Age: 10.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Concussion, Crying, Electrocardiogram QT prolonged, Electrocardiogram ambulatory abnormal, Head injury
Clinical narrative: amnesia; severe concussion; wenckebach episodes/heart block; hit her head/hit the back left side of her head/head trauma; collapsed/fall; lost consciousness; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (amnesia), CONCUSSION (severe concussion), ATRIOVENTRICULAR BLOCK SECOND DEGREE (wenckebach episodes/heart block), HEAD INJURY (hit her head/hit the back left side of her head/head trauma), FALL (collapsed/fall) and LOSS OF CONSCIOUSNESS (lost consciousness) in a 10-year-old female patient who received mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (batch no. 3043000) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Covid-19 vaccine (no issues). Past adverse reactions to the above products included No adverse effect with Covid-19 vaccine.    On 02-Oct-2024, the patient received dose of mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use) .25 milliliter. On 03-Oct-2024, the patient experienced AMNESIA (amnesia) (seriousness criterion hospitalization), CONCUSSION (severe concussion) (seriousness criterion hospitalization), ATRIOVENTRICULAR BLOCK SECOND DEGREE (wenckebach episodes/heart block) (seriousness criterion hospitalization), HEAD INJURY (hit her head/hit the back left side of her head/head trauma) (seriousness criterion hospitalization), FALL (collapsed/fall) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (lost consciousness) (seriousness criterion medically significant). The patient was treated with Ceftriaxone sodium (Ceftriaxone) at an unspecified dose and frequency and Doxycycline at an unspecified dose and frequency. At the time of the report, AMNESIA (amnesia), CONCUSSION (severe concussion), ATRIOVENTRICULAR BLOCK SECOND DEGREE (wenckebach episodes/heart block), HEAD INJURY (hit her head/hit the back left side of her head/head trauma), FALL (collapsed/fall) and LOSS OF CONSCIOUSNESS (lost consciousness) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2024, Electrocardiogram: normal. On an unknown date, Computerised tomogram head: severe concussion. On an unknown date, Electrocardiogram: prolonged qr interval and was in the 400's and heart block. On an unknown date, Laboratory test: back negative.     For mRNA-1273.712 (MODERNA COVID-19 VACCINE 2024-2025 PFS) (Intramuscular use), the reporter considered AMNESIA (amnesia), CONCUSSION (severe concussion), ATRIOVENTRICULAR BLOCK SECOND DEGREE (wenckebach episodes/heart block), HEAD INJURY (hit her head/hit the back left side of her head/head trauma), FALL (collapsed/fall) and LOSS OF CONSCIOUSNESS (lost consciousness) to be related.   Company comment: This spontaneous case concerns a 10-year-old female patient who experienced serious (due to hospitalization) unexpected event of Amnesia, Concussion, Atrioventricular block second degree, Head injury and unexpected serious (due to hospitalization and medically significant) event of Fall and unexpected serious  (due to medically significant) event of Loss of consciousness. The events are assessed as related to vaccination due to close temporal association. The benefit-risk relationship of product is not affected by this report.    No concomitant medications were reported. Patient was feeling fine prior and only lost consciousness for a few seconds. She was face down and cryied after the fall. The amnesia lasted more than 8 hours.  The cardiology team suspected Lyme disease since they saw a heart block on the ekg. The Lyme test came back negative and a repeat Lyme test a few days later also came back negative. Patient wore a Holter monitor for 7 days during the middle of October to monitor her heart function. The results came back and showed 12 wenckebach episodes during deep sleep over the 7 days. Holter monitor results are normal for deep sleep for certain people and are not related to the incident on 03-Oct-24.  It was reported that cardiology team would do a 3 day Holter monitor in 6 months before fully discharging the patient from their care. She was still being followed and was on restriction from the neurosurgery team for the concussion because of its severity. The medical team does not have an answer for what caused the collapse after thorough evaluation and all signs are pointing to the Covid vaccine received on 02-Oct-2024 as the cause.  The patient did not experience any additional symptoms/events. No medications prior to adverse event. Ceftriaxone and doxycycline after event for 14 days until Lyme results came back negative.