Reporte zur Charge 33030bd

Symptomtext

Diagnosed with PMR with GCA; Diagnosed with PMR with GCA; Temporal pain; jaw pain; body pain; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 at 14:00 as dose 1, single (Lot number: 33030) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), GIANT CELL ARTERITIS (non-serious) all with onset 27Dec2021 at 14:00, outcome "unknown" and all described as "Diagnosed with PMR with GCA"; HEADACHE (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "Temporal pain"; PAIN (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "body pain"; PAIN IN JAW (non-serious) with onset 27Dec2021 at 14:00, outcome "unknown", described as "jaw pain". The events "diagnosed with pmr with gca", "temporal pain", "jaw pain" and "body pain" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Negative, notes: Other. Therapeutic measures were taken as a result of polymyalgia rheumatica, giant cell arteritis, headache, pain in jaw, pain. Clinical Course: Age group reported as (18-64 Years). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. Other medications in two weeks: Na. Adverse event: Temporal pain, develop to jaw pain then body pain. Diagnosed with PMR with GCA. No covid prior vaccination. Covid was tested post vaccination. Prednisone was given as treatment for AE. No Other medical history. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid test post vaccination, type: Other, test name Home kit.; Sender's Comments: Based on the available information in the case, the causal association between the event polymyalgia rheumatica and the suspect drug 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.