Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM |
Fainted; barely breathing; weak pulse; This serious case was reported by a consumer via call center representative and described the occurrence of fainting in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. Concurrent medical conditions included parkinson's disease and hypertension. On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 hr 15 min after receiving Shingrix, the patient experienced fainting (Verbatim: Fainted) (serious criteria GSK medically significant), difficulty breathing (Verbatim: barely breathing) and pulse weak (Verbatim: weak pulse). The outcome of the fainting was unknown and the outcome of the difficulty breathing and pulse weak were not reported. It was unknown if the reporter considered the fainting, difficulty breathing and pulse weak to be related to Shingrix. The company considered the fainting to be unrelated to Shingrix. It was unknown if the company considered the difficulty breathing and pulse weak to be related to Shingrix. Additional Information: GSK Receipt Date: 20-OCT-2025 The caregiver reported the case on behalf of consumer (patient) stated that consumer had his first dose of Shingrix administered and they were not allowed to wait in the hospital for 15 minutes to ensure the consumer did not have an allergic reaction. The caregiver further stated the physician administering the vaccine was going to lunch and told the patient they needed to leave the office. The consumer had the dose administered then one hour and 15 minutes later he fainted. The patient was barely breathing, and he had a weak pulse. He was at a store when he fainted. Paramedics were called. The patient was treated at the store and released. The caregiver stated the paramedics administered some type of injection to the consumer after being informed the consumer had received a dose of Shingrix. The caregiver stated the physician was trying to kill the patient. Stated the report from the paramedics had been redacted with crucial information deleted concerning care of the consumer. No other products were received by the patient. No further information was provided or obtained. The batch number was not provided and a request for this information had been made.; Sender's Comments: A case of Syncope, 1 hr 15 min after receiving Shingrix, in a 74-year-old male patient. Based on the available information, a possible causality that the event was caused by the GSK product cannot be ascertained. Further follow up information has been sought.
Hypertension; Parkinson's disease
Test Name: Pulse rate; Result Unstructured Data: (Test Result:weak pulse,Unit:unknown,Normal Low:,Normal High:)