Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: drug ineffective; Vaccination site swelling; suspected COVID-19; Itchiness at injection site; Vaccine caused redness; Lower abdominal pain; 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-163-3833565-00 (agency).  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 08Apr2021 (Batch/Lot number: unknown) at the age of 74 years as dose 2, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), first regimen subcutaneous (ongoing) (Lot number: 1151378) at 150 mg/ml, (150 mg,1 in 12 wk), second regimen subcutaneous (ongoing) (Lot number: 1155977) and third regimen subcutaneous (ongoing) (Lot number: 1153815) at 150 mg/ml, (150 mg,1 in 10 wk) for psoriasis. The patient's relevant medical history was not reported. Concomitant medication(s) included: COLCHICINE; ROSUVASTATIN; CLOPIDOGREL. Past drug history included: Codeine, reaction(s): "Codeine Allergy", notes: Codeine Allergy. Vaccination history included: Bnt162b2 (Dose 1:, Route of Administration: Intramuscular), administration date: 18Mar2021, when the patient was 73 years old, for COVID-19 Immunization, reaction(s): "Swollen at injection site", "Vaccine caused redness at injection site", "Itchiness at injection site". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "drug ineffective"; SUSPECTED COVID-19 (medically significant) with onset 10Nov2021, outcome "unknown", described as "suspected COVID-19"; VACCINATION SITE PRURITUS (non-serious) with onset 08Apr2021, outcome "recovered" (13Apr2021), described as "Itchiness at injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 08Apr2021, outcome "recovered" (13Apr2021), described as "Vaccine caused redness"; ABDOMINAL PAIN LOWER (non-serious) with onset 08Apr2021, outcome "recovered" (13Apr2021), described as "Lower abdominal pain"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Vaccination site swelling". The action taken for risankizumab was dosage not changed. It was reported that: Arthritis was flaring in hands, feet, lower back ,shoulders, neck and jaw, COVID-19, brain fog, nightmares, chronic obstructive pulmonary disease, dizzy, lower abdominal pain, gallstones, exposed to COVID-19, first dose COVID-19 vaccine caused swollen at injection site, redness at injection site, itch at injection site, second dose COVID-19 vaccine caused itchiness at injection site, redness at injection site, arthritis flare up two weeks before Skyrizi injection due/continued to see improvement fade after subsequent doses and plaque psoriasis flare up on scalp, in ears, under breasts, under arms, groin/blotching on lower left leg with Skyrizi (Risankizumab). On unknown dates, the patient experienced arthritis was flaring in hands, feet, lower back, shoulders, neck and jaw, brain fog, nightmares, chronic obstructive pulmonary disease, dizzy, gallstones, arthritis flare up two weeks before skyrizi injection due/continued to see improvement fade after subsequent doses and plaque psoriasis flare up on scalp, in ears, under breasts, under arms, groin/blotching on lower left leg. In Dec2020, the patient experienced COVID-19. On 18Mar2021, the patient experienced FIRST DOSE COVID-19 vaccine caused swollen at injection site, first dose covid-19 vaccine caused redness at injection site and first dose COVID-19 Vaccine Caused Itch at Injection Site. In Mar2021, the first dose COVID-19 vaccine caused redness at injection site and first dose COVID-19 vaccine caused itch at injection site resolved. On 08Apr2021, the patient experienced lower abdominal pain, second dose COVID-19 vaccine caused itchiness at injection site and second dose COVID-19 vaccine caused redness at injection site. On 13Apr2021, the second dose COVID-19 vaccine caused itchiness at injection site and second dose COVID-19 vaccine caused redness at injection site resolved. On 10Nov2021, the patient experienced Exposed To COVID-19. On unknown dates, COVID-19, brain fog, nightmares and dizzy resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had plaques itchy and burning on scalp, in ears, under breasts, under arms and groin. She had blotching on lower left leg. She had arthritis flaring in hands, feet, back and shoulders. On 10Nov2021, she was exposed to Covid-19 but did not have it. In Dec2021 she had covid-19 and had Symptoms of fatigue, fever of 103.0, brain fog, cough, achy, dizzy, nausea, diarrhoea, lost taste, and smell, and had nightmares. She had Chronic obstructive pulmonary disease. Her Arthritis flare up two weeks before injection was due, and she had Pain in hands, neck, shoulder, jaw, and lower back. On 18 Mar2021, she had swollen, red, and itch at injection site after first dose of Pfizer vaccine. On 08Apr2021, she had itchiness and redness at injection site after second dose and lasted five days. She had lower abdominal pain and gallstones. She reported seeing improvement after her second injection one month into therapy and this improvement seemed to fade with time. She continued to see her improvement fade after subsequent doses. Her doctor changed the dosing of Skyrizi from every 12 weeks to every 10 weeks. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 18Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 08Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer.  Causality for Skyrizi (Risankizumab): The reporter's causality for the event(s) of arthritis was flaring in hands, feet, lower back ,shoulders, neck and jaw, covid-19, brain fog, nightmares, chronic obstructive pulmonary disease, dizzy, lower abdominal pain, gallstones, exposed to COVID-19, first dose COVID-19 Vaccine caused swollen at injection site, first dose COVID-19 vaccine caused redness at injection site, first dose COVID-19 vaccine caused itch at injection site, second dose COVID-19 vaccine caused itchiness at injection site and second dose COVID-19 vaccine caused redness at injection site with Skyrizi(Risankizumab) was no reasonable possibility. The reporter's causality for the event(s) of arthritis flare up two weeks before skyrizi injection due/continued to see improvement fade after subsequent doses and plaque psoriasis flare up on scalp, in ears, under breasts, under arms, groin/blotching on lower left leg with Skyrizi (Risankizumab) was a reasonable possibility.   Causality of Pfizer BioNTech Covid-19 Vaccine (Tozinameran): The reporter's causality for the event(s) Arthritis flare up (Arthritis), COVID-19 (COVID-19), Foggy feeling , Nightmares (Nightmare), Chronic obstructive pulmonary disease (Chronic obstructive pulmonary disease), Dizzy (Dizziness), Lower abdominal pain (Abdominal pain lower), Gallstones (Cholelithiasis), Exposure to COVID-19 (Exposure to SARS-CoV-2) was Not Reported and Vaccination site swelling (Vaccination site swelling), Vaccination site erythema (Vaccination site erythema) was Probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be 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.