chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo inappropriately reconstituted; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA583A, expiry date 31st August 2022) for prophylaxis.   On 22nd August 2022, the patient received Menveo. On 22nd August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The registered nurse reported that one day before the reporting date, a patient received the the powder (MenA) portion only of Menveo diluted with sterile solution and another patient received the liquid portion of Menveo (MCWY) diluted as well with sterile solution.  It was unknown which patient received each part of the vaccine. The reporter mentioned that the patients were a female and a male but it was unknown which one received the powder portion or the liquid portion. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received Menveo vaccine which was incorrectly reconstituted, which led to wrong solution used in drug reconstitution. This case is for 2 of 2 linked patients reported by same reporter.; Sender's Comments:  US-GSK-US2022122727:Same reporter
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received HAV (Havrix) (batch number 7HJ74, expiry date 21st August 2022) for prophylaxis.   On 22nd August 2022, the patient received Havrix. On 22nd August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The medical assistant reported that a patient was administered a dose Havrix after expiration date. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 59.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose of Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th August 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th August 2022, unknown after receiving Twinrix and Twinrix 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 Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The clinic director reported that the patient was administered a dose Twinrix which had an expiration date of 7th Aug 2022. This was the patient's first dose in the series. At the time of reporting, the dose has not been repeated. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 50.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 50-year-old female patient who received HAVRIX (batch number KM72C, expiry date 18th June 2022) for prophylaxis. Co-suspect products included HAVRIX Pre-Filled Syringe Device injection syringe for prophylaxis. On 22nd August 2022, the patient received HAVRIX (intramuscular) 1 ml and HAVRIX Pre-Filled Syringe Device. On 22nd August 2022, unknown after receiving HAVRIX and HAVRIX 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 Information: GSK receipt date: 23-Aug-2022. Reporter's comment: The medical assistant reported that a patient received an expired vaccine. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of HAVRIX in right deltoid, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose December 28 2021, Unknown if 2nd dose was administered; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th December 2021, which batch number 3BD9E and expiry date 6th April 2023).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The reporter reported that the patient was administered Shingrix 1st dose on 28th December 2021 and was back to received 2nd dose.  It was unknown if 2nd dose was administered on date of call to Medical Information The reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Administered after the expiration date; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 44-year-old female patient who received HBV (Engerix B) (batch number K2L79, expiry date 12th August 2022) for prophylaxis.   On 22nd August 2022, the patient received the 1st dose of Engerix B. On 22nd August 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The pharmacist stated that Engerix-B was administered to a patient after expiration date. The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 61.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 61-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 23rd August 2022, unknown after receiving Twinrix and Twinrix 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 Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The health care professional reported that an expired Twinrix was administered on the day of reporting. No reactions were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Age: 0.83
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 10 month old patient; 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 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st August 2022, 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 Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The health care professional called on the day of reporting to report Kinrix was administered to a 10 months old patient. The outside phone number for GlaxoSmithKline medical information given for future reference and transfer provided. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Suspected COVID-19, Throat tightness
Clinical narrative: THROAT CLOSED UP; DIFFICULTY SWALLOWING; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a other company (Pfizer, Inc) concerned a 34 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bee allergy, and drug allergy (Acetaminophen). The patient was not a pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: Unknown) dose was not reported, 1 in total, dose 1 administered in left arm on 03-APR-2021 12:00 for covid-19 prophylaxis. Age at time of vaccination 33 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1) The patient received non-company suspect vaccine tozinameran (Pfizer Biontech covid-19 vaccine) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: FH8027 and expiry: Unknown) dose was not reported, dose 2 administered in left arm on 11-DEC-2021 11:00 for covid-19 prophylaxis. No concomitant medications were reported.  On 2022 (Date and month unspecified), the patient experienced suspected covid-19 infection (Dose number in series: 2). The patient received non-company suspect drug Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, from 08-AUG-2022 to 09-AUG-2022 for treatment of covid-19. On 09-AUG-2022, the patient experienced throat closed up, and difficulty swallowing (Dose number in series: 2). The patient took treatment with Antihistamine (drug unspecified). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran (Pfizer Biontech covid-19 vaccine) was not applicable, and with Paxlovid was not reported. The patient was recovering from throat closed up, and difficulty swallowing, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Osteoarthritis
Clinical narrative: OSTEOARTHRITIS; UPPER EXTREMITY DYSFUNCTION; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (oral, batch number: 1159488 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced osteoarthritis, and upper extremity dysfunction. Treatment medications (dates unspecified) included: methotrexate, and celecoxib. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient had not recovered from osteoarthritis, and upper extremity dysfunction. This report was non-serious.  This case, involving the same patient is linked to 20220853756 and 20220853753.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia
Clinical narrative: METALLIC TASTE; This spontaneous report received from a consumer via other manufacturer (pfizer) concerned a 60 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart disease, and allergy (drug unspecified). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808980, expiry: Unknown) dose was not reported, 1 total, administered at right arm on 01-APR-2021 for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose was not reported, 1 total, administered on 22-OCT-2021 at right arm for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). Age at time of vaccination 60 days old. Concomitant medications included rosuvastatin for drug used for unknown indication.   The patient also received Moderna covid-19 vaccine (elasomeran) (Dose number in series 3) (form of admin and route of admin was not reported, batch number: 016B21A , expiry: Unknown) dose was not reported, administered on 12-JUL-2022 10:00 at right arm for covid-19 prophylaxis.  The patient also received paxlovid (form of admin and route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on 03-AUG-2022 to 08-AUG-2022 for the treatment of covid-19.  On 04-AUG-2022, the patient experienced metallic taste within 1 hour of the first dose (paxlovid) which lasted throughout 5 days treatment (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with paxlovid was drug discontinued. The patient recovered from metallic taste on 09-AUG-2022 (duration 5 days). This report was non-serious.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Pruritus, Urticaria
Clinical narrative: COVID-19; ITCHINESS ON ARMS AND TORSO; HIVES; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, GERD (Gastroesophageal reflux disease) and allergy (unspecified), and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805029, expiry: unknown) dose was not reported, 1 total, administered on 11-MAR-2021 at 14:00 at right arm for covid-19 prophylaxis. It was unknown whether the patient experienced adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Age at time of vaccination 51 years old. Concomitant medications included dexlansoprazole (Dexilant) and methotrexate (Otrexup) for drug used for unknown indication. The patient also received 2 doses of moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin and route of admin was not reported, batch number: 004F21A and 001M21A, expiry: unknown) dose was not reported, at right arm, first dose administered on 23-OCT-2021 at 13:00 and second dose on 13-APR-2022 at 13:00 for covid-19 prophylaxis.  On unspecified date, the patient experienced covid-19 (Dose number in series 2). The patient received Paxlovid (form of admin and route of admin was not reported, batch number: 2692129, expiry: unknown) dose was not reported, administered on 28-JUL-2022 for covid-19.  On 29-JUL-2022, at 16:00, the patient experienced itchiness on arms and torso began after 2nd dose of Paxlovid and hives after 4th dose (Dose number in series 2). On 30-JUL-2022, Paxlovid was suspended after consultation with prescribing doctor. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride (Benadryl).  The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with Paxlovid was treatment discontinued. The patient recovered from itchiness on arms and torso, and hives on 01-AUG-2022, and the outcome of covid-19 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: FAST IRREGULAR HEARTBEAT; This spontaneous report received from a consumer 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, and batch number were not reported) dose was not reported, administered on 29-JUL-2022 for covid-19 prophylaxis. 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 patient experienced fast irregular heartbeat. Laboratory data (dates unspecified) included: Heart rate Fast (Irregular). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fast irregular heartbeat was not reported. This report was non-serious.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: REBOUND OF COVID SYMPTOMS 5 DAYS AFTER LAST DOSE OF PAXLOVID; This spontaneous report received from a patient concerned a 74 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, and batch number were not reported) dose was not reported, administered on 11-DEC-2021 13:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 74 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced rebound of covid symptoms 5 days after last dose of paxlovid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rebound of covid symptoms 5 days after last dose of paxlovid. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discolouration, Injection site discomfort, Injection site erythema, Injection site pain
Clinical narrative: 2 INCH CIRCLE THAT IS DARKER WHERE THE VACCINE WAS GIVEN; INJECTION SITE PRESSURE EVERY TIME MOVES IT; INJECTION SITE STINGS/BURN; ARM WAS REALLY RED WHERE THE SHOT WAS GIVEN; This spontaneous report received from a patient concerned a 70 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: 204B21A expiry: 10-MAY-2022) dose was not reported, administered on 14-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported. On 14-SEP-2021, the patient experienced arm was really red where the shot was given. On 2022, the patient experienced 2 inch circle that is darker where the vaccine was given, injection site pressure every time moves it, and injection site stings/burn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from 2 inch circle that is darker where the vaccine was given, injection site stings/burn, and injection site pressure every time moves it, and the outcome of arm was really red where the shot was given was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: HOSPITALIZED; This spontaneous report received from a consumer 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, batch number and expiry were not reported) dose, start therapy date were not reported 01 total administered on 2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, it was reported that reporter's mother was hospitalized after receiving the vaccine, and number of days of hospitalization not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalized was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220832500-covid-19 vaccine ad26.cov2.s-hospitalized . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION/GOT COVID AGAIN; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. 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 06-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 43 years old. No concomitant medications were reported. On 2022, the patient experienced covid-19 infection/got covid again. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection/got covid again was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Off label use
Clinical narrative: This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, and autoimmune, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient was previously treated with non company vaccine Pfizer Biontech Covid-19 Vaccine (dose number in series 1) (form of admin, route of admin and batch number were not reported) dose was not reported administered on 21-FEB-2021 10:00 in left arm for covid-19 prophylaxis. It was unknown if patient experienced any adverse event after Pfizer Biontech Covid-19 Vaccine (dose number in series 1). The patient received covid-19 vaccine ad26. cov2. s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 14-AUG-2021 11:00 in left arm for covid-19 prophylaxis. It was unknown if patient experienced any adverse event after covid-19 vaccine ad26. cov2. s (dose number in series 2). Past drug included EVUSHELD on 21-FEB-2022 10:00 at Gluteus Medius Left for unknown indication. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 07-JUL-2022 12:00 in left arm for covid-19 prophylaxis. The drug was associated with Off label use. Age at time of vaccination 55 years old. The batch number was not reported and has been requested. Concomitant medications included calcium levomefolate, calcium/colecalciferol, calendula officinalis/carotenoids NOS/crocus sativus/phospholipids/Ribes nigrum, cetirizine hydrochloride, dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol, magnesium, Oenothera biennis oil, Pancrelipase, retinol and thyroid for drug used for unknown indication. On an unspecified date in 2022, the patient experienced covid-19 (dose number in series 3). The patient received non company suspect Paxlovid (form of admin, route of admin and batch number were not reported) dose was not reported, administered from 27-JUL-2022 to 01-AUG-2022 for covid-19 treatment. On 04-AUG-2022 at 12:00, three and half days after completing 5 days Paxlovid treatment the patient experienced rebound Covid (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued on 01-AUG-2022. The patient had not recovered from covid-19 infection and Covid rebound, and the outcome of off label dosing frequency was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Off label use, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. Initial information was processed along with additional information was received on 22-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 1 diabetes, asthma, allergies, hypothyroidism, and drug allergy (Omnicef allergy). The patient initially received Moderna covid-19 vaccine (elasomeran) (dose number in series 1) (form of admin and route of admin were not reported, batch number: unknown, expiry: unknown) dose not reported, administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient experienced any adverse reaction following vaccination with Moderna covid-19 vaccine (elasomeran) (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 08-MAR-2021 for covid-19 prophylaxis. The product was associated with Off label use (off label dosing frequency) (dose number in series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included cetirizine hydrochloride, ciclesonide, insulin aspart, levothyroxine, lisinopril, and salbutamol sulfate. On an unspecified date in JUL-2022, the patient experienced covid-19 symptoms (dose number in series 2) for which patient was treated with non-company drug Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered from 26-JUL-2022 till 01-AUG-2022 for treatment of covid-19. On 07-AUG-2022, the patient experienced rebound covid-19 symptoms and had covid 19 test positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of off label dosing frequency was not reported. This report was non-serious. This report was associated with product quality complaint: 90000246993. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via webform concerned an elderly female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 20-MAR-2021 for covid-19 prophylaxis.  The patient did not experience any adverse event after covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 26-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 71 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in MAY-2022, the patient experienced covid-19 and had mild symptoms with an annoying cough that lasted a few months (suspected covid-19 infection) (dose number in series 2). The patient enquired if JNJ was offering third shot and said physicians seemed to know nothing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious. This report was associated with product quality complaint: 90000246807
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a 71 year old female of an unspecified race and ethnicity. Initial information was processed along with the additional information received on 23-AUG-2022 The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (dose number in series: 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on 20-MAR-2021 for covid-19 prophylaxis.  The patient had no adverse event following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series: 1). The patient additionally received booster covid-19 vaccine ad26.cov2.s (dose number in series:2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose was not reported, 1 total administered on 26-NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2022, the patient got Covid and had mild symptoms with an annoying cough that lasted a few months (coded as suspected covid-19 infection) (dose number in series:2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection. This report was non-serious. This report was associated with a product quality complaint: 90000246808. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Petechiae
Clinical narrative: This spontaneous report received from a patient concerned an 84 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: 1821286 expiry: 20-MAR-2022) dose was not reported, administered on 22-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 84 years old. No concomitant medications were reported. On 2021, the patient experienced blue/petechiae spots on both feet, and swelling in both feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swelling in both feet, and had not recovered from blue/petechiae spots on both feet. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 POSITIVE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 19-AUG-2022. The patient's weight, height, and medical history were not reported. The patient previously received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received booster with covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 1828906 expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. No concomitant medications were reported.  On 17-AUG-2022, the patient experienced covid-19 positive (Dose number in series 2). Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000246966.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous report received from a patient via a company representative via other manufacturer concerned a 66 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total, administered on 24-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 65 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient additionally received second dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 2) (Form, route of administration, batch number, expiry: unknown) dose were not reported administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine (unspecified manufacturer) (Dose number in series 2). The patient received non-company suspect drugs (Rinvoq) upadacitinib (form of admin unknown, oral, batch number was not reported, expiry: unknown) dose, frequency and therapy dates were not reported for moderate to severe rheumatoid arthritis. The patient received non-company suspect vaccine (Moderna covid-19) elasomeran (Dose number in series 3) (form of admin unknown, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, administered on 20-JAN-2022 for covid-19 prophylaxis. In 2022, the patient experienced covid-19 (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, covid-19 vaccine, and elasomeran was not applicable; and dose of upadacitinib was not changed. The patient was recovering from covid-19. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 15-MAR-2021 for covid-19 prophylaxis. The number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19 virus test positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with upadacitinib was not reported. The patient was recovering from covid-19 virus test positive. This report was non-serious. This report was associated with product quality complaint: 90000247168. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20220848259.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 69 year old female. Initial information was processed along with additional information on 19-AUG-2022. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 10-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 67 years old. No concomitant medications were reported. No adverse events reported following vaccination (dose number in series 1). The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 30-Oct-2021 for covid-19 prophylaxis.  On 16-AUG-2022, the patient started symptoms two days ago with a sore throat (dose number in series 2). On 17-AUG-2022 (day before reporting), the patient got fever and a headache and tested first time negative in the afternoon (dose number in series 2). On 18-AUG-2022, more than 2 weeks following booster shot with Janssen covid-19 vaccine, the patient tested again late at night with home test and this one was positive (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint.  The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria as reported complaints were adverse events). this record is for the primary vaccination, however the patient tested positive for covid after the booster. this record therefore captures an adverse event in relation to the primary vaccine. record captures the lack of effect in relation to the booster shot. based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20220841198.; Sender's Comments: V0: 20220841147-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer (patient's wife) concerned a 69 year old male. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 in left arm for covid-19 prophylaxis.  The patient did not mentioned any side effects after covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809 expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-OCT-2021 in left arm for covid-19 prophylaxis. Age at time of vaccination 69 years old. No concomitant medications were reported.  On 14-AUG-2022, the patient experienced covid-19 symptoms, he had fever, coughing, and body aching (dose number in series 2) (confirmed clinical vaccination failure, and confirmed covid-19 infection). On 17-AUG-2022, around 3 to 4 pm Laboratory data included: COVID-19 virus test Positive at home test. Patient's wife reported that she has contacted the doctor and he was supposed to prescribe something to help them feel better (dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered 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 product quality complaint number: 90000247158 and 90000247157.; Sender's Comments: V0: 20220841198-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. 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. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Dysgeusia, Vomiting
Clinical narrative: COVID-19; VOMITING; BAD DYSGEUSIA; 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, and batch number were not reported) dose was not reported, administered on 05-APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ibuprofen for drug used for unknown indication, and paracetamol for drug used for unknown indication.  On 28-JUL-2022, the patient experienced bad dysgeusia, and vomiting. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad dysgeusia, and vomiting, and the outcome of covid-19 was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HAD THE VIRUS (COVID-19); This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously first dose of received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient had the virus (covid-19) (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had the virus (covid-19) was not reported. This report was non-serious.