chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, MNQ, RV1
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis and Rota (Rotarix liquid formulation) for prophylaxis.   On an unknown date, the patients received Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Bexsero, Menveo and Rotarix liquid formulation. On an unknown date, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B, Bexsero, Menveo and Rotarix liquid formulation, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUN-2025 The reporter called and reported a temperature excursion for Infanrix, Pediarix, Kinrix, Havrix, Engerix-B, Bexsero, Menveo (1 vial) and Rotarix (liquid) vaccines.  Medical assistant mentioned that the excursion happened on 16th May 2025, and since then, they had been using the vaccines. Due to the conditions of the excursion, they explained to the healthcare professional that the products (except Rotarix liquid version) should not be use and they should be discarded.   At the end of the call, healthcare professional mentioned that she already reported this excursion in a prior call and mentioned that former agent informed that the vaccines were stable,  Healthcare professional informed to be confused due to the below recommended temperature that they just provided. Due to the information from healthcare professional, it seemed that they had been using these vaccines after a temperature excursion which led to incorrect storage of drug.
Age: 0.17
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administration of Kinrix to a 2 month patient; Administration of Kinrix to a 2 month patient and the intended vaccine was Infanrix; 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 2-month-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 19-JUN-2025, the patient received the 1st dose of Kinrix. On an unknown date, the patient did not receive Infanrix. On 19-JUN-2025, an unknown time after receiving Kinrix and not applicable after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration of Kinrix to a 2 month patient) and wrong vaccine administered (Verbatim: Administration of Kinrix to a 2 month patient and the intended vaccine was Infanrix). 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-JUN-2025 The patient's age was 2 months and 23 days old. The nurse reported that last week, they had a child patient, and they got Kinrix, which was not recommended until 4 to 6 years old and HCP mentioned that the intended vaccine was Infanrix, it was given by mistake, which led to inappropriate age at vaccine administration and wrong vaccine administered The Vaccine Administration Facility is the same as Primary Reporter.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Shingrix adjuvant only administration; Shingrix adjuvant only administration; 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 a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 93N4J, expiry date 25-APR-2027) for prophylaxis.   On 24-JUN-2025, the patient received Shingrix. On 24-JUN-2025, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant only administration) and inappropriate dose of vaccine administered (Verbatim: Shingrix adjuvant only administration). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 24-JUN-2025 The healthcare professional wanted to know how to proceed after a patient received only the adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The Vaccine Administration Facility is the same as Primary Reporter.
Age: 1.0
Sex: M
Vaccine: MEN, MMR
Symptoms: No adverse event, Wrong product administered
Clinical narrative: accidentally given MENQUADFI to a 12-month-old patient instead of an MMR vaccine with no reported adverse event; Initial information received on 25-Jun-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 month old male patient who accidentally received Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] to a 12-month-old patient instead of an Measles vaccine, Mumps vaccine, Rubella vaccine (MMR) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Jun-2025, the patient received a 0.5ml  dose of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection, frequency-once (lot U8375AB and expiry date- 30-Apr-2028) via intramuscular route in the right arm for Immunization instead of Measles vaccine, Mumps vaccine, Rubella vaccine with no reported adverse event (latency-same day).  Action taken was 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: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Heart rate increased, Heart rate irregular, Nervous system disorder
Clinical narrative: brain fog, increase average heart rate & heart rate variability, deregulation of autonomic nervous system
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: he had a fever; ache/pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-JUN-2025, the patient received the 2nd dose of Shingrix (left arm). On 24-JUN-2025, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: he had a fever) and pain (Verbatim: ache/pain). The outcome of the fever and pain were not resolved.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.     It was unknown if the company considered the fever and pain to be related to Shingrix.   Additional Information: GSK receipt date: 24-JUN-2025 The patient reported that he had received Shingrix vaccine and had a fever (grade/temp not disclosed,) pain and aches.  The reporter mentioned that at the time of the call to GlaxoSmithKline, the adverse events had not resolved.  No further information was obtained/provided.
Sex: F
Vaccine: VARZOS
Symptoms: Hiccups, Muscle spasms
Clinical narrative: Persistent hiccup condition that started 3 days after the last dose of Shingrix; spasm in her thoracic region; This non-serious case was reported by a nurse via call center representative and described the occurrence of hiccups in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced hiccups (Verbatim: Persistent hiccup condition that started 3 days after the last dose of Shingrix) and spasms (Verbatim: spasm in her thoracic region). The outcome of the hiccups and spasms were not resolved.   It was unknown if the reporter considered the hiccups and spasms to be related to Shingrix.     It was unknown if the company considered the hiccups and spasms to be related to Shingrix.   Additional Information: GSK receipt Date: 23-JUN-2025 The nurse reported that there was a female patient (over 50 years) that was experiencing some type of spasm in her thoracic region, causing a certain type of hiccup condition.  It was persistent and started 3 days after the last dose of Shingrix. At the moment of the call patient's details and dates were not available.  The health care professional requested to be contact buck in order to provide all information missing please. The vaccine administration facility was the same as primary reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, Cardiac arrest, Death, Depression
Clinical narrative: I was speaking to my mother on the phone Sunday evening 3/7/21.  I always did when I got home from work I called her to check in on her. It was idk exactly but prob around 5pm. She had been very depressed as she couldn't get healed from one broken bone b4 her ex-husband gave her another one. That's the reason she had been in the hospital then and for what seemed like so long prior to the Covid outbreak. We were talking when she got pretty upset and actually yelled at the nurses as they came in. I was shocked because she is always nice and had been so pleasant and happy 2 speak w me on then. But when I said now mom take it easy on them, assuming she maybe in pain she explained. She was angry telling them she didn't want another one of those darned shots as the last one had made her feel awful. Saying she already had covid twice so she didn't see why she needed it. They said they were required to give it to her and thats when she started objecting further saying it was there fault she had gotten covid to begin with as she was under their care and supposed to have been u Der quarantine and she's right. Thats why she was so depressed. We could only talk on the phone, I would drive over put our hands on the glass. The following day they where calling us to come say our final goodbyes, just like they had a couple weeks prior which I now believe was after they gave her the first shot.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Impetigo, Pyrexia, Rash
Clinical narrative: (1) Rash - see 12/24/2024 office visit and 12/25/24 phone call report (2) also see 12/27 24 office visit for Impetigo, fever, loss of appetite
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Feeling hot, Headache, Mobility decreased, Pain
Clinical narrative: The pt tolerated the injection well and felt fine until she was going to bed a noticed she had a hard time lifting her arm. The next day she had body aches, felt feverish, body felt warm the touch. Pt took Tylenol with little help for the headache. Wed night she noted redness on her left arm (not the area of the shot) areas were tender to the touch.
Age: 61.0
Sex: F
Vaccine: PNC20
Symptoms: Pyrexia, Tenderness
Clinical narrative: The pt tolerated the injection well and felt fine until she was going to bed a noticed she had a hard time lifting her arm. The next day she had body aches, felt feverish, body felt warm the touch. Pt took Tylenol with little help for the headache. Wed night she noted redness on her left arm (not the area of the shot) areas were tender to the touch.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP called and reported MMRII administered 4/21/2025 that expired 4/19/2025.; This spontaneous report has been received from an other health professional, regarding to a 4-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 21-APR-2025, the patient was vaccinated with a expired dose ( Expired product administered) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), at a dose of 0.5 milliliter (ml), expiration date 19-APR-2025, as prophylaxis (strength, dosage, route of administration, anatomical site of injection, vaccination scheme frequency, lot number and expiration date were not reported).
Sex: M
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: throbbing headache; fever; tiredness/fatigue; sore at the site; chills; This spontaneous report was received from a male patient of unknown age referring to himself. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were unknown.  The patient had a "wellness exam" with his primary care provider. On 26-JUN-2025, he was vaccinated with Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) (route reported as injection; strength, dose, lot # and expiration date were not reported) for prophylaxis (it was reported he received an unspecified pneumococcal vaccine, he stated listed on the sheet was "Pneumococcal 13, 15, and 20." He was unable to determine which vaccine he received).   On the same day, the patient had experienced throbbing headache, fever, tiredness, sore at the site (Vaccination site pain), chills and fatigue. He reported a decrease in the severity of the side effects from 26-JUN-2025. The patient requested information on how long he could expect these side effects. It was unknown if any lab/diagnostic tests were performed. The patient had not sought any medical attention or received any treatment. Outcome of all events was reported as not recovered.  The causality between Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE) and all events was not reported.  Lot # is being requested and will be submitted if received.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Peripheral facial palsy; This serious case was reported by a consumer and described the occurrence of facial palsy in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included No prior history, No diabetes. Concomitant products included atorvastatin, ramipril, ezetimibe and omeprazole.   On 18-MAY-2025, the patient received the 2nd dose of Shingrix. On 09-MAR-2025, the patient received the 1st dose of Shingrix. On 20-JUN-2025, 33 days after receiving Shingrix and 103 days after receiving Shingrix, the patient experienced facial palsy (Verbatim: Peripheral facial palsy) (serious criteria GSK medically significant). The patient was treated with prednisone. The outcome of the facial palsy was not resolved.   It was unknown if the reporter considered the facial palsy to be related to Shingrix and Shingrix.     The company considered the facial palsy to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 23-JUN-2025 The patient self-reported this case for himself. The patient was treating with high dose oral prednisone for 6 days plus a 4-day taper. Patient had taken concomitants include atorvastatin for many years, Ramipril, Ezetimibe, Vit D, Omeprazole and Multivitamin. Peripheral facial palsy symptoms were treated.; Sender's Comments: Facial paralysis is an unlisted event which is considered unrelated to GSK vaccine Shingrix (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Four patients had intervals of up to 2 years; This non-serious case was reported by a other health professional and described the occurrence of drug dose administration interval too long in a specified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose up to 2 years ago).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Four patients had intervals of up to 2 years). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 20-JUN-2025 Health care professional noted approximately 4 patients had longer than recommended interval between dose 1 and dose 2 of Shingrix.  Reporter stated that four patients had intervals of up to 2 years. No specific patient details given and there were no other adverse effects noted. The patients received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: A rash looking like chicken pox; This non-serious case was reported by a consumer and described the occurrence of varicella-like rash in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date). Concomitant products included atorvastatin calcium (Atorvastatin).   On 12-JUN-2025, the patient received the 2nd dose of Shingrix (left arm). On 13-JUN-2025, 1 days after receiving Shingrix, the patient experienced varicella-like rash (Verbatim: A rash looking like chicken pox). The outcome of the varicella-like rash was resolving.   It was unknown if the reporter considered the varicella-like rash to be related to Shingrix.     It was unknown if the company considered the varicella-like rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2025 The patient had taken subsequent dose of Shingrix on 12 Jun 2025. The reporter called patient received Shingrix vaccine on 12 Jun 2025 and had a rash on 13 Jun 2025. There was nothing that reporter would like to share about the primary disease. There was nothing that reporter would like to share about a complicating disease. There was nothing that reporter would like to provide any additional information about this report.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Extra dose administered; Inappropriate schedule of vaccine administered; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix) and methotrexate sodium (Methotrexate).   On 30-AUG-2018, the patient received the 3rd dose of Shingrix (right arm). On 19-JUL-2018, the patient received the 2nd dose of Shingrix (right arm). On 19-JUL-2018, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine administered). On 30-AUG-2018, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered and drug dose administration interval too short were not applicable.   Additional Information: GSK receipt date: 20-JUN-2025 The patient did not have any Lot number of expiry information for any of the three doses received The reporter was a male patient that reported that he was looking at his vaccination records, and it showed that he received three doses of Shingrix. The patient received a third dose of Shingrix on 30th August 2018 which led to extra dose administration. The patient received the first dose of Shingrix on 30th May 20218, and the second dose on 19th July 2018, not two months apart which led to drug dose administration interval too short. The patient stated that there was a good chance that he received all three doses in his right arm, but he did not have this information in his records. The patient stated that neither his local pharmacy nor his physician showed any record of having provided any Shingrix vaccines to him. The patient had no Healthcare Provider information available to provide The patient mentioned that he was on Methotrexate (unknown product information) pre-existing receiving any Shingrix vaccines and is still on Methotrexate today at the time of reporting.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Extra dose administered
Clinical narrative: administered PEDIARIX and HAVRIX to a patient who was already up to date with vaccinations; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9D25P, expiry date 25-OCT-2025) for prophylaxis.   Co-suspect products included HAV (Havrix 720) (batch number 22GP3, expiry date 11-SEP-2026) for prophylaxis.   On 20-JUN-2025, the patient received Pediarix and Havrix 720. On 20-JUN-2025, an unknown time after receiving Pediarix and Havrix 720, the patient experienced extra dose administered (Verbatim: administered PEDIARIX and HAVRIX to a patient who was already up to date with vaccinations). The outcome of the extra dose administered was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2025 The medical assistant reports that she administered Pediarix and Havrix to a patient who was already up to date with vaccinations which led to extra dose administered. The patient did not need the vaccinations.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Impaired work ability, Incomplete course of vaccination, Influenza like illness
Clinical narrative: Flu-like symptoms; did not received 2nd dose yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In JUL-2024, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In JUL-2024, 1 day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: did not received 2nd dose yet). In JUL-2024, the outcome of the influenza-like symptoms was resolved. The outcome of the incomplete course of vaccination was not applicable.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUN-2025 The patient received her first Shingrix dose and one day after vaccination she developed unspecified flu-like symptoms and missed one day of work (AE, recovered).  She has not yet received the second dose but plans to (adverse event: inappropriate schedule of vaccine).  Nothing else was reported. This report was filed with limited detail as the patient declined to provide her mailing address or answer questions regarding the adverse event report.  Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: it was a rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a 57-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis (I have rheumatoid arthritis) and fibromyalgia (I have Fibromyalgia, so with pain that those 2 things give me in a daily basis).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: it was a rash). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     It was unknown if the company considered the rash to be related to Shingles vaccine.   Additional Information: GSK receipt date: 16-JUN-2025  This case was reported by a patient via interactive digital media. Patient got the shot; patient was 57 and thought he/she got bit then patient turned around and looked in the mirror and saw it was a rash. Patient had rheumatoid arthritis and fibromyalgia, so with pain that those 2 things give me in a daily basis, patient asked that they could handle Shingles better.
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: A nineteen year old patient received a one milliliter dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old patient who received HBV (Engerix B) for prophylaxis.   In MAY-2025, the patient received the 1st dose of Engerix B. In MAY-2025, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: A nineteen year old patient received a one milliliter dose). The outcome of the overdose 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 Registered Nurse called to ask what to do in this case regarding a patient's Engerix B schedule. A nineteen-year-old patient received a one milliliter dose last May 2025, which led to overdose. On the day before reporting on 17-JUN-2025, patient received a zero point five milliliter dose. The reporter asked for advise. Vaccination date was obtained in the call (no specific day of administration mentioned by the Registered Nurse's end for first dose). No vaccine detail and no patient demographics were obtained in the call. No further information was obtained in the call.
Vaccine: VARZOS
Symptoms: Rash, Skin discolouration
Clinical narrative: I had the vaccine but developed a small patch on my waste area; discoloration; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of patchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced patchy rash (Verbatim: I had the vaccine but developed a small patch on my waste area) and skin discoloration (Verbatim: discoloration). The outcome of the patchy rash and skin discoloration were resolving.   It was unknown if the reporter considered the patchy rash and skin discoloration to be related to Shingles vaccine.     It was unknown if the company considered the patchy rash and skin discoloration to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUN-2025 This case was reported by the patient via interactive digital media. The patient had the vaccine but developed a small patch on his/her waste area.  The patient used a prescription from the Dermatologist that had really reduced all but the discoloration. The patient also said that the Vitamins from Zosterex had taken him/her closer to recovery. The patient asked to give them a try which was available.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Skin fissures, Vaccination failure
Clinical narrative: suspected vaccination failure; after getting both doses of shin cracks and keep getting breakouts of the shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: after getting both doses of shin cracks and keep getting breakouts of the shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine 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 Patient asked what they should do after getting both doses of shin cracks if they keep getting breakouts of the shingles. 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 regarding completion of primary schedule, time to onset for shingles and laboratory confirmation of shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2).
Age: 1.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Incorrect Vaccine; Received at 16 months of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 16-month-old male patient who received DTPa-IPV (Kinrix) (batch number 4L454, expiry date 16-OCT-2026) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis.   On 16-JUN-2025, the patient received Kinrix. On an unknown date, the patient did not receive DTaP vaccine. On 16-JUN-2025, an unknown time after receiving Kinrix and not applicable after receiving DTaP vaccine, the patient experienced wrong vaccine administered (Verbatim: Incorrect Vaccine) and inappropriate age at vaccine administration (Verbatim: Received at 16 months of age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-JUN-2025 The nurse reported that they had a medication error and calling to see about any actions or anything that they should take as a result.  Essentially, they had a 16-months old child who received a Kinrix vaccine that was not indicated until the age of four, which led to inappropriate age at vaccine administration. The patient was going to receive a DTAP vaccine and instead he received a DTAP/IPV vaccine, which led to wrong vaccine administered.
Age: 54.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Product preparation error
Clinical narrative: supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally; she was supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 9D52, expiry date 25-MAR-2027) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9D52, expiry date 25-MAR-2027) for prophylaxis and Hepatitis B vaccine for prophylaxis.   On 18-JUN-2025, the patient received Shingrix and Shingrix. On an unknown date, the patient did not receive Hepatitis B vaccine. On 18-JUN-2025, an unknown time after receiving Shingrix and Shingrix and not applicable after receiving Hepatitis B vaccine, the patient experienced accidental overdose (Verbatim: supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally) and wrong vaccine administered (Verbatim: she was supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally). The outcome of the accidental overdose and wrong vaccine administered were not applicable.   Additional Information: GSK receipt date: 20-JUN-2025 The pharmacist reported that a patient received two Shingrix doses at the same time. She was supposed to get Shingrix and a Hepatitis B vaccine but got two Shingrix vaccines accidentally which led to, accidental overdose and wrong vaccine administered.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Interchange of vaccine products, Wrong product administered
Clinical narrative: accidentally administer a Menveo to a patient on June 17th 2025 instead of the Bexsero vaccine; interchange of vaccine products; 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 21-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number 57H54, expiry date 31-JAN-2026) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Meningococcal vaccine A/C/Y/W conj (dip tox) (Menactra) and Meningococcal vaccine A/C/Y/W conj (dip tox) (Menactra).   On 17-JUN-2025, the patient received Menveo. On an unknown date, the patient did not receive Bexsero. On 17-JUN-2025, an unknown time after receiving Menveo and not applicable after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: accidentally administer a Menveo to a patient on June 17th 2025 instead of the Bexsero vaccine) and interchange of vaccine products (Verbatim: interchange of vaccine products). The outcome of the wrong vaccine administered and interchange of vaccine products were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUN-2025 The medical assistant explained that they accidentally administered a Menveo to a patient instead of the Bexsero vaccine that was originally prescribed, which led to wrong vaccine administered. The patient received 2 prior doses of Menactra back and the reporter asked to the treating physician about it and they mentioned that nothing can happen from this mistake and the Menveo dose can be considered as a booster, which led to interchange of vaccine products
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 1st dose on 31-MAY-2025 and 2nd dose on 01-JUN-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 31-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On 01-JUN-2025, the patient received the 2nd dose of Twinrix. On 01-JUN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: received 1st dose on 31-MAY-2025 and 2nd dose on 01-JUN-2025). The outcome of the drug dose administration interval too short was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-JUN-2025 The pharmacist reported that the patient received their first dose of Twinrix in May 2025 and the second dose in June 2025 and wanted to know when the third dose should be given. They did not want to provide more data and declined to receive follow-up. The reporter was conflictive and rude during the call, stating that they did not see why providing more data for the case would help them get an answer. The patient received 2nd dose of Twinrix vaccine earlier than the recommended interval, which led to shortening of the vaccination.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a shot October 22nd, 2023, and then the next shot was not until January 12th 2025; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 22-OCT-2023).   On 12-JAN-2025, the patient received the 2nd dose of Shingrix. On 12-JAN-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received a shot October 22nd, 2023, and then the next shot was not until January 12th 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK receipt date: 01-APR-2025 The patient who received a shot in OCT 2023 and then the next shot was not until 12th JAN 2025 and because of the gap there was a recommendation by a pharmacist to get a 3rd dose. However her insurance was blocking that, so they were calling to see if it was medically necessary for her to receive that other one. The vaccine administration facility was the same as primary reporter. No other information was provided. The patient received 2nd dose of Shingrix later than recommendation, which led to lengthening of vaccine schedule.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: almost died from Covid last may; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (almost died from Covid last may) in a 97-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced COVID-19 (almost died from Covid last may) (seriousness criterion life threatening). At the time of the report, COVID-19 (almost died from Covid last may) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medications were reported.  It was reported that patient almost died from Covid last May. Ever since then they made sure to keep up with all boosters. But they were worried about availability although they would be making it available for everyone 65 and older.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.; Reporter's Comments: Age is a contributor for the event. The benefit-risk relationship of the product is not affected by this report.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Headache, Nausea
Clinical narrative: chest pain; upper back pain; sore body; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache) and CHILLS (chills) in a 30-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 25-Jun-2025, the patient experienced CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chest pain; upper back pain; sore body; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache) and CHILLS (chills) in a 30-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046734) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jun-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 25-Jun-2025, the patient experienced CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHEST PAIN (chest pain), BACK PAIN (upper back pain), PAIN (sore body), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: now have heart issues/heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (now have heart issues/heart condition) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (now have heart issues/heart condition). At the time of the report, CARDIAC DISORDER (now have heart issues/heart condition) had not resolved.            No concomitant medications were reported.  The patient had both doses of vaccine for Covid and now had heart issues.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2025: Follow-up received contains non-significant information included reference number added. On 27-Jun-2025: Follow-up received contains non-significant information included reference numbers were added.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Influenza like illness, Malaise, Pyrexia
Clinical narrative: flu like symptoms; malaise; illness; high fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), ILLNESS (illness) and PYREXIA (high fever) in a 43-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) for an unknown indication.    Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of COVID-19 vaccine prot. subunit (NVX CoV 2373) (Novavax COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), ILLNESS (illness) and PYREXIA (high fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (malaise), ILLNESS (illness) and PYREXIA (high fever) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant medications were reported.  The patient experienced flu-like symptoms and fever following every COVID-19 vaccine received (both Moderna and Novavax). Reported fever after second Novavax dose. Reactions including high fever, malaise, and illness lasting 24-48 hours. Despite the side effects, the patient continued vaccination due to immunocompromised status.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: myocardial infarction; This is a spontaneous report received from an Other HCP from a sales representative.  A 45-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant, life threatening), 24 hrs after the suspect product(s) administration, outcome "recovered". Therapeutic measures were taken as a result of myocardial infarction.  Clinical course: It was unknown if the patient had any other vaccine on the same date or in four weeks. It was also unknown if the patient took other medications in 2 weeks. The providers husband experience a myocardial infarction within 24 hours after the 2nd dose of the original Pfizer BioNTech COVID-19 vaccine.; Sender's Comments: Based on the close temporal relationship, the association between the event myocardial infarction with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.