Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A lot of Rabavert vaccine has spilled over the patient's leg and the patient's mother is wondering if that dose will be effective because the patient should have received the full dose; A lot of Rabavert vaccine has spilled over the patient's leg and the patient's mother is wondering if that dose will be effective because the patient should have received the full dose; Third dose of Rabavert vaccine was administered on day 10 and fourth on day 17; Case reference number US-BN-2022-001474 is a spontaneous case report initially received on 05-Jul-2022 from a non healthcare professional (reference number: USBAV22-0473) and concerns a 19-months-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 18-Jun-2022, the patient was vaccinated with the first dose of Rabavert (Rabies Virus (Inactivated, Strain Flury LEP); batch number unknown) at unknown dose, administered intramuscularly, for post-exposure immunization.  On 21-Jun-2022, three days after the first dose, the patient was vaccinated with the second dose of Rabavert (batch number unknown) at unknown dose, administered intramuscularly.  On 28-Jun-2022, ten days after the first dose, the patient was vaccinated with the third dose of Rabavert (batch number unknown) at unknown dose, administered intramuscularly. (explicitly coded as Inappropriate schedule of vaccine administered')  On 05-Jul-2022, 17 days after the firs dose, the patient was vaccinated with the fourth dose of Rabavert (batch number unknown) at unknown dose, administered intramuscularly. During the vaccination a lot of it leaked out over the patient's leg (explicitly coded as Inappropriate schedule of vaccine administered'; Accidental exposure to product' and Vaccine underdose').  At the time of this report, it was unknown if the patient experienced any adverse event due to Rabavert.  Additional information received from Bavarian Nordic on 06-Jul-2022 included the local case ID.  This case is linked with case no. US-BN-2022-001528, concerning the same reporter.; Reporter's Comments: A 19-months-old female patient was vaccinated with the first dose of Rabavert administered intramuscularly, for post-exposure immunization. Ten days after the first dose, the patient was vaccinated with the third dose of Rabavert, which is considered as inappropriate schedule of vaccine administered. Seventeen days after the firs dose, the patient was vaccinated with the fourth dose of Rabavert administered intramuscularly and during the vaccination a lot of it leaked out over the patient's leg, which is considered as inappropriate schedule of vaccine administered, accidental exposure to product and vaccine underdose. No associated adverse events were reported. Inappropriate schedule of vaccine administered, accidental exposure to product and vaccine underdose are listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered, accidental exposure to product and vaccine underdose are not related to Rabavert, but to a human factor. The case is non-serious.; Sender's Comments: A 19-months-old female patient was vaccinated with the first dose of Rabavert administered intramuscularly, for post-exposure immunization. Ten days after the first dose, the patient was vaccinated with the third dose of Rabavert, which is considered as inappropriate schedule of vaccine administered. Seventeen days after the firs dose, the patient was vaccinated with the fourth dose of Rabavert administered intramuscularly and during the vaccination a lot of it leaked out over the patient's leg, which is considered as inappropriate schedule of vaccine administered, accidental exposure to product and vaccine underdose. No associated adverse events were reported. Inappropriate schedule of vaccine administered, accidental exposure to product and vaccine underdose are listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered, accidental exposure to product and vaccine underdose are not related to Rabavert, but to a human factor. The case is non-serious.