Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, Malaise, Pain
Clinical narrative: COVID-19/ got tested for covid and it did came back positive; COVID-19/ got tested for covid and it did came back positive; Squamous cell carcinoma of the face; feeling unwell; feels bad; ache; FACILITATED COLLECT This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer Inc. (manufacturer Control Number: 21K-163-4044053-00). A 49-year-old female patient received second dose of bnt162b2 (BNT162B2), intramuscular on unknown date in 2021 (Lot number was not reported) as single dose, first dose was administered on unknown date in 2021 intramuscular (Lot number was not reported) as single dose, both for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date at an unknown dose for moderate to severe hidradenitis suppurativa. Medical history included moderate to severe hidradenitis suppurativa. Concomitant medications were not reported. On unknown date in 2021 patient experienced squamous cell carcinoma of the face, covid-19, feeling unwell, feels bad, ache. The patient underwent laboratory tests and procedures which included sars-cov-2 test (COVID-19 TEST): positive on unknown date in 2021. As reported: Solicited report by a consumer of an adult female with events of Squamous Cell on Face and non-serious not feeling well, felt bad/lousy, covid-19 and achiness with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced Squamous Cell on Face, Not Feeling Well, Felt Bad/Lousy, Covid-19 and Achiness. PFIZER BIONTECH Covid-19 Vaccine (Tozinameran) was also considered suspect. In 2021, the patient had procedure on face to removed squamous cell. She was doing ok but it did not look nice. She had cough. She started felt bad right after her second vaccine. She had fever and achiness and felt lousy, she thought it was from the vaccine. She finally went and got tested for covid and it did came back positive. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. The patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Change History On 07Sep2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative ethology and narrative description. The events of "Covid-19" and "Not Feeling Well" were added. On 16Sep2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative ethology, suspect drug information, laboratory/diagnostic procedures and narrative description. The events of "Felt Bad/Lousy" and "Achiness" were added. Action taken with adalimumab and outcome of the events were unknown.  Causality for Humira (Adalimumab): the reporter's causality for the event(s) of Squamous Cell on Face, Not Feeling Well, Felt Bad/Lousy, Covid-19 And Achiness was not provided. Withheld opinion is that the event of Squamous Cell on Face is not assessable. Withheld opinion is that there is no reasonable possibility that the events of Not Feeling Well, Felt Bad/Lousy, Covid-19 and Achiness are related to Humira (Adalimumab). The reporter considered the events Feels bad, COVID-19 and ache possible related to BNT162B2. The reporter's assessment of the causal relationship of the events Squamous cell carcinoma of the face and feeling unwell with suspect product 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's assessment of the causal relationship of the reported events with suspect product adalimumab 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 lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.