Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug interaction, Dyspnoea, Headache
Clinical narrative: Wearing off effect; Wearing off effect; body cramps; COVID-19; COVID-19; fever; headache; difficulty breathing; cough; sore throat; She had sore arm with Pfizer vaccines; 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-163-4310327-00.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jun2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2, single and intramuscular, administration date 20May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (ongoing) (Batch/Lot number: unknown) for psoriasis. Relevant medical history included: "Elbows got scaly a week or two before injection time" (unspecified if ongoing); "Body cramps" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 27Dec2021, outcome "recovered" and all described as "COVID-19"; PYREXIA (non-serious) with onset 27Dec2021, outcome "unknown", described as "fever"; HEADACHE (non-serious) with onset 27Dec2021, outcome "unknown", described as "headache"; DYSPNOEA (non-serious) with onset 27Dec2021, outcome "unknown", described as "difficulty breathing"; COUGH (non-serious) with onset 27Dec2021, outcome "unknown", described as "cough"; OROPHARYNGEAL PAIN (non-serious) with onset 27Dec2021, outcome "unknown", described as "sore throat"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "She had sore arm with Pfizer vaccines"; MUSCLE SPASMS (non-serious) with onset 27Dec2021, outcome "recovered", described as "body cramps"; THERAPEUTIC RESPONSE SHORTENED (non-serious), outcome "not recovered", described as "Wearing off effect". The action taken for risankizumab was dosage not changed.  Clinical course. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Study number was facilitated collect.  Reporter's causality: The reporter's causality for the event(s) of COVID-19 and sore arm with Skyrizi (RISANKIZUMAB) was no reasonable possibility. Causality for the event(s) of vaccination site pain with Pfizer vaccine was possible and no causality was reported for event Covid-19. No causality was reported with Skyrizi (RISANKIZUMAB) and Pfizer vaccine for event(s) cramps, wearing off effect and body cramps.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) ,cough, dyspnea, headache pyrexia, muscle cramp vaccination site pain  and sore throat cannot be ruled out. However, a possible contributory role of the suspect vaccine BNT162B2 to reported event of ,Therapeutic response shortened and drug interaction cannot be ruled out  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.