VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1176369
Sex: U
Age: 45
State:

Vax Date: 04/03/2021
Onset Date: 04/03/2021
Rec V Date: 04/07/2021
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: Hot, panic attack; no med passed

Other Meds:

Current Illness:

ID: 1176370
Sex: F
Age: 56
State: CA

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 04/07/2021
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: PATIENT REPORTED DIZZINESS "VERTIGO" 10 MINUTES POST VACCINATION PLACED. THEN COMPLAINED OF TIGHTENING SENSATION IN THROAT 3 MINUTES AFTER DIZZINESS BEGAN. ALSO REPORTED JAW TIGHTNESS WITH THROAT SENSATION. 1ST SET OF VS: 141/91, HEART RATE 87, PULSE OXIMETRY 100% ROOM AIR ZYRTEC 10 MG CHEWABLE GIVEN PO AT 9 AM. 2ND SET OF VS: 127/90 , HEART RATE 77, PULSE OXIMETRY 100% ROOM AIR REPORTED LESSENING OF THROAT TIGHTNESS AND RESOLUTON OF JAW STIFFNESS APPROXIMATELY 15 MINUTES AFTER 9 AM DOSE OF ZYRTEC ORAL MED. DOCTOR ONSITE AND ADVISED PATIENT TO NOTIFY HER PERSONAL PHYSICIAN OF TODAY'S REACTION TO THE COVID-19 VACCINE. PATIENT WITH HISTORY OF ALLERGY TO PENICILLIN, ASPIRIN, SULFA, ERYTHROMYCIN, BENADRYL (DROWSINESS). LAST SET OF VS 123/85, HR 75, PULSE OXIMETRY 98% DANGLED FEET AT BEDSIDE FOR 5 MINUTES, THEN STOOD AND TRANSFERRED TO WHEELCHAIR. PATIENT WENT VIA WHEELCHAIR WITH TRANSPORT PERSONNEL AND HUSBAND TO CAR ABOUT 9:45 AM.

Other Meds:

Current Illness:

ID: 1176371
Sex: F
Age: 45
State: FL

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 04/07/2021
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: n/a

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: C/o anxiety, shaking of head, did not eat breakfast. B/P 122/71, HR 82, O2Sat 98, T 98.

Other Meds: Lasinopril

Current Illness: n/a

ID: 1176437
Sex: F
Age:
State: TN

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

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: severely ill.; fever; pain; received 2 Engerix-B vaccines and experience allergic reaction to binders.; suffered greatly; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received HBV (Engerix B) for prophylaxis. On an unknown date, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced sickness (serious criteria hospitalization), fever (serious criteria hospitalization), pain (serious criteria hospitalization), allergic reaction and emotional suffering. On an unknown date, the outcome of the sickness, fever, pain, allergic reaction and emotional suffering were recovered/resolved. It was unknown if the reporter considered the sickness, fever, pain, allergic reaction and emotional suffering to be related to Engerix B. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist was looking for binders in Engerix B vaccine because the patient was allergic to binders from the vaccine. The 5 years prior to the report, the patient received the 1st dose of Engerix B vaccine and experienced allergic reaction to binders. The patient was severely ill, had fever and pain that went about 2 to 3 months. The patient was hospitalized and went to the Emergency room (ER) and suffered greatly. The physician fount out that the patient might be allergic to ingredients in the Engerix B. They were trying to find out what in the Engerix B and the patient might be allergic to and they were guessing aluminum hydroxide. The reporter did not have the details about lot numbers, dates or patient information at the moment of the call. The reporter consented to follow up via fax. For further tolerance of 2nd odse, refer case US2021073794, reporter for same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021073794:same reporter, same patient, same vaccine, different dose-2nd dose

Other Meds:

Current Illness:

ID: 1176438
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: This case was reported by another health professional via interactive digital media and described the occurrence of Asperger's disorder in a male patient exposed to DTPa (Reduced antigen) (Tdap Vaccine) in utero. The parent received the product for prophylaxis. On an unknown date, the mother received Tdap Vaccine. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed at an unknown time during the pregnancy. The patient was diagnosed with Asperger's disorder (serious criteria GSK medically significant) and Tourette's syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Asperger's disorder and Tourette's syndrome were unknown. It was unknown if the reporter considered the Asperger's disorder and Tourette's syndrome to be related to Tdap Vaccine. Additional details were reported as follows: The age at vaccination was not reported. Twenty-six years before the date of reporting, the patient had a reaction to TDap then diagnosed with Asperger's and Tourette's syndrome (TS). The reporter push vaccines unless high risk patients.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR074518: same reporter Deleted case

Other Meds:

Current Illness:

ID: 1176440
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: Was vaccinated and still got and has never been the same; Was vaccinated and still got and has never been the same; Very sick to this day; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), meningococcal infection (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown and the outcome of the sickness was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, meningococcal infection and sickness to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, the patient was vaccinated and still got the disease and had never been the same. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation of meningococcal infection (specific serogroup) were unknown at the time of reporting. The reporter stated that, the patient was 18 years old and graduating and got bit by a mosquito and almost died. Till the time of reporting, the patient was very sick. No further information was available.

Other Meds:

Current Illness:

ID: 1176441
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: She broke out in shingles / suspected vaccination failure; She broke out in shingles; covid; quarantined for 2 weeks; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included covid-19 (experienced in 2019). On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, covid-19 and quarantine. On an unknown date, the outcome of the vaccination failure, shingles, covid-19 and quarantine were unknown. It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient reported for herself. The age at vaccination was not reported. The patient had Covid twice, the 1st time was in 2019 and the 2nd time was in 2020. The 2nd time she had the virus, she quarantined for 2 weeks with her daughter. On 5th April 2021, the patient received the 2nd dose of Covid-19 vaccine. However, after her 1st dose, she said she experienced soreness at the injection site, and felt as if a truck ran over her. The patient already had 2 shingle shots last year and broke out in shingles so she was confused as to why the vaccine would cause her to get it again. This case was considered as suspected vaccination failure as time to onset for target disease and laboratory confirmation were unknown at the time of reporting.

Other Meds:

Current Illness:

ID: 1176451
Sex: M
Age: 65
State: FL

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 04/07/2021
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: hand neuropathy; upset stomach; redness at injection site; neck pain; arm soreness / arm pain; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included sulfonamide allergy. On 1st April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, 10 hrs after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), upset stomach, injection site erythema, neck pain, pain in arm, chills and fever. On an unknown date, the outcome of the peripheral neuropathy, upset stomach, injection site erythema, neck pain, pain in arm, chills and fever were not recovered/not resolved. It was unknown if the reporter considered the peripheral neuropathy, upset stomach, injection site erythema, neck pain, pain in arm, chills and fever to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on 1st April 2021 at 4 PM and about 10 hours later, the patient reports arm soreness, arm pain, redness at injection site, fever, chills, upset stomach, hand neuropathy, and neck pain. The formulation was unknown. At time of report the events are unresolved. The reporter did not consent to follow up.

Other Meds:

Current Illness: Sulfonamide allergy

ID: 1176453
Sex: M
Age: 57
State: SD

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 04/07/2021
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: Erectile Dysfunction; Bruising at the injection site; Itching of bilateral palms of his hands; This case was reported by a consumer via call center representative and described the occurrence of erectile dysfunction in a 57-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. On 24th March 2021, the patient received Boostrix (intramuscular). On an unknown date, less than 2 weeks after receiving Boostrix, the patient experienced erectile dysfunction (serious criteria GSK medically significant), injection site bruising and itching both hands. On an unknown date, the outcome of the erectile dysfunction, injection site bruising and itching both hands were unknown. It was unknown if the reporter considered the erectile dysfunction, injection site bruising and itching both hands to be related to Boostrix. Additional details were provided as follows: The case was reported by the patient's spouse. The patient experienced bruising at the injection site, itching of bilateral palms of his hands, and erectile dysfunction. The patient went to the doctor regarding the bruising and was told it might last one to one half weeks longer. The reporter did not consent to follow up. All the information was not available.

Other Meds:

Current Illness:

ID: 1176454
Sex: F
Age:
State: TN

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

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: was severely ill.; fever; pain; received 2 Engerix-B vaccines and experience allergic reaction to binders.; suffered greatly; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received HBV (Engerix B) for prophylaxis. Previously administered products included Engerix B with an associated reaction of pyrexia (1st dose received on an unknown date and also experienced sickness, pain etc, refer case US2021AMR074309). On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced sickness (serious criteria hospitalization), fever (serious criteria hospitalization), pain (serious criteria hospitalization), allergic reaction and emotional suffering. Rechallenge with Engerix B was positive. On an unknown date, the outcome of the sickness, fever, pain, allergic reaction and emotional suffering were unknown. It was unknown if the reporter considered the sickness, fever, pain, allergic reaction and emotional suffering to be related to Engerix B. Additional details were reported as follows: The age at vaccination was not reported. The pharmacist was looking for binders in Engerix B vaccine because the patient was allergic to binders from the vaccine. The 5 years prior to the report, the patient received the 2nd dose of Engerix B vaccine and experienced allergic reaction to binders. The patient was severely ill, had fever and pain that went about 2 to 3 months. The patient was hospitalized and went to the Emergency room (ER) and suffered greatly. The physician fount out that the patient might be allergic to ingredients in the Engerix B. They were trying to find out what in the Engerix B and the patient might be allergic to and they were guessing aluminum hydroxide. The reporter did not have the details about lot numbers, dates or patient information at the moment of the call. The reporter consented to follow up via fax.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR074309:same reporter, same patient, same vaccine, different dose-1st dose

Other Meds:

Current Illness:

ID: 1176465
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/10/2021
Rec V Date: 04/07/2021
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: ANAPHYLACTIC REACTION DESCRIBED AS SEVERE ALLERGIC REACTION, WITHIN 3 MINUTES OF GETTING THE VACCINE; 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: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 15:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine. Treatment medications (dates unspecified) included: epinephrine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine was not reported. The reporter provided causality between anaphylactic reaction and severe allergic reaction and covid-19 vaccine ad26.cov2.s was possible. Company causality between anaphylactic reaction described as severe allergic reaction, within 3 minutes of getting the vaccine and covid-19 vaccine ad26.cov2.s was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 2021032606-covid-19 vaccine ad26.cov2.s-Anaphylactic reaction. This event is considered related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1176466
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: PE; DVT; This spontaneous report received from a physician via a company representative concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included family history of DVT, and family history of PE. 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On unspecified date in 2021, the patient experienced PE (pulmonary embolism) and DVT (deep vein thrombosis). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the PE and DVT was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332653-Covid-19 Vaccine AD26.COV2.S-PE and DVT. 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: MEDICAL HISTORY

Other Meds:

Current Illness: Familial risk factor

ID: 1176467
Sex: F
Age:
State: TX

Vax Date:
Onset Date: 03/11/2021
Rec V Date: 04/07/2021
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: ELEVATED BLOOD PRESSURE; CHEST PAIN; RASH ON HER FACE THAT WAS BURNING AND SWOLLEN; RASH ON HER FACE THAT WAS BURNING AND SWOLLEN; RASH ON FACE AND RASH ON ALL OVER LEGS AND KNEES; HEADACHE; This spontaneous report received from a patient concerned a female 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, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination on Left Deltoid. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chest pain, elevated blood pressure, rash on her face that was burning and swollen, rash on face and rash on all over legs and knees and headache. She had went to the hospital twice but was not admitted both were the outpatient visits. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash on her face that was burning and swollen, and rash on her face that was burning and swollen on 11-MAR-2021, and rash on face and rash on all over legs and knees on MAR-2021, and had not recovered from elevated blood pressure, chest pain, and headache. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333394-COVID-19 vaccine Ad26.COV2.S-elevated blood pressure. This event is 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 event.

Other Meds:

Current Illness:

ID: 1176469
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 04/07/2021
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: LOSS OF HEARING FOR A BIT; DIZZINESS, COULD NOT HOLD HEAD UP; VISUAL DISTURBANCE; SWEAT; SORE ARM; NAUSEA; This spontaneous report received from a patient via a company representative 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 was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 25-MAR-2021, the subject experienced loss of hearing for a bit. On 25-MAR-2021, the subject experienced dizziness, could not hold head up. On 25-MAR-2021, the subject experienced visual disturbance. On 25-MAR-2021, the subject experienced sweat. On 25-MAR-2021, the subject experienced sore arm. On 25-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of hearing for a bit, dizziness, could not hold head up, visual disturbance, sweat, and nausea on 25-MAR-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1176470
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 04/07/2021
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: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included she thought it was her allergies, as it as starting to get bad in state. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 rapid POC test positive (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. The case was associated with a product quality complaint number: 90000174423 The suspected product quality complaint has been confirmed to be voided: does not meet PQC criteria, based on the PQC evaluation/investigation performed.; Sender's Comments: V1: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.

Other Meds:

Current Illness: Allergy NOS

ID: 1176471
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 04/07/2021
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: DIFFICULTY SLEEPING; SHORTNESS OF BREATH; TIREDNESS; BODY ACHES; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 33 year old male. The patient's weight was 166 pounds, and height was 68 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient have no known drug allergies. the patient did not have any drug abuse, illicit drug use. patient did not had other medical history or medicines. patient reports fairly healthy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced injection site pain. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced shortness of breath. On 25-MAR-2021, the subject experienced difficulty sleeping. Laboratory data (dates unspecified) included: Body mass index (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on 15-MAR-2021, and injection site pain on 13-MAR-2021, and had not recovered from shortness of breath, and difficulty sleeping. This report was non-serious

Other Meds:

Current Illness: Alcohol use (Moderate. No more than 1 glass of wine in a day); Non-smoker

ID: 1176472
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: PATIENT FELT SMALL LUMP FEW HOURS AFTERWARDS AT INJECTION SITE; FELT BODY ACHES; ALL RED (AT INJECTION SITE ONLY); FEELING A LITTLE TIRED; This spontaneous report received from a patient concerned a 62 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, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, vaccinated at right arm, once a total administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced subject felt small lump few hours afterwards at injection site. On MAR-2021, the subject experienced felt body aches. On MAR-2021, the subject experienced all red (at injection site only). On MAR-2021, the subject experienced feeling a little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient felt small lump few hours afterwards at injection site, all red (at injection site only), felt body aches and feeling a little tired was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176473
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: HIT HARD; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, 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 hit hard (coded as ill-defined disorder). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hit hard was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176474
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: BURNING SENSATION ON THE ARM; 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, batch number 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 burning sensation on the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of burning sensation on the arm was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176475
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 04/07/2021
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: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 32 year old female. The patient's weight was 68.1 kilograms, and height was not reported. The patient's pre-existing medical conditions included patient had no medical history. The patient received covid-19 vaccine (suspension for injection, intramuscular and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on Right deltoid. No concomitant medications were reported. On 26-MAR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1176476
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 04/07/2021
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: BAD HEADACHE; This spontaneous report received from a patient concerned a female 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, batch number: Unknown) dose was not reported, 1 total, 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 numbers. No concomitant medications were reported. On 24-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176477
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 04/07/2021
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: BODY ACHE; FEVER; BACK PAIN; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroidism, 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, intramuscular, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced back pain. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and back pain, and the outcome of body ache was not reported. This report was non-serious.

Other Meds:

Current Illness: Hypothyroidism

ID: 1176478
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: SHOOK SEVERELY ALL THAT NIGHT; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients 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. 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, multiple subjects received vaccine and shook severely all that night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shook severely all that night was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176479
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: ALMOST BLACKED OUT; ACHES; HEADACHE; FATIGUE; DEHYDRATED; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's past medical history included surgery to the ankle. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced dehydrated. On 24-MAR-2021, the subject experienced aches. On 24-MAR-2021, the subject experienced headache. On 24-MAR-2021, the subject experienced fatigue. On 27-MAR-2021, the subject experienced almost blacked out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from aches, headache, and almost blacked out, and the outcome of fatigue and dehydrated was not reported. This report was non-serious.; Sender's Comments: V0 : medical assessment comment not required as per standard procedure as the case assessed as non serious

Other Meds:

Current Illness:

ID: 1176480
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: VAGINAL SPOTTING; VACCINE EXPOSURE DURING PREGNANCY; YEAST INFECTION; FATIGUE; This spontaneous pregnancy report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included alcoholic, and concurrent conditions included diabetes (gestational), and nonsmoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug use. It was not reported whether the patient had been pregnant before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced yeast infection. On MAR-2021, the subject experienced fatigue. Laboratory data included: Laboratory test (NR: not provided) NEGATIVE. On 09-MAR-2021, the subject experienced vaccine exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. On 14-MAR-2021, the subject experienced vaginal spotting. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaginal spotting on 22-MAR-2021, had not recovered from vaccine exposure during pregnancy, and the outcome of fatigue and yeast infection was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Diabetes mellitus gestational; Nonsmoker

ID: 1176481
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/18/2021
Rec V Date: 04/07/2021
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: DID NOT SLEEP WELL; LITTLE TIRED; FELT HEAVY CHILLS/ FREEZING; BAD HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included covid-19.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 18-MAR-2021 09:45 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021 around 20:00, the subject experienced felt heavy chills/ freezing. On 18-MAR-2021 20:00, the subject experienced bad headache. On 19-MAR-2021, treatment medications included: paracetamol. On an unspecified date, the subject experienced did not sleep well, and little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt heavy chills/ freezing, bad headache, and little tired, and the outcome of did not sleep well was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176482
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 03/27/2021
Rec V Date: 04/07/2021
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: FEVER; 5 HOURS AFTER SHE GOT THE SHOT, SHE WAS SHIVERING UNCONTROLLABLY; This spontaneous report received from a patient concerned a female 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 batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 11:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced 5 hours after she got the shot, she was shivering uncontrollably. Laboratory data included: Body temperature (NR: not provided) 102 F, 103 F. On 27-MAR-2021 17:00, the subject experienced fever. On 28-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 5 hours after she got the shot, she was shivering uncontrollably, and fever on 28-MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176483
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/27/2021
Rec V Date: 04/07/2021
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: BODY ACHES; DIZZINESS; CHILLS; HEADACHE; FEVER; NAUSEA; 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: 1805031,expiry: UNKNOWN) dose was not reported, once a total administered on 27-MAR-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 101.7 (units unspecified). On 27-MAR-2021 18:00, the subject experienced body aches. On 27-MAR-2021 18:00, the subject experienced dizziness. On 27-MAR-2021 18:00, the subject experienced chills. On 27-MAR-2021 18:00, the subject experienced headache. On 27-MAR-2021 18:00, the subject experienced fever. On 27-MAR-2021 18:00, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, dizziness, chills, fever, and nausea on MAR-2021, and had not recovered from headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176484
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: BODYACHE; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned female 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, batch number: 1802072, expiry: UNKNOWN) 1 total administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced bodyache, chills, fever, nausea, and headache. Laboratory data (dates unspecified) included: Body temperature increased (NR: not provided) 102 F. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea, chills, bodyache and headache was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176485
Sex: M
Age:
State: IN

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 04/07/2021
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: BODY PAIN SPECIFICALLY AT HIPS, NECK, HEAD; FEELING WARM INSIDE; CHILLS, FELT LIKE BLOCKS OF ICE; ARM PAIN AT INJECTION SITE; FEELING LOOPY AND HYPER; SLIGHTLY DIZZY; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's past medical history included heart murmur, and concurrent conditions included hiv positive, emphysema, chronic obstructive pulmonary disease, sulfa allergy, alcohol user consumes half a cup liquor per week, and cigarette smoker pack a day, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry : UNKNOWN) dose was not reported, administered on 26-MAR-2021 at around14:00 on left arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced feeling loopy and hyper. On 26-MAR-2021, the subject experienced slightly dizzy. On 27-MAR-2021, the subject experienced body pain specifically at hips, neck, head. On 27-MAR-2021, the subject experienced feeling warm inside. On 27-MAR-2021, the subject experienced chills, felt like blocks of ice. On 27-MAR-2021, the subject experienced arm pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling loopy and hyper, and slightly dizzy on 26-MAR-2021, and was recovering from chills, felt like blocks of ice, body pain specifically at hips, neck, head, feeling warm inside, and arm pain at injection site. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Half a cup liquor per week); Chronic obstructive pulmonary disease; Cigarette smoker (1 Pack per day); Emphysema; HIV positive; Sulfonamide allergy

ID: 1176486
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 04/07/2021
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: CHILLS AFTER TAKING THEIR LANTUS MEDICATION; INJECTION SITE PAIN IN THEIR LEFT ARM; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, non-smoker, non-alcoholic and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included insulin glargine. On 26-MAR-2021, the subject experienced chills after taking their lantus medication. On 26-MAR-2021, the subject experienced injection site pain in their left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain in their left arm, and chills after taking their lantus medication. This report was non-serious.

Other Meds: LANTUS

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

ID: 1176487
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/20/2021
Rec V Date: 04/07/2021
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: RASH ON LEGS AND ARMS; SORENESS; TIREDNESS; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 60 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, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAR-2021, the subject experienced soreness. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced rash on legs and arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 22-MAR-2021, and fever on MAR-2021, and had not recovered from soreness, tiredness, and rash on legs and arms. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.

Other Meds:

Current Illness:

ID: 1176488
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 04/07/2021
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: FAST HEART BEAT; BODY ACHE; ITCHY RASH (PUFFY); RASH (THEY SEEM LIKE WARTS); HEADACHE; 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 penicillin allergy, inflammatory bowel disease, nonsmoker, and abstains from alcohol, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 14:30 to left arm for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced body ache. On 26-MAR-2021, the subject experienced itchy rash (puffy). On 26-MAR-2021, the subject experienced rash (they seem like warts). On 27-MAR-2021, the subject experienced fast heart beat. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine was not applicable. The patient recovered from body ache, and had not recovered from rash (they seem like warts), headache, fast heart beat, and itchy rash (puffy). This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Inflammatory bowel disease; Nonsmoker; Penicillin allergy

ID: 1176489
Sex: M
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: COLD; CHILLS; MUSCLE ACHE; HEADACHE; 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 pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced cold. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced muscle ache. On MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache, headache, cold and chills was not reported. This report was non-serious. Additional information was received from patient on 26-MAR-2021 following information was updated and incorporated into case narrative: Cold and chills event added

Other Meds:

Current Illness:

ID: 1176490
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 03/20/2021
Rec V Date: 04/07/2021
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: RINGING IN EAR; HEAD COLD; DIGESTIVE ISSUE; COVID POSITIVE; SHAKES; 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 pre-existing medical conditions included unknown.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered to the left arm, on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced covid positive. On 20-MAR-2021, the subject experienced shakes. On 21-MAR-2021, the subject experienced digestive issue. On 22-MAR-2021, the subject experienced ringing in ear. On 22-MAR-2021, the subject experienced head cold. On 25-MAR-2021, Laboratory data included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shakes on 21-MAR-2021, and digestive issue on 23-MAR-2021, and had not recovered from head cold, covid positive, and ringing in ear. This report was non-serious. ; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1176491
Sex: M
Age:
State: AK

Vax Date:
Onset Date: 03/27/2021
Rec V Date: 04/07/2021
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: LEFT FOREARM STARTED SWELLING; INJECTION SITE 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 was not reported, administered on left deltoid on 27-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 27-MAR-2021, the subject experienced left forearm started swelling. On 27-MAR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left forearm started swelling, and injection site pain. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176492
Sex: U
Age:
State: IL

Vax Date:
Onset Date: 03/26/2021
Rec V Date: 04/07/2021
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: ARM FELT SWOLLEN; REDNESS ALL OVER; HEADACHE; FEVER; 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 penicillin allergy, and smoker. 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, vaccinated on left deltoid, once a total administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced arm felt swollen. On 26-MAR-2021, the subject experienced redness all over. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt swollen on MAR-2021, and had not recovered from headache, fever, and redness all over. This report was non-serious.

Other Meds:

Current Illness: Penicillin allergy; Smoker (occasionally)

ID: 1176493
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 04/07/2021
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: RASH ON HER LEGS; HIVES; ITCHING; 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 pre-existing medical conditions included the patient was not pregnant at the time of reporting. 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 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced itching. On 25-MAR-2021, the subject experienced hives. On an unspecified date, the subject experienced rash on her legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hives, and itching, and the outcome of rash on her legs was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176494
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: Itchy Rash all over body; Very Tired; Body Aches; clammy hot and cold; headache; This spontaneous report received from a patient concerned a 59 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, route of admin not reported, batch number: Unk) 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, the subject experienced itchy rash all over body. On MAR-2021, the subject experienced very tired. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced clammy hot and cold. On MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash all over body, very tired, body aches, clammy hot and cold, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176495
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 04/07/2021
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: TACHYCARDIA; SLIGHTLY LOW WHITE BLOOD CELL COUNT; CHEST PAIN; BLOODY NOSE; HIVES IN BACK (RED AND ELEVATED); ACHINESS; PRE MENSTRUAL BLEEDING; NAUSEA; FATIGUE; HEADACHE; MINOR CHILLS; This spontaneous report received from a physician concerned a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and relatively healthy individual. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 25-MAR-2021 07:00 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, Laboratory data included: Chest X-ray (NR: not provided) Normal, and ECG (NR: not provided) Normal. On 25-MAR-2021, the subject experienced minor chills. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced achiness. On 26-MAR-2021, the subject experienced pre menstrual bleeding. On 26-MAR-2021, the subject experienced nausea. Laboratory data included: Heart rate (NR: not provided) 69 {beats}/min. On 27-MAR-2021, the subject experienced tachycardia. On 27-MAR-2021, the subject experienced slightly low white blood cell count. On 27-MAR-2021, the subject experienced chest pain. On 27-MAR-2021, the subject experienced bloody nose. On 27-MAR-2021, the subject experienced hives in back (red and elevated). Laboratory data included: Decreased hemoglobin (NR: not provided) 1.9 (unspecified unit), Heart rate (NR: not provided) 90 {beats}/min, 106 {beats}/min, and White blood cell count (NR: not provided) 3.6 (unspecified unit). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain on 29-MAR-2021, achiness, bloody nose, hives in back (red and elevated), and fatigue on 27-MAR-2021, and pre menstrual bleeding, minor chills, and headache on 28-MAR-2021, was recovering from tachycardia, and the outcome of slightly low white blood cell count and nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness: Alcohol use (occasionally, one drink a month); Non-smoker

ID: 1176496
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 04/07/2021
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: HEADACHE; UPSET STOMACH; FEVER; This spontaneous report received from a vaccine facility 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 was not reported, administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 25-MAR-2021, the subject experienced upset stomach. On 25-MAR-2021, the subject experienced fever. On 26-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and the outcome of fever and upset stomach was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176497
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: THROAT SWELLING; RAPID HEART BEAT; DRY MOUTH; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included history of allergies.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. Batch number was not reported and same has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced throat swelling, rapid heart beat, and dry mouth. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, acetylsalicylic acid, and lorazepam. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swelling, rapid heart beat, and dry mouth. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176498
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 03/27/2021
Rec V Date: 04/07/2021
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: LOWER PART OF LEFT LEG FROM ANKLE UP TO KNEE PERIODICALLY PAINFUL- NOT SHARP PAIN JUST AN ACHE; HEADACHE; FEVER 106 DEGREES; MUSCLE ACHE; STOMACH CRAMPS; SEVERE RINGING IN EARS; RUNNY NOSE; STUFFY NOSE; TROUBLE BREATHING IN MORNING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included asymptomatic covid, and concurrent conditions included asthma. 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 26-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced stomach cramps. On 27-MAR-2021, the subject experienced severe ringing in ears. On 27-MAR-2021, the subject experienced runny nose. On 27-MAR-2021, the subject experienced stuffy nose. On 27-MAR-2021, the subject experienced trouble breathing in morning. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever 106 degrees. On 27-MAR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 106 F. On 28-MAR-2021, the subject experienced lower part of left leg from ankle up to knee periodically painful- not sharp pain just an ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach cramps, severe ringing in ears, trouble breathing in morning, headache, and fever 106 degrees on 27-MAR-2021, had not recovered from runny nose, stuffy nose, and lower part of left leg from ankle up to knee periodically painful- not sharp pain just an ache, and the outcome of muscle ache was not reported. This report was non-serious.

Other Meds:

Current Illness: Asthma

ID: 1176499
Sex: F
Age:
State: MD

Vax Date:
Onset Date: 03/05/2021
Rec V Date: 04/07/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: WARMTH IN THE ARM; ACHINESS AND PAIN IN THE ARM AROUND THE INJECTION AREA; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight was not reported and height was 167 centimeters. The patient's concurrent conditions included penicillin allergy, non-smoker, and non-alcoholic, and other pre-existing medical conditions included patient have no history of drug abuse. 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 05-MAR-2021 13:45 on left arm for prophylactic vaccination. Concomitant medications included amlodipine for blood pressure. On 05-MAR-2021, the subject experienced injection site pain. On 23-MAR-2021, the subject experienced warmth in the arm. On 23-MAR-2021, the subject experienced achiness and pain in the arm around the injection area. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain on MAR-2021, and had not recovered from achiness and pain in the arm around the injection area, and warmth in the arm. This report was non-serious. Additional information was received from patient on 31-MAR-2021.The following information was updated and incorporated into the case: Patient height, medical history (penicillin allergy) added, Concomitant product amlodipine added. Vaccination time added, Expiry date added.

Other Meds: AMLODIPINE

Current Illness: Abstains from alcohol; Non-smoker; Penicillin allergy

ID: 1176500
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: CHILLS; SORE ARM; SLIGHT HEADACHE; This spontaneous report received from a consumer via a company representative 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, batch number: Unk) 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 chills, sore arm and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, sore arm, and slight headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176501
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 04/07/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: VOMITING; FEVER; HEADACHE; NAUSEA; FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 29 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: Unknown) dose was not reported, administered on 25-MAR-2021 at left deltoid muscle for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced vomiting. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 101-105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on MAR-2021, and had not recovered from headache, nausea, fever, and fatigue. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1176502
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: SHARP PAIN IN BACK; ARM PIT HURT; NO ENERGY TOO; HEADACHES; 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, once a total administered, start therapy date 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 headaches, back pain, arm pit hurt, and no energy. The action taken with covid-19 vaccine was not applicable. The outcome of the headaches, back pain, arm pit hurt and no energy was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176503
Sex: M
Age:
State: VA

Vax Date:
Onset Date: 03/24/2021
Rec V Date: 04/07/2021
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: RED RASH (STARTED ON FEET AND STOMACH BUT NOW EVERYWHERE)/ ITCHY/ ALLERGIC REACTION SOMETHING; This spontaneous report received from a patient concerned a 51 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: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced red rash (started on feet and stomach but now everywhere)/ itchy/ allergic reaction something. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, hydrocortisone, and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red rash (started on feet and stomach but now everywhere)/ itchy/ allergic reaction something. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176504
Sex: U
Age:
State: WA

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 04/07/2021
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: NUMBNESS IN LEFT WRISTS WHICH MOVES TOWARDS LEFT HAND; 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 was not reported, administered on left arm on 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced numbness in left wrists which moves towards left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numbness in left wrists which moves towards left hand was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1176505
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 04/07/2021
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: BOOBS WERE FILLED WITH CYSTS; PAINFUL BOOBS; SWOLLEN BOOBS; NIGHT SWEATS; LITTLE FAINT; GOT PERIODS EARLY/IMPACTING CYCLE; CHILLS; FEVER; TIRED; This spontaneous report received from a patient concerned multiple patients. 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced boobs were filled with cysts, painful boobs, swollen boobs, night sweats, little faint, got periods early/impacting cycle, chills, fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats, little faint, and tired, had not recovered from fever, and chills, and the outcome of painful boobs, swollen boobs, boobs were filled with cysts and got periods early/impacting cycle was not reported. This report was non-serious.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm