chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MEN, MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero administration instead of Menquadfi; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number TP294, expiry date 31-OCT-2024) for prophylaxis.   Co-suspect products included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On 03-NOV-2023, the patient received Bexsero. On an unknown date, the patient did not receive Menquadfi. On 03-NOV-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Bexsero administration instead of Menquadfi). The outcome of the wrong vaccine 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: 24-MAR-2025 The health care professional wanted to know how to proceed after realizing that a patient received more than one year ago Bexsero instead of Menquadfi, which led to wrong vaccine administered (according to the patient's administration schedule) when he was 11 years old. The vaccine administration facility was the same as primary reporter.
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Improper Storage Error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa (Infanrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   In MAR-2025, the patient received Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Bexsero, Menveo, Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix B and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Improper Storage Error). 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: 25-MAR-2025 The health care professional requested data for Bexsero, Menveo (1-vial), Havrix, Kinrix, Pediarix, Boostrix, Infanrix, Engerix-B, Rotarix (liquid) stored at 0 degree Celsius unknown amount of time.  Excursion started on 20-MAR-2025.  No signs of freezing or slushing.  Vaccines had been used in patients but not aware of number of patients, which led to incorrect storage of drug.
Age: 66.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Given intramuscularly; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 66-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 30-SEP-2026) for prophylaxis.   On 24-MAR-2025, the patient received Priorix (intramuscular). On 24-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Given intramuscularly). The outcome of the subcutaneous injection formulation administered by other route 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: 25-MAR-2025 The patient was inadvertently given the Priorix intramuscularly instead of subcutaneously, which led subcutaneous injection formulation administered by other route.  The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: recently got another one on January; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in 2018).   On 20-JAN-2025, the patient received the 2nd dose of Shingrix. On 20-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: recently got another one on January). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 25-MAR-2025 The pharmacist's mother received a first dose on 2018 and recently got another one on 20 January 2025, which led to drug dose administration interval too long. Pharmacist wanted to ask if efficacy was affected once there had been more than six months after the first dose.; Sender's Comments:  US-GSK-US2025035954:same reporter
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose at age 10 and second dose at age 16; This non-serious case was reported by a consumer via sales rep and described the occurrence of drug dose administration interval too long in a patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (received 1st dose at the age 10).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too long (Verbatim: first dose at age 10 and second dose at age 16). The outcome of the drug dose administration interval too long 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: 25-MAR-2025 The doctor enquired if she needs to continue a possible 3rd dose of Bexsero vaccine if the adolescent received first dose at age 10 and second dose at age 16. The patient did not received second dose of vaccine within the recommended timeframe which led to drug dose administration interval too long.  The case was raised for the apparent deviation of the recommended schedule, but no more data available.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received their 2nd dose due to COVID and pandemic; This non-serious case was reported by a other health professional via sales rep and described the occurrence of social problem in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patients did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: never received their 2nd dose due to COVID and pandemic). The outcome of the social problem was not reported.   Additional Information: GSK Receipt Date: 26-MAR-2025 The reporter reported that they had several patients that received 1st dose in 2020 and then never received their 2nd dose due to Covid and pandemic.  The reporter asked should these patients restart the series or just get the 2nd dose.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: the dose had expired on March 14th 2025; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 65-year-old female patient who received HBV (Engerix B) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 26-MAR-2025, the patient received Engerix B. On 26-MAR-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: the dose had expired on March 14th 2025). 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 : 26-MAR-2025 Engerix B was administered on March 26th 2025 and the dose had expired on March 14th 2025 which led to expired vaccine used.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix; received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix; 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 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 3K3E7, expiry date 09-JUN-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: received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix) and inappropriate dose of vaccine administered (Verbatim: received Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 26-MAR-2025 A Nurse called to report that they administered to a 51-year-old male patient Shingrix reconstituted with sterile water diluent instead of the adjuvant portion that comes with Shingrix which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter wanted to know what exactly is in the liquid adjuvant, is there any vaccine in the liquid that comes with Shingrix?
Age: 69.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Havrix late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose of Havrix vaccine in 16-APR-2008).   On 04-JUN-2024, the patient received the 2nd dose of Havrix. On 04-JUN-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too long (Verbatim: Havrix late second dose). The outcome of the drug dose administration interval too long 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: 26-MAR-2025 The pharmacist asked if she could administer a third dose of Havrix to a patient due to a wide range of time between the first two doses.  First dose on 16 April 2008 and the second in 4 June 2024, which led to drug dose administration interval too long.
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder; accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder) and inappropriate dose of vaccine administered (Verbatim: accidentally reconstituted vaccine with a sterile diluent instead of the lyophilized powder). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 26-MAR-2025 Other HCP reported that one of their Medical Assistants accidentally reconstituted the Shingrix vaccine with a sterile diluent instead of the lyophilized powder when the 1st dose was administered to a patient. Reporter would like to know if it's still okay to administer the 2 doses of Shingrix to the patient since the initial dose was prepared and administered to the patient incorrectly. What should they do in this situation and is it safe for the patient or not. Reporter asked if there are any additional side effects for the patient they should be aware of. The patient received Shingrix vaccine with a sterile diluent instead of the lyophilized powder of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't received the 2nd dose yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22-OCT-2023 with batch number L227A and lot expiry 30-SEP-2025).   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: hadn't received the 2nd dose yet.). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 26-MAR-2025 The pharmacist reported that a patient received 1st dose of Shingrix on 22-OCT-2023, but had not received the 2nd dose yet. The vaccine administration facility was the same as primary reporter. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: short 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix) and Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   In MAR-2025, the patient received the 3rd dose of Twinrix. In MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: short 3rd 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: 26-MAR-2025 The patient received 3 doses of Twinrix, a month apart each.  It was unclear if the 3rd dose was administered on 13-March-2025 or 14-March-2025.  The patient received 3rd dose in shorter interval which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (had the 1st dose 3 to 4 years 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: Late 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 27-MAR-2025 On 27th March 2025, a nurse practitioner called to inform that a patient had received the first dose 3 to 4 years earlier, but she had never received the second one. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: now he wants to get the second dose of Shingrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix 3 years 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: now he wants to get the second dose of Shingrix.). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 26-MAR-2025 The reporter reported that a pharmacist called to ask if a 79 year old male patient could get the second dose of Shingrix if the first dose was administered 3 years ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult female patient received Engerix-B pediatric first dose; adult female patient received Engerix-B pediatric first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 47-year-old female patient who received HBV (Engerix B pediatric) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis.   On 27-MAR-2025, the patient received the 1st dose of Engerix B pediatric. On 27-MAR-2025, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult female patient received Engerix-B pediatric first dose) and adult use of a child product (Verbatim: adult female patient received Engerix-B pediatric first dose). The outcome of the underdose and adult use of a child product were not applicable.   Additional Information: GSK Receipt Date: 27-MAR-2025 The nurse reported that, on the day of reporting, an adult patient received Engerix-B pediatric first dose, which led to an underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than three years interval between the first and second dose of Shingrix; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Patient took first dose on unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: More than three years interval between the first and second dose of Shingrix). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 27-MAR-2025 The reporter told that if more than three years went by between the first and second dose of the vaccination did the patient needed to start the series over or just give the second dose now. The interval between first and second dose of the Shingrix was more than three years which led to drug dose administration interval too long.  The reporter did not want to provided personal information but yes that what occurred.  The second dose of Shingrix which it appeared correct based on CDC guidelines but wanted to double check.  No worries if it was not a simple yes or no answer and chat dropped while attempting to obtain additional information.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: adult dose administered inadvertently to adolescent; adult dose administered inadvertently to adolescent; 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 18-year-old male patient who received HBV (Engerix B adult) (batch number 4bx39, expiry date 29-JUL-2027) for prophylaxis.   On 27-MAR-2025, the patient received Engerix B adult. On 27-MAR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: adult dose administered inadvertently to adolescent) and overdose (Verbatim: adult dose administered inadvertently to adolescent). 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: 27-MAR-2025 Other HCP reported that an adult dose of Engerix B was administered to an 18 year old patient today, which led to adult product administered to child and overdose.
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: administered doses of Bexsero to multiple patients after a temperature excursion out of range and out of the supported in house extended stability data; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) (batch number DD72H, expiry date 30-NOV-2027) and (batch number 52N4S, expiry date 30-NOV-2027) for prophylaxis.   On an unknown date, the patients received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patients experienced incorrect storage of drug (Verbatim: administered doses of Bexsero to multiple patients after a temperature excursion out of range and out of the supported in house extended stability data). 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: 27-MAR-2025 A pharmacist called to report that they administered Bexsero to multiple patients after a temperature excursion, which led to incorrect storage of drug. The reporter asked that it was a valid dose. The Bexsero vaccine was exposed to 67 degree fahrenheit for 67 hours 48 minutes.  No prior excursions.  The reporter asked that you have any stability data that exceeds 48 hours of stability for Bexsero. Medical information specialist (MIS) tried to get more details of the patients involved but pharmacist stated that he did not have more information of their initials, ages or gender.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 months and 17 days that was inadvertently given the kinrix vaccine; 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 5-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 27-MAR-2025, the patient received Kinrix. On 27-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 5 months and 17 days that was inadvertently given the kinrix vaccine). 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: 27-MAR-2025 The clinic director reported that they had a patient who was 5 months and 17 days that was inadvertently given the Kinrix vaccine. The reporter just wanted to know if that was not harmful. The reporter did not know what number of Dtap-ipv dose was or which vaccine was supposed to be administered instead of Kinrix. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Multiple vaccines given/received 3rd dose in 2023; Multiple vaccines given/received 4th dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2027) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9K2MA) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021 with batch number PF454) and Shingrix (received 2nd dose in 2022 with batch number NR2X5).   On 27-MAR-2025, the patient received the 4th dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. On 27-MAR-2025, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Multiple vaccines given/received 4th dose). On an unknown date, the patient experienced extra dose administered (Verbatim: Multiple vaccines given/received 3rd dose in 2023). The outcome of the extra dose administered and extra dose administered were not applicable.   Additional Information: GSK Receipt Date: 27-MAR-2025 The pharmacist request information about the administration of Shingrix every year, specifying that they wish to receive recommendations on how to proceed after a patient got the vaccine today and after speaking with the patient they commented that they try and get the vaccine every single year.  They did specify that the previous vaccines were administered in 2021, 2022, 2023 and on 27-MAR-2025, which led to extra dose administered. The lot number for the vaccine that was administered in 2021 was PF454, the lot number for the vaccine that was administered on 2022 was NR2X5, the lot number that was administered in 2023 was 9K2MA and the lot number of the vaccine that was administered on March 27th 2025 was 9L944 and the expiration date was March 30th 2027.  They did state that they did not have any information about the expiration date for the previous vaccines. The vaccine administration facility was the same as primary reporter.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Underdose
Clinical narrative: Administration of less of the standard dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 4-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 27-MAR-2025, the patient received Kinrix. On 27-MAR-2025, an unknown time after receiving Kinrix, the patient experienced incomplete dose administered (Verbatim: Administration of less of the standard dose). 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: 27-MAR-2025 The nurse reported that the patient received Kinrix less than 0.5 standard dose because of child movements, which led to incomplete dose administered.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix via intramuscular instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a female patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix via intramuscular instead of subcutaneous). The outcome of the subcutaneous injection formulation administered by other route 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: 27-MAR-2025 A pharmacist called to inform that the patient received a dose of Priorix via intramuscular instead of subcutaneous which led to incorrect route of administration. The reporter didn't have any more details available at the moment of the call. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: received a dose of Priorix via intramuscular instead of subcutaneous; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a male patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: received a dose of Priorix via intramuscular instead of subcutaneous). The outcome of the subcutaneous injection formulation administered by other route 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: 27-MAR-2025  The pharmacist reported that two patients received a dose of Priorix via intramuscular instead of subcutaneous which led to subcutaneous injection formulation administered by other route. The Vaccine Administration Facility was the same as Primary Reporter.
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: someone who was 6 months late for their second dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: someone who was 6 months late for their second dose of Twinrix). The outcome of the drug dose administration interval too long 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: 27-MAR-2025 The pharmacist called with inquiry and while in conversation said through a friend she heard of someone who was 6 months late for their second dose of Twinrix which led to drug dose administration interval too long.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: received the child hep B, the Engerix-B ped dose instead of the adult dose; received the child hep B, the Engerix-B ped dose instead of the adult dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 52-year-old female patient who received HBV (Engerix B pediatric) (batch number LG749, expiry date 13-SEP-2026) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Heplisav b).   On an unknown date, the patient received the 2nd dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: received the child hep B, the Engerix-B ped dose instead of the adult dose) and adult use of a child product (Verbatim: received the child hep B, the Engerix-B ped dose instead of the adult dose). 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: 27-MAR-2025 Medical assistant called to provide the information as a patient received her second dose of Hepatitis B, Engerix-B pediatric dose instead of the adult dose, which led to underdose and adult use of a child product.  She had her first dose February first the regular dose that she was supposed to have. That was Heplisav which you guys did not have, so, she received that one and for her second one a kids dose. So, they were just wondering if like, she need a third dose of the kid's to be up to date with her two hepatitis B series. The reporter requested to not store her personally identifiable information (PII).  For pharmacovigilance follow-up the reporter's information was stored at member of public/the reporter's details in upper section.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Wrong route of administration; 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 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 05-FEB-2025, the patient received the 1st dose of Shingrix (subcutaneous). On 05-FEB-2025, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Wrong route of administration). The outcome of the intramuscular formulation administered by other route was not applicable.   Additional Information: GSK Receipt Date: 27-MAR-2025 The healthcare professional explained that a patient received their first dose of Shingrix on 5th February 2025, but it was given subcutaneously instead of intramuscular which led to intramuscular formulation administered by other route.
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Administration after 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: 28-MAR-2025 A CMA (certified medical assistant) started a chat and informed that she believed a patient had received a dose of Bexsero that was in a temperature excursion with the following conditions: 30.71 degrees F, 186 hours and 35 mins, which led to an incorrect storage of drug. No previous excursion was reported. Reporter did not have any details about the patient.
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: An 18 years old male patient accidentally received a dose of Shingrix instead of Varivax.; administered Shingrix instead of Varivax; 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 18-year-old male patient who received Herpes zoster (Shingrix) (batch number A5T73, expiry date 28-MAR-2027) for prophylaxis.   Co-suspect products included Varicella zoster vaccine live (Oka/Merck) (Varivax) for prophylaxis.   On an unknown date, the patient received Shingrix and Varivax. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: An 18 years old male patient accidentally received a dose of Shingrix instead of Varivax.) and wrong vaccine administered (Verbatim: administered Shingrix instead of Varivax). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were not applicable.   Additional Information: GSK receipt date: 28-MAR-2025 The medical assistant called to report that they accidentally administered Shingrix instead of Varivax to a 18 years old patient which led to, inappropriate age at vaccine administration and wrong vaccine administered. The reporter had a questioned how long should they wait to give the correct vaccine. Did they had to give him the second dose of Shingrix.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administration instead of Infanrix; Kinrix under recommended age administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7745R, expiry date 22-AUG-2025) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 24-FEB-2025, the patient received Kinrix. On an unknown date, the patient received Infanrix. On 24-FEB-2025, immediately after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Kinrix administration instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Kinrix under recommended age administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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:28-MAR-2025 Registered Nurse wanted to know how to proceed with a patient that received Kinrix instead of Infanrix and if there was any possible harm for him in this situation, which led to wrong vaccine administered and inappropriate age at vaccine administration. Information her inquiries and also for Kinrix under recommended age administration was given. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Inappropriate Route of Administration; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 25-year-old male patient who received MMR (Priorix) (batch number 4ZC23, expiry date 01-SEP-2025) for prophylaxis.   On 25-NOV-2024, the patient received Priorix (intramuscular). On 25-NOV-2024, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Inappropriate Route of Administration). The outcome of the subcutaneous injection formulation administered by other route 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: 28-MAR-2025 The reporter reported that an intramuscular administration of Priorix vaccine to a patient, which led to subcutaneous injection formulation administered by other route. The patient demographics, vaccine detail and vaccination date were obtained during this call.  No further information was provided from the Vaccine Coordinator´s end in this call. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: 5 doses administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old male patient who received HBV (Engerix B) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis.   On 28-MAR-2025, the patient received the 5th dose of Engerix B. On 28-MAR-2025, an unknown time after receiving Engerix B, the patient experienced extra dose administered (Verbatim: 5 doses administered). The outcome of the extra 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: 28-MAR-2025 On 28th March 2025, a nurse called to inform that earlier that day, a patient had received a dose of Engerix-B but had already completed their vaccination series, making it an additional dose.  The reporter confirmed that it had been the fifth dose of Engerix-B the patient had received, which led to Extra dose administered.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose - Inappropriate Schedule (wrong accelerated schedule); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 31-year-old female patient who received HAB (Twinrix) (batch number 324BY, expiry date 28-SEP-2026) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 27-MAR-2025, the patient received the 2nd dose of Twinrix. On 27-MAR-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose - Inappropriate Schedule (wrong accelerated schedule)). The outcome of the drug dose administration interval too long 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: 28-MAR-2025 and 01-APR-2025 Registered Pharmacist asked for the following patient´s Twinrix schedule, when the third dose could be administered. The vaccination date, vaccine detail and patient demographics were obtained in this call.  No further information was obtained from the Registered Pharmacist´s end. The reporter consented to follow up. The Vaccine administration Facility was the same as Primary Reporter. The patient received 2nd dose of Twinrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: only the adjuvant portion of the Shingrix vaccine was administered to a patient.; only the adjuvant portion of the Shingrix vaccine was administered to a patient.; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number A5T73, expiry date 28-MAR-2027) for prophylaxis.   On 28-MAR-2025, the patient received Shingrix. On 28-MAR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only the adjuvant portion of the Shingrix vaccine was administered to a patient.) and inappropriate dose of vaccine administered (Verbatim: only the adjuvant portion of the Shingrix vaccine was administered to a patient.). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 28-MAR-2025 The nurse reported that the adjuvant portion of the Shingrix vaccine was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter.
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 3rd dose; Early 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 54-year-old patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (patient received first dose on 17th October, 2024).   On 06-MAR-2025, the patient received the 3rd dose of Engerix B. On 30-OCT-2024, the patient received the 2nd dose of Engerix B. On 30-OCT-2024, an unknown time after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). On 06-MAR-2025, the patient experienced drug dose administration interval too short (Verbatim: Early 3rd dose). The outcome of the drug dose administration interval too short and drug dose administration interval too short 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: 31-MAR-2025 Other HCP reported that a patient had received the series of Engerix-B with the schedule, 1st dose on 17th October 2024, 2nd dose on 30th October 2024 and 3rd dose on 6th March 2025. Reporter did not give more details about this and declined follow-up by safety team. The patient received 2nd dose of Engerix B,?earlier than the recommended interval, which led to shortening of vaccinations schedule. Patient received 3rd dose of Engerix B,?later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 9-year-old patient received an adult dose of Havrix this morning; 9-year-old patient received an adult dose of Havrix this morning; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 9-year-old male patient who received HAV (Havrix 1440 adult) (batch number HR4RB, expiry date 18-DEC-2025) for prophylaxis.   On 31-MAR-2025, the patient received the 1st dose of Havrix 1440 adult. On 31-MAR-2025, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: 9-year-old patient received an adult dose of Havrix this morning) and adult product administered to child (Verbatim: 9-year-old patient received an adult dose of Havrix this morning). The outcome of the overdose and adult product administered to child 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:31-MAR-2025 The reporter stated that a 9-year-old patient received an adult dose of Havrix this morning, which led to overdose and adult product administered to child. The reporter consented to follow up via postal. The Vaccine Administration Facility is the same as Primary Reporter.