chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 Lot # L037339, 0.5 ml - 10 Pk SD PFS, expiry date 09-FEB-2018; route of administration was not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to three separate temperature excursion (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1 degrees Celsius), the second one lasting for 40 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third one lasting for 40 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.1 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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 was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 488 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 mg/1ml injection (lot # J015547, expiry date 03-FEB-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two temperature excursions (dates unspecified), one lasting for 64 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), and the second lasting for 16 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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 was received from a physician and a support services director via company representatives and refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L038522, expiry date 11-AUG-2017; strength and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (dates unspecified). The vaccine was stored in a refrigerator in the lowest temperature recorded of 31 degrees Fahrenheit (-0.56 degrees Celsius) for 80 hours and 32 degrees Fahrenheit (0 degrees Celsius) for 64 hours (exact dates and sequence were not reported). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 05-NOV-2014, the patient was vaccinated with an improperly stored dose of M-M-R II injection (lot# J003625, expiry date 22-MAR-2015, albumin status HSA; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to seven separate temperature excursions (dates unspecified): two concerning a freezer (one lasting for 72 hours with the highest recorded temperature of 8 degrees Fahrenheit (-13.33 degrees Celsius) and the second lasting for 24 hours with the highest recorded temperature of 6 degrees Fahrenheit (-14.44 degrees Celsius) and five concerning a refrigerator (one lasting for 72 hours with the highest recorded temperature of 47 degrees Fahrenheit (8.33 degrees Celsius), the second lasting for 72 hours with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), the third lasting for 248 hours with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), the fourth lasting for 112 hours with the highest recorded temperature of 49 degrees Fahrenheit (9.44 degrees Celsius) and the last lasting for 72 hours with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L037339, 0.5 ml - 10 Pk SD PFS-Luer-Lok, expiry date 09-FEB-2018; route of administration was not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to three separate temperature excursion (dates unspecified): one lasting for 64 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1 degrees Celsius), the second one lasting for 24 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius) and the third one lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.1 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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 was received from a physician and support services director and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 20-NOV-2015, the patient was vaccinated with an improperly stored dose of PUEUMOVAX 23 0.5 ml prefilled syringe (lot # L022795, expiration date: 05-NOV-2016; dose and route of administration were not provided). The dose of the vaccine was exposed to the following separate temperature excursion (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 8.3 degree Fahrenheit, the second one lasting for 24 hours, with the lowest recorded temperature of 8.4 degrees Fahrenheit, the third one lasting for 24 hours, with the lowest recorded temperature of 8.1 degrees Fahrenheit, the fourth one lasting for 24 hours, with the lowest recorded temperature of 8.5 degrees Fahrenheit. The vaccine was stored in a refrigerator No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 09-JAN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II injection (lot# J003625, expiry date 22-MAR-2015, albumin status HSA; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to a temperature excursion (date unspecified) concerning a refrigerator. The excursion lasted for 48 hours with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator and/or in the freezer. No adverse effects were reported. There was no product quality complaint 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 and from a support service director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-JUN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection (lot# K023328, expiry date 23-JUN-2016; dose and route of administration were not reported. There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified) lasting for 1488 hours, with the lowest recorded temperature of 27 degrees Fahrenheit (-2.77 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director and refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 06-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection (lot # K001500, expiry date: 06-NOV-2016; exact dose and route of administration were not reported). There were no concomitant therapies reported. On an unknown date, the dose of the vaccine was exposed to a temperature excursion for 24 hours, with the highest recorded temperature of 47 degrees Fahrenheit (8.33 degrees Celsius). the vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 19-APR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # L037339, 0.5 ml - 10 Pk SD PFS-Luer-Lok, expiry date 09-FEB-2018; route of administration was not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to three separate temperature excursion (dates unspecified): one lasting for 96 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1 degrees Celsius), the second one lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (0 degrees Celsius) and the third one lasting for 24 hours, with the lowest recorded temperature of 30 degrees Fahrenheit (-1.1 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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 was received from a physician and a support services director via company representatives and refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 20-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot# L038522, expiry date 11-AUG-2017; strength and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (dates unspecified). The vaccine was stored in a refrigerator in the lowest temperature recorded of 31 degrees (-0.56 degrees Celsius) for 80 hours and 32 degrees Fahrenheit (0 degrees Celsius) for 40 hours (exact dates and sequence were not reported). No adverse effects were reported. There was no product quality complaint 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 and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 30-JUL-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection (lot# K023328, expiry date 23-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (dates unspecified) lasting for 2688 hours, with the lowest recorded temperature of 27 degrees Fahrenheit (-2.77 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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 was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 30-JAN-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml injection, lot # H022280, expiration date 16-JUL-2014 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 708 hours, with the lowest recorded temperature of 20 degrees Fahrenheit (-6.666666667 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. On 05-DEC-2014, the patient was vaccinated with an improperly stored RECOMBIVAX HB 10 Pk 10mcg/1ml SD LLok w Cap AD (lot # K008988, expiry date 04-FEB-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 144 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.55 degrees Celsius and the second one lasting for 48 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 04-SEP-2014, the patient was vaccinated with an improperly stored dose of GARDASIL 5 mg/0.5 ml injection, lot # J014219, expiration date 05-OCT-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 168 hours, with the lowest recorded temperature of 34 degrees (1.111111111 degrees Celsius) and another lasting for 24 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 23-FEB-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL (lot # K023435 with an expiration date on 05-NOV-2016; dose and route of administration were not reported). The dose of the vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.556 degrees Celsius) and the second one lasting for 48 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 18-FEB-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 10x1 single dose vial (SDV) injection (lot# K009482, expiry date 06-MAR-2017; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified), lasting for 152 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 07-JUL-2016 , the patient was vaccinated with an improperly stored dose of GARDASIL lot # L033347 , 0.5 ml - 10 Pk SD PFS-Luer-Lok, expiry date 23-JUL-2017; route of administration was not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): lasting for 48 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.1 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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 was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 01-MAY-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml injection, lot # H022280, expiration date 16-JUL-2014 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 2892 hours, with the lowest recorded temperature of 20 degrees Fahrenheit (-6.666666667 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5 ml, lot # K005797 with expiration date 21-MAR-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Celsius degree (the highest recorded temperature was not reported). The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Celsius degree (the highest recorded temperature was not reported). The total cumulative excursion time of the third time was 48 hours with the lowest recorded temperature of 1 Celsius degree (the highest recorded temperature was not reported). The total cumulative excursion time of the fourth time was 72 hours with the highest recorded temperature of 9 Celsius degree (the lowest recorded temperature was not reported). 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 referring to a patient of unknown age and gender. On 22-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5 ml, lot # K005797, expiration date 21-MAR-2015). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 1 Celsius degree (the highest recorded temperature was not reported). 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: This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 06-MAR-2014, the patient was vaccinated with an improperly stored dose of M-M-R II injection (lot# J003625, expiry date 22-MAR-2015, albumin status HSA; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to three separate temperature excursions (dates unspecified): one concerning a freezer (lasting for 72 hours with the highest recorded temperature of 6 degrees Fahrenheit (-14.44 degrees Celsius)) and two concerning a refrigerator (one lasting for 248 hours with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius), and the second lasting for 336 hours with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius)). No adverse effects were reported. There was no product quality complaint 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 reports was received from a physician and support services director and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L022795, expiration date: 05-NOV-2016; dose and route of administration were not provided). The dose of the vaccine was exposed to the following separate temperature excursion (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 8.3 degrees Fahrenheit, the second one lasting for 24 hours, with the lowest recorded temperature of 8.4 degrees Fahrenheit, the third one lasting for 24 hours, with the lowest recorded temperature of 8.1 degrees Fahrenheit, the fourth one lasting for 8 hours, with the lowest recorded temperature of 8.5 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous reports as received from a physician and from a support services director via two company representatives refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 29-JUN-2015, patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II injection (lot# J003625, expiry date 11-MAR-2016, albumin status HSA; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to six separate temperature excursions (dates unspecified), all of them concerning a refrigerator: the first lasting for 168 hours with highest recorded temperature of 49 degrees Fahrenheit (9.44 degrees Celsius), the second one lasting for 336 hours with the highest recorded temperature of 59 degrees Fahrenheit (15 degrees Celsius), the third one lasting for 1172 hours with the lowest recorded temperature of -3 degrees Celsius, the fourth lasting for 80 hours with the lowest recorded temperature of 30 degrees Fahrenheit (-1.11 degrees Celsius), the fifth lasting for 416 hours with the highest recorded temperature of 47 degrees Fahrenheit (8.33 degrees Celsius) and the last lasting for 24 hours with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius). The vaccine was stored in the refrigerator and/or in the freezer. No adverse effects were reported. There was no product quality complaint 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 and from a support services director via two company representatives refers to a patient of an unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10PK-0.5 ml SD-PFS LLok w Tip (lot# L022262, expiry date 05-NOV-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): lasting for 48 hours, with the lowest recorded temperature of 39 degrees Fahrenheit (-1.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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 was received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 11-MAY-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection (lot# K023328, expiry date 23-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified) lasting for 152 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (-0.55 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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: Information has been received from a physician 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 08-JUL-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5 ml SD-PFS LLokwTip" (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 40 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 304 hours with the lowest recorded temperature of 33 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and from a support services director via company representative and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 21-APR-2015, the patient was vaccinated with a dose of an improperly stored GARDASIL (lot # K023435 with an expiration date on 05-NOV-2016; dose and route of administration were not reported). The dose of the vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.556 degrees Celsius) and the second one lasting for 48 hours, with the lowest recorded temperature of 32 Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. 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 and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 10-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection (lot# K023328, expiry date 23-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to 3 temperature excursions (dates unspecified): one lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius) and the second lasting for 176 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.88 degrees Celsius), and the last one lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint 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: Information has been received from a physician and a practice manager via two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 12-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). 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 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 19-FEB-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 twice. The total cumulative excursion time of the first time was 828 hours with the lowest recorded temperature of -3 Celsius. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 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 referring to a patient of unknown age and gender. On 19-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 144 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 144 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: 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 25-MAY-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 144 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 144 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 event 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: This spontaneous report was received from a nurse practitioner regarding unknown patients of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with unspecified number of improperly stored doses of M-M-R II (lot# L040960, batch/lot# M008588, expiry dates and dosing details not known). The lot# L040960 was stored at 9.6 Celsius(C) for 46 hours and batch/lot# M008588 was stored at 9.6 Celsius(C) for 19 hours. No adverse effects were reported. There was no product quality complaint (PQC) involved. 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-MAR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II single 0.5 ml dose (rHA, lot # L008684, expiration date 13-MAR-2017, dose and route unknown). This specified lot number vaccine was exposed to temperature excursion for eight times. The total cumulative excursion time of the first time was 24 hours with the highest recorded temperature of 7 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the second time was 360 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was refrigerator (R). The total cumulative excursion time of the third time was 24 hours with the highest recorded temperature of 6 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the fourth time was 24 hours with the highest recorded temperature of 8 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the fifth time was 24 hours with the highest recorded temperature of 11 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the sixth time was 72 hours with the highest recorded temperature of 15 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the seventh time was 248 hours with the highest recorded temperature of 9 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine this time was freezer (F). The total cumulative excursion time of the eighth time was 144 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 and a practice manager referring to a patient of unknown age and gender. On 20-APR-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 120 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 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 two company representatives referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 21-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot # L010598, expiration date 06-AUG-2016, route unknown). 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 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 09-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 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 01-DEC-2014 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 48 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 effect was reported. This is one of several reports received 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 medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M004328, expiry date: 26-JAN-2018) (incorrect product storage). Medical assistant reported that the vaccine underwent temperature excursion at unknown temperature for 23 hours. The vaccine was exposed to an unspecified temperature of 12 hours previously as well. No adverse effects were reported. This is one of the 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: 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-DEC-2014 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 48 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 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 referring to a patient of unknown age and gender. On 03-JUN-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 144 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 144 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 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 referring to a patient of unknown age and gender. On 13-AUG-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second timer was 48 hours with the lowest recorded temperature of 0 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.