Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Presyncope, Syncope
Clinical narrative: faint; felt like he was going to pass out; he started to get weak; he got dizzy spells/dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2022 and was forwarded to Moderna on 10-Feb-2022.    This spontaneous case was reported by a patient and describes the occurrence of SYNCOPE (faint) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045621A, 052E21A and 09021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARVEDILOL, NIFEDIPINE, WARFARIN SODIUM, LISINOPRIL, ACETYLSALICYLIC ACID (BAYER ASPIRIN), LORAZEPAM and DOCUSATE SODIUM (DOCULAX) for an unknown indication.   On 02-Feb-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2022, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant), PRESYNCOPE (felt like he was going to pass out) and ASTHENIA (he started to get weak). At the time of the report, SYNCOPE (faint), PRESYNCOPE (felt like he was going to pass out) and ASTHENIA (he started to get weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 160. After a few days patient got dizzy spells. Patient went to the doctors on Monday 7-Feb-2022 and his doctors did not know what to do for him. On 7-Feb-2022, patient almost fell again.  No relevant medical history was reported. No treatment drug was provided by reporter.  Company Comment: This spontaneous case concerns a 79-year-old, male patient with relevant history of intake of the anti-hypertensive drugs carvedilol, nifedipine and lisinopril, who experienced the unexpected, serious (medically significant) event of syncope and other associated unexpected and expected, non-serious events. The events occurred 3 days after administration of the booster dose of the Moderna mRNA-1273 vaccine. Two days after the onset of symptoms, the patient sought consult as he almost fell again. However, the report stated that the doctors 'did not know what to do for him'. Treatment information and outcomes of the events were unknown at the time of the report. The history of intake of the anti-hypertensive drugs carvedilol, nifedipine and lisinopril, which may cause the common side effect of dizziness, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 79-year-old, male patient with relevant history of intake of the anti-hypertensive drugs carvedilol, nifedipine and lisinopril, who experienced the unexpected, serious (medically significant) event of syncope and other associated unexpected and expected, non-serious events. The events occurred 3 days after administration of the booster dose of the Moderna mRNA-1273 vaccine. Two days after the onset of symptoms, the patient sought consult as he almost fell again. However, the report stated that the doctors 'did not know what to do for him'. Treatment information and outcomes of the events were unknown at the time of the report. The history of intake of the anti-hypertensive drugs carvedilol, nifedipine and lisinopril, which may cause the common side effect of dizziness, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.