Received Jun 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | A5T73 | LA |
lip swelling; cold sore on his lower lip; shoulder was sore from the injection/tenderness in shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number A5T73, expiry date 28-MAR-2027) for prophylaxis. The patient's past medical history included cold sores (had cold sores all his life). Previously administered products included multi vitamin and loratadine (allergy pill). On 29-MAY-2025, the patient received the 1st dose of Shingrix (left arm). On 30-MAY-2025, 1 days after receiving Shingrix, the patient experienced shoulder soreness (Verbatim: shoulder was sore from the injection/tenderness in shoulder). On 04-JUN-2025, the patient experienced cold sores lip (Verbatim: cold sore on his lower lip). On 06-JUN-2025, the patient experienced lip swelling (Verbatim: lip swelling). The patient was treated with docosanol. The outcome of the shoulder soreness was resolved and the outcome of the cold sores lip and lip swelling were not resolved. The reporter considered the shoulder soreness to be related to Shingrix. It was unknown if the reporter considered the cold sores lip and lip swelling to be related to Shingrix. The company considered the shoulder soreness to be related to Shingrix. It was unknown if the company considered the cold sores lip and lip swelling to be related to Shingrix. Additional Information: GSK Receipt Date: 10-JUN-2025 Patient received his first dose of Shingrix in his left arm on 29-MAY-2025 from his Physician, and reports that starting on 30-MAY-2025, his shoulder was sore from the injection. The patient reported that he felt mild tenderness in his shoulder for the next day or two (no specific dates provided) that was 0.5 on a scale of 1 to 10. The patient reported that on 4-JUN-2025, he developed a cold sore on his lower lip, but he has had cold sores all his life. The patient used Over the Counter Docosanol Cream on the cold sore from 4-JUN-2025 through 6-JUN-2025, and the cold sore was diminishing. The patient reported that on the evening on 6-JUN-2025, through the morning of 7-JUN-2025, the cold sore spread to the right side of his lower lip and swelled up enormously. The patient reported that his lip was three times the normal size and he could not put his teeth together, the swelling went down by half over the next 24 hours, and on 10-JUN-2025, the swelling has gone down by half again. The patient stated he has never had an outbreak like this in his entire life and the patient did not know if the vaccine was given as an IM injection. The patient reported that he takes a Multi Vitamin and over the counter allergy pill, Loratadine, but did not take concurrently with Shingrix.
Medical History/Concurrent Conditions: Cold sores (had cold sores all his life)