chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004961: US-009507513-1705USA004965: US-009507513-1705USA004967: US-009507513-1705USA004962: US-009507513-1705USA004960: US-009507513-1608USA012794: US-009507513-1705USA004973: US-009507513-1705USA004963: US-009507513-1705USA004952:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 6 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-00950713-1608USA012794:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old male patient. The patient administered the vaccine on 14-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 10.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 10 year old female patient. The patient administered the vaccine on 18-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068: US-009507513-1704USA013406.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old male patient. The patient administered the vaccine on 20-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old male patient. The patient administered the vaccine on 20-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to an 11 month old male patient. The patient administered the vaccine on 21-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old female patient. The patient administered the vaccine on 21-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old male patient. The patient administered the vaccine on 24-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 1 year old male patient. The patient administered the vaccine on 25-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to an 11 month old male patient. The patient administered the vaccine on 25-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to an 11 months old female patient. The patient administered the vaccine on 25-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014068.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 19-APR-2017 to 23-MAY-2017, the patients were vaccinated with improperly stored doses of PROQUAD lot # M036295 with expiration date: 12-DEC-2018, lot# M041084 with expiration date: 04-APR-2018, lot# M044022 with expiration date: 01-MAY-2018 and lot# M042501 with expiration date: 17-APR-2018 (dose, route and site of administration were not reported). The sterile diluent (manufacturer unknown) was used to reconstitute the PROQUAD. The sterile diluent (manufacturer unknown) did not undergo a temperature excursion. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 24 hours. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA014497: US-009507513-1705USA014496: US-009507513-1705USA014495: US-009507513-1705USA014494.
Sex: M
Vaccine: SMALL
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pericardial disease, Pericarditis, Troponin I increased
Clinical narrative: Initial solicited report received on 17 May 2017 from an investigator (Defense Health Agency) in the trial. A 22-year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 19 October 2016. On 03 November 2016, 15 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified, and on 07 November 2016, 19 days post vaccination the subject was diagnosed with I31.9 disease of pericardium, unspecified. The lab data included within 30 days post vaccination on 30 October 2016, the Troponin I was abnormal (the highest value was recorded as 51.00), ECG was abnormal, Echocardiogram was normal, MRI (heart, brain and spinal cord) and Lumbar puncture (spinal tap) were not performed. Treatments were not reported. The events outcome was not reported. Relationship to investigational product according to company: associated Relationship to investigational product according to investigator: not reported. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study.; Sender's Comments: This case involves a healthy 22-year-old male who developed acute pericarditis unspecified with favorable temporal association post vaccination with ACAM2000. Acute pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Cholecystectomy, Cholelithiasis, Condition aggravated, Dehydration, Dizziness
Clinical narrative: On May 17th around 1-2am, I woke up with nausea, vomiting, and severe dizziness. I did not have these symptoms when I went to bed around 11pm May 16th. I stayed in bed a full day May 17th and was unable to keep down fluids or food. I went to the emergency room the morning of the 18th. I was diagnosed with gallstones and treated for nausea and dehydration. I began taking  prednisone prescribed by neurologist on May 19th, as I was having a flare-up of multiple sclerosis. My gallbladder was surgically removed May 24. I am currently waiting on multiple sclerosis MRIs.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Multiple sclerosis, Nausea, Vomiting
Clinical narrative: On May 17th around 1-2am, I woke up with nausea, vomiting, and severe dizziness. I did not have these symptoms when I went to bed around 11pm May 16th. I stayed in bed a full day May 17th and was unable to keep down fluids or food. I went to the emergency room the morning of the 18th. I was diagnosed with gallstones and treated for nausea and dehydration. I began taking  prednisone prescribed by neurologist on May 19th, as I was having a flare-up of multiple sclerosis. My gallbladder was surgically removed May 24. I am currently waiting on multiple sclerosis MRIs.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness
Clinical narrative: A couple minutes after injections pt pass out for roughly 2-3 minutes then came too.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning an unspecified patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 04-MAY-2017, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot # M027884 and expiration date of 19-APR-2019 (dose, frequency and route of administration were not reported). The vaccine was exposed to a temperature of 1 Celsius degree for 44 minutes. There was reported a prior temperature excursion, the vaccine also was exposed to a temperature of 1 Celsius degree for 35 minutes. The call was placed because of a Digital Data logger report. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot number: M032141 with an expiration date of 02-OCT-2017; dose regimen details and anatomical location were not provided) reconstituted with sterile water diluent (unknown lot number and expiration date) for prophylaxis. The sterile water diluent did not undergo an excursion. The temperature was 6°F to 14°F for a time frame of  2.5 hours and 15°F to 46°F for 1.5 hours. No previous excursions were reported. The temperature excursions were detected by a data logger. There was no PQC involved. This is one of two cases from the same reporter. Additional information is not expected since consent to contact the patient's physician was not provided. Sender's Comments: US-009507513-1705USA009248.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to an 8 week old infant, gender unknown.  There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 19-SEP-2016, the 8 week old infant received vaccination with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported.  The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions.   This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004952: US-009507513-1705USA004967: US-009507513-1705USA004960: US-009507513-1705USA004965: US-009507513-1705USA004973: US-009507513-1608USA012794: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004946: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA005004: VAQTA US-009507513-1705USA005005: VAQTA US-009507513-1705USA005006: VAQTA US-009507513-1705USA005007: VAQTA US-009507513-1705USA004887: RECOMBIVAX HB US-009507513-1705USA004888: RECOMBIVAX HB US-009507513-1705USA004889: RECOMBIVAX HB US-009507513-1705USA004890: RECOMBIVAX HB US-009507513-1705USA004891: RECOMBIVAX HB US-009507513-1705USA004892: RECOMBIVAX HB US-009507513-1705USA004893: RECOMBIVAX HB US-009507513-1705USA004894: RECOMBIVAX HB US-009507513-1705USA004895: RECOMBIVAX HB US-009507513-1705USA004896: RECOMBIVAX HB US-009507513-1705USA004897: RECOMBIVAX HB US-009507513-1705USA004898: RECOMBIVAX HB US-009507513-1705USA004899: RECOMBIVAX HB US-00950751.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 4 month infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 20-SEP-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of ROTATEQ experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004996: US-009507513-1705USA004997: US-009507513-1705USA004998: US-009507513-1705USA004999: US-009507513-1705USA004893: US-009507513-1705USA004892: US-009507513-1705USA004891: US-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004887: US-009507513-1608USA012916: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004965: US-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004975: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004973: US-009507513-1705USA004974: US-009507513-1705USA005007: US-009507513-1705USA005006: US-009507513-1705USA005005: US-009507513-1705USA005004: US-009507513-1705USA004943:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 4 month infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of ROTATEQ experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1705USA004982: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899: US-009507513-1705USA004893: US-009507513-1705USA004892: US-009507513-1705USA004891: US-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004887: US-009507513-1608USA012916: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004965: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004970: US-009507513-1705USA004975: US-009507513-1705USA004971: US-009507513-1705USA004966: US-009507513-1705USA004972: US-009507513-1705USA004973: US-009507513-1705USA004974: US-009507513-1705USA005007: US-009507513-1705USA005006: US-009507513-1705USA005005: US-009507513-1705USA005004: US-009507513-1705USA004943:
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 9 weeks infant (gender not reported). There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1705USA004982: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004894: US-009507513-1705USA004895: US-009507513-1705USA004896: US-009507513-1705USA004897: US-009507513-1705USA004898: US-009507513-1705USA004899: US-009507513-1705USA004893: US-009507513-1705USA004892: US-009507513-1705USA004891: US-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004887: US-009507513-1705USA004883: US-009507513-1608USA012916: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004952: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004960: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004963: US-009507513-1705USA004964: US-009507513-1705USA004965: US-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004975: US-009507513-1705USA004973: US-009507513-1705USA004974: US-009507513-1705USA005007: US-009507513-1705USA005006: US-009507513-1705USA005005: US-009507513-1705USA005004: US-009507513-1705USA004943:
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant concerning to a patient with unspecified demographics. The patient's concurrent conditions, medical history, drug reactions and/ or allergies were not reported. On 09-MAY-2017, the patient was inadvertently vaccinated with an expired dose of GARDASIL 9 with lot # L010596 and expiration date on 06-APR-2017 for prophylaxis (the dose, rote, frequency, and strength were not provided). No adverse effects were reported. Lot number L010596 has been verified to be a valid lot number for GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report been received from a registered nurse and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis; Then, on unknown dates, the patient received the second and third dose of GARDASIL (strength, dose, frequency, route of administration, lot number and expiration date were not reported). Subsequently, on unknown dates, the patient was vaccinated with an unknown number of doses of GARDASIL 9. There were no adverse effects reported. Additional information is not expected as the reporter did not consent for further follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist concerning  to an adult female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant therapies were unknown.   On 08-MAY-2017, the patient was vaccinated with an unspecified dose of ZOSTAVAX 19400 PFU, lot # M019645 with expiration date on 18-JUL-2017 for prophylaxis (the route, strength, frequency, and dose were not provided). Afterwards, on an unspecified date in May 2017, the patient experienced itching, redness, and warmth, as well as a firm lump at the injection site after the vaccination. It was unknown whether the patient sought medical attention and if laboratory diagnostic studies were performed. At the reporting time, the patient's itching had resolved  on an unspecified date in May 2017, after the patient took some diphenhydramine hydrochloride (BENADRYL). It was also stated that the lump was still present, and the site was still a little bit warm, and still had a bit of redness in the area of the injection site. The causal relationship between the events and the ZOSTAVAX was not provided.  Additional information is not expected because the reporter did not consent for further follow up.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions or allergies and concomitant medication were not reported. From 17-APR-2017 to 11-MAY-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M037770, expiry date 01-JUN-2019 and lot # M043731, expiry date 22-JUN-2019; dose and route were not reported). The doses were stored under temperature of 47F to 77F for 84 hours. There was no previous temperature excursion and data logger was not involved. No adverse reactions were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007430.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 10-MAY-2017, the patient was vaccinated with a dose of improperly stored GARDASIL 9 injection, lot # M041990 with expiration date 28-JUN-2019 (dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA011219: US-009507513-1705USA011218: US-009507513-1705USA011216: US-009507513-1705USA011217.