chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L023936, exp. date: 15-MAR-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 04-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 19-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L008665, exp. date: 10-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 19-OCT-2015 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 16-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L008665, exp. date: 10-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L008665, exp. date: 10-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 20-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F; In September of 2015, the coldest temperature was 34 for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1, 031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 03-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 19-OCT-2015 the patient was vaccinated with dose of improperly stored ROTATEQ (lot # L008031) with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 20-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 22-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 21-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 22-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 21-OCT-2015 the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 28-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 27-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has  been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 26-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency) orally. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 01-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 290-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 30-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency unspecified) orally. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures an cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L028666, exp. date: 04-NOV-2016) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Myalgia
Clinical narrative: Information has been received from a 68 year old male consumer referring to himself. There was no concurrent condition or medical history reported. The patient stated that, in June 2013, he got an initial PNEUMOVAX 23 and more recently on 02-DEC-2015 the patient got another dose of PNEUMOVAX 23 25/0.5 (unit unknown) (0.5 ml, lot # unknown) intramuscularly at a pharmacy. There was no concomitant medication reported. The patient stated that within 12 hours after receiving PNEUMOVAX 23 on 02-DEC-2015, he noticed a very obvious pink line about a quarter inch wide running down from the injection site area to his bicep. The patient also felt sore in the muscle and today, on 04-DEC-2015, there was still a mild amount of tenderness around the injection site. The patient mentioned he went back to the pharmacy today to let them know about his adverse reaction. Treatment with TYLENOL was given. The patient got general yearly blood work. At the time of the report, the outcome of pink line from the injection site area to bicep and sore in the muscle was unknown, and the outcome of tenderness around the injection site was not recovered. 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 health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a patient's mother via social media regarding an 18 year old female patient. No historical or concurrent conditions were reported. On an unknown date, the patient was vaccinated with GARDASIL (lot# unspecified). No concomitant medications were reported. On an unknown date, the patient died. The reporter considered death to be related to GARDASIL. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Incorrect route of drug administration, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported. On 25-AUG-2015 the patient administered a ZOSTAVAX (dosage, strength and lot # were not reported) intramuscularly by herself (Incorrect route of drug administration). There was no concomitant medication reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up the patient's arm onto her chest." The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered. Follow up information has been received from the pharmacist on 22-DEC-2015, referring to the 50 year old female patient. It was stated that, on 25-AUG-2015, at 05:00 pm, the patient vaccinated herself with ZOSTAVAX subcutaneous route (previously reported as intramuscular), on the left arm, (Lot # L002422, expiration date not reported). On 27-AUG-2015, at 09:00 am, the patient experienced injection site pain, injection site swelling and injection site erythema and burning. The patient was diagnosed to have cellulitis on site reaction and was prescribed with KEFLEX. On 30-AUG-2015, the patient felt better and the outcome of the reported events was reported as resolved. Later, on 16-SEP-2015, the patient vaccinated herself with a FLUZONE intramuscular route, on the left arm (Lot # UI422AA, expiration date not reported). The reporter considered the event cellulitis on site reaction to be required medical/surgical intervention to prevent significant outcome. Additional information is not expected as all follow-up has been received. Patient's demographics, vaccine administration fields, events and narrative were updated. This is an amended report. The seriousness criteria of medically significant for event vaccination site cellulitis should be checked. Statement in narrative was also added.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Rash
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported. On 25-AUG-2015 the patient administered a ZOSTAVAX (dosage, strength and lot # were not reported) intramuscularly by herself (Incorrect route of drug administration). There was no concomitant medication reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up the patient's arm onto her chest." The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered. Follow up information has been received from the pharmacist on 22-DEC-2015, referring to the 50 year old female patient. It was stated that, on 25-AUG-2015, at 05:00 pm, the patient vaccinated herself with ZOSTAVAX subcutaneous route (previously reported as intramuscular), on the left arm, (Lot # L002422, expiration date not reported). On 27-AUG-2015, at 09:00 am, the patient experienced injection site pain, injection site swelling and injection site erythema and burning. The patient was diagnosed to have cellulitis on site reaction and was prescribed with KEFLEX. On 30-AUG-2015, the patient felt better and the outcome of the reported events was reported as resolved. Later, on 16-SEP-2015, the patient vaccinated herself with a FLUZONE intramuscular route, on the left arm (Lot # UI422AA, expiration date not reported). The reporter considered the event cellulitis on site reaction to be required medical/surgical intervention to prevent significant outcome. Additional information is not expected as all follow-up has been received. Patient's demographics, vaccine administration fields, events and narrative were updated. This is an amended report. The seriousness criteria of medically significant for event vaccination site cellulitis should be checked. Statement in narrative was also added.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported. On 25-AUG-2015 the patient administered a ZOSTAVAX (dosage, strength and lot # were not reported) intramuscularly by herself (Incorrect route of drug administration). There was no concomitant medication reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up the patient's arm onto her chest." The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered. Follow up information has been received from the pharmacist on 22-DEC-2015, referring to the 50 year old female patient. It was stated that, on 25-AUG-2015, at 05:00 pm, the patient vaccinated herself with ZOSTAVAX subcutaneous route (previously reported as intramuscular), on the left arm, (Lot # L002422, expiration date not reported). On 27-AUG-2015, at 09:00 am, the patient experienced injection site pain, injection site swelling and injection site erythema and burning. The patient was diagnosed to have cellulitis on site reaction and was prescribed with KEFLEX. On 30-AUG-2015, the patient felt better and the outcome of the reported events was reported as resolved. Later, on 16-SEP-2015, the patient vaccinated herself with a FLUZONE intramuscular route, on the left arm (Lot # UI422AA, expiration date not reported). The reporter considered the event cellulitis on site reaction to be required medical/surgical intervention to prevent significant outcome. Additional information is not expected as all follow-up has been received. Patient's demographics, vaccine administration fields, events and narrative were updated. This is an amended report. The seriousness criteria of medically significant for event vaccination site cellulitis should be checked. Statement in narrative was also added.
Age: 50.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Rash, Rash erythematous, Swelling
Clinical narrative: Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported. On 25-AUG-2015 the patient administered a ZOSTAVAX (dosage, strength and lot # were not reported) intramuscularly by herself (Incorrect route of drug administration). There was no concomitant medication reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up the patient's arm onto her chest." The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered. Follow up information has been received from the pharmacist on 22-DEC-2015, referring to the 50 year old female patient. It was stated that, on 25-AUG-2015, at 05:00 pm, the patient vaccinated herself with ZOSTAVAX subcutaneous route (previously reported as intramuscular), on the left arm, (Lot # L002422, expiration date not reported). On 27-AUG-2015, at 09:00 am, the patient experienced injection site pain, injection site swelling and injection site erythema and burning. The patient was diagnosed to have cellulitis on site reaction and was prescribed with KEFLEX. On 30-AUG-2015, the patient felt better and the outcome of the reported events was reported as resolved. Later, on 16-SEP-2015, the patient vaccinated herself with a FLUZONE intramuscular route, on the left arm (Lot # UI422AA, expiration date not reported). The reporter considered the event cellulitis on site reaction to be required medical/surgical intervention to prevent significant outcome. Additional information is not expected as all follow-up has been received. Patient's demographics, vaccine administration fields, events and narrative were updated. This is an amended report. The seriousness criteria of medically significant for event vaccination site cellulitis should be checked. Statement in narrative was also added.
Age: 45.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Feeling abnormal, Malaise, Vertigo
Clinical narrative: Case number PHHY2015US165698, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 600913) website on 14 Dec 2015. This report refers to a 45-year-old male patient. Historical condition was not reported. Past medication included azelastine hydrochloride (manufacturer unknown) for the indication of hypersensitivity. Current condition included allergic to molds and mites. Concomitant medication included ibuprofen (manufacturer unknown). The patient was vaccinated with FLUVIRIN (batch number: 05339, 2164569) in the left arm intramuscularly on 02 Oct 2015. On the same day of vaccination the patient experienced, dizziness, vertigo, and foggy head. The patient felt dizzy while he was shopping and felt sick. The symptoms continued days later (condition unchanged) and the patient was taken to an emergency room. The seriousness of the events was reported as non-serious and causality was not reported. The seriousness assessment of the event vertigo was upgraded based on the information available in source document. As the batch was not a valid one, as per procedures, would not investigate. Follow up information received from Quality assurance department on 21 Dec 2015: As the vaccine batch number was not valid, investigation could not be performed by Quality assurance department.
Sex: U
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema, Pain
Clinical narrative: Redness at injection site. Aching.
Sex: U
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site. Aching.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Asthenia, Cellulitis, Culture, Skin infection, X-ray
Clinical narrative: Cellulitis, cephalexin 500 mg PO BID 10 days, vancomycin 1,000 mg BID 24 hours IV, CLEOCIN 150 mg cup PO BID x 10 days, ROCEPHIN 1 gram IV.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Blood lactic acid normal, Cellulitis, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Cellulitis, cephalexin 500 mg PO BID 10 days, vancomycin 1,000 mg BID 24 hours IV, CLEOCIN 150 mg cup PO BID x 10 days, ROCEPHIN 1 gram IV.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Leukocytosis, Rash
Clinical narrative: Cellulitis, cephalexin 500 mg PO BID 10 days, vancomycin 1,000 mg BID 24 hours IV, CLEOCIN 150 mg cup PO BID x 10 days, ROCEPHIN 1 gram IV.
Age: 93.0
Sex: F
Vaccine: FLU3, PNC13, FLU3, PNC13, FLU3, PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis, cephalexin 500 mg PO BID 10 days, vancomycin 1,000 mg BID 24 hours IV, CLEOCIN 150 mg cup PO BID x 10 days, ROCEPHIN 1 gram IV.
Age: 45.0
Sex: F
Vaccine: FLUR3, FLUR3
Symptoms: Eye disorder, Flushing, Head discomfort, Headache, Throat tightness
Clinical narrative: Redness, throat closing, unable to swallow, rash, thick tongue within first 10 mins of vaccine then after 30-40 min in ED started having pressure and shooting pains out of right eye. Then blurred vision (R) eye with severe headache just on rt side of head. After that treated for optic neuritis to (R) eye with high dose of SOLU-MEDROL then PO prednisone. Headache continues tx with ELAVIL by Neuro MD Bell's palsy (R) side of face. Dx with Optic Neuritis treated and released from Eye Specialist on Nov 12, 2015.
Age: 45.0
Sex: F
Vaccine: FLUR3, FLUR3
Symptoms: Visual impairment
Clinical narrative: Redness, throat closing, unable to swallow, rash, thick tongue within first 10 mins of vaccine then after 30-40 min in ED started having pressure and shooting pains out of right eye. Then blurred vision (R) eye with severe headache just on rt side of head. After that treated for optic neuritis to (R) eye with high dose of SOLU-MEDROL then PO prednisone. Headache continues tx with ELAVIL by Neuro MD Bell's palsy (R) side of face. Dx with Optic Neuritis treated and released from Eye Specialist on Nov 12, 2015.
Age: 45.0
Sex: F
Vaccine: FLUR3, FLUR3
Symptoms: Dysphagia, Erythema, Eye pain, Fatigue, Headache
Clinical narrative: Redness, throat closing, unable to swallow, rash, thick tongue within first 10 mins of vaccine then after 30-40 min in ED started having pressure and shooting pains out of right eye. Then blurred vision (R) eye with severe headache just on rt side of head. After that treated for optic neuritis to (R) eye with high dose of SOLU-MEDROL then PO prednisone. Headache continues tx with ELAVIL by Neuro MD Bell's palsy (R) side of face. Dx with Optic Neuritis treated and released from Eye Specialist on Nov 12, 2015.
Age: 45.0
Sex: F
Vaccine: FLUR3, FLUR3
Symptoms: Nausea, Ocular discomfort, Optic neuritis, Rash, Throat tightness
Clinical narrative: Redness, throat closing, unable to swallow, rash, thick tongue within first 10 mins of vaccine then after 30-40 min in ED started having pressure and shooting pains out of right eye. Then blurred vision (R) eye with severe headache just on rt side of head. After that treated for optic neuritis to (R) eye with high dose of SOLU-MEDROL then PO prednisone. Headache continues tx with ELAVIL by Neuro MD Bell's palsy (R) side of face. Dx with Optic Neuritis treated and released from Eye Specialist on Nov 12, 2015.
Age: 45.0
Sex: F
Vaccine: FLUR3, FLUR3
Symptoms: Tongue disorder, VIIth nerve paralysis, Vision blurred
Clinical narrative: Redness, throat closing, unable to swallow, rash, thick tongue within first 10 mins of vaccine then after 30-40 min in ED started having pressure and shooting pains out of right eye. Then blurred vision (R) eye with severe headache just on rt side of head. After that treated for optic neuritis to (R) eye with high dose of SOLU-MEDROL then PO prednisone. Headache continues tx with ELAVIL by Neuro MD Bell's palsy (R) side of face. Dx with Optic Neuritis treated and released from Eye Specialist on Nov 12, 2015.