Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Carbohydrate antigen 125, Computerised tomogram, Endometriosis, Magnetic resonance imaging, Ovarian cyst ruptured
Clinical narrative: a 6 x 10 x 6 ovarian endometrioma settled in front of bladder; Ovarian cyst ruptured; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Dec2022 as dose 4 (booster), single (Lot number: GJ3275) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Beta-thalassemia" (unspecified if ongoing); "Covid", start date: 11Dec2020, stop date: 11Dec2020. Concomitant medication(s) included: ESCITALOPRAM; CLONAZEPAM; MUSHROOM COMPLEX [ALLIUM SATIVUM;GANODERMA LUCIDUM;HERICIUM ERINACEUS;INONOTUS OBLIQUUS;LENTINUS EDODES]. Vaccination history included: BNT162b2 (DOSE 1,SINGLE, Batch/Lot number: ER2613, Anatomical location: Left arm), administration date: 17Mar2021, for COVID-19 immunisation; BNT162b2 (DOSE 2, SINGLE, Batch/Lot number: ER8730, Anatomical location: Left arm), administration date: 07Apr2021, for COVID-19 immunisation, reaction(s): "Ovarian cyst ruptured"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot number 3302688), administration date: 17Nov2021, for COVID-19 immunisation. The following information was reported: OVARIAN CYST RUPTURED (medically significant) with onset 07Apr2023, outcome "unknown"; ENDOMETRIOSIS (medically significant), outcome "unknown", described as "a 6 x 10 x 6 ovarian endometrioma settled in front of bladder". The patient underwent the following laboratory tests and procedures: Carbohydrate antigen 125: (unspecified date) 120, notes: CA-125 = 120; Computerized tomogram: (unspecified date) Unknown results; Magnetic resonance imaging: (unspecified date) 6 x 10 x 6 ovarian endometrioma, notes: settled in front of bladder, location unusual, Unknown if malignant. No lymph node inflammation. No ascites; SARS-CoV-2 test: (Feb2022) Negative, notes: Nasal Swab; (Sep2022) Negative, notes: Nasal Swab; (11Dec2020) Positive, notes: Other; Ultrasound scan: (unspecified date) Unknown results. Therapeutic measures were taken as a result of ovarian cyst ruptured, endometriosis. Clinical course: Never had cysts prior. Bilat salpingo-oophorectomy w/ hysterectomy scheduled 08May2023. Tramadol Aug2021 & Apr2023. Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Ovarian cyst ruptured, Endometriosis and the use of suspect product Comirnaty cannot be fully excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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. Linked Report(s): US-PFIZER INC-202300185334 same patient and reporter, different doses and event.