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
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1504863
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 07/21/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included irregular heartbeat, occasional chest pain, non smoker and non alcoholic. The patient did not have any drug abuse/illicit drug use and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 05-AUG-2021) dose was not reported, 1 total, administered on left arm on 07-APR-2021, 14:00 for prophylactic vaccination. Concomitant medications included bisoprolol for irregular heartbeat and isosorbide mononitrate for occasional chest pain. On 21-JUL-2021, the patient had antibody tests (SARS-CoV-2 IgG antibody test) (NR: not provided) which resulted as negative (confirmed immunological vaccine failure). Laboratory test describes that, the assay detects spike protein of SARSCOV2 including the receptor binding domain (RBI)). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210745217- covid-19 vaccine ad26.cov2.s -CONFIRMED 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: BISOPROLOL; ISOSORBIDE MONONITRATE

Current Illness: Abstains from alcohol; Chest pain; Heartbeats irregular; Non-smoker

ID: 1504864
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: POSSIBLE BLOOD CLOT; PAIN; UNABLE TO CYCLING, YOGA, PILATES AND HIKING; UNABLE TO WALK; MENSTRUAL CYCLE SUDDENLY STOPPED; NUMBNESS IN LEFT LEG; TINGLING IN LEFT LEG; This spontaneous report received from a patient via a company representative via social media (News) concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, 1 total, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in APR-2021, after about an a week of vaccination, patient suddenly experienced the numbness and tingling in left leg and her menstrual cycle was suddenly stopped. On an unspecified date, patient reported that she was not able to do cycling, yoga, pilates, hiking and walking because of pain. The patient reported that she was still in lot of pain and no periods. On an unspecified date in 2021, she recently got an ultrasound to check for blood clots but the result was not provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain and menstrual cycle suddenly stopped, and the outcome of numbness in left leg, tingling in left leg, unable to cycling, yoga, pilates and hiking, unable to walk and possible blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210745336-covid-19 vaccine ad26.cov2. s- Possible blood clot. This event is considered unassessable. The event 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 events.

Other Meds:

Current Illness:

ID: 1504865
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: I CHEST TIGHTNESS; TENDERNESS TO LEFT ARM EFFECTING ROM/TENDER TO TOUCH LEFT UPPER ARM; FEVER OF 101F; NAUSEA; HEADACHE; PAIN AT INJECTION SITE (LEFT ARM); FACIAL FLUSHING; FEELING LIKE BLOOD PRESSURE IS HIGH/BLOOD PRESSURE ELEVATED AS HIGH AS 150/100; CANNOT MOVE LEFT ARM UP; INFLAMMATION TO THE LEFT UPPER ARM; VISION DISTURBANCES; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for premedication. On 24-MAR-2021, the subject experienced feeling like blood pressure is high/blood pressure elevated as high as 150/100. On 24-MAR-2021, the subject experienced facial flushing. On 24-MAR-2021, the subject experienced cannot move left arm up. On 24-MAR-2021, the subject experienced inflammation to the left upper arm. On 24-MAR-2021, the subject experienced vision disturbances. On 24-MAR-2021, the subject experienced tenderness to left arm effecting rom/tender to touch left upper arm. On 24-MAR-2021, the subject experienced fever of 101f. On 24-MAR-2021, the subject experienced nausea. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced pain at injection site (left arm). Laboratory data included: Body temperature (NR: not provided) 101 F. On 25-MAR-2021, the subject experienced chest tightness. Laboratory data included: Blood pressure (NR: not provided) elevated as high as 150/100. Treatment medications (dates unspecified) included: metoprolol succinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 101f, nausea, and headache on 25-MAR-2021, was recovering from feeling like blood pressure is high/blood pressure elevated as high as 150/100, vision disturbances, and chest tightness, and had not recovered from pain at injection site (left arm), facial flushing, tenderness to left arm effecting rom/tender to touch left upper arm, cannot move left arm up, and inflammation to the left upper arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case is assessed as non-serious.

Other Meds: TYLENOL REGULAR

Current Illness:

ID: 1504866
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 07/20/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: HEADACHE; COULD NOT SEE CLEARLY; FELT THERE WAS SOMETHING IN HIS EYE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, non-smoker, and wears readers. The patient experienced drug allergy when treated with methotrexate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A and expiry: UNKNOWN) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-JUL-2021, the subject experienced could not see clearly. On 20-JUL-2021, the subject experienced felt there was something in his eye. On 21-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 21-JUL-2021, and had not recovered from could not see clearly, and felt there was something in his eye. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.

Other Meds:

Current Illness: Alcohol use; Eyeglasses wearer (Wears readers but does not use contact lenses.); Non-smoker

ID: 1504867
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 07/09/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: VOMITING; FLU; BODY ACHES; CHILLS; GENERALLY UNWELL; HEADACHE; MUSCLE ACHES; FEVER; NAUSEA; LEFT ARM PAIN AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's past medical history included immunocompromised medical issue, gi upset, and digestive issues, and concurrent conditions included chronic idiopathic urticaria, cigarette smoker, non alcohol user, respiratory allergy, hives, and chemotherapy, and other pre-existing medical conditions included patient had history of drug abuse or illicit drug use of recreational drugs in her college days not recently and had not for a long time. patient has intermittent symptoms. gastrointestinal upset following episode of hives. speculate unrelated. patient had multiple drug allergies, highly sensitive immune system, had respiratory and pre-existing allergy with no known diagnosis. medical diagnosis: chemotherapy injection, 2 injections every 4 weeks. patient was sensitive to pharmaceutical products, and had multiple drug allergies opioid allergy. The patient was previously treated with omalizumab for hives, severe allergic reactions, urticaria, and cortisone for urticaria. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-JUL-2021 for prophylactic vaccination. Concomitant medications included epinephrine for allergy. On 09-JUL-2021, the subject experienced vomiting. On 09-JUL-2021, the subject experienced flu. On 09-JUL-2021, the subject experienced body aches. On 09-JUL-2021, the subject experienced chills. On 09-JUL-2021, the subject experienced generally unwell. On 09-JUL-2021, the subject experienced headache. On 09-JUL-2021, the subject experienced muscle aches. On 09-JUL-2021, the subject experienced fever. On 09-JUL-2021, the subject experienced nausea. On 09-JUL-2021, the subject experienced left arm pain at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, headache, fever, and nausea on 12-JUL-2021, flu, body aches, generally unwell, and muscle aches on 13-JUL-2021, and left arm pain at site of injection on 16-JUL-2021. This report was non-serious.

Other Meds: EPIPEN

Current Illness: Abstains from alcohol; Allergic respiratory disease; Chemotherapy (2 injection every 4 weeks); Chronic idiopathic urticaria (had swelling to wrists (get as large as thigh) no known diagnosis, often treated at walk in clinic with cortisone.); Cigarette smoker (6-7 cigarettes per day); Hives

ID: 1504868
Sex: U
Age:
State:

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

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a company representative via social media concerned 4 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) dose, 1 total, 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 patient's experienced suspected Clinical vaccinated failure, and covid-19 infection. Laboratory data (dates unspecified) included: COVID-19 (NR: not provided) Positive. Of 43 patients who tested positive for COVID, eight patients got infected by COVID even after getting vaccinated. Out of the 8 people that tested COVID positive, four got the Johnson & Johnson vaccine. Symptoms similar to flu vaccine (little bit sore throat and a little bit of body aches) were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186776 The suspected product quality complaint has been confirmed to be not-voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210746023-Covid-19 vaccine ad26.cov2.s- Suspected Clinical Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

Date Died:

ID: 1504869
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: DEATH; This spontaneous report received from a patient 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 were not reported)1 total 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 patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210746676-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1504871
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: NUMBNESS IN RIGHT ARM FOR 5-6 WEEKS; TINGLING IN RIGHT ARM FOR 5-6 WEEKS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 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 numbness in right arm for 5-6 weeks, and tingling in right arm for 5-6 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in right arm for 5-6 weeks, and tingling in right arm for 5-6 weeks. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed non-serious.

Other Meds:

Current Illness:

ID: 1504872
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/21/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION/CHEST CONGESTION/HEADACHE/STIFF NECK/FEEL LIKE FLU/COUGHING; This spontaneous report received from social media (article) via a company representative concerned a female patient of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry date: unknown) dose was not reported, 1 total administered on an unknown date in APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced congestion in her chest, headache, stiff neck, felt like flu and cough (Suspected Covid-19 infection). The patient was completed the incubation period of 28 days post vaccination (Suspected clinical vaccination failure). It was reported that in the past week, the patient's husband got sick with COVID and on 21-JUL-2021, Wednesday, the patient and her son got tested positive for the coronavirus. The patient mentioned that she would have to get the booster shot again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection/chest congestion/headache/stiff neck/feel like flu/coughing and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint 90000186972.; Sender's Comments: V0: 20210747841-JANSSEN COVID-19 VACCINE Ad26.COV2.S- SUSPECTED CLINICAL VACCINATION FAILURE. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds:

Current Illness:

ID: 1504873
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 07/21/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report was received from a male patient of unspecified age, race and ethnicity. 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 administration was not reported, batch number: 202A21A , and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date, in APR-2021 for prophylactic vaccination. It was unknown if the product was stored in appropriate temperature conditions and if it was properly stored from receipt to administration. No concomitant medications were reported. On 21-JUL-2021, the patient was tested positive for coronavirus disease (COVID-19) (suspected clinical vaccination failure and confirmed covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186828. The suspected product quality complaint has been confirmed to be not voided (the reported allegation could not be confirmed. A manufacturing related root cause could not be identified) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 20210747956- JANSSEN COVID-19 VACCINE-Suspected clinical 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: 1504874
Sex: F
Age:
State: UT

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: CONFIRMED COVID-19 INFECTION; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. 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 confirmed covid-19 infection, and confirmed immunological vaccine failure. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed immunological vaccine failure was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504875
Sex: U
Age:
State: NH

Vax Date:
Onset Date: 07/22/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: RECEIVED VACCINE TWICE; 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: 1805022, and 1808978 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUL-2021, the subject experienced received vaccine twice. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received vaccine twice was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504876
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/22/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: ACHES; PITIFUL FEELING; CHILLS; FEVERISH FEELING; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-JUL-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 22-JUL-2021, the subject experienced aches. On 22-JUL-2021, the subject experienced pitiful feeling. On 22-JUL-2021, the subject experienced chills. On 22-JUL-2021, the subject experienced feverish feeling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, aches, feverish feeling, and pitiful feeling. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504877
Sex: U
Age:
State: MO

Vax Date:
Onset Date: 07/24/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: OUT OF SPECIFICATION PRODUCT USAGE; INCORRECT PRODUCT STORAGE; 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, and batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 24-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the subject experienced out of specification product usage. On 24-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product usage and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504878
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 07/17/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: COUGH; CONGESTION; CHILLS; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 13:07 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the subject experienced chills. On 17-JUL-2021, the subject experienced nausea. On 17-JUL-2021, the subject experienced headache. On 17-JUL-2021, the subject experienced fever. On 21-JUL-2021, the subject experienced cough. On 21-JUL-2021, the subject experienced congestion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, nausea, headache, and fever, and had not recovered from cough, and congestion. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504879
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: FATIGUE/FELT TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included infliximab for rheumatoid arthritis. On 14-MAR-2021, the subject experienced fatigue/felt tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fatigue/felt tired was not reported. This report was non-serious.

Other Meds: REMICADE

Current Illness: Rheumatoid arthritis

ID: 1504880
Sex: F
Age:
State: KY

Vax Date:
Onset Date: 07/23/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: BAD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 23-JUL-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504881
Sex: U
Age:
State:

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

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: FELT LITTLE NAUSEOUS; This spontaneous report received from a patient via a 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 felt little nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt little nauseous was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504882
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 04/25/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: LOW HEART RATE; This spontaneous report received from a patient concerned a 67 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known allergies and no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, and lisinopril for high blood pressure. On 25-APR-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) below 60 bpm. On 24-JUL-2021, Laboratory data included: Heart rate (NR: not provided) 69 bpm. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 115/72 mmHg, and Heart rate (NR: not provided) 68-78 bpm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low heart rate. This report was non-serious.

Other Meds: AMLODIPINE; LISINOPRIL

Current Illness: Abstains from alcohol; Blood pressure high (115/72 mm of Hg); Non-smoker

ID: 1504883
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: TRIGGERED FIBROMYALGIA; HAVE BEEN SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 01-APR-2021, the subject experienced have been sick. On an unspecified date, the subject experienced triggered fibromyalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the triggered fibromyalgia and have been sick was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504884
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/24/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: BODY STIFFNESS; COULD NOT MOVE/UNABLE TO MOVE; COUGH; BODY PAIN; MUSCLE ACHE; POUNDING IN HEAD/HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-JUL-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-JUL-2021, the subject experienced body stiffness. On 24-JUL-2021, the subject experienced could not move/unable to move. On 24-JUL-2021, the subject experienced cough. On 24-JUL-2021, the subject experienced body pain. On 24-JUL-2021, the subject experienced muscle ache. On 24-JUL-2021, the subject experienced pounding in head/headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from could not move/unable to move, and body pain, and the outcome of body stiffness, muscle ache, pounding in head/headache and cough was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504885
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: PAIN RADIATING DOWN THE ARM; PAIN IN ARM AT THE INJECTION SITE; This spontaneous report received from a patient via a 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: 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 pain radiating down the arm, and pain in arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm at the injection site and pain radiating down the arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504886
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: FEELING ABNORMAL FOR A WHILE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced feeling abnormal for a while. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling abnormal for a while. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504887
Sex: U
Age:
State: MN

Vax Date:
Onset Date: 07/24/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: 06-SEP-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the subject experienced administration of expired vaccine. On 24-JUL-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect storage of drug was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1504889
Sex: F
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

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

Other Meds:

Current Illness:

ID: 1504890
Sex: F
Age: 65
State: FL

Vax Date: 01/11/2021
Onset Date: 02/08/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: paralysis in my legs; Little cold; Flu like symptoms; Very Achy; Pain in leg; Hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (paralysis in my legs) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included OMEPRAZOLE from 24-Feb-2021 to 26-Feb-2021 for Heartburn. On 11-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced FEELING COLD (Little cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Very Achy), PAIN IN EXTREMITY (Pain in leg) and PAIN IN EXTREMITY (Hurting arm). On an unknown date, the patient experienced DIPLEGIA (paralysis in my legs) (seriousness criterion medically significant). At the time of the report, DIPLEGIA (paralysis in my legs) had resolved and FEELING COLD (Little cold), INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Very Achy), PAIN IN EXTREMITY (Pain in leg) and PAIN IN EXTREMITY (Hurting arm) outcome was unknown. Patient reported that she had started taking Pharmacy brand Omeprazole for heartburn maybe for a two day period but when that adverse event occurred, she immediately stopped taking it because she had thought that maybe combined with her Covid vaccine and it caused this paralysis. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Non Significant follow up appended to AER On 22-Jul-2021: Follow-up received on 22-Jul-2021 and included Newevent was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: OMEPRAZOLE

Current Illness:

ID: 1504891
Sex: F
Age: 68
State: NY

Vax Date: 02/12/2021
Onset Date: 02/14/2001
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: INR was too high; Missed dose; She's so weak; No appetite; Fever; Got sick; felt tired and very sick; Weak and tired; This spontaneous case was reported by a consumer and describes the occurrence of INTERNATIONAL NORMALISED RATIO INCREASED (INR was too high) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2001, the patient experienced FATIGUE (Weak and tired). On 14-Feb-2012, the patient experienced ILLNESS (Got sick; felt tired and very sick). On an unknown date, the patient experienced INTERNATIONAL NORMALISED RATIO INCREASED (INR was too high) (seriousness criterion hospitalization prolonged), ASTHENIA (She's so weak), DECREASED APPETITE (No appetite), PYREXIA (Fever) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, INTERNATIONAL NORMALISED RATIO INCREASED (INR was too high), ILLNESS (Got sick; felt tired and very sick), ASTHENIA (She's so weak), DECREASED APPETITE (No appetite), PYREXIA (Fever), FATIGUE (Weak and tired) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications include, Komento 2mg. No additional treatment information was reported. The patient was hospitalized 2 weeks after receiving the first dose of Moderna vaccine due to increased INR. She was in the hospital for two months. She reported wanting to take the second dose, but her physician is not sure if she should. This is a 68-year-old female patient with a serious event of international normalized ratio increased and other non-serious cases. A very limited information regarding this event (INR was too high) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of other non-serious event, a causal relationship cannot be excluded. However, hospital discharge summary is required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: New event added (seriousness criterion of hospitalization), event outcome updated.; Sender's Comments: This is a 68-year-old female patient with a serious event of international normalized ratio increased and other non-serious cases. A very limited information regarding this event (INR was too high) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of other non-serious event, a causal relationship cannot be excluded. However, hospital discharge summary is required for further assessment.

Other Meds: COUMADIN

Current Illness:

ID: 1504892
Sex: F
Age: 59
State: VA

Vax Date: 03/04/2021
Onset Date: 03/04/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: The racing heart has turned into just episodes of heart fluttering; Feels like motor running in gut after 1st dose; Had to grab head to not fall out after 1st dose, Heavy head; Freezing after 1st dose; Shaking after 1st dose; Tinnitus, thumping in my ears; can't work or read a computer screen; ear thumping; lost 22 pounds; Not able to do normal activities including use of phone to scroll, computer without getting dizzy, bending over, cleaning and any exercise that involves exertion, jumping or bending; Arm tightening and releasing after 1st dose; Headache after 1st dose, intermittent pain in the right back of my head; More than 36 days and has not got the second dose/she has not got her second dose yet; Dizzy after 1st dose; Difficulty swallowing; Difficulty breathing; Fizzing in gut after 1st dose; Pain under left ribcage after 1st dose, thought I was dying many times.; neuropathy in my feet with cold and tingling down my legs as well as stumbly feeling feet; Heart racing after 1st dose; Looked up at ceiling and saw black dots; Whole room flipped after 1st dose; Vertigo after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in my feet with cold and tingling down my legs as well as stumbly feeling feet) and CARDIAC FLUTTER (The racing heart has turned into just episodes of heart fluttering) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAFUSION WOMEN'S from 01-Jan-2010 to an unknown date and VITAFUSION FIBER WELL FIT from 01-Jan-2010 to an unknown date for an unknown indication. On 04-Mar-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OCULAR DISCOMFORT (Looked up at ceiling and saw black dots) and DISCOMFORT (Whole room flipped after 1st dose). 04-Mar-2021, the patient experienced VERTIGO (Vertigo after 1st dose). On 08-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in my feet with cold and tingling down my legs as well as stumbly feeling feet) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (Fizzing in gut after 1st dose), MUSCULOSKELETAL CHEST PAIN (Pain under left ribcage after 1st dose, thought I was dying many times.), DYSPHAGIA (Difficulty swallowing) and DYSPNOEA (Difficulty breathing). 08-Mar-2021, the patient experienced PALPITATIONS (Heart racing after 1st dose) and DIZZINESS (Dizzy after 1st dose). In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days and has not got the second dose/she has not got her second dose yet). On an unknown date, the patient experienced CARDIAC FLUTTER (The racing heart has turned into just episodes of heart fluttering) (seriousness criterion medically significant), GASTROINTESTINAL PAIN (Feels like motor running in gut after 1st dose), HEAD DISCOMFORT (Had to grab head to not fall out after 1st dose, Heavy head), PERIARTHRITIS (Freezing after 1st dose), TREMOR (Shaking after 1st dose), TINNITUS (Tinnitus, thumping in my ears), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), WEIGHT DECREASED (lost 22 pounds), MALAISE (Not able to do normal activities including use of phone to scroll, computer without getting dizzy, bending over, cleaning and any exercise that involves exertion, jumping or bending), LIMB DISCOMFORT (Arm tightening and releasing after 1st dose) and HEADACHE (Headache after 1st dose, intermittent pain in the right back of my head). The patient was treated with PROBIOTICS NOS for Discomfort abdominal, at an unspecified dose and frequency. At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in my feet with cold and tingling down my legs as well as stumbly feeling feet), CARDIAC FLUTTER (The racing heart has turned into just episodes of heart fluttering), OCULAR DISCOMFORT (Looked up at ceiling and saw black dots), DISCOMFORT (Whole room flipped after 1st dose), VERTIGO (Vertigo after 1st dose), PALPITATIONS (Heart racing after 1st dose), GASTROINTESTINAL PAIN (Feels like motor running in gut after 1st dose), ABDOMINAL DISCOMFORT (Fizzing in gut after 1st dose), MUSCULOSKELETAL CHEST PAIN (Pain under left ribcage after 1st dose, thought I was dying many times.), HEAD DISCOMFORT (Had to grab head to not fall out after 1st dose, Heavy head), PERIARTHRITIS (Freezing after 1st dose), TREMOR (Shaking after 1st dose), DYSPHAGIA (Difficulty swallowing), DYSPNOEA (Difficulty breathing), TINNITUS (Tinnitus, thumping in my ears), VISUAL IMPAIRMENT (can't work or read a computer screen), EAR DISCOMFORT (ear thumping), WEIGHT DECREASED (lost 22 pounds), MALAISE (Not able to do normal activities including use of phone to scroll, computer without getting dizzy, bending over, cleaning and any exercise that involves exertion, jumping or bending), DIZZINESS (Dizzy after 1st dose), LIMB DISCOMFORT (Arm tightening and releasing after 1st dose) and HEADACHE (Headache after 1st dose, intermittent pain in the right back of my head) had not resolved and PRODUCT DOSE OMISSION ISSUE (More than 36 days and has not got the second dose/she has not got her second dose yet) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Differential white blood cell count: inconclusive (Inconclusive) Inconclusive. On 17-Mar-2021, Electrocardiogram: inconclusive (Inconclusive) Inconclusive. On 17-Mar-2021, Full blood count: inconclusive (Inconclusive) Inconclusive. On 17-Mar-2021, Metabolic function test: inconclusive (Inconclusive) Inconclusive. On 22-Mar-2021, Fibrin D dimer: inconclusive (Inconclusive) Inconclusive. On 01-Apr-2021, Magnetic resonance imaging head: inconclusive (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: 158/78 (High) 158/78. On an unknown date, Heart rate: 145 breaths per minute (abnormal) racing heart rate up to 145 BPM at rest. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She had not got her second dose yet. Company comment: This case concerns a 36-year-old female patient who received the first dose of mRNA-1273 and after 36 days had not received the second dose (product dose omission. The patient also experienced additional adverse events which show temporal relationship with the administration of the product and hence causal association cannot be excluded. The event of product doe omission is assessed as not applicable. Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Additional information added on 29-May-2021, had updated reporter information, patient information, Lab details, concomitant medication, new events,start date of event and outcome of events. On 21-Jul-2021: Follow up received on 21-Jul-2021, new events were added.; Sender's Comments: This case concerns a 36-year-old female patient who received the first dose of mRNA-1273 and after 36 days had not received the second dose (product dose omission. The patient also experienced additional adverse events which show temporal relationship with the administration of the product and hence causal association cannot be excluded. The event of product doe omission is assessed as not applicable.

Other Meds: VITAFUSION WOMEN'S; VITAFUSION FIBER WELL FIT

Current Illness:

ID: 1504893
Sex: M
Age: 66
State: OH

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Scatter brain; Incoherent; Brain fog; Lost his mind; Has no reflexes; Can't move but he can hear; He can't talk; This spontaneous case was reported by a consumer and describes the occurrence of THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent) and FEELING ABNORMAL (Brain fog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THINKING ABNORMAL (Lost his mind) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Scatter brain) (seriousness criterion hospitalization), INCOHERENT (Incoherent) (seriousness criterion hospitalization), FEELING ABNORMAL (Brain fog) (seriousness criterion hospitalization), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk). At the time of the report, THINKING ABNORMAL (Lost his mind), FEELING ABNORMAL (Scatter brain), INCOHERENT (Incoherent), FEELING ABNORMAL (Brain fog), AREFLEXIA (Has no reflexes), MOVEMENT DISORDER (Can't move but he can hear) and SPEECH DISORDER (He can't talk) outcome was unknown. Concomitant medications were not provided. Treatment information was not provided. Reporter stated that the patient had been admitted to a total of 3 psychiatric hospitals and was currently there in the hospital. Reporter also stated that on 21-Apr-2021 the patient was acting normal for a total of 20 hours and then he started back acting weird. Company Comment: Very limited information regarding this events has been provided 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. Further information has been requested This case was linked to US-MODERNATX, INC.-MOD-2021-089085, US-MODERNATX, INC.-MOD-2021-111101 (E2B Linked Report).; Sender's Comments: Very limited information regarding this events has been provided 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. Further information has been requested US-MODERNATX, INC.-MOD-2021-089085:MOD-2021-089085 Dose 1 case US-MODERNATX, INC.-MOD-2021-111101:cross link

Other Meds:

Current Illness:

ID: 1504894
Sex: F
Age: 56
State: IN

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Bleeding after the injection; Hematoma that lasted 12 days; Left arm was also sore; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding after the injection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding after the injection) (seriousness criterion medically significant), HAEMATOMA (Hematoma that lasted 12 days) and PAIN IN EXTREMITY (Left arm was also sore). At the time of the report, HAEMORRHAGE (Bleeding after the injection), HAEMATOMA (Hematoma that lasted 12 days) and PAIN IN EXTREMITY (Left arm was also sore) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications use was not provided. Treatment information was not provided by the reporter. The patient is scheduled to receive the second dose of the Moderna COVID-19 vaccine on 03-May-2021. 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 23-Jul-2021: Follow up received: Contain non significant 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:

Current Illness:

ID: 1504895
Sex: M
Age:
State: MA

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No laboratory data was provided. No concomitant medications were reported. No treatment information was provided. Company Comment: Based on current available information and the temporal association between product use and the start date of the event acausal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received contains patient demographics, suspect drug start date were updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the event acausal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1504896
Sex: F
Age: 64
State: NJ

Vax Date: 04/15/2021
Onset Date: 04/17/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: advised by her HCP not to get second vaccine; exhaustion is more than debilitating; She has MS; She is exhausted, and it is more than being tired/ This exhaustion is more than debilitating; still dizzy since the vaccine in April; Face is burning hot; Spasm; Flu; Body twists so hard; Shaking/ her entire body shakes after the first vaccine; hypothermia; Chills/ she is waking up with chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (She has MS) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8482374) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pain NOS and Allergy to vaccine (ingredient PEG that was in the vaccine). Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) for Pain, GABAPENTIN and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication. On 15-Apr-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced BURNING SENSATION (Face is burning hot), MUSCLE SPASMS (Spasm), INFLUENZA (Flu), MUSCLE TWITCHING (Body twists so hard), TREMOR (Shaking/ her entire body shakes after the first vaccine) and CHILLS (Chills/ she is waking up with chills). 17-Apr-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hypothermia) and PYREXIA (Fever). On an unknown date, the patient experienced MULTIPLE SCLEROSIS (She has MS) (seriousness criterion medically significant), OFF LABEL USE (advised by her HCP not to get second vaccine), ASTHENIA (exhaustion is more than debilitating), FATIGUE (She is exhausted, and it is more than being tired/ This exhaustion is more than debilitating) and DIZZINESS (still dizzy since the vaccine in April). At the time of the report, MULTIPLE SCLEROSIS (She has MS), BURNING SENSATION (Face is burning hot), MUSCLE SPASMS (Spasm), INFLUENZA (Flu), MUSCLE TWITCHING (Body twists so hard), FEELING OF BODY TEMPERATURE CHANGE (hypothermia) and PYREXIA (Fever) outcome was unknown, TREMOR (Shaking/ her entire body shakes after the first vaccine), ASTHENIA (exhaustion is more than debilitating), CHILLS (Chills/ she is waking up with chills), FATIGUE (She is exhausted, and it is more than being tired/ This exhaustion is more than debilitating) and DIZZINESS (still dizzy since the vaccine in April) had not resolved and OFF LABEL USE (advised by her HCP not to get second vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications included maintenance medicines. On an unspecified date the patient had blood work with results listed as normal. 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 22-Jul-2021: Significant follow-up included updates to address, allergies, events, and tests.; 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: GABAPENTIN; OXYCODONE AND ACETAMINOPHEN; ZOLOFT

Current Illness: Allergy to vaccine (ingredient PEG that was in the vaccine); Pain NOS

ID: 1504897
Sex: M
Age: 72
State: FL

Vax Date: 03/04/2021
Onset Date: 03/17/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Shingles after the 1st dose/hingles on the right side of myannus and up along my private area.; Urinary Tract Infection after the 1st dose/She confirmed I had a UTI; Nerve pain from the shingles after the 1st dose/I had nerve pain in the whole area where the shingles had been; I started having bad abdominal pain and lost my appetite; lost my appetite/I tried to eat but had little success for about seven days; I had no bowel movement for about a week/My bowel movements were eratic I had diarhea then constipation this went on for about six weeks; This spontaneous case was reported by a physician and describes the occurrence of HERPES ZOSTER (Shingles after the 1st dose/hingles on the right side of myannus and up along my private area.) and URINARY TRACT INFECTION (Urinary Tract Infection after the 1st dose/She confirmed I had a UTI) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 045C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by reporter. Concurrent medical conditions included Food allergy (allergic to Sorgum.), Allergy to plants (allergic to sage.), Rheumatoid arthritis since 1991, Hypertension since 2004, BPH since 2004 and Pain (joint pain and swelling.) since 1991. Concomitant products included TAMSULOSIN for BPH, RAMIPRIL for Hypertension, METHOTREXATE for Pain in joint, HYDROXYCHLOROQUINE SULFATE (HCQS) and FOLIC ACID for Rheumatoid arthritis, METOPROLOL SUCCINATE (METOPROLOL EG [METOPROLOL SUCCINATE]) for Tachycardia. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HERPES ZOSTER (Shingles after the 1st dose/hingles on the right side of myannus and up along my private area.) (seriousness criterion hospitalization) and URINARY TRACT INFECTION (Urinary Tract Infection after the 1st dose/She confirmed I had a UTI) (seriousness criterion hospitalization). On 20-Mar-2021, the patient experienced ABDOMINAL PAIN (I started having bad abdominal pain and lost my appetite) and DECREASED APPETITE (lost my appetite/I tried to eat but had little success for about seven days). On an unknown date, the patient experienced NEURALGIA (Nerve pain from the shingles after the 1st dose/I had nerve pain in the whole area where the shingles had been) and BOWEL MOVEMENT IRREGULARITY (I had no bowel movement for about a week/My bowel movements were eratic I had diarhea then constipation this went on for about six weeks). The patient was hospitalized from 19-Mar-2021 to 19-Mar-2021 due to HERPES ZOSTER and URINARY TRACT INFECTION. The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) on 19-Mar-2021 for Shingles, at an unspecified dose and frequency; SILVER SULFADIAZINE for Shingles, at an unspecified dose and frequency and CIPROFLOXACIN on 19-Mar-2021 for UTI, at an unspecified dose and frequency. On 15-Jun-2021, HERPES ZOSTER (Shingles after the 1st dose/hingles on the right side of myannus and up along my private area.) and URINARY TRACT INFECTION (Urinary Tract Infection after the 1st dose/She confirmed I had a UTI) had resolved. At the time of the report, NEURALGIA (Nerve pain from the shingles after the 1st dose/I had nerve pain in the whole area where the shingles had been), ABDOMINAL PAIN (I started having bad abdominal pain and lost my appetite), DECREASED APPETITE (lost my appetite/I tried to eat but had little success for about seven days) and BOWEL MOVEMENT IRREGULARITY (I had no bowel movement for about a week/My bowel movements were eratic I had diarhea then constipation this went on for about six weeks) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 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, patient's concomitant medication is a confounder. This case was linked to MOD-2021-263708 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant Follow-up Reporter type changed, New Event, Medical History, Concomitant Medications and Treatment Medication was updated.second dose information updated. Several previous events deleted.; 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, patient's concomitant medication is a confounder.

Other Meds: METHOTREXATE; HCQS; FOLIC ACID; METOPROLOL EG [METOPROLOL SUCCINATE]; RAMIPRIL; TAMSULOSIN

Current Illness: Allergy to plants (allergic to sage.); BPH; Food allergy (allergic to Sorgum.); Hypertension; Pain (joint pain and swelling.); Rheumatoid arthritis

ID: 1504898
Sex: F
Age: 29
State: NY

Vax Date: 04/17/2021
Onset Date: 05/17/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: dress syndrome; Burning sensation in skin; itching; Full body rash; Rash on feet and hands; Redness; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stevens-Johnson syndrome. Concurrent medical conditions included Eczema (Treatment of prednisone caused weaker skin and more breakage) since 1994, Psoriasis (Treatment of prednisone caused weaker skin and more breakage) since 1994, Anxiety since 15-Jan-2021 and Drug allergy (Lamotrigine allergy). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Jan-2021 to an unknown date for Anxiety, DESOGESTREL, ETHINYLESTRADIOL (APRI) for Birth control. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SKIN BURNING SENSATION (Burning sensation in skin), ERYTHEMA (Redness), PRURITUS (itching), RASH (Full body rash) and RASH (Rash on feet and hands). The patient was hospitalized from 26-May-2021 to 03-Jun-2021 due to DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form; PANTOPRAZOLE for Adverse event, at a dose of 40 mg once a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, prn and ACETAMINOPHEN for Adverse event, at a dose of UNK, prn. On 12-Jul-2021, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (dress syndrome) had resolved with sequelae. At the time of the report, SKIN BURNING SENSATION (Burning sensation in skin) and PRURITUS (itching) outcome was unknown, ERYTHEMA (Redness) and RASH (Full body rash) had resolved and RASH (Rash on feet and hands) had not resolved. 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-2021-219189 (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: ZOLOFT; APRI

Current Illness: Anxiety; Drug allergy (Lamotrigine allergy); Eczema (Treatment of prednisone caused weaker skin and more breakage); Psoriasis (Treatment of prednisone caused weaker skin and more breakage)

ID: 1504899
Sex: F
Age: 71
State: PA

Vax Date: 01/29/2021
Onset Date: 02/12/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Guillian Barre; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillian Barre) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No medical history was provided. Previously administered products included for Product used for unknown indication: PNEUMOCOCCAL VACCINE and SHINGRIX. Concomitant products included AMLODIPINE, MESALAMINE, ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, SIMVASTATIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) and PANTOPRAZOLE SODIUM for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillian Barre) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 15-Feb-2021 to 23-Feb-2021 due to GUILLAIN-BARRE SYNDROME. The patient was treated with GABAPENTIN at a dose of 200 milligram and IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) for CSF protein increased, at an unspecified dose and frequency. At the time of the report, GUILLAIN-BARRE SYNDROME (Guillian Barre) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Lumbar puncture: protein in fluid (abnormal) protein in fluid. 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. Lab data on 14Feb2021, include an X-ray of the hip; no results provided. On the 23Feb2021, the patient was discharged from the hospital. The patient was still unable to walk so was taken to a rehab center. During the transition from hospital to rehab center, patient spent two days in speech and paralysis on left side of face went away after a few days. The patient states that it has pretty much gone away and felt that she had a mild case. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: AMLODIPINE; MESALAMINE; ASPIRIN [ACETYLSALICYLIC ACID]; CALCIUM; SIMVASTATIN; LISINOPRIL; TRIAMTERENE & HCTZ; PANTOPRAZOLE SODIUM

Current Illness:

ID: 1504900
Sex: F
Age: 64
State: WI

Vax Date: 02/22/2021
Onset Date: 03/22/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: sore throat; diarrhea; no appetite; fatigue; back of my head was aching really bad; fever of 100?F; like the wind was knocked out of me, short of breath; feet were burning like I had neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (like the wind was knocked out of me, short of breath) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DYSPNOEA (like the wind was knocked out of me, short of breath) (seriousness criterion medically significant), BURNING SENSATION (feet were burning like I had neuropathy), HEADACHE (back of my head was aching really bad) and PYREXIA (fever of 100?F). On 23-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite) and FATIGUE (fatigue). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency; LEVALBUTEROL [LEVOSALBUTAMOL] at an unspecified dose and frequency and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) at a dose of 2x daily. At the time of the report, DYSPNOEA (like the wind was knocked out of me, short of breath), BURNING SENSATION (feet were burning like I had neuropathy), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea), DECREASED APPETITE (no appetite), FATIGUE (fatigue), HEADACHE (back of my head was aching really bad) and PYREXIA (fever of 100?F) had resolved. Concomitant drugs was not provided. Treatment drugs included increased nebulizer, valeramide, Chromalin. Patient lied down and slept for 4 hours. 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. 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 events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness: Asthma

ID: 1504901
Sex: M
Age: 77
State: AL

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Mild dementia; Tired and exhausted for a long while; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (Mild dementia) in a 78-year-old male 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 Hypercholesteremia, Pain and BPH. Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) and OXYBUTYNIN for BPH, PARACETAMOL (TYLENOL) and IBUPROFEN for Pain. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (Mild dementia) (seriousness criterion medically significant) and FATIGUE (Tired and exhausted for a long while). At the time of the report, DEMENTIA (Mild dementia) and FATIGUE (Tired and exhausted for a long while) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included 11-12 unspecified medications. Treatment information was not mentioned by the reporter. The patient reportedly might have used lozenges after vaccination The patient went to his neurologist for mild dementia. On an unknown date, neurologist ran a battery of tests such as heart scans and blood tests to check for things such as Lyme disease and HIV. The results from his local physician showed it was positive for HIV and his second test showed HIV antibodies but no HIV in his blood. Very limited information regarding these events have been provided at this time. Further information has been requested. This case was linked to MOD-2021-262688 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

Other Meds: FLOMAX [TAMSULOSIN HYDROCHLORIDE]; OXYBUTYNIN; TYLENOL; IBUPROFEN

Current Illness: BPH; Hypercholesteremia; Pain

ID: 1504902
Sex: F
Age:
State: NY

Vax Date: 03/02/2021
Onset Date: 03/21/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Dizzy; fell out of bed could not get up; Shaking; Low grade fever; falling re-injured my back; fell out of bed could not get up; Back pain; Leg pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), FALL (fell out of bed could not get up), MOBILITY DECREASED (fell out of bed could not get up), TREMOR (Shaking) and PYREXIA (Low grade fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Q-Tip up nose) on 07-Apr-2020. Concurrent medical conditions included Chronic back pain since 1985, High cholesterol since 2016 and Depression. Concomitant products included OXYCODONE and GABAPENTIN for Back pain, SERTRALINE for Depression, SIMVASTATIN for High cholesterol, VITAMIN D3, FISH OIL, IRON and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization), FALL (fell out of bed could not get up) (seriousness criterion hospitalization), MOBILITY DECREASED (fell out of bed could not get up) (seriousness criterion hospitalization), TREMOR (Shaking) (seriousness criterion hospitalization), PYREXIA (Low grade fever) (seriousness criterion hospitalization), BACK INJURY (falling re-injured my back), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Leg pain). The patient was hospitalized from 21-Mar-2021 to 26-Mar-2021 due to DIZZINESS, FALL, MOBILITY DECREASED, PYREXIA and TREMOR. The patient was treated with Rehabilitation therapy for Fall; Rehabilitation therapy for Mobility decreased; Rehabilitation therapy for Back pain and Rehabilitation therapy for Pain in extremity. On 21-Mar-2021, DIZZINESS (Dizzy), TREMOR (Shaking) and PYREXIA (Low grade fever) had resolved. At the time of the report, FALL (fell out of bed could not get up), MOBILITY DECREASED (fell out of bed could not get up), BACK INJURY (falling re-injured my back), BACK PAIN (Back pain) and PAIN IN EXTREMITY (Leg pain) had not resolved. On 07April2020, the patient undergone Q-TIP up nose and tested positive for COVID-19 with no symptoms. Admitted to hospital from 21-mar-2021 to 26-mar-2021 and in rehabilitation till 24-apr-2021. This case was linked to MOD-2021-060871 (Patient Link). 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-2021-060871 (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: SIMVASTATIN; OXYCODONE; GABAPENTIN; SERTRALINE; VITAMIN D3; FISH OIL; IRON; VITAMIN C [ASCORBIC ACID]

Current Illness: Chronic back pain; Depression; High cholesterol

ID: 1504903
Sex: M
Age: 71
State: PA

Vax Date: 01/06/2021
Onset Date: 07/07/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Bell Palsy; Headache on left side of his head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell Palsy) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2021, the patient experienced BELL'S PALSY (Bell Palsy) (seriousness criterion medically significant) and HEADACHE (Headache on left side of his head). The patient was treated with PREDNISONE for Bell's palsy, at a dose of UNK dosage form. At the time of the report, BELL'S PALSY (Bell Palsy) and HEADACHE (Headache on left side of his head) had resolved. Concomitant medications included hypertension medication, unspecified. The patient experienced mild Bell Palsy after the second dose and described the symptoms as left side of his face was numb and felt similar to when a dentist works on one side of the face which makes that side numb (left side of face muscles were numb for a while), droopy eye, and he could smile only on his right side of the face. Patient also reported headache on left side of his head. The symptoms started on 07 Jul 2021 and stopped after finishing Prednisolone that was prescribed by his doctor. 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: Hypertension

ID: 1504904
Sex: U
Age:
State: GA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine."; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") (seriousness criterion medically significant). At the time of the report, DEAFNESS (aware of several people who have experienced hearing loss after receiving their Covid-19 vaccine.") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter. Treatment medication not reported. Company comment:Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1504905
Sex: F
Age: 74
State: MD

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Was unconscious on the floor; Couldn't get up; muscle loss (rhabdomyolysis); Ear Infection; Fell on ground; Bad reaction to 2nd dose; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Was unconscious on the floor) and RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Was unconscious on the floor) (seriousness criteria hospitalization and medically significant), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)) (seriousness criterion medically significant), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose) and VERTIGO (vertigo). On an unknown date, the patient experienced MOBILITY DECREASED (Couldn't get up). At the time of the report, LOSS OF CONSCIOUSNESS (Was unconscious on the floor), RHABDOMYOLYSIS (muscle loss (rhabdomyolysis)), EAR INFECTION (Ear Infection), FALL (Fell on ground), VACCINATION COMPLICATION (Bad reaction to 2nd dose), VERTIGO (vertigo) and MOBILITY DECREASED (Couldn't get up) outcome was unknown. Ear infection at the time and was given 5 days course of steroids and the unknown medications. for other events. The blood work, CT scan, MRI, and other tests were done but none of them could pinpoint it to the vaccine. Patient was hospitalized for 3 days. No concomitant medication was reported by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is expected. This case was linked to MOD-2021-052530 (Patient Link). Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been reported at this time. Further information is expected.

Other Meds:

Current Illness:

ID: 1504906
Sex: M
Age: 69
State: TX

Vax Date: 04/03/2021
Onset Date: 05/02/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: seizure/ massive seizure; light headed; Shoulder popped out; not allowed to drive or work; not allowed to drive or work; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure/ massive seizure), DIZZINESS (light headed) and JOINT DISLOCATION (Shoulder popped out) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Type 2 diabetes mellitus. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced SEIZURE (seizure/ massive seizure) (seriousness criteria hospitalization, medically significant and life threatening), DIZZINESS (light headed) (seriousness criteria hospitalization and life threatening) and JOINT DISLOCATION (Shoulder popped out) (seriousness criterion hospitalization). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (not allowed to drive or work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not allowed to drive or work). On 05-May-2021, SEIZURE (seizure/ massive seizure) outcome was unknown. At the time of the report, DIZZINESS (light headed), JOINT DISLOCATION (Shoulder popped out), IMPAIRED DRIVING ABILITY (not allowed to drive or work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not allowed to drive or work) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product was not reported. Treatment was not reported. Patient has never had a seizure before and is also a Type 2 diabetic. 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. Further information has been requested. This case was linked to MOD-2021-264175 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow-up received on 22-JUL-2021 Contains updated information on patient demographics, updated event seriousness; 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:

ID: 1504907
Sex: M
Age: 61
State: OK

Vax Date: 02/13/2021
Onset Date: 03/15/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Cardiac Infraction; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Cardiac Infraction) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination. No relevant medical history was provided. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN LOW) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Cardiac Infraction) (seriousness criteria medically significant and intervention required). At the time of the report, MYOCARDIAL INFARCTION (Cardiac Infraction) outcome was unknown. Patient stated that they put a stent in there. Company 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: BRILINTA; ASPIRIN LOW; LIPITOR

Current Illness:

ID: 1504908
Sex: M
Age:
State: NJ

Vax Date: 03/17/2021
Onset Date: 05/01/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Infection; Sick; TSA levels increased and blood work done today and this is coming back to the way that normally/; Blood pressure increased; This spontaneous case was reported by a physician and describes the occurrence of INFECTION (Infection) and ILLNESS (Sick) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) tablet for Myelofibrosis. Concurrent medical conditions included Myelofibrosis. Concomitant products included WARFARIN SODIUM (COUMADIN), OLMESARTAN MEDOXOMIL (BENICAR) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 10 mg twice a day. In May 2021, the patient experienced ILLNESS (Sick) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization), BLOOD THYROID STIMULATING HORMONE INCREASED (TSA levels increased and blood work done today and this is coming back to the way that normally/) and BLOOD PRESSURE INCREASED (Blood pressure increased). The patient was hospitalized for 5 days due to ILLNESS and INFECTION. At the time of the report, INFECTION (Infection), ILLNESS (Sick), BLOOD THYROID STIMULATING HORMONE INCREASED (TSA levels increased and blood work done today and this is coming back to the way that normally/) and BLOOD PRESSURE INCREASED (Blood pressure increased) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) Increased. On an unknown date, Blood test: abnormal (abnormal) Abnormal. On an unknown date, Blood thyroid stimulating hormone: increased (High) Increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 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. Concomitant medication and the underlying Myelofibrosis are potential confounders for the event "infection"; 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. Concomitant medication and the underlying Myelofibrosis are potential confounders for the event "infection"

Other Meds: COUMADIN; BENICAR; CRESTOR

Current Illness: Myelofibrosis

ID: 1504909
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Bronchitis; Pharyngitis; Coughed up blood; Hoarse voice; Treatment non compliance; Inappropriate route of vaccination; This spontaneous case was reported by a health care professional and describes the occurrence of BRONCHITIS (Bronchitis), PHARYNGITIS (Pharyngitis), HAEMOPTYSIS (Coughed up blood) and DYSPHONIA (Hoarse voice) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product MACITENTAN for Primary pulmonary hypertension. Concurrent medical conditions included Primary pulmonary hypertension. Concomitant products included TADALAFIL (ADCIRCA) and RIVAROXABAN (XARELTO) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form and MACITENTAN (Oral) 10 mg. On an unknown date, the patient experienced BRONCHITIS (Bronchitis) (seriousness criterion hospitalization), PHARYNGITIS (Pharyngitis) (seriousness criterion hospitalization), HAEMOPTYSIS (Coughed up blood) (seriousness criterion hospitalization), DYSPHONIA (Hoarse voice) (seriousness criterion hospitalization), TREATMENT NONCOMPLIANCE (Treatment non compliance) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). The patient was hospitalized from 28-May-2021 to 01-Jun-2021 due to BRONCHITIS, DYSPHONIA, HAEMOPTYSIS and PHARYNGITIS. At the time of the report, BRONCHITIS (Bronchitis), PHARYNGITIS (Pharyngitis), HAEMOPTYSIS (Coughed up blood), DYSPHONIA (Hoarse voice), TREATMENT NONCOMPLIANCE (Treatment non compliance) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Blood pressure measurement: low (Low) Low. On 28-May-2021, Oxygen saturation: low (Low) Low. For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested.

Other Meds: ADCIRCA; XARELTO; MACITENTAN

Current Illness: Primary pulmonary hypertension

ID: 1504910
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Short breath; Very ill/disperatly ill; Fever; Spittle like form egg whites; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Short breath), ILLNESS (Very ill/disperatly ill) and PYREXIA (Fever) in an 88-year-old patient of an unknown gender 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 Disability. 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Short breath) (seriousness criterion hospitalization), ILLNESS (Very ill/disperatly ill) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization) and SALIVA DISCOLOURATION (Spittle like form egg whites). At the time of the report, DYSPNOEA (Short breath), ILLNESS (Very ill/disperatly ill), PYREXIA (Fever) and SALIVA DISCOLOURATION (Spittle like form egg whites) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) temperature was 102 that indicated fever. No relevant concomitant medications were reported. No treatment information was provided. Very scant and mostly unintelligible information has been received and follow-up has been requested. Based on current available information and the possible temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Very scant and mostly unintelligible information has been received and follow-up has been requested. Based on current available information and the possible temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness: Disability

ID: 1504911
Sex: U
Age:
State:

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: I'm 100 percent disabled by the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) (seriousness criterion disability). At the time of the report, VACCINATION COMPLICATION (I'm 100 percent disabled by the Moderna shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. 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. Company Comment Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1504912
Sex: M
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/22/2021
Rec V Date: 07/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Kidney Stone after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney Stone after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Kidney disorder. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient experienced NEPHROLITHIASIS (Kidney Stone after the first dose) (seriousness criterion medically significant). The patient was treated with CIPROFLOXACIN at a dose of UNK, bid. At the time of the report, NEPHROLITHIASIS (Kidney Stone after the first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Very limited information regarding the event has been provided at this time. Reporter did not provide permission to follow-up.; Sender's Comments: Very limited information regarding the event has been provided at this time. Reporter did not provide permission to follow-up.

Other Meds:

Current Illness: Kidney disorder

ID: 1504913
Sex: M
Age:
State: MA

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Hearing loss; bilateral tinnitus rushed into my head; Dizziness; Vertigo-like dizziness; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. Concurrent medical conditions included Hearing loss. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), TINNITUS (bilateral tinnitus rushed into my head), DIZZINESS (Dizziness), VERTIGO (Vertigo-like dizziness) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, DEAFNESS (Hearing loss) outcome was unknown, TINNITUS (bilateral tinnitus rushed into my head), DIZZINESS (Dizziness) and VERTIGO (Vertigo-like dizziness) had not resolved and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. Concomitant medications were not reported. Treatment medications were not reported. Patient initially administered with Pfizer BIONTECH COVID-19 vaccine and started experiencing Tinnitus. 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. However, more information is 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 events, a causal relationship cannot be excluded. However, more information is required for further assessment.

Other Meds:

Current Illness:

ID: 1504914
Sex: M
Age: 79
State: VA

Vax Date: 05/17/2021
Onset Date: 05/19/2021
Rec V Date: 07/27/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Hospitalized for 17 days because of kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Hospitalized for 17 days because of kidney problems) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for an unreported indication: METFORMIN, FORXIGA and INSULIN. Concurrent medical conditions included Diabetes. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced RENAL DISORDER (Hospitalized for 17 days because of kidney problems) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 19-May-2021 to 04-Jun-2021 due to RENAL DISORDER. On 04-Jun-2021, RENAL DISORDER (Hospitalized for 17 days because of kidney problems) had resolved. Patient has to do dialysis three times a week. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: ASPIRIN (E.C.); LIPITOR

Current Illness: Diabetes

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm