Reporte zur Charge EH9899, EH1284,

Symptomtext

Losing my breath; My fingers in my left arm (where I got my vaccine) started going numb; Prolonged panic attack; I was shaking profusely; Lost feeling in my fingers and legs; My heartbeat felt really irregular; My body went limp and I fell out of the bed; Unable to swallow; My eyes rolling in the back of my head; Unable to sit up; This is a spontaneous report from a contactable other HCP (patient). This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm at single dose for COVID-19 immunisation on 21Dec2020 at 12:30 (35-year-old at the time of vaccination). The Lot number reported as EH9899, EH1284, EW0153 (pending clarification). Relevant history was unknown. Relevant concomitant drug included fluoxetine hydrochloride (PROZAC). No other vaccine in four weeks. Known allergy was None. The patient was not pregnant. Within 30 minutes after receiving the vaccine on 21Dec2020 at 01:15 PM, her fingers in her left arm (where she got her vaccine) started going numb. Her heartbeat felt really irregular and she started losing her breath. Her husband immediately took her to the emergency department. She was shaking profusely, lost feeling in her fingers and legs, was unable to swallow, unable to sit up, and her eyes rolling in the back of her head. She felt as if she was having a prolonged panic attack but with no feeling in her body and that she could not breathe. She arrived at the hospital, they immediately put her in a bed, her body went limp and she fell out of the bed. They then took an EKG and saw her heart was beating irregular and that she needed medication to calm her heart down. Additional lab tests included Holters and MRI with unknown result. AES resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment therapy was received (not specified). Outcome of events was not resolved. No COVID prior vaccination. No COVID test post vaccination.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the events Dyspnoea, Hypoaesthesia, Panic attack, tremor, sensory loss, heart rate irregular, gait disturbance, dysphagia, eye movement disorder, sitting disability and the suspect drug BNT162B2. 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.