Age: 16.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: inadvertently administered a dose of vaccine that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum of 30 degrees F with no reported adverse event; undergone temperature excursion down to 30 degrees F for 3 hours and 15 minutes, due to a refrigerator malfunction with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA056272(CLUSTER), 2023SA056079(CLUSTER), 2023SA056272(CLUSTER), 2023SA056292(CLUSTER), 2023SA056689(CLUSTER), 2023SA056927(CLUSTER), 2023SA057080(CLUSTER), 2023SA057083(CLUSTER), 2023SA057086(CLUSTER), 2023SA057807(CLUSTER), 2023SA057197(CLUSTER), 2023SA057388(CLUSTER), 2023SA057474(CLUSTER), 2023SA057807(CLUSTER) and 2023SA057388(CLUSTER).  This case involves a 16 years old male patient to whom  inadvertently administered a dose of vaccine that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum of 30 degrees f with no reported adverse event and undergone temperature excursion down to 30 degrees f for 3 hours and 15 minutes, due to a refrigerator malfunction with no reported adverse event involving vaccines influenza quadrival a-b vaccine [Fluzone Quadrivalent] and meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On 07-Feb-2023, the patient received 0.5ml, 1 X dose of suspect meningococcal a-c-y-w135 (t conj) vaccine (strength, formulation was unknown, lot U7594AA and expiry date was unknown) via intramuscular route in the left deltoid for Immunization. On 07-Feb-2023, the patient received an unknown dose of suspect influenza quadrival a-b vaccine (strength, formulation, lot number and expiry date was unknown) via intramuscular route in the left deltoid for prophylactic vaccination.Information for batch and expiry date was requested.  It was reported regarding a non-serious event of undergone temperature excursion down to 30 degrees f for 3 hours and 15 minutes, due to a refrigerator malfunction with no reported adverse event (product storage error) (onset date: 07-Feb-2023, latency: same day) involving meningococcal a-c-y-w135 (t conj) VACCINE and influenza quadrival a-b vaccine.  On 07-Feb-2023 the patient developed a non-serious event of inadvertently administered a dose of vaccine that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum of 30 degrees f with no reported adverse event (poor quality product administered)(Latency: same day) following the administration of meningococcal a-c-y-w135 (t conj) vaccine and following the administration of influenza quadrival a-b vaccine.  Action taken : not applicable.  Outcome: Unknown  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.