Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: The patient had tested positive for COVID-19, asymptomatic and currently had covid; The patient had tested positive for COVID-19, asymptomatic and currently had covid; lump on arm it was red and inflamed; lump on arm it was red and inflamed; lump on arm it was red and inflamed; 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-163-4264386-00.  A 70 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 70 years as dose 3 (booster), single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, Drug: Moderna Covid-19 Vaccine (Elasomeran) (Injection) (Elasomeran), Unknown, Unknown, Unknown, Route of Admin: 1) Intra-muscular, Indication for use: 1) Covid-19 Vaccination), administration date: 08Mar2021, when the patient was 69 years old, for Covid-19 immunization; Moderna covid-19 vaccine (Dose 2, Drug: Moderna Covid-19 Vaccine (Elasomeran) (Injection) (Elasomeran), Unknown, Unknown, Unknown, Route of Admin: 1) Intra-muscular, Indication for use: 1) Covid-19 Vaccination), administration date: 05Apr2021, when the patient was 69 years old, for Covid-19 immunization. The following information was reported: ASYMPTOMATIC COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovering" and all described as "The patient had tested positive for COVID-19, asymptomatic and currently had covid"; VACCINATION SITE MASS (non-serious) with onset Nov2021, outcome "recovering", VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE INFLAMMATION (non-serious) all with onset Nov2021, outcome "unknown" and all described as "lump on arm it was red and inflamed". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for risankizumab was unknown.  On an unknown date, the patient experienced Asymptomatic Covid-19. In Nov2021, the patient experienced got covid-19 booster and patient had lump on arm it was red and inflamed. PFIZER BIONTECH Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had tested positive for COVID-19, asymptomatic and currently had covid. When she got the COVID-19 booster she had a lump on her arm and it was red and inflamed. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for SKYRIZI (RISANKIZUMAB) The reporter's causality for the event(s) of Asymptomatic Covid-19 and got covid-19 booster and patient had lump on arm it was red and inflamed onset in Nov2021 with skyrizi (risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of got covid-19 booster and patient had lump on arm it was red and inflamed onset in Nov2021 and got covid-19 booster and patient had lump on arm it was red and inflamed onset in Nov2021 was not provided.  Suspect drug (information):  Suspect Drug(s) (include generic name): Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Injection) (Tozinameran), Unknown, Unknown Daily Dose: Booster dose (1 in 1 Once) Route of Administration: Intra-muscular Therapy Dates (From/to): 18Nov2021 Product-Reaction level: Seq No: 2 Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Injection) (Tozinameran), Unknown, Unknown Daily Dose: Booster dose (1 in 1 Once) Route of Administration: Intra-muscular Therapy Dates (From/to): 18Nov2021-18Nov2021 Causality:  Asymptomatic COVID-19 (Asymptomatic COVID-19) Action(s) taken with drug: Not Applicable~ Causality as per reporter (Drug/Vaccine): Not Reported De challenge: N/A Vaccination site lump (Vaccination site mass) Action(s) taken with drug: Not Applicable Causality as per reporter (Drug/Vaccine): Possible De challenge: N/A Vaccination site erythema (Vaccination site erythema) Action(s) taken with drug: Not Applicable~ Causality as per reporter (Drug/Vaccine): Possible De challenge: N/A Vaccination site inflammation (Vaccination site inflammation) Action(s) taken with drug: Not Applicable Causality as per reporter (Drug/Vaccine): Possible De challenge: N/A  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.Based on the current available limited information in the case provided, the causal association between the events vaccination site mass, vaccination site erythema and vaccination site inflammation and the use of suspect product BNT162B2 cannot be fully excluded.