Sex: F
Vaccine: RAB
Symptoms: No adverse event, Wrong technique in product usage process
Clinical narrative: grandchildren received their Day 3 second doses of IMOVAX,given 1.5 to 2 hours after reconstitution with no reported adverse event; Initial information received on 24-Jan-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 6 years old female patient who received their day 3 second doses of imovax, given 1.5 to 2 hours after reconstitution with no reported adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included RABIES VACCINE INACT (CHICK EMBRYO) (RABAVERT) for Prophylactic vaccination.  On 22-Jan-2022, the patient received a dose of 0.5 ml of suspect RABIES (HDC) VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in the left arm as Immunisation.  On 22-JAN-2022 the patient developed a non-serious event "grandchildren received their day 3 second doses of imovax,given 1.5 to 2 hours after reconstitution with no reported adverse event" (wrong technique in product usage process) following the administration of RABIES (HDC) VACCINE.  It was reported" Patient states that she was reading in bed and saw a black thing flying in and out of the room. She called wildlife control to check the house. On Sunday, she woke up with a bat in her room. Caller states that her daughter and two grandchildren were in the house. Caller states that her primary care doctor convinced her to get a rabies vaccine prophylactically to be safe at this time. Caller states that she took herself and her two grandchildren to receive their rabies vaccines. Caller states that during the second round of vaccinations at the doctor's office, the doctor tried to convince her that these vaccinations were not necessary. Caller states that the vaccine, which was purple in color, was in a syringe when the Medical Assistant entered the room but it was nearly 1.5 to 2 hours before her and her two grandchildren received the vaccine because she was trying to be convinced that she didn't require the vaccine. Caller states that she was required to sign a waiver at this time stating that she was going against the doctor's advice and wished to receive the IMOVAX. Caller states that she is not sure if the Medical Assistant took the IMOVAX vaccines back to the refrigerator at this time. Caller asked for stability information of IMOVAX vaccine after it has been reconstituted. Caller states that she will contact the clinic to find out what time the vaccine was reconstituted and what time it was actually administered."  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the event (grandchildren received their Day 3 second doses of IMOVAX, given 1.5 to 2 hours after reconstitution with no reported adverse event).  At time of reporting, the outcome was Unknown for the event grandchildren received their day 3 second doses of imovax,given 1.5 to 2 hours after reconstitution with no reported adverse event.  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.