Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 2 | 93N4J | LA |
Muscle hardening; pretty irritated and a lump; pretty irritated and a lump; she presented a significant redness near the injection site; she presented a significant warmth near the injection site; she presented a significant swelling near the injection site; she presented a significant pain near the injection site; Itching in the upper left arm (injection site); Irritation at the injection site; Lump at the injection site; This serious case was reported by a pharmacist via call center representative and described the occurrence of muscle induration in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 93N4J, expiry date 25-APR-2027) for prophylaxis. Previously administered products included Shingrix (received 1st dose on an unknown date). On 23-JUN-2025, the patient received the 2nd dose of Shingrix (left deltoid). In JUN-2025, less than a week after receiving Shingrix, the patient experienced injection site erythema (Verbatim: she presented a significant redness near the injection site), injection site warmth (Verbatim: she presented a significant warmth near the injection site), injection site swelling (Verbatim: she presented a significant swelling near the injection site), injection site pain (Verbatim: she presented a significant pain near the injection site), injection site itching (Verbatim: Itching in the upper left arm (injection site)), injection site irritation (Verbatim: Irritation at the injection site) and injection site lump (Verbatim: Lump at the injection site ). On 24-JUN-2025, the patient experienced muscle induration (Verbatim: Muscle hardening) (serious criteria GSK medically significant), skin irritation (Verbatim: pretty irritated and a lump) and mass (Verbatim: pretty irritated and a lump). In JUN-2025, the outcome of the muscle induration, skin irritation and mass were resolved. The outcome of the injection site erythema, injection site warmth, injection site swelling and injection site pain were resolving and the outcome of the injection site itching, injection site irritation and injection site lump were unknown. It was unknown if the reporter considered the muscle induration, injection site erythema, injection site warmth, injection site swelling, injection site pain, injection site itching, injection site irritation, injection site lump, skin irritation and mass to be related to Shingrix. The company considered the muscle induration to be unrelated to Shingrix. It was unknown if the company considered the injection site erythema, injection site warmth, injection site swelling, injection site pain, injection site itching, injection site irritation, injection site lump, skin irritation and mass to be related to Shingrix. Additional Information: GSK Receipt Date: 27-JUN-2025 The registered pharmacist reported that a series of adverse reactions presented in a patient that received the second dose of Shingrix after that at the injection site she presented a significant warmth, redness and swelling, pain near the injection site. She improved on the day of reporting (27-JUN-2025) but had just itching in the upper (left) arm, where she received the vaccine. 1 day after vaccination, the patient had her muscle harden, pretty irritated and a lump, but now that has resolved. The vaccine administration facility was the same as primary reporter.; Sender's Comments: Myosclerosis is an unlisted event which is considered unrelated to GSK vaccine Shingrix.