Symptomtext
Extra dose administered; Medication error; No adverse event; This non-serious case was retrieved during Vaccines Adverse Event Reporting System (VAERS) monitoring on 11-APR-2022 with the following VAERS Primary ID 2091402. The original narrative from the sender is the following: "Mistakenly an extra dose of ACTHIB with no reported adverse event; Initial information received on 19-Jan-2022 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2-year-old male patient who had mistakenly an extra dose of ACT-HIB with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included 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) for Immunisation. On 17-Jan-2022, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot UJ525AA, expiration: 16-Jul-2022, via intramuscular route in the right thigh as Immunisation. On 17-JAN-2022 the patient developed a non-serious event ""mistakenly an extra dose of ACT-HIB with no reported adverse event"" (extra dose administered) following the administration of HIB (PRP/T) VACCINE. It was reported ""Caller states that a 2 yo was mistakenly an extra dose of ACTHIB and would like to know if it is safe? Caller would like to know how to proceed? Additional Description of event Adverse events: A 2- year-old patient received an extra dose of ACTHIB. Caller states that the patient had already had 3 doses of ACTHIB and was seen on 17-Jan-2022 where she received the 4th dose of HIB via VAXELIS. Caller states that after the patient received VAXELIS he was also given a dose of ACTHIB by mistake on the same day."" Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable. It was not reported if the patient received a corrective treatment for the event (mistakenly an extra dose of ACTHIB with no reported adverse event). At time of reporting, the outcome was Unknown for the event mistakenly an extra dose of ACT-HIB 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 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." The reporter did not provide an assessment of the causal relationship between Vaxelis and the reported events "Extra dose administered, Medication error, and No adverse event". No further information is expected.
