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.

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.

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.

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.

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

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.

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).

No symptoms reported; Caller, a vaccine coordinator, reported AE on behalf of a patient who was administered improperly stored VARIVAX following a TE that occurred on 1/28/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE F; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age or gender. The patient’s medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 28-JAN-2025, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # Y011019, expiration date: 18-JUN-2026) (strength, route of administration, anatomical location not provided) as prophylaxis; which underwent a temperature excursion with a temperature at 11 Fahrenheit (F)/6 F up to 14 F for 30 minutes (product storage error). There was none previous temperature excursion. No symptoms were reported. This is one of several cases reported by the same reporter.

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.

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.