chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RAB
Symptoms: Incorrect route of product administration
Clinical narrative: RabAvert fourth dose administered via subcutaneous route; Case reference number US-BN-2023-001537 is a spontaneous case report initially received from a pharmacist via Agency (reference number: USBAV23-1512) on 18-Sep-2023 and concerns 23-month-old child patient.   The patient had no relevant medical history.  The patient's concomitant medication details were not provided.  On an unknown date, patient's mother suspected that patient might have been bitten.    On an unknown dates, the patient received four doses of RabAvert (batch number: unknown), first two administered in Emergency room, and next two at the pharmacy, at unknown doses, for unknown indication. Route of administration for first three doses was not reported however, in regard to the fourth dose, it was stated that the mother believed it may not have been administered correctly, specifically, that it might have been given subcutaneously (explicitly coded as Inappropriate route of vaccination').   At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  Additional information received from Agency on 19-Sep-2023 included local Agency case ID.; Reporter's Comments: A 23-month-old child patient received four doses of RabAvert for unknown indication. Route of administration for first three doses was not reported however, regarding the fourth dose, it was stated that the mother believed it may not have been administered correctly, specifically, that it might have been given subcutaneously, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient had no relevant medical history, and concomitant medication details were not provided. Incorrect route of product administration 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 23-month-old child patient received four doses of RabAvert for unknown indication. Route of administration for first three doses was not reported however, regarding the fourth dose, it was stated that the mother believed it may not have been administered correctly, specifically, that it might have been given subcutaneously, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient had no relevant medical history, and concomitant medication details were not provided. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient was vaccinated with the first dose of Rabavert on 06-Feb-2023, and did not received the second dose; Case reference number US-BN-2023-001796 is a spontaneous case report initially received from a pharmacist (reference number: USBAV23-1901) on 14-Nov-2023 and concerns a patient of unknown age and gender.   The patient's medical history and concomitant medication details were not provided.  On 06-Feb-2023, the patient was vaccinated with the first dose of Rabavert (batch number: unknown) at an unknown dose, route or site of administration, for unknown indication. As reported, the patient did not receive the second dose of vaccination (explicity coded as 'incomplete course of vaccination').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to Rabavert vaccine.  No further information received.; Reporter's Comments: A patient of unknown age and gender was vaccinated with the first dose of Rabavert and as reported, the patient did not receive the second dose of vaccination, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Rabavert vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination 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 patient of unknown age and gender was vaccinated with the first dose of Rabavert and as reported, the patient did not receive the second dose of vaccination, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Rabavert vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was vaccinated with the four doses of RabAvert after exposure to bats, the fifth dose was due on 28th day but that should be done 17 days ago; Case reference number US-BN-2023-001803 is a spontaneous case report initially received from a consumer (reference number: USBAV23-1907) on 15-Nov-2023 and concerns a female patient of unspecified age.   The patient's relevant medical history and concomitant medication details were not provided.  On unspecified dates, the patient was vaccinated with the first, the second, the third and the fourth dose of RabAvert (batch number: unknown) at an unknown dose, route or site of administration, for post exposure to rabies (bats). As reported, the fifth dose was due on 28th day and that should be done 17 days ago (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A female patient of unspecified age was vaccinated with the first, the second, the third and the fourth dose of RabAvert, at an unknown dose, route or site of administration, for post exposure to rabies. Reportedly, the fifth dose was due on 28th day and that should be done 17 days ago which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age was vaccinated with the first, the second, the third and the fourth dose of RabAvert, at an unknown dose, route or site of administration, for post exposure to rabies. Reportedly, the fifth dose was due on 28th day and that should be done 17 days ago which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert vaccine. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the first dose of RabAvert on 31-Oct-2023, and the second dose on day eight instead of day seven, it was 20 hours late; Case reference number US-BN-2023-001804 is a spontaneous case report initially received from a nurse (reference number: USBAV23-1908) on 15-Nov-2023 and concerns a male patient approximately 20 years of age.  The patient's medical history and concomitant medication details were not provided.  On 31-Oct-2023, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at a dose reported as standard, intramuscularly, at unknown site of administration for indication reported as pre-vaccination series.  On 08-Nov-2023, eight days after vaccination with the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at a dose reported as standard, intramuscularly, at unknown site of administration. It was reported that the patient received the second dose on day eight instead of day seven and it was about 20 hours late (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information provided.; Reporter's Comments: A male patient approximately 20 years of age was vaccinated with the second dose of RabAvert for indication reported as pre-vaccination series on the day eight instead of day seven and it was about 20 hours late, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration 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 male patient approximately 20 years of age was vaccinated with the second dose of RabAvert for indication reported as pre-vaccination series on the day eight instead of day seven and it was about 20 hours late, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the first dose of RabAvert post exposure, but had not yet received the second dose.; Case reference number US-BN-2023-001822 is a spontaneous case report initially received from a pharmacist via Agency (reference number: USBAV23-1954) on 22-Nov-2023 and concerns a patient of unknown age and gender.   The patient's medical history and concomitant medications information was not provided.  On an unspecified date, the patient had the exposure to rabies virus.  On 14-Nov-2023, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at unknown dose, via unspecified route and site of administration, for post exposure to rabies. On the same day, the patient was vaccinated with co-suspect Hyperrab (immunoglobulin human anti-rabies), administered in in unspecified dose, via unspecified route of administration and at unknown site.  At the time of reporting, as stated, the patient had not yet received the second dose of RabAvert yet (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information provided.; Reporter's Comments: A patient of unknown age and gender had not yet received the second dose of RabAvert after the patient was vaccinated with the first dose of RabAvert along with co-suspect Hyperrab (immunoglobulin human anti-rabies) for post exposure to rabies, after the patient had the exposure to rabies virus on an unspecified date, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medications information was not provided. Inappropriate schedule of product administration 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 patient of unknown age and gender had not yet received the second dose of RabAvert after the patient was vaccinated with the first dose of RabAvert along with co-suspect Hyperrab (immunoglobulin human anti-rabies) for post exposure to rabies, after the patient had the exposure to rabies virus on an unspecified date, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medications information was not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: RAB
Symptoms: Lack of vaccination site rotation
Clinical narrative: The patient received immunoglobulins at the hospital in the same anatomical location location as Rabavert; Case reference number US-BN-2023-010586 initially downloaded (reference number USBAV23-1913) on 15-Nov-2023, is a spontaneous case received from other health professional and concerns a patient of unspecified age or gender.  The patient's relevant medical history and concomitant medication details were not provided.  On unspecified date, the patient received as reported immunlobulins at the hospital at the same anatomical location as the dose of Rabavert (batch number unknown), at an unknown dose, route or site of administration, for unknown indication (explicitly coded as 'lack of vaccination site rotation').   As reported, clinical supervisor stated that they have been told that same site administration cancels out Rabavert and were advised to give a dose to the patient in anterolateral thigh. As reported, the RabAvert vaccine was not administered in the anterolateral thigh.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received on 16-Nov-2023 included amended reporter's details.; Reporter's Comments: A  patient of unspecified age or gender received (as reported) immunlobulins at the hospital at the same anatomical location as the dose of Rabavert, at an unknown dose, route or site of administration, for unknown indication which is considered as lack of vaccination site rotation. Lack of vaccination site rotation is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A  patient of unspecified age or gender received (as reported) immunlobulins at the hospital at the same anatomical location as the dose of Rabavert, at an unknown dose, route or site of administration, for unknown indication which is considered as lack of vaccination site rotation. Lack of vaccination site rotation is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's relevant medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient missed third dose of RabAvert; Case reference number US-BN-2023-010603 is a spontaneous case report initially received from health professional (reference number: USBAV23-1992) on 28-Nov-2023 and concerns a patient of unspecified age or gender.  The patient's medical history and concomitant medication details were not provided.  On unspecified dates, reported as expected, the patient received the first and second doses of RabAvert (batch number unknown), at an unknown dose, route or site of administration, for rabies pre-exposure.  As reported, the patient missed to received the third dose, and the reporter asked if the titer needs to be determined or vaccination series restarted (explicitly coded as 'inappropriate schedule of vaccine administered').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  No further information was provided.; Reporter's Comments: A patient of unspecified age and gender missed to received the third dose of RabAvert, and the reporter asked if the titer needs to be determined or vaccination series restarted which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender missed to received the third dose of RabAvert, and the reporter asked if the titer needs to be determined or vaccination series restarted which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient did not sure when the last time had the injection of Rabavert, but it was over a year and had two doses until now; Case reference number US-BN-2023-010704 is a spontaneous case report initially receive from pharmacist via Med Communications (reference number: USBAV23-2119) on 18-Dec-2023 and concerns an adult female patient.  The patient's medical history and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with the first dose of Rabavert (batch numbers: unknown), the dose, route or anatomical location were unknown and for pre-exposure prophylactic.  On an unknown date, unknown amount of time after first dose of Rabavert, the patient was vaccinated with second dose of Rabavert (batch numbers: unknown), the dose, route or anatomical location were unknown. The patient was not sure when the last time had the injection, but it was over a year, as reported (explicitly coded as 'Incomplete course of vaccination').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Rabavert vaccine.  No further information provided.; Reporter's Comments: An adult female patient was not sure when the last time had the injection after the patient was vaccinated with the first and the second dose of Rabavert, but it was over a year, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Rabavert vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Incomplete course of vaccination 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: An adult female patient was not sure when the last time had the injection after the patient was vaccinated with the first and the second dose of Rabavert, but it was over a year, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Rabavert vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient missed the second dose of RabAvert on day seven.; Case reference number US-BN-2023-010707 is a spontaneous case report initially received on 18-Dec-2023 from a nurse (reference number: USBAV23-2122) and concerns a patient of unknown demographics.    The patient's medical history and concomitant medication details were not provided.  On unspecified day, reported as day zero, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at unknown dose, route, or site of administration, and unknown indication.   On an unspecified date, reported as day seven, the second dose of RabAvert was missed (explicitly coded as 'inappropriate schedule of vaccine administered'). The health care professional wondered if the patient would be protected if the second dose would be administered on day 28.   At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information provided.; Reporter's Comments: A patient of unknown demographics missed the second dose of RabAvert on the day 7 after the first dose, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration 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 patient of unknown demographics missed the second dose of RabAvert on the day 7 after the first dose, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient was vaccinated with the second dose of RabAvert, 19 days after the first dose; Case reference number US-BN-2024-000086 is a spontaneous case report initially received from a nurse (reference number: USBAV24-0126) on 19-Jan-2024 and concerns a 49-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  The patient was not pregnant.  On 21-Dec-2023, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at unknown dose, route, or site of administration, for pre-exposure prophylaxis.   On 09-Jan-2024, 19 days after the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at unknown dose, route, or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  Laboratory tests were not performed.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A 49-year-old female patient was vaccinated with the second dose of RabAvert 19 days after the first dose for pre-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 49-year-old female patient was vaccinated with the second dose of RabAvert 19 days after the first dose for pre-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. No associated adverse events were reported. Inappropriate schedule of vaccine administered is listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of vaccine administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Depressed mood, Malaise
Clinical narrative: The patient was getting sick; Case reference number US-BN-2024-000122 is a spontaneous case report initially received from a consumer (reference number: USBAV24-0207) on 30-Jan-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication were not provided.  On unspecified dates, the patient received first, second and third dose of RabAvert vaccine (batch number: unknown), at an unknown dose, route, or anatomical location, for unknown indication.  On unspecified date, for unknown amount time of vaccination with RabAvert, as reported, the patient was getting sick. As reported, patient was due to have post exposure booster.  At the time of initial report, it was unknown if the patient recovered from the event of getting sick.  The reporter assessed the event of getting sick as non-serious and possibly related to RabAvert.  No further information provided.; Reporter's Comments: A female patient of unspecified age received first, second and third dose of RabAvert vaccines for unknown indication. On unspecified date, for unknown amount time of vaccination with RabAvert, as reported, the patient was getting sick. Malaise is listed per company convention as a non-specific event. The patient's medical history and concomitant medication were not provided. Due to implied temporal relationship and lack of alternative etiology, the causality for reported malaise is assessed as related to RabAvert. The case is non-serious.; Sender's Comments: A female patient of unspecified age received first, second and third dose of RabAvert vaccines for unknown indication. On unspecified date, for unknown amount time of vaccination with RabAvert, as reported, the patient was getting sick. Malaise is listed per company convention as a non-specific event. The patient's medical history and concomitant medication were not provided. Due to implied temporal relationship and lack of alternative etiology, the causality for reported malaise is assessed as related to RabAvert. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the second dose of RabAvert vaccine 93 days after the first dose; Case reference number US-BN-2024-000147 is a spontaneous case report initially received from a health professional (reference number USBAV24-0254) on 05-Feb-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 20-Oct-2023, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administration, for pre-exposure.  On 24-Jan-2024, 96 days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route or site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  Additional information received on 06-Feb-2024 included confirmation that the suspect product was RabAvert.; Reporter's Comments: A female patient of unspecified age was vaccinated with the second dose of RabAvert for pre-exposure on the day 96 after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration 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 female patient of unspecified age was vaccinated with the second dose of RabAvert for pre-exposure on the day 96 after the first dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: RabAvert vaccine expired at the end of Feb 2024 and accidentally administrated to the patient; Case reference number US-BN-2024-000623 is a spontaneous case report initially received from Pharmacist (reference number: USBAV24-0487) on 11-Mar-2024 and concerns an adult male patient.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, as reported, the patient was bit by a dog.  On an unspecified dates, unknown amount of time after animal exposure, the patient received first, second and third dose of RabAvert (batch number: unknown) at an unknown dose, route or site of administration, for rabies post exposure prophylaxis indication.  On an unspecified date, reported as today, unknown amount of time after animal exposure the patient received fourth dose of RabAvert (batch number: YRBA813, expiration date: reported as end of Feb-2024), administered intramuscularly at an unknown dose and site (explicitly coded as 'expired vaccine used').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  No further information was provided.; Reporter's Comments: An adult male patient received fourth dose of RabAvert (with expiration date reported as end of Feb-2024), on administered intramuscularly at an unknown dose and site which is currently considered as expired vaccine used. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult male patient received fourth dose of RabAvert (with expiration date reported as end of Feb-2024), on administered intramuscularly at an unknown dose and site which is currently considered as expired vaccine used. Expired product administered is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received second dose of RabAvert four days after animal exposure; Case reference number US-BN-2024-000629 is a spontaneous case report initially received from a consumer via Company (reference number: USBAV24-0509) on 13-Mar-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, reported as, 15 years ago, the patient was bitten by dog, the dog did not have rabies and the patient never had the rabies vaccine. As reported, the patient did not remember if had a full series of rabies vaccine, doctors did not have any records.  On 08-Mar-2024, the patient was exposed to a swipe of the claw of a raccoon, as reported the raccoon did not appear to be rabid but its hands were wet from dipping them in the water where the patient fed some cats. As reported, it was Friday night, and it was late, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, route, or site administration, for postexposure.  On 12-Mar-2024, four days after animal exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route, or site administration (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  No further information was provided.; Reporter's Comments: A female patient of unspecified age was vaccinated with the second dose of RabAvert, four days after animal exposure, at an unknown dose, route, or site administration which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age was vaccinated with the second dose of RabAvert, four days after animal exposure, at an unknown dose, route, or site administration which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to RabAvert. The patient's medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: RAB, UNK
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received fourth dose of RabAvert on 20-Feb-2024, for post-exposure prophylaxis; Case reference number US-BN-2024-000634 is a spontaneous case initially received from a consumer (reference number: USBAV24-0514) on 14-Mar-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medications were not provided.  On an unspecified date, the patient had animal exposure.  On unspecified dates, an unknown amount of time after animal exposure, the patient was vaccinated with the three doses of RabAvert (batch numbers: unknown), at unknown doses, routes, or sites of administration, for post-exposure prophylaxis.  On an unspecified date, the patient believed that had injection with a dose of co-suspect of human rabies immune globulin (HRIG) (brand name: unknown, batch number: unknown), at an unknown dose, route, or site of administration, for post-exposure prophylaxis.  On 20-Feb-2024, an unknown amount of time after animal exposure, the patient was vaccinated with the fourth dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration. As reported, this was the last dose of RabAvert and the patient had only four doses (explicitly coded as 'inappropriate schedule of vaccine administered').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A male patient of unknown age was vaccinated with the fourth dose of RabAvert for post-exposure prophylaxis, after the patient had animal exposure. As reported, this was the last dose of RabAvert and the patient had only four doses, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration 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 male patient of unknown age was vaccinated with the fourth dose of RabAvert for post-exposure prophylaxis, after the patient had animal exposure. As reported, this was the last dose of RabAvert and the patient had only four doses, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received two doses of RabAvert vaccine in April 2023 with no doses received since; Case reference number US-BN-2024-000643 is a spontaneous case report initially received from a pharmacist via Agency (reference number: USBAV24-0528) on 18-Mar-2024 and concerns a female patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date in Apr-2023, reported as on day zero, the patient was vaccinated with the first dose of RabAvert vaccine (batch number: unknown), at unknown dose, route or site of administration, for pre-exposure prophylaxis.  On unspecified date in Apr-2023, reported as on day seven, the patient was vaccinated with second dose of RabAvert vaccine (batch number: unknown), at unknown dose, route or site of administration.   As reported, the third dose of RabAvert was not administered and the patient asked if the third dose should be administered now or to be waited (explicitly coded as 'incomplete course of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information provided.; Reporter's Comments: A female patient of unspecified age was not administered the third dose of RabAvert, for pre-exposure, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Rabipur vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination 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 female patient of unspecified age was not administered the third dose of RabAvert, for pre-exposure, which is considered as incomplete course of vaccination. It was unknown if the patient experienced any adverse event due to Rabipur vaccine. Incomplete course of vaccination is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incomplete course of vaccination has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired dose of RabAvert administered to the patient; Case reference number US-BN-2024-001734 is a spontaneous case report initially received from a nurse (reference number: USBAV24-0587) on 28-Mar-2024 and concerns a 22-year-old male patient.  The patient's relevant medical history and concomitant medications were not provided.  On 28-Mar-2024, also reported as today, the patient was vaccinated with a dose of, as reported, expired RabAvert vaccine (batch number: ARBA731B), at unknown dose, route, or site of administration for unknown indication (explicitly coded as 'expired vaccine used').  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A 22-year-old male patient was vaccinated with a dose of, as reported, expired RabAvert for an unknown indication. No associated adverse events were reported. Expired product administered is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Expired product administered is not related to RabAvert, but to a human factor. The case is non-serious.; Sender's Comments: A 22-year-old male patient was vaccinated with a dose of, as reported, expired RabAvert for an unknown indication. No associated adverse events were reported. Expired product administered is listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Expired product administered is not related to RabAvert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Extra dose administered
Clinical narrative: The patient was vaccinated with the third dose of RabAvert, for post-exposure, and was previously vaccinated with Imovax; Case reference number US-BN-2024-001754 is a spontaneous case report initially received on 03-Apr-2024 from a consumer via Communications (reference number: USBAV24-0640) and concerns a female patient of unknown age.  The patient's historical vaccine included Imovax (rabies vaccine, batch number: unknown), as reported 25 years ago.    The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date, the patient was both bitten and scratched by a cat, and the doctor ordered the shots.  On 23-Mar-2024, an unknown amount of time after exposure, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, administered intramuscularly, for bite and scratch by a cat.  On 26-Mar-2024, an unknown amount of time after exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, administered intramuscularly.  On 01-Apr-2024, an unknown amount of time after exposure, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose, administered intramuscularly (explicitly coded as 'extra dose administered').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to the RabAvert.  No further information was provided.; Reporter's Comments: A female patient of unknown age was vaccinated with the third dose of RabAvert after receiving previously two doses of Rabavert and receiving Imovax vaccine as pre-exposure prophylaxis, for bite and scratch by a cat, which is considered as extra dose administered. No associated adverse events were reported. Extra dose administered is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Extra dose administered is not related to Rabavert, but to a human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age was vaccinated with the third dose of RabAvert after receiving previously two doses of Rabavert and receiving Imovax vaccine as pre-exposure prophylaxis, for bite and scratch by a cat, which is considered as extra dose administered. No associated adverse events were reported. Extra dose administered is listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Extra dose administered is not related to Rabavert, but to a human factor. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Nausea
Clinical narrative: Nausea; Case reference number US-BN-2024-001755 is a spontaneous case initially received from a consumer (reference number: USBAV24-0639) on 03-Apr-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 29-Mar-2024, the patient was vaccinated with the first dose of RabAvert vaccine (batch number: unknown), at an unknown dose, route, or site of administration, for pre-exposure vaccination.   On unspecified date, reported as for the past four days, the patient experienced severe nausea.  At the time of the initial report, the outcome of the event of nausea was unknown.  The reporter did not provide seriousness and causality assessment.  No further information was provided.; Reporter's Comments: A female patient of unknown age experienced non-serious nausea unspecified amount of time after the first dose of RabAvert was administered for pre-exposure prophylaxis. Nausea is listed and expected per the insert for RabAvert. The patient's concomitant medications and medical history were not reported. Considering suggestive temporal relationship, event has been considered as related to RabAvert.; Sender's Comments: A female patient of unknown age experienced non-serious nausea unspecified amount of time after the first dose of RabAvert was administered for pre-exposure prophylaxis. Nausea is listed and expected per the insert for RabAvert. The patient's concomitant medications and medical history were not reported. Considering suggestive temporal relationship, event has been considered as related to RabAvert.