chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Extra dose administered, Herpes zoster, Inappropriate schedule of product administration, Vaccination failure
Clinical narrative: Suspected vaccination failure; still get them; I had the first shot years ago; just got the 2 new ones last year; 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 and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still get them), drug dose administration interval too long (Verbatim: I had the first shot years ago) and extra dose administered (Verbatim: just got the 2 new ones last year). The outcome of the vaccination failure and shingles were not reported and the outcome of the drug dose administration interval too long and extra dose administered were not applicable.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine, Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date :22-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had the first shot years ago and just got the 2 new ones last year and still get them which led to extra dose administered. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. 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. Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 50.0
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles currently for the 2nd time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 15 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 5 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles currently for the 2nd time). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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: 21-MAY-2025 This case was reported by a patient via interactive digital media. Patient had shingles for the 2nd time and first time was about 15 years ago.  Patient was 50 then, had both vaccines 5 years ago. Also state that it was very painful. 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   laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles (1st dose)and Shingles(2nd dose)
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: my mother have muscle pain in the arm for a month and a half since the vaccine was given.Muscle pain since vaccine administration one month ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2025, the patient received Shingrix. In APR-2025, an unknown time after receiving Shingrix, the patient experienced muscle pain (Verbatim: my mother have muscle pain in the arm for a month and a half since the vaccine was given.Muscle pain since vaccine administration one month ago). The outcome of the muscle pain was not resolved.   It was unknown if the reporter considered the muscle pain to be related to Shingrix.     It was unknown if the company considered the muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2025 The patient had muscle pain in the arm for a month and a half since the vaccine was given one month ago.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspeceted vaccination failure; I got shingles after the Shingrix vaccines; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspeceted vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got shingles after the Shingrix 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 Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 23-MAY-2025 This case was reported by a patient via interactive digital media. The patient reported that she got shingles after the administration of Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine 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  Shingrix.
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: far just very sore arm; fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of adverse event (received 1st dose of vaccine on an unknown date and had terrible reaction).   On 23-MAY-2025, the patient received the 2nd dose of Shingles vaccine. In MAY-2025, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: far just very sore arm) and fatigue (Verbatim: fatigue). The outcome of the pain in arm and fatigue were not reported.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and fatigue to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-MAY-2025 This case was reported by a patient via interactive digital media. Patient had a terrible reaction to the first dose.  He/she received the second dose that day (date of reporting).  He/she experienced a very sore arm and fatigue. Hoped that this one would not be as severe. The important thing was that it was done.
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: shingles vaccine made me pretty sick for 2-3 days after; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included COVID-19 VACCINE.   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 sickness (Verbatim: shingles vaccine made me pretty sick for 2-3 days after). The outcome of the sickness was resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-MAY-2025 This case was reported by a patient via interactive digital media. Reporter reported that everybody reacts differently to drugs and vaccines.  Covid vaccines did not make him/her felt a thing but both doses of the shingles vaccine made him/her pretty sick for 2-3 days after.  It was still worth it because shingles could be really terrible and last a long time (like a year for some people).
Sex: M
Vaccine: MNQ
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 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVBO44A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, 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 and 16-MAY-2025 A registered nurse asked the recommendations after giving several vaccines that were exposed to a below temperature excursion reported in case of 29.9 degree Fahrenheits as the lowest reached for following product Menveo, which led to incorrect storage of drug. The vaccine administration facility was the same as primary reporter. No expiration date was given for the vaccines nor date of administration. This is one of 5 linked cases reported by same reporter.; Sender's Comments:  US-GSK-US2025061548:Same reporter,Different patient US-GSK-US2025061546:Same reporter,Different patient US-GSK-US2025061545:Same reporter,Different patient US-GSK-US2025061564:Same reporter,Different patient US-GSK-US2025061538:Same reporter,Different patient
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash, Rash pruritic, Scab
Clinical narrative: Suspected vaccination failure; Shingles; driving me out of my mind; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included dry skin (history of (moderate) dry skin).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feeling abnormal (Verbatim: driving me out of my mind). The outcome of the vaccination failure and feeling abnormal were not reported and the outcome of the shingles was resolving.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling abnormal to be related to Shingrix and Shingrix.     The company considered the vaccination failure, shingles and feeling abnormal to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2025 and 16-MAY-2025 The patient self reported this case for himself Patient does not remember having chicken pox (as a child). Reporter thought he might have had a possible after effect from the shingles shot.  he had a rash that he had been getting off and on since he had received the shingles shot. The reporter had received the Shingrix shot 1 and shot 2.  He did not know the dates or lot numbers of the injections.  About a month or so after receiving the second shot, he went to see his physician for a rash on his left leg.  His doctor diagnosed it as shingles.  When he first saw the physician, there had been about a dozen spots.  About 3 to 5 spots remained.  The spots were itchy and felt a bit scabby. He had also experienced fluid filled blisters on his left butt cheek, which had been driving him out of his mind.  He said that the blisters had been somewhat similar to what he had on his leg.  Additionally, he had developed a rash on the top of his head that he had never had before.  He had been seeing a dermatologist and had been using 3 to 4 unspecified creams and salves, as well as taking showers with liquid soap, but the event had not resolved. This case was considered as suspected vaccination failure as details 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster and Feeling abnormal are unlisted events which are considered unrelated to GSK Shingrix.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Stress, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; driving me out of my mind; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included dry skin (history of (moderate) dry skin).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feeling abnormal (Verbatim: driving me out of my mind). The outcome of the vaccination failure and feeling abnormal were not reported and the outcome of the shingles was resolving.   The reporter considered the vaccination failure and shingles to be possibly related to Shingrix and Shingrix. It was unknown if the reporter considered the feeling abnormal to be related to Shingrix and Shingrix.     The company considered the vaccination failure, shingles and feeling abnormal to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 15-MAY-2025 and 16-MAY-2025 The patient self reported this case for himself Patient does not remember having chicken pox (as a child). Reporter thought he might have had a possible after effect from the shingles shot.  he had a rash that he had been getting off and on since he had received the shingles shot. The reporter had received the Shingrix shot 1 and shot 2.  He did not know the dates or lot numbers of the injections.  About a month or so after receiving the second shot, he went to see his physician for a rash on his left leg.  His doctor diagnosed it as shingles.  When he first saw the physician, there had been about a dozen spots.  About 3 to 5 spots remained.  The spots were itchy and felt a bit scabby. He had also experienced fluid filled blisters on his left butt cheek, which had been driving him out of his mind.  He said that the blisters had been somewhat similar to what he had on his leg.  Additionally, he had developed a rash on the top of his head that he had never had before.  He had been seeing a dermatologist and had been using 3 to 4 unspecified creams and salves, as well as taking showers with liquid soap, but the event had not resolved. This case was considered as suspected vaccination failure as details 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 and laboratory confirmation of disease) is considered unrelated to GSK Shingrix. Herpes zoster and Feeling abnormal are unlisted events which are considered unrelated to GSK Shingrix.
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: but we are missing two of these sterile saline diluents; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: but we are missing two of these sterile saline diluents). The outcome of the wrong solution used in drug reconstitution was not applicable.   Additional Information: GSK Receipt Date :21-MAY-2025 Nurse reported that they had the Hiberix vaccine at their clinic and they had an issue with an sterile diluent what, they did not know if it filled out of the container but they were missing two of these sterile saline diluents and unfortunately, they did not want to waste these two doses of the lyophilized vaccine and just wondered if they were able to use a regular sterile saline that they had in vials, in replacement of the sterile saline that comes with the hiberix vaccine which led to Wrong solution used in drug reconstitution.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix - Administration of only the adjuvant component; patient received only the adjuvant portion of Shingrix without the lyophilized component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 47N3Y, expiry date 30-MAR-2027) for prophylaxis.   On 21-MAY-2025, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix - Administration of only the adjuvant component) and inappropriate dose of vaccine administered (Verbatim: patient received only the adjuvant portion of Shingrix without the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 21-MAY-2025 A pharmacist reported that a patient received only the adjuvant portion of Shingrix without the lyophilized component.  The pharmacist asked if they could reconstitute the powder with a different diluent such as sterile water and then administered this solution to the patient. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong product administered
Clinical narrative: Maladministration INFANRIX instead of BOOSTRIX; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received DTPa (Infanrix) (batch number 9KB9G, expiry date 07-JUL-2026) for prophylaxis.   On 22-MAY-2025, the patient received Infanrix. On 22-MAY-2025, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Maladministration INFANRIX instead of BOOSTRIX). The outcome of the wrong vaccine administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:22-MAY-2025 Medical Assistant calls to report the maladministration of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (INFANRIX) instead of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX) on a eleven year old male patient which led to Wrong vaccine administered. Medical Assistant requires guidance on this patient´s vaccination schedule. Vaccination date, vaccine detail and patient demographics were obtained in this call. No further information was obtained in this call.
Sex: F
Vaccine: MENB
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised; This serious case was reported by a pharmacist via call center representative and described the occurrence of immunocompromised in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included ravulizumab (Ultomiris).   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced immunocompromised (Verbatim: immunocompromised) (serious criteria GSK medically significant). The outcome of the immunocompromised was not reported.   It was unknown if the reporter considered the immunocompromised to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     The company considered the immunocompromised to be unrelated to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAY-2025 The pharmacist called to ask if a patient who was currently taking Ultomiris could receive a booster dose of Bexsero or what was the dosing schedule for boosters. Patient was fully vaccinated for Meningococcal B about 4 years ago. The reporter described that after the 2 doses of Bexsero the patient was taking Ultomiris and was immunocompromised. Health care professional was aware about centers for disease control guidance on this topic.; Sender's Comments: Immunodeficiency is an unlisted event which is considered unrelated to GSK vaccine  Bexsero and Bexsero Pre-Filled Syringe Device.
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unapproved vaccine administration; Overdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 6-month-old male patient who received HBV (Engerix B adult) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis.   On 15-OCT-2024, the patient received the 2nd dose of Engerix B adult. On 15-OCT-2024, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: Unapproved vaccine administration) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAY-2025 Health Care Provider called to inform that during an audit it was found an adult dose of Engerix-B was administered to a child which led adult product administered to child and overdose. She wanted safety data for infants that received Engerix-B adult dose. The reporter consented to follow up.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: intramuscular administration of Priorix-inappropriate route of administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: intramuscular administration of Priorix-inappropriate route of administration). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-MAY-2025 Anonymous healthcare provider called to report the maladministration of Priorix, it was given Intramuscularly instead of subcutaneously, which led to subcutaneous injection formulation administered by other route. No vaccination date, no vaccine detail and no patient demographics were obtained in this call.  No further information was obtained in this call.
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of the AS01B Adjuvant of Shingrix Alone; Patient may only have received Shingrix diluent vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in two patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of the AS01B Adjuvant of Shingrix Alone) and inappropriate dose of vaccine administered (Verbatim: Patient may only have received Shingrix diluent vaccine). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK receipt date: 23-MAY-2025 The reporter reported that a patient may only had received Shingrix diluent vaccine.  Do not have the information on the patient at this time or if this was a first or second dose.  Two diluents missing from the box and two powders left, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 1.58
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration in 19 month old; Use Boostrix as the 4th dose in Dtap series/accidentally received dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number cx4hl, expiry date 19-JAN-2026) for prophylaxis.   Previously administered products included DTaP (received first 3 doses).   On 22-MAY-2025, the patient received the 1st dose of Boostrix. On 22-MAY-2025, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration in 19 month old) and wrong vaccine administered (Verbatim: Use Boostrix as the 4th dose in Dtap series/accidentally received dose of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong 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: 23-MAY-2025 Healthcare professional called in to report that a 19 month old patient initially received their first 3 doses as DTaP and accidentally received a dose of Boostrix, which led wrong vaccine administered and inappropriate age at vaccine administration.  The reporter did not consent to follow-up.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Engerix-B second adult dose administration to a pediatric patient; adult dose of Engerix-B to an 11-year-old patient as a second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 11-year-old female patient who received HBV (Engerix B) (batch number J3952, expiry date 01-DEC-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine on unknown date).   On 30-SEP-2024, the patient received the 2nd dose of Engerix B. On 30-SEP-2024, an unknown time after receiving Engerix B, the patient experienced adult product administered to child (Verbatim: Engerix-B second adult dose administration to a pediatric patient) and overdose (Verbatim: adult dose of Engerix-B to an 11-year-old patient as a second dose). The outcome of the adult product administered to child and overdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-MAY-2025 The medical assistant asked for side effects and how to proceed with the third dose after giving an adult dose of Engerix-B to an 11-year-old patient as a second dose, which led to adult product administered to child and overdose. On 30th September 2024 the patient correctly received the first pediatric dose.  The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rashes appearance two weeks after vaccine administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced rash (Verbatim: Rashes appearance two weeks after vaccine administration). The outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2025 The reporter got somebody and experienced rashes after two weeks after getting the Shingrix vaccine.  The reporter want to know if this was related to the vaccine administration or not. The reporter did not consent to follow-up.
Age: 0.42
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix late second dose; Kinrix wrong age; received a dose of Kinrix instead of Pediarix; 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 5-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 5J7EF, expiry date 29-NOV-2026) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) (batch number 3RT93, expiry date 03-APR-2026) for prophylaxis.   Previously administered products included Pediarix (1st dose received on 09-SEP-2024 with batch number-9P329 and expiry date-06-MAR-2026).   On 17-MAR-2025, the patient received the 2nd dose of Pediarix. On 17-DEC-2024, the patient received the 1st dose of Kinrix. On 17-DEC-2024, not applicable after receiving Pediarix and an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix wrong age) and wrong vaccine administered (Verbatim: received a dose of Kinrix instead of Pediarix). On 17-MAR-2025, the patient experienced drug dose administration interval too long (Verbatim: Pediarix late second dose). The outcome of the drug dose administration interval too long, inappropriate age at vaccine administration and wrong 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: 23-MAY-2025 The patient received a dose of Kinrix instead of their corresponding second dose of Pediarix which led wrong vaccine administered and inappropriate age at vaccine administration.  The reporter explained that patient got a first dose of Pediarix on 9th September 2024, and since they were not aware of the mistake with Kinrix vaccine at that time, a late second dose of Pediarix was administered which led to lengthening of vaccination schedule.  The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction; This is a spontaneous report received from a Pharmacist from medical information team.  An adult female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown".  Clinical course: Pharmacist states that her patient previously experienced an anaphylactic reaction to the 2021 COVID vaccine. She states that the patient is recommended to get vaccinated again and she wants to know if there is any overlap with the ingredients of the 2021 formulation and current 2024-2025 Comirnaty PFS formulation. Caller is requesting information on the active and inactive ingredients. Caller did not specify any ingredient as they are unsure which component of the vaccine the patient is allergic to.; Sender's Comments: There is a reasonable possibility that the event anaphylactic reaction was related to BNT162b2 based on known drug safety profile.
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: Just in reading glasses, now in stronger reading glasses, vision got worse; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "Just in reading glasses, now in stronger reading glasses, vision got worse". Therapeutic measures were taken as a result of visual impairment.  Additional information: Caller's friend, his dad had recently passed and when caller was telling her symptoms, that's really weird. Caller's friend had a similar experience. Just in reading glasses, now in stronger reading glasses, vision got worse.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499225 same reporter/drug, different patient/event;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Renal cancer
Clinical narrative: Surgery to remove cancerous kidney; couldn't walk at all; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 75-year-old female patient received BNT162b2 (BNT162B2), on 04May2021 as dose 2, single (Lot number: ER8735) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "colon cancer", start date: 2009 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EW0150), administration date: 12Apr2021, when the patient was 75-year-old, for Covid-19 immunization. The following information was reported: RENAL CANCER (medically significant) with onset 2021, outcome "unknown", described as "Surgery to remove cancerous kidney"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "couldn't walk at all". Therapeutic measures were taken as a result of renal cancer. Clinical course: In Sep2021, patient was walking 40 minutes each day. In Sep2021, Surgery to remove cancerous kidney after which she couldn't walk at all. Oct2021 to Sep2022 gradually increased walking from zero to 20 minutes per day.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202500052642 Same patient, different dose and event;
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: left arm is red and swollen, as well as painful; left arm is red and swollen, as well as painful; left arm is red and swollen, as well as painful; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), ERYTHEMA (non-serious), outcome "not recovered" and all described as "left arm is red and swollen, as well as painful".  Additional information: the pain has not relented at all, and it has continued past 48 hours after the vaccine was administered. The patient mentioned it was red and swollen, and she expected it to be less red and warm than the previous day.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Genital Yeast Infection; I have like a very foul odor that is coming from like my groin area; My penis smells like really bad stinky feet; This is a spontaneous report received from a Consumer or other non HCP.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FUNGAL INFECTION (non-serious), outcome "unknown", described as "Genital Yeast Infection; I have like a very foul odor that is coming from like my groin area; My penis smells like really bad stinky feet".  Additional information: when the patient went to see the doctor, she was doing an examination and she was telling him that she was really concerned because he had like a very foul odor that was coming from like his groin area and she was telling him also that she thinks that his penis smelled like really bad stinky feet and she did not think that the patient did any cleaning or anything like that because he was not circumcised but she told him that when she was doing the exam, when she was smelling his penis head, she said it smelled like really bad stinky feet.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Vaccine: COVID19
Symptoms: Chronic fatigue syndrome, Malaise
Clinical narrative: don't feel good; chronic fatigue syndrome; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "don't feel good"; CHRONIC FATIGUE SYNDROME (non-serious), outcome "unknown".  Additional information: The patient reported that after they took the COVID vaccines, they didn't feel good and experienced chronic fatigue syndrome.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial injury, Postural orthostatic tachycardia syndrome
Clinical narrative: bad heart; POTS; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INJURY (medically significant), outcome "unknown", described as "bad heart"; POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious), outcome "unknown", described as "POTS". Clinical course: Three high school sport athlete and two college sport daughters had to give up their swimming and track career after taking Pfizer Covid shot. One now had a bad heart and had POTS.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 0.25
Sex: M
Vaccine: PNC20
Symptoms: Infant irritability, Pyrexia
Clinical narrative: Within 24 hours of the vaccine he started throwing his head back and forth from side to side against the bed/floor.  He was fussy/irritable/hard to console.  Had fever.  All symptoms lasted 3 days.
Age: 0.17
Sex: M
Vaccine: DTPPVHBHPB, FLU3, RV5
Symptoms: Wrong product administered
Clinical narrative: It was discovered through cross comparison of billing report and VFC vaccine data entry that patient was given a different vaccine than what was ordered.  No documentation in chart of concern from parents after vaccinations on 4/23/25 and Dr reached out to mom today to let her know what happened.
Age: 88.0
Sex: F
Vaccine: PNC21
Symptoms: Purpura, Rash, Rash erythematous
Clinical narrative: Purpuric rash circumferential left upper extremity, with notable erythema, pain and pruritic.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Brain fog, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Joint pain, headache, tinnitus, brain fog, dizziness, memory and concentration issues, fatigue. All ongoing.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Headache, Memory impairment, Tinnitus
Clinical narrative: Joint pain, headache, tinnitus, brain fog, dizziness, memory and concentration issues, fatigue. All ongoing.
Age: 5.0
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Wrong product administered
Clinical narrative: Patient was scheduled for flu vaccine and Vaxelis was inadvertently administered. Client left the office prior to becoming aware wrong vaccine was given. Supervisor was notified and I was advised to contact parent to let them know. I left VM for guardian to contact office to inform them of incident. I have not received a call back.  Several days later mother returned call and she is out of town, so she advised nurse she would call her father to bring in the patient for correct vaccine.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash maculo-papular, Rash pruritic, Varicella
Clinical narrative: Pruritic macularpapular rash approximately 1 week after receiving Shingrix vaccination.  Progressive since then.  Son has now developed a rash which his pediatrician diagnosed as chickenpox.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Varicella
Clinical narrative: Pruritic macularpapular rash approximately 1 week after receiving Shingrix vaccination.  Progressive since then.  Son has now developed a rash which his pediatrician diagnosed as chickenpox.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Fall, Loss of consciousness, Malaise, Nausea
Clinical narrative: Bexsero and Menveo Vial 1 only was given to Patient on her left arm Intramuscularly at around 4.55 pm. Pt was advised to stay at medical facility for 15 minutes. She was staying in our waiting room. After about 10 minutes she started complaining of nauseated and all at sudden she fell on ground and passed out for around 30-60 seconds then she was feeling all good. We told her not to get up in the mean time we called 911 and so care unit came and an medical officer checked her very throughlly and allowed her to leave. She was doing ok when she left
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine expired 5/23/25 - given 5/27/25. No adverse reaction reported from patient.
Age: 30.0
Sex: F
Vaccine: IPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient notified of error of vaccine administration Polio given instead of Tuberculin placement and asked to come back in to office for evaluation.
Vaccine: MMR, MMR, UNK, MMR
Symptoms: Lacrimation increased, Ocular hyperaemia, Pyrexia, Rash, Rhinorrhoea
Clinical narrative: severe measleslike symptoms following vaccination; This spontaneous report was received from a non-health care professional and refers to a Child patient of unknown gender (exact age unknown).   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 15-Apr-2025, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), reported lot #4015995 was confirmed as invalid lot # for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live; expiration date: 24-Sep-2026 (formulation, site of administration not provided), 0.5ML administered intramuscularly (IM) with sterile diluent (MERCK STERILE DILUENT) for prophylaxis.  On 21-Apr-2025, the patient experienced severe measles like symptoms following vaccination, high fever for 4 days, cough, conjunctivitis, runny nose, and koplik spots (Measles). On 24-APR-2025, another symptom rash (reported as rash for 6 days) started. On 26-Apr-2025, a polymerase chain reaction (PCR) test and Measles virus assay (MeVA) test (MeVA testing determines if a case was caused by measles vaccine strain or wild-type measles virus) were both positive. On an unknown day in April 2025, respiratory viral test (RVP) was negative.    At the reporting time, the outcome of severe measles was unknown.   The reporter considered the events of severe measles and measles virus test positive to be related to the suspect vaccine and sterile diluent (reported as MMR vaccine reactions). This is one of the 3 reports received from the same reporter. Follow up information from FDA (agency #US-009507513-2283670) on 19-May-2025.  Patient information was updated, it was confirmed that concerned to a 1-year-old patient. The lot # Y015995 was reported and has been verified to be valid for this product, expiration date confirmed as 24-Sep-2026.