Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, Incorrect route of product administration, Product administration error, Stress, Wrong technique in product usage process
Clinical narrative: The third dose of RabAvert was administered and the needle was a 1/4 inch into the administration site; not sure if it went subcutaneous; The third dose of RabAvert was administered and the needle was a 1/4 inch into the administration site; Patient was bitten by a bat on Tuesday and was vaccinated one day after bite on Wednesday; Stressing out; Case reference number US-BN-2022-001849 is a spontaneous case report initially received on 11-Aug-2022 from consumer via Communication (reference number: USBAV22-0962) and concerns a female patient of an unknown age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as Tuesday night, the patient was bitten by a bat.  On 03-Aug-2022, also reported as Wednesday, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown) at a dose reported as 1 vaccine, administered intramuscularly, at an unknown site of administration, for post-exposure immunisation after bat bite (explicitly coded as Inappropriate schedule of vaccine administered').   On 06-Aug-2022, three days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at a dose reported as 1 vaccine administered intramuscularly, at an unknown site of administration, for post-exposure immunisation after bat bite.  On 10-Aug-2022, seven days after the first dose, the patient was vaccinated with the third dose of RabAvert (batch number: unknown) at a dose reported as 1 vaccine at an unknown route or site of administration, for post-exposure immunisation after bat bite. The third dose was administered with the 2 inch needle for reconstitution, but the needle did not stick all the way. As reported, the needle had been placed maybe a ¼ inch in and it was not provided if it went intramuscularly or not, as reported the patient was not sure if the vaccine was administered subcutaneously (explicitly coded as 'inappropriate route of vaccination' and 'product administration error').  As reported, since the patient was not sure if the third dose went intramuscularly, another dose of Rabavert vaccine was ordered and if by some chance the vaccine did go intramuscularly patient asked will it hurt her to get another one today and that stressing the patient out.   At the time of this report the outcome of the event of stressing out was unknown.  The reporter did not provide seriousness assessment for the event of stressing out and assessed event as not related to product.  Additional information received on 12-Aug-2022 included local case ID.; Reporter's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert at a dose reported as 1 vaccine, administered intramuscularly, at an unknown site of administration, for post-exposure immunisation after bat bite which is considered as inappropriate schedule of vaccine administered. Three days after the first dose, the patient was vaccinated with the second dose of RabAvert, and seven days after the first dose, the patient was vaccinated with the third dose of RabAvert. The third dose was administered with the 2 inch needle for reconstitution, but the needle did not stick all the way. Reportedly, the needle had been placed maybe a ¼ inch in and it was not provided if it went intramuscularly or not, as reported the patient was not sure if the vaccine was administered subcutaneously which is considered as inappropriate route of vaccination and product administration error. The patient was not sure if the third dose went intramuscularly and another dose of Rabavert vaccine was ordered. The patient asked will it hurt her to get another one which was stressing the patient out. Stress is considered listed according to guidelines for RabAvert while incorrect route of product administration, inappropriate schedule of product administration and product administration error are all considered listed per company conventions. The outcome of stress was unknown. Stress is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Incorrect route of product administration, inappropriate schedule of product administration and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the first dose of RabAvert at a dose reported as 1 vaccine, administered intramuscularly, at an unknown site of administration, for post-exposure immunisation after bat bite which is considered as inappropriate schedule of vaccine administered. Three days after the first dose, the patient was vaccinated with the second dose of RabAvert, and seven days after the first dose, the patient was vaccinated with the third dose of RabAvert. The third dose was administered with the 2 inch needle for reconstitution, but the needle did not stick all the way. Reportedly, the needle had been placed maybe a ¼ inch in and it was not provided if it went intramuscularly or not, as reported the patient was not sure if the vaccine was administered subcutaneously which is considered as inappropriate route of vaccination and product administration error. The patient was not sure if the third dose went intramuscularly and another dose of Rabavert vaccine was ordered. The patient asked will it hurt her to get another one which was stressing the patient out. Stress is considered listed according to guidelines for RabAvert while incorrect route of product administration, inappropriate schedule of product administration and product administration error are all considered listed per company conventions. The outcome of stress was unknown. Stress is assessed as related due to plausible temporal relationship, known product safety profile and since contributory role of the suspect product cannot be excluded. Incorrect route of product administration, inappropriate schedule of product administration and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.