Received Sep 9, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 2Xb45 | — |
Injection site pain; Injection site swelling; Nausea; Headache; Eye pain; Insomnia; neck pain exacerbated; hot/cold flashes; hot/cold flashes; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number SSDB9, expiry date 26-APR-2027) and (batch number 2Xb45, expiry date 26-APR-2027) for prophylaxis. Concurrent medical conditions included fibromyalgia, rheumatoid arthritis and chronic pain (Neck pain from 2 failed surgeries). Concomitant products included acyclovir, duloxetine, meloxicam, hydrochlorothiazide, valsartan (Valsartan Hctz), levothyroxine and ezetimibe (Zetia). On 23-AUG-2025 12:30, the patient received Shingrix (intramuscular, left deltoid). On 23-AUG-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: Injection site pain), injection site swelling (Verbatim: Injection site swelling), nausea (Verbatim: Nausea), headache (Verbatim: Headache), eye pain (Verbatim: Eye pain), insomnia (Verbatim: Insomnia), neck pain (Verbatim: neck pain exacerbated), hot flashes (Verbatim: hot/cold flashes) and cold flash (Verbatim: hot/cold flashes). In AUG-2025, the outcome of the hot flashes and cold flash were resolved (duration 4 hrs). On 24-AUG-2025, the outcome of the injection site swelling, nausea and eye pain were resolved (duration 1 day). The outcome of the injection site pain, headache, insomnia and neck pain were not resolved. It was unknown if the reporter considered the injection site pain, injection site swelling, nausea, headache, eye pain, insomnia, neck pain, hot flashes and cold flash to be related to Shingrix. It was unknown if the company considered the injection site pain, injection site swelling, nausea, headache, eye pain, insomnia, neck pain, hot flashes and cold flash to be related to Shingrix. Additional Information: GSK receipt date: 25-AUG-2025 Most of the symptoms were resolved within 4 hours, but the headache, injection site pain and insomnia and neck pain are ongoing. The pharmacist did not provide the correct lot number from the Shingrix box, but provided lot numbers for the two separate components
Chronic pain (Neck pain from 2 failed surgeries); Fibromyalgia; Rheumatoid arthritis
ACYCLOVIR; DULOXETINE; MELOXICAM; VALSARTAN HCTZ; LEVOTHYROXINE; ZETIA