Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Asthenia, Bone pain, Dyspnoea, Fatigue
Clinical narrative: had me in so much pain/ still achy; could not speak; could not get up to get help; could barely breathe; still achy and weak; get very tired; extreme muscle pain; bone pain; This non-serious case was reported by a consumer and described the occurrence of muscle pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy bilateral (double mastectomy), surgery (reconstruction surgery), delivery (patient did not need an epidural or any significant pain relief when delivering her daughter) and cancer. Previously administered products included Tylenol (received on an unknown date) and Advil (received on an unknown date). Concurrent medical conditions included attention deficit hyperactivity disorder (predominantly inattentive type), anxiety depression, insomnia and migraine. Concomitant products included amfetamine aspartate;amfetamine sulfate;dexamfetamine saccharate;dexamfetamine sulfate (Adderall), gabapentin, mirtazapine, trazodone and topiramate (Topamax).   On 24-NOV-2023, the patient received the 1st dose of Shingrix. On 24-NOV-2023, less than a day after receiving Shingrix, the patient experienced muscle pain (Verbatim: extreme muscle pain) and bone pain (Verbatim: bone pain). On an unknown date, the patient experienced pain (Verbatim: had me in so much pain/ still achy), aphasia (Verbatim: could not speak), mobility decreased (Verbatim: could not get up to get help), difficulty breathing (Verbatim: could barely breathe), weakness (Verbatim: still achy and weak) and tiredness (Verbatim: get very tired). The outcome of the muscle pain, bone pain, pain and weakness were not resolved and the outcome of the aphasia, mobility decreased, difficulty breathing and tiredness were not reported.   It was unknown if the reporter considered the muscle pain, bone pain, pain, aphasia, mobility decreased, difficulty breathing, weakness and tiredness to be related to Shingrix.     It was unknown if the company considered the muscle pain, bone pain, pain, aphasia, mobility decreased, difficulty breathing, weakness and tiredness to be related to Shingrix.   Linked case(s) involving the same patient: US2024AMR071005   Additional Information: GSK Receipt Date: 02-JUN-2024 The patient self-reported this case. The patient had extreme muscle and bone pain with both doses of the vaccine, more than with any cancer treatment or surgery she ever had. The patient reported just as a reference, she did not need anything more than Tylenol, Advil for a few days while recovering from double mastectomy and reconstruction surgeries. The patient did not need an epidural or any significant pain relief when delivering her daughter, but this vaccine had her in so much pain that she could not speak or get up to get help. The patient could barely breathe. After a week, the patient was still achy and weak, and she get very tired by the end of the day. The patient reported that she could not tell anyone else to do this. No symptoms were treated. This case had been linked to the case US2024AMR071005, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR071005:same patient case for 1nd dose.