Sex: M
Vaccine: DTAP, DTAPIPVHIB, HIBV, IPV
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
Clinical narrative: child receives vaccines on delayed schedule, individually, not as combined products like Pentacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer and transmitted to Sanofi on 01-Nov-2021.  This case involved a child male patient who received vaccines on delayed schedule, individually, not as combined products like pentacel (Inappropriate schedule of product administration) with no reported adverse event while receiving vaccines diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel), poliomyelitis vaccine (inactivated) (IPOL), diphtheria, tetanus and acellular pertussis vaccine (Daptacel) and haemophilus type b (hib) vaccine (ACT-HIB).  The patient's medical history, past medical treatment(s), vaccination(s), concomitants and family history were not provided.  On an unknown date, the patient received a dose of diphtheria, tetanus, ac pertussis, ipv and hib vaccine, poliomyelitis vaccine (inactivated), diphtheria, tetanus and acellular pertussis vaccine and haemophilus type b (hib) vaccine, all with (unknown frequency and dosage) via unknown route (with an unknown batch number and expiry date) for an unknown indication.  On an unknown date, (unknown latency) the patient received vaccines on delayed schedule, individually, not as combined products like pentacel (Inappropriate schedule of product administration).  It was reported "Caregiver asks if there is a maximum length of time between vaccine schedule for Daptacel, ActHIB, Ipol? She asks why is it not necessary to get ActHIB vaccine if not completed series at age 5? She reports child receives vaccines on delayed schedule, individually, not as combined products like Pentacel. Additional Description of event Adverse events : She reports child receives vaccines on delayed schedule, individually, not as combined products. She states her child gets one vaccine monthly."  No adverse event was reported.  No relevant laboratory details were provided.  Action taken with all the suspects were not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for inappropriate schedule of product administration.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.  No further details were provided.  Initial information regarding an unsolicited valid non-serious case was received from a consumer and transmitted to Sanofi on 01-Nov-2021.  This case involved a child male patient who received vaccines on delayed schedule, individually, not as combined products like pentacel (Inappropriate schedule of product administration) with no reported adverse event while receiving vaccines diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel), poliomyelitis vaccine (inactivated) (IPOL), diphtheria, tetanus and acellular pertussis vaccine (Daptacel) and haemophilus type b (hib) vaccine (ACT-HIB).  The patient's medical history, past medical treatment(s), vaccination(s), concomitants and family history were not provided.  On an unknown date, the patient received a dose of diphtheria, tetanus, ac pertussis, ipv and hib vaccine, poliomyelitis vaccine (inactivated), diphtheria, tetanus and acellular pertussis vaccine and haemophilus type b (hib) vaccine, all with (unknown frequency and dosage) via unknown route (with an unknown batch number and expiry date) for an unknown indication.  On an unknown date, (unknown latency) the patient received vaccines on delayed schedule, individually, not as combined products like pentacel (Inappropriate schedule of product administration).  It was reported Caregiver asks if there is a maximum length of time between vaccine schedule for Daptacel, ActHIB, Ipol? She asks why is it not necessary to get ActHIB vaccine if not completed series at age 5? She reports child receives vaccines on delayed schedule, individually, not as combined products like Pentacel. Additional Description of event Adverse events : She reports child receives vaccines on delayed schedule, individually, not as combined products. She states her child gets one vaccine monthly.  No relevant laboratory details were provided.  Action taken with all the suspects were not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for inappropriate schedule of product administration.  This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error.  No further details were provided.