Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Injection site swelling, Nasal dryness, Nasal mucosal disorder, Needle track marks
Clinical narrative: 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): 22K-163-4220167-00 (RA). A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 61 years as dose 1, single, intramuscular, administration date 01Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis; metformin (METFORMIN) (Batch/Lot number: unknown). The patient's relevant medical history was not reported. Concomitant medication(s) included: COSENTYX; FLU, administration date 2021. The following information was reported: PRECANCEROUS CONDITION (medically significant), outcome "recovering", described as "precancerous lesion on arm/skin precancer spots/pre skin cancer"; DIABETES MELLITUS (medically significant), outcome "unknown", described as "Diabetes"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in arm"; SKIN INDURATION (non-serious), outcome "unknown", described as "Skin induration"; SKIN DISORDER (non-serious), outcome "unknown", described as "Skin disorder"; SKIN HYPERPIGMENTATION (non-serious), outcome "unknown", described as "hyperpigmentation lighter"; EPISTAXIS (non-serious), outcome "unknown", described as "Nosebleed"; NASAL MUCOSAL DISORDER (non-serious), outcome "unknown", described as "some mucous problems"; NASAL DRYNESS (non-serious), outcome "unknown", described as "Nasal dryness"; NEEDLE TRACK MARKS (non-serious), outcome "unknown", described as "needle track marks"; INJECTION SITE SWELLING (non-serious), outcome "unknown", described as "injection site swelling"; PAIN (non-serious), outcome "unknown", described as "Stinging"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Immune system disorder"; PIGMENTATION DISORDER (non-serious), outcome "unknown", described as "pigmentation skin"; SKIN DISCOLOURATION (non-serious), outcome "unknown", described as "Skin discolouration"; SKIN DISORDER (non-serious), outcome "unknown", described as "skin disorder"; ASTHENIA (non-serious), outcome "unknown", described as "Energy decreased"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". The patient underwent the following laboratory tests and procedures: biopsy skin: precancer spots. The action taken for Risankizumab and Metformin was unknown. The reporter's assessment of the causal relationship of the event with the suspect product 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 information provided and temporal association, causal relationship between the reported events and the suspect BNT162B2 cannot be excluded.