hysterectomy; cycle reduction; oestradiol high; hemorrhage uterine / bleeding; amenorrhea; luteinising hormone increased; this is a spontaneous report received from a contactable reporter(s) (pharmacist) from the regulatory authority-web. regulatory number: it-minisal02-843075. a 45 year-old female patient received bnt162b2 (comirnaty), intramuscular, administered in arm left, administration date 24may2021 13:34 (lot number: fc3558, expiration date: 30sep2021) at the age of 45 years as dose 1, 0.3 ml, single for covid-19 immunisation. the patient's relevant medical history and concomitant medications were not reported. the following information was reported: uterine disorder (disability, medically significant) with onset jan2022, outcome "recovered with sequelae", described as "hysterectomy"; polymenorrhoea (disability) with onset 02jun2021, outcome "unknown", described as "cycle reduction"; oestradiol increased (disability) with onset 02jun2021, outcome "recovered with sequelae", described as "oestradiol high"; uterine haemorrhage (disability) with onset 02jun2021, outcome "recovered with sequelae", described as "hemorrhage uterine / bleeding"; amenorrhoea (disability) with onset 02jun2021, outcome "recovered with sequelae", described as "amenorrhea"; blood luteinising hormone increased (disability) with onset 02jun2021, outcome "recovered with sequelae", described as "luteinising hormone increased". the events "hysterectomy", "hemorrhage uterine / bleeding" were evaluated at the physician office visit and emergency room visit. the events "cycle reduction", "oestradiol high", "amenorrhea" and "luteinising hormone increased" were evaluated at the physician office visit. the patient underwent the following laboratory tests and procedures: blood luteinising hormone: (02jun2021) increased; blood test: (unspecified date) unknown; hysteroscopy: (unspecified date) unknown; oestradiol: (02jun2021) high; specialist consultation: (unspecified date) unknown. the reporter informed that cycle reduction occurred immediately after the first dose of pfizer anti-covid 19 vaccine, amenorrhea after the second dose in a healthy female with regular cycle; bleeding in the following 6 months leading to hysterectomy after frequent visits and accesses to the emergency room. all supported by examinations and present reporting. in january, removal of the uterus - hysterectomy. therapeutic measures were taken as a result of uterine disorder. no follow-up attempts are possible. no further information is expected.; sender's comments: linked report(s) : it-pfizer inc-202200322052 same patient and drug, different dose and events

test date: 20210602; test name: luteinising hormone; result unstructured data: test result:increased; test name: blood test; result unstructured data: test result:unknown; test name: hysteroscopy; result unstructured data: test result:unknown; test date: 20210602; test name: oestradiol; result unstructured data: test result:high; test name: gynecological visist; result unstructured data: test result:unknown

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