States she took a diphenhydramine 25 mg pill on 01/29/2025 at 2:30 pm and then took a nap. States that at about 4:30 pm on same day she woke up with a burning sensation at her left upper thigh and right leg “muscle spasms” in her calf and foot. States lasted about 15 minutes and then went away with no reoccurrence since that time. Stated she just wanted to report it as she had received vaccines on 01/27/2025 and had never had anything like that happen before.

shakes, lack of temperature control, headache, fatigue, increased heart rate – lasting for about 6 hours, eventually subsided, did not result in hospital/ER visit. Pt used tylenol, rested and increased fluid intake

Patient received an extra dose by mistake of Arexvy. First dose was received 12/15/23 and second dose was received 1/29/25. Patient has a sore arm, some fatigue and slight sore throat. No other adverse effects reported by patient. Called patient to discuss incident at 10:20am on 1/30/25

Vaccine given at approximately 3:15 PM. By 3:20 PM, patient reported dry mouth and warm, tingling sensation in mouth/throat, with some nausea. Denied swelling, shortness of breath, itching, redness, hives, or difficulty swallowing. Offered Pt some water. At 3:30 PM, patient reported also feeling jittery/dizzy; no other new symptoms. Pt declined offer to call ambulance but ate a cookie. Vitals normal for patient, as noted below. By 3:35 PM, noted that jitteriness, nausea, and tingling were gone. Still denied swelling or SOB. (Called patient’s PCP at 3:39 PM and discussed reaction with receptionist; was transferred to nurse line voicemail. Attempted to call back to discuss live at 3:42 PM but again was unable to connect with nurse at this time, so left voicemail with my and the patient’s cell numbers.) Patient noted feeling better at check-ins at 3:55 PM and 4:03 PM, with just some remaining warmth and some voice change. Still denied swelling and shortness of breath. Pt was comfortable leaving pharmacist care at 4:15 PM–only warmth in mouth remaining. Counseled to call 911 immediately if SOB, swelling, or dizziness developed. Pt noted she has medical alert pendant at home and cell phone with her. Called patient to follow-up at 5:47 PM; reported only having warm tongue at this point; did not have diphenhydramine available at home. Reinforced when to call 911 and advised to contact PCP if symptoms remained by next morning. Staff from PCP office called back when she received message at 8:47 AM on 1/30/25. I provided an update on the course of events since the initial voicemail; she planned to call the patient to check-in today and notify the physician.

Death

Numbness starting upper arm travels down to hand Numbness happens many times a day

Inappropriate age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number 47Y5M, expiry date 26-JUN-2026) for prophylaxis. On 02-JAN-2025, the patient received Infanrix. On 02-JAN-2025, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age). 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: 03-JAN-2025 The health care professional reported that a seven years and ten months old patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.

sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Varicella zoster vaccine with an associated reaction of illness (received 1st dose of Shingles vaccine on an unknown date, refer linked case US2025AMR004636). 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 sickness (Verbatim: sick). Rechallenge with Shingles vaccine was positive. The outcome of the sickness was not reported. It was unknown if the reporter considered the sickness to be related to Shingles vaccine. It was unknown if the company considered the sickness to be related to Shingles vaccine. Linked case(s) involving the same patient: US2025AMR004636 Additional Information: GSK Receipt Date: 11-JAN-2025 This case was reported by a patient via interactive digital media. Patient got two of the shots and they both made him/her sick.; Sender’s Comments: US-GSK-US2025AMR004636:same patient

Allergic to vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine 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 allergy to vaccine (Verbatim: Allergic to vaccine). The outcome of the allergy to vaccine was not reported. It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine. It was unknown if the company considered the allergy to vaccine to be related to Shingles vaccine. Additional Information: GSK receipt Date: 31-DEC-2024 This case was reported by a patient via interactive digital media. The Patient was allergic to vaccine.

No additional AE; patient who was administered improperly stored VARIVAX following a TE; This spontaneous report was received from an other reporter referring to a patient of unknown age and gender. The patient’s medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. On 28-JAN-2025, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (lot # Y011019, expiration date: 18-JUN-2026; strength, dose, anatomical location and route of administration were not provided) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of 11 degree Fahrenheit (F)/ 6F to 14F (the time frame was 30 Minutes) (product storage error). There were no previous temperature excursions. No additional adverse event (AE) was reported (no adverse event).