Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea haemorrhagic, Drug ineffective, Fat tissue increased, General symptom
Clinical narrative: Covid-19; COVID-19; Bloody diarrhea; Sinus disorder; General symptom; Fat tissue increased; Heart racing; Pain; Heartbeats irregular; Flu; 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-163-4526574-00 (Agency).  A 43-year-old female patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 30Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 42 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen since 2016 (Batch/Lot number: unknown) at unk, (1 in 2 wk), second regimen (Batch/Lot number: unknown) at unk, (1 in 2 wk) and third regimen (ongoing) (Batch/Lot number: unknown) at unk, (1 in 2 wk), all subcutaneous for colitis ulcerative. The patient's relevant medical history included: "Sinuses" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset Aug2022, outcome "recovered", described as "Flu"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Covid-19"; COVID-19 (medically significant), outcome "unknown"; DIARRHOEA HAEMORRHAGIC (non-serious), outcome "recovered", described as "Bloody diarrhea"; SINUS DISORDER (non-serious), outcome "not recovered"; GENERAL SYMPTOM (non-serious), outcome "unknown"; FAT TISSUE INCREASED (non-serious), outcome "unknown"; PALPITATIONS (non-serious), outcome "unknown", described as "Heart racing"; PAIN (non-serious), outcome "unknown"; HEART RATE IRREGULAR (non-serious), outcome "unknown", described as "Heartbeats irregular". The patient underwent the following laboratory tests and procedures: Heart rate: Irregular; SARS-CoV-2 test: Positive. The action taken for adalimumab was dosage not changed.   Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter contact for lot number information was unsuccessful. Therapy dates of Humira were reported as 2016 - 01Apr2021. In Aug2022, the patient experienced FLU. On unknown dates, FLU, BLOOD DIARRHEA and FLU resolved.   The reporter's assessment of the causal relationship of "covid-19", "bloody diarrhea", "flu", "sinus disorder", "general symptom", "heart racing" and "pain" 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 "covid-19", "fat tissue increased" and "heartbeats irregular" related to BNT162b2.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of SINUSES, UNSPECIFIED SYMPTOMS, LEGS STARTED GETTING FAT, RACING HEART, FLU onset in Aug2022, BLOOD DIARRHEA, PAIN, COVID, HEART BEATING IRREGULAR AFTER COVID VACCINE, FLU unknown onset and FLU unknown onset was not provided.  Causality for Humira: Causality as per reporter (Drug/Vaccine) was Not Reported for events Sinus disorder (Sinus disorder), General symptom (General symptom), Fat tissue (Fat tissue increased), Heart racing (Palpitations), Flu (Influenza), Bloody diarrhea (Diarrhoea haemorrhagic), Pain (Pain), COVID-19 (COVID-19), Heartbeats irregular (Heart rate irregular), Flu (Influenza). Dechallenge. NA for all. Action(s) taken with drug: Dose Not Changed for all.  Causality for BNT162B2: Causality as per reporter (Drug/Vaccine) was Not Reported for events Sinus disorder (Sinus disorder), General symptom (General symptom), Heart racing (Palpitations), Flu (Influenza), Bloody diarrhea (Diarrhoea haemorrhagic), Pain (Pain), Flu (Influenza). Causality as per reporter (Drug/Vaccine) was possible for events Fat tissue (Fat tissue increased), COVID-19 (COVID-19), Heartbeats irregular (Heart rate irregular) Action(s) taken with drug: Unknown, Dechallenge: N/A for all  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, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "covid-19", "bloody diarrhea", "flu", "sinus disorder", "general symptom", "heart racing" and "pain"  "covid-19", "fat tissue increased" and "heartbeats irregular".