Received Apr 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | UNK | — |
Pain in arm; general soreness / between my toes and web of hands hurt and thumbs; miserable; In bed all day; Muscle pain; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling miserable in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of pain (received first dose on an unknown date (refer case US2025AMR048591)). Concurrent medical conditions included migraine headache (since child). On 19-APR-2025, the patient received the 2nd dose of Shingrix. On 20-APR-2025, 1 days after receiving Shingrix, the patient experienced feeling miserable (Verbatim: miserable), bedridden (Verbatim: In bed all day) and muscle pain (Verbatim: Muscle pain). On 21-APR-2025, the patient experienced pain in arm (Verbatim: Pain in arm) and general body pain (Verbatim: general soreness / between my toes and web of hands hurt and thumbs). The outcome of the feeling miserable, bedridden and muscle pain were resolving and the outcome of the pain in arm and general body pain were not resolved. The reporter considered the feeling miserable and bedridden to be related to Shingrix. It was unknown if the reporter considered the muscle pain, pain in arm and general body pain to be related to Shingrix. The company considered the feeling miserable and bedridden to be related to Shingrix. It was unknown if the company considered the muscle pain, pain in arm and general body pain to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR048591 Additional Information: GSK Receipt Date: 21-APR-2025 The reporter received a text message this morning from a friend (patient) who had received the Shingrix vaccine. The patient mentioned that she was miserable and in bed all day suffering from the effects of vaccination. The patient also mentioned that she got vaccine on Saturday and on Sunday morning she did not had a single muscle that did not hurt. The patient stated it was the worst reaction to any vaccine she ever had. She slept all day in between moaning in pain and only thing she did was feed cats and that was Herculean effort. The patient was hurt on the first one too but yesterday was just awful and still sore but can handle today so far. She meant in between the toes and web of hands hurt and thumbs and you name it, there was nothing which did not hurt. The patient stated that today her arm does which is to be expected and general soreness like survived a battle. She has had migraine headaches since she was a child.; Sender's Comments: US-GSK-US2025AMR048591:Same patient/Diffrent dose
Migraine headache (since child)