Received Apr 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPV | DTAP + IPV (QUADRACEL) | SANOFI PASTEUR | UNK | U8623AA | IM / RL |
| HEPA | HEP A (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
QUADRACEL was administered to the patient instead Hepatitis A vaccine with no AE; 1 year old received Quadracel with no reported adverse event; Initial information received on 24-Mar-2026 regarding an unsolicited valid non-serious case received from other healthcare professional. This case involves a 1 year male patient who received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel] instead of Hepatitis A vaccine with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Concomitant medication(s) included MMR and Varicella. On 24-Mar-2026, the patient received a 0.5 mL of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine suspension for injection (batch number: U8623AA, expiry date: 31-Aug-2027) (strength: standard) via intramuscular route in right thigh instead of Hepatitis A vaccine (with an unknown formulation, strength, batch and expiry date) both for immunization with no adverse event (Wrong product administered) (Product administered to patient of inappropriate age) (latency: same day). Action taken: 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.
Mmr; Varicella vaccine