Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Craniocerebral injury, Electrocardiogram, Feeling abnormal, General physical health deterioration, Head discomfort
Clinical narrative: she had a fainting incident where she smashed her head on the bathtub and her husband found her/smashed her head/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/passed out; she had traumatic brain injury as she had a concussion.; Tremors in the right leg; changed her life negatively/sometimes she doesn't feel like being alive; stressed out; her head is going to explode; she doesn't even feel like being alive; This spontaneous case was reported by a consumer and describes the occurrence of HEAD INJURY (she had a fainting incident where she smashed her head on the bathtub and her husband found her/smashed her head/she had traumatic brain injury as she had a concussion), SYNCOPE (she had a fainting incident where she smashed her head on the bathtub and her husband found her/passed out) and CRANIOCEREBRAL INJURY (she had traumatic brain injury as she had a concussion.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 HEAD INJURY (she had a fainting incident where she smashed her head on the bathtub and her husband found her/smashed her head/she had traumatic brain injury as she had a concussion) (seriousness criteria hospitalization and disability), SYNCOPE (she had a fainting incident where she smashed her head on the bathtub and her husband found her/passed out) (seriousness criteria hospitalization, disability and medically significant), CRANIOCEREBRAL INJURY (she had traumatic brain injury as she had a concussion.) (seriousness criteria hospitalization, disability and medically significant), TREMOR (Tremors in the right leg), GENERAL PHYSICAL HEALTH DETERIORATION (changed her life negatively/sometimes she doesn't feel like being alive), STRESS (stressed out), HEAD DISCOMFORT (her head is going to explode) and FEELING ABNORMAL (she doesn't even feel like being alive). At the time of the report, HEAD INJURY (she had a fainting incident where she smashed her head on the bathtub and her husband found her/smashed her head/she had traumatic brain injury as she had a concussion), SYNCOPE (she had a fainting incident where she smashed her head on the bathtub and her husband found her/passed out), TREMOR (Tremors in the right leg), GENERAL PHYSICAL HEALTH DETERIORATION (changed her life negatively/sometimes she doesn't feel like being alive), STRESS (stressed out), HEAD DISCOMFORT (her head is going to explode) and FEELING ABNORMAL (she doesn't even feel like being alive) outcome was unknown and CRANIOCEREBRAL INJURY (she had traumatic brain injury as she had a concussion.) had not resolved.      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. Patient mentioned the Moderna vaccine had changed the life negatively. Patient stated was stressed out over the safety form the Safety department. Patient stated it was overwhelming, upsetting, and concerning for patient to try to complete the safety document and mentioned it was daunting and a major challenge and could not do it right now. Also stated the safety form was making feel like head was going to explode. The caller reported patient passed out after receiving the second Moderna COVID-19 dose, and smashed the head causing a traumatic brain injury. The caller mentioned that traumatic brain injury had been a major financial impact to patient. Patient received subsequent treatments for stroke, passed out, she had traumatic brain injury as she had a concussion and nightmare. It was reported that patient was undergoing speech therapy, physical therapy, occupational therapy, and vision therapy  Company comment: This spontaneous case concerns a 62-year-old female patient with no relevant medical history, who experienced the unexpected serious events (hospitalization and disability) of Syncope, Head injury and Traumatic brain injury after mRNA- 1273 Moderna vaccine. The events occurred at an unknown date after the second dose of mRNA- 1273 vaccine. Resonance magnetic imaging, Computer tomography scan, Electrocardiogram and ultrasounds were unremarkable. Very limited information was provided regarding clinical manifestations. Speech therapy, physical therapy, occupational therapy, and vision therapy were required. The rechallenge is not applicable, since the events were reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Updated outcome of the event head injury and updated additional information on I-narrative supplement On 23-Nov-2021: Events and narrative updated.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient with no relevant medical history, who experienced the unexpected serious events (hospitalization and disability) of Syncope, Head injury and Traumatic brain injury after mRNA- 1273 Moderna vaccine. The events occurred at an unknown date after the second dose of mRNA- 1273 vaccine. Resonance magnetic imaging, Computer tomography scan, Electrocardiogram and ultrasounds were unremarkable. Very limited information was provided regarding clinical manifestations. Speech therapy, physical therapy, occupational therapy, and vision therapy were required. The rechallenge is not applicable, since the events were reported exclusively after the second dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.