sudden visual disturbance in one eye; ophthalmic examination outcome suspected optic neuritis; off-label use; drug use in unapproved population; this is a spontaneous report received from a contactable reporter(s) (consumer or other non hcp) from the medicines agency () -web. regulatory number: it-minisal02-843152 (minisal02). a 33 year-old female patient received bnt162b2 (comirnaty), intramuscular, administered in arm right, administration date 13nov2021 (lot number: 1f1005a) as dose 1, 0.3 ml single for covid-19 immunisation. relevant medical history included: "breast feeding" (unknown if ongoing); "caesarean section", start date: oct2021 (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: the patient cured of covid for less than 12 months. concomitant medication(s) included: iron. past drug history included: heparin low-molecular-weight. the following information was reported: visual impairment (disability) with onset 08dec2021, outcome "not recovered", described as "sudden visual disturbance in one eye"; optic neuritis (disability) with onset 08dec2021, outcome "not recovered", described as "ophthalmic examination outcome suspected optic neuritis"; off label use (non-serious) with onset 13nov2021, outcome "unknown", described as "off-label use"; product use issue (non-serious) with onset 13nov2021, outcome "unknown", described as "drug use in unapproved population". the events "sudden visual disturbance in one eye" and "ophthalmic examination outcome suspected optic neuritis" were evaluated at the emergency room visit. the patient underwent the following laboratory tests and procedures: lumbar puncture: unknown results; magnetic resonance imaging head: unknown results; neurological examination: unknown results; ophthalmological examination: suspected optic neuritis; visual evoked potentials: unknown results. therapeutic measures were taken as a result of visual impairment. clinical course: iron supplement post pregnancy, 20 days before heparin low-molecular-weight post cesarean - actions taken (access emergency room, ophthalmic examination outcome suspected optic neuritis, neurological examination, high dose cortisone and for 5 days, mri brain, lumbar puncture, visual evoked potential) - impact on quality of life (7/10). reporter comment: no previous disease. no previous symptoms. caesarean section first pregnancy october. vaccine in november (1 dose because the patient cured of covid for less than 12 months). diagnosis in the assessment phase suspect medical product. i report to provide data on the eventual possibility that the vaccine may have slatentized the onset of symptoms (not caused the disease but if it may be related to its manifestation). no follow-up attempts are possible. no further information is expected

test name: lumbar puncture; result unstructured data: test result:unknown results; test name: mri brain; result unstructured data: test result:unknown results; test name: neurological examination; result unstructured data: test result:unknown results; test name: ophthalmic examination; result unstructured data: test result:suspected optic neuritis; test name: visual evoked potential; result unstructured data: test result:unknown results

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