Sex: F
Vaccine: RAB, RAB
Symptoms: Erythema, Immunoglobulin therapy, Interchange of vaccine products, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Woke up with some dots and it looked like a bat; cold-like symptoms like sore throat and congestion; had a little redness in the skin after administration; Received two doses of Rabavert and one dose of another brand that they had in stock; Case reference number US-BN-2022-001090 is a spontaneous case report initially received on 12-May-2022 from a consumer via Communication (reference number: USBAV22-0181) and concerns a 2-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, 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 2.5 international units, administered intramuscularly at an unknown site of administration, for post-exposure prophylaxis due to a bat bite. As reported, the patient received the immune globulin as well.  On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an at a dose reported as 2.5 international units, administered intramuscularly, unknown site of administration, for post-exposure prophylaxis due to a bat bite.  On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the third dose of Rabies vaccine (generic name: unknown, reported as other brand vaccine) at an unknown dose, route or site of administration (explicitly coded as 'Interchange of vaccine products'), for post-exposure prophylaxis due to a bat bite.  On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the fourth dose of RabAvert (batch number: unknown) at a dose reported as 2.5 international units, administered intramuscularly at an unknown site of administration, for post-exposure prophylaxis due to a bat bite.  On an unspecified date, an unknown amount of time after RabAvert administration, the patient woke up with some dots and it looked like a bat and they all went to emergency room.   On an unspecified date, an unknown amount of time after RabAvert administration, the patient had a little redness in the skin.  *On an unspecified date, three weeks after vaccination with the rabies vaccine (as reported), the patient experienced cold-like symptoms like sore throat and congestion.*  At the time of this report, the outcome of events 'animal bite', 'redness' and *cold-like symptoms like sore throat and congestion* was unknown.  The reporter assessed *all* the events as non serious and as possibly related to Rabavert vaccination.  Additional information received on 13-May-2022 included two doses of Rabavert and additional co-suspect vaccine.  Additional information received on 16-May-2022 included fourth dose of Rabavert, patient's age and gender and additional events.  Additional information received on 08-Jun-2022 included local case ID.  Additional information received on 13-Jun-2022 included updated local case ID.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from Communications on 07-Jun-2022 included additional event (cold-like symptoms like sore throat and congestion).  Additional information received on 08-Jun-2022 included local case ID.  Additional information received on 13-Jun-2022 included updated local case ID.; Reporter's Comments: A 2-year-old female patient was vaccinated with the third dose of Rabies vaccine (generic name: unknown, reported as other brand vaccine) after receiving 2 doses of RabAvert for post-exposure prophylaxis due to a bat bite, which is considered as interchange of vaccine products. On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the fourth dose of RabAvert. On an unspecified date, an unknown amount of time after RabAvert administration, the patient woke up with some dots and it looked like a bat, as reported. Also, on an unspecified date, an unknown amount of time after RabAvert administration, the patient had a little redness in the skin. Reportedly, on an unspecified date, three weeks after vaccination with the rabies vaccine (as reported), the patient experienced non-serious events of cold-like symptoms like sore throat and congestion. Erythema is considered as listed, whilst animal bite and nasopharyngitis are not listed for RabAvert according to the guidelines. Interchange of vaccine products is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of events was unknown, as reported. Animal bite has been considered as not related to the suspect product, whilst the events of erythema and nasopharyngitis have been considered as related to RabAvert, since the contributory role of the suspect vaccine cannot be excluded. Interchange of vaccine products has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 2-year-old female patient was vaccinated with the third dose of Rabies vaccine (generic name: unknown, reported as other brand vaccine) after receiving 2 doses of RabAvert for post-exposure prophylaxis due to a bat bite, which is considered as interchange of vaccine products. On an unspecified date, an unknown amount of time after the first dose, the patient was vaccinated with the fourth dose of RabAvert. On an unspecified date, an unknown amount of time after RabAvert administration, the patient woke up with some dots and it looked like a bat, as reported. Also, on an unspecified date, an unknown amount of time after RabAvert administration, the patient had a little redness in the skin. Reportedly, on an unspecified date, three weeks after vaccination with the rabies vaccine (as reported), the patient experienced non-serious events of cold-like symptoms like sore throat and congestion. Erythema is considered as listed, whilst animal bite and nasopharyngitis are not listed for RabAvert according to the guidelines. Interchange of vaccine products is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome of events was unknown, as reported. Animal bite has been considered as not related to the suspect product, whilst the events of erythema and nasopharyngitis have been considered as related to RabAvert, since the contributory role of the suspect vaccine cannot be excluded. Interchange of vaccine products has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.