Received Jun 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | IM / LA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | — |
Back pain; Light-headed feeling/Dizziness; Headache; knees achy/arm started hurting/knees hurt; legs hurt/pain in hands; Could not move well; hurting in chest and back; Achy all over body/aching from ribs and arms, hands, and neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 21-MAY-2025, the patient received Shingrix. On 21-MAY-2025, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Achy all over body/aching from ribs and arms, hands, and neck). On 22-MAY-2025, the patient experienced dizziness (Verbatim: Light-headed feeling/Dizziness), headache (Verbatim: Headache), arthralgia (Verbatim: knees achy/arm started hurting/knees hurt), leg pain (Verbatim: legs hurt/pain in hands), mobility decreased (Verbatim: Could not move well) and chest pain (Verbatim: hurting in chest and back). On an unknown date, the patient experienced back pain (Verbatim: Back pain). The patient was treated with ibuprofen sodium (Ibuprofen). The outcome of the general body pain, mobility decreased, chest pain and back pain were unknown and the outcome of the dizziness, headache, arthralgia and leg pain were resolving. It was unknown if the reporter considered the general body pain, dizziness, headache, arthralgia, leg pain, mobility decreased, chest pain and back pain to be related to Shingrix. It was unknown if the company considered the general body pain, dizziness, headache, arthralgia, leg pain, mobility decreased, chest pain and back pain to be related to Shingrix. Additional Information: GSK receipt date: 16-JUN-2025 Consumer was the reporter. Patient was vaccinated with her first dose of Shingrix on 21 MAY 2025. Consumer stated that evening she started hurting in her arms. The next morning, she stated she could not move well. Consumer stated throughout the day she experienced her legs and knees hurt, she had a headache, and she was light-headed. Consumer states she took a pain reliever and felt a little bit better (unknown what pain reliever was taken.) The consumer stated later in the day her hands and arms were aching. At that time, she took a BC Powder and that made her feel better. The consumer did consult with her PCP and was advised to take Ibuprofen 4 tablets, four times daily. Consumer stated as long as she was taking that medication at that frequency, she does feel better but if she stopped taking the medication she felt achy again. At the onset of the call the consumer stated she was aching from her ribs up, including arms, hands and neck. Consumer stated the achy feeling in her knees and legs was feeling better. Her headaches and dizzy feeling had cleared up. Consumer stated the worst part till the time of reporting, was the pain/ache in her hand and arms. Consumer also stated if she was standing up doing work or something else she will start hurting in her chest and back. Consumer states before the SHINGRIX vaccine was administered she had blood drawn for lab tests.