chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse 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 LIQUID PEDVAXHIB lot # M047666 with expiration date 24-OCT-2019 and lot # N000238 with expiration date 25-OCT-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 (1.2) degrees Celsius for 9 hours/ 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-009507513-1707USA008700: US-009507513-1707USA008699: US-009507513-1707USA008701:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JUL-2017, the patient was vaccinated with the improperly stored (in -11 degrees Celsius for 13 full days) dose of VARIVAX (for prophylaxis, lot # reported as M0048200, expiration date 07-DEC-2018; route of administration was not reported) that was reconstituted with the properly stored sterile diluent. No adverse effects and no previous temperature excursion were reported. Digital data logger was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a 3 year old male patient. The patient has no relevant medical history or concomitant medications. On 13-JUL-2017 the patient was vaccinated with VARIVAX, (lot# reported as M046926, expiration date 28-NOV-2018) 0.5 ml, intramuscularly to the left arm for routine vaccination. Other suspect therapies included sterile diluent (STERILE DILUENT) (lot # M015993, expiration date 03-DEC-2018). The VARIVAX had undergone a temperature excursion. The vaccine was stored between -14 Celsius degree to -10 Celsius degree for 5 hours on 12-JUL-2017. The CMA reports she believed that patient had not experienced an adverse reaction, as the facility had not received a call from the patient's family. There was no relevant laboratory data. As of 15-JUL-2017, it was unknown if the patient continued to receive VARIVAX, it is believed that the patient did not experience an adverse reaction, and the outcome of receiving VARIVAX that had undergone a temperature excursion was unknown. This is one of two reports received from the same reporter.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Tuberculin test, Ultrasound antenatal screen
Clinical narrative: This spontaneous, prospective pregnancy report was received from a registered nurse and refers to a 20 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 07-JUL-2017, the patient was vaccinated with VARIVAX lot # M034583 with expiration date on 27-JUL-2018, subcutaneously, because it was a required vaccination for nursing school. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (strength, dose, frequency, lot # and expiration date were not reported). On the same date, the patient reported to the clinic to receive a Purified Protein Derivative (PPD) test. The nurse reported that after receiving a PPD test, the patient informed that she was pregnant. On 11-JUL-2017, the patient verified pregnancy by ultrasound at an unspecified physician's office. The last menstrual period (LMP) and estimated date of delivery (EDD) were not reported and could not be calculated. The pregnancy outcome was pending. The fetus outcome was unknown. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from nurse refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # M043562, expiry 03-JUN-2018 (dose and route not reported) for prophylaxis. No adverse effects reported. No additional information was provided. Temperature: 32 F to 35 F Time frame: 30 minutes. Data logger was used. Previous temperature excursion? Yes 32F to 35F (34.6F) for 5 minutes 32F to 35F (35.1F) for 30 minutes. This case is one of the 3 reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA009024: US-009507513-1707USA009025:
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On 26-JUN-2017 (reported as 4 days ago), the patient was possibly vaccinated with VARIVAX injection (dose, route of administration, lot # and expiration date were not reported) and PROQUAD injection (dose, route of administration, lot # and expiration date were not reported). Sterile diluent (manufacturer unknown) was used to reconstitute the vaccine. No symptoms were reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1707USA008374.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of GARDASIL (dose and route of administration were not reported) for prophylaxis. The excursion details were as follows: lot # K010574, expiration date 08-APR-2017 and lot # K011562, expiration date 08-APR-2017 - 31F or colder (23F) for 80 hours, 32F to 35F for 63 hours, 47F to 77F for 7 hours. The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA008728: US-009507513-1707USA008729: US-009507513-1707USA008730: US-009507513-1707USA008731.
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse practitioner and refers to a 16 year old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL 9 dose form reported as: 50 mg (also reported as unknown) for prophylaxis. On an unknown date, the patient experienced injection site swelling and bruising for an unspecified reason. The outcome of the event and the relatedness between the event and GARDASIL 9 were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a pharmacist concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified dates, the patients were administered separate doses of improperly stored ZOSTAVAX lot # M035692, expiration date 07-NOV-2017 (dose, frequency, route of administration were not reported). There were two temperature excursions 15°F to 46°F , both with a time frame of 14 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of VAQTA lot# M036459 with expiration date: 18-JAN-2018, lot# N005274 with expiration date: 03-APR-2018, lot# N0005605 with expiration date: 08-APR-2018 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly. The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA009050: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis that were improperly stored. The storage temperature was 9C and time frame was 1 hour. No adverse effects was reported. There was no previous excursion or data logger. This is one of the reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006444: US-009507513-1707USA008758: US-009507513-1707USA008759.
Sex: U
Vaccine: RV5
Symptoms: Culture stool positive, Diarrhoea, Mucous stools, Occult blood positive, White blood cells stool positive
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 3 month old patient of unspecified gender. The patient had no allergies. No concurrent conditions, and medical history were reported. Concomitant therapies included ranitidine hydrochloride(ZANTAC). On 19-JUN-2017, the patient was vaccinated with ROTATEQ lot M043836 with expiry date: 17-JUN-2018, dose 1 (dosing detail, route were unknown) for prophylaxis. On the same day, the patient experienced severe diarrhea. A stool culture performed at physician's medical practice and the results of the culture was negative. On an unknown date approximately in 2017 (reported as a few days later), the patient was taken to pediatric emergency room and stool culture was performed in the pediatric emergency room showed white blood cells and mucus in the patient's stool; positive for occult blood. No treatment was given for diarrhea. As of 10-JUL-2017, the patient does not have blood in stool but continues to have diarrhea containing mucus. The outcome of diarrhea was not recovered and that of occult blood was unknown. The reporter did not provide the causality between the events and ROTATEQ. There were no product quality complaints (PQC) involved.
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistance, concerning a 4 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-JUL-2017, the patient was vaccinated with an expired dose of MMRII lot number L024268 and expiration date of 01-JUL-2017 for prophylaxis (dose and route of administration were not reported). reconstituted with sterile diluent (lot number and expiration date were not reported) No adverse effects were reported.; Sender's Comments: CL-009507513-1707USA006497:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-JUN-2013, the patient was vaccinated with GARDASIL (lot # J002641, expiry date: 10-DEC-2015) (route: intramuscular) at the age of 13 years old. Then on 05-JUL-2017, a dose of GARDASIL 9 (lot # N007931, expiry date: 17-NOV-2019) was administered when the patient was 17 years old (inappropriate schedule of drug administration). No adverse effects reported. The outcome of the events was unknown. The causality of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report received from a medical assistant referred to a 51 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. The patient was administered RECOMBIVAX HB (dose, lot and expiry date not reported) on 23-MAY-2011, 28-JUN-2011 and 26-SEP-2011 (inappropriate schedule of drug administration). A titre was perfomed on an unspecified date and the results were negative for hepatitis B (Hepatitis B antibody negative). Concomitant medication included VAQTA taken on 29-JUN-2017. Outcome of Hepatitis B antibody negative was unknown. Causality assessment was not reported. Additional information is not expected as consent to contact is not provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as "nurse") refers to an unspecified number of patients of unknown age. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot M039642, expiration 03-JUL-2019; lot M045653, expiration 03-JUL-2019. There was no adverse events. The doses of vaccines experienced temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA008739: US-009507513-1707USA008737:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 63-year-old patient of unknown gender. The patient had no pertinent medical history or known drug reactions and allergies. On 11-JUL-2017, the patient was vaccinated with a dose of PROQUAD injection, subcutaneously (dose, lot #, expiry date were not reported) instead of a dose of ZOSTAVAX due to human error. Concomitant therapies included sterile diluent. No adverse effect was reported. The patient did not seek medical attention and had no lab diagnostic performed. 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 with prophylaxis. On an unknown date the patient was vaccinated with PROQUAD lot # M018638 for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PROQUAD.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a company employee, who referred to her mother, a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions and allergies was provided. On an unknown date (reported as years ago), the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) as prophylaxis. On an unknown date, the patient experienced shingles. The outcome of the event was unknown. The relatedness between the event and suspect therapy was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 12 month old patient. On an unknown date, 12 month old patient received the third dose of ROTATEQ. No adverse effects were reported. No further details were provided.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On an unknown date (reported as a long time ago), the patient was vaccinated with VARIVAX injection (dose, route of administration, lot # and expiration date were not reported) and PROQUAD injection (dose, route of administration, lot # and expiration date were not reported). Sterile diluent (manufacturer unknown) was used to reconstitute the vaccine. No symptoms were reported. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted. Sender's Comments: US-009507513-1707USA005223.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant and refers to an unspecified patients of unknown age. On an unknown date, an unspecified patient received an improperly stored dose of the following GARDASIL 9 lot # M013636, expiry date:15-FEB-2018 (incorrect product storage). No adverse effect was reported. The outcome of incorrect product storage and no adverse event were unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Migraine
Clinical narrative: This spontaneous report as received from a female patient of unknown age referring herself. The patient's current conditions, medical history and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, dose, route of administration, lot/batch# and expiration date were not reported) for prophylaxis. On an unknown date (reported as 'after receiving injection), the patient experienced migraine because PNEUMOVAX 23 contained monosodium glutamate (MSG).The outcome of migraine was unknown. The causality assessment was not provided by the reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a 64 year old female patient via a company representative regarding herself. On 2016, the patient was vaccinated with ZOSTAVAX, subcutaneous for prophylaxis. On an unknown date, the patient's arm at the site swelled to the size of a baseball(vaccination site swelling and vaccination site mass). The outcome of vaccination site mass and vaccination site swelling was reported as recovered. Causality assessment was not provided. Additional information is not expected as no contact details have been provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. 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 GARDASIL 9 lot # M042853, expiration date 17-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 (1.2) degrees Celsius for 9 hours/ 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-009507513-1707USA008700: US-009507513-1707USA008701: US-009507513-1707USA002177.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse 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 PNEUMOVAX 23 lot # M037533 with expiration date 07-MAY-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 (1.2) degrees Celsius for 9 hours/ 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-009507513-1707USA002177: US-009507513-1707USA008701: US-009507513-1707USA008699:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse 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 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 0 to 1 (1.2) degrees Celsius for 9 hours/ 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-009507513-1707USA008700: US-009507513-1707USA002177: US-009507513-1707USA008699:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of LIQUID PEDVAXHIB (dose and route of administration were not reported) for prophylaxis. The excursion details were as follows: lot # L014426, expiration date 08-MAR-2018 - 31F or colder (20F) for 156 hours, 32F to 35F for 119 hours lot # reported as K0110778, expiration date 31-MAR-2017 - 32F to 35F for 16 hours lot # K019700, expiration date 16-JUL-2017 - 31F or colder (20F) for 85 hours, 32F to 35F for 169 hours lot # K025006, expiration date 22-JUL-2017 - 31F or colder (30F) for 111 hours, 32F to 35F for 170 hours, 47F to 77F for 7 hours lot # L004740, expiration date 16-NOV-2017 - 32F to 35F for 16 hours The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006088: US-009507513-1707USA008729: US-009507513-1707USA008730: US-009507513-1707USA008731.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of PNEUMOVAX 23 (dose and route of administration were not reported) for prophylaxis. The excursion details were as follows: lot # K020214, expiration date 25-MAR-2016 - 31F or colder (23F) for 84 hours, 32F to 35F for 63 hours, 47F to 77F for 7 hours The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA006088: US-009507513-1707USA008730: US-009507513-1707USA008731: US-009507513-1707USA008728:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of ROTATEQ (orally; dose was not reported) for prophylaxis. The excursion details were as follows: lot # K020181, expiration date 24-JUN-2016 - 31F or colder (28F) for 15 hours, 32F to 35F for 32 hours lot # L004466, expiration date 02-AUG-2016 - 32F to 35F for 32 hours lot # K011948, expiration date 07-JUN-2016 - 31F or colder (20F) for 53 hours, 32F to 35F for 55 hours lot # K009753, expiration date 28-APR-2016 - 31F or colder (23F) for 84 hours, 32F to 35F for 42 hours lot # K010325, expiration date 10-MAY-2016 - 31F or colder (23F) for 67 hours, 32F to 35F for 63 hours lot # K023534, expiration date 22-MAY-2016 - 31F or colder (30F) for 48 hours, 32F to 35F for 100 hours lot # K014826, expiration date 28-MAY-2016 - 31F or colder (23F) for 84 hours, 32F to 35F for 63 hours, 47F to 77F for 7 hours The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006088: US-009507513-1707USA008731: US-009507513-1707USA008728: US-009507513-1707USA008729:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of VAQTA (dose and route of administration were not reported) for prophylaxis. The excursion details were as follows: lot # K019560, expiration date 02-JUN-2017 - 31F or colder (23F) for 67 hours, 32F to 35F for 79 hours, 47F to 77F for 7 hours lot # reported as L0002717, expiration date 02-JUN-2017 - 31F or colder (20F) for 68 hours, 32F to 35F for 71 hours lot # reported as K012547, expiration date 04-JUN-2017 - 32F to 35F for 32 hours lot # K010579, expiration date 12-FEB-2017 - 31F or colder (23F) for 95 hours, 32F to 35F for 63 hours, 47F to 77F for 3 hours lot # reported as K023232, expiration date 25-FEB-2017 - 31F or colder (20F) for 68 hours, 32F to 35F for 88 hours lot # L004743, expiration date 01-JUN-2017 - 31F or colder (20F) for 53 hours, 32F to 35F for 55 hours The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006088: US-009507513-1707USA008730: US-009507513-1707USA008729: US-009507513-1707USA008728:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as "nurse") refers to an unspecified number of patients of unknown age. On unknown date the patients were vaccinated with improperly stored doses of ROTATEQ (lot M040268, expiration 14-MAY-2018; lot M040271, expiration 30-APR-2018). There was no adverse events. The doses of vaccines experienced temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006990: US-009507513-1707USA008739:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as "nurse") refers to an unspecified numer of  patients of unknown age. On unknown date the patients were vaccinated with improperly stored doses of VAQTA ((lot M038572, expiration 11-MAR-2018; lot N003194, expiration 28-OCT-2017). There was no adverse events. The doses of vaccines experienced temperature excursion of 47 to 77 degrees Fahrenheit for 15 minutes. There was no previous temperature excursions. Digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA006990: US-009507513-1707USA008737:
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a nurse practitioner via Pfizer and refers to a patient of unknown age and gender. On an unknown date, PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported) had an unspecified excursion in the refrigerator. It could not be probed if the vaccine was administered to any patient or not after the excursion. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (lot #, expiration date, dose and route were not reported) for prophylaxis that were improperly stored (Incorrect product storage). The storage temperature was 9C and time frame was 1 hour. No adverse effects was reported. This is one of the three report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with M-M-R II (lot #, expiration date, dose and route were not reported) for prophylaxis that were improperly stored (Incorrect product storage). The storage temperature was 9C and time frame was 1 hour. No adverse effects was reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of the three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent condition, drug allergies and concomitant medications were not reported. On unknown dates the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # M042169 , Expiry date : 22-JUN-2018 and Lot # M042172, Expiry date:08-JUN-2018 ) (Strength, dose and route of administration were not reported) for prophylaxis, which experienced a temperature excursion between 47° Fahrenheit to 77° Fahrenheit for 30 minutes. It was unknown if there was previous temperature excursions. Data logger was not involved. There was no product quality complaint involved. No adverse effects were reported (incorrect product storage and no adverse event). This is 1 of 4 reports from the same reporter.  Sender's Comments: US-009507513-1707USA008614:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # M015930 with an expiration date 29-MAR-2018 for prophylaxis (dose and route of administration were not reported) reconstituted in properly stored sterile diluent (STERILE DILUEN) (lot# reported as N004801 with an expiration date 09-JUL-2019). There was no adverse effect reported. Administered dose of vaccine experienced the temperature  excursion from 9 to 25 degrees Celsius for 2 hours. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA008179:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored GARDASIL 9 (lot # M011840 with expiration date 01-FEB-2018, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA009010: US-009507513-1707USA009011: US-009507513-1707USA009012: US-009507513-1707USA009013: US-009507513-1707USA009014.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # M033086 with expiration date 05-MAY-2018, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009011: US-009507513-1707USA009012: US-009507513-1707USA009013: US-009507513-1707USA009014:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored RECOMBIVAX HB (lot # M040422 with expiration date 07-JUL-2019, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009010:  US-009507513-1707USA009012: US-009507513-1707USA009013: US-009507513-1707USA009014:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored VAQTA (lot # N005605 with expiration date 08-APR-2018 and lot # M039202 with expiration date 11-MAR-2018, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009010: US-009507513-1707USA009011: US-009507513-1707USA009013: US-009507513-1707USA009014.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored ROTATEQ (lot # M041181 with expiration date 31-MAY-2018, dose unknown) orally for prophylaxis.    No adverse effects were reported. The vaccines were stored under temperature 9-25 degrees Celsius with time frame 2 hour and 31 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009010: US-009507513-1707USA009011: US-009507513-1707USA009012: US-009507513-1707USA009014.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding concurrent condition or medical history was unknown. On unknown dates, the patients each were vaccinated with a dose of improperly stored M-M-R II (lot # M010426 with expiration date 01-MAR-2018, lot # M015931 with expiration date 30-MAR-2018, lot # M029919 with expiration date 13-JUN-2018, route and dose unknown) for prophylaxis. No adverse effects were reported. The vaccines with lot # M010426 were stored under temperature 9-25 degrees Celsius with time frame 1 hour and 13 minutes and the vaccines with lot # M015931 and lot # M029919 were stored under temperature 9-25 degrees Celsius with time frame 2 hour and 31 minutes. There was no previous temperature excursion. No data logger involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA008913: US-009507513-1707USA009010: US-009507513-1707USA009011: US-009507513-1707USA009012: US-009507513-1707USA009013.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from nurse refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M042853, expiry 17-JUL-2018; lot # M041990, expiry 28-JUN-2018 and lot # M035486, expiry 05-JUN-2019 (dose and route not reported) for prophylaxis. No adverse effects reported. No additional information was provided. Temperature: 32 F to 35 F. Time frame: 30 minutes. Data logger was used. Previous temperature excursion? Yes. 32F to 35F (34.6F) for 5 minutes. 32F to 35F (35.1F) for 30 minutes. This case is one of the 3 reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from nurse refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA lot # N005274, expiry 03-APR-2018 (dose and route not reported) for prophylaxis. No adverse effects reported. No additional information was provided. Temperature: 32 F to 35 F. Time frame: 30 minutes. Data logger was used. Previous temperature excursion? Yes 32F to 35F (34.6F) for 5 minutes, 32F to 35F (35.1F) for 30 minutes. This case is one of the 3 reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA004978: US-009507513-1707USA009024.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reaction or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX lot# L016959 with expiration date: 12-MAR-2018, lot# L029631 with expiration date: 14-AUG-2017 (therapy type, dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly(lot# and expiration date not provided). The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009051: US-009507513-1707USA009052: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUL-2015, at age 11 years, the patient received the first dose of the HPV vaccination series. The nurse states that is unknown if it was GARDASIL (dose, lot # and expiration date were not reported) or GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). The nurse states that the patient received the second dose in the HPV vaccination series on 27-FEB-2017 and it was GARDASIL 9 lot# M036059, expiration date 03-JUN-2019 (dose and route of administration were not reported). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information was received on 11-JUL-2017 from a pharmacist regarding a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, site of administration and lot number not reported). On an unknown date, the patient came into the pharmacy on 11-JUL-2017, because she had developed "redness and a raised hard bump" at the injection site. It was not reported what date the reaction first developed. The pharmacist stated she did not have time to answer any further questions. The outcome of the events were unknown. The relationship between the events and ZOSTAVAX was not provided. No further information was provided. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to a 53 year old female patient. The patient's past medical history, concurrent conditions or concomitant medication were not provided. On 06-JUL-2017, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB, 10 mcg/1.0 mL, expiration date 15-APR-2017 (Lot #, dose number, and route of administration were not provided). No adverse effect reported. The nurse reported that the adverse event (NOS) had been previously reported and evaluated. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant, referring to multiple unspecified patients. The patients' medical history, concurrent conditions, concomitant therapy, drug and allergy history were not provided. It was reported that on unknown dates, multiple unspecified patients were vaccinated with ROTATEQ, lot number L035510, expiration date 13-MAY-2017 (dose, frequency and administration route were not reported), for prophylaxis. At the reporting time, this vaccine was already expired and it was very possible that this vaccine had been administered. No adverse effects were reported. As on 19-JUL-2017, all telephone attempts to obtain follow up information had been unsuccessful. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1705USA015628.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot# M014926 with expiration date: 17-FEB-2019 and lot# M025192 with expiration date: 21-MAR-2019 (dose and route of administration were not reported) as prophylaxis. The sterile diluent (manufacturer unknown) used was stored properly (lot# and expiration date not reported). The doses of vaccine were stored between 47 degrees Fahrenheit (F) to 77F for 3 hours and 18 minutes. No previous temperature excursions were detected. Digital data logger was involved. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA006289: US-009507513-1707USA009050: US-009507513-1707USA009052: US-009507513-1707USA009053: US-009507513-1707USA009054: US-009507513-1707USA009055: US-009507513-1707USA009056: US-009507513-1707USA009057.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 101.2 greater than 24hours.