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 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: 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 06-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: 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-JUN-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 28-JUN-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 27-JUN-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 23-JUN-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 20-JUN-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:
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 patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not  reported. On 20-JUN-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 19-JUN-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 17-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 15-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 13-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-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 # N001489 with expiry date 12-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 # N001489 with expiry date 12-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 11-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-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 # N001489 with expiry date 12-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 06-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-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 29-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-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 28-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-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 26-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-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 26-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-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 20-JUN-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N001489 with expiry date 12-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:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse via company representative, referring to a male patient in his early 60s. The patient's medical history, concurrent conditions, drug and allergy history were not provided. On an unknown date (reported as "a few years ago"), the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, administration route, lot number and expiration date were not provided), for prophylaxis. Concomitant therapies included a sterile diluent. It was reported that on an unspecified date (reported as "a few months ago"), the patient went to the office and was diagnosed with shingles. It was also stated that the nurse was not interested in a Varicella-Zoster Virus (VZV) analysis by polymerase chain reaction (PCR). The outcome of herpes zoster was unknown. The causality assessment between ZOSTAVAX and the event was not reported.
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring a patient of unknown age.  The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-SEP-2017, the patient was administered improperly stored dose of VARIVAX lot # N012619 with expiration date of 21-APR-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F (12.2F) for 30 minutes. No previous temperature excursion was reported. The call was because of a "data logger". This one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA004378.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of VAQTA (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: N005796 (expiration date 26-MAY2018) (0.5 ml) and N008823 (expiration date: 26-MAY-2018). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004346: US-009507513-1709USA004345: US-009507513-1709USA004343: US-009507513-1709USA004344.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This information has been received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD with lot number N010865 and expiration date on 01-OCT-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using a properly stored sterile diluent (unknown lot number and expiration date). It was reported that on unspecified dates, the vaccine was exposed to a temperature between -9 Centigrade degrees and 8 Centigrade degrees (-7 Centigrade degrees) for 16 hours and 55 minutes. There was previous temperature excursion between -14 Centigrade degrees and -10 Centigrade degrees (-12.9 Centigrade degrees) for 48 minutes. The call was placed because of a Digital Data logger report. No product quality complained was involved. No adverse effects were reported.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with a dose  of RECOMBIVAX HB 2.5/0.5 (units not provided) (lot # N011851, expiration date: 19-DEC-2019; dose number and route of administration were unknown) and a dose of ROTATEQ (lot # N005080 with expiration date 03-OCT-2018, or lot # reported as N0118511 with expiration date 19-FEB-2019; orally, dose number was unknown), both for prophylaxis. The doses were improperly stored at 48.6 Fahrenheit (F) degrees for 2 hours. The temperature excursion was detected by a digital data logger. There were no previous temperature excursions and no adverse effects reported. This is one of several reports received from the same reporter. Lot number N0118511 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1709USA004383.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Varicella virus test negative
Clinical narrative: This spontaneous report was received from a physician concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. In August 2017, the patient was vaccinated with a dose of VARIVAX, lot # N012132, expiration date: 17-APR-2019, for prophylaxis, which was reconstituted with sterile diluent (MRK) (lot # and expiration date were unknown). Concomitant medications were not reported. On an unspecified date in 2017, the patient developed a rash on an unspecified part of the body. Subsequently, a culture of the lesions was performed and the result was negative for varicella. At the time of reporting, the patient had recovered from the rash (reported as "the lesions healed"). The causality assessment between the rash with VARIVAX and sterile diluent (MRK) was not provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA004204.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of RECOMBIVAX HB (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: M018625 (expiration date 11-AUG-2018), M040423 (expiration date: 03-JUL-2019), and N006321 (expiration date: 08-NOV-2019). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004346: US-009507513-1709USA004345: US-009507513-1709USA004047: US-009507513-1709USA004344.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of PEDVAXHIB (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: N001348 (expiration date 31-OCT-2019), and N004632 (expiration date: 02-NOV-2019). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004346: US-009507513-1709USA004345: US-009507513-1709USA004343: US-009507513-1709USA004047.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of GARDASIL 9 (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: M042853 (expiration date 17-JUL-2019), M044717 (expiration date: 19-JUL-2019), and N004799 (expiration date: 15-NOV-2019). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA004346: US-009507513-1709USA004047: US-009507513-1709USA004343: US-009507513-1709USA004344:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of ROTATEQ (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: M042179 (expiration date 22-JUN-2018), and M044397 (expiration date: 20-JUN-2018). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004047: US-009507513-1709USA004345: US-009507513-1709USA004343: US-009507513-1709USA004344.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring a patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-SEP-2017, the patient was administered improperly stored dose of VARIVAX lot # N012619 with expiration date of 21-APR-2019, for prophylaxis (strength, dose, route and frequency were not reported). No adverse effects reported. It was stated that the vaccines underwent a temperature excursion of 6°F (degrees Fahrenheit) to 14°F (12.2F) for 30 minutes. No previous temperature excursion was reported. The call was because of a "data logger". This one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA004002.
Sex: U
Vaccine: HEP, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with a dose of RECOMBIVAX HB 2.5/0.5 (units not provided) (lot # N011851, expiration date: 19-DEC-2019; dose number and route of administration were unknown) and a dose of ROTATEQ (lot # N005080 with expiration date 03-OCT-2018, or lot # reported as N0118511 with expiration date 19-FEB-2019; orally, dose number was unknown), both for prophylaxis. The doses were improperly stored at 48.6 Fahrenheit (F) degrees for 2 hours. The temperature excursion was detected by a digital data logger. There were no previous temperature excursions and no adverse effects reported. This is one of several reports received from the same reporter. Lot number N0118511 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1709USA004084.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Palpitations
Clinical narrative: On 9/10/2017 around 3 a.m. in the morning I experienced 3 heart palpitations and then an extended period of heart racing that I am guessing lasted around 45 minutes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Eyelid oedema, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented to office 9/1/17 with left arm swelling, redness and warmth from site of upper outer aspect  down to and involving dorsum of left  hand. Mom notes swelling of eyelids and lips as well.- though practioner unable to fully appreciate this. Patient c/o itchiness at injection site. No mention in visit note about when symptoms began. Recommended: Diphenhydramine HCL 7.5 ml q 4-6 hrs until swelling improves, then may switch to Zyrtec 1-2 x/ day until symptoms completely resolved. If breathing trouble, severe mouth/ lip swelling or diffuse hives along with stomachache to go to ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Lip swelling
Clinical narrative: Patient presented to office 9/1/17 with left arm swelling, redness and warmth from site of upper outer aspect  down to and involving dorsum of left  hand. Mom notes swelling of eyelids and lips as well.- though practioner unable to fully appreciate this. Patient c/o itchiness at injection site. No mention in visit note about when symptoms began. Recommended: Diphenhydramine HCL 7.5 ml q 4-6 hrs until swelling improves, then may switch to Zyrtec 1-2 x/ day until symptoms completely resolved. If breathing trouble, severe mouth/ lip swelling or diffuse hives along with stomachache to go to ER.
Sex: U
Vaccine: VARCEL
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 VARIVAX (dose and route unknown, lot # M009764 with expiry date 23-FEB-2018, N009768 with expiry date 24-MAR-2019, N012487 with expiry date 20-APR-2019 and M024681 with expiry date 18-MAY-2018) for prophylaxis. No adverse effect was reported. The vaccines were under the temperature range 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-009507513-1709USA004452.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (lot # reported as M050833, expiration date 18-DEC-2017, route and dose not reported) for prophylaxis. The doses of vaccine were improperly stored 10.6 degree Fahrenheit for 1 hour 6 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates in March 2017, the unspecified patients were vaccinated with improperly stored RECOMBIVAX HB, (0.5ml, lot# M039642 with expiration date 03-JUL-2019, lot# L025738 with expiration date 14-AUG-2017, intramuscular) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature excursion of 25 degrees Fahrenheit (unsupported) for 10 days. Data logger was involved. There was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from an administrator, who also worked as a medical assistant, referring to an unknown number of patients of unknown age and gender. Information about concurrent condition, concomitant therapies, drug reactions/allergies and medical history was unknown. From 02-JUN-2017 to 22-JUL-2017, the patients each was vaccinated with improperly stored VARIVAX (dose, route and lot # were unknown) for prophylaxis. The reporter stated that if the VARIVAX were to go over 14 Fahrenheit (F), the patients who were administered the vaccines would need to be revaccinated (It was also reported that "no doses were administered" (conflict information)). No adverse effect was reported. The vaccines were under the temperature in the range of 6 F to 14 F: 6 F for 1 hour and 30 mins, 8 F for 5 hours, 5.6 F for 45 mins, 8 F for 7 hours, 8 F for 3 hours, 6 F for 1 hour, 9.7 F for 30 mins, 6.4 F for 5 hours. There was no previous temperature excursion. A data logger was used.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On 23-AUG-2017, the patient was vaccinated with an expired dose of GARDASIL lot # L012190, expiration date 13-APR-2017 (dose and route were not reported), for prophylaxis. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse practitioner concerning a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 25-AUG-2017, the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # M026878, expiration date: 27-JUL-2017) (strength, dose, frequency and route were not reported) with sterile diluent for prophylaxis (expired vaccine used). No adverse effect was reported.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 20-DEC-2010, the patient was vaccinated with a dose of PNEUMOVAX 23. On 13-APR-2015, the patient was vaccinated with a dose of  PREVNAR 13. There was no adverse event reported.
Sex: U
Vaccine: VARCEL
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 VARIVAX (dose and route unknown, lot # M042495 with expiry date 19-OCT-2018, lot # M047661 with expiry date 02-DEC-2018 and lot # N012131 with expiry date 17-APR-2019) 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-009507513-1709USA004610: US-009507513-1709USA004610.
Age: 39.0
Sex: F
Vaccine: HEP, MMR, TDAP, VARCEL
Symptoms: Poor quality drug administered, Product storage error
Clinical narrative: Information has been received from a other source referring to a 39 years old female patient. Concurrent condition included non-smoker. Information about concomitant medication and medical history of the patient was not provided. On 13-JUL-2017 the patient was vaccinated with excursion vaccines of M-M-R II, varicella virus vaccine live (manufacturer unknown), hepatitis b vaccine (manufacturer unknown) and (unspecified) TDaP (strength, route and lot # were not reported) for prophylaxis (Incorrect product storage and poor quality vaccine administered). This is one of 3 reports received from the same reporter. Sender's Comments: US-009507513-1708USA010246: US-009507513-1709USA000698.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported.  Nurse reported that on 22-AUG-2017 the expired PROQUAD lot # M007963 and expiry date 15-AUG-2017(Dose,frequency,route unknown) was given to a patient for prophylaxis. o adverse effects.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M044395, expiration date 31-MAY-2018 (dose was not reported) for prophylaxis. No adverse effects were reported. Product quality complaint was not involved. The administered doses of ROTATEQ were stored in the temperature between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 2 hours and 53 minutes and then for 1 hour and 19 minutes. Data logger was not involved. No additional information was reported.