chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 24-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 48, 1 and R; 48, 0 and R;  72, unknown 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 03-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5 ml) (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 384, 34 and R; 72, 31 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: 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 11-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (2.5 mL/five dose vial, lot # J015868, expiration date 25-FEB-2015, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 64 hours. The lowest temperature was 32 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: 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 10-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 480. 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-JUN-2015, 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 once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 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: 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 # 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 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: 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 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 6876 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 and a practice manager referring to a patient of unknown age and gender. On 09-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (2.5 mL/five dose vial, lot # J015868, expiration date 25-FEB-2015, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 16 hours. The lowest recorded temperature was 32 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: 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 17-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: 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-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 56, 33 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 24, 48 and R. The total cumulative excursion time (hour), the highest 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 lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the fourth excursion was 120, 29 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 36, 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 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 27-MAY-2016, the patient was vaccinated with a dose of PNEUMOVAX 23, 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 1.1 Celsius degrees for 920 hours and 0 Celsius degrees for 168 hours with lowest temperature recorded to 34 and 32 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 representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 02-NOV-2015, 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). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced two temperature excursions of 48 hours each. For one excursion the lowest recorded temperature was 34 F (1.111111111 Celsius) and for the other excursion the lowest recorded temperature was 32 F. 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 the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-OCT-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 once. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 72, 47 and R. The storage criteria was  refrigerator (R). This is one of several reports received from the same source.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice and manager referring to a patient of unknown age and gender. On 25-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 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 72, 29 and R. The total cumulative (hour), the highest recorded temperature ((Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 208, 31 and R. The total cumulative time (hour), the highest recorded temperature ((Fahrenheit degree) and the type of excursion (R/F) for the third excursion was 112, 30 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 16, 33 and R. The total cumulative excursion time (hour), the highest recorded temperature ((Fahrenheit degree) and the type of excursion (R/F) for the fifth excursion was 64, 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: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-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: 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 05-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 once. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the excursion was 32, 33 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 15-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 degree 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: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 02-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 (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: 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 01-OCT-2015, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 64 hours with 48 C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 328 hours with 29 C, 264 hours with 33 C, 8 hours with 30 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 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 12-MAR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10 SDV" 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 and then at 33 Fahrenheit (F) Degrees (0.555555556 Celsius)for a total of 72 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.
Age: 9.0
Sex: U
Vaccine: MMRV
Symptoms: Rash erythematous
Clinical narrative: This spontaneous report as received from a nurse practitioner (patient's mother) via company representative refers to a 9 year old male patient. Patient's pertinent medical history, concurrent condition and concomitant medication were not known. No previous drug reactions/allergies were reported. On 19-AUG-2016, the patient was vaccinated with PROQUAD (lot # L037968, expiry date 29-MAR-2017) via injection in the upper right arm (strength and dosing details were unknown). About one week after the vaccination (approximately on 26-AUG-2016), the patient experienced red bumps on his face and forehead. The patient was seen by an unspecified eye doctor. The outcome of the events were unknown. Causality assessment was not provided. No product quality complaint was involved. 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 23-JUL-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. 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 40, 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: 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 25-SEP-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 temperature: 34F (1.111 Celsius degrees) for 88 hours, 32 F (0 Celsius degrees) for 176 hours, 29 F (-1.666 Celsius degrees) for 120 hours, 31 F (-0.555 Celsius degrees) for 272 hours, 33 F (0.555 Celsius degrees) for 64 hours and 30F (-1.111 Celsius degrees) for 72 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: 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-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 2 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 24, 33, 0.555555556 and R; 48, 34, 1.111111111 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 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 10-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: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 17-DEC-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 48 hours, the lowest recorded temperature was 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: 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 23-MAY-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; 256, 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 23-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # J014855, expiration date 16-APR-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, 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: 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 02-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 60 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 regarding medical history, concurrent conditions and concomitant medications was not provided. On 23-JUL-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot number and expiration date: K004016 and 08-MAR-2015 respectively; strength, and route of administration were not provided). Nonetheless, no adverse effects were reported. On an unspecified dates, PNEUMOVAX 23 vaccine had two temperature excursions; one on 192 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and the other one of 1128 hours with a lowest recorded temperature of 33 F (0.555555556). 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 the several reports received from the same reporter. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Injection site pain, Injection site reaction, Rash macular
Clinical narrative: This spontaneous report was received from a licensed practical Nurse referring to a 76 year old female patient. The patient's concurrent conditions included post-menopausal, thyroid nodular and immunoglobulin A deficiency and the patient's drug reactions or allergies included penicillin, information regarding the patient's medical history was not provided. On 10-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 dose number 1, via intramuscular in the right deltoid (lot number, expiration date and dose were not reported).Concomitant therapies included Lisinopril (manufacturer unknown), atenolol and potassium. On 12-OCT-2016, the patient experienced pain at injection site, radiating to right arm pit and developed 3 red blotches and the largest one measured 7.5 cm, all on right deltoid. Additionally, it was also reported that the patient contacted physician (unspecified if required office visit), who recommended using warm compresses and BENADRYL as needed. No laboratories were performed and a product quality complaint was not involved. The patient recovered from the events on an unspecified date in October 2016. The causality between PNEUMOVAX 23 and the adverse events was not reported. 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 01-APR-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 medication 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: 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 11-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 144, 31 and R; 48, 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: 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 20-JUL-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 384, 34 and R; 72, 31 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: 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 15-OCT-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 40, 31 and R; 24, 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: 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-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: 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 18-MAY-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 72, 31 and R; 384, 34 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 25-FEB-2014, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5 mL (lot # H017304, expiration date 05-DEC-2015, dose and route were unknown). No adverse effects were reported. The vaccine was exposed to temperature excursion once. The total cumulative excursion time was 72 hours. The lowest recorded temperature was 32 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: 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 21-JAN-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: 33 F for 92 hours and 34 F for 28 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: 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 07-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 05ml)(lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for one time. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer)(R/F) were 216, 34 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: 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 28-JAN-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported. The total cumulative hours out of range were 360 hours with 34 degrees C and 168 hours with 33 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: 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 10-AUG-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. 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 152, 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 10-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (product name reported as "HPV;SDV; 10-pack"; lot # J009243, expiration date 23-APR-2016). 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/ Celsius) and the type of excursion (R/F) for each time were 40, unknown and R; 48, 34 and R; 712, 33 and R; 488, 32 and R; 72, 28 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 06-JUL-2015, the patient was vaccinated with an improperly stored dose of VAQTA, 50 U/1ml injection, lot # J014589, expiration date 15-JAN-2016 (dose and route unspecified). This specified lot number vaccine was exposed to temperature excursions for eight 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 136 hours, 32 F for 120 hours, 31 F for 288 hours, 30 F for 1400 hours, 29 F for 24 hours, 26 F for 472 hours, 27 F for 208 hours and 28 F for 1128 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 company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 14-NOV-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 1704 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 19-AUG-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. 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 200, 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: 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 10-SEP-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 3 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit for each time were 200, 32, 0 and R; 24 33, 0.555555556 and R; 124, 34 1.111111111 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 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 16-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 1140 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 regarding medical history, concurrent conditions and concomitant medications was not provided. On 25-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml 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 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1356 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: 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 27-JUL-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 120 hours with 53 C as the highest recorded temperature. On the other hand, the total cumulative hours out of range were 24 hours with 34 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: 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 28-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 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 48, 1 and R; 8, 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: 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 20-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 0.5ml(lot # L007531, expiration date 04-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 each time were 8, 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.