chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: four month old was given Fluarix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 54C23, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 4 months year old patient received Fluarix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 34-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the vaccine after being exposed to freezing temperatures (-1 C for total amount of time of 25 min), which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter US-GLAXOSMITHKLINE-US2021218238:same reporter
Age: 80.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 80-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the vaccines after being exposed to freezing temperatures (-1 C for total amount of time of 25 min), which led to incorrect storage of drug. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218242:same reporter US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter US-GLAXOSMITHKLINE-US2021218238:same reporter
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: exposed to freezing temperatures; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 58-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received the vaccine after being exposed to freezing temperatures (-1 C for total amount of time of 25 min), which led to incorrect storage of drug. The reporter consented to follow up. This was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021218245:same reporter US-GLAXOSMITHKLINE-US2021218244:same reporter US-GLAXOSMITHKLINE-US2021218239:same reporter US-GLAXOSMITHKLINE-US2021218238:same reporter
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received vaccine 1 month after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date 31st August 2021) for prophylaxis.   On 30th September 2021, the patient received Menveo. On 30th September 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received a vaccine one month after the expiration date, which led to expired vaccine used. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: extra dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th November 2019) and Shingrix (received 2nd dose on 19th February 2020).   On 7th October 2021, the patient received the 3rd dose of Shingrix. On 7th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient an accidentally received 3rd dose of Shingrix, which led to extra dose administered. No symptoms reported The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st vaccination on 03/28/2019 / 2nd vaccination was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was in pharmacy on 19th October 2021, but did not receive 2nd dose of Shingrix on 19th October 2021. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination The reporter consented to follow up.
Sex: U
Vaccine: FLU4, HEP, MENB, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: vaccines administered after being exposed to freezing temperatures.; This case was reported by a physician via call center representative and described the occurrence of incorrect product storage in an unspecified number of patients who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Engerix B, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device and Menveo. On an unknown date, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent 2021-2022 season, Flulaval Tetra Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Boostrix, Boostrix Pre-Filled Syringe Device and Menveo, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patients were administered doses of vaccines after being exposed to freezing temperatures, which led to incorrect product storage. The vaccines affected were Bexsero, Engerix-B, Menveo, Boostrix and Flulaval QIV. The reporter contacted first via phone to receive stability data, than contacted via chat to ask for revaccination information. She did not have details of how many patients were affected at time of chat or who the patients were. She was good to follow up with via the email above to provide details once she had them. The reporter consented to follow up. GSK Note- the formulations for Engerix B, Boostrix, Flulaval tetra was not confirmed and therefore captured as per source document.
Age: 61.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Myalgia, Pyrexia, Rheumatoid arthritis
Clinical narrative: After chemo was left with RA; Systemic reactions as fever; Malaise; Myalgia; 2nd dose had not been administered; This case was reported by a physician via call center representative and described the occurrence of rheumatoid arthritis in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer (diagnosed with breast cancer in mid September 2019), breast cancer (had surgery on 27th September 2019) and chemotherapy (started immunocompromising chemotherapy after first dose).   On 29th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), fever, malaise, myalgia and incomplete course of vaccination. The patient was treated with methotrexate and hydroxychloroquine. On an unknown date, the outcome of the rheumatoid arthritis, fever, malaise, myalgia and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, fever, malaise and myalgia to be related to Shingrix.  Additional details provided were as follows: The case was reported by pediatrician for himself/herself. The age at vaccination was not applicable for 2nd dose. This patient received a dose of Shingrix and started immunocompromising chemotherapy after that. It was mentioned that after the first dose the patient experienced systemic reactions described as fever, malaise and myalgia.  The reporter mentioned that after chemotherapy, patient was left with rheumatoid arthritis and as a measure was treated with methotrexate and hydroxychloroquine. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow-up.
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Newborn had been given Fluarix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number FT779, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On XXOctober 20XX, the patient received the 1st dose of Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On XXOctober 20XX, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter called to report that, a newborn baby, had been given Fluarix on the day of her birth, which led to inappropriate age at vaccine administration.  The Lot number was taken from the box and not from PFS (pre-filled syringe). The reporter consented to follow up by email.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 15Oct2019, did not return for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 5th October 2021, the patient received the 2nd dose of Shingrix. On 5th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows : The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219377:same reporter US-GLAXOSMITHKLINE-US2021219379:same reporter US-GLAXOSMITHKLINE-US2021219378:same reporter US-GLAXOSMITHKLINE-US2021219382:same reporter
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 14th October 2021, the patient received the 1st dose of Shingrix. On 14th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219377:same reporter US-GLAXOSMITHKLINE-US2021219378:same reporter US-GLAXOSMITHKLINE-US2021219382:same reporter US-GLAXOSMITHKLINE-US2021219375:same reporter
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 18th October 2021, the patient received the 1st dose of Shingrix. On 18th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219382:same reporter US-GLAXOSMITHKLINE-US2021219379:same reporter US-GLAXOSMITHKLINE-US2021219378:same reporter US-GLAXOSMITHKLINE-US2021219375:same reporter
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219377:same reporter US-GLAXOSMITHKLINE-US2021219382:same reporter US-GLAXOSMITHKLINE-US2021219379:same reporter US-GLAXOSMITHKLINE-US2021219375:same reporter
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number 29T59, expiry date 1st October 2021) for prophylaxis.   On 20th October 2021, the patient received the 1st dose of Shingrix. On 20th October 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient was administered expired dose of Shingrix vaccine, which led to expired vaccine used. The reporter consented to follow up. This case was 1 of 5 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021219379:same reporter US-GLAXOSMITHKLINE-US2021219378:same reporter US-GLAXOSMITHKLINE-US2021219375:same reporter US-GLAXOSMITHKLINE-US2021219377:same reporter
Age: 16.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received a dose which expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HBV (Engerix B) (batch number YL2L3, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 20th October 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Engerix-B, a day before reporting date which expired a week ago, which led to expired vaccine used. The reporter consented to follow up via email.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: was reconstituted with saline; was reconstituted with saline; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA636A, expiry date 30th September 2022) for prophylaxis.   On 21st October 2021, the patient received Menveo. On 21st October 2021, unknown after receiving Menveo, the patient experienced inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.  Additional details provided were as follows: Nurse reports that a patient was administered a dose of Menveo that was reconstituted with saline instead of the supplied CWY diluent which led to inappropriate dose of vaccine administered and wrong solution used in drug reconstitution. The reporter consented to follow up.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient of 3 years old received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. In September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The case was reported by medical assistant. 3 years old patient received Kinrix, which led to inappropriate age at vaccine administration. The reporter wanted to know how to proceed. The reporter consented to follow up.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Deep vein thrombosis, Infection, Vaccination failure
Clinical narrative: Deep vein thrombosis; SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19; Infection; This spontaneous report received from a health care professional via a regulatory authority(Vaccine )(VAERS ID: 1656422) concerned a 41 year old male, unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A expiry: unknown) dose was not reported, one total administered on 24-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  On 01-AUG-2021, the patient experienced suspected clinical vaccination failure, covid-19, deep vein thrombosis and infection (Breakthrough covid infection) and was hospitalized (date unspecified) for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deep vein thrombosis, covid-19, and infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000193189. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from regulatory authority department on 22-OCT-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2:This version updates- Product quality complaint investigation result. This updated information does not alter the causality of previously reported events .  20210920620-COVID-19 VACCINE AD26.COV2.S-deep vein thrombosis, covid-19,  infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210920620-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
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Injection site warmth, Skin swelling
Clinical narrative: Woke up feeling discomfort on the left side of my neck,. By 1:30 PM I felt a hard lump that also moved underneath the skin as I touched it.  The site was not red, just a bit warm. I started taking aspirin and applied salon pass to see if it helped with the swelling but it hasn?t. Woke up today and it is still there and I?m experiencing moderate fatigue.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Chest X-ray, Computerised tomogram, Differential white blood cell count, Extra dose administered
Clinical narrative: About 30 minutes after receiving the booster, the left side of my throat  became very sore and painful when swallowing.  The right side was fine.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Odynophagia, Oropharyngeal pain
Clinical narrative: About 30 minutes after receiving the booster, the left side of my throat  became very sore and painful when swallowing.  The right side was fine.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypokinesia, Muscle spasms, Pruritus, Suspected COVID-19
Clinical narrative: LOST 6-8 POUNDS; BAD TICKLE IN THE BACK OF THROAT THAT WON'T GO AWAY; LEGS CRAMPED UP; COULD NOT MOVE FINGERS OR MOVE BETWEEN HER ARMS TO HER ELBOW FOR 5 MINUTES; BAD ITCHING; COVID SYMPTOM; BODY FELT SO BAD; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 174 pounds, and height was 63 inches. The patient's concurrent conditions included: fibromyalgia, graves' disease, endometriosis, hypertension, penicillin allergy, celery allergy, bees allergy, dust allergy, mold allergy, pollen allergy, drinks alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage and also had not been sick in 10 years before getting vaccine despite having 3 autoimmune diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. Concomitant medications included fexofenadine/pseudoephedrine hydrochloride for allergy. On 29-SEP-2021, the patient experienced bad itching. On 29-SEP-2021, the patient experienced covid symptom. On 29-SEP-2021, the patient experienced body felt so bad. On 14-OCT-2021, the patient experienced legs cramped up. On 14-OCT-2021, the patient experienced could not move fingers or move between her arms to her elbow for 5 minutes. On an unspecified date, the patient experienced lost 6-8 pounds, and bad tickle in the back of throat that won't go away. Laboratory data (dates unspecified) included: Weight (NR: not provided) 6-8 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid symptom on OCT-2021, and legs cramped up, and could not move fingers or move between her arms to her elbow for 5 minutes on 14-OCT-2021, had not recovered from lost 6-8 pounds, and bad tickle in the back of throat that won't go away, and the outcome of bad itching and body felt so bad was not reported. This report was non-serious. This case, from the same reporter is linked to 20211039718.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Weight, Weight decreased
Clinical narrative: LOST 6-8 POUNDS; BAD TICKLE IN THE BACK OF THROAT THAT WON'T GO AWAY; LEGS CRAMPED UP; COULD NOT MOVE FINGERS OR MOVE BETWEEN HER ARMS TO HER ELBOW FOR 5 MINUTES; BAD ITCHING; COVID SYMPTOM; BODY FELT SO BAD; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 174 pounds, and height was 63 inches. The patient's concurrent conditions included: fibromyalgia, graves' disease, endometriosis, hypertension, penicillin allergy, celery allergy, bees allergy, dust allergy, mold allergy, pollen allergy, drinks alcohol, and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage and also had not been sick in 10 years before getting vaccine despite having 3 autoimmune diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027 expiry: 29-SEP-2021) dose was not reported, administered on 28-SEP-2021 for prophylactic vaccination. Concomitant medications included fexofenadine/pseudoephedrine hydrochloride for allergy. On 29-SEP-2021, the patient experienced bad itching. On 29-SEP-2021, the patient experienced covid symptom. On 29-SEP-2021, the patient experienced body felt so bad. On 14-OCT-2021, the patient experienced legs cramped up. On 14-OCT-2021, the patient experienced could not move fingers or move between her arms to her elbow for 5 minutes. On an unspecified date, the patient experienced lost 6-8 pounds, and bad tickle in the back of throat that won't go away. Laboratory data (dates unspecified) included: Weight (NR: not provided) 6-8 pounds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid symptom on OCT-2021, and legs cramped up, and could not move fingers or move between her arms to her elbow for 5 minutes on 14-OCT-2021, had not recovered from lost 6-8 pounds, and bad tickle in the back of throat that won't go away, and the outcome of bad itching and body felt so bad was not reported. This report was non-serious. This case, from the same reporter is linked to 20211039718.
Sex: U
Vaccine: COVID19
Symptoms: Dysentery
Clinical narrative: DYSENTERY FOR THREE WEEKS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was previously dosed with semi-full strands of RNA. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, one total, 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 patient experienced dysentery for three weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dysentery for three weeks. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211042943-Covid-19 vaccine ad26.cov2.s- Dysentery. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: VERY TIRED; HEADACHE; SLIGHT FEVER; This spontaneous report received from a consumer concerned a 7 decade old male. 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 no drug abuse or illicit drug usage. 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 19-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-OCT-2021, the patient experienced very tired. On 19-OCT-2021, the patient experienced headache. On 19-OCT-2021, the patient experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from very tired, headache, and slight fever. This report was non-serious.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SORENESS; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a parent concerned a 31 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: autistic. He experienced allergy to amoxicillin when treated with Amoxicillin. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1805022 and expiry: unknown) dose was not reported, 1 total administered on left arm on 13-MAR-2021 for prophylactic vaccination. Concomitant medications included Abilify (aripiprazole) used for unknown indication which caused him to have high triglycerides but he did not take anything for the high triglycerides. On an unspecified date, the patient experienced some soreness after getting the Janssen COVID-19 vaccine. He experienced nausea, diarrhea, fever, headaches, sinus congestion, and loss of smell. On 18-AUG-2021, COVID-19 virus test result was positive which confirmed covid-19 infection. On the same date, he reported confirmed clinical vaccination failure.   The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and soreness, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211043553 and 20211043945. This report was associated with product quality complaint number: 90000198697.; Sender's Comments: V0 20211043252-COVID-19 VACCINE AD26.COV2.S-confirmed 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; SORENESS; This spontaneous report received from a patient concerned a 51 years old. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure (Takes Medication). 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: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, after vaccination, the patient stated that she did not experienced any adverse effects except for some soreness.  On 18-AUG-2021, the patient said that she had done the nasal swab test which came out to be positive (confirmed clinical vaccination failure and confirmed covid-19 infection). The patient stated that she believed that the vaccine did what it was suppose to do in lessening the symptoms from acquiring COVID-19. She also said that following that confirmed diagnosis, she experienced nausea, diarrhea, fever, headaches, sinus congestion, and loss of smell. The patient said that currently all symptoms had gone away with her sense of smell just recently recovering within the past few weeks. Laboratory data included: COVID-19 virus test (NR: not provided) POSITIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness, was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a Product Quality Complaint: 90000198689 This case, from the same reporter is linked to 20211043252 and 20211043945.; Sender's Comments: V0; 20211043553-COVID-19 VACCINE AD26.COV2.S-confirmed 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
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hip surgery
Clinical narrative: HIP SURGERY; SHINGLES ON RIGHT SIDE OF FACE; This spontaneous report received from a patient concerned a 72 year old female of unspecified race and ethnicity. The patient's weight and height were not reported. The patient's past medical history included: hip surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 21-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose and frequency were not reported from an unspecified date for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On MAR-2021, the patient experienced shingles on right side of face. On 20-JUN-2021, the patient experienced hip surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shingles on right side of face on APR-2021, and the outcome of hip surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211044314-covid-19 vaccine ad26.cov2.s-hip surgery .This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 21-OCT-2021) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient 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.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a consumer 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: Unknown) dose was not reported, administered on 20-OCT-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 21-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Gingival bleeding, Taste disorder, Wound haemorrhage
Clinical narrative: BLEEDING OF THE GUMS; NOSEBLEED FOR 3 DAYS; CUT THAT WOULDN'T STOP BLEEDING; CHANGE IN TASTE (PEANUT BUTTER DIDN'T TASTE THE SAME); This spontaneous report received from a patient concerned a 46 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: Unk) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUN-2021, the patient experienced bleeding of the gums. On 01-JUN-2021, the patient experienced nosebleed for 3 days. On 01-JUN-2021, the patient experienced cut that wouldn't stop bleeding. On 01-JUN-2021, the patient experienced change in taste (peanut butter didn't taste the same). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding of the gums, and change in taste (peanut butter didn't taste the same) on 29-JUN-2021, nosebleed for 3 days on 03-JUN-2021, and cut that wouldn't stop bleeding on 02-JUN-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Insomnia
Clinical narrative: BONES HURT FOR WEEKS; HAVE NOT HAD A GOOD NIGHTS SLEEP; 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  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced bones hurt for weeks. On MAR-2021, the patient experienced have not had a good nights sleep. The action taken with covid-19 vaccine was not applicable. The patient recovered from bones hurt for weeks, and had not recovered from have not had a good nights sleep. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy skin, Fatigue, Injection site pain, Purpura
Clinical narrative: This spontaneous report received from a parent concerned a 34-year-old male. The patient's height, and weight not reported. The patient's pre-existing medical conditions included: No known allergy. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 1805031, expiry: unknown), dose not reported, administered Mar 16, 2021 for immunization. No concomitant medications reported. On Mar 17, 2021, patient experienced soreness in injection arm. On Mar 17, 2021, patient experienced tirednesss. On May 5, 2021, patient experienced severe itchy rash from scalp to foot all over large patches 4-6 inches in width with raised especially on chest and back/COVID-19 rash. On Jun 17, 2021, laboratory data included: Skin biopsy (NR: not provided) COVID rash. On an unspecified date, patient bled from itching (even with the medications). Treatment medications (dates unspecified) included: prednisone, clobetasol propionate and betamethasone dipropionate. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from soreness in injection arm, and tirednesss on Mar 18, 2021; but has not recovered from severe itchy rash from scalp to foot all over large patches 4-6 inches in width with raised especially on chest and back/COVID-19 rash, and bled from itching (even with the medications).