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
46,275
AK1,340
AL3,356
AR2,185
AS39
AZ9,909
CA42,109
CO8,141
CT5,392
DC1,098
DE1,123
FL22,626
FM3
GA8,920
GU59
HI1,525
IA3,325
ID1,828
IL13,721
IN19,479
KS3,183
KY4,255
LA3,086
MA10,308
MD8,791
ME2,258
MH7
MI12,301
MN8,230
MO6,322
MP15
MS1,645
MT1,673
NC10,560
ND929
NE2,019
NH2,260
NJ11,112
NM2,684
NV2,689
NY22,879
OH12,914
OK4,520
OR6,015
PA15,580
PR1,508
QM1
RI1,515
SC3,999
SD838
TN5,765
TX22,229
UT2,998
VA10,335
VI33
VT1,302
WA10,211
WI7,610
WV1,619
WY610
XB5
XL1
XV2

ID: 1363941
Sex: U
Age:
State: OR

Vax Date:
Onset Date: 05/27/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25-MAY-2021) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363942
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 05/25/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: FEELING HAZY; RAISED BUMP AT INJECTION SITE; HEADACHE; WATER BLISTERS UNDER NOSE AND TURNED INTO SORES ON UPPER LIP AND UNDER LEFT NOSTRIL AND COMING DOWN TO LIP; FELT HORRIBLE; DISORIENTATED; DIZZINESS; SHORTNESS OF BREATH; TIREDNESS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21/06/2021) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced tiredness. On 26-MAY-2021, the subject experienced water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip. On 26-MAY-2021, the subject experienced felt horrible. On 26-MAY-2021, the subject experienced disorientated. On 26-MAY-2021, the subject experienced dizziness. On 26-MAY-2021, the subject experienced shortness of breath. On 26-MAY-2021, the subject experienced raised bump at injection site. On 26-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced feeling hazy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt horrible, disorientated, dizziness, tiredness, and headache, had not recovered from water blisters under nose and turned into sores on upper lip and under left nostril and coming down to lip, raised bump at injection site, and shortness of breath, and the outcome of feeling hazy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363943
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 05/28/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: LEFT UPPER ARM HURTING; SLIGHT AND POUNDING HEADACHE; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 17676, and batch number: 17676) dose was not reported, administered on 28-MAY-2021 15:50:00 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced left upper arm hurting. On 28-MAY-2021, the subject experienced slight and pounding headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from slight and pounding headache, and left upper arm hurting. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363944
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: FLU-LIKE SYMPTOMS; MUCUS; This spontaneous report received from a consumer concerned a 21 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-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 MAY-2021, the subject experienced flu-like symptoms. On MAY-2021, the subject experienced mucus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu-like symptoms, and mucus on MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210556420.

Other Meds:

Current Illness:

ID: 1363945
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: LUMP ON ARM AT THE INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced lump on arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lump on arm at the injection site. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363946
Sex: M
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: COLD SWEAT; MIGRAINE HEADACHES; ARM SORE 5-6 HOURS; LEGS HURTING AFTER JANITORIAL WORK; CHILLS; BODY TEMPERATURE; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced cold sweat. On MAY-2021, the subject experienced migraine headaches. On MAY-2021, the subject experienced arm sore 5-6 hours. On MAY-2021, the subject experienced legs hurting after work. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced body temperature. Treatment medications included: paracetamol. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweat, migraine headaches, arm sore 5-6 hours, legs hurting after work, chills, and body temperature on 29-MAY-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363947
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: CONFUSED; BRAIN WASN'T WORKING RIGHT; REALLY DIZZY; LEGS COULD BARELY HOLD UP; NO ENERGY; HEADACHE; FEVER; SWOLLEN GLANDS; ACHY; PAIN IN BACK OF RIGHT KNEE/PAIN IN LEFT KNEE; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included obsessive-compulsive disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 23-JUL-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for fever. On 15-MAY-2021, the subject experienced swollen glands. On 15-MAY-2021, the subject experienced achy. On 15-MAY-2021, the subject experienced pain in back of right knee/pain in left knee. On 15-MAY-2021, the subject experienced headache. On 15-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101 Unit Not reported. On 16-MAY-2021, the subject experienced no energy. On 23-MAY-2021, the subject experienced legs could barely hold up. On 24-MAY-2021, the subject experienced really dizzy. On 25-MAY-2021, the subject experienced confused. On 25-MAY-2021, the subject experienced brain wasn't working right. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen glands, achy, and fever on 16-MAY-2021, and confused, and brain wasn't working right on 27-MAY-2021, and had not recovered from headache, no energy, pain in back of right knee/pain in left knee, legs could barely hold up, and really dizzy. This report was non-serious.

Other Meds: IBUPROFEN

Current Illness: Obsessive-compulsive disorder (OCD diagnosis- medicated)

ID: 1363948
Sex: U
Age:
State: MA

Vax Date:
Onset Date: 05/29/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: 05/26/2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363949
Sex: M
Age:
State: IA

Vax Date:
Onset Date: 05/28/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: BODY ACHES; HEADACHES; BOTTOM LIP TWITCHING ON AND OFF; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808986 expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced bottom lip twitching on and off. On 29-MAY-2021, the subject experienced body aches. On 29-MAY-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and headaches on MAY-2021, and had not recovered from bottom lip twitching on and off. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363950
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number:unknown) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced brownish and scaly rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brownish and scaly rash was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363951
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/12/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: LUMP IN LEFT ARM; SORENESS IN LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced lump in left arm. On 12-MAY-2021, the subject experienced soreness in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump in left arm, and soreness in left arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363952
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 05/29/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: BRUISING ON ANKLES; RED SPOTS ON LEGS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-MAY-2021, the subject experienced bruising on ankles. On 29-MAY-2021, the subject experienced red spots on legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red spots on legs, and bruising on ankles. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363953
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: DIFFICULTY SWALLOWING; WAKE UP ALMOST EVERY HOUR; CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; LETHARGY; SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 30 year old male. The patient's weight was 170 pounds, and height was 175 centimeters. The patient's concurrent conditions included Tourette's syndrome, seasonal allergy, penicillin allergy, non alcoholic, and cigarette smoker, and other pre-existing medical conditions included no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, and expiry: 01-FEB-2023) dose was not reported, frequency 1 total, administered on right deltoid 07-APR-2021 for prophylactic vaccination. Concomitant medications included clonazepam for Tourette's syndrome. On 07-APR-2021, the patient experienced soreness on the injection site which lasted for 2 weeks. He also experienced lethargy. Then on the last week of APR-2021, he developed throat pain, cough and high grade fever. His chest was hurt really bad and he felt as if his lungs was on fire. He was also coughing really hard that woke him up every hour. The fever lasted of a day and the rest of symptoms lasted for 3 days. He did not performed COVID test because he just thought the symptoms were just allergic reaction. Then, on the 24-MAY-2021, he started to develop the same symptoms that he had before. It was started as a pain on the throat, he thought it was just an allergy because he had a seasonal allergy. He had a difficulty swallowing which developed into cough. His chest hurt so bad that he felt as if his chest and lungs were on fire. He described his coughing associated with burning sensation that caused him to wake up almost every hour. He also noted that after vaccinated he still followed social distancing and wearing mask protocol. His HCP did not prescribe any medication for COVID-19 infection, but he was taking Tylenol, increased his fluid intake and started using a nasal spray. On 28-MAY-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive., Fever (NR: not provided) 102 F and the patient had confirmed covid-19 infection, confirmed clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargy, and soreness on the injection site on 21-APR-2021, had not recovered from difficulty swallowing, confirmed covid-19 infection, and wake up almost every hour, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210557859-Covid-19 vaccine ad26.cov2.s - CONFIRMED COVID-19 INFECTION and CONFIRMED CLINICAL VACCINATION FAILURE . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds: CLONAZEPAM

Current Illness: Abstains from alcohol; Cigarette smoker (1 pack a week.); Penicillin allergy; Seasonal allergy; Tourette's syndrome

ID: 1363954
Sex: F
Age:
State: DE

Vax Date:
Onset Date: 05/29/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: SLEEPY; TIRED; This spontaneous report received from a patient concerned a 94 year old female. The patient's weight was 137 pounds, and height was not reported. The patient's concurrent conditions included atrial fibrillation, oral cancer, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had allergies but can not remember which allergies patient had. patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. Concomitant medications included diltiazem for atrial fibrillation, acetylsalicylic acid, biotin, calcium carbonate/magnesium hydroxide/zinc, colecalciferol, glucosamine hydrochloride, glucosamine sulfate, magnesium, and nutrients nos. On 29-MAY-2021, the subject experienced sleepy. On 29-MAY-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Clear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sleepy, and tired. This report was non-serious.

Other Meds: DILTIAZEM; ASPRIN; CALCIUM CARBONATE;MAGNESIUM HYDROXIDE;ZINC; GLUCOSAMINE SULFATE; MAGNESIUM; BIOTIN; ENSURE [NUTRIENTS NOS]; VITAMIN D3; GLUCOSAMINE HCL

Current Illness: Abstains from alcohol; Atrial fibrillation; Non-smoker; Oral cancer stage unspecified

ID: 1363955
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 05/26/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: STOMACH PAIN; VOMITING; DIARRHEA; NAUSEA; CHILLS; FEVER; MUSCLE ACHES; This spontaneous report received from a parent concerned a 20 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 26-MAY-2021, the subject experienced chills. On 26-MAY-2021, the subject experienced fever. On 26-MAY-2021, the subject experienced muscle aches. Treatment medications included: paracetamol. On 27-MAY-2021, the subject experienced stomach pain. On 27-MAY-2021, the subject experienced vomiting. On 27-MAY-2021, the subject experienced diarrhea. On 27-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and muscle aches on 26-MAY-2021, had not recovered from stomach pain, vomiting, and diarrhea, and the outcome of nausea was not reported. This report was non-serious.

Other Meds: ACETYLSALICYLIC ACID

Current Illness: Alcohol use (not in excess); Non-smoker

ID: 1363956
Sex: U
Age:
State: OH

Vax Date:
Onset Date: 05/29/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: THE SYRINGE WAS DEFECTIVE; 0.1 ML OF VACCINE WAS GIVEN DUE TO DEFECTIVE SYRINGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .1 ml, administered on 29-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAY-2021, the subject experienced 0.1 ml of vaccine was given due to defective syringe. On an unspecified date, the subject experienced the syringe was defective. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 0.1 ml of vaccine was given due to defective syringe and the syringe was defective was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363957
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 05/30/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: CHEST PAIN; 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: 04219-21A, expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chest pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363958
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 05/24/2021
Rec V Date: 06/01/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: HORRIBLE BACK PAIN (WITH A PAIN SCALE OF 7.5 OUT OF 10); SWOLLEN POUCH ON LEFT LOWER BACK APPROXIMATELY FOUR INCHES DIAMETER AND THREE INCHES HEIGHT DIAGNOSED AS LYMPHATIC ISSUE DUE TO VACCINE; FEVER OF MORE OR LESS 100 F; This spontaneous report received from a consumer concerned a 20 year old male. The patient's weight was 150 pounds, and height was 190 centimeters. The patient's pre-existing medical conditions included the patient had no pertinent medical history. the patient had no known allergies. the patient had no history of drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced horrible back pain (with a pain scale of 7.5 out of 10). On 24-MAY-2021, the subject experienced swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine. On 24-MAY-2021, the subject experienced fever of more or less 100 f. Laboratory data included: Body temperature (NR: not provided) more or less 100 F. Treatment medications included: paracetamol. On 25-MAY-2021, Laboratory data included: Blood test (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen pouch on left lower back approximately four inches diameter and three inches height diagnosed as lymphatic issue due to vaccine on MAY-2021, and was recovering from horrible back pain (with a pain scale of 7.5 out of 10), and fever of more or less 100 f. This report was non-serious. This case, from the same reporter is linked to 20210557778.

Other Meds:

Current Illness:

ID: 1363959
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/01/2021
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Symptoms: HEADACHE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious

Other Meds:

Current Illness:

ID: 1363960
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 05/28/2021
Rec V Date: 06/01/2021
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Symptoms: LUMP IN THE CREASE OF ARM; BODY SORENESS; CHILLS; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 28-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced body soreness. On 28-MAY-2021, the subject experienced chills. On 29-MAY-2021, the subject experienced lump in the crease of arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on MAY-2021, and had not recovered from lump in the crease of arm, and body soreness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363961
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 05/20/2021
Rec V Date: 06/01/2021
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Symptoms: LAYERS OF PUSTULES ON TOP OF PUSTULES ON HER LEFT ARM, PUSTULES STARTED LEAKING OUT; LESIONS ON HER RIGHT FOREARM AND WRIST, LESIONS CONTINUING TO SPREAD, LESION ON HER INTERIOR LOWER RIGHT LEG JUST ABOVE ANKLE; SKIN PEELED OFF ON THE LEFT FOREARM, SKIN PEELING FROM OTHER LESIONS; LESIONS ON HER RIGHT FOREARM AND WRIST, LESION ON HER INTERIOR LOWER RIGHT LEG JUST ABOVE ANKLE; RASH BOTH RIGHT AND LEFT FOREARMS, LEFT TORSO, CHEST, LEFT BREAST, RASHY SYMPTOMS" ON BOTH BUTTOCKS AND HIPS AND BOTH UPPER THIGHS, RASH ON THE BACK OF HER NECK, RASH ON FACE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included psoriatic arthritis, premature atrial complexes, microscopic colitis, psoriasis, partial knee replacement, total knee replacement, three tumor removals, complete hysterectomy, and clostridium difficile colitis, and concurrent conditions included dilaudid allergy, rare alcohol use, cigarette smoker, and nsaid allergy, and other pre-existing medical conditions included the patient had no known drug abuse or illicit drug usage and no egg allergy. The patient experienced itchiness and rash when treated with influenza vaccine, and itchiness when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included diltiazem, diphenhydramine hydrochloride, ergocalciferol, metoprolol succinate, ubidecarenone, and vitamin b complex. On 20-MAY-2021, the subject experienced lesions on her right forearm and wrist, lesion on her interior lower right leg just above ankle. On 20-MAY-2021, the subject experienced rash both right and left forearms, left torso, chest, left breast, rashy symptoms" on both buttocks and hips and both upper thighs, rash on the back of her neck, rash on face. On 22-MAY-2021, the subject experienced layers of pustules on top of pustules on her left arm, pustules started leaking out. On 22-MAY-2021, the subject experienced lesions on her right forearm and wrist, lesions continuing to spread, lesion on her interior lower right leg just above ankle. On 22-MAY-2021, the subject experienced skin peeled off on the left forearm, skin peeling from other lesions. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) slightly elevated sodium levels and high triglycerides. Treatment medications (dates unspecified) included: calamine/glycerol/zinc oxide, methylprednisolone, and hydrocortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash both right and left forearms, left torso, chest, left breast, rashy symptoms" on both buttocks and hips and both upper thighs, rash on the back of her neck, rash on face, layers of pustules on top of pustules on her left arm, pustules started leaking out, lesions on her right forearm and wrist, lesions continuing to spread, lesion on her interior lower right leg just above ankle, skin peeled off on the left forearm, skin peeling from other lesions, and lesions on her right forearm and wrist, lesion on her interior lower right leg just above ankle. This report was non-serious.

Other Meds: VITAMIN B COMPLEX; VITAMIN D [ERGOCALCIFEROL]; METOPROLOL SUCCINATE; CARDIZEM [DILTIAZEM]; COQ10 [UBIDECARENONE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Alcohol use; Cigarette smoker (Half a pack a day usually but since on prednisone she was taking a pack per day); Drug allergy

ID: 1363962
Sex: M
Age:
State: OR

Vax Date:
Onset Date: 05/28/2021
Rec V Date: 06/01/2021
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Symptoms: NOT FEELING WELL; DIARRHEA; DRY COUGH; VOMITING TWICE; FEVER; NAUSEA; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 19 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known drug allergy, no medical history, not taking any routine medications. the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 22-MAY-2021 16:00 for prophylactic vaccination. Concomitant medications included dextromethorphan hydrobromide/ethanol/guaifenesin for dry cough, and paracetamol for headache. On 28-MAY-2021, the subject experienced fever. On 28-MAY-2021, the subject experienced nausea. On 28-MAY-2021, the subject experienced headache. On 28-MAY-2021, the subject experienced fatigue. On 29-MAY-2021, the subject experienced diarrhea. On 29-MAY-2021, the subject experienced dry cough. On 29-MAY-2021, the subject experienced vomiting twice. Laboratory data included: Body temperature (NR: not provided) 103 F. On an unspecified date, the subject experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vomiting twice, had not recovered from fever, nausea, headache, diarrhea, and dry cough, and the outcome of fatigue and not feeling well was not reported. This report was non-serious.

Other Meds: TYLENOL; ROBITUSSIN [DEXTROMETHORPHAN HYDROBROMIDE;ETHANOL;GUAIFENESIN]

Current Illness: Abstains from alcohol; Non-smoker

ID: 1363963
Sex: F
Age:
State:

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Onset Date:
Rec V Date: 06/01/2021
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Symptoms: SWELLING OF LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included used to getting high, and concurrent conditions included citrus acid allergy. 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 swelling of legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swelling of legs was not reported. This report was non-serious.

Other Meds:

Current Illness: Fruit allergy

ID: 1363964
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/06/2021
Rec V Date: 06/01/2021
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Symptoms: RAPID HEART BEAT; FEELING OUT OF BREATH; CHEST DISCOMFORT; SWEATING; CHILLS; FEVER; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced rapid heart beat. On 06-MAR-2021, the subject experienced feeling out of breath. On 06-MAR-2021, the subject experienced chest discomfort. On 06-MAR-2021, the subject experienced sweating. On 06-MAR-2021, the subject experienced chills. On 06-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating, chills, and fever, and had not recovered from rapid heart beat, feeling out of breath, and chest discomfort. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363965
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 05/25/2021
Rec V Date: 06/01/2021
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Symptoms: EXPIRED VACCINE USED; This spontaneous report received from a health care professional concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no illness at the time of vaccination. the patient had no past history of similar event. the patient had no adverse event after any previous vaccinations. the patient had no history of allergy to vaccine, drug or food. the patient had no pre-existing acute illness 30 days prior to vaccination. patient had no history of hospitalization in last 30 days, the patient had no family history of any disease (relevant to vaccination) or allergy. the patient was not pregnant at time of vaccination. the patient was not breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 1805029 expiry: 25-MAY-2021) .5 ml, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021, the subject experienced expired vaccine used. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine used was not reported. This report was non-serious. This case, from the same reporter is linked to 20210549259.

Other Meds:

Current Illness:

ID: 1363966
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/01/2021
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Symptoms: GREEN PHLEGM; EARS HURTING; PRESSURE/PAIN IN CHEST; SORE THROAT; TINGLING, BOTHERSOME, HURTING NECK GLANDS; HURTING NECK GLANDS; DISCOMFORT; SWELLING OF THE GLANDS IN THE NECK AREA; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included diagnosis of covid-19, and lost smell in one nostril. The patient was previously treated with ibuprofen for lost smell in one nostril. 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 26-MAY-2021 11:15 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 MAY-2021, the subject experienced discomfort. On MAY-2021, the subject experienced swelling of the glands in the neck area. Treatment medications included: salbutamol sulfate. On 26-MAY-2021, the subject experienced tingling, bothersome, hurting neck glands. On 26-MAY-2021, the subject experienced hurting neck glands. On 27-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced pressure/pain in chest. On 29-MAY-2021, the subject experienced green phlegm. On 29-MAY-2021, the subject experienced ears hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from discomfort, and the outcome of tingling, bothersome, hurting neck glands, sore throat, pressure/pain in chest, green phlegm, ears hurting, hurting neck glands and swelling of the glands in the neck area was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363967
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 05/24/2021
Rec V Date: 06/01/2021
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Symptoms: HEAVY VAGINAL BLEEDING WITH CLOTS; SPOT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced spot. On 29-MAY-2021, the subject experienced heavy vaginal bleeding with clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy vaginal bleeding with clots, and the outcome of spot was not reported. This report was non-serious.

Other Meds:

Current Illness: Hypertension

ID: 1363968
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 05/16/2021
Rec V Date: 06/01/2021
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Symptoms: LIGHT COUGH; RUNNY NOSE; COLD; NASAL CONGESTION; CHILLS; BODY PAIN; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAY-2021, the subject experienced body pain. On 16-MAY-2021, the subject experienced chills. On 28-MAY-2021, the subject experienced light cough. On 28-MAY-2021, the subject experienced runny nose. On 28-MAY-2021, the subject experienced cold. On 28-MAY-2021, the subject experienced nasal congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body pain, and chills on 16-MAY-2021, and was recovering from light cough, runny nose, cold, and nasal congestion. This report was non-serious.

Other Meds:

Current Illness:

ID: 1363969
Sex: M
Age: 68
State: CA

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 06/01/2021
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Symptoms: suicidal thoughts; Depression; Chest pain; Fingers go numb/my arm feels numb; lack of sleep and sleeping issues; Nightmares; Stressed out; Weakness; Runny Nose; very angry; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SUICIDAL IDEATION (suicidal thoughts) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in November 2019. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal thoughts) (seriousness criterion medically significant), DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose), ANGER (very angry) and HEADACHE (Headache). At the time of the report, SUICIDAL IDEATION (suicidal thoughts) and ANGER (very angry) outcome was unknown and DEPRESSION (Depression), CHEST PAIN (Chest pain), HYPOAESTHESIA (Fingers go numb/my arm feels numb), SLEEP DISORDER (lack of sleep and sleeping issues), NIGHTMARE (Nightmares), STRESS (Stressed out), ASTHENIA (Weakness), RHINORRHOEA (Runny Nose) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2019, COVID-19: positve Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment medications was not provided. Company comment: Very limited information regarding the events has been provided at this time. Further information is not expected. Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Initial Additional information received On 04-May-2021: Initial Additional information received. On 10-May-2021: Initial Additional information received. On 17-May-2021: Initial Additional information received. On 20-May-2021: Initial Additional information received.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

Other Meds:

Current Illness:

ID: 1363970
Sex: M
Age: 52
State: NC

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 06/01/2021
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Symptoms: smelled an antiseptic smell / smells a chemicals all day and night/still persisting; showered and still smelled it/showered and still smelled it\ band-aid smell; Arm has minor soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (smelled an antiseptic smell / smells a chemicals all day and night/still persisting), SKIN ODOUR ABNORMAL (showered and still smelled it/showered and still smelled it\ band-aid smell) and MYALGIA (Arm has minor soreness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAROSMIA (smelled an antiseptic smell / smells a chemicals all day and night/still persisting) (seriousness criterion medically significant), SKIN ODOUR ABNORMAL (showered and still smelled it/showered and still smelled it\ band-aid smell) (seriousness criterion medically significant) and MYALGIA (Arm has minor soreness) (seriousness criterion medically significant). At the time of the report, PAROSMIA (smelled an antiseptic smell / smells a chemicals all day and night/still persisting) had not resolved and SKIN ODOUR ABNORMAL (showered and still smelled it/showered and still smelled it\ band-aid smell) and MYALGIA (Arm has minor soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. The treatment information was unknown. This patient is going to continue to call Moderna until he gets a call back from the Safety department. Patient is very frustrated and bothered that Moderna has not made more information public even though millions of vaccines have been administered. He feels he is in a rare side effect group and that this information should be taken more serious. He has seen a specialist regarding his side effect which has not gone away after his first vaccine over 90 days ago. He states he "smells a chemical smell all day and night, it started immediately after receiving the vaccine". This has been the worst experience for this patient and he wishes he never got the vaccine. Patient explains that his doctor said the mRNA has woven itself into the endothelial cells and that's why he is smelling these strange cells". Follow-up 2: patient reported after receiving the 1st dose of Moderna vaccine. this was the fourth time the call was made. Caller mentioned, that I contacted the HCP as per Moderna advise, and the doctor has no information for the adverse reaction I developed after the vaccination and mentioned, that the mRNA grafted in to patient's olfactory Celia and in to my own DNA. Also mentioned if this adverse reaction of "antiseptic Smell" , persisting more than 60 days time period , then its going to remain with him for ever. So patient is very upset and safety 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. Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Significant follow up appended. On 15-Apr-2021: Followup information was received on 24-Apr-2021. events was updated reason for his side effects is because the mRNA has attached itself tot he epithelial cells and havewoven themselves into the DNA. On 18-May-2021: Significant follow up appended; 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: 1363971
Sex: M
Age: 25
State: NJ

Vax Date: 03/28/2021
Onset Date: 04/12/2021
Rec V Date: 06/01/2021
Hospital: Y

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Symptoms: thrombocytopenia; ITP; Petechia rash; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (thrombocytopenia) and IMMUNE THROMBOCYTOPENIA (ITP) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anxiety and Stomachache. Concomitant products included LAMOTRIGINE (LAMICTAL) for Anxiety, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced RASH (Petechia rash) and FATIGUE (Tiredness). On an unknown date, the patient experienced THROMBOCYTOPENIA (thrombocytopenia) (seriousness criteria hospitalization and medically significant) and IMMUNE THROMBOCYTOPENIA (ITP) (seriousness criteria hospitalization and medically significant). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, THROMBOCYTOPENIA (thrombocytopenia), IMMUNE THROMBOCYTOPENIA (ITP), RASH (Petechia rash) and FATIGUE (Tiredness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No laboratory details was given. Reportedly, the patient had to go to the hospital for a week and was still being monitored. Treatment information was given as steroids Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up information received on 20 May 2021 contain significant information includes updation of 2 more medically significant events and patient was hospitalized for the events too.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

Other Meds: LAMICTAL; PROTONIX [OMEPRAZOLE]

Current Illness:

ID: 1363972
Sex: F
Age: 66
State: AZ

Vax Date: 01/19/2021
Onset Date: 02/17/2021
Rec V Date: 06/01/2021
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Symptoms: Fainting spell; She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good; Her right arm got kind of sore; Chills; Vomiting; Nausea; Fever; Diarrhea; Dizziness; Weak; She lost 6 pounds in 3 days; Confusion; Off work X 6 days; This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (Fainting spell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Diabetes, Heart disease, unspecified and Asthma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-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 DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weak), WEIGHT DECREASED (She lost 6 pounds in 3 days), CONFUSIONAL STATE (Confusion), IMPAIRED WORK ABILITY (Off work X 6 days), PYREXIA (Fever), VOMITING (Vomiting) and NAUSEA (Nausea). On an unknown date, the patient experienced SYNCOPE (Fainting spell) (seriousness criterion medically significant), AMNESIA (She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good), PAIN IN EXTREMITY (Her right arm got kind of sore) and CHILLS (Chills). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SYNCOPE (Fainting spell), AMNESIA (She couldn't remember her job or her boss's name, with whom she worked since 2009/she can't remember as good), DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ASTHENIA (Weak), WEIGHT DECREASED (She lost 6 pounds in 3 days), CONFUSIONAL STATE (Confusion), IMPAIRED WORK ABILITY (Off work X 6 days), PAIN IN EXTREMITY (Her right arm got kind of sore), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown. Concomitant medication use included medications for diabetes, heart disease and high blood pressure. Specific medications were not provided by the reporter. Treatment of the events included Zofran. On 11Feb2021, after receiving the first dose of vaccine but before the second, the patient "had a nuclear injection" before she went on a treadmill. The patient also stated that "she had radiation that may have affected her reaction to the vaccine." No further information was provided. Further clinical course is unknown 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. This case was linked to MOD-2021-155323 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow-up received on 20-May-2021included additional events were added.; 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: ASPIRIN (E.C.)

Current Illness: Asthma; Diabetes; Heart disease, unspecified; Penicillin allergy

ID: 1363973
Sex: M
Age: 56
State: DE

Vax Date: 04/05/2021
Onset Date: 04/12/2021
Rec V Date: 06/01/2021
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Symptoms: Passing out, dry cough so bad that he would faint; Stood up to cough, passed out, and fell and his head hit the concrete; Head hit the concrete floor, hitting head on floor; Bad, dry cough; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. G17-C21A and G26-B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker (30+ years of smoking.) and Vapor cigarette smoker (vaping the past two years.). Concomitant products included BENZTROPINE [BENZATROPINE], FLUOXETINE, TAMSULOSIN, CLONAZEPAM, AMLODIPINE and LURASIDONE HYDROCHLORIDE (LATUDA) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) (seriousness criterion medically significant), FALL (Stood up to cough, passed out, and fell and his head hit the concrete), HEAD INJURY (Head hit the concrete floor, hitting head on floor) and COUGH (Bad, dry cough). On 12-May-2021, LOSS OF CONSCIOUSNESS (Passing out, dry cough so bad that he would faint) and COUGH (Bad, dry cough) had resolved. At the time of the report, FALL (Stood up to cough, passed out, and fell and his head hit the concrete) and HEAD INJURY (Head hit the concrete floor, hitting head on floor) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) Went to get tested for COVID-19 due to dry, bad cough and came back negative. The patient stated that approximately one week after the first dose, he was having a bad dry cough. The dry cough was so bad that when he was sitting on recliner he would cough so bad, he would faint and pass out. One time the patient stood up to cough, passed out, and fell and his head hit the concrete floor. He went to emergency department three times because of this cough. On 12 MAY 2021, the patient stopped experiencing coughing and passing out. The patient also stated that he has no other side effects and that his healthcare provider thinks this experience was attributed to the first vaccine. Patient was prescribed an "inhaler" from his healthcare provider to help with "lungs and stuff." The patient also has an appointment with a pulmonologist in June. Action taken with mRNA-1273 in response to the events was not applicable. Head injury was due to fall and thus cannot be directly associated with mRNA-1273 use. The other events are temporarily associated with the product use and a causal relationship cannot be excluded This case was linked to MOD-2021-138832 (Patient Link).; Sender's Comments: Head injury was due to fall and thus cannot be directly associated with mRNA-1273 use. The other events are temporarily associated with the product use and a causal relationship cannot be excluded

Other Meds: BENZTROPINE [BENZATROPINE]; FLUOXETINE; TAMSULOSIN; CLONAZEPAM; AMLODIPINE; LATUDA

Current Illness: Smoker (30+ years of smoking.); Vapor cigarette smoker (vaping the past two years.)

ID: 1363974
Sex: F
Age: 78
State: NJ

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 06/01/2021
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Symptoms: Resurge in aplastic anemia; Swollen arm; Been cold; Chills; Running Fever; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever). On 23-Feb-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (Inconclusive) Inconclusive. On 18-Dec-2020, Red blood cell analysis: 14 (Inconclusive) hemoglobin. On 23-Feb-2021, Haemoglobin: 10.8 (Low) dropped. On 23-Feb-2021, Platelet count: 21 (Low) dropped. On 14-May-2021, Haemoglobin: 8.8 (Low) dropped. On 14-May-2021, Platelet count: 13 (Low) dropped. On 14-May-2021, White blood cell count: 2.2 (Low) dropped. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient stated her aplastic anemia gotten worse after taking vaccine. The patient also stated that she had been under a lot of stress because her husband was sick, and she was not sure if that also a contributing factor. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional information received captured patient demographics.; 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: SYNTHROID; METOPROLOL TARTRATE; FEBUXOSTAT

Current Illness: Aplastic anemia

ID: 1363975
Sex: M
Age: 82
State: NJ

Vax Date: 02/06/2021
Onset Date: 04/27/2021
Rec V Date: 06/01/2021
Hospital: Y

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Symptoms: Developed blood clot; Sever pain in his stomach; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016L20A) for COVID-19 vaccination. Concomitant products included RIVAROXABAN (XARELTO), AMLODIPINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Sever pain in his stomach) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Developed blood clot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 28-Apr-2021 to 04-May-2021 due to ABDOMINAL PAIN UPPER and THROMBOSIS. The patient was treated with Surgery (leading to two and half feet of his small intestine removed) for Thrombosis. At the time of the report, THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) outcome was unknown. Patient started having severe pain in his stomach on 27-Apr-2021. He was taken to the hospital on 28-Apr-2021, patient's doctor said that he had a clot in his intestine and that caused the pain, was operated removed to two and half feet of his small intestine. Patient was discharged from the hospital on 04-May-2021. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. 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: XARELTO; AMLODIPINE; BYSTOLIC; EDARBYCLOR

Current Illness:

ID: 1363976
Sex: F
Age:
State: FL

Vax Date: 02/06/2021
Onset Date: 05/17/2021
Rec V Date: 06/01/2021
Hospital: Y

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Symptoms: Weakness; Weight decreased; Violent; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness), ABNORMAL LOSS OF WEIGHT (Weight decreased) and AGGRESSION (Violent) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 8CDPBC and 031L20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced ASTHENIA (Weakness) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (Weight decreased) (seriousness criterion hospitalization) and AGGRESSION (Violent) (seriousness criterion hospitalization). At the time of the report, ASTHENIA (Weakness), ABNORMAL LOSS OF WEIGHT (Weight decreased) and AGGRESSION (Violent) outcome was unknown. No treatment information was provided. Action taken with the mRNA-1273 in response to the event is not applicable. Patient was currently admitted in the hospital and the doctors could not figure out the root cause of her illness. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

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ID: 1363977
Sex: F
Age: 50
State: CA

Vax Date: 03/06/2021
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Rec V Date: 06/01/2021
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Symptoms: Clots in left arm after taking 2 shots; Swollen arm after 2 vaccine shots; pain in left arm; 50 days gap between 2 vaccine doses; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Clots in left arm after taking 2 shots) in a 50-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 Idiopathic thrombocytopenic purpura, Spina bifida and Psoriasis. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Clots in left arm after taking 2 shots) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm after 2 vaccine shots), VACCINATION SITE PAIN (pain in left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 days gap between 2 vaccine doses). The patient was treated with APIXABAN (ELIQUIS) at a dose of 25 mg twice a day and APIXABAN (ELIQUIS) at a dose of 5 mg twice a day. At the time of the report, THROMBOSIS (Clots in left arm after taking 2 shots), PERIPHERAL SWELLING (Swollen arm after 2 vaccine shots) and VACCINATION SITE PAIN (pain in left arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 days gap between 2 vaccine doses) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) clot in the left arm. Patient went to emergency after 3 weeks of taking Moderna COVID-19 second Vaccine. No relevant concomitant medications were reported Reportedly, the treatment with Apixaban (Eliquis) needed to continue for 6 months. 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: Idiopathic thrombocytopenic purpura; Psoriasis; Spina bifida

ID: 1363978
Sex: M
Age: 49
State: NC

Vax Date: 01/20/2021
Onset Date: 02/01/2021
Rec V Date: 06/01/2021
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Symptoms: pain in his hands disappeared but now moved to the thighs,His thighs were painful,thighs were inflamed, pain moved to knee and legs, pain in feet; arms and biceps were swollen, thighs were swollen,His feet were swollen; his skin (entire body) started to peel off,The skin on his whole body was gone; his skin was very itchy; developed blisters all over the body; did not get a second shot; his whole body started to be inflamed, thighs were inflamed; could not shower for a few days; Rash,also given Prednisone for 2 weeks for the rash; skin test diagnosed him with Bullous pemphigoid; his neck got worse,he could not turn his head; his neck was swollen.; did not sleep well.; experienced stiffness in his neck; This spontaneous case was reported by an other health care professional and describes the occurrence of PEMPHIGOID (skin test diagnosed him with Bullous pemphigoid) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (experienced stiffness in his neck). On 11-Feb-2021, the patient experienced INSOMNIA (did not sleep well.). On 15-Feb-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (his neck got worse,he could not turn his head) and SWELLING (his neck was swollen.). On 16-Feb-2021, the patient experienced PEMPHIGOID (skin test diagnosed him with Bullous pemphigoid) (seriousness criterion medically significant), PAIN (pain in his hands disappeared but now moved to the thighs,His thighs were painful,thighs were inflamed, pain moved to knee and legs, pain in feet), PERIPHERAL SWELLING (arms and biceps were swollen, thighs were swollen,His feet were swollen), SKIN EXFOLIATION (his skin (entire body) started to peel off,The skin on his whole body was gone), PRURITUS (his skin was very itchy), BLISTER (developed blisters all over the body), INTENTIONAL PRODUCT USE ISSUE (did not get a second shot), INFLAMMATION (his whole body started to be inflamed, thighs were inflamed), IMPAIRED SELF-CARE (could not shower for a few days) and RASH (Rash,also given Prednisone for 2 weeks for the rash). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form; ACETAMINOPHEN for Adverse event, at a dose of 1 dosage form; IBUPROFEN for Adverse event, at a dose of 1 dosage form; DOXYCYCLINE for Adverse event, at a dose of 1 dosage form; MESALAMINE for Adverse event, at a dose of 1 dosage form; CLOBETASOL PROPIONATE (CLOBETASOL [CLOBETASOL PROPIONATE]) (topical) for Adverse event, at a dose of 1 dosage form and HYDROXYZINE for Itching, at a dose of 1 dosage form. At the time of the report, PEMPHIGOID (skin test diagnosed him with Bullous pemphigoid), MUSCULOSKELETAL STIFFNESS (experienced stiffness in his neck), INSOMNIA (did not sleep well.), MUSCULOSKELETAL DISCOMFORT (his neck got worse,he could not turn his head), SWELLING (his neck was swollen.), PAIN (pain in his hands disappeared but now moved to the thighs,His thighs were painful,thighs were inflamed, pain moved to knee and legs, pain in feet), PERIPHERAL SWELLING (arms and biceps were swollen, thighs were swollen,His feet were swollen), SKIN EXFOLIATION (his skin (entire body) started to peel off,The skin on his whole body was gone), PRURITUS (his skin was very itchy), BLISTER (developed blisters all over the body), INTENTIONAL PRODUCT USE ISSUE (did not get a second shot), INFLAMMATION (his whole body started to be inflamed, thighs were inflamed), IMPAIRED SELF-CARE (could not shower for a few days) and RASH (Rash,also given Prednisone for 2 weeks for the rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Skin test: abnormal (abnormal) Skin test diagnosed him with bullous pemphigoid.. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. It was noted that the patient was being treated by a dermatologist. A "skin test" was completed and results indicate a diagnosis of bullous pemphigoid. It was advised that the patient not receive the second dose of the vaccine. Company Comment : Very limited information regarding these events has been provided at this time. Additional information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. Additional information required.

Other Meds:

Current Illness:

ID: 1363979
Sex: F
Age: 67
State: IL

Vax Date: 06/01/2020
Onset Date: 02/12/2021
Rec V Date: 06/01/2021
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Symptoms: Adrenal gland insufficiency; thyroid issues; fatigue; lymph nodes enlarged; abdominal pain; This spontaneous case was reported by a physician and describes the occurrence of ADRENAL INSUFFICIENCY (Adrenal gland insufficiency) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Cartilage disorder from October 2020 to 15-Jan-2021, Hip dislocation from October 2020 to 15-Jan-2021, COVID-19 (26-Oct-2020 nasal swab test COVID-19 positive) on 20-Oct-2020, Surgery (hand surgery) in 2011 and Hip surgery in 2020. Concurrent medical conditions included GERD since 1962, Indigestion since 1962, Pain in hip since 2011, Joint pain since 2011 and Drug allergy (MORPHINE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM CODEINE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM OXYCODONE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM). In June 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ABDOMINAL PAIN (abdominal pain). On 18-Feb-2021, the patient experienced LYMPHADENOPATHY (lymph nodes enlarged). On an unknown date, the patient experienced ADRENAL INSUFFICIENCY (Adrenal gland insufficiency) (seriousness criterion medically significant), THYROID DISORDER (thyroid issues) and FATIGUE (fatigue). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, ADRENAL INSUFFICIENCY (Adrenal gland insufficiency), ABDOMINAL PAIN (abdominal pain), THYROID DISORDER (thyroid issues), LYMPHADENOPATHY (lymph nodes enlarged) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: unknown (Inconclusive) Blood work done-results unknown. On 18-Feb-2021, Computerised tomogram: abnormal (abnormal) Enlarged lymph nodes in abdominal region. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ABDOMINAL PAIN (abdominal pain) and LYMPHADENOPATHY (lymph nodes enlarged) to be possibly related. No further causality assessments were provided for ADRENAL INSUFFICIENCY (Adrenal gland insufficiency), THYROID DISORDER (thyroid issues) and FATIGUE (fatigue). The patient was treated with CIPRO and PREDNISONE (indication not specified). Company comment:Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities, further information required.

Other Meds:

Current Illness: Drug allergy (MORPHINE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM CODEINE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM OXYCODONE ALLERGY MANIFESTED BY RASH, VOMITING, DELIRIUM); GERD; Indigestion; Joint pain; Pain in hip

ID: 1363980
Sex: F
Age: 55
State: MD

Vax Date: 05/17/2021
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Rec V Date: 06/01/2021
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Symptoms: Bells palsy in face; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells palsy in face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells palsy in face) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells palsy in face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided. Company comment; Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1363981
Sex: M
Age: 74
State: NC

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 06/01/2021
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Symptoms: Did not go for 2nd shot; Passed out; Extreme arm pain; Could not lift up arms; Trouble with bowels; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PAIN IN EXTREMITY (Extreme arm pain), HYPOKINESIA (Could not lift up arms) and ABDOMINAL DISCOMFORT (Trouble with bowels). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not go for 2nd shot). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), PAIN IN EXTREMITY (Extreme arm pain), HYPOKINESIA (Could not lift up arms) and ABDOMINAL DISCOMFORT (Trouble with bowels) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not go for 2nd shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment : Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363982
Sex: F
Age: 19
State: NJ

Vax Date: 05/02/2021
Onset Date: 05/16/2021
Rec V Date: 06/01/2021
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Symptoms: Encephalitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ENCEPHALITIS (Encephalitis) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c219) for COVID-19 vaccination. No Medical History information was reported. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 16-May-2021, the patient experienced ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (Encephalitis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. The patient's mother reported that on 06-May-2021, patient developed a headache on both sides of her head and lost coherence and mobility. On 15-May-2021, she had the same episode and lasted seven hours and they went to the hospital and on 16-May-2021 she was diagnosed with encephalitis, and still waiting for autoimmune test result. No treatment information provided. Company Comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363983
Sex: M
Age: 34
State: PA

Vax Date: 05/13/2021
Onset Date: 05/13/2021
Rec V Date: 06/01/2021
Hospital: Y

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Symptoms: Heart Attack; Panic attack; Couldnt breathe; Felt like chest caved in; Chest pain; Blood clot; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack), PAIN IN EXTREMITY (Arm Pain), PANIC ATTACK (Panic attack), DYSPNOEA (Couldnt breathe), CHEST DISCOMFORT (Felt like chest caved in), CHEST PAIN (Chest pain) and THROMBOSIS (Blood clot) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The patient's past medical history included Flu vaccination (received about 5 weeks ago before he got the Covid Shot and had chest pain) and Sinusitis (the patient stated that he violently threw up and he was sick for 2 weeks; the doctors then said that it may have been a stroke or a heart attack but he definitely had sinusitis.). Concurrent medical conditions included Diabetes, Cholesterol high and Blood pressure high. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain) (seriousness criterion hospitalization). On 15-May-2021, the patient experienced PANIC ATTACK (Panic attack) (seriousness criterion hospitalization), DYSPNOEA (Couldnt breathe) (seriousness criterion hospitalization), CHEST DISCOMFORT (Felt like chest caved in) (seriousness criterion hospitalization), CHEST PAIN (Chest pain) (seriousness criterion hospitalization) and THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant). On 15-May-2021 at 4:00 PM, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 3 days due to CHEST DISCOMFORT, CHEST PAIN, DYSPNOEA, MYOCARDIAL INFARCTION, PAIN IN EXTREMITY, PANIC ATTACK and THROMBOSIS. The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) ongoing since an unknown date at an unspecified dose and frequency; LISINOPRIL ongoing since an unknown date at a dose of 5 mg; METOPROLOL SUCCINATE ongoing since an unknown date at a dose of 50 mg; NITROGLYCERIN ongoing since an unknown date at a dose of 10 mg as required; PRASUGREL ongoing since an unknown date at a dose of 10 milligram; SPIRONOLACTONE ongoing since an unknown date at a dose of 25 mg and ROSUVASTATIN ongoing since an unknown date at a dose of 80 milligram. At the time of the report, MYOCARDIAL INFARCTION (Heart Attack), PAIN IN EXTREMITY (Arm Pain), PANIC ATTACK (Panic attack), DYSPNOEA (Couldnt breathe), CHEST DISCOMFORT (Felt like chest caved in), CHEST PAIN (Chest pain) and THROMBOSIS (Blood clot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. The patient reported that he had a heart attack on 15 May 2021, after football practice Patient was in the hospital for 3 days. Treatment also included catheter placement and then a stint in heart. 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: Cholesterol high; Diabetes

ID: 1363984
Sex: F
Age:
State: NC

Vax Date: 05/11/2021
Onset Date:
Rec V Date: 06/01/2021
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Symptom List:

Symptoms: wanted to rule out cellulitis; left arm is now the side of the softball; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (wanted to rule out cellulitis) in a 63-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 reported. On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (wanted to rule out cellulitis) (seriousness criterion medically significant) and INDURATION (left arm is now the side of the softball). At the time of the report, CELLULITIS (wanted to rule out cellulitis) and INDURATION (left arm is now the side of the softball) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications listed. No treatment listed. 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: 1363985
Sex: F
Age: 74
State: NY

Vax Date: 04/29/2021
Onset Date: 05/09/2021
Rec V Date: 06/01/2021
Hospital: Y

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Symptoms: lost weight; lack appetite; Patient is taken to the hospital with chest pain, it like a knife going in chest; arm pain; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight) and DECREASED APPETITE (lack appetite) in a 74-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 reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest) (seriousness criterion hospitalization). On an unknown date, the patient experienced WEIGHT DECREASED (lost weight) (seriousness criterion hospitalization), DECREASED APPETITE (lack appetite) (seriousness criterion hospitalization), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills). The patient was hospitalized on 09-May-2021 due to CHEST PAIN, DECREASED APPETITE and WEIGHT DECREASED. The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form and CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight), DECREASED APPETITE (lack appetite), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Electrocardiogram: normal (normal) arteries are clean and blood pressure is ok. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363986
Sex: M
Age:
State: GA

Vax Date: 05/15/2021
Onset Date: 05/01/2021
Rec V Date: 06/01/2021
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Symptoms: Strength less than half in his right hand; Paralyses started 72 hours after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralyses started 72 hours after vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced ASTHENIA (Strength less than half in his right hand). In May 2021, the patient experienced PARALYSIS (Paralyses started 72 hours after vaccine) (seriousness criterion medically significant). At the time of the report, PARALYSIS (Paralyses started 72 hours after vaccine) and ASTHENIA (Strength less than half in his right hand) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. Patient received covid vaccine on 15 May 2021. Per father son paralyses started 72 hours after strength less than half in his right hand. No treatment information was provided Company Comment : Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1363987
Sex: F
Age: 56
State: MN

Vax Date: 05/10/2021
Onset Date: 05/10/2021
Rec V Date: 06/01/2021
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Symptoms: blood clot from ankle the groin; flu like symptoms; difficulty walking; soreness in Left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot from ankle the groin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced THROMBOSIS (blood clot from ankle the groin) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (difficulty walking) and MYALGIA (soreness in Left arm). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot from ankle the groin), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (difficulty walking) and MYALGIA (soreness in Left arm) outcome was unknown. No concomitant medications were provided. The patient went to the ER after experiencing the blood clot (from her ankle to the groin area) and was provided treatment with Xarelto. 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: 1363988
Sex: M
Age: 59
State: FL

Vax Date: 04/20/2021
Onset Date:
Rec V Date: 06/01/2021
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Symptoms: Bell's palsy 10 days after getting 1st dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. No Medical History information was reported. On 20-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 BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product used was not provided by the reporter. This patient returned to take the second dose of vaccination and mentioned that 10 days after 1st dose of vaccination he noticed Bell's Palsy while taking shower. He did not see a HCP (Health Care Professional) nor given any medication. Pharmacist advised patient to see HCP and discuss about getting 2nd dose. Company comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

Date Died: 05/17/2021

ID: 1363989
Sex: M
Age: 71
State: WI

Vax Date: 01/29/2021
Onset Date: 03/03/2021
Rec V Date: 06/01/2021
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Symptoms: Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was liver cancer. It is unknown if an autopsy was performed. No concomitant medications was reported. No treatment medications was provided. 03-Mar-2021: Husband was diagnosed with liver cancer. It was in his ducts and everything. He had cancer at the time we took both vaccines. He died 10 weeks after being diagnosed with liver cancer. Caller felt the vaccine escalated the process. Company comment: Very limited information regarding the event has been provided at this time. Further information has been requested. This case was linked to MODERNATX, INC.-MOD-2021-019697 (E2B Linked Report).; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested. MODERNATX, INC.-MOD-2021-019697:Wife's case; Reported Cause(s) of Death: Liver cancer

Other Meds:

Current Illness:

ID: 1363990
Sex: F
Age: 54
State:

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 06/01/2021
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Symptoms: experiencing a cycle but has been menopausal; tinnitus in left ear; tingly feeling in arm, hands and back / feels like body parts are on pins and needles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history for the patient was reported. Concomitant products included SPIRONOLACTONE and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal) (seriousness criterion medically significant), TINNITUS (tinnitus in left ear) and PARAESTHESIA (tingly feeling in arm, hands and back / feels like body parts are on pins and needles). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal), TINNITUS (tinnitus in left ear) and PARAESTHESIA (tingly feeling in arm, hands and back / feels like body parts are on pins and needles) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No medical history was provided by the reporter. Treatment information was not provided. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds: SPIRONOLACTONE; PRESERVISION

Current Illness:

Total 2021 VAERS Injuries: 419,296

Page last modified: 03 October 2021 5:28pm