Age: 32.0
Sex: M
Vaccine: FLUC4
Symptoms: Product quality issue, Vaccination failure
Clinical narrative: This serious spontaneous case, initially received on 22-Jan-2018, reported by other non-health professional concerning a 32-year-old, adult, male patient. The patient's previous vaccination history included FLUVIRIN TRIVALENT on 15-Oct-2014, FLUCELVAX TRIVALENT on 16-Sep-2015 and FLUCELVAX QID on 23-Nov-2016. On 31-Oct-2017, the patient was administered with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018, manufacturer: Seqirus, dose, route of administration and anatomical location: not reported). It was reported that, the patient experienced chills, body aches and nasal congestion. On an unspecified date, nasal swab test was performed. On 21-Jan-2018, after 2 months 22 days of vaccination, the patient was tested positive for type A flu. This case was associated with product quality complaint, hence quality assurance investigation report (QAIR) had been requested and the corresponding QAIR reference number was 1027556. It was reported that, based on the investigation performed, it can be concluded that FLUCELVAX (195250) was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. There was currently no evidence of a potential negative signal for LOE (lack of efficacy) issues of batch 195250 from the FLUCELVAX QIV campaign season and no deviations were found that for any temperature excursion of the final packaged product for batch 195250. The outcome of the event (influenza) was not reported. Non-significant follow-up report received from quality assurance team on 02-Feb-2018: The QAIR number (1027556) was updated. Follow-up received from quality assurance department (QA) on 17-Mar-2018: It was reported that, based on the investigation performed, it could be concluded that FLUCELVAX (195250) was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. There was currently no evidence of a potential negative signal for LOE (lack of efficacy) issues of batch 195250 from the FLUCELVAX QIV campaign season and no deviations were found that for any treatment excursion of the final packaged product for batch 195250. Expiry date (30-Jun-2018) of the product was updated. Narrative amended accordingly. Non-significant follow-up received from quality assurance department on 27-Mar-2018: No additional information was received. Hence, no changes were made in the narrative. Follow-up report received from the reporter on 29-Mar-2018: The patient's date of birth was added. The patient's previous vaccination history (FLUVIRIN TRIVALENT on 15-Oct-2014, FLUCELVAX TRIVALENT on 16-Sep-2015 and FLUCELVAX QID on 23-Nov-2016) was added. Laboratory investigation (nasal swab test) was added. Signs and symptoms (chills, body aches, and nasal congestion) for the event were updated. Amended narrative accordingly. Non-significant case correction received with IRD 29-Mar-2018: Acronym 'QAI' was changed to 'QAIR'. Narrative amended accordingly. Update 04-Jul-2018: Non-significant case correction was performed with IRD 22-Jan-2018: Case comment was corrected. No changes were made in narrative.