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: 1409462
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: NEEDING TO HOLD ON TO THE WALL WHEN WALKED; BLOOD PRESSURE WAS LOW AT FIRST; FELT FAINT/DIZZY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergies to bees, and other pre-existing medical conditions included the first symptom patient had as a rare allergic reaction was an intense headache. The patient felt numbness in lips and it spread, symmetrically from the center. The tip of tongue began growing numb. The patient felt some swelling in mouth. That slow ramp up was not typical of an allergic response, but it was precisely what happened the last time the patient was stung by an itsy bitsy baby bee hiding in a bushel of plums and the patient was in the emergency room. The patient experienced rare allergic reaction when treated with bnt 162 for drug used for unknown indication, and terrifying side effects when treated with tetanus vaccine for drug used for unknown indication. The patient received benadryl unspecified (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced needing to hold on to the wall when walked, blood pressure was low at first, and felt faint/dizzy. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with benadryl unspecified was not reported. The outcome of the blood pressure was low at first, felt faint/dizzy and needing to hold on to the wall when walked was not reported. This report was non-serious.

Other Meds:

Current Illness: Allergy to insect sting

ID: 1409463
Sex: F
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: GOT AN ENERGY BOOST FROM THE SHOT; This spontaneous report received from a patient concerned an 8 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fatigue.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced got an energy boost from the shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got an energy boost from the shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20210621123.

Other Meds:

Current Illness: Fatigue

ID: 1409464
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 4 decade old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included multiple medical issues. 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 an unspecified date in MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had a negative antibody test, suspected immunological vaccination failure. It was reported that patient felt that the medical personnel during the vaccine clinic might have administered a partial dose to the patient possibly due to a drop of liquid coming out during administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with PQC number: 90000182451 The suspected product quality complaint has been confirmed to be void does not apply to this PQC error based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210622043-covid-19 vaccine ad26.cov2.s-suspected immunological vaccination failure. This event(s) is considered not related. The event(s) has an unknown/unclear 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: Multimorbidity

ID: 1409465
Sex: M
Age:
State: SC

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/18/2021
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: SWELLING IN BACK OF THROAT; SWELLING AROUND TONSILS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-JUN-2021, the subject experienced swelling in back of throat. On 10-JUN-2021, the subject experienced swelling around tonsils. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling in back of throat and swelling around tonsils was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409466
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 06/08/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VOMITING; BODY ACHES WHICH FELT LIKE AFTER A VERY HARD WORKOUT; PAIN IN STOMACH LIKE CRAMPING; HEART POUNDING IT FELT LIKE BLOOD RUSHING THROUGH THE BODY VERY QUICKLY; UNABLE TO SLEEP; HEADACHE ALL THE TOP OF THE HEAD; NAUSEA; ARM HURTS WHEN IT MOVES; SORE ARM IN INJECTION SITE AREA THAT IS CANNOT BE TOUCHED OR LAY ON IT; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and other pre-existing medical conditions included the patient has not had covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced arm hurts when it moves. On 08-JUN-2021, the subject experienced sore arm in injection site area that is cannot be touched or lay on it. On 08-JUN-2021, the subject experienced nausea. Laboratory data included: Pain scale (NR: not provided) 6. On 09-JUN-2021, the subject experienced vomiting. On 09-JUN-2021, the subject experienced body aches which felt like after a very hard workout. On 09-JUN-2021, the subject experienced pain in stomach like cramping. On 09-JUN-2021, the subject experienced heart pounding it felt like blood rushing through the body very quickly. On 09-JUN-2021, the subject experienced unable to sleep. On 09-JUN-2021, the subject experienced headache all the top of the head. Laboratory data included: Pain scale (NR: not provided) 6-7. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Negative. Treatment medications (dates unspecified) included: ondansetron, acetylsalicylic acid/caffeine/paracetamol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm in injection site area that is cannot be touched or lay on it, nausea, vomiting, body aches which felt like after a very hard workout, pain in stomach like cramping, heart pounding it felt like blood rushing through the body very quickly, unable to sleep, and headache all the top of the head, and the outcome of arm hurts when it moves was not reported. This report was non-serious.

Other Meds:

Current Illness: Penicillin allergy

ID: 1409467
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: MIGRAINE HEADACHES; TWITCHING OF FACE; This spontaneous report received from a patient via a company representative concerned a 21 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced migraine headaches, and twitching of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine headaches and twitching of face was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409468
Sex: F
Age:
State: GA

Vax Date:
Onset Date: 06/05/2021
Rec V Date: 06/18/2021
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: HUGE BLISTERS ALL OVER TOES AND FEET; FEET HURTING; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included elevated heart rate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 05-JUN-2021 for prophylactic vaccination. Concomitant medications included losartan for elevated heart rate, and metoprolol for elevated heart rate. On 05-JUN-2021, the subject experienced feet hurting. On 06-JUN-2021, the subject experienced huge blisters all over toes and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from feet hurting, and huge blisters all over toes and feet. This report was non-serious.

Other Meds: METOPROLOL; LOSARTAN

Current Illness: Heart rate high

ID: 1409469
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 06/11/2021
Rec V Date: 06/18/2021
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: LUMP AT SITE OF INJECTION; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included none, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced lump at site of injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump at site of injection. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409470
Sex: F
Age:
State: IN

Vax Date:
Onset Date: 05/19/2021
Rec V Date: 06/18/2021
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: NEUROLOGICAL PAIN; SHINGLES; INJECTION SITE ITCHING; LEFT SIDE INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, oak allergy, and sumac allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A121A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced left side injection site pain. On 01-JUN-2021, the subject experienced injection site itching. On 02-JUN-2021, the subject experienced shingles. On an unspecified date, the subject experienced neurological pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left side injection site pain on 22-MAY-2021, had not recovered from shingles, and injection site itching, and the outcome of neurological pain was not reported. This report was non-serious.

Other Meds:

Current Illness: Allergy; Seasonal allergy

ID: 1409471
Sex: F
Age:
State: SC

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 06/18/2021
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: HIGH BLOOD PRESSURE; COULDN'T WALK; COULDN'T DO ANYTHING; SO SICK; NOT FEELING WELL; VERTIGO; VOMITING; NAUSEA; This spontaneous report received from a patient concerned a 96 year old female. The patient's weight was 128 pounds, and height was not reported. The patient's concurrent conditions included arthritis, neuropathy, thyroid issue, non smoker, non alcohol user, diabetes, and cannot walk without a walker, 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: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced vomiting. On MAR-2021, the subject experienced nausea. On 31-MAR-2021, the subject experienced vertigo. On an unspecified date, the subject experienced high blood pressure, couldn't walk, couldn't do anything, so sick, and not feeling well. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 200 over something. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vertigo, high blood pressure, not feeling well, couldn't walk, couldn't do anything, and so sick, and the outcome of nausea and vomiting was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Arthritis; Diabetes; Neuropathy; Non-smoker; Thyroid disorder; Walker user

ID: 1409473
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
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: This spontaneous report received from a patient concerned a patient of unspecified age and sex.The patient's height, and weight were not reported. The patient's concurrent conditions included graves disease, and issue with heart. 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 09-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On JUN-2021, the subject experienced loss of appetite. On JUN-2021, the subject experienced dizzy. On JUN-2021, the subject experienced weak. On 11-JUN-2021, the subject experienced chest feels tight. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the loss of appetite, dizzy, weak and chest feels tight was not reported. This report was non-serious.

Other Meds:

Current Illness: Graves' disease; Heart disorder

ID: 1409474
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: HEADACHE; FATIGUE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination.The batch number was not reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and fatigue was not reported. This report was non-serious. This case, from the same reporter is linked to 20210624187.

Other Meds:

Current Illness:

ID: 1409475
Sex: M
Age:
State: NC

Vax Date:
Onset Date: 06/11/2021
Rec V Date: 06/18/2021
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: 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 past medical history included stent placement, and concurrent conditions included diabetic. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-JUN-2021, the subject experienced swelling of left ankle. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of left ankle. This report was non-serious.

Other Meds:

Current Illness: Diabetic

ID: 1409476
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: 101 FEVER; HEADACHE; MUSCLE ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced 101 fever, headache, and muscle aches. 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 101 fever, headache and muscle aches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409477
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: OFF LABEL USE WITHOUT ADVERSE EVENT; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received from a physician concerned a 17 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. patient had no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 04-AUG-2021) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced off label use without adverse event. On 12-JUN-2021, the subject experienced inappropriate age at vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use without adverse event and inappropriate age at vaccine administration was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1409478
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: THYROIDITIS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced thyroiditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from thyroiditis. This report was non-serious.; Sender's Comments: V0.Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.

Other Meds:

Current Illness:

ID: 1409479
Sex: M
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: BLOOD CLOTS; This solicited report received from a consumer via PPSCVM000808: Janssen CarePath for XARELTO concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots and not sure what was causing it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with rivaroxaban was not reported. The outcome of blood clots was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots was not related; and between rivaroxaban, and blood clots was not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210627971- covid-19 vaccine ad26.cov2.s-Blood Clots-This event is considered un-assessable. This event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.

Other Meds:

Current Illness:

ID: 1409480
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: MYOCARDIAL INFARCTION; TROPONIN INCREASED; This spontaneous report received from a consumer via social media (twitter) and concerned multiple patients with different age groups 6-17 years, 18-29 years, 30-39 years, 40-49 years. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin) 1 total, dose, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported. Per procedure no follow up will be requested. No concomitant medications were reported. On an unspecified date, the patients experienced myocardial infarction, and troponin increased. The onset interval reported was 0 days, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days, 7 days, 8 days, 9 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocardial infarction and troponin increased was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210628314-COVID-19 VACCINE AD26.COV2.S-MYOCARDIAL INFARCTION. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1409481
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: ACHE; CHILLS; SORE ARM; SLIGHTLY KICKING MY BUTT; 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 was not reported, administered on 11-JUN-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 12-JUN-2021, the subject experienced ache. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced sore arm. On 12-JUN-2021, the subject experienced slightly kicking my butt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache, sore arm, chills and slightly kicking my butt was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409482
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/10/2021
Rec V Date: 06/18/2021
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: This spontaneous report received from a patient via a company representative concerned a 20 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: 1821288, and expiry: UNKNOWN) dose was not reported, administered on 10-JUN-2021 14:25 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the subject experienced headache. On 11-JUN-2021, the subject experienced could not think, confused. On 11-JUN-2021, the subject experienced vomit. On 11-JUN-2021, the subject experienced cough. On 11-JUN-2021, the subject experienced lack of air. On 11-JUN-2021, the subject experienced heavy sweating. On 11-JUN-2021, the subject experienced extreme pain in his legs (described as the worst of any workout he has ever done in his life). On 11-JUN-2021, the subject experienced chills. On 11-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: salbutamol. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not think, confused, vomit, cough, lack of air, heavy sweating, extreme pain in his legs (described as the worst of any workout he has ever done in his life), chills, fever, and headache on 12-JUN-2021. 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: 1409483
Sex: M
Age:
State:

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: LIGHT FEVER; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-JUN-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 12-JUN-2021, the subject experienced light fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of light fever was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409484
Sex: F
Age:
State:

Vax Date:
Onset Date: 05/18/2021
Rec V Date: 06/18/2021
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: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 1 total, dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 12-MAY-2021 or 13-MAY-2021, the patient had contact with COVID-19 and was tested positive on 18-MAY-2021 (suspected clinical vaccination failure and suspected covid-19 infection). The patient never had fever. The patient had few chills, runny nose and body aches. It was reported that COVID-19 had never affected the patient's lungs. The patient had oxygen at home and used as needed and monitored her levels on a daily basis. The patient had stayed hydrated, took Tylenol (paracetamol) daily, double doses of Vitamin D (ergocalciferol), Vitamin C (ascorbic acid,), Elderberry (sambucus nigra) and zinc. The patient had not visited hospital. On 27-MAY-2021, the patient tested negative for COVID-19. The patient was still working to get strength back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000182683. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210628624- covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness: COPD

ID: 1409485
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-JUNE-2021, the patient took a blood test to check that he had generated antibodies and the result was the following: Immunoglobulin G (IgG) antibodies: 0.018 Negative - 0.018 index (S/C) [Assay results were reported as an index value of the ratio of specimen to calibrator absorbance (S/C or S/CO)], Immunoglobulin M (IgM) antibodies: 1.17 Positive - 1.17 index (S / C) Given this result, the antibodies that protect against the virus had not been generated after 60 days of application of the vaccine (confirmed immunological vaccine failure). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000182752. The suspected product quality complaint has been confirmed to be non-voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210628716-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds:

Current Illness:

ID: 1409486
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/08/2021
Rec V Date: 06/18/2021
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: STOMACH PAIN; BACK DISCOMFORT; NAUSEA; MALAISE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-JUN-2021, the subject experienced malaise. On 12-JUN-2021, the subject experienced stomach pain. On 12-JUN-2021, the subject experienced back discomfort. On 12-JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, stomach pain, and back discomfort, and the outcome of malaise was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409487
Sex: U
Age:
State: UT

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and expiry: 11-JUN-2021) .5 ml, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced expired vaccine used. On 12-JUN-2021, the subject experienced incorrect product storage. The outcome of the expired vaccine used and incorrect product storage was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409488
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous report received from a patient concerned a 77 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included hypertension, depression, allergy to cat dander ( sneezing, watering eyes), no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced dryness of mouth (drug allergy) when treated with codeine. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced right and left arm soreness two to three days after the shot. On JUN-2021, the subject experienced headache. On JUN-2021, the subject experienced redness at injection site. On 10-JUN-2021, the subject experienced bleeding spots under the skin on right arm. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding spots under the skin on right arm, headache, right and left arm soreness two to three days after the shot and redness at injection site was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergic to cats; Depression; Hypertension; Non-smoker

ID: 1409489
Sex: F
Age:
State: ID

Vax Date:
Onset Date: 05/15/2021
Rec V Date: 06/18/2021
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: MAGNETS STUCK TO INJECTION SITE; This spontaneous report received from a patient concerned a 42 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: 1808986, expiry: 18-AUG-2021) dose was not reported, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the subject experienced magnets stuck to injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from magnets stuck to injection site. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409490
Sex: F
Age:
State:

Vax Date:
Onset Date: 05/13/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: MENSTRUAL CYCLE LASTED 10 DAYS; FEVER; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no illness at the time of vaccination, no known allergies. with the existing information. in the past 14 days, patient had not been in close contact with anyone who tested positive for covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and expiry: JUN-2021) .5 ml, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 97.5 F. On 13-MAY-2021, the subject experienced fever. On JUN-2021, the subject experienced menstrual cycle lasted 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of menstrual cycle lasted 10 days was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409491
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 06/04/2021
Rec V Date: 06/18/2021
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: EXTREMELY ITCHY EYES; BLURRED VISION; This spontaneous report received from a patient concerned a 60 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 04-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-JUN-2021, the subject experienced extremely itchy eyes. On 04-JUN-2021, the subject experienced blurred vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from extremely itchy eyes, and blurred vision. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409492
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 06/14/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: ADMINISTERED VACCINE AT ROOM TEMPERATURE FOR 4 HOURS; VACCINE STORED OUTSIDE OF THE RECOMMENDED STORAGE CONDITIONS; This spontaneous report received from a health care professional concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 14-JUN-2021 13:36 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced administered vaccine at room temperature for 4 hours. On 14-JUN-2021, the subject experienced vaccine stored outside of the recommended storage conditions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered vaccine at room temperature for 4 hours and vaccine stored outside of the recommended storage conditions was not reported. This report was non-serious. This case, from the same reporter is linked to 20210630313.

Other Meds:

Current Illness:

ID: 1409493
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: VACCINE ERROR ADMINISTERED 10 MINUTES PAST 6 HOURS OF 1ST PUNCTURE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine error administered 10 minutes past 6 hours of 1st puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine error administered 10 minutes past 6 hours of 1st puncture was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409494
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 06/18/2021
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: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, a month after vaccination, the patient donated blood and found out he still did not have the antibodies (confirmed immunological vaccine failure), then after a month again he donated blood and did not have the antibody or antigen in blood. Laboratory data included: Antibody test (NR: not provided) Negative. On JUN-2021, Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210630149-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological Vaccine Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.

Other Meds:

Current Illness:

ID: 1409495
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BLOOD GLUCOSE STABILIZATION/UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a consumer concerned a 75 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. Concomitant medications included insulin aspart for type 2 diabetes, insulin degludec for type 2 diabetes, liraglutide for type 2 diabetes, and metformin for type 2 diabetes. On JUN-2021, the subject experienced blood glucose stabilization/unexpected therapeutic benefit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood glucose stabilization/unexpected therapeutic benefit was not reported. This report was non-serious.

Other Meds: NOVOLOG; VICTOZA; TRESIBA; METFORMIN

Current Illness: Type II diabetes mellitus

ID: 1409496
Sex: U
Age:
State: MI

Vax Date:
Onset Date: 06/09/2021
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: LEFT OUT OF FRIDGE BEYOND 6 HOURS; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1821288, expiry: 01-AUG-2021) dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUN-2021, the subject experienced left out of fridge beyond 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of left out of fridge beyond 6 hours was not reported. This report was non-serious. This case, from the same reporter is linked to 20210619240.

Other Meds:

Current Illness:

ID: 1409497
Sex: M
Age:
State: GA

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: CHILLS; HEADACHES; FEVER; FATIGUE; BODY ACHES; LOSS OF APPETITE; SORE ARM; This spontaneous report received from a parent concerned an 18 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 expiry: UNKNOWN) dose was not reported, administered on 12-JUN-2021 17:45 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the subject experienced sore arm. On 13-JUN-2021, the subject experienced body aches. On 13-JUN-2021, the subject experienced loss of appetite. On 13-JUN-2021, the subject experienced chills. On 13-JUN-2021, the subject experienced headaches. On 13-JUN-2021, the subject experienced fever. On 13-JUN-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm, and the outcome of chills, fever, headaches, body aches, loss of appetite and fatigue was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409498
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/14/2021
Rec V Date: 06/18/2021
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: BLURRED VISION; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2021, the subject experienced blurred vision. On 14-JUN-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blurred vision and bad headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409499
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/12/2021
Rec V Date: 06/18/2021
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: BODY ACHES; CHILLS; FEVER; 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, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUN-2021, treatment medications included: paracetamol. On 12-JUN-2021, the subject experienced body aches. On 12-JUN-2021, the subject experienced chills. On 12-JUN-2021, the subject experienced fever. On 12-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, chills, headache, and body aches. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409500
Sex: M
Age:
State: AZ

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 06/18/2021
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: HIGH BLOOD PRESSURE/BLOOD PRESSURE OUT OF WHACK; This spontaneous report received from a patient concerned a 68 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. the patient did not drink caffeine and had no high sodium. the patient had no change in his life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 165-180 (unit not reported), 140-165 (unit not reported). On MAR-2021, treatment medications included: metoprolol. On 24-MAR-2021, the subject experienced high blood pressure/blood pressure out of whack. On 15-JUN-2021, Laboratory data included: Blood pressure (NR: not provided) 165-180 (unit not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure/blood pressure out of whack. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Diabetes; Non-smoker

ID: 1409501
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MYALGIA; This spontaneous report received from a patient concerned a 70 year old female. The patient's weight was 179 pounds, and height was 66 inches. The patient's concurrent conditions included crohn's disease, osteoporosis and alcohol use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included alprazolam, hydrocodone, and paracetamol. n an unspecified date, the subject experienced myalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myalgia was not reported. This report was non-serious. This case, involving the same patient is linked to 20191214985 and 20210616536.

Other Meds: XANAX; HYDROCODONE; TYLENOL

Current Illness: Alcohol use (occasionally - wine every once in a while); Crohn's disease (Takes medication monthly now instead of every 2 months because the drug "dissipates too quickly"); Osteoporosis

ID: 1409503
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 05/06/2021
Rec V Date: 06/18/2021
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: MUSCLE TWITCH IN BOTH ARMS; This spontaneous report received from a parent concerned a 25 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, expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced muscle twitch in both arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle twitch in both arms on 2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409504
Sex: U
Age:
State: NY

Vax Date:
Onset Date: 06/15/2021
Rec V Date: 06/18/2021
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: RECEIVED A VACCINE OUTSIDE OF 6 HOUR WINDOW; This spontaneous report received from a health care professional concerned a 47 year old of unspecified 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: 202A21A, expiry: 07-AUG-2021) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUN-2021, the subject experienced received a vaccine outside of 6 hour window. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received a vaccine outside of 6 hour window was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409505
Sex: M
Age:
State: WA

Vax Date:
Onset Date: 06/14/2021
Rec V Date: 06/18/2021
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: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409506
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ARM SWELLED UP; BRUISES AROUND AREA PUNCTURED TURNED BLACK AND BLUE; This spontaneous report received from a parent 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced arm swelled up, and bruises around area punctured turned black and blue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm swelled up and bruises around area punctured turned black and blue was not reported. This report was non-serious. This parent/child case is linked to 20210555169.

Other Meds:

Current Illness:

ID: 1409507
Sex: F
Age: 24
State: TX

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 06/18/2021
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: None

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

Symptoms: Ringing/pain in both ears, nasal drip

Other Meds: None

Current Illness: None

ID: 1409508
Sex: F
Age: 40
State: VA

Vax Date: 04/30/2021
Onset Date: 04/30/2021
Rec V Date: 06/18/2021
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: bactrim

Symptom List: Vomiting

Symptoms: SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION. LEFT SHOULDER PAIN POST COVID VACCINE ADMINISTRATION. EXAM IS NORMAL BUT APPEARS INJECTION WAS PLACED INTHE INSERTION OF THE DELTOID OR POSSIBLY SUBACROMIAL SPACE VICE THE DELTOID MUSCLE BELLY BASED ON PHYSICAL EXAM AND SUBJECTIVE COMPLAINT.

Other Meds: OCP, zyrtec

Current Illness: none

ID: 1409509
Sex: F
Age: 28
State: MD

Vax Date: 06/10/2021
Onset Date: 06/17/2021
Rec V Date: 06/18/2021
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: Allergy to strawberry

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Itchy, painfully, swollen and hard patch at injection site Started on the night of June 16th

Other Meds: None

Current Illness: Asthma

ID: 1409510
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/18/2021
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: BODY ACHES; CHILLS; FEVER; A LOT OF FATIGUE; 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, chills, fever, and a lot of fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, body aches and a lot of fatigue was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409511
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 06/15/2021
Rec V Date: 06/18/2021
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: BONES HURTING SEVERELY ALL OVER THE HIPS KNEES ANKLES RIBS ARMS AND BACK; TINGLING IN RIGHT ARM; NUMBNESS IN RIGHT ARM; BODY ACHES LIKE THE FLU; LIPS TINGLING BUT NOT SWOLLEN HAPPENED ONLY ONCE FOR HALF HOUR; SQUEEZING LIKE PRESSURE ON RIGHT ARM FELT LIKE RUBBER AROUND BANDS ARMS AND BLOCKING CIRCULATION; JOINT PAIN; HEADACHE ON RIGHT TOP SIDE OF HEAD; FEVER TEMP HIGHEST 104.1F TO RANGE OF 102F; MUSCLE PAIN; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient not tested positive for covid, not aware that has had covid before, ended up in emergency room last fall due to non covid virus. The patient experienced got sick like in vomiting when treated with hydromorphone hydrochloride, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-JUN-2021, the subject experienced bones hurting severely all over the hips knees ankles ribs arms and back. On 15-JUN-2021, the subject experienced tingling in right arm. On 15-JUN-2021, the subject experienced numbness in right arm. On 15-JUN-2021, the subject experienced body aches like the flu. On 15-JUN-2021, the subject experienced lips tingling but not swollen happened only once for half hour. On 15-JUN-2021, the subject experienced squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation. On 15-JUN-2021, the subject experienced joint pain. On 15-JUN-2021, the subject experienced headache on right top side of head. On 15-JUN-2021, the subject experienced fever temp highest 104.1f to range of 102f. On 15-JUN-2021, the subject experienced muscle pain. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lips tingling but not swollen happened only once for half hour on 15-JUN-2021, and was recovering from tingling in right arm, squeezing like pressure on right arm felt like rubber around bands arms and blocking circulation, numbness in right arm, fever temp highest 104.1f to range of 102f, body aches like the flu, headache on right top side of head, muscle pain, joint pain, and bones hurting severely all over the hips knees ankles ribs arms and back. This report was non-serious.

Other Meds:

Current Illness:

ID: 1409512
Sex: F
Age: 40
State: KS

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 06/18/2021
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: Heart rate irregular; vision was blurry; pale; face was itchy/itching all over body sporadic and not localized; Redness in face/blotchy red hot; metallic taste afte the vaccine was administered; anaphylatic reaction; warmness up the arm and into the neck after getting the vaccine; facial swelling; Hives; Irritable; didn't feel good/truck ran over her; Vaccination site warmth; itchiness at injection site; Fatigue; Headache; Nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (anaphylatic reaction) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sulfonamide allergy (developed hives and stomach upset when young adult) and Drug allergy (Erythromycin -developed hives when young adult). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 11-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylatic reaction) (seriousness criterion medically significant), FEELING HOT (warmness up the arm and into the neck after getting the vaccine), SWELLING FACE (facial swelling), URTICARIA (Hives), IRRITABILITY (Irritable), VACCINATION COMPLICATION (didn't feel good/truck ran over her), PALLOR (pale), PRURITUS (face was itchy/itching all over body sporadic and not localized), ERYTHEMA (Redness in face/blotchy red hot), DYSGEUSIA (metallic taste afte the vaccine was administered), VACCINATION SITE WARMTH (Vaccination site warmth), VACCINATION SITE PRURITUS (itchiness at injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Jan-2021, the patient experienced VISION BLURRED (vision was blurry). On an unknown date, the patient experienced HEART RATE IRREGULAR (Heart rate irregular). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) on 11-Jan-2021 for Nausea, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) on 11-Jan-2021 for Nausea, at an unspecified dose and frequency; EPINEPHRINE on 11-Jan-2021 at an unspecified dose and frequency and PREDNISONE on 11-Jan-2021 at an unspecified dose and frequency. On 19-Jan-2021, ANAPHYLACTIC REACTION (anaphylatic reaction) had resolved. At the time of the report, FEELING HOT (warmness up the arm and into the neck after getting the vaccine), SWELLING FACE (facial swelling), URTICARIA (Hives), IRRITABILITY (Irritable), VACCINATION COMPLICATION (didn't feel good/truck ran over her), PALLOR (pale), PRURITUS (face was itchy/itching all over body sporadic and not localized), ERYTHEMA (Redness in face/blotchy red hot), VACCINATION SITE PRURITUS (itchiness at injection site), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) had resolved, VISION BLURRED (vision was blurry) had not resolved and DYSGEUSIA (metallic taste afte the vaccine was administered), HEART RATE IRREGULAR (Heart rate irregular) and VACCINATION SITE WARMTH (Vaccination site warmth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Blood pressure measurement (120-80 mmHg): 104/60 mmHg (Inconclusive) at 10:16 am and 164/90 mmHg (Inconclusive) at 10:25 am. On 11-Jan-2021, Heart rate: 129 (Inconclusive) at 10:16 am, 79 (Inconclusive) at 10:20 am and 125 (Inconclusive) at 10:25 am. On 11-Jan-2021, Oxygen saturation: 84 (Inconclusive) 84 and 97 (Inconclusive) 97. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous), the reporter did not provide any causality assessments. The patient received the vaccine at 9:50 am on 11-Jan-2021 and returned to the room at 10:10 am with the symptoms. EMS was notified and Epi Pen administered at 10:16 am. The patient's oxygen saturation was initially 80% and the hands were very cold. The patient was transported to ER and was dismissed later on in the day. The signs and symptoms of anaphylactic reaction were reported as itching/pruritis, hives/uriticria, irregular heart rate/palpitations, nausea, difficulty breathing, swelling of upper airway, sensation of throat closing, angioedema, prickling/tingling sensation, feeling hot and flushing. 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 26-Jan-2021: Additional event was updated. On 14-Apr-2021: The diagnosis, symptoms, patient information and vaccination site details were 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:

Current Illness: Drug allergy (Erythromycin -developed hives when young adult); Sulfonamide allergy (developed hives and stomach upset when young adult)

ID: 1409513
Sex: F
Age: 54
State: IL

Vax Date: 01/12/2021
Onset Date: 02/11/2021
Rec V Date: 06/18/2021
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: urticial lesion on my left inner lower eyelid; cough; wheezing; swollen eyelid; Idiopathic urticaria; Generalised itching/pruritus; Hive like rash that keeps moving around her body, look similar to bulls eyes; Angioedema; swollen lips; Hives on left wrist/still experiencing hives.; Hoarseness; Generalized redness/erythema; Prickling/Tingling; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema), LIP SWELLING (swollen lips), URTICARIA (Hives on left wrist/still experiencing hives.), DYSPHONIA (Hoarseness), ERYTHEMA (Generalized redness/erythema), PARAESTHESIA (Prickling/Tingling), SWELLING OF EYELID (swollen eyelid), IDIOPATHIC URTICARIA (Idiopathic urticaria), PRURITUS (Generalised itching/pruritus), EYELID DISORDER (urticial lesion on my left inner lower eyelid), COUGH (cough), WHEEZING (wheezing) and RASH (Hive like rash that keeps moving around her body, look similar to bulls eyes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. Concurrent medical conditions included Depression since 2006, Hypertension since 2005, Hypothyroidism since 2005, Kidney disorder since 2016, Obesity since 2019, GERD since 2014 and Restless legs syndrome since 2015. Concomitant products included FAMOTIDINE from 2020 to an unknown date for GERD, LOSARTAN from 2015 to an unknown date, SPIRONOLACTONE from 2015 to an unknown date and FUROSEMIDE from 2015 to an unknown date for Hypertension, LEVOTHYROXINE from 2005 to an unknown date for Hypothyroidism, MAGNESIUM OXIDE from 2016 to an unknown date for Magnesium low, POTASSIUM CHLORIDE from 2015 to an unknown date for Potassium low, ACETYLSALICYLIC ACID (BABY ASPIRIN) from 2011 to an unknown date for Pulmonary embolism, ROPINIROLE from 2015 to an unknown date for Restless legs syndrome, COLECALCIFEROL (VITAMIN D 3) from 2015 to an unknown date for Vitamin D deficiency, LIRAGLUTIDE (SAXENDA) from February 2020 to an unknown date for Weight loss, VITAMIN B COMPLEX WITH C from 2016 to an unknown date for an unknown indication. On 12-Jan-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 4:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), LIP SWELLING (swollen lips) (seriousness criterion medically significant), URTICARIA (Hives on left wrist/still experiencing hives.) (seriousness criterion medically significant), DYSPHONIA (Hoarseness) (seriousness criterion medically significant), ERYTHEMA (Generalized redness/erythema) (seriousness criterion medically significant), PARAESTHESIA (Prickling/Tingling) (seriousness criterion medically significant), PRURITUS (Generalised itching/pruritus) (seriousness criterion medically significant) and RASH (Hive like rash that keeps moving around her body, look similar to bulls eyes) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING OF EYELID (swollen eyelid) (seriousness criterion medically significant), IDIOPATHIC URTICARIA (Idiopathic urticaria) (seriousness criterion medically significant), EYELID DISORDER (urticial lesion on my left inner lower eyelid) (seriousness criterion medically significant), COUGH (cough) (seriousness criterion medically significant) and WHEEZING (wheezing) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itching, at a dose of 40 mg; METHYLPREDNISOLONE (MEDROL DOSEPAK) in February 2021 at a dose of 1 dosage form; PREDNISONE in March 2021 at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of 1 dosage form; DOXYCYCLINE at a dose of 100 mg twice a day and CETIRIZINE at a dose of 1 dosage form. At the time of the report, ANGIOEDEMA (Angioedema), DYSPHONIA (Hoarseness), ERYTHEMA (Generalized redness/erythema), PARAESTHESIA (Prickling/Tingling), IDIOPATHIC URTICARIA (Idiopathic urticaria), PRURITUS (Generalised itching/pruritus), EYELID DISORDER (urticial lesion on my left inner lower eyelid), COUGH (cough) and WHEEZING (wheezing) outcome was unknown and LIP SWELLING (swollen lips), URTICARIA (Hives on left wrist/still experiencing hives.), SWELLING OF EYELID (swollen eyelid) and RASH (Hive like rash that keeps moving around her body, look similar to bulls eyes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy cervix: unknown (Inconclusive) Unknown. On an unknown date, C1 esterase inhibitor test normal: normal (normal) Normal. On an unknown date, Complement factor C3: normal (normal) Normal. On an unknown date, Complement factor C4: normal (normal) Normal. On an unknown date, Full blood count: normal (normal) Normal. On an unknown date, Metabolic function test: normal (normal) Normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had a dermatology consultation and was getting utricaria every day.Patient had taken intramuscular steroid injections in the month of march and april. Steroids gave relief but post 10 days therapy utricaria recurred. The action taken for mRNA-1273 was not applicable. Most recent follow-up on 14-jun-2021 contain no significant information Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product safety profile. Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: significant followup added to include AE contact information,new events and lab details On 14-Jun-2021: The follow-up on 14-jun-2021 contain no significant information; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the product safety profile.

Other Meds: LOSARTAN; VITAMIN D 3; SAXENDA; LEVOTHYROXINE; SPIRONOLACTONE; FUROSEMIDE; FAMOTIDINE; POTASSIUM CHLORIDE; ROPINIROLE; MAGNESIUM OXIDE; BABY ASPIRIN; VITAMIN B COMPLEX WITH C

Current Illness: Depression; GERD; Hypertension; Hypothyroidism; Kidney disorder; Obesity; Restless legs syndrome

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm