Age: 69.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, COVID-19, Drug ineffective, Hypersomnia, SARS-CoV-2 test
Clinical narrative: sick with COVID; sick with COVID; slept a lot; 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-163-4520987-00 (Agency).  A 70-year-old female patient received BNT162b2 (BNT162B2), on 26Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 69 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Jan2021 as dose 1, single (Lot number: 027L0A), on 04Mar2021 as dose 2, single (Lot number: 011M20A) and on 10Dec2021 as dose 3 (booster), single (Lot number: 048F21A), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2021 (ongoing) (Lot number: 1164825) at 40 mg (40 mg, (citrate free (1 in 2 week)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history included: "Tobacco use", stop date: 1998, notes: Tobacco use; "Abstains from Alcohol" (unspecified if ongoing); "Tuberculosis" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE; DILTIAZEM; MECLIZINE [MECLOZINE HYDROCHLORIDE] taken for dizziness; LEFLUNOMIDE taken for rheumatoid arthritis; MELOXICAM taken for arthritis; FOLIC ACID taken for rheumatoid arthritis; CITALOPRAM; LISINOPRIL; TOPIRAMATE; PREGABALIN; ONDANSETRON; BENZONATATE; MONTELUKAST; PRAVASTATIN. Past drug history included: Statin, reaction(s): "Statin allergy", notes: Statin allergy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Aug2022, outcome "recovered" (28Aug2022) and all described as "sick with COVID"; HYPERSOMNIA (non-serious) with onset 21Aug2022, outcome "recovered" (28Aug2022), described as "slept a lot". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 99.8 Fahrenheit; SARS-CoV-2 test: (28Aug2022) Negative; (21Aug2022) Positive. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of drug ineffective, covid-19, hypersomnia.  Clinical Course: Solicited report from a consumer of a 70-year-old female with events of non-serious slept a lot and sick with COVID with Humira 40mg/0.4ml (Adalimumab). On 21Aug2022, the patient experienced slept a lot and sick with COVID. On 28Aug2022, the slept a lot and sick with COVID resolved. Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 vaccine (Tozinameran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient was treated with Paxlovid. Causality for Humira 40mg/0.4ml (Adalimumab) The reporter's causality for the event(s) of slept a lot and sick with COVID with Humira 40mg/0.4ml (Adalimumab) was no reasonable possibility. On 25Aug2022, received updates to patient demographics, medical history, event information, reporter opinion of causality, suspect drug information, concomitant drug information, treatment drug information, laboratory/diagnostic procedures and narrative description. The event of "slept a lot" was added.  The reporter considered "sick with covid" and "slept a lot" not related to BNT162b2.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported covid-19, drug ineffective, hypersomnia.