Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAPIPVHIB | DTAP + IPV + HIB (PENTACEL) | SANOFI PASTEUR | UNK | UK345AB | — |
received the pentacel on 01APR2026 but was given a second dose today, 15APR2026/doses being given earlier than recommended intervals with no AE; Initial information received on 15-Apr-2026 regarding an unsolicited valid non-serious case received from a health care professional (HCP). This case involves a 13-week-old male infant who received the Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] on 01-Apr-2026 but was given a second dose on 15-Apr-2026, with no reported adverse event. The patient's past medical history, past drugs, vaccination(s), and family history were not provided. Concomitant medication(s) included rotavirus vaccine live oral 1v (Rotarix). On 01-Apr-2026, the patient received a 0.5 mL dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection of standard strength (batch: UK345AB, expiration date: 31-Jan-2027) via unknown route in unknown administration site for immunisation. On 15-Apr-2026, the patient received an extra 0.5 mL dose of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv (Vero)/Hib(Prp/T) Vaccine, Powder and suspension for suspension for injection of standard strength (batch and expiration date: unknown) via unknown route in unknown administration site for immunization, with no reported adverse event (Extra dose administered) (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.
Comments: NONE
Rotarix