chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Injection site erythema, Injection site swelling, Injection site warmth, Nervousness
Clinical narrative: Patient states that the morning of Monday 12/20/2024 at 5:00AM, she experienced intense cold from head to toe. She felt shaky to the point, that she did not want to walk. These symptoms continued until 10:00PM that night. She did not take her temperature but felt deep internal cold all over her body and suspects that she had a fever. In addition, just below the site of injection was red mound swollen to where she can cup it with her hand. By Tuesday, the arm was less raised and not as red/pink but still hot to the touch.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient states that the morning of Monday 12/20/2024 at 5:00AM, she experienced intense cold from head to toe. She felt shaky to the point, that she did not want to walk. These symptoms continued until 10:00PM that night. She did not take her temperature but felt deep internal cold all over her body and suspects that she had a fever. In addition, just below the site of injection was red mound swollen to where she can cup it with her hand. By Tuesday, the arm was less raised and not as red/pink but still hot to the touch.
Age: 37.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received the SHINGRIX vaccine instead of the FLU vaccine; Shingrix given to the patient less than 50 years; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 37-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 03-DEC-2024, the patient received Shingrix. On 03-DEC-2024, an unknown time after receiving Shingrix, the patient experienced wrong vaccine administered (Verbatim: received the SHINGRIX vaccine instead of the FLU vaccine) and inappropriate age at vaccine administration (Verbatim: Shingrix given to the patient less than 50 years). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   See case US2024AMR152904 for details regarding the baby case.   Additional Information: GSK Receipt Date: 03-DEC-2024 and 04-DEC-2024 The patient reported that adult patient received Shingrix vaccine instead of the FLU vaccine the patient was supposed to receive the Flu vaccine manufacturer unknown but received Shingrix which led to Inappropriate age at vaccine administration and Wrong vaccine administered. Female consumer was erroneously given Shingrix by her pharmacy, instead of flu vaccine. Consumer was currently breastfeeding. The patient gives consent to follow up with the pharmacy that inadvertently provided the Shingrix vaccine.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Muscular weakness, Pain, Pain in extremity, Tenderness
Clinical narrative: Pain down arm and weakness for a few days after vaccine.  Typically have arm soreness after Covid shots, but this was different.  Left arm tender and painful with certain movements for months after shot.  I didn't report because I thought it was related to something else until I asked a health care provider during a health screening,  if vaccines could be given too high and create an adverse reaction.  When I was told, yes, I contacted my PCP.
Age: 1.0
Sex: U
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called and reported administration of PROQUAD to multiple patients after a possible temperature excursion. HCP did not have complete excursion information and patient demographics were unknown. No additional information was known by reporter. No; This spontaneous report has been received from a health care professional, referring a 12-month-old patient of unknown gender. The patient's medical history, previous adverse drug reactions, drug allergy, concurrent conditions, and concomitant medication were not provided.   On 17-OCT-2024, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (strength, dose, frequency, route of administration, site of administration, and vaccination scheme were not provided; lot # Y002099 which has been verified to be a valid number, expiration date reported and validated as 09-JUL-2025) as a prophylaxis; which experienced a temperature excursion before administration (product storage error). However, no signs or symptoms were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2412USA006214: US-009507513-2412USA006402: US-009507513-2412USA006216: US-009507513-2412USA006311: US-009507513-2412USA006100: US-009507513-2412USA005703:
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: one of them only received the DTaP-IPV part and not the whole component; Initial information received on 23-Dec-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves, a 6 months old female patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB (Prp/T) Vaccine [Pentacel (Vero)] and one of them  only received the DTAP-IPV part and not the whole component.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Hepatitis B Vaccine; Pneumococcal Vaccine Conj 20v (Crm197) (Prevnar 20) and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Immunisation.  On 22-Nov-2024, the patient received 0.5 ml (Standard) (1 X-once) dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/HIB (Prp/T) Vaccine Suspension for injection (lot UK041AA, 31-Aug-2025) via intramuscular route in the right thigh and one of them only received the DTAP-IPV part and not the whole component (single component of a two-component product administered) (latency- same day).  Reportedly, HCP said that in Nov-2024, they had 2 patients that were given PENTACEL. They don't know which child only received the liquid component so they are asking if they need to revaccinate the 2 children. Infant is currently 7 months old but was 6 months old when she received PENTACEL  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: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug/received Havrix vaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 2-year-old female patient who received HAV (Havrix) (batch number TF27T, expiry date FEB-2026) for prophylaxis.   On 20-AUG-2024, the patient received the 1st dose of Havrix (intramuscular, right thigh). On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug/received Havrix vaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 02-DEC-2024 The patient received Havrix vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 17 linked report, reported by same reporter; Sender's Comments:  US-GSK-US2024123266:Same reporter US-GSK-US2024AMR153927:same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Colonoscopy, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; Colonoscopy; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). In DEC-2020, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and colonoscopy (Verbatim: Colonoscopy). The outcome of the vaccination failure and colonoscopy were not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and colonoscopy to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles and colonoscopy to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 16-DEC-2024 The patient did not report the location where the vaccine was provided. It was unknown in which arm the vaccines were administered.  The patient reported that he got the first dose of Shingrix and received the second dose in April or May of 2021 and had an episode of Shingles after receiving these two doses. The patient did not provide the date of the episodes.  The patient reported that recently he got a colonoscopy, and about a week after he had the second episode of shingles and the liquid was provided for the colonoscopy process was a clear cranberry liquid with high concentrations of sugar.  The patient reported that he searched and found that high amounts of sugar can trigger shingles.  The patient reported that in his case, the shingles have been triggered by the anesthesia and the high concentrations of sugar given during the colonoscopy procedure. The patient reported that he still has shingles, and it has not resolved.  The patient inquired that it was recommended to get another series of the vaccine. Not all information was available.  Adverse event would be filed with limited information. The patient declined to provide additional information.  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 vaccine Shingrix (dose 1) and Shingrix (dose 2).
Age: 44.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blister, Rash
Clinical narrative: rash; blister; Initial information received on 26-Dec-2024 regarding an unsolicited valid courtesy non-serious case received from a consumer/non-healthcare professional.  This case involves a 44 years old female patient who experienced rash and blister after receiving Novavax COVID-19 Vaccine and Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants used.   On 04-Oct-2024, the patient received a dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine (lot UT8408LA, with unknown strength, dose and expiry) via intramuscular route in unknown administration site as prophylactic vaccination. On 04-Oct-2024, the patient received a 0.5 ml dose of suspect Novavax COVID-19 Vaccine not produced by Sanofi Pasteur injection (lot 6024MF012, with unknown strength and expiry) via intramuscular route in unknown administration site as Covid-19 immunization.  On 05-OCT-2024 the patient developed large rash (rash) on back of right thigh. Raised vesicles approximately 3mm in diameter (blister). Started behind and above the knee (Latency: 1 day) following the administration of Influenza Usp Trival A-B Subvirion No Preservative Vaccine and Novavax COVID-19 Vaccine.  Action taken: not applicable.   Treatment: Applied topical hydrocortisone was used with no effect. Continues to spread up leg wrapping towards the groin. Only stopped and reversed by using Benadryl 2-3 times/day for next 5 days.  At time of reporting, the outcome was Recovered / Resolved on an unknown date in 2024 for the events.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administration error
Clinical narrative: Patient received the vaccine about 19 hours after reconstitution; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of drug administration error in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-DEC-2024, the patient received Shingrix. On 02-DEC-2024, an unknown time after receiving Shingrix, the patient experienced drug administration error (Verbatim: Patient received the vaccine about 19 hours after reconstitution). The outcome of the drug administration error was unknown.   Additional Information: GSK Receipt Date: 03-DEC-2024 The pharmacist reported that the patient received the vaccine about 19 hours after reconstitution of subsequent dose of Shingrix vaccine, which led to drug administration error.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Pain in extremity
Clinical narrative: sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On an unknown date, the patient received Arexvy and COVID-19 vaccine. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pain in arm (Verbatim: sore arm). The outcome of the pain in arm was not resolved.   The reporter considered the pain in arm to be related to Arexvy.     The company considered the pain in arm to be related to Arexvy.   Additional Information: GSK receipt date: 02-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that, she went right away and received her RSV and new Covid vaccine on same day.  The RSV packed quite a punch with a sore arm but she was good as new and protected. The reporter considered the pain in arm to be related to COVID-19 vaccine.    The follow-up could not be possible as no contact details were available.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 5-year-old female patient who received HAV (Havrix) (batch number BM4R5, expiry date APR-2026) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date OCT-2024) for prophylaxis.   On 10-SEP-2024, the patient received Havrix (intramuscular, right thigh) and Pediarix (intramuscular, right thigh). On an unknown date, an unknown time after receiving Havrix and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown.   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: 02-DEC-2024 The patient received Pediarix and Havrix vaccines after temperature excursion, which led to an incorrect storage of drug. No adverse event were reported. This was 1 of 17 linked cases, reported by same reporter.; Sender's Comments:  US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter
Age: 10.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: received Menveo and Boostrix vaccines after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number LB93L, expiry date JUN-2025) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) (batch number TD2FD, expiry date MAY-2026) for prophylaxis.   On 27-AUG-2024, the patient received the 1st dose of Menveo (intramuscular, left deltoid) and the 1st dose of Boostrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Menveo and Boostrix, the patient experienced incorrect storage of drug (Verbatim: received Menveo and Boostrix vaccines after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Menveo and Boostrix vaccines after temperature excursion, which led to an incorrect storage of drug. No adverse event were reported. This was 1 of 17 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024123266:Same reporter
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number NR394, expiry date JUL-2025) for prophylaxis.   On 20-AUG-2024, the patient received the 1st dose of Menveo (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received menveo vaccine. The other health professional reported that she does not know which vaccines were administered after the temperature excursion to which patients which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter
Age: 5.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: vaccines were administered after the temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number E9Y29, expiry date OCT-2025) for prophylaxis.   On 11-SEP-2024, the patient received the 5th dose of Pediarix (intramuscular, left thigh). On an unknown date, an unknown time after receiving Pediarix, the patient experienced incorrect storage of drug (Verbatim: vaccines were administered after the temperature excursion). The outcome of the incorrect storage of drug was unknown.   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: 02-DEC-2024 The patient received Pediarix vaccine. The other health professional reported that she does not know which vaccines were administered after the temperature excursion to which patients which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024123266:Same reporter US-GSK-US2024123268:Same reporter
Age: 3.0
Sex: U
Vaccine: HEPA, HIBV
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 3-year-old patient who received Hib (Hiberix) (batch number 7AC3C, expiry date SEP-2025) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number TF27T, expiry date FEB-2026) for prophylaxis.   Previously administered products included Hiberix (Received first dose on unknown date), Hiberix (Received second dose on unknown date) and Hiberix (Received third dose on unknown date). Additional patient notes included Ethnicity.   On 19-AUG-2024, the patient received the 4th dose of Hiberix (intramuscular, left thigh) and the 1st dose of Havrix (intramuscular, right thigh). On an unknown date, an unknown time after receiving Hiberix and Havrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 02-DEC-2024 The patient received Hiberixand Havrix vaccine after temperature excursion, which led to incorrect storage of drug. This was 1 of 17 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153925:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: received Havrix vaccine after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 5-year-old patient who received HAV (Havrix) (batch number BM4R5, expiry date APR-2026) for prophylaxis.   Additional patient notes included: (redacted)  On 21-AUG-2024, the patient received the 1st dose of Havrix (intramuscular, left thigh). On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: received Havrix vaccine after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Havrix vaccine after temperature excursion, which led to an incorrect storage of drug. No adverse event were reported. This was 1 of 17 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR153916:Original Case : US2024AMR153742 US-GSK-US2024AMR153917:Original Case : US2024AMR153742 US-GSK-US2024AMR153918:Original Case : US2024AMR153742 US-GSK-US2024AMR153919:Original Case : US2024AMR153742 US-GSK-US2024AMR153920:Original Case : US2024AMR153742 US-GSK-US2024AMR153921:Original Case : US2024AMR153742 US-GSK-US2024AMR153929:Original Case : US2024AMR153742 US-GSK-US2024AMR153923:Original Case : US2024AMR153742 US-GSK-US2024AMR153924:Original Case : US2024AMR153742 US-GSK-US2024AMR153742:Original Case : US2024AMR153742 US-GSK-US2024AMR153926:Original Case : US2024AMR153742 US-GSK-US2024AMR153927:Original Case : US2024AMR153742 US-GSK-US2024AMR153928:Original Case : US2024AMR153742 US-GSK-US2024AMR153922:Original Case : US2024AMR153742 US-GSK-US2024123268:Same reporter US-GSK-US2024123266:Same reporter
Age: 14.0
Sex: F
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: administered after temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 14-year-old female patient who received HBV (Engerix B) (batch number 95D74, expiry date MAR-2025) for prophylaxis.   On 21-AUG-2024, the patient received the 3rd dose of Engerix B (right deltoid). On an unknown date, an unknown time after receiving Engerix B, the patient experienced incorrect storage of drug (Verbatim: administered after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Engerix B vaccine. As per the reporter it was not sure which vaccines were administered after the temperature excursion which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter.; Sender's Comments:  US-GSK-US2024123266:Same reporter US-GSK-US2024123268:Same reporter
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, TDAP
Symptoms: Product storage error
Clinical narrative: Incorrect storage of drug; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TD2FD, expiry date MAY-2026) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 95D74, expiry date MAR-2025) for prophylaxis and HAV (Havrix) (batch number BM4R5, expiry date APR-2026) for prophylaxis.   Additional patient notes included patient weight: 119.   On 05-AUG-2024, the patient received the 1st dose of Boostrix (intramuscular, left deltoid), the 1st dose of Engerix B (intramuscular, right deltoid) and the 2nd dose of Havrix (intramuscular, right deltoid). On an unknown date, an unknown time after receiving Boostrix, Engerix B and Havrix, the patient experienced incorrect storage of drug (Verbatim: Incorrect storage of drug). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-DEC-2024 The patient received Boostrix, Engerix -B and Havrix vaccine. The other health professional reported that she does not know which vaccines were administered after the temperature excursion to which patients which led to incorrect storage of drug. This was 1 of 15 cases reported by same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles three times; 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, less than a year 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 three times). 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: 17-DEC-2024 This case was reported by a patient via interactive digital media. Reporter reported that patient had the shingles shot about a year ago then had the second one a couple months after that. In less than a year patient had the shingles three times. This case was considered as suspected vaccination failure as details regarding completion of time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine shingles dose 1 and shingles dose 2.
Sex: M
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: drug dose interval too short; drug dose interval too long; 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 19-year-old male patient who received HBV (Engerix B adult) (batch number YY37B, expiry date 24-AUG-2026) and (batch number 4T39P, expiry date 09-DEC-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 4T39P, expiry date 09-DEC-2025) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b adulto).   On 02-DEC-2024, the patient received the 3rd dose of Engerix B adult. On 12-JUL-2024, the patient received the 2nd dose of Engerix B adult. On 12-JUL-2024, not applicable after receiving Engerix B adult, not applicable after starting Engerix B adult and an unknown time after receiving Engerix B adult, the patient experienced drug dose administration interval too long (Verbatim: drug dose interval too long). On 02-DEC-2024, the patient experienced drug dose administration interval too short (Verbatim: drug dose interval too short). The outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.   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: 02-DEC-2024 Nurse reported that she administered a third dose of Engerix-B to a patient on 02-DEC-2024. She administered an adult dose to the patient. She initially thought the patient had received an adult dose for the first two doses as well when she was looking at the medical record and recorded NDC numbers, and so she asked the doctor if it was ok for the patient to also receive an adult dose, and the doctor said yes. After the nurse had administered the adult dose, she was looking back in the chart and realized they may not have received adult dose for the first two doses, based on billing charges.  However, lot number she provided for first two doses does correspond with adult formulation. The patient received second dose of Engerix B, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received Third dose of Engerix B earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: MENB
Symptoms: Occupational exposure to product
Clinical narrative: vaccine leak; Product Complaint; While trying to remove bubble in pre-filled syringe, the vaccine leaked onto the nurse's ungloved hand; This non-serious case was reported by a nurse via call center representative and described the occurrence of occupational exposure via skin contact with product in a female patient who received Men B NVS (Bexsero) (batch number 77KA5, expiry date 30-NOV-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On 02-DEC-2024, an unknown time after receiving Bexsero, the patient experienced occupational exposure via skin contact with product (Verbatim: While trying to remove bubble in pre-filled syringe, the vaccine leaked onto the nurse's ungloved hand). On an unknown date, the patient experienced product leakage (Verbatim: vaccine leak) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the occupational exposure via skin contact with product, product leakage and pharmaceutical product complaint were unknown.   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: 02-DEC-2024 The reporter stated that seven Bexsero pre-filled syringes each contained a large (full width of the syringe, about half the volume of vaccine), clear, air bubble that was observed during preparation for administration and was unable to be remove without wasting vaccine. While trying to remove bubble during this phone call, the vaccine leaked onto the nurse's ungloved hand which led to occupational exposure via skin contact with product. Confirmed that all operations were performed appropriately before the defect was discovered. The product was not administered. There were not any visible damage present on the syringe. There were not any temperature excursions during storage. The product was at room temperature when particle was observed. Requested return of the suspect pre-filled syringes and all the original packaging without further manipulation/handling.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, MENB, TDAP
Symptoms: Product storage error
Clinical narrative: Improper Storage Error; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Kinrix, Boostrix, Pediarix and Bexsero. On an unknown date, an unknown time after receiving Kinrix, Boostrix, Pediarix and Bexsero, the patient experienced incorrect storage of drug (Verbatim: Improper Storage Error). The outcome of the incorrect storage of drug was unknown.   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: 03-DEC-2024 The physician reported that the stability data for Bexero, Kinrix, Pedarix and Boostrix which was stored at 8.7 degree Celsius for 45 minutes on 01-MAY-2024, patient involvement and at 8.1 degree Celsius for approximately 18 minutes may be lower, patient involvement. The vaccine was administered to patients after temperature excursion prior to confirming stability of vaccines, which led to incorrect storage of drug.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a child patient who received Hib (Hiberix) (expiry date 23-OCT-2024) for prophylaxis.   On 03-DEC-2024, the patient received Hiberix. On 03-DEC-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: received an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 04-DEC-2024 The reporter reported that the patient received an expired dose of Hiberix vaccine which led to, expired vaccine used. The reporter did not had lot number of the vaccine or demographics for the patient.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received Hib (Hiberix) (expiry date 12-NOV-2024) for prophylaxis.   On 06-DEC-2024, the patient received Hiberix. On 06-DEC-2024, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 06-DEC-2024 The clinic supervisor reported that an expired dose of Hiberix was administered to a patient today (on the day of reporting) which led to, expired vaccine used. The reporter did not have lot number at the time of the call. The vaccine administration facility was the same as primary reporter.
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: gave a dose of Bexsero to an 8 year old patient/wrong age; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received Men B NVS (Bexsero) (batch number ES49H, expiry date 31-MAY-2027) for prophylaxis.   On 22-NOV-2024, the patient received the 1st dose of Bexsero. On 22-NOV-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: gave a dose of Bexsero to an 8 year old patient/wrong age). The outcome of the inappropriate age at vaccine administration was unknown.   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: 06-DEC-2024 Nurse reported that they had an administration error since they gave a dose of Bexsero to an 8 year old patient. It was the first dose of a meningitis b vaccine for the patient.  The Vaccine Administration Facility was the same as primary reporter. The patient received Bexsero earlier than the recommended age which led to inappropriate age at vaccine administration.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Brain fog, Diarrhoea, Headache, Muscle discomfort, Musculoskeletal discomfort
Clinical narrative: brain fog; muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps); runny nose; headache; diarrhea; muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps); Initial information received on 19-Dec-2024 regarding an unsolicited valid  non-serious case received from a Patient.  This case involves a 62 years old male patient who experienced brain fog, muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps), runny nose, headache and diarrhea after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadtt].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 1 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot number, dose, strength and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination. There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date the patient developed brain fog, muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps) (muscle strain) (myalgia), runny nose (rhinorrhoea), headache and diarrhea (diarrhoea) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine.  Action taken: not applicable.  The patient was treated with Iptacopan Hydrochloride Monohydrate (Fabhalta) for Headache, Rhinorrhoea and Diarrhoea.  At time of reporting, the outcome was Unknown for the events.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Rhinorrhoea
Clinical narrative: brain fog; muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps); runny nose; headache; diarrhea; muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps); Initial information received on 19-Dec-2024 regarding an unsolicited valid  non-serious case received from a Patient.  This case involves a 62 years old male patient who experienced brain fog, muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps), runny nose, headache and diarrhea after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadtt].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose 1 of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine Solution for injection (lot number, dose, strength and expiry not reported) via unknown route in unknown administration site as prophylactic vaccination. There will be no information on batch number and expiration date corresponding to the one at time of event occurrence.  On an unknown date the patient developed brain fog, muscle joints (reports it feels like an "ice pick" and described as a "tearing sensation if he overstretches in biceps and triceps) (muscle strain) (myalgia), runny nose (rhinorrhoea), headache and diarrhea (diarrhoea) (unknown latency) following the administration of Meningococcal A-C-Y-W135 (T Conj) Vaccine.  Action taken: not applicable.  The patient was treated with Iptacopan Hydrochloride Monohydrate (Fabhalta) for Headache, Rhinorrhoea and Diarrhoea.  At time of reporting, the outcome was Unknown for the events.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: given daptacel instead of adacel with no reported adverse event; Initial information received on 30-Dec-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 11 years old male patient who received diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] instead of diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi); and HPV vaccine VLP rL1 9v (yeast) (Gardasil 9) both for Immunisation.  On 17-Dec-2024, the patient received 0.5 ml of diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection with standard strength (expiry date- 30-Sep-2025 and lot 3CA03C3) once via intramuscular route in the left arm as Immunization instead of diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (strength, expiry date and lot number not reported) with no reported adverse event (wrong product administered) (latency- same day).   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.
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: Chills; Fever; Sore throat; Cough; felt like he was hit by a truck; Headaches; This spontaneous case, initially received on 18-Dec-2024, was reported by a non health professional and concerns an adult male patient.  Administration of company suspect drug(s): On an unknown date, the patient received Fluvirin for Flu vaccine, Flu vaccine, Flu vaccine., dose, route of administration and anatomical location were not provided. Lot number: No batch number available.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Chills (outcome: Unknown), Fever (outcome: Unknown), Sore throat (outcome: Unknown), Cough (outcome: Unknown), felt like he was hit by a truck (outcome: Unknown), Headaches (outcome: Unknown).  Consumer called to inquire about an alternative flu vaccine. He received the flu vaccine three years in a row and had a rection. He explained after an hour or 2 getting vaccine he experienced chills, fever, dore throat, cough.  He felt like he was hit by a truck. He had never had a reaction with other vaccines such as covid, pneumonia, tetanus. He mentioned he did not have an egg allergy. Unable to determine what year he received the vaccine. He stopped taking few years ago.  Patient called back and stated the medication was Fluvirin. He had it 10 years ago 2015 season. He also reported headaches after receiving the vaccine. Symptoms went away after a couple hours.   Fluvirin action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non serious and causality was not reported.; Reporter's Comments: All events were considered related.
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Chills; Fever; Sore throat; Cough; felt like he was hit by a truck; Headaches; This spontaneous case, initially received on 18-Dec-2024, was reported by a non health professional and concerns an adult male patient.  Administration of company suspect drug(s): On an unknown date, the patient received Fluvirin for Flu vaccine, Flu vaccine, Flu vaccine., dose, route of administration and anatomical location were not provided. Lot number: No batch number available.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Chills (outcome: Unknown), Fever (outcome: Unknown), Sore throat (outcome: Unknown), Cough (outcome: Unknown), felt like he was hit by a truck (outcome: Unknown), Headaches (outcome: Unknown).  Consumer called to inquire about an alternative flu vaccine. He received the flu vaccine three years in a row and had a rection. He explained after an hour or 2 getting vaccine he experienced chills, fever, dore throat, cough.  He felt like he was hit by a truck. He had never had a reaction with other vaccines such as covid, pneumonia, tetanus. He mentioned he did not have an egg allergy. Unable to determine what year he received the vaccine. He stopped taking few years ago.  Patient called back and stated the medication was Fluvirin. He had it 10 years ago 2015 season. He also reported headaches after receiving the vaccine. Symptoms went away after a couple hours.   Fluvirin action taken: Not Applicable  Reporter's assessment: The reporter considered the events as non serious and causality was not reported.; Reporter's Comments: All events were considered related.
Age: 0.25
Sex: M
Vaccine: PNC20, RV1
Symptoms: Miliaria, Rash, Urticaria
Clinical narrative: Hives, rashes spreading through out his whole that comes and goes.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Pyrexia
Clinical narrative: fever, muscle pain in legs and thighs, muscle weakness in legs upon standing