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.

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)

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.

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

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).

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.

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.

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.

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.

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.