Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Tremor, Vaccination site pain, Vaccination site swelling
Clinical narrative: he thinks he passed out; Shaking; Chills; Cannot get a full breath of air (it hurts to take a full breath) which was the worse episode/ Troubles breathing/ Short winded; Left arm where the injection was swollen; Left arm where the injection was pretty badly sore; Eyesight has also been affected, reading was too fuzzy eyeglasses will not even help; Headache, terrible pain in my head in one spot which he did not have before; Dizziness and lightheadedness; Felt so weak; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (he thinks he passed out) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. I0C021-724 (?)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Concussion (Two brain concussions last year) in 2021.    On 24-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2022, the patient experienced LOSS OF CONSCIOUSNESS (he thinks he passed out) (seriousness criterion medically significant), TREMOR (Shaking), CHILLS (Chills), DYSPNOEA (Cannot get a full breath of air (it hurts to take a full breath) which was the worse episode/ Troubles breathing/ Short winded), VACCINATION SITE SWELLING (Left arm where the injection was swollen), VACCINATION SITE PAIN (Left arm where the injection was pretty badly sore), VISION BLURRED (Eyesight has also been affected, reading was too fuzzy eyeglasses will not even help), HEADACHE (Headache, terrible pain in my head in one spot which he did not have before), DIZZINESS (Dizziness and lightheadedness) and ASTHENIA (Felt so weak). At the time of the report, LOSS OF CONSCIOUSNESS (he thinks he passed out), TREMOR (Shaking), CHILLS (Chills), VACCINATION SITE SWELLING (Left arm where the injection was swollen), VACCINATION SITE PAIN (Left arm where the injection was pretty badly sore), VISION BLURRED (Eyesight has also been affected, reading was too fuzzy eyeglasses will not even help), HEADACHE (Headache, terrible pain in my head in one spot which he did not have before) and ASTHENIA (Felt so weak) outcome was unknown and DYSPNOEA (Cannot get a full breath of air (it hurts to take a full breath) which was the worse episode/ Troubles breathing/ Short winded) and DIZZINESS (Dizziness and lightheadedness) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2022, Blood pressure measurement: low (Low) Started out form 120-130 initially then went down to 113-117 and continually got lower and lower to 105/65 then 93/56 then 73/46 (around 10am).. On 26-Feb-2022, Blood pressure measurement: low (Low) Was 117/62-65 then 129/69 then 130/64/ 132/71 until it became 133/65-67 at 2:00pm..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. On 25-Feb-2022 the patient  started monitoring his blood pressure which started out form 120-130 initially then went down to 113-117 and continually got lower and lower to 105/65 then 93/56 then 73/46 (around 10am) after which he could not remember anything after that because he thought he passed out. He woke up the next day 26Feb2022 (around 5:00am), still felt very weak. He checked his blood pressure which was 117/62-65 then 129/69 then 130/64/ 132/71 until it became 133/65-67 at 2:00pm. On 27-Feb-2022  Patient reported it was a pretty much normal day, he was able to move around and did his grocery at 6:00pm. Patients had not experienced symptoms like that before receiving the Moderna COVID-19 vaccine. No history of COVID-19 infection.  No history of Myocarditis/pericarditis. No cardiac lab values (ECG, cardiac test, cardiac enzymes) were available. The patient reported that this vaccine has affected his brain. Treatment information was not provided.  Company Comment- This spontaneous case concerns a 76-year old, male patient with relevant medical history of two brain concussions in the past, who experienced the unexpected serious (medically significant) event of Loss of consciousness along with multiple non-serious events, which occurred one day after receiving a dose of mRNA-1273 vaccine. The next day after vaccination when he woke up he had tremors with chills along with difficulty in breathing. The injection site on left arm was swollen and painful. He had a severe headache with blurred vision and dizziness. He felt very weak. He monitored his blood pressure which was showing a declining trend later he passed out and could not recall anything. The next day when he woke up, he was still weak but his blood pressures had improved. At the time of report he still had dizziness and difficulty in breathing but the other events had resolved. The relevant medical history could be a possible confounder to the event Loss of consciousness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 76-year old, male patient with relevant medical history of two brain concussions in the past, who experienced the unexpected serious (medically significant) event of Loss of consciousness along with multiple non-serious events, which occurred one day after receiving a dose of mRNA-1273 vaccine. The next day after vaccination when he woke up he had tremors with chills along with difficulty in breathing. The injection site on left arm was swollen and painful. He had a severe headache with blurred vision and dizziness. He felt very weak. He monitored his blood pressure which was showing a declining trend later he passed out and could not recall anything. The next day when he woke up, he was still weak but his blood pressures had improved. At the time of report he still had dizziness and difficulty in breathing but the other events had resolved. The relevant medical history could be a possible confounder to the event Loss of consciousness. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.