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: 1423017
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: THREW A BLOOD CLOT IN HEART; OFF LABEL USE; DRUG USE FOR UNAPPROVED DOSING REGIMEN; This spontaneous report received from a patient via social media (Facebook) 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 and expiry: UNKNOWN) dose, start therapy date were not reported, 2 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, the patient got the second J&J Covid shot (off label use and drug use for unapproved dosing regimen), and experienced a blood clot in heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from threw a blood clot in heart, and the outcome of off label use and drug use for unapproved dosing regimen was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This report received via social media concerns a female of unspecified age and race/ethnicity who "threw a blood clot in her heart" an unspecified time after receiving a second Janssen Covid-19 vaccination. Medical history, concomitant medications, diagnosis, latency, diagnostic testing, corrective treatments, and outcome were not reported. At this time, this case does not appear to be consistent with recently reported Thrombosis with Thrombocytopenia Syndrome following Covid-19 vaccine administration. In light of missing information (medical history, concomitant medications, diagnosis, latency, diagnostic testing to clarify the type of clot, platelet counts, anti-PF4 antibody, tests for hypercoagulability, corrective treatments), the relationship with Janssen Covid-19 vaccine is considered unclassifiable.

Other Meds:

Current Illness:

ID: 1423018
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital: Y

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: BLOOD CLOTS IN LEG; 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) 1 total, 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 patient had blood clots in leg and was in and out of the hospital but still had the clot (at the time of this report). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood clots in leg. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210644769-JANSSEN COVID-19 VACCINE-Blood clots in leg. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1423019
Sex: F
Age:
State: CT

Vax Date:
Onset Date: 03/14/2021
Rec V Date: 06/24/2021
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: STOMACH ACHE; HEADACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient did not take any medication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced stomach ache. On 14-MAR-2021, the subject experienced headache. On 14-APR-2021, Laboratory data included: CT scan (NR: not provided) Not reported, Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stomach ache, and headache. This report was non-serious.

Other Meds:

Current Illness: Alcoholic (Glass of wine very occasionally.); Non-smoker

ID: 1423020
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: ANXIETY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anxiety was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423021
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/24/2021
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: EXCESSIVE DROOLING/SLOBBERING; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and high blood pressure, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 07-AUG-2021) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included metformin for diabetes, lisinopril for high blood pressure, and tamsulosin. On JUN-2021, the subject experienced excessive drooling/slobbering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from excessive drooling/slobbering. This report was non-serious.

Other Meds: METFORMIN; LISINOPRIL; TAMSULOSIN

Current Illness: Blood pressure high; Diabetes

ID: 1423022
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/20/2021
Rec V Date: 06/24/2021
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: VACCINE GIVEN TO PATIENT 17 YEARS OF AGE; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 17 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: Unknown) dose was not reported, administered on 20-JUN-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 20-JUN-2021, the subject experienced vaccine given to subject 17 years of age. On 20-JUN-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given to patient 17 years of age and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423023
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 04/09/2021
Rec V Date: 06/24/2021
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: SWELLING OF THE FACE; GENERALIZED ITCHING; HIVES ALL OVER HER BODY; FEVER; CHILLS; This spontaneous report received from a patient concerned a 66 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: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced fever. On 15-MAY-2021, the subject experienced hives all over her body. On 19-JUN-2021, the subject experienced swelling of the face. On 19-JUN-2021, the subject experienced generalized itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 10-APR-2021, and had not recovered from hives all over her body, swelling of the face, and generalized itching. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423024
Sex: U
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: VACCINE FROM A TEMPERATURE EXCURSION WAS ADMINISTERED; VACCINE WAS ADMINISTERED AT A DIFFERENT SITE; TEMPERATURE EXCURSION OF VACCINE PRODUCT; 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine from a temperature excursion was administered, vaccine was administered at a different site, and temperature excursion of vaccine product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion of vaccine product, vaccine from a temperature excursion was administered and vaccine was administered at a different site was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423025
Sex: M
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: THE INJECTION SITE FEELS NUMB WHEN RUBBED; WHEN STRETCHES ARM BACK GETS A SHARP NEEDLE LIKE PAIN; RED DOT AT INJECTION SITE; This spontaneous report received from a health care professional concerned a 28 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 07-AUG-2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced the injection site feels numb when rubbed, when stretches arm back gets a sharp needle like pain, and red dot at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the red dot at injection site, the injection site feels numb when rubbed and when stretches arm back gets a sharp needle like pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423026
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/12/2021
Rec V Date: 06/24/2021
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: RIGHT ARM PAIN; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, and non alcohol use, and other pre-existing medical conditions included the patient had no known allergies and 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: 201ALIA expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced right arm pain. On 21-JUN-2021, Laboratory data included: Pain scale (NR: not provided) 8/10. 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 right arm pain. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1423027
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: FELT HORRIBLE; BODY ON FIRE; MASSIVE FEVER; 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 felt horrible, body on fire, and massive fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt horrible, massive fever and body on fire was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423028
Sex: U
Age:
State: TX

Vax Date:
Onset Date: 06/21/2021
Rec V Date: 06/24/2021
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: BODY ACHE; CHEST PAIN; ANXIETY; 88 BPM HEART RATE; BODY CHILLS; MUSCLE ACHE; FEVER 102; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-JUN-2021 16:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 21-JUN-2021, the subject experienced body ache. On 21-JUN-2021, the subject experienced chest pain. On 21-JUN-2021, the subject experienced anxiety. On 21-JUN-2021, the subject experienced 88 bpm heart rate. On 21-JUN-2021, the subject experienced body chills. On 21-JUN-2021, the subject experienced muscle ache. On 21-JUN-2021, the subject experienced fever 102. Laboratory data included: Body temperature (NR: not provided) fever 102, and Heart rate (NR: not provided) 88 BPM heart rate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 102, body ache, chest pain, anxiety, 88 bpm heart rate, body chills and muscle ache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423029
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 06/22/2021
Rec V Date: 06/24/2021
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: ITCHY THROAT/SCRATCHY THROAT (VERY UNCOMFORTABLE); ANXIETY; 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, and batch number were not reported) dose was not reported, administered on 22-JUN-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 22-JUN-2021, the subject experienced itchy throat/scratchy throat (very uncomfortable). On 22-JUN-2021, the subject experienced anxiety. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy throat/scratchy throat (very uncomfortable), and the outcome of anxiety was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423030
Sex: U
Age:
State: MO

Vax Date:
Onset Date: 06/22/2021
Rec V Date: 06/24/2021
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: VACCINE ADMINISTERED TO PATIENTS AT 4 HOURS 55 MINUTES, 5 HOURS AND 5 HOURS 20 MINUTES RESPECTIVELY , WHICH WAS STORED OUT AT ROOM TEMPERATURE FOR 5 HOURS; VACCINE WAS STORED OUT FOR 5 HOURS AT ROOM TEMPERATURE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 22-JUN-2021, the subject experienced vaccine administered to subjects at 4 hours 55 minutes, 5 hours and 5 hours 20 minutes respectively, which was stored out at room temperature for 5 hours. On 22-JUN-2021, the subject experienced vaccine was stored out for 5 hours at room temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered to patients at 4 hours 55 minutes, 5 hours and 5 hours 20 minutes respectively , which was stored out at room temperature for 5 hours and vaccine was stored out for 5 hours at room temperature was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423031
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/22/2021
Rec V Date: 06/24/2021
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: CHEST FELT TIGHTER, UNCOMFORTABLE; SHAKING IN BOTH ARMS/HANDS; SHORTNESS OF BREATH; CHEST PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced shortness of breath. On 22-JUN-2021, the subject experienced chest pain. On 22-JUN-2021, the subject experienced chest felt tighter, uncomfortable. On 22-JUN-2021, the subject experienced shaking in both arms/hands. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, chest pain, shaking in both arms/hands, and chest felt tighter, uncomfortable. This report was non-serious.

Other Meds:

Current Illness:

ID: 1423032
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/24/2021
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: VACCINE WAS KEPT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist 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 was previously treated with mrna 1273 for prophylactic vaccination. 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 12-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-JUN-2021, the subject experienced vaccine was kept at room temperature for more than 2 hours. On 12-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was kept at room temperature for more than 2 hours and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210648291 and 20210417942.

Other Meds:

Current Illness:

ID: 1423033
Sex: F
Age:
State: VA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 06/24/2021
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: Anaphylactic reaction; Heartbeat fast; Hands were shaking; Dizzy and lightheaded; Could not swallow; Flushed; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 38-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 Rhinitis (She did have severe sinusitis 2 years ago) and Sinuplasty (This responded well to sinuplasty). Concomitant products included BIOTIN, KERATIN (BIOTIN PLUS KERATIN), COLLAGEN BOVINE and LINACLOTIDE (LINZESS) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed). The patient was treated with EPINEPHRINE 14-Jan-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intravenous) 14-Jan-2021 at a dose of 1 dosage form. On 14-Jan-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction), TACHYCARDIA (Heartbeat fast), TREMOR (Hands were shaking), DIZZINESS (Dizzy and lightheaded), DYSPHAGIA (Could not swallow) and FLUSHING (Flushed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Blood pressure measurement: 106/71 (normal) 106/71. On 14-Jan-2021, Body temperature: 36.6 (normal) 36.6. On 14-Jan-2021, Heart rate: 87 (normal) Temporal pulse 87. On 14-Jan-2021, Oxygen saturation: 98 (normal) 98%. On 14-Jan-2021, Respiratory rate: 18 (Inconclusive) 18 bpm. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was taken to ER, treated with IV fluid and also IV steroid. Patient was observed for 4 hours, improved completely and discharged form the ER. She was recommended to take epi-pen, vitamin D, vitamin C and zinc. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 05-Apr-2021: Added medical history, lab data, concomitant medications and new event; updated patient demography and event stop 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 event, a causal relationship cannot be excluded.

Other Meds: BIOTIN PLUS KERATIN; COLLAGEN BOVINE; LINZESS

Current Illness:

ID: 1423034
Sex: U
Age:
State: VT

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: Almost 2000 people had a similar reaction (not the redness)/hearing loss response; Almost 2000 people had a similar reaction (not the redness)/tinnitus; similar reaction; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 28-May-2021 and was forwarded to Moderna on 28-May-2021. Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response) (seriousness criterion medically significant), TINNITUS (Almost 2000 people had a similar reaction (not the redness)/tinnitus) and VACCINATION COMPLICATION (similar reaction). At the time of the report, DEAFNESS (Almost 2000 people had a similar reaction (not the redness)/hearing loss response), TINNITUS (Almost 2000 people had a similar reaction (not the redness)/tinnitus) and VACCINATION COMPLICATION (similar reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. Very limited information regarding these events have been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow- up received added new events which upgraded the case to serious.; Sender's Comments: Very limited information regarding these events have been provided at this time.

Other Meds:

Current Illness:

ID: 1423035
Sex: M
Age: 37
State: CA

Vax Date: 02/15/2021
Onset Date: 03/24/2021
Rec V Date: 06/24/2021
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: erythematous palms; anxiety; hands swelling; Itchiness; joint pain; muscle aches; Rheumatoid Arthritis; slight elevation of Scleroderma; This spontaneous case was reported by an other health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) and SCLERODERMA (slight elevation of Scleroderma) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Seasonal allergy since 19-May-2021. Concomitant products included AMLODIPINE for an unknown indication. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced SCLERODERMA (slight elevation of Scleroderma) (seriousness criterion medically significant). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis) (seriousness criterion medically significant), PALMAR ERYTHEMA (erythematous palms), ANXIETY (anxiety), PERIPHERAL SWELLING (hands swelling), PRURITUS (Itchiness), ARTHRALGIA (joint pain) and MYALGIA (muscle aches). The patient was treated with PREDNISONE at a dose of 20mg; BUSPIRONE HYDROCHLORIDE (BUSPAR) at a dose of 15mg bid; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and OMEPRAZOLE at a dose of 5mg OD. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis), SCLERODERMA (slight elevation of Scleroderma), PALMAR ERYTHEMA (erythematous palms), ANXIETY (anxiety), PERIPHERAL SWELLING (hands swelling) and MYALGIA (muscle aches) outcome was unknown and PRURITUS (Itchiness) and ARTHRALGIA (joint pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood immunoglobulin E: increased (abnormal) Consultation with the Allergist on 19th Mar 2021 recorded high Ig E of 161 and mentioned as seasonal Allergies. On 24-May-2021, Antinuclear antibody: positive ana (Positive) Positive. On 24-May-2021, Rheumatoid factor quantitative: low (Low) low titer level, slight elevation of Scleroderma. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The past history of Rheumatoid arthritis is a confounder.. This case was linked to MOD-2021-116524 (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. The past history of Rheumatoid arthritis is a confounder.

Other Meds: AMLODIPINE

Current Illness: Seasonal allergy

ID: 1423036
Sex: F
Age: 75
State: CA

Vax Date: 02/08/2021
Onset Date: 03/09/2021
Rec V Date: 06/24/2021
Hospital: Y

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: shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criteria hospitalization and medically significant). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-137907 (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:

Current Illness:

ID: 1423037
Sex: F
Age:
State: MD

Vax Date: 05/26/2021
Onset Date:
Rec V Date: 06/24/2021
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: Non responsive; Slept the rest of the day; Chills; Extremely fatigued; Fever; She vomitted and totally incapacinated.; This spontaneous case was reported by a consumer and describes the occurrence of UNRESPONSIVE TO STIMULI (Non responsive) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included LISINOPRIL, INSULIN and ATORVASTATIN for an unknown indication. On 26-May-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNRESPONSIVE TO STIMULI (Non responsive) (seriousness criterion medically significant), SOMNOLENCE (Slept the rest of the day), CHILLS (Chills), FATIGUE (Extremely fatigued), PYREXIA (Fever) and VOMITING (She vomitted and totally incapacinated.). On 27-May-2021, VOMITING (She vomitted and totally incapacinated.) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (Non responsive), SOMNOLENCE (Slept the rest of the day), CHILLS (Chills), FATIGUE (Extremely fatigued) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication was not provided. This case concerns a 38-year-old female with a serious unexpected event of unresponsive to stimuli, and nonserious somnolence, chills, fatigue, pyrexia and vomiting. Event latency within 24 hours after mRNA-1273. 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 09-Jun-2021: Added patient demographics height 4'6'' inches, weight 100 pounds, race, ethnic group. Added new medical history diabetic, high blood pressure. Added drug information's start date, dose number, batch number, body site. Added concomitant medications Lisinopril ,Insulin in siding scale, Atorvastatin. Added events were non responsive,extremely fatigued, she slept the rest of the day, vomited. Added event out come recovered.; Sender's Comments: This case concerns a 38-year-old female with a serious unexpected event of unresponsive to stimuli, and nonserious somnolence, chills, fatigue, pyrexia and vomiting. Event latency within 24 hours after mRNA-1273. 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: LISINOPRIL; INSULIN; ATORVASTATIN

Current Illness: Blood pressure high; Diabetes

ID: 1423038
Sex: F
Age: 26
State: IN

Vax Date: 04/26/2021
Onset Date: 06/04/2021
Rec V Date: 06/24/2021
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: convulsions; Uncontrollable movement on her face / Uncontrollable movement of entire body; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (convulsions) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 648B21A and 037C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant) and DYSKINESIA (Uncontrollable movement on her face / Uncontrollable movement of entire body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 25 mg. At the time of the report, SEIZURE (convulsions) and DYSKINESIA (Uncontrollable movement on her face / Uncontrollable movement of entire body) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. It was reported that the patient started experiencing uncontrollable movement on her face and entire body, it like convulsions almost. The pharmacist was not sure what she could use to help it but she was told to use Benadryl 25mg. She is still having the symptoms bad. This case concerns a 26-year-old female with a serious unexpected event of seizure, and non-serious dyskinesia. Event latency 7 days after second dose mRNA-1273. 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.; Sender's Comments: This case concerns a 26-year-old female with a serious unexpected event of seizure, and nonserious dyskinesia. Event latency 7 days after second dose mRNA-1273. 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:

ID: 1423040
Sex: F
Age: 62
State:

Vax Date: 02/01/2021
Onset Date: 04/01/2021
Rec V Date: 06/24/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Cellulitis of legs; Infections; Skin Breakdown; Skin peeling; Laceration of leg; Hives; Swelling of legs; Arthritis; skin red; Sickness; diverticulitis; chills; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Sickness), CELLULITIS (Cellulitis of legs), INFECTION (Infections), SKIN DISORDER (Skin Breakdown), SKIN EXFOLIATION (Skin peeling), SKIN LACERATION (Laceration of leg), URTICARIA (Hives), PERIPHERAL SWELLING (Swelling of legs), ARTHRITIS (Arthritis), CHILLS (chills), DIVERTICULITIS (diverticulitis) and ERYTHEMA (skin red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concomitant products included CALCIUM, VITAMIN D3, SIMVASTATIN, GABAPENTIN, OMEPRAZOLE, DICLOFENAC, METHOTREXATE, METOPROLOL TARTRATE and LOSARTAN POTASSIUM for an unknown indication. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced CHILLS (chills) (seriousness criterion hospitalization). On 18-Apr-2021, the patient experienced DIVERTICULITIS (diverticulitis) (seriousness criteria hospitalization and medically significant). In May 2021, the patient experienced ILLNESS (Sickness) (seriousness criterion hospitalization). On an unknown date, the patient experienced CELLULITIS (Cellulitis of legs) (seriousness criteria hospitalization and medically significant), INFECTION (Infections) (seriousness criterion hospitalization), SKIN DISORDER (Skin Breakdown) (seriousness criterion hospitalization), SKIN EXFOLIATION (Skin peeling) (seriousness criterion hospitalization), SKIN LACERATION (Laceration of leg) (seriousness criterion hospitalization), URTICARIA (Hives) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Swelling of legs) (seriousness criterion hospitalization), ARTHRITIS (Arthritis) (seriousness criterion hospitalization), ERYTHEMA (skin red) (seriousness criterion hospitalization) and DIARRHOEA (diarrhea). The patient was treated with CIPROFLOXACIN from February 2021 to 19-May-2021 at a dose of 1 dosage form; METRONIDAZOLE from February 2021 to 19-May-2021 at a dose of 500 mg; DOXYCYCLINE from February 2021 to 19-May-2021 at a dose of 1 dosage form and CLINDAMYCIN at a dose of 200 milligram four times per day. At the time of the report, ILLNESS (Sickness) had not resolved, CELLULITIS (Cellulitis of legs), SKIN DISORDER (Skin Breakdown), SKIN EXFOLIATION (Skin peeling), SKIN LACERATION (Laceration of leg), URTICARIA (Hives), PERIPHERAL SWELLING (Swelling of legs), ARTHRITIS (Arthritis), ERYTHEMA (skin red) and DIARRHOEA (diarrhea) outcome was unknown, INFECTION (Infections) had resolved and CHILLS (chills) and DIVERTICULITIS (diverticulitis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: no infection (Inconclusive) no infection found in body.. It was reported that, in Feb 2021, the patient received 2nd dose Moderna vaccine. Computed tomography scan showed no infection found in the body. In 2021, her legs got bigger and called physician and went to the emergency room, hospital thought it was cellulitis prescribed metronidazole. In Feb 2021 and legs were about the same. In Apr or May 2021, legs got much worsened, getting cuts like legs were breaking. The patient was applying ice twice a day. On 18 Apr 2021, she was diagnosed with diverticulitis. She had abdominal pain and chills every night, although denied temperature. In May 2021, she was sick for four weeks and had been in and out of the hospital with infection during that time she did not take Humira. She was on antibiotic. In May 2021, she took a Humira injection and next day broke out with hives on her arms. Her last day of antibiotics was 19 May 2021. She reported went to physician initially about legs. The physician prescribed clindamycin 200 milligram, four times a day for five days. Her ankles started to break down, and two other spots. Skin looks peeled and red, legs were huge and could not wear shoes. Second hospital said that was not cellulitis and it looked like it was veins, could be arthritis. She also had diarrhea for four months. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-May-2021, Blood test: result was not provided. Company Comment: Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-219970 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Other Meds: CALCIUM; VITAMIN D3; SIMVASTATIN; GABAPENTIN; OMEPRAZOLE; DICLOFENAC; METHOTREXATE; METOPROLOL TARTRATE; LOSARTAN POTASSIUM

Current Illness:

ID: 1423041
Sex: M
Age:
State:

Vax Date: 03/16/2021
Onset Date:
Rec V Date: 06/24/2021
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: Heart failure; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart failure) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Aortic stenosis. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 CARDIAC FAILURE (Heart failure) (seriousness criterion medically significant). At the time of the report, CARDIAC FAILURE (Heart failure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, C-reactive protein: 12.1 (High) 12.1 (Normal Level, < 0.5). In June 2021, Ejection fraction: 60 percent (Inconclusive) 60 % in September and 30 percent (Inconclusive) Now 30%. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Very limited information regarding this event has been provided at this time. Further information has been requested. Of note, the patient's medical history of Aortic Stenosis is a confounding factor that may play a possible contributory role.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Of note, the patient's medical history of Aortic Stenosis is a confounding factor that may play a possible contributory role.

Other Meds:

Current Illness: Aortic stenosis

ID: 1423042
Sex: F
Age: 64
State: PA

Vax Date: 07/15/2019
Onset Date: 03/01/2021
Rec V Date: 06/24/2021
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: RA flares horrible; Pain over her entire body; Swelling over her entire body; Jaw pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (RA flares horrible) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product SARILUMAB (KEVZARA) injection for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis. On 15-Jul-2019, the patient started SARILUMAB (KEVZARA) (Subcutaneous) 200 milligram. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced RHEUMATOID ARTHRITIS (RA flares horrible) (seriousness criterion medically significant), PAIN (Pain over her entire body), SWELLING (Swelling over her entire body) and PAIN IN JAW (Jaw pain). The patient was treated with PREDNISONE at a dose of titrating Prednisone dose like before. At the time of the report, RHEUMATOID ARTHRITIS (RA flares horrible), PAIN (Pain over her entire body), SWELLING (Swelling over her entire body) and PAIN IN JAW (Jaw pain) had resolved. No concomitant products use was 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. History of rheumatoid arthritis is a known confounder. This case was linked to MOD-2021-219899 (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. History of rheumatoid arthritis is a known confounder.

Other Meds:

Current Illness: Rheumatoid arthritis

ID: 1423043
Sex: F
Age: 66
State:

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 06/24/2021
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: rheumatoid arthritis flare up; hand got numb; issues in spine and collar area; back pain; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and NAPROXEN SODIUM (ALEVE) for an unknown indication. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose and NAPROXEN SODIUM (ALEVE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) (seriousness criterion medically significant), HYPOAESTHESIA (hand got numb), SPINAL DISORDER (issues in spine and collar area) and BACK PAIN (back pain). At the time of the report, RHEUMATOID ARTHRITIS (rheumatoid arthritis flare up) and HYPOAESTHESIA (hand got numb) had not resolved and SPINAL DISORDER (issues in spine and collar area) and BACK PAIN (back pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported. Action taken with co-suspects ADALIMUMAB (HUMIRA) (Subcutaneous) and NAPROXEN SODIUM (ALEVE) (unknown route) was unknown. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1423044
Sex: M
Age: 70
State: NJ

Vax Date: 06/12/2021
Onset Date: 06/14/2021
Rec V Date: 06/24/2021
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: Passed out; Feeling sweaty; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050CZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for COPD. On 12-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERHIDROSIS (Feeling sweaty), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (Feeling sweaty), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Treatment medication included aspirin and ice pack on injection site. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SYMBICORT; SPIRIVA

Current Illness: COPD

ID: 1423045
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) (seriousness criterion medically significant). At the time of the report, EYE HAEMORRHAGE (Second moderna shot 18 hours ago burst blood vessel in eye/burst a blood in eye after my second moderna shot) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1423046
Sex: F
Age: 41
State: NJ

Vax Date: 05/04/2021
Onset Date: 05/04/2021
Rec V Date: 06/24/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: inflammatory response to vaccine; experienced rash on her body from head to toe that was red; her nerves are in overdrive; experienced rash on her body from head to toe that was red and on the face with bumps; tingling; tiredness; injection site pain; fever; chills; body aches; This spontaneous case was reported by an other caregiver and describes the occurrence of RASH ERYTHEMATOUS (experienced rash on her body from head to toe that was red), NERVOUS SYSTEM DISORDER (her nerves are in overdrive) and VACCINATION COMPLICATION (inflammatory response to vaccine) in a 41-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 Spinal tap. On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced RASH ERYTHEMATOUS (experienced rash on her body from head to toe that was red) (seriousness criterion hospitalization) and FATIGUE (tiredness). 04-May-2021, the patient experienced NERVOUS SYSTEM DISORDER (her nerves are in overdrive) (seriousness criterion hospitalization), INJECTION SITE PAIN (injection site pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). On an unknown date, the patient experienced VACCINATION COMPLICATION (inflammatory response to vaccine) (seriousness criterion hospitalization), SKIN SWELLING (experienced rash on her body from head to toe that was red and on the face with bumps) and PARAESTHESIA (tingling). The patient was treated with GABAPENTIN ongoing since an unknown date at a dose of 1 dosage form. On 06-May-2021, INJECTION SITE PAIN (injection site pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved. At the time of the report, RASH ERYTHEMATOUS (experienced rash on her body from head to toe that was red), NERVOUS SYSTEM DISORDER (her nerves are in overdrive), VACCINATION COMPLICATION (inflammatory response to vaccine), SKIN SWELLING (experienced rash on her body from head to toe that was red and on the face with bumps), PARAESTHESIA (tingling) and FATIGUE (tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, imaging: inconclusive (Inconclusive) inconclusive. Patient saw a skin doctor prescribed with topical steroids and experienced tingling in hands, and bottoms of feet. She saw physician on 10-JUN-2021 who gave additional steroids for symptoms.She took medications for 2 days but the symptoms got worsened and then went to hospital and admitted. Taken some labs, MRI and spinal tap. Prescribed with Gabapentin for symptoms. They were concerned for Guillain-Barre syndrome and continued hospitalization and then discharged on 15-Jun-2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-Jun-2021. Added new event and information on hospital discharge; 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: 1423047
Sex: M
Age: 62
State: VA

Vax Date: 03/30/2021
Onset Date: 04/06/2021
Rec V Date: 06/24/2021
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: Blood clots in his left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in his left leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included APIXABAN and ENOXAPARIN 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 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (Blood clots in his left leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in his left leg) 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. 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. Further information has been requested. This case was linked to MOD-2021-220804 (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. Further information has been requested.

Other Meds: APIXABAN; ENOXAPARIN

Current Illness:

ID: 1423048
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: Cripple; left with no immune system; 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 DISABILITY (Cripple) and IMMUNODEFICIENCY (left with no immune system) 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) at an unspecified dose. On an unknown date, the patient experienced DISABILITY (Cripple) (seriousness criterion medically significant) and IMMUNODEFICIENCY (left with no immune system) (seriousness criterion medically significant). At the time of the report, DISABILITY (Cripple) and IMMUNODEFICIENCY (left with no immune system) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not provided by reporter. Treatment information not provided by reporter. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Company Comment Very limited information regarding these events has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.

Other Meds:

Current Illness:

ID: 1423049
Sex: F
Age: 80
State: ME

Vax Date: 04/29/2021
Onset Date:
Rec V Date: 06/24/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Blood pressure in the 250/110's range, blood pressure has gotten much worse; No appetite; Diarrhea; Dehydrated; Nauseous; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) in an 81-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 Constipation (Normally she is constipated). Concurrent medical conditions included Hypertension. On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse) (seriousness criteria hospitalization and disability), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting). The patient was hospitalized on 19-May-2021 due to HYPERTENSION. At the time of the report, HYPERTENSION (Blood pressure in the 250/110's range, blood pressure has gotten much worse), DECREASED APPETITE (No appetite), DIARRHOEA (Diarrhea), DEHYDRATION (Dehydrated), NAUSEA (Nauseous) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: 250/110 (High) High and 200/110 (High) High. Concomitantly the patient was receiving unspecified medication for hypertension . Reportedly, the patient was taken to the hospital on 19 May 2021. At the hospital, the patient's blood pressure was high and the doctors were not able to bring it down. Since the second vaccine, the patient's blood pressure has gotten much worse. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and medical history of Hypertension are confounding factors that may play possible contributory roles.

Other Meds:

Current Illness: Hypertension

ID: 1423050
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: blinded right eye; eye infection; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (blinded right eye) and EYE INFECTION (eye infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 BLINDNESS UNILATERAL (blinded right eye) (seriousness criterion medically significant) and EYE INFECTION (eye infection) (seriousness criterion medically significant). At the time of the report, BLINDNESS UNILATERAL (blinded right eye) and EYE INFECTION (eye infection) outcome was unknown. Concomitant medication not provided by reporter. Treatment information not provided by reporter. Action taken with mRNA-1273 was not applicable. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1423051
Sex: M
Age: 71
State: NJ

Vax Date: 04/01/2021
Onset Date: 04/29/2021
Rec V Date: 06/24/2021
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: Tremor

Symptoms: Atrial fibrillation; Woke up dizzy; Sweating; He felt very weak, he sat on the sofa for the rest of the day; Redness; Big lump; It was very hard; It itched a little bit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 021B21A) 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 APIXABAN (ELIQUIS) for an unknown indication. On 01-Apr-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard) and PRURITUS (It itched a little bit). On 30-Apr-2021, the patient experienced DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day). On 17-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM ongoing since an unknown date at an unspecified dose and frequency; FUROSEMIDE ongoing since an unknown date at an unspecified dose and frequency; AMIODARONE HYDROCHLORIDE (PACERONE) ongoing since an unknown date for Blood pressure, at a dose of 200 mg once a day and AMIODARONE HYDROCHLORIDE (PACERONE) in April 2021 for Blood pressure, at a dose of 200 mg three times a day. On 30-Apr-2021, ERYTHEMA (Redness), MASS (Big lump), INDURATION (It was very hard), PRURITUS (It itched a little bit), DIZZINESS (Woke up dizzy), HYPERHIDROSIS (Sweating) and ASTHENIA (He felt very weak, he sat on the sofa for the rest of the day) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Cardiac stress test: normal (normal) Normal. On 17-May-2021, Electrocardiogram: normal (normal) Normal. On an unknown date, Blood pressure measurement: unknown (Inconclusive) Unknown. Treatment for the events included Letopherol and cardio inversion. Action taken with mRNA-1273 in response to the events were not applicable. This case was linked to MOD-2021-220992 (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. Further information has been requested.

Other Meds: ELIQUIS

Current Illness:

ID: 1423052
Sex: F
Age: 31
State: NY

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 06/24/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: stomach infection; blood sugar increased; nausea; vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL DISCOMFORT (stomach infection) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 37B21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Chronic kidney disease and Thyroid disorder. Concomitant products included SODIUM BICARBONATE for Chronic kidney disease, LEVOTHYROXINE for Thyroid disorder, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach infection) (seriousness criterion hospitalization) BLOOD SUGAR INCREASED (blood sugar increased), NAUSEA (nausea), and VOMITING (vomiting). The patient was hospitalized for 4 days due to ABDOMINAL DISCOMFORT. At the time of the report, ABDOMINAL DISCOMFORT (stomach infection), BLOOD SUGAR INCREASED (blood sugar increased), NAUSEA (nausea), and VOMITING (vomiting)outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) sugar was too high.. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No Treatment medications were reported. This case was linked to MOD-2021-221039 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information included non-significant information. Patient Initials were updated.; 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: NOVOLOG; BASAGLAR; SODIUM BICARBONATE; LEVOTHYROXINE

Current Illness: Chronic kidney disease; Diabetes; Thyroid disorder

ID: 1423053
Sex: F
Age: 59
State: MD

Vax Date: 03/10/2021
Onset Date: 05/14/2021
Rec V Date: 06/24/2021
Hospital: Y

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: Diagnosed with severe depression at the time of discharge; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEPRESSION (Diagnosed with severe depression at the time of discharge). ) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was reported. Concomitant products included ZOLPIDEM for Difficulty sleeping. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Wife went to doctor on 05Apr2021 and was diagnosed with depression. On 28Apr2021, wife was hospitalized due to depression. According to the husband, wife damaged and burned his car and so he had to send her to the hospital. On 14May2021, wife was discharged and diagnosed with severe depression and was prescribed with 3 medications. On 14-May-2021, the patient experienced DEPRESSION (Diagnosed with severe depression at the time of discharge). The patient was hospitalized from 28-Apr-2021 to 14-May-2021 due to DEPRESSION. The patient was treated with FLUOXETINE HCL for Adverse event, at a dose of 20 mg once a day; OLANZAPINE for Adverse event, at a dose of 10 mg once a day and TRAZODONE for Adverse event, at a dose of 50 mg once a day. At the time of the report, DEPRESSION (Diagnosed with severe depression at the time of discharge) outcome was unknown. This case was linked to MOD-2021-221012 (Patient Link).; Sender's Comments: Limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds: ZOLPIDEM

Current Illness: Depression

ID: 1423054
Sex: F
Age: 31
State: NY

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 06/24/2021
Hospital: Y

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: Throwing up; Feeling nauseous; blood sugar increased; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Throwing up) and NAUSEA (Feeling nauseous) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 37B21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Chronic kidney disease and Thyroid disorder. Concomitant products included SODIUM BICARBONATE for Chronic kidney disease, LEVOTHYROXINE for Thyroid disorder, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-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 VOMITING (Throwing up) (seriousness criterion hospitalization) and NAUSEA (Feeling nauseous) (seriousness criterion hospitalization). The patient was treated with PARACETAMOL (TYLENOL) for Back pain, at a dose of UNK dosage form. Patient stated that after each vaccination she was hospitalized but did not remember the specific dates of admission. She stated that it was a week after vaccination but could not provide a specific date. Patient stated that each hospitalization lasted for 4 days and she was in the same hospital for both hospitalization. She was admitted to the the hospital due to stomach infection and sugar was too high BLOOD SUGAR INCREASED (blood sugar increased) (seriousness criterion hospitalization). Another time she was admitted to the hospital was due to sugar was too high, feeling nauseous, throwing up .At the time of the report, VOMITING (Throwing up), BLOOD SUGAR INCREASED (blood sugar increased) and NAUSEA (Feeling nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) was admitted to the hospital twice due to sugar was too high. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. This case was linked to MOD-2021-221023 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Patient initials were updated; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. Patient medical condition may provide an alternative justification for the events occurrence.

Other Meds: NOVOLOG; BASAGLAR; SODIUM BICARBONATE; LEVOTHYROXINE

Current Illness: Chronic kidney disease; Diabetes; Thyroid disorder

Date Died: 06/09/2021

ID: 1423055
Sex: M
Age: 59
State: KY

Vax Date: 05/13/2021
Onset Date: 05/27/2021
Rec V Date: 06/24/2021
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: suffered a massive heart attack; Feeling of faintness; Palpitations; Shortness of Breath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (suffered a massive heart attack), SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Feeling of faintness) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant) and DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant). On 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (suffered a massive heart attack) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was suffered a massive heart attack. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) outcome was unknown. No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 was not applicable. A Patient called to report that two weeks after the first dose of the Moderna Covid-19 vaccine on 27-May-2021, his boyfriend began to experience palpitations, shortness of breath and feeling of faintness. The caller stated that her boyfriend did not want to go to the emergency room and only set an appointment with his Health Care Provider, but on the 09-Jun-2021, the day that he was going to the appointment, he suffered a massive heart attack and passed away. This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Sender's Comments: This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Reported Cause(s) of Death: suffered a massive heart attack

Other Meds:

Current Illness:

ID: 1423056
Sex: M
Age:
State:

Vax Date: 01/08/2021
Onset Date: 01/09/2021
Rec V Date: 06/24/2021
Hospital: Y

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: Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No medical history was provided by the reporter. On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient experienced a stroke after he got the vaccine and was in subacute for 5 months at the time of reporting. 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, details regarding medical history and concomitant medications are required for further assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, details regarding medical history and concomitant medications are required for further assessment.

Other Meds:

Current Illness:

Date Died:

ID: 1423057
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: Problems breathing; This spontaneous case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Problems breathing) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Polio. 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 DYSPNOEA (Problems breathing) (seriousness criterion death). The reported cause of death was problems breathing. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications was not provided. Treatment medications was not provided. Action taken with mRNA-1273 in response to events was not applicable. As a young child, patient was in an iron lung. This is a case of fatal Dyspnoea in a male subject with a hx of polio, who died after receiving the second dose of vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of fatal Dyspnoea in a male subject with a hx of polio, who died after receiving the second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Problems breathing

Other Meds:

Current Illness: Polio

ID: 1423059
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: myocarditis; shortness of breath; chest pain; fever; chills; myalgia; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), DYSPNOEA (shortness of breath) and CHEST PAIN (chest pain) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), DYSPNOEA (shortness of breath) (seriousness criterion hospitalization prolonged), CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, DYSPNOEA and MYOCARDITIS. The patient was treated with ACETAMINOPHEN for Adverse event, at a dose of UNK dosage form. At the time of the report, MYOCARDITIS (myocarditis) was resolving and DYSPNOEA (shortness of breath), CHEST PAIN (chest pain), PYREXIA (fever), CHILLS (chills) and MYALGIA (myalgia) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high (High) 14 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). On an unknown date, Ejection fraction: abnormal (abnormal) 34%, generalized hypokinesis. On an unknown date, Electrocardiogram: normal (normal) normal left ventricular function. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Patchy subepicardial and midmyocardial delayed enhancement. On an unknown date, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, Troponin: high (High) Baseline 39.5 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range) and high (High) peak 46 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was hemodynamically stable, no clinical heart failure. Concomitant medication not provided. Company Comment Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1423060
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: myocarditis; NSVT episodes; chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criteria hospitalization prolonged and medically significant), VENTRICULAR TACHYCARDIA (NSVT episodes) (seriousness criteria hospitalization prolonged and medically significant) and CHEST PAIN (chest pain) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHEST PAIN, MYOCARDITIS and VENTRICULAR TACHYCARDIA. At the time of the report, MYOCARDITIS (myocarditis) and VENTRICULAR TACHYCARDIA (NSVT episodes) was resolving and CHEST PAIN (chest pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, C-reactive protein: high (High) 4 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).. In 2021, Ejection fraction: abnormal (abnormal) 53%, inferolateral hypokinesis. In 2021, Electrocardiogram: abnormal (abnormal) Inferior, anterolateral STelevation. In 2021, imaging: abnormal (abnormal) Edema, delayed enhancement. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Troponin: high (High) baseline-1327 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range). and high (High) Peak-1433 (Values are expressed as the multiple of the upper limit of normal for each laboratory's reference range).. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis), VENTRICULAR TACHYCARDIA (NSVT episodes) and CHEST PAIN (chest pain) to be possibly related. Discharged in stable condition. Treatment information not provided. Company Comment : Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product sue and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1423061
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/24/2021
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: Vaccine-induced myocarditis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (Vaccine-induced myocarditis) in an adolescent male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Vaccine-induced myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Vaccine-induced myocarditis) 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. A medical professional physician reported that a second case of apparent vaccine-induced myocarditis in a teenage male 3 days after Moderna vaccine was admitted. No concomitant medication reported. No treatment information was reported. Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1423062
Sex: F
Age: 34
State: MI

Vax Date: 02/05/2021
Onset Date: 03/05/2021
Rec V Date: 06/24/2021
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: My lungs hurt like I had Pneumonia; Lethargic; Shaking and trembling; Fever; Exhaustion, Slept on and off most day; Chills; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PNEUMONIA (My lungs hurt like I had Pneumonia) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Alcohol use (1 drink per week) and Spontaneous abortion on 23-Sep-2020. Concurrent medical conditions included Allergy to plants (Allergic to tree) and Allergy to nuts (Allergic to nuts). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Jan-2020 to an unknown date for Pregnancy. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-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 21-Oct-2020 and the estimated date of delivery was 19-Aug-2021. On 05-Mar-2021, the patient experienced PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day), CHILLS (Chills) and EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-May-2021, the patient experienced TREMOR (Shaking and trembling). On 04-May-2021, the patient experienced LETHARGY (Lethargic). On an unknown date, the patient experienced PNEUMONIA (My lungs hurt like I had Pneumonia) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the nineteenth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with PARACETAMOL (TYLENOL) from 05-Mar-2021 to 07-Mar-2021 for Fever, at a dose of 1 dosage form. On 05-Mar-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, PNEUMONIA (My lungs hurt like I had Pneumonia), TREMOR (Shaking and trembling), LETHARGY (Lethargic), PYREXIA (Fever), FATIGUE (Exhaustion, Slept on and off most day) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2020, Pregnancy test: positive (Positive) Positive. On 04-Jan-2021, Ultrasound scan: normal (normal) normal. On 05-Mar-2021, Body temperature: 100.0 (High) Fever 100.0. Patient reported the estimated date of conception was 02 NOV 2020. On 15 AUG 2017, patient gave a live birth. 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-2021-011644, MOD-2021-011644 (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: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness: Allergy to nuts (Allergic to nuts); Allergy to plants (Allergic to tree)

ID: 1423063
Sex: F
Age:
State: KS

Vax Date: 12/21/2020
Onset Date: 12/21/2020
Rec V Date: 06/24/2021
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: face turned flushed; taste of metal; elevated blood pressure; tachycardia; hypertension; Allergic reaction; vomiting; rash on face; itchy throat; This is a spontaneous report from a contactable physician (patient herself). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EH9899), via intramuscular route, administered in left arm on 21Dec2020 16:33 (age at vaccination: 41-year-old) as 1st dose, single dose, for COVID-19 immunization. The vaccine was administered in a hospital. The patient's medical history included on an unknown date in 1979, anaphylactic reaction after general anaesthesia due to which the patient was in coma for 7-days; On an unknown date in 2016, tachycardia after Lidocaine inj. topical injection causing short of breath, hypotension; shortness of breath after Benzocaine topical during a dentist procedure causing short of breath, vomiting, wheezing; From 2012, the patient was allergic to yellow jacket, vispid, bee and seafood. Concomitant medication(s) included levothyroxine sodium taken for hypothyroidism from 07Aug2018 at a dose of 50mcg daily. On 21Dec2020 16:42, 9 minutes after the vaccine, the patient experienced vomiting, rash on face, tachycardia, hypertension, itchy throat, taste of metal. On an unknown date, the patient's face turned flushed and elevated blood pressure. The events of vomiting, rash, tachycardia, hypertension and throat irritation were considered to be medically significant. The patient reported that he got an allergic reaction to the first dose first dose of the vaccine and his allergist does not want him to get the 2nd dose. The patient was taken to the emergency room due to the event and was treated with Epinephrine SC was given, IV decadron and famotidine given oral loratadine (due to allergy to beta drugs), IV fluid was started. The patient was discharged from emergency room 4 hours later. Tachycardia lasted for 24 hours. The patient underwent antibody test on an unknown date for which the results were unknown; ON 21Dec2020, the patient's histamine level was normal and tryptase test (done 1 hour after event) was also normal. The patient was not deceased. The outcome of the event dysgeusia, flushing and blood pressure increase were unknown, and all the other events were recovered on 22Dec2020. Reporter considerd the Pfizer product had a casual effect to the adverse event. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of rash,throat irritation,flushing,tachycardia.But also consider relevant medical history of anaphylaxis,allergic history and concomitant medications . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Other Meds: LEVOTHYROXINE SODIUM

Current Illness:

ID: 1423064
Sex: F
Age:
State:

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 06/24/2021
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: hands were shaking; second degree burns; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer or other non Healthcare Professional (caregiver, reported for her Mother who is the patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiration date: UNKNOWN), via an unspecified route of administration on 19Feb2021 as a single dose for COVID-19 immunisation. Medical history included breast cancer and liver cancer from an unspecified date and unknown if ongoing. The patient's concomitant medications were not reported. Reporter stated that on an unspecified date, her mom (patient) was making hot chocolate and her hands were shaking and she spilled hot chocolate on herself. Reporter stated her mom was taken to the emergency room and she was diagnosed with second degree burns and received a tetanus shot this past Friday. Reporter stated her mother is scheduled to receive the second dose next week and her doctor told her to wait two weeks before receiving the second dose. Reporter wanted to know if her mother should receive the second dose of the vaccine after having the Tetanus shot. She was told different things by HCPs (Healthcare Professionals) and wanted to know what Pfizer says. Reporter also stated that her mom was a breast and liver cancer survivor. Reporter clarified if her mom had breast and liver cancer prior to the 1st dose and she said yes, and stated her mom has a history of breast cancer and therefore has a compromised immune system and she was afraid of getting COVID-19. Reporter also mentioned that her mom's 2nd dose was scheduled 4 weeks between. Reporter would like to know if receiving the second dose of the vaccine outside the 3 week interval is just as effective. Reporter would like to know if the second dose can be given greater than 4 weeks after first dose. Reporter would like to know if the vaccination series will have to be repeated if given after 4 weeks. The outcome of the events were unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1423065
Sex: F
Age:
State: WA

Vax Date: 02/24/2021
Onset Date:
Rec V Date: 06/24/2021
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: outbreak of herpes on her lips/ lip got worse/ way across the lip; outbreak of herpes on her lips/ lip got worse/ way across the lip; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200) intramuscularly, administered in Arm Left on 24Feb2021 14:45 (at the age of 72-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid condition (thyroid tests are normal and fine) and had a long history of herpes and she saw a virologist years ago. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) 25 mcg tablet once a day by mouth taken for hypothyroidism from an unspecified start date and ongoing. No vaccination was taken 4 weeks prior to COVID-19 vaccine. The patient took the first dose about a week ago and she had an outbreak of herpes on her lips. The outbreak was kind of a low grade, she had a history of herpes and stated her outbreak was not due to the vaccine. When the patient was queried about when outbreak on her lips started, she stated that she went into the vaccine with one little spot on her lip, she has a long history of herpes and she saw a virologist years ago and was suggested that she just had to watch the foods she eats, she overloads with foods that activate it and she had to cut back. Patient called her family doctor and asked if she could take valacyclovir (VALTREX) since her lip got worse, which had to do with stress and eating poorly for a while, too much coffee and not from the vaccine. She woke up yesterday morning with more working its way across the lip. She took only one dose of Valtrex yesterday and it was 500mg, and it had helped her. She was willing to live with it for whatever period of time she should wait for taking an antiviral medication. The patient stated that she would eat very clean and when she called the doctor, the nurse told her she could take Valtrex. She wanted to know if she can take it. The patient did not visit any clinic or physician office. The outcome of the event was reported as unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based from timing of event occurrence , vaccination and patient current medical condition, the reported events were assessed as probably related and cannot e totally excluded to suspected drug BNT162B2. Case should be reassessed pending new drug information and patient follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate

Other Meds: SYNTHROID

Current Illness: Thyroid activity decreased (Verbatim: low thyroid thyroid tests are normal and fine)

ID: 1423066
Sex: M
Age:
State:

Vax Date: 08/19/2020
Onset Date: 01/01/2021
Rec V Date: 06/24/2021
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: elevation in triglycerides; sore arm after vaccine; weight loss, improved energy; COVID infection jan2021; COVID infection jan2021; This is a spontaneous report from a non-contactable consumer, based on information received by Pfizer, for BNT162B2. A male patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIOEH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as an unspecified dose for covid-19 immunization and lenvatinib mesilate (LENVIMA), oral from 19Aug2020 (Batch/Lot number was not reported) to an unspecified date, at 12 mg for renal cancer. The patient medical history and concomitant medications were not reported. It was reported that Patient feeling better since COVID infection jan2021 as previously reported. Was able to restart Lenvima 08Feb2021 after MD hold approximately 2 weeks while positive for virus. Patient reports last labs still show some elevation in triglycerides, lowered red blood count and some change in thyroid level, has weight loss, but energy improving since COVID symptoms Jan2021. Had 1st Covid vaccine and had sore arm for a bit but improved. MD aware of all symptoms. No additional issues due to medication being on hold noted at this time. The patient underwent lab tests and procedures which included blood triglycerides: some elevation in triglycerides, red blood cell count: lowered, sars-cov-2 test: positive for virus on Jan2021, thyroid function test: some change in thyroid level, weight: loss on Jan2021. Treatment drug include EVEROLMUS 5mg/QC ,PO for renal cancer .The outcome for the events sore arm after vaccine, weight loss, improved energy was resolving and for remaining all events outcome was unknown.

Other Meds:

Current Illness:

ID: 1423067
Sex: M
Age:
State:

Vax Date: 03/11/2021
Onset Date: 03/12/2021
Rec V Date: 06/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: he records his blood pressure every day, it had been 160-170 /90 since Friday (12Mar2021); This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiry date unknown), via an unspecified route of administration on 11Mar2021 as first dose, single dose for COVID-19 immunisation. Medical history included high blood pressure and autoimmune disease. The patient reported that he records his blood pressure every day, and it had been 160-170 /90 since Friday (12Mar2021). Therapeutic measures were taken as a result of the event. The patient stated that he had been increasing his blood pressure medication from 25 mg to 40 mg, and that his HCP instructed him to call if his blood pressure goes up to 180 in 2 days in a row. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Other Meds:

Current Illness:

ID: 1423068
Sex: F
Age:
State: FL

Vax Date: 03/12/2021
Onset Date: 03/12/2021
Rec V Date: 06/24/2021
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: Heart pain; Rapid heart beat; Arm pain shooting through arm; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm left on 12Mar2021 15:15 (Batch/Lot number was not reported) (at the age of 23 years old) as 1st dose, single dose for COVID-19 immunization. Medical history included allergies to sulfa from an unknown date. The patient's concomitant medications were not reported. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 at 20:45, the patient experienced rapid heart beat, heart pain, arm pain shooting through arm. The outcome of the events was not recovered. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm