Symptomtext
the patient did not receive the full dose with no reported adverse event; Initial and live follow up information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 1 years old male patient who did not receive the full dose with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation. On 11-Oct-2022, the patient received a dose of 0.25 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot UJ663AAA, expiration date: 04-May-2023, via intramuscular route in unknown administration site as Immunization. On 11-OCT-2022 the patient did not receive the full dose with no reported adverse event (incorrect dose administered) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. The caller reported the needle was displaced and the medication squirted out. The caller inquired does the patient need to be revaccinated. The patient may have gotten a partial dose but they were not positive. This situation was reported as a medication error due to not securing the needle properly for the injection. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event (the patient did not receive the full dose with no reported adverse event). At time of reporting, the outcome was Unknown for the 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 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.