Age: 1.42
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Febrile convulsion, Pyrexia, Rash maculo-papular, Respiratory tract infection
Clinical narrative: fever/temperature actually reached her T max/103; macular papular rash covering her body; second febrile seizure; Fever respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of FEBRILE CONVULSION (second febrile seizure) in a 17-month-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever/temperature actually reached her T max/103), RASH MACULO-PAPULAR (macular papular rash covering her body), FEBRILE CONVULSION (second febrile seizure) (seriousness criterion medically significant) and RESPIRATORY TRACT INFECTION (Fever respiratory infection). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL at an unspecified dose and frequency. At the time of the report, PYREXIA (fever/temperature actually reached her T max/103), RASH MACULO-PAPULAR (macular papular rash covering her body), FEBRILE CONVULSION (second febrile seizure) and RESPIRATORY TRACT INFECTION (Fever respiratory infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 temperature actually reached her T max- 103 temperature..     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant was reported by patient.  It was reported that patient received first dose of vaccine. Patient was noted with initial fever a day later to had a macular papular rash, covering her body. Patient temperature actually reached her T max, so the seizure happened with 103 temperature, approximately 6 hours after her vaccination. Patient was treated with Ibuprofen and paracetamol and then discharged to home she actually ended up with a second febrile seizure, that happened about 6 weeks later with other symptoms of fever respiratory infection.  Company comment: This spontaneous case concerns a 17-month-old female patient who experienced the unexpected serious (medically significant) AESI of Febrile convulsion, two days after receiving the first dose of mRNA-1273. She developed fever, maculopapular rash and had a seizure when the temperature was 103 degrees Fahrenheit. The patient was treated with Ibuprofen and paracetamol and discharged. Six weeks later the patient had one more episode of febrile convulsion which was attributed to respiratory infection and fever. The outcome was reported as unknown. Details of mother, date of vaccination, obstetric history, investigation reports were not provided. Fever remains a confounder for the event of Febrile convulsions. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 17-month-old female patient who experienced the unexpected serious (medically significant) AESI of Febrile convulsion, two days after receiving the first dose of mRNA-1273. She developed fever, maculopapular rash and had a seizure when the temperature was 103 degrees Fahrenheit. The patient was treated with Ibuprofen and paracetamol and discharged. Six weeks later the patient had one more episode of febrile convulsion which was attributed to respiratory infection and fever. The outcome was reported as unknown. Details of mother, date of vaccination, obstetric history, investigation reports were not provided. Fever remains a confounder for the event of Febrile convulsions. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.