Sex: M
Vaccine: COVID19
Symptoms: Respiration abnormal, Seizure, Syncope
Clinical narrative: fainting/passing out; eyes darting around; his breathing didn't look right; shallow breathing; non responsive for about a minute to verbal commands; fell to the floor; the vaccine was administered on the left arm because she remembers sitting with him and he mentioned the extreme soreness; seizure; This is a spontaneous report from a contactable consumer (caregiver, patient's friend). A 42-year-old male patient received bnt162b2 (COMIRNATY, COVID 19 Vaccine, mRNA), dose 1 via an unspecified route of administration, administered in arm on 17Sep2021 17:00 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization.  Medical history included blood pressure abnormal and for years he had been regularly on a low dosage blood pressure pill. Concomitant medications were not reported. The patient experienced seizure on 18Sep2021 03:00. He was not responsive to verbal commands, eyes darting around, and he fell to the floor. No investigation assessment. Caller was not sure so she herself  talked to a pharmacist and a nurse and they said it could be a seizure. She explains that her friend was collapsed in the bathroom, she heard a noise and so went to her friend and saw his mouth was ajar, his breathing didn't look right, his eyes were darting around and he was non responsive for about a minute to verbal commands. She went to other room to get phone because she wasn't sure. This happened within 12 hours of the receiving the shot, it was under 12 hours. The pharmacist said it could be directly be link to the shot, the pharmacist reported this. Caller asks should her friend get the second shot. Caller stated that she almost called an ambulance but then her friend came around after a minute and minute and a half. this was very scary to her. The seizure happened in the middle of the night on 18Sep2021 around 3AM. Caller was probed when the seizure started or if she knew how long it lasted, caller stated that her own reaction time was late because she was asleep, she then heard a thud, and it took time to realize and question what she heard, she then got to the nearby bathroom, and then discovered him, his body was limp, he was shallow breathing, eyes darting, he was on the floor non responsive to verbal command, but the time she got there it was about a minute and half longer. She was unsure how much longer he was laying in there before she saw him. She added that he has not fainted before like that, he has no history, this was an isolated event, he did not have any further side effect or adverse reaction after. Outcome: This was still unknown because maybe there would be something that cannot be seen with the eyes, she knew the shots last for 6 month after second dose. She did not know biochemically what was occurring  but nothing that she can visually see and there are no changes in his behaviors. Covid Vaccine: Lot and Expiry are Unknown, as this would be with her friend. She will try to provide this information during follow up. She thinks the vaccine was administered on the left arm because she remembers sitting with him and he mentioned the extreme soreness, but she cant say 100% it's the left arm. Caller stated that she herself was worried and concerned when she saw him, he did not have a memory of the event happening. Medical conditions: She knew that for years he has been regularly on a low dosage blood pressure pill but there have never been side effects or fainting, passing out, nothing. This event is just odd. Investigation: No he doesn't have chronic health conditions. Allergies: No, even his eating habits, he eats whatever he wants, he does not show any signs of being allergic to anything, just nothing, no chronic discomfort or nothing. The seriousness of seizure and fainting/passing out was medically significant. The outcome of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.