chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was unaware of previous doses. MD told patient at his most recent appointment that he needed to get Shingrix. However when I went to document the vaccine in system, it shows that the patient received both doses via his primary care in 11/2023 and 01/2024
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Rash
Clinical narrative: headache, dizziness, rash across the torso treated with Benadryl every 4 hours, ongoing
Age: 0.83
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong patient received product
Clinical narrative: Hep A given to the wrong sibling, given to the 10 month old younger sibling of the patient it was intended for
Age: 17.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Injection site erythema, Injection site reaction, Pyrexia, Rash macular, Streptococcus test negative
Clinical narrative: Recieved Trumenba and Flulaval vaccine in left deltoid on 01/27/25. Patient returned to office on 01/29/25 reporting rash and fever. Patient/caregiver state sore throat (scratchy throat) and cough began 1-2days before given vaccines. Patient/caregiver report fever and rash began on 01/27/25 after vaccination. Rash: site of rash: (left deltoid with macular serpiginous rash/ +erythema/no signs infection otherwise)
Age: 41.0
Sex: F
Vaccine: YF
Symptoms: Chills, Dizziness
Clinical narrative: PATIENT EXPERIENCED CHILLS ALONG WITH DIZZINESS, ALSO ACCORDING TO PATIENT HEART WAS BETEAING RAPIDLY .
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Patient's parent reported on 1/30/2025 at 3:23pm that patient developed a "golf-ball sized knot" at approximately 12:00pm on 1/30/2025 at the injection site where she received her HPV vaccine the day prior. Patient also reports mild pain around the site. No other symptoms reported. Parent states that after her first HPV vaccine, the patient experienced only mild site pain. Parent was advised to contact primary care provider.
Age: 76.0
Sex: M
Vaccine: PNC20
Symptoms: Condition aggravated, Gout
Clinical narrative: Severe gout flare - pt is on allopurinol 100 mg for prevention and stated never had flares prior to vaccination. Currently prescribed indomethacin 50 mg to treat flares
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, VARCEL
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Pt briefly lost consciousness approx. 10-15 minutes post vaccination. Witnessed by mother and clerical staff. Medical staff called to lobby. Pt awake and alert appearing pale. No s/s of respiratory distress noted.  O2 saturation 99%. Pulse:77. BP:108/82 with pt moving arm frequently.  Pt assessed by APN.  Pt ambulatory with steady gait, interactive with staff, and pallor greatly improved just a few minutes after incident. Dc'd home with mother.
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash, Rash macular
Clinical narrative: Patient experienced the beginning of a rash starting on right side of tors on 1/10/25 which subsequently spread to torso (abdomen, sides of torso and back, upper arms about 2 weeks after initial administration of the vaccine.  Experienced moderately severe itching with the breakout of many red spots lesions.  Sought treatment at dermatology office on January 28th  for diagnosis and treatment (contact physician's office for full details).
Age: 71.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pityriasis rosea, Skin lesion
Clinical narrative: Patient experienced the beginning of a rash starting on right side of tors on 1/10/25 which subsequently spread to torso (abdomen, sides of torso and back, upper arms about 2 weeks after initial administration of the vaccine.  Experienced moderately severe itching with the breakout of many red spots lesions.  Sought treatment at dermatology office on January 28th  for diagnosis and treatment (contact physician's office for full details).
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Throat tightness
Clinical narrative: Patient began scratching lower left arm approximately 3 minutes after vaccine administration. At approximately 15 minutes post-injection, patient stated she felt like her throat was closing
Age: 8.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Blood glucose normal, Immediate post-injection reaction, Incontinence, Seizure, Syncope
Clinical narrative: Following vaccination patient had an immediate episode of syncopy with some seizure activity. Also had incontinence.. Mom reported history of syncope with previous vaccines. This was not disclosed to clinic staff until after the episode.
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Lethargy, Limb mass, Pain in extremity, Pyrexia
Clinical narrative: Patient experienced a sore arm and bump on her arm for multiple days and felt lethargic and feverish but reports no actual md office or er/urgent care visits.
Age: 0.17
Sex: F
Vaccine: HIBV
Symptoms: No adverse event
Clinical narrative: No adverse event, Revaccination as treatment, no outcomes at this time.
Age: 5.0
Sex: M
Vaccine: DTPPVHBHPB, IPV
Symptoms: Erythema, Pyrexia, Vomiting, Wrong product administered
Clinical narrative: Patient came in to clinic to get updated vaccines. He was due for Dtap and polio and is 5 years old. He was unintentionally given more vaccines than necessary at the time. He was given vaxelis which contains DTaP, IPV, HIB, and Hep B; it is intended for use from 6 weeks to 4 years of age. There was also a separate IPOL (polio/IPV) vaccine given. Reviewing this patients vaccine record, it appears he should have gotten either Kinrix (DTaP & IPV) which is for 4 years to 6 years of age or Infanrix (DTaP) and IPOL (polio/IPV). The MA in charge of the patient and asked (redacted) and (redacted) to perform the vaccines which they did. In the rush and because they just stepped in to help they accidentally gave him the wrong vaccine. The next day patients mom called asking why his vaccines weren't showing up as updated in his chart. As this was being looked into we realized the mistake of the incorrect vaccine. We contacted the state to see what needed to happen and what this all meant. Through this we discovered that all of his vaccines including the ones he was getting updated were still valid but just needed to inform the parents and check for adverse reactions to vaccines as we generally would with any vaccine. Mother was contacted and informed. Mother stated that both of patients arms were red, he had been vomiting and had some fever but confirmed that he was having no problems with breathing. We told her that we would recommend she brought her son in to a provider to be evaluated for his reaction.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperventilation, Laboratory test normal, Loss of consciousness, Vomiting
Clinical narrative: After 24 hours she passed out and when we could get her awake she started throwing up and was hyperventilating
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Contraindication to vaccination
Clinical narrative: No adverse event; HCP called and reported administration of PROQUAD to a patient while on a possible immunosuppressant. A 4-year-old patient is on Dupixent and received a dose of PROQUAD on 17JAN2025. No additional information was known by reporter. No additional AE/P; This spontaneous report was received from nurse concerns to a 4-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions included immunosuppression. Concomitant medications included dupilumab (DUPIXENT).   On 17-JAN-2025, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered for prophylaxis (strength, exact dose, lot #, expiry date, and anatomical route of administration were not provided) to patient while on a possible immunosuppressant (contraindicated product administered).   No additional adverse event.   Additional information is not expected.
Age: 23.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/no PQC reported.; CRT agent transferred nurse who called to report a 4th dose of GARDASIL 9 was inadvertently administered to a patient. Caller stated patient received doses of GARDASIL 9 on 12/29/2023, 3/15/2024, 7/18/2024, and then received 4th dose on 11/1/2024. Ca; This spontaneous report was received from nurse and refers to a 23-year-old patient of unknown gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-DEC-2023, 15-MAR-2023 and 18-JUL-2024 the patient was vaccinated with first, second and third doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, exact doses, lot #, expiry dates, and anatomical routes of administration were not provided). In addition, on 01-NOV-2024, the patient received 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #Y013469 (who had been verified to be a valid number, expiration date reported as 10-OCT-2026) (Extra dose administered).   No additional adverse event.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events were reported; HCP called to report a Temperature Excursion  on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROPQUAD was inadvertently administered after suffering from a T; This spontaneous report as received from a registered nurse and refers to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).  On 14-JAN-2025, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # Y010050, expiration date: 25-NOV-2025, albumin status validated as rHA) (route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with a temperature that reached -11.6 degrees Celsius (C) for 3 hours and 5 minutes (product storage error). Previous excursions could not be confirmed neither if product was still supported. No symptomatic adverse events were reported.      This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2501USA008885: US-009507513-2501USA008877:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events were reported; HCP called to report a Temperature Excursion  on case number 02740636. The case is still ongoing and it could not be confirmed if the products were still supported. The HCP reports that PROQUAD was inadvertently administered after suffering from a Te; This spontaneous report as received from a registered nurse and refers to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions or allergies were not reported. Concomitant medications included sterile diluent (manufacturer unknown).  On 02-DEC-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL (lot # Y013574, expiration date not provided but upon internal validation established as 03-FEB-2026, albumin status rHA) (route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with a temperature that reached -11.6 degrees Celsius (C) for 3 hours and 5 minutes (product storage error). Previous excursions could not be confirmed neither if product was still supported. No symptomatic adverse events were reported.      This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2501USA008885: US-009507513-2501USA008877:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptomatic adverse events were reported; temperature excursion vaccine; This spontaneous report was received from a nurse and refer to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history  On 18-NOV-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # Y004553, expiration date not reported but upon internal validation established as 20-FEB-2026 which was exposed to temperature excursion with the sterile diluent(MERCK STERILE DILUENT), (dose, route, anatomical location were not reported) for prophylaxis. No symptomatic adverse events were reported.  This is one of several reports from the same source.; Sender's Comments:  US-009507513-2501USA008885:
Age: 0.75
Sex: F
Vaccine: HEP, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; Product origin unknown; This spontaneous report was received from a Physician via medical records (MR) regarding a case in litigation and refers to a 9-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 11-JAN-2005, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (manufactured unknown) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). The vaccine could either be hepatitis b vaccine (recombinant) (RECOMBIVAX HB) or hepatitis b vaccine rhbsag (yeast) (ENGERIX B) (Product origin unknown). On 25-APR-2005, the patient received the second dose of hepatitis b vaccine (recombinant) (manufactured unknown) (Inappropriate schedule of product administration). On 26-AUG-2005, the patient received the third dose of hepatitis b vaccine (recombinant) (manufactured unknown) (Inappropriate schedule of product administration).  This is one of the 3 cases referred to the same patient.; Sender's Comments:  US-009507513-2412USA007989: US-009507513-2501USA009383:
Age: 1.33
Sex: F
Vaccine: MMR, MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Inappropriate schedule of vaccine administered; Product origin unknown; This spontaneous report was received from a Physician via medical records (MR) regarding a case in litigation and refers to a 16-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 26-AUG-2005, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufactured unknown) administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); which could either be measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection or  measles vaccine live (schwartz), mumps vaccine live (rit 4385), rubella vaccine live (wistar ra 27/3) (PRIORIX) (Product origin unknown).  On 30-JUN-2009, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided); and the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufactured unknown). On 21-JUL-2009, the patient received the second dose of varicella virus vaccine live (oka/merck) (VARIVAX) (Inappropriate schedule of product administration).  This is one of the 3 cases referred to the same patient.; Sender's Comments:  US-009507513-2412USA007989: US-009507513-2501USA009376: US-009507513-2412USA007989:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: No additional AE/PQC; HCP called to report that MMR II and VARIVAX were inadvertently reconstituted with the diluent for HIBRIX (0.9% NaCl) instead of the Merck diluent provided and administered to the same patient on the same day.  No symptoms reported. No further inform; This spontaneous report was received from a other health professional referred to a patient of unknown age and gender. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On 27-JAN-2025, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1, 0.5 milliliter, intramuscular (strength, anatomical location, vaccination scheme, lot number and expiration date were not reported), for prophylaxis. On the same date, the patient was vaccinated with her/his first dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 milliliter, intramuscular (strength, anatomical location, vaccination scheme, lot number and expiration date were not reported), for prophylaxis. Both vaccines were inadvertently reconstituted with sodium chloride (Manufacture Unknown) diluent for Haemophilus influenzae type b. (HIBERIX) (also reported as "HIBRIX" conflicting information), (product preparation error).  No adverse event was reported.  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event was reported; Nurse calling with a report of an adverse event regarding an expired administration of GARDASIL 9.  Nurse stated that a dose of GARDASIL 9 with a labeled expiration date of 1/2/2025 was inadvertently administered to a patient today, 1/27/2025.  Nurse; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-JAN-2025, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml / two or three dose series, lot #X005044, expiration date: 02-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Medical Assistant calling to report inadvertently administering an expired dose of GARDASIL 9 to a patient.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-JAN-2025, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (lot number reported as X005044, which has been verified as valid, expiration date reported and validated as 02-JAN-2025) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not provided) (Expired product administered).  No additional adverse events were reported. The reporter also confirmed that the product did not undergo any temperature excursion and it was supported per Post-Expiry Memo.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no symptoms reported; GARDASIL 9 administered to a patient after product experienced a temperature excursion; This spontaneous report was received from a nurse referring to a patient, age and gender was not reported. Information regarding the patient's concurrent conditions, historical conditions and concomitant or historical medications was not provided.  On 28-JAN-2025, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection for prophylaxis, 0.5 milliliter, lot number Y013712, which has been verified to be valid, expiration date reported and validated as 26-OCT-2026 (strength, scheme, route of administration and anatomical site not provided).   The administered dose of the vaccine was stored at an unknown temperature during an unknown time frame. There were no symptoms reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; Nurse reported that an expired VARIVAX was administered today. No symptoms reported.   She also mentioned that the vaccine had a temperature excursion on 4/1/2024 but did not know the excursion details.  She will call back with temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 28-JAN-2025 the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X002100 and expiration date 19-JAN-2025 for prophylaxis (exact dose, dose number (reported as "1 dose" which could indicate both, one dose and first dose), route and site of administration were not provided)) (expired product administered). No symptoms reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Oesophageal carcinoma
Clinical narrative: diagnosed with stage four esophageal cancer; This serious case was reported by a consumer via interactive digital media and described the occurrence of esophageal cancer in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine, the patient experienced esophageal cancer (Verbatim: diagnosed with stage four esophageal cancer) (serious criteria GSK medically significant). The outcome of the esophageal cancer was not reported.   It was unknown if the reporter considered the esophageal cancer to be related to Shingles vaccine.     The company considered the esophageal cancer to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the shingles vaccine and six months later he/she was diagnosed with stage four esophageal cancer. The reporter mentioned that he/she could not prove any connection, but it did make them wonder.; Sender's Comments: Oesophageal carcinoma is an unlisted event which is considered unrelated to GSK vaccine Shingles vaccine.
Age: 49.0
Sex: M
Vaccine: HEPAB
Symptoms: Abdominal pain upper
Clinical narrative: Right upper quadrant pain; This non-serious case was reported by a physician via call center representative and described the occurrence of upper abdominal pain in a adult male patient who received HAB (Twinrix) for prophylaxis.   On 14-AUG-2024, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced upper abdominal pain (Verbatim: Right upper quadrant pain). Rechallenge with Twinrix was positive. The outcome of the upper abdominal pain was not resolved.   It was unknown if the reporter considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.     It was unknown if the company considered the upper abdominal pain to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2024123891   Additional Information: GSK Receipt Date: 31-DEC-2024 The patient experienced right upper quadrant pain after Twinrix second dose. This pain persisted. Follow up by Safety Team was accepted to his personal email.; Sender's Comments:  US-GSK-US2024123891:same reporter
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received the rsv vaccine now again in December of 2024; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a elderly male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Previously administered products included Arexvy (Received 1st dose on September of 2022).   In DEC-2024, the patient received Arexvy. In DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received the rsv vaccine now again in December of 2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 02-JAN-2025 The reporter reported that patient received Arexvy vaccine second dose again in December of 2024 which led to extra dose administered. It was in error.  The patient wanted to know if there were any harmful side effects from double dosing.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Recovering from the second vaccine now, it totally wipes you out; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of exhaustion in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced exhaustion (Verbatim: Recovering from the second vaccine now, it totally wipes you out). The outcome of the exhaustion was resolving.   It was unknown if the reporter considered the exhaustion to be related to Shingles vaccine.     It was unknown if the company considered the exhaustion to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-JAN-2025 The case was received from the patient via interactive digital media. Recovering from the second vaccine now, it totally wiped you out.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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.   The patient's past medical history included shingles.   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: 03-JAN-2025 This case was reported by a patient via interactive digital media. Patient had shingles twice and patient had the shots after first shingles tie and then experienced second shingles that was not quite as bad but painful would not wish this on worst enemy. 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. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: RVX
Symptoms: Extra dose administered
Clinical narrative: taken the rsv vaccine in September of 2022 and now again in December of 2024.  It was in error; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Previously administered products included rsv vaccine (in September 2022).   In DEC-2024, the patient received RSV vaccine. In DEC-2024, an unknown time after receiving RSV vaccine, the patient experienced extra dose administered (Verbatim: taken the rsv vaccine in September of 2022 and now again in December of 2024.  It was in error). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 02-JAN-2025 The patient received RSV vaccine in September of 2022 and now again in December of 2024 it was in error, which led extra dose administered.  The patient asked was there any harmful side effects from double dosing, were there harmful side effects from double dosing the RSV vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; receive two doses shingles vaccine last year and came down with shingles 2 weeks ago; 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: receive two doses shingles vaccine last year and came down with shingles 2 weeks ago). 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 : 14-JAN-2025 This case was reported by a patient via interactive digital media. The patient reported that he/she got the two doses of shingles vaccine last year and came down with shingles two weeks ago. The reporter mentioned that he/she almost through the blister stage. The reporter had a question did the body build an immunity against shingles after you have contracted it.  This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of 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 1 and Shingles vaccine 2.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Gave Arexvy instead of Abrysvo; Gave Arexvy instead of Abrysvo; This non-serious prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included RSV vaccine prot. subunit PreF 2v (Abrysvo) for prophylaxis.   On an unknown date, the patient received Arexvy and Abrysvo. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Gave Arexvy instead of Abrysvo) and wrong vaccine administered (Verbatim: Gave Arexvy instead of Abrysvo). The outcome of the vaccine exposure during pregnancy and wrong vaccine administered were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Exposure (Abrysvo): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 16-JAN-2024 The reporter reported that a pregnant patient received Arexvy instead of Abrysvo, which led to vaccine exposure during pregnancy and wrong vaccine administered. But in the end baby were totally fine.  The patient did not had a lot of time to decide on whether or not to get the maternal vaccine. The patient read there was a higher risk of a preterm labor so wanted to ask if that happened to anyone who got it or any other issues, also, thinking of doing the Beyfortus shot for baby.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, 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: 18-JAN-2025 This case was reported by a patient via interactive digital media. Patient reported that the shingles vaccines gave shingles to the patient. 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. The follow-up could not be possible as no contact details were available; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still got shingles again, on the opposite side; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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: still got shingles again, on the opposite side). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK receipt date: 21-JAN-2025 The case was received from the patient's wife via interactive digital media. The patient has had the vaccine and he still got shingles again, on the opposite side. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset 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.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: down for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose of vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling unwell (Verbatim: down for a few days). The outcome of the feeling unwell was resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by a patient via interactive digital media. Patient was the reporter. Patient had the Shingles vaccination, both of them.  2nd one was no joke. He/she was down for a few days.  But it was definitely better than to get shingles. His/her mother in law had shingles.  He/she heard all about it and the pain that came with it and she had residual pain in her left arm. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Broke through; 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: Broke through). 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: 21-JAN-2025 This case was reported by a patient via interactive digital media. The patient had a 2 shot vaccination. He/she broke through shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine (Dose 1) and Shingles vaccine (Dose 2).
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: kicked their butt; This non-serious case was reported by a consumer and described the occurrence of feeling unwell in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix on an unknown date).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling unwell (Verbatim: kicked their butt). The outcome of the feeling unwell was not reported.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.     It was unknown if the company considered the feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-JAN-2025 The reporter reported that a couple of people talked to said that the 2nd Shingrix dose kicked their butt. This case has been linked to the case US2025AMR006731 reported by the same reporter.; Sender's Comments:  US-GSK-US2025AMR006731:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Shingles at injection site; 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 the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles at injection site). The outcome of the shingles was not resolved.   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: 26-JAN-2025 The patient self-reported this case for himself/herself. The patient had first shot and developed shingles at the injection site. The patient reported that it had been almost 4 months and he/she was still in a breakout stage. The patient asked should he/she get the 2nd shot.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the first dose was administered on August 12th 2024 and the second dose on January 2nd 2025.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 43-year-old male patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 12-AUG-2024).   On 02-JAN-2025, the patient received the 2nd dose of Twinrix. On 02-JAN-2025, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: the first dose was administered on August 12th 2024 and the second dose on January 2nd 2025.). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JAN-2025 The pharmacist called to verify when the 3rd dose of Twinrix should be administered if the first dose was administered on 12th August 2024 and the second dose on 2nd January 2025. the patient received the 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. The vaccine administration facility was the same as primary reporter.; Sender's Comments:  US-GSK-US2025000316:Same reporter/ Different patient (Wife case)
Age: 0.42
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: possibly underage; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) for prophylaxis.   On 10-DEC-2024, the patient received FluLaval 2024-2025 season. On 10-DEC-2024, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced inappropriate age at vaccine administration (Verbatim: possibly underage). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-JAN-2025 The register nurse stated that they were getting a billing error edit for age on a flu vaccine, Flulaval. The child was 24 weeks and 2 days when administered which led to inappropriate age at vaccine administration. The vaccine was given on 10th December 2024. The reporter did not collect any further information as it was uncertain based on PI if patient was underage as it just stated 6 months and depends on what the definition of 6 months.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received Arexvy twice, once in 2023 and the second dose was given on 26Dec2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 52Z52, expiry date 16-OCT-2025) for prophylaxis.   Previously administered products included Arexvy (received 1st dose in 2023).   On 26-DEC-2024, the patient received the 2nd dose of Arexvy. On 26-DEC-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received Arexvy twice, once in 2023 and the second dose was given on 26Dec2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 03-JAN-2025 The patient received Arexvy twice, which led to an extra dose administered.
Age: 1.17
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the first dose on December 19th 2024; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 2-year-old male patient who received HAV (Havrix) (batch number C24B9, expiry date 06-MAY-2026) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT (HAVRIX).   On 02-JAN-2025, the patient received Havrix. On 02-JAN-2025, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: Patient received the first dose on December 19th 2024). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 03-JAN-2025 Reporter stated that a patient were not transferred to the system and patient ended up receiving a dose of Pediarix, Priorix, Hiberix and Havrix on 02-JAN-2024.  Later patient's mother provided the immunization records and it was realized that extra doses were administered. Patient received the first dose on 19-DEC-2024.  Male patient, 2 years and 2 months old. Patient received booster dose within a month which led to shortening of vaccination schedule. For another vaccines received by patient please refer US2025000647, US2025000645 and US2025000650.; Sender's Comments:  US-GSK-US2025000647:Same patient US-GSK-US2025000645:Same patient US-GSK-US2025000650:Same patient