Received Feb 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | LA |
she had trouble sleeping; she had pain at injection site; chills; stomach pain; she was cold; body aches; no appetite; been sleepy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 08-FEB-2025, the patient received the 1st dose of Shingrix (left arm). On 08-FEB-2025, several minutes after receiving Shingrix, the patient experienced injection site pain (Verbatim: she had pain at injection site). On 10-FEB-2025, the patient experienced difficulty sleeping (Verbatim: she had trouble sleeping). In FEB-2025, the patient experienced chills (Verbatim: chills), stomach pain (Verbatim: stomach pain), cold (Verbatim: she was cold), general body pain (Verbatim: body aches), appetite absent (Verbatim: no appetite) and sleepiness (Verbatim: been sleepy). The outcome of the injection site pain, difficulty sleeping, chills, stomach pain, cold and appetite absent were resolved and the outcome of the general body pain was not resolved and the outcome of the sleepiness was resolving. It was unknown if the reporter considered the injection site pain, difficulty sleeping, chills, stomach pain, cold, general body pain, appetite absent and sleepiness to be related to Shingrix. It was unknown if the company considered the injection site pain, difficulty sleeping, chills, stomach pain, cold, general body pain, appetite absent and sleepiness to be related to Shingrix. Additional Information: GSK Receipt Date: 12-FEB-2025 The patient self-reported this case. The patient received 1st dose of Shingrix dose and within minutes she had pain at injection site that had resolved. On Monday she stated she had trouble sleeping because she had chills, stomach pain and she was cold and had body aches. The patient had been sleepy but stated she was feeling better.