chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 06-MAY-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokw TIP) (lot # K019386, expiration date 09-JUN-2016) This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1392 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-FEB-2016 the patient was vaccinated with an improperly stored dose of VAQTA 50U/1ml (lot # L018498, expiration date 28-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 744 with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 03-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 31-JAN-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-JUL-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot # L014878, expiration date 17-JAN-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 128 hours with highest recorded temperature of 49 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-MAR-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot# J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 28 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAY-2014 the patient was vaccinated with an improperly stored dose of M-M-R II (HSA) (lot # H014991, expire date 10-AUG-2014, strength: 0.5ml, dose: 0.5 ml; route unknown). The total cumulative excursion time was 24 hours with highest recorded temperature of -14 centigrade degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml (lot # K012424, expiration date 05-JUN-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1008 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 09-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 744 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. The is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 07-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 64 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 23-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mISD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 1080 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5ml single-dose vial (SDV) (lot # M005714, expiration date 03-OCT-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 112 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5 ml single-dose vial (SDV) (lot # M005714, expiration date 03-OCT-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5 ml single-dose vial (SDV) (lot # M005714, expiration date 03-OCT-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 suspension ten 0.5ml single-dose vial (SDV) (lot # M005714, expiration date 03-OCT-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-JUL-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition, concomitant medication and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX lot no. M032141/ expiration date-02-OCT-2017 (incorrect product storage). No adverse event was reported. Temperature and Time of excursion was 17F for 2 hours. There was no previous excursion and call was not because of data logger. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 24 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 01-AUG-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # M000442, expiration date 31-MAR-2018, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 24 hours with the lowest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-AUG-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot # L014878, expiration date 17-JAN-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 128 hours with the highest recorded temperature of 49 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 10-MAR-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manage referring to a patient of unknown age and gender. On 27-JUL-2016 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot # L014878, expiration date 17-JAN-2018, dose and route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 128 hours with highest recorded temperature of 49 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-FEB-2014 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # J011272, expiration date 21-APR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 24-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml Prefilled Syringe (PFS) (lot # K020795, expiration date 19-MAR-2016, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received form the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5ml, lot # L044475, expiration date 12-MAY-2017, route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-AUG-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml (0.5 ml, lot # L044475, expiration date 12-MAY-2017, route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5ml, lot # L044475, expiration date 12-MAY-2017, route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 02-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 576 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5ml, lot # L044475, expiration date 12-MAY-2017, route unknown). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 144 hours with the highest recorded temperature of 12 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-JUL-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 64 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-FEB-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 152 hours with the lowest recorded temperature of 0 Fahrenheit degree. The total cumulative excursion time of the second time was 776 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 15-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot #K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 888 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 18-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS-LLowkwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 216 hours with the lowest recorded temperature of 27 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-AUG-2014, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (HSA) (lot # H014991, expire date 31-AUG-2014, strength: 0.5ml, dose: 0.5 ml; route unknown). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the highest recorded temperature of -14 centigrade degree. The total cumulative excursion time of the second time was 80 hours with the highest recorded temperature of -13 centigrade degree. The storage criteria and the type of excursion for this vaccine was freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional  information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-SEP-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -0.55 Celsius Degrees for 32 hours, 1.11 Celsius Degrees for 208 hours, 0 Celsius Degrees for 152 hours and 0.55 Celsius Degrees for 200 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-MAR-2016 the patient was vaccinated with an improperly stored dose of ROTATEQ oral dose, 10-pack (lot # K010224, expiration date 13-MAY-2016) orally. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature 0 Fahrenheit degree. The total cumulative excursion time of the second time was 920 hours with the lowest recorded temperature of 1.11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: MMR
Symptoms: Wrong drug administered
Clinical narrative: Patient requested vaccination for TDaP. Received MMR by mistake.
Age: 87.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Localised infection, Skin warm
Clinical narrative: Arm infected (warm and red to touch for several days) dr prescribed antibiotics to prepare for surgery.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning to a 13 year old female patient. Her medical history and concurrent conditions were not reported. On 03-MAR-2016 at 10:00, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies was reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, concerning to a 14 year old male patient. His medical history and concurrent conditions were not reported. On 02-FEB-2016 at 13:00, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies were reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, concerning to a 4 year old female patient (also reported as 14 year old). Her medical history and concurrent conditions were not reported. On 11-MAR-2016 at 10:30, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies was reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported/ On 24-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at 1.11 Celsius Degrees for 40 hours, 0.55 Celsius Degrees for 200 hours, 0 Celsius Degrees for 152 hours and -0.55 Celsius Degrees for 32 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, concerning to a 18 year old white female patient. Her medical history and concurrent conditions were not reported. On 04-FEB-2016 at 12:30, the patient was vaccinated for the second time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies were reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Age: 22.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant therapies were not provided. On 26-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II (lot # as reported M001200, expiration date 28-AUG-2016, dose 2, 0.5 ml, subcutaneous). No adverse event was reported and no product quality complice (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a Registered Nurse concerning to multiple unspecified patients (ages and genders not reported) who on unknown date were vaccinated with an improperly stored doses of VAQTA (Lot No. M017982, exp. 13-SEP-2017) (dose and route not reported). The doses were part of an excursion with temperature of 35F for 1 hour. There was no previous temperature excursion. The reporter did not know if any adverse effect were reported. This is one of several reports from the same source. 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 non health care professional referring to unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions/allergies or concomitant information was not reported. On 03-OCT-2016, the patients were vaccinated with improperly stored doses of VARIVAX lot # L032391, expiration date: 26-AUG-2017 (strength, dose and route of administration were not provided). No adverse events were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 504 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 06-AUG-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -0.55 Celsius Degrees for 32 hours, 0 Celsius Degrees for 152 hours, 0.55 Celsius Degrees for 200 hours and 1.11 Celsius Degrees for 176 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, Measles antibody positive, Mumps antibody test, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with M-M-R II, intramuscularly, (dose and frequency not reported). The outcome of the event was unknown. No further details provided. This is one of two reports received from the same reporter. As of 07-OCT-2016 all telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant, via a company representative, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route of administration, lot # and expiry date were unknown). Then, on an unknown date (reported as "9 months after the first dose), the patient was vaccinated with the second dose of GARDASIL (strength, dose, route of administration, lot # and expiry date were unknown). No adverse effects were reported and no product quality complaint was involved. Additional information is not expected, no permission for further contact was provided.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, concerning to a 15 year male patient. His medical history and concurrent conditions were not reported. On 26-APR-2016 at 11:00, the patient was vaccinated for the first time with an improperly stored dose of VARIVAX subcutaneously, lot number L013826 and expiration date of 21-APR-2017 (dose was not provided). No concomitant therapies was reported. It was reported that the vaccines were stored at 26.5F for 3 hours and previously stored at 46F for 50 hours and at 46F for 20 minutes (dates unspecified). The temperature excursion was captured via a Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up was received.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via an unspecified reporter, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVis 10SDV" and lot number J011998 with expiration date of 12-FEB-2015 (route of administration was unknown), which was stored at -6.66 Celsius Degrees for 1176 hours. The type of excursion was refrigerator and the vaccine status in excursion. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.