chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Cerebrovascular accident, Herpes zoster, Laboratory test abnormal, Lumbar puncture abnormal
Clinical narrative: Suspected vaccination failure; Shingles/ Shingles entered the spine; stroke; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/ Shingles entered the spine) (serious criteria other: serious as per reporter) and stroke (Verbatim: stroke) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the shingles and stroke were resolving.   It was unknown if the reporter considered the vaccination failure, shingles and stroke to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, shingles and stroke to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 21-JUN-2025 This case was reported by a patient via interactive digital media. After both vaccines that the facility thought the patient needed, Shingles raised its ugly head. The blisters were few some on left elbow and left hand on the palm. The patient never had shingles before. A few days after, the patient couldn't remember driving home. A trip to the emergency room and they diagnosed a stroke after many tests and finally after a lumbar puncture it was seen that the shingles had entered the spine. The doctors said only 0.03% experiences this. The patient spent the next year in a wheelchair, then a walker and cane, today the patient could walk 2 miles a day. There was some progress and maybe 90% recovery. The Shingles was serious. This case was considered as suspected vaccination failure as details regarding time to onset for shingles was 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)  Herpes zoster and Cerebrovascular accident are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure, Walking aid user, Wheelchair user
Clinical narrative: Suspected vaccination failure; Shingles/ Shingles entered the spine; stroke; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles/ Shingles entered the spine) (serious criteria other: serious as per reporter) and stroke (Verbatim: stroke) (serious criteria GSK medically significant). The outcome of the vaccination failure was not reported and the outcome of the shingles and stroke were resolving.   It was unknown if the reporter considered the vaccination failure, shingles and stroke to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure, shingles and stroke to be unrelated to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 21-JUN-2025 This case was reported by a patient via interactive digital media. After both vaccines that the facility thought the patient needed, Shingles raised its ugly head. The blisters were few some on left elbow and left hand on the palm. The patient never had shingles before. A few days after, the patient couldn't remember driving home. A trip to the emergency room and they diagnosed a stroke after many tests and finally after a lumbar puncture it was seen that the shingles had entered the spine. The doctors said only 0.03% experiences this. The patient spent the next year in a wheelchair, then a walker and cane, today the patient could walk 2 miles a day. There was some progress and maybe 90% recovery. The Shingles was serious. This case was considered as suspected vaccination failure as details regarding time to onset for shingles was 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)  Herpes zoster and Cerebrovascular accident are unlisted events which are considered unrelated to GSK vaccine Shingles vaccine (dose 1 and 2)
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: suspected vaccination failure; developed shingles on the chest and stomach/went away in a couple of months; received the shingles shot at 60 and then at 62; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   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 vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: developed shingles on the chest and stomach/went away in a couple of months) and drug dose administration interval too long (Verbatim: received the shingles shot at 60 and then at 62). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved and the outcome of the drug dose administration interval too long was not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 23-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she had received the shingles shot at age 60 and again at 62, but he/she still developed shingles on his/her chest and stomach. Fortunately, it was mild, with no blisters, and the symptoms resolved within a couple of months. The patient received 2nd dose of Shingles vaccine, later than the recommended interval, which led to lengthening of vaccination schedule. This case was considered as suspected vaccination failure since the details regarding, 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, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles 3 years after my original shingles shot; 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, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles 3 years after my original shingles shot). 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: 21-JUN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got shingles three years after his/her original shingles shot. The patient mentioned that trust him/her not fun at all. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, 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 regarding completion of primary vaccine schedule, and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have had shingles twice after having the two shingles vaccines; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   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 vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I have had shingles twice after having the two shingles vaccines). 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 and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2025 This case was reported by a patient via interactive digital media. The patient has had shingles twice after having the two shingles vaccines. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 & 2).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; My dad got it 3 times received the vaccine; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles times).   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: My dad got it 3 times received the vaccine). 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: 22-JUN-2025 This case was reported by a consumer via interactive digital media. He received the vaccine but still got it again and it was even worse.  Stress was the number one culprit for bringing shingles on. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Eye irrigation, Occupational exposure to product
Clinical narrative: nurse that got the Shingrix vaccine in her eye while handling it; nurse that got the Shingrix vaccine in her eye while handling it; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of occupational exposure to product via eye in a female patient who received Herpes zoster (Shingrix) (batch number MG5S9, expiry date 30-MAR-2027) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced occupational exposure to product via eye (Verbatim: nurse that got the Shingrix vaccine in her eye while handling it) and inadvertent exposure to vaccine (Verbatim: nurse that got the Shingrix vaccine in her eye while handling it). The outcome of the occupational exposure to product via eye and inadvertent exposure to vaccine were not applicable.   Additional Information: GSK Receipt Date: 16-JUN-2025 and 17-JUN-2025 The Vaccine Administration Facility was the same as Primary Reporter On 16 June 2025, a pharmacist from Healthcare Center called to report the incident of a nurse that got the Shingrix vaccine in her eye while handling it which led to occupational exposure to product via eye and inadvertent exposure to vaccine. According to the health care provider, the nurse had already washed her eye with water, but he wanted to have an updated version of the Safety Data Sheet for Shingrix since they had an old version, and in consequence for knowing how to proceed in case of eye contact. The pharmacist got the information about the nurse and the vaccine and commented that she was feeling better after washing her eye with water.
Age: 57.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expire dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received HBV (Engerix B) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 16-JUN-2025, the patient received the 2nd dose of Engerix B. On 16-JUN-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Expire dose). 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: 17-JUN-2025 A patient was accidentally administered an expired dose of Engerix-B which led to expired vaccine use. So, the reporter contacted the CDC they said that they would have to repeat the dose. The reporter was trying to find out if there was a grey period between the expiration date and the date of administration, that it might still count. Also, this was the 2nd Engerix-B dose, the 1st was administered on 14th May 2025. The lot number that healthcare professional provided (PE9G5) was for the 2nd dose.
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: a shingles vaccine was given in 2019 and one today; 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 Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose in 2019).   On 17-JUN-2025, the patient received the 2nd dose of Shingles vaccine. On 17-JUN-2025, an unknown time after receiving Shingles vaccine, the patient experienced drug dose administration interval too long (Verbatim: a shingles vaccine was given in 2019 and one today). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 17-JUN-2025 The Licensed Practical Nurse contacted and mentioned product, enquired if a Shingles vaccine was given in 2019 and one today which led to lengthening of vaccination schedule. The reporter enquired if they need another one if it was 6 years between. No clarification was obtained in regard to the specific name of the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: received only the adjuvant of Shingrix as a first dose; received only the adjuvant of Shingrix as a first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: received only the adjuvant of Shingrix as a first dose) and inappropriate dose of vaccine administered (Verbatim: received only the adjuvant of Shingrix as a first dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 18-JUN-2025 The nurse reported that they may have accidentally administered only the adjuvant portion of the Shingrix vaccine to 1 out of 7 patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This had been the first dose of Shingrix for all seven patients. At the time, it was unclear whether any form of immunity screening or antibody titers specific to Shingrix were available.  It was also uncertain whether all seven patients would need to be revaccinated due to the possible administration of the adjuvant only. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: A patient could have potentially received only the adjuvant of Shingrix a as a first dose; A patient could have potentially received only the adjuvant of Shingrix a as a first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: A patient could have potentially received only the adjuvant of Shingrix a as a first dose) and inappropriate dose of vaccine administered (Verbatim: A patient could have potentially received only the adjuvant of Shingrix a as a first dose). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 18-JUN-2025 On 18th June 2025, an nurse called to report that they may have accidentally administered only the adjuvant portion of the Shingrix vaccine to 1 out of 7 patients, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. This had been the first dose of Shingrix for all seven patients. At the time, it was unclear whether any form of immunity screening or antibody titers specific to Shingrix were available.  It was also uncertain whether all seven patients would need to be revaccinated due to the possible administration of the adjuvant only. This was 1 of the 7 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076589:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: A patient could have potentially received only the adjuvant of Shingrix a as a first dose; A patient could have potentially received only the adjuvant of Shingrix a as a first dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 39H2S, expiry date 10-MAR-2027) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: A patient could have potentially received only the adjuvant of Shingrix a as a first dose) and inappropriate preparation of medication (Verbatim: A patient could have potentially received only the adjuvant of Shingrix a as a first dose). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable.   Additional Information: GSK receipt date: 18-JUN-2025 A nurse called to report that they accidentally could have administered only the adjuvant portion of Shingrix which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. This would be the first dose of Shingrix. Was there any immunity screening? Any titers test for Shingrix? Do we have to revaccinate all the 7 patients involved in this possible administration of the adjuvant only? This is 1 of the 7 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025076586:Same reporter/Diffrent patient US-GSK-US2025076585:Same reporter/Diffrent patient US-GSK-US2025076590:Same reporter/Diffrent patient US-GSK-US2025076593:Same reporter/Diffrent patient US-GSK-US2025076594:Same reporter/Diffrent patient US-GSK-US2025076598:Same reporter/Diffrent patient
Sex: M
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: A patient received a dose of Arexvy after a temperature excursion.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 88-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) 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: A patient received a dose of Arexvy after a temperature excursion.). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 18-JUN-2025 The pharmacist called to request information about the stability of Arexvy vaccines exposed to 70 degree Fahrenheit for 2 hours. No prior excursion reported. The healthcare professional wanted to know the stability information. The healthcare professional would like to know the recommendations after vaccinating two patients with Arexvy after this temperature excursion. The first patient who received the dose of Arexvy after a temperature excursion was an 88 years old male which led to incorrect storage of drug. This US2025076611 case reporter by same reporter.; Sender's Comments:  US-GSK-US2025076611:same reporter
Sex: F
Vaccine: RSV
Symptoms: Product storage error
Clinical narrative: A patient received a dose of Arexvy after a temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 87-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) 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: A patient received a dose of Arexvy after a temperature excursion). The outcome of the incorrect storage of drug was not applicable.   Additional Information: GSK Receipt Date: 18-JUN-2025 The pharmacist called to request information about the stability of Arexvy vaccines exposed to 70 deg F for 2 hours. No prior excursion reported. The healthcare professional wanted to know the stability information. The healthcare professional would like to know the recommendations after vaccinating patient with Arexvy after this temperature excursion which led to incorrect storage of drug. The second patient who received the dose of Arexvy after a temperature excursion was an 87 year old female.; Sender's Comments:  US-GSK-US2025076610:same reporter
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a dose of Kinrix out of the recommended age.; 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 3-year-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 21-JAN-2025, the patient received Kinrix. On 21-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age.). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUN-2025 The nurse reported that they administered a dose of Kinrix to 6 different patients under the age of 4 years old, which led to inappropriate age at vaccine administration.  The reporter said that did they need to continue with the same schedule as recommended in the package insert. This was 1 of 6 linked cases, reported by the same reporter.; Sender's Comments:  GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076587:Same reporter/Diffrent patient
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered a dose of Kinrix to 6 different patients under the age of 4 years old; 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 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 21-JAN-2025, the patient received Kinrix. On 21-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administered a dose of Kinrix to 6 different patients under the age of 4 years old). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUN-2025 The nurse reported that they administered a dose of Kinrix to 6 different patients under the age of 4 years old, which led to inappropriate age at vaccine administration.  The reporter said that did they need to continue with the same schedule as recommended in the package insert. This was 1 of 6 linked cases, reported by the same reporter.; Sender's Comments:  GSK-US2025076583:Same reporter/Diffrent patient US-GSK-US2025076587:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076592:Same reporter/Diffrent patient US-GSK-US2025076595:Same reporter/Diffrent patient
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received a dose of Kinrix out of the recommended age (patient is less than 4 years old); 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 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 21-JAN-2025, the patient received Kinrix. On 21-JAN-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old).). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUN-2025 The nurse reported that they administered a dose of Kinrix to 6 different patients under the age of 4 years old, which led to inappropriate age at vaccine administration.  The reporter said that did they need to continue with the same schedule as recommended in the package insert. This is 3 of 6 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076583:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076592:Same reporter/Diffrent patient US-GSK-US2025076595:Same reporter/Diffrent patient
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old).; 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 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 29-JUL-2024, the patient received Kinrix. On 29-JUL-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received a dose of Kinrix out of the recommended age (patient is less than 4 years old).). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUN-2025 The register nurse called to report that they administered a dose of Kinrix to 6 different patients under the age of 4 years old. The reporter asked that did they need to continue with the same schedule as recommended in the PI. The male patient was 3 years old now, he received Kinrix on 29th July 2024 which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2025076587:Same reporter/Diffrent patient US-GSK-US2025076584:Same reporter/Diffrent patient US-GSK-US2025076588:Same reporter/Diffrent patient US-GSK-US2025076592:Same reporter/Diffrent patient
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Pediarix Expired dose administered; 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 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number AC21B163BC, expiry date 06-OCT-2008) for prophylaxis.   On 28-OCT-2008, the patient received Pediarix. On 28-OCT-2008, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix Expired dose administered). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUN-2025 A medical assistant reported that the patient received an expired dose of Pediarix in 2008. The expiration date was 6th Oct 2008, and the vaccine was given on 28th Oct 2008 which led to Expired vaccine used. The medical assistant asked if this dose was considered valid.; Sender's Comments:  US-GSK-US2025076591:Same reporter/Diffrent patient
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: no titers after administration/zero immunity; This non-serious case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a female patient who received MMR (Priorix) for prophylaxis.   In APR-2025, the patient received Priorix (subcutaneous use). On an unknown date, an unknown time after receiving Priorix, the patient experienced therapy non-responder (Verbatim: no titers after administration/zero immunity). The outcome of the therapy non-responder 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-JUN-2025 The patient called to request information about Priorix and the development of titers after vaccination. The patient received a dose of the GlaxoSmithKline MMR vaccine (did not confirm it was Priorix but it was from GlaxoSmithKline), and after receiving the dose in late April 2025, no titers were developed (reported: zero immunity). The patient was unsure if any previous doses had been administered. A pharmacist recommended receiving another dose, checking titers again, and, if there was still no response, consulting with an immunologist. The vaccine administration facility was the same as the primary reporter.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 71-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "slightly anemic" (not ongoing); "used to be a smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, start date: 2025. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jun2025, outcome "recovering" and all described as "COVID". Clinical course: The patient had been diagnosed with COVID on 24Jun2025 and stated that about 3 to 5 years ago took the vaccinations with the booster. The patient had gotten better. On 24Jun2025 was probably the worst day, was miserable on 23Jun2025 night and 24Jun2025. He was doing better on 25Jun2025. The patient took within the last couple of days codeine, Tylenol and a nasal spray called fluticasone propionate with no issue. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500129432 Same Pt/Vaccine, Diff Dose/AE;
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: vaccine administered to patient after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) with no reported ae; Initial information received on 24-Jun-2025 regarding an unsolicited valid non-serious case received from Nurse.  This case involves an unknown age and unknown gender patient where IPV (VERO) [IPOL] vaccine was administered to patient after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, vaccine was administered to patient with 0.5 ml 1x (once) dose of suspect IPV (VERO) Suspension for injection lot number not reported via unknown route in unknown administration site (strength, lot/batch number and expiration date: not provided) for immunization after excursion of max temperature reached: 9.3 degrees celsius for 1 hour 5 minutes, then 8.2 degrees celsius for 3 minutes (1 hour 8 minutes) with no reported ae (poor quality product administered) (latency- same day).  Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  Action taken- not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: PNC20, TD, VARZOS
Symptoms: Purpura, Rash
Clinical narrative: Purpuric rash bilateral LE and abdomen. Diagnosed at ED, no notes available for review at time of this submission. Received prednisone and hydroxyzine at ED and symptoms resolved after about 1 week.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autonomic nervous system imbalance, Blindness transient, Blood test, Bradycardia, COVID-19
Clinical narrative: 4-13-21; Driven home from work with lightheadedness; 6-03-21: DVT's right leg; 8-05-21: Driven home from work with lightheadedness, near syncope; 8-10-21: Driven to hospital from work with lightheadedness, near syncope. Overnight in hospital--tachycardia.  Through 2022: Continued issues with lightheadedness, transient visual obscuration (TVO's), and unexplained autonomic dysfunction; 5-25-22 Failed Tilt Table Test- POTS diagnosis; 5-25-22: FIRST COVID DIAGNOSIS; 10-13-22: Ambulance from work--1st Vertigo Attack.  After serveral months, diagnosed with Meniere's Disease.  Continues to-date with these issues including Bradychardia, fatigue.  Latest revised diagnosis related to autonomic dysfunction is, "Veso Depressor Syncope"
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Chest X-ray, Computerised tomogram head, Computerised tomogram thorax, Deep vein thrombosis
Clinical narrative: 4-13-21; Driven home from work with lightheadedness; 6-03-21: DVT's right leg; 8-05-21: Driven home from work with lightheadedness, near syncope; 8-10-21: Driven to hospital from work with lightheadedness, near syncope. Overnight in hospital--tachycardia.  Through 2022: Continued issues with lightheadedness, transient visual obscuration (TVO's), and unexplained autonomic dysfunction; 5-25-22 Failed Tilt Table Test- POTS diagnosis; 5-25-22: FIRST COVID DIAGNOSIS; 10-13-22: Ambulance from work--1st Vertigo Attack.  After serveral months, diagnosed with Meniere's Disease.  Continues to-date with these issues including Bradychardia, fatigue.  Latest revised diagnosis related to autonomic dysfunction is, "Veso Depressor Syncope"
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Electrocochleogram
Clinical narrative: 4-13-21; Driven home from work with lightheadedness; 6-03-21: DVT's right leg; 8-05-21: Driven home from work with lightheadedness, near syncope; 8-10-21: Driven to hospital from work with lightheadedness, near syncope. Overnight in hospital--tachycardia.  Through 2022: Continued issues with lightheadedness, transient visual obscuration (TVO's), and unexplained autonomic dysfunction; 5-25-22 Failed Tilt Table Test- POTS diagnosis; 5-25-22: FIRST COVID DIAGNOSIS; 10-13-22: Ambulance from work--1st Vertigo Attack.  After serveral months, diagnosed with Meniere's Disease.  Continues to-date with these issues including Bradychardia, fatigue.  Latest revised diagnosis related to autonomic dysfunction is, "Veso Depressor Syncope"
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram, Fatigue, Magnetic resonance imaging head, Meniere's disease, Postural orthostatic tachycardia syndrome
Clinical narrative: 4-13-21; Driven home from work with lightheadedness; 6-03-21: DVT's right leg; 8-05-21: Driven home from work with lightheadedness, near syncope; 8-10-21: Driven to hospital from work with lightheadedness, near syncope. Overnight in hospital--tachycardia.  Through 2022: Continued issues with lightheadedness, transient visual obscuration (TVO's), and unexplained autonomic dysfunction; 5-25-22 Failed Tilt Table Test- POTS diagnosis; 5-25-22: FIRST COVID DIAGNOSIS; 10-13-22: Ambulance from work--1st Vertigo Attack.  After serveral months, diagnosed with Meniere's Disease.  Continues to-date with these issues including Bradychardia, fatigue.  Latest revised diagnosis related to autonomic dysfunction is, "Veso Depressor Syncope"
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Syncope, Tachycardia, Tilt table test positive, Ultrasound Doppler
Clinical narrative: 4-13-21; Driven home from work with lightheadedness; 6-03-21: DVT's right leg; 8-05-21: Driven home from work with lightheadedness, near syncope; 8-10-21: Driven to hospital from work with lightheadedness, near syncope. Overnight in hospital--tachycardia.  Through 2022: Continued issues with lightheadedness, transient visual obscuration (TVO's), and unexplained autonomic dysfunction; 5-25-22 Failed Tilt Table Test- POTS diagnosis; 5-25-22: FIRST COVID DIAGNOSIS; 10-13-22: Ambulance from work--1st Vertigo Attack.  After serveral months, diagnosed with Meniere's Disease.  Continues to-date with these issues including Bradychardia, fatigue.  Latest revised diagnosis related to autonomic dysfunction is, "Veso Depressor Syncope"
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: 4-13-21; Driven home from work with lightheadedness; 6-03-21: DVT's right leg; 8-05-21: Driven home from work with lightheadedness, near syncope; 8-10-21: Driven to hospital from work with lightheadedness, near syncope. Overnight in hospital--tachycardia.  Through 2022: Continued issues with lightheadedness, transient visual obscuration (TVO's), and unexplained autonomic dysfunction; 5-25-22 Failed Tilt Table Test- POTS diagnosis; 5-25-22: FIRST COVID DIAGNOSIS; 10-13-22: Ambulance from work--1st Vertigo Attack.  After serveral months, diagnosed with Meniere's Disease.  Continues to-date with these issues including Bradychardia, fatigue.  Latest revised diagnosis related to autonomic dysfunction is, "Veso Depressor Syncope"
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction
Clinical narrative: Patient presents with mother to the facility this date following a vaccine reaction given by Public Health on 06/25/2025. Mother reports onset of symptoms occurred last night, 06/26/2025 to include temperature of 100.1, erythema, and edema to the left upper extremity extending mid upper arm.  Examination unremarkable with the exception of a flat, reddened rash and mild- moderate edema localize to the left upper extremity, starting at superior aspect of extremity extending to mid upper extremity. Injection site raised, measuring approximately 10mm x 8mm with erythema, edema, warmth and tenderness to touch. Otherwise, general appearance normal. Patient/mother instructed to continue with children's Tylenol and ibuprofen as directed on packaging. To apply cold compress to affected area five times per day x 10 minutes as needed. May also use children's Benadryl as directed on packaging. Discussed red flag symptoms in which to present to nearest ER. Reassured mother of localized allergic reaction, who stated patient's left upper arm is already getting better, that this is likely a delayed onset reaction, not uncommon, and the fact that it is already improving is a good sign. Informed her vaccinate benefits still outweighs risk. Informed mother reaction site should continue getting better and be resolved within the next week or so. Otherwise, she is to return to either location of administration or the facility.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injection site swelling, Rash macular
Clinical narrative: Patient presents with mother to the facility this date following a vaccine reaction given by Public Health on 06/25/2025. Mother reports onset of symptoms occurred last night, 06/26/2025 to include temperature of 100.1, erythema, and edema to the left upper extremity extending mid upper arm.  Examination unremarkable with the exception of a flat, reddened rash and mild- moderate edema localize to the left upper extremity, starting at superior aspect of extremity extending to mid upper extremity. Injection site raised, measuring approximately 10mm x 8mm with erythema, edema, warmth and tenderness to touch. Otherwise, general appearance normal. Patient/mother instructed to continue with children's Tylenol and ibuprofen as directed on packaging. To apply cold compress to affected area five times per day x 10 minutes as needed. May also use children's Benadryl as directed on packaging. Discussed red flag symptoms in which to present to nearest ER. Reassured mother of localized allergic reaction, who stated patient's left upper arm is already getting better, that this is likely a delayed onset reaction, not uncommon, and the fact that it is already improving is a good sign. Informed her vaccinate benefits still outweighs risk. Informed mother reaction site should continue getting better and be resolved within the next week or so. Otherwise, she is to return to either location of administration or the facility.