chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown ages and genders. No medical history, concurrent conditions or concomitant medications were reported. On an unknown dates, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (strength, dosing regimen, anatomical location, lot number and expiration date were unknown) for prophylaxis. Also, it was reported that all vaccines were considered "okay" for use with the exception of the M-M-R II (case # 1609USA014777). All vaccines that were in inventory at the time of the excursion that were "okayed" for use after review with the respective pharmaceutical companies were marked with Black X to designate exposure. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014777: US-009507513-1609USA014778: US-009507513-1609USA013289.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of an unknown gender and age. The patient's pertinent medical history, concurrent conditions and concomitant therepies were not reported. On 27-NOV-2016, the patient was vaccinated with an expired dose of M-M-R-II human serum albumin, lot# K015374, expiration date 18-SEP-2016 (dose and route of administration were not reported) for prophylaxis. No adverse effects were reported. Additional information has been rerquested.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was inadvertently administered an expired dose of MMR II; Information was received 30-NOV-2016 via a note from a company representative regarding a female nurse who reported that on 26-SEP-2016 a female patient of unspecified age was inadvertently administered an expired dose of MMR II (lot# M001200, expiration 28-AUG-2016).  No adverse effect was reported.  No further details were provided.  A phone call was placed to the nurse on the same day but she was unable to be reached.  A call back was requested. Additional information was requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were each vaccinated with a dose of improperly stored of GARDASIL 9 (lot # M018810, expiration date 28-MAY-2018, dose and route were not provided) for prophylaxis, which were exposed to 28.8 Fahrenheit (F) for 8 hours 43 minutes. There was no previous temperature excursion. No adverse effects were reported. The data logger issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA009007: US-009507513-1612USA009008.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 21-NOV-2016, the patient was vaccinated with improperly stored M-M-R II (lot # L036853, expiration date 24-SEP-2017, 0.5 ml, subcutaneous) for prophylaxis. No adverse effects were reported. The excursion temperature was 52 Fahrenheit degree for 17 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. 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-009507513-1612USA010695: US-009507513-1612USA010696:
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site warmth, Local reaction
Clinical narrative: This spontaneous report was received from a physician refers to a 65 year old female patient. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date the patient was vaccinated with  PNEUMOVAX23 0.5 ml, first dose, once, intramuscular (lot # unspecified) for prophylaxis. The physician reported that an unknown patient experienced an adverse injection site reaction described as a significant localized reaction on the left deltoid, 10 x 11.5 cm, soreness and tenderness in the area, warmth. There was no redness, and swelling/non-pitting edema. The physician provided limited information at the time of the call, but agreed to provide additional information via written correspondence in the future. No further information provided. The outcome of injection site reaction and causality assessment was unknown at the time of this report. Additional information has been requested.
Age: 31.0
Sex: U
Vaccine: HEP, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 31 year old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 02-DEC-2016, the patient was inadvertently administered a dose of PROQUAD (lot#, expiration date, dose and route unknown) instead of an intended dose of M-M-R II; and also inadvertently administered a pediatric dose of RECOMBIVAX HB instead of an intended adult dose. This error did not occur due to product confusion but rather the provider who administered the dose was distracted and selected the incorrect products. No dose of M-M-R II was administered. No adverse effect was reported. 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 referring to unspecified patients of unknown age and gender. The nurse reported that on an unknown date, the unspecified patients was vaccinated with an improperly stored dose of VARIVAX (lot # L024252, expiration date 30-JUN-2017) (dose, route and frequency unknown) for prophylaxis. No adverse effects were reported. No further information provided.   Temperature: 14.5 F Time frame: 48 minutes No previous temperature excursions. Call was due to a data logger: Yes Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported.  On unknown dates, since 01-AUG-2016, the patients were administered improperly stored doses of GARDASIL, lot # K006124, expiration date 02-FEB-2017, (dosages and therapy routes were not provided), for prophylaxis. No adverse experiences had been reported. The doses of GARDASIL were exposed to a temperature of 31.3F and were out of range for 4 months. A data logger was not used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 13 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA011123: US-009507513-1612USA011124: US-009507513-1612USA011125: US-009507513-1612USA011126: US-009507513-1612USA011127: US-009507513-1612USA011128: US-009507513-1612USA011129: US-009507513-1612USA011130: US-009507513-1612USA011131: US-009507513-1612USA011132: US-009507513-1612USA011133: US-009507513-1612USA011134: US-009507513-1612USA011135: US-009507513-1612USA011136: US-009507513-1612USA011137: US-009507513-1612USA011138: US-009507513-1612USA011139: US-009507513-1612USA011140: US-009507513-1612USA011141: US-009507513-1612USA011142: US-009507513-1612USA011143: US-009507513-1612USA011144: US-009507513-1612USA011145: US-009507513-1612USA011146: US-009507513-1612USA011147: US-009507513-1612USA011148: US-009507513-1612USA011149: US-009507513-1612USA011150: US-009507513-1612USA011151: US-009507513-1612USA011152: US-009507513-1612USA011153: US-009507513-1612USA011154.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a female patient of unknown age. Information about concurrent condition, medical history, drug reactions/allergies and concomitant therapy were not provided. On 06-FEB-2009, the patient was vaccinated with her first dose of GARDASIL (strength, dose, route, lot # and expiration date were unknown) for prophylaxis, then the second dose on 02-SEP-2009 and the third dose on 15-AUG-2016, which was outside of the recommendations in the GARDASIL prescribing information. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect dose administered, Product use issue
Clinical narrative: This solicited report has been received from an unknown reporter, referring to unspecified patients of unknown age and gender who were enrolled in a marketed research. The patients' medical history, concurrent condition and concomitant therapy were not reported. It was reported the patients were found receiving multiple doses (product use issue) of pneumococcal vaccine, polyvalent (23-valent) (manufacturer, dose and route were unknown) on unspecified dates. It was also reported there was too much uncertainty about who received which vaccine. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 27-MAY-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) (lot # L030587, expiry date 10-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. It was reported that the PROQUAD was stored at a temperature of 4 degrees Centigrade between 06-OCT-2015 to 09-AUG-2016. It was reported that there was no previous temperature excursion. No adverse effects were reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. There was no product quality complaint reported. This report was not because of a data logger. This is one of the many reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA011225: US-009507513-1612USA011226: US-009507513-1612USA011227.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Malaise, Swelling
Clinical narrative: Information has been received from a registered nurse via Pfizer (manufacturer control # 2016524387) on 28-NOV-2016 referring to a currently 88 year old female patient. Information about concurrent condition, medical history, drug reaction/allergies and concomitant therapy were not reported. On an unknown date in between 2005 and 2008, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route, lot # and expiration date were unknown) for prophylaxis. On an unknown date (reported as several years ago), the patient experienced redness, swelling and was not feeling well after receiving PNEUMOVAX 23. The outcome of the events was unknown. The causality assessment between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Rubella
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient who is currently 55 years old. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date in 1970's the patient was vaccinated with M-M-R II (dosing details were not reported) for prophylaxis. On an unknown date in 1970's the patient experienced arthralgia and rubella. The outcome of the events was unknown. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. Additional information is not expected as the reporter did not wish further contact.
Age: 67.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed practical nurse referring to a 67 year old patient of unknown gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 lot # M000592 and expiry date: 12-OCT-2017 (dose and route were not reported) for prophylaxis, (volume/dose reported as 0.5). The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. The vaccine was purchased with private pay insurance. This is one of several reports received from the same reporter. Additional information is not expected because all information required has been received. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA003097: US-009507513-1610USA004377: US-009507513-1612USA006598: US-009507513-1612USA006599.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored ROTATEQ (lot# M007311, expiration date 30-NOV-2017; lot# M025572, expiration date 02-JAN-2018) (dose, frequency and route were unknown) for prophylaxis. The vaccines were exposure to 31.6 Fahrenheit for 16 hours. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007536: US-009507513-1612USA007537:
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 referring to a 6 months old patient. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. 12-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M006112 with an expiration date of 16-NOV-2017, orally, (volume/dose reported as 2), for prophylaxis (dose was not reported). The vaccine was exposed to temperature of 49 Fahrenheit for 32 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. The vaccine was purchased with private pay insurance. This is one of several reports received from the same reporter. Additional information is not expected because all information required has been received. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA004377: US-009507513-1612USA006675: US-009507513-1612USA006674: US-009507513-1612USA006673: US-009507513-1610USA003097: US-009507513-1612USA006672.
Sex: U
Vaccine: PNC13
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 12-DEC-2016, the patient was inadvertently administered a dose of PREVNAR 13 (dose and route were unknown), instead of the indicated PNEUMOVAX 23 (wrong drug administered). No adverse effect was reported. Additional information is not expected as there is no consent for follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored private stock PEDVAXHIB (reported as PEDVAX HIB) (lot# M032148, expiration date 18-APR-2019) (dose, frequency and route were unknown) for prophylaxis. The vaccines were exposure to 31.6 Fahrenheit for 16 hours. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007536: US-009507513-1612USA007537.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored private stock VAQTA (lot# M036459, expiration date 18-JAN-2018) (dose, frequency and route were unknown) for prophylaxis. The vaccines were exposure to 31.6 Fahrenheit for 16 hours. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007532: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007536: US-009507513-1612USA007537.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored vaccine for children stock (reported as VFC stock) ROTATEQ (lot# M007298, expiration date 19-NOV-2017) (dose and frequency were unknown) orally for prophylaxis. At the time of report, the storage temperature and time frame were not determined. There was previous temperature excursion of the vaccines reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007535: US-009507513-1612USA007536: US-009507513-1612USA007537.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored vaccine for children stock (reported as VFC stock) PEDVAXHIB (reported as PEDVAX HIB) (lot# M025193, expiration date 21-MAR-2019) (dose, frequency and route were unknown) for prophylaxis. At the time of report, the storage temperature and time frame were not determined. There was previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007536: US-009507513-1612USA007537.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored vaccine for children stock (reported as VFC stock) VAQTA (lot# M022924, expiration date 24-JAN-2018) (dose, frequency and route were unknown) for prophylaxis. At the time of report, the storage temperature and time frame were not determined. There was previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007537.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to an unspecified number of unspecified patients. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, these patients received improperly stored vaccine for children stock (reported as VFC stock) GARDASIL 9 (lot# M018810, expiration date 28-MAY-2018) (dose, frequency and route were unknown) for prophylaxis. At the time of report, the storage temperature and time frame were not determined. There was previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA006622: US-009507513-1612USA007532: US-009507513-1612USA007533: US-009507513-1612USA007534: US-009507513-1612USA007535: US-009507513-1612USA007536:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an administrator refers to an unspecified number patients of unknown demographics. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an unknown date the patients were vaccinated with improperly stored VARIVAX injection (dosing regimen unspecified) (lot M027885, expiry 30-JUN-2018) (dose, route and frequency unspecified) for prophylaxis. Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 7.7 F, Time frame: 24 hours, there were no previous temperature excursions. Was this a call because of a data logger was reported as no. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported. On unspecified dates, the patients were each vaccinated with a dose of improperly stored of PEDVAXHIB (lot #, expiration date, dose and route were not provided) for prophylaxis, which were exposed to 28.8 Fahrenheit (F) for 8 hours 43 minutes. There was no previous temperature excursion. No adverse effects were reported. The data logger issue was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA000631: US-009507513-1612USA009008.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concomitant therapy and drug reactions were not reported.    On unspecified dates, the patients were each vaccinated with a dose of improperly stored of ROTATEQ (lot #, expiration date and dose were not provided) orally for prophylaxis, which were exposed to 28.8 Fahrenheit (F) for 8 hours 43 minutes. There was no previous temperature excursion. No adverse effects were reported. The data logger issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA000631: US-009507513-1612USA009007:
Sex: F
Vaccine: HPV9
Symptoms: Nephropathy, Renal hypertension
Clinical narrative: Information has been received from a physician referring to a 26 year old female patient.  The patient had no pertinent medical history nor known allergies. In approximately June 2016 (reported as "about 6 months ago"), the patient was vaccinated with the first dose of GARDASIL 9 (strength, route, lot#, dose and expire date were unknown) for prophylaxis. Concomitant medication was unknown. After the vaccination, on an unspecified date of 2016, the patient developed "a renal disease that causes hypertension". The patient had sought for medical attention. The patient was currently prescribed an unspecified dose of prednisone (manufacture unknown) and unspecified blood pressure medication for this condition. The outcome of the events was unknown. The physician reported that this condition did not appear to be linked to GARDASIL 9. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to unknown number of unspecified patients of unknown age and gender.   The patients' medical history, concurrent conditions and concomitant medications were not provided. On some unspecified dates the patients might have received an unknown number of doses of RECOMBIVAX HB (lot # M018625, expiration date 11-AUG-2018, dose, route and site of administration unknown) for prophylaxis. The vaccines were administrated after a temperature excursion to 29.29 degrees Fahrenheit for 111 hours. No adverse effect was reported in any patients. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments:  US-009507513-1612USA009524.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of M-M-R II injection, (lot # M027637; expiration date: 02-JUN-2018), (lot # reported as M029230; expiration date: 08-JUN-2018), (lot # M025607; expiration date: 18-MAY-2018), (lot # reported as M022407; expiration date: 02-MAY-2018), (route of administration, albumin status, strength and dose were not reported) for prophylaxis. The temperature excursion with M-M-R II was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010295: US-009507513-1612USA003446: US-009507513-1612USA010294: US-009507513-1612USA010291: US-009507513-1612USA010292.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of GARDASIL 9 injection, (lot # M030380 ; expiration date: 01-FEB-2019), (lot # M028323; expiration date: 26-SEP-2018), (route of administration, strength and dose were not reported) for prophylaxis. The temperature excursion with GARDASIL 9 was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA010295: US-009507513-1612USA010293: US-009507513-1612USA003446: US-009507513-1612USA010291: US-009507513-1612USA010292.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning on multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients received improperly stored doses of PNEUMOVAX 23 injection, (lot # M013156; expiration date: 15-OCT-2017), (route of administration, strength and dose were not reported) for prophylaxis. The temperature excursion with PNEUMOVAX 23 was at 58 Fahrenheit degrees for 28 hours. The temperature excursion was detected by a data logger. There were no prior excursions. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003446: US-009507513-1612USA010293: US-009507513-1612USA010294: US-009507513-1612USA010291: US-009507513-1612USA010292.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M016238, expiration date 07-DEC-2017, oral; dose was unknown) for prophylaxis. No adverse effects were reported. The excursion temperature was 52 Fahrenheit degree for 17 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. 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-009507513-1612USA010696: US-009507513-1612USA001267.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # M026309, expiration date 11-NOV-2018; dose and route were unknown) for prophylaxis. No adverse effects were reported. The excursion temperature was 52 Fahrenheit degree for 17 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. 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-009507513-1612USA001267: US-009507513-1612USA010695:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patient's were vaccinated with an approximately 6 doses of improperly stored VARIVAX, lot # M023380, expiration date of 11-MAY-2018 (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 7 hours and 41 minutes: 1.9 grades Centigrade. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA010953.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information about patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates in the past, the patients were vaccinated with doses of GARDASIL 9 (dose, route of administration and site of vaccination, lot number and expiration date were not reported). On unknown dates, the patients experienced syncope. The outcome of syncope was reported as recovered on unknown dates for all patients. The relatedness between the event and GARDASIL 9 was not reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003795: US-009507513-1611USA007576.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to an unspecified patients of an unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unspecified dates, the patient's were vaccinated with an approximately 6 doses of PROQUAD, lot # M032498 and an expiration date of 02-JAN-2018 (strength, dose number, and anatomical location were not provided) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 7 hours and 41 minutes: 1.9 grades Centigrade. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA010857.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 10 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 11 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 11 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA003650.
Age: 1.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 14 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Health Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 4 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 6 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 15 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 13 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 1.67
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 20 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with  PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 1.75
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 21 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 16 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 9 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 06-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 6 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 15 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 11 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 12 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 3.0
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 3 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 13-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 15 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 15-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 1.5
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 18 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 15-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.