Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Pulmonary congestion, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: On Aug2022, the patient experienced COVID; COVID; COVID; chest congestion (Congestion pulmonary); MARKETING OPROGRAM NAME NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-ABBVIE-4136501.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 02Aug2021 as dose 1, single (Batch/Lot number: unknown) and on 05Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 39 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1165533) at 40 mg (40 mg (40mg/0.4ml citrate free form strength 40 mg)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Dec2021, outcome "recovered" and all described as "COVID"; PULMONARY CONGESTION (medically significant) with onset Dec2021, outcome "recovering", described as "chest congestion (Congestion pulmonary)"; DISEASE RECURRENCE (medically significant) with onset Aug2022, outcome "recovered", described as "On Aug2022, the patient experienced COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial. On Aug2022, the patient experienced COVID. The reporter's causality for the event of COVID onset 01Dec2021 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. (Withheld) opinion was that the causality for the events of COVID onset 01Dec2021 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Primary reporter did not have the lot number information, because the information was not available in the patient's file. Assessment Results: HUMIRA 40MG/0.4ML - COVID-19, Non-Health Care Professional, Global Introspection: Not Reported; HUMIRA 40MG/0.4ML - COVID-19, Non-Health Care Professional, Global Introspection: Not Reported; HUMIRA 40MG/0.4ML - Congestion pulmonary, Non-Health Care Professional, Global Introspection: Not Reported; Pfizer BionTech Covid-19 vaccine - Congestion pulmonary, Market Authorization Holder (MAH); Pfizer BionTech Covid-19 vaccine - Congestion pulmonary, Non-Health Care Professional, Global Introspection: Not Reported. Result of assessment of Pfizer BionTech Covid-19 vaccine COVID-19 as per Market Authorization Holder (MAH) and Pfizer BionTech Covid-19 vaccine -COVID-19, Non-Health Care Professional, Global Introspection was Possible.  The reporter considered "covid" related to BNT162b2. The reporter's assessment of the causal relationship of "on aug2022, the patient experienced covid" and "chest congestion (congestion pulmonary)" 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 information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, the pandemic and patient general health condition. However on conservative basis, the possible causality cannot be excluded. Moreover , Event disease recurrence and pulmonary congestion a possible contributory role of the Comirnaty vaccine cannot be completely excluded. Case will be reassessed upon additional information.