Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Melanocytic naevus, Pain, Skin cancer
Clinical narrative: Skin cancer; Mole of skin; Flu symptoms; Pain; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 25Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 61 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as cf (Batch/Lot number: unknown) subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu symptoms"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021); SKIN CANCER (medically significant), outcome "unknown"; MELANOCYTIC NAEVUS (non-serious), outcome "unknown", described as "Mole of skin". The action taken for adalimumab was unknown. Patient with events of skin cancer and non-serious mole, flu symptoms and pains with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced skin cancer and mole. In 2021, the patient experienced flu symptoms and pains. in 2021, the flu symptoms and pains resolved. PFIZER BIONTECH COVID-19 VACCINE (tozinameran) was also considered suspect. The patient's mole removed for skin cancer. She had pains and flu symptoms for a couple of days after Covid-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file. Causality for Humira (ADALIMUMAB). The reporter's causality for the event(s) of skin cancer, mole, flu symptoms and pains was not provided. Company's opinion is that the events of skin cancer and mole are not assessable. Company's opinion is that there is no reasonable possibility that the events of flu symptoms and pains are related to Humira (ADALIMUMAB). Drug: Humira Causality: 1) Skin cancer (Skin cancer), Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr (Drug/Vaccine): Not assessable. 2) Mole of skin (Melanocytic naevus), Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr (Drug/Vaccine): Not assessable. 3) Flu symptoms (Influenza), Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr (Drug/Vaccine): Not assessable. 4) Pain (Pain), Causality as per reporter (Drug/Vaccine): Not Reported, Causality as per Mfr (Drug/Vaccine): Not assessable.  The reporter's assessment of the causal relationship of "skin cancer", "mole of skin", "flu symptoms" 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.  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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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