Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cataract, Drug ineffective, Illness, Pyrexia, Sinusitis
Clinical narrative: cataract; Sinus infection; made him sick; had a fever; COVID; COVID; 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-163-4379980-00 (AbbVie).  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at unk (citrate free), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset May2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset May2022, outcome "recovered" (2022) and all described as "COVID"; CATARACT (medically significant), outcome "unknown"; SINUSITIS (non-serious), outcome "unknown", described as "Sinus infection"; ILLNESS (non-serious), outcome "unknown", described as "made him sick"; PYREXIA (non-serious), outcome "unknown", described as "had a fever". The action taken for adalimumab was unknown.  Clinical course: Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. The patient had received the COVID vaccination which made him sick and he had a fever. On 03Jun2022, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology and narrative description. The reporter's assessment of the causal relationship of "covid", "sinus infection", "sickness" and "fever" with the suspect product(s) BNT162b2 was also provided at the time of this report as possible. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's assessment of the causal relationship of "covid", "cataract", "sinus infection", "made him sick" and "had a fever" 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.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of cataract, sick, COVID, sinus infection and fever was not provided. The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of sinus infection was not provided. Causality of Pfizer vaccine with both events: Causality as per reporter (Drug/Vaccine): Possible. AbbVie's opinion is that there is no reasonable possibility that the events of cataract, sick, COVID and fever are related to Humira (Adalimumab). AbbVie's opinion is that the event of sinus infection is not assessable.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (13Jun2022): Follow-up attempts are completed. No further information is expected.  Follow-up (10Jun2022): This is a solicited follow-up report from a Non-Interventional Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer from AbbVie, MFR Control No. 22K-163-4379980-00). A contactable 69-year-old male consumer (patient) reported for himself. Updated information included onset date of event (Drug ineffective and suspected COVID-19) was updated (from unknown to May2022); stop date of the event (suspected COVID-19) was updated (from unknown to 2022); new events (cataract, Sinus infection, Sickness and Fever) added and updated narrative accordingly.  Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on the information available a possible contributory role of the suspect( BNT162B2), cannot be excluded for the reported events of drug ineffective,Covid-19,sinusitis, covid cataract, illeness and pyrexia. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees. and investigators, as appropriate.