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: 1489554
Sex: U
Age:
State: MN

Vax Date:
Onset Date: 07/16/2021
Rec V Date: 07/21/2021
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: DOSE GIVEN POST EXPIRY TIME; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-JUL-2021, the subject experienced dose given post expiry time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dose given post expiry time was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489555
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: SHAKING; COULD HARDLY GET OUT OF BED; CHILLS; HIGH FEVER; REALLY FATIGUED/SO TIRED; This spontaneous report received from a patient via a company representative concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included stress.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. 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 shaking, could hardly get out of bed, chills, high fever, and really fatigued/so tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, shaking, high fever, could hardly get out of bed and really fatigued/so tired was not reported. This report was non-serious.

Other Meds:

Current Illness: Stress (not sure if it is because of the stress she has in her house hunting process or it is because of the vaccine)

ID: 1489556
Sex: M
Age:
State: MO

Vax Date:
Onset Date: 07/15/2021
Rec V Date: 07/21/2021
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: MUSCLE SORENESS WHICH WAS WORSE IN HIS SIDES AND BACK; FATIGUE; 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 back pain. 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 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUL-2021, the subject experienced muscle soreness which was worse in his sides and back. On 15-JUL-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and had not recovered from muscle soreness which was worse in his sides and back. This report was non-serious.

Other Meds:

Current Illness: Back pain

ID: 1489557
Sex: M
Age:
State: OR

Vax Date:
Onset Date: 04/21/2021
Rec V Date: 07/21/2021
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: TROUBLE BREATHING; CONGESTION; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-APR-2021 19:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-APR-2021, the subject experienced fever. On 04-MAY-2021, the subject experienced trouble breathing. On 04-MAY-2021, the subject experienced congestion. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing, and congestion on 07-MAY-2021, and fever on 21-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210432473 and 20210428876.

Other Meds:

Current Illness:

ID: 1489558
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 07/14/2021
Rec V Date: 07/21/2021
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: ACHY; FEVER; This spontaneous report received from a parent concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included brain tumor, and allergy to tree nuts. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced achy. On 14-JUL-2021, the subject experienced fever. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and achy. This report was non-serious. This case, from the same reporter is linked to 20210738675.

Other Meds:

Current Illness: Allergy to nuts; Brain tumor

ID: 1489559
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: BODY PAIN/BODY ACHES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 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 number. No concomitant medications were reported. On an unspecified date, the subject experienced body pain/body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body pain/body aches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489561
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 03/12/2021
Rec V Date: 07/21/2021
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: MUSCLE WEAKNESS; FEVER; BODY ACHE; CONGESTION; OXYGEN WENT DOWN TO 86; TROUBLE BREATHING; TROUBLE SLEEPING; VOMITING; HEADACHE; This spontaneous report received from a parent concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, chronic obstructive pulmonary disease, asthma, high blood pressure, non alcohol user, and cigarette smoker. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine, and prednisolone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered to left deltoid on 12-MAR-2021 around 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced headache 40 minutes after her vaccine and resolved the day after. The patient had trouble breathing during the day of vaccine lasted for one day and the patient had vomiting all day after she got her vaccine and resolved the next day. The patient also had trouble sleeping the day of her vaccination but resolved the day after. On 28-MAR-2021,16 days after the vaccination, she experienced trouble breathing, fever, body ache and congestion. Her oxygen went down to 86. These symptoms lasted for a week and a half and resolved. On an unspecified date, the patient experienced muscle weakness. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) high, and Oxygen saturation (NR: not provided) 86 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from oxygen saturation decreased to 86, and trouble breathing on APR-2021, trouble sleeping, vomiting, and headache on 13-MAR-2021, and body ache, congestion, and fever on 07-APR-2021, and the outcome of muscle weakness was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210739940.; Sender's Comments: V0: V0: 20210739000-COVID-19 VACCINE AD26.COV2.S-Oxygen went down to 86. 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: MEDICAL HISTORY

Other Meds:

Current Illness: Abstains from alcohol; Asthma; Blood pressure high; Cigarette smoker (3 cigarettes a day); COPD; Diabetes

ID: 1489562
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 06/11/2021
Rec V Date: 07/21/2021
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: NAUSEA; EYES ARE HURTING/OCULAR PAIN; A RASH ON HER LEFT FOOT AND RIGHT ARM A FEW HOURS POST VACCINATION, ALMOST LIKE THE BLOOD HAD COME TO THE SURFACE; RECURRING HEADACHES; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and several antibiotic allergies, and other pre-existing medical conditions included patient had taking aspirin occasionally as a blood thinner. no previous reactions to injections and/or immunizations.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid for blood thinner. On 11-JUN-2021, the subject experienced eyes are hurting/ocular pain. On 11-JUN-2021, the subject experienced a rash on her left foot and right arm a few hours post vaccination, almost like the blood had come to the surface. On 11-JUN-2021, the subject experienced recurring headaches. On 12-JUN-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: acetylsalicylic acid, and calamine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a rash on her left foot and right arm a few hours post vaccination, almost like the blood had come to the surface on 13-JUN-2021, and nausea on 12-JUN-2021, and had not recovered from recurring headaches, and eyes are hurting/ocular pain. This report was non-serious.

Other Meds: ASPIRINE

Current Illness: Allergic reaction to antibiotics; Penicillin allergy

ID: 1489563
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 07/16/2021
Rec V Date: 07/21/2021
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: VERY TIRED; HEADACHE (ABOVE THE EYE); LIGHTHEADEDNESS/DIZZINESS; This spontaneous report received from a consumer concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and alcohol use, and other pre-existing medical conditions included the patient had no known drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUL-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 16-JUL-2021, the subject experienced lightheadedness/dizziness. On 17-JUL-2021, the subject experienced very tired. On 17-JUL-2021, the subject experienced headache (above the eye). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheadedness/dizziness, very tired, and headache (above the eye). This report was non-serious.

Other Meds:

Current Illness: Alcohol use (once a week.); Cigarette smoker (1 pack-per-day.)

ID: 1489564
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 07/06/2021
Rec V Date: 07/21/2021
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: SEVERE ITCHING; RED WHELPS ON LEGS,THIGH AND STOMACH; FATIGUE; INJECTION SITE SORENESS; INJECTION SITE RED; INJECTION SITE SWOLLEN; LIGHTHEADNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, diabetes type 2, penicillin allergy, non alcoholic, and non smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with amoxicillin, sulfamethoxazole/trimethoprim, ciprofloxacin, erythromycin, and pravastatin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-JUL-2021, the subject experienced lightheadness. On 06-JUL-2021, the subject experienced fatigue. On 06-JUL-2021, the subject experienced injection site soreness. On 06-JUL-2021, the subject experienced injection site red. On 06-JUL-2021, the subject experienced injection site swollen. On 15-JUL-2021, the subject experienced severe itching. On 15-JUL-2021, the subject experienced red whelps on legs, thigh and stomach. Treatment medications included: calamine, and cortisone. On 17-JUL-2021, treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadness, and fatigue on 07-JUL-2021, severe itching, and red whelps on legs,thigh and stomach on 16-JUL-2021, and injection site soreness, injection site red, and injection site swollen on 10-JUL-2021. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Hypertension; Non-smoker; Penicillin allergy; Type II diabetes mellitus

ID: 1489565
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 07/16/2021
Rec V Date: 07/21/2021
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: ITCHING ALL OVER, DEEP ITCH ON THE HANDS, FEET, STOMACH, HEAD, LEGS; FLU LIKE SYMPTOMS; HURTING ALL OVER/ACHY; MUSCLE ACHES; FEVER (DID NOT TAKE TEMP); NAUSEA; TIRED; SORENESS TO LEFT ARM INJECTION SITE; LIGHT HEADED; 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 concurrent conditions included arthritis neck shoulders, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no history of drug abuse or illicit drug use. takes muscle relaxer and med to lose weight.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095 expiry: UNKNOWN) dose was not reported, administered on 16-JUL-2021 for prophylactic vaccination. Concomitant medications included lidocaine for arthritis. On 16-JUL-2021, the subject experienced light headed. On 16-JUL-2021, the subject experienced flu like symptoms. On 16-JUL-2021, the subject experienced hurting all over/achy. On 16-JUL-2021, the subject experienced muscle aches. On 16-JUL-2021, the subject experienced fever (did not take temp). On 16-JUL-2021, the subject experienced nausea. On 16-JUL-2021, the subject experienced tired. On 16-JUL-2021, the subject experienced soreness to left arm injection site. On 18-JUL-2021, the subject experienced itching all over, deep itch on the hands, feet, stomach, head, legs. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride/zinc acetate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, fever (did not take temp), nausea, tired, light headed, itching all over, deep itch on the hands, feet, stomach, head, legs, soreness to left arm injection site, flu like symptoms, and hurting all over/achy. This report was non-serious.

Other Meds: LIDOCAINE 5%

Current Illness: Alcohol use (Socially); Arthritis (Med hx arthritis neck shoulders lidocaine 5%); Non-smoker

ID: 1489566
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: NIGHT SWEATS; CHILLS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced night sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the night sweats and chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489567
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: SORENESS; MINOR FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUL-2021, the subject experienced soreness. On JUL-2021, the subject experienced minor fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor fatigue and soreness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489568
Sex: M
Age:
State: TN

Vax Date:
Onset Date: 07/08/2021
Rec V Date: 07/21/2021
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: INSOMNIA (COULD NOT SLEEP FOR THREE TO FOUR NIGHTS); COUGH; BODY ACHE; SORE THROAT; FEVER; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight was 169 pounds, and height was 66 inches. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies, no drug abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced injection site pain. On 11-JUL-2021, the subject experienced sore throat. On 11-JUL-2021, the subject experienced cough. On 11-JUL-2021, the subject experienced body ache. On 11-JUL-2021, the subject experienced fever. On 15-JUL-2021, the subject experienced insomnia (could not sleep for three to four nights). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on 09-JUL-2021, and fever on 14-JUL-2021, was recovering from body ache, and insomnia (could not sleep for three to four nights), and had not recovered from cough, and sore throat. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (1-2 beers per week); Non-smoker

ID: 1489569
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: MUSCLE TWITCHES NEAR THE SHOT AREA; BACK ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced muscle twitches near the shot area, and back ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle twitches near the shot area and back ache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489570
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: FLU SYMPTOMS; CHIPPED TOOTH FROM SHIVERING; GRIMACING OF FACE; 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 was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu symptoms, chipped tooth from shivering, and grimacing of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms, and the outcome of chipped tooth from shivering and grimacing of face was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489571
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: HEADACHE; .This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, 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 headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache. This report was non-serious. This case, from the same reporter is linked to 20210740675.

Other Meds:

Current Illness:

ID: 1489572
Sex: F
Age: 47
State: IA

Vax Date: 03/31/2021
Onset Date: 04/12/2021
Rec V Date: 07/21/2021
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: SHAKING FROM THE HANDS; VISION SEEMED TO BE BLURRED; SPASMS IN UPPER ARM REGION; This spontaneous report received from a patient concerned a 47 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: 1808980 expiry: 04-AUG-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced shaking from the hands. On 12-APR-2021, the subject experienced vision seemed to be blurred. On 12-APR-2021, the subject experienced spasms in upper arm region. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shaking from the hands, vision seemed to be blurred, and spasms in upper arm region. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489573
Sex: U
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: PAINFUL MIGRAINE HEADACHE; LIPS NUMB; CRAMPS ON EYES MOUTH AND FINGERS; FINGER NUMB; STRONG HEADACHE; 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 was not reported, administered on 16-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 JUL-2021, the subject experienced painful migraine headache. On JUL-2021, the subject experienced lips numb. On JUL-2021, the subject experienced cramps on eyes mouth and fingers. On JUL-2021, the subject experienced finger numb. On JUL-2021, the subject experienced strong headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the strong headache, painful migraine headache, lips numb, cramps on eyes mouth and fingers and finger numb was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489574
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: GUILLAIN-BARRE SYNDROME; PAIN; This spontaneous social media report via Johnson and Johnson was received from a consumer via a company representative and concerned a female patient of unspecified age, race and ethnicity. The patient's weight, height and medical history were not reported. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number unknown), dose and vaccination date not reported, for prophylactic vaccination. The company is unable to perform follow-up to obtain the batch number. No concomitant medications were reported. The consumer reported that, on unspecified dates, that their aunt 'after days of pain and sending her home 3 times' (not reported what type of facility sent the patient home), she was diagnosed with Guillain-Barre syndrome 'as a reaction to the vaccine'.. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome of the pain and Guillain-Barre syndrome was not reported. This report was serious (other medically important condition).; Sender's Comments: V0: This spontaneous report received from a consumer via social media concerns a female of unknown age, race, and ethnicity who was diagnosed with Guillain-Barre syndrome (GBS) an unspecified period of time after receiving the Janssen Covid-19 vaccine. Medical history, concomitant medications, clinical symptoms, diagnostic testing, corrective treatment, and outcome were not reported. Information is limited in this case. Therefore, the relationship of GBS to vaccination is considered unclassifiable due to insufficient information. More information will be requested if contact information is available.

Other Meds:

Current Illness:

ID: 1489575
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 07/21/2021
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: SIDE EFFECTS WERE EXAGGERATED; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-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 JUL-2021, the subject experienced side effects were exaggerated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from side effects were exaggerated. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489576
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 06/17/2021
Rec V Date: 07/21/2021
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: SHORTNESS OF BREATH; UNABLE TO WALK; BRUISE IN THE STOMACH; HEADACHE; ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 09041738 expiry: UNKNOWN) dose was not reported, administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUN-2021, the subject experienced arm pain. On 19-JUN-2021, the subject experienced headache. On JUL-2021, the subject experienced bruise in the stomach. On an unspecified date, the subject experienced shortness of breath, and unable to walk. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, had not recovered from arm pain, bruise in the stomach, and shortness of breath, and the outcome of unable to walk was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489577
Sex: M
Age:
State: MD

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 07/21/2021
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: NUMBNESS IN RIGHT HAND AND FINGERTIPS OF RIGHT HAND; FEELING FATIGUE INTERMITTENTLY; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced feeling fatigue intermittently. On 31-MAY-2021, the subject experienced numbness in right hand and fingertips of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling fatigue intermittently, and numbness in right hand and fingertips of right hand. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489578
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 07/19/2021
Rec V Date: 07/21/2021
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: RECEIVED VACCINE WHILE UNDER 18; RECEIVED ONLY 0.3 ML OF THE DOSE AND REFUSED TO GET THE REST OF IT; This spontaneous report received from a pharmacist concerned a 14 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 expiry: UNKNOWN) 0.3 ml, administered on 19-JUL-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 19-JUL-2021, the subject experienced received vaccine while under 18. On 19-JUL-2021, the subject experienced received only 0.3 ml of the dose and refused to get the rest of it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine while under 18 and received only 0.3 ml of the dose and refused to get the rest of it was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1489579
Sex: F
Age: 59
State: CA

Vax Date: 02/17/2021
Onset Date: 02/01/2021
Rec V Date: 07/21/2021
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: 7 day heavy periods after 9 and half years post menopause; extreme pain in hands,feet, right thigh, random electrical pain in legs; neuropathy; face went numb mostly from my lips up, Numbness moved through my arm and hands then my feet; dull headache; Face was tingling; Face was numb; neck throbbing, My neck felt like i was in a car accident; Migraine; vision blurred; left calf feels like on fire or extreme sunburn; feels like legs have bug crawling and biting me; band of pressure across my face; impairs my breathing; gained 11 pounds in 2 weeks, total weight gain post vaccine is more than 20 pounds; Inflammation; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy) and POSTMENOPAUSAL HAEMORRHAGE (7 day heavy periods after 9 and half years post menopause) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Sulfa drugs), Hives since 2020 and Hypothyroidism (The patient states that she can't regulate thyroid since having the vaccine.) since 2016. Concomitant products included VITAMINS NOS (MULTI-VIT), VIT D [VITAMIN D NOS], ASCORBIC ACID (VIT C), MAGNESIUM, VITAMIN B1 NOS (VIT B1 [VITAMIN B1 NOS]), ESTRADIOL, LEVOTHYROXINE, PROGESTERONE (PROMETRIUM [PROGESTERONE]) and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced MIGRAINE (Migraine) and VISION BLURRED (vision blurred). On 17-Feb-2021, the patient experienced PARAESTHESIA (Face was tingling) and HYPOAESTHESIA (Face was numb). 17-Feb-2021, the patient experienced NECK PAIN (neck throbbing, My neck felt like i was in a car accident) and HYPOAESTHESIA (face went numb mostly from my lips up, Numbness moved through my arm and hands then my feet). 17-Feb-2021, the patient experienced HEADACHE (dull headache). On 20-Feb-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant) and PAIN IN EXTREMITY (extreme pain in hands,feet, right thigh, random electrical pain in legs). On 15-Mar-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (7 day heavy periods after 9 and half years post menopause) (seriousness criterion medically significant). In 2021, the patient experienced BURNING SENSATION (left calf feels like on fire or extreme sunburn), FORMICATION (feels like legs have bug crawling and biting me), DISCOMFORT (band of pressure across my face), DYSPNOEA (impairs my breathing), WEIGHT INCREASED (gained 11 pounds in 2 weeks, total weight gain post vaccine is more than 20 pounds) and INFLAMMATION (Inflammation). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy), POSTMENOPAUSAL HAEMORRHAGE (7 day heavy periods after 9 and half years post menopause), HYPOAESTHESIA (Face was numb), NECK PAIN (neck throbbing, My neck felt like i was in a car accident), HYPOAESTHESIA (face went numb mostly from my lips up, Numbness moved through my arm and hands then my feet), PAIN IN EXTREMITY (extreme pain in hands,feet, right thigh, random electrical pain in legs) and HEADACHE (dull headache) had not resolved and PARAESTHESIA (Face was tingling), MIGRAINE (Migraine), VISION BLURRED (vision blurred), BURNING SENSATION (left calf feels like on fire or extreme sunburn), FORMICATION (feels like legs have bug crawling and biting me), DISCOMFORT (band of pressure across my face), DYSPNOEA (impairs my breathing), WEIGHT INCREASED (gained 11 pounds in 2 weeks, total weight gain post vaccine is more than 20 pounds) and INFLAMMATION (Inflammation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 17-Feb-2021, within 15 mins of vaccination, the patient experienced tingling and numbness in face. On 17-Feb-2021, within an hour of vaccination, the patient had dull headache, which turned into migraine with blurred vision on an unspecified date. The patient was advised by a medical director at vaccination site that the numbness would disappear within 48 hours, however outcome was unknown. On an unknown date, 5 months after vaccination, the patient's face turned completely numb and experienced a band of pressure due to which she can't breathe. On an unknown date, the patient felt random electrical pains in legs, outcome was unknown. About 3 weeks after the vaccination, the patient had a 7 day heavy periods and 3 more since then after being menopause for 9 years. On an unknown date, the patient gained 11 pounds in a week period. She had a total weight gain of over 20 lbs since the vaccine . Th doctor thinks it as inflammation. On an unknown date, the patient had a painful biopsy and ultrasound to rule out cancer. Results obtained negative. On an unknown date, the patient had a brain scan and multiple ultrasounds. The report states that the patient eats healthy food. Concomitant medications included inhaler (unspecified) administered twice daily, and sound sleep for an unknown indication. No treatment medication information was provided 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. Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Significant Follow-up; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MULTI-VIT; VIT D [VITAMIN D NOS]; VIT C; MAGNESIUM; VIT B1 [VITAMIN B1 NOS]; ESTRADIOL; LEVOTHYROXINE; PROMETRIUM [PROGESTERONE]; CETRIZINE

Current Illness: Drug allergy (Sulfa drugs); Hives; Hypothyroidism (The patient states that she can't regulate thyroid since having the vaccine.)

ID: 1489580
Sex: F
Age: 67
State: NY

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 07/21/2021
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: Bell's Palsy; right arm developed red rash which was described as 2 &1/2 inch swollen; Achy painful to touch; Heaviness; headache on her left side; left side of the face was achy; Patient's right arm developed red rash which was described as 2&1/2 inch swollen,achy,painful to touc/Red raised rash; Warm and painful; Itches; Right arm was sore; Fatigue/tiredness; Headache; Chills; Joint aches/aches in all joints; Feels like muscle ache/aches in all joints and muscle; sluggish; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Allergies include penicillin and IV chemo (unsure if it was mixed).) and Drug hypersensitivity (Allergies include penicillin and IV chemo (unsure if it was mixed).). Concomitant products included ZOLEDRONIC ACID MONOHYDRATE (ZOMETA) for Cancer. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced FATIGUE (Fatigue/tiredness), HEADACHE (Headache), CHILLS (Chills), ARTHRALGIA (Joint aches/aches in all joints) and MYALGIA (Feels like muscle ache/aches in all joints and muscle). On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Patient's right arm developed red rash which was described as 2&1/2 inch swollen,achy,painful to touc/Red raised rash), VACCINATION SITE WARMTH (Warm and painful), VACCINATION SITE PAIN (Right arm was sore) and VACCINATION SITE PRURITUS (Itches). On 02-Mar-2021, the patient experienced FACIAL PAIN (left side of the face was achy) and HEADACHE (headache on her left side). On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), SLUGGISHNESS (sluggish), PAIN (Achy painful to touch), DISCOMFORT (Heaviness) and INJECTION SITE SWELLING (right arm developed red rash which was described as 2 &1/2 inch swollen). At the time of the report, BELL'S PALSY (Bell's Palsy), VACCINATION SITE WARMTH (Warm and painful), FACIAL PAIN (left side of the face was achy), SLUGGISHNESS (sluggish), PAIN (Achy painful to touch), DISCOMFORT (Heaviness), VACCINATION SITE PAIN (Right arm was sore), INJECTION SITE SWELLING (right arm developed red rash which was described as 2 &1/2 inch swollen), VACCINATION SITE PRURITUS (Itches), MYALGIA (Feels like muscle ache/aches in all joints and muscle) and HEADACHE (headache on her left side) outcome was unknown and RASH ERYTHEMATOUS (Patient's right arm developed red rash which was described as 2&1/2 inch swollen,achy,painful to touc/Red raised rash), FATIGUE (Fatigue/tiredness), HEADACHE (Headache), CHILLS (Chills) and ARTHRALGIA (Joint aches/aches in all joints) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. After one week of vaccination, the patient developed a red rash that was 2.5 in, swollen, achy and painful to touch. After 6 days the rash got bigger and faded and then finally resolved. On 02-Mar-2021, the patient stated that she felt sluggish and tired for 6 weeks. Patient reported visiting her doctor who ordered a brain and sinus scan. The patient reported that the doctor suspected Bell's Palsy due to the vaccination and advised her not to get the 2nd dose. The patient was not given any prescription for treatment medications and reported that she did not take any medications. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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 09-Jul-2021: Follow up received on 09-Jul-2021 was significant and diagnostic tests, concomitant medication, additional events, outcome of events and case upgraded to serious (event: Bell's palsy).; 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: ZOMETA

Current Illness: Drug hypersensitivity (Allergies include penicillin and IV chemo (unsure if it was mixed).); Penicillin allergy (Allergies include penicillin and IV chemo (unsure if it was mixed).)

ID: 1489581
Sex: F
Age: 35
State: PA

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 07/21/2021
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: Nausea, Pain in extremity, Pyrexia

Symptoms: Breech delivery Baby B; Pregnant patient received both doses of moderna vaccine. Patient is expecting twins.; First dose: Jan 6 Second dose: Jan 31 2021; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of BREECH DELIVERY (Breech delivery Baby B) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy (Sulfa) and Smoker. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Jul-2020 and the estimated date of delivery was 19-Apr-2021. On 06-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose: Jan 6 Second dose: Jan 31 2021). On 31-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of moderna vaccine. Patient is expecting twins.). On 01-Apr-2021, the patient experienced BREECH DELIVERY (Breech delivery Baby B) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twenty-fourth week of the pregnancy. The patient gave birth to 2 neonates. The vaginal delivery occurred on 01-Apr-2021, which was reported as Full-term. For neonate 1, the birth weight was 3300 grams (7lbs 4oz). The outcome was reported as Term Birth w/o Complications. Mono-di-twins sex: male, lenght 50.8 cm, head cirumference 33 cm. For neonate 2, the birth weight was 3600 grams (7lbs 15oz). The outcome was reported as Term Birth w/o Complications. Breech delivery; Mono-di-twins sex: male, lenght 50.8 cm, head cirumference 31.8 cm. On 31-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of moderna vaccine. Patient is expecting twins.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose: Jan 6 Second dose: Jan 31 2021) had resolved. On 01-Apr-2021, BREECH DELIVERY (Breech delivery Baby B) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. On 24-Aug-2020, the patient received a positive pregnancy test result. The patient received weekly ultrasounds and fetal non-stress test (NST). On an unknown date the patient began oral prenatal vitamins, which she was continuing at the time of the pregnancy outcome report. Neonate-1 APGAR score #1 and 2: to unknown Neonate-2 APGAR score #1 and 2: to unknown This is a case of product exposure during pregnancy with an associated adverse event of breech delivery in one of the newborn (gemelar pregnancy). Based on temporal association a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: No new information. On 14-Jul-2021: Pregnancy outcome form completed.; Sender's Comments: This is a case of product exposure during pregnancy with an associated adverse event of breech delivery in one of the newborn (gemelar pregnancy). Based on temporal association a causal relationship cannot be excluded.

Other Meds: BABY ASPIRIN; VITAMINS NOS

Current Illness: Penicillin allergy; Smoker; Sulfonamide allergy (Sulfa)

ID: 1489582
Sex: F
Age: 75
State: CO

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 07/21/2021
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: Stroke; Neck aches; Itching at the injection site; Soreness at the injection site; Random headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced NECK PAIN (Neck aches), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Random headaches). On 18-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), NECK PAIN (Neck aches), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and HEADACHE (Random headaches) outcome was unknown. Concomitant medications were not provided. Treatment information was not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. 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 18-Jul-2021: Follow up received on 19-JUL-2021 updated new event-Stroke and outcome of the event.; 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: 1489583
Sex: F
Age:
State: IN

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 07/21/2021
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: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Her blood pressure was also elevated 186/119; Headache; Anaphylactic reaction; Hives all over her body; Tightness in her chest; Fever; Nausea; Vomiting; Body aches; This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Obesity. 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 ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). 30-Mar-2021, the patient experienced URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Body aches). On an unknown date, the patient experienced HYPERTENSION (Her blood pressure was also elevated 186/119) and HEADACHE (Headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), HYPERTENSION (Her blood pressure was also elevated 186/119), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Body aches) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Blood pressure measurement: 186/119 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction), URTICARIA (Hives all over her body), CHEST DISCOMFORT (Tightness in her chest), HYPERTENSION (Her blood pressure was also elevated 186/119), PYREXIA (Fever), NAUSEA (Nausea), VOMITING (Vomiting), MYALGIA (Body aches) and HEADACHE (Headache) to be related. Patient received treatment in the emergency department (unspecified). No concomitant medication was reported. Company Comment: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021 and included relevant medical history, outcome of events and Causality. On 16-Jul-2021: Follow-up received on 16-JUL-2021 and included events (anaphylactic reaction and hypertension); Sender's Comments: Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Obesity

ID: 1489584
Sex: F
Age: 66
State: FL

Vax Date: 02/11/2021
Onset Date: 03/11/2021
Rec V Date: 07/21/2021
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: Hypersensitivity reaction; Redness; Rash in her trunk and torso upper area/ Rash in her kness; Psoriasis worsened; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Psoriasis since 02-Jan-1975, Hypertension since 03-Jan-1995 and Vitamin D3 deficiency. Concomitant products included ESTRADIOL for Hormone replacement therapy, AMLODIPINE, LOSARTAN and CHLORTHALIDONE for Hypertension, VITAMIN D3 for Vitamin D3 deficiency. On 11-Feb-2021 at 6:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PSORIASIS (Psoriasis worsened). On 22-Mar-2021, the patient experienced RASH (Rash in her trunk and torso upper area/ Rash in her kness). On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) (seriousness criterion medically significant) and ERYTHEMA (Redness). The patient was treated with PREDNISONE for Rash, at a dose of 60 mg and CLOBETASOL (topical) for Psoriasis, at an unspecified dose and frequency. On 01-Jul-2021, ERYTHEMA (Redness) had resolved. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), PSORIASIS (Psoriasis worsened) and RASH (Rash in her trunk and torso upper area/ Rash in her kness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 15-APR-2021, the patient went to a dermatologist and was prescribed a longer term prednisone therapy. 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. The patient's medical history of Psoriasis is a possible confounding factor. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow-up information received on 15 Apr 2021and new treatment information is reported. On 16-Jul-2021: Follow-up information received and information about Patient demographics, Medical history, Concomitants, and New Event is reported; 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. The patient's medical history of Psoriasis is a possible confounding factor.

Other Meds: VITAMIN D3; ESTRADIOL; AMLODIPINE; LOSARTAN; CHLORTHALIDONE

Current Illness: Hypertension; Psoriasis; Vitamin D3 deficiency

ID: 1489585
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: Rheumatoid arthritis flair for 6 months; Arm where the shot was given ache; Dizzy; Fever in the right arm where the shot was given; Very bad headache/Headache; Sever fever; Red area around the shot; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flair for 6 months) in a female 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. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flair for 6 months) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm where the shot was given ache), DIZZINESS (Dizzy), INJECTION SITE WARMTH (Fever in the right arm where the shot was given), HEADACHE (Very bad headache/Headache), PYREXIA (Sever fever) and VACCINATION SITE ERYTHEMA (Red area around the shot). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flair for 6 months) had not resolved, PAIN IN EXTREMITY (Arm where the shot was given ache), DIZZINESS (Dizzy), INJECTION SITE WARMTH (Fever in the right arm where the shot was given) and VACCINATION SITE ERYTHEMA (Red area around the shot) outcome was unknown and HEADACHE (Very bad headache/Headache) and PYREXIA (Sever fever) had resolved. No concomitant medication was provided. The patient stated that on the night of her second shot, she had a severe fever and a very bad headache. She ended up taking a migraine medication as the headache was so bad. That cut the fever and did away with the headache, but she still had a fever in the right arm where the shot was given. She had no problems after that, except the RA problems, however, from time to time, the arm where she had the shot given would ache. Treatment included an unspecified medication for migraine for the event headache and that cut the fever also. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, except Rheumatoid arthritis, a causal relationship cannot be excluded. Concerning the event Rheumatoid arthritis, very limited information regarding the event has been provided at this time. Further information is not expected. This case was linked to MOD-2021-027371, MOD-2021-027371 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow-up information was received. New event updated and case upgraded to serious.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, except Rheumatoid arthritis, a causal relationship cannot be excluded. Concerning the event Rheumatoid arthritis, very limited information regarding the event has been provided at this time. Further information is not expected.

Other Meds:

Current Illness:

ID: 1489586
Sex: F
Age:
State: OH

Vax Date: 04/10/2021
Onset Date: 04/10/2021
Rec V Date: 07/21/2021
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: Felt like I was at my lifes end; more Afib eposides; Still weaker; I was so ill with vaccine one; feel pain; heart rate increased; intentional dose omission; threw up; chill/severe chills; Was tired / tired all the time; fever; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Felt like I was at my lifes end) and ATRIAL FIBRILLATION (more Afib eposides) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer and Lymphadenectomy. Concurrent medical conditions included Hypertension (More episodes), Atrial fibrillation (high blood pressure) and Thyroid disorder. Concomitant products included RIVAROXABAN (XARELTO) for Atrial fibrillation, METOPROLOL, OXYBUTYNIN HYDROCHLORIDE (OXYBUTIN) and LEVOTHYROXINE for an unknown indication. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chill/severe chills) and FATIGUE (Was tired / tired all the time). On 12-Apr-2021, the patient experienced VOMITING (threw up). On an unknown date, the patient experienced NEAR DEATH EXPERIENCE (Felt like I was at my lifes end) (seriousness criterion medically significant), ATRIAL FIBRILLATION (more Afib eposides) (seriousness criterion medically significant), ASTHENIA (Still weaker), ILLNESS (I was so ill with vaccine one), PAIN (feel pain), HEART RATE INCREASED (heart rate increased) and INTENTIONAL DOSE OMISSION (intentional dose omission). The patient was treated with ACETAMINOPHEN on 11-Apr-2021 for Fever, at an unspecified dose and frequency. On 11-Apr-2021, PYREXIA (fever) had resolved. On 13-Apr-2021, CHILLS (chill/severe chills) had resolved. At the time of the report, NEAR DEATH EXPERIENCE (Felt like I was at my lifes end), ATRIAL FIBRILLATION (more Afib eposides), ILLNESS (I was so ill with vaccine one), PAIN (feel pain), VOMITING (threw up), FATIGUE (Was tired / tired all the time), HEART RATE INCREASED (heart rate increased) and INTENTIONAL DOSE OMISSION (intentional dose omission) outcome was unknown and ASTHENIA (Still weaker) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Heart rate: fast (High) Fast. On an unknown date, Heart rate: irregular (abnormal) Irregular. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Patient was still weaker and could mow tiny yard in 12 minutes but now takes 35minutes. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient stated of still being weaker and tired all the time, was so ill with vaccine one and will not take second and felt like was at life end and firmly believe it cause to have more Afib episodes that actually felt pain with them now. 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 19-Jul-2021: Additional information includes-reporters address, patients-race, height and weight, patient history-thyroid, Indication for concomitant medication Xarelto and added the events and case upgraded to serious; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: XARELTO; METOPROLOL; OXYBUTIN; LEVOTHYROXINE

Current Illness: Atrial fibrillation (high blood pressure); Hypertension (More episodes); Thyroid disorder

ID: 1489587
Sex: M
Age:
State: AZ

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

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: bled 2 colors of blood; Cut himself in his finger (like a paper cut); vertigo; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bled 2 colors of blood) 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. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (bled 2 colors of blood) (seriousness criterion medically significant), LIMB INJURY (Cut himself in his finger (like a paper cut)) and VERTIGO (vertigo). At the time of the report, HAEMORRHAGE (bled 2 colors of blood), LIMB INJURY (Cut himself in his finger (like a paper cut)) and VERTIGO (vertigo) outcome was unknown. No concomitants were reported. No treatment was reported. This case was linked to MOD-2021-089420 (Patient Link).

Other Meds:

Current Illness:

ID: 1489588
Sex: F
Age: 42
State:

Vax Date: 05/15/2021
Onset Date: 05/15/2021
Rec V Date: 07/21/2021
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: I convalescent l have8 days l was on the hospital for one surgery; I convalescent l have8 days l was on the hospital for one surgery; And today like a ball came out behind my knee. Like if it was a little bag of skin, like something coming out behind my right knee.; I am worried because the first day I got the vaccine I felt my veins were going to explode and this lasted for about two days; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of SURGERY (I convalescent l have8 days l was on the hospital for one surgery) and CONVALESCENT (I convalescent l have8 days l was on the hospital for one surgery) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced VASCULAR PAIN (I am worried because the first day I got the vaccine I felt my veins were going to explode and this lasted for about two days). On 20-May-2021, the patient experienced SKIN MASS (And today like a ball came out behind my knee. Like if it was a little bag of skin, like something coming out behind my right knee.). On an unknown date, the patient experienced SURGERY (I convalescent l have8 days l was on the hospital for one surgery) (seriousness criterion hospitalization) and CONVALESCENT (I convalescent l have8 days l was on the hospital for one surgery) (seriousness criterion hospitalization). The patient was hospitalized for 8 days due to SURGERY. The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. On 17-May-2021, VASCULAR PAIN (I am worried because the first day I got the vaccine I felt my veins were going to explode and this lasted for about two days) had resolved. At the time of the report, SURGERY (I convalescent l have8 days l was on the hospital for one surgery), CONVALESCENT (I convalescent l have8 days l was on the hospital for one surgery) and SKIN MASS (And today like a ball came out behind my knee. Like if it was a little bag of skin, like something coming out behind my right knee.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication provided. No treatment information was provided. She was hospitalized and underwent surgery to detect if cancer is there or not. Not much details are provided. Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Added new events convalescent and surgery. Case upgraded to serious as per FU with seriousness criteria hospitalization.; 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: 1489589
Sex: M
Age: 60
State: OR

Vax Date: 03/23/2021
Onset Date: 04/23/2021
Rec V Date: 07/21/2021
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: Erythema, Pruritus

Symptoms: "swollen and painful right cervical lymph node "; hardness of right cervical lymph node; cannot raise head; mild swollen of left cervical lymph node; pass out; lot of fatigue; lost of appetite; nausea; minor fever; shivering throbbing headache; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (pass out) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (pass out) (seriousness criterion medically significant), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ), PYREXIA (minor fever), HEADACHE (shivering throbbing headache) and PAIN IN EXTREMITY (sore arm ). On 29-Apr-2021, the patient experienced LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node), HEAD DISCOMFORT (cannot raise head) and LYMPHADENOPATHY (mild swollen of left cervical lymph node). On 24-Apr-2021, PAIN IN EXTREMITY (sore arm ) had resolved. On 25-Apr-2021, LOSS OF CONSCIOUSNESS (pass out), FATIGUE (lot of fatigue), DECREASED APPETITE (lost of appetite), NAUSEA (nausea ) and PYREXIA (minor fever) had resolved. On 01-May-2021, LYMPHADENOPATHY (mild swollen of left cervical lymph node) had resolved. At the time of the report, LYMPH NODE PAIN ("swollen and painful right cervical lymph node "), LYMPH NODE PAIN (hardness of right cervical lymph node) and HEAD DISCOMFORT (cannot raise head) outcome was unknown. the swelling and hardness of right cervical lymph node was the cause of clinic visit, the Physician said it was "benign", no treatment for it. This symptoms still bothering the patient. Patient assumed that was previously exposed COVID-19 in March2020 but had no confirmed results, his test was suspended and was not repeated. Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. The concomitant taken by the patient was, vitamin C , vitamin D , man's 50 plus gummy, risperidone.

Other Meds: RISPERIDONE; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]

Current Illness:

ID: 1489590
Sex: M
Age: 40
State: MI

Vax Date: 05/12/2021
Onset Date: 06/09/2021
Rec V Date: 07/21/2021
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: seen patient of at this time for syncopal episodes while driving and at work; worsened Bipolar; Decreased level of consciousness; worsened Depression; Difficulty breathing/issues with breathing; worsened Anxiety; Feeling ill; felt really tired; felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar) and DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (2 surgeries on other leg). Concurrent medical conditions included Bipolar disorder, Gout (In one leg), Penicillin allergy (reaction- nausea), Drug allergy (Revatio (reaction- nausea)), Drug allergy (Vicodin (reaction- nausea)), Seasonal allergy (reaction- congestion), Anxiety (worse with COVID mask use) and Depression (worse with COVID mask use). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 19-Apr-2021 to an unknown date for Depression, INDOMETACIN (INDOCIN [INDOMETACIN]) from 07-Oct-2020 to an unknown date for Gout, NAPROXEN SODIUM (ALEVE) from 24-Sep-2019 to an unknown date for Pain. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), ILLNESS (Feeling ill) and FATIGUE (felt really tired). On 14-Jun-2021, the patient experienced ANXIETY (worsened Anxiety). On an unknown date, the patient experienced SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work) (seriousness criterion medically significant), BIPOLAR DISORDER (worsened Bipolar) (seriousness criterion medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), DEPRESSION (worsened Depression) and DYSPNOEA (Difficulty breathing/issues with breathing). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and OLANZAPINE (ZYPREXA) (oral) ongoing from 07-Jul-2021 for Bipolar affective disorder aggravated, at a dose of 10 mg. At the time of the report, SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ANXIETY (worsened Anxiety), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANXIETY (worsened Anxiety) to be possibly related. No further causality assessments were provided for SYNCOPE (seen patient of at this time for syncopal episodes while driving and at work), BIPOLAR DISORDER (worsened Bipolar), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DEPRESSION (worsened Depression), SOMNOLENCE (felt really tired like he couldn't keep his eyes open / his son later woke him and he stated he hadn't realized he went to sleep/Feels like he almost wants to fall asleep), DYSPNOEA (Difficulty breathing/issues with breathing), ILLNESS (Feeling ill) and FATIGUE (felt really tired). After getting the vaccine in the morning, the patient felt really tired. The patient went to the family doctor for a previously scheduled appointment regarding his condition. On the way there he couldn't keep the eyes open, and felt as if he didn't get enough sleep. The patient hadn't realized that he slept. The patient had assistance from his son because he felt like he could catch his train of thought. The patient told his O2 level was fine and was instructed to take Benadryl. The HCP reported that anxiety, depression and bipolar might be psychological and wondered why these had gotten worse. 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, history of bipolar depression and anxiety may remain as risk factors. This case was linked to MOD-2021-215030, MOD-2021-214836 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up contains New event , Medical history On 08-Jul-2021: Follow-up included: Medical history was updated, Patient weight, anatomical location of vaccine administered, Dose 1 details added On 14-Jul-2021: Case has been updated from non-serious to serious due to the addition of Serious events. New non-serious events also have been added. Patient's demographic details and reporter contact details were updated. Patient's medical history including allergies and current conditions, concomitant medications and treatment details were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, history of bipolar depression and anxiety may remain as risk factors.

Other Meds: INDOCIN [INDOMETACIN]; ALEVE; WELLBUTRIN

Current Illness: Anxiety (worse with COVID mask use); Bipolar disorder; Depression (worse with COVID mask use); Drug allergy (Vicodin (reaction- nausea)); Drug allergy (Revatio (reaction- nausea)); Gout (In one leg); Penicillin allergy (reaction- nausea); Seasonal allergy (reaction- congestion)

ID: 1489591
Sex: F
Age:
State:

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 07/21/2021
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: inferred pulmonary embolism; deep vein thrombosis in right femoral vein; It was the second trimester in her pregnancy /Pregnant; Chest pain (non-cardiac); Shortness of breath; Feeling unwell; Insomnia; Feeling anxious; sore upper arm after first vaccine; Fever; Vaccination site pain; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (inferred pulmonary embolism) and DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PULMONARY EMBOLISM (inferred pulmonary embolism) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein) (seriousness criterion medically significant), EXPOSURE DURING PREGNANCY (It was the second trimester in her pregnancy /Pregnant), NON-CARDIAC CHEST PAIN (Chest pain (non-cardiac)), DYSPNOEA (Shortness of breath), MALAISE (Feeling unwell), INSOMNIA (Insomnia), ANXIETY (Feeling anxious), MYALGIA (sore upper arm after first vaccine), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue). The delivery occurred on an unknown date. For neonate 1, patient was 25 weeks pregnant during the vaccination. The patient was treated with HEPARIN for DVT, at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (inferred pulmonary embolism), DEEP VEIN THROMBOSIS (deep vein thrombosis in right femoral vein), NON-CARDIAC CHEST PAIN (Chest pain (non-cardiac)), DYSPNOEA (Shortness of breath), MALAISE (Feeling unwell), INSOMNIA (Insomnia), ANXIETY (Feeling anxious), MYALGIA (sore upper arm after first vaccine), PYREXIA (Fever), VACCINATION SITE PAIN (Vaccination site pain) and FATIGUE (Fatigue) outcome was unknown and EXPOSURE DURING PREGNANCY (It was the second trimester in her pregnancy /Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: abnormal (abnormal) DVT in right femoral vein. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was not reported. Concomitant was not reported. In the emergency room, patient was diagnosed by sonogram for DVT in her right femoral vein. A chest x-ray was taken and due to the patient's symptoms a pulmonary embolism was inferred to be the cause without further need of investigation by CT scan due to the increased risk for pregnant females. patient was treated with a shot of low molecular weight heparin (LMWH) and continues to get a LMWH subdermal shot every twelve hours for the duration of her pregnancy. After one night in the ICU, the patient was discharged with no further complications for pregnant patient or the fetus to date. The blue-sky scenario is this patient developed a blood clot prior to vaccination, and the body's response to the vaccine caused enough stress to cause the emergent crisis. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-251142 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received contains No New Information.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1489592
Sex: F
Age: 79
State: CA

Vax Date: 03/05/2021
Onset Date: 03/06/2021
Rec V Date: 07/21/2021
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: Asthenia, Chills, Headache, Myalgia

Symptoms: interstitial cystitis; feeling very sick in the morning; After not much sleep; projectile vomiting; shaking and teeth chattering; impossible to eat w/out vomiting / She couldn't eat or; she had all over excruciating pain; UTI; extreme back pain; weak legs and unsteady/ very unsteady; arm was sore at the site; aching head to feet, body that had ever been in pain was more painful; rigor chills, teeth chattering; Nauseated; cytokine reaction; headache; sick to her stomach; dizziness/; This spontaneous case was reported by a consumer and describes the occurrence of CYTOKINE STORM (cytokine reaction) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cystitis interstitial from 1996 to 1999. On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CYTOKINE STORM (cytokine reaction) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), HEADACHE (headache) and NAUSEA (Nauseated). On an unknown date, the patient experienced CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), MYALGIA (aching head to feet, body that had ever been in pain was more painful) and CHILLS (rigor chills, teeth chattering). At the time of the report, CYTOKINE STORM (cytokine reaction), CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), HEADACHE (headache), MYALGIA (aching head to feet, body that had ever been in pain was more painful), CHILLS (rigor chills, teeth chattering) and NAUSEA (Nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 degree Celsius (High) 100.6 and 99.1 degree Celsius (High) 99.1. Relevant concomitant medications were not reported. Treatment information was not provided. Patient visited her cardiologist and primary care doctors and they reported good strong immune response. Patient also visited oncologist; he reported cytokine reaction. Patient also had a medical history of interstitial cystitis for 3 years but again she developed interstitial cystitis after the 2nd dose. 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 11-Jul-2021: Additional information received on 10-JUL-2021 regarding the 2nd Dose events and lab data. On 12-Jul-2021: Follow-up information received on 12-JUL-2021 contains updated event onset date.; 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: 1489593
Sex: M
Age:
State:

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 07/21/2021
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: patient passed out; shot may him whoosy however he stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient passed out) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (patient passed out) (seriousness criterion medically significant) and CONFUSIONAL STATE (shot may him whoosy however he stayed in bed). At the time of the report, LOSS OF CONSCIOUSNESS (patient passed out) outcome was unknown and CONFUSIONAL STATE (shot may him whoosy however he stayed in bed) had resolved. Concomitant and treatment information not provided. This case was linked to MOD-2021-033479 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1489594
Sex: F
Age:
State: NY

Vax Date: 01/11/2021
Onset Date:
Rec V Date: 07/21/2021
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: severe idiosyncratic multi-symptom; rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair; Elevated liver enzymes; Scalp is itchy; long term delayed reaction; Lymph Nodes are swollen; This spontaneous case was reported by a consumer and describes the occurrence of IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair) and HEPATIC ENZYME INCREASED (Elevated liver enzymes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included PREDNISONE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and BETAMETHASONE for an unknown indication. On 11-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 IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom) (seriousness criterion medically significant), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair) (seriousness criterion medically significant), HEPATIC ENZYME INCREASED (Elevated liver enzymes) (seriousness criterion medically significant), PRURITUS (Scalp is itchy), SKIN REACTION (long term delayed reaction) and LYMPHADENOPATHY (Lymph Nodes are swollen). At the time of the report, IDIOSYNCRATIC DRUG REACTION (severe idiosyncratic multi-symptom), RASH (rash soon after second vaccination that went up her arm to her Lymph Nodes/rash did not get better/rash is covering 90% of her body/Entire body had rash except for feet, face/rash on chest/rash on arms/rash on head through hair), HEPATIC ENZYME INCREASED (Elevated liver enzymes), PRURITUS (Scalp is itchy), SKIN REACTION (long term delayed reaction) and LYMPHADENOPATHY (Lymph Nodes are swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. .Very limited information regarding these events have been provided at this time. Further information has been requested.

Other Meds: PREDNISONE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; BETAMETHASONE

Current Illness:

ID: 1489595
Sex: M
Age: 84
State: WV

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 07/21/2021
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: Pain in extremity

Symptoms: Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L02A) for COVID-19 vaccination. Concomitant products included APIXABAN (ELIQUIS) for Drug therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (Sore muscles) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-256561 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: METOPROLOL SUCCINATE; DOXYCYCLINE; ELIQUIS

Current Illness:

ID: 1489596
Sex: M
Age: 84
State: WV

Vax Date: 01/22/2021
Onset Date: 02/25/2021
Rec V Date: 07/21/2021
Hospital:

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: Rash on chest that went to his stomach; Went to hospital for fast heart rate; Trouble breathing; Felt like he had the flu; Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing) and RASH (Rash on chest that went to his stomach) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain). In May 2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the flu). On 30-May-2021, the patient experienced TACHYCARDIA (Went to hospital for fast heart rate) (seriousness criterion medically significant) and DYSPNOEA (Trouble breathing) (seriousness criterion medically significant). On 01-Jul-2021, the patient experienced RASH (Rash on chest that went to his stomach) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing), RASH (Rash on chest that went to his stomach), INFLUENZA LIKE ILLNESS (Felt like he had the flu), MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Heart rate: fast (High) Fast. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-256548 (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: METOPROLOL SUCCINATE; DOXYCYCLINE; ELIQUIS

Current Illness:

ID: 1489597
Sex: F
Age: 33
State: NJ

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 07/21/2021
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: had a kidney failure; severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down; letargic; could not stand up/could not use her legs; could not walk; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (had a kidney failure) and NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dialysis. Concurrent medical conditions included Kidney failure. Concomitant products included PREGABALIN (LYRICA), GABAPENTIN and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, 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 experienced RENAL FAILURE (had a kidney failure) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down) (seriousness criterion medically significant), LETHARGY (letargic), DYSSTASIA (could not stand up/could not use her legs) and GAIT DISTURBANCE (could not walk). At the time of the report, RENAL FAILURE (had a kidney failure), NEUROPATHY PERIPHERAL (severe neuropathy in both her legs, about a month and a half later, it's on her legs and into her feet and keeps traveling down), LETHARGY (letargic), DYSSTASIA (could not stand up/could not use her legs) and GAIT DISTURBANCE (could not walk) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was in prison when she took the second dose and they sent her home early as she had a kidney dialysis on 19-4-2021. The patient was in ICU after 9 days of second dose. Concomitant medications- Pracoceic Treatment- Physical therapy twice a week, medication for neuropathy. Very limited information regarding this event has been provided at this time. However, discharge summary/hospital notes are required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. However, discharge summary/hospital notes are required for further assessment.

Other Meds: LYRICA; GABAPENTIN; ZANAFLEX

Current Illness: Kidney failure

ID: 1489598
Sex: F
Age: 36
State: NE

Vax Date: 03/09/2021
Onset Date: 03/09/2021
Rec V Date: 07/21/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Diagnosed with Cramp-Fasciculation Disorder; Couldn't walk up steps without cramping her legs; While lying down it felt like she sprang her left ankle tendon which was very painful; While lying down it felt like she sprang her left ankle tendon; Experienced shooting pain throughout her body at random places; middle of her face went numb; right arm at the injection site was itching; muscle spasms; felt woozy; This spontaneous case was reported by a consumer and describes the occurrence of CRAMP-FASCICULATION SYNDROME (Diagnosed with Cramp-Fasciculation Disorder) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A,) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (felt woozy). On 06-Apr-2021, the patient experienced PAIN (Experienced shooting pain throughout her body at random places), HYPOAESTHESIA (middle of her face went numb), VACCINATION SITE PRURITUS (right arm at the injection site was itching) and MUSCLE SPASMS (muscle spasms). On an unknown date, the patient experienced GAIT INABILITY (Couldn't walk up steps without cramping her legs), ARTHRALGIA (While lying down it felt like she sprang her left ankle tendon which was very painful), LIGAMENT SPRAIN (While lying down it felt like she sprang her left ankle tendon) and CRAMP-FASCICULATION SYNDROME (Diagnosed with Cramp-Fasciculation Disorder) (seriousness criterion medically significant). The patient was treated with BACLOFEN ongoing since an unknown date at a dose of 5 mg as required; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and GABAPENTIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (Experienced shooting pain throughout her body at random places), DIZZINESS (felt woozy), HYPOAESTHESIA (middle of her face went numb), VACCINATION SITE PRURITUS (right arm at the injection site was itching), MUSCLE SPASMS (muscle spasms), GAIT INABILITY (Couldn't walk up steps without cramping her legs), ARTHRALGIA (While lying down it felt like she sprang her left ankle tendon which was very painful), LIGAMENT SPRAIN (While lying down it felt like she sprang her left ankle tendon) and CRAMP-FASCICULATION SYNDROME (Diagnosed with Cramp-Fasciculation Disorder) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CRAMP-FASCICULATION SYNDROME (Diagnosed with Cramp-Fasciculation Disorder) to be related. No further causality assessments were provided for PAIN (Experienced shooting pain throughout her body at random places), DIZZINESS (felt woozy), HYPOAESTHESIA (middle of her face went numb), VACCINATION SITE PRURITUS (right arm at the injection site was itching), MUSCLE SPASMS (muscle spasms), GAIT INABILITY (Couldn't walk up steps without cramping her legs), ARTHRALGIA (While lying down it felt like she sprang her left ankle tendon which was very painful) and LIGAMENT SPRAIN (While lying down it felt like she sprang her left ankle tendon). No concomitant medications were provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request. This case was linked to MOD-2021-256639 (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. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.

Other Meds:

Current Illness:

ID: 1489599
Sex: F
Age:
State: CA

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 07/21/2021
Hospital:

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: Delayed due to due to sleep apnea; Minor sore arm; increase in energy for about 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of APNOEA (Delayed due to due to sleep apnea) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Mast cell activation syndrome (Mast cell reaction), Tachycardia (POTS) and Excessive daytime sleepiness. Concurrent medical conditions included Drug allergy (Novocain), Drug allergy (slurines), Drug allergy (singular), Drug allergy (Cromolyn sodium) and Drug allergy (Most add meds). Concomitant products included IVABRADINE HYDROCHLORIDE (CORLANOR), RIVASTIGMINE (EXELON), BUPROPION HYDROCHLORIDE (WELLBUTRIN), KETOTIFEN, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FAMOTIDINE (PEPCID [FAMOTIDINE]), NALTREXONE, IMMUNOGLOBULINS NOS and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. 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 APNOEA (Delayed due to due to sleep apnea) (seriousness criterion medically significant), PAIN IN EXTREMITY (Minor sore arm) and ENERGY INCREASED (increase in energy for about 3 weeks). At the time of the report, APNOEA (Delayed due to due to sleep apnea), PAIN IN EXTREMITY (Minor sore arm) and ENERGY INCREASED (increase in energy for about 3 weeks) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment 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 events, a causal relationship cannot be excluded. However, the patient's comorbidities are risk factors and confounds causality assessment. Further information has been requested. This case was linked to MOD-2021-256730 (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. However, the patient's comorbidities are risk factors and confounds causality assessment.Further information has been requested.

Other Meds: CORLANOR; EXELON; WELLBUTRIN; KETOTIFEN; ZYRTEC ALLERGY; PEPCID [FAMOTIDINE]; NALTREXONE; IMMUNOGLOBULINS NOS; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Drug allergy (slurines); Drug allergy (singular); Drug allergy (Novocain); Drug allergy (Most add meds); Drug allergy (Cromolyn sodium)

ID: 1489600
Sex: F
Age:
State: CA

Vax Date: 03/30/2021
Onset Date: 05/08/2021
Rec V Date: 07/21/2021
Hospital:

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: severe neuropathy in feet; Gait disruption,Couldn't walk more than 10 meters; Radiating sciatic, bilateral; Adrenaline rushes; Felt like an electric shot like pain; hot flashes; Major headaches level 7 pain; Full body tenderness; Flu like pain; tachycardia spiked to 130,tachycardia continues; Shortness of breath; large joint pain; severe mast cell reaction ( is a mast cell patient); Nausea; Fatigue; loss of appetite; lost 10 % of body weight; 2nd dose 08May2021 (delayed due to a sleep study due to sleep apnea; Arm soreness/progressed into shooting leg pain; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (severe neuropathy in feet) and GAIT INABILITY (Gait disruption,Couldn't walk more than 10 meters) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Mast cell activation syndrome. Concurrent medical conditions included Drug allergy (Novocain (all cains)allergy), Drug allergy (Singulair allergy), Drug allergy (Cromolyn sodium allergy), Postural orthostatic tachycardia syndrome and Ehlers-Danlos syndrome. Concomitant products included IVABRADINE HYDROCHLORIDE (CORLANOR), RIVASTIGMINE (EXELON [RIVASTIGMINE]), BUPROPION HYDROCHLORIDE (WELLBUTRIN), KETOTIFEN, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), NALTREXONE, IMMUNOGLOBULINS NOS (IMMUNOGLOBULIN I.V) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness/progressed into shooting leg pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 08May2021 (delayed due to a sleep study due to sleep apnea). On 14-May-2021, the patient experienced DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (lost 10 % of body weight), NAUSEA (Nausea) and FATIGUE (Fatigue). On 16-May-2021, the patient experienced MAST CELL ACTIVATION SYNDROME (severe mast cell reaction ( is a mast cell patient)). On 22-May-2021, the patient experienced ARTHRALGIA (large joint pain). On 26-May-2021, the patient experienced TACHYCARDIA (tachycardia spiked to 130,tachycardia continues) and DYSPNOEA (Shortness of breath). On 02-Jun-2021, the patient experienced TENDERNESS (Full body tenderness) and INFLUENZA LIKE ILLNESS (Flu like pain). On 08-Jun-2021, the patient experienced FEELING ABNORMAL (Adrenaline rushes), PAIN (Felt like an electric shot like pain), HOT FLUSH (hot flashes) and HEADACHE (Major headaches level 7 pain). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (severe neuropathy in feet) (seriousness criterion medically significant). an unknown date, the patient experienced GAIT INABILITY (Gait disruption,Couldn't walk more than 10 meters) (seriousness criterion medically significant) and SCIATICA (Radiating sciatic, bilateral). The patient was treated with KETOROLAC TROMETHAMINE (TORADOL) (intravenous) on 08-Jun-2021 for Headache, at a dose of 30 mg; DEXAMETHASONE (DECADRON [DEXAMETHASONE]) for Neuropathy, at an unspecified dose and frequency and GABAPENTIN for Neuropathy, at an unspecified dose and frequency. On 08-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 08May2021 (delayed due to a sleep study due to sleep apnea) had resolved. At the time of the report, NEUROPATHY PERIPHERAL (severe neuropathy in feet), MAST CELL ACTIVATION SYNDROME (severe mast cell reaction ( is a mast cell patient)), DYSPNOEA (Shortness of breath), FEELING ABNORMAL (Adrenaline rushes), DECREASED APPETITE (loss of appetite), WEIGHT DECREASED (lost 10 % of body weight), SCIATICA (Radiating sciatic, bilateral), TENDERNESS (Full body tenderness), INFLUENZA LIKE ILLNESS (Flu like pain), PAIN IN EXTREMITY (Arm soreness/progressed into shooting leg pain), PAIN (Felt like an electric shot like pain), HOT FLUSH (hot flashes), HEADACHE (Major headaches level 7 pain), ARTHRALGIA (large joint pain), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown and GAIT INABILITY (Gait disruption,Couldn't walk more than 10 meters) and TACHYCARDIA (tachycardia spiked to 130,tachycardia continues) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, Heart rate: 130 (High) tachycardia spiked to 130. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Medical history also included Mast cell reaction, allergies to slurines and ADD medicines. Treatment also included IV medicines and topical pain cream. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded This case was linked to MOD-2021-256724 (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: CORLANOR; EXELON [RIVASTIGMINE]; WELLBUTRIN; KETOTIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]; NALTREXONE; IMMUNOGLOBULIN I.V; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Drug allergy (Singulair allergy); Drug allergy (Novocain (all cains)allergy); Drug allergy (Cromolyn sodium allergy); Ehlers-Danlos syndrome; Postural orthostatic tachycardia syndrome

ID: 1489601
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/21/2021
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: Heart inflammation/inflammation of heart muscle/myocarditis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of MYOCARDITIS (Heart inflammation/inflammation of heart muscle/myocarditis) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Heart inflammation/inflammation of heart muscle/myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Heart inflammation/inflammation of heart muscle/myocarditis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment information was not provided. The Center for Disease Control and Prevention (CDC) Advisory Committee stated that some teenagers and young adults who received COVID-19 vaccines experienced heart inflammation/myocarditis. The committee said that the the recipients were predominantly adolescent and young male adults. It said that the condition often went away without complications and could be caused by variety of viruses. CDC monitoring systems had not found more cases than would be expected in the population. A doctor for Health Security said that vaccines were known to cause myocarditis and would be important to monitor if it was causally related to the vaccine. The CDC said that the cases typically occurred four days post receiving mRNA vaccines but did not specify which vaccine as had given emergency authorization to two mRNA vaccines i.e. Moderna Inc and Pfizer/BioNTech. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1489602
Sex: F
Age: 72
State: PA

Vax Date: 06/02/2021
Onset Date: 07/10/2021
Rec V Date: 07/21/2021
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: Lump in vein; blood clot on hand; Superficial thrombophlebitis; Negative reaction/Most severe reaction/delayed reaction; Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful; Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive; Warm/warmer than surrounding skin; Tender/tender to touch; Could not move hand and wrist/ Unable to use hand/Unable to turn wrist; Panicked; swelling of right hand: from below last thumb joint to past wrist; purplish discoloration/red discoloration; Redness/erythema local/ with red; frightening experience; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021. This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (Lump in vein) and THROMBOSIS (blood clot on hand) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 005C21AAAAA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Carpal tunnel syndrome (More painful) since 1998. Previously administered products included for Product used for unknown indication: FLU (welts on upper torso) in 1996. Concurrent medical conditions included Vascular disorder NOS (Vascular issue), Vein disorder (Clogged lower vein), Allergic to cats, Hypertension since 2003, Hyperlipidemia since 2003, Type 2 diabetes mellitus since 2004, Neuropathy since 2004, Osteoarthritis since 2006, Left bundle branch block since 2006, Cholesterol, Allergy to antibiotic (Allergic to ampicillin - felt ill, nauseous.), Sulfonamide allergy (Allergic to Sulfa drugs - difficulty breathing), Allergy to nuts (Allergic to almond - swelling of tongue, mild to moderate), Drug allergy (Allergic to other -cillin meds-no antibiotic reaction, caused nausea.), Perfume sensitivity (Allergic to chemical fragrances a used some allergic asmtha, issue has mostly gone/resolved itself) and Allergic asthma. Concomitant products included LOSARTAN POTASSIUM and LABETALOL HCL for Blood pressure, SIMVASTATIN for Cholesterol, UBIQUINOL for Energy increased, GABAPENTIN for Pain management, IRON for Supplementation therapy, METFORMIN HCL for Type 2 diabetes mellitus, HORSE CHESTNUT EXTRACT for Vein disorder. On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced DEEP VEIN THROMBOSIS (Lump in vein) (seriousness criterion medically significant), THROMBOSIS (blood clot on hand) (seriousness criterion medically significant), THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis), VACCINATION COMPLICATION (Negative reaction/Most severe reaction/delayed reaction), PAIN IN EXTREMITY (Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful), PERIPHERAL SWELLING (Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive), FEELING HOT (Warm/warmer than surrounding skin), TENDERNESS (Tender/tender to touch), MOBILITY DECREASED (Could not move hand and wrist/ Unable to use hand/Unable to turn wrist), PANIC REACTION (Panicked), JOINT SWELLING (swelling of right hand: from below last thumb joint to past wrist), SKIN DISCOLOURATION (purplish discoloration/red discoloration), ERYTHEMA (Redness/erythema local/ with red) and FEELING ABNORMAL (frightening experience). The patient was treated with VITIS VINIFERA SEED (GRAPE SEED EXTRACT [VITIS VINIFERA SEED]) for Vascular disorder NOS, at an unspecified dose and frequency. On 12-Jul-2021, THROMBOPHLEBITIS SUPERFICIAL (Superficial thrombophlebitis), VACCINATION COMPLICATION (Negative reaction/Most severe reaction/delayed reaction), FEELING HOT (Warm/warmer than surrounding skin), TENDERNESS (Tender/tender to touch), MOBILITY DECREASED (Could not move hand and wrist/ Unable to use hand/Unable to turn wrist), PANIC REACTION (Panicked), JOINT SWELLING (swelling of right hand: from below last thumb joint to past wrist), SKIN DISCOLOURATION (purplish discoloration/red discoloration), ERYTHEMA (Redness/erythema local/ with red) and FEELING ABNORMAL (frightening experience) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (Lump in vein), PAIN IN EXTREMITY (Woke up in extreme pain, wave of huge pain/extreme pain / pain was overwhelming./ Painful) and PERIPHERAL SWELLING (Badly swollen hand,Swollen/ swelling of right hand: from below last thumb joint to past wrist/ Swollen lump on surface vein below thumb/ swelling was too restrictive) had resolved and THROMBOSIS (blood clot on hand) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) mmHg. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After second shot on 10-Jul-2021 patient experienced extreme pain, swelling of right hand: from below last thumb joint to past wrist. Swollen lump on surface vein below thumb, tender to touch, and warmer than surrounding skin, with red, purplish discoloration. On scale of 1 to 10, the pain level was a 10. Unable to turn wrist, swelling was too restrictive and pain was overwhelming. Unable to use hand. Over course of approximately 2 days the swelling died down and the pain lessened. The hard lump blood clot on the vein remains. Patient consulted Cardiologist. diagnosed it as Superficial Thrombophlebitis, informed to patient it was blood clot in the wall of a peripheral/surface vein caused by inflammation. cardiologist recommended for at-home treatment was: warm compresses, raising my arm above my heart as much as possible for at least 1-2 days, & using an anti-inflammatory NSAID like Aleve, etc. Patient indicated that he swelling and associated pain would most likely dissipate within a couple of days. He also stated the blood clot would take several months to improve/resolve. 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-2021-235384 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Significant follow up received and added Patient medical history, concomitants,NewAE ,vaccine details,causality and outcome details, and patient demographics are updated.; 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: HORSE CHESTNUT EXTRACT; IRON; UBIQUINOL; GABAPENTIN; LOSARTAN POTASSIUM; METFORMIN HCL; SIMVASTATIN; LABETALOL HCL

Current Illness: Allergic asthma; Allergic to cats; Allergy to antibiotic (Allergic to ampicillin - felt ill, nauseous.); Allergy to nuts (Allergic to almond - swelling of tongue, mild to moderate); Carpal tunnel syndrome (More painful); Cholesterol; Drug allergy (Allergic to other -cillin meds-no antibiotic reaction, caused nausea.); Hyperlipidemia; Hypertension; Left bundle branch block; Neuropathy; Osteoarthritis; Perfume sensitivity (Allergic to chemical fragrances a used some allergic asmtha, issue has mostly gone/resolved itself); Sulfonamide allergy (Allergic to Sulfa drugs - difficulty breathing); Type 2 diabetes mellitus; Vascular disorder NOS (Vascular issue); Vein disorder (Clogged lower vein)

Date Died: 06/26/2021

ID: 1489603
Sex: M
Age: 89
State: FL

Vax Date: 03/11/2021
Onset Date: 04/10/2021
Rec V Date: 07/21/2021
Hospital: Y

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: Fluid in lungs; Lethargic after second vaccine; disoriented/confusion; Dehydration; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), DEHYDRATION (Dehydration), PULMONARY OEDEMA (Fluid in lungs), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 024M20A) for COVID-19 vaccination. Concurrent medical conditions included COPD since 06-Jan-2021. Concomitant products included PREDNISONE from 10-May-2020 to an unknown date for Bullous pemphigoid, ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization), LETHARGY (Lethargic after second vaccine) (seriousness criterion hospitalization) and DISORIENTATION (disoriented/confusion) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criteria hospitalization and medically significant). The patient died on 26-Jun-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, DEHYDRATION (Dehydration), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) had resolved and PULMONARY OEDEMA (Fluid in lungs) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After 2nd vaccine 09-apr-2021, 36 hrs later (name) Lethargic, Disorientated ems to hospital. Some dehydration, fluids, than he has fluid in lungs. 8 days hospital. Never the some after discharged 4/19/21. (name) declined until his DEATH on 26-Jun-2021. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-042828 (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.; Reported Cause(s) of Death: Unknown cause of death

Other Meds: CRESTOR; AGGRENOX; PREDNISONE

Current Illness: COPD

Date Died:

ID: 1489604
Sex: U
Age:
State:

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

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: Death; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided Concomitant product was not reported. Treatment was not reported. Company Comment : Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm