Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Illness, Lower respiratory tract infection, Nasopharyngitis, Respiratory tract congestion
Clinical narrative: Chest cold; Head cold; Constipation; Diarrhea; COVID-19; COVID-19; Chest Congestion; Sinus pain; Runny nose; Cough; Dehydration; Sick; 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-163-4312432-00 (Agency).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Sep2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 11Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1157573) at citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Mar2022, outcome "not recovered" and all described as "COVID-19"; ILLNESS (non-serious) with onset Mar2020, outcome "not recovered", described as "Sick"; LOWER RESPIRATORY TRACT INFECTION (non-serious), outcome "not recovered", described as "Chest cold"; NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Head cold"; RESPIRATORY TRACT CONGESTION (non-serious) with onset Mar2022, outcome "not recovered", described as "Chest Congestion"; SINUS PAIN (non-serious) with onset Mar2022, outcome "unknown", described as "Sinus pain"; RHINORRHOEA (non-serious) with onset Mar2022, outcome "unknown", described as "Runny nose"; COUGH (non-serious) with onset Mar2022, outcome "unknown", described as "Cough"; CONSTIPATION (non-serious), outcome "unknown", described as "Constipation"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; DEHYDRATION (non-serious) with onset 2022, outcome "unknown", described as "Dehydration". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Mar2022) unknown results. The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Device issue with Humira (Adalimumab) was Reasonable possibility.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of COVID-19 and Sickness and Chest cold and Head cold with Humira (Adalimumab) was No reasonable possibility.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of Respiratory tract congestion and Sinus pain and Runny nose and Cough and Constipation and Diarrhea and Dehydration with Humira (Adalimumab) was not provided.  Causality for Pfizer Biontech COVID-19 Vaccine (TOZINAMERAN) :The reporter's causality for the event(s) of COVID-19 and Sickness and Respiratory tract congestion and Sinus pain and Runny nose and Cough with Pfizer Biontech COVID-19 Vaccine was Not Reported.  Causality for Pfizer Biontech COVID-19 Vaccine (TOZINAMERAN) :The reporter's causality for the event(s) of Chest cold and Head cold and Constipation and Diarrhea and Dehydration with Pfizer Biontech COVID-19 Vaccine was Possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from patient to patient and may be influenced by multiple factors, including the virulence of the infecting pathogen, inherent disease condition, concurrent medical conditions, and concomitant medications, however, a contributory role of the suspect drug cannot be excluded for the events of drug ineffective and COVID 19. Considering the temporal association and /or product profile, a causal role of the suspect drug cannot be completely denied for the other reported events.