chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: The HBP stated patient did not experienced any adverse issues or side effects related to the administered VARIVAX dose.; A HBP (responsible for vaccine storage) called to report a TE for VARIVAX that occurred on 02/24/2025 and the vaccine was also inadvertently administered on 02/26/2025.; This spontaneous report was received from an other health professional and refers to a 16-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   It was reported a temperature excursion (TE) for Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) that occurred on 24-Feb-2025.  On 26-Feb-2025, the patient was inadvertently received Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), lot #Y013350, expiration date: 02-Aug-2026, 0.5 mL / once as prophylaxis (Product storage error). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). Operator of device was health professional. It was stated patient did not experienced any adverse issues or side effects related to the administered Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX) dose (No adverse event).
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reported expired dose of PROQUAD was administered.  No other information provided.  No additional AEs/PQC reported.; No additional AEs/PQC reported; This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 03-Mar-2025, the was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), formulation: injection, lot #X021757, expiration date: 23-Feb-2025, 0.5 mL, administered by subcutaneous route (anatomical location was not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not provided) (expired vaccine used). No additional adverse events reported (no adverse event).
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: inadvertently received the PROQUAD vaccine instead of the MMR-II; No additional AE reported; Information has been received from a nurse and referred to a 60-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown date, the patient inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis, instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR-II) (Wrong vaccine administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT)(lot and expiration date were unknown). No other adverse event was reported.
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE; inadvertently administered an expired dose of MMR II; This spontaneous report was received from a physician and referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 03-Mar-2025, the patient was inadvertently administered an expired dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (expiration date: 02-Mar-2025) (dose, route, anatomical site, lot # was not reported) for prophylaxis (expired product administered). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT). No other AE was reported (No adverse event).  This is a non-valid case due to lack of patient's identifies.  Lot # is being requested and will be submitted if received.
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired vaccine used; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported.   On 10-Mar-2025, the patient started therapy with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #X019557, expiration date: 19-Jan-2025) for prophylaxis (expired vaccine used). The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (lot #1950610, expiration date: 11-Oct-2025). Product had not experienced any temperature excursions through the date of administration. No side effects/symptoms were reported at this time (no adverse event).
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; HCP/Medical Assistant called to report that 2 adults received pediatric doses of RECOMBIVAX HB.  One was administered on 3/5/2025 and the other on 2/25/2025. No other information was available at the time of the call.  No adverse effects were reporte; HCP/Medical Assistant called to report that 2 adults received pediatric doses of RECOMBIVAX HB.  One was administered on 3/5/2025 and the other on 2/25/2025. No other information was available at the time of the call.  No adverse effects were reporte; This spontaneous report was received from a physician assistant and refers to an adult patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.   On 05-MAR-2025, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) suspension for injection (RECOMBIVAX HB) 0.5 mL, administered as prophylaxis (strength, Lot No., expiration date, dose number, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). It was reported that the patient received a pediatric dose of the previous mention vaccine (product administered to patient of inappropriate age) (underdose).  No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Reporter's Comments:
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; dose of GARDASIl-9 expired on 1/2/2025 and was administered on 3/18/2025 to a 17-year-old female consumer; This spontaneous report was received from a physician assistant and refers to a 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-Mar-2025, the patient was vaccinated with an expired dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (dose, route, anatomical site, lot #X005044, expiration date: 02-Jan-2025) for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).  Additional information is not expected.
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: No adverse event; HCP/Medical Assistant called to report that 2 adults received pediatric doses of RECOMBIVAX HB. One was administered on 3/5/2025 and the other on 2/25/2025. No other information was available at the time of the call. No adverse effects were reporte; HCP/Medical Assistant called to report that 2 adults received pediatric doses of RECOMBIVAX HB. One was administered on 3/5/2025 and the other on 2/25/2025. No other information was available at the time of the call. No adverse effects were reporte; This spontaneous report was received from a physician assistant and refers to an adult patient of unknown age and gender.   The patient's medical history, concurrent conditions, concomitant medications and previous drugs reactions or allergies were not reported.   On 25-FEB-2025, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) suspension for injection (RECOMBIVAX HB) 0.5 mL, administered as prophylaxis (strength, Lot No., expiration date, dose number, route and anatomical location of administration and vaccination scheme frequency were not provided). It was reported that the patient received a pediatric dose of the previous mention vaccine (product administered to patient of inappropriate age) (underdose).  No additional adverse event was reported (no adverse event).  This is one of two reports received from the same reporter.; Reporter's Comments:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Breakthrough herpes zoster; This non-serious case was reported by a nurse via sales rep and described the occurrence of herpes zoster in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced herpes zoster (Verbatim: Breakthrough herpes zoster). The outcome of the herpes zoster was unknown.   The reporter considered the herpes zoster to be related to Shingrix.     The company considered the herpes zoster to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-MAR-2025 The patient received the shingrix first dose and experienced breakthrough herpes zoster.  Patient received first dose of Shingrix and did not go back for second dose.  Patient had breakthrough case of shingles after receiving only one dose.
Age: 17.0
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 yrs patint administered dose of kinrix; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of inappropriate age at vaccine administration in a 17-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 10-MAR-2025, the patient received Kinrix. On 10-MAR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 17 yrs patint administered dose of kinrix). The outcome of the inappropriate age at vaccine administration was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-MAR-2025 The patient was administered dose of Kinrix at not recommended age due to their facility not having supply of an appropriate vaccine for polio for the patient's age group which led inappropriate age at vaccine administration. The reporter confirmed the patient has not reported any medical concerns or symptoms after been administered the Kinrix. The reporter consented for follow up.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had the vaccine but got shingles/ suspected vaccination failure; had the vaccine but got shingles, got the vaccine milder case but still painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the vaccine but got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had the vaccine but got shingles, got the vaccine milder case but still painful). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine but got shingles, the patient was glad that patient got the vaccine milder case but was still painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: got shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient received the Shingles vaccines and then got shingles. Agonizing, finally was given a nerve block after suffering for a month and a half.  That was helpful finally helped with pain and although not immediate gave the relief. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming 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 completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; am suffering with it no/horrible and I got both shots; 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: am suffering with it no/horrible and I got both shots). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: Follow up information recived on 15-MAR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she recived both shot of Shingles vaccine and suffering with it now and it was horrible.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; awful experience second time with shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: awful experience second time with shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 16-MAR-2025 This case was reported by a patient via interactive digital media. Reporter reported that he/she had awful experience second time with shingles after getting all the preventive shots. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Age: 17.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: patient needed a polio vaccine and they accidentally gave Kinrix; Wrong age/17 year old patient needed a polio vaccine and they accidentally gave Kinrix; 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 17-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   Co-suspect products included Polio vaccine for prophylaxis.   Previously administered products included Pediarix (received in JAN-2008 from lot number AC21B125BB), Pediarix (received in MAR-2008 from lot number AC21B136CA), Pediarix (received in MAY-2008 from lot number AC21B136CA), Ipol (received in JAN-2008), Ipol (received in 16-MAY-2008), Daptacel (received in MAR-2008), Daptacel (received in MAR-2009), Adacel (received in FEB-2019) and Adacel (received in 19-OCT-2020).   On 10-MAR-2025, the patient received Kinrix. On an unknown date, the patient did not receive Polio vaccine. On 10-MAR-2025, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient needed a polio vaccine and they accidentally gave Kinrix) and inappropriate age at vaccine administration (Verbatim: Wrong age/17 year old patient needed a polio vaccine and they accidentally gave Kinrix). 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: 11-MAR-2025 and 12-MAR-2025 Manager explained that a patient needed a polio vaccine, and they accidentally gave Kinrix without noticing that it was not recommended for that age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The patient was administered a dose of Kinrix due to their facility not having a supply of an appropriate vaccine for polio for the patient's age group.  The reporter confirmed the patient has not reported any medical concerns or symptoms after being administered the Kinrix. The patient received Prior doses of Diphtheria, Tetanus, Pertussis and Poliovirus vaccines: was received DTaP-Hib combined vaccine (unknown brand) in December 2011. No additional information provided. No additional AE/PQC (adverse event or product quality complaint provided).
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: the 1.0 mL was given to a pediatric patient; the 1.0 mL was given to a pediatric patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 15-month-old male patient who received HAV (Havrix adult) for prophylaxis.   On 13-MAR-2025, the patient received the 1st dose of Havrix adult. On 13-MAR-2025, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: the 1.0 mL was given to a pediatric patient) and overdose (Verbatim: the 1.0 mL was given to a pediatric patient). The outcome of the adult product administered to child and overdose were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-MAR-2025 A Registered Nurse called just to have some information an adult Hepatitis A vaccine, and reported that the 1.0 milliliter of Havrix (adult dose) was given to a pediatric patient which led to adult product administered to child and overdose.  She just wanted, kind of get more information, other than potential increase of local reactions is there anything else that we need to be aware of.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient; supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVB043A, expiry date 31-JUL-2025) for prophylaxis.   On 14-MAR-2025, the patient received Menveo. On 14-MAR-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient) and inappropriate dose of vaccine administered (Verbatim: supplied diluent of Menveo (2-vial) was mixed with another sterile diluent and administered to the patient). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date:17-MAR-2025 The reporter stated that Menveo 2-vial was not reconstituted with the supplied diluent, but with another sterile diluent, and administered to a patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate Schedule of Vaccine; 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 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 17-MAR-2025 Pharmacy Student requested data regarding patient who received 1st Shingrix vaccine in 2020 (date unknown), 2nd dose in 2023 (date unknown).  The reporter asked if the patient needs to receive a 3rd dose to complete series or it the 2 Shingrix vaccines was a complete series. The reporter consented to follow up. The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 13-year-old patient who received HBV (Engerix B Junior) (expiry date 09-MAR-2025) for prophylaxis.   On 18-MAR-2025, the patient received the 2nd dose of Engerix B Junior. On 18-MAR-2025, an unknown time after receiving Engerix B Junior, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 18-MAR-2025 A field representative called in stating that had called in requesting data about the administration of a Engerix-B after an expired dose was administered with the dose having expired, which led to expired vaccine used.
Vaccine: FLUR4
Symptoms: Fatigue, Influenza like illness, Pain
Clinical narrative: adult experienced flu like symptoms- tired/ achy; adult experienced flu like symptoms- achy; adult experienced flu like symptoms- tired; Initial information received on 19-Mar-2025 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves Adult and unknown gender patient who experienced flu like symptoms- tired/ achy after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect Influenza Quadrivalent Recombinant Vaccine lot number not reported via intramuscular route in unknown administration site for flu (Influenza) (strength, expiry date was unknown). The information on batch number and expiration date corresponding to the one at time of event occurrence was requested.  On an unknown date the patient developed flu like symptoms- tired/ achy (influenza like illness), (pain) and (fatigue) (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for all the events.
Vaccine: FLUR4
Symptoms: Chills, Immediate post-injection reaction
Clinical narrative: experienced chills immediately after injection for about 20 min; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who experienced chills immediately after injection for about 20 min, after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received (1 dosage form, once) dose of suspect Influenza Quadrivalent Recombinant Vaccine, Intravenous infusion (strength: not reported) (lot number, expiry date: not reported) via intramuscular route in unknown administration site for flu (Influenza).  On an unknown date the patient developed chills immediately after injection for about 20 min (chills) (unknown latency) following the administration of Influenza Quadrivalent Recombinant Vaccine.  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received corrective treatment for the event.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event (duration: 20 minutes)
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion for opened IPOL at 48 F for 10 minutes with no reported adverse event; Initial information received on 18-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age / gender patient who received (opened) IPV (VERO) [IPOL] exposed to temperature excursion at 48 f for 10 minutes with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of (opened) IPV (VERO) Suspension for injection (strength- unknown, expiry date- 21-NOV-2025 and lot W1C831M) via unknown route in unknown administration site for Immunization was exposed to temperature excursion for at 48 f for 10 minutes with no reported adverse event (poor quality product administered) (same day latency).   Reportedly, human error was unknown. There was previous excursion. Reason for excursion was unknown, and the vaccine was administered.   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: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: administration of PENTACEL at an earlier than the recommended scheduled time with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] earlier than the recommended scheduled time 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 pneumococcal vaccine Conj 20V (CRM197) [pneumococcal vaccine Conj 20V (CRM197)]; and diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3V (Vero), tetanus vaccine toxoid (pediarix)on 16-Jan-2025  both for Immunisation.  On 28-Jan-2025, the patient received 0.5ml (Dose 1) (once) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine, Suspension for injection, Strength standard and lot UK167AA with expiry date 31-Oct-2025 via intramuscular route in the right thigh for Immunisation earlier than the recommended scheduled time with no reported adverse event (inappropriate schedule of product administration) (Latency Same day).  Reportedly, Caller confirmed that the patient received Pentacel approximately one month too early. Treatment received: no.  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: 1.25
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: they have a patient who is 15 months and 18 days old who was given adacel instead of daptacel with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months and 18 days old female patient who was administered diphtheria-2/tetanus/5 AC pertussis vaccine [Ada-Cel] instead of DaptaCel 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 Varicella zoster vaccine live (Oka/Merck) (Varivax); and HIB vaccine (Hib) both for Immunisation.  On 05-Mar-2025, the patient received 0.5ml (Dose 4) dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Strength standard, Frequency once and lot 3CA10C1 with expiry date 31-Dec-2025 via intramuscular route in the left thigh for immunization instead of daptacel with no reported adverse event (wrong product administered) (Latency Same day).  Reportedly, A 15 months and 18 days old who was given ADACEL instead of Daptacel. The caller states that this was 4th dose in the tetanus-diphtheria-pertussis vaccination series for the patient and the other doses were given with Vaxelis.  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: 1.5
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: partial administration of PENTACEL component, didn't get the Hib portion of the vaccine, they only got the liquid portion with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 18 months old male patient who had partial administered pentacel component, didn't get the hib portion of the diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)], they only got the liquid portion 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 Hepatitis B vaccine and pneumococcal vaccine conj 15V (CRM197) for Prophylactic vaccination (Immunisation).  On 13-Mar-2025, the patient had partial administered pentacel component, didn't get the hib portion of unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine , powder and suspension for suspension for injection (lot UK109AA) (Expiry date: 30-Sep-2025, Frequency: once, strength: standard) via unknown route in unknown administration site for immunization, they only got the liquid portion with no reported adverse event (single component of a two-component product administered) (Latency: same day).  Reportedly, Caller would like to know does this count as the child being vaccinated or does the child need to be re-vaccinated. Call recording disclosed. Nurse stated that the situation did not happen in the office but in a daycare. They found out about the partial administration of PENTACEL when the parent gave a sheet that says patient received the product, but the Hib (Haemophilus influenzae type B) part was crossed out. For DTap:3rd and for IPV: 3rd dose   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: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Exposure via skin contact, No adverse event, Underdose
Clinical narrative: vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event; vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient who was receiving diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] that didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event and vaccine didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Mar-2025, Caller reported that diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension of injection, (Unknown strength) lot 2CA77C1 with expiry date 30-Apr-2025, for immunization, which didn't go into the patient and it was noted on outside of the patient's leg with no reported adverse event (accidental exposure to product) (exposure via skin contact).  Reportedly. They were using the VanishPoint needle, a needle that retracts into the syringe after injection.They ended up giving the patient another dose of DAPTACEL yesterday after she discussed it with the doctor.  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: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: accidentally administered FLUZONE HD to a 27-year-old pregnant patient with no reported adverse event; Initial information received on 19-Mar-2025 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 27 years old pregnant female patient who was exposed to  influenza usp trival a-b high dose subvirion vaccine [Fluzone HD] which was accidentally administered  with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported accidentally administered FLUZONE HD to a 27-year-old pregnant patient with no reported adverse event  .The reported event occurred at 32 weeks and 4 days of pregnancy.  The date of last menstrual period was not reported. The estimated due date is May-2025. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  Concomitant medications included RSV vaccine for Immunisation.  On 19-Mar-2025, the patient accidentally administered 0.5 ml  dose of suspect influenza usp trival a-b high dose subvirion vaccine, Suspension for injection in pre-filled syringe ,lot UT8437AA,expiry date:30-Jun-2025,Strength = High Dose and frequency:once, via intramuscular route in the right deltoid for influenza immunization [immunization] during pregnancy with no reported adverse event (exposure during pregnancy) (latency :same day)  Reportedly there were no symptoms or adverse event during the call.  Action taken  was not applicable.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient administered expired IPOL with no reported adverse event; Initial information received on 20-Mar-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 4 years old male patient who administered expired IPV (VERO) [IPOL] 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 Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Daptacel) and Measles vaccine live (Enders-Edmonston), Mumps vaccine live (Jeryl Lynn), Rubella vaccine live (Wistar RA 27/3), Varicella zoster vaccine live (Oka/Merck) (Proquad) for prophylactic vaccination (Immunisation).  On 05-Mar-2025, the patient received a dose of 0.5 ml of expired IPV (VERO), suspension for injection (lot W1A191M, expiry date: 16-Feb-2025, strength: standard and frequency: once) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation) with no reported adverse event (expired product administered) (Latency: same day).  Reportedly, They wanted to know the next steps that they needed to take with the patient's immunization.  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.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Patient received Arexvy while she was pregnant; patient received Arexvy instead of Abrysvo; patient received Arexvy instead of Abrysvo; This non-serious retrospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On an unknown date, the patient received Arexvy and did not receive Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient received Arexvy while she was pregnant), wrong vaccine administered (Verbatim: patient received Arexvy instead of Abrysvo) and drug use in unapproved population (Verbatim: patient received Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and drug use in unapproved population were not applicable.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Exposure (Abrysvo): Trimester unknown Pregnancy Outcome: Live neonate with a congenital anomaly   See case US2025AMR030558 for details regarding the baby case.   Additional Information: GSK Receipt Date: 12-MAR-2025 A pharmacist mentioned that a patient received Arexvy instead of Abryvso while she was pregnant, which led to Wrong vaccine administered, Drug use in unapproved population and Vaccine exposure during pregnancy. The pharmacist asked if GlaxoSmithKline had any study showing a correlation of giving Arexvy to pregnant women and respiratory issues in newborns.; Sender's Comments:  US-GSK-US2025AMR030558:Child case
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site abscess
Clinical narrative: Developed an injection site abscess
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: local skin reaction at vaccine site, left upper arm mild itchiness. Redness & swelling, mild nausea, head ache and fatigue. Cold compresses, Benadryl and Tylenol as needed upper arm pain. Began about 2 hours after vaccine given with symptoms peak 24 hours after.
Age: 64.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site swelling, Local reaction, Nausea
Clinical narrative: local skin reaction at vaccine site, left upper arm mild itchiness. Redness & swelling, mild nausea, head ache and fatigue. Cold compresses, Benadryl and Tylenol as needed upper arm pain. Began about 2 hours after vaccine given with symptoms peak 24 hours after.
Age: 11.0
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient who received first dose of GARDASIL 9 at 11 years of age came to their facility at 20 years of age to complete the series; No additional AE details provided; This spontaneous report was received from Other health professional and refers to a 20-year-old patient of unknown gender.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On an unknown date (reported as at 11 years of age), the patient was vaccinated with 1 dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (strength, frequency, route of administration, site of administration, vaccination scheme, expiration date, and lot # were not reported). On unknown date (reported as at 20 years of age), the patient went to the facility to complete the series with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), (strength, frequency, route of administration, site of administration, vaccination scheme, expiration date, and lot # were not reported) as a prophylaxis (Inappropriate schedule of product administration). No additional AE details provided was unknown.