Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Loss of consciousness, Oesophageal disorder, Product dose omission issue
Clinical narrative: vision issues; weakness/ very debilitating symptoms; anxiety; angry during the call; agitated during the call; headaches; lot of fatigue; Patient did not receive the 2nd dose of the Moderna COVID19 vaccine according to his HCPs recommendations; passing out; imbalance; Dizziness; confusion; difficulty walking; lack of time and space; disorientation; issues with esophagus; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passing out) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL, LAMOTRIGINE (LAMICTAL), MULTIVITAMINS [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], VITAMIN B12 NOS, PYRIDOXINE HYDROCHLORIDE (VITAMIN B6) and FOLIC ACID for an unknown indication.    On 09-Sep-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (passing out) (seriousness criterion medically significant), BALANCE DISORDER (imbalance), DIZZINESS (Dizziness), CONFUSIONAL STATE (confusion), GAIT DISTURBANCE (difficulty walking), FEELING ABNORMAL (lack of time and space), DISORIENTATION (disorientation) and OESOPHAGEAL DISORDER (issues with esophagus). On an unknown date, the patient experienced VISUAL IMPAIRMENT (vision issues), ASTHENIA (weakness/ very debilitating symptoms), ANXIETY (anxiety), ANGER (angry during the call), AGITATION (agitated during the call), HEADACHE (headaches), FATIGUE (lot of fatigue) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose of the Moderna COVID19 vaccine according to his HCPs recommendations). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (passing out), CONFUSIONAL STATE (confusion), GAIT DISTURBANCE (difficulty walking), FEELING ABNORMAL (lack of time and space), DISORIENTATION (disorientation), OESOPHAGEAL DISORDER (issues with esophagus), ANGER (angry during the call), AGITATION (agitated during the call) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive the 2nd dose of the Moderna COVID19 vaccine according to his HCPs recommendations) outcome was unknown and BALANCE DISORDER (imbalance), VISUAL IMPAIRMENT (vision issues), ASTHENIA (weakness/ very debilitating symptoms), ANXIETY (anxiety), DIZZINESS (Dizziness), HEADACHE (headaches) and FATIGUE (lot of fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       After vaccination on the 11Sep2021 patient started to experience issues with esophagus, dizziness, disorientation, imbalance, lack of time and space, difficulty walking, confusion, passing out and going to the ER patient stated he was taken by an ambulance and in the hospital where he stayed for 3 hours it was confirmed by HCPs that he was experiencing side effects related directly to the vaccine. Patient mentioned that he did many tests, chest scans and CT scans, and that there was concerning and alarming EKGs. Patient was waiting to see cardiologist next week. The symptoms are ongoing YES imbalance, headaches, vision issues, lot of fatigue, weakness, some dizziness, anxiety, very debilitating symptoms since 3 and a half week ago Patient did not receive the 2nd dose of the Moderna COVID19 vaccine according to his HCPs recommendations. Patient was angry and agitated during the call.  Treatment medication includes Tylenol and ibuprofen.  This is a case of Product Dose Omission Issue concerning a 54-year-old male patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred 3 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since the event only happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.; Sender's Comments: This is a case of Product Dose Omission Issue concerning a 54-year-old male patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred 3 days after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since the event only happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine)  is not affected by this report.