Age: 0.42
Sex: F
Vaccine: FLUX
Symptoms: Otitis media, Pneumonia, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: positional asphyxia; bronchopneumonia; decreased appetite; fever; diarrhea; difficulty in sleeping; otitis media; 5 months old female patient received influenza vaccination; Initial information received on 14-Apr-2020 regarding an unsolicited valid serious case from a healthcare professional  issued from a literature article.  This case involves a 5 months old female patient who developed positional asphyxia (asphyxia), bronchopneumonia (pneumonia) and otitis media (otitis media), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed serious decreased appetite (anorexia), fever (pyrexia), diarrhea (diarrhoea), difficulty in sleeping (insomnia) and was diagnosed with bronchopneumonia (pneumonia), on the same day following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  On an unknown date, the patient developed a non-serious otitis media, on the same day following the administration of INFLUENZA VACCINE.  On an unknown date, the patient developed a serious positional asphyxia (asphyxia), on the eight days following the administration of INFLUENZA VACCINE. This event was assessed as medically significant and was leading to death.  It was an actual medication error due to product administered to patient of inappropriate age.  Laboratory details were not reported.  Final diagnosis was (fatal) positional asphyxia, bronchopneumonia and otitis media.   The patient received AMOXICILLIN as treatment.  On an unknwon date, the patient died due to positional asphyxia, 8 days after the vaccination. The outcome of the other events were not reported.  It was unknown if an autopsy was done. the cause of death was determined to be positional asphyxia in a car seat.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   There will be no information available on batch number for this case.; Sender's Comments: This case concerns five month old female patient who presented with bronchopneumonia, otitis media same day and died due to positional asphyxia in a car seat eight days after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset in too short to be compatible for bronchopneumonia, otitis media. Concomitant medication included PCV 13. Bronchopneumonia, otitis media are more likely to be caused by infectious etiology. To be noted that cause of death was reported as positional asphyxia in a car seat. It is unknown if autopsy was performed. Patient's history, medical condition at time of vaccination, autopsy results, clinical course of the events and lab test excluding other etiology would be needed to fully assess this case. Based upon reported information the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: positional asphyxia