Received May 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / LA |
Vomiting; Diarrhea; Pain injection site; broke an eye blood vessel/ my left eye broke a blood vessels in the eye and the white part is totally red; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 24-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. In APR-2025, less than a week after receiving Shingrix, the patient experienced broken blood vessel in eye (Verbatim: broke an eye blood vessel/ my left eye broke a blood vessels in the eye and the white part is totally red). On 25-APR-2025, the patient experienced injection site pain (Verbatim: Pain injection site). On 26-APR-2025, the patient experienced vomiting (Verbatim: Vomiting) and diarrhea (Verbatim: Diarrhea). The outcome of the injection site pain was unknown and the outcome of the vomiting and diarrhea were resolved and the outcome of the broken blood vessel in eye was not resolved. It was unknown if the reporter considered the injection site pain, vomiting, diarrhea and broken blood vessel in eye to be related to Shingrix. It was unknown if the company considered the injection site pain, vomiting, diarrhea and broken blood vessel in eye to be related to Shingrix. Additional Information: GSK Receipt Date: 30-APR-2025 The patient self reported this case for herself. The patient reported an adverse event for the Shingrix vaccine on 30th April 2025. She stated that she had received the first dose of Shingrix on 24th April 2025, in her left arm at a local pharmacy. The lot/expiration details were unknown. She mentioned that she had experienced pain at the injection site on the next day. On 26th April 2025, she reported vomiting and diarrhea. The patient stated that she had recovered from these symptoms but noted, the vomiting was so bad that her left eye broke a blood vessel, and the white part was totally red.