Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: had a Transient Ischemic Attack. it was probably this second dose that caused it; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had a Transient Ischemic Attack. it was probably this second dose that caused it) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Ventricular tachycardia. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ROSUVASTATIN CALCIUM (CRESTOR), METOPROLOL and VITAMINS NOS for an unknown indication.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TRANSIENT ISCHAEMIC ATTACK (had a Transient Ischemic Attack. it was probably this second dose that caused it) (seriousness criterion medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (had a Transient Ischemic Attack. it was probably this second dose that caused it) outcome was unknown.            Patient's doctor thinks that it was probably the second dose that caused the Transient Ischemic Attack (TIA). When the TIA happened, patient was having some anxiety during the last year; besides having some ventricular tachycardias. The patient wasn't taking any medication, only vitamins. Now the patient is taking aspirin 81 mg, Crestor (rosuvastatin) and metoprolol daily. Patient's doctor said that patient should do some antibody blood tests before the booster.  No treatment information were reported by the reporter.  Company Comment: This spontaneous case concerns a 61-year-old patient, of unknown gender, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI of transient ischaemic attack. The event occurred 6 days after administration of the second dose of the Moderna mRNA-1273 vaccine. No further clinical information (including details about laboratory test/s) was available for medical review. The outcome of the event was unknown at the time of the report. The patient's advanced age remains a confounder since the risk of stroke doubles with each decade after age 55 in both men and women. 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 61-year-old patient, of unknown gender, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI of transient ischaemic attack. The event occurred 6 days after administration of the second dose of the Moderna mRNA-1273 vaccine. No further clinical information (including details about laboratory test/s) was available for medical review. The outcome of the event was unknown at the time of the report. The patient's advanced age remains a confounder since the risk of stroke doubles with each decade after age 55 in both men and women. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.