Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Concussion, Craniocerebral injury, Electrocardiogram, Head injury
Clinical narrative: Received subsequent treatments for stroke; she had a fainting incident where she smashed her head on the bathtub and her husband found her; she had traumatic brain injury as she had a concussion.; she had a fainting incident where she smashed her head on the bathtub and her husband found her; she had traumatic brain injury as she had a concussion.; Tremors in the right leg; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Received subsequent treatments for stroke), SYNCOPE (she had a fainting incident where she smashed her head on the bathtub and her husband found her), CRANIOCEREBRAL INJURY (she had traumatic brain injury as she had a concussion.), HEAD INJURY (she had a fainting incident where she smashed her head on the bathtub and her husband found her), CONCUSSION (she had traumatic brain injury as she had a concussion.) and TREMOR (Tremors in the right leg) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025B21A) for COVID-19 vaccination.   No Medical History information was reported.  On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Received subsequent treatments for stroke) (seriousness criteria hospitalization, disability and medically significant), SYNCOPE (she had a fainting incident where she smashed her head on the bathtub and her husband found her) (seriousness criteria disability and medically significant), CRANIOCEREBRAL INJURY (she had traumatic brain injury as she had a concussion.) (seriousness criteria disability and medically significant), HEAD INJURY (she had a fainting incident where she smashed her head on the bathtub and her husband found her) (seriousness criterion disability), CONCUSSION (she had traumatic brain injury as she had a concussion.) (seriousness criterion disability) and TREMOR (Tremors in the right leg) (seriousness criterion disability). At the time of the report, CEREBROVASCULAR ACCIDENT (Received subsequent treatments for stroke), SYNCOPE (she had a fainting incident where she smashed her head on the bathtub and her husband found her), CRANIOCEREBRAL INJURY (she had traumatic brain injury as she had a concussion.), HEAD INJURY (she had a fainting incident where she smashed her head on the bathtub and her husband found her), CONCUSSION (she had traumatic brain injury as she had a concussion.) and TREMOR (Tremors in the right leg) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: un-remarkable (normal) normal. On an unknown date, Ultrasound scan: un-remarkable (normal) normal.  No concomitant medication were provided by the reporter. No treatment medication were provided by the reporter. No lab data provided by the reporter.  Company comment: This case concerns a 62-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of cerebrovascular accident, syncope, craniocerebral injury, head injury, concussion and tremor. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 62-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected events of cerebrovascular accident, syncope, craniocerebral injury, head injury, concussion and tremor. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.