Received Oct 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 3 | UNK | — |
FOOT PAIN; limping and difficulty staying; Extra dose administered; Red sore area at shoulder injection site; large red area at the injection site; Flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included peripheral neuropathy (Peripheral neuropathy in feet). Previously administered products included Shingrix (received first dose on 26-OCT-2019) and Shingrix (received second dose on 05-JAN-2020). On 18-SEP-2025, the patient received the 3rd dose of Shingrix. In SEP-2025, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms) and injection site erythema (Verbatim: large red area at the injection site). On 18-SEP-2025, the patient experienced extra dose administered (Verbatim: Extra dose administered) and injection site pain (Verbatim: Red sore area at shoulder injection site). On 20-SEP-2025, the patient experienced foot pain (Verbatim: FOOT PAIN) and limping (Verbatim: limping and difficulty staying). On 22-SEP-2025, the outcome of the injection site pain was resolved (duration 4 days). The outcome of the extra dose administered was not applicable and the outcome of the influenza-like symptoms was resolved (duration 1 day) and the outcome of the injection site erythema was resolved and the outcome of the foot pain and limping were not resolved. It was unknown if the reporter considered the influenza-like symptoms, injection site erythema, injection site pain, foot pain and limping to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms, injection site erythema, injection site pain, foot pain and limping to be related to Shingrix. Additional Information: GSK Receipt Date: 20-SEP-2025 and 22-SEP-2025 The patient reported that he accidently received three doses of Shingrix. The first dose was on 26th October 2019 and 05th January 2020 and then mistakenly his doctor gave him another dose last Thursday. The patient had flu like symptoms for a day and a large red area at the injection site, about 5 or so inches in diameter and otherwise he felt fine now. The patient stated he had large sore shoulder which was about the size of his hand that he had since Thursday 18th September 2025 resolved this morning on 22nd September 2025. The extra dose was administered and he also mentioned that he believed the reason why he got an accidental third dose of Shingrix was because the first two doses were given at pharmacy and his regular doctor retired, and this was a new doctor (who evidentially did not have all his immunization records). The patient also stated, he had really bad pain in his foot starting Saturday, he was limping around and this had not resolved. The patient woke up a couple hours early that morning due to the pain and he was not sure if this was due to the vaccine or if it was just a coincidence. The patient asked was it ok to have the three doses and was anything for him to be concerned about and he will of course seek medical help if he have any other symptoms.
Medical History/Concurrent Conditions: Peripheral neuropathy (Peripheral neuropathy in feet)