My son (age 6) received his 4th Moderna COVID vaccine (2024-2025 booster- 3-11- .25 ML) at about 5 pm at a local pharmacy. He has not had reactions to the vaccine before. At 11 pm he woke us up and was covered in full body hives. We gave him benedryl and took him to the emergency room. The benedryl helped and he got no further treatment in the emergency room. He took zyrtec for a few days until the hives were gone. Follow up with pediatrician and allergist suggests this was an immune reactions. They do not recommend avoiding vaccines in the future, but perhaps switching brands.

Anxiety, dizziness occurred immediately after 2nd vaccination (Boostrix) as the needle was retracted. He was advised to take a sip of his water, which he did After drinking some water, he immediately rolled his head back and started to have leg jerking movements, such as a seizure event. This lasted about 5 seconds and we immediately called 911. He gained consciousness within a few seconds. He sat and elevated his feet, but he did not recall any of the events after the vaccine for about 2 minutes. He was very pale so we offered more water and chocolate and cookies EMT took over after about 5 minutes.

Late second dose; 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 female patient who received HAB (Twinrix) (batch number D4774, expiry date 12-SEP-2026) for prophylaxis. Previously administered products included Twinrix (1st dose received on 12th August 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: Late second dose). 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 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 vaccine administration facility is the same as primary reporter. The patient received second dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. The case is linked with case US2025000310, reported by the same reporter for husband.; Sender’s Comments: US-GSK-US2025000310:Same reporter/ Different patient (Husband case)

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 55-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient’s past medical history included shingles (before the age of 50). 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 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. 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: 09-JAN-2025 This case was reported by a patient via interactive digital media. Patient stated that most likely, but he/she gotta use and shingles before 50 and got shingles shot and now he/she had it again at 55. Patient said it was awful. 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, completion of primary vaccination schedule, time to onset of shingles and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.

No other AE; HCP reporting a 12 year old patient initiated the series on 02/05/2021 and the second dose was not administered until 12/09/2024.; This spontaneous report was received from a physician and refers to a 12-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 05-FEB-2021, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided). On 09-DEC-2024, the patient was vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of product administration). The patient had not received the third dose or completed the series as of yet. No symptoms reported and no additional details provided. Confirmed no product or quality events to report. No other adverse event (AE) or product quality complaint (PQC) was reported.

On the date listed, rash all over back of ankles, swollen ankles, rash on arm joints. Prior days, headaches, joint aches, fever 102 degrees.

Burkitt?s Lymphoma, Intensive Chemotherapy lasting approximately 3 months

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. 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: 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 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: 11-JAN-2025 This case was reported by a patient via interactive digital media. The patient had received both doses of shingles vaccine but after got shingles. 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 time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.

third dose received on 24-mar2004; 2nd dose received on 13-nov-2002; first dose received on 27-SEP-2002; This spontaneous report was received from other health care professional from a medical record, from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (MARRS # 2501USA005583) and concerns male patient (transgender) of 11 weeks old. There was no information about the patient’s concurrent conditions, concomitant therapies or medical history provided. On 27-SEP-2002, the patient started therapy with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). On 13-NOV-2002, the patient received 2nd dose administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered) On 24-MAR-2004, the patient received the third dose administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered). This is one of two reports regarding the same patient.; Sender’s Comments: US-009507513-2501USA005583:

Provider stated that she had a patient syncopize on exam table after a dose of gardasil 9 this past year. She said the patient remained alert and recovered. No injury noted.; This spontaneous report was received from Physician via Company Representative referred to a 16-year-old female patient. The patient’s medical history was not reported. The patient’s concurrent conditions were not reported. Concomitant therapies were not reported. On an unknown date in 2024, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, dose number, frequency, scheme, lot #, expiry date, route of administration, and anatomical location were not provided). On an unknown date in 2024, the reporter stated that she had a patient syncopize on exam table after the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (syncope), and reported that the patient remained alert and recovered on an unknown date; it was also reported that no injury was noted. The reporter did not assess the causal relationship between the syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection. Upon internal review syncope was determined to be medically significant event. Additional information is not expected.