chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: This spontaneous report was received from a physician concerning a 68 years old female patient. The patient had no concurrent conditions. The patient's drug reactions included allergy to penicillin and cephalexin(KEFLEX). On 26-APR-2017, the patient was vaccinated with a dose of PNEUMOVAX23, lot # N003993, expiration date 20-OCT-2018, for prophylaxis (dose number, route and anatomical location of administration was unknown). There were no concomitant medications. On 28-APR-2017, the patient came to the physician's office with a complaint of "redness and swelling to the injection site and the entire arm". The patient received treatment with triamcinolone acetonide (KENALOG) injection, doxycycline 100 mg twice daily, and methylprednisolone (MEDROL) dose pack. Afterwards, the patient stopped taking methylprednisolone (MEDROL) dose pack on an unknown date because of unspecified "side effects". No laboratory diagnostics were performed. On 01-MAY-2017, the physician spoke with the patient, and she stated that the "redness and swelling resolved". At the time of reporting, the outcome of the unspecified "side effects" was unknown. The causality assessment between the events and PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 08-MAY-2017 from a licensed practical nurse regarding a 4 month old infant (gender not provided). Medical history, concurrent conditions and concomitant medications were not reported. On 12-SEP-2016 the patient was administered a dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. Administered dose of vaccine experienced a 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. No adverse events were 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-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA004944: US-009507513-1608USA012794: 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-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004973: US-009507513-1705USA004972: US-009507513-1705USA004971: US-009507513-1705USA004970: US-009507513-1705USA004969: US-009507513-1705USA005004: Original case 1608USA012908; US-009507513-1705USA005005: Original case 1608USA012908; US-009507513-1705USA005006: Original case 1608USA012908; US-009507513-1705USA005007: Original case 1608USA012908; US-009507513-1705USA004946: Original case 1608USA012916; US-009507513-1705USA004975: Original case 1608USA012916; US-009507513-1705USA004974: Original case 1608USA012916; US-009507513-1705USA004899: Original case 1608USA012916; US-009507513-1705USA004898: Original case 1608USA012916; US-009507513-1705USA004897: Original case 1608USA012916; US-009507513-1705USA004896: Original case 1608USA012916; US-009507513-1705USA004895: Original case 1608USA012916; US-009507513-1705USA004894: Original case 1608USA012916; US-009507513-1705USA004893: Original case 1608USA012916; US-009507513-1705USA004892: Original case 1608USA012916; US-009507513-1705USA004891: Original case 1608USA012916; US-009507513-1705USA004890: Original case 1608USA012916; US-009507513-1705USA004889: Original case 1608USA012916; US-009507513-1705USA004888: Original case 1608USA012916; US-009507513-1705USA004887: Original case 1608USA012916; US-009507513-1608USA012794: US-00950.
Age: 0.5
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 6 month infant (gender not reported). There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On 13-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-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004981: Original Case : 1608USA012794 US-009507513-1705USA004982: Original Case : 1608USA012794 US-009507513-1705USA004983: Original Case : 1608USA012794 US-009507513-1705USA004984: Original Case : 1608USA012794 US-009507513-1705USA004985: Original Case : 1608USA012794 US-009507513-1705USA004944: Original Case : 1608USA012794 US-009507513-1705USA004952: Original Case : 1608USA012794 US-009507513-1608USA012794: Original Case : 1608USA012794 US-009507513-1705USA004954: Original Case : 1608USA012794 US-009507513-1705USA004955: Original Case : 1608USA012794 US-009507513-1705USA004956: Original Case : 1608USA012794 US-009507513-1705USA004957: Original Case : 1608USA012794 US-009507513-1705USA004958: Original Case : 1608USA012794 US-009507513-1705USA004959: Original Case : 1608USA012794 US-009507513-1705USA004960: Original Case : 1608USA012794 US-009507513-1705USA004961: Original Case : 1608USA012794 US-009507513-1705USA004962: Original Case : 1608USA012794 US-009507513-1705USA004963: Original Case : 1608USA012794 US-009507513-1705USA004964: Original Case : 1608USA012794 US-009507513-1705USA004966: Original Case : 1608USA012794 US-009507513-1705USA004967: Original Case : 1608USA012794 US-009507513-1705USA004968: Original Case : 1608USA012794 US-009507513-1705USA004973: Original Case : 1608USA012794 US-009507513-1705USA004972: Original Case : 1608USA012794 US-009507513-1705USA004969: Original Case : 1608USA012794 US-009507513-1705USA004970: Original Case : 1608USA012794 US-009507513-1705USA004971: Original Case : 1608USA012794 US-009507513-1705USA004951: Original Case : 1608USA012794 US-009507513-1705USA004950: Original Case : 1608USA012794 US-009507513-1705USA004974: Original Case : 1608USA012794 US-009507513-1705USA004942: Original Case : 1608USA012794 US-009507513-1705USA004945: Original Case : 1608USA012794 US-009507513-1705USA004946: Original Case : 1608USA012794 US-009507513-1705USA004947.
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 concerning a 6 month old patient, gender unknown. There was no information about the patient's concurrent conditions, concomitant medication, or medical history provided. On 19-SEP-2016, the patient was vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported). No symptoms were reported. The administered dose of vaccine experienced a 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 and no further temperature 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-009507513-1608USA012916: 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-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004946: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: 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-009507513-1705USA004966: US-009507513-1705USA004967: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004973: US-009507513-1705USA005007: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: 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-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004952: US-009507513-1705USA004887: US-009507513-1705USA004891: US-009507513-1705USA004975: US-009507513-1705USA004974:
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a licensed practical nurse concerning a 6 month old patient of unknown gender. No information was provided regarding the patient's past medical history, concurrent condition, or concomitant medication. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date 28-SEP-2017) orally. No symptoms were reported. The administered dose of vaccine experienced a 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 and no further temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA004952: US-009507513-1705USA004965: US-009507513-1608USA012794: US-009507513-1608USA012908: US-009507513-1608USA012916: 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-009507513-1705USA004942: 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-009507513-1705USA004955: 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-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004973: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA004946: US-009507513-1705USA005004: US-009507513-1705USA005005: US-009507513-1705USA005006: US-009507513-1705USA005007: 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-009507513-1705USA004890: US-009507513-1705USA004889: US-009507513-1705USA004888: US-009507513-1705USA004887: US-009507513-1705USA004891:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed vocational nurse and referred to an unspecified number of patients of unknown ages and genders. The patients' relevant medical history, concurrent conditions, and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ orally (strength, doses, and frequencies were not reported; lot number M032641 and expiration date 07-MAY-2018) for prophylaxis. There were no adverse effects reported. The vaccine data logger measured a temperature of 0.3°C for a total time frame of 15 hours. There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEP, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 10-MAY-2017 from a nurse regarding multiple unspecified patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On multiple unspecified dates, multiple unspecified patients were administered doses of ROTATEQ lot # M040271 expiration 30-APR-2018, oral for prophylaxis and RECOMBIVAX HB lot # L048849 expiration 04-FEB-2018, intramuscular for prophylaxis which were improperly stored. No adverse effects were reported. The vaccines were stored between 47 degrees Fahrenheit and 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because of a data logger. No further information was reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Information was received on 11-MAY-2017 from a physician via a company representative. The physician reported that a patient who was seen by a partner in the practice,  a 12 year old of unknown gender, who was vaccinated with the first dose of GARDASIL 9 (lot, expiration, dose and site not reported) on an unknown date. About a day later, the patient presented with a high fever. The patient recovered on an unknown date. The patient received their second dose of GARDASIL 9 (lot, expiration, dose and site not reported) months later. About a day after receiving the second dose, the patient presented with a high fever. The outcome of the fever was not reported. No other information was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of PROQUAD from lot # M036295 with expiration date on 13-FEB-2018 and also the lot # reported as M040143 with expiration date on 27-MAR-2018 (strength, dose, route of administration and anatomical location were not provided), that were reconstituted with a sterile diluent (manufacturer unknown) (lot #, expiration date, strength, dose and route of administration were not provided) for prophylaxis. The storage temperature was reported as 6 to 14 degrees Fahrenheit (°F) (8 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010492: US-009507513-1705USA010490: US-009507513-1705USA010491: US-009507513-1705USA010488: US-009507513-1705USA010489:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M039202 with expiration date 11-MAR-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014902: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007306: US-009507513-1705USA007307: US-009507513-1705USA007308:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M035456 with expiration date 01-MAY-2018 and lot # M039061 with expiration date 28-APR-2018, orally (dose was not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 13.1 degrees Celsius for 7 hours and 50 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014902: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007305: US-009507513-1705USA007307: US-009507513-1705USA007308:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # reported as M040142 with expiration date 27-MAR-2018 (dose and route of administration were not reported), which were reconstituted with sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -2.4 degrees Celsius for 1 hour and 14 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014902: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007305: US-009507513-1705USA007306: US-009507513-1705USA007308:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse 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. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M041080 with expiration date 06-OCT-2018 and lot # M037642 with expiration date 01-SEP-2018 (dose and route of administration were not reported), which were reconstituted with sterile diluent (STERILE DILUENT). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of -2.4C degrees Celsius for 1 hour 14 minutes. A Digital Data Logger was involved. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014902: US-009507513-1705USA007303: US-009507513-1705USA007304: US-009507513-1705USA007305: US-009507513-1705USA007306: US-009507513-1705USA007307:
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: This spontaneous report as received from a healthcare worker also reported as a corporate executive via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with ZOSTAVAX, for prophylaxis (dose, route of administration, lot number and expiration date were not reported).        The reporter stated that according to some pharmacist, the patient "died from getting ZOSTAVAX" on an unknown date. The cause of patient's death was not reported. It was also unknown whether an autopsy has been performed. No further details were noted on the after-hours adverse event voicemail. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history and concomitant therapies was reported. On unknown dates, the patients received incorrectly stored doses of PNEUMOVAX23 (dose and route of administration were not reported) lot # L048264, expiration date: 10-JUN-2017. No adverse effects were reported. The vaccines were stored in the temperature between 47 and 77 degrees Fahrenheit for 3 hours 15 minutes. The temperature excursion was detected by a 'Digital Data Logger'. Vaccines underwent previous temperature excursion: they were stored in temperature between 47 and 77 degrees Fahrenheit for 3 hours 30 minutes. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report was received from a nurse referring to a 15 years old female patient. The patient's drug reaction/allergies and current conditions included mupirocin calcium (Bactroban) hypersensitivity, however the patient did not have any previous medical history. On 16-MAY-2017 the patient was vaccinated with GARDASIL 9 lot number N000326, expiration date on 14-OCT-2017 (dose and route of administration were not provided) for prophylaxis. The patient had none concomitant medications. On 16-MAY-2017, within 30 seconds to a minute after receiving GARDASIL 9, the patient experienced losing consciousness, therefore, she was monitored during 45 minutes.     The patient sough medical attention, lab diagnostic studies were not performed, the patient did not receive treatment for the event, however she had recovered. The causality assessment between GARDASIL 9 and the event was unknown at the time of reporting. Upon internal review, the event of losing consciousness  was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments: US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 08-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 20-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 10-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M005974, expiration date 02-FEB-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine were exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because all information was obtained.; Sender's Comments:  US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 14- MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 18-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 15-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 28-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 13-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported).The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 10-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 20-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 31-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 22-MAR-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M025871, expiration date: 24-MAY-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M033214, expiration date: 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained.; Sender's Comments:  US-009507513-1611USA004113:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 01-FEB-2017, the patient was vaccinated with improperly stored dose of VARIVAX lot # M033214, expiration date: 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required data has been obtained. Sender's Comments: US-009507513-1611USA004113.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored dose of GARDASIL 9 with lot # M017983 and expiration date on 30-MAY-2018 (strength, dose, route of administration and anatomical location were not provided), for prophylaxis. The storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (34 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA010492: US-009507513-1705USA010490: US-009507513-1705USA010491: US-009507513-1705USA006600: US-009507513-1705USA010489.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of ROTATEQ from lot # M040268 with expiration date on 14-MAY-2018, and also the lot # M038846 with expiration date on 26-APR-2018 (strength and dose were not reported), taken orally for prophylaxis. The storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (34 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010492: US-009507513-1705USA010490: US-009507513-1705USA010491: US-009507513-1705USA010488: US-009507513-1705USA006600:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored VAQTA from lot # M047658 with expiration date on 28-OCT-2017, and also lot # M038572 with expiration date on 11-MAR-2018 (strength, dose, route of administration and anatomical location were not provided), for prophylaxis. The storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (34 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA010492: US-009507513-1705USA006600: US-009507513-1705USA010491: US-009507513-1705USA010488: US-009507513-1705USA010489.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB from lot # N002913 with expiration date on 23-FEB-2019, and also the lot # M037248 with expiration date on 21-FEB-2019 (strength, dose, route of administration and anatomical location were not provided), for prophylaxis. The storage temperature was reported as 32 to 35 degrees Fahrenheit (°F) (34 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA010492: US-009507513-1705USA010490: US-009507513-1705USA006600: US-009507513-1705USA010488: US-009507513-1705USA010489:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX with lot # M036295 and expiration date on 13-FEB-2018, also the lot # reported as M040143 and expiration date on 27-MAR-2018 (strength, dose, route of administration and anatomical location were not provided) reconstituted with an sterile diluent (manufacturer unknown) (lot #, expiration date, strength, dose and route of administration were not provided), for prophylaxis. The storage temperature was reported as 6 to 14 degrees Fahrenheit (°F) (8 °F) for a time frame of 30 minutes. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA006600: US-009507513-1705USA010490: US-009507513-1705USA010491: US-009507513-1705USA010488: US-009507513-1705USA010489.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of PEDVAXHIB with lot number M046134 and expiration date of 27-SEP-2019 (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was stored from 47 Fahrenheit degrees (°F) to 77°F for 18 minutes and reconstituted with properly stored sterile diluent with lot number reported as N007550 and expiration date of 03-MAY-2018. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA010584. US-009507513-1705USA009159:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple unspecified patients of unknown age and gender. The concurrent conditions and medical history of the patients were not reported. On unknown dates,  the patients were vaccinated with an improperly stored dose of MMR II with lot number M029230 and expiration date of 08-JUN-2018 (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was stored from 47 Fahrenheit degrees (°F) to 77°F for 18 minutes and reconstituted with properly stored sterile diluent with lot number reported as N007550 and expiration date of 03-MAY-2018. There was no previous temperature excursion. The temperature excursions were detected by a data logger. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA009159: US-009507513-1705USA010583:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a 12 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 20-FEB-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 with a Lot # L014415 and an expiration date of 25-JUL-2017 (dose not reported) intramuscularly for prophylaxis, however no adverse effects reported. It was reported that the vaccine was exposed to temperature of 32 Fahrenheit degrees (F) to 35 F for a time frame of 35 days and 4 hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccine. There was no product quality complaint involved. This is one of the reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA010738:
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Rash
Clinical narrative: Diffuse rash on chest treated with diphenhydramine 50mg po and hydrocortisone cream 1% topically. Resolved by 05/22/2017 AM.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm Red and swollen.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Electroencephalogram normal, Seizure
Clinical narrative: Patient had questionable seizure activity.
Age: 43.0
Sex: F
Vaccine: HEP, HEPA, MMR, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Client described "red and itchy area about 6 inches long" in fatty part of arm. Denies having any pustules or vesicular lesions.