chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring  to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved.  This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # US-009507513-1710USA009209 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # US-009507513-1710USA009209 is being deleted from our files and the case is consolidated into case # 1711USA003866 with the correct Aware Date 18-SEP-2017.; Sender's Comments: US-009507513-1708USA011654:
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 16 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009219 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009219 is being deleted from our files and the case is consolidated into case # 1711USA003961 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 17 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009220 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009220 is being deleted from our files and the case is consolidated into case # 1711USA003966 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 16 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009221 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009221 is being deleted from our files and the case is consolidated into case # 1711USA004009 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 12.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009222 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009222 is being deleted from our files and the case is consolidated into case # 1711USA004023 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 11.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-Jun-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009223 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009223 is being deleted from our files and the case is consolidated into case # 1711USA004039 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 11 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009224 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009224 is being deleted from our files and the case is consolidated into case # 1711USA004048 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 13 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009225 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009225 is being deleted from our files and the case is consolidated into case # 1711USA004060 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009226 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009226 is being deleted from our files and the case is consolidated into case # 1711USA004065 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 24 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-MAY-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # M036059 and expiration date 03-JUN-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # M036059. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009227 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009227 is being deleted from our files and the case is consolidated into case # 1711USA004074 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The day after the patient received the immunization, the patient had a red, hot rash at injection site. The rash continued to spread down the arm towards the elbow, and by 10/5/17 the rash was almost gone. The patient treated the rash with cold compresses.
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: The day after the patient received the immunization, the patient had a red, hot rash at injection site. The rash continued to spread down the arm towards the elbow, and by 10/5/17 the rash was almost gone. The patient treated the rash with cold compresses.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13, FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient presented to the pharmacy with a red, swollen arm. Her arm was hot to touch and patient complained of it itching.
Age: 73.0
Sex: F
Vaccine: PNC13, PNC13, FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Patient presented to the pharmacy with a red, swollen arm. Her arm was hot to touch and patient complained of it itching.
Age: 53.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Urticaria
Clinical narrative: Hives. 3 Days after administration a very serious itch developed by a hive. Just one at a time but it would occur for 4 days. Treated each occurrence with hydrocortisone cream. Also experienced dark urine during this time period.
Age: 53.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Chromaturia, Pruritus, Urticaria
Clinical narrative: Hives. 3 Days after administration a very serious itch developed by a hive. Just one at a time but it would occur for 4 days. Treated each occurrence with hydrocortisone cream. Also experienced dark urine during this time period.
Age: 17.0
Sex: F
Vaccine: HPV9, FLU4, HPV9
Symptoms: Syncope, Tonic posturing
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17 years old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. The patient did not take any concomitant medications. On 02-NOV-2017, the patient was vaccinated with her first dose of GARDASIL 9 injection as routine vaccination, lot # N018273, expiration date 17-JUN-2019 (dose, route of administration and anatomical location were not reported) for prophylaxis. 30 seconds after vaccination, the patient experienced a syncopal episode with tonic clonic activity. The event lasted 60 seconds and during it the patient's vital signs (unspecified) were checked and observed for an unspecified period of time. The pateitn did not received any treatment for the adverse event. The patient recovered from the events (on 02-NOV-2017). The causality between the events and GARDASIL 9 was not reported. Upon internal review, the event of tonic clonic activity was considered to be medically significant.
Age: 17.0
Sex: F
Vaccine: HPV9, FLU4, HPV9
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 17 years old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. The patient did not take any concomitant medications. On 02-NOV-2017, the patient was vaccinated with her first dose of GARDASIL 9 injection as routine vaccination, lot # N018273, expiration date 17-JUN-2019 (dose, route of administration and anatomical location were not reported) for prophylaxis. 30 seconds after vaccination, the patient experienced a syncopal episode with tonic clonic activity. The event lasted 60 seconds and during it the patient's vital signs (unspecified) were checked and observed for an unspecified period of time. The pateitn did not received any treatment for the adverse event. The patient recovered from the events (on 02-NOV-2017). The causality between the events and GARDASIL 9 was not reported. Upon internal review, the event of tonic clonic activity was considered to be medically significant.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Enema administration, Full blood count, Haematochezia, Intussusception
Clinical narrative: infant developed fussiness, apparent abdominal pain, passed bright red bloody stool, taken to hospital via ambulance. US consistent with intussusception. Baby transferred to higher level of care, s/p air enema. Admitted x 2 days. seen in follow up clinic on 10/27 and patient doing well.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Irritability, Metabolic function test, Ultrasound abdomen abnormal
Clinical narrative: infant developed fussiness, apparent abdominal pain, passed bright red bloody stool, taken to hospital via ambulance. US consistent with intussusception. Baby transferred to higher level of care, s/p air enema. Admitted x 2 days. seen in follow up clinic on 10/27 and patient doing well.
Age: 52.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Redness, swelling, erythema at site. Aches, fever. 2 and 3 days after injection.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: After the injection I had pain in left deltoid, pain is everytime I go to lift my arm up or lift anything.  Pain has gotten worse over the last month and has been constant since the day after injection. Pain almost feels the same as the day after receiving the IM injection.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure to product, Dry skin, Exposure via eye contact, Exposure via skin contact, Eye irrigation
Clinical narrative: This spontaneous report was received from a registered nurse, reporting on herself a 65 year old female patient. The patient's medical history included an splenectomy, lymphoma, No immunoglobulin M (IgM) and shingles. The patient's stated an allergy to penicillin, KEFLEX, tuberculosis test serum, CYMBALTA and intravenous BENADRYL. Ramipril, sotalol, DEXILANT, domperidone, ibuprofen, SKELAXIN, ZOLOFT, ZYRTEC, potassium, magnesium, ZOFRAN, PHENERGAN, SYNTHROID, SINGULAIR, were reported as concomitant medications. On 27-OCT-2017, an unspecified amount of VARIVAX for prevention of chickenpox (lot # M034585, expiration date 27-JUL-2018) and sterile diluent (Lot # and expiration date not provided) "got in" in the patient's right eye and right cheek while she was preparing the dose for an unspecified patient. Then, the patient flushed her right eye with water. Since on an unspecified date in October 2017, the skin underneath patient's right eye was dry and irritated. Besides, she had "2 raised welts" on her right cheek. The patient reported that a treatment was given for the events and, additionally, laboratory diagnostics studies were not performed. The outcome for the events of irritated skin and dry skin was not recovered at the time of reporting, and for urticaria was not reported. The causal relationship between the aforementioned events and VARIVAX and the sterile diluent was not provided. There was no product quality complaint involved.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin irritation, Urticaria
Clinical narrative: This spontaneous report was received from a registered nurse, reporting on herself a 65 year old female patient. The patient's medical history included an splenectomy, lymphoma, No immunoglobulin M (IgM) and shingles. The patient's stated an allergy to penicillin, KEFLEX, tuberculosis test serum, CYMBALTA and intravenous BENADRYL. Ramipril, sotalol, DEXILANT, domperidone, ibuprofen, SKELAXIN, ZOLOFT, ZYRTEC, potassium, magnesium, ZOFRAN, PHENERGAN, SYNTHROID, SINGULAIR, were reported as concomitant medications. On 27-OCT-2017, an unspecified amount of VARIVAX for prevention of chickenpox (lot # M034585, expiration date 27-JUL-2018) and sterile diluent (Lot # and expiration date not provided) "got in" in the patient's right eye and right cheek while she was preparing the dose for an unspecified patient. Then, the patient flushed her right eye with water. Since on an unspecified date in October 2017, the skin underneath patient's right eye was dry and irritated. Besides, she had "2 raised welts" on her right cheek. The patient reported that a treatment was given for the events and, additionally, laboratory diagnostics studies were not performed. The outcome for the events of irritated skin and dry skin was not recovered at the time of reporting, and for urticaria was not reported. The causal relationship between the aforementioned events and VARIVAX and the sterile diluent was not provided. There was no product quality complaint involved.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to 19 month old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored doses of VAQTA which had the lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 19-month-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 2-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Age: 2.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 2-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 09-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 18-month-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 12-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 22-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: Original Case: 1709USA007325: US-009507513-1709USA012768.
Age: 1.33
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 19 month old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 23-MAY-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB. On 25-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Age: 1.25
Sex: U
Vaccine: HIBV, HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 15-month-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 06-JUN-2017, the patient was administered improperly stored PEDVAXHIB (lot reported as: N00236, expiry date: 24-OCT-2019). On 06-SEP-2017, the patient was vaccinated with improperly stored doses of VAQTA which had the lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 10-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a 13-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012768.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has received from a medical assistant referring to 15 years old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions, drug and allergy history. Concomitant therapies included sterile diluent (MRK). On 22-SEP-2017, the patients were vaccinated with improperly stored doses VARIVAX (lot # N017396, expiration date 07-JUN-2019, dose and route was not provided) for prophylaxis. The doses of VARIVAX were exposed to a temperature excursion of 15° Fahrenheit (°F) to 46°F during a time frame of 1 hour and 23 minutes, which was detected by the data logger. There was a previous temperature excursion of 6°F to 14°F for 1 hour and 16 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003604: US-009507513-1711USA003603: US-009507513-1711USA003605: US-009507513-1709USA011228.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 16 years old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions, drug and allergy history. Concomitant therapies included sterile diluent (MRK). On 22-SEP-2017, the patient were vaccinated with improperly stored doses VARIVAX (lot # N017396, expiration date 07-JUN-2019, dose and route was not provided) for prophylaxis. The doses of VARIVAX were exposed to a temperature excursion of 15 Fahrenheit (F) to 46 F during a time frame of 1 hour and 23 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 F to 14 F for 1 hour and 16 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003604: US-009507513-1711USA003605: US-009507513-1711USA003602: US-009507513-1709USA011228.
Age: 17.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 17 years old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions, drug and allergy history. Concomitant therapies included sterile diluent (MRK). On 22-SEP-2017, the patient were vaccinated with improperly stored doses VARIVAX (lot # N017396, expiration date 07-JUN-2019, dose and route was not provided) for prophylaxis. The doses of VARIVAX were exposed to a temperature excursion of 15 Fahrenheit (F) to 46 F during a time frame of 1 hour and 23 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 F to 14 F for 1 hour and 16 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003603: US-009507513-1711USA003602: US-009507513-1711USA003605: US-009507513-1709USA011228.
Age: 15.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 15 years old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions, drug and allergy history. Concomitant therapies included sterile diluent (MRK). On 22-SEP-2017, the patient were vaccinated with improperly stored doses VARIVAX (lot # N017396, expiration date 07-JUN-2019, dose and route was not provided) for prophylaxis. The doses of VARIVAX were exposed to a temperature excursion of 15 Fahrenheit (F) to 46 F during a time frame of 1 hour and 23 minutes, which was detected by the data logger. There was a previous temperature excursion of 6 F to 14 F for 1 hour and 16 minutes. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1711USA003603: US-009507513-1711USA003602: US-009507513-1711USA003604: US-009507513-1709USA011228.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Injection site warmth, Muscle tightness, Myalgia, Rash macular
Clinical narrative: Site was warm to the touch, skin was blotchy, muscle was very tight and very sore even to the touch, upset stomach.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose given to adult patient.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Feeling abnormal, Feeling cold, Nausea, Pain
Clinical narrative: About 6 PM. started to feel bad, achy, chills. Took my temperature about 8:30 PM and it was 102.8.  Couldn't get warm, was in front of a fire, had 3 blankets, still couldn't get warm, shaking and very achy. As of 11/9/17, around 6 AM this morning, temp was down to 101.1. Still achy, but never had a sore throat, no headache, felt nauseous but never vomited. As of now, still have a low grade fever, and very very achy.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: About 6 PM. started to feel bad, achy, chills. Took my temperature about 8:30 PM and it was 102.8.  Couldn't get warm, was in front of a fire, had 3 blankets, still couldn't get warm, shaking and very achy. As of 11/9/17, around 6 AM this morning, temp was down to 101.1. Still achy, but never had a sore throat, no headache, felt nauseous but never vomited. As of now, still have a low grade fever, and very very achy.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Insomnia, Joint range of motion decreased, Musculoskeletal pain, Neck pain
Clinical narrative: Normal pain following injection, within 24 hours noted increased pain, worse with movement, decreased range of motion- described pain as throbbing, made it difficult to sleep, pain mostly in upper inner arm. Pain is worse with raising arm, or moving across midline, or reaching behind. Had pain in neck ongoing, pain in L shoulder blade and with inspiration beginning 11/8/17. Has had headaches on and off since receiving vaccination. Saw physician approx. 3 weeks later, had a steroid injection and was given steroid dose pack which helped- felt about 85% better. Also had muscle relaxers but these were not as helpful, only took a couple. Has Excedrin since vaccination and this has helped with headache and decreased pain. Does not relieve completely but makes it more manageable. Pain in shoulder had resolved, but noted it returning 11/6/17 when putting on shirt and when reaching for items behind. Has resumed taking Excedrin and feels it is still helping. Notes pain gets worse later in the day. Feels better if sleeps on side where vaccination was administered or on back. Wakes up at night with aching pain.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Painful respiration, Sleep disorder
Clinical narrative: Normal pain following injection, within 24 hours noted increased pain, worse with movement, decreased range of motion- described pain as throbbing, made it difficult to sleep, pain mostly in upper inner arm. Pain is worse with raising arm, or moving across midline, or reaching behind. Had pain in neck ongoing, pain in L shoulder blade and with inspiration beginning 11/8/17. Has had headaches on and off since receiving vaccination. Saw physician approx. 3 weeks later, had a steroid injection and was given steroid dose pack which helped- felt about 85% better. Also had muscle relaxers but these were not as helpful, only took a couple. Has Excedrin since vaccination and this has helped with headache and decreased pain. Does not relieve completely but makes it more manageable. Pain in shoulder had resolved, but noted it returning 11/6/17 when putting on shirt and when reaching for items behind. Has resumed taking Excedrin and feels it is still helping. Notes pain gets worse later in the day. Feels better if sleeps on side where vaccination was administered or on back. Wakes up at night with aching pain.
Age: 18.0
Sex: F
Vaccine: HEP, MNQ, VARCEL
Symptoms: Erythema, Injection site pain, Peripheral swelling
Clinical narrative: Student developed redness and swelling to left arm that start 11/8.  Pain present at the site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Pt called our office on 11-9-17 at 8:41 am to notify us she has a reaction to this vaccine the evening she was given the vaccine. Reaction included arm sore, "splotches" on arm. Pt took BENADRYL which was helpful.
Age: 47.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia
Clinical narrative: Numbness of right arm from below shoulder to above elbow. As of this date, 11/9/17, numbness has resolved 90%.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Influenza virus test negative, Myalgia, Pyrexia, Tremor
Clinical narrative: Shaking chills, fever (38.7), muscle aches.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Influenza, Oral herpes, Pain
Clinical narrative: Complained of fluish like symptoms, joint pain, body aches and cold sore on lip.