chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; can still get shingles again; 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: can still get shingles again). 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: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient said even if you were vaccinated, you could still get shingles again and it happened to the patient. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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 the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Got second shingle vaccine last week had flu-like symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   In MAR-2025, the patient received the 2nd dose of Shingles vaccine. In MAR-2025, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Got second shingle vaccine last week had flu-like symptoms). In MAR-2025, the outcome of the influenza-like symptoms was resolved (duration 3 days).   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient got second shingle vaccine last week and had flu-like symptoms for about 3 days. The patient did not feel great, but it was over and done with. The patient was glad that it was only 2 doses.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got the shot Now I get shingles every two weeks; 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: got the shot Now I get shingles every two weeks). 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: 31-MAR-2025 This case was reported by a patient via interactive digital media. The patient never had shingles until he/she got the Shingles shot and now the patient got shingles every two weeks. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of 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 Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; 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: Shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   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: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient had administered with shingles shots and got shingles right now, but they were not as bad as they would have been if did not have the shots. 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. The follow-up could not be possible as no contact details were available.; 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.
Age: 69.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Injection site discolouration, Mobility decreased, Pain, Pain in extremity
Clinical narrative: 2 inches purple color around injection site below the skin; weakness; limiting the motion of patient's arm; sore arm/arm hurts during movements; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a 69-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 35P2C, expiry date 30-NOV-2025) for prophylaxis.   On 08-JAN-2025, the patient received the 1st dose of Arexvy (left arm). In JAN-2025, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm/arm hurts during movements). In MAR-2025, the patient experienced mobility decreased (Verbatim: limiting the motion of patient's arm). On an unknown date, the patient experienced injection site discoloration (Verbatim: 2 inches purple color around injection site below the skin) and weakness (Verbatim: weakness). The outcome of the injection site discoloration, pain in arm, mobility decreased and weakness were unknown.   It was unknown if the reporter considered the injection site discoloration, pain in arm, mobility decreased and weakness to be related to Arexvy.     It was unknown if the company considered the injection site discoloration, pain in arm, mobility decreased and weakness to be related to Arexvy.   Additional Information: GSK Receipt Date: 18-MAR-2025 The reporter reported that a patient received Arexvy vaccine and two days later arm sored.  A week later, the arm still sored, this was continued.  Patient started using massages and it did help a little while but then it comes back right on patient's  side, right where the needle went in, there was a purple 2 inches across like a very sore to touch below the skin.   Also, when patient goes to left her arm up, because patient did yoga, it wants to stop and it hurts to go pass that high.  It was like weakness.  It was 2 months later and it was limiting the motion of patient arm.  It was slowing getting better but patient can not find anything online talking about long term side effects with Arexvy.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: pediatric patient received an adult dose; pediatric patient received an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 18-year-old female patient who received HBV (Engerix B adult) (batch number H39Z4, expiry date 04-DEC-2025) for prophylaxis.   On 03-MAR-2025, the patient received Engerix B adult. On 03-MAR-2025, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: pediatric patient received an adult dose) and overdose (Verbatim: pediatric patient received an adult dose). The outcome of the adult product administered to child and overdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-MAR-2025 Nurse called to inform that a pediatric patient received an adult dose of Engerix-B, which led to adult product administered to child and overdose.
Age: 57.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Underdose
Clinical narrative: pediatric havrix vaccine administered to a 57 years old adult; pediatric havrix vaccine administered to a 57 years old adult; Expired Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 57-year-old female patient who received HAV (Havrix pediatric) (batch number F3Y25, expiry date 15-FEB-2025) for prophylaxis.   On 18-MAR-2025, the patient received Havrix pediatric. On 18-MAR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric havrix vaccine administered to a 57 years old adult), underdose (Verbatim: pediatric havrix vaccine administered to a 57 years old adult) and expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the adult use of a child product, underdose and expired vaccine used 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: 18-MAR-2025 Pharmacist reported that a pediatric havrix vaccine was administered to a 57 years old adult which led to adult use of a child product and underdose. The vaccine had actually expired on 15 February 2025 which led to expired vaccine used. Over a month ago so, it was still in the stock. The reporter wanted to know if there was a recommendation to revaccinate with an adult dose The reporter was not sure which number of dose it was and she did not know the date of birth of the patient.
Age: 12.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: administer an Engerix-B vaccine and it was expired; Drug dose administration interval too long; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received HBV (Engerix B) (expiry date 09-MAR-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received the 1st dose of Engerix-B in 29-JUL-2024).   On 18-MAR-2025, the patient received the 3rd dose of Engerix B. On 23-OCT-2024, the patient received the 2nd dose of Engerix B. On 23-OCT-2024, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long). On 18-MAR-2025, the patient experienced expired vaccine used (Verbatim: administer an Engerix-B vaccine and it was expired). The outcome of the expired vaccine used and drug dose administration interval too long 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: 19-MAR-2025 On 19-Mar-2025 a Registered Nurse called and reported that had a medical assistant, before the day of reporting, who administered an Engerix-B vaccine and it was expired, it expired 09-Mar-2025.  The Vaccine Administration Facility was the same as Primary Reporter. The vaccines was administered on 18-Mar-2025, the patient received prior Engerix-B doses on 29-July-2024 and 23-Oct-2024, which led to expired vaccine used and drug dose administration interval too long.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Priorix; administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Priorix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 54-year-old female patient who received MMR (Priorix) (batch number 3ZE3E, expiry date 22-NOV-2028) for prophylaxis.   On 17-MAR-2025, the patient received Priorix. On 17-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Priorix) and inappropriate preparation of medication (Verbatim: administered only the diluent sterile water) without mixing with the powder (lyophilized part) of Priorix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication 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: 19-MAR-2025 The reporter reported that the patient was administered only the diluent (sterile water) without mixing with the powder (lyophilized part) of Priorix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Can it be diluted with other sterile water? The vaccine administration facility is the same as primary reporter.; Sender's Comments:  US-GSK-US2025033667:Same reporter/Different patient
Sex: M
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: administered only the diluent; administered only the diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 56-year-old male patient who received MMR (Priorix) (batch number 3ZE3E, expiry date 22-NOV-2028) for prophylaxis.   On 17-MAR-2025, the patient received Priorix. On 17-MAR-2025, an unknown time after receiving Priorix, the patient experienced inappropriate dose of vaccine administered (Verbatim: administered only the diluent ) and inappropriate preparation of medication (Verbatim: administered only the diluent ). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication 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: 19-MAR-2025 Reporter stated that they administered only the diluent (sterile water) without mixing with the powder (lyophilized part) of Priorix.  Also asked if can it be diluted with other sterile water. The patient received only adjuvant of Priorix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with the case US2025033666,reported by the same reporter.; Sender's Comments:  US-GSK-US2025033666:Same reporter/Different patient
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Hypersensitivity, Injection site rash
Clinical narrative: rash on injection site; got an allergic reaction from it; This non-serious case was reported by a nurse via call center representative and described the occurrence of injection site rash in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number D252F) for prophylaxis.   On 27-FEB-2025, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced injection site rash (Verbatim: rash on injection site) and allergic reaction (Verbatim: got an allergic reaction from it). The outcome of the injection site rash was unknown and the outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the injection site rash and allergic reaction to be related to Pediarix and Pediarix Pre-Filled Syringe Device.     It was unknown if the company considered the injection site rash and allergic reaction to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   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-MAR-2025 Registered nurse called and reported the followed they gave one of our patient, a baby, the Hepatitis B vaccine, and then the baby got an allergic reaction from it, they had sent the baby to an allergist and now the allergist asked like a sample for the vaccine so they could do a skin test.
Age: 63.0
Sex: F
Vaccine: RSV
Symptoms: Expired product administered
Clinical narrative: it was expired; 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 63-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number P7M3Z, expiry date 02-MAR-2025) for prophylaxis.   On 20-MAR-2025, the patient received Arexvy. On 20-MAR-2025, an unknown time after receiving Arexvy, the patient experienced expired vaccine used (Verbatim: it was expired). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 20-MAR-2025  The other health professional reported that the RSV vaccine was given on the day of reporting and did not realize that it was expired which led to expired vaccine used.
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: adult patient needing the hepatitis B vaccine and he inadvertently received the Pediarix vaccine; adult patient inadvertently received the pediarix vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included Hepatitis b vaccine for prophylaxis.   On an unknown date, the patient received Pediarix and did not received Hepatitis b vaccine. On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: adult patient needing the hepatitis B vaccine and he inadvertently received the Pediarix vaccine) and adult use of a child product (Verbatim: adult patient inadvertently received the pediarix vaccine). The outcome of the wrong vaccine administered 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-MAR-2025 Clinical Pharmacist specifically had a question in regard to the Pediarix vaccination. They had an adult patient needing the hepatitis B vaccine and he inadvertently received the Pediarix vaccine which led to Adult use of a child product and Wrong vaccine administered. So, pharmacist just wondering if there were any safety concerns or like if have to re-do the hepatitis B vaccine. The pharmacist only knew that the patient was an adult and that he was starting the schedule for hepatitis B vaccine.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: only one patient that received the antigen alone; received the antigen alone; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 4H79Y, 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 inappropriate preparation of medication (Verbatim: only one patient that received the antigen alone) and inappropriate dose of vaccine administered (Verbatim: received the antigen alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 20-MAR-2025 On 20/Mar/2025, a nurse called to inform that it was discovered in a box of Shingrix that there were 3 vials left of Shingrix the vial that was left over out of the 3 was the gE antigen component.  According to reporter, it was only one patient that received the antigen alone, and there were 9 suspect patients.  No more information was provided by the reporter about this incident as it was unknown who the patient was.  The Vaccine Administration Facility is the same as Primary Reporter. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site rash
Clinical narrative: bullseye rash in the arm where Shingrix was administered; Injection site pain; Redness; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingrix) for an unknown indication.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site rash (Verbatim: bullseye rash in the arm where Shingrix was administered), injection site pain (Verbatim: Injection site pain) and injection site erythema (Verbatim: Redness). The action taken with Shingrix was unknown. The outcome of the injection site rash, injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site rash, injection site pain and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site rash, injection site pain and injection site erythema to be related to Shingrix.   Additional Information: GSK receipt date: 20-MAR-2025 Physician stated that a patient experienced bullseye rash in the arm where Shingrix was administered. Reporter asked if the patient get the second shot if their first reaction was painful, redness, and a bullseye effect or not.
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: a patient that received the hepatitis B vaccine for pediatric when it should have been for adult; a patient that received the hepatitis B vaccine for pediatric when it should have been for adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 33-year-old female patient who received HBV (Engerix B pediatric) (batch number 42B22, expiry date 07-MAR-2026) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: a patient that received the hepatitis B vaccine for pediatric when it should have been for adult) and underdose (Verbatim: a patient that received the hepatitis B vaccine for pediatric when it should have been for adult). The outcome of the adult use of a child product and underdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-MAR-2025 The nurse reported that a patient that received the hepatitis B vaccine for pediatric when it should have been for adult, which led to adult use of a child product and underdose. The reporter need to know if that should be repeated or know, what should be done about that. The first dose was administered a couple of weeks ago.
Age: 2.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.; 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 2-year-old female patient who received HBV (Engerix B 10 mcg) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On 19-MAR-2025, the patient received Engerix B 10 mcg. On 19-MAR-2025, an unknown time after receiving Engerix B 10 mcg, the patient experienced expired vaccine used (Verbatim: MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.MA called stating their newest MA adminstered an expired ENGERIX-B yesterday to a patient.). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 20-MAR-2025 The reporter reported that newest medical assistant administered an expired Engerix B one day before the reporting to a patient, which led to expired vaccine used. The vaccine expired on 14-Mar-2025.
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: 8 year old female patient received Kinrix second dose; 8 year old female patient received Kinrix second dose; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included Kinrix (received 1st dose of Kinrix in 2022).   On 20-MAR-2025, the patient received the 2nd dose of Kinrix. On 20-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 8 year old female patient received Kinrix second dose) and extra dose administered (Verbatim: 8 year old female patient received Kinrix second dose). The outcome of the inappropriate age at vaccine administration and extra dose administered 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-MAR-2025 The doctor reported that an 8 year old female patient received Kinrix second dose on 20th March 2025 which led to inappropriate age at vaccine administration and extra dose administration. The first Kinrix was in 2022. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient has never received Twinrix 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 45-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Patient received first dose of Twinrix 10 years ago).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: The patient has never received Twinrix second dose.). 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: 20-MAR-2025 The pharmacist reported that a 45 year-old female patient received Twinrix first dose 10 years ago in another facility and she has never received Twinrix second dose. Till the time of reporting, the patient did not received the second dose of Twinrix which led to incomplete course of vaccination. The Vaccine Administration Facility is the same as primary reporter.
Age: 83.0
Sex: M
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed; one of those patients was given an incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 83-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis.   On 20-MAR-2025, the patient received Arexvy. On 20-MAR-2025, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: Pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed) and inappropriate dose of vaccine administered (Verbatim: one of those patients was given an incomplete dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 20-MAR-2025 The pharmacist asked about guidance on revaccination on two patient that was vaccinated, nevertheless after mixing doses, the pharmacist realized that after vaccination one of the powder vials (diluent) was not mixed and one of those patients was given an incomplete dose. The pharmacist did not know which of this patient was given the incomplete dose. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2025034229:same reporter different patient
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: administered a dose of Priorix intramuscularly instead of subcutaneously; 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 61-year-old male patient who received MMR (Priorix) (batch number XX9N4, expiry date 01-JUN-2026) for prophylaxis.   On 21-MAR-2025, the patient received Priorix (intramuscular). On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: administered a dose of Priorix intramuscularly instead of subcutaneously). 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: 21-MAR-2025 Pharmacist called to report that on 21st March 2025 has administered a dose of Priorix intramuscularly instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Intramuscular 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 patient who received MMR (Priorix) (batch number A2B72, expiry date 13-SEP-2026) 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: Intramuscular 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: 21-MAR-2025 The patient had received a dose of Priorix via intramuscular instead of subcutaneous, which led subcutaneous injection formulation administered by other route.  The reporter consented to follow up.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: received one dose of Twinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix on 19-SEP-2024), Heplisav b (received first dose of Heplisav b on 19-SEP-2024) and Heplisav b (received second dose of Heplisav b on 19-OCT-2024).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: received one dose of Twinrix ). 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-MAR-2025 and 22-MAR-2025 The pharmacist reported that a patient received one dose of Twinrix and one of Heplisav-B and a second dose of Heplisav-B on.  The pharmacist provided the lot number and expiration date of one of the Heplisav-B vaccines administered was 944915 and 19th September 2026.  That was the only vaccine from which she had that kind of information. The Vaccine Administration Facility was the same as Primary Reporter. Till the time of reporting the patient did not receive the second dose of Twinrix which led to incomplete course of vaccination.
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: I administered the vaccine IM instead of SQ by accident; 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) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 21-MAR-2025, the patient received Priorix. On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: I administered the vaccine IM instead of SQ by accident). 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: 21-MAR-2025 The pharmacist reported that they administered Priorix vaccine by intramuscular route instead of subcutaneous route, which led to subcutaneous injection formulation administered by other route.
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Wrong Route of Administration; Administration to adult patient; 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 adult male patient who received MMR (Priorix) (batch number X3M3D) 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: Wrong Route of Administration) and inappropriate age at vaccine administration (Verbatim: Administration to adult patient). The outcome of the subcutaneous injection formulation administered by other route 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: 21-MAR-2025 The pharmacist stated that the Priorix was administered intramuscularly instead of subcutaneous and to an adult patient which led to subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Reconstitution error/administered the liquid portion only of Shingrix; Reconstitution error/administered the liquid portion only of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 5y4tl, expiry date 31-JAN-2027) for prophylaxis.   On 19-MAR-2025, the patient received Shingrix. On 19-MAR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Reconstitution error/administered the liquid portion only of Shingrix) and inappropriate preparation of medication (Verbatim: Reconstitution error/administered the liquid portion only of Shingrix). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable.   Additional Information: GSK Receipt Date: 24-MAR-2025 Lead Medical Assistant called to report that one of the office nurses administered the liquid portion only of Shingrix on March 19th 2025 which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The reporter asked when the complete dose should be repeated.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix via IM; 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 patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix via IM ). 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: 24-MAR-2025 The reporter reported that the patient received the Priorix via Intramuscular route, which led to subcutaneous injection formulation administered by other route.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix was administered to a patient via intramuscular route; 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 patient who received MMR (Priorix) for prophylaxis.   On 22-MAR-2025, the patient received Priorix (intramuscular). On 22-MAR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: Priorix was administered to a patient via intramuscular route). 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: 24-MAR-2025 Priorix was administered to a patient via intramuscular route, which led subcutaneous injection formulation administered by other route.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got around to get the 2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine in March 2024).   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: never got around to get the 2nd dose). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 24-MAR-2025 On 24th March 2025, a physician had called on behalf of himself to inform about Shingrix. He had gotten his first dose a year ago in March 2024, but he had never gotten around to getting the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: when the vaccine (PRIORIX) was left in the freezer for a short period of time (twenty minutes) a dose was administered to a patient; 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 MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix. On an unknown date, an unknown time after receiving Priorix, the patient experienced incorrect storage of drug (Verbatim: when the vaccine (PRIORIX) was left in the freezer for a short period of time (twenty minutes) a dose was administered to a patient). 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: 24-MAR-2025 The Clinical Operations Manager needed stability data (general question) when the Priorix vaccine was left in the freezer for a short period of time (twenty minutes) a dose was administered to a patient which led to incorrect storage of drug. The Clinical Operations Manager did not know specifics on lowest temperature the vaccine reached.
Sex: M
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: received a dose of Priorix that had expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received MMR (Priorix) (batch number 447N4, expiry date 11-MAY-2024) for prophylaxis.   On 21-MAR-2025, the patient received Priorix. On 21-MAR-2025, an unknown time after receiving Priorix, the patient experienced expired vaccine used (Verbatim: received a dose of Priorix that had expired). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-MAR-2025 The nursing supervisor reported that a patient received a dose of Priorix that had expired, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: F
Vaccine: HEP, HEP
Symptoms: Incorrect dose administered
Clinical narrative: Engerix-B adult dose to 19-year-old; Engerix-B adult dose to 19-year-old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B) (batch number MD9SL, expiry date 08-DEC-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On 24-MAR-2025, the patient received the 2nd dose of Engerix B. On 21-FEB-2025, the patient received the 1st dose of Engerix B. On 21-FEB-2025, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: Engerix-B adult dose to 19-year-old). On 24-MAR-2025, the patient experienced overdose (Verbatim: Engerix-B adult dose to 19-year-old). The outcome of the overdose and overdose were not applicable.   Additional Information: GSK Receipt Date: 24-MAR-2025 The pharmacist called to report the adult dose 20mcg/1ml of Engerix-B was inadvertently administered to a 19-year-old patient for her first and second dose, which led to overdose. Suspect Vaccine Start Date was 2-21-2025.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 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 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 24M7E, expiry date 06-APR-2026) for prophylaxis.   Previously administered products included Shingrix (patient had First dose on January 3rd 2022 Lot number 9EY93, expiry date April 15th 2023 ).   On 11-NOV-2024, the patient received the 2nd dose of Shingrix. On 11-NOV-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 24-MAR-2025 Other HCP reported that a patient got first dose of Shingrix on January 3rd 2022 and a late second dose on November 11th 2024, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long)