Received Aug 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 9L944 | IM / LA |
pain at injection site; sore shoulder; stiffness at the neck area; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 9L944, expiry date 30-MAR-2025) for prophylaxis. Concomitant products included paracetamol (Tylenol) and hydrocortisone hydrogen succinate (Hydrocortisone). On 21-APR-2025, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), shoulder soreness (Verbatim: sore shoulder) and stiff neck (Verbatim: stiffness at the neck area). The outcome of the injection site pain, shoulder soreness and stiff neck were unknown. It was unknown if the reporter considered the injection site pain, shoulder soreness and stiff neck to be related to Shingrix. It was unknown if the company considered the injection site pain, shoulder soreness and stiff neck to be related to Shingrix. Additional Information: GSK Receipt Date: 25-JUL-2025 The reporter was the patient. He reported that he received the 1st dose of Shingrix vaccine on April 21st, 2025. He reported both doses were administered in the left arm at a immunization clinic. He reported with the first dose pain at injection site, sore shoulder and stiffness at the neck area.; Sender's Comments: US-GSK-US2025AMR098370:Same patinet dose 2nd
TYLENOL; HYDROCORTISONE