Age: 45.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cholesteatoma, Ear pain, Memory impairment, Multiple sclerosis relapse
Clinical narrative: Cholesteatoma; Ear pain; memory impairment; Multiple sclerosis relapse; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022SA244372 (Agency).  A 45-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 45 years for covid-19 immunisation; teriflunomide (TERIFLUNOMIDE), since 19Nov2020 (Batch/Lot number: unknown) at 1x/day (unk, 1x/day), oral for multiple sclerosis. The patient's relevant medical history included: "Cholesteatoma" (ongoing), notes: cyst on her ear that was painful (cholesteatoma, ear pain); "Ear pain" (ongoing), notes: cyst on her ear that was painful (cholesteatoma, ear pain). The patient's concomitant medications were not reported. Past drug history included: Aubagio, stop date: 01Jan2021, reaction(s): "Multiple sclerosis", notes: The consumer stopped Aubagio approximately 01Jan2021, and she reported that she stopped Aubagio due to issues with her previous healthcare provider. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant) with onset Aug2021, outcome "not recovered"; CHOLESTEATOMA (medically significant), outcome "not recovered"; EAR PAIN (medically significant), outcome "not recovered"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered". The events "cholesteatoma", "multiple sclerosis relapse", "ear pain" and "memory impairment" required physician office visit. The action taken for teriflunomide was unknown. Therapeutic measures were taken as a result of cholesteatoma, ear pain. Therapeutic measures were not taken as a result of multiple sclerosis relapse.  Clinical course: It was reported that patient was in relapse (multiple sclerosis relapse, latency, approximately 9 months) since Aug2021, which started after she received the Pfizer covid vaccine. She reported that that she had a cyst on her ear that was painful (cholesteatoma, ear pain) last year also, but came back like 2 weeks after it was lanced. she was taking Bactrim 800/160 twice a day. The consumer was going to take cognitive therapy for she loses thing often. She was in the process of restarting Aubagio, at the time of her report, Aubagio was discontinued, approximately 01Jan2021.  The reporter's assessment of the causal relationship of "cholesteatoma","ear pain" and "memory impairment" with the suspect product(s) BNT162b2 was not reported at the time of this report and for the event "multiple sclerosis relapse" is not related at the time of the report.   Company causality assessment of the causal relationship of "cholesteatoma", "ear pain" and "memory impairment" and "multiple sclerosis relapse" with the suspect product(s) BNT162b2 was not reported at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cholesteatoma", "ear pain" and "memory impairment" and "multiple sclerosis relapse" and the suspect vaccine Comirnaty cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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.