chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 29-JUN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD at a dose of 0.5 (units not specified), lot # N013865 with expiry date 31-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 15-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 5 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N002336 with expiry date 19-JUL-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006208.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy report has been received from a 35 year old female patient reporting on herself. The patient had no pertinent medical history or drug reactions/allergies. The patient's concurrent conditions and concomitant therapies were not reported. On 01-SEP-2017 the patient was vaccinated with VARIVAX one injection for prophylaxis. The route of administration was reported as injection. Dose, number dose, lot number and expiration date were not provided. Other suspect therapies included the sterile diluent (unknown lot number and expiration date). The patient stated that she found out she was pregnant on 05-SEP-2017 and that she believed she was 4 or 5 weeks pregnant at the time of vaccination. Date of Last Menstrual Period (LMP) was 08-AUG-2017 and the Estimated Date of Delivery (EDD) was 15-MAY-2018. The patient explained that a doctor had not yet verified her pregnancy. The pregnancy outcome was unknown. The patient declined to provide her physician's contact and declined to allow follow-up contact regarding her pregnancy.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M041181 / expiration date 31-MAY-2018, dose and route were not reported) for prophylaxis. The vaccine was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 2 hours and 41 minutes. There was no previous temperature excursion nor data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003854: US-009507513-1709USA003853: US-009507513-1708USA009093.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M042324/expiration date 10-JUN-2018, dose and route were not reported) for prophylaxis. The vaccine was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 2 hours and 41 minutes. There was no previous temperature excursion nor data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA009093: US-009507513-1709USA003852: US-009507513-1709USA003854.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unspecified dates, the patients were vaccinated with improperly stored VAQTA (lot # M033611 / expiration date 02-MAR-2018, lot # N005796 / expiration date 26-MAY-2018, dose and route were not reported) for prophylaxis. The vaccine (lot # N005796) was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 2 hours and 41 minutes. The vaccine (lot # M033611) was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 6 hours and 42 minutes. There was no previous temperature excursion nor data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA003853: US-009507513-1709USA003852: US-009507513-1708USA009093.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a multiple unspecified patients of unknown ages. On an unknown dates, the patients were vaccinated with GARDASIL 9 lot # N001533 for prophylaxis. On an unknown dates the patients experienced incorrect product storage and no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Sender's Comments: US-009507513-1709USA004393: US-009507513-1709USA004394.
Sex: U
Vaccine: HPV9
Symptoms: Therapeutic response unexpected
Clinical narrative: This spontaneous report was received from a medical assistant and refers to some patients of unknown age and gender with skin cancer. The patients' medical history, allergies, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL 9 for prophylaxis (strength, dosage schedule, route, lot number and expiration date were not reported). The reporter stated that a physician reported to them that he read in a unspecified pilot study that some patients who were vaccinate with GARDASIL 9 experienced a decrease in their skin cancer (therapeutic response unexpected). The outcome of therapeutic response unexpected was unknown. The relatedness between the event and GARDASIL 9 was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant medications were not provided. On 05-SEP-2017, the patient was vaccinated with a expired dose of VARIVAX lot # L029466, expiration date on 06-AUG-2017 (dose, frequency and strength were not reported) for prophylaxis. At the reporting time no adverse event was experienced.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. Concomitant therapies included sterile diluent (MRK). On an unknown date, the patient received an improperly stored dose of VARIVAX for prophylaxis, lot # M024683 and expiry date 18-MAY-2018 (anatomical location, dose and route of administration were not reported). No adverse effects reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature between -9° Celsius (C) and 8° C for 2 hours and 31 minutes. The medical assistant reported that there was no previous temperature excursion. The call was not placed because of a Digital Data logger report.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a licensed practical nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. Concomitant therapies included sterile diluent (MRK). On an unknown date, the patient received an improperly stored dose of M-M-R II, lot # reported as N045390 and expiry date 14-NOV-2018 (anatomical location, dose and route of administration were not reported). No adverse effects reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 1 hour and 30 minutes. The licensed practical nurse reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. Lot number N045390 is an invalid lot number for M-M-R II.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a multiple unspecified patients of unknown ages. On an unknown dates the patients were vaccinated with PEDVAXHIB lot # N003536, expiration date: 02-NOV-2019 for prophylaxis. On an unknown dates the patients experienced incorrect product storage and no adverse event. The reporter considered incorrect product storage and no adverse event to be not related to PEDVAXHIB. Sender's Comments: US-009507513-1709USA004394: US-009507513-1709USA004014.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to multiple unspecified patients of unknown ages. On an unknown dates the patients were vaccinated with M-M-R II lot # M039914, expiration date: 26-SEP-2018 for prophylaxis. On an unknown dates, the patient's experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to M-M-R II. Sender's Comments: US-009507513-1709USA004393: US-009507513-1709USA004014.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent. From 07-JUL-2017 to 09-AUG-2017, the patients each was vaccinated with improperly stored doses of PROQUAD (dose and route unknown, lot # N010865 with expiry date 01-OCT-2018, N004631 with expiry date 07-AUG-2018 and M019232 with expiry date 17-OCT-2017) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature ranged of -14 degree Celsius to -10 degree Celsius for 24 hours, -9 degree Celsius to 8 degree Celsius for 24 hours and 9 degree Celsius to 25 degree Celsius for 24 hours. There was no previous temperature excursion. A data digital logger was used. Sender's Comments: US-009507513-1709USA004452: US-009507513-1708USA006160.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to an unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent. From 07-JUL-2017 to 09-AUG-2017, the patients each was vaccinated with improperly stored doses of ZOSTAVAX (dose and route unknown, M037654 with expiry date 29-NOV-2017, N014018 with expiry date 04-JUL-2018 and L024999 with expiry date 03-JAN-2018) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature ranged of -14 degree Celsius to -10 degree Celsius for 24 hours, -9 degree Celsius to 8 degree Celsius for 24 hours and 9 degree Celsius to 25 degree Celsius for 24 hours. There was no previous temperature excursion. A data digital logger was used. Sender's Comments: US-009507513-1709USA004451: US-009507513-1708USA006160.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a certificated medical assistant (also reported as registered nurse) referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent. On an unknown date, the patients each was vaccinated with PROQUAD (dose and route unknown, lot # N013865 with expiry date 31-OCT-2018 and lot # N002325 with expiry date 19-JUL-2018) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature of -11.8 degree Celsius (-14 degree Celsius to -10 degree Celsius) for 3 hours and 35 mins. There was no previous excursion. A data logger was used. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004611: US-009507513-1708USA013799.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a certificated medical assistant (also reported as registered nurse) referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent. On an unknown date, the patients each was vaccinated with M-M-R II (dose, lot # and route unknown) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature of -11.8 degree Celsius (-14 degree Celsius to -10 degree Celsius) for 3 hours and 35 mins. There was no previous excursion. A data logger was used. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA013799: US-009507513-1709USA004610.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unspecified dates, an unspecified amount of patients received improperly stored doses of RECOMBIVAX HB, (lot# M036156, exp. 23-FEB-2019) (dose, frequency, route unknown) for prophylaxis. No adverse effects reported. No further information provided. Vaccines RECOMBIVAX HB. Temperature: 47 degrees Fahrenheit (F) to 77 degrees F. Time frame: 1 Hour 35 Minutes. No previous temperature excursion. Digital Data logger report was involved. As of 30-AUG-2017, a request was made for patient identifiers and dates of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports from the same reporter (1707USA004913, 1709USA004724 and 1709USA004725). Narrative updated. Sender's Comments: US-009507513-1707USA004913: US-009507513-1709USA004724: US-009507513-1709USA004725.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unspecified dates, an unspecified amount of patients received improperly stored doses of ROTATEQ (lot# N003401-valid exp.13-OCT-2018) (dose, frequency and route not reported) for prophylaxis. No adverse effects reported. No further information provided. Vaccines ROTATEQ. Temperature: 47 degrees Fahrenheit (F) to 77 degrees F. Time frame: 1 Hour 35 Minutes. No previous temperature excursion. Digital Data logger report was involved. As of 30-AUG-2017, a request was made for patient identifiers and dates of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports from the same reporter (1707USA004913, 1709USA004723 and 1709USA004725). Narrative updated. Sender's Comments: US-009507513-1707USA004913: US-009507513-1709USA004723: US-009507513-1709USA004725.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to an unspecified number patients of unknown age and gender. No information regarding the patients pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On unspecified dates, an unspecified amount of patients received improperly stored doses of PROQUAD (Lot# N002915, exp. 24-JUL-2018) (dose, frequency and route not reported) for prophylaxis which was reconstituted with properly stored sterile water diluent (manufacturer unknown). No adverse effects reported. No further information provided. Vaccines involved: PROQUAD Temperature: 6 degrees Fahrenheit (F) to 14 degrees F. Time frame: 55 Minutes. No previous temperature excursion. Digital Data logger report was involved. As of 30-AUG-2017, a request was made for patient identifiers and dates of vaccination. All telephone attempts to obtain follow up information have been unsuccessful. This is one of several reports from the same reporter (1707USA004913, 1709USA004723 and 1709USA004724). Narrative updated. Sender's Comments: US-009507513-1709USA004724: US-009507513-1707USA004913: US-009507513-1709USA004723.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Headache
Clinical narrative: Headache for three days following vaccination. We are a hospital and mandate vaccination. We are just beginning the vaccination for our facility for the 2017-2018 flu season and have seen multiple cases of extended headache from this vaccine.
Age: 17.0
Sex: F
Vaccine: IPV, MMR, TDAP, VARCEL
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Generalized red, slightly raised rash (small bumps, all bumps identical in appearance) BENADRYL given soon after appearance of rash, mom states immediate improvement following BENADRYL, 90% of rash resolved by 9/11 (otherwise asymptomatic).
Age: 24.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site pain
Clinical narrative: Bump at site, sore/tender arm that has not resolved.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Eye swelling, Inflammation, Pain, Pain in extremity, Rash
Clinical narrative: RIGHT ARM INFLAMMATION. RASH ON BACK, RIGHT EYE SWOLLEN. RIGHT ARM PAINFUL TO MOVE. TREATMENT PRESCRIBED BY PCP: CEPHALEXIN, IBUPROFEN, PREDNISONE FOR 6 DAYS, STARTING 9/10/17. OUTCOME UNKNOWN.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: PT PRESENTED WITH A REACTION ON THE UPPER LEFT ARM. IT WAS RED, NOT SWOLLEN, WARM TO THE TOUCH. IT SPREAD FROM UPPER HALF OF ARM DOWN TO ELBOW. PT WENT TO URGENT CARE ON 9/10/17 AND GOT ANTIBIOTIC COURSE FOR TREATMENT.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dysgeusia, Headache, Paraesthesia, Pyrexia
Clinical narrative: Child began complaining of bad headache, body tingling and taste buds were off. Mom stated he had a low-grade fever. Lasted 1 day. Mom did not obtain medical care for him.