Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diabetes mellitus, Pyrexia
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-163-4323384-00 (RA). A male patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single, intramuscular, administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 19Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation; Risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (ongoing) (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIABETES MELLITUS (medically significant), outcome "not recovered", described as "diabetic condition"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever". The patient underwent the following laboratory tests and procedures: body temperature: (2021) fever. The action taken for Risankizumab was dosage not changed. Clinical course: solicited report from "PRIVATE" by a consumer of a male with events of non-serious diabetic condition and reaction/first dose Pfizer vaccination cases fever and chills with Skyrizi (Risankizumab). There was no reported medical history. On an unknown date, reaction/first dose Pfizer vaccination cases fever and chills resolved. Pfizer BioNTech Covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 vaccine trial. Concomitant drugs not reported. Other relevant history was not reported. For fever (pyrexia) duration was 3 day. For chills (chills) duration was 3 day. Causality for SKYRIZI (RISANKIZUMAB). The reporter's causality for the event(s) of Diabetic condition and Reaction/First dose Pfizer Vaccination cases fever and chills unknown onset and Reaction/First dose Pfizer Vaccination cases fever and chills unknown onset with SKYRIZI(RISANKIZUMAB) was no reasonable possibility. Product-Reaction level Seq. No: 1- Drug: SKYRIZI (RISANKIZUMAB), NOT AVAILABLE. Causality: Diabetic (Diabetes mellitus). Action(s) taken with drug: Dose not changed. Causality as per reporter (Drug/Vaccine): No reasonable possibility- Dechallenge: N/A Fever (Pyrexia) Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): No reasonable possibility Dechallenge: N/A Chills Action(s) taken with drug: Dose not changed Causality as per reporter (Drug/Vaccine): No reasonable possibility Dechallenge: N/A Seq. No: 2 Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN,UNKNOWN Causality: Diabetic (Diabetes mellitus) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Fever (Pyrexia) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A Chills Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge: N/A. The reporter considered "chills" and "fever" related to bnt162b2. 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 provided and plausible temporal association, the causality between BNT162B2 and the events Diabetes mellitus, Chills, and pyrexia cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.