chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: We had a patient in our office that got his first dose of Shingrix December of 2022 and just got his second dose May of 2025; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got his first dose of Shingrix December of 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: We had a patient in our office that got his first dose of Shingrix December of 2022 and just got his second dose May of 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 14-MAY-2025 This case was reported by a consumer via interactive digital media. The reporter reported that they had a patient in our office that got his first dose of Shingrix December of 2022 and just got his second dose May of 2025, which was the clearly past the recommended 6 months. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter wanted to ask if the patient should start the series over and get a third dose or only the two doses or not.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; contracted shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: contracted shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 02-MAY-2025 The reporter reported that he/she knew a woman (patient) who contracted shingles after getting the Shingrix booster or second dose. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. This was 1 of the 2 linked cases, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description,  time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (dose 1 and 2) US-GSK-US2025AMR062323:Same reporter/ Different patient
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: I got really sick from the first one; incomplete course of vaccination; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness (Verbatim: I got really sick from the first one) and incomplete course of vaccination (Verbatim: incomplete course of vaccination). The outcome of the sickness was not reported and the outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-MAY-2025 Patient asked if they can get second dose of Shingrix at month 7 or do they need to start the series over, and if they have to start over can they wait a year.  Also stated that they got really sick from the first one.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syringe issue, Underdose
Clinical narrative: leakage on a BEXSERO dose; Product complaint; Underdose/Incomplete dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis. This case was associated with a product complaint.   On 05-MAY-2025, the patient received Bexsero. On 05-MAY-2025, an unknown time after receiving Bexsero, the patient experienced accidental underdose (Verbatim: Underdose/Incomplete dose). On an unknown date, the patient experienced product leakage (Verbatim: leakage on a BEXSERO dose) and pharmaceutical product complaint (Verbatim: Product complaint). The outcome of the accidental underdose, product leakage and pharmaceutical product complaint were not applicable.   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: 12-MAY-2025 and 13-MAY-2025 The nurse reported a leakage on a Bexsero dose given to a patient which led to accidental underdose and mentions maybe only one drop leaked and was not administered to the patient.
Vaccine: MENB
Symptoms: Incorrect dose administered
Clinical narrative: due to difficulty expelling the air bubble possibility that approximately 150 patients received incomplete doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in an unspecified number of patients who received Men B NVS (Bexsero) (batch number 77KA5, expiry date 30-NOV-2027) and (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete dose administered (Verbatim: due to difficulty expelling the air bubble possibility that approximately 150 patients received incomplete doses). The outcome of the incomplete dose administered was not applicable.   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: 14-MAY-2025 Nurse called and inform that due to difficulty expelling the air bubble of Bexsero Prefilled Syringe there was a possibility that approximately 150 patients received incomplete doses during the last 3 months.  Reporter was not sure of the total amount of patients and the dates of administration.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: An adult 27 years old female patient received a pediatric dose of Engerix-B.; An adult 27 years old female patient received a pediatric dose of Engerix B; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 27-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (patient took 1st dose on unknown date).   On 07-MAY-2025, the patient received the 2nd dose of Engerix B. On 07-MAY-2025, an unknown time after receiving Engerix B, the patient experienced adult use of a child product (Verbatim: An adult 27 years old female patient received a pediatric dose of Engerix-B.) and underdose (Verbatim: An adult 27 years old female patient received a pediatric dose of Engerix B). The outcome of the adult use of a child product and underdose were not applicable.   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: 14-MAY-2025 Other HCP reported that they accidentally administered a pediatric dose of Engerix-B to 27 years old adult patient, which led to adult use of a child product and underdose. The vaccine was administered on 7th MAY 2025. It was her second dose of the series. Reporter asked if dose needs to be repeated. Also asked are there any safety concerns.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who got his first Shingrix vaccine 7 months ago; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (who got his first Shingrix vaccine 7 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient who got his first Shingrix vaccine 7 months ago). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date : 15-MAY-2025 Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration of Infanrix over age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number 223Y9, expiry date 07-SEP-2026) for prophylaxis.   On 15-MAY-2025, the patient received Infanrix. On 15-MAY-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Infanrix over age). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 15-MAY-2025 Medical assistance reported that a patient received by error Infanrix. The school required a Tdap vaccine for catch up. The reporter did not consent to follow-up. A 7 years old patient received a dose of Infanrix, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter. A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Arexvy, which led to incorrect storage of vaccine. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.). The outcome of the incorrect storage of drug was not applicable.   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: 16-MAY-2025 Other HCP reported after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for Arexvy (lot numbers: 44TR9 & DL32D), Boostrix (39LB7 & 2B723), Menveo (1 vial: AMVBO44A & LB93L), Havrix (423NO), Fluarix (PG52S) & Shingrix (M7G39), which led to incorrect storage of drug. Consented to follow up.; Sender's Comments:  US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9 degree fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree fahrenheit). The outcome of the incorrect storage of drug was not applicable.   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: 15-MAY-2025 The nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Boostrix which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments:  US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion). The outcome of the incorrect storage of drug was not applicable.   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: 15-MAY-2025 The nurse reported after giving several vaccines that were exposed to a temperature of 29.9 degree Fahrenheit as the lowest reached for Boostrix, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2025061574:same reporter,Different patient US-GSK-US2025061574:same reporter,Different patient US-GSK-US2025061573:same reporter,Different patient US-GSK-US2025061573:same reporter,Different patient US-GSK-US2025061572:same reporter,Different patient US-GSK-US2025061571:same reporter,Different patient US-GSK-US2025061570:same reporter,Different patient US-GSK-US2025061569:same reporter,Different patient US-GSK-US2025061568:same reporter,Different patient US-GSK-US2025061567:same reporter,Different patient US-GSK-US2025061565:same reporter,Different patient US-GSK-US2025061564:same reporter,Different patient US-GSK-US2025061563:same reporter,Different patient US-GSK-US2025061562:same reporter,Different patient US-GSK-US2025061561:same reporter,Different patient US-GSK-US2025061560:same reporter,Different patient US-GSK-US2025061559:same reporter,Different patient US-GSK-US2025061558: US-GSK-US2025061557: US-GSK-US2025061556: US-GSK-US2025061555: US-GSK-US2025061554: US-GSK-US2025061553: US-GSK-US2025061552: US-GSK-US2025061551: US-GSK-US2025061550: US-GSK-US2025061549: US-GSK-US2025061547: US-GSK-US2025061546: US-GSK-US2025061545: US-GSK-US2025061538: US-GSK-US2025061537: US-GSK-US2025061536: US-GSK-US2025061534: US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 52-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached.). The outcome of the incorrect storage of drug was not applicable.   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: 15-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Boostrix, which led to incorrect storage of vaccine. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments:  US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9 degree F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter. A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree F as the lowest reached for following product Shingrix, which led to incorrect storage of vaccine. No expiration date given for the vaccines nor date of administration. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number 423NO) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9 degree F as the minimum reached.). The outcome of the incorrect storage of drug was not applicable.   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: 21-MAY-2025 Other HCP reported after giving several vaccines that were exposed to a temperature of 29.9 degree F as the lowest reached for  Havrix, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Wrong age; Wrong dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 1-year-old male patient who received HAV (Havrix adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   On 12-MAY-2025, the patient received Havrix adult. On 12-MAY-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Wrong age) and overdose (Verbatim: Wrong dose). The outcome of the adult product administered to child and overdose were not applicable.   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: 15-MAY-2025 Registered Nurse explained that a 1 year old patient received an adult dose of Havrix on May 12th 2025, which led to adult product administered to child and overdose.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: hot area on the arm below the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G5T3, expiry date 20-JUL-2026) for prophylaxis.   On 12-MAY-2025, the patient received Shingrix. On 15-MAY-2025, 3 days after receiving Shingrix, the patient experienced injection site warmth (Verbatim: hot area on the arm below the injection site). The outcome of the injection site warmth was unknown.   The reporter considered the injection site warmth to be related to Shingrix.     The company considered the injection site warmth to be related to Shingrix.   Additional Information: GSK receipt date: 16-MAY-2025 The pharmacist reported they had a patient who received her Shingrix shot on Monday (12th MAY 2025). The patient had a raised, hot area about 4 inches below the injection site. The reporter assumed that the adverse event was related to the Shingrix vaccine.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: a patient received a dose of Havrix that had already expired; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 16-JAN-2025, the patient received the 1st dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: a patient received a dose of Havrix that had already expired). The outcome of the expired vaccine used was not applicable.   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: 16-MAY-2025 A pharmacist called to inform that a patient received a dose of Havrix that had already expired, which led to Expired vaccine used. Reporter mentioned that was the 1st dose of the series for such patient.  The reporter consented to follow up.
Age: 42.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HAV (Havrix) (batch number 95DB2, expiry date 13-DEC-2024) for prophylaxis.   On 30-JAN-2025, the patient received the 1st dose of Havrix. On 30-JAN-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose administered). The outcome of the expired vaccine used was not applicable.   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: 16-MAY-2025 The patient received a dose of Havrix that had already expired, which led expired vaccine used. The reporter consented to follow up.
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: clinics have been administering Kinrix vaccine in children less than 4 yo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patients received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: clinics have been administering Kinrix vaccine in children less than 4 yo). The outcome of the inappropriate age at vaccine administration was not applicable.   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: 16-MAY-2025 The pharmacist reported that in the multiple clinics have been administering Kinrix vaccine in children less than 4 years of age, which led to inappropriate age at vaccine administration. The reporter asked if Kinrix was given prior to age 4 does it need to be repeated
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix vaccine had been incorrectly reconstituted, using saline solution; Shingrix vaccine had been incorrectly reconstituted, using saline solution; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number E754F, expiry date 31-MAR-2027) for prophylaxis.   On 16-MAY-2025, the patient received Shingrix. On 16-MAY-2025, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix vaccine had been incorrectly reconstituted, using saline solution) and inappropriate dose of vaccine administered (Verbatim: Shingrix vaccine had been incorrectly reconstituted, using saline solution). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 16-MAY-2025 On 16th May 2025, a registered nurse had called to report that a Shingrix vaccine had been incorrectly reconstituted using saline solution and had been administered to a patient on the same day, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: administered an expired dose of Engerix B; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-day-old female patient who received HBV (Engerix B) (batch number 553J7, expiry date 28-MAR-2025) for prophylaxis.   On 16-MAY-2025, the patient received the 1st dose of Engerix B. On 16-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: administered an expired dose of Engerix B). The outcome of the expired vaccine used was not applicable.   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: 16-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter On 16 May 2025, a nurse administered an expired dose of Engerix B vaccine to a 2 day old patient which led to expired vaccine used.  The nurse wanted to know how to proceed in this case.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19) in a 61-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (covid-19). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) from 15-Apr-2025 to 20-Apr-2025 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2025, SARS-CoV-2 test: Positive.         No concomitant medications provided by the reporter.  It was reported that patient was received   Moderna- Covid-19 Vaccine and he thought that vaccine would be good. And he thought that he would not get COVID for life because he took the vaccine. But patient had COVID-19 infection three times.  Patient had COVID-19 infection multiple times. Also, it was reported that after received the vaccine (Moderna- Covid-19 Vaccine) the three time he had the infection.  After second time COVID-19 infection the patient was sick, and patient thought that he would die, and patient was received treatment medication.  It was reported that when first time patient had COVID, he took treatment medication, and it worked great, but he took it within 24 hours of the onset of the illness. It was reported that patient had latest covid-19 infection diagnosis on 15-Apr-2025 and patient was received treatment medication.   This case was linked to US-MODERNATX, INC.-MOD-2025-786089 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live significant information was received in which reporter detail was updated, patient demographic was updated (DOB, height, weight), lab data was added, and new reference number was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786089:same reporter different patient
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: Unknown number of administrations of VAQTA and VAXELIS SYRINGES following a temperature excursion. Temperature 0.44 C; This non-serious spontaneous safety report, with reference number 02760646 (interaction number: 02760638), was received by partner on 26-FEB-2025 and forwarded on 27-FEB-2025 from a health professional.  This case was considered non-valid due to no patient identifiers being provided.  Due to the nature of the event, the causality between the event 'Unknown number of administrations of VAQTA and VAXELIS SYRINGES following a temperature excursion. Temperature 0.44 C' and Vaxelis was not applicable.  Further information is expected.  SIGNIFICANT FOLLOW-UP INFORMATION was received from a health professional on 17-MAR-2025.   Patient identifiers were provided; therefore, the case has become valid.   Due to the nature of the event, the causality between the event 'Unknown number of administrations of VAQTA and VAXELIS SYRINGES following a temperature excursion. Temperature 0.44 C' and Vaxelis was not applicable.  No further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: expired VAXELIS was administered; This non-serious spontaneous safety report, with reference number 02763945 (interaction number: 02763936), was received by partner on 04-MAR-2025 and forwarded on 04-MAR-2025 from other health professional.  This case was considered non-valid due to no patient identifiers provided.  Due to the nature of the event, the causality between the event 'expired VAXELIS was administered' and Vaxelis was not applicable.  Further information is expected.  FOLLOW-UP INFORMATION was received on 25-MAR-2025 from a healthcare professional. The case becomes valid.  Due to the nature of the event, the causality between the event 'expired VAXELIS was administered' and Vaxelis was not applicable.  Further information is not expected
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: administration of an expired VAXELIS to three patients; This spontaneous safety report, with reference number 2025SA067138, was received by the partner on 05-MAR-2025 and forwarded on 06-MAR-2025, from the physician.   Due to the nature of the event, the causality between the event "administration of an expired VAXELIS to three patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007666.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: administration of an expired VAXELIS to three patients.; This spontaneous safety report, with reference number 2025SA067169, was received by the partner on 05-MAR-2025 and forwarded on 06-MAR-2025, from the physician.   Due to the nature of the event, the causality between the event "administration of an expired VAXELIS to three patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007665.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: administration of an expired VAXELIS to three patients.; This spontaneous safety report, with reference number 2025SA067179, was received by the partner on 05-MAR-2025 and forwarded on 06-MAR-2025, from other health professional.   Due to the nature of the event, the causality between the event "administration of an expired VAXELIS to three patients" and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007665.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: medication error/inappropriate use caused by the administration of expired VAXELIS to a patient; This non-serious spontaneous safety report, with reference number 2025SA067192, was received by partner on 05-MAR-2025 and forwarded on 06-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the events medication error/inappropriate use caused by the administration of expired VAXELIS to a patient' and Vaxelis were not applicable.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: VAXELIS vaccine that expired 2/26/2025 and was administered to a patient; This non-serious spontaneous safety report, with reference number 02766549 (interaction number: 02766543), was received by partner on 07-MAR-2025 and forwarded on 07-MAR-2025 from other health professional.  Due to the nature of the event, the causality between the event 'VAXELIS vaccine that expired 2/26/2025 and was administered to a patient' and Vaxelis was not applicable.  Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: VAXELIS to a patient aged 5 years and 6 months. They wanted to know if it is okay if the patient received the vaccine; This non-serious, spontaneous, safety report was received by partner, on 11-MAR-2025 and forwarded on 12-MAR-2025 from a healthcare professional.   The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events; "VAXELIS to a patient aged 5 years and 6 months. They wanted to know if it is okay if the patient received the vaccine".   This case is considered an off-label use, due to product administered to patient of inappropriate age.   Further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: 9-month-old son received VAXELIS that was improperly stored; This spontaneous safety report, with reference numbers 2025SA075227/ 02445318), was received by the partner on 12-MAR-2025 and forwarded on 13-MAR-2025, from a health care professional.  Additional safety information with reference number 0244949, was received by partner on 14-MAR-20225 and forwarded on 17-MAR-2025.   Due to the nature of the event, the causality between the event "9-month-old son received VAXELIS" that was improperly stored and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: accidentally given an expired VAXELIS vaccine to a 6-month-old/arrangement of the day and year in "26/02/25", the expiration date...confused her; This non-serious spontaneous safety report, with reference number 2025SA080015, was received by partner on 17-MAR-2025 and forwarded on 18-MAR-2025 from other health professional.  Due to the nature of the event, the causality between the event 'accidentally given an expired VAXELIS vaccine to a 6-month-old' and Vaxelis were not applicable.  Further information is expected.  Significant follow-up information was received by the partner on 17-MAR-2025 and forwarded on 20-MAR-2025, from other health professional. The case is maintained as non-serious.  Due to the nature of the event, the causality between the event 'accidentally given an expired VAXELIS vaccine to a 6-month-old' and Vaxelis were not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: Expired VAXELIS administered to a patient; This non-serious spontaneous safety report, with reference numbers (2025SA079521and 02451593), was received by partner on 17-MAR-2025 and forwarded on 18-MAR-2025 from a health professional.  Due to the nature of the event, the causality between the event "expired Vaxelis administered to a patient" and Vaxelis was not applicable.  Further information is expected.  This non-serious spontaneous safety report was forwarded on 30-APR-2025 from a health professional.  Due to the nature of the event, the causality between the event "expired Vaxelis administered to a patient" and Vaxelis was not applicable.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Pyrexia
Clinical narrative: Baby has H.influenza (untypable) [NOT a Vaxelis compound]; started a fever, of 104 degrees; This non-serious spontaneous safety report with reference number: 2025SA085952 was received by a partner on 21-MAR-2025 and forwarded on 24-MAR-2025 from other health professional.  The reporter did not assess the causal relationship between Vaxelis and 'baby has HIB', 'started a fever, of 104 degrees'.  Further information is expected.  Significant follow-up information was received on 07-APR-2025 from a healthcare provider. The case is maintained as non-serious.  The reporter assessed the causal relationship between Vaxelis and 'baby has HIB/Baby has H. influenza (untypable)', as not related.    The reporter did not assess the causal relationship between Vaxelis and the event 'started a fever, of 104 degrees.  Further information is expected.
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42 day vaccination schedule; No adverse event; This non-serious spontaneous safety report, with reference number 02775781 (interaction number: 02775778), was received by partner on 24-MAR-2025 and forwarded on 25-MAR-2025 from other health professional.  Due to the nature of the event, the causality between the event 'patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42-day vaccination schedule' and Vaxelis was not applicable.  Further information is expected.  Significant follow-up information was received on 10-APR-2025 from a health professional.  Due to the nature of the event, the causality between the event "patient received ROTATEQ, VAXELIS and VAXNEUVANCE at 41 days instead of the recommended 42-day vaccination schedule" and Vaxelis was not applicable.  No further information is expected.
Sex: M
Vaccine: DTPPVHBHPB
Symptoms: Expired product administered
Clinical narrative: expired VAXELIS was administered to a patient today; This Spontaneous Safety Report with reference number: 2025SA090728 was received by a partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.  Due to the nature of the event, the causality between the event 'expired VAXELIS was administered to a patient today' and Vaxelis was not applicable.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778063 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007745, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: No adverse event, Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; No adverse event; This non-serious spontaneous safety report, with reference number 02778134 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007746, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; This non-serious spontaneous safety report, with reference number 02778056 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007747, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.  FOLLOW-UP INFORMATION was forwarded on 24-APR-2025 from a healthcare professional. The case is maintained as non-serious.  : The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported event.   No further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds; This non-serious spontaneous safety report, with reference number 02778084 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007748, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. HCP reported that VAXELIS and GARDASIL-9 were administered.; VAXELIS was administered, no symptomatic events.; This non-serious spontaneous safety report, with reference number 02778100 (interaction number: 02777948), was received by partner on 27-MAR-2025 and forwarded on 28-MAR-2025 from other health professional.   Due to the nature of the event, the causality between the event 'HCP called regarding T/E for VAXELIS (prefilled), GARDASIL-9, and PNEUMOVAX-23. VAXELIS was administered, no symptomatic events. Temperature: 47.5F Time frame: 0 hours 36 minutes 51 seconds' and Vaxelis was not applicable.  This case shares the same event with the following companion cases: MCM-007744, MCM-007745, MCM-007746, MCM-007747, MCM-007749, MCM-007750, MCM-007751, MCM-007752, MCM-007753, MCM-007754, MCM-007755, MCM-007756, MCM-007757, MCM-007759, MCM-007760, MCM-007769, MCM-007770, MCM-007771.  Further information is expected.