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
46,958
AK1,346
AL3,396
AR2,223
AS40
AZ10,005
CA42,776
CO8,247
CT5,458
DC1,108
DE1,143
FL22,936
FM3
GA9,043
GU61
HI1,548
IA3,359
ID1,849
IL13,909
IN19,586
KS3,225
KY4,315
LA3,127
MA10,426
MD8,887
ME2,303
MH7
MI12,428
MN8,329
MO6,410
MP15
MS1,658
MT1,687
NC10,704
ND936
NE2,043
NH2,275
NJ11,291
NM2,716
NV2,733
NY23,129
OH13,033
OK4,552
OR6,098
PA15,777
PR1,535
QM1
RI1,533
SC4,046
SD850
TN5,851
TX22,647
UT3,031
VA10,480
VI33
VT1,314
WA10,358
WI7,708
WV1,644
WY614
XB5
XL1
XV2

ID: 1370288
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: HORRIBLE TASTE IN MOUTH, TONGUE AND LIPS; BREATHING ISSUE R/T ASTHMA; DIARRHEA; SICK; ARM HURTS AT INJECTION SITE; MUSCLE ACHES; 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 concurrent conditions included asthma. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAY-2021, the subject experienced breathing issue r/t asthma. On 11-MAY-2021, the subject experienced diarrhea. On 11-MAY-2021, the subject experienced sick. On 11-MAY-2021, the subject experienced arm hurts at injection site. On 11-MAY-2021, the subject experienced muscle aches. On an unspecified date, the subject experienced horrible taste in mouth, tongue and lips. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from horrible taste in mouth, tongue and lips, and the outcome of muscle aches, breathing issue r/t asthma, arm hurts at injection site, diarrhea and sick was not reported. This report was non-serious.

Other Meds:

Current Illness: Asthma

ID: 1370289
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: PAIN IN HANDS AND THUMB; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced pain in hands and thumb. Laboratory data (dates unspecified) included: Antinuclear antibody positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in hands and thumb was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370290
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: ARMPIT SORENESS; SOME SWELLING AT INJECTION SITE; INJECTION SITE SORENESS; This spontaneous report received from a patient via a company representative 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced armpit soreness, some swelling at injection site, and injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some swelling at injection site, injection site soreness and armpit soreness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370291
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 05/30/2021
Rec V Date: 06/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: DIFFICULTY BREATHING WHEN LAYING DOWN, SHORTNESS OF BREATH; DIFFICULTY BREATHING ON EXERTION; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, penicillin allergy, and non-smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 04-JUL-2021) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. Concomitant medications included lisinopril for high blood pressure. On 30-MAY-2021, the subject experienced difficulty breathing when laying down, shortness of breath. On 30-MAY-2021, the subject experienced difficulty breathing on exertion. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from difficulty breathing when laying down, shortness of breath, and difficulty breathing on exertion. This report was non-serious.

Other Meds: LISINOPRIL

Current Illness: Blood pressure high; Non-smoker; Penicillin allergy

ID: 1370292
Sex: M
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: BLOOD CLOTS; 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 (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, with frequency 1 total administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots. It was reported that the patient experienced blood clots after receiving the vaccination for which the prison has failed to provide the medical treatment. The action taken with covid-19 vaccine was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine Blood clots. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1370293
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 05/27/2021
Rec V Date: 06/03/2021
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 pharmacist concerned 30 multiple patients (13 male, 15 female, 2 unaccounted). No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1802068, 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, patients experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370294
Sex: F
Age:
State: SC

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: BUG-BITE LIKE ABOUT 10-20 ITCHY SPOTS ON ARM,LEGS AND STOMACH THAT APPEARS LIKE MOSQUITO AND INSECT BITE; This spontaneous report received from a patient concerned a 38 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 (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, treatment medications included: diphenhydramine hydrochloride. On 03-APR-2021, the subject experienced bug-bite like about 10-20 itchy spots on arm, legs and stomach that appears like mosquito and insect bite. On MAY-2021, treatment medications included: permethrin. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from bug-bite like about 10-20 itchy spots on arm, legs and stomach that appears like mosquito and insect bite. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370295
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 05/27/2021
Rec V Date: 06/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: GOT UP LIMPING A LITTLE BIT SORE TO THE TOUCH; RIGHT HIP BOTHERING/ SORENESS; LEFT LEG SWELLING,PARTICULARLY AROUND AND ABOVE THE ANKLE BY 4 INCHES; 3-4 EPISODES OF DIARRHEA PER DAY/ LOOSE STOOL THAT HAS BEEN BOTH LIQUID AND SEMI FORMED/ STOOLS ARE NORMAL COLOR; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included leg injury, and darker skin discoloration, and concurrent conditions included asthma allergies, kiwi allergy, and reflux, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 2028A21A expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included bismuth subsalicylate. On 27-MAY-2021, the subject experienced 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color. On 29-MAY-2021, the subject experienced left leg swelling, particularly around and above the ankle by 4 inches. On 30-MAY-2021, the subject experienced got up limping a little bit sore to the touch. On 30-MAY-2021, the subject experienced right hip bothering/ soreness. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from left leg swelling,particularly around and above the ankle by 4 inches, right hip bothering/ soreness, and 3-4 episodes of diarrhea per day/ loose stool that has been both liquid and semi formed/ stools are normal color, and the outcome of got up limping a little bit sore to the touch was not reported. This report was non-serious.

Other Meds: PEPTO-BISMOL

Current Illness: Acid reflux (oesophageal); Allergic asthma; Fruit allergy

ID: 1370296
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: LOSS OF APPETITE; FEVER; FATIGUE; NAUSEA; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced loss of appetite, fever, fatigue, and nausea. The action taken with covid-19 vaccine was not applicable. The patient recovered from loss of appetite, fever, fatigue, and nausea. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370297
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: RESTORED TO CIRCULATION PATTERNS AND COMFORTABLE NERVE RESPONSES IN BACK AND LEGS ALONG WITH A GENERALLY GOOD FEELING OF NORMAL SELF FROM WHAT SEEMS LIKE YEARS AGO; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's past medical history included sciatica, and general pain in spine. The patient received covid-19 vaccine (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 restored to circulation patterns and comfortable nerve responses in back and legs along with a generally good feeling of normal self from what seems like years ago. The action taken with covid-19 vaccine was not applicable. The outcome of restored to circulation patterns and comfortable nerve responses in back and legs along with a generally good feeling of normal self from what seems like years ago was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370298
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: CHILLS; FEVER; SWEATING PROFUSELY; ACHE; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced sweating profusely. On MAY-2021, the subject experienced ache. On 25-MAY-2021, the subject experienced chills. On 25-MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the sweating profusely, ache, fever and chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370299
Sex: F
Age:
State: PA

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total dose administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, patient got tested for antibodies (specifically antibodies to the spike protein) for travel purposes. The patient's other option was to got a negative covid-19 test. As per the patient, the antibody test was valid for 4 months while negative covid-19 test was only valid for 5 days from travel. Patient opted for antibody testing. Test for covid-19 vaccine antibodies came back negative. So, patient did not had antibodies to the spike protein. The patient tested for S1-RBD Antibodies (S), or worse case scenario patient did not develop antibodies to the spike protein. The action taken with covid-19 vaccine was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine. Suspected immunological vaccine 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:

Current Illness:

ID: 1370300
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: DIARRHEA/MUSHY POOP; CRAMPING IN STOMACH WHEN EATS; DIDN'T EAT; SORE ARM; FEELS DIZZY; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041A21A, 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 feels dizzy. On 28-MAY-2021, the subject experienced flu like symptoms. On 28-MAY-2021, the subject experienced sore arm. On 29-MAY-2021, the subject experienced diarrhea/mushy poop. On 29-MAY-2021, the subject experienced cramping in stomach when eats. On 29-MAY-2021, the subject experienced didn't eat. The action taken with covid-19 vaccine was not applicable. The patient was recovering from diarrhea/mushy poop, cramping in stomach when eats, and sore arm, had not recovered from feels dizzy, and flu like symptoms, and the outcome of didn't eat was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370301
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: ITCHING OFF AND ON TO ARM; A LITTLE REDNESS TO ARM; 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 pre-existing medical conditions included unknown. 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 31-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-JUN-2021, the subject experienced itching off and on to arm. On 01-JUN-2021, the subject experienced a little redness to arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching off and on to arm, and a little redness to arm. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370302
Sex: U
Age:
State: MT

Vax Date:
Onset Date: 05/26/2021
Rec V Date: 06/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: EXPIRED PRODUCT 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: 180501A expiry: 25-MAY-2021) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAY-2021, the subject experienced expired product administered. The outcome of expired product administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370303
Sex: F
Age:
State: AZ

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: NAUSEA AFTER STARTING TO EAT A LITTLE BIT; This spontaneous report received from a patient concerned a 21 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 (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced nausea after starting to eat a little bit. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from nausea after starting to eat a little bit. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370304
Sex: U
Age:
State: WI

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 62 year old of unspecified 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 (suspension for injection, route of admin not reported, batch number: 1821288, and expiry: 1-AUG-2021) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine was not applicable. The outcome of incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370305
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: SLEEPY; This spontaneous report received from a patient via a company representative . 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: The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sleepy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sleepy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370306
Sex: U
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: COUGHING; SORE THROAT; SLUGGISH; HEADACHE; This spontaneous report received from a patient concerned a 53 year old of unspecified sex. The patient's weight was 215 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol consumer, and cigarette smoker, and other pre-existing medical conditions included patient have no known allergies and no drug abuse or illicit drug use.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 041a21a, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 28-MAY-2021, the subject experienced coughing. On 28-MAY-2021, the subject experienced sore throat. On 28-MAY-2021, the subject experienced sluggish. On 28-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 2021, was recovering from sluggish, and had not recovered from coughing, and sore throat. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Patient consumes alcohol on weekends.); Cigarette smoker (Patient consumes cigarette 0.5 ppd.)

ID: 1370307
Sex: U
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: VACCINE ADMINISTERED AFTER TRANSPORTATION OF THE PREFILLED SYRINGE OUTSIDE OF THE ACCEPTABLE LIMIT; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered after transportation of the prefilled syringe outside of the acceptable limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after transportation of the prefilled syringe outside of the acceptable limit was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370308
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 05/31/2021
Rec V Date: 06/03/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List:

Symptoms: DIZZINESS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known allergies and has not had covid or been tested positive for covid. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAY-2021, the subject experienced dizziness. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from dizziness. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370309
Sex: U
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List:

Symptoms: PRODUCT TEMPERATURE EXCURSION ISSUE; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.. No concomitant medications were reported. On an unspecified date, the subject experienced product temperature excursion issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of product temperature excursion issue was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1370310
Sex: F
Age: 52
State: KS

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

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Symptom List:

Symptoms: Grabbing chest; sensitivity to noise; loss of short term and long term memory; inability to function daily; sore arm; Headache that would come and go; Shake and was shivering, Teeth chattering; Feeling cold,Cold to touch; Not feeling well,Unable to lie still; Her arm itching; A rash at the injection site; Redness at site; Slightly raised that covered the whole deltoid; Fatigue; Body ache; Warm pressure from neck up to top of head; Red raised Rash at injection site; Warm at the injection site; Feeling disoriented; Bones are hurting; Feeling very hot; Face pale gray in color,Slight pale to pinker; Skin dry; Anxious; Irritable; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST DISCOMFORT (Grabbing chest) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma, Pollen allergy (Seasonal Allergy to Pollens) and Drug allergy (allergic to Benadryl ,Demerol, Aspirin). On 08-Jan-2021 at 9:06 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced INJECTION SITE RASH (A rash at the injection site). On 01-Jan-2021 at 9:18 AM, the patient experienced INJECTION SITE PRURITUS (Her arm itching). On 08-Jan-2021, the patient experienced CHEST DISCOMFORT (Grabbing chest) (seriousness criterion hospitalization), DISORIENTATION (Feeling disoriented), IRRITABILITY (Irritable), MUSCULOSKELETAL DISCOMFORT (Warm pressure from neck up to top of head), RASH PAPULAR (Red raised Rash at injection site), INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE ERYTHEMA (Redness at site), INJECTION SITE SWELLING (Slightly raised that covered the whole deltoid), FATIGUE (Fatigue) and MYALGIA (Body ache). On 08-Jan-2021 at 9:25 AM, the patient experienced FEELING HOT (Feeling very hot) and VACCINATION COMPLICATION (Not feeling well,Unable to lie still). On 08-Jan-2021 at 9:29 AM, the patient experienced FEELING COLD (Feeling cold,Cold to touch). On 08-Jan-2021 at 9:31 AM, the patient experienced BONE PAIN (Bones are hurting), PALLOR (Face pale gray in color,Slight pale to pinker), DRY SKIN (Skin dry) and CHILLS (Shake and was shivering, Teeth chattering). On 08-Jan-2021 at 9:33 AM, the patient experienced ANXIETY (Anxious). On 11-Jan-2021, the patient experienced TINNITUS (sensitivity to noise), AMNESIA (loss of short term and long term memory), IMPAIRED WORK ABILITY (inability to function daily), PAIN IN EXTREMITY (sore arm) and HEADACHE (Headache that would come and go). The patient was treated with EPINEPHRINE (EPIPEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Grabbing chest), DISORIENTATION (Feeling disoriented), BONE PAIN (Bones are hurting), FEELING HOT (Feeling very hot), PALLOR (Face pale gray in color,Slight pale to pinker), DRY SKIN (Skin dry), ANXIETY (Anxious), IRRITABILITY (Irritable), VACCINATION COMPLICATION (Not feeling well,Unable to lie still), MUSCULOSKELETAL DISCOMFORT (Warm pressure from neck up to top of head), TINNITUS (sensitivity to noise), AMNESIA (loss of short term and long term memory), FEELING COLD (Feeling cold,Cold to touch), IMPAIRED WORK ABILITY (inability to function daily), PAIN IN EXTREMITY (sore arm), RASH PAPULAR (Red raised Rash at injection site), INJECTION SITE WARMTH (Warm at the injection site), INJECTION SITE PRURITUS (Her arm itching), INJECTION SITE RASH (A rash at the injection site), INJECTION SITE ERYTHEMA (Redness at site), INJECTION SITE SWELLING (Slightly raised that covered the whole deltoid), CHILLS (Shake and was shivering, Teeth chattering), FATIGUE (Fatigue), MYALGIA (Body ache) and HEADACHE (Headache that would come and go) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Blood pressure measurement (118-68 mmHg): 118/68 mmHg (Inconclusive) 118/68. On 08-Jan-2021, Heart rate: pulse 64 (Inconclusive) Pulse 64. 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. No Concomitant Medicines were provided Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Rash, injection site itching, injection site rash, injection site erythema, injection site swelling, chills, fatigue, myalgia and headache are consistent with the product known safety profile of the product. This case was linked to US-MODERNATX, INC.-MOD-2021-005925 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: A follow up was received on 13 Apr 2021 with Outcome of the Existing Events was changed from Unknown to Not Recovered and Not Resolved.New Events Musculoskeletal Discomfort,Tinnitus,Amnesia,Rash Papular,Impaired working ability,Pain in extremity have been added.Allergic to Aspirin was added; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Rash, injection site itching, injection site rash, injection site erythema, injection site swelling, chills, fatigue, myalgia and headache are consistent with the product known safety profile of the product. US-MODERNATX, INC.-MOD-2021-005925:

Other Meds:

Current Illness: Asthma; Drug allergy (allergic to Benadryl ,Demerol, Aspirin); Pollen allergy (Seasonal Allergy to Pollens)

ID: 1370311
Sex: F
Age: 65
State: CA

Vax Date: 02/02/2021
Onset Date: 02/15/2021
Rec V Date: 06/03/2021
Hospital: Y

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Symptoms: Stage four kidney failure; organ shutting down; Dress syndrome; leiomyosarcoma; loss of appetite; itching; Patient is very sick since 1 dose; Did not received 2 dose; rash that went from her neck, chest, abdomen, and upper thighs; very fatigued; felt throat was closing up; very thirsty; she "started not feeling well"; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), LEIOMYOSARCOMA (leiomyosarcoma), RENAL FAILURE (Stage four kidney failure) and ORGAN FAILURE (organ shutting down) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Blood cholesterol increased. Concurrent medical conditions included Blood pressure high, Immune disorder (NOS) and Osteoarthritis. Concomitant products included ATENOLOL and LEVOTHYROXINE for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MALAISE (she "started not feeling well"), THIRST (very thirsty), THROAT TIGHTNESS (felt throat was closing up), RASH (rash that went from her neck, chest, abdomen, and upper thighs) and FATIGUE (very fatigued). On an unknown date, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) (seriousness criterion medically significant), LEIOMYOSARCOMA (leiomyosarcoma) (seriousness criterion medically significant), RENAL FAILURE (Stage four kidney failure) (seriousness criteria hospitalization and medically significant), ORGAN FAILURE (organ shutting down) (seriousness criterion hospitalization), DECREASED APPETITE (loss of appetite), PRURITUS (itching), ILLNESS (Patient is very sick since 1 dose) and PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose). The patient was treated with PREDNISONE at a dose of 60 mg. At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), LEIOMYOSARCOMA (leiomyosarcoma), RENAL FAILURE (Stage four kidney failure), ORGAN FAILURE (organ shutting down), MALAISE (she "started not feeling well"), DECREASED APPETITE (loss of appetite), THIRST (very thirsty), THROAT TIGHTNESS (felt throat was closing up), ILLNESS (Patient is very sick since 1 dose), PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose) and FATIGUE (very fatigued) outcome was unknown and PRURITUS (itching) and RASH (rash that went from her neck, chest, abdomen, and upper thighs) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding concomitant diseases and medications that could be confounders for the events. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: A Followup received on 25 May2021 has information on Newadverse events and concomitant medications were added. Contact information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding concomitant diseases and medications that could be confounders for the events. Further information has been requested.

Other Meds: ATENOLOL; LEVOTHYROXINE

Current Illness: Blood pressure high; Immune disorder (NOS); Osteoarthritis

ID: 1370312
Sex: F
Age: 62
State: FL

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 06/03/2021
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Symptoms: have not received second dose; terrible feeling/ feeling off; No strength; No strength to walk; lethargic; had vomited; lost control of bowels; tingling all over my body; Stroke; completely lost consciousness; Seizure; barely move her arm; lightheaded; sick to my stomach/ Stomach issues; arm was painful; interrupted her sleep; vaccination was given directly into the infected area; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (completely lost consciousness) and SEIZURE (Seizure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spider bite. On 15-Apr-2021 at 7:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was painful), INSOMNIA (interrupted her sleep), DIZZINESS (lightheaded), GASTROINTESTINAL DISORDER (sick to my stomach/ Stomach issues), PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given directly into the infected area) and HEADACHE (headache). On 16-Apr-2021, the patient experienced MONOPARESIS (barely move her arm). On 17-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (completely lost consciousness) (seriousness criterion medically significant), SEIZURE (Seizure) (seriousness criterion medically significant), PARAESTHESIA (tingling all over my body) and ANAL INCONTINENCE (lost control of bowels). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received second dose), FEELING ABNORMAL (terrible feeling/ feeling off), ASTHENIA (No strength), GAIT DISTURBANCE (No strength to walk), LETHARGY (lethargic) and VOMITING (had vomited). On 15-Apr-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (vaccination was given directly into the infected area) had resolved. On 16-Apr-2021, INSOMNIA (interrupted her sleep) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LOSS OF CONSCIOUSNESS (completely lost consciousness), SEIZURE (Seizure), DIZZINESS (lightheaded), FEELING ABNORMAL (terrible feeling/ feeling off), GASTROINTESTINAL DISORDER (sick to my stomach/ Stomach issues), ASTHENIA (No strength), PARAESTHESIA (tingling all over my body), GAIT DISTURBANCE (No strength to walk), ANAL INCONTINENCE (lost control of bowels), LETHARGY (lethargic), HEADACHE (headache) and VOMITING (had vomited) outcome was unknown, PRODUCT DOSE OMISSION ISSUE (have not received second dose) had resolved and PAIN IN EXTREMITY (arm was painful) and MONOPARESIS (barely move her arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: inconclusive (Inconclusive) inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. The patient's left arm was already itchy and swollen from a spider bite. Pharmacist injected arm where the spider bite was located, even though she noted the spider bite. During the night her arm was painful and interrupted her sleep. The next day, she could barely move her arm and it was very painful. The patient was transported to hospital emergency room. IVs and CT scan for over two weeks followed were performed. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient demographics, new serious events ,new non serious events added. event outcome of painful arm( unknown to not recovered), and arm discomfort( unknown to not recovered) were changed.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness: Spider bite

ID: 1370313
Sex: F
Age: 78
State: NJ

Vax Date: 03/18/2021
Onset Date: 04/15/2021
Rec V Date: 06/03/2021
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Symptoms: Diverticulitis; cannot lift anything up or drive; painful arm between the elbow and shoulder; muscle spasms; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms) and ABDOMINAL PAIN UPPER (stomach pain). On an unknown date, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) had resolved, MUSCLE SPASMS (muscle spasms), ABDOMINAL PAIN UPPER (stomach pain) and MUSCULAR WEAKNESS (cannot lift anything up or drive) outcome was unknown and MYALGIA (painful arm between the elbow and shoulder) had not resolved. No concomitant medication were provided Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Action taken with mRNA-1273 Moderna vaccine was Not applicable Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up was accepted on 27-May-2021 On 26-May-2021: Non significant follow up; 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: 1370314
Sex: F
Age: 31
State: CO

Vax Date: 05/02/2021
Onset Date: 05/02/2021
Rec V Date: 06/03/2021
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Symptoms: Lost partial vision in her left eye; Tingling on the injection site; Swelling of the face; Blurred vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLINDNESS UNILATERAL (Lost partial vision in her left eye) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. Concurrent medical conditions included Allergy. On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced PARAESTHESIA (Tingling on the injection site), SWELLING FACE (Swelling of the face) and VISION BLURRED (Blurred vision). On an unknown date, the patient experienced BLINDNESS UNILATERAL (Lost partial vision in her left eye) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. At the time of the report, BLINDNESS UNILATERAL (Lost partial vision in her left eye) had not resolved and PARAESTHESIA (Tingling on the injection site), SWELLING FACE (Swelling of the face) and VISION BLURRED (Blurred vision) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Patient is immunocompromised. Based on the current available information which shows a strong temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up received on 31-MAY-2021: New AEs were updated(Blurred vision,partial vision lost); Sender's Comments: Based on the current available information which shows a strong temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Allergy

ID: 1370315
Sex: F
Age:
State: MD

Vax Date:
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Rec V Date: 06/03/2021
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Symptoms: Hemolysis aggravated; fever; rigors; hemolysis aggravated; This literature-non-study case was reported in a literature article and describes the occurrence of HAEMOLYSIS (hemolysis aggravated) in a 32-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 Paroxysmal nocturnal haemoglobinuria (10-year history), Aplastic anemia and Transfusion (Transfusion dependent.). Concomitant products included RAVULIZUMAB for Paroxysmal nocturnal hemoglobinuria. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (hemolysis aggravated) (seriousness criterion medically significant), CONDITION AGGRAVATED (Hemolysis aggravated), PYREXIA (fever) and CHILLS (rigors). At the time of the report, HAEMOLYSIS (hemolysis aggravated), CONDITION AGGRAVATED (Hemolysis aggravated), PYREXIA (fever) and CHILLS (rigors) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Aspartate aminotransferase: 25 (Inconclusive) pre-vaccination was 19units/Liter Post vaccination was 25units/liter. In 2021, Blood bilirubin: 2.7 mg/dl (Inconclusive) Pre-vaccination was 0.7 milligram/deciliter Post vaccination was 2.7 milligram/deciliter.. In 2021, Blood grouping: a positive (normal) A positive. In 2021, Blood lactate dehydrogenase: 255 (Inconclusive) Pre-vaccination was 255Units/liter. In 2021, Body temperature: 39 (High) 39 degrees celsius. In 2021, Haemoglobin: 8.4 mg/dl (Low) noted to have a 3g/dL hemoglobin decrease. Hemoglobin pre-vaccination was 11.3. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HAEMOLYSIS (hemolysis aggravated), CONDITION AGGRAVATED (Hemolysis aggravated), PYREXIA (fever) and CHILLS (rigors) to be possibly related. It was reported that the last dose of the concomitant medication ravulizumab, was given four weeks prior to vaccination. PNH Clone was reported as 39% RBC, 99% granulocytes. The patient was also reported to be part of a clinical trial with danicopan, an oral complement factor D inhibitor. She missed two doses of danicopan immediately after her second vaccination due to concerns that the drug may interfere with vaccine potency; therefore danicopan was not at therapeutic levels at the time of her reaction. She also took danicopan throughout her first vaccination and did not experience breakthrough hemolysis. On an unspecified date, it was reported that approximately 12 hours after receiving the second dose of the Moderna Covid-19 vaccine, the patient experienced fever and rigors. On an unspecified date, she presented to a local hospital where investigations were done. She was transfused two units of packed red blood cells. 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. However, additional details regarding the subject's other medical history and concomitant medications are required for further assessment.; 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. However, additional details regarding the subject's other medical history and concomitant medications are required for further assessment.

Other Meds: RAVULIZUMAB

Current Illness: Aplastic anemia; Paroxysmal nocturnal haemoglobinuria (10-year history); Transfusion (Transfusion dependent.)

ID: 1370316
Sex: F
Age: 82
State: NY

Vax Date: 03/15/2021
Onset Date: 02/15/2021
Rec V Date: 06/03/2021
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Symptoms: lyme disease type symptoms; blood sugar decreased; right arm pain at injection site; fatigue; generalized body ache; chills; runny nose; cough; left arm pain-no injection; left eye twitch; This spontaneous case was reported by a nurse and describes the occurrence of LYME DISEASE (lyme disease type symptoms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014MZ01) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid arthritis, Arm injury (left arm cannot raise arm) in 2012, Dislocation of vertebra (3 vertebrae out of place), Radiofrequency ablation (ablation in neck), Low back pain (bilateral), HLA-B*27 positive, Kidney stones, Reiter's syndrome, Salmonella infection, unspecified (dating back to 1981) and Knee replacement (two knee replacements). Concurrent medical conditions included Diabetes, Asthma, Lyme disease and Fibromyalgia (fibromyalgia with neck and shoulder pain). Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for Asthma, INSULIN GLARGINE (LANTUS) for Diabetes, MINOCYCLINE, DAPSONE, ATOVAQUONE, PROGUANIL HYDROCHLORIDE (MALARONE) and LEUCOVORIN [FOLINIC ACID] for Lyme disease, CODEINE PHOSPHATE (CODINE), PARACETAMOL (TYLENOL) and DIAZEPAM (VALIUM) for Pain. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced BLEPHAROSPASM (left eye twitch). On 15-Mar-2021, the patient experienced RHINORRHOEA (runny nose), COUGH (cough) and PAIN IN EXTREMITY (left arm pain-no injection). On 12-Apr-2021, the patient experienced LYME DISEASE (lyme disease type symptoms) (seriousness criterion medically significant), BLOOD GLUCOSE DECREASED (blood sugar decreased), VACCINATION COMPLICATION (right arm pain at injection site), FATIGUE (fatigue), MYALGIA (generalized body ache) and CHILLS (chills). On 20-Mar-2021, BLEPHAROSPASM (left eye twitch), RHINORRHOEA (runny nose) and COUGH (cough) had resolved. At the time of the report, LYME DISEASE (lyme disease type symptoms), PAIN IN EXTREMITY (left arm pain-no injection), VACCINATION COMPLICATION (right arm pain at injection site), FATIGUE (fatigue), MYALGIA (generalized body ache) and CHILLS (chills) outcome was unknown and BLOOD GLUCOSE DECREASED (blood sugar decreased) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood glucose: abnormal (abnormal) abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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: LANTUS; MINOCYCLINE; DAPSONE; MALARONE; LEUCOVORIN [FOLINIC ACID]; DULERA; CODINE; TYLENOL; VALIUM

Current Illness: Asthma; Diabetes; Fibromyalgia (fibromyalgia with neck and shoulder pain)

ID: 1370317
Sex: M
Age: 41
State: GA

Vax Date: 05/20/2021
Onset Date: 04/23/2021
Rec V Date: 06/03/2021
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Symptoms: brain fog; left arm injection site was sore; fatigue; body aches; fever; chills; fatigued/Tired; body aches; left arm injection site was sore; This spontaneous case was reported by a patient and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history per source document.). Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication. On 20-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced the first episode of VACCINATION SITE PAIN (left arm injection site was sore), FATIGUE (fatigued/Tired) and the first episode of MYALGIA (body aches). On 20-May-2021, the patient experienced FATIGUE (fatigue), the second episode of MYALGIA (body aches), PYREXIA (fever), CHILLS (chills) and the second episode of VACCINATION SITE PAIN (left arm injection site was sore). On 24-May-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog) (seriousness criterion medically significant). On 27-Apr-2021, FATIGUE (fatigued/Tired) had resolved. On 23-May-2021, FATIGUE (fatigue), the last episode of MYALGIA (body aches) and the last episode of VACCINATION SITE PAIN (left arm injection site was sore) had resolved. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (brain fog), PYREXIA (fever) and CHILLS (chills) outcome was unknown. Patient received both Moderna Covid-19 vaccine in his left arm shoulder deltoid muscle. Action taken with mRNA-1273 in response to the events was not applicable. Treatment medication was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: ACETAMINOPHEN

Current Illness:

ID: 1370318
Sex: U
Age:
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Rec V Date: 06/03/2021
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Symptoms: cant see; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (cant see) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (cant see) (seriousness criterion medically significant). At the time of the report, BLINDNESS (cant see) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication information was provided. Company Comment : This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time, and no reporter can be contacted for follow-up.; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time, and no reporter can be contacted for follow-up.

Other Meds:

Current Illness:

Date Died:

ID: 1370319
Sex: M
Age:
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Rec V Date: 06/03/2021
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Symptoms: Son died 10 days after his first moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Son died 10 days after his first moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. A male patient of an unknown age who received mRNA-1273 died 10 days after his first dose of vaccine. No medical conditions or conmeds were provided. Very limited information regarding these events has been provided at this time. Further information is being pursued.; Sender's Comments: A male patient of an unknown age who received mRNA-1273 died 10 days after his first dose of vaccine. No medical conditions or conmeds were provided. Very limited information regarding these events has been provided at this time. Further information is being pursued.; Reported Cause(s) of Death: Son died 10 days after his first moderna vaccine

Other Meds:

Current Illness:

ID: 1370320
Sex: M
Age: 58
State: CA

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 06/03/2021
Hospital: Y

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Symptoms: sustained a stroke; lot of chest pain; experienced difficulty in breathing; heart rate went high up; headache; tingling sensation over the face, tingling sensation in the tongue; problem to speak well; " face felt wearied", "squeezing felling of the face"; 'I can't see clearly, can't read clearly, all letters are seen double; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (sustained a stroke), CHEST PAIN (lot of chest pain) and DYSPNOEA (experienced difficulty in breathing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stent placement. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRASUGREL for an unknown indication. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PARAESTHESIA (tingling sensation over the face, tingling sensation in the tongue), SPEECH DISORDER (problem to speak well), FEELING ABNORMAL (" face felt wearied", "squeezing felling of the face"), VISUAL IMPAIRMENT ('I can't see clearly, can't read clearly, all letters are seen double) and HEADACHE (headache). On 19-May-2021 at 5:00 AM, the patient experienced CHEST PAIN (lot of chest pain) (seriousness criterion hospitalization), DYSPNOEA (experienced difficulty in breathing) (seriousness criterion hospitalization) and HEART RATE INCREASED (heart rate went high up). On 20-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (sustained a stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 20-May-2021 to 23-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (sustained a stroke), CHEST PAIN (lot of chest pain), DYSPNOEA (experienced difficulty in breathing), PARAESTHESIA (tingling sensation over the face, tingling sensation in the tongue), SPEECH DISORDER (problem to speak well), FEELING ABNORMAL (" face felt wearied", "squeezing felling of the face"), VISUAL IMPAIRMENT ('I can't see clearly, can't read clearly, all letters are seen double), HEART RATE INCREASED (heart rate went high up) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included blood thinner medications started while the patient was at the hospital. The patient saw their healthcare provider on 23-May-2021 who advised them to cancel the scheduled second dose of the vaccine until the patients health is stabilized. The stent placement is in the heart. Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested. Subject's history of stent placement in the heart can be a confounding factor.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested. Subject's history of stent placement in the heart can be a confounding factor.

Other Meds: LIPITOR; BABY ASPIRIN; METOPROLOL; VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; PRASUGREL

Current Illness:

ID: 1370321
Sex: M
Age: 49
State: CA

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

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Symptoms: heart disorder; Inappropriate schedule of vaccine administered; started feeling short of breath; pain in the back and chest; pain in the back and chest; pain bone; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISORDER (heart disorder) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007S21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Blood pressure high (Patient was diagnosed at the hospital) on 19-Mar-2021. On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced BONE PAIN (pain bone) and CHILLS (chills). On 16-May-2021, the patient experienced DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest) and BACK PAIN (pain in the back and chest). On 19-May-2021, the patient experienced CARDIAC DISORDER (heart disorder) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered). The patient was hospitalized on 19-Mar-2021 due to CARDIAC DISORDER. The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 06-Apr-2021, BONE PAIN (pain bone) and CHILLS (chills) had resolved. At the time of the report, CARDIAC DISORDER (heart disorder), DYSPNOEA (started feeling short of breath), CHEST PAIN (pain in the back and chest), BACK PAIN (pain in the back and chest) and PRODUCT DOSE OMISSION ISSUE (Inappropriate schedule of vaccine administered) 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. Patient received medications for diabetes and high blood pressure however, drug names were not provided. Company comment: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information was received.; Sender's Comments: This case concerns a 49-year-old male patient who missed the appointment to be given the second dose of the vaccine because of symptoms (Product dose omission). The other events show temporal association with the use of mRNA-1273 and, a causal relationship cannot be excluded. Nausea is consistent with the product known safety profile of the product. The event of product dose omission is not applicable.

Other Meds:

Current Illness: Diabetes

ID: 1370322
Sex: M
Age: 67
State: OK

Vax Date: 01/07/2021
Onset Date: 02/16/2021
Rec V Date: 06/03/2021
Hospital: Y

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Symptoms: AFIB; chest pain; he couldn't see the road; He's sluggish; chest discomfort; fogginess in head; he sleeps a lot; fogginess in head; Headache; chest discomfort; high blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) and ATRIAL FIBRILLATION (AFIB) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (high blood pressure), the first episode of CHEST DISCOMFORT (chest discomfort), the first episode of FEELING ABNORMAL (fogginess in head) and HEADACHE (Headache). On 14-May-2021, the patient experienced ATRIAL FIBRILLATION (AFIB) (seriousness criteria hospitalization and medically significant) and SOMNOLENCE (he sleeps a lot). On 24-May-2021, the patient experienced the second episode of CHEST DISCOMFORT (chest discomfort) and the second episode of FEELING ABNORMAL (fogginess in head). On 25-May-2021, the patient experienced VISUAL IMPAIRMENT (he couldn't see the road) and SLUGGISHNESS (He's sluggish). The patient was hospitalized from 05-Apr-2021 to 06-Apr-2021 due to ATRIAL FIBRILLATION and CHEST PAIN. At the time of the report, CHEST PAIN (chest pain), ATRIAL FIBRILLATION (AFIB), BLOOD PRESSURE INCREASED (high blood pressure), VISUAL IMPAIRMENT (he couldn't see the road), SLUGGISHNESS (He's sluggish), SOMNOLENCE (he sleeps a lot), the last episode of CHEST DISCOMFORT (chest discomfort), the last episode of FEELING ABNORMAL (fogginess in head) and HEADACHE (Headache) outcome was unknown. Unknown On 03-Mar-2021, Blood pressure measurement result was unknown. On 09-Mar-2021, patient had head scan and coronary test and results were unknown. On 05-Apr-2021, patient had Electrocardiogram and X-ray tests and results were unknown. On 19-Apr-2021, lab work result was unknown. On 27-apr-2021 patient wore heart monitor for two days. On 28-Apr-2021, Angiogram result was unknown .On 25-May-2021, Electrocardiogram result was unknown. No concomitant medications were reported. No treatment information was provided. Patient was in the emeragncy two times and hospitalized one time. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up was received on 25-may-2021 contains new laboratory data and new event.; 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: 1370323
Sex: M
Age:
State:

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Onset Date:
Rec V Date: 06/03/2021
Hospital: Y

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Symptoms: Infection; Confusion; Could not get out of the bed; Very sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (Infection) and CONFUSIONAL STATE (Confusion) in a 90-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 provided. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), BEDRIDDEN (Could not get out of the bed) and MALAISE (Very sick). At the time of the report, INFECTION (Infection), CONFUSIONAL STATE (Confusion), BEDRIDDEN (Could not get out of the bed) and MALAISE (Very sick) had not resolved. Concomitant product use was not provided. Treatment information was not provided. Company Comment: Very limited information regarding the events has been provided at this time. Reporter did not provide permission to follow-up. Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Reporter did not provide permission to follow-up.

Other Meds:

Current Illness:

ID: 1370324
Sex: U
Age:
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Rec V Date: 06/03/2021
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Symptoms: Seizure; Vomiting; Muscle aches; Chills; Pain in my arm from shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant), VOMITING (Vomiting), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in my arm from shot). At the time of the report, SEIZURE (Seizure), VOMITING (Vomiting), MYALGIA (Muscle aches), CHILLS (Chills) and VACCINATION SITE PAIN (Pain in my arm from shot) outcome was unknown. Not Provided The case pertains to one patient from chatbot. No concomitant medications were reported. The patient had these symptoms after second dose. 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. Reporter did not allow further contact; 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: 1370325
Sex: F
Age: 62
State: TN

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 06/03/2021
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Symptoms: Magnets stuck to her arm; Worse chills; Arm still hurts; 2 inches below the injection site there was a red spot which had since turned into a scar; Her arm swelled up; 104.3 degree F fever; Low pulse oxygen level of 77%/Breathing was worse than before the vaccination; Didn't feel good all weekend until Sunday; 2 inches below the injection site there was a red spot which had since turned into a scar; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PYREXIA (104.3 degree F fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer (5 years ago) in 2016, COVID-19 (hospitalized 01-Nov-2020) on 28-Oct-2020 and Pneumonia (almost died from pneumonia complications from COVID-19) on 01-Nov-2020. Concurrent medical conditions included Total lung capacity decreased (was left with 55% lung capacity after the pneumonia) since November 2020. Concomitant products included ALBUTEROL SULFATE for an unknown indication. On 29-Apr-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (104.3 degree F fever) (seriousness criterion medically significant), DYSPNOEA (Low pulse oxygen level of 77%/Breathing was worse than before the vaccination), VACCINATION SITE SCAR (2 inches below the injection site there was a red spot which had since turned into a scar), CHILLS (Worse chills), VACCINATION SITE ERYTHEMA (2 inches below the injection site there was a red spot which had since turned into a scar) and VACCINATION SITE SWELLING (Her arm swelled up). 29-Apr-2021, the patient experienced FEELING ABNORMAL (Didn't feel good all weekend until Sunday). 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (Arm still hurts). On 22-May-2021, the patient experienced VACCINATION SITE REACTION (Magnets stuck to her arm). On 30-Apr-2021, PYREXIA (104.3 degree F fever), DYSPNOEA (Low pulse oxygen level of 77%/Breathing was worse than before the vaccination) and CHILLS (Worse chills) had resolved. On 02-May-2021, FEELING ABNORMAL (Didn't feel good all weekend until Sunday) had resolved. On 20-May-2021, VACCINATION SITE SWELLING (Her arm swelled up) had resolved. At the time of the report, VACCINATION SITE SCAR (2 inches below the injection site there was a red spot which had since turned into a scar), VACCINATION SITE REACTION (Magnets stuck to her arm) and VACCINATION SITE ERYTHEMA (2 inches below the injection site there was a red spot which had since turned into a scar) outcome was unknown and VACCINATION SITE PAIN (Arm still hurts) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Oxygen saturation: 77 (Low) 77%. On 29-Apr-2021, Pyrexia: 104.3 degree f (High) 104.3 degree F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment provided were Tylenol. Follow-up received on 25MAY2021 included no new information. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: No new information.

Other Meds: ALBUTEROL SULFATE

Current Illness: Total lung capacity decreased (was left with 55% lung capacity after the pneumonia)

ID: 1370326
Sex: F
Age: 75
State: MS

Vax Date: 03/22/2021
Onset Date:
Rec V Date: 06/03/2021
Hospital: Y

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Symptoms: in the hospital for pneumonia; first dose on 22Mar2021 (no second dose); This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (in the hospital for pneumonia) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. WSY86RS56) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (in the hospital for pneumonia) (seriousness criteria hospitalization and medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 22Mar2021 (no second dose)). The patient was hospitalized from 16-Apr-2021 to 19-Apr-2021 due to PNEUMONIA. At the time of the report, PNEUMONIA (in the hospital for pneumonia) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose on 22Mar2021 (no second dose)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment drug information provided. No concomitant drug information provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1370327
Sex: F
Age:
State: OR

Vax Date: 03/20/2021
Onset Date:
Rec V Date: 06/03/2021
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Symptoms: Passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0470 2orZ 1A) for COVID-19 vaccination. No medical history was provided by the reporter. On 20-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not reported. Treatment information was not provided. 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. Further information has been requested.; 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. Further information has been requested.

Other Meds:

Current Illness:

ID: 1370328
Sex: F
Age:
State: OR

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

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Symptoms: Tachyarrhythmia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TACHYARRHYTHMIA (Tachyarrhythmia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TACHYARRHYTHMIA (Tachyarrhythmia) (seriousness criterion hospitalization). At the time of the report, TACHYARRHYTHMIA (Tachyarrhythmia) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable. Very limited information regarding this event/s has been provided at this time. Further information has been requested..; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested..

Other Meds:

Current Illness:

ID: 1370329
Sex: F
Age: 47
State: TX

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 06/03/2021
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Symptoms: Woke up in the middle of the night and she was choking; Not able to breath; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHOKING (Woke up in the middle of the night and she was choking) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever). On 09-May-2021, the patient experienced CHOKING (Woke up in the middle of the night and she was choking) (seriousness criterion medically significant) and DYSPNOEA (Not able to breath). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 30-Apr-2021, PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever) had resolved. On 09-May-2021, CHOKING (Woke up in the middle of the night and she was choking) and DYSPNOEA (Not able to breath) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Reportedly, the patient woke up in the middle of the night and was choking. Patient was not able to breath. All of a sudden the patient was fine and went back to sleep. It was for a few seconds. 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: 1370330
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 06/03/2021
Hospital: Y

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Symptoms: Stroke; Lost sight in one eye; Double vision; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and BLINDNESS UNILATERAL (Lost sight in one eye) 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 information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced BLINDNESS UNILATERAL (Lost sight in one eye) (seriousness criterion medically significant) and DIPLOPIA (Double vision). On 16-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 16-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), BLINDNESS UNILATERAL (Lost sight in one eye) and DIPLOPIA (Double vision) outcome was unknown. Concomitant product use was not provided. It was reported that the patient is planning to go to rehab center from Hospital. Treatment information was unknown. 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:

Current Illness:

ID: 1370331
Sex: F
Age:
State: MD

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

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Symptoms: Surgery after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (Surgery after 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SURGERY (Surgery after 1st dose). At the time of the report, SURGERY (Surgery after 1st dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. No treatment medications were reported. Patient had a surgery after first vaccination so patient wanted to reschedule the second dose of vaccine Company Comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1370332
Sex: F
Age: 28
State: MN

Vax Date: 03/20/2021
Onset Date: 03/20/2021
Rec V Date: 06/03/2021
Hospital:

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Symptoms: Missed second dose of the Moderna COVID-19 vaccine; Spontaneous abortion; Lot of pain in my whole arm; Exposure during pregnancy; Strong headache; Pain in the muscle where I got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Spontaneous abortion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine). On 08-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Spontaneous abortion) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine). The patient was treated with IBUPROFEN (oral) at a dose of 500 mg. At the time of the report, ABORTION SPONTANEOUS (Spontaneous abortion), PRODUCT DOSE OMISSION ISSUE (Missed second dose of the Moderna COVID-19 vaccine), PAIN IN EXTREMITY (Lot of pain in my whole arm), EXPOSURE DURING PREGNANCY (Exposure during pregnancy), HEADACHE (Strong headache) and VACCINATION SITE PAIN (Pain in the muscle where I got the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Followup received contains NNI; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Very limited information regarding this events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1370333
Sex: M
Age: 81
State: MI

Vax Date: 03/10/2021
Onset Date: 03/17/2021
Rec V Date: 06/03/2021
Hospital: Y

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: Swelling on left and right side of temporal areas of the face; High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition; Diagnosed him with temporal arthritis; Double vision in both eyes; Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis), SWELLING FACE (Swelling on left and right side of temporal areas of the face) and DIPLOPIA (Double vision in both eyes) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol total abnormal NOS (Patient takes Lipitor for cholesterol). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced SWELLING FACE (Swelling on left and right side of temporal areas of the face) (seriousness criterion hospitalization) and DIPLOPIA (Double vision in both eyes) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition) (seriousness criterion hospitalization), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis) (seriousness criterion hospitalization) and OFF LABEL USE (Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to). The patient was hospitalized from 16-Apr-2021 to 19-Apr-2021 due to DIPLOPIA, GIANT CELL ARTERITIS and INFLAMMATION. The patient was treated with PREDNISONE at a dose of 60 mg and PREDNISONE on 25-May-2021 at a dose of 40 milligram. At the time of the report, INFLAMMATION (High levels of inflammation in hid body, was admitted in the hospital for four days regarding this condition), GIANT CELL ARTERITIS (Diagnosed him with temporal arthritis), SWELLING FACE (Swelling on left and right side of temporal areas of the face), DIPLOPIA (Double vision in both eyes) and OFF LABEL USE (Did not receive my second dose of the Moderna COVID-19 Vaccination per health care provider's recommendation due to) outcome was unknown. Not Provided mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. On 17Mar2021, the patient began to experience double vision in both eyes as well as swelling on the left and right side of the temporal areas of the face. The patient underwent a biopsy of both sides of the face, results were not provided. Ultimately, the patient was diagnosed with "temporal arthritis" along with "having high levels of inflammation in his body" by his rheumatologist. On 16Apr2021, the patient was admitted in the hospital for four days until 19Apr2021 for observation. The patient received high doses of steroids/prednisone for treatment including 60 milligrams for one month and then 40 milligrams starting 25May2021. It was recommended by the patient's physician that he not receive his second Moderna COVID-19 vaccination which was originally scheduled for 07Apr2021. Further clinical course is unknown/not reported at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non-significant follow-up received. Follow-up contained no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LIPITOR

Current Illness: Cholesterol total abnormal NOS (Patient takes Lipitor for cholesterol)

ID: 1370334
Sex: F
Age: 72
State: OK

Vax Date: 02/21/2021
Onset Date: 03/21/2021
Rec V Date: 06/03/2021
Hospital:

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Symptoms: Larger itchy red spot below hte infection site; Larger itchy red spot below hte infection site; Red spot on arm looked like a giant hive; Condition aggravated; Like having a RA flare; Flu-like reaction; Nausea; Fever of 101 for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Like having a RA flare) and ANGIOEDEMA (Red spot on arm looked like a giant hive) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis and Osteoarthritis. Concomitant products included VALSARTAN and AMLODIPINE for Blood pressure management, MELOXICAM for Pain, METHOTREXATE for Rheumatoid arthritis, RITUXIMAB (RITUXAN), METOPROLOL and FOLIC ACID for an unknown indication. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Like having a RA flare) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like reaction) and PYREXIA (Fever of 101 for 24 hours). 21-Mar-2021, the patient experienced CONDITION AGGRAVATED (Condition aggravated) and NAUSEA (Nausea). On 25-Mar-2021, the patient experienced ANGIOEDEMA (Red spot on arm looked like a giant hive) (seriousness criterion medically significant), ERYTHEMA (Larger itchy red spot below hte infection site) and PRURITUS (Larger itchy red spot below hte infection site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 22-Mar-2021, PYREXIA (Fever of 101 for 24 hours) had resolved. On 26-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like reaction) had resolved. On 27-Mar-2021, RHEUMATOID ARTHRITIS (Like having a RA flare), CONDITION AGGRAVATED (Condition aggravated) and NAUSEA (Nausea) had resolved. On 11-Apr-2021, ANGIOEDEMA (Red spot on arm looked like a giant hive), ERYTHEMA (Larger itchy red spot below hte infection site) and PRURITUS (Larger itchy red spot below hte infection site) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative SARS COVID-2 IG antibody.. 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-2021-169506 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 25-May-2021 contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: RITUXAN; METHOTREXATE; METOPROLOL; VALSARTAN; AMLODIPINE; FOLIC ACID; MELOXICAM

Current Illness: Osteoarthritis; Rheumatoid arthritis

ID: 1370335
Sex: F
Age: 51
State: KY

Vax Date: 02/25/2021
Onset Date: 03/26/2021
Rec V Date: 06/03/2021
Hospital: Y

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Symptoms: Blood clots in lungs, legs and brain; She cant speak or stand on her own/in diaper; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots in lungs, legs and brain) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced THROMBOSIS (Blood clots in lungs, legs and brain) (seriousness criteria hospitalization prolonged and medically significant) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) (seriousness criterion hospitalization prolonged). The patient was treated with HEPARIN (intravenous) at a dose of UNK dosage form. At the time of the report, THROMBOSIS (Blood clots in lungs, legs and brain) and PHYSICAL DISABILITY (She cant speak or stand on her own/in diaper) outcome was unknown. Concomitant medications were not provided. Reporter stated that hospital is trying to send the patient to a nursing home. No further treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1370336
Sex: U
Age:
State:

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

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Symptoms: Fainted; Anxiety; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and ANXIETY (Anxiety). At the time of the report, SYNCOPE (Fainted) and ANXIETY (Anxiety) outcome was unknown. No relevant concomitant medications were provided the reporter. Patient had anxiety and fainted. Patient had received the second dose and was fine. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to Patient Link.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1370337
Sex: F
Age:
State: OR

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 06/03/2021
Hospital:

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Symptoms: transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion; possible hepatic venous outflow obstruction; sinusoidal obstruction syndrome; darkened urine; malaise; Reduced sense of smell; elevated liver tests; fatigue; mild myalgias; local soreness at injection site; reduced range in motion at injection site; reduced sense of smell; This non-study case was reported in an article and describes the occurrence of TRANSPLANT REJECTION (transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion), VENOOCCLUSIVE LIVER DISEASE (possible hepatic venous outflow obstruction) and VENOOCCLUSIVE LIVER DISEASE (sinusoidal obstruction syndrome) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cirrhosis of liver, Hepatitis C, Hepatocellular carcinoma and Infection (Cured with direct acting antiviral medications four years earlier.). Concurrent medical conditions included Liver transplant (Received from a decreased donor.) since 18-Aug-2020. Concomitant products included TACROLIMUS, AZATHIOPRINE SODIUM (AZATHIOPRINE [AZATHIOPRINE SODIUM]) and PREDNISONE for Immunosuppression NOS. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSPLANT REJECTION (transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion) (seriousness criterion medically significant), VACCINATION SITE PAIN (local soreness at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (reduced range in motion at injection site), HYPOSMIA (reduced sense of smell), MYALGIA (mild myalgias), CHROMATURIA (darkened urine), FATIGUE (fatigue), MALAISE (malaise), HYPOSMIA (Reduced sense of smell), LIVER FUNCTION TEST INCREASED (elevated liver tests), VENOOCCLUSIVE LIVER DISEASE (possible hepatic venous outflow obstruction) (seriousness criterion medically significant) and VENOOCCLUSIVE LIVER DISEASE (sinusoidal obstruction syndrome) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (METHYLPREDNISOLONE WITH AZATHIOPRINE) (intravenous) for Sinusoidal obstruction syndrome, at a dose of 3 day course; MYCOPHENOLATE MOFETIL for Sinusoidal obstruction syndrome, at a dose of 1 dosage form and IMMUNOGLOBULIN ANTI-THYMOCYTE at a dose of 1 milligram/kilogram once a day. At the time of the report, TRANSPLANT REJECTION (transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion) was resolving, VACCINATION SITE PAIN (local soreness at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (reduced range in motion at injection site), HYPOSMIA (reduced sense of smell), MYALGIA (mild myalgias), VENOOCCLUSIVE LIVER DISEASE (possible hepatic venous outflow obstruction) and VENOOCCLUSIVE LIVER DISEASE (sinusoidal obstruction syndrome) had resolved and CHROMATURIA (darkened urine), FATIGUE (fatigue), MALAISE (malaise), HYPOSMIA (Reduced sense of smell) and LIVER FUNCTION TEST INCREASED (elevated liver tests) 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 considered TRANSPLANT REJECTION (transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion), VACCINATION SITE PAIN (local soreness at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (reduced range in motion at injection site), HYPOSMIA (reduced sense of smell), MYALGIA (mild myalgias), CHROMATURIA (darkened urine), FATIGUE (fatigue), MALAISE (malaise), HYPOSMIA (Reduced sense of smell), LIVER FUNCTION TEST INCREASED (elevated liver tests), VENOOCCLUSIVE LIVER DISEASE (possible hepatic venous outflow obstruction) and VENOOCCLUSIVE LIVER DISEASE (sinusoidal obstruction syndrome) to be possibly related. Patient was advised to begin tapering off concomitant medication prednisone; she decreased it to 2.5 mg daily for two weeks starting one day after vaccination and then discontinued it entirely. The liver test elevation did not improve after intravenous steroid therapy, and a repeat liver biopsy showed similar histology to the initial biopsy, with persistent ACR (Reject activity index (RAI) score 5) and slightly reduced central venular dilation and sinusoidal congestion. Patient was treated with anti-thymocyte globulin 1 mg/kg daily for a 6-day duration, and the liver tests gradually decreased. A third liver biopsy after completion of anti-thymocyte globulin showed improved ACR (RAI score 2) and no central venular dilation or sinusoidal congestion. Fifteen days after vaccination, Aspartate aminotransferase (AST): 229 U/L, Alanine aminotransferase (ALT): 199 U/L, Alkaline phosphatase (ALP): 576 U/L, Bilirubin: 6.0 mg/dl, Albumin: 3.3 g/dl, Tacrolimus, 12-hour trough: 8.3 ng/ml; negative for Cytomegalovirus DNA, Hepatitis C RNA, Herpes Simplex Virus-1/2 DNA, Adenovirus DNA, SARS-CoV-2 RNA, Donor Specific Antibodies, SARS-CoV-2 Spike Protein Antibodies Receptor Binding Domain; positive for SARS-CoV-2 Spike Protein Antibodies S1 Subunit. Twenty-one days after vaccination, AST: 191 U/L, ALT: 195 U/L, ALP: 522 U/L, Bilirubin: 4.9 mg/dl, Albumin: 2.0 g/dl, Tacrolimus, 12-hour trough: 7.0 ng/ml. Twenty-five days after vaccination, AST: 188 U/L, ALT: 245 U/L, ALP: 449 U/L, Bilirubin: 5.5 mg/dl, Albumin: 2.6 g/dl, Tacrolimus, 12-hour trough: 8.3 ng/ml; negative for Donor Specific Antibodies, SARS-CoV-2 Spike Protein Antibodies Receptor Binding Domain; positive for SARS-CoV-2 Spike Protein Antibodies S1 Subunit. Twenty-nine days after vaccination, AST: 125 U/L, ALT: 229 U/L, ALP: 467 U/L, Bilirubin: 5.2 mg/dl, Albumin: 2.6 g/dl, Tacrolimus, 12-hour trough: 11.3 ng/ml. Thirty-six days after vaccination, patient's AST: 94 U/L, ALT: 145 U/L, ALP: 437 U/L, Bilirubin: 2.7 mg/dl. Company Comment: Transplant rejection is the body's inherent response to foreign body, veno-occlusive liver disease , elevated liver enzyme test, involves a pre-existing underlying condition , Con-med Tacrolimus is a high risk for chromaturia and as such these events are unlikely related to mRNA-1273. The remaining events show temporal association with product use and as such cannot be excluded although malaise and fatigue are confounded by patient's condition and treatment for condition.; Sender's Comments: Transplant rejection is the body's inherent response to foreign body, veno-occlusive liver disease , elevated liver enzyme test, involves a pre-existing underlying condition , Con-med Tacrolimus is a high risk for chromaturia and as such these events are unlikely related to mRNA-1273. The remaining events show temporal association with product use and as such cannot be excluded although malaise and fatigue are confounded by patient's condition and treatment for condition.

Other Meds: TACROLIMUS; AZATHIOPRINE [AZATHIOPRINE SODIUM]; PREDNISONE

Current Illness: Liver transplant (Received from a decreased donor.)

Total 2021 VAERS Injuries: 424,759

Page last modified: 03 October 2021 5:28pm