chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 12-MAR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported and nor 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 was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 19-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokw Tip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.77777778 Celsius) for 408 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No concomitant therapies not 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 was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 23-JUL-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -0.55 Celsius Degrees for 40 hours, 0.55 Celsius Degrees for 40 hours, 1.11 Celsius Degrees for 88 hours and 0 Celsius Degrees for 152 hours. The type of excursion was refrigerator. No adverse effects 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: 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-NOV-2014 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot# J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 48, 1 and R. The storage criteria was refrigerator (R). 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 was received from a physician via company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 25-AUG-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained 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 via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 20-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mLVls 10SDV, (lot number L035885, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 had a temperature excursion. The lowest temperature excursion was of 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 48, 34, and R; 144, 31 and R. The storage criteria 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 28-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength 0.5 mL, lot # L027282, expiration date 21-SEP-2017, dose and route were unknown). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first excursion was 16, 33 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 208, 31 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 72, 29 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 112, 30 and R. The total cumulative excursion time (hour, the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 88, 32 and R. 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 was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5 mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius) for 216 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". 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 was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 21-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 516 hours (sum of hours in excursion). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events 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: Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 03-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot number L040181, with an expiration date of 18-AUG-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 vaccine had a temperature excursion. The highest temperature excursion was of 47 Fahrenheit (F), (8.333333333 Celsius degrees) for a total of 24 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 06-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB "10Pk 10mcg/1mL SD LLok Cap AD", lot # L001441 with expiration date 17-AUG-2017 (route of administration and anatomical location were not reported). There were no concomitant therapies and adverse effects reported. No product quality complain was involved. On an unspecified date, the RECOMBIVAX HB had six temperature excursion of 34 F (1.11 Celsius Degrees) for 88 hours, 29 F (-1.6 Celsius Degrees) for 120 hours, 30 F (-1.1 Celsius Degrees) for 96 hours, 31 F (-0.5 Celsius Degrees) for 320 hours, 32 F (0 Celsius Degrees) for 200 hours and 33 F (0.5 Celsius Degrees) for 64 hours, respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type of excursion were reported as "Refrigerator (R)". 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 was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 11-MAR-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok w Tip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.11 Celsius Degrees for 504 hours. The type of excursion was refrigerator. No adverse effects 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 was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 08-DEC-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first time was 24, 34 and R. The total cumulative excursion time (hour); the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first time was 72, 47 and R. The storage criteria 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 12-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 72, unknown and R; 48, 1 and R. The storage criteria 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 via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 19-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL, lot # J009788 with expiration date of 17-MAR-2016, (strength, dose and route of administration were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the reported temperature excursion lasted 416 hours, where the lowest recorded temperature was 26 F (-3.333333333 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "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: This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 25-NOV-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336(dose, route and the expiration date were not reported). The total cumulative hours out of range were 24 hours with 34 C as the the lowest recorded temperature. The storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports 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 company representatives and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 14-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVls 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to two temperature excursions for a sum of 72 hours at a highest temperature recorded of 47 degrees F (8.333333333 degrees C), and the other for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained 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: Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 09-APR-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 16 and 64. The lowest recorded temperatures were of 33 and 34 respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". 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 via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 16-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number K003074 with expiration date of 13-MAR-2015 (route of administration and anatomical location were unknown). The sum of hours of the vaccine excursion was 424 hours and the lowest recorded temperature reported was 33 degrees F (0.555555556 Celsius degrees). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not reported. On 21-DEC-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and the expiration date were not reported). The total cumulative hours out of range were 64 hours with 48 degrees C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 degrees C, 304 hours with 33 degrees C, 88 hours with 30 degrees C, 40 hours with 34 degrees C as the lowest recorded temperature. The storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports 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 refers to a patient of unknown age and gender. On 13-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "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: This spontaneous report as received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-AUG-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 33 Fahrenheit (F)Degrees (0.555555556 Celsius) for a total of 1560 hours and then at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 336 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases 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 company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 19-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1212 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type reported as "refrigerator (R)". No adverse events 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 refers to a patient of unknown age and gender. On 24-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "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: This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 07-DEC-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # L002310 exp date 08-JUL-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 208 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "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 a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 01-JUL-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mLVls 10SDV, (lot number L035882, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 vaccine had a temperature excursion. The lowest temperature excursion was of 34 degrees Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, 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 was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 13-OCT-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml 10 Vls SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 34 degrees Fahrenheit (1.111111111 degrees Celsius) (lowest recorded temperature) for 216 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events 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 was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 23-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 28-MAR-2016, the patient was vaccinated with VAQTA "10Pk 25U/0.5 ml SD LLok w Cap Ped", lot # L030442 with expiration date 19-DEC-2016, which was stored at 1.11 Celsius Degrees for 216 hours. The type of excursion was refrigerator and the vaccine status was reported as "in excursion". There were no concomitant medications and adverse effects reported. No product quality complain was involved. This is one of several cases from the same reporter. 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 20-JUL-2015 the patient was vaccinated with an improperly stored dose of VAQTA (25U/0.5 ml; lot # K007791, expiration date: 22-AUG-2016; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 6 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 1172, -3, -3 and R; 80, 30, -1.111111111 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the highest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 336, 59, 15 and R; 168, 49, 9.444444444 and R; 24, 48, 8.888888889 and R; 416, 47, 8.333333333 and R. 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 was received from a physician via company representatives and refers to patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 07-AUG-2014, the patient was vaccinated with 0.5 ml dose of PNEUMOVAX 23 "10 single DS 0.5 ml LVis 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccines was improperly stored exposed to temperature excursion for a sum of 48 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complained 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 company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 30-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). On unspecified date, the vaccine experienced two temperature excursions of 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R). No adverse effects were reported and no product quality complaint was involved. 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: This spontaneous report was received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases 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 company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 02-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23, lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to two temperature excursions, one for a sum of 24 hours at a highest temperature recorded of 47 degrees F (8.333333333 degrees C) and other for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". 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 via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration was unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases 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 company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 17-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On unspecified dates, the vaccine had two temperature excursions; one for 48 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another one for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received 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 16-DEC-2015, the patient received an improperly stored dose of ROTATEQ 2 ml, 10 unit dose tube, (lot # L000434, expiration 10-JUL-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 224, 34 and R. The storage criteria was refrigerator (R). 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 a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 29-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, (lot number L035882, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 vaccine had a temperature excursion. The lowest temperature excursion was of 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, 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 refers to a patient of unknown age and gender. On 08-APR-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "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: This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 19-JAN-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336 (dose, route and the expiration date were not reported). The total cumulative hours out of range were 24 hours with 34 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports 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 company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 18-DEC-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5mL SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On unspecified dates, the vaccine had two temperature excursions; one for 48 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another one for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several 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 refers to a patient of unknown age and gender. On 15-DEC-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # L002310, expiration date 08-JUL-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 208 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". 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: Information has been received from a physician via a company representative concerning a patient of unknown age and gender. On 02-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23-10PK 0.5 ml SD PFS LLokwTip, (lot number L040181, with an expiration date of 18-AUG-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 had a temperature excursion. The lowest temperature excursion was of 32 Fahrenheit (F), (0 Celsius degrees) for a total of 80 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, 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 was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 10-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 864 hours, the highest recorded temperature was 59.9 F (15.5 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. 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 29-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for each time were 40, 34, and R; 136, 33 and R. The storage criteria was 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 29-MAY-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 48, 0 and R; 48, 1 and R; 24, -1 and R; 72, unknown and R. The storage criteria was refrigerator (R). 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 was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 16-JUL-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 "10 Single DS 0.5 ml LVIs 10SDV", lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to temperature excursion for a sum of 48 hours at a lowest temperature recorded of 34 degrees F (1.11111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. There was no product quality complained 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 refers to a patient of unknown age and gender. On 04-MAY-2015, the patient was vaccinated with improperly stored PNEUMOVAX (lot # K024976 exp date 09-JUN-2016) (dose and route not reported). The temperature and time of excursion was 1.11 degrees C for 64 hours. The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "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
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was were vaccinated with improperly stored GARDASIL lot # K008931, expiry date: 04-MAR-2017 (dosing details, route of administration were not reported). It was reported that the vaccines were exposed to a temperature 30.9F during a time frame of 16 hours and 14 minutes. No previous temperature excursion was reported. There no product quality complaints (PQC) involved. This is 1 of the 2 reports from the same reporter. Additional information has been requested.