Received Jul 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 55TH4 | IM / LA |
5 bumps appear on her left arm at injection site; one bump on her right foot; bumps itch and open when scratched; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 55TH4, expiry date 31-JAN-2027) for prophylaxis. On 30-JUN-2025, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUL-2025, an unknown time after receiving Shingrix, the patient experienced injection site swelling (Verbatim: 5 bumps appear on her left arm at injection site), local swelling (Verbatim: one bump on her right foot) and pruritus (Verbatim: bumps itch and open when scratched). The outcome of the injection site swelling, local swelling and pruritus were not resolved. It was unknown if the reporter considered the injection site swelling, local swelling and pruritus to be related to Shingrix. It was unknown if the company considered the injection site swelling, local swelling and pruritus to be related to Shingrix. Additional Information: GSK Receipt Date: 08-JUL-2025 The patient mentioned she had normal reactions following the vaccination (not disclosed) for the first two days following vaccination. However, she then had 5 bumps appear on her left arm at injection site and one bump on her right foot. The patient mentioned that the bumps look like mosquito bites which itched, when scratched then they open up and the open bumps that hurt a little bit. The patient stated she did not take any medication and had no health concerns.