Received Feb 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | — | IM / LA |
selling in her neck; tender to touch; States there are no visual signs of bruising it just feels like bruising; she developed a headache; nausea; she had chills; fever; aches and pains; This non-serious case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 04-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. On 04-FEB-2025, 3 hrs after receiving Shingrix, the patient experienced chills (Verbatim: she had chills), fever (Verbatim: fever) and pain (Verbatim: aches and pains). On 05-FEB-2025, the patient experienced headache (Verbatim: she developed a headache) and nausea (Verbatim: nausea). On 06-FEB-2025, the patient experienced neck swelling (Verbatim: selling in her neck), tenderness (Verbatim: tender to touch) and contusion (Verbatim: States there are no visual signs of bruising it just feels like bruising). The outcome of the chills, fever, pain and headache were resolved and the outcome of the nausea and neck swelling were not resolved and the outcome of the tenderness and contusion were not reported. It was unknown if the reporter considered the chills, fever, pain, headache, nausea, neck swelling, tenderness and contusion to be related to Shingrix. It was unknown if the company considered the chills, fever, pain, headache, nausea, neck swelling, tenderness and contusion to be related to Shingrix. Additional Information: GSK receipt date: 06-FEB-2025 The reporter was the patient who received the first dose of Shingrix vaccine series in her left deltoid. The vaccine was administered at the pharmacy. The reporter stated she had experienced chills, fever, aches, and pains 3 hours after receiving vaccine and symptoms have resolved. Also, stated she developed a headache and nausea 1 day after receiving the vaccine. The headache had resolved but the nausea still remains. The reporter mentioned that 2 days after receiving the vaccine she noticed swelling in her left neck that was tender to touch and feels like bruising. The reporter stated there were no visual signs of bruising it just feels like bruising. The selling in her neck still remains. The patient did not have a lot number or number of vaccine on the papers she received from the pharmacy.