chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: HCP stated female patient started her series at age 45 and has not received their 3rd dose within the guidelines of PI.; No additional AE reported; This spontaneous report was received from a Pharmacist and refers to a 45-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On an unknown date in November 2024, the patient was vaccinated with the first dose of with Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date in December 2024, the patient was vaccinated with the second dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL®9) for prophylaxis (dose, route of administration, anatomical location, lot number and expiration date were not reported).  The reporter stated that the patient did not receive the third dose. No additional adverse events were reported. Additional information is not expected.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: female patient last received 2 doses of GARDASIL-9 in 2021 but did not complete the series; No additional AE; This spontaneous report was received from a nurse referring to a 27-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.  On an unknown date in 2021, she received the first and second dose of Human Papillomavirus 9-valent vaccine, recombinant suspension for injection for prophylaxis (dose, route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported), the reporter did not know why patient did not receive the 3rd dose (Inappropriate schedule of product administration). There was not adverse event reported (No adverse event).
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received first dose of Rabavert for pre-exposure and did not receive the second dose on day seven; Case reference number US-BN-2024-002069 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-1402) on 18-Jun-2024 and concerns a female patient.  The patient's medical history and concomitant medication were not provided.  On 20-May-2024, the patient was vaccinated with the first dose of Rabavert (batch number: unknown) at an unknown dose, via unknown route and site of administration for pre-exposure vaccination. As reported, patient did not get the second dose on day seven (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 Rabavert.  No further information was provided.; Reporter's Comments: A female patient was vaccinated with the first dose of Rabavert for pre-exposure vaccination. As reported, patient did not get the second dose on day seven, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event 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 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 was vaccinated with the first dose of Rabavert for pre-exposure vaccination. As reported, patient did not get the second dose on day seven, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event 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 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: Patient received day zero dose of RabAvert and was supposed to receive the day seven dose but cant get it; Case reference number US-BN-2024-002110 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-1497) on 26-Jun-2024 and concerns an adult female patient.  The patient's medical history and concomitant medication were not provided.  On an unspecified date, reported as day zero, 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. As reported patient received day zero dose and was supposed to receive the day seven dose but could not get it (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.  Additional information received from Med Communications on 02-Jul-2024 included missing description from the initial source form.; Reporter's Comments: An adult female patient was vaccinated with the first dose of RabAvert for pre-exposure. As reported the patient received day zero dose and was supposed to receive the day seven dose but could not get it, 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 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 vaccinated with the first dose of RabAvert for pre-exposure. As reported the patient received day zero dose and was supposed to receive the day seven dose but could not get it, 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Vaccine: RAB
Symptoms: Product preparation issue
Clinical narrative: The patient received only diluent of RabAvert; The patient received only diluent of RabAvert; Case reference number US-BN-2024-002121 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1545) on 01-Jul-2024 and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with only a diluent of RabAvert (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication (explicitly coded as 'product administration error' and 'active ingredient not added to diluent'). As reported, the reporter wanted to know how long the powder goof would for at room temperature.  At the time of the initial report, it was unknown if the patient experienced an adverse event due to RabAvert.  No further information was provided.; Reporter's Comments: A patient of unspecified age and gender was vaccinated with only a diluent of RabAvert, at an unknown dose, route, and site of administration, for unknown indication which is considered as product administration error and 'active ingredient not added to diluent. Product administration error and product preparation error are both considered listed per company conventions. At this point, it was unknown if the patient experienced an adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Product administration error and product preparation error are both 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 was vaccinated with only a diluent of RabAvert, at an unknown dose, route, and site of administration, for unknown indication which is considered as product administration error and 'active ingredient not added to diluent. Product administration error and product preparation error are both considered listed per company conventions. At this point, it was unknown if the patient experienced an adverse event due to RabAvert. The patient's medical history and concomitant medication details were not provided. Product administration error and product preparation error are both assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-1545:
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: Patient received last dose of Rabavert, but it was administered in the buttock, instead of the deltoid; Case reference number US-BN-2024-002123 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-1549) on 02-Jul-2024 and concerns a patient of unknown age and gender.   The patient's medical history and concomitant medication were not provided.  On an unspecified date, the patient was vaccinated with, as reported, last dose of Rabavert (batch number: unknown) at an unknown dose, route and site of administration for unknown indication. As reported, a dose of Rabavert was administered in the buttock, instead of 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.  No further information was provided.; Reporter's Comments: A patient of unknown age and gender with a dose of Rabavert was administered in the buttock, instead of the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Rabavert. The patient's medical history and concomitant medication 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 unknown age and gender with a dose of Rabavert was administered in the buttock, instead of the deltoid which is considered as vaccine administered at inappropriate site. Product administered at inappropriate site is considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Rabavert. The patient's medical history and concomitant medication 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 the first dose of RabAvert on 05-Jul-2024, for pre-exposure, and missed the second dose; Case reference number US-BN-2024-002192 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1663) on 15-Jul-2024 and concerns a 25-years-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 05-Jul-2024, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), intramuscularly, at an unknown dose, or route of administration, for pre-exposure prophylaxis. As reported the patient missed 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 25-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure prophylaxis. As reported the patient missed the second 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. 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 25-year-old female patient was vaccinated with the first dose of RabAvert for pre-exposure prophylaxis. As reported the patient missed the second 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. 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: Incomplete course of vaccination
Clinical narrative: The patient received two doses of RabAvert in May-2024, for pre-exposure prophylaxis, and did not receive the third dose; Case reference number US-BN-2024-002193 is a spontaneous case initially received from pharmacist via Med Communications (reference number USBAV24-1664) on 15-Jul-2024 and concerns a 28-years-old female patient.  The patient's medical history and concomitant medication details were not provided.  On 23-May-2024, 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 prophylaxis against rabies.  On 30-May-2024, seven days after the first dose of RabAvert, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, route, or site of administration.   As reported, the vaccination with the first and the second dose of RabAvert was almost eight weeks ago and the patient never got the third dose (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 28-years-old female patient never got the third dose of RabAvert which is considered as incomplete course of vaccination. Incomplete course of vaccination 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 28-years-old female patient never got the third dose of RabAvert which is considered as incomplete course of vaccination. Incomplete course of vaccination 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, No adverse event
Clinical narrative: The second dose of RabAvert delayed one day; Case reference number US-BN-2024-002276 is a spontaneous case initially received from a nurse via Med Communication (reference number USBAV24-1827) on 31-Jul-2024 and concerns a *43-year-old female patient*.  The patient's medical history and concomitant medication were not reported.  *On 24-Jul-2024, reported as week ago, the patient received the first dose of RabAvert (batch number: FDP00447, expiry date: 30-Apr-2027), at a dose of 1.00, intramuscularly*, at an unknown site of administration, for pre-exposure vaccination.  *On 01-Aug-2024, reported as delayed one day, eight days after the first dose, the patient received the second dose of RabAvert (batch number: FDP00555, expiry date: 30-Sep-2027), at a dose of 1.00, intramuscularly, * at an unknown site of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). *As reported, the second dose was delayed one day to match with the patient's son schedule* (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of this follow up report, the patient did not experience fever, and the patient *did not experience any other adverse event due to RabAvert*.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow up report received from a nurse on 14-Aug-2024 included: confirmation that the patient did not experience fever, and that the second dose was delayed for one day.  The case is linked to case ID US-BN-2024-002277 due to the same report and family member.  Follow up information received from a nurse on 12-Sep-2024: New information included patient's details, Rabavert dosing information, and confirmation that patient did not experience any adverse event due to RabAvert vaccine.; Reporter's Comments: A 43-year-old female patient received the second dose of RabAvert for pre-exposure vaccination, as reported with one day delay, which is considered as inappropriate schedule of vaccine administered. The patient did not experience 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 reported. 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 43-year-old female patient received the second dose of RabAvert for pre-exposure vaccination, as reported with one day delay, which is considered as inappropriate schedule of vaccine administered. The patient did not experience 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 reported. 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: Product administered to patient of inappropriate age
Clinical narrative: Patient received second dose of preexposure prophylaxis with Rabavert on day 10, instead of day seven; Case reference number US-BN-2024-002289 is a spontaneous case initially received from a health care professional via Med Communications (reference number: USBAV24-1849) on 01-Aug-2024 and concerns a 40-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 22-Jul-2024, the patient was vaccinated with the first dose of RabAvert (batch number: FDP0055), at an unknown dose, via intramuscular use in unknown site of administration, for pre-exposure prophylaxis.  On 01-Aug-2024, ten days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: FDP0055), at an unknown dose, via intramuscular use in unknown site of administration (explicitly coded as 'inappropriate schedule of drug 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 40-year-old male patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis, as reported ten days after the first dose, which is considered as inappropriate schedule of drug 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 40-year-old male patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis, as reported ten days after the first dose, which is considered as inappropriate schedule of drug 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: Product preparation issue
Clinical narrative: The patient only received the diluent and not the vial that contained the actual vaccine; The patient only received the diluent and not the vial that contained the actual vaccine; Case reference number US-BN-2024-002293 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-1865) on 02-Aug-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, the patient had contact with an animal.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose and site, intramuscularly, for post-exposure rabies prophylaxis. On the same date, the patient received a dose of immunoglobulin human anti-rabies (HRI), at an unknown dose, route, or site of administration.  On 02-Aug-2024, an unknown amount of time after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose or site, administered intramuscularly. As reported, the patient only received the diluent and not the vial that contained the actual vaccine (explicitly coded as 'active ingredient not added to diluent' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the RabAvert vaccine.  No further information was provided.; Reporter's Comments: A male patient of unspecified age was vaccinated with the second dose of RabAvert, at an unknown dose or site, administered intramuscularly. Reportedly, the patient only received the diluent and not the vial that contained the actual vaccine which is considered as active ingredient not added to diluent and product administration error. Product preparation error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the 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 male patient of unspecified age was vaccinated with the second dose of RabAvert, at an unknown dose or site, administered intramuscularly. Reportedly, the patient only received the diluent and not the vial that contained the actual vaccine which is considered as active ingredient not added to diluent and product administration error. Product preparation error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to the 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.
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: The patient received RabAvert vaccine which expired in Apr-2024; Case reference number US-BN-2024-002315 is a spontaneous case initially received from physician via Med Communications (reference number: USBAV24-1894) on 07-Aug-2024 and concerns patient of unspecified gender or age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, as reported the patient had been exposed to a bat but was not bitten.  On 06-Aug-2024, unknown amount of time after contact with bat, the patient received the first dose of RabAvert (batch number: unknown; expiration date: Apr-2024), at unknown dose, route or site of administration (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: A patient of unknown demographics was vaccinated with a dose of RabAvert, which had expired approximately 4 months earlier. Indication was exposure to a bat, but without a bite. This is considered expired vaccine used, which is listed per company convention. No associated adverse events were reported. The patient's medical history and concomitant medication details were not provided. The use of expired vaccine is not related to RabAvert, but to a human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with a dose of RabAvert, which had expired approximately 4 months earlier. Indication was exposure to a bat, but without a bite. This is considered expired vaccine used, which is listed per company convention. No associated adverse events were reported. The patient's medical history and concomitant medication details were not provided. The use of expired vaccine is not related to RabAvert, but to a human error. The case is non-serious. USBAV24-1894:
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received the first dose of RabAvert on day 0 and second dose on day 4; Case reference number US-BN-2024-002346 is a spontaneous case initially received from a pharmacist via Med Communications (reference number USBAV24-1967) on 14-Aug-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 day zero, the patient received the first dose of RabAvert vaccine (batch number: unknown), at an unknown dose, route or site of administration, for pre-exposure.  On an unspecified date, reported as day four, the patient received the second dose of RabAvert vaccine (batch number: unknown), at an unknown dose, route or site of administration (explicitly coded ' inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A male patient of unspecified age received the second dose of RabAvert vaccine for pre-exposure, reported as on the day 4, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events 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 second dose of RabAvert vaccine for pre-exposure, reported as on the day 4, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events 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. USBAV24-1967:
Sex: F
Vaccine: RAB
Symptoms: Incorrect route of product administration
Clinical narrative: The patient received a dose of RabAvert vaccine subcutaneously instead of intramuscularly by mistake; Case reference number US-BN-2024-002350 is a spontaneous case initially received from a other health professional via Med Communications (reference number USBAV24-1978) on 15-Aug-2024 and concerns a female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, reported as last week, the patient was vaccinated with the first dose of RabAvert (batch number: FDP00533), at an unknown dose, intramuscularly for pre-exposure prophylaxis.  On an unspecified date, unknown amount of time after first dose of RabAvert, reported as today, the patient was vaccinated with the second dose of RabAvert (batch number: FDP00533), at an unknown dose, subcutaneously (explicitly coded as 'Inappropriate route of vaccination'). As reported, the second dose of RabAvert was administered subcutaneously instead intramuscularly by mistake.  At the time of the initial report, it was unknown if the patient experienced any adverse events due to RabAvert vaccine.  Additional information received from pharmacist via Med Communication (reference number: USBAV24-1983) on 15-Aug-2024: included additional reporter, confirmation of patient's date of birth, confirmation that second dose of RabAvert was given subcutaneously, and reference number.  Additional information received from Bavarian Nordic on 16-Aug-2024: Information included additional reference number (BN_2024_02939).  Additional information received from pharmacist via Med Communication (reference number: USBAV24-1993) on 16-Aug-2024: included additional reported, confirmation of batch number and additional reference number.; Reporter's Comments: A female patient was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis subcutaneously, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route 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 was vaccinated with the second dose of RabAvert for pre-exposure prophylaxis subcutaneously, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse events due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1978: USBAV24-1983: USBAV24-1993:
Vaccine: RAB
Symptoms: Product preparation issue
Clinical narrative: The patient was administered a dose of Rabavert, but it appears that the freeze-dried component of the vaccine was not properly diluted; The patient was administered a dose of Rabavert, but it appears that the freeze-dried component of the vaccine was not properly diluted; Case reference number US-BN-2024-002377 is a spontaneous case initially received from health care professional via Med Communication (reference number: USBAV24-2035) on 19-Aug-2024 and concerns a 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 a dose of RabAavert (batch number: unknown), at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. As reported, the freeze-dried component of the vaccine was not properly diluted (explicitly coded as 'product concentrate not diluted' and 'product administration error').  At the time of initial report, it was unknown if the patient experienced any adverse event due to RabAvert.  Additional information received from health care professional via Med Communication (reference number: USBAV24-2061) on 21-Aug-2024: included reference number (USBAV24-2061).; Reporter's Comments: A patient of unknown age and gender was vaccinated with a dose of RabAavert, at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. Reportedly, the freeze-dried component of the vaccine was not properly diluted which is considered as product concentrate not diluted and product administration error. Product preparation error and product administration error are both considered listed per company conventions. 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 for both reported events. The case is non-serious.; Sender's Comments: A patient of unknown age and gender was vaccinated with a dose of RabAavert, at an unknown dose, via intramuscular use at unknown site of administration for pre-exposure prophylaxis. Reportedly, the freeze-dried component of the vaccine was not properly diluted which is considered as product concentrate not diluted and product administration error. Product preparation error and product administration error are both considered listed per company conventions. 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 for both reported events. The case is non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received two doses of RabAvert for pre-exposure on 13-Aug-2024 and 23-Aug-2024; Case reference number US-BN-2024-002390 is a spontaneous case initially received from a nurse via Med Communication (reference number: USBAV24-2096) on 23-Aug-2024 and concerns a female patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  On 13-Aug-2024, the patient was vaccinated with the first dose of RabAvert (batch number: FDP00543), at an unknown dose, administered intramuscularly in unknown site of administration, for pre-exposure.  On 23-Aug-2024, 10 days after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: FDP00543), at an unknown dose, administered intramuscularly in unknown 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.  No further information was provided.; Reporter's Comments: A female patient of unknown age was vaccinated with the second dose of RabAvert for pre-exposure, 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. 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 female patient of unknown age was vaccinated with the second dose of RabAvert for pre-exposure, 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. 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.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Electrocardiogram ambulatory abnormal, Injection site pain, Malaise, Ventricular extrasystoles
Clinical narrative: Sore injection site, feeling sick within 24 hrs and lasting 24 hrs
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Neck pain, Swelling
Clinical narrative: She has shingles, started with sore and swollen neck
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: On the patient's left arm, deltoid area, shows redness, warm and tenderness.  Measuring 3 inch in a circular diameter. Vaccine was given on 06/24/25 and patient was brought in by caregiver, Stepparent.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered a 4th dose of HPV Gardasil 9 to left deltoid. No adverse reactions were noted. Administration error was found before patient left the clinic and she was education on error. Instructed to contact clinic if any reactions occurred. No reports from patient. She actually returned to clinic on 6/10/2025for a visit and denied any problems or concerns related to the vaccine that was administered on 5/9/2025
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 19 year old was accidently given pediatric dose
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Resident was given vaccine that expired on 6/14/25.  Resident monitored for any ill effects from vaccine and none were noted.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was given DTap instead of  TDap.  No adverse effects noted.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Resident was given vaccine covid spikevax moderna that expired on 6/14/2025. Resident displayed no complications related to vaccine.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No reaction occurred after the MCV was administered to the patient.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6/27/2025 DTap was given to a 10 year old patient.  The DTap vaccine should not be administered to children over the age of 7.  This should have been a Td vaccine.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was administered a fourth dose of HPV Gardasil 9 to right deltoid. No adverse reaction noted. Administration error was discovered after patient left clinic. Patient was notified per phone call of error. Pt denies any adverse reactions. Counseled patient to notify clinic if she experiences any adverse side effects. She stated understanding.
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Injection site erythema
Clinical narrative: Patient developed softball size are of warmth and redness, pain at the injection site, headache, dizziness, chills and sweats
Age: 52.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site pain, Injection site warmth
Clinical narrative: Patient developed softball size are of warmth and redness, pain at the injection site, headache, dizziness, chills and sweats
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Diplopia, Dizziness, Feeling hot, Hypotonia, Impaired driving ability
Clinical narrative: Immunization was given in exam room. Then patient was escorted to lab for blood draw. He was sitting at lab station when he became limp an unresponsive. LPN notified provider immediately, his legs were elevated, he was snoring and non responsive, Carotid pulse was strong. After about one min he became rigid and almost slipped out of his chair and then became responsive. He recognized that he passed out and felt hot, double vision and woozy. He was given water and juice and an ice pack. He still did not quite feel up for driving but was able to walk to an exam room to lay down for a few min. Repeat vitals were normal/consistent with arrival vitals. After about 45 min he felt better be still somewhat dizzy. He was able to walk to his wife's car and she drove home.
Age: 35.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle rigidity, Snoring, Unresponsive to stimuli
Clinical narrative: Immunization was given in exam room. Then patient was escorted to lab for blood draw. He was sitting at lab station when he became limp an unresponsive. LPN notified provider immediately, his legs were elevated, he was snoring and non responsive, Carotid pulse was strong. After about one min he became rigid and almost slipped out of his chair and then became responsive. He recognized that he passed out and felt hot, double vision and woozy. He was given water and juice and an ice pack. He still did not quite feel up for driving but was able to walk to an exam room to lay down for a few min. Repeat vitals were normal/consistent with arrival vitals. After about 45 min he felt better be still somewhat dizzy. He was able to walk to his wife's car and she drove home.
Age: 55.0
Sex: F
Vaccine: PNC21
Symptoms: Cellulitis, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Cellulitis. My right arm swelled and reddened almost immediately, and became extremely hot and painful. The swelling, redness, and heat has continued to spread for 5 days, with constant pain. I received a diagnosis of cellulitis and was prescribed Keflex on June 26, 2025. Here is the provider's note: Skin: General Skin rash, erythema, and abnormally warm. Rash: site of rash: (r arm). Assessment / Plan 1. Acute cellulitis presentation favoring cellulitis vs delayed cutaneous adverse reaction from capvaxie shot. Site is blanchable but spreading per pt. Will treat with Keflex and triamcinolone cream. Will let me know how she's feeling tomorrow. will continue to use ice, tylenol. advil. L03.90: Cellulitis, unspecified cephalexin 500 mg capsule - Take 1 capsule(s) every 12 hours by oral route for 5 days. Qty: (10) capsule.  2. Adverse effect of vaccine, initial encounter capvaxie vaccine T50.Z95A: Adverse effect of other vaccines and biological substances, initial encounter 3. Adverse effect of pneumococcal vaccine, initial encounter Capvaxie vaccine T50.A95A: Adverse effect of other bacterial vaccines, initial encounter Patient Instructions I've added on a steroid cream that may help clear the area sooner.
Age: 1.92
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no symptoms and no reactions, just a uncessary does of DTAP given off schedule.
Age: 19.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Dizziness, Muscle contractions involuntary, Musculoskeletal stiffness, Pallor, Urinary incontinence
Clinical narrative: She got her vaccines this morning, she was sitting for a couple of mins and when she was checking out at the front desk she got light headed and then sat down, her body locked up she got really stiff, her arms curled up and it looked like she was having a seizure and she lost control of Blatter and looked really pale. We did call EMS because of the possible seizure they came and check her out and she decline to go the to ER.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Hives on arms, neck, face, and legs immediately after vaccines were given
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC20
Symptoms: Decreased appetite, Erythema, Injection site erythema, Injection site macule, Injection site swelling
Clinical narrative: MOP reported pt had a slight fever for a few days following the injections.  Pt also had a wet cough that turned dry over the past week. He was given tylenol prn for the fevers (highest was 102, tracking around 100 degrees F). This morning around 0700 (27 June), pt presented with mild, eurythmic raised macules on his inner right thigh. By 1045, it had spread to cover most of his thighs, parts of his inner arms, and a couple of spots on the top of his feet. Pt did not react when touched and MOP reported he has not been scratching the areas. MOP states pt has been lethargic this past week and has decreased appetite. Provider administered Benadryl during appt  (apx 1055). by 1115, the rash had started to subside.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC20
Symptoms: Lethargy, Productive cough, Pruritus, Pyrexia
Clinical narrative: MOP reported pt had a slight fever for a few days following the injections.  Pt also had a wet cough that turned dry over the past week. He was given tylenol prn for the fevers (highest was 102, tracking around 100 degrees F). This morning around 0700 (27 June), pt presented with mild, eurythmic raised macules on his inner right thigh. By 1045, it had spread to cover most of his thighs, parts of his inner arms, and a couple of spots on the top of his feet. Pt did not react when touched and MOP reported he has not been scratching the areas. MOP states pt has been lethargic this past week and has decreased appetite. Provider administered Benadryl during appt  (apx 1055). by 1115, the rash had started to subside.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Uveitis
Clinical narrative: uveitis
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no adverse reaction noted.
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Fatigue, Pyrexia, Somnolence, Vomiting
Clinical narrative: Child was sleepy on the hour drive home after vaccinations were administered. She napped most of the drive home and was more tired than usual that afternoon. She took her afternoon nap and vomited 1-2 Tbsp of partially digested breast milk (no blood or discoloration) shortly after waking up around 3pm. She had a fever of 100.5F at 6:30pm on 29Jan2015. She vomited in her sleep some time between 10pm 29Jan2025 and 6am 30Jan2025. No treatment was administered for vomiting. No additional bouts of vomiting occurred after this instance. Body temperature reduced to 99.7F by 7:15pm on 30Jan2015. Elevated body temperature resolved by 8pm 31Jan2025 without intervention.
Age: 74.0
Sex: F
Vaccine: HEPAB
Symptoms: Joint range of motion decreased, Musculoskeletal stiffness
Clinical narrative: patient complains of stiffness and decreased ROM in arm. pt has been taking OTC pain medication, which has been helping. pt states they side effect is going away and improving.