Received Feb 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
terrible pain; sick; could not move; Threw up; Urinated on her self; Diarrhea; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Zostavax (received dose in 2017), Shingrix with an associated reaction of pain in extremity (received 1st dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447) and RSV vaccine with an associated reaction of pain in extremity (received a dose on 23-JUL-2024, for tolerance refer linked case US2025AMR010447). On 24-JAN-2025, the patient received the 2nd dose of Shingrix. On 25-JAN-2025 01:30, 1 days after receiving Shingrix, the patient experienced pain (Verbatim: terrible pain), sickness (Verbatim: sick), mobility decreased (Verbatim: could not move), vomiting (Verbatim: Threw up), enuresis (Verbatim: Urinated on her self) and diarrhea (Verbatim: Diarrhea). The outcome of the pain, sickness, mobility decreased and enuresis were unknown and the outcome of the vomiting was resolved and the outcome of the diarrhea was not resolved. It was unknown if the reporter considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix. It was unknown if the company considered the pain, sickness, mobility decreased, vomiting, enuresis and diarrhea to be related to Shingrix. Linked case(s) involving the same patient: US2025AMR010447 Additional Information: GSK Receipt Date: 27-JAN-2025 The patient self-reported this case for herself. The patient received the second dose on Friday. On Saturday 25 January 2025, at 1:30 am after the second dose of Shingrix, the patient woke up in terrible pain, she was sick and could not move. She threw up, urinated on herself and had diarrhea. The vomiting recovered in JAN-2025.; Sender's Comments: US-GSK-US2025AMR010447:Dose 1/ Same patient