chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a 4 year old patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On 17-MAY-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX lot # M039452 with expiration date 19-DEC-2017 (dose and route of administration were not reported) instead of VARIVAX because ZOSTAVAX was mistakenly ordered instead of VARIVAX. No treatment was given. The patient did not seek medical attention. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1706USA001908:
Age: 62.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: This spontaneous report was received from a medical assistant via a company representative and refers to a 62-year-old female patient. No information regarding the patient's concurrent conditions was reported. The patient had no medical history. The patient did not have any known drug reaction/allergies. On 16-MAY-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not reported) in the right arm, on the front side, pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (TDAP) (dose, route of administration, lot# and expiration date were not reported). On 16-MAY-2017, shortly after the injection, the patient became red at the injection site and developed a knot. It was not known if the patient received care from the physician's office. No treatment information was provided. No laboratory test diagnostic was performed. The outcome of the events was unknown. The causality between the events and suspect therapies was not provided. Additional information is not expected as there was no consent to contact the reporter.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients may have received a possibly improperly stored dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported) and other unspecified vaccines. The vaccines were delivered into the office in a brown paper bag at unspecified temperature for an unspecified amount of time. At the time of this report, the vaccines were stored at proper temperature in a cooler on the delivery trunk. It was unspecified if previous temperature excursion occurred. No adverse effects reported. Product quality complaint was not involved. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: HPV4, UNK
Symptoms: Erythema, Skin warm, Vaccination error
Clinical narrative: This spontaneous report was received from a consumer reporting on her 18 year old male patient (the reporter's nephew). No information about the patient's medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAY-2017, approximately at 3:30 PM, the patient was vaccinated with a second dose of meningococcal vaccine (reported as "Meningitis B booster") (dose, route of administration, lot number and expiry date not provided) during a scheduled doctor's visit. As a second dose that day, he was accidentally vaccinated with GARDASIL (dose, route of administration, lot number and expiry date not provided). He was not planning to get the GARDASIL and he had never received this vaccine before. When the patient came out of the exam room, he told his mother that the nurse asked what he was for and he said "he really didn't know". The nurse claimed that the patient said he was getting GARDASIL, however the patient had never heard of this vaccine. On an unknown date, in approximately May 2017, the patient's arm was red, hot and the area of redness was about the size of deck of cards. The outcome of the events was unknown. The relatedness between the event of arm being red and hot and GARDASIL was not specified. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist who referred to an unspecified patient of unknown demographics. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 23-MAY-2017, the patient was administered an expired dose of VARIVAX (lot# L01799 and expiration date: 19-MAY-2017; dose, route of administration and anatomical location were not reported) for prophylaxis. A dose of sterile diluent (manufacturer unknown) (lot# N007932 and expiration date: 06-MAY-2018) was used to reconstitute the vaccine. The vaccine had no prior temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Extra dose administered
Clinical narrative: This spontaneous report was received from a physician referring to a 15 year old female patient with Rokitansky-Kuster syndrome. The patient's medical history was not reported. She was not taking any concomitant medication and did not have drug reactions/allergies. On 27-APR-2017, the patient received the third dose of GARDASIL 9 and, on 23-MAY-2017, she was vaccinated with a fourth dose (lot # M041212, expiration date 21-JUN-2019) for prophylaxis (dose and route of administration were not reported). On 23-MAY-2017, after the patient was administered that fourth dose of GARDASIL 9, a little while later, she experienced chest pain. It was reported that she sought medical attention. The outcome of this event was reported as not recovered. No laboratory diagnostic studies were performed. Causality relationship between the event and GARDASIL 9 therapy was not reported. No product quality complaint was involved. 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 healthcare worker concerning to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 15-MAY-2017, the patient was vaccinated with an improperly stored ROTATEQ dose, orally for prophylaxis (the lot #, expiration date, strength, and frequency were not provided). The stored conditions were reported as follow: temperature: 32 Fahrenheit degrees to 35 Fahrenheit degrees, for a period of 24 hours. There was not previous temperature excursion reported. A data logger was 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 medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug an allergy history were not reported. On 24-MAY-2017, one dose of an improperly stored VAQTA had been administered to the patient, lot # M027879, expiration date 24-JAN-2018 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The patient's concomitant medication was not reported. On an unspecified date, was registered a temperature range between 47° Fahrenheit (F) and 77°F during a time frame of 1 hour. Previous temperature excursion had been reported with the same temperature range and time frame (47° F to 77°F for one hour). Adverse effects were not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was not provided. On unknown dates, the unspecified number of improperly stored doses of ZOSTAVAX subcutaneously, lot # M035148, expiration date 25-OCT-2017 (dose and anatomical location were not reported) were administered to the unspecified number of patients. It was reported that the doses of vaccine were exposed to temperatures of 6.4 degrees Fahrenheit for 15 minutes and 11.84 degrees Fahrenheit for 7 hours and 15 minutes before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. Digital Data Logger was used. No product quality complaint (PQC) was involved. 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 medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 19-APR-2017 to 23-MAY-2017,the patients were vaccinated with improperly stored doses of VARIVAX lot # M005973 with expiration date 02-FEB-2018, lot# M025867 with expiration date 24-MAY-2018 , lot# M033906 with expiration date 20-JUL-2018 (dose and route of administration were not reported). The vaccines were reconstituted with a sterile diluent (lot# and expiration date were not reported) that did not undergo a temperature excursion. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 8 hours. Data logger was not involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA014497: US-009507513-1705USA014496: US-009507513-1705USA014464: US-009507513-1705USA014495:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysgraphia, Dyspnoea, Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a currently 68-year-old female patient of who was reporting on herself. The patient's concurrent conditions included high blood pressure and allergy to tetanus vaccine (details were not reported). The patient's medical history included shingles from which she recovered before vaccination with ZOSTAVAX. The patient reported that on an unknown date "before 25-JUL-2013", she had contact with shingles. On 25-JUL-2013, the patient was vaccinated with ZOSTAVAX, subcutaneously "as a booster" for prevention for herpes zoster dose (lot number, expiration date and anatomical location were not reported). Concomitant therapies inducted many unspecified medications. On an unknown date, the patient experienced shingles. The patient also reported that her current case of shingles gotten in her eye and she could not breathe and write anymore (onset dates of the events and details were not provided). The patient sought medical attention and was seen by her physician on an unknown date. On an unknown date, the patient was hospitalized and received an unspecified treatment for the events. During her hospitalization, the patient was taken off an unspecified medication. There were no laboratory tests performed. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of herpes zoster ophthalmic was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner concerning a 20 year old patient of an unknown gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported. On unknown dates, the patient was vaccinated for the first and second dose of the GARDASIL (strength, dose, route, lot# and expiration date) for prophylaxis. After that, on 26-MAR-2016, the patient received the third dose of the human papillomavirus series with GARDASIL 9 (strength, dose and route were unknown) lot# L019297, expiration date 18-AUG-2017, for prophylaxis. No adverse event effect was reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided.   On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000491: US-009507513-1706USA000492:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000492:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions between -14 and -10 degrees Celsius for 3 hours and 45 minutes and between -9 and 8 degrees Celsius for 3 hours and 30 minutes. There were no previous excursions reported. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with the properly stored sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine underwent the temperature excursions of more than -14 but less than -10 degrees Celsius for 3 hours and 45 minutes and more than -9 but less than 8 degrees Celsius for 3 hours and 30 minutes, which were detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown demographics. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with the properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. The vaccine underwent the temperature excursions of more than -14 but less than -10 degrees Celsius for 3 hours and 45 minutes and more than -9 but less than 8 degrees Celsius for 3 hours and 30 minutes, which were detected by a data logger. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (other health professional) refers to unspecified number of patients of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9, 1 DF intramuscularly for prophylaxis. Temperature excursion 32 to 35 degree Fahrenheit for 5 minutes and 47 to 77 Fahrenheit for 17 minutes. No adverse reactions (no adverse event) per primary reporter. No further information to report. This is one of the several reports from same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001928:Original Case: 1706USA001387: US-009507513-1706USA001927:Original Case: 1706USA001387: US-009507513-1706USA001929:Original Case: 1706USA001387.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 02-JUN-2017, the patient was vaccinated with PROQUAD (lot # reported as M049123, expiry date: 13-JUN-2018), (route: subcutaneous) reconstituted with properly stored diluent MRK (lot #N002578, expiry date: 05-AUG-2019). No adverse effects reported. The outcome of the events was unknown. 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 medical assistant refers to an unspecified number of patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M041770, expiry date 26-JUN-2018, lot # M040270 expiry date 29-APR-2018, lot# M038724,  expiry date 24-APR-2018, lot# M032643, expiry date 04-MAR-2018, M007298, expiry date 19-NOV-2017, M025568, 07-NOV-2017) for prophylaxis since 15-MAR-2017. No adverse events were reported. Temperature of 47 degree Fahrenheit to 77 degree Fahrenheit and time frame was 6.5 hours. There was no previous temperature excursion. It was stated that it was because of data logger. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 02-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis.  A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001714: US-009507513-1706USA001721: US-009507513-1706USA001722: US-009507513-1706USA001723: US-009507513-1706USA001719: US-009507513-1706USA001724: US-009507513-1706USA001725: US-009507513-1706USA001726: US-009507513-1706USA001727: US-009507513-1706USA001728: US-009507513-1706USA001729:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 05-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001721: US-009507513-1706USA001722: US-009507513-1706USA001714: US-009507513-1706USA001724: US-009507513-1706USA001720: US-009507513-1706USA001725: US-009507513-1706USA001729: US-009507513-1706USA001726: US-009507513-1706USA001727: US-009507513-1706USA001728: US-009507513-1706USA001719:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 24-MAR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis.  A digital data logger was used. No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: US-009507513-1706USA001721: US-009507513-1706USA001722: US-009507513-1706USA001723: US-009507513-1706USA001719: US-009507513-1706USA001724: US-009507513-1706USA001725: US-009507513-1706USA001726: US-009507513-1706USA001714: US-009507513-1706USA001728: US-009507513-1706USA001729:
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. It was reported by the pharmacist that on 01-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, route of administration, and frequency were not reported), for prophylaxis. A digital data logger was used.  No adverse effects were reported. This is one of multiple reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014153: US-009507513-1706USA001720: US-009507513-1706USA001721: US-009507513-1706USA001722: US-009507513-1706USA001723: US-009507513-1706USA001719: US-009507513-1706USA001724: US-009507513-1706USA001725: US-009507513-1706USA001726: US-009507513-1706USA001727: US-009507513-1706USA001714: US-009507513-1706USA001729:
Age: 0.08
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician and refers to a 1 month old patient of unknown gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided. On 17-MAY-2017, the patient was inadvertently vaccinated with a dose of ZOSTAVAX lot # M039452 with expiration date 19-DEC-2017 (dose and route of administration were not reported) instead of VARIVAX because ZOSTAVAX was mistakenly ordered instead of VARIVAX. No treatment was given. The patient did not seek medical attention. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA009078:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (other health professional) refers to unspecified number of patients of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ, 1 DF orally for prophylaxis (incorrect product storage). Temperature excursion 32 to 35 degree Fahrenheit for 5 minutes and 47 to 77 Fahrenheit for 17 minutes. No adverse reactions (no adverse event) per primary reporter. NO further information to report. This is one of the several reports from same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001928: Original Case : 1706USA001387 US-009507513-1706USA001929: Original Case : 1706USA001387 US-009507513-1706USA001387: Original Case : 1706USA001387.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (other health professional) refers to unspecified number of patients of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date in April 2017, the patient was vaccinated with improperly stored MMR II, 1 DF for prophylaxis (incorrect product storage). Temperature excursion 32 to 35 degree Fahrenheit for 5 minutes and 47 to 77 Fahrenheit for 17 minutes. No adverse reactions (no adverse event) per primary reporter. NO further information to report. This is one of the several reports from same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (other health professional) refers to unspecified number of patients of unknown age. Pertinent medical histories and concomitant medications were not reported. On an unknown date in April 2017, the patient was vaccinated with improperly stored PEDVAXHIB, 1 DF Intramuscular injection for prophylaxis (incorrect product storage). Temperature excursion 32 to 35 degree Fahrenheit for 5 minutes and 47 to 77 Fahrenheit for 17 minutes. No adverse reactions (no adverse event) per primary reporter. NO further information to report. This is one of the several reports from 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 nurse refers to an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of VARIVAX from lot # M010480 with expiry:01-MAR-2018, and M004329 with expiry: 26-JAN-2018, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursion of -13.6 degree Celsius for 3.5 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001439:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender.  The patients medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date(s), the patients were vaccinated with improperly stored doses of M-M-R II from lot #s L039613 with expiry: 08-OCT-2017; L036851 with expiry: 23-SEP-2017 and L026553 with expiry: 16-JUL-2017, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursions of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. 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 refers to an unspecified number of patients of unknown age and gender.  The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of ROTATEQ, orally, from lot M040267 with expiry: 14-MAY-2018, for prophylaxis (dose and anatomical location not reported). The vaccine lot had a temperature excursions of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001439:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of with GARDASIL 9 from lot# M032650 with expiry: 31-MAR-2019; M041990 with expiry: 28-JAN-2019, and L043213 with expiry: 28-AUG-2017, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursion of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA001439.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of PNEUMOVAX23 from lot# M037533 with expiry: 17-MAY-2018, for prophylaxis (dose, route and anatomical location not reported). The vaccine lot had a temperature excursion of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001439: US-009507513-1706USA001439:
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Dizziness, Erythema, Heart rate irregular, Peripheral swelling
Clinical narrative: Called c/o of arm red/hot and swollen going down to elbow. Denied fever. Encouraged to put ice pack, push flushed. OTC antihistamine OTC q 6 hrs and Tylenol or Ibuprofen (which ever she could take). If no better in 24 hrs call and come in to be seen. Called back on 06/05/17 and stated "she had to go to ER via EMS-"got dizzy and heart rate irregular" Was given IV fluids and IV antibiotic- was told had cellulitis and was sent home on Doxycycline per patient-stayed approximately 5 hrs in ER. Informed to continue to push fluids and the tx the ER dr had given her and if any other problems to call and come in and be seen by Dr.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Called c/o of arm red/hot and swollen going down to elbow. Denied fever. Encouraged to put ice pack, push flushed. OTC antihistamine OTC q 6 hrs and Tylenol or Ibuprofen (which ever she could take). If no better in 24 hrs call and come in to be seen. Called back on 06/05/17 and stated "she had to go to ER via EMS-"got dizzy and heart rate irregular" Was given IV fluids and IV antibiotic- was told had cellulitis and was sent home on Doxycycline per patient-stayed approximately 5 hrs in ER. Informed to continue to push fluids and the tx the ER dr had given her and if any other problems to call and come in and be seen by Dr.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Skin lesion
Clinical narrative: Information was received from a patient's son/daughter concerning their 79 year old father. The patient's concurrent conditions included  well-controlled diabetes and liver cirrhosis. On an unknown date,the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unspecified date, the patient noted a lesion, approximately 3" in diameter on his forehead at his hairline. He denied any pain associated with the lesion. Only minor itching was present at the wounds site. After 72 hours, his doctor diagnosed a mild case of shingles (herpes zoster) and did not treat with medication. Within the following 72 hours, the itching ceased and the lesion had almost completely healed. There were no other lesions present on the patient. The causal relationship between the event and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site swelling, Local reaction
Clinical narrative: This spontaneous report was received from a nurse practitioner via company representative and refers to a unspecified female patient with the age reported as "around the age of sixty five"). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 for prophylaxis (also reported as "the appropriate age for the administration") (dose, route of administration, anatomical location lot# and expiration date were not reported).  According to the reporter, the vaccination resulted in an immediate local reaction described also as 'lots swelling at the insertion site". The outcome of the events was unknown. The relatedness between the vents and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 13-year-old patient of unknown gender. The patient's concomitant medications, pertinent medical history and known drug reactions or allergies were not reported. On 24-MAY-2017, the patient was vaccinated with a dose of PROQUAD, subcutaneously (exact dose, lot # and expiry date were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient had no medical history, concurrent condition, drug and allergy history to be reported. The patient's concomitant medications were not provided. On 30-MAY-2017, the patient was vaccinated with an expired dose of GARDASIL lot # M014929, expiration date 27-MAY-2017, (route, dose were not provided) for prophylaxis. The patient's concomitant medications were not provided. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Electroencephalogram abnormal, Fall, Feeling abnormal, Jaw fracture
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 16-year-old female patient. The patient's medical history included a lot of Staphylococcal infections on skin, 3 in the past year. Her concomitant medications included unspecified dermatology medications for skin. The patient had no drug reactions or allergies. On 15-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (dose, lot number and expiration date were not reported), for prevention from Human papillomavirus (HPV). On 24-MAY-2017, the patient experienced a six minute seizure where she was totally unconscious. She fell to the floor and cracked her jaw, but no teeth were broken. She lost control of her bladder. The patient was taken to an unspecified emergency room (ER) by her father. On the way to the ER, the father noticed blotches on her arm, but by the time they got to the ER, the blotches had already resolved and were not seen by the ER personnel. At the ER, the patient received oxygen; no other treatment was given. The patient was not admitted into the hospital. The patient had a Computed Tomography (CT) scan and a Magnetic Resonance Imaging (MRI) on her head performed on an unspecified date in May 2017, after the ER visit. She also had an Electroencephalography (EEG) performed on 31-MAY-2017. The results of CT an MRI were reported as "negative", but the EEG was "positive". The patient would see an unspecified specialist on 01-JUN-2017 (reported as "later today"). The reporter thought that the patient would be prescribed an unspecified anti-seizure medication. The outcome of the seizure and being totally unconscious was resolved after 6 minutes on approximately 24-MAY-2017. The outcome of blotches on her arm was resolved on an unknown date in May 2017. The outcome of the cracked jaw was reported as improving and the outcome of losing control of the bladder was not reported. The patient's present status was reported as "not feeling good". The causality assessment between the events and GARDASIL 9 was not provided. Upon internal review, the events of seizure and being totally unconscious were considered to be medically significant. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness, Nuclear magnetic resonance imaging brain normal, Rash macular, Seizure, Urinary incontinence
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a 16-year-old female patient. The patient's medical history included a lot of Staphylococcal infections on skin, 3 in the past year. Her concomitant medications included unspecified dermatology medications for skin. The patient had no drug reactions or allergies. On 15-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection, intramuscularly (dose, lot number and expiration date were not reported), for prevention from Human papillomavirus (HPV). On 24-MAY-2017, the patient experienced a six minute seizure where she was totally unconscious. She fell to the floor and cracked her jaw, but no teeth were broken. She lost control of her bladder. The patient was taken to an unspecified emergency room (ER) by her father. On the way to the ER, the father noticed blotches on her arm, but by the time they got to the ER, the blotches had already resolved and were not seen by the ER personnel. At the ER, the patient received oxygen; no other treatment was given. The patient was not admitted into the hospital. The patient had a Computed Tomography (CT) scan and a Magnetic Resonance Imaging (MRI) on her head performed on an unspecified date in May 2017, after the ER visit. She also had an Electroencephalography (EEG) performed on 31-MAY-2017. The results of CT an MRI were reported as "negative", but the EEG was "positive". The patient would see an unspecified specialist on 01-JUN-2017 (reported as "later today"). The reporter thought that the patient would be prescribed an unspecified anti-seizure medication. The outcome of the seizure and being totally unconscious was resolved after 6 minutes on approximately 24-MAY-2017. The outcome of blotches on her arm was resolved on an unknown date in May 2017. The outcome of the cracked jaw was reported as improving and the outcome of losing control of the bladder was not reported. The patient's present status was reported as "not feeling good". The causality assessment between the events and GARDASIL 9 was not provided. Upon internal review, the events of seizure and being totally unconscious were considered to be medically significant. Additional information has been requested.