chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 05-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases 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 16-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperatures were of 32 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 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 0.5mLVIs 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 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: 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 02-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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-JAN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 48 hours, the lowest recorded temperature 34 Fahrenheit degree and the type of excursion was refrigerator (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: 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 05-JAN-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 132 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: 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 31-JUL-2015 the patient was vaccinated with two improperly stored doses of RECOMBIVAX HB 5 microgram/0.5 mL (lot # J009051, expiration date 26-MAR-2016, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion twice. The total cumulative excursion time was 24 hours and 32 hours. The lowest recorded temperature was 34 Celsius degree. The highest recorded temperature was 48 Celsius degree. The storage criteria of the vaccine and the type of excursion were 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route 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 840, 34 and R; 168, 32 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: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representatives referring to a patient of unknown age and gender. On 10-FEB-2014, the patient was vaccinated with an improperly stored dose of VAQTA, lot # J006521, expiration date 23-AUG-2015 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions for two times. The storage criteria and the type of excursion (R/F) were refrigerator (R). The lowest recorded temperature (Fahrenheit degree (F)) and total cumulative excursion time (hour) were as following: 34 F for 80 hours and 33 F for 336 hours. 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 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 was not reported. On 30-NOV-2015, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL 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 672 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-MAR-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 was (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion was (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: 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 13-APR-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/freeze) (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 08-JUN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 ml (thimerosal free, lot # L033343, expiration date 13-SEP-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were 24, 47 and R. The storage criteria was refrigerator (R). 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 26-JAN-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (5 microgram/0.5ml (thimerosal free, lot # L007558, expiration date 10-NOV-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 reach time were 40, 34, and R. The storage criteria was refrigerator (R). This is one of several reports 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 23-JUN-2015 the patient was vaccinated with two improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 mL (lot # H017304, expiration date 11-JUL-2015, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion twice. The first cumulative excursion time and lowest recorded temperature was 16 hours, 33 Celsius degree. The second cumulative excursion time and lowest recorded temperature was 64 hours, 34 Celsius degree. The storage criteria of the vaccine and the type of excursion were 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 06-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). 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) and the type of excursion (R/F) were 208, 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: 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 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 492 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: RV5
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. The patient's concurrent conditions and medical history were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ 2ml, 10 unit dose tube, lot # J010140; expiration date 26-APR-2016 (dose and dose number were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the ROTATEQ had 6 temperatures excursions of 80, 416, 24, 1172, 336 and 168 hours. The lowest recorded temperature was -3 Celsius and the highest recorded temperature was 59F (15 Celsius). 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 cases 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 company representatives and from a support services director concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 22-APR-2014, the patient was vaccinated with an improperly stored GARDASIL "PFS 6x1.5mg/0.5ml w/oSftySyr" lot # J009098, expiration date 04-DEC-2015 (route and dose were not provided). This vaccine had a temperature excursion of 2652 hours. The highest temperature recorded was 59.9 degrees Fahrenheit (15.5 degrees Celsius). The vaccine status was reported an "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 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 01-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL 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 1764 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: 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 19-FEB-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 six 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 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 second excursion was 24, 34 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 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 fourth excursion was 112, 32 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 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 sixth excursion was 112, 30 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 representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot #L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 144 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-DEC-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: 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 14-SEP-2015 the patient was vaccinated with two improperly stored doses of RECOMBIVAX HB 5 microgram/0.5 mL(lot # J009051, expiration date 26-MAR-2016, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion twice. The total cumulative time was 24 hours and 32 hours. The lowest recorded temperature was 34 Celsius degree. The highest recorded temperature was 48 Celsius degree. The storage criteria of the vaccine and the type of excursion were 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: 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 15-MAY-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 192, 208, 512, 24, 1000, 472, 136 and 32. The lowest recorded temperatures were of 31, 27, 28, 29, 30, 26, 34 and 32 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: 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 15-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-FEB-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion three times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) were as following: the first excursion was 24, 33 and R; the second excursion was 272, 31 and R; the third excursion was 120, 29 and R. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 27-MAR-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 72, unknown and R; 48, 0 and R; 48, 1 and R; 24, -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 20-JUN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "HPV 10x1 sdv", lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications 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 longest reported temperature excursion lasted 72 hours, where the lowest recorded temperature was 32 F (0 Celsius degrees). There was also another excursion on an unknown date which lasted 24 hours with a lowest recorded temperature of 34 F (1.111111111 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: 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 05-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 875 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route not reported). 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 each time were 24, 8.3 and R; 24, 9 and R; 24, 8.5 and R; 24, 8.4 and R; 24, 8.1 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: 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 27-MAR-2-15, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv") Lot No. K001631 ,exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 48. The lowest recorded temperatures was 32. 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: 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 01-MAR-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 six 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 56, 33 and R. The total cumulative time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 120, 29 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 24, 49 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 24, 48 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 24, 31 and R. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the sixth excursion was 48, 34 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 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 26-FEB-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 -2.77 Celsius Degrees for 192 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.  The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 08-OCT-2015, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 1056 hours. The lowest recorded temperature was 27 Fahrenheit degrees (-2.777777778 Celsius) The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
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 concurrent conditions and medical history were not reported. On 11-NOV-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 6 times with the following lowest recorded temperatures: 34F (1.111 celsius degrees) for 88 hours, 29F (-1.666 celsius degrees) for 184 hours and 30F (-1.111 celsius degrees) for 152 hours, 31F (-0.555 celsius degrees) for 344 hours, 32F (0 celsius degrees) for 264 hours and 33 F (0.555 celsius degrees) for 152 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 15-OCT-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 56, 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: M
Vaccine: PPV
Symptoms: Inflammation, Swelling
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer company representative regarding a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (dosing details, lot# and expiry date not known). On an unknown date in October 2016, the patient experienced inflammation and swelling. The outcome of inflammation and swelling was unknown. The reporter considered inflammation and swelling to be related to PNEUMOVAX 23. 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 22-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9, 0.5 ml injection, lot # L007495 with expiration date 24-JAN-2017 (route and dose were not reported). This specified lot number vaccine was exposed to temperature excursion. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) was 16, 31 and R, respectively. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-NOV-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion. The total cumulative excursion time was 88 hours, the lowest recorded temperature was 33 Fahrenheit degree and the type of excursion was refrigerator (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: 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 17-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 ten 0.5ml single-dose vial (SDV) (lot # K019561, expiration date 20-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 47 and R; 112, 49 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 22-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 4 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 152, 30, -1.111111111 and R; 184, 29, 1.666666667 and R; 24, 33, 0.555555556 and R; 320, 31, -0.555555556 and R; 160, 32, 0 and 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 30-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 5 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 152, 30, -1.111111111 and R; 184, 29, -1.666666667 and R; 24, 33, 0.555555556 and R;, 320, 31, -0.555555556 and R; 224, 32, 0 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 representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 09-JUN-2016, the patient was vaccinated with a dose 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 temperatures excursion of 0 Celsius degrees for 168 hours and 1.1 Celsius degrees for 920 hours with lowest temperatures recorded of 32 and 34 Fahrenheit degrees respectively. 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: This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 11-MAY-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 0 Celsius degrees for 168 hours  and 1.1 Celsius degrees for 920 hours with lowest temperature recorded of 32 and 34 Fahrenheit degrees respectively. 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: 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 24-AUG-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 1 time. 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) was 16,33, 0.555555556 and 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 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, 264 hours with 33 degrees C, 88 hours with 30 degrees C and 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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 11-APR-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route 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/Celsius) and the type of excursion (R/F) for each time were 24, 8.7 and R; 24, 9 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: 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 15-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 72 and 40. The lowest recorded temperature was 28. 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-DEC-2016) (route and dose were not reported). 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 (Celsius) and the type of excursion (R/F) were 72, 9 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: RV5
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. The patient's concurrent conditions and medical history were not reported. On 27-MAR-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ 2ml, 10 unit dose tube, lot # J010140; expiration date 26-APR-2016 (dose and dose number were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the ROTATEQ had 5 temperatures excursions of 24, 80, 1172, 336 and 200 hours. The lowest recorded temperature was -3 Celsius and the highest recorded temperature was 59F (15 Celsius). 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 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 06-MAR-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 -2.77 Celsius Degrees for 384 hours and 0 Celsius Degrees for 40 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.