Received Apr 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| IPV | POLIO VIRUS, INACT. (IPOL) | SANOFI PASTEUR | UNK | X1C891M | OT / LL |
2 year old receiving IPOL which was due again at age 4 years with no reported adverse event; Initial information received on 17-Apr-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 2 years old female patient who recieved IPV (VERO) [IPOL] which was due again at age 4 years 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 Measles vaccine, Mumps vaccine, Rubella vaccine and Varicella zoster vaccine for Immunisation. On an unknown date, the patient received an unknown dose of suspect IPV (VERO), Suspension for injection (unknown strength, expiry date and lot number not reported,) via unknown route in unknown administration site for immunization On 17-Apr-2025, the patient received 0.5 dose of suspect IPV (VERO), Suspension for injection, lot X1C891M, Strength = standard, Frequency = once, expiry date:31-Oct-2026, via intramuscular route in the left thigh for immunization which was due again at age 4 years with no reported adverse event (extra dose administered) (latency: same day). 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.; Sender's Comments: US-SA-2025SA113400:IPOL
Mmr; Varicella vaccine