Received Mar 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (ACTHIB) | SANOFI PASTEUR | 4 | UK113AB | OT / LL |
received another set of 6 month vaccines with no reported adverse event; Initial information received on 05-Mar-2025 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves 5 months old male patient who received another set of 6 month HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event. 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), Pertussis vaccine acellular 3-component, Polio vaccine inact 3v (Vero), Tetanus vaccine toxoid (Pediarix), pneumococcal vaccine conj 7v (CRM197) (Prevnar) and rotavirus vaccine live reassort oral 5 V (Rotateq) for prophylactic vaccintion (Immunisation) On 25-Feb-2025, the patient received a dose of 0.5 ml (dose 4) of suspect HIB (PRP/T) vaccine [ACT-HIB], Powder and solvent for solution for injection (lot number UK113AB and expiry date 30-Sep-2025) (Frequency: Possibly 4 times and strength: standard) via intramuscular route in the left thigh for Immunisation with no reported adverse event (extra dose administered) (Latency: same day). Reportedly, Caller is calling because they have a 6 month old male patient and the patient first received the vaccines and then traveled for two months and got vaccines while traveling. When the patient came back for his six-month appointment, his shot record was not clear. He received another set of 6 month vaccines. The patient's dad wants the HCP to call and see if there is any information about adverse reactions to a child being essentially double vaccinated. They are requesting if there's anything that could happen beside redness, swelling of the injection site, fussiness, decreased appetite, fever, and all that stuff. Action taken 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 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.
Pediarix; Prevnar; Rotateq