Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | RA |
Keeps awake/Cannot sleep on right side; miserable; arm feels heavy; right arm was hurting all the time; pain she was feeling was at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. The patient's past medical history included shingles (got shingles (not a severe case)) and shoulder operation (had shoulder surgery was already going to therapy). Previously administered products included Shingles vaccine (she had another shingles vaccine 10-15 years ago). On 16-JUL-2025, the patient received the 1st dose of Shingrix (right arm). On 16-JUL-2025, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: right arm was hurting all the time) and injection site pain (Verbatim: pain she was feeling was at the injection site). On an unknown date, the patient experienced difficulty sleeping (Verbatim: Keeps awake/Cannot sleep on right side), feeling miserable (Verbatim: miserable) and heaviness in arm (Verbatim: arm feels heavy). The patient was treated with ibuprofen sodium (Ibuprofen) and cola spp., manganese glycerophosphate, phosphoric acid (Biotone). The outcome of the pain in arm, injection site pain, difficulty sleeping, feeling miserable and heaviness in arm were not resolved. It was unknown if the reporter considered the pain in arm, injection site pain, difficulty sleeping, feeling miserable and heaviness in arm to be related to Shingrix. It was unknown if the company considered the pain in arm, injection site pain, difficulty sleeping, feeling miserable and heaviness in arm to be related to Shingrix. Additional Information: GSK Receipt Date: 24-SEP-2025 The patient reported that right after receiving the vaccine, she noticed persistent pain in her right arm. She had been undergoing therapy for a left shoulder surgery done on 20-MAY-2025, using both arms during therapy. After completing therapy, her left shoulder pain resolved, but she continued to feel pain at the injection site of the Shingrix vaccine. The patient stated the pain kept her awake 24 by 7 and has been going on for several months. She took Ibuprofen, one or two tablets in the morning, and occasionally another if she used her arm a lot. She applied a cold pack in the morning, took hot showers, rubbed Biotone on her arm if needed, and rested to relieve the pain. She used a pillow at night to lie her arm and could not sleep on her right side due to the pain. ' She described her arm was feeling heavy, felt miserable and she had to keep her arm at her side to not exert it too much. Her physician suggested the pharmacist might have injected the vaccine into a vein and recommended using a massager. The patient mentioned that her physician advised that she receive Shingrix due to hearing it would help with dementia, but the patient does not have dementia. The batch number was not provided and a request for this information has been made.
Medical History/Concurrent Conditions: Shingles (got shingles (not a severe case)); Shoulder operation (had shoulder surgery was already going to therapy)