Received May 7, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | IM / RA |
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | IM / RA |
Flu like symptoms/chills/fever/fatigue; Vomiting; Diarrhea; heart racing; shaking; lower back pain; stomach cramps; stayed in bed; injection site pain; legs gave out; fell to the ground; sweating; could not stand up; felt faint; face turned white; panic; could not breath; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of injection site pain (received first dose on an unknown date). On 21-APR-2026, the patient received the 2nd dose of Shingrix (intramuscular, right arm). On 22-APR-2026, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms/chills/fever/fatigue), vomiting (Verbatim: Vomiting), diarrhea (Verbatim: Diarrhea), heart racing (Verbatim: heart racing), tremor (Verbatim: shaking), low back pain (Verbatim: lower back pain), stomach cramps (Verbatim: stomach cramps), difficulty breathing (Verbatim: could not breath), felt faint (Verbatim: felt faint), pallor facial (Verbatim: face turned white), panic reaction (Verbatim: panic), bedridden (Verbatim: stayed in bed), injection site pain (Verbatim: injection site pain), lower extremities weakness of (Verbatim: legs gave out), fall (Verbatim: fell to the ground), sweating (Verbatim: sweating) and difficulty in standing (Verbatim: could not stand up). Rechallenge with Shingrix was positive. The outcome of the influenza-like symptoms, vomiting, diarrhea, heart racing, tremor, stomach cramps, felt faint, pallor facial, bedridden, injection site pain, lower extremities weakness of, fall, sweating and difficulty in standing were unknown and the outcome of the low back pain was not resolved and the outcome of the difficulty breathing and panic reaction were resolved (duration 15 min). It was unknown if the reporter considered the influenza-like symptoms, vomiting, diarrhea, heart racing, tremor, low back pain, stomach cramps, difficulty breathing, felt faint, pallor facial, panic reaction, bedridden, injection site pain, lower extremities weakness of, fall, sweating and difficulty in standing to be related to Shingrix. It was unknown if the company considered the influenza-like symptoms, vomiting, diarrhea, heart racing, tremor, low back pain, stomach cramps, difficulty breathing, felt faint, pallor facial, panic reaction, bedridden, injection site pain, lower extremities weakness of, fall, sweating and difficulty in standing to be related to Shingrix. Additional Information: GSK Receipt Date: 27-APR-2026 The consumer reported that she had the vaccine administered Tuesday evening and that on Wednesday morning she developed a fever of 101.8 degree F. She experienced chills, felt like she was getting the flu, and was tired and achy. Suddenly she developed very bad stomach cramps with diarrhea and vomiting. She could not stand up, her legs gave out and she fell to the ground. Her face turned very pale and she began sweating. Her heart started racing and she felt she could not breathe, she felt unable to get enough air and felt like she was going to pass out. Her body shook uncontrollably and her fever reached 102 degree F. She reported severe lower back pain that remained unresolved and stayed in bed all day. She said the adverse event occurred quickly, was very intense, and that she panicked because she could not breathe. The event lasted approximately 15 minutes. The batch number was not provided upon follow- up with the reporter.
Test Date: 202604; Test Name: Body temperature; Result Unstructured Data: (Test Result:102,Unit:degree F,Normal Low:,Normal High:); Test Date: 20260422; Test Name: Body temperature; Result Unstructured Data: (Test Result:101.8,Unit:degree F,Normal Low:,Normal High:)