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Life Threatening? No
Write-up: Seizure; Breastfeeding after Vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 3-month-old infant of an unknown gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding since 18-Jun-2021. MEDICAL HISTORY (Patient): Concurrent medical conditions included Seizure since 18-Jun-2021. On 18-Jun-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jun-2021, after exposure to mRNA-1273 (Moderna COVID-19 Vaccine), the infant was diagnosed with SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant) and EXPOSURE VIA BREAST MILK (Breastfeeding after Vaccination). The infant was treated with LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) ongoing since an unknown date for Seizure, at an unspecified dose and frequency. At the time of the report, SEIZURE (Seizure) and EXPOSURE VIA BREAST MILK (Breastfeeding after Vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Specialist consultation: seizure (abnormal) baby was Diagnosed with Seizure by MD. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication not provided. Reporter reported that the baby started having a seizure 7 hours later the breastfeed. The baby did not have a fever. The baby had a seizure at home and another one at the hospital. The baby was Diagnosed with Seizure by MD. Company Comment: This is a case of product exposure during breastfeeding with an associated adverse event of seizure in the baby. Based on temporal association a causal relationship cannot be excluded This case was linked to MOD-2021-231410 (Parent-Child Link). See case MOD-2021-231410 for details regarding the Parent case.; Sender''s Comments: This is a case of product exposure during breastfeeding with an associated adverse event of seizure in the baby. Based on temporal association a causal relationship cannot be excluded
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