chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 12-OCT-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 120 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second 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 effect 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 and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 608 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 280 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 01-MAR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 608 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 23-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 544 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 15-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 232 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 08-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 488 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 10-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursion: first lasting for 488 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 32 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 29-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 376 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 17-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting 488 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 712 hours, with the lowest temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 192 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M005714, expiry: 03-OCT-2017; lot # L043214, expiry: 30-AUG-2017; lot # L026602, expiry date: 19-OCT-2017). The vaccines were exposed on following dates: 10-AUG-2016 at 28.9F for 3.8 hours, 11-AUG-2016 at 31.8F 1.7 hours and 26-AUG-2016 at 31.F for 3.75 for 3.75 hours. They were logged by a data logger and there were no prior excursions. Medical assistant reported that she has not been informed of any adverse effects. This is one of the three reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a multiple unspecified patient's of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patient's were vaccinated with improperly stored doses of GARDASIL 9 (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored VARIVAX (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit for 2 hours and 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. 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 and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 18-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 240 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 06-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patient were vaccinated with improperly stored GARDASIL 9 lot # L043214 and expiration date: 30-AUG-2017; lot # M004116 and expiration date: 12-OCT_2017; lot # M007764 and expiration date: 30-JAN-2017; (route and dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with a dose of improperly stored PEDVAXHIB, orally, lot number M014926, expiration date 17-FEB-2019, (dose was not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patients were inadvertently vaccinated with an improperly stored dose of ROTATEQ (orally, dose, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On 27-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting of 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 25-APR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medication were not provided. On 25-SEP-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # M024681, expiration date 18-MAY-2018, 0.5 ml, once, subcutaneous). The vaccine was exposed to 28 Fahrenheit degree for 2 hours 10 minutes. No adverse effects were reported. Data logger was involved. There was no prior excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot #, expiration date, site and doses were not reported). It was reported that the vaccine was exposed to temperatures ranging from 29 Fahrenheit degrees (F) to 35 F for cumulative time frame of 16 hours before administration to the patients. No previous temperature excursion was reported. Digital Data Logger was not involved. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information was received from a certificated medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-OCT-2016, the patient was administered an expired dose of ZOSTAVAX (lot # L024999, expired on 06-OCT-2016; dose and route were unknown). No adverse effects were reported. 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 and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-JAN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine underwent a temperature excursion of the lowest recorded temperature of 34 degrees Fahrenheit for 136 hours. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 11-OCT-2016, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose and route of administration were not reported, lot # M012991 with expiration date 14-MAR-2018). The dose was exposed to temperature exposure of 16 Celsius degrees for 135 hours 33 minutes. There was no previous temperature excursion and the data logger was not involved. No adverse effects were reported. 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 and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-MAR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 632 hours, with the lowest recorded temperature of 34 degrees and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 544 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L035637 and expiration date 09-JUN-2017, lot # L039638 and expiration date 23-AUG-2017, orally; exact doses were not reported). No adverse effect was reported. This is one of the 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 and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 08-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test negative, Facial paralysis
Clinical narrative: Developed Bells Palsy one day after receiving GARDASIL 9.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On an multiple unspecified dates, the multiple unspecified patients were vaccinated with improperly stored doses (incorrect product storage) of GARDASIL (lot, expiry date and dosage regimen was unknown) for a year. No adverse effects reported. No product quality complaint was filed. 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 and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 15-JUN-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 24-OCT-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 with 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. Approximately in October 2016 (reported as since 11-OCT-2016), the patient was vaccinated with improperly stored VARIVAX lot # M025871, expiry date: 24-MAY-2018, 0.5 ml, subcutaneously. It was reported that the vaccines were exposed to a temperature of -14.81C for 12 minutes, and -13.31C for 35 minutes, and a previous excursion on 11-OCT-2016 of -12C for 20 minutes and -6C for 45 minutes. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Allergy test, Anaphylactic reaction, Joint swelling, Multiple allergies, Pyrexia
Clinical narrative: This spontaneous report was received from a 57 year old female patient reporting on herself. The patient had no pertinent medical history, drug reactions or allergies. On 15-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 injection, route of administration reported as "intramuscular or subcutaneous", (dose, dose number, lot#, expiry date and site of administration were not reported). The patient had no concomitant medications. On 16-OCT-2015, the patient experienced swollen shoulder (unspecified shoulder) and fever. On an unknown date in 2015, the patient saw her physician who stated they were unsure of why she suffered these reactions and no specific treatment was provided by her physician. On 31-DEC-2015, the patient experienced anaphylactic reaction to an unspecified food source. On 12-JAN-2016, after seeing an allergist, the patient was diagnosed with allergies, but to unknown sources. The patient underwent an unspecified allergy testing, on an unknown date. The patient stated that she experienced multiple allergies and anaphylactic episodes since receiving the PNEUMOVAX 23 (dates unspecified). An unspecified treatment was given for the events. The outcome of anaphylactic reaction and multiple allergies was reported as recovering. The outcome of swollen shoulder and fever was reported as recovered on approximately 30-OCT-2015 and 23-OCT-2015 respectively. Upon internal review the event of multiple anaphylactic episodes including anaphylactic reaction to an unspecified food source was considered to be medically significant. The reporter considered all events to be related to PNEUMOVAX 23. 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 and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-MAY-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit and the second lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects 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 was received from a licensed nurse practitioner and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patients were inadvertently vaccinated with an improperly stored dose of VAQTA (dose, route of administration, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner and refers to a multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patients were inadvertently vaccinated with an improperly stored dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 04-MAR-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 632 hours, with the lowest recorded temperature of 34 degrees Fahrenheit and the second lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit. The vaccine was stored in a refrigerator. No adverse effects were reported. 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: This spontaneous report as received from a licensed nurse practitioner refers to a multiple patients of unknown age and gender. The patents' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patents were inadvertently vaccinated with an improperly stored dose of M-M-R II (therapy type, dose, route of administration, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reaction or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, indication, lot # and expiration date were not reported). On an unknown date, the patient contacted the pharmacist to report and injection site reaction described as 3-inch by 3-inch red area that was painful and hot to the touch. The outcome of the injection site reaction described as 3-inch by 3-inch red area that was painful and hot to touch was not specified (also reported as the reactions lasted for an unspecified time). The relatedness between the injection site reaction described as 3-inch by 3-inch red area that was painful and hot to touch and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with VAQTA (lot# M017982, expiration date: 13-SEP-2017, dose and route of administration were not provided) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Erythema, Nodule, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a Pharmacist referring a female 50 year old patient. The patient's medical history and concurrent conditions were not reported. On 27-AUG-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection (dose, route of administration were not reported, lot # L040178 with expiration date 18-AUG-2017) because the patient was a smoker. EFFEXOR XR 75mg (manufacturer unknown). On the same date the injection site of the patient had redness, warmth to the touch, swelling and a knot was felt and there was pain in the armpit area; the arm had swelling around the arm and past the elbow. The events were recovered within a week, on approximately 03-SEP-2016. The reporter stated that a product quality complaint was not involved. The causal relationship between the events and PNEUMOVAX 23 was unknown. Multiple cases reported by primary reporter for PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: HPV9, UNK
Symptoms: Depression, Dizziness, Fatigue, Vertigo, Visual impairment
Clinical narrative: This spontaneous report was received from a nurse via company representative who is the mother of the patient (child) of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in SEP-2016 (reported as 3.5 weeks ago) the patient was vaccinated with GARDASIL 9, intramuscular. On an unknown date in September 2016, the patient experienced unspecified visual disturbances, depression, fatigue and dizziness. The patient was scheduled to have unspecified testing done to help diagnose vertigo. The patient had received 3 other unspecified vaccines on that same day. It was not determined if GARDASIL 9 was the source of the symptoms experienced by the patient. The outcome of the events were unknown. The patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed nurse practitioner and refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 22-SEP-2016 or 23-SEP-2016, the patients were inadvertently vaccinated with an improperly stored dose of RECOMBIVAX HB (dose, route of administration, lot # and expiration date were not reported). The administered doses of vaccines were exposed to a temperature of 1 Celsius degrees, for 1 hour and 46 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with VARIVAX (lot# M010482 with expiration date: 01-MAR-2018, lot# L049536 with expiration date: 08-DEC-2017 and lot# M025870 with expiration date: 24-MAY-2018; dose and route of administration were not provided) that was improperly stored. 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: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant 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-OCT-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 injection, lot # K012424, expiration date 05-JUN-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a pharmacist referring to 9 patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates between 27-SEP-2016 and 10-OCT-2016, the patients were inadvertently administered a dose of improperly stored ZOSTAVAX (8 doses of lot # L046896, expiration date 23-FEB-2017; 1 dose of M032139, expiration date 02-OCT-2016; dose and route were unknown). The vaccines were stored under the temperature 6 Celsius degree for 432 hours. There was no previous temperature excursion. No digital data logger was involved. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with GARDASIL 9 ( (lot# M011117, expiration date: 17-DEC-2017, dose and route of administration were not provided) that was improperly stored. 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 and a practice manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 11-FEB-2016, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 0.5 ml prefilled syringe (lot # L024132, expiration date: 21-JAN-2017; dose and route were not provided). The vaccine was exposed to following separate temperature excursions: first lasting for 56 hours, with the lowest recorded temperature of 33 degrees Fahrenheit (0.56 degrees Celsius), second lasting for 24 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.56 degrees Celsius), third lasting for 24 hours, with the highest recorded temperature of 48 degrees Fahrenheit (8.89 degrees Celsius), fourth lasting for 120 hours, with the lowest recorded temperature of 29 degrees Fahrenheit (-1.67 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. 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: This spontaneous report was received from a physician and refers to multiple patients of unknown age and gender. Information on the patients' concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patients were vaccinated with M-M-R II (lot # L039613, expiration date: 08-OCT-2017, dose and route of administration ere not provided) that was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 53 year old female patient with asplenia. The patient was allergic to unspecified cephalosporins and unspecified corticosteroids. Concomitant therapies included morphine (manufacturer unknown). On 03-OCT-2016, the patient received a dose of PNEUMOVAX 23 (lot # was reported as M035104, expiration date 06-MAY-2018; 0.5 ml, once; intramuscular) (reported as "she was indicated for it"). On 04-OCT-2016, the patient developed a 2 by 3 inch patch of redness,  that was itchy, which had moved down her arm from the injection site at the deltoid toward the bicep. It was a red patch of irritation with a little lump at the injection site. The patient was seen by the pharmacist on 05-OCT-2016 in regards to the reaction. No treatment was given for the events and no lab diagnostics studies were performed. At the reporting time, the patient did not recover from the events. The causality was not reported. Additional information has been requested.