Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Basal cell carcinoma, Diarrhoea, Feeling abnormal, Headache, Malaise
Clinical narrative: basal cell cancer on face and torso; Diarrhea; Foggy feeling in head/ brain fog; Nausea; Headache; ill/ ill feeling; This is a solicited (Non-interventional study) report based on the information from contactable consumer (patient) received by Pfizer (Mfr. Control No: 21K-163-3963570-00). A 38-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not provided) via intramuscularly on 16Apr2021 (at age of 38-years-old) as dose 1, single for COVID-19 immunisation. Patient also received adalimumab (HUMIRA) ongoing since Nov2020 at 40mg/ 0.4mL, Solution for injection in pre-filled pen at 1 in 2 weeks via subcutaneous for fibromyalgia, irritable bowel syndrome and psoriatic arthritis. No relevant medical history was reported. The patient's past medications include methotrexate for unknown indication. Patient did not have any known allergies. Patient was non-tobacco user and abstains from alcohol. Family History included basal cell runs in family. Concomitant medication included sulfasalazine from May2020 to Feb2021 for unknown indication, tramadol for pain and inflammation and hydralazine for high blood pressure. In Nov2020, the patient experienced off label use. In Apr2021, the patient experienced basal cell cancer on face and torso, diarrhea, foggy feeling in head/ brain fog , nausea, headache and ill/ ill feeling. Patient reported physician found a basal cell cancer on face. She was diagnosed through visuals in physical exam. She had this spot underneath breast for past three years and she observed that it grows in the past two months, the spot on her face and torso. She mentioned that basal cell runs in the family. She stated that they were withheld and basal cell was a predominant condition on their race. She used methotrexate for six years prior HUMIRA therapy and Sulfasalazine from May2020 to Feb2021. The alternative etiology of nausea, headache, brain fog, ill and diarrhea were reported as covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Jun2021, patient received 2nd dose COVID-19 Vaccine bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE) for covid-19 immunisation. Lab test included on 28May2021 and 23Jun2021, includes Physical Exam: Basal cell. The action taken for adalimumab with respect to events was dose not changed. The outcome for event basal cell cancer on face and torso was not recovered and for all other events was recovered in May2021.  The reporter's causality for the events of basal cell cancer on face and torso, off label use and headache was not provided. The reporter's causality for the events of ill, brain fog, diarrhea and nausea with HUMIRA 40mg/ 0.4ml (adalimumab) was no reasonable possibility. Abbvie's opinion was that there was no reasonable possibility that the events of basal cell cancer on face and torso, off label use, ill, brain fog, diarrhea, nausea and headache are related to HUMIRA 40mg/ 0.4ml (adalimumab).  Causality of HUMIRA for events basal cell carcinoma, off label use, ill feeling, foggy feeling in head, diarrhea, nausea and headache. Causality as per reporter (Drug/vaccine): not reported Causality as per Company (Drug/vaccine): No reasonable possibility.  Causality of PFIZER BIONTECH COVID-19 VACCINE for basal cell carcinoma: Causality as per reporter (Drug/vaccine): not assessable. For event Off label use: Causality as per reporter (Drug/vaccine): not reported. For events ill feeling, foggy feeling in head, diarrhea, nausea and headache: Causality as per reporter (Drug/vaccine): Probable    No follow up attempts are needed. Information about lot/batch number cannot be obtained. ; Sender's Comments: Due to implausible temporal association, the event of basal cell carcinoma is assessed as unrelated to suspected vaccine bnt162b2. The patient has been on the medication for just few days, while it is known that the process of carcinogenesis takes months to years, moreover the patient had similar spot under her breast before vaccination. However,a possible contributory role of suspect product  bnt162b2 to the reported event nausea, headache, diarrhea, malaise and foggy feeling cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product 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.