Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal
Clinical narrative: knocked her on her butt/ patient felt like she had been checked out totally; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of feeling abnormal in a 71-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2024-2025 season) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   The patient's past medical history included hypertension (blood pressure higher, outcome unknown), gastroesophageal reflux disease (acid reflux, outcome unknown), blood pressure decreased (blood pressure was really low, outcome unknown), tryptase increased (triptase level had gone up to 47-48, outcome recovering resolving) and bladder spasm (outcome unknown). Previously administered products included Antacid. Concomitant products included avapritinib (Ayvakit), avapritinib, avapritinib and cimetidine (Tagamet).   In OCT-2024, the patient received Fluarix Quadrivalent 2024-2025 season and COVID-19 vaccine. In OCT-2024, an unknown time after receiving Fluarix Quadrivalent 2024-2025 season, the patient experienced feeling abnormal (Verbatim: knocked her on her butt/ patient felt like she had been checked out totally). The outcome of the feeling abnormal was unknown.   The reporter considered the feeling abnormal to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.     The company considered the feeling abnormal to be related to Fluarix Quadrivalent 2024-2025 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 05-NOV-2024 The patient's relevant medical history was not provided.  Concomitant medications included Amihiptophine, Tagamet (cimetidine) and Xetex. On an unknown date, the patient received Ayvakit (avapritinib) (100 milligrams (mg), 1 per 1-day, unknown route of administration, lot number 2210563 and expiration date 31-Oct-2026) for neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue, unspecified.  It was also reported that the patient received AVAPRITINIB (100 mg, 1 per 1-day, unknown route of administration, lot number 22L05G3 and expiration date: 31-Oct-2026) in approximately 2021.  On 17-Jan-2023, the patient sourced AVAPRITINIB from another pharmacy. On an unknown date, the patient experienced blood pressure was low (blood pressure decreased) and acid reflux (gastrooesophageal reflux disease). The patient went to the clinic because her blood pressure was low. Investigations related to the events were not provided.  Treatment included half tablet of antacid for gastrocesophageal reflux disease. On an unknown date, the patient reported blood pressure was really low (blood pressure decreased), blood pressure higher (hypertension), bladder spasms (bladder spasm), and triptase level has gone up to 47-48 (tryptase increased).  The patient went to the acute care cancer center due to having a really low blood pressure.  She had been getting off of the amihiptophine, which typically raised her blood pressure.  After stopping the medication, it made her blood pressure lower.  The patient's Xertex had been reduced from 1 tablet to 1/2 tablet because she had bladder spasm.  The patient's tryptase level had gone up to 47 to 48, and the patient believed that the only possible cause was her exposure to a very warm temperature in her state.  Investigations related to the events and treatments were not provided. In Oct-2024 (reported on 10-Oct-2024), the patient kind of knocked her on her butt (unevaluable event). She had her COVID, and flu shot this week, which knocked her on her butt.  The patient felt like she had been checked out totally.  The action taken with AVAPRITINIB in relation to the events of hypertension, blood pressure decreased, gastro oesophageal reflux disease, bladder spasm, tryptase increased, and unevaluable event was dosage maintained.  The outcomes of the events of hypertension (non-serious), blood pressure decreased (non-serious) and gastrooesophageal reflux disease (non-serious), bladder spasm (non-serious), tryptase increased (non-serious), and unevaluable event ((non-serious) were unknown. At the time of the report, AVAPRITINIB therapy was ongoing. Follow up information was received on 10-Oct-2024 from the patient which included previously reported event of blood pressure decreased with new verbatim, newly reported events of hypertension, bladder spasm, tryptase increased, and unevaluable event.  Additional information concerning these events had been requested. The events of hypertension, blood pressure decreased, gastrooesophageal reflux disease, bladder spasm, tryptase increased, and unevaluable event were not medically confirmed.  The other company s view was that the events of hypertension, blood pressure decreased, tryptase increased, and unevaluable event were not related to avapritinib. As per the available information the patient was getting off a drug amihiptophine which makes her blood pressure higher. However, due to this drug withdrawal the patient's blood pressure became really low. The event of tryptage increased was more likely related to the underlying disease, and possibly triggered by the warm temperature. The event of unevaluable event (knocked her on her butt) was attributed to the COVID-19 and Flu shot the patient received.