Age: 1.0
Sex: M
Vaccine: FLU4
Symptoms: Death
Clinical narrative: patient found deceased in bed, no reason of death has been determined (Death NOS); Initial information was received regarding an unsolicited valid serious case from the nurse (Reference number 00322310) on 19-Oct-2020.  This case involved a 13 month old male patient who found deceased in bed (death) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], HIB (PRP/T) VACCINE [ACT-HIB], MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) [PROQUAD] and after treatment with PARACETAMOL [ACETAMINOPHEN].  The patient's medical history included seizure and COVID-19 (coronavirus disease of 2019).  The patient had no pre-existing physician-diagnosed allergies and birth defects and at the time of reporting, it was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Past medical treatment(s), vaccination(s) and family history were not reported.  The patient did not receive any concomitant medication.  On 23-Sep-2020, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot UJ185AA and expiration date was not reported) via an unknown route in the right vastus lateralis and a 0.5 ml dose of suspect PROQUAD (not produced by Sanofi Pasteur, lot S038146 and expiration date was not reported) via subcutaneous route in the left thigh for prophylactic vaccination.  On 14-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe, lot UT7081JA and expiration date 30-Jun-2021) via an intramuscular route in the left vastus lateralis for prophylactic vaccination.  Either on 14-Oct-2020 or 15-Oct-2020, the patient had received a 4 ml dose of PARACETAMOL (batch number, expiration date and route of administration not reported) for an unknown indication and then the patient put to bed at usual time.   At that time, the patients body temperature was 97.7 Fahrenheit.  On 15-Oct-2020 in the morning, the patient found deceased in bed (death), same day or 1 day following administration of PARACETAMOL, 1 day following the vaccination of INFLUENZA QUADRIVAL A-B VACCINE and 22 days following the vaccination of HIB (PRP/T) VACCINE and PROQUAD.  No other illness and symptoms were reported.   At the time of reporting, it was unknown if an autopsy was done and the cause of death was not known, as no reason of death was determined.  Follow up information was received regarding an unsolicited valid serious case from the nurse on 10-Nov-2020. New suspect vaccines added and information on the medical history and concomitant medication updated.  Follow up information was received regarding an unsolicited valid serious case from the physician on 12-Jan-2021.  New suspect added and information regarding medical history and laboratory test updated.; Sender's Comments: Follow up information received on 12-Jan-2021, changes the previous medical assessment of the case. This case involves a 13 months old male patient who died, 1 day after receiving FLUZONE QUADRIVALENT, PARACETAMOL also 22 days after receiving ACT-HIB and PROQUAD (not produced by Sanofi Pasteur). Time to onset is compatible with FLUZONE QUADRIVALENT and ACETAMINOPHEN. The patient had history of seizure and COVID 19. Information regarding autopsy results for cause of death and laboratory data ruling out alternative etiology needed for complete assessment of the case. Based upon the reported information, the role of an individual product cannot be assessed.; Reported Cause(s) of Death: patient found deceased in bed, no reason of death has been determined (Death NOS)