Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Medication error, Product storage error, Pruritus
Clinical narrative: patient received a 0.5ml dose of invalid (due to a previous temp excursion) Ipol; itching all over her body; itching (no rash) on the left thigh (at the injection site); Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00525650).  This case involves a 5 year old female patient who experienced itching at the injection site (vaccination site pruritus) and itching all over her body (pruritus), after she received invalid (due to a previous temp excursion) IPV (VERO) [IPOL] (product storage error), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR], and VARICELLA ZOSTER VACCINE [VARICELLA VACCINE].  Past medical history, medical treatment, vaccination, family history and concomitant medication were not reported.  On 11-Feb-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5706AA, expiry date: 11-Mar-2022] and 0.5 mL dose of suspect of IPV (VERO) [lot T1D481M, expiry date: 22-Jul-2025] via an unknown route at the left thigh for prophylactic vaccination.  On the same day, on that visit, the patient also received a dose of suspect MMR (not produced by Sanofi Pasteur) and a dose of suspect VARICELLA VACCINE [lot number and expiry date not reported] via an unknown route at the right thigh for prophylactic vaccination.   On 11-Feb-2021, the patient developed a non-serious itching (no rash) on the left thigh (at the injection site) (vaccination site pruritus) on the same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, IPV (VERO), MMR and VARICELLA VACCINE.  On 11-Feb-2021 at evening, the patient developed a non-serious itching all over her body (pruritus), on the same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE, IPV (VERO), MMR and VARICELLA VACCINE.  It was also a case of actual medication error due to incorrect product storage of IPV (VERO). (latency: unknown) It was reported that, the patient experienced a reaction after receiving an invalid IPOL vaccine (which experienced a temperature excursion) as the IPOL was later deemed no longer suitable for use on 11-Mar-2021.   At the time of reporting, reporter wanted to know that, if that episode contraindicates the patient being revaccinated with IPOL vaccine also wanted to know any other recommendations.   Details of laboratory data not reported.  The patient was treated with BENADRYL [AMMONIUM CHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL, SODIUM CITRATE].  At the time of reporting, event outcome was unknown for vaccination site pruritus and pruritus. Event outcome for product storage error was not applicable.   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. 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.