Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Blood test, Hysterectomy, Immunisation reaction, Inflammation
Clinical narrative: Hysterectomy; Cyst in left ovary; Adverse reaction to covid booster shot; Pus; Inflammation; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4515136-00 (Manufacturer Control Number).  A 42-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for COVID-19 immunization. The following information was reported: HYSTERECTOMY (medically significant), outcome "recovering"; OVARIAN CYST (non-serious), outcome "recovering", described as "Cyst in left ovary"; IMMUNISATION REACTION (non-serious), outcome "recovered", described as "Adverse reaction to covid booster shot"; PURULENCE (non-serious), outcome "recovering", described as "Pus"; INFLAMMATION (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Biopsy: Cyst in left ovary and pus; Blood test: Positive with less inflammation; X-ray: Positive with less inflammation. The action taken for upadacitinib was unknown.  Clinical course: Solicited report from the by a consumer of a adult female with events of hysterectomy, and non-serious cyst in left ovary, adverse reaction to COVID booster shot, pus, and inflammation with Upadacitinib modified-release tablet. There was no reported medical history. It was unknown if patient was enrolled in COVID-19-vaccine trial. The patient reported her blood work and x-ray were coming back positive with less inflammation. She had done biopsy in her uterus, cyst in left ovary and pus. She also had a reaction to the booster shot. She was having hysterectomy.  Causalities: The reporter's causality for the event(s) of adverse reaction to COVID booster shot, cyst in left ovary, inflammation, pus and hysterectomy with Upadacitinib modified-release tablet was not provided. The reporter's causality for the event(s) of cyst in left ovary, inflammation, pus and hysterectomy with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was not provided The reporter's causality for the event(s) of adverse reaction to COVID booster shot with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was reasonable possibility. Agency's opinion was that the causality for the event(s) of adverse reaction to COVID booster shot and hysterectomy with Upadacitinib modified-release tablet was no reasonable possibility. Agency's opinion was that the causality for the event(s) of cyst in left ovary, inflammation and pus with Upadacitinib modified-release tablet was not assessable. Agency's alternative etiology for adverse reaction to COVID booster shot with Upadacitinib modified-release tablet: more likely related to use of COVID 19 vaccine.. Agency's alternative etiology for hysterectomy with Upadacitinib modified-release tablet: surgical procedure performed, more likely related to underlying uterine disorder. Change History 11Oct2022, received updates to event information and suspect product information. Primary reporter did not have the lot number information, because the information was not available in the patient's file.  The reporter's assessment of the causal relationship of "hysterectomy", "cyst in left ovary", "pus" and "inflammation" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "adverse reaction to covid booster shot" related to BNT162b2, BNT162b2 omi ba.4-5.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of cyst in left ovary, inflammation, pus and hysterectomy . The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.