Received Oct 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | IM / LA |
severe shivering; Shaking; pain at injection site/ touchy at injection site/ sore at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (first dose of SHINGRIX was administered 90 days prior and patient had no issues with that dose). On 08-AUG-2025 12:35, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 08-AUG-2025, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site/ touchy at injection site/ sore at injection site). On 08-AUG-2025 21:45, the patient experienced shivering (Verbatim: severe shivering) and tremor (Verbatim: Shaking). The patient was treated with paracetamol (Tylenol Arthritis). The outcome of the injection site pain was unknown and the outcome of the shivering and tremor were not resolved. It was unknown if the reporter considered the injection site pain, shivering and tremor to be related to Shingrix. It was unknown if the company considered the injection site pain, shivering and tremor to be related to Shingrix. Additional Information: GSK Receipt Date: 09-SEP-2025 and 10-SEP-2025 The patient self-reported this case for himself and stated that after the vaccination the injection site was painful, touchy, and sore. Consumer stated the dose was administered at 12:35pm and he began shaking and shivering at 9:45pm which continued throughout the night with 2 different episodes happening. Patient took Tylenol Arthritis and that seemed to help with the shivering. Patient had his first dose of Shingrix administered 90 days prior and had no issues with that dose. No further information was obtained/provided.