chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: ACTHIB that was administered past the expiration date, 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 2 years old and unknown gender patient who was administered with HIB (PRP/T) vaccine [ACT-HIB] past the expiration date, 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 3-component, Tetanus vaccine toxoid (Infanrix); Hepatitis a vaccine inact (Havrix); and Pneumococcal vaccine conj 13v (CRM197) (Prevnar 13) all for Immunisation.  On 01-Apr-2025, the patient received 0.5 ml of dose 1 of HIB (PRP/T) vaccine (Powder and solvent for solution for injection) with standard strength (expiry date- 31-Mar-2025 and lot UK0258A) via intramuscular route in the right thigh for Immunization past the expiration date, with no reported adverse event (expired product 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.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: inappropriate use due to administration of the liquid dtap-ipv portion of pentacel only. the act-hib was not administered to the patient 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 19 months old female patient who recieved diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] was exposed to  inappropriate use due to administration of the liquid dtap-ipv portion of pentacel only. the act-hib was not administered to the patient 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 a vaccine, Measles vaccine, Mumps vaccine, Rubella vaccine ;and Varicella zoster vaccine  all for Immunisation.  On 20-Mar-2025, the patient received a dose 4  of 0.5 ml dose  of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine,Suspension for injection, lot UK167AA,expiry date :31-oct-2025,Strength = standard, frequency :once ,via intramuscular route in the lower right thigh for immunization was exposed to inappropriate use due to administration of the liquid dtap-ipv portion of pentacel only. the act-hib was not administered to the patient with no reported adverse event (single component of a two-component product administered) (latency: same day).  Reportedly,The ACTHIB was not administered to the patient. Nurse reported that a patient received only the DTAP-IPV portion of PENTACEL.The patient did not receive the ACTHIB portion at their facility. The physician noted that the patient did not require ACTHIB, but if they wanted to receive the dose they could obtain it at the health department.  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.
Vaccine: FLU3
Symptoms: Device connection issue, Exposure via skin contact, No adverse event, Underdose
Clinical narrative: the needle wasn't all the way attached and it came out and rolled down the patient's arm with no reported adverse event; the needle wasn't all the way attached and it came out and rolled down the patient's arm with no reported adverse event; the needle wasn't all the way attached and it came out and rolled down the patient's arm with no reported adverse event; Initial information received on 03-Apr-2025 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a patient with unknown age and gender on whom Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] fell and came into contact with patient's arm 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 suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8496JA, expiry date 30-Jun-2025; strength not reported) for Immunization.   On an unknown date, while administering the dose to the patient the needle wasn't all the way attached and it came out and rolled down the patient's arm with no reported adverse event (accidental exposure to product), (exposure via skin contact) and (Incomplete dose administered) (latency same day).  Reportedly, the pharmacist was administering the Fluzone NP PFS-during the process the needle wasn't all the way attached or something and some of the vaccine came out and rolled down the patient's arm. During the administration, more than half of the vaccine went into the patient but about of third of it leaked out.  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: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: administering an expired acthib to a patient with no reported ae; Initial information received on 03-Apr-2025 regarding an unsolicited valid  non-serious case received from  a other health professional.  This case involves a 1 year and 3 months old male patient who was administered with expired HIB (PRP/T) vaccine [ACT-HIB] with no reported AE (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.  On 03-Apr-2025, the patient was administered with expired dose of 0.5ml (dose 4) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection standard strength, lot UK025AA, expiry date- 31-Mar-2025, frequency once, via intramuscular route in the left thigh for Immunization and was administered with expired vaccine with no reported ae (Expired vaccine used) (latency-same day).  Reportedly- The vaccine expired 3 days ago. It was a medical assistant who administered the expired vaccine to the patient.  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.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Ipol was administered post excursion with no reported adverse event; Initial information received on 03-Apr-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case was linked to US-SA-2025SA098047  This case involves a patient with unknown age and gender who was administered to IPV (Vero) [Ipol] (opened) post excursion 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 suspect IPV (Vero), Suspension for injection (lot X1D141M, expiry date 31-Oct-2026; strength not reported) for Immunization and Ipol was administered post excursion with no reported adverse event (poor quality product administered)    Reportedly, temperature excursion of negative disposition -max/lowtemperature reached: 24.2 ° F with duration of 12 hours. There was no previous excursion and no humar error involved. The product was administered after the excursion and extended stability data does not 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-2025SA098047:General vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Patient received diluent only in the back of patients arm; Patient received diluent only in the back of patients arm; This non-serious case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included infection.   On an unknown date, the patient received Shingrix (unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Patient received diluent only in the back of patients arm) and inappropriate dose of vaccine administered (Verbatim: Patient received diluent only in the back of patients arm). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were not applicable.   Additional Information: GSK Receipt Date: 31-MAR-2025 The reporter did not know this was which dose of the Shingrix vaccine. The patient with Infection only given diluent. Practice manager informed that the nurse did not reconstitute Shingrix vaccination and patient received diluent only in the back of patients arm which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 60.0
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; I have a very light case of them on my thigh; 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: I have a very light case of them on my thigh). 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 and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-APR-2025 This case was reported by a patient via interactive digital media. Consumer reported got the shot at the required age of 60. He/she was thankful for that he/she did.  They may had lowered the age now. Consumer reported his doctor thinks they had a very light case of them on thigh.  Patient only had 2 spots. Patient got in the next day which started as nerve itching on the thigh. Consumer physician gave an antiviral medication the next day to the patient had symptoms.  Consumer reported yes, he /she believes getting the shot and the medication, catching it early had decreased the symptoms and get the shot.  Anyone that was suffering from severe pain she said t,hey prescribe gabapentin also which helps with the nerve pain. 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 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: 3.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a three-year-old patient after administrating Boostrix instead as a fourth dose; Boostrix administration out of the recommended age; 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 3-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number X449Y, expiry date 20-OCT-2026) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis.   On 25-JAN-2025, the patient received Boostrix. On an unknown date, the patient received Infanrix. On 25-JAN-2025, an unknown time after receiving Boostrix and not applicable after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: a three-year-old patient after administrating Boostrix instead as a fourth dose) and inappropriate age at vaccine administration (Verbatim: Boostrix administration out of the recommended age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 31-MAR-2025  A Medical Assistant asked if they need to give an extra dose of Infanrix to a three-year-old patient after administrating Boostrix instead as a fourth dose in the administration schedule. The patient received Boostrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Vaccine: DTAP, DTAPHEPBIP, HEP, HEPA, MENB, MNQ
Symptoms: Product storage error
Clinical narrative: Bexsero, Engerix-B, Havrix, Menveo, Infanrix and Pediarix were administered to patients; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) (batch number FH443, expiry date 30-SEP-2027) and (batch number A274J, expiry date 30-SEP-2027) for prophylaxis.   Co-suspect products included HBV (Engerix B) (batch number 95BJ9, expiry date 26-JUL-2026) for prophylaxis, HAV (Havrix) (batch number A3X2K, expiry date 07-SEP-2026) for prophylaxis, DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) and (batch number 9KB9G, expiry date 07-JUL-2026) for prophylaxis, Men ACWY-CRM NVS (Menveo) (batch number X7R4B, expiry date 30-SEP-2025) and (batch number LN75D, expiry date 30-SEP-2025) for prophylaxis and DTPa-HBV-IPV (Pediarix) (batch number 5YB7L, expiry date 29-NOV-2026) and (batch number D252F, expiry date 10-APR-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, the patient received Engerix B, Havrix and Infanrix. On an unknown date, the patient received Menveo. On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Bexsero, Engerix B, Havrix, Infanrix, Menveo and Pediarix, the patient experienced incorrect storage of drug (Verbatim: Bexsero, Engerix-B, Havrix, Menveo, Infanrix and Pediarix were administered to patients). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 03-APR-2025 A medical assistant wanted to confirm the stability of Pediarix, Rotarix (1 vial), Havrix, Engerix-B, Kinrix, Infanrix, Menveo (1 vial) & Bexsero after a below temperature excursion of 18.98°F for 2 hours and 55 minutes that occurred on March 7, 2025 which led to incorrect storage of drug.  During that period of time some of them (Bexsero, Engerix-B, Havrix, Menveo, Infanrix and Pediarix) were administered to patients without knowing that these vaccines had been through this temperature excursion, so the agent tried to collect the adverse event details (given that they were no longer viable according to the excursion data provided), but the healthcare professional only had their lot number and expiration date and mentioned she needed to review all the information that they had in order to know how many and which patients received the vaccines and, after gathering everything, she will be calling back medical information to provide all the left information needed, so case number was provided.
Sex: F
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: 10065066--DEVICE CONNECTION ISSUE^ 10069327---PRODUCT QUALITY ISSUE Leuer lock detaches from vaccine syringe
Sex: F
Vaccine: RSV
Symptoms: Product quality issue
Clinical narrative: 10069327---PRODUCT QUALITY ISSUE FROM: RSV vaccination Abrysvo Lot number LN5492 date of expiration 10/25, 2 vials will not pop down the center to mix the medication.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Electroencephalogram normal, Seizure
Clinical narrative: Pt received Merck MMR vaccine 2/24/25 and on 3/5/25 experienced a seizure. Patient was admitted overnight 3/5/25 and had a normal EEG. Pt followed up with PCP (reporting institution) 3/14/25
Age: 60.0
Sex: F
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: When preparing an abrysvo vaccine, the Lure lock form the transfer vial came off. This resulted in the NP being unable to pull the vaccine contents back into the syringe. The transfer apparatus was not able to be removed form the vial, dose was wasted.
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Balance disorder, Loss of consciousness
Clinical narrative: EVENT: PATIENT HAD AN EPISODE OF NOT BEING ABLE TO GET UP OFF BATHROOM FLOOR. TAKEN BY AMBULANCE TO HOSPITAL NO CLEAR DIAGNOSIS. HE PREVIOUSLY HAD AN EPISODE OF PASSING OUT. BROUGHT TO LOCAL HOSPITAL BY AMBULANCE. THIS WAS IMMEDIATELY FOLLOWING A BLUE LIGHT TREATMENT TO HIS SCALP AT THE DERMATOLOGIST'S. HAD A FLU SHOT THE DAY BEFORE. PATIENT MENTIONS HE CONTINUES TO HAVE BALANCE PROBLEMS
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Condition aggravated, Migraine, Multiple sclerosis relapse
Clinical narrative: Patient reports worsening of migraines and hospitalization for 5 days for migraine. Patient reports new diagnosis of anemia and scheduled for colonoscopy in 2 weeks. Patient reports an MS relapse in 2020 after COVID vaccine.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Patient in clinic for the Shingrix vaccine. Received the diluent component only as the vaccine was not reconstituted.
Age: 63.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Severe nausea, diarrhea and stomach cramps occurred about 5 hours after taking Vivotif.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: My father took shingrx four shingles. And now he has AIDP/GBS
Age: 61.0
Sex: M
Vaccine: PNC21
Symptoms: Muscle spasms, Neck pain
Clinical narrative: Received Capvaxive vaccine at annual physical on 03/19/2025. Started to receive neck pain on 3/21/2025. Went to urgent care on 3/25/2025 and was diagnosed with serious neck muscle spasms. Being treated with muscle relaxants and ibuprofen. I never had a negative reaction to any vaccine but wanted to report this due to timing related to vaccination.
Vaccine: VARCEL, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic events reported.; Inbound call from HBP regarding T/E for VARIVAX on 1/29/2025. HBP reported that vaccines were administered to patients.; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-Jan-2025, Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) experienced temperature excursion (T/E) at 14.65 degree Fahrenheit for 13 hours 15 minutes. No previous temperature excursion was reported.  On 21-Mar-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX REFRIGERATOR STABLE) (lot #Y011712, expiration date: 02-Jul-2026) 0.5 mL as prophylaxis. The vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT) (Product storage error). No symptomatic events reported (No adverse event).
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered an Expired Vaccine; Initial report received on 17-Mar-2025.  A medical assistant reported that a 65-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had expired.  No medical history or concomitant medications were reported.  On 17-Mar-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number 941061, expiration date 10-Dec-2024, and NDC number 43528-003-05)] intramuscularly in the left arm. The patient was administered an expired vaccine. No adverse reactions were reported.  No additional information was reported.   Company Comment: ?The company assessed the event as non-serious.; Sender's Comments: ?The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: Blister at the Bottom of the Ear Lobe; A Red Spot, Spread Down the Neck to the Clavicle, It's a Red Rash; Initial report received on 17-Mar-2025.  A consumer reported that she, a 57-year-old female, received non-branded hepatitis B vaccine for hepatitis B immunization and developed a red spot (red rash) on the right side of her neck that spread down to the clavicle and  a blister at the bottom of her ear lobe.  No medical history or concomitant medications were reported.  On 06-Mar-2025, the patient received dose 1 of a hepatitis B vaccine  intramuscularly in the left arm.  On an unknown date, after receiving hepatitis B vaccine, the patient reported a red spot on the right side of her neck that spread down to her clavicle.  She reported this as a red rash.  On 17-Mar-2025, 12 days after receiving HEPLISAV-B, the patient reported that she found a blister at the bottom of her ear lobe. The patient noted the other potential cause of the rash could be imitation large silver hoop earrings she wore on 09-Mar-2025. The patient's rash has improved and is noted to be resolving.  No additional information was reported.    Company Comment: ?The company assessed the events as non-serious.; Sender's Comments: ?The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received Heplisav-B In Late February, and A Second Dose of Engerix Pediatric Dose Today; Initial report received on 27-Mar-2025.   A medical assistant reported that a 57-year-old female (race, ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) as the first dose for hepatitis B immunization  and received ENGERIX-B as the second dose.    No medical history or concomitant medications were reported.    On 11-Feb-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot# 944918, NDC # 43628-0003-05, expiration date not available)] intramuscularly in the left deltoid.   On 27-Mar-2025, 44 days after having been vaccinated with HEPLISAV-B, the patient was given a pediatric dose of a hepatitis B vaccine [ENGERIX-B (Lot#, expiration date, site and route not reported)]..  No side effects were reported.    No other information was available.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received Heplisav-B and then Received Twinrix; Initial report received on 31-Mar-2025.   A pharmacist reported that a 56-year-old male (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and received TWINRIX as the second dose.   No medical history or concomitant medication were reported.    On 31-Dec-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (Lot #, expiration date, NDC#, site and route not reported)].   On 01-Feb-2025, the patient received dose 2 of a hepatitis B vaccine [TWINRIX (Lot # M4B34, expiration date 28-Sep-2026, NDC # not reported)] intramuscularly in the left arm. TWINRIX was given at a different pharmacy due to the patient's insurance coverage. No adverse effects were reported.  No additional information was provided.     Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: redness to skin; This non-serious case was reported by a consumer via call center representative and described the occurrence of skin red in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-APR-2025 11:30, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 07-APR-2025, 3 days after receiving Shingrix, the patient experienced skin red (Verbatim: redness to skin). The outcome of the skin red was not resolved.   It was unknown if the reporter considered the skin red to be related to Shingrix.     It was unknown if the company considered the skin red to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-APR-2025 The case was self reported by patient. The patient received Shingrix vaccine and experienced redness to skin. The patient developed a 4 inch by 2 inch area of redness on his bicep about 5 inches from the injection site. Nothing else was reported.
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: one small spot of a sore one time; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin ulcer in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (Father and mother both get shingles multiply times) and skin ulcer (Father and mother bad with lots of sores).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced skin ulcer (Verbatim: one small spot of a sore one time). The outcome of the skin ulcer was resolved (duration 1 week).   It was unknown if the reporter considered the skin ulcer to be related to Shingles vaccine.     It was unknown if the company considered the skin ulcer to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-MAR-2025 The case was received from the patient via interactive digital media. The patient was reporter. The reporter saw his/her father and mother both get shingles multiply times, bad with lots of sores.  The reporter got the vaccine a few years ago and had only had one small spot of a sore one time. The reporter had heard people say you only get it once, but he/she know his/her parents both suffered with them many times. The reporter had a place on his/her back about a couple inches round.  Lasted about a week before going down.  The reporter thought it was mostly from nerves because of some things going on at that time in their family life.  It looked just like the multiple sores his/her parents had a few years earlier.  The father of the reporter had them all around his midsection more than once.  The last time the mother of the reporter had them it was in her hair and by her ear and almost to her eye.  They were worried it might cause problems with her eyes.  So the reporter had seen and tried to doctor them for his/her parents.; Sender's Comments:  US-GSK-US2025AMR037427:same reporter different patient US-GSK-US2025AMR037429:same reporter different patient US-GSK-US2025AMR037427:same reporter different patient
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero vaccine that vaccination was unrefrigerated for four hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: Bexsero vaccine that vaccination was unrefrigerated for four hours). The outcome of the incorrect storage of drug was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-MAR-2025 The case was received from a consumer via (Bexsero GSK chatbot) interactive digital media. The unrefrigerated Bexsero vaccination for four hours which led to incorrect storage of drug. No further information available.
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; 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: 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 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: 01-APR-2025 This case was reported by a patient via interactive digital media. The patient got the Shingles vaccine 2 years ago in 2023 (from the date of reporting) and still got shingles painful and itchy left side wrapping his/her back . 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 the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine
Vaccine: RVX
Symptoms: Feeling abnormal
Clinical narrative: I feel worse since I received this vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced feeling bad (Verbatim: I feel worse since I received this vaccine). The outcome of the feeling bad was not reported.   It was unknown if the reporter considered the feeling bad to be related to RSV vaccine.     It was unknown if the company considered the feeling bad to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient felt worse since he/she received this vaccine. The follow-up could not be possible as no contact details were available.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got a small outbreak two weeks later; 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.   In FEB-2025, the patient received Shingrix. On an unknown date, more than 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: got a small outbreak two weeks later). 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: 02-APR-2025 This case was reported by a patient via (Shingrix chatbot) interactive digital media. The patient had the shingles vaccination in February 2025, a month ago. The patient got a small outbreak two weeks later.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I had the vaccine and I've had shingles three times; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: I had the vaccine and I've had shingles three times). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     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: 02-APR-2025 This case was reported by a patient via interactive digital media. The patient had the vaccine and have had shingles three times. 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 vaccine Shingles vaccine
Vaccine: VARZOS
Symptoms: Extra dose administered, Pain
Clinical narrative: burning pain at my belt level; got the three shot regiment; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain burning in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine (2 dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain burning (Verbatim: burning pain at my belt level) and extra dose administered (Verbatim: got the three shot regiment). The outcome of the pain burning was not resolved and the outcome of the extra dose administered was not applicable.   It was unknown if the reporter considered the pain burning to be related to Shingles vaccine.     It was unknown if the company considered the pain burning to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-APR-2025 The patient got the three Shingles shot regiment, which led extra dose administered. At the time of reporting the patient felt a burning pain at belt level left of spine and 6 inches up, not all the time, no rash visible yet. It was going on for about 8 months or so.
Vaccine: VARZOS
Symptoms: COVID-19
Clinical narrative: first Shingrix shot in the fall of 2019. Then Covid broke out and I never got the second shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first shot in the fall of 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced social problem (Verbatim: first Shingrix shot in the fall of 2019. Then Covid broke out and I never got the second shot). The outcome of the social problem was not applicable.   Additional Information: GSK Receipt Date: 04-APR-2025 The patient self-reported this case. The patient got the first Shingrix shot in the fall of 2019 and then Covid broke out and he/she never got the second shot.  The reporter asked what should I do now.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got the shingles and prayed to die was in that much pain; 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: still got the shingles and prayed to die was in that much pain). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date:03-APR-2025 This case was reported by a patient via interactive digital media. The patient had gotten both shots still got the shingles and prayed to die was in that much pain. This case was considered as suspected vaccination failure as details regarding 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 the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine( Dose 1 & 2).
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth
Clinical narrative: Warm at the injection site; Itchy at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site warmth 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 injection site warmth (Verbatim: Warm at the injection site) and injection site itching (Verbatim: Itchy at the injection site). The outcome of the injection site warmth and injection site itching were not reported.   It was unknown if the reporter considered the injection site warmth and injection site itching to be related to Shingles vaccine.     It was unknown if the company considered the injection site warmth and injection site itching to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-APR-2025 This case was reported by a patient via interactive digital media. The patient self reported this case for himself/herself. Patient had received the set of vaccines for shingles and experienced nothing at all.  Warmth and itchiness at the injection site were the only indications.
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm swelled up so bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced swelling arm (Verbatim: arm swelled up so bad). Shingles vaccine was discontinued. The outcome of the swelling arm was not reported.   It was unknown if the reporter considered the swelling arm to be related to Shingles vaccine.     It was unknown if the company considered the swelling arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-APR-2025 This case was reported by a patient via interactive digital media. The reporter took the first shot and it was awful. The reporter arm swelled up so bad. The reporter refused to go back and get the second shot. The reporter just pray he/she did not get it.
Age: 57.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: Vaccine was administered inappropriately. Patient received PREVNAR20 2/20/25. Second dose was unncessary.
Age: 27.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine was given on March 10th, three days past beyond use date.  Vaccine had been stored at frozen, then thawed on January 10, 2025 and stored at 2C.  Eight weeks of eligible use in the fridge ended on March 7th.  Patient did not report any adverse events related this to this vaccine administration.  Revaccination was offered to patient and he is considering it.
Age: 0.33
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: The vaccine was given via IM injection rather than by mouth.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles outbreak on back, base of spine; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 75GZ7) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix), duloxetine hydrochloride (Cymbalta), gabapentin, metformin hydrochloride (Metformin), carvedilol, sitagliptin phosphate (Januvia), empagliflozin (Jardiance), sacubitril, valsartan (Entresto), nitrazepam and oxybutynin hydrochloride (Oxybutynin).   On 08-MAR-2025, the patient received the 2nd dose of Shingrix. On 08-MAR-2025, less than a day after receiving Shingrix, the patient experienced shingles (Verbatim: shingles outbreak on back, base of spine). Rechallenge with Shingrix was positive. The outcome of the shingles was resolving.   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.   Linked case(s) involving the same patient:  US2025035987   Additional Information: GSK Receipt Date: 25-MAR-2025 Patient reported that there was shingles outbreaks within 48 hours of second injection of Shingirx. The 2nd outbreak was on back, about 3 times the size of first outbreak at the base of spine.; Sender's Comments:  US-GSK-US2025035987:SAME PATIENT
Age: 17.0
Sex: F
Vaccine: TD
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: Patient given Td on 04/07/2025 vaccine given too soon, patient was due on 06/02/2025. Patient reported headache as of 04/09/2025 headache has subsided .
Age: 65.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Injection site pain, Magnetic resonance imaging abnormal, Muscle oedema
Clinical narrative: Patient developed left arm pain near injection site after she recieved the vaccines above. MRI of the left shoulder did show some edema in her posterior deltoid area.
Age: 1.58
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: PATIENT WAS GIVEN THE 0.3 ML DOSE FROM AN UNDILUTED VIAL. NO ADVERSE SIGN/SYMPTOMS HAVE BEEN NOTICED AT THIS TIME. THE ERROR WAS FOUND WITHIN AN HOUR OF ADMINISTERING THE DOSE TO THE PATIENT AND MOTHER WAS IMMEDIATLEY NOTIFIED. WE EXPLAINED TO MOM THAT Dose does not need repeated and mom knows to watch for local side effects at the injection site (redness, swelling, and tenderness) and systemic effects (decreased appetite, drowsiness, fever, irritability). Mom was very understanding and did not have any further questions.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Urticaria
Clinical narrative: The day following the injections- father reported that there was 2 small "hives" where the injections were given (right deltoid only). He gave her benedryl. Did not have any troubles breathing. Today, the "hives" were gone, but there was slight bruising where the injections were given. He reported information via phone, staff did not see site.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Idiopathic environmental intolerance, Parosmia
Clinical narrative: I developed Multiple Chemical Sensitivities in January of 2022 after receiving injection number 1 on 1/8/21; injection #2 on 1/29/21 - Pfizer Lot#EL9262 and final booster on 12/13/21.  Location DOH - Orange - Pfizer Lot#FJ1620 . I have suffered from smells affecting my normal day to day life.  I have gone to every kind of doctor with no relief.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Chest pain, Dyspnoea, Pain, Pyrexia
Clinical narrative: Patient started having the following symptoms day after receiving vaccine: chest pain, shortness of breath, body ache, backache, and fever for 2 days
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Loss of consciousness
Clinical narrative: Child started to pass out.