chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had two shingles episodes since the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (shingles outbreaks several times a year) and stress.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had two shingles episodes since the vaccine). 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 This case was reported by a patient via interactive digital media. The patient get shingles outbreaks several times a year as a stress response. The patient got the two-part Shingrix vaccine a year ago (in 2024). It made no difference. The patient had two shingles episodes since the vaccine and they had not been any milder. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (h/o shingles, insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had shingles down my leg from my hip to my knee!; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had shingles down my leg from my hip to my knee!). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-MAY_2025 This case was reported by a patient via interactive digital media. Patient had the complete vaccine and had shingles down my leg from hip to knee. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected Vaccination failure; I've had shingles 3 times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I've had shingles 3 times). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved (duration 6 months).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date :21-MAY-2025 This case was reported by a patient via interactive digital media. Reporter had shingles 3 times even after he/she got the vaccine all three times it lasted for 6 months. He/she had never been in so much pain for so long it was a nightmare. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: the redness from my injection site is spreading; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site erythema (Verbatim: the redness from my injection site is spreading). The outcome of the injection site erythema was not reported.   Additional Information: GSK Receipt Date: 20-MAY-2025 It was reported that redness from his/her injection site had spread.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: inadvertently administered a third dose of Shingrix to a patient; wrong vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3334Y, expiry date 25-MAR-2027) for prophylaxis.   Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Varivax) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26-MAR-2024) and Shingrix (received 2nd dose on 28-MAY-2024). Concomitant products included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).   On 14-MAY-2025, the patient received the 3rd dose of Shingrix. On an unknown date, the patient received Varivax. On 14-MAY-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: inadvertently administered a third dose of Shingrix to a patient) and wrong vaccine administered (Verbatim: wrong vaccine administered). The outcome of the extra dose administered and wrong vaccine administered were not applicable.   Additional Information: GSK receipt date: 14-MAY-2025 and 15-MAY-2025 The reporter reported that the patient received 3rd dose of Shingrix vaccine which led to, extra dose administered. She had received her first dose of the varicella vaccine on 6th March 25 and had been scheduled for her second dose of varicella on 14th May 2025. When asked, the nurse did not provide a reason why the patient had received the varicella vaccine after the Shingrix vaccination.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unapproved 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 11-year-old female patient who received DTPa (Infanrix) (batch number 9KB9G, expiry date 07-JUL-2026) for prophylaxis.   Concomitant products included Diphtheria vaccine toxoid, Pertussis vaccine acellular 3-component, Tetanus vaccine toxoid (Boostrix).   On 14-MAY-2025, the patient received Infanrix. On 14-MAY-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved 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: 14-MAY-2025 Office Manager reported that they had a patient in office today. So, they gave her a dtap and a tdap vaccine. So, they were just wondering if there were any contraindications that they need to be concerned about? Consented to follow up. The second line agent provided the information that with this Infanrix shot at the age of 11 years which led to inappropriate age at vaccine administration, patient had 5 DTAP vaccines.
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: several vaccines that were exposed to 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 elderly 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: several vaccines that were exposed to a below temperature excursion). The outcome of the incorrect storage of drug was not applicable.   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 of 29.9 degree Fahrenheit as the lowest reached for product which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. No expiration date given for the vaccines nor date of administration. This was 1 of 5 linked cases, reported by same reporter different patient.; Sender's Comments:  US-GSK-US2025061534:same reporter US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient
Sex: F
Vaccine: RSV
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 female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) 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°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 registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree Fahrenheit as the lowest reached Arexvy 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 US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
Sex: F
Vaccine: RSV
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 RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) 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 Fahrenheit). The outcome of the incorrect storage of drug was not applicable.   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. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments:  US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061538:same patient,Different suspect US-GSK-US2025061545:
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 60-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. 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 US-GSK-US2025061545: US-GSK-US2025061538:
Sex: M
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 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 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 The registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree Fahrenheit as the lowest reached 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 US-GSK-US2025061545:
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: several vaccines that were exposed to 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 adult female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S) for prophylaxis.   On an unknown date, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: several vaccines that were exposed to 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 A registered 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 product which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. This is one of 4 linked cases reported by same reporter different patient.; Sender's Comments:  US-GSK-US2025061548:same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient
Sex: F
Vaccine: FLU3, HEPA, MNQ, RSV, TDAP, VARZOS
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 adult female patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) (batch number 44TR9) and (batch number DL32D) for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) and (batch number 2B723) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number AMVBO44A) and (batch number LB93L) for prophylaxis, HAV (Havrix) (batch number 423NO) for prophylaxis and Flu Seasonal TIV Dresden (Fluarix) (batch number PG52S) for prophylaxis.   On an unknown date, the patient received Shingrix and Arexvy. On an unknown date, the patient received Boostrix. On an unknown date, the patient received Menveo. On an unknown date, the patient received Havrix and Fluarix. On an unknown date, an unknown time after receiving Shingrix, Arexvy, Boostrix, Menveo, Havrix and Fluarix, 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 02294438 of 29.9 degree Fahrenheit as the lowest reached for following products: Arexvy (lot numbers: 44TR9 and DL32D), Boostrix (39LB7 and 2B723), Menveo (1 vial: AMVBO44A and LB93L), Havrix (423NO), Fluarix (PG52S) & Shingrix (M7G39) which led to incorrect storage of drug. The Vaccine Administration Facility is the same as Primary Reporter. No expiration date was given for the vaccines nor the date of administration. Consented to follow up.; Sender's Comments:  US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
Sex: M
Vaccine: VARZOS
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 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 Fahrenheit). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 and 16-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Shingrix which led to incorrect storage of drug. The Vaccine Administration Facility was the same as Primary Reporter.; Sender's Comments:  US-GSK-US2025061548: US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
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 female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723) and (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 The registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree Fahrenheit as the lowest reached Boostrix which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2025061548: US-GSK-US2025061548: US-GSK-US2025061564:SAME PATIENT SAME REPORTER, DIFFERENT SUSPECT US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 5 months old female patient received a dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 5 months old female patient received a dose of Kinrix). 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: 20-MAY-2025 On 19th May 2025, an reporter called to report that they had administered a dose of Kinrix to a five month old female patient, which led to Inappropriate age at vaccine administration.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administration of the second dose of Havrix 4 months after the initial dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old male patient who received HAV (Havrix) (batch number 423NL, expiry date 16-NOV-2025) for prophylaxis.   Previously administered products included Havrix (received 1st dose of vaccine on 26th January 2024, batch no F3Y25, expiry date 15th February 2025).   On 28-MAY-2024, the patient received the 2nd dose of Havrix. On 28-MAY-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: administration of the second dose of Havrix 4 months after the initial dose). The outcome of the drug dose administration interval too short 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 :19-MAY-2025 An office coordinator called in to request data about the administration of the second dose of Havrix 4 months after the initial dose. The patient was 18 months of age at the time of the second dose.  They requested medical information and declined to receive follow-up.  The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Wrong Solution Used (Dose mixed inadvertently with another diluent); was inadvertently given to a patient; 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 patient who received Herpes zoster (Shingrix) (batch number 74NC9, expiry date 13-NOV-2026) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Wrong Solution Used (Dose mixed inadvertently with another diluent)) and inappropriate dose of vaccine administered (Verbatim: was inadvertently given to a patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 19-MAY-2025 Nurse calls to ask about the efficacy of the Shingrix dose that was inadvertently given to a patient. The nurse mixed a Shingrix vaccine with a regular diluent (non-specified from the Registered Nurse´s end). Vaccine detail was obtained in this call.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: administered a pediatric dose of Engerix-B to an adult patient; administered a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 7NX57, expiry date 12-DEC-2026) for prophylaxis.   On 19-MAY-2025, the patient received Engerix B pediatric. On 19-MAY-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: administered a pediatric dose of Engerix-B to an adult patient ) and adult use of a child product (Verbatim: administered a pediatric dose of Engerix-B to an adult patient ). The outcome of the underdose and adult use of a child product 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: 20-MAY-2025 Healthcare professional explained that they administered a pediatric dose of Engerix-B to an adult patient on May 19th 2025, which led to underdose and adult use of a child product.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix-b possible expired dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number AHBVB767BA) for prophylaxis.   On 31-DEC-2009, the patient received Engerix B. On 31-DEC-2009, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix-b possible expired dose administration). 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: 20-MAY-2025 Registered nurse wanted to know the expiration date of an Engerix-B that was administered in 2009 given that their system flagged that the vaccine was expired when it was applied which led to expired vaccine use. The Medical Information agent tried to find it through the lot number provided, but had no luck, thus transferred to the Vaccine Service Center was effectuated. The Medical Information agent could catch in their call while leaving after introducing both parts that the expiration date of the product provided by the Vaccine Service Center agent was in 2010, but still made the adverse event report given that the health care provider mentioned that she was not sure that they had the real date of administration because they don't administer vaccines at the end of the year.
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: tech giving a Shingrix vaccine subcutaneously; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: tech giving a Shingrix vaccine subcutaneously). The outcome of the intramuscular formulation administered by other route was not applicable.   Additional Information: GSK Receipt Date: 20-MAY-2025 A pharmacy intern called to inform about a pharmacy tech given a Shingrix vaccine subcutaneously, which led to an intramuscular formulation administered by other route. Reporter did not have information about other details concerned this incident.
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Havrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   On 20-MAY-2025, the patient received Havrix. On 20-MAY-2025, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Havrix.). 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: 21-MAY-2025 The pharmacy manager reported that a child patient received an expired dose of Havrix vaccine, which led to expired vaccine used. The reporter asked was it a valid dose
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Twinrix late 4th dose on the rapid schedule; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 03-JAN-2024, lot no 58160-0815-52), Twinrix (received 2nd dose on 10-JAN-2024, lot no 58160-0815-52) and Twinrix (received 3rd dose on 12-FEB-2024, lot no 58160-0815-52).   On an unknown date, the patient did not receive the 4th dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Twinrix late 4th dose on the rapid schedule). The outcome of the incomplete course of vaccination 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 The pharmacist student reported that they have a patient who was on the rapid Twinrix dose schedule and she was getting her 4th dose and her Twinrix last dose was on 12th February 2024. Till the time of reporting, the patient did not receive 4th dose (booster) of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in APR-2018).   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: Shingrix - Late second dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 21-MAY-2025 The pharmacist reported that a patient received the first Shingrix dose in April 2018 and never got the second dose. The pharmacist asked if the patient should re start the series or just receive a second dose. Till the time of reporting the patient did not received second doe of Shingrix which led to incomplete course of vaccination.
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Menveo 2 vial inadvertent liquid portion only administration; Menveo 2 vial inadvertent liquid portion only administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAB043A, expiry date 31-JUL-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo 2 vial inadvertent liquid portion only administration) and inappropriate dose of vaccine administered (Verbatim: Menveo 2 vial inadvertent liquid portion only administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 21-MAY-2025 The Clinic Supervisor wanted to know the recommendations and the required waiting period if revaccination was necessary after only the liquid portion of Menveo (2-vial) had been administered, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The health care provider had been unaware of which patient may have received this until they realized, days later, that a few patients had received Menveo.  Only the lot number, expiration date, and a possible range of administration dates had been shared.  The Vaccine Administration Facility was the same as the Primary Reporter.  The suspected vaccine start date was possibly between 12th March 2025, and 29th April 2025.
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 1 month old male patient received a dose of Havrix.; 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 1-month-old male patient who received HAV (Havrix) (batch number L4EA4, expiry date 22-JAN-2027) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: A 1 month old male patient received a dose of Havrix.). 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: 21-MAY-2025 The reporter reported that a pediatrician called to report the administration of Havrix to a 1 month old male patient, which led to inappropriate age at vaccine administration.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Insomnia, Pain, Pruritus
Clinical narrative: Itchy and painful infection site; Itchy and painful infection site; Itchy and painful infection site; insomnia; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Itchy and painful infection site), PRURITUS (Itchy and painful infection site), INFECTION (Itchy and painful infection site) and INSOMNIA (insomnia) in a 52-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (Itchy and painful infection site), PRURITUS (Itchy and painful infection site), INFECTION (Itchy and painful infection site) and INSOMNIA (insomnia). At the time of the report, PAIN (Itchy and painful infection site), PRURITUS (Itchy and painful infection site), INFECTION (Itchy and painful infection site) and INSOMNIA (insomnia) was resolving.            No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.
Age: 60.0
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I now have covid again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (I now have covid again) in a 60-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (2 years ago) in 2023. Concurrent medical conditions included Immune disorder (NOS).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I now have covid again). At the time of the report, COVID-19 (I now have covid again) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. The patient could not even afford to go to the physician for it due to the company's insurance. No treatment information was provided.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate, Heart rate irregular, Myocarditis, Palpitations
Clinical narrative: ALL the symptoms of myocarditis.; heart palpitations; heart problem; irregular heart beat; This is a spontaneous report received from a Consumer or other non HCP.  An 18-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 18 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: MYOCARDITIS (medically significant) with onset Jul2021, outcome "not recovered", described as "ALL the symptoms of myocarditis."; PALPITATIONS (non-serious) with onset Jul2021, outcome "not recovered", described as "heart palpitations"; CARDIAC DISORDER (non-serious) with onset Jul2021, outcome "not recovered", described as "heart problem"; HEART RATE IRREGULAR (non-serious) with onset Jul2021, outcome "not recovered", described as "irregular heart beat". The patient underwent the following laboratory tests and procedures: Heart rate: irregular. Therapeutic measures were not taken as a result of myocarditis, palpitations, cardiac disorder, heart rate irregular.  Clinical course: The patient was forced to take the Pfizer vaccine when he was in basic training for the military around Jun2021, he was 19 at the time. He had heart problems ever since, heart palpitations, irregular heartbeat, as-well as all the symptoms of myocarditis.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: I woke up unable to walk. I now live with a lifelong disability; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT INABILITY (hospitalization, disability), 10 days after the suspect product(s) administration, outcome "unknown", described as "I woke up unable to walk. I now live with a lifelong disability". The patient now live with a lifelong disability, patient had 2 surgeries, got hospitalized multiple times a year and this has been going on for a few years now.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: nurse only gave her 1 component and not the other. he thinks that the patient only received the hib component, but he is not sure with no reported ae; Initial information received on 21-May-2025 regarding an unsolicited valid  non-serious case received from a consumer/ non-healthcare professional.  This case involves a 16 months old female patient and reporter reported that nurse only gave patient 1 component of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] and not the other. Reporter thought that the patient only received the HIB component, but he was not sure with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in May 2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) once via unknown route in the leg for Immunization and nurse only gave her 1 component and not the other. Reporter thought that the patient only received the HIB component, but he was not sure with no reported adverse event (single component of a two-component product administered) (latency- same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.  Action taken was not applicable.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: menquadfi was given twice to a patient 19 days apart with no reported adverse event; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 years old male patient who has been administered Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] twice, 19 days apart with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV Vaccine for prophylactic vaccination.  On 01-May-2025, the patient received a 0.5 ml 1x (once) (dose:1) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (batch number: U8369BA, expiry date: 31-Mar-2028) via intramuscular route in the left arm and on 20-May-2025 the patient had received a 0.5 ml 1x  (dose:2) of same vaccine  (batch number and expiry date) via intramuscular route in the left arm for immunization.  On 20-MAY-2025 Meningococcal A-C-Y-W135 (T CONJ) Vaccine was given twice to a patient 19 days apart with no reported adverse event (Inappropriate schedule of product administration) (latency: 19 days).  Action taken: not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: one of the nurses administered daptacel that "went out of date" to a patient with no reported ae; Initial information received on 21-May-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom one of the nurses administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] that "went out of date"  with no reported ae (adverse event).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2025, one of the nurses administered Diphtheria-15/Tetanus/5 AC Pertussis Vaccine Suspension for injection (dose, strength unknown) lot 2CA54C3 expiry date-07-Apr-2025 via unknown route in unknown administration site for Immunization that "went out of date" to a patient with no reported ae (expired product administered) (same day latency).  Action taken: not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: starting the following day, pt experienced full body itching.  Then again the following Sat, and one more day.  symptoms came and went.