chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 22-JUL-2016, the patient was vaccinated with an improperly stored ROTATEQ 2 ml oral injection (lot# L008997, expiry date 04-DEC-2020; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius) and the second one lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit, the second lasting for 24 hours, with the highest recorded temperature of 46.3 degrees Fahrenheit, the third lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit, the fourth lasting for 24 hours, with the highest recorded temperature of 48.1 degrees Fahrenheit, the fifth lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit, the sixth lasting for 96 hours, with the highest recorded temperature for 46.8 degrees Fahrenheit, the seventh lasting for 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit, the eighth lasting 24 hours, with the highest recorded temperature of 46.2, the ninth lasting for 36 hours, with the highest recorded temperature of 48.2 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On  21-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-JUL-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (Lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
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-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
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-FEB-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 13-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23  0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice.  The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 08-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified): lasting for 72 hours, with the lowest recorded temperature of 28 degree Fahrenheit (-2.222222222 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius) and another lasting for 72 hours, with the highest recorded temperature of 9 degrees Fahrenheit (also reported as 9 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 04-DEC-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius) and another lasting for 72 hours, with the highest recorded temperature of 9 degrees Fahrenheit (also reported as 9 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 25-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-JAN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursion (dates unspecified): lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius) and another lasting for 72 hours, with the highest recorded temperature of 9 degrees Fahrenheit (also reported as 9 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representative and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 09-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius), the second lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degree Celsius), the third lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius) and the fourth lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 04-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23  0.5ml (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice.  The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of -1 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 0 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature excursion (date unspecified) lasting for 48 hours, with the lowest recorded temperature of 1 degree Fahrenheit (also reported as 1 degree Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-MAR-2015 the patient was vaccinated with an improperly stored dose (wistar ra 27-3) M-M-R II (strength: 0.5ml, lot # K015374, expiration date 18-DEC-2016, route unspecified). The total cumulative excursion time was 16 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received 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 two company representatives from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-AUG-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 16 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 22-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK- 0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times.  The total cumulative excursion time of the first time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the second time was 272 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the fourth time was 1172 with the lowest recorded temperature of -3 Celsius. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representative and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius), the second lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degree Celsius), the third lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius) and the fourth lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 17-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius), the second lasting for 12 hours, with the highest recorded temperature of 48.2 degrees Fahrenheit (9 degrees Celsius), the third lasting for 24 hours, with highest recorded temperature of 48.1 degrees Fahrenheit (8.944444444 degrees Celsius), the fourth lasting 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius), the fifth lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degrees Celsius), the sixth lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius), the seventh lasting for 24 hours, with the highest recorded temperature of 46.3 degrees Fahrenheit (7.944444444 degrees Celsius), the eighth lasting for 24 hours, with the highest recorded temperature of 46.2 degrees Fahrenheit (7.888888889 degrees Celsius) and the ninth lasting 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit (8.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 27-APR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml injection, lot # K005402, expiration date 07-NOV-2015 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to the following temperature excursions (dates unspecified): the first lasting for 24 hours, with the highest recorded temperature of 47.5 degrees Fahrenheit (8.611111111 degrees Celsius), the second lasting for 372 hours, with the highest recorded temperature of 59.9 degrees Fahrenheit (15.5 degrees Celsius), the third lasting for 24 hours, with the highest recorded temperature of 64.8 degrees Fahrenheit (18.222222222 degrees Celsius), the fourth lasting for 48 hours, with the highest recorded temperature of 48.2 degrees Fahrenheit (9 degrees Celsius), the fifth lasting for 24 hours, with the highest recorded temperature of 48.1 degrees Fahrenheit (8.944444444 degrees Celsius), the sixth lasting for 48 hours, with the highest recorded temperature of 46.4 degrees Fahrenheit (8 degrees Celsius), the seventh lasting for 96 hours, with the highest recorded temperature of 47.2 degrees Fahrenheit (8.444444444 degrees Celsius), the eighth lasting for 24 hours, with the highest recorded temperature of 46.2 degrees Fahrenheit (7.888888889 degrees Celsius), the ninth lasting for 72 hours, with the highest recorded temperature of 46.3 degrees Fahrenheit (7.944444444 degrees Celsius), the tenth lasting for 24 hours, with the highest recorded temperature of 46.6 degrees Fahrenheit (8.111111111 degrees Celsius) and the eleventh lasting for 48 hours, with the highest recorded temperature of 46.8 degrees Fahrenheit (8.222222222 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via a company representative referring to a patient of unknown age and gender. On 26-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot# K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 80 hours with the lowest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the second time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the third time was 1172 hours with the lowest recorded temperature -3 Celsius. The total cumulative excursion time of the fourth time was 184 hours with the highest record temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 19-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10pk-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time of the first time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the second time was 1172 hours with the lowest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the fourth time was 88 hours with the highest recorded temperature of 47 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 14-APR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10PK-0.5ml SD-PFS LLokw Tip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion four times.  The total cumulative excursion time of the first time was 256 hours with the highest recorded temperature of 47 Fahrenheit degree. The total cumulative excursion time of the second time was 80 hours with the lowest recorded temperature of 30 Fahrenheit degree. The total cumulative excursion time of the third time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the fourth time was 1172 hours with the lowest recorded temperature of -3 Celsius degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 14-JAN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot# J005068, expire date 18-JAN-2015; dose and route unknown). The total cumulative excursion time was 92 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. On 06-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion three times. The total cumulative excursion time of the first time was 336 hours with the highest recorded temperature of 59 Fahrenheit degree. The total cumulative excursion time of the second time was 1172 hours with the lowest recorded temperature of -3 Celsius degree. The total cumulative excursion time of the third time was 16 hours with the lowest recorded temperature of 30 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site pain
Clinical narrative: Information has been received from an 83 years old male patient concerning himself. The patient had no concomitant medications, pertinent medical history or drug reaction/allergies. On 29-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot # and expiration date were not reported) intramuscularly. On 29-SEP-2016, the patient developed pain 2 hours after receiving PNEUMOVAX 23. Six hours after the pain set in, the pain became "extreme". The pain had lessened but his arm (not specified which) still hurts when he lifted his arm to his head. the patient had spoken with the physician and had an appointment scheduled. No diagnostic study was performed. He received unspecified treatment and the outcome of the event was reported as recovering. The causality between the event and the vaccine was not reported. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
Age: 83.0
Sex: M
Vaccine: FLU4, PPV, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from an 83 years old male patient concerning himself. The patient had no concomitant medications, pertinent medical history or drug reaction/allergies. On 29-SEP-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, lot # and expiration date were not reported) intramuscularly. On 29-SEP-2016, the patient developed pain 2 hours after receiving PNEUMOVAX 23. Six hours after the pain set in, the pain became "extreme". The pain had lessened but his arm (not specified which) still hurts when he lifted his arm to his head. the patient had spoken with the physician and had an appointment scheduled. No diagnostic study was performed. He received unspecified treatment and the outcome of the event was reported as recovering. The causality between the event and the vaccine was not reported. No product quality complaint was involved. Additional information is not expected as there is no consent to contact the reporter.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 64-year-old female patient who received FLUARIX QUADRIVALENT (batch number 92D9J, expiry date 25th May 2017). The patient's past medical history included psoriasis. Concomitant products included simvastatin. On 5th October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 6th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash, pruritus, joint pain and pain in hand. In October 2016, the patient experienced numbness. The patient was treated with SARNA and BENADRYL. On an unknown date, the outcome of the rash, pruritus, joint pain, pain in hand and numbness were not recovered/not resolved. The reporter considered the rash, pruritus, joint pain and pain in hand to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the numbness to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The patient did not have any known allergies. The patient received FLUARIX QUADRIVALENT on her left arm. The patient experienced rash on her forehead, palms of her hands, on hands, on elbow, on the bottoms of her feet and an area just above the buttocks and itching at these locations. The patient also experienced pain in her elbow joint and in her hands. She also felt numb.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Pruritus, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 64-year-old female patient who received FLUARIX QUADRIVALENT (batch number 92D9J, expiry date 25th May 2017). The patient's past medical history included psoriasis. Concomitant products included simvastatin. On 5th October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 6th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash, pruritus, joint pain and pain in hand. In October 2016, the patient experienced numbness. The patient was treated with SARNA and BENADRYL. On an unknown date, the outcome of the rash, pruritus, joint pain, pain in hand and numbness were not recovered/not resolved. The reporter considered the rash, pruritus, joint pain and pain in hand to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the numbness to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The patient did not have any known allergies. The patient received FLUARIX QUADRIVALENT on her left arm. The patient experienced rash on her forehead, palms of her hands, on hands, on elbow, on the bottoms of her feet and an area just above the buttocks and itching at these locations. The patient also experienced pain in her elbow joint and in her hands. She also felt numb.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 64-year-old female patient who received FLUARIX QUADRIVALENT (batch number 92D9J, expiry date 25th May 2017). The patient's past medical history included psoriasis. Concomitant products included simvastatin. On 5th October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 6th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash, pruritus, joint pain and pain in hand. In October 2016, the patient experienced numbness. The patient was treated with SARNA and BENADRYL. On an unknown date, the outcome of the rash, pruritus, joint pain, pain in hand and numbness were not recovered/not resolved. The reporter considered the rash, pruritus, joint pain and pain in hand to be possibly related to FLUARIX QUADRIVALENT. It was unknown if the reporter considered the numbness to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The patient did not have any known allergies. The patient received FLUARIX QUADRIVALENT on her left arm. The patient experienced rash on her forehead, palms of her hands, on hands, on elbow, on the bottoms of her feet and an area just above the buttocks and itching at these locations. The patient also experienced pain in her elbow joint and in her hands. She also felt numb.
Age: 60.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Local skin rash/swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS, FLU4, VARZOS
Symptoms: Rash, Skin swelling
Clinical narrative: Local skin rash/swelling.
Age: 65.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Peripheral swelling
Clinical narrative: I received a Tdap vaccine, triple vaccine for tetanus, diphtheria and pertussis. Two days later my left arm was swollen from armpit to fingertips. Vaccine was in right deltoid. I have history of lymphedema in left arm. I believe that the vaccine triggered a reaction in the lymph system and caused a worsening of lymphedema in the left arm. This event has required intensive physical therapy for lymphedema treatment, that has been going on for 3 weeks and the problem is not resolved.
Age: 21.0
Sex: M
Vaccine: FLUX, HEP
Symptoms: Asthenia, Pyrexia, Vomiting
Clinical narrative: Fever 102, vomiting, weakness.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Excruciating headache, nausea and body aches onset at noon. Worsened throughout day. Developed fever, fatigue, tachycardia and vomiting that night. Nausea/vomiting uncontrolled with ZOFRAN. Headache and body aches uncontrolled with ibuprofen and TYLENOL. Symptoms lasted until 8pm on 10/13/16, then slowly improved. 10/14/16- nausea and headache remained, though mild.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Tachycardia, Vomiting
Clinical narrative: Excruciating headache, nausea and body aches onset at noon. Worsened throughout day. Developed fever, fatigue, tachycardia and vomiting that night. Nausea/vomiting uncontrolled with ZOFRAN. Headache and body aches uncontrolled with ibuprofen and TYLENOL. Symptoms lasted until 8pm on 10/13/16, then slowly improved. 10/14/16- nausea and headache remained, though mild.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Chest pain, Musculoskeletal pain, Neck pain, Pruritus
Clinical narrative: Pain in neck, shoulder, chest. Itching in chest.
Age: 12.0
Sex: M
Vaccine: HPVX
Symptoms: Skin papilloma
Clinical narrative: My son developed a wart on his knee that we haven't been able to get rid of.  It's been frozen off 4 times and the last time there were multiple in the same spot.
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Herpes zoster, Herpes zoster oticus, Myelitis transverse
Clinical narrative: This spontaneous case, initially received on 05-Oct-2016, was reported by a Non-Health Professional and concerns a female patient. Weight: not provided; Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received H1N1 Influenza Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced a bad reaction of transverse myelitis (medically significant) and since this happened, the patient has also experienced multiple cases of shingles in her ear and inner leg on unspecified dates. Outcome for all events: not reported.; Sender's Comments: Company comments: Listedness:  Brand of vaccine not specified. Assessment according to the CCDS for CSL's H1N1 Influenza Vaccine transverse myelitis and herpes zoster are unlisted. Causality: Unassessable for event transverse myelitis as there was no information relating time of event onset following vaccination, event description, mode of diagnosis, treatment and outcome. Herpes zoster in considered not related to H1N1 Influenza vaccine as it is a viral infection that cannot be transmitted via vaccination.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Periarthritis, Shoulder operation
Clinical narrative: This is a spontaneous report from a contactable medical assistant reporting on behalf of the physician communicated to a Pfizer sales representative. A 67-year-old female patient of an unspecified ethnicity received PREVNAR 13 (Lot M77339, Expiration Date Jul2017), via an unspecified route of administration, first dose on 06May2016 and second dose on 19May2016, both at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced frozen shoulder on an unspecified date. On 19May2016 patient referred to a Chiropractor to seek a treatment for a frozen shoulder and she was referred to an Orthopedic Surgeon.  Therapeutic measures taken as a result of frozen shoulder included surgery. The outcome of the event was unknown.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Initial solicited report and follow up information received on 05 October 2016 from an investigator participating in a study. This is a prospective pregnancy registry case. This case involves a 40-year-old female subject who had vaccine exposure during pregnancy. The date of LMP was not reported. The estimated date of delivery was reported 13 January 2017. The mother's health status reported healthy. The father's healthy status was not reported. The father's age was not reported at the time of report. The current pregnancy history reported subject had no health issue and the subject had allergy to cephalexin. The subject previous pregnancy was not reported. The subject's maternal drug exposure was not reported. The subject received a first intradermal dose of Fluzone ID on the left arm on 03 October 2016 (batch number not reported). The subject's pregnancy complication was not reported. The subject's treatment for infertility was not reported. The subject's family history of congenital abnormality was not reported. The subject notice non serious adverse event of a 3 inch red, warm, indurated area at the injection site on 04 October 2016 i.e. one day after vaccination the subject received Fluzone ID in back part of upper left arm. The non-serious adverse event of a 3 inch red, warm, indurated ares at the injection site were ongoing at the time of report. Prenatal testing were not performed. The pregnancy was ongoing at the time of report. List of documents held by sender: none. Sender's Comments: A 40-year-old female subject received a dose of study vaccine at 25 weeks of pregnancy (calculated from the expected date of delivery). The subject had non-serious adverse events of 3 inch red, warm and indurated areas at the vaccination site, the day after vaccination.
Sex: F
Vaccine: FLU4
Symptoms: Rash generalised
Clinical narrative: Initial unsolicited report received from a pharmacist on 06-OCT-2016. This case involves a 55-year-old female patient who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 03-OCT-2016. Patient's Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On 04-OCT-2016, one day following the vaccination, the patient developed a general rash. It was reported that the patient required emergency room/doctor visit. Lab data and corrective treatment were not reported. The outcome of the event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia
Clinical narrative: Initial unsolicited case received from a consumer on 07 Oct 2016. This case involves a female patient (age was not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QIV (Batch number: UT5673KA, expiry date-30 Jun 2017 (dose in series, route and site of administration was not reported) on 04 October 2016. The patient illness at the time of vaccination and preexisting physician diagnosed allergies, birth defects, medical conditions and any other vaccinations within four weeks of vaccination was reported as none. The patient Concomitant medications were not reported. On 04 Oct 2016, 30 minute after the vaccination, the patient had developed a metallic taste in mouth. The patient relevant laboratory data was reported as none. The patient corrective treatment was not reported. The outcome of event was reported as unknown. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea
Clinical narrative: Initial unsolicited report received from a consumer (parent) on 11-OCT-2016. This case involves an 11-year-old male patient who was vaccinated with a first dose of ADACEL batch number: C4775AA, expiration date: 16-JUL-2017 (dose, dose in series, route of administration were not reported), in left deltoid on 23-SEP-2015. Patient received previously 5 doses of DTaP without issue with the vaccination. Patient's Illness at time of vaccination was not reported and Pre-existing physician diagnosed allergies to milk, cats, dogs and crab, birth defects, medical conditions was reported as Asthma. Concomitant medications were not reported. On 23-SEP-2015, same day following the vaccination, the patient developed shortness of breath and having difficulty breathing. Lab data was reported as none and corrective treatment was reported as neb treatment. On an unspecified date, the patient recovered from the event. List of documents held by sender: none.