Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Bleeding time prolonged, COVID-19, Drug hypersensitivity, Drug ineffective, Gastrointestinal disorder
Clinical narrative: covid positive; covid positive; Immunosuppression; Colopathy; Oral intake reduced; Bleeding time prolonged; Memory disturbance; Sleep excessive; Drug effect incomplete; Vision decreased; Allergic reaction to drug; Sickness; 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-163-4423489-00 (Agency). A 46-year-old female patient received BNT162b2 (BNT162B2), in May2021 as dose 1, single (Batch/Lot number: unknown) and on 22May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset May2021, outcome "not recovered", described as "Sickness"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "covid positive"; IMMUNOSUPPRESSION (medically significant), outcome "recovering"; GASTROINTESTINAL DISORDER (non-serious), outcome "recovering", described as "Colopathy"; HYPOPHAGIA (non-serious), outcome "unknown", described as "Oral intake reduced"; BLEEDING TIME PROLONGED (non-serious), outcome "unknown"; MEMORY IMPAIRMENT (non-serious), outcome "not recovered", described as "Memory disturbance"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Sleep excessive"; THERAPEUTIC PRODUCT EFFECT INCOMPLETE (non-serious), outcome "recovering", described as "Drug effect incomplete"; VISUAL IMPAIRMENT (non-serious), outcome "not recovered", described as "Vision decreased"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction to drug". Solicited report by a consumer of an adult female with events of non-serious covid positive diagnosis/immune system was shut down immediately from covid vaccine and shut colon down, did not eat for six weeks, bled for 13 weeks, memory trouble, slept often, flet half blind, sick, treated for allergies and benadryl and medication reactions and humira not working well for rheumatoid arthritis with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced covid positive diagnosis/immune system was shut down immediately from covid vaccine and shut colon down, did not eat for six weeks, bled for 13 weeks, memory trouble, slept often, flet half blind, treated for allergies and benadryl and medication reactions and humira not working well for rheumatoid arthritis. In May2021, the patient experienced sick. In Dec2021, the sick resolved. In 2022, the patient experienced sick. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Weight: Changes, notes: Changes. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of drug hypersensitivity. The reporter's assessment of the causal relationship of "covid positive", "oral intake reduced", "bleeding time prolonged", "memory disturbance", "sleep excessive", "sickness", "vision decreased" and "allergic reaction to drug" 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 "immunosuppression" and "colopathy" related to BNT162b2. Causality for humira(adalimumab): The reporter's causality for the event(s) of covid positive diagnosis/immune system was shut down immediately from covid vaccine and shut colon down unknown onset, covid positive diagnosis/immune system was shut down immediately from covid vaccine and shut colon down unknown onset and humira not working well for rheumatoid arthritis with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of covid positive diagnosis/immune system was shut down immediately from covid vaccine and shut colon down unknown onset, did not eat for six weeks, bled for 13 weeks, memory trouble, slept often, flet half blind, sick onset in May2021, sick onset in 2022 and treated for allergies and benadryl and medication reactions was not provided. Suspect drugs: Drug: humira (solution for injection in pre-filled pen) (adalimumab), Unknown. Causality: Colopathy (gastrointestinal disorder), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): probable, Dechallenge: N/A. Immunosuppression, Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Oral intake reduced (hypophagia), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Bleeding time prolonged (bleeding time prolonged), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Memory disturbance (memory impairment), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Sleep excessive (hypersomnia), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Vision decreased (visual impairment), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Sickness (illness), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Allergic reaction to drug (drug hypersensitivity), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. covid-19 (covid-19), Action(s) taken with drug:  unknown, Causality as per reporter (drug/vaccine): probable, Dechallenge: N/A. Drug effect incomplete (therapeutic product effect incomplete), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): probable, Dechallenge: N/A. Drug: Pfizer biontech covid-19 vaccine (tozinameran) (tozinameran), unknown, unknown. Causality: Colopathy (gastrointestinal disorder), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): probable, Dechallenge: N/A. Immunosuppression, Action(s) taken with drug:  unknown, Causality as per reporter (drug/vaccine): probable, Dechallenge: N/A. Oral intake reduced (hypophagia), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Bleeding time prolonged (bleeding time prolonged), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Memory disturbance (memory impairment), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Sleep excessive (hypersomnia), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Vision decreased (visual impairment), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Sickness (illness), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Allergic reaction to drug (drug hypersensitivity), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported, Dechallenge: N/A. Covid-19 (covid-19), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): probable, Dechallenge: N/A, Drug effect incomplete (therapeutic product effect incomplete), Action(s) taken with drug: unknown, Causality as per reporter (drug/vaccine): not reported. Dechallenge: N/A. Did event abate after stopping drug: NA.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and known profile of the Comirnaty vaccine the reported events of Drug ineffective ,COVID-19 and Drug hypersensitivity  were assessed as related to the  Comirnaty vaccine. Based on the information provided by the reporter, it appears unlikely that suspect drug contributed to the reported  events Visual impairment , Illness , Hypersomnia ,Memory impairment ,Bleeding time prolonged ,Hypophagia .Gastrointestinal disorder ,Immunosuppression.