Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthma, Epilepsy, Hypersomnia, Illness, Tinnitus
Clinical narrative: epilepsy; tinnitus on both ears; occurrence of sthmatic bronchitis; the first covid vaccine and booster patient was sick and sleep for about one day; the first covid vaccine and booster patient was sick and sleep for about one day; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4410114-00.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) subcutaneous for crohn's disease, hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSOMNIA (medically significant) with onset Mar2021, outcome "recovered" (Mar2021), ILLNESS (medically significant) with onset Mar2021, outcome "recovered" (2021) and all described as "the first covid vaccine and booster patient was sick and sleep for about one day"; EPILEPSY (medically significant), outcome "unknown"; TINNITUS (medically significant), outcome "unknown", described as "tinnitus on both ears"; ASTHMA (medically significant), outcome "recovering", described as "occurrence of sthmatic bronchitis". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "epilepsy", "tinnitus on both ears" and "occurrence of sthmatic bronchitis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "the first covid vaccine and booster patient was sick and sleep for about one day" related to BNT162b2.  Additional information: Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Epilepsy, sick after second Covid-19 vaccine/It put patient down, first covid vaccine and booster patient was sick and sleep for about one day onset in Mar2021, first covid vaccine and booster patient was sick and sleep for about one day onset in Mar2021, first covid vaccine and booster patient was sick and sleep for about one day onset in Dec2021, first covid vaccine and booster patient was sick and sleep for about one day onset in Dec2021, Tinnitus on both ears and occurrence of asthmatic bronchitis with Humira (Adalimumab) was no reasonable possibility. Agency's opinion is that the events of Epilepsy, Tinnitus on both ears and occurrence of asthmatic bronchitis are not assessable. Agency's opinion is that there is no reasonable possibility that the events of sick after second Covid-19 vaccine/It put patient down, first covid vaccine and booster patient was sick and sleep for about one day onset in Mar2021, first covid vaccine and booster patient was sick and sleep for about one day onset in Mar2021, first covid vaccine and booster patient was sick and sleep for about one day onset in Dec2021 and first covid vaccine and booster patient was sick and sleep for about one day onset in Dec2021 are related to Humira (Adalimumab).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  events of EPILEPSY, TINNITUS,ASTHMA  .The reported events likely represent intercurrent medical conditions. Based on available information, a possible contributory role of Comirnaty vaccine  cannot be excluded for the reported events hypersomnia and illness.