Received May 12, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | — |
Sore arm near the injection site; cold; chills; feeling very tired with no energy; no energy; fever that was 101.5 all the way up to 105.5; This non-serious case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sore arm near the injection site), cold (Verbatim: cold), chills (Verbatim: chills), fever (Verbatim: fever that was 101.5 all the way up to 105.5), tiredness (Verbatim: feeling very tired with no energy) and loss of energy (Verbatim: no energy). The outcome of the injection site pain, cold, chills, tiredness and loss of energy were resolved and the outcome of the fever was resolved (duration 12 hrs). It was unknown if the reporter considered the injection site pain, cold, chills, fever, tiredness and loss of energy to be related to Shingrix. It was unknown if the company considered the injection site pain, cold, chills, fever, tiredness and loss of energy to be related to Shingrix. Linked case(s) involving the same patient: US2026AMR062925 Additional Information: GSK Receipt Date: 07-MAY-2026 The patient received dose 1 of Shingrix on a Thursday. The patient experienced cold chills approximately 8 to 18 hours after receiving the dose. The patient also reported soreness in the arm near the injection site. About 8 hours after the dose, she developed a fever ranging from 101.5 degree F to 105.5 degree F, which lasted for approximately 12 hours. The following day, she felt very tired and lacked energy. By the time she woke up on Sunday morning, the patient reported that she had recovered and was feeling fine. The batch number was not provided and we and unable to contact the reporter. For tolerance of 2nd dose refer case US2026AMR062925.; Sender's Comments: US-GSK-US2026AMR062925:2nd dose same patient
Test Name: Body temperature; Result Unstructured Data: (Test Result:101.5-105.5,Unit:degree F,Normal Low:,Normal High:)