Sex: F
Vaccine: VARZOS
Symptoms: Medical device implantation, Nausea, Pain, Pain in extremity, Syncope
Clinical narrative: fainted in the kitchen; fell forward/fell again in the hallway; right arm was sore; broke my right humerus bone; patient was in pain/everything hurt; Felt terrible started 12 hours later; Sick to my stomach; This serious case was reported by a consumer via call center representative and described the occurrence of faint in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received in December 2022 and had no symptoms).   On 12-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 12-MAY-2023, 12 hrs after receiving Shingrix, the patient experienced pain (Verbatim: patient was in pain/everything hurt) (serious criteria hospitalization), feels awful (Verbatim: Felt terrible started 12 hours later) (serious criteria hospitalization) and stomach discomfort (Verbatim: Sick to my stomach) (serious criteria hospitalization). On 13-MAY-2023, the patient experienced faint (Verbatim: fainted in the kitchen) (serious criteria hospitalization and GSK medically significant), fall (Verbatim: fell forward/fell again in the hallway) (serious criteria hospitalization), pain in arm (Verbatim: right arm was sore) (serious criteria hospitalization) and humerus fracture (Verbatim: broke my right humerus bone) (serious criteria hospitalization and clinically significant/intervention required). On 13-MAY-2023, the outcome of the feels awful and stomach discomfort were resolved (duration 1 day). The outcome of the faint, fall, pain, pain in arm and humerus fracture were resolved.   It was unknown if the reporter considered the faint, fall, pain, feels awful, stomach discomfort, pain in arm and humerus fracture to be related to Shingrix.     It was unknown if the company considered the faint, fall, pain, feels awful, stomach discomfort, pain in arm and humerus fracture to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-NOV-2023 and 28-NOV-2023 The patient self-reported this case. The patient received 2nd Shingrix shot in the afternoon and within 12 hours she started having symptoms. The patient felt horrible that evening, everything hurt and was sick to her stomach. The patient went to bed at 10 pm and woke up at 2:30 am needing a drink, to get some water, she walked to the kitchen, fainted, fell forward and broke her right humerus bone. The patient must of managed to get up and she fell backward in the hallway when her husband heard her. He was able to get her up and back to bed. The patient went to urgent care the next morning and they sent her to the emergency room after they x-rayed her arm.  The orthopedic Healthcare professional (HCP) decided to perform surgery and placed a plate and 8 screws, recovery took 12 weeks before being released from the HCP. This adverse event had now resolved. It was a terribly long recovery, and now on the Shingrix commercial it was stating that fainting might occur. The reporter stated that, that was not in the original side effects, and wanted to tell her story in the hope that it never happens to anyone else. The patient was looking to see if there was a class action suit for those that took the shot and had the same or similar thing happen. Consent to follow-up granted.