Received Sep 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | UNK | IM / LA |
Injection site pain; Flu-like symptoms; Facial tic; Difficulty sleeping; facial involuntary movements (muscle contractions); nodding (little fast nodding); This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (shingles as a teenager). Concurrent medical conditions included arthritis, frozen shoulder, epilepsy, facial flushing (face flushes with exertion, since having shingles) and allergy to antibiotic (allergic to penicillin, erythromycin, sulfa). On 20-AUG-2025, the patient received Shingrix (intramuscular, left deltoid). In AUG-2025, an unknown time after receiving Shingrix, the patient experienced muscle contractions involuntary (Verbatim: facial involuntary movements (muscle contractions)) and nodding of head (Verbatim: nodding (little fast nodding)). On 20-AUG-2025, the patient experienced injection site pain (Verbatim: Injection site pain), influenza-like symptoms (Verbatim: Flu-like symptoms), facial tic (Verbatim: Facial tic) and difficulty sleeping (Verbatim: Difficulty sleeping). The outcome of the injection site pain was resolving and the outcome of the influenza-like symptoms was resolved and the outcome of the facial tic and difficulty sleeping were not resolved and the outcome of the muscle contractions involuntary and nodding of head were unknown. It was unknown if the reporter considered the injection site pain, influenza-like symptoms, difficulty sleeping, muscle contractions involuntary and nodding of head to be related to Shingrix. The reporter considered the facial tic to be related to Shingrix. It was unknown if the company considered the injection site pain, influenza-like symptoms, difficulty sleeping, muscle contractions involuntary and nodding of head to be related to Shingrix. The company considered the facial tic to be related to Shingrix. Additional Information: GSK Receipt Date: 26-AUG-2025 This report was submitted via the online direct entry reporting system. Facial tic was reported as worsened. he doctor's office did not give the patient/reporter the lot and expiration date. The reporter was the patient. On 20 Aug 2025, she received her first Shingrix dose, in her left arm, at her rheumatologist's office. That day she developed flu-like symptoms and had pain at the injection site. That evening she developed involuntary facial tics on the left side of her face. The tics were now on both sides of her face and occur every night. She had difficulty sleeping due to the facial tics. Two days after vaccination, she spoke with her rheumatologist. The doctor thought the tics were an expression of arthritic/injection pain. The patient believed the tics were related to Shingrix vaccination. According to her it started with facial involuntary movements (muscle contractions) and nodding (little fast nodding), mostly present in the left side which was the same side of the vaccine administration (left shoulder). She mentioned she had already called to the Safety area of GSK, and that a pharmacist told her to call the Medical Information line for getting more information, she confirmed that the side effect was reported to the CDC. Nothing else was reported.
Allergy to antibiotic (allergic to penicillin, erythromycin, sulfa); Arthritis; Epilepsy; Facial flushing (face flushes with exertion, since having shingles); Frozen shoulder
Medical History/Concurrent Conditions: Shingles (shingles as a teenager)