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: 1524814
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 07/21/2021
Rec V Date: 08/04/2021
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: STOMACH HURT; SHORTNESS OF BREATH; CHEST PAIN; FLU LIKE SYMPTOMS(COLD, CHILLS, HEADACHE, HEAD CONGESTION AND SICK); LOT OF MUCUS; This spontaneous report received from a consumer concerned a 56 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and low platelet count. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 21-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the subject experienced flu like symptoms (cold, chills, headache, head congestion and sick). On 21-JUL-2021, the subject experienced lot of mucus. On 25-JUL-2021, the subject experienced chest pain. On 25-JUL-2021, the subject experienced shortness of breath. On an unspecified date, the subject experienced stomach hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from flu like symptoms(cold, chills, headache, head congestion and sick), lot of mucus, stomach hurt, chest pain, and shortness of breath. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1524815
Sex: M
Age:
State: MA

Vax Date:
Onset Date: 08/02/2021
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: VACCINE ADMINISTERED 35 MINUTES AFTER 2 HOUR LIMIT AT ROOM TEMPERATURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 59 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: 206A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced vaccine administered 35 minutes after 2 hour limit at room temperature. On 02-AUG-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered 35 minutes after 2 hour limit at room temperature and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524816
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/05/2021
Rec V Date: 08/04/2021
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: Maternal exposure during pregnancy; Vomiting; Chills; Fever 101.5 degrees Fahrenheit; This solicited pregnancy report received from a consumer concerned a 30 year old female. The patient was enrolled in a non-company sponsored study Registryt number: C06669). The patient's weight was 47.62 kilograms, and height was 152 centimeters. No past medical history or concurrent conditions were reported. The patient was gravida 1, para 0. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-APR-2021 for covid-19 immunisation. No concomitant medications were reported. On 05-APR-2021, the patient experienced maternal exposure during pregnancy. On 05-APR-2021, the patient experienced vomiting. On 05-APR-2021, the patient experienced chills. On 05-APR-2021, the patient experienced fever 101.5 degrees fahrenheit. The date of the patient's last menstrual period was 30-JAN-2021. Laboratory data (dates unspecified) included: Fever (NR: not provided) 101.5 degrees Fahrenheit. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, and fever 101.5 degrees fahrenheit on 06-APR-2021, and the outcome of maternal exposure during pregnancy was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and vomiting, chills, and fever 101.5 degrees fahrenheit as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy was not related and company causality between covid-19 vaccine ad26.cov2.s, and vomiting, chills, and fever 101.5 degrees fahrenheit as related. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524817
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 07/29/2021
Rec V Date: 08/04/2021
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: SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; VACCINES WERE GIVEN OUTSIDE OF THE 6 HOUR TIME FRAME; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced vaccines were given outside of the 6 hour time frame. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sore throat, fever, pain at the injection site and vaccines were given outside of the 6 hour time frame was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802909 and 20210803269.

Other Meds:

Current Illness:

ID: 1524818
Sex: U
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 08/04/2021
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: TERRIBLE PAIN; FEEL ROTTEN/SICK; NAUSEA; 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: Unk) dose was not reported, administered on 31-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-AUG-2021, the subject experienced terrible pain. On 01-AUG-2021, the subject experienced feel rotten/sick. On 01-AUG-2021, the subject experienced nausea. On 01-AUG-2021, the subject experienced fever. Laboratory data included: Fever (NR: not provided) 102.4 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, terrible pain, fever, and feel rotten/sick. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524819
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 08/02/2021
Rec V Date: 08/04/2021
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: USED SHORTER THAN RECOMMENDED NEEDLE LENGTH FOR ADMINISTRATION; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's weight was 294 pounds, and height was 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: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced used shorter than recommended needle length for administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of used shorter than recommended needle length for administration was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524820
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 07/29/2021
Rec V Date: 08/04/2021
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: SORE THROAT; HEADACHE; FEVER; PAIN AT THE INJECTION SITE; VACCINE ADMINISTERED OUTSIDE OF THE 6 HOUR TIME FRAME OF STORAGE CONDITION; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional 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 29-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-JUL-2021, the subject experienced vaccine administered outside of the 6 hour time frame of storage condition. On 29-JUL-2021, the subject experienced out of specification product use. On an unspecified date, the subject experienced sore throat, headache, fever, and pain at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, sore throat, fever, pain at the injection site, vaccine administered outside of the 6 hour time frame of storage condition and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20210802801.

Other Meds:

Current Illness:

ID: 1524821
Sex: M
Age:
State: ME

Vax Date:
Onset Date: 08/02/2021
Rec V Date: 08/04/2021
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: EXPIRED DOSE ADMINISTERED (VIAL WAS PUNCTURED AT 08:50 AND ADMINISTERED AT 15:10); This spontaneous report received from a consumer concerned a 34 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: 1821286, and batch number: 1821286 expiry: 21-OCT-2021) dose was not reported, administered on 02-AUG-2021 15:10 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced expired dose administered (vial was punctured at 08:50 and administered at 15:10). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose administered (vial was punctured at 08:50 and administered at 15:10) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524822
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 07/08/2021
Rec V Date: 08/04/2021
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: PALPITATIONS; DIZZINESS; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-JUL-2021, the subject experienced palpitations. On 08-JUL-2021, the subject experienced dizziness. On 08-JUL-2021, the subject experienced slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from palpitations, dizziness, and slight headache on 08-JUL-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524823
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
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: HIGHLY SENSITIVE SKIN; CHILLS; FEVER AT 101 DEGREES; EXTREME FATIGUE(COULDN'T GET OUT OF BED OR EAT FOR 8 HOURS); HEADACHE; 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) 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 highly sensitive skin, chills, fever at 101 degrees, extreme fatigue (couldn't get out of bed or eat for 8 hours), and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, highly sensitive skin, fever at 101 degrees, extreme fatigue(couldn't get out of bed or eat for 8 hours) and headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524824
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
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: FEVER; TIRED; 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 fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and tired. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524825
Sex: F
Age:
State:

Vax Date:
Onset Date: 07/27/2021
Rec V Date: 08/04/2021
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: NUMBNESS; MINOR TINGLING; SHARP PAIN IN THE LEFT SIDE OF NECK; UNABLE TO GET LONG PERIOD OF SLEEP; WARM AT THE SITE OF INJECTION; VOMITING; NAUSEA; FATIGUE; BLINDING HEADACHE; This spontaneous report received from a patient concerned a 62 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 27-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-JUL-2021, the subject experienced unable to get long period of sleep. On 27-JUL-2021, the subject experienced warm at the site of injection. On 27-JUL-2021, the subject experienced vomiting. On 27-JUL-2021, the subject experienced nausea. On 27-JUL-2021, the subject experienced fatigue. On 27-JUL-2021, the subject experienced blinding headache. On an unspecified date, the subject experienced sharp pain in the left side of neck, numbness, and minor tingling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from warm at the site of injection on 31-JUL-2021, was recovering from blinding headache, fatigue, unable to get long period of sleep, nausea, and vomiting, had not recovered from minor tingling, and numbness, and the outcome of sharp pain in the left side of neck was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524826
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
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: HURTS; 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 hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hurts was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524827
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 07/26/2021
Rec V Date: 08/04/2021
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: INJECTION SITE REACTION ALONG WITH BODY; TINGLING ARM; SENSITIVE AT THE SITE OF INJECTION; BODY ACHES; ITCHINESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 32 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A23A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On JUL-2021, Laboratory data included: Blood test (NR: not provided) reports were not received., and COVID-19 virus test (NR: not provided) Negative. On 26-JUL-2021, the subject experienced body aches. On 26-JUL-2021, the subject experienced itchiness at the injection site. On 26-JUL-2021, the subject experienced tingling arm. On 26-JUL-2021, the subject experienced sensitive at the site of injection. On an unspecified date, the subject experienced injection site reaction along with body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site reaction along with body, and was recovering from body aches, itchiness at the injection site, tingling arm, and sensitive at the site of injection. This report was non-serious.

Other Meds: VITAMINS NOS

Current Illness: Alcohol use (Patient takes alcohol sometimes.); Non-smoker

ID: 1524828
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 05/11/2021
Rec V Date: 08/04/2021
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: NOT ABLE TO SLEEP; LEFT ARM SORENESS; SHOULDER AND UNDER NECK MUSCLE SORENESS; CHILLS; This spontaneous report received from a patient concerned a 74 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: 1821286, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid. On 11-MAY-2021, the subject experienced chills. On 24-MAY-2021, the subject experienced shoulder and under neck muscle soreness. On 07-JUN-2021, the subject experienced not able to sleep. On 07-JUN-2021, the subject experienced left arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not able to sleep, and left arm soreness on 14-JUN-2021, chills on 11-MAY-2021, and shoulder and under neck muscle soreness on 24-MAY-2021. This report was non-serious.

Other Meds: ASPIRIN BAYER

Current Illness:

ID: 1524829
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/04/2021
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: UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included latex allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A2IA expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexpected therapeutic benefit was not reported. This report was non-serious.

Other Meds:

Current Illness: Latex allergy (I have had a mild latex allergy for several years)

ID: 1524830
Sex: M
Age:
State: KY

Vax Date:
Onset Date: 08/02/2021
Rec V Date: 08/04/2021
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: ADMINISTRATION OF VACCINE TO INAPPROPRIATE AGE GROUP; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 14 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: 201A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021, the subject experienced administration of vaccine to inappropriate age group. On 02-AUG-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine to inappropriate age group and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524831
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 08/04/2021
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: DROPPING WEIGHT (ARMS, LEGS, FINGERS THINNER); BODY ACHES; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 230 pounds, and height was not reported. The patient's pre-existing medical conditions included patient donates plasma twice weekly. 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 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced dropping weight (arms, legs, fingers thinner). On JUN-2021, the subject experienced body aches. On AUG-2021, Laboratory data included: Weight (NR: not provided) 230 pounds. Laboratory data (dates unspecified) included: Weight (NR: not provided) 252 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dropping weight (arms, legs, fingers thinner), and body aches. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524832
Sex: M
Age:
State:

Vax Date:
Onset Date: 07/01/2021
Rec V Date: 08/04/2021
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: STRONG COUGH WITH PHLEGM; DIARRHEA; SHIVERS; FEVER; HEADACHE; CHEST HURT; STOMACH HURT; NASAL SECRETION; VACCINE ALMOST KILLED ME; UNKNOWN SIDE EFFECTS; IN BED ALL THE TIME; COUGH FOR 10 DAYS AND NOW WITH BLOOD; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was healthy young man with no previous health conditions. the patient was taking antibiotics, inhalers and expectorants. 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 07-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the subject experienced cough for 10 days and now with blood. On JUL-2021, the subject experienced chest hurt. On JUL-2021, the subject experienced stomach hurt. On JUL-2021, the subject experienced nasal secretion. On JUL-2021, the subject experienced vaccine almost killed me. On JUL-2021, the subject experienced unknown side effects. On JUL-2021, the subject experienced in bed all the time. On JUL-2021, the subject experienced headache. On 08-JUL-2021, the subject experienced strong cough with phlegm. On 08-JUL-2021, the subject experienced diarrhea. On 08-JUL-2021, the subject experienced shivers. On 08-JUL-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, shivers, diarrhea, strong cough with phlegm, cough for 10 days and now with blood, chest hurt, stomach hurt, nasal secretion, headache, vaccine almost killed me, unknown side effects and in bed all the time was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524833
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 07/30/2021
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ARM FEELS A LITTLE WARM; REDNESS; SORE ARM; BODY ACHES; CHILLS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 14-SEP-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the subject experienced body aches. On 30-JUL-2021, the subject experienced chills. On 01-AUG-2021, the subject experienced sore arm. On 02-AUG-2021, the subject experienced redness. On an unspecified date, the subject experienced arm feels a little warm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and chills on 31-JUL-2021, had not recovered from sore arm, and the outcome of redness and arm feels a little warm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1524834
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
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: COLITIS SYMPTOMS DID CAME BACK AFTER GOT THE COVID VACCINE; This spontaneous report received from a patient concerned a 73 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported, and dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. No concomitant medications were reported. On an unspecified date, the subject experienced colitis symptoms did came back after got the covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from colitis symptoms did came back after got the covid vaccine. This report was non-serious.

Other Meds:

Current Illness: Crohn's disease aggravated; Ulcerative colitis

ID: 1524835
Sex: F
Age: 72
State: NJ

Vax Date: 02/20/2021
Onset Date: 02/20/2021
Rec V Date: 08/04/2021
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: cellulitis in three areas on my leg; Every time I get an insect bite it becomes red hot and swollen and requires medical attention.; She is not taking the second Moderna COVID-19 vaccination; infected; inflamed; infection on my eye lid; It was burning like she burned herself/3 hours later it looked like someone took an iron to her arm and burned it. It was painful and hot.; two red welts on the injection site and to the left of it; hard as a rock; itchy; It was painful and hot.; right eye was bright red; huge swelling blew up from under my eye to my eyebrow; it pinched; weakness in the muscle; neuralgia pain; always feels a little lightheaded; hurt, there was weakness in the muscle, neuralgia pain,headache, and fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis in three areas on my leg) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bee sting and Mosquito bite. Concomitant products included ALPRAZOLAM (XANAX), D-MANNOSE, ELDERBERRY [SAMBUCUS NIGRA], ASCORBIC ACID, BIOFLAVONOIDS NOS, HESPERIDIN COMPLEX, ROSA CANINA, RUTOSIDE (VITAMIN C COMPLEX [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN COMPLEX;ROSA CANINA;RUTOSIDE]), VITAMIN D3, VITAMIN B12 NOS, VACCINIUM MACROCARPON (AZO-CRANBERRY) and PROBIOTICS NOS for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE MUSCLE WEAKNESS (weakness in the muscle), NEURALGIA (neuralgia pain), DIZZINESS (always feels a little lightheaded), FATIGUE (hurt, there was weakness in the muscle, neuralgia pain,headache, and fatigue) and HEADACHE (headache). On 23-Feb-2021, the patient experienced OCULAR HYPERAEMIA (right eye was bright red), SWELLING FACE (huge swelling blew up from under my eye to my eyebrow) and EYE PAIN (it pinched). On 27-Feb-2021, the patient experienced VACCINATION SITE WARMTH (It was burning like she burned herself/3 hours later it looked like someone took an iron to her arm and burned it. It was painful and hot.), VACCINATION SITE URTICARIA (two red welts on the injection site and to the left of it), VACCINATION SITE INDURATION (hard as a rock), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (It was painful and hot.). On 28-Feb-2021, the patient experienced EYELID INFECTION (infection on my eye lid). On 04-Mar-2021, the patient experienced VACCINATION SITE INFECTION (infected) and VACCINATION SITE INFLAMMATION (inflamed). On an unknown date, the patient experienced CELLULITIS (cellulitis in three areas on my leg) (seriousness criterion medically significant), ALLERGY TO ARTHROPOD BITE (Every time I get an insect bite it becomes red hot and swollen and requires medical attention.) and INTENTIONAL DOSE OMISSION (She is not taking the second Moderna COVID-19 vaccination). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency; CEFALEXIN (KEFLEX [CEFALEXIN]) for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE for Adverse event, at an unspecified dose and frequency and DEXAMETHASONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOMYCIN / POLY B / DEXAMETHASONE) for Adverse event, at an unspecified dose and frequency. On 27-Feb-2021, INJECTION SITE MUSCLE WEAKNESS (weakness in the muscle), FATIGUE (hurt, there was weakness in the muscle, neuralgia pain,headache, and fatigue) and HEADACHE (headache) had resolved. On 03-Mar-2021, VACCINATION SITE WARMTH (It was burning like she burned herself/3 hours later it looked like someone took an iron to her arm and burned it. It was painful and hot.), VACCINATION SITE INDURATION (hard as a rock) and VACCINATION SITE PAIN (It was painful and hot.) had resolved. At the time of the report, CELLULITIS (cellulitis in three areas on my leg) had not resolved and NEURALGIA (neuralgia pain), DIZZINESS (always feels a little lightheaded), OCULAR HYPERAEMIA (right eye was bright red), SWELLING FACE (huge swelling blew up from under my eye to my eyebrow), EYE PAIN (it pinched), EYELID INFECTION (infection on my eye lid), VACCINATION SITE INFECTION (infected), VACCINATION SITE INFLAMMATION (inflamed), ALLERGY TO ARTHROPOD BITE (Every time I get an insect bite it becomes red hot and swollen and requires medical attention.), VACCINATION SITE URTICARIA (two red welts on the injection site and to the left of it), VACCINATION SITE PRURITUS (itchy) and INTENTIONAL DOSE OMISSION (She is not taking the second Moderna COVID-19 vaccination) 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 events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MODERNA, INC.-MOD-2021-036668 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: follow-up was received and contains no new information On 26-Jul-2021: adverse event added and treatment medication added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. US-MODERNATX, INC.-MOD-2021-036668:

Other Meds: XANAX; D-MANNOSE; ELDERBERRY [SAMBUCUS NIGRA]; VITAMIN C COMPLEX [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN COMPLEX;ROSA CANINA;RUTOSIDE]; VITAMIN D3; VITAMIN B12 NOS; AZO-CRANBERRY; PROBIOTICS NOS

Current Illness:

ID: 1524836
Sex: F
Age: 59
State: CA

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Will not receive second dose; Hypersensitivity reaction; flu like symptoms; Cough; flushing; Decreased level of consciousness; Dizzy; Funny feeling in heart palpitation/Skipping heart beat/Heart palpitation was racing; Shortness of breath/had trouble breathing; Hoarseness; Unusual taste; Hand hurt for 10days; Felt like confusion; Weak; Tightness in chest; Strange feeling; Fever; Fatigue; Chills; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included VITAMINS NOS (DAILY MULTIVITAMIN) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced ASTHENIA (Weak), CHEST DISCOMFORT (Tightness in chest), FEELING ABNORMAL (Strange feeling), CONFUSIONAL STATE (Felt like confusion), PAIN IN EXTREMITY (Hand hurt for 10days), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Apr-2021, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), DIZZINESS (Dizzy), PALPITATIONS (Funny feeling in heart palpitation/Skipping heart beat/Heart palpitation was racing), DYSPNOEA (Shortness of breath/had trouble breathing), DYSPHONIA (Hoarseness), TASTE DISORDER (Unusual taste), HYPERSENSITIVITY (Hypersensitivity reaction), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Cough) and FLUSHING (flushing). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Will not receive second dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Apr-2021, PAIN IN EXTREMITY (Hand hurt for 10days) had resolved. On 30-Apr-2021, DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), DIZZINESS (Dizzy), ASTHENIA (Weak), CHEST DISCOMFORT (Tightness in chest), FEELING ABNORMAL (Strange feeling), PALPITATIONS (Funny feeling in heart palpitation/Skipping heart beat/Heart palpitation was racing), CONFUSIONAL STATE (Felt like confusion), DYSPNOEA (Shortness of breath/had trouble breathing), DYSPHONIA (Hoarseness), TASTE DISORDER (Unusual taste), INFLUENZA LIKE ILLNESS (flu like symptoms), COUGH (Cough), FLUSHING (flushing), PYREXIA (Fever), FATIGUE (Fatigue), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) had resolved with sequelae, HYPERSENSITIVITY (Hypersensitivity reaction) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Will not receive second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Other concomitant medication included unspecified healthy supplements. Company Comment: Based on the available information and based on the infectious nature of the condition, the events are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up : patient demographics (ethnicity, height and weight) updated, added events of decreased level of consciousness, dyspnea, hoarseness, unusual taste, flu like symptoms, cough, flushing, updated event outcome of events On 31-Jul-2021: Live follow up : updated event outcome; Sender's Comments: Based on the available information and based on the infectious nature of the condition, the events are assessed as unlikely related to mRNA-1273.

Other Meds: DAILY MULTIVITAMIN

Current Illness:

ID: 1524837
Sex: M
Age: 52
State: IL

Vax Date: 05/04/2021
Onset Date: 04/05/2021
Rec V Date: 08/04/2021
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: falling asleep 3 hours; Shaking, extremely cold.; extremely cold; my jaws freezed up and I couldn't speak.; heart rate increased/palpitations; Numbness; Chest tightness; Decreased level of consciousness; After weeks of medical testing costing thousands of dollars, it was found that I have an adenoma which is very close to to a phenochromocytoma/That is a small adrenal tumor that releases metanephrine which directly raises blood pressure; My blood pressure felt as if it was raising faster than ever in my life, well past 250/The next morning and for the next 5 weeks or so my blood pressure was extremely elevated, in the 190-230 range, even with bp medicine; thought he was going to loose consciousness; shortness of breath; terrible chills like he was going into shock,chills so bad he couldn't get out from under the blanket; head felt like it was being crushed by a cinderblock; Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ADRENAL ADENOMA (After weeks of medical testing costing thousands of dollars, it was found that I have an adenoma which is very close to to a phenochromocytoma/That is a small adrenal tumor that releases metanephrine which directly raises blood pressure) and BLOOD PRESSURE ABNORMAL (My blood pressure felt as if it was raising faster than ever in my life, well past 250/The next morning and for the next 5 weeks or so my blood pressure was extremely elevated, in the 190-230 range, even with bp medicine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy (Turned blue, could not breath,started passing out, couldn't stand, never given penicillin ever again) since 01-Jan-1977, Drug allergy (chlorine shortness of breath) since 01-Jan-1972, Lyme's disease (Autoimmune problems), Allergy (Chlorine,Previously had strong chlorine allergy, but had 2 chlorine gas exposures at this time with reactions last 2 weeks for each. Reaction caused adrenal glands to hurt like I was stabbed.) since 28-Jul-2001 and Drug allergy (Had reactions to 2 different new bp pills: close to passing out, white flashes over eyes, vomitting) since 01-Mar-2001. Concomitant products included MONTELUKAST SODIUM from 06-Jan-2019 to an unknown date for Allergy, PROPRANOLOL from 01-Jan-2017 to an unknown date, ENALAPRIL MALEATE from 01-Jan-2017 to 18-Jun-2021 and METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) from 01-Jan-2012 to an unknown date for Blood pressure high. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021 at 7:45 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction). On 04-May-2021, the patient experienced PRESYNCOPE (thought he was going to loose consciousness), DYSPNOEA (shortness of breath), CHILLS (terrible chills like he was going into shock,chills so bad he couldn't get out from under the blanket) and HEADACHE (head felt like it was being crushed by a cinderblock). On an unknown date, the patient experienced DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness) (seriousness criterion medically significant), ADRENAL ADENOMA (After weeks of medical testing costing thousands of dollars, it was found that I have an adenoma which is very close to to a phenochromocytoma/That is a small adrenal tumor that releases metanephrine which directly raises blood pressure) (seriousness criterion medically significant), BLOOD PRESSURE ABNORMAL (My blood pressure felt as if it was raising faster than ever in my life, well past 250/The next morning and for the next 5 weeks or so my blood pressure was extremely elevated, in the 190-230 range, even with bp medicine) (seriousness criterion medically significant), INSOMNIA (falling asleep 3 hours), TREMOR (Shaking, extremely cold.), NASOPHARYNGITIS (extremely cold), TRISMUS (my jaws freezed up and I couldn't speak.), PALPITATIONS (heart rate increased/palpitations), HYPOAESTHESIA (Numbness) and CHEST DISCOMFORT (Chest tightness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of consciousness), ADRENAL ADENOMA (After weeks of medical testing costing thousands of dollars, it was found that I have an adenoma which is very close to to a phenochromocytoma/That is a small adrenal tumor that releases metanephrine which directly raises blood pressure), BLOOD PRESSURE ABNORMAL (My blood pressure felt as if it was raising faster than ever in my life, well past 250/The next morning and for the next 5 weeks or so my blood pressure was extremely elevated, in the 190-230 range, even with bp medicine), PRESYNCOPE (thought he was going to loose consciousness), DYSPNOEA (shortness of breath), PALPITATIONS (heart rate increased/palpitations), HYPOAESTHESIA (Numbness), CHEST DISCOMFORT (Chest tightness) and HEADACHE (head felt like it was being crushed by a cinderblock) outcome was unknown and HYPERSENSITIVITY (Hypersensitivity reaction), INSOMNIA (falling asleep 3 hours), TREMOR (Shaking, extremely cold.), NASOPHARYNGITIS (extremely cold), TRISMUS (my jaws freezed up and I couldn't speak.) and CHILLS (terrible chills like he was going into shock,chills so bad he couldn't get out from under the blanket) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Blood pressure measurement: high (High) blood pressure last night was well over 250, today it's 190. In 2021, Blood test: abnormal (abnormal) The metanephrine was found to be three times past the normal limit in the blood test. In 2021, Heart rate: irregular (Inconclusive) Irregular. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 08-Jun-2021 updated with patient demographics, concurrent medication and conditions. New events are updated. Treatment information added. On 28-Jul-2021: follow up received on 28-JUL-2021,Suspect drug details and medical history and concomitant medications, patient details updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PROPRANOLOL; ENALAPRIL MALEATE; METOPROLOL [METOPROLOL SUCCINATE]; MONTELUKAST SODIUM

Current Illness: Allergy (Chlorine,Previously had strong chlorine allergy, but had 2 chlorine gas exposures at this time with reactions last 2 weeks for each. Reaction caused adrenal glands to hurt like I was stabbed.); Drug allergy (Had reactions to 2 different new bp pills: close to passing out, white flashes over eyes, vomitting); Drug allergy (chlorine shortness of breath); Lyme's disease (Autoimmune problems); Penicillin allergy (Turned blue, could not breath,started passing out, couldn't stand, never given penicillin ever again)

ID: 1524838
Sex: F
Age:
State: KS

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
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: Heart trouble; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart trouble) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Cardiac ablation. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart trouble). At the time of the report, CARDIAC DISORDER (Heart trouble) was resolving. No concomitant products were provided by the reporter. The reporter stated that after second vaccine dose the patient started having heart trouble for which the patient underwent heart ablation in the hospital. The patient currently is doing well. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Non-significant follow up received, Patient requested follow up form via mail address.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1524839
Sex: F
Age: 69
State: NJ

Vax Date: 05/02/2021
Onset Date: 05/02/2021
Rec V Date: 08/04/2021
Hospital: Y

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: Pain on her legs doesn't let her stay straight / horrific pain in my upper legs, both of them / it's like a pain shower in my leg; Unbearable side effects for 2 months; Broke her leg; Thinks she's gonna die", "lost her life", "is ruined, totally destroyed", "is killing her family; Condition aggravated; I've lost 10 lbs; Pain on her legs doesn't let her walk/pain on her legs doesn't let her walk; Patient stated "I'm ready to kill myself"; Pain on her legs doesn't let her stand up; Pain on her legs doesn't let her sleep; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (Patient stated "I'm ready to kill myself"), PAIN IN EXTREMITY (Pain on her legs doesn't let her stay straight / horrific pain in my upper legs, both of them / it's like a pain shower in my leg) and VACCINATION COMPLICATION (Unbearable side effects for 2 months) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis (since 19. Received a steroid injection from her rheumatologist, but it didn't offer relief.). On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VACCINATION COMPLICATION (Unbearable side effects for 2 months) (seriousness criterion hospitalization). On 02-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Pain on her legs doesn't let her stay straight / horrific pain in my upper legs, both of them / it's like a pain shower in my leg) (seriousness criterion hospitalization) and INSOMNIA (Pain on her legs doesn't let her sleep). On 15-Jul-2021, the patient experienced SUICIDAL IDEATION (Patient stated "I'm ready to kill myself") (seriousness criterion medically significant), GAIT DISTURBANCE (Pain on her legs doesn't let her walk/pain on her legs doesn't let her walk) and DYSSTASIA (Pain on her legs doesn't let her stand up). On an unknown date, the patient experienced LOWER LIMB FRACTURE (Broke her leg), FEELING ABNORMAL (Thinks she's gonna die", "lost her life", "is ruined, totally destroyed", "is killing her family), CONDITION AGGRAVATED (Condition aggravated) and WEIGHT DECREASED (I've lost 10 lbs). At the time of the report, SUICIDAL IDEATION (Patient stated "I'm ready to kill myself"), PAIN IN EXTREMITY (Pain on her legs doesn't let her stay straight / horrific pain in my upper legs, both of them / it's like a pain shower in my leg), VACCINATION COMPLICATION (Unbearable side effects for 2 months), GAIT DISTURBANCE (Pain on her legs doesn't let her walk/pain on her legs doesn't let her walk), INSOMNIA (Pain on her legs doesn't let her sleep), DYSSTASIA (Pain on her legs doesn't let her stand up), LOWER LIMB FRACTURE (Broke her leg), FEELING ABNORMAL (Thinks she's gonna die", "lost her life", "is ruined, totally destroyed", "is killing her family), CONDITION AGGRAVATED (Condition aggravated) and WEIGHT DECREASED (I've lost 10 lbs) outcome was unknown. Concomitant product use was not provided by the reporter. The patient was given with steroid shot. 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-Jul-2021: Follow up received on 15-Jul-2021: Added patient demographics and suspect product details. On 30-Jul-2021: Follow-up received contains additional event of weight loss.; 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: Rheumatoid arthritis (since 19. Received a steroid injection from her rheumatologist, but it didn't offer relief.)

ID: 1524840
Sex: F
Age: 78
State: NY

Vax Date: 01/11/2021
Onset Date: 03/13/2021
Rec V Date: 08/04/2021
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: blood test showed aggresstion stage of rheumatoid arthritis; a lot of pain in knuckles, thumb, wrist; hands were numb; swelling; pain in right hand; 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 RHEUMATOID ARTHRITIS (blood test showed aggresstion stage of rheumatoid arthritis) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE+CHONDROITIN SULPHATE) for Arthritis, MONASCUS PURPUREUS (RED YEAST RICE) for Cholesterol, UBIDECARENONE (COQ10 [UBIDECARENONE]) for Heart disorder and Cholesterol, THIOCTIC ACID (ALA [THIOCTIC ACID]) for Hyperglycaemia and Nerve pain, TRAZODONE for Insomnia, OXITRIPTAN (5-HTP [OXITRIPTAN]) for Mood disorder, SITOSTEROL (MODUCARE), DHEA, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), MENAQUINONE-7 (K2), MELATONIN, BORON, FISH OIL (OMEGA 3 FISH OILS), BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (blood test showed aggresstion stage of rheumatoid arthritis) (seriousness criterion medically significant), ARTHRITIS (a lot of pain in knuckles, thumb, wrist), HYPOAESTHESIA (hands were numb), SWELLING (swelling) and PAIN IN EXTREMITY (pain in right hand). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PREDNISONE on 17-Jul-2021 for Rheumatoid arthritis, at a dose of 5 mg; MELOXICAM for Pain, at a dose of 7.5 mg and HYDROXYCHLOROQUINE at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (blood test showed aggresstion stage of rheumatoid arthritis), ARTHRITIS (a lot of pain in knuckles, thumb, wrist), HYPOAESTHESIA (hands were numb), SWELLING (swelling) and PAIN IN EXTREMITY (pain in right hand) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) Aggression stage of Rheumatoid arthritis .. On an unknown date, X-ray: abnormal (abnormal) Inflamed osteoarthritis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered RHEUMATOID ARTHRITIS (blood test showed aggresstion stage of rheumatoid arthritis), ARTHRITIS (a lot of pain in knuckles, thumb, wrist), HYPOAESTHESIA (hands were numb), SWELLING (swelling) and PAIN IN EXTREMITY (pain in right hand) to be probably related. Patient was referred for a physical therapy by her doctor and also stated that she was about to stop HCQ as it is causing too many side effects . Patient reported that Osteoarthritis had become much worse in her fingers and other parts of her body which was only mild to moderate before . She had an appointment to have an Ultrasound to see if there is any tissue damage . She stated that she must have had a dormant factor for Rheumatoid arthritis and the vaccine for COVID-19 brought it out . Bio identical Hormones- Topical brest 80/20, Progest/test 1mg/100mg/1mg/gm anti versame . 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 31-Jul-2021: Follow up received contains Patient details, Dose 1 and 2 details, Concomitant and treatment drugs, New events, lad data . On 31-Jul-2021: Concomitant medications added .; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Other Meds: TRAZODONE; RED YEAST RICE; MODUCARE; DHEA; 5-HTP [OXITRIPTAN]; B12 [CYANOCOBALAMIN]; K2; MELATONIN; BORON; COQ10 [UBIDECARENONE]; GLUCOSAMINE+CHONDROITIN SULPHATE; ALA [THIOCTIC ACID]; OMEGA 3 FISH OILS; PROBIOTIC [BIFIDOBACTERIUM LACTIS];

Current Illness:

ID: 1524841
Sex: F
Age:
State: FL

Vax Date: 07/21/2021
Onset Date: 07/22/2021
Rec V Date: 08/04/2021
Hospital: Y

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: hemorrhagic bullous; she had a blister in her leg the size of 3or 4cm dose; haemorrhagic blisters in legs/ skin blisters with blood; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (she had a blister in her leg the size of 3or 4cm dose), BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) and BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Anaphylaxis (Iodine), Drug allergy (patient allergic to iodine. DNA filaxis (contrast materisLXCT)) on 03-May-1999, Depression and Dementia. Concomitant products included DONEPEZIL HYDROCHLORIDE (ARICEPT) from 01-Oct-2015 to an unknown date and MEMANTINE HYDROCHLORIDE (NAMENDA) from 01-Oct-2015 to an unknown date for Dementia, SERTRALINE from 01-Oct-2015 to an unknown date and BUPROPION from 01-Oct-2015 to an unknown date for Depression, ASA from 01-Oct-2015 to an unknown date for an unknown indication. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced BLISTER (she had a blister in her leg the size of 3or 4cm dose) (seriousness criterion hospitalization) and BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) (seriousness criterion hospitalization). On 22-Jul-2021 at 7:00 AM, the patient experienced BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Jul-2021 to 28-Jul-2021 due to BLISTER and BLOOD BLISTER, and then on 22-Jul-2021 due to BULLOUS HAEMORRHAGIC DERMATOSIS. At the time of the report, BLISTER (she had a blister in her leg the size of 3or 4cm dose) and BLOOD BLISTER (haemorrhagic blisters in legs/ skin blisters with blood) had not resolved and BULLOUS HAEMORRHAGIC DERMATOSIS (hemorrhagic bullous) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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 28-Jul-2021: Follow up received on 28-JUL-2021 contains Significant information that includes, Event update, Seriousness criteria update.; 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: SERTRALINE; BUPROPION; ARICEPT; NAMENDA; ASA

Current Illness:

ID: 1524842
Sex: F
Age:
State: CA

Vax Date: 05/15/2021
Onset Date:
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Clot; big lump/almost like 3 inches diameter round/very hard lump; Pain in both arms at the deltoid/pain in legs; Lower legs and arm were weak/weakness in muscle; Headache in the left side of her head; Patient has not received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) 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 MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], FISH OIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Clot) (seriousness criterion medically significant), VACCINATION SITE MASS (big lump/almost like 3 inches diameter round/very hard lump), PAIN IN EXTREMITY (Pain in both arms at the deltoid/pain in legs), ASTHENIA (Lower legs and arm were weak/weakness in muscle), HEADACHE (Headache in the left side of her head) and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Clot), VACCINATION SITE MASS (big lump/almost like 3 inches diameter round/very hard lump), PAIN IN EXTREMITY (Pain in both arms at the deltoid/pain in legs), ASTHENIA (Lower legs and arm were weak/weakness in muscle) and HEADACHE (Headache in the left side of her head) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date. Patient had to shower with hot but tolerated water to make sure the clot doesn't form all over. Company comment: Very limited information regarding these events have been provided at this time. Further information is requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information is requested.

Other Meds: MULTIVITAMIN [VITAMINS NOS]; VITAMIN D [VITAMIN D NOS]; FISH OIL; BABY ASPIRIN

Current Illness:

ID: 1524843
Sex: F
Age: 67
State: MA

Vax Date: 03/24/2021
Onset Date: 05/04/2021
Rec V Date: 08/04/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Can still feel body tremoring/can still feel episodes trying to occur/Progressed to shaking; Gastroparesis/ Gastric emptying profoundly decreased within 4 hours; Gastric motility issues/dysmotility of the whole digestive system/motility of the stomach is greatly reduced; Constipation; Gets sicker; Lost almost 50 pounds; Can't eat or swallowdue to dysmotility of the whole digestive system; Deep belches/episodes where body starts belching; Hard to breath; Hard to speak; This spontaneous case was reported by an other health care professional and describes the occurrence of IMPAIRED GASTRIC EMPTYING (Gastroparesis/ Gastric emptying profoundly decreased within 4 hours), GASTRIC HYPOMOTILITY (Gastric motility issues/dysmotility of the whole digestive system/motility of the stomach is greatly reduced), CONSTIPATION (Constipation), ILLNESS (Gets sicker), ABNORMAL LOSS OF WEIGHT (Lost almost 50 pounds), DYSPHAGIA (Can't eat or swallowdue to dysmotility of the whole digestive system), ERUCTATION (Deep belches/episodes where body starts belching), DYSPNOEA (Hard to breath), SPEECH DISORDER (Hard to speak) and TREMOR (Can still feel body tremoring/can still feel episodes trying to occur/Progressed to shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Gastroparesis (Gastroparesis "on and off") and Hypertension. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced IMPAIRED GASTRIC EMPTYING (Gastroparesis/ Gastric emptying profoundly decreased within 4 hours) (seriousness criteria hospitalization and medically significant), GASTRIC HYPOMOTILITY (Gastric motility issues/dysmotility of the whole digestive system/motility of the stomach is greatly reduced) (seriousness criterion hospitalization), CONSTIPATION (Constipation) (seriousness criterion hospitalization), ILLNESS (Gets sicker) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (Lost almost 50 pounds) (seriousness criterion hospitalization), DYSPHAGIA (Can't eat or swallowdue to dysmotility of the whole digestive system) (seriousness criterion hospitalization), ERUCTATION (Deep belches/episodes where body starts belching) (seriousness criterion hospitalization), DYSPNOEA (Hard to breath) (seriousness criterion hospitalization) and SPEECH DISORDER (Hard to speak) (seriousness criterion hospitalization). On 26-Jul-2021, the patient experienced TREMOR (Can still feel body tremoring/can still feel episodes trying to occur/Progressed to shaking) (seriousness criterion hospitalization). The patient was treated with LORAZEPAM (ATIVAN) on 04-May-2021 for Adverse event, at a dose of UNK, qid and OLANZAPINE on 04-May-2021 for Adverse event, at a dose of UNK. At the time of the report, IMPAIRED GASTRIC EMPTYING (Gastroparesis/ Gastric emptying profoundly decreased within 4 hours), CONSTIPATION (Constipation), ILLNESS (Gets sicker), ABNORMAL LOSS OF WEIGHT (Lost almost 50 pounds), DYSPHAGIA (Can't eat or swallowdue to dysmotility of the whole digestive system), ERUCTATION (Deep belches/episodes where body starts belching), DYSPNOEA (Hard to breath) and SPEECH DISORDER (Hard to speak) outcome was unknown and GASTRIC HYPOMOTILITY (Gastric motility issues/dysmotility of the whole digestive system/motility of the stomach is greatly reduced) and TREMOR (Can still feel body tremoring/can still feel episodes trying to occur/Progressed to shaking) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Gastric emptying study: decreased (Low) Profoundly decreased within 4 hours. On 04-May-2021, Weight: decreased (abnormal) lost almost 50 pounds. On an unknown date, Biopsy: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The reporter stated that, she believed that there is something wrong with the patient's autonomic nervous system. Concomitant medications included blood pressure medications. Other lab tests included MRI and EEG. But the results were not available. Other treatment provided included medications to increase motility. Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Gastroparesis (Gastroparesis "on and off"); Hypertension

ID: 1524844
Sex: F
Age:
State: MI

Vax Date: 04/30/2021
Onset Date: 05/11/2021
Rec V Date: 08/04/2021
Hospital: Y

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: Fluid around her heart; Thickening in her intestines; Fever of 101?F; Began vomiting; Having pain in her belly, where her gallbladder is, then complained that it was moving to other side; Felt nauseated/Feel like have to puke; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDIAL EFFUSION (Fluid around her heart) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Immune system disorder, Kidney stones, Asplenia (No spleen) and IQ test abnormal. On 30-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) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced NAUSEA (Felt nauseated/Feel like have to puke). On 18-Jun-2021, the patient experienced ABDOMINAL PAIN (Having pain in her belly, where her gallbladder is, then complained that it was moving to other side). On 21-Jul-2021, the patient experienced PERICARDIAL EFFUSION (Fluid around her heart) (seriousness criteria hospitalization and medically significant). On 24-Jul-2021, the patient experienced VOMITING (Began vomiting). On 27-Jul-2021, the patient experienced PYREXIA (Fever of 101?F). On an unknown date, the patient experienced GASTROINTESTINAL WALL THICKENING (Thickening in her intestines). The patient was hospitalized from 21-Jul-2021 to 22-Jul-2021 due to PERICARDIAL EFFUSION. The patient was treated with NAPROXEN SODIUM (NAPROXEN [NAPROXEN SODIUM]) ongoing since an unknown date at a dose of 500 mg; COLCHICINE ongoing since an unknown date at a dose of .6 milligram once a day; AMOXICILLIN, CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM [AMOXICILLIN;CLAVULANATE POTASSIUM]) at a dose of 875/125 and Surgery (pericardiocentesis) for Pericardial effusion. At the time of the report, PERICARDIAL EFFUSION (Fluid around her heart), ABDOMINAL PAIN (Having pain in her belly, where her gallbladder is, then complained that it was moving to other side), GASTROINTESTINAL WALL THICKENING (Thickening in her intestines), NAUSEA (Felt nauseated/Feel like have to puke), VOMITING (Began vomiting) and PYREXIA (Fever of 101?F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, Echocardiogram: abnormal (abnormal) moderate fluid around her heart. On 25-Jul-2021, Bacterial test: negative (Negative) Negative. On 27-Jul-2021, Body temperature: 101 (High) 101 degrees Fahrenheit. It was reported that there was a little thickening in patient intestines. Patient took medicine for 4 days, then patient's mother stopped it because doctor was uncertain of cause of thickening. Patient was also prescribed Pepcid, but she's presently not taking. No concomitant medications were provided; 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: Asplenia (No spleen); Immune system disorder; IQ test abnormal (IQ of 55); Kidney stones

ID: 1524845
Sex: F
Age: 67
State: PA

Vax Date: 03/02/2021
Onset Date: 03/12/2021
Rec V Date: 08/04/2021
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: She had hit the bone under the eye brow on left side.; she had a black out for 5-10 minutes while walking; She lost lots of blood; She had concussion; She had constant headache.; This spontaneous case was reported by a consumer and describes the occurrence of SKELETAL INJURY (She had hit the bone under the eye brow on left side.), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking), HAEMORRHAGE (She lost lots of blood), CONCUSSION (She had concussion) and HEADACHE (She had constant headache.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. Concomitant products included VITAMINS NOS and ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced SKELETAL INJURY (She had hit the bone under the eye brow on left side.) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking) (seriousness criteria hospitalization and medically significant), HAEMORRHAGE (She lost lots of blood) (seriousness criteria hospitalization and medically significant), CONCUSSION (She had concussion) (seriousness criterion hospitalization) and HEADACHE (She had constant headache.) (seriousness criterion hospitalization). The patient was hospitalized on 12-Mar-2021 due to CONCUSSION, HAEMORRHAGE, HEADACHE, LOSS OF CONSCIOUSNESS and SKELETAL INJURY. The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SKELETAL INJURY (She had hit the bone under the eye brow on left side.), LOSS OF CONSCIOUSNESS (she had a black out for 5-10 minutes while walking), HAEMORRHAGE (She lost lots of blood), CONCUSSION (She had concussion) and HEADACHE (She had constant headache.) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged. Patient received her 1st dose on 02Mar2021 on her left arm. On 12Mar2021, she had a black out for 5-10 minutes while walking. She had hit the bone under the eye brow on left side. She ended up in hospital on same day. She had lost lots of blood. She had concussion. She had constant headache. Concomitant product included as Cerefolin Nac. Company comment- Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-269924 (Patient Link). Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VITAMINS NOS; CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]

Current Illness:

ID: 1524846
Sex: F
Age: 67
State: OH

Vax Date: 03/01/2021
Onset Date: 07/01/2021
Rec V Date: 08/04/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: puss coming out of her leg; Blood coming out of her leg; cellulitis; leg was red; leg was itchy; left leg swollen, leg got so big it looked like it could burst,left foot swollen; back pain; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis), ABSCESS LIMB (puss coming out of her leg) and HAEMORRHAGE (Blood coming out of her leg) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stroke (Agent felt her speech was not clear so it was hard at times to understand some details.) in 2005 and Cellulitis in 2013. Concomitant products included HYDROCHLOROTHIAZIDE, CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) and IRBESARTAN (AVAPRO) for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced PERIPHERAL SWELLING (left leg swollen, leg got so big it looked like it could burst,left foot swollen). In July 2021, the patient experienced BACK PAIN (back pain). On 16-Jul-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ABSCESS LIMB (puss coming out of her leg) (seriousness criterion hospitalization), HAEMORRHAGE (Blood coming out of her leg) (seriousness criteria hospitalization and medically significant), ERYTHEMA (leg was red) and PRURITUS (leg was itchy). The patient was hospitalized on 16-Jul-2021 due to ABSCESS LIMB, CELLULITIS and HAEMORRHAGE. The patient was treated with MULTIVITAMIN [VITAMINS NOS] at a dose of 1 dosage form and LINEZOLID for Redness and Swelling, at a dose of 1 dosage form. At the time of the report, CELLULITIS (cellulitis), ABSCESS LIMB (puss coming out of her leg), HAEMORRHAGE (Blood coming out of her leg), BACK PAIN (back pain), PERIPHERAL SWELLING (left leg swollen, leg got so big it looked like it could burst,left foot swollen), ERYTHEMA (leg was red) and PRURITUS (leg was itchy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Hepatic enzyme: high (High) Liver enzymes up. Patient has tried a few other antibiotics and ended up having a bad allergic reaction, not sure which one, so they took her off both. Very limited information regarding these events have been provided at this time. Other factors could have contributed to the events, as there was a very long latency from the start of the event and date of last dose of vaccine. No further information is expected. This case was linked to MOD-2021-037218 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Other factors could have contributed to the events, as there was a very long latency from the start of the event and date of last dose of vaccine. No further information is expected.

Other Meds: HYDROCHLOROTHIAZIDE; CIPRO [CIPROFLOXACIN]; BACTRIM; AVAPRO

Current Illness:

ID: 1524847
Sex: U
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/04/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Flu like symptoms; Positive for COVID; 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 INFLUENZA LIKE ILLNESS (Flu like symptoms) and CORONAVIRUS TEST POSITIVE (Positive for COVID) 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. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion hospitalization) and CORONAVIRUS TEST POSITIVE (Positive for COVID) (seriousness criterion hospitalization). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) and CORONAVIRUS TEST POSITIVE (Positive for COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Coronavirus test positive: positive (Positive) Positive. No concomitant Medications were provided. No treatment Medications were provided. The patient received two doses of moderna vaccine in January 2021 and had been doing ok. The patient was nowin the hospital with positive covid and flu like symptoms. The patient got COVID After the Vaccine. Very limited information regarding these events has been provided at this time. This Spontaneous report also states that two doses are given on the same month with no specified day (unknown batch lot#). No further information is expected. Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. This Spontaneous report also states that two doses are given on the same month with no specified day (unknown batch lot#). No further information is expected.

Other Meds:

Current Illness:

ID: 1524848
Sex: M
Age:
State:

Vax Date: 05/10/2021
Onset Date:
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: on his other arm he noticed blood clots; he noticed a bruise on his arm; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (on his other arm he noticed blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 THROMBOSIS (on his other arm he noticed blood clots) (seriousness criterion medically significant) and CONTUSION (he noticed a bruise on his arm). At the time of the report, THROMBOSIS (on his other arm he noticed blood clots) and CONTUSION (he noticed a bruise on his arm) outcome was unknown. No concomitant medication was not reported. No treatment medication was not reported Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding these events has been provided at this time. This Spontaneous report states that two doses are given on the same date (unknown batch lot#). Information needs to be clarified. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. This Spontaenous report states that two doses are given on the same date (unknown batch lot#). Information needs to be clarified. Further information has been requested.

Other Meds:

Current Illness: Diabetic

ID: 1524849
Sex: U
Age:
State:

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: was diagnosed with disease hyperthyroidism; Feeling symptoms but I just thought it was a side effect of the shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) 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 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) (seriousness criterion medically significant) and VACCINATION COMPLICATION (Feeling symptoms but I just thought it was a side effect of the shot). At the time of the report, HYPERTHYROIDISM (was diagnosed with disease hyperthyroidism) and VACCINATION COMPLICATION (Feeling symptoms but I just thought it was a side effect of the shot) outcome was unknown. Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding these events has been provided at this time. No further information is expected. Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected.

Other Meds:

Current Illness:

ID: 1524850
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Breast Cancer Scare; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST CANCER (Breast Cancer Scare) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Breast Cancer Scare) (seriousness criterion medically significant). At the time of the report, BREAST CANCER (Breast Cancer Scare) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.

Other Meds:

Current Illness:

ID: 1524851
Sex: U
Age: 64
State: NC

Vax Date: 04/06/2021
Onset Date: 05/04/2021
Rec V Date: 08/04/2021
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: Low grade Malt B-cell lymphoma; Arm soreness; This spontaneous case was reported by a patient and describes the occurrence of EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044321A and 0311321A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Anxiety and Cholesterol. Concomitant products included SERTRALINE for Anxiety, ATORVASTATIN for Cholesterol. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). In June 2021, the patient experienced EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) (seriousness criterion medically significant). On 04-May-2021, PAIN IN EXTREMITY (Arm soreness) had resolved. At the time of the report, EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (Low grade Malt B-cell lymphoma) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Mammogram: abnormal (abnormal) low grade Malt B-cell lymphoma. On 09-Jul-2021, Biopsy: abnormal (abnormal) low grade Malt B-cell lymphoma. On 28-Jul-2021, Positron emission tomogram: abnormal (abnormal) Abnormal. The patient stated not experiencing any side effects after the first dose. The patient has not taken anything to help with the symptoms of arm soreness. The first week of June the patient found a lump just above the left breast. The patient went in the last week of June to see their health care provider for the lump. On 14-Jul-2021, the results of laboratory came back as low grade Malt B-cell lymphoma. Action taken with mRNA-1273 in response to the event was Not Applicable Company's 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. There is a short time between the administration of vaccine and the development of breast tumor. Unlikely, that the events are related to the vaccine. Very limited information has been provided at this time. Further information is expected.; 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. There is a short time between the administration of vaccine and the development of breast tumor. Unlikely, that the events are related to the vaccine.Very limited information has been provided at this time. Further information is expected.

Other Meds: SERTRALINE; ATORVASTATIN

Current Illness: Anxiety; Cholesterol

ID: 1524852
Sex: F
Age:
State: ND

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
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: placenta separate after the vaccine (unconfirmed vaccine); baby was delivered at 32 weeks; pregnancy; This spontaneous retrospective pregnancy case was reported by an other health care professional and describes the occurrence of PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)), PREMATURE DELIVERY (baby was delivered at 32 weeks) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)) (seriousness criteria hospitalization and medically significant), PREMATURE DELIVERY (baby was delivered at 32 weeks) (seriousness criterion hospitalization) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) (seriousness criterion hospitalization). The delivery occurred on an unknown date, which was reported as Premature. For neonate 1, The outcome was reported as Pre-Term Birth NOS. At the time of the report, PREMATURE SEPARATION OF PLACENTA (placenta separate after the vaccine (unconfirmed vaccine)), PREMATURE DELIVERY (baby was delivered at 32 weeks) and MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. This is a case of product exposure during pregnancy with associated AEs. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs. Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1524853
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
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: third patient they have seen that has received the COVID-19 vaccine and now has cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) 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 NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (third patient they have seen that has received the COVID-19 vaccine and now has cancer) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Positron emission tomogram: abnormal (abnormal) Cancer. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. The patient explained they found a lump just above the left breast. The patient went and had a few test done. Treatment information was also not reported. Company comment: Very limited information regarding this event has been provided at this time. Details including patient demographics, medical history, concomitant medications, date of vaccine administration, details of the tests/diagnostics and final diagnosis is required for further assessment.; Sender's Comments: Very limited information regarding this event has been provided at this time. Details including patient demographics, medical history, concomitant medications, date of vaccine administration, details of the tests/diagnostics and final diagnosis is required for further assessment.

Other Meds:

Current Illness:

ID: 1524854
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Diagnosed with 2 blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Diagnosed with 2 blood clots) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Diagnosed with 2 blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Diagnosed with 2 blood clots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication information was provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1524855
Sex: F
Age: 51
State: NJ

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 08/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: her eye hurts and bothers her too much; facial paralysis on the left side of her face; pain in the injection site; tiredness; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (facial paralysis on the left side of her face) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced VACCINATION SITE PAIN (pain in the injection site) and FATIGUE (tiredness). On 07-May-2021, the patient experienced FACIAL PARALYSIS (facial paralysis on the left side of her face) (seriousness criterion medically significant). On an unknown date, the patient experienced EYE PAIN (her eye hurts and bothers her too much). The patient was treated with Manual therapy (Accupunture) for Facial paralysis. At the time of the report, FACIAL PARALYSIS (facial paralysis on the left side of her face), EYE PAIN (her eye hurts and bothers her too much), VACCINATION SITE PAIN (pain in the injection site) and FATIGUE (tiredness) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient stated that she did not take any concomitant medications. Patient's recovery was moderate and not complete. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been provided at this time. Further information is expected; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information has been provided at this time. Further information is expected

Other Meds:

Current Illness:

ID: 1524856
Sex: M
Age:
State: MA

Vax Date: 02/27/2021
Onset Date: 03/27/2021
Rec V Date: 08/04/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: TIA Mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 037B21A) for COVID-19 vaccination. Concomitant products included AMLODIPINE, LISINOPRIL, HYDROCHLOROTHIAZIDE and SIMVASTATIN for an unknown indication. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 27-Mar-2021 to 29-Mar-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 29-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (TIA Mini stroke) had resolved. Treatment was not reported. Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-272348 (Patient Link). Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: AMLODIPINE; LISINOPRIL; HYDROCHLOROTHIAZIDE; SIMVASTATIN

Current Illness:

ID: 1524857
Sex: F
Age: 66
State: CA

Vax Date: 06/16/2021
Onset Date: 07/16/2021
Rec V Date: 08/04/2021
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: Appendicitis; pain from my incisions; terrible stomach aches/pains; vomiting; soreness and redness, but it wasn't intense; barely felt any soreness; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (barely felt any soreness). On 17-Jul-2021, the patient experienced ERYTHEMA (soreness and redness, but it wasn't intense). On 19-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (terrible stomach aches/pains) and VOMITING (vomiting). On 20-Jul-2021, the patient experienced INCISION SITE PAIN (pain from my incisions). On an unknown date, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization prolonged and medically significant). The patient was treated with OXYCODONE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and Surgery (to remove appendix) for Appendicitis. On 16-Jul-2021, VACCINATION SITE PAIN (barely felt any soreness) had resolved. On 20-Jul-2021, ABDOMINAL PAIN UPPER (terrible stomach aches/pains) and VOMITING (vomiting) had resolved. On 22-Jul-2021, ERYTHEMA (soreness and redness, but it wasn't intense) had resolved. At the time of the report, APPENDICITIS (Appendicitis) and INCISION SITE PAIN (pain from my incisions) outcome was unknown. No concomitant medication information was provided. she was given blood work, urine tests, an EKG, a CT scan, and an Ultrasound. Then she was diagnosed with appendicitis and admitted around 4:30 PM. She given medicines in preparation for surgery including IV antibiotics, and oxycodone. Then had surgery to remove her appendix. After the surgery she has not had the same pain as prior, but has had pain from her incisions. Company comment-Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1524858
Sex: M
Age: 30
State: NC

Vax Date: 02/26/2021
Onset Date: 03/21/2021
Rec V Date: 08/04/2021
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: Did not receive the second dose and received the first dose on 26FEB2021; pain under his right ear, his eye, and jawline; a loss of taste; couldn't move the right side of face as he couldn't eat lunch that day / Food kept falling out of his mouth; pain under his right ear, his eye, and jawline; pain in jawline; Bell's Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) and FACIAL PARALYSIS (couldn't move the right side of face as he couldn't eat lunch that day / Food kept falling out of his mouth) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No rmedical history was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced OFF LABEL USE (Did not receive the second dose and received the first dose on 26FEB2021), EAR PAIN (pain under his right ear, his eye, and jawline), AGEUSIA (a loss of taste), FACIAL PARALYSIS (couldn't move the right side of face as he couldn't eat lunch that day / Food kept falling out of his mouth) (seriousness criterion medically significant), EYE PAIN (pain under his right ear, his eye, and jawline) and PAIN IN JAW (pain in jawline). The patient was treated with PREDNISONE at a dose of 60 mg and VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of Tablet. At the time of the report, BELL'S PALSY (Bell's Palsy) and OFF LABEL USE (Did not receive the second dose and received the first dose on 26FEB2021) had resolved and EAR PAIN (pain under his right ear, his eye, and jawline), AGEUSIA (a loss of taste), FACIAL PARALYSIS (couldn't move the right side of face as he couldn't eat lunch that day / Food kept falling out of his mouth), EYE PAIN (pain under his right ear, his eye, and jawline) and PAIN IN JAW (pain in jawline) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood glucose: normal (normal) Normal. In 2021, Blood pressure measurement: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Patient did not receive a second dose and inquired about receiving a second dose. One week before receiving the second dose (not clear if patient has received the second dose), he got Bell's Palsy. He never had Bell's Palsy ever before.He had strength in both arms. He was prescribed the following medications prednisone 60 mg which was tapered by taking 10 mg less per day for an 8 day regimen. However, he was not sure if it was accurate. After a month or so, the majority of his face has recovered. He stated that he does not have any other side effects and has fully recovered at this point. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1524859
Sex: M
Age:
State:

Vax Date: 07/15/2021
Onset Date: 07/17/2021
Rec V Date: 08/04/2021
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: achiness; sick for two days/still sick, like very sick; This is a spontaneous report from a contactable consumer reporting for the son. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Jul2021 15:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated the patient went to the pharmacy, he got the vaccine the first dose and he was sick on Sunday (18Jul2021), clarifying he had been sick for two days. The reporter further stated the patient was minor had his 1st vaccine on 15Jul, clarifying had his shot on Thursday (15Jul2021) and it's Monday (19Jul2021), he was still sick , like very sick and unfortunately he was excited about the camp but now he was at camp, 3 hours from home and he spent all 2 and half days in a nurse's office and the reporter did not know what to do. Reporter stated the patient got the vaccine on 15Jul2021 about 3:30 pm and he didn't start to show the achiness, sickness until Saturday morning (17Jul2021), clarifyign he seemed ok like Friday but Saturday, Sunday and today (19Jul2021) were just bad." For lot number, the reporter stated, "EY0 Don't know if it is a O or a zero 584.". The outcome of the events was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1524860
Sex: M
Age:
State: AL

Vax Date: 06/27/2021
Onset Date: 06/28/2021
Rec V Date: 08/04/2021
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: got sore in the arm where he got the shot in/mild-to-moderate pain and soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0196; Expiration Date: Sep2021), via an unspecified route of administration, administered in Arm Left on 27Jun2021 around lunchtime, 11:00-11:30 (at the age of 42-year-old) as dose 1, single for COVID-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing phentermine as diet pill. The patient received the first dose of the Pfizer Covid-19 vaccine in his left arm and had been experiencing mild-to-moderate pain and soreness at injection site on 28Jun2021 that continued to 19Jul2021. The patient stated he got received his first vaccine on 27Jun2021 and he was concerned about taking his second vaccine shot, clarifying the reason why he was concerned about taking the second vaccine shot was due to the side effect that he was experiencing from the first vaccine shot which was normal. The patient had got sore in the arm where he got the shot in but his side effect had extended a week and his arm had been sore every day since. The patient further stated he experienced the side effects that's soreness in his arm and soreness had continued for the past three weeks, just pain aching pain in his arm. The patient reported that it had been 3 weeks and he continued to have the same level of pain in his arm each day unless he took a muscle relaxer or over the counter pain medication. The patient reported that he was calling to see if the soreness in his arm for 3 weeks was normal, if it had been reported before, and if it was safe for him to take the second shot of the Covid-19 vaccine. The patient was supposed to get the second dose of the Pfizer Covid-19 vaccine on 18Jul2021. The patient reported that he did not go to the emergency room or physician's office because he knew that a sore arm was a normal side effect of the Covid-19 vaccine. There was no investigation assessment. The event outcome was not recovered.

Other Meds: PHENTERMINE

Current Illness:

ID: 1524861
Sex: F
Age:
State: FL

Vax Date: 05/16/2021
Onset Date:
Rec V Date: 08/04/2021
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: Cold; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16May2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated because she got the first dose for the Pfizer Covid 19 Vaccine on the 16May and she was supposed to be scheduled for the second dose on the 07Jun but she was unable to take it because she said she had cold in 2021 and she wanted to know if she could receive the second dose or she would start with the first dose again. The event outcome was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1524862
Sex: F
Age:
State: TX

Vax Date: 07/05/2021
Onset Date: 07/06/2021
Rec V Date: 08/04/2021
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: I also got palpitations and chest tightness; I also got palpitations and chest tightness; My left hand got swollen in the afternoon and it lasted all night; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Lot Number: EW0181), via an unspecified route of administration, administered in arm left on 05Jul2021 09:30 (at the age of 27-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included pantoprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took carbamazepine and experienced drug allergy. The patient stated her left hand got swollen in the afternoon and it lasted all night, the day after she got the vaccine on 06Jul2021 19:00. She also got palpitations and chest tightness on 06Jul2021 19:00. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 (PCR and RDT): Negative on 02Jul2021 (Nasal Swab). No treatment was received as a result of the events. The event outcome was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds: PANTOPRAZOLE

Current Illness:

ID: 1524863
Sex: F
Age:
State: NY

Vax Date: 05/03/2021
Onset Date: 06/13/2021
Rec V Date: 08/04/2021
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: cold sores/had an outbreak/not just a single sore, it was her entire mouth; This is a spontaneous report from a contactable consumer (patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Lot Number: eW0167), via an unspecified route of administration, administered in arm left on 03May2021 10:00 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. Medical history included currently undergoing in vitro fertilisation (IVF) (so hormones also playing a role), allergies: Sulfa drugs (hives) and ongoing cold sores. Concomitant medications included clobetasol for poison ivy (topical) and levocetirizine for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN, Lot Number: ER8730), via an unspecified route of administration, administered in arm left on 12Apr2021 10:00 (at the age of 36-year-old) as dose 1, single for COVID-19 immunisation. The patient stated she had cold sores, which had been under control for a decade with 1-2 outbreaks a year. She stated starting 6 weeks after her vaccine on 13Jun2021, she had an outbreak that did not go away for more than a few days before returning again. She stated her immune system just didn't seem able to suppress it, clarifying it was extremely aggressive (not just a single sore, it was her entire mouth) and didn't respond as well to antivirals as past out breaks. The patient went to doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the event and included Valtrex prescription. The event outcome was not recovered.

Other Meds: CLOBETASOL; LEVOCETIRIZINE

Current Illness: Cold sores; In vitro fertilization

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm