Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Constipation, Extra dose administered, Irritability, Pyrexia, Vomiting
Clinical narrative: Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven-months old male patient who experienced constipation (reported as parents also complained), vomiting, fussiness and complaints of a fever his temperature was 99.8, while he received vaccines PREVNAR, ROTAVIRUS VACCINE and PENTACEL. The patient was to receive Influenza vaccine but received doses of PREVENAR, Rotavirus and PENTACEL second time. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On 02-Nov-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot C5591AA expiry date: 15-Nov-2019 via unknown route. On 23-Oct-2018 he also received a dose of the same vaccine lot C5552AA expiry date: 10-Oct-2019 via unknown route. On 02-Nov-2018, the patient received a dose of suspect ROTAVIRUS VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route. On 23-Oct-2018 he also received a dose of the same vaccine with an unknown batch number via unknown route. On 02-Nov-2018, the patient received a dose of suspect PREVNAR not produced by Sanofi Pasteur lot number not reported via unknown route. On 23-Oct-2018 he also received a dose of the same vaccine with an unknown batch number via unknown route. On an unknown date, the patient developed a non-serious constipation (reported as the parents also complained), vomiting, fussiness, complaints of a fever his temperature was 99.8 following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE, following the administration of ROTAVIRUS VACCINE and following the administration of PREVNAR. It was actual medication error due to extra dose administered and wrong vaccine administered. (Other relevant tests included No lab data.) It was also reported that No other symptoms were reported and no other treatment recommended/needed (the parents were advised to give the child one ounce of prune juice). Final diagnosis was complaints of a fever his temperature was 99.8, fussiness, vomiting and constipation. No corrective treatment was received. It was also reported that the patient was not given any treatment and the parents were advised to give the child one ounce of prune juice. The patient outcome is reported as Unknown for constipation, as Unknown for vomiting, as Unknown for fussiness and as recovered for complaints of a fever his temperature was 99.8 (The child was not febrile when he was seen in the office). This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Documents held by sender: none. List of documents held by sender: none.