Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Squamous cell carcinoma of skin
Clinical narrative: Cold; sinus stuffy nose; cough; headache; Squamous cell carcinoma on scalp, above knee, upper calf; Basal cell carcinoma of lower calf;  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4199554-00 .  A 70 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2021 (Batch/Lot number: unknown) at the age of 70 years as dose 1, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "removed a squamous cell carcinoma on upper calf", start date: 10Dec2012, stop date: 10Dec2012, notes: removed a squamous cell carcinoma on upper calf; "Basal cell carcinoma of inside elbow", start date: 2015 (unspecified if ongoing), notes: Basal cell carcinoma of inside elbow. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient's concomitant medications were not reported. The following information was reported: SQUAMOUS CELL CARCINOMA OF SKIN (medically significant) with onset 2021, outcome "not recovered", described as "Squamous cell carcinoma on scalp, above knee, upper calf"; BASAL CELL CARCINOMA (medically significant) with onset 2021, outcome "not recovered", described as "Basal cell carcinoma of lower calf"; NASOPHARYNGITIS (non-serious) with onset 08Dec2021, outcome "not recovered", described as "Cold"; NASAL CONGESTION (non-serious) with onset 08Dec2021, outcome "not recovered", described as "sinus stuffy nose"; COUGH (non-serious) with onset 08Dec2021, outcome "unknown", described as "cough"; HEADACHE (non-serious) with onset 08Dec2021, outcome "unknown", described as "headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) negative. The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of squamous cell carcinoma of skin.  Clinical course: Doctor removed a squamous cell carcinoma on upper calf on 10Dec2012. Started before rinvoq on patient's inside of elbow was basal cell carcinoma in 2015. He had squamous cell carcinoma on scalp, above knee removed them two to three months ago either in Sep2021 or Oct2021. He had basal cell carcinoma on lower calf and doctor was changing to humira. On 08Dec2021, he had cold started cough, sinus stuffy nose and headache. He went for covid test, it was negative.  Causality for rinvoq (upadacitinib): The reporter's causality for the event(s) of squamous cell carcinoma on scalp, above knee, upper calf and basal cell carcinoma on lower calf with rinvoq(upadacitinib) was a reasonable possibility. The reporter's causality for the event(s) of cold and sinus stuffy nose with rinvoq (upadacitinib) was no reasonable possibility. Pfizer biontech covid-19 vaccine(tozinameran)(tozinameran), causality: Causality as per reporter (drug/vaccine) given as possible' for events squamous cell carcinoma of skin, basal cell carcinoma, cold. Causality for Nasal congestion, cough and headache not reported by reporter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of squamous cell carcinoma of skin, basal cell carcinoma are assessed as  Unrelated to the suspect drug bnt162b2 and consider possible contributory effects from patient's medical history  Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of Cold, Nasal congestion, Cough and Headache.