Received May 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | UNK | — |
Severely elevated liver enzymes; dizziness; Abdominal pain; headache; vomiting; This serious case was reported by a consumer and described the occurrence of elevated liver enzymes in a 53-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On 16-APR-2025, the patient received the 1st dose of Shingles vaccine. On 16-APR-2025, less than a day after receiving Shingles vaccine, the patient experienced elevated liver enzymes (Verbatim: Severely elevated liver enzymes) (serious criteria hospitalization), dizziness (Verbatim: dizziness) (serious criteria hospitalization), abdominal pain (Verbatim: Abdominal pain) (serious criteria hospitalization), headache (Verbatim: headache) (serious criteria hospitalization) and vomiting (Verbatim: vomiting) (serious criteria hospitalization). The outcome of the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting were resolving. It was unknown if the reporter considered the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting to be related to Shingles vaccine. It was unknown if the company considered the elevated liver enzymes, dizziness, abdominal pain, headache and vomiting to be related to Shingles vaccine. Additional Information: GSK Receipt Date: 26-APR-2025 The patient took shingles vaccine and was hospitalized with abdomen pain, dizziness, vomiting, nausea, and severely elevated liver enzymes. She also mentioned, she had to have her blood drawn numerous times to make sure but becoming more stable. Reporter mentioned she was taken off all medications in the hospital due to potential increase in liver enzyme.; Sender's Comments: Hepatic enzyme increased and Dizziness are unlisted events which are considered unrelated to GSK Shingles vaccine. Abdominal pain, Headache and Vomiting are listed events which, due to the following criteria (insufficient information on medical history, concurrent conditions, concomitant medications and investigation details) are considered unrelated to GSK Shingles vaccine.