Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Anxiety, COVID-19, Influenza like illness, Malaise, Pneumonia
Clinical narrative: anxiety; sick with flu like symptoms; pneumonia; COVID-19; Not feeling well; This is a solicited report from a contactable consumer (reported for himself) received from non-interventional study (FACILITATED COLLECT) based on information received by Pfizer, (manufacturer control number: 21K-163-4098933-00).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 20Sep2021 as dose 1, single (Batch/Lot number: unknown), on 28Oct2021 as dose 2, single (Batch/Lot number: unknown) and on 30Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, all intramuscular for covid-19 immunisation; and adalimumab (HUMIRA), first regimen since 24Sep2021 (ongoing) (Lot number: 1153557) at citrate free, second regimen (ongoing) (Lot number: 1153085) at citrate free and third regimen (ongoing) (Lot number: 1160173) at citrate free, all subcutaneous for colitis ulcerative. There was no medical history (no relevant medical history and no known allergies). Concomitant medications included fexofenadine hydrochloride (MUCINEX), paracetamol (TYLENOL), Azithromycin (ZITHROMAX), Amoxicillin (AMOXICILLIN), Prednisone (PREDNISONE), all taken for unspecified indication, start and stop date were not reported. Upon follow up (on 01Nov2021) It was reported that patient experienced not feeling well on an unspecified date in 2021. The patient experienced COVID-19 on 22Sep2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included COVID-19 Test: COVID-19 in Sep2021. The action taken in response to the event for adalimumab was unknown. The outcome of the events was resolved on an unspecified date in 2021. Upon follow up (on 05May2022) It was reported that patient experience On an unknown date, the patient experienced anxiety. In Oct2021, the patient experienced Pneumonia. In 2021, the not feeling well and COVID-19 resolved. In 2022, the patient experienced Sick with Flu like Symptoms. The action taken for adalimumab was dosage not changed. The Causality as per reporter for the drug humira reported as for Pneumonia was No reasonable possibility. Anxiety was Not Related, Flu like symptoms was Not Reported. Causality as per reporter for the drug BNT162B2 reported as for Pneumonia was Not Reported, Anxiety was Possible, Flu like symptoms was Possible.   The reporter's assessment of the causal relationship of the event "COVID-19" with the suspect product adalimumab (HUMIRA) was "reasonable possibility" and Feeling unwell (Malaise) was Not Reported. The reporter's assessment of the causal relationship of the event "COVID-19" with the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was unknown and Feeling unwell (Malaise) was Not Reported. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (01Nov2021): This is a follow-up solicited report from a Non-interventional (FACILITATED COLLECT) based on the information received by Pfizer manufacture number (21K-163-4098933-00) included updated vaccine administration date details, event onset date of covid-19, event outcome details, causality details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05May2022): This is a solicited follow-up report based on the information received by Pfizer (Mfr Control No.: 21K-163-4098933-00). A contactable 62-year-old male consumer (Patient) reported for herself that:  Updated Information Included: Dose 2 and 3 of BNT162B2 was updated in dosage regimen. Dosage regimen was updated for huimira. Concomitant drugs updated (Azithromycin, Amoxicillin, Prednisone). New Event added (anxiety, Pneumonia,Sick with Flu like Symptoms).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the Limited information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Covid 19 and pneumonia cannot be established as the event covid-19 occurred within 2 days of vaccination. Minimum of 14 day gap is required for the immune response after 1st dose. Based on the available reported information, the causal association between the events malaise, influenza like illness and anxiety and the suspect drug BNT162B2 cannot be excluded.