Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Hypoaesthesia, Loss of consciousness, Loss of personal independence in daily activities, Magnetic resonance imaging
Clinical narrative: losing consciousness/episodes of passing out; gasping for air; coughing; cold; brain is on fire, my head is on fire; vasovagal episodes; can't walk; he couldn't even balance himself; He is having numbness, tingling on the whole left side of his body; He is having numbness, tingling on the whole left side of his body; He can't work. He can't do his job. He can't drive, he can't do anything; delirious; His oxygen saturation got worse, down to 85%-88% while sleeping he was gasping for air; This is a spontaneous report from a contactable Other HCP. A 40-years-old male patient (reporter's husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on Apr2021 (Batch/Lot number was not reported) at age of 39-years-old as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at age of 39-years-old on 27Mar2021 for COVID-19 immunization and experienced passing out within hours, stops breathing, feel like head and brain were on fire, flushed, paresthesia with the initial vaccine. The patient experienced losing consciousness/episodes of passing out (hospitalization) with outcome of recovering, delirious with outcome of not recovered, his oxygen saturation got worse, down to 85%-88% while sleeping he was gasping for air with outcome of not recovered, coughing with outcome of not recovered, cold with outcome of not recovered, brain is on fire, head is on fire with outcome of not recovered, vasovagal episodes outcome of not recovered, can't walk with outcome of not recovered, couldn't even balance himself with outcome of not recovered, tingling on the whole left side of his body with outcome of unknown, numbness on the whole left side of his body with outcome of not recovered, He can't work. He can't do his job. He can't drive, he can't do anything with outcome of unknown, all on an unspecified date in 2021; and gasping for air/SOB on 01Jun2021 with outcome of not recovered. Clinical course reported as follow: The patient had some good moments probably a good week after receiving his second dose. The same thing happened after the 2nd dose, lasted 7-10 days. Then he got better. Then "3-4 weeks later, he started losing consciousness/passing out during heavy physical activity in front of the reporter, during intercourse, he passed out." He was getting short of breath and would lose consciousness. The reporter clarified there was about 45 seconds to 1 minute of loss of consciousness and patient was only responsive to painful stimuli, not to voice. The reporter stated patient would be at their farm doing his normal activities rounding up cattle he would get SOB. "Something simple he could do before would now make him SOB." Patient has gone to the doctors and been in the hospital. He has been seen by Cardiology and Neurology, and neurology said they couldn't find anything. Patient has had 1.8-2 second pauses in his heart rate, which he was told he had vagal nerve issues associated with the COVID vaccine. The reporter stated on 01Jun21 patient was talking with her on the phone and he became SOB, passing out and gasping for air and lost consciousness for 5 minutes. The reporter went home and found patient passed out on the floor. He kept saying his brain was on fire, his head was on fire and he was kind of delirious. Called the doctor and he was admitted to the hospital on 10Jun21 with 1.8-2 sec pauses on (his heart) EKG and did a stress test, echo was fine. Then the doctors sent patient home without the cardiac monitor, the hospital forgot it. His oxygen saturation got worse, down to 85%-88% while sleeping he was gasping for air. The reporter spent the next 4 days in the ED with him everyday. He started coughing the next day and it was a cold that exacerbated his symptoms." He then started having vasovagal episodes and passing out completely. "Sometimes he coughs so hard he passes out and sometimes he doesn't, or sometimes he passes out and it is because his head is on fire or both. Patient went to the Doctor and got sent home with a dose of steroids, to control his cough, and the doctors put a cardiac monitor patch on him for the past couple of days. The next day comes and patient couldn't walk, he couldn't balance heal to toe, he had to walk/help him to the car he couldn't even balance himself. He was having numbness, tingling on the whole left side of his body." Then patient was admitted to the hospital and he had an EEG for 24 hours and a lot more testing was done. Patient was getting progressively worse and it was ongoing. Sometimes it went a few min to 20 min and one night the reporter didn't think she would get patient back. Patient was a healthy person who has never been sick and then got the COVID vaccine and is now doing this. He can't work. He can't do his job. He can't drive, he can't do anything. Patient has had MRI's, CT's, and all of the testing has been negative. So, basically he will go to the doctor and the doctor doesn't know. He is still having episodes. He has had over 100 episodes in clusters where he would lose consciousness and come back, lose consciousness and come back. In the hospital, patient did it for 6 hours straight without a doctor coming to see them.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  passed out,Delirium, oxygen saturation decreased.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