Age: 11.0
Sex: F
Vaccine: DTAP, DTAPIPV, DTPPVHBHPB, IPV, MEN, TD, TDAP, UNK, DTAP, DTAPIPV, DTPPVHBHPB, IPV, MEN, TD, TDAP
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Vaccines were exposed to 31.5f upto 2 hours 45 minutes and These vaccines were administered to 40 patients over a span of 1 week with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who received vaccines diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (Vaxelis), diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [tenivac], diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel], diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (vero)], meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi], ipv (vero) [ipol], diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] and diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] were exposed to 31.5f upto 2 hours 45 minutes and These vaccines were administered to 40 patients over a span of 1 week with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included hpv vaccine vlp rl1 4v (yeast) (Gardasil) for Prophylactic vaccination (immunisation).  On an unknown date, a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection, diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection, ipv (vero) Suspension for injection, meningococcal a-c-y-w135 (t conj) vaccine Solution for injection, diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection, diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection, diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (unknown formulation) not produced by Sanofi Pasteur (Strength: standard except for Fluzone High Dose Quadrivalent, dose: 0.5 ml, route: intramuscular, lot number, expiration date, administration site: Unknown, indication: immunization (immunisation) for all the suspects) were exposed to 31.5f upto 2 hours 45 minutes and These vaccines were administered to 40 patients over a span of 1 week with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that "temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data. These vaccines were administered to 40 patients over a span of 1 week, starting on 15-Jun-2023 till stopping at 22-Jun-2023. ADACEL and MENQUADFI administered"  No lab data reported.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event vaccines were exposed to 31.5f upto 2 hours 45 minutes and adacel, menquadfi administered to patients after excursion with no reported adverse event.  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 guidelines. 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.; Sender's Comments:  US-SA-2023SA238269:01715866 US-SA-2023SA240011:01715866