chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure, Zoster sine herpete
Clinical narrative: Suspected vaccination failure; recently developed internal shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, several years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and zoster sine herpete (Verbatim: recently developed internal shingles). The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was not resolved.   It was unknown if the reporter considered the vaccination failure and zoster sine herpete to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the zoster sine herpete to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2025 The patient had the multi dose at some point in time but have recently developed internal shingles. The got both doses of Shingrix probably 7 or more years ago and was right now dealing with internal shingles. So the patient wanted to know if the efficacy of the vaccine ran out in that 7 or so years so should she get another round of Shingrix. The patient also wanted to know if a booster dose/third dose required with Shingrix. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix (1st dose)and Shingrix(2nd dose).
Vaccine: RVX
Symptoms: Respiratory syncytial virus infection, Vaccination failure
Clinical narrative: Suspected vaccination failure; had the injection and still caught RSV; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and respiratory syncytial virus infection (Verbatim: had the injection and still caught RSV). The outcome of the vaccination failure and respiratory syncytial virus infection were not reported.   It was unknown if the reporter considered the vaccination failure and respiratory syncytial virus infection to be related to RSV vaccine.     The company considered the vaccination failure to be unrelated to RSV vaccine. It was unknown if the company considered the respiratory syncytial virus infection to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the injection and still caught respiratory syncytial virus infection. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for respiratory syncytial virus infection and laboratory confirmation regarding respiratory syncytial virus infection were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine RSV vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: within 10 days got Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 10 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: within 10 days got Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date : 15-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had a friend who got the vaccine and within 10 days got Shingles. Read up on it.  1 out 10 could develop Shingles after the vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; friend who get their shingles shots and still get the 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: friend who get their shingles shots and still get the shingles). 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: 15-MAY-2025 This case was reported by a patient's friend via interactive digital media. The reporter knew a friend (patient) who got their Shingles shots and still got the shingles and said so asked why to take it. 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 vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles very badly; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 very badly). 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: 13-MAY-2025 The reporter know several people that still broke out with shingles very badly that got the vaccine so did not said if get the vaccine would not get shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAY-2025 This case was reported by a patient via interactive digital media. The patient had the 1st vaccination and got shingles, it was a horrible nightmare.
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like side effects; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included facial droop (was in the hospital for a week in January) and watering eyes. Additional patient notes included sagging left side of mouth.   On 14-MAY-2025, the patient received the 1st dose of Shingles vaccine. In MAY-2025, less than a week after receiving Shingles vaccine, the patient experienced influenza like illness (Verbatim: flu like side effects). The outcome of the influenza like illness was not resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.     It was unknown if the company considered the influenza like illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2025 This case was reported by a patient via interactive digital media. Patient got the first vaccine shot and was having some flu-like side effects.
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: am suffering with my second outbreak /both arms and left hip/ Some on my neck and under my chin; 1st was last September/ Then was right arm; Suspected vaccination failure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In SEP-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: 1st was last September/ Then was right arm). On an unknown date, the patient experienced shingles (Verbatim: am suffering with my second outbreak /both arms and left hip/ Some on my neck and under my chin). The outcome of the vaccination failure and shingles were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles 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 and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAY-2025 This case was reported by a patient via interactive digital media. The patient stated he/she also been vaccinated and was suffering with second outbreak.  The patient had 1st in last September and then was right arm.  The patient stated this time both arms and left hip and some on neck and under chin.  The patient stated it was miserable and he/she will be 80 in a couple of weeks. The patient stated it was not the way wanted to celebrate his/her birthday This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria ((insufficient information provided about   primary vaccination schedule,  time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 53-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (Sister got shingles at 49).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAY-2025 This case was reported by a patient via interactive digital media. The patient made his/her appointment and got both shots of Shingles vaccine and had just a sore arm. The patient reported he/she glad to had vaccine, if he/she get it would be mild.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: got my first shingrix vaccine in 2023.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2023).   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: got my first shingrix vaccine in 2023.). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 13-MAY-2025 The patient got his/her first dose of Shingrix vaccine in 2023. The patient had a questioned should he/she still get the second dose even though it had been two years later. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix; a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number AK334, expiry date 14-JUN-2027) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 30-APR-2025, the patient received the 1st dose of Boostrix. On an unknown date, the patient received Infanrix. On 30-APR-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix) and inappropriate age at vaccine administration (Verbatim: a vaccine given to a 2 years old, it was the Boostrix instead of the infanrix). 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: 01-MAY-2025 Registered Nurse reported that yesterday, there was a vaccine given to a 2 years old, it was the Boostrix instead of the Infanrix, which led to Wrong vaccine administered and Inappropriate age at vaccine administration. And reporter was just wanting to see if there are any adverse reactions or anything that need to do on our end besides the incident report. The reporter Consented to follow up. HCP stated that the 2 years old patient was supposed to receive the 4th dose of Infanrix.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: they did not get their 2nd one; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrox (received first dose on 20-FEB-2025).   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: they did not get their 2nd one). 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: 05-MAY-2025 Reporter stated that one of their patients got Twinrix on 20-FEB-2025, but they did not get their 2nd one, they were just wondering if they have to restart the series over or just to the 2nd one now. Till the time of reporting the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Injection site reaction
Clinical narrative: topical reaction at the site of the injection; A 64 years old female patient received an extra dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of vaccine on 30th April 2019) and Shingrix (received 2nd dose of vaccine on 20th July 2019).   On 13-FEB-2025, the patient received the 3rd dose of Shingrix. On 13-FEB-2025, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: A 64 years old female patient received an extra dose of Shingrix). On an unknown date, the patient experienced injection site reaction (Verbatim: topical reaction at the site of the injection). The outcome of the injection site reaction was resolved and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.     It was unknown if the company considered the injection site reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAY-2025 On 6th May 2025, a pharmacist called to report that a 64 year old female patient had received an extra dose of Shingrix by mistake.  The first dose had been administered on 30th April 2019, followed by the second dose on 20th July 2019.  On 13th February 2025, a third dose had mistakenly been given, which led to Extra dose administered. The patient had experienced a reaction and had visited her medical provider, who had pulled some titers tests and reviewed her medical records.  A medical professional had identified a topical reaction at the injection site.  The patient was not immunocompromised.  The pharmacist stated that the patient was fine.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not gotten a second dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   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: has not gotten a second dose of Shingrix). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK Receipt Date: 06-MAY-2025 The physician reported that if a patient went beyond 6 months and has not gotten a second dose of Shingrix does the patient start the 2 dose series over again or just get the second shot even if it is past 6 months. No further details available. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: left leg was numb from the knee down to the toes; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of numbness of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (Nothing happened after Shingrix first dose).   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 numbness of extremities (Verbatim: left leg was numb from the knee down to the toes). The outcome of the numbness of extremities was resolved (duration 6 months).   It was unknown if the reporter considered the numbness of extremities to be related to Shingrix.     It was unknown if the company considered the numbness of extremities to be related to Shingrix.   Additional Information: GSK receipt date: 06-MAY-2025 Physician reported that after Shingrix second dose, her left leg was numb from the knee down to the toes for 6 months. Also indicated that nothing happened after Shingrix first dose.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Potential inappropriate schedule.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 41-year-old male patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B (patient received a dose of Hep B vaccine back in 1998).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: Potential inappropriate schedule.). The outcome of the incomplete course of vaccination was not applicable.   Additional Information: GSK receipt date: 07-MAY-2025 Other HCP reported that a patient received a dose of Hepatitis B vaccine back in 1998 and never got another one to complete the series, which led to incomplete course of vaccination. Reporter did not know which was the brand name of such Hepatitis B vaccine, so they didn't know if it was Engerix B or not. No more details were given by reporter. Did not consent to follow-up.
Sex: F
Vaccine: MENB, MENB
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Bexsero possible out of the recommended age administration; received another dose on 24 AUG 2024; she was administered BEXSERO on 23 JUN 2023; This non-serious case was reported by a consumer via sales rep and described the occurrence of product prescribing error in a 71-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy (her spleen was removed in June 2023).   On 23-JUN-2023, the patient received the 1st dose of Bexsero. On 24-AUG-2024, the patient received the 2nd dose of Bexsero. On 23-JUN-2023, an unknown time after receiving Bexsero and not applicable after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: she was administered BEXSERO on 23 JUN 2023). On 24-AUG-2024, the patient experienced inappropriate age at vaccine administration (Verbatim: received another dose on 24 AUG 2024). On an unknown date, the patient experienced product prescribing error (Verbatim: Bexsero possible out of the recommended age administration). The outcome of the product prescribing error, inappropriate age at vaccine administration 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: 07-MAY-2025 Physician prescribed Bexsero every two years, but when she went to the pharmacy, she was denied the vaccine (given that she was over 25 years old, above the upper age limit recommended in the vaccine's prescribing information). The patient went to the hospital for an injury and received two vaccines (at different times) before going to the pharmacy to try to get Bexsero. Unfortunately, the Medical Information agent's call was disconnected and he was unable to confirm if either of those two vaccines was Bexsero. Also stated that she was in an accident and her spleen was removed in June 2023. Consumer stated she was administered Bexsero on 23 June 2023 and received another dose on 24 August 2024, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: a patient was administered only the adjuvant portion or Shingrix; a patient was administered only the adjuvant portion or Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 92NN2, expiry date 30-MAR-2027) for prophylaxis.   On 30-APR-2025, the patient received the 1st dose of Shingrix. On 30-APR-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: a patient was administered only the adjuvant portion or Shingrix) and inappropriate dose of vaccine administered (Verbatim: a patient was administered only the adjuvant portion or Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 08-MAY-2025 The pharmacist reported that a patient was administered only the adjuvant portion or Shingrix (without reconstitution) which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Previous vaccination schedule was being used after October 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in unspecified number of patients 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 inappropriate schedule of vaccine administered (Verbatim: Previous vaccination schedule was being used after October 2024). The outcome of the inappropriate schedule of 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: 09-MAY-2025 The Vaccine Administration Facility was the same as Primary Reporter. A medical assistant called in to request data about the vaccination series and different changes that had been done to the schedule.  They mentioned that they were receiving lots with the previous Prescribing information.  They mentioned that every pediatric patient from October 24th, 2024 onward until today had received the previous schedule, without specifying number, age, gender or status which led to inappropriate schedule of vaccine administered. The reporter declined any type of follow up.
Sex: F
Vaccine: TDAP
Symptoms: Interchange of vaccine products, Product administered to patient of inappropriate age
Clinical narrative: Unapproved age; Interchange of vaccines; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9532Y, expiry date 23-MAY-2025) for prophylaxis.   Previously administered products included adacel (received her four doses at 9th, 18th, 16th months and 26th months).   On an unknown date, the patient received the 1st dose of Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Unapproved age) and interchange of vaccine products (Verbatim: Interchange of vaccines). The outcome of the inappropriate age at vaccine administration and interchange of vaccine products were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-MAY-2025 Reporter stated that a child five years old, was seen at children's for her last erasion, she was in line with her immunizations.  However, when she went to the hospital this last erasion, they decided to give her a tdap, she is five, she got the tdap which was Adacel. So, apparently, while they were there, the provider decided that child needed the tdap shot, because they had four shots but not a fifth of her dtap.  They wanted to know if they need to perform another dtap, if they have already an adult tdap that was given, given that the child already received her four others at 9th, 18th, 16th months and 26th months and they turned around and gave her this tdap, in this past year. Also wanted to know if she is covered then given the amount in this vaccine, is it appropriate dosing or do they need to give her another dtap or what. She actually had, those previous four doses, were pentacels. The patient received Boostrix at the age of 5 years after four doses of Adacel, which led to interchange of vaccine products and inappropriate age at vaccine administration.
Age: 51.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received a 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 51-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose of Twinrix vaccine on unknown date 6 months prior).   On 12-MAY-2025, the patient received the 2nd dose of Twinrix. On 12-MAY-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received a 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: 12-MAY-2025 A pharmacist wanted to know if he should give a third dose of Twinrix or restart the series after a patient received a late second dose (6 months after the first dose was given) which led to drug dose administration interval too long. The reporter did not consent to follow-up.
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Admin. after below 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 DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, Herpes zoster (Shingrix) for prophylaxis and RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In APR-2025, the patient received Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy. In APR-2025, an unknown time after receiving Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy and an unknown time after receiving Pediarix, Infanrix, Havrix, Engerix B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy, the patient experienced incorrect storage of drug (Verbatim: Admin. after below temperature excursion). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-MAY-2025 On 12th May 2025 a Clinic manager/AMAS called to report a temperature excursion for Pediarix, Infanrix, Havrix, Engerix-B, Menveo, Bexsero, Boostrix, Kinrix, Shingrix and Arexvy. Healthcare professional reported that since 07th April 2025 the vaccines were exposed to below recommended temperatures, and on 29th April 2025 the products were exposed to a minimum temperature of 29.9 °F which led to incorrect storage of drug. Healthcare professional asked that so patients that had been vaccinated during those excursions, during that time frame, do they need to be revaccinated? or what's the protocol for that? During the call, Healthcare professional did not share any patient information, she said that at the moment of the call, she did not have any information due to the situation, they add the list of all the vaccines, but they don't have the details of which patients received which vaccine.
Sex: M
Vaccine: MMR
Symptoms: Product preparation issue
Clinical narrative: Priorix administration of only the diluent portion; Priorix administration of only the diluent portion; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 45-year-old male patient who received MMR (Priorix) (batch number 2JX7Y, expiry date 01-JUN-2026) for prophylaxis.   On 13-MAY-2025, the patient received Priorix. On 13-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate preparation of medication (Verbatim: Priorix administration of only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: Priorix administration of only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine 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: 13-MAY-2025 A nurse called to report that a patient was given only the diluent portion of the Priorix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administration. The nurse asked for safety information concerning this situation.
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was given one year after the first one; This non-serious case was reported by a nurse via call center representative 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 of Bexsero vaccine a year ago).   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: second dose was given one year after the first one). 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: 14-MAY-2025 A registered nurse wanted to know how much time could pass between the first and second dose of Bexsero that keeps valid the administration.  Information found in the prescribing information was given regarding the two and three-dose schedule administration.  Then, the health care provider asked if it would be valid if the second dose was given one year after the first one.  The agent asked if one or more patients received the second dose in this condition, to which the health care provider responded it maybe 2 or 3 patients around 18 years old but did not have any data from them nor from the vaccines used. The Vaccine Administration Facility is the same as Primary Reporter. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Sex: M
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number DL32D) and (batch number 44TR9) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached.). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 The nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion of 29.9 degree Fahrenheit as the lowest reached for Arexvy which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 39LB7) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-MAY-2025 Nurse asked the recommendations after giving Boostrix vaccine that was exposed to a below temperature excursion of 29.9°F as the lowest reached, which led to incorrect storage of drug. This is one of the three linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025061548:SAME REPORTER US-GSK-US2025061546:Same reporter,Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Administration after a below temperature excursion of 29.9°F as the minimum reached; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a male patient who received Herpes zoster (Shingrix) (batch number M7G39) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Administration after a below temperature excursion of 29.9°F as the minimum reached). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 Nurse asked the recommendations after giving Shingrix vaccine that was exposed to a below temperature excursion, which led to incorrect storage of drug. This is one of the three linked cases reported by the same reporter.; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: pediatric dose of the Havrix vaccine was given to an adult; pediatric dose of the Havrix vaccine was given to an 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 42-year-old female patient who received HAV (Havrix pediatric) (batch number G79C4, expiry date 20-SEP-2025) for prophylaxis.   On 15-APR-2025, the patient received Havrix pediatric. On 15-APR-2025, an unknown time after receiving Havrix pediatric, the patient experienced adult use of a child product (Verbatim: pediatric dose of the Havrix vaccine was given to an adult) and underdose (Verbatim: pediatric dose of the Havrix vaccine was given to an adult). The outcome of the adult use of a child product and underdose were not applicable.   Additional Information: GSK Receipt Date: 15-MAY-2025 Nurse reported that a pediatric dose of the Havrix vaccine was given to an adult patient, which led to adult use of child product and underdose.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Hypersomnia, Malaise
Clinical narrative: fever; shakings chills; upset stomach; crushing headache; arm soaring; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 7ZM55, expiry date 15-NOV-2026) for prophylaxis.   On 02-MAY-2025, the patient received Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever), chills (Verbatim: shakings chills), upset stomach (Verbatim: upset stomach), headache (Verbatim: crushing headache) and pain in arm (Verbatim: arm soaring). The outcome of the fever, chills, upset stomach, headache and pain in arm were not reported.   It was unknown if the reporter considered the fever, chills, upset stomach, headache and pain in arm to be related to Shingrix.     It was unknown if the company considered the fever, chills, upset stomach, headache and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter reported on 15th May 2025, a 53 years old female patient called to report that her pharmacy called her stating that the lot of Shingrix she received may or not may be good so she needed to start again the dosing and receive two more shots.  Patient mentioned that she got really sick after getting the dose of Shingrix on 2nd May 2025, like really sick.  Patient was upset about it and experienced fever, shakings chills, upset stomach, she did not vomited but she wanted to, and crushing headache, arm soaring, she slept for 2 days because she was sick. Patient asked how did you know that the vaccine was works, that if it was good or not.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; shakings chills; upset stomach; crushing headache; arm soaring; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 7ZM55, expiry date 15-NOV-2026) for prophylaxis.   On 02-MAY-2025, the patient received Shingrix. In MAY-2025, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever), chills (Verbatim: shakings chills), upset stomach (Verbatim: upset stomach), headache (Verbatim: crushing headache) and pain in arm (Verbatim: arm soaring). The outcome of the fever, chills, upset stomach, headache and pain in arm were not reported.   It was unknown if the reporter considered the fever, chills, upset stomach, headache and pain in arm to be related to Shingrix.     It was unknown if the company considered the fever, chills, upset stomach, headache and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2025 The reporter reported on 15th May 2025, a 53 years old female patient called to report that her pharmacy called her stating that the lot of Shingrix she received may or not may be good so she needed to start again the dosing and receive two more shots.  Patient mentioned that she got really sick after getting the dose of Shingrix on 2nd May 2025, like really sick.  Patient was upset about it and experienced fever, shakings chills, upset stomach, she did not vomited but she wanted to, and crushing headache, arm soaring, she slept for 2 days because she was sick. Patient asked how did you know that the vaccine was works, that if it was good or not.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect product administration duration
Clinical narrative: Havrix - Delayed second dose.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug administration duration too long in a 60-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received 1st dose in 2009).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced drug administration duration too long (Verbatim: Havrix - Delayed second dose.). The outcome of the drug administration duration 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: 16-MAY-2025 The pharmacist mentioned that a patient received the first Havrix vaccine in 2009 and then a second dose of Havrix in 2023. The Healthcare professional asked if the patient should received extra doses. The patient received 2nd dose of Havrix, later than the recommended interval, which led to lengthening of vaccinations schedule.