chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: The information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were reported. On an unspecified date, an unspecified number of patients were vaccinated with an improperly stored dose of VAQTA (lot#M012324, expiration date 5-APR-2018) (dosage, frequency and route were not reported) for prophylaxis(incorrect product storage). No adverse effect reported. The vaccine was stored at a temperature from 32F to 35 F for 6 days. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA004001: US-009507513-1708USA003819: US-009507513-1707USA006766:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were reported. On an unspecified date, an unspecified number of patients were vaccinated with an improperly stored dose of ROTATEQ (lot#M046000, expiration date 27-JUN-2018) (dosage, frequency and route were not reported) for prophylaxis (Incorrect product storage). The vaccine was stored at a temperature from 32F to 35 F for 6 days. There was no previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. No adverse effect reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA003819: US-009507513-1707USA006766: US-009507513-1708USA004000:
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 25-JUL-2017 the patient received a dose of PNEUMOVAX 23 (unknown lot number & expiration date). On 30-JUL-2017, the patient inadvertently received another dose of PNEUMOVAX 23 (unknown lot number & expiration date) (extra dose administered). No adverse effects reported. No PQC involved. No further information provided.
Sex: F
Vaccine: HPV4
Symptoms: Bedridden, Disability, Laboratory test
Clinical narrative: This spontaneous report as received from a consumer refers to a 28 year old female patient (also reported as unspecified family member). The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient received unspecified number of doses of GARDASIL (lot # and expiry date were not reported), back when it first came out and experienced side effects from the vaccine and is now bedridden(disability). The reporter states that that no one was able to figure out what's wrong with the patient despite all the tests performed. The outcome of the adverse events were considered as not recovered. Causality assessment was not provided. No PQC involved. No further information was provided.
Age: 53.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This spontaneous report was received from a nurse referring to two unspecified patients of unknown age and gender, both HIV positive. On 08-AUG-2017, the patients were vaccinated with PNEUMOVAX 23 lot # M042324, expiration date 10-JUN-2018, for prophylaxis. On 09-AUG-2017, both patients experienced fever (pyrexia), muscle aches (myalgia) and chills. The outcome of pyrexia, myalgia and chills was reported as not recovered/not resolved.
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Lethargy, Malaise
Clinical narrative: This spontaneous report was received from a nurse referring to a 81 year old female patient. On 07-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N005096 for prophylaxis. On 07-AUG-2017 at night, the patient experienced lethargy, feeling abnormal and malaise. The outcome of lethargy, feeling abnormal and malaise was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided.  On or about 29-JUL-2014, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (Dose, route of administration, site of administration, Lot number and expiration date were not provided) by a physician at a medical group facility. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-OCT-2015, the patient was treated by an advanced practice registered nurse (APRN) for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valcyclovir for management of her painful symptoms.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.    Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA lot # N008823 for prophylaxis. The vaccine was exposed to a temperature ranges between 47°Fahrenheit (F) to 77°F, during a time frame of 30 minutes wich was call by a data logger with no previous temperature excursions. This is one of several reports from the same source.; Sender's Comments: US-009507513-1708USA002910: US-009507513-1708USA004847:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On 03-AUG-2017 the patient was vaccinated with GARDASIL 9 lot # N001533 for prophylaxis.  The vaccine was exposed to a temperature ranges between 47°Fahrenheit (F) to 77°F, during a time frame of 30 minutes wich was call by a data logger with no previous temperature excursions.    This is one of several reports from the same source.; Sender's Comments: US-009507513-1708USA004846: US-009507513-1708USA002910:
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Impaired work ability, Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report was received from a physician via field representative concerning a 26 year old female patient. Patient's medical history and concurrent conditions were unknown. She was allergic to amoxicillin, latex and had got a rash from children's Motrin a while ago. On 27-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (0.5 ml (normal dose), route, lot# and expiry date not reported) for prevention from Human papillomavirus (HPV). Concomitant therapies included albuterol sulfate (manufacturer unknown), alprazolam (XANAX), fluticasone propionate, salmeterol xinafoate (ADVAIR), aspirin (manufacturer unknown), escitalopram oxalate (LEXAPRO), iron (unspecified), folic acid and vitamins (unspecified). Physician reported that on the same day, at night, the patient experienced chills, body aches and a high fever. She took unspecified Ibuprofen. On 28-JUL-2017, she was still experiencing these same adverse events, and her face also started swelling. The patient missed work for a day and took unspecified Benadryl. On 29-JUL-2017, she experienced nausea. She took Benadryl and returned to work on that date. Physician mentioned that on 01-AUG-2017, the patient called the office complaining of nausea. She wanted to know if this was because of the vaccine. Physician told the patient she couldn't be sure, but it's possible. She advised the patient to take things that made her feel better. On 04-AUG-2017, the patient was contacted and all adverse events had resolved. Reporting physician considered the event nausea to be possibly related to GARDASIL 9. Causality assessment of rest other events were not provided.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: This spontaneous report was received from a physician via field representative concerning a 26 year old female patient. Patient's medical history and concurrent conditions were unknown. She was allergic to amoxicillin, latex and had got a rash from children's Motrin a while ago. On 27-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 injection (0.5 ml (normal dose), route, lot# and expiry date not reported) for prevention from Human papillomavirus (HPV). Concomitant therapies included albuterol sulfate (manufacturer unknown), alprazolam (XANAX), fluticasone propionate, salmeterol xinafoate (ADVAIR), aspirin (manufacturer unknown), escitalopram oxalate (LEXAPRO), iron (unspecified), folic acid and vitamins (unspecified). Physician reported that on the same day, at night, the patient experienced chills, body aches and a high fever. She took unspecified Ibuprofen. On 28-JUL-2017, she was still experiencing these same adverse events, and her face also started swelling. The patient missed work for a day and took unspecified Benadryl. On 29-JUL-2017, she experienced nausea. She took Benadryl and returned to work on that date. Physician mentioned that on 01-AUG-2017, the patient called the office complaining of nausea. She wanted to know if this was because of the vaccine. Physician told the patient she couldn't be sure, but it's possible. She advised the patient to take things that made her feel better. On 04-AUG-2017, the patient was contacted and all adverse events had resolved. Reporting physician considered the event nausea to be possibly related to GARDASIL 9. Causality assessment of rest other events were not provided.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored vaccine VAQTA (dose, strength, frequency unknown) that underwent temperature excursion every day since May 2017. She also reported that the vaccines may also have had temperature excursions prior to May 2017. For VAQTA lot numbers were:  N005746 expiration 26-MAY-2018, M047658 expiration 28-OCT-2017. The vaccine was stored at 32 to 35 degrees Fahrenheit for 25 hours and 47 to 77 degrees Fahrenheit for 55 hours. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported.  Lot number N005746 is an invalid lot number for VAQTA. This is one of the several reports from the same reporter. This report has been linked to reports 1707USA002962, 1708USA004862 and 1708USA004863.; Sender's Comments:  US-009507513-1707USA002962: US-009507513-1708USA004862: US-009507513-1708USA004863:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On an unknown date, the patients were vaccinated with improperly stored vaccine ROTATEQ (dose, strength, frequency unknown) that underwent temperature excursion every day since May 2017. She also reported that the vaccines may also have had temperature excursions prior to May 2017. For ROTATEQ vaccine, lot numbers are:  N003401 expiration 13-OCT-2018, M031553 expiration 19-MAR-2018, L046320 expiration 29-SEP-2017. The vaccine was stored at 32 to 35 degrees Fahrenheit for 25 hours and 47 to 77 degrees Fahrenheit for 55 hours. For the lot number N003401, the administration dates are: 06-JUN-2017, 29-JUN-2017. Excursion temperatures and time: 8.11 to 11.7 degrees from 09-MAY-2017 to 16-MAY-2017 for 63 hours, 8.11 to 9.6 degrees from 25-MAY-2017 to 06-JUN-2017 for 46 hours, 8.6 to 8.7 degrees from 06-JUN-2017 to 29-JUN-2017 for 60 hours. For the lot number L046320, the administration dates are: 16-MAY-2017, 18-MAY-2017, 13-JUN-2017, 19-JUN-2017, 21-JUN-2017, 26-JUN-2017, 10-JUL-2017, 11-JUL-2017, 12-JUL-2017. The excursion temperatures and time: 8.9-11.7 degrees from 09-MAY-2017 to 16-MAY-2017 for 63 hours, 8.8 to 8.9 degrees from 25-MAY-2017 to 13-JUN-2017 for 73 hours, 8.7 degrees on 19-JUN-2017 for 5 hours and 47 minutes, 8.7 to 8.8 degrees from 15-JUN-2017 to 21-JUN-2017 for 30 hours and 30 minutes, 0.0 to 1.7 degrees from 30- JUN- 2017 to 10- JUL-2017 52 hours and 59 minutes, 0.2 degrees on 11-JUL-2017 for 9 hours and 45 minutes, -0.2 degrees on 12-JUL-2017 for 6 hours and 41 minutes. The phone call was a result of the data logger.  No adverse effects were reported. This is one of the several reports from the same reporter. This report has been linked to reports 1707USA002962, 1708USA004862 and 1708USA004863.; Sender's Comments: US-009507513-1707USA002962: US-009507513-1708USA004861: US-009507513-1708USA004863:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a currently 65 year old female patient. In August 2016 (reported as a year ago) the patient was vaccinated with ZOSTAVAX for immunisation. Other suspect therapies included sterile diluent. The patient developed Shingles within one year of the vaccination on an unspecified date. The outcome of Shingles was unknown. The causality assessment was not provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to and refers to unspecified amount of patients of unknown ages and genders. On an unknown dates, the patients were vaccinated with a dose of RECOMBIVAX HB lot # M022077, expiration date 10-MAR-2019 for prophylaxis, which were stored in the range of 9 Celsius degrees to 25 Celsius degrees for 21 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported. Concomitant therapies included sterile diluent. Digital data logger was involved. This is one of several reports from the same source. Sender's Comments: US-009507513-1708USA005389.
Age: 34.0
Sex: F
Vaccine: MMR, PPV, MMR, PPV
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On 09-AUG-2017 the patient was vaccinated with PNEUMOVAX 23, subcutaneous for prophylaxis. Other suspect therapies included M-M-R II. On 09-AUG-2017, 1 day after onset of therapy the patient experienced wrong technique in product usage process. On an unknown date the patient experienced no adverse event. The outcome of wrong technique in product usage process and no adverse event is unknown.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with LIQUID PEDVAXHIB for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to LIQUID PEDVAXHIB.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a other health professional refers to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, 19400 DF, subcutaneous for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005392:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a vaccine coordinator refers to and refers to unspecified amount of patients of unknown ages and genders. On an unknown dates, the patients were vaccinated with a dose of M-M-R II lot # M007279, expiration date 09-FEB-2018 for prophylaxis, which were stored in the range of 9 celcius degrees to 25 celcius degrees for 21 hours and 30 minutes. No previous temperature excursion was reported. No adverse effects were reported.  Concomitant therapies included sterile diluent(STERILE DILUENT). Digital data logger was involved. This is one of several reports from the same source.; Sender's Comments: US-009507513-1708USA005286:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a other health professional refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, 19400 DF, subcutaneous for prophylaxis. On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005366:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from an office manager refers to multiple patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (lot # M044717, expiry date: 19-JUL-2019) (dosing details were not reported) for prophylaxis at a temperature of 35 degree Fahrenheit for 5 full days (incorrect product stored). No adverse effects reported. No previous temperature excursions reported. This is one of the two reports received from the same reporter. Sender's Comments: US-009507513-1708USA002323.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # N000326, expiration date 14-OCT-2019, for prophylaxis. The vaccine was exposed to 32 degree Fahrenheit to 35 degree Fahrenheit for 40 minutes. There was a previous temperature excursion at 32 degree Fahrenheit to 35 degree Fahrenheit for 3 hours 10 minutes. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA005627: US-009507513-1708USA005628: US-009507513-1708USA005626.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions and allergies and concomitant therapies was reported. On an unknown dates, multiple doses of improperly stored VAQTA lot # N005274 with expiration date 03-APR-2018 were administered to multiple unspecified patients for prophylaxis. Improperly stored vaccines underwent following temperature excursion: 9 Celsius degrees to 25 Celsius degrees (8.5 Celsius degrees) for 12 hours. Data logger was involved. No adverse event was reported.; Sender's Comments: US-009507513-1708USA000956: US-009507513-1708USA005615: US-009507513-1708USA005616: US-009507513-1708USA005617:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions and allergies and concomitant therapies was reported. On an unknown dates, multiple doses of improperly stored LIQUID PEDVAXHIB lot # M046140 with expiration date 27-SEP-2019 were administered to multiple unspecified patients for prophylaxis. Improperly stored vaccines underwent following temperature excursion: 9 Celsius degrees to 25 Celsius degrees (8.5 Celsius degrees) for 12 hours. Data logger was involved. No adverse event was reported.; Sender's Comments:  US-009507513-1708USA000956: US-009507513-1708USA005614: US-009507513-1708USA005616: US-009507513-1708USA005617:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions and allergies and concomitant therapies was reported. On an unknown dates, multiple doses of improperly stored GARDASIL 9 lot # M042853 with expiration date 17-JUL-2019 were administered to multiple unspecified patients for prophylaxis. Improperly stored vaccines underwent following temperature excursion: 9 Celsius degrees to 25 Celsius degrees (8.5 Celsius degrees) for 12 hours. Data logger was involved. No adverse event was reported. Sender's Comments: US-009507513-1708USA000956: US-009507513-1708USA005614: US-009507513-1708USA005615: US-009507513-1708USA005617.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a unspecified patients of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions and allergies and concomitant therapies was reported. On an unknown dates, multiple doses of improperly stored ROTATEQ lot # M041184 with expiration date 31-MAY-2018 were administered to multiple unspecified patients for prophylaxis. Improperly stored vaccines underwent following temperature excursion: 9 Celsius degrees to 25 Celsius degrees (8.5 Celsius degrees) for 12 hours. Data logger was involved. No adverse event was reported.; Sender's Comments:  US-009507513-1708USA000956: US-009507513-1708USA005614: US-009507513-1708USA005615: US-009507513-1708USA005616:
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates,the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M045653, expiration date 03-JUL-2019, for prophylaxis. The vaccine was exposed to 32 degree Fahrenheit to 35 degree Fahrenheit for 40 minutes. There was a previous temperature excursion at 32 degree Fahrenheit to 35 degree Fahrenheit for 3 hours 10 minutes. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments:  US-009507513-1708USA005415: US-009507513-1708USA005627: US-009507513-1708USA005628:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates,the patients were vaccinated with improperly stored VAQTA (strength, dose and route of administration were not reported) of lot # N008823, expiration date 26-MAY-2018, for prophylaxis. The vaccine was exposed to 32 degree Fahrenheit to 35 degree Fahrenheit for 40 minutes. There was a previous temperature excursion at 32 degree Fahrenheit to 35 degree Fahrenheit for 3 hours 10 minutes. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA005415: US-009507513-1708USA005626: US-009507513-1708USA005628:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (strength, dose and route of administration were not reported) lot # M041768, expiration date 25-JUN-2018, for prophylaxis. The vaccine was exposed to 32 degree Fahrenheit to 35 degree Fahrenheit for 40 minutes. There was a previous temperature excursion at 32 degree Fahrenheit to 35 degree Fahrenheit for 3 hours 10 minutes. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint(PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA005415: US-009507513-1708USA005626: US-009507513-1708USA005627:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of GARDASIL 9 single dose, lo# M013636, expiration date 15-FEB-2018 (route of administration and anatomical location were not reported), were administered to the patients. No adverse effects have been reported. The doses were stored in a temperature of 30 degrees Fahrenheit for 2 hours and 15 minutes. Data logger was involved. There was no previous temperature excursion reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005633: US-009507513-1708USA003399.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates, the unspecified number of improperly stored doses of ROTATEQ single dose, orally, lot#M045545, expiration date 10-JUN-2018, were administered to the patients. No adverse effects have been reported. The doses were stored in a temperature of 30 Fahrenheit degrees for 2 hours and 15 minutes. Data logger was involved. There was no previous temperature excursion reported. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA003399: US-009507513-1708USA005632:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies provided. On unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (lot # M041184 with the expiration date of 31-MAY-2018; dose number and exact dose were not reported), orally, for prophylaxis. No adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of 51 Fahrenheit degrees for 15 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA002664:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. There was no information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies provided. On unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot # N000237 with the expiration date of 25-OCT-2019; dose number, exact dose and route of administration were not reported), for prophylaxis. No adverse effects were reported. The administered doses of vaccine experienced a temperature excursion of 51 Fahrenheit degrees for 15 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This was one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA002664.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal discomfort, Nausea, Vomiting
Clinical narrative: On 8/2/2017, pt came into office for 12 yr WCC. Dad refused HPV vaccine stating pt had a reaction to the 1st dose on 8/10/2016 vaccine. Dad reports pt was fine during WCC visit, but once he was home, he developed an upset stomach, with nausea and vomiting. Dad states no one else in home became sick. Dad also did not contact our office after incident.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient developed erythema and local site pain within 24 hours of vaccine administration.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity, Pyrexia
Clinical narrative: My arm was very sore the evening after I received the injection and the next day I had a raised red area  around the injection site (about 5 to 6 inches in diameter) and I had a fever and temp of 101 degrees. I also had aching in my legs. The second day after the injection, the arm  was not as sore and the redness had  gotten lighter. The fever was gone.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Over 24 hours after immunization, left deltoid developed expanding erythema at injection site, increased warmth, increasing pain and low grade temperature elevation. Seen the following day, diagnosed with cellulitis and started on antibiotic.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site induration, Administration site warmth, Injection site erythema
Clinical narrative: Patient received the vaccine on Friday morning and is experiencing some redness, warmth and hardness in the right arm near and around the administration site.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient developed severe pain down arm and tingling.
Age: 24.0
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 24 year old patient. On 12-JUL-2017, the patient was vaccinated with PROQUAD lot # M010477. Other suspect therapies included sterile diluent. No adverse effects was reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash, Rash, Rash generalised
Clinical narrative: This spontaneous report has been received from a pharmacist and an employee referring to a 62 year old female patient with asthma. Concomitant medication included unspecified thyroid medication. There were no drug reactions/allergies. On 16-JUL-2017, the patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, lot # N012492 with expiration date 17-MAR-2018) for preventing against shingles (prophylaxis). On the same day, within five minutes of being administered the vaccine, the patient experienced a rash at the injection site. On 17-JUL-2017, the patient "developed rash all over her body". On an unspecified date in July 2017, patient also experienced a rash on her neck and bruising at the injection site. The patient went into pharmacy on 19-JUL-2017 and reported the events. No laboratory diagnosis was performed. Unspecified treatment was given to the patient. At the time of the report, the patient did not recover from the events. The causality between ZOSTAVAX and the events was unknown. The pharmacist accepted the offer to receive the varicella zoster virus identification program (VZVIP) packet. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003459:
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia, Rash, Rash papular, Rash pruritic
Clinical narrative: This spontaneous report was received from a licensed vocational nurse and refers to a 24-year-old female patient. No information regarding the patient's medical history, concomitant medications and concurrent conditions was provided. On 31-JUL-2017, the patient was vaccinated with GARDASIL 9 lot # N004799, expiration date: 15-NOV-2019, intramuscularly in the right arm (dose was not reported) against human papillomavirus. Other suspect therapy included DEPO-PROVERA (dates unknown). On 01-AUG-2017, the patient experienced a flesh colored rash with 1 mm raised papules on her arms (bilaterally), neck, and chest with itchiness. On an unknown date, the patient experienced alopecia with the use of DEPO-PROVERA. The patient contacted a physician and she was given an unspecified treatment for the events of rash papular and rash pruritic. The action taken with GARDASIL 9 was not applicable. The action taken with DEPO-PROVERA was not provided. The outcome of rash papular and rash pruritic was reported as not recovered. The outcome of alopecia was unknown. The casual relationship between the events and suspect therapies was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Joint injection, Muscular weakness, Pain in extremity
Clinical narrative: This spontaneous report was received from a 65-year-old female patient with no drug reactions or allergies in the past, who was reporting on herself. The patient's concurrent conditions included degenerative disc disease, synovial cyst on spine, osteoarthritis, hypertension, high cholesterol and obesity. The patient's medical history included hysterectomy. On 01-JUN-2017, the patient was intramuscularly vaccinated with PNEUMOVAX23 injection (dose, lot # and expiration date were not reported), in her right upper arm. Concomitant therapies included LIPITOR, diclofenac, aspirin (manufacturer unknown), unspecified calcium, unspecified vitamins and glucosamine. On 01-JUN-2017, 2 hours after receiving PNEUMOVAX23, the patient experienced pain at injection site and developed "swelling the size of a baseball" at the injection site. Then, when she stood up "her right leg went out". The patient stated that she was on the couch until 20-JUN-2017 icing and elevating her leg. She sought medical attention. On 20-JUN-2017, the patient was seen by her family physician and she was prescribed dexamethasone (manufacturer unknown) for a period of 7 days. The reporter stated, that on an unknown date in June 2017, after she finished dexamethasone, the pain went away. However, on an unspecified date in approximately 2017, after finishing dexamethasone, the patient began having "pain in right leg and it felt weak and tingly". On 03-AUG-2017, she saw an orthopedist and received a "cortisone shot" in her right knee. On an unknown date the x-ray of the back was performed (results were not provided). The outcome of the event of pain in right leg/pain was reported as not recovered. The outcome of the events of "her right leg went out/ was on the couch until 06/20/2017 icing and elevating her leg", "it felt weak and tingly" and "swelling the size of a baseball at the injection site" was not reported. The relatedness between the adverse events and PNEUMOVAX23 was not reported. No product quality complaint was involved. Upon internal review, the events of "her right leg went out/ was on the couch until 06/20/2017 icing and elevating her leg" and "it felt weak" were determined to be medically significant. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Paraesthesia, Spinal X-ray
Clinical narrative: This spontaneous report was received from a 65-year-old female patient with no drug reactions or allergies in the past, who was reporting on herself. The patient's concurrent conditions included degenerative disc disease, synovial cyst on spine, osteoarthritis, hypertension, high cholesterol and obesity. The patient's medical history included hysterectomy. On 01-JUN-2017, the patient was intramuscularly vaccinated with PNEUMOVAX23 injection (dose, lot # and expiration date were not reported), in her right upper arm. Concomitant therapies included LIPITOR, diclofenac, aspirin (manufacturer unknown), unspecified calcium, unspecified vitamins and glucosamine. On 01-JUN-2017, 2 hours after receiving PNEUMOVAX23, the patient experienced pain at injection site and developed "swelling the size of a baseball" at the injection site. Then, when she stood up "her right leg went out". The patient stated that she was on the couch until 20-JUN-2017 icing and elevating her leg. She sought medical attention. On 20-JUN-2017, the patient was seen by her family physician and she was prescribed dexamethasone (manufacturer unknown) for a period of 7 days. The reporter stated, that on an unknown date in June 2017, after she finished dexamethasone, the pain went away. However, on an unspecified date in approximately 2017, after finishing dexamethasone, the patient began having "pain in right leg and it felt weak and tingly". On 03-AUG-2017, she saw an orthopedist and received a "cortisone shot" in her right knee. On an unknown date the x-ray of the back was performed (results were not provided). The outcome of the event of pain in right leg/pain was reported as not recovered. The outcome of the events of "her right leg went out/ was on the couch until 06/20/2017 icing and elevating her leg", "it felt weak and tingly" and "swelling the size of a baseball at the injection site" was not reported. The relatedness between the adverse events and PNEUMOVAX23 was not reported. No product quality complaint was involved. Upon internal review, the events of "her right leg went out/ was on the couch until 06/20/2017 icing and elevating her leg" and "it felt weak" were determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant (clinical coordinator) 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 medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of  VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK STERILE DILUENT) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA005841: US-009507513-1708USA005839: US-009507513-1708USA005840: US-009507513-1708USA005836: US-009507513-1708USA005838:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report has been received from a pharmacist referring to multiple unspecified patients. The patients' medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, these unspecified patients vaccinated with ZOSTAVAX (dose, route, lot# and expiration date not reported) for prophylaxis. On unknown dates, the patient developed injection site reactions (no further clarifying information was provided). The outcome of the injection site reactions was unknown. The causality between ZOSTAVAX and injection site reactions was not reported. The pharmacist accepted the offer to receive the varicella zoster virus identification program (VZVIP) packet. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1707USA007593:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (strength, dose and route of administration were not reported) of lot # N000237, expiration date 25-OCT-2019, for prophylaxis. The vaccine was exposed to 0 degree celcius to 1 degree celcius for 21 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. There was no product quality complaint(PQC) involved. This is one of the two reports received from same reporter.; Sender's Comments:  US-009507513-1708USA005432:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-JUL-2017, the patient received an improperly stored dose of ROTATEQ, lot # M038209 with expiration date 23-APR-2018 (dose and route were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature of 32 degrees F to 35 degrees F (34 degrees F) for a time frame of 2 weeks. Digital Data logger was involved. There was no previous temperature excursion. Product quality complaint (PQC) was not involved. No further details were provided.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Arthritis, Laboratory test, Rhabdomyolysis
Clinical narrative: This spontaneous report has been received from a physician via a company representative and refers to a 13-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In August 2015 and in August 2016, the patient was vaccinated with the first and second dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). In August 2016, after the second dose, the patient experienced rhabdomyolysis and polyarticular arthritis and was hospitalized. The patient received treatment for the adverse events. The patient had unspecified laboratory test performed. The outcome of the events was not reported (dechallenge was also reported as "Yes, after stopping therapy"). The relatedness between the events and GARDASIL 9 was not reported. Upon internal review, the events of rhabdomyolysis and polyarticular arthritis were considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date, the patient was vaccinated with ROTATEQ lot # M042172, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage, no adverse event and circumstance or information capable of leading to medication error. The outcome of incorrect product storage, no adverse event and circumstance or information capable of leading to medication error is unknown. The reporter considered incorrect product storage, no adverse event and circumstance or information capable of leading to medication error to be not related to ROTATEQ.  Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Two days after vaccine, around triceps area of left arm, where ZOSTAVAX was given, developed patch of redness, warmth, pain. This worsened overnight and by the third day post vaccine was causing numbness in left hand, swelling in axilla in addition to upper arm and lymphadenopathy in left axilla. She was taking ADVIL and icing the area for treatment.
Age: 55.0
Sex: F
Vaccine: HEPAB, TDAP, VARZOS
Symptoms: Lymphadenopathy, Oedema peripheral
Clinical narrative: Two days after vaccine, around triceps area of left arm, where ZOSTAVAX was given, developed patch of redness, warmth, pain. This worsened overnight and by the third day post vaccine was causing numbness in left hand, swelling in axilla in addition to upper arm and lymphadenopathy in left axilla. She was taking ADVIL and icing the area for treatment.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pustule, Rash, Rash pustular
Clinical narrative: DATE GIVEN 7/19/2017. RASH ONSET 7/29/2017 3 POX... 1 LOWER EXTREMETY, 1 ON ABDOMEN AND 1 ABOVE EYE.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Cyanosis, Feeling abnormal, Heart rate increased, Hypersensitivity, Loss of consciousness
Clinical narrative: Patient received the shot and stood up. She exited the little room and said she didn't feel good- she had no color in her face. We sat her down and she passed out. While I was trying to get her to stay awake she looked like she was having a seizure (shaking did not last long). A lady nearby told me she was a nurse and asked me if she had histories of seizures. I said no. (At this time the pharmacy nurse was calling 911) the nurse said she was very pale and lips were blue. The pharmacy nurse then administered an EPIPEN because she felt she was having an allergic reaction. EMTs arrived. They took her blood pressure and checked her heart rate which was a little fast but not of a big concern being that she received the EPIPEN.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Pallor, Seizure like phenomena, Tremor
Clinical narrative: Patient received the shot and stood up. She exited the little room and said she didn't feel good- she had no color in her face. We sat her down and she passed out. While I was trying to get her to stay awake she looked like she was having a seizure (shaking did not last long). A lady nearby told me she was a nurse and asked me if she had histories of seizures. I said no. (At this time the pharmacy nurse was calling 911) the nurse said she was very pale and lips were blue. The pharmacy nurse then administered an EPIPEN because she felt she was having an allergic reaction. EMTs arrived. They took her blood pressure and checked her heart rate which was a little fast but not of a big concern being that she received the EPIPEN.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: More than expected redness and warmth lateral to injection site. Injection was Hib on Left thigh. Patient was given antibiotics and will follow up in clinic on 8/16/17.