomitant medications reported. No treatment information was provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1305020
Sex: F
Age: 59
State: NJ

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 05/11/2021
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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (Hearing loss) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SUDDEN HEARING LOSS (Hearing loss) (seriousness criterion medically significant) and VACCINATION SITE PAIN (Arm hurt a bit). On 07-Apr-2021, SUDDEN HEARING LOSS (Hearing loss) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm hurt a bit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient takes many concomitant medications but details were not provided. Patient took Tylenol (paracetamol) for her arm pain. Reporter states that when experiencing the sudden hearing loss event, she couldn't hear a single thing. She also noted that the event had resolved before she went to bed that same day. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1305021
Sex: F
Age: 75
State: FL

Vax Date: 02/16/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: Neuropathy; Sweating; barely can walk; Fogginess in her mind; sleep problems; canceled appointment for second shot even though her HCP advised her to get it; Chilis; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), GAIT DISTURBANCE (barely can walk), FEELING ABNORMAL (Fogginess in her mind), SLEEP DISORDER (sleep problems), INTENTIONAL PRODUCT USE ISSUE (canceled appointment for second shot even though her HCP advised her to get it) and CHILLS (Chilis). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), HYPERHIDROSIS (Sweating), GAIT DISTURBANCE (barely can walk), FEELING ABNORMAL (Fogginess in her mind) and CHILLS (Chilis) had not resolved, SLEEP DISORDER (sleep problems) was resolving and INTENTIONAL PRODUCT USE ISSUE (canceled appointment for second shot even though her HCP advised her to get it) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No relevant concomitant medications were provided. No treatment information was provided. This case of a 75-year-old female patient who canceled appointment for second (Intentional deviation from dosage regimen) due to events experienced following the first dose of mRNA-1273. The event of Intentional deviation from dosage regimen is assessed as not applicable. Based on temporality and excluding other etiologies, the causal relationship between the other events and the product use cannot be excluded. Chills is consistent with the product known safety profile. This case was linked (E2B Linked Report).; Sender's Comments: This case of a 75-year-old female patient who canceled appointment for second (Intentional deviation from dosage regimen) due to events experienced following the first dose of mRNA-1273. The event of Intentional deviation from dosage regimen is assessed as not applicable. Based on temporality and excluding other etiologies, the causal relationship between the other events and the product use cannot be excluded. Chills is consistent with the product known safety profile.

Other Meds:

Current Illness:

ID: 1305022
Sex: F
Age:
State: FL

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 05/11/2021
Hospital: Y

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Symptoms: Fell down; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical History not reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FALL (Fell down) (seriousness criterion hospitalization). At the time of the report, FALL (Fell down) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She was due for second dose today. She fell and was now is in the hospital. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1305023
Sex: M
Age: 67
State: FL

Vax Date: 01/13/2021
Onset Date: 02/12/2021
Rec V Date: 05/11/2021
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Symptoms: inflammation of bowels; inflammation of stomach; flu like symptoms; runny nose; local pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATORY BOWEL DISEASE (inflammation of bowels) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029k20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac ablation on 27-Jun-2019. Concurrent medical conditions included Atrial fibrillation (resolved with meds and ablation), Blood pressure high and Allergic rhinitis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Atrial fibrillation, AMLODIPINE and BISOPROLOL for Blood pressure high, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for GERD, FENOFIBRATE for Hyperlipidemia, ZOLPIDEM for Insomnia. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), RHINORRHOEA (runny nose) and VACCINATION SITE PAIN (local pain). On 13-Feb-2021, the patient experienced INFLAMMATORY BOWEL DISEASE (inflammation of bowels) (seriousness criterion medically significant) and GASTRITIS (inflammation of stomach). On 30-Apr-2021, INFLAMMATORY BOWEL DISEASE (inflammation of bowels) and GASTRITIS (inflammation of stomach) had resolved with sequelae. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and VACCINATION SITE PAIN (local pain) had resolved and RHINORRHOEA (runny nose) outcome was unknown. The patient went to their doctor who referred him to a gastrointestinal specialist. The patient had an endoscopy and ABD CT (abdominal computerized tomogram) scan. The patient stated that diverticulitis was suspected. The scans were reported as cleared, and an obstruction was cleared as well. There was inflammation of the stomach and bowels. Additional treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. Company comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds: FENOFIBRATE; AMLODIPINE; BISOPROLOL; NEXIUM [ESOMEPRAZOLE SODIUM]; ASPIRIN [ACETYLSALICYLIC ACID]; ZOLPIDEM

Current Illness: Allergic rhinitis; Atrial fibrillation (resolved with meds and ablation); Blood pressure high

ID: 1305024
Sex: M
Age: 63
State: FL

Vax Date: 04/20/2021
Onset Date: 04/20/2021
Rec V Date: 05/11/2021
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Symptoms: it was convulsive shaking; I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes; chill bumps; I could not stand up; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (it was convulsive shaking) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced SEIZURE (it was convulsive shaking) (seriousness criterion medically significant), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up). On 20-Apr-2021, SEIZURE (it was convulsive shaking), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that, patient was scared to take the 2nd vaccine. Patient almost fell back. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1305025
Sex: F
Age: 59
State: UT

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 05/11/2021
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Symptoms: Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it; Headache; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. On 29-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 MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) (seriousness criterion medically significant), HEADACHE (Headache) and MYALGIA (Muscle aches). At the time of the report, MUSCULAR WEAKNESS (Weakness in her right arm, she can't snap her fingers, when she picks up a cup, it feels like she's going to drop it) outcome was unknown and HEADACHE (Headache) and MYALGIA (Muscle aches) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included medicine for high blood pressure everyday (unspecified name). The patient might go to emergency room because her doctor was concerned if she was having a stroke. No treatment information was provided. 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.; 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: Blood pressure high

ID: 1305026
Sex: F
Age:
State: OH

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 05/11/2021
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Symptoms: almost passed out; blood pressure was 40/60; tired after the shot.; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (almost passed out) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Breast cancer (11 years ago). Concomitant products included VENLAFAXINE, ROSUVASTATIN and LEVOTHYROXINE for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (almost passed out) (seriousness criterion medically significant), BLOOD PRESSURE DECREASED (blood pressure was 40/60) and FATIGUE (tired after the shot.). At the time of the report, LOSS OF CONSCIOUSNESS (almost passed out), BLOOD PRESSURE DECREASED (blood pressure was 40/60) and FATIGUE (tired after the shot.) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 40/60 Low. On an unknown date, Heart rate: 50 (Low) went down. 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 details were not 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. Further information has been requested This case was linked to US-MODERNATX, INC.-MOD-2021-103634 (E2B Linked Report).; 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. Further information has been requested US-MODERNATX, INC.-MOD-2021-103634:Case for dose 2

Other Meds: VENLAFAXINE; ROSUVASTATIN; LEVOTHYROXINE

Current Illness:

Date Died:

ID: 1305027
Sex: U
Age:
State: TX

Vax Date:
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Rec V Date: 05/11/2021
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Symptoms: died after receiving the Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after receiving the Moderna Covid-19 vaccine) in a patient of an unknown age and gender 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 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. Not Provided Concomitant medications were not reported. No treatment information was provided. Action taken with mRNA-1273 in response to the drug was not applicable. Company comment: This is a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. died on an unknown date after the first dose of vaccine. No Medical History or Concomitant medications were reported. Very limited information has been reported at this time. Further information is not expected. This case was linked to US-MODERNATX, INC.-MOD-2021-012533, US-MODERNATX, INC.-MOD-2021-020196, MOD21-10588, MOD21-086364, MOD21-086368 (Linked Report).; Sender's Comments: This is a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. died on an unknown date after the first dose of vaccine. No Medical History or Concomitant medications were reported. Very limited information has been reported at this time. Further information is not expected. US-MODERNATX, INC.-MOD-2021-012533: US-MODERNATX, INC.-MOD-2021-020196: MOD21-10588: MOD21-086364: MOD21-086368:; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1305028
Sex: F
Age:
State: MA

Vax Date: 04/20/2021
Onset Date: 04/21/2021
Rec V Date: 05/11/2021
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Symptoms: If she walks little bit then she felt she passed out; After 2 weeks, she had shortness of breath; Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to antibiotic (all cillins), Drug allergy (ibuprofen (MOTRIN)), Sulfonamide allergy (trimethoprim/sulfamethoxazole (BACTRIM)), Allergic to cats and Asthma. Concomitant products included DILTIAZEM, LISINOPRIL and ISOSORBIDE MONONITRATE (IMDUR) for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) (seriousness criterion medically significant) and DYSPNOEA (After 2 weeks, she had shortness of breath). At the time of the report, LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) had resolved and DYSPNOEA (After 2 weeks, she had shortness of breath), DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient received her first dose of Moderna COVID-19 vaccine on 20-APR-2021. After two weeks, she had shortness of breath and "if she walks little bit then she felt she passed out." The patient's health care provider did some test (unspecified) and everything came out normal, her lungs are clear and her oxygen level is normal. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: DILTIAZEM; LISINOPRIL; IMDUR

Current Illness: Allergic to cats; Allergy to antibiotic (all cillins); Asthma; Drug allergy (ibuprofen (MOTRIN)); Sulfonamide allergy (trimethoprim/sulfamethoxazole (BACTRIM))

ID: 1305029
Sex: F
Age: 53
State: TX

Vax Date: 03/03/2021
Onset Date: 04/06/2021
Rec V Date: 05/11/2021
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Symptoms: developed lupus three days after her second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (developed lupus three days after her second dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. Concomitant products included GABAPENTIN and ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 06-Apr-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (developed lupus three days after her second dose) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 20 milligram. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (developed lupus three days after her second dose) outcome was unknown. Not Provided Patient reported she was prescribed prednisone 20 mg all of last week, but she does not think it helped. Company Comment 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. This case was linked to MOD-2021-040998 (Patient Link).

Other Meds: GABAPENTIN; ACYCLOVIR [ACICLOVIR SODIUM]

Current Illness:

ID: 1305030
Sex: F
Age:
State: MD

Vax Date: 03/08/2021
Onset Date: 05/04/2021
Rec V Date: 05/11/2021
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Symptoms: Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup); Blood pressure was 175/85; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 036A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and VITAMINS NOS for an unknown indication. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) (seriousness criterion medically significant). At the time of the report, EPISTAXIS (Nose was bleeding like a faucet/large amount of blood (estimates about 1/4 cup)) and BLOOD PRESSURE INCREASED (Blood pressure was 175/85) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: 175/85 (High) 175/85. On an unknown date, Blood pressure measurement: 144/70 (Inconclusive) 144/70. The reporter had she noticed a large amount of blood (estimates about 1/4 cup) around her computer tray and that her nose was bleeding like a faucet. Her husband took her to the ER, where her blood pressure was 175/85. Caller does not normally have high blood pressure, and is not on blood pressure medication. When she left the ER, her blood pressure was 144/70 and they clamped her nose and gave her some oxymetazoline nose spray for any break-through bleeding. Her husband maintains that the nose bleed was caused by the vaccine. Treatment procedure in the Emergency Room (ER) included nose clamped and medication included oxymetazoline. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. 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.; 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: CRESTOR; VITAMINS NOS

Current Illness:

ID: 1305031
Sex: M
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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of NEPHROTIC SYNDROME (experiencing nephrotic syndrome) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NEPHROTIC SYNDROME (experiencing nephrotic syndrome) (seriousness criterion medically significant). At the time of the report, NEPHROTIC SYNDROME (experiencing nephrotic syndrome) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No adverse event as Medical History was reported. Treatment of events was not reported. Concomitant medication use was not provided by the reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

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ID: 1305032
Sex: M
Age:
State: CA

Vax Date: 01/26/2021
Onset Date: 02/05/2021
Rec V Date: 05/11/2021
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Symptoms: sore arm; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient self-reported). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 26Jan2021, as a single dose for COVID-19 immunization. The patient did not experience any adverse effect. The patient's medical history and concomitant medications were not reported. The patient wanted to know how effective the COVID vaccine was after the first dose. Also mentioned that he had previously called regarding this. The patient also wanted to know how alcohol consumption will affect the vaccine and if there were any information and reports of any side effects with alcohol consumption. The patient reported that on 05Feb2021, he had sore arm after the second dose. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts have been completed and no further information is expected.

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ID: 1305033
Sex: F
Age:
State: PA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 05/11/2021
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Symptoms: nausea; vertigo; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 08Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer Sponsored Program from a contactable consumer (Patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 02Feb2021 13:40 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 69-year-old. Medical history included severe allergic reaction to Dimyristoyl Glycerol. The patient's concomitant medications were not reported. The patient experienced nausea and vertigo on 02Feb2021 around 21:30 with outcome of unknown. The events were reported as non-serious. Information on the lot/batch number has been requested.

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ID: 1305034
Sex: F
Age:
State: SC

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 05/11/2021
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Symptoms: Injection site on left arm sore,warm to touch and redness all around the injection site; Injection site on left arm sore,warm to touch and redness all around the injection site; Injection site on left arm sore,warm to touch and redness all around the injection site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 07Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 70-year-old female patient (Non-pregnant) received second dose of bnt162b2 (BNT162B PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot Number: EL9269, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 (at the age of 70-years-old) as single dose for COVID-19 immunization. Medical history included Known allergies: penicillin. Concomitant medications were not reported. The patient previously took cefalexin monohydrate (KEFLEX [CEFALEXIN]), sulfamethoxazole trimethoprim (BACTRIM). The patient historical vaccine includes BNT162B2, received first dose Lot number: EL3246, administration date: 15Jan2021, vaccine location: Left arm. On 05Feb2021 patient experienced injection site on left arm sore, warm to touch and redness all around the injection site. Patient was not tested COVID positive post vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested. Follow-up (07Feb2021): New information received from same contactable consumer includes: Events, second dose, Known allergies and Lot No. were updated.

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ID: 1305035
Sex: F
Age:
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Vax Date: 12/01/2020
Onset Date: 12/01/2020
Rec V Date: 05/11/2021
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Symptoms: Allergic reaction; This is a spontaneous report from a contactable nurse. The nurse reported events for herself and for her sister. This case refers to her sister. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date in Dec2020 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date in Dec2020, 5 hours after receiving the vaccine. The patient was treated with antihistamine. The outcome of the event was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile and strong temporal relationship there is reasonable possibility of causal association between the event hypersensitivity and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

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ID: 1305036
Sex: F
Age:
State: NY

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 05/11/2021
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Symptoms: Numbness of left cheek, lips and entire chin; This is a spontaneous report from a contactable Nurse or other healthcare professional. A 56-years-old non-pregnant female received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 26Jan2021 at 09:30 in the left arm as a single dose for COVID-19 immunization. The past medical history included Diabetes, high cholesterol and eczema. The concomitant medications which were received within 2 weeks of vaccination included Insulin, Crestor, Dupixent, Truliciyy and Tylenol. The patient was allergic to Augmentin, latex and Levaquin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 27Jan2021 at 12:00, the patient experienced numbness of left cheek, lips and entire chin. The patient did not receive any treatment for the adverse event. The outcome for the event was not recovered. Information on the lot/batch number has been requested. Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Other Meds: INSULIN; CRESTOR; DUPIXENT; TRULICITY; TYLENOL

Current Illness:

ID: 1305037
Sex: M
Age:
State: FL

Vax Date: 01/09/2021
Onset Date: 01/01/2021
Rec V Date: 05/11/2021
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Symptoms: abdominal pain and ended up getting shingles; Pain; abdominal pain and ended up getting shingles; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 09Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. A few days after the patient got that first dose of Pfizer COVID-19 Vaccine, he developed shingles and pain. Shingles is a painful and pretty debilitating condition because the pain is very bad. Further described shingles and pain, he had developed abdominal pains. The patient went to the regular doctor and the doctor could not figure out what it was so the doctor sent him for a CT (computerized tomogram) scan which proved there was nothing abnormal or positive in a bad way. Those CT result was negative or normal across the board. They also did blood tests and urine tests on him, all of the blood tests and urine tests results were negative and normal across the board. A few days after they went to that regular doctor, on Saturday, 16Jan2021 the pains got much more severe so she took her husband to the emergency room. They then ran another abdominal CT scan and they also agreed results of the abdominal CT scan were negative and normal across the board. They again ran blood tests and urine tests on him all with results of negative and normal across the board. They sent him home with a pain killer. About 2-3 hours after he got home from that emergency room visit he developed a rash around his abdomen, on his right side from his groin to the back of his hip on right side; that was Saturday night, 16Jan2021. Sunday they could not go to the doctor's office because they were closed. On Monday 18Jan2021, they went back to the regular doctor who checked him again. The doctor saw the rash and said no wonder they could not find anything on the CT scans, this is Shingles. The doctor gave him a couple of pain killers and an antiviral medication which he has been taking; but one of them he was developing a cough from so he stopped that medication and the cough stopped. Then he was having diarrhea here and there, so they looked up the side effects of the medications he was taking and stopped that medication because of the diarrhea. He was also taking an antiviral medication for the shingles. Clarification of which of those products stopped for cough and which for diarrhea not provided. The patient suspended the treatment with painkillers because he received the information that patients should not be taking painkillers prior to the administration of the vaccine. Patient had an appointment due tomorrow 30Jan2021 to receive the second dose of the vaccine and wanted to know if the patient should take the second dose of the vaccine. The outcome of the events was unknown. Information on batch/lot number has been requested.

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Total 2021 VAERS Injuries: 359,999

Page last modified: 03 October 2021 5:28pm