VAERS 2021 Database www.vaers.hhs.gov

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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: 1313235
Sex: M
Age:
State:

Vax Date:
Onset Date: 05/02/2021
Rec V Date: 05/13/2021
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: SUSPECTED URETHRAL MUCOSITIS; CLOT; PENIS TIP GOT RED; PENIS PAIN; SAW ANGELS AND DEMONS IN BED; TERRIBLE MALAISE; HEADACHE; FEVER 40 DEGREE; This spontaneous report received from a patient concerned a 26-year-old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021 at night, the patient experienced some symptoms after vaccination including Fever of 40 degrees Celsius, headache, and a terrible malaise. The patient also reported seeing angels and demons in bed; Also, the patient noticed that the penis tip got red and experienced pain. On 05-MAY-2021, the patient continued with the symptoms, and it seemed as if a clot was generated. On 06-MAY-2021, the patient had an appointment with general physician who informed that he never saw an adverse reaction like this after vaccination and that it could be a urethral mucositis. On 10-May-2021, the patient would have an appointment with the urologist to inform the symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever 40 degree Celsius, saw angels and demons in bed, headache, terrible malaise, penis tip got red, penis pain, clot and urethral mucositis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210513944-covid-19 vaccine ad26.cov2.s -thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1313236
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
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: DIZZINESS; SORE ARM; CHILLS; JOINT PAIN; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, 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 dizziness, sore arm, chills, joint pain, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, sore arm, chills, joint pain, and headache. This report was non-serious.

Other Meds:

Current Illness:

Date Died: 04/01/2021

ID: 1313237
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/13/2021
Hospital: Y

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: WAS ON VENTILATOR; SUSPECTED COVID-19 INFECTION; DEATH; This spontaneous report received from a media article via a company representative concerned a 61 year old female of unspecified race and unspecified Ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included exposure to covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 10-MAR-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. A day later of vaccination patient traveled extensively and returned home nine days later. On an unspecified date in MAR-2021, the patient was not feeling well and had difficulty in breathing. Later, patient's sister drove her to the hospital where she had ups and downs but was eventually put on a ventilator. On an unknown date in APR-2021, the patient died due to unknown cause of death. It was unspecified if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died an APR-2021 and the outcome of was on ventilator and suspected covid-19 infection was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: V0: 20210514186-covid-19 vaccine ad26.cov2.s-Death, was on ventilator, suspected covid-19 infection. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness: Exposure to COVID-19

ID: 1313238
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 05/08/2021
Rec V Date: 05/13/2021
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: ACCIDENTALLY SPILLED SOME VACCINE IN THE EYE AS PHARMACIST WAS DRAWING IT UP; This spontaneous report received from a health care professional concerned a 45 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, ophthalmic, batch number: 052A21A, expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAY-2021, the subject experienced accidentally spilled some vaccine in the eye as pharmacist was drawing it up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of accidentally spilled some vaccine in the eye as pharmacist was drawing it up was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.

Other Meds:

Current Illness:

ID: 1313239
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 05/07/2021
Rec V Date: 05/13/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 67 year old female. Initial information was processed along with the additional information received on 10-MAY-2021 and 11-MAY-2021. The patient's weight, height, and medical history were not reported. The patient was not pregnant at the time of reporting and had a family history of confirmed covid cases. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 21-JUN-2021) dose was not reported, 1 total administered to left arm on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAY-2021, the patient got tested for SARS-CoV-2 IgG antibody test (NR: not provided) which came out negative. The patient experienced confirmed immunological vaccine failure. The patient had no adverse effects from the vaccine and would like to get the vaccine again if possible. The patient had her blood tested so that she could donate if she had antibodies. Per patient only 4 among them haven't been infected as they were the older ones, so maybe its just lifestyle. The patient inquired if she could get the second dose of the vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments:Covid-19 vaccine confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1313240
Sex: F
Age:
State: KY

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 05/13/2021
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: STOMACH ACHES; GENERALIZED BODY PAIN; ATRIAL FIBRILLATION; HEARTBEAT SPED UP AND THEN SLOWED DOWN/IRREGULAR HEARTBEAT; BRAIN FOG; FEVER; HEADACHE; NAUSEA; This spontaneous report was received from a 71-year-old, White, not Hispanic or Latino female patient. The patient's height, and weight were not reported. The patient's concurrent conditions included Hashimoto thyroiditis, celiac disease, arthritis, autoimmune disease. The patient was diagnosed with atrial fibrillation (Afib) in JAN-2018 and seldom had an episode of Afib since then. The patient had no known allergies and was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (JANSSEN COVID-19 VACCINE) (suspension for injection, route of administration was not reported, batch number: 1808978 and expiry: unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, following vaccination, the patient had an episode of atrial fibrillation almost every day unlike the time before vaccination and her heartbeat sped up and then slowed down (irregular heartbeat). On the same day, the patient experienced brain fog, fever (axillary temperature of up to 100 degrees) and headache. Since the vaccination, the patient's nausea worsened. On 31-MAR-2021, the patient experienced stomach aches and generalized body pain. Due to the ongoing concern of reports of blood clots associated with the JANSSEN COVID-19 VACCINE, the patient's doctor put her on a blood thinner (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach aches, and fever on 09-APR-2021, and headache on 04-MAY-2021, had not recovered from atrial fibrillation, generalized body pain, heartbeat sped up and then slowed down/irregular heartbeat, and brain fog, and the outcome of nausea was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210516760-COVID-19 VACCINE AD26.COV2.S- Atrial fibrillation. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY

Other Meds:

Current Illness: Arthritis; Atrial fibrillation (Patient was diagnosed with atrial fibrillation in JAN-2018 and seldom had an episode of Afib before covid vaccination.); Autoimmune disorder; Celiac disease; Hashimoto's thyroiditis

ID: 1313242
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/13/2021
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: TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included disabled. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.

Other Meds:

Current Illness: Disability

ID: 1313243
Sex: M
Age:
State: MO

Vax Date:
Onset Date: 04/30/2021
Rec V Date: 05/13/2021
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: DEPRESSIVE EPISODE; IRRITABLE; BODY ACHE; INSOMNIA; FEVER; HEADACHE; INJECTION SITE PAIN; TIRED; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included granule storage platelet disorder, early-stage prostate cancer, itch, face peeled, and huge sunburn like reaction, and concurrent conditions included alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with morphine, and articaine hydrochloride/epinephrine bitartrate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced depressive episode. On 30-APR-2021, the subject experienced irritable. On 30-APR-2021, the subject experienced body ache. On 30-APR-2021, the subject experienced insomnia. On 30-APR-2021, the subject experienced fever. On 30-APR-2021, the subject experienced headache. On 30-APR-2021, the subject experienced injection site pain. On 30-APR-2021, the subject experienced tired. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.5 F, running greater than 100 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache on 01-MAY-2021, and injection site pain on 02-MAY-2021, had not recovered from fever, headache, irritable, depressive episode, and insomnia, and the outcome of tired was not reported. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (One to two beers every month); Non-smoker

ID: 1313244
Sex: U
Age:
State: NY

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 05/13/2021
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: INAPPROPRIATE DOSE OF VACCINE ADMINISTERED; VACCINE UNDERDOSE; ACCIDENTAL EXPOSURE TO PRODUCT; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .3 ml, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAY-2021, the subject experienced inappropriate dose of vaccine administered. On 10-MAY-2021, the subject experienced vaccine underdose. On 10-MAY-2021, the subject experienced accidental exposure to product. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate dose of vaccine administered and vaccine underdose was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1313245
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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: DIZZY FOR 3 DAYS; FEELING SICK; LIVER PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced liver pain. On APR-2021, the subject experienced feeling sick. On 09-APR-2021, the subject experienced dizzy for 3 days. The action taken with covid-19 vaccine was not applicable. The patient recovered from dizzy for 3 days on 12-APR-2021, and the outcome of feeling sick and liver pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1313246
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
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: NECK PAIN; SHOULDERS PAIN/ ANKLE PAIN/ POLYARTHRALGIA/ MIDDLE FINGER JOINT ISSUES; PAIN IN HANDS/ FOREARMS HURTING/ SHIN PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included shin pain. The patient was previously treated with gabapentin for shin pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced neck pain, shoulders pain/ ankle pain/ polyarthralgia/ middle finger joint issues, and pain in hands/ forearms hurting/ shin pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in hands/ forearms hurting/ shin pain, shoulders pain/ ankle pain/ polyarthralgia/ middle finger joint issues and neck pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1313247
Sex: U
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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: SHORTNESS OF BREATH AT NIGHT'; OXYGEN SATURATION DROPPED DURING SLEEP; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, frequency one total administered on 15-MAR-2021 for prophylactic vaccination .The batch number was not reported and has been requested. No concomitant medications were reported. On Apr-2021 (around five weeks after vaccination) patient experienced shortness of breath at night and oxygen saturation was decreased during sleep. Laboratory data (dates unspecified) included: Oxygen saturation (NR: not provided) 86 percentage The action taken with covid-19 vaccine was not applicable. The outcome of the shortness of breath at night' and oxygen saturation dropped during sleep was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: covid-19 vaccine shortness of breath, oxygen saturation decreased to 86%. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Other Meds:

Current Illness:

ID: 1313248
Sex: U
Age:
State: OH

Vax Date:
Onset Date: 05/10/2021
Rec V Date: 05/13/2021
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: VACCINE ADMINISTERED OUTSIDE OF EXPIRY SAFETY GUIDELINES; VACCINE REMOVED FROM FRIDGE AT 09:40 , EXPIRED 15:40H AND VACCINE RECEIVED IN ERROR BETWEEN 16:40-17:00H; DOSE WAS ADMINISTERED BEYOND STABILITY STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1821286 expiry: 23-JUL-2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced vaccine administered outside of expiry safety guidelines. On 10-MAY-2021, the subject experienced vaccine removed from fridge at 0940 expired 1540h and vaccine received in error between 1640-1700h. On 10-MAY-2021, the subject experienced dose was administered beyond stability storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered outside of expiry safety guidelines, vaccine removed from fridge at 0940 expired 1540h and vaccine received in error between 1640-1700h and dose was administered beyond stability storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210518205 and 20210518106.

Other Meds:

Current Illness:

ID: 1313249
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 03/30/2021
Rec V Date: 05/13/2021
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: DIZZINESS; DEBILITATING HEAD PRESSURE; STRUGGLES TO FALL ASLEEP; TERRIBLE THROBBING HEADACHE; BURNING IN LEGS VEINS; THROBBING IN LEGS VEINS; BRUISING IN LEGS; RADIATING PAIN THROUGH HIPS; INJECTION SITE BRUISING; INJECTION SITE KNOT; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: 09-JUN-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Blood test (NR: not provided) Did not find anything abnormal, and MRI (NR: not provided) Did not find anything abnormal. On 30-MAR-2021, the subject experienced injection site bruising. On 30-MAR-2021, the subject experienced injection site knot. On 04-APR-2021, the subject experienced radiating pain through hips. On 10-APR-2021, the subject experienced bruising in legs. On 12-APR-2021, the subject experienced burning in legs veins. On 12-APR-2021, the subject experienced throbbing in legs veins. On 26-APR-2021, the subject experienced dizziness. On 26-APR-2021, the subject experienced debilitating head pressure. On 26-APR-2021, the subject experienced struggles to fall asleep. On 26-APR-2021, the subject experienced terrible throbbing headache. Treatment medications (dates unspecified) included: pseudoephedrine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site bruising on 13-APR-2021, injection site knot on 31-MAR-2021, bruising in legs on 11-APR-2021, burning in legs veins, and throbbing in legs veins on 19-APR-2021, and radiating pain through hips on 08-APR-2021, was recovering from terrible throbbing headache, and had not recovered from dizziness, debilitating head pressure, and struggles to fall asleep. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1313250
Sex: M
Age:
State: OH

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/13/2021
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: SWELLING OF THE LEFT ELBOW; SOFT KNOT IN LEFT ELBOW; This spontaneous report received from a patient concerned an 81 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced swelling of the left elbow. On MAY-2021, the subject experienced soft knot in left elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of the left elbow and soft knot in left elbow was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1313251
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 05/13/2021
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: ITCHY; RASH ON BOTH LEGS, MORE ON THE LEFT AND ON BACK; BOUTS OF NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the patient experienced bouts of nausea. On 11-MAY-2021, the patient experienced itchy. On 11-MAY-2021, the patient experienced rash on both legs, more on the left and on back. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash on both legs, more on the left and on back, itchy, and bouts of nausea. This report was non-serious. This case, from the same reporter is linked to 20210521685.

Other Meds:

Current Illness:

ID: 1313252
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 04/02/2021
Rec V Date: 05/13/2021
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: LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high cholesterol, sulfa drug allergy, peanut and shell fish allergy, tree nuts allergy, mango allergy, chocolate allergy, allergic to color, allergic to flowers/ allergic to soil, allergic to horses, allergic to cats and dogs, and pecan tree allergy, and other pre-existing medical conditions included patient carries an epipen patient was tested for 48 things. The patient was previously treated with . The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043a21a, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. Concomitant medications included azelastine for allergy, cetirizine hydrochloride for allergy, fluticasone propionate for allergy, and rosuvastatin calcium for high cholesterol. On 02-APR-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lightheadedness. This report was non-serious.

Other Meds: AZELASTINE; FLONASE [FLUTICASONE PROPIONATE]; CRESTOR; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness: Allergic reaction to antibiotics; Allergic to horses; Allergy; Allergy to animals; Allergy to nuts; Food allergy; Fruit allergy; High cholesterol; Peanut allergy; Reaction to coloring; Seasonal allergy

ID: 1313253
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
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: TESTICULAR PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced testicular pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from testicular pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1313254
Sex: F
Age: 87
State: WA

Vax Date: 03/29/2021
Onset Date: 03/30/2021
Rec V Date: 05/13/2021
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: passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; Wiped out, Fatigue; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) 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 TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRAVASTATIN for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on). 30-Mar-2021, the patient experienced FATIGUE (Wiped out, Fatigue). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown and FATIGUE (Wiped out, Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: result not mentioned (Inconclusive) result not mentioned. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included discontinuation of glipizide. Company comment: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-070319 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information On 04-May-2021: Updated outcome of fatigue, added route of administration of suspect drug.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: NASACORT; FLOVENT; LISINOPRIL; VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]; PRAVASTATIN

Current Illness:

ID: 1313255
Sex: F
Age: 65
State: IL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 05/13/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Gonarthrosis; Slept all day and night; Sick as a dog; Felt very Drained; Chills; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OSTEOARTHRITIS (Gonarthrosis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. The patient's past medical history included Rheumatoid arthritis since an unknown date. Concurrent medical conditions included Non-tobacco user. Concomitant products included METHOTREXATE for Rheumatoid arthritis. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient experienced OSTEOARTHRITIS (Gonarthrotic) (seriousness criterion hospitalization), HYPERSOMNIA (Slept all day and night), ILLNESS (Sick as a dog), FATIGUE (Felt very Drained), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Physical therapy (4 Physical therapy visits at home) for Osteoarthritis. At the time of the report, OSTEOARTHRITIS (Gonarthrotic), HYPERSOMNIA (Slept all day and night), FATIGUE (Felt very Drained), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown and ILLNESS (Sick as a dog) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Everything good. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had knee replacement on 10-Feb-2021. She had to stopped Humira two week prior and two week after surgery then she went back to every two weeks dose. The Nurse was sent for first three days at home and they changed her bandages than was give four physical therapy visits at home. She said Humira helped her knee replacement. Her rheumatoid arthritis was also in control with Humira and she was able to move again and live normal life. Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: patient demographics updated, medical history updated, concomitant medications updated (Methotrexate), Humira therapy details updated, event term updated (total knee replacement to Gonarthrotic), seriousness criteria updated from non-serious to hospitalization for the event Gonarthrotic.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: METHOTREXATE

Current Illness: Non-tobacco user; Rheumatoid arthritis

ID: 1313256
Sex: F
Age: 36
State: MI

Vax Date: 03/11/2021
Onset Date: 03/11/2021
Rec V Date: 05/13/2021
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: Day 50 and has not received second injection; Autonomic nervous system symptoms; Neurological pain in her legs making it difficult to walk; Unexplained, rapid heart rate; Pressure in her head; Ringing in her ears; Paresthesia in her tongue and throat; Paresthesia in her tongue and throat; Neurological pain all over; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms) in a 36-year-old female patient who received mRNA-1273 (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms) (seriousness criterion medically significant), GAIT DISTURBANCE (Neurological pain in her legs making it difficult to walk), HEART RATE INCREASED (Unexplained, rapid heart rate), HEAD DISCOMFORT (Pressure in her head), TINNITUS (Ringing in her ears), PARAESTHESIA ORAL (Paresthesia in her tongue and throat), PHARYNGEAL PARAESTHESIA (Paresthesia in her tongue and throat) and NEURALGIA (Neurological pain all over). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Day 50 and has not received second injection). At the time of the report, AUTONOMIC NEUROPATHY (Autonomic nervous system symptoms), GAIT DISTURBANCE (Neurological pain in her legs making it difficult to walk), HEART RATE INCREASED (Unexplained, rapid heart rate), HEAD DISCOMFORT (Pressure in her head), TINNITUS (Ringing in her ears), PARAESTHESIA ORAL (Paresthesia in her tongue and throat), PHARYNGEAL PARAESTHESIA (Paresthesia in her tongue and throat) and NEURALGIA (Neurological pain all over) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Day 50 and has not received second injection) had resolved. The action taken with mRNA-1273 (Intramuscular) was unknown. It was reported the patient has been to the emergency room 4 times and had a whole laundry list of tests and labs. Nothing has been successful. The symptoms began within the first 5 minutes after vaccination and had progressively gotten worse. She denies pregnancy. Company comment: Limited information regarding the events and medical history has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events and medical history has been provided at this time. A causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1313257
Sex: M
Age:
State: MO

Vax Date: 04/14/2021
Onset Date: 04/18/2021
Rec V Date: 05/13/2021
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: headache; muscle aches and pains; pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a male patient of an unknown age 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. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) and MYALGIA (muscle aches and pains). On 01-May-2021, PNEUMONIA (pneumonia) had resolved. At the time of the report, HEADACHE (headache) and MYALGIA (muscle aches and pains) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications included IV (which may had antibiotics), doxycycline and its dose lasted till Wednesday last week (28Apr2021). Patient was not taking any other medications. It was reported that on 14 Apr 2021, the patient had taken 1st dose of Moderna COVID-19 vaccine (Lot number 011M20A) in the right upper arm and 6 hours later patient was sick and had chills, fever. On 18 Apr 2021, the patient went to urgent care and diagnosed with pneumonia. On 01 May 2021 the event Pneumonia was resolved (Duration 14 days). Patient was scheduled to get 2nd dose of vaccine on 12-May-2021. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. 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 event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1313258
Sex: M
Age: 55
State: IL

Vax Date: 01/05/2021
Onset Date: 12/15/2020
Rec V Date: 05/13/2021
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: Rash around neck; fatigue; hip replacement; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021. This spontaneous case was reported by a physician and describes the occurrence of HIP ARTHROPLASTY (hip replacement) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. No Medical History information was reported. On 05-Jan-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2020, the patient experienced HIP ARTHROPLASTY (hip replacement) (seriousness criterion medically significant) and FATIGUE (fatigue). On an unknown date, the patient experienced RASH (Rash around neck). At the time of the report, HIP ARTHROPLASTY (hip replacement) had resolved and RASH (Rash around neck) and FATIGUE (fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient was taking Humira medication but stopped in 2022 and restarted on 05-JAN-2021. No treatment information was provided. there is no reasonable possibility that the events of hip replacement surgery, after First dose of covid vaccine developed rash around neck and after second dose of covid vaccine patient was fatigue are related to humira (adalimumab); Sender's Comments: Based on reporter's causality the hip replacement event is assessed as unlikely related to mRNA-1273, while fatigue and rash events are possibly related to mRNA-1273.

Other Meds:

Current Illness:

ID: 1313259
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 05/13/2021
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: Mild Brain pause; Unable to think clearly; Vision Problem; Pressure in her head; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Mild Brain pause) in a 77-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 report provided by the reporter. Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL for Hypertension. 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 MENTAL IMPAIRMENT (Mild Brain pause) (seriousness criterion medically significant), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head). At the time of the report, MENTAL IMPAIRMENT (Mild Brain pause), THINKING ABNORMAL (Unable to think clearly), VISUAL IMPAIRMENT (Vision Problem) and HEAD DISCOMFORT (Pressure in her head) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. The rechallenge was positive. This case was linked to MOD-2021-114463 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: ATENOLOL

Current Illness: Hypertension

ID: 1313260
Sex: M
Age:
State: TX

Vax Date: 05/08/2018
Onset Date: 05/08/2018
Rec V Date: 05/13/2021
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: Rash; Initial information regarding an unsolicited valid non-serious case was received from the Physician via Medical Information (Reference number- 00577192) and transmitted to Sanofi on 26-Apr-2021. This case involves a male patient (demographics not reported) who had rash while after receiving DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 08-May-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U5654AA; expiry date: 27-Apr-2019) via unknown route in unknown administration site for prophylactic vaccination. On 08-MAY-2018 the patient developed a non-serious rash on the same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The reporter stated, the patient has had a rash ever since he received the vaccine and believed it may have been caused by the vaccine. The reporter wanted to know if there are any known issues with this vaccine. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the event was not recovered.

Other Meds:

Current Illness:

ID: 1313261
Sex: F
Age: 74
State: CA

Vax Date: 04/13/2021
Onset Date: 04/27/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: NKDA

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

Symptoms: Patient woke up with right upper and lower extremity weakness on 4/27/2021. She did not go to the ER. I suspect stroke and have ordered CT brain.

Other Meds: Vitamin D3, metformin, levothyroxine, glipizide, atorvastatin, hydrochlorothiazide, amlodipine, aspirin, benazepril.

Current Illness:

ID: 1313262
Sex: F
Age: 69
State: FL

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: nka

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: SOB, ears clogged and sweaty. Customer c/o sob, clammy skin. Customer also c/ that her ears felt plugged for a second. EMS and Nurse onsite responded.. B/P 160/80, HR 66. On 96 cust stated she was fine, just had some anxiety. 1st dose.

Other Meds: B/P as needed

Current Illness: High+Low B/P

ID: 1313263
Sex: F
Age: 70
State:

Vax Date: 04/14/2021
Onset Date: 04/16/2021
Rec V Date: 05/13/2021
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: N17.9 - Acute kidney failure, unspecified

Other Meds:

Current Illness:

ID: 1313264
Sex: F
Age: 51
State:

Vax Date: 04/24/2021
Onset Date: 04/24/2021
Rec V Date: 05/13/2021
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: Tinnitus started approximately 4 hours after receiving my first dose of the Pfizer COVID 19 vaccine. Other symptoms include dizziness, fatigue, difficulty concentrating at times. The tinnitus has been constant. I saw my PCP, an ENT specialist, and an Audiologist. There is no treatment for the tinnitus and it may be permanent.

Other Meds:

Current Illness:

ID: 1313265
Sex: F
Age: 88
State:

Vax Date: 03/18/2021
Onset Date: 03/24/2021
Rec V Date: 05/13/2021
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: N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia

Other Meds:

Current Illness:

ID: 1313266
Sex: F
Age: 60
State: IN

Vax Date: 05/08/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies: Nitrates and nitrites

Symptom List: Injection site pain

Symptoms: Sudden onset of sore throat coughing runny nose coughing up phlegm

Other Meds: Acedazolamide, Pregabalin, Duloxetine, Ropinirole, Doxepin, Tylenol p.m., daily baby aspirin Hair skin and nail vitamins, Omeprazole, BUPROPION HCL

Current Illness: None

ID: 1313267
Sex: F
Age: 78
State:

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: N17.9 - Acute kidney failure, unspecified

Other Meds:

Current Illness:

ID: 1313268
Sex: M
Age: 70
State:

Vax Date: 03/24/2021
Onset Date: 04/01/2021
Rec V Date: 05/13/2021
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: E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified

Other Meds:

Current Illness:

ID: 1313269
Sex: M
Age: 66
State: MI

Vax Date: 05/07/2021
Onset Date: 05/07/2021
Rec V Date: 05/13/2021
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: NO

Symptom List: Tremor

Symptoms: HE COMPLAINED OF CHEST PAIN. ON SITE EMS RESPONDED. VITALS LISTED BELOW. THE NON CARDIAC PAIN SUBSIDED AND HE WAS RELEASED TO HOME

Other Meds: ALBUTEROL

Current Illness: NO

ID: 1313271
Sex: F
Age: 29
State: TN

Vax Date: 05/11/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: Lymph node Tenderness in armpit, chills

Other Meds: Nuvaring

Current Illness:

ID: 1313272
Sex: M
Age: 67
State:

Vax Date: 01/30/2021
Onset Date: 02/03/2021
Rec V Date: 05/13/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: N17.9 - Acute kidney failure, unspecified

Other Meds:

Current Illness:

ID: 1313273
Sex: M
Age: 60
State: MA

Vax Date: 03/27/2021
Onset Date: 05/06/2021
Rec V Date: 05/13/2021
Hospital: Y

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

Lab Data:

Allergies: None

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

Symptoms: Saddle pulmonary embolus diagnosed 5/12/21 with unilateral leg swelling starting over one month prior.

Other Meds:

Current Illness: None

ID: 1313274
Sex: F
Age: 70
State: TN

Vax Date: 03/27/2021
Onset Date: 03/27/2021
Rec V Date: 05/13/2021
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: Medications: sporins Food: milk, oysters, peanuts, peaches, kiwi, eggs

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Minor symptoms immediately after vaccinations, including vertigo at first vaccine and brown out on second. Pain developed over a few hours, including a bad headache after first vaccine. In four days this moved to fairly severe whole body muscular and nerve pain. Had second vaccination 4/17/2021, lot number ER8731. Pain still persisting almost a month later. Myalgia?

Other Meds: Senior vitamins and minerals

Current Illness: Minor cold the week before second vaccination on 4/17/2021. No symptoms of COVID but maybe had it in December 2020.

ID: 1313275
Sex: M
Age: 74
State:

Vax Date: 02/06/2021
Onset Date: 02/08/2021
Rec V Date: 05/13/2021
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: N17.9 - Acute kidney failure, unspecified

Other Meds:

Current Illness:

ID: 1313276
Sex: M
Age: 60
State:

Vax Date: 03/27/2021
Onset Date: 04/10/2021
Rec V Date: 05/13/2021
Hospital: Y

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: N17.9 - Acute kidney failure, unspecified

Other Meds:

Current Illness:

ID: 1313277
Sex: M
Age: 36
State: IN

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium

Other Meds:

Current Illness:

ID: 1313278
Sex: F
Age: 65
State:

Vax Date: 02/06/2021
Onset Date: 02/11/2021
Rec V Date: 05/13/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness

Other Meds:

Current Illness:

ID: 1313279
Sex: M
Age: 58
State: PA

Vax Date: 03/22/2021
Onset Date: 04/06/2021
Rec V Date: 05/13/2021
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: BaclofenHives / Urticaria Duricef [Cefadroxil]Diarrhea MethocarbamolIndigestion / GI upset OxycodoneRash, Nausea and Vomiting Sulfamethoxazole-trimethoprimIndigestion / GI upset TramadolIndigestion / GI upset

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

Symptoms: Non adverse events listed but tested positive for COVID-19 on 4/6/21

Other Meds: acetaminophen (TYLENOL) 500 mg tablet albuterol HFA (PROVENTIL;VENTOLIN) 90 mcg/actuation inhaler buprenorphine-naloxone (SUBOXONE) 8-2 mg film film clobetasol-emollient 0.05 % topical foam clonazePAM (KlonoPIN) 1 mg tablet clotrimazole (LO

Current Illness: None

ID: 1313280
Sex: F
Age: 37
State:

Vax Date: 04/23/2021
Onset Date: 04/23/2021
Rec V Date: 05/13/2021
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: Amoxicillin

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

Symptoms: -immediate headache 5 min post vaccination -dizziness 10 min post -fogginess and confusion 45 min post -increased mucus 1 hour post -flu-like symptoms in evening (lasted 48 hours) -throat/trachea inflammation 10:00pm with wheezing, felt like throat closing and asthma attack (relieved w essential oil to open airways). (lasted 48 hours) -woke up with swollen lips & eyes and inflammation in tonsils & trachea, coughing, coughing up black mucus, felt like asthma attack and migraine, can?t take deep breath (lasted 48 hours) -9:00am took 2 Advil -coughing & flu like symptoms continued -swollen tonsils & closing trachea as if having an asthma attack -enlarged lymph nodes (and above left clavicle) one week post vaccine (lasted almost 2 weeks)

Other Meds: None

Current Illness:

ID: 1313281
Sex: M
Age: 54
State: VA

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild

Other Meds:

Current Illness:

ID: 1313282
Sex: F
Age: 83
State:

Vax Date: 02/16/2021
Onset Date: 03/18/2021
Rec V Date: 05/13/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)

Other Meds:

Current Illness:

ID: 1313283
Sex: M
Age: 42
State: PA

Vax Date: 05/06/2021
Onset Date: 05/07/2021
Rec V Date: 05/13/2021
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: Severe ringing in both ears. I have not sought treatment. The ringing is a constant high pitch ring and throughout the day as the ringing gets worse it will also throb to the pace of my pulse.

Other Meds:

Current Illness:

ID: 1313284
Sex: F
Age: 48
State: CA

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/13/2021
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: Site: Redness at Injection Site-Medium, Additional Details: Pt had fever for two days and bruise at injection site for two weeks.

Other Meds:

Current Illness:

ID: 1313285
Sex: F
Age: 82
State:

Vax Date: 03/02/2021
Onset Date: 03/04/2021
Rec V Date: 05/13/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - Acute renal injury (CMS/HCC)

Other Meds:

Current Illness:

ID: 1313286
Sex: M
Age: 23
State: CA

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 05/13/2021
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: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm