Age: 27.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Hypersomnia, Liver injury
Clinical narrative: liver damage; sleeping as much as 18 hours; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4283709-00.  A 27 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single and intramuscular, administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIVER INJURY (medically significant) with onset 2022, outcome "unknown", described as "liver damage"; HYPERSOMNIA (non-serious) with onset 2022, outcome "recovering", described as "sleeping as much as 18 hours". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of fatigue, liver damage, sleeping as much as 18 hours, covid vaccine related issues/second vaccine was the worst, sore arm following covid vaccine, covid, plaque psoriasis flare and body aches was not provided.  The reporter's assessment of the causal relationship of the events Liver damage and Sleep excessive with the suspect product BNT162B2 was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical Course: events of non-serious fatigue, liver damage, sleeping as much as 18 hours, covid vaccine related issues/second vaccine was the worst, sore arm following covid vaccine, covid, plaque psoriasis flare and body aches with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced fatigue, sore arm following covid vaccine, plaque psoriasis flare and body aches. In 2021, the patient experienced covid vaccine related issues/second vaccine was the worst. In 2022, the patient experienced liver damage and sleeping as much as 18 hours. In Feb2022, the patient experienced covid. On unknown dates, fatigue and body aches resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) and Moderna Covid-19 Vaccine (Elasomeran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per Limited information in the case report,  a casual association between reported events Liver injury, Hypersomnia  with the suspect product BNT162B2 cannot be excluded  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