Received Mar 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
Weakness in legs; pain in neck; head pain; shoulder pain; chest pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle weakness lower limb in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On 19-FEB-2025, the patient received the 1st dose of Shingrix (intramuscular, right arm). In FEB-2025, an unknown time after receiving Shingrix, the patient experienced neck pain (Verbatim: pain in neck), headache (Verbatim: head pain), shoulder pain (Verbatim: shoulder pain) and chest pain (Verbatim: chest pain). On an unknown date, the patient experienced muscle weakness lower limb (Verbatim: Weakness in legs). The patient was treated with gabapentin, baclofen and paracetamol (Tylenol). The outcome of the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain were not resolved. It was unknown if the reporter considered the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain to be related to Shingrix. It was unknown if the company considered the muscle weakness lower limb, neck pain, headache, shoulder pain and chest pain to be related to Shingrix. Additional Information: GSK Receipt Date: 04-MAR-2025 Patient experienced muscle weakness in legs and pain going up both sides of head, shoulders, and chest. Patient stated the onset of muscle weakness was approximately 10-12 days following vaccination and the neck pain going up both sides of the head, shoulders, and chest presented a few days prior to the muscle weakness. The patient was self-treating the symptoms with Gabapentin, Baclofen, and Tylenol, the dose and frequency were not provided. The patient stated Gabapentin, baclofen and Tylenol were prescribed to her for a different diagnosis prior to vaccination with Shingrix. The patient had not been treated by a doctor for the adverse event after vaccination. The patient stated she was being treated by physical therapy but did not specify if the treatment was for a different diagnosis prior to vaccination with Shingrix. The vaccine was administered at Pharmacy. The patient stated she was very active and she hiked approximately 30 miles per week and she has been unable to hike due to the muscle weakness in her legs