Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle strain, Nausea, Pain, Pyrexia
Clinical narrative: I passed out in the bathroom; pulled the muscles in her back; This lead to uncontrollable muscle spasms in my back; dizziness; nausea/felt like I was going to throw up; I broke out into an all over clammy sweat and felt like I was going to throw up; body aches head to toe; low grade fever; This is a spontaneous report from a contactable other hcp (patient).  A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Jun2021 10:00 (Lot Number: EWO183) at the age of 57-year-old as single dose for covid-19 immunisation. The patient was not pregnant. Known allergies included erythromyicine. Concomitant medication included fluoxetine (reported as floxitine) 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. The patient previously received first dose of bnt162b2(lot number: EWD176) on 10May2021 05:00 PM at the age of 57-year-old, at arm left for covid-19 immunisation. On 01Jun2021, the patient experienced body aches head to toe, low grade fever. On 02Jun2021 08:00 AM, dizziness which lead to nausea which lead to a need to sit down immediately to avoid falling to the ground. Upon sitting, the patient broke out into an all over clammy sweat and felt like she was going to throw up. On the third time of getting up(03Jun2021), about 20 minutes after the first dizzy episode, she had to use the restroom. She passed out in the bathroom, woke up wedged between the toilet and the wall. The patient had no idea how long she was passed out. When she moved out of that position to stand up, she pulled the muscles in her back. This led to uncontrollable muscle spasms in her back. That morning (03Jun2021) Advice nurse directed her to the Urgent care due to passing out. She compromised with her doctor for lab work: blood and Urine, and EKG and muscle relaxer medication. 3 hours later, arriving home at 3:30 she took the medications and went to sleep. The muscle relaxer significantly reduced her pain. The adverse events resulted in Emergency room/department or urgent care. Treatment received for the adverse events included pain medications and lab results all showed normal levels. The patient had no covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the event pass out cannot be excluded completely. The case will be reassessed once more information become 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.