Age: 5.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Vaccination failure; Strain A of the flu/Influenza test was positive for influenza virus A; Diagnosed with the strain A of the flu; This is a spontaneous case, reported by other health professional (nurse) on 21-Feb-2019, concerning a 05-year-old, female, child patient.  The patient did not have any medical history and did not take any medications at the time of vaccination.  On 29-Sep-2018, the patient was administered Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture-derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252664 and expiry date: 30-Jun-2019] for influenza prophylaxis.  On 20-Feb-2019, 4 months and 22 days after vaccination, the patient underwent influenza test and was diagnosed with strain (reported as string) A of the flu (influenza A virus test positive) (considered as vaccination failure). The reporter was unsure of any treatment medications for the event.   The outcome of the event was recovered on an unspecified date.  The reporter assessed this case as non-serious.  Non-significant follow up received from the reporter on 29-Apr-2019: The Med-info number (SEQ19-01197) was added in the additional information tab. It was reported that attempts were made to reach the reporter on 28-Mar-2019 and 29-Mar-2019 but the reporter had not reached back to them to date. No new information available. Hence, no changes were made in narrative.  Follow-up received from the other health professional on 28-May-2019: The start date of the lab test (influenza A virus test) was added as 20-Feb-2019 in the patient tab. The start dates of the events (influenza and influenza A virus test positive) were added as 20-Feb-2019 in the event tab. The new event (vaccination failure) was added in event tab. The outcome of the event influenza' was changed from not reported' to recovered' in the event tab. Eventually, as determined causality' of the event (influenza) was changed from unassessable to related' in event assessment tab. It was stated that, the reporter was unsure of any treatment medications for the event. The narrative and case comment were amended accordingly.  Non-significant follow-up received on 11-Jul-2019: It was reported that attempt was made to reach the reporter on 10-Jun-2019, 20-Jun-2019 and 10-Jul-2019 but no information was obtained. No changes were made in the narrative.; Reporter's Comments: A 5-year-old, female, child underwent influenza test and was diagnosed with strain A of the flu (influenza A virus test positive) (considered as vaccination failure), 4 months 22 days after Flucelvax QIV vaccination (coded to influenza and vaccination failure). Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the event influenza cannot be ruled out and were assessed as related to suspect vaccine. Further assessment will be done upon receipt of new information. The company assessed the case as serious (medically significant).