chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: gave ACT-HIB using a separate sterile diluent with no adverse event; Initial information received on 28-Mar-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient to whom gave HIB (PRP/T) vaccine [ACT-HIB] using a separate sterile diluent with no 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 suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (lot number, strength and expiry date not reported) via unknown route in unknown administration site for Immunization using a separate sterile diluent with no adverse event (Product preparation error) (Latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, A medical assistant states that one of their medical assistants gave ACT-HIB using a separate sterile diluent, so they want to know if patient needs to be revaccinated and if there is anything that they need to look out for.  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: 56.0
Sex: M
Vaccine: YF
Symptoms: Product preparation error
Clinical narrative: inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event; Initial information received on 31-Mar-2025 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 56 years old male patient for whom yellow fever vaccine - [YF-VAX], inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Mar-2025, the patient received an unknown dose (0.5ml) of suspect yellow fever vaccine; Solution for injection with unknown strength (lot UK125AA with expiry date 30-Oct-2026) via subcutaneous route in the left arm for Immunization, inappropriate use due to being diluted with a diluent that was not supplied by the manufacturer with no reported adverse event (product preparation error) (latency: same day).  Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: intramuscular formulation admistered by other route; administration of ADACEL to a pregnant patient by subcutaneous route with no reported adverse event; Initial information received on 01-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 30 years old pregnant female patient who was inappropriately administered to Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] of intramuscular formulation by subcutaneous route with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.  The reported maternal exporsure during pregnancy occurred at 30 Weeks of pregnancy.  The date of last menstrual period was not reported. The estimated due date is 10-Jun-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.   On 31-Mar-2025, the patient received 0.5mL of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, Suspension for injection (lot UA115AA, expiry date 01-Mar-2026,strength standard and frequency once) via subcutaneous route in unknown administration site for Immunisation and inappropriate use due to the administration of adacel to a pregnant patient by subcutaneous route with no reported adverse event (incorrect route of product administration), (exposure during pregnancy).  Reportedly, there was no other vaccines as concomitants involved.  Action taken was not applicable.  Additionally, at time of reporting, the pregnancy is still ongoing.  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: No adverse event
Clinical narrative: vaccines were administered before they could be quarantined.  One Pentacel vaccine was given with no reported adverse event; Initial information received on 01-Apr-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 with Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (vero)] before they could be quarantined 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 7V (CRM197) (Prevnar) and Rotavirus vaccine LIVE Reassort Oral 5V (Rotateq) for Immunisation.  On 31-Mar-2025 or 01-Apr-2025, the patient received a 0.5ml dose of suspect Diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection standard strength, frequency-once (lot UK225AB, expiry date-unknown) via intramuscular route in unknown administration site for Immunization and was administered before they could be quarantined no reported adverse event (poor quality product administered) (latency- same day).  Reportedly- One Pentacel vaccine was given and two Prevnar vaccines were given.  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: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administration of an expired dose of ACT-HIB, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient who was administration with an expired dose of HIB (PRP/T) Vaccine ACT-HIB], 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 (Dtap) for Immunisation; and Hepatitis b vaccine (Hepatitis b) for Immunisation.  On 01-Apr-2025, the patient received 0.5mL (dose 2) of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection (lot UK010AA, expiry date 28-Feb-2025, frequency once and strength standard) via intramuscular route in the right thigh for Immunisation and administration of an expired dose of act-hib, with no reported adverse event (expired product administered) (latency same day).   Reportedly, ACT-HIB was administered to a patient but they did not noticed that the vaccine was expired. They need to see what they need to do on their side.  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered ACTHIB with diluent that was not provided with the ActHIB vaccine, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who was administered HIB (PRP/T) Vaccine [ACT-HIB] with diluent that was not provided with the acthib vaccine, 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 (Pneumococcal vaccine); Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr); Influenza vaccine (Influenza) for  and Varicella zoster vaccine (Varicella vaccine) for Immunisation.  On 10-Jan-2025, the patient received 0.5mL (dose 4) of suspect HIB (PRP/T) Vaccine, Powder and solvent for solution for injection (lot UK0218A, expiry date 05-Feb-2028, frequency one and strength standard) via intramuscular route in right VL(abbreviation of VL is not reported) site for Immunisation and it was administered with diluent that was not provided with the ACTHIB vaccine, with no reported adverse event (product preparation error) (latency same day).   Reportedly, Medical assistant called and stated she administered ACTHIB with diluent that was not provided with the ActHIB vaccine. She requested information for appropriate follow-up.  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: 0.17
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administered an expired dose of Act-Hib vaccine to a 2-month-old baby, with no reported adverse event; Initial information received on 02-Apr-2025 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old female patient who received an expired dose of Hib (Prp/T) vaccine [Act-Hib] 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 in Apr-2025, the patient received an expired dose of suspect Hib (Prp/T) vaccine, Powder and solvent for solution for injection, (unknown strength), Expiry date 31-Mar-2025, lot number not reported via unknown route in unknown administration site for prophylactic vaccination (immunisation) with no reported adverse event (Expired product administered) (Latency Same day).  Information regarding batch number corresponding to the one at time of event occurrence will not be available.  Reportedly, medical assistant had administered an Act-Hib vaccine to a 2-month-old baby, noting that the vaccine expired in Mar-2025.She asked whether there is a grace period for using the vaccine past its expiration date.  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: 42.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion/temperature reached: 8.5 °C to 8.8 °C for 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to US-SA-2025SA112035  This case involves a 42 years old male patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] and the vaccine was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone] Suspension for injection (once) (strength- standard, expiry date- 20-Jun-2025and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event (product storage error).   On 14-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the left deltoid for immunization.  Reportedly, reason: Monthly cycle count, inventory checking. There was no previous excursion. Human error was involved. Product was administered post excursion.   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.; Sender's Comments:  US-SA-2025SA114290: US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA112035: US-SA-2025SA113835:
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Max/low temperature reached: 8.5 °C to 8.8 °CDuration: 30 minutes with no reported adverse event; Initial information received on 16-Apr-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case was linked to US-SA-2025SA112035 [master case]   This case involves a 24 years old female patient who received influenza USP TRIVAL A-B subvirion vaccine [Fluzone] and the vaccine was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Apr-2025, influenza USP TRIVAL A-B subvirion vaccine [Fluzone], Suspension for injection (strength- standard, expiry date- 20-JUN-2025 and lot U8442BA) for Influenza immunisation was exposed to temperature excursion where max/low temperature reached: 8.5 °c to 8.8 °c duration: 30 minutes with no reported adverse event (product storage error)(latency: same day).  On 11-Apr-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B subvirion vaccine via intramuscular route in the left arm.  Reportedly, Human error was involved. Previous Excursion: No. Human was present; Product was administered post excursion. The extended stability data Doesn't cover the excursion.  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.; Sender's Comments:  US-SA-2025SA113179: US-SA-2025SA113257: US-SA-2025SA114290: US-SA-2025SA112035:
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: 2-year-old was administered dose of DAPTACEL which was not due again until 4 years of age with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked t oUS-SA-2025SA113271 (cluster case)  This case involves a 2 years old female patient who received a dose of Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] which was not due again until 4 years of age 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 Measles vaccine, Mumps vaccine, Rubella vaccine (MMR) and Varicella zoster vaccine (Varicella vaccine) both for Immunisation.  On an unknown date, the patient received an unknown dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, Suspension for injection, (unknown strength, expiry date and lot number not reported,) via unknown route in unknown administration site for immunization  On 17-Apr-2025, the patient received an extra 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine, Suspension for injection, Strength Standard, frequency once, Expiry date 31-Aug-2026, lot 3CA55C1 via intramuscular route in the right thigh for immunization, which was not due again until 4 years of age with no reported adverse event (Extra dose administered) (Latency Same day).  Action taken was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SA-2025SA113271:IPOL
Vaccine: FLUX
Symptoms: Condition aggravated, Multiple sclerosis pseudo relapse
Clinical narrative: Multiple sclerosis (MS) pseudorelapse; This literature report (initial receipt 25-Mar-2025) concerns a unknown patient who was diagnosed with relapsing multiple sclerosis (RMS).  Patients with RMS aged 18-55 years were grouped into three cohorts: cohort 1 (C1) received the influenza vaccine (trade name, manufacturer and lot number not reported - to be requested upon follow up) >/= 2 weeks before starting ofatumumab (OMB); cohort 2 (C2) received the vaccine >/= 4 weeks after starting OMB; and cohort 3 (C3) was currently being treated with interferon/glatiramer acetate and received the influenza vaccine =4 weeks after enrollment.  One patient from cohort 2 experienced a serious adverse event (AE) (Multiple sclerosis (MS) pseudorelapse).; Reporter's Comments: Causality : Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. The event Multiple sclerosis pseudo relapse has no biological or pharmacological plausible relation for the product contributing to the event. The nature of underlying disease with tendency to relapse provide an alternative explanation.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Pt developed pain in R deltoid that has persisted for approx 3 months, pain is gradually improving. Occasionally radiates to R side of neck
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got shingles right after the vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced shingles (Verbatim: got shingles right after the vaccine). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 18-APR-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got shingles right after the (Shingrix) vaccine.
Vaccine: VARZOS
Symptoms: Pain, Skin discolouration, Vaccination failure, Zoster sine herpete
Clinical narrative: Suspected vaccination failure; internal 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 zoster sine herpete (Verbatim: internal shingles). The patient was treated with gabapentin, lidocaine, naproxen and tramadol. The outcome of the vaccination failure was not reported and the outcome of the zoster sine herpete was not resolved.   It was unknown if the reporter considered the vaccination failure and zoster sine herpete 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 zoster sine herpete to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-APR-2025 This case was reported by a patient via interactive digital media. The reporter reported that he/she was dealing with it now.  His/her were considered internal shingles, a few spots on his/her back but no blisters.  The pain started with what felt like I was being stabbed in the back.  He/she went to urgent aid, and they sent him/her to the Emergency Room checking for heart issues or a pulmonary embolism.  After a day in the hospital, he/she ended up on gabapentin, lidocaine patches, antibacterial medications, prescription strength naproxen and tramadol.  After 10 days he/she went off everything except the Naproxen and lidocaine patches.  The pain was still there but at least after almost 3 weeks it was no longer excruciating.  He/she had the vaccine, could not imagine how bad it would have been without it.  Get the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for zoster sine herpete and laboratory confirmation regarding zoster sine herpete were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Pediarix expired with expiration date April 11, 2025 was administered to a patient in April 15, 2025; 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 14-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number PE24L, expiry date 11-APR-2025) for prophylaxis.   On 15-APR-2025, the patient received Pediarix. On 15-APR-2025, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Pediarix expired with expiration date April 11, 2025 was administered to a patient in April 15, 2025). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 16-APR-2025 Medical assistant called to report a Pediarix expired with expiration date April 11, 2025 was administered to a patient in April 15, 2025 which led to expired vaccine used.
Vaccine: HEPA
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 patient who received HAV (Havrix) (batch number AHAVB349BA) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-APR-2025 CMA (clinic assistant manager) was trying to obtain a lot number for what she stated was a Havrix vaccine.  She stated that according to what she was looking at, the vaccine expired in 2006 but was administered in 2010, which led to expired vaccine used. Upon checking the lot number with the batch number tool, it did not pull up as a vaccine. However, the HCP stated that it said Havrix. The Vaccine Administration Facility is the same as Primary Reporter. The reporter declined to provide any patient information and declined followup.
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: unfortunately some of them have been administered intramuscularly; This non-serious case was reported by a other health professional via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in specified number of patient who received MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Priorix (intramuscular). On an unknown date, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: unfortunately some of them have been administered intramuscularly). The outcome of the subcutaneous injection formulation administered by other route was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-APR-2025 The Clinical Pharmacy Manager called to inform the following about Priorix vaccine but unfortunately some of them had been administered intramuscularly, which led to subcutaneous injection formulation administered by other route. The reporter clarified that two patients had received Priorix via intramuscular administration.  The gender of the patients was unknown, as well as other details such as lot number, expiration date or date of administration. The reported consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Started at around 12:00am same night I received the vaccine. Woke up with large very itchy hives on both inner thighs, inner arms, armpits, Has continued every night since. Took Allgra hives medication about 2 days later which seems to calm the hive down but they return next night.  Several days later, experienced swelling on left side of upper lip and swollen bottom lip. Used ice to calm down. Returned again  when bottom lip swelled again. Went to local walk in clinic. Doctor mentioned that the swelling of lip might have more to do with my blood pressure med and that I should see my doctor. He prescribed a 5 day steroid. I am on day 3. Went to see my doctor who prescribed and different bp med and recommended that I see an allergist. Have appointment next week.  This morning woke up with hives on inner left and right arms and inner thighs (l&r).
Age: 28.0
Sex: F
Vaccine: HEP, MMR, UNK, VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: Pt states sx's started eve of 4/21/25. Pain, warmth, redness, itching. Not relieved by cold, heat, benadryl.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Patient complains of dizziness a minute after the admonition of HPV9. She recovered after 5 minutes.
Age: 19.0
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: No additional AE/PQC; HCP called to ask if a 19 year old patient received a pediatric dose of VAQTA will it be counted as valid or they should restart the adult vaccine The dose was administered on 03/12/2025.  No symptoms reported. Consent was provided to follow up with; This spontaneous report was received from a licensed practiced nurse (LPN) via a company representative referring to a 19-year-old patient of unknown gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 12-MAR-2025, the patient was vaccinated with a pediatric dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25/0.5 (0.5 ml once, lot#: y006122, expiration date: 17-MAY-2025) via route of intramuscular (IM) for prophylaxis by a healthcare professional (underdose). No additional adverse events were reported (no adverse event).
Vaccine: DTPPVHBHPB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: here were no symptomatic events from the patient. No additional AE; a patient was co-administered VAXELIS and PEDVAXHIB. Both products contain the Haemophilus b Conjugate in the vaccines; This spontaneous report was received from Other health professional and refers to a 2-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, past drug reactions and allergies were not reported.   On 21-APR-2025, the patient was co-vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), Injection 0.5 mL and with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine (VAXELIS), Injection 0.5 mL; both administered as prophylaxis (route of administration, anatomical site of injection, vaccination scheme frequency, lot number and expiration date were not reported for any of the administered vaccines). Both products contain the Haemophilus b Conjugate in the vaccines (Overdose). There were no symptomatic events, and no additional adverse event was reported for the patient.
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HCP called to report inadvertent administration of expired VAQTA to a patient. Vaccine expired on 12APR2025 and was administered to a patient on 22APR2025. Limited patient demographics provided. No additional AE/PQC. No additional information.; This spontaneous report was received from other health professional and refers to a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 22-Apr-2025, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA), lot #X025482, expiration date: 12-Apr-2025, administered for prophylaxis (dose, strength, route of administration and anatomical site of injection where not provided) (Expired product administered).  Limited patient demographics was provided. No additional adverse event and no additional information were provided (no adverse event).
Age: 47.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse event (AE); Pharmacist reports 47 year old female received first dose of GARDASIL 9 on 3/24/2025; This spontaneous report was received from a Pharmacist on 21-Apr-2025 and refers to a 47-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 24-Mar-2025, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (GARDASIL) (strength, dose, route, lot # and expiration date were not reported) for prophylaxis (Product administered to patient of inappropriate age). No additional adverse event (AE).   Lot # is being requested and will be submitted if received.
Age: 68.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered Infanrix to adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 68-year-old female patient who received DTPa (Infanrix) (batch number 47Y5M, expiry date 06-JUN-2026) for prophylaxis.   On 14-APR-2025, the patient received Infanrix. On 14-APR-2025, an unknown time after receiving Infanrix, the patient experienced adult use of a child product (Verbatim: administered Infanrix to adult patient). The outcome of the adult use of a child product was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-APR-2025 The reporter administered DTAP instead of TDAP to an adult female patient, which led to adult use of a child product.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st Twinrix dose was administer on 02-MAR-2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX) and Hepatitis b vaccine rHBsAg (yeast) (Heplisav b).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st Twinrix dose was administer on 02-MAR-2025). The outcome of the incomplete course of vaccination 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 : 14-APR-2025 The reporter were given a patient a dose of twinrix, on the 2nd of march and they followed the 0,1,6 month vaccine schedule but apparently they had a floater pharmacist who had given the 2nd dose Heplisav instead of Twinrix. Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: shingrix adjuvant only given; shingrix adjuvant only given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: shingrix adjuvant only given) and inappropriate dose of vaccine administered (Verbatim: shingrix adjuvant only given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 14-APR-2025 The patient received Shingrix adjuvant only which led inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: significantly reduced my cold sore episodes; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of unexpected therapeutic effect in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (I've also had shingles at least three times) and cold sores (I have had bad cold sores since I was a child). Previously administered products included methotrexate with an associated reaction of herpes zoster (since I started methotrexate in 2016).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: significantly reduced my cold sore episodes). The outcome of the unexpected therapeutic effect was not applicable.   Additional Information: GSK Receipt Date: 15-APR-2025 Consumer reported that he/she had bad cold sores since was a child, and it only got worse since started methotrexate in 2016. Consumer also had shingles at least three times. Consumer reported about not sure if they're related but received the Shingrix vaccine in 2020 when patient was 25years old and it significantly reduced cold sore episodes. Patient was a huge abreva fan, especially if he/she not able to get valaciclovir prescribed quickly. Consumer It was expensive but find it lessens healing time by about half.
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Developed rash after vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Developed rash after vaccine). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-APR-2025 The patient self-reported this case. The patient developed rash after Shingrix vaccine
Sex: F
Vaccine: RVX
Symptoms: Cough, Fatigue, Malaise
Clinical narrative: Coughing; exhausted; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   In OCT-2024, the patient received RSV vaccine. In OCT-2024, 2 days after receiving RSV vaccine, the patient experienced sickness (Verbatim: Sick). On an unknown date, the patient experienced cough (Verbatim: Coughing) and exhaustion (Verbatim: exhausted). The outcome of the sickness, cough and exhaustion were not reported.   It was unknown if the reporter considered the sickness, cough and exhaustion to be related to RSV vaccine.     It was unknown if the company considered the sickness, cough and exhaustion to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 14-APR-2025 This case was reported by a patient's husband via interactive digital media. The patient and reporter got the RSV shot in October and 2 days later they got very sick. The patient and the reporter were coughing, sick and exhausted for more than 6 months. This case is linked with case US2025AMR046636, reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR046636:Same reporter
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had shingles this year (24); This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I had shingles this year (24)). 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: 18-APR-2025 This case was reported by a patient via interactive digital media.  Reporter stated that he/she had shingles this year in 24 and stated believe me hurt. Patient also had the 2 shots and he/she was sure they would have been so much worse. Patient indicated that his/her were small but oh the pain. 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  clinical description, time to onset and  laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1 & 2).
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Haemorrhage, Herpes zoster, Neuralgia, Peripheral swelling
Clinical narrative: nerve pain; Suspected vaccination failure; diagnosed with Shingles on arm today/ white swollen line at first. Next day had 6 red spots that bled; 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 16-APR-2025, 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: diagnosed with Shingles on arm today/ white swollen line at first. Next day had 6 red spots that bled). On an unknown date, the patient experienced nerve pain (Verbatim: nerve pain). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved and the outcome of the nerve pain was resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve pain 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 and nerve pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 16-APR-2025 This case was reported by a patient via interactive digital media. The patient reported he/she was diagnosed with Shingles on arm today.  It started on vacation and waited to come home to their own doctor.  It was a white swollen line at first and next day had 6 red spots that bled and nerve pain.  The patient had both shingles shots so did not think they could get it, but still can get it (Shingles). The patient reported it as a mild case and did not need the antibiotics and if it spreads they will be put on antibiotics.  The patient reported he/she was not in pain and putting antibiotic cream on it twice a day.  The patient suggested to others get the vaccine shots. The patient stated he/she so glad they did got vaccine or I would be in pain and have a bad case. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine (Dose 1 and Dose 2).