Sex: F
Vaccine: RAB
Symptoms: Accidental exposure to product, Exposure via ingestion, Fear of death, Product administration error, Viral titre
Clinical narrative: Patient touched a little bit of the vaccine with fingers and mouth; Vaccination was not performed properly; The patient thought that will die of rabies; Small ingestion of rabies vaccine; Case reference number US-BN-2022-004566 is a spontaneous case report initially received on 04-Nov-2022 from a consumer via Agency (reference number: USBAV22-1864) and concerns a 64-year-old female patient.  The patient had no medical history. The patient's concomitant vaccination included Imovax (rabies vaccine) and tetanus.  On 03-Nov-2022, the patient was exposed to rabies via a bat. On the same day, a nurse wanted to vaccinate the patient with a tetanus vaccine, but after the patient told the nurse that a rabies vaccine should be administered, the patient was vaccinated with the first dose of RabAvert (rabies virus (inactivated, strain flury LEP) (PCEC); batch number: unknown) at an unknown dose, administered intramuscularly at an unknown site of administration, for post exposure to rabies. On the same day, the nurse gave the box with the insert to the patient and the used vial was still inside the box. The patient touched a little bit of the vaccine with fingers and then touched the mouth and probably had a small ingestion of the rabies vaccine, as reported (explicitly coded as 'inadvertent exposure to vaccine'). The patient thought that the vaccination was not carried out properly (explicitly coded as 'product administration error').  On an unspecified date, an unknown amount of time after the vaccination, the patient contacted poison control and the doctor said that the vaccine was attenuated and that the patient could not get the disease, but the doctor also said that if a small amount was ingested and if it went through the digestive system and in case of any tear in the digestive tract, this would allow the vaccine to enter the blood stream. The patient was afraid of death of rabies.  On an unspecified date, reported also as at one point, the patient performed a titer test and the results were okay, as reported.  At the time of this report, the outcome of the events was unknown.  The reporter assessed the event of fear of death as serious due to the seriousness criteria of life threatening and possibly related to the product.   Additional information received from Bavarian Nordic on 07-Nov-2022 included the local BN case ID.; Reporter's Comments: A 64-year-old female patient had an exposure to rabies, involving a bat. The patient received RabAvert intramuscularly. Following administration, the patient touched the vial and had contact with the remaining amounts of the vaccine. The patient touched her mouth (which is considered accidental exposure to product and exposure via ingestion). The patient was told by a physician that theoretically, the ingested vaccine could enter the bloodstream in case there are injuries to the GI tract. The patient reported she was not vaccinated properly (which is considered product administration error), and she thought she would die of rabies (assessed as life-threatening by the reporter, coded as fear of death). Fear of death is unlisted per the agency for RabAvert. Accidental exposure to product, exposure via ingestion and product administration error are considered listed per company conventions. Medical history and concomitant medications were unknown. Concomitant vaccines included Imovax and Tetanus vaccine. According to agency, if the vaccine enters the bloodstream (via injection error), it could cause shock. However, RabAvert contains an inactivated rabies virus (strain Flury LEP produced on chicken embryos), which means the vaccine is only immunogenic but not infectious. Therefore, the event of fear of death is assessed as not related to RabAvert, but to anxiety and insufficient information provided to the patient. The events of accidental exposure to product, exposure via ingestion and product administration error are considered not related to RabAvert, but to human error.; Sender's Comments: A 64-year-old female patient had an exposure to rabies, involving a bat. The patient received RabAvert intramuscularly. Following administration, the patient touched the vial and had contact with remaining amounts of the vaccine. The patient touched her mouth (which is considered accidental exposure to product and exposure via ingestion). The patient was told by a physician that theoretically, the ingested vaccine could enter the bloodstream in case there are injuries to the GI tract. The patient reported she was not vaccinated properly (which is considered product administration error), and she thought she would die of rabies (assessed as life-threatening by the reporter, coded as fear of death). Fear of death is unlisted per the agency for RabAvert. Accidental exposure to product, exposure via ingestion and product administration error are considered listed per company conventions. Medical history and concomitant medications were unknown. Concomitant vaccines included Imovax and Tetanus vaccine. According to agency, if the vaccine enters the bloodstream (via injection error), it could cause shock. However, RabAvert contains an inactivated rabies virus (strain Flury LEP produced on chicken embryos), which means the vaccine is only immunogenic but not infectious. Therefore, the event of fear of death is assessed as not related to RabAvert, but to anxiety and insufficient information provided to the patient. The events of accidental exposure to product, exposure via ingestion and product administration error are considered not related to RabAvert, but to human error.