Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy muscle, Blood test, Computerised tomogram, Dermatomyositis, Gait disturbance
Clinical narrative: losing function of my arms/muscles extremely weak, couldn't get dressed on my own, or walk up a flight of stairs; losing function of my arms/muscles extremely weak, couldn't get dressed on my own, or walk up a flight of stairs; Dermatomyositis; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Right Arm on 06Jan2021 (Batch/Lot Number: EJ3248) as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication received within 2 weeks of vaccination included sertraline taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Pregnancy at time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient previously received first dose of bnt162b2 (brand= Pfizer, lot number= EJ1685,) via Intramuscular in Right arm on 06Jan2021 (as reported) at the age of 35-year-old for covid-19 immunisation. The patient experienced dermatomyositis on 02Feb2021, losing function of her arms/muscles extremely weak, couldn't get dressed on her own, or walk up a flight of stairs on Apr2021. Reported Event: In Feb. started getting patches of dry skin on the eyelids, and puffy underneath the eyes. By April the patient started losing function of her arms/muscles extremely weak, couldn't get dressed on her own, or walk up a flight of stairs. Went through multiple blood tests, MRI, CT, and muscle biopsy, in May she was diagnosed with the autoimmune disease, Dermatomyositis. Adverse event start date 02Feb2021. Treatment: Medication, high dose of a Steroid and Imuran. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Serious: Yes. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: Yes. Seriousness criteria-Congenital anomaly/birth defect: No.; Sender's Comments: Based on the available information in the case, the causal association between the events dermatomyositis, loss of personal independence in daily activities, gait disturbance and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.