chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Vertigo
Clinical narrative: New enhancing brain lesion after vaccination event on 09/24/2024, confirmed by MRI on 11/2/2024.  PMRI done prior to vaccination in mid-September 2024 did not show this lesion.  Following vaccination, new neurologic symptoms appeared, including vertigo and balance/gait difficulties.
Sex: M
Vaccine: RAB
Symptoms: Anosmia
Clinical narrative: Loss of a sense of smell; Case reference number US-BN-2024-002414 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-2166) on 29-Aug-2024 and concerns a 65-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 21-Aug-2024, the patient was vaccinated with the first dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration for post exposure from a bat bite.  On 24-Aug-2024, three days after the first dose, the patient was vaccinated with the second dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration.  On the same day, the patient experienced loss of smell. The patient did not receive any treatment for the event loss of smell.  On 28-Aug-2024, seven days after the first dose, the patient was vaccinated with the third dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration.  On 04-Sep-2024, 14 days after the first dose, the patient was vaccinated with the fourth dose of Rabavert (batch number: FDP0052, expiry date: Nov-2027), at an unknown dose, via intramuscular use in unknown site of administration.  On the same day, the patient recovered from the event loss of smell.  The reporter assessed the seriousness of the event loss of smell as non-serious and causality was not provided for the event loss of smell.  Additional information received from health care professional via Med Communication (reference number: USBAV24-2238) on 04-Sep-2024: Information included reference number (USBAV24-2238), Rabipur dosage information and updated outcome for the event of loss of smell.; Reporter's Comments: A 65-year-old male patient experienced a non-serious event of loss of smell on the day 0 after the patient was vaccinated with the second dose of Rabavert for post exposure from a bat bite. Anosmia is unlisted and unexpected for RabAvert. The patient's medical history and concomitant medication details were not provided. The patient recovered from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of anosmia is considered as related to RabAvert. This case is considered as non-serious.; Sender's Comments: A 65-year-old male patient experienced a non-serious event of loss of smell on the day 0 after the patient was vaccinated with the second dose of Rabavert for post exposure from a bat bite. Anosmia is unlisted and unexpected for RabAvert. The patient's medical history and concomitant medication details were not provided. The patient recovered from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of anosmia is considered as related to RabAvert. This case is considered as non-serious.
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patent received the second dose of RabAvert vaccine on day 10; Case reference number US-BN-2024-002455 is a spontaneous case initially received from other health care professional via Med Communications (reference number USBAV24-2313) on 10-Sep-2024 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as day zero, the patient received the first dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration, for pre-exposure prophylaxis.  On an unspecified date, reported as day ten, the patient received 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').  On an unspecified date, reported as day 28, the patient received the third dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration.  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 patient of unknown demographics received the second dose of RabAvert for pre-exposure prophylaxis on the day 10 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 is 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 received the second dose of RabAvert for pre-exposure prophylaxis on the day 10 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient had been exposed to rabies on Friday, and only got the first dose of RabAvert on 12-Sep-2024; Case reference number US-BN-2024-002501 is a spontaneous case initially received from consumer via Med Communications (reference number USBAV24-2351) on 12-Sep-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as on Friday, the patient had rabies exposure. As reported, it was unknown if the animal had rabies.  On 12-Sep-2024, unknown amount of time after rabies exposure, the patient received the first dose of RabAvert (batch number: unknown), at an unknown dose, route and site of administration, for rabies post-exposure prophylaxis (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 unspecified age received the first dose of RabAvert for rabies post-exposure prophylaxis on 12-Sep-2024, after the patient had rabies exposure, reported as on Friday, 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 is 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 unspecified age received the first dose of RabAvert for rabies post-exposure prophylaxis on 12-Sep-2024, after the patient had rabies exposure, reported as on Friday, 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: On day 14 the patient was incorrectly given HyperRab (HRIG) instead of fourth RabAvert dose; Case reference number US-BN-2024-002522 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2423) on 18-Sep-2024 and concerns a 32-year-old male patient.   The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was exposed to a bat.  On an unspecified date, reported as day zero, unknown amount of time after animal exposure, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration for post-exposure.  On an unspecified date, reported as day three, unknown amount of time after animal exposure, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration.  On an unspecified date, reported as day seven, unknown amount of time after animal exposure, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration.  On an unspecified date, reported as day 14, unknown amount of time after animal exposure, the patient was incorrectly given HyperRab (HRIG; immunoglobulin human anti-rabies; batch number: unknown), at an unknown dose, route, or site of administration for post-exposure, instead of fourth dose of RabAvert (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 the RabAvert vaccination.  No further information was provided.; Reporter's Comments: A 32-year-old male patient was incorrectly given HyperRab, reported as on the day 14, for post-exposure, instead of the fourth dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the RabAvert vaccination. Inappropriate schedule of product administration is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 32-year-old male patient was incorrectly given HyperRab, reported as on the day 14, for post-exposure, instead of the fourth dose of RabAvert, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to the RabAvert vaccination. Inappropriate schedule of product administration is considered as unlisted per company convention. The patient's medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was vaccinated with three doses of Rabavert at the same time; Patient was vaccinated with three doses of Rabavert at the same time; Case reference number US-BN-2024-002556 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2522) on 26-Sep-2024 and concerns a 7-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient experienced dog bite.   On 25-Sep-2024, unknown amount of time after the animal exposure, reported around 10:00 pm, the patient was vaccinated with three doses of Rabavert (batch number: unknown) one milliliter, intramuscularly in unknown site of administration for post exposure prophylaxis (explicitly coded as 'vaccine overdose' and '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 7-year-old male patient was vaccinated with three doses of Rabavert for post exposure prophylaxis, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Rabavert. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 7-year-old male patient was vaccinated with three doses of Rabavert for post exposure prophylaxis, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Rabavert. Inappropriate schedule of product administration and overdose are considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration and overdose are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient got the first dose of RabAvert last year on 03NOV2023 and never came for the second dose; Case reference number US-BN-2024-002673 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-2786) on 22-Oct-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 03-Nov-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 treatment.   As reported, the patient never came for the second dose of RabAvert (explicitly codes 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 was provided.; Reporter's Comments: A male patient received the first dose of RabAvert for pre-exposure prophylaxis, but never returned for a second dose, which is considered incomplete course of vaccination. This is a listed event as per company convention. No associated adverse events were reported. Medical history was not reported. Incomplete course of vaccination is not related to RabAvert, but to human error. The case is non-serious.; Sender's Comments: A male patient received the first dose of RabAvert for pre-exposure prophylaxis, but never returned for a second dose, which is considered incomplete course of vaccination. This is a listed event as per company convention. No associated adverse events were reported. Medical history was not reported. Incomplete course of vaccination is not related to RabAvert, but to human error. The case is non-serious.
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: Adult patient received RabAvert dose into the anterolateral thigh instead of deltoid area; Case reference number US-BN-2024-002768 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-2978) on 11-Nov-2024 and concerns an adult patient of unknown age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the dose of RabAvert (batch number: unknown) along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis (explicitly coded as 'vaccine administered at inappropriate site').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to Rabavert.  No further information was provided.; Reporter's Comments: An adult patient of unknown age and gender was vaccinated with the dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An adult patient of unknown age and gender was vaccinated with the dose of RabAvert, along with device constituents prefilled syringe, needle for injection and needle for reconstitution at an unknown dose, route in anterolateral thigh for post exposure prophylaxis, which is considered as vaccine administered at inappropriate site. It was unknown if the patient experienced any adverse events due to RabAvert. Product administered at inappropriate site is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received first, and second dose of Rabavert and having late for the third dose; Case reference number US-BN-2024-002776 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3013) on 13-Nov-2024 and concerns a male patient of unknown age.   The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient was vaccinated with the first and second dose of RabAvert along with device constituents prefilled syringe, needle for injection, and needle for reconstitution (batch number: unknown), at an unknown dose, route, or site of administration for post-exposure prophylaxis.  On unspecified date, reported as last Sunday, the patient was supposed to get third dose of RabAvert, however patient came today and administered the third dose of RabAvert along with device constituents prefilled syringe, needle for injection, and needle for reconstitution (batch number: unknown), at an unknown dose, route, or site of administration,  which was late for the 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 male patient of unknown age was late for the administration of the third dose of RabAvert, after the patient was vaccinated with the first and the second dose of RabAvert along with device constituents prefilled syringe, needle for injection, and needle for reconstitution for post-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. 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 is 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 late for the administration of the third dose of RabAvert, after the patient was vaccinated with the first and the second dose of RabAvert along with device constituents prefilled syringe, needle for injection, and needle for reconstitution for post-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: The patient received RabAvert vaccine in the finger where the bite was, instead intramuscularly in the deltoid; Case reference number US-BN-2024-002818 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3135) on 26-Nov-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient had rabies exposure, reported as a finger bite.  On unspecified date, unknown amount of time after rabies exposure, the patient was vaccinated with the RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route, for indication post exposure vaccination. As reported, the patient received RabAvert vaccine in the finger (wound) where the animal was bitten, instead intramuscularly in the deltoid (explicitly coded as 'vaccine administered at inappropriate site').   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 unknown age received RabAvert vaccine in the finger (bite wound), instead intramuscularly in the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site 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 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 unknown age received RabAvert vaccine in the finger (bite wound), instead intramuscularly in the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site 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 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: Inappropriate schedule of product administration, Insurance issue
Clinical narrative: The patient received only one dose of RabAvert vaccine, the second dose was delayed due to lack of insurance coverage; Case reference number US-BN-2024-002827 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3171) on 02-Dec-2024 and concerns a 78-year-old female patient.   The patient's current medical condition included diabetes mellitus, thyroid issues, hypertension and hyperlipidemia.  The patient's concomitant medication details were not provided.  On unspecified date, patient experienced dog exposure.  On 27-Nov-2024, the patient received the first dose of RabAvert vaccine (batch number: unknown), at unknown dose, intramuscularly, at unknown site of administration, for post exposure. The patient only had one dose of RabAvert, the second one was delayed due to lack of insurance coverage (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 was provided.; Reporter's Comments: A 78-year-old female patient received the first dose of RabAvert vaccine, at unknown dose, intramuscularly, at unknown site of administration, for post exposure. The patient only had one dose of RabAvert, since the second one was delayed due to lack of insurance coverage 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 current medical condition included diabetes mellitus, thyroid issues, hypertension and hyperlipidemia while concomitant medication details were not provided. Inappropriate schedule of product administration is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 78-year-old female patient received the first dose of RabAvert vaccine, at unknown dose, intramuscularly, at unknown site of administration, for post exposure. The patient only had one dose of RabAvert, since the second one was delayed due to lack of insurance coverage 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 current medical condition included diabetes mellitus, thyroid issues, hypertension and hyperlipidemia while concomitant medication details were not provided. Inappropriate schedule of product administration 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 first dose of RabAvert on 14-Oct-2024, second dose on 21-Oct-2024, and patient is about 30 days late for the third dose.; Case reference number US-BN-2024-002876 is a spontaneous case initially received from a pharmacist via Med Communications (reference USBAV24-3259) on 10-Dec-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 14-Oct-2024, the patient was vaccinated with the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route or site of administration for pre-exposure prophylaxis.  On 21-Oct-2024, seven days after the first dose, the patient was vaccinated with the second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown) at an unknown dose, route or site of administration.   As reported, the patient is about 30 days late for the third dose (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.   No further information was provided.; Reporter's Comments: A female patient of unknown age is about 30 days late for the third dose of RabAvert for pre-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is 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 unknown age is about 30 days late for the third dose of RabAvert for pre-exposure prophylaxis, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient missed second dose of Rabavert vaccine; Case reference number US-BN-2024-002919 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3348) on 19-Dec-2024 and concerns a 31-years-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 15-Dec-2024, the patient took first dose of RabAvert along with device constituents prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose and site of administration, intramuscularly, for post exposure prophylaxis. As reported the patient missed second dose of RabAvert which was due on 18-Dec-2024. (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 31-years-old male patient missed second dose of RabAvert which was due on 18-Dec-2024 and that 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 31-years-old male patient missed second dose of RabAvert which was due on 18-Dec-2024 and that 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: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received first dose of RabAvert vaccine, it was due on day seven for the second dose but did not receive it; Case reference number US-BN-2025-000015 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-0032) on 06-Jan-2025 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On 30-Dec-2024, the patient received first dose of RabAvert vaccine (batch number: unknown) along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution intramuscularly, at unknown dose, site of administration for indication pre-exposure for travel.  As reported the patient did not receive the second dose of RabAvert vaccine on day seven (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert.  No further information was provided.; Reporter's Comments: A male patient of unspecified age received the first dose of RabAvert vaccine for indication pre-exposure for travel.  As reported the patient did not receive the second dose of RabAvert vaccine on the day seven, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due RabAvert. 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 is 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 unspecified age received the first dose of RabAvert vaccine for indication pre-exposure for travel.  As reported the patient did not receive the second dose of RabAvert vaccine on the day seven, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due RabAvert. 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 is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB, UNK
Symptoms: Unevaluable event
Clinical narrative: The patient received Antirabies vaccine and dose of RabAvert vaccine; Case reference number US-BN-2025-000018 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-0038) on 06-Jan-2025 and concerns a male patient with unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unknown date, the patient had unspecified rabies exposure.  On 29-Dec-2024, unknown of time after exposure to rabies, the patient received first dose of Rabies Vaccine Inactivated (rabies vaccine inact (human diploid) reported as Antirabies vaccine (batch number: unknown), at unknown dose, route or site of administration for indication post-exposure prophylaxis.   On 06-Jan-2024, unknown of time after exposure to rabies, the patient received second dose of RabAvert vaccine along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at unknown dose, route or site of administration for post-exposure prophylaxis (explicitly coded as 'Interchange of vaccine products').   At the time of initial report, it was unknown if the patient experienced any adverse events due RabAvert.  No further information was provided.; Reporter's Comments: A male patient with unspecified age received the first dose of Rabies vaccine inactivated for indication post-exposure prophylaxis. An unknown of time after exposure to rabies, the patient received the second dose of RabAvert vaccine for post-exposure prophylaxis, which is considered as interchange of vaccine products. It was unknown if the patient experienced any adverse events due RabAvert. Interchange of vaccine products is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient with unspecified age received the first dose of Rabies vaccine inactivated for indication post-exposure prophylaxis. An unknown of time after exposure to rabies, the patient received the second dose of RabAvert vaccine for post-exposure prophylaxis, which is considered as interchange of vaccine products. It was unknown if the patient experienced any adverse events due RabAvert. Interchange of vaccine products is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Interchange of vaccine products is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient received first dose of RabAvert and then got sidetracked and did not come on time for second dose for 13 days; Case reference number US-BN-2024-001914 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-1030) on 14-May-2024 and concerns a male patient of unspecified age.  The patient's relevant medical history and concomitant medications were not provided.  On unspecified date, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at unknown dose, route, or site of administration for pre-exposure.  It was reported that the patient was sidetracked, and the patient did not come on time for second dose of RabAvert. As reported, the patient was 13 days out of the first dose of RabAvert (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 of unspecified age did not come on time for the second dose of RabAvert, after the patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported, the patient was 13 days out of the first dose of RabAvert, 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 of unspecified age did not come on time for the second dose of RabAvert, after the patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported, the patient was 13 days out of the first dose of RabAvert, 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: Incomplete course of vaccination
Clinical narrative: Patient received only one dose of Rabavert, did not complete the rest of the series; Case reference number US-BN-2024-001946 is a spontaneous case report initially received from a nurse via Med Communication (reference number: USBAV24-1144) on 24-May-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient had dog bite.  On 17-May-2024, unknown amount of time after the dog bite, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) intramuscularly, at an unknown dose, at unknown site of administration for rabies post exposure prophylaxis in unvaccinated individual. As reported, the patient received only one dose of RabAvert, did not complete the rest of the series (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 male patient of unknown age was vaccinated with the first dose of RabAvert, intramuscularly, at an unknown dose, at unknown site of administration for rabies post exposure prophylaxis in unvaccinated individual.Reportedly, the patient received only one dose of RabAvert and did not complete the rest of the series 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 male patient of unknown age was vaccinated with the first dose of RabAvert, intramuscularly, at an unknown dose, at unknown site of administration for rabies post exposure prophylaxis in unvaccinated individual.Reportedly, the patient received only one dose of RabAvert and did not complete the rest of the series 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: Nausea
Clinical narrative: Nauseous; Case reference number US-BN-2024-001964 is a spontaneous case initially received from a consumer via Med Communications (reference number USBAV24-1183) on 29-May-2024 and concerns a female patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient was bitten by cat.  On an unspecified date, reported as on Sunday, for an unknown amount of time after cat bite, the patient was vaccinated with a dose of RabAvert (batch number: unknown), at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins (brand name: unknown, batch number: unknown), at an unknown dose, around the bite, for cat bite. The patient was treated with antibiotics (brand name: unknown, batch number: unknown), at an unknown dose, route or site administration, for an unknown indication.  On an unspecified date, the patient felt nauseous and as reported took some medication for nausea.   At the time of initial report, it was unknown if the patient recovered from the event of nausea.  The reporter assessed the event of nausea as non-serious and possibly related to RabAvert product or, as reported antibiotics.  No further information was provided.; Reporter's Comments: A female patient of unspecified age felt nauseous and as reported took some medication for nausea was vaccinated with a dose of RabAvert, at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins, at an unknown dose, around the bite, for cat bite. The patient was also treated with antibiotics. Nausea is listed and expected for RabAvert. At this point it was unknown if the patient recovered from the event of nausea. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. Causal relationship is however confounded with co-suspect product and antibiotic treatment. The case is non-serious.; Sender's Comments: A female patient of unspecified age felt nauseous and as reported took some medication for nausea was vaccinated with a dose of RabAvert, at unknown dose or site administration, intramuscularly, for cat bite, and co-suspect immunoglobulins, at an unknown dose, around the bite, for cat bite. The patient was also treated with antibiotics. Nausea is listed and expected for RabAvert. At this point it was unknown if the patient recovered from the event of nausea. The patient's medical history and concomitant medication details were not provided. Causality is assessed as related due to known product safety profile and since contributory role of suspect product cannot be excluded. Causal relationship is however confounded with co-suspect product and antibiotic treatment. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received first dose of RabAvert on 23-May-2024, for rabies pre-exposure prophylaxis, and did not receive the second dose a week later; Case reference number US-BN-2024-001972 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1211) on 31-May-2024 and concerns female patient of unspecified age.  The patient's relevant medical history and concomitant medication details were not provided.  On 23-May-2024, reported as last Thursday, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, or site of administration for rabies pre-exposure prophylaxis.   On an unspecified date, as reported yesterday, a week later, the patient did not receive the second dose of RabAvert (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 did not receive the second dose of RabAvert (week later than the first dose of RabAvert was administered intramuscularly, at an unknown dose, or site of administration for rabies pre-exposure prophylaxis) 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 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 did not receive the second dose of RabAvert (week later than the first dose of RabAvert was administered intramuscularly, at an unknown dose, or site of administration for rabies pre-exposure prophylaxis) 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 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.