Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture, Blood test, COVID-19, Cellulitis, Computerised tomogram
Clinical narrative: cellulitis; Ear swelling; Glands swollen; Covid-19; face swollen; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3833478-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), since Jan2020 (ongoing) (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history included: "Gallstones removal", start date: 24Jul2020, stop date: 31Jul2020, notes: on 24Jul2020, the patient experienced Gallstones removal. On 31Jul2020, the Gallstones removal resolved; "Psoriasis", start date: 2008 (unspecified if ongoing), notes: Psoriasis (Started 2008); "Abstains from Alcohol" (unspecified if ongoing); "ADULT ONSET TYPE 2 DIABETES" (unspecified if ongoing), notes: ADULT ONSET TYPE 2 DIABETES; "PRE DIABETES" (unspecified if ongoing), notes: Pre diabetes; "Pregnancy" (unspecified if ongoing), notes: Pregnancy; "Non-tobacco user" (unspecified if ongoing); "sleep" (unspecified if ongoing); "Depression" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Nitrous sulfide" (unspecified if ongoing), notes: Drug allergy Nitroslulfide manifested by methylenetetrahydrofolate reductase gene defect. Concomitant medication(s) included: LOSARTAN taken for hypertension; METFORMIN taken for diabetes mellitus; LATUDA taken for depression; TRAZODONE taken for sleep disorder; LORAZEPAM taken for sleep disorder. Past drug history included: Gaviscon, reaction(s): "Nausea", notes: Drug allergy Gaviscon manifested by nausea; Tramadol, reaction(s): "Nausea and nervousness", notes: Drug allergy Tramadol manifested by nausea and nervousness; Methotrexate, reaction(s): "Methylenetetrahydrofolate reductase gene defect", notes: Drug allergy Methotrexate manifested by methylenetetrahydrofolate reductase gene defect.; Vencomycin, reaction(s): "Redman syndrome", notes: Drug allergy vancomycin manifested by red man syndrome; Tramadol, reaction(s): "Nausea and nervousness", notes: Drug allergy Tramadol manifested by nausea and nervousness.  The following information was reported: CELLULITIS (hospitalization) with onset 05Mar2021, outcome "recovered" (10Mar2021); SWELLING FACE (non-serious) with onset 05Mar2021, outcome "recovered" (10Mar2021), described as "face swollen"; COVID-19 (medically significant) with onset 10Mar2021, outcome "recovered" (31Mar2021); EAR SWELLING (non-serious), outcome "not recovered"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "Glands swollen". The event "cellulitis" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood culture: (07Mar2021) Negative; Blood test: (07Mar2021) Normal; Computerised tomogram: (07Mar2021) Normal; Culture urine: (07Mar2021) Normal; Lymphocyte count: (unspecified date) Normal; Metabolic function test: (07Mar2021) Normal; Neutrophil count (1.7-6.7): (07Mar2021) 7.4, notes: Normal value: 1.7 to 6.7; SARS-CoV-2 test: (10Mar2021) Positive, notes: On 10Mar2021, The patient experienced Covid 19 infection; White blood cell count: (07Mar2021) Normal. The action taken for BNT162b2 was unknown; for risankizumab was dosage not changed. Therapeutic measures were taken as a result of cellulitis.   Clinical comment: The patient was recovering from ear condition that had her ear and the gland swollen. In 2021, she went for her first Covid-19 vaccine and had an adverse reaction event. Her face swollen and had cellulitis. She had cellulitis to her face which started about 24 to 36 hours after her first dose of the Covid-19 vaccine. She went to the hospital. Her physician prescribed antibiotics and was treated with antibiotics. She was rushed to the emergency room on 07Mar2021 for intravenous antibiotics and was discharged after seven hours. She also acquired the Covid-19 infection while in the hospital and was currently recovered from that. The symptoms of fever, fatigue, cough and headaches unified under the covid-L9 infection. The symptoms of swollen face unified under cellulitis to face. It was unknown if she was enrolled in a Covid-19 vaccine trail. On 24Jul2020, the patient experienced Gallstones removal. On 31Jul2020, the Gallstones removal resolved  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN) The reporter's causality for the event(s) of Covid 19 Infection was probable, for Cellulitis of face (Cellulitis) it was possible. For Glands swollen (Lymphadenopathy) and Ear swelling (Ear swelling) was not assessable with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN.  Causality for SKYRIZI (RISANKIZUMAB) The reporter's causality for the events of Gallstones removal, Covid 19 Infection and Covid vaccine reaction face swollen cellulitis to face with Skyrizi (Risankizumab) was no reasonable possibility. The reporter's causality for the events of Glands swollen and Ear swelling was not provided.Manufacture's opinion is that there is no reasonable possibility that the events of Gallstones removal, Covid 19 infection and Covid vaccine reaction face swollen and Cellulitis to face are related to SKYRIZI (Risankizumab). Manufacture's opinion is that the events of Glands swollen and Ear swelling are not assessable.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.