Received Aug 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | — | — |
Warm to the touch; black and blue; Swollen face/the lower left side of her face / chin (jowl area) was a little swollen; This non-serious case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included dermal filler injection (had filler placed in the chin area about 1 year ago) and trigger finger release (had hand surgery (trigger finger surgery) last Tuesday (5 August 2025) in which she was given Propofol and Versed). Previously administered products included Shingrix with an associated reaction of swelling face (received first dose on an unknown date and had a little swelling on her face). On 08-AUG-2025, the patient received the 2nd dose of Shingrix. On 11-AUG-2025, 3 days after receiving Shingrix, the patient experienced facial swelling (Verbatim: Swollen face/the lower left side of her face / chin (jowl area) was a little swollen). On 12-AUG-2025, the patient experienced skin warm (Verbatim: Warm to the touch) and skin discoloration (Verbatim: black and blue). The outcome of the facial swelling, skin warm and skin discoloration were not resolved. It was unknown if the reporter considered the facial swelling, skin warm and skin discoloration to be related to Shingrix. It was unknown if the company considered the facial swelling, skin warm and skin discoloration to be related to Shingrix. Additional Information: GSK receipt date: 12-AUG-2025 The patient had the second dose of Shingrix and one day prior to the reporting date, the patient had the lower left side of her face/chin (jowl area) was a little swollen and was more swollen on the day of reporting. 4 days after vaccination, the patient was looking a little black and blue and was warm to the touch. There was no discomfort, and the patient did not feel unwell. This report was filed with limited information. The patient disconnected the call prior to gathering further details or clarification. The consumer did not wish to provide any contact information.
Medical History/Concurrent Conditions: Dermal filler injection (had filler placed in the chin area about 1 year ago); Trigger finger release (had hand surgery (trigger finger surgery) last Tuesday (5 August 2025) in which she was given Propofol and Versed)