chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 20 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 09-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 16 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017 the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 08-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-SEP-2018, the patient was vaccinated with an expired dose of M-M-R II (lot # M035935 exp date 09-AUG-2018) (dose and route not reported). No adverse effects were reported.
Age: 0.5
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date in September 2018, reported as "last week",  the patient was vaccinated with GARDASIL 9 lot # R003557, expiration date 20-NOV-2020 (dose and route were not provided) for prophylaxis (drug administered to patient of inappropriate age).  No adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 18 years old male patient. On 18-FEB-2015, at age of 14 years old, the patient was vaccinated with the first dose of GARDASIL 9 (dose and lot # not provided) intramuscularly. The medical assistant reported that the patient missed his second dose of GARDASIL 9 and presented to the office on 17-SEP-2018 requesting his second injection of GARDASIL 9 (dose and lot # not reported) intramuscularly. No adverse effects were reported
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling (3cm) and redness at site, non tender.
Age: 28.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Chest X-ray, Headache, Hyperhidrosis, Injection site swelling
Clinical narrative: Headache, fever of 102, severe body aches, severe sweating, swelling at injection site, break out of chicken box of about 75 within 2 weeks of injection.
Age: 28.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Varicella
Clinical narrative: Headache, fever of 102, severe body aches, severe sweating, swelling at injection site, break out of chicken box of about 75 within 2 weeks of injection.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Presyncope
Clinical narrative: Felt dizzy and lightheaded. No syncope but near syncope while still in the exam room. Blood pressure was monitored, given apple juice. After sitting felt fine and left.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Electromyogram abnormal, Fall, Full blood count normal
Clinical narrative: Mild dizziness starting in day after vaccine. Dizziness persisted and grew steadily worse over the next 11 months. For the last several weeks the dizziness is 24/7 and I have fallen from imbalance four times over the last three months. I've worked with my health care providers (PCP, neurologist, ENT, optometrist) to check for many possible causes. MRI for brain, nothing. Ultrasound for carotids, nothing. Xray for hip, nothing. ENT exams, nothing. EMG found peripheral neuropathy in legs. Many blood and urine tests, nothing. Eyes, nothing. I am scheduled a set of tests in November at Hospital for balance and then a follow-up meeting with neurologist.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Neuropathy peripheral, Nuclear magnetic resonance imaging brain normal, Peripheral sensorimotor neuropathy, Ultrasound Doppler, Ultrasound Doppler normal
Clinical narrative: Mild dizziness starting in day after vaccine. Dizziness persisted and grew steadily worse over the next 11 months. For the last several weeks the dizziness is 24/7 and I have fallen from imbalance four times over the last three months. I've worked with my health care providers (PCP, neurologist, ENT, optometrist) to check for many possible causes. MRI for brain, nothing. Ultrasound for carotids, nothing. Xray for hip, nothing. ENT exams, nothing. EMG found peripheral neuropathy in legs. Many blood and urine tests, nothing. Eyes, nothing. I am scheduled a set of tests in November at Hospital for balance and then a follow-up meeting with neurologist.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Ultrasound thyroid normal, X-ray of pelvis and hip normal
Clinical narrative: Mild dizziness starting in day after vaccine. Dizziness persisted and grew steadily worse over the next 11 months. For the last several weeks the dizziness is 24/7 and I have fallen from imbalance four times over the last three months. I've worked with my health care providers (PCP, neurologist, ENT, optometrist) to check for many possible causes. MRI for brain, nothing. Ultrasound for carotids, nothing. Xray for hip, nothing. ENT exams, nothing. EMG found peripheral neuropathy in legs. Many blood and urine tests, nothing. Eyes, nothing. I am scheduled a set of tests in November at Hospital for balance and then a follow-up meeting with neurologist.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Broke in hives, starting under both breasts, and towards back on sides of body.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Electrocardiogram, Fatigue, Immediate post-injection reaction, Laboratory test normal, Syncope
Clinical narrative: Extremely tired immediately after, about a week after I started having fainting/ syncope problems. It got so bad that I was fainting once a day sometimes more. It lasted for about 3 years and I can finally say I have had no more episodes this year. I saw a few doctors, they checked my heart, my brain to rule out seizures, a lot of testing and nobody figured out why it was happening.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: After flu shot there was little to no pain, but that evening experienced pain in arm and had difficulty moving arm. At day 7 after the shot, patient still experiencing pain in arm and decreased mobility.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Rash, Throat irritation
Clinical narrative: This spontaneous report as received from a nurse refers to a 14 year old female patient. Patient's medical history, concurrent condition and concomitant medications were reported as none. On 30-AUG-2018, the patient was vaccinated with MENACTRA (dosing details unknown) for prophylaxis, and shortly after on 30-AUG-2018, the patient was vaccinated with GARDASIL 9, intramuscularly (dosing details unknown) for prevention of Human Papilloma Virus. On 30-AUG-2018, about 5 minutes after GARDASIL 9, was administered the patient slid off the chair and fell on the ground. The nurse was unable to provide a reason why the patient slid off the chair and the nurse did not define this as syncope. On 30-AUG-2018, the patient also experienced rash on both arms, but not at the injection site. The patient stated her throat felt funny on 30-AUG-2018, but nurse reports there was no swelling of throat. Patient sought medical attention and received treatment for the event. Lab diagnostics/ studies performed was reported as none. The outcome of fall, oropharyngeal discomfort and rash was reported as recovered/resolved. Causality assessment was not provided. No product quality complaint was present.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 20-AUG-2018, patient was administered with VARIVAX (lot number M036272, that expired on 17-AUG-2018; strength, dose, route were not reported) for prophylaxis. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, 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. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-MAR-2015, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 05-JAN-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis . No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Age: 15.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter.  Sender's Comments: US-009507513-1804USA005153.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding an 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding an 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia, Urticaria
Clinical narrative: Patient reported hives, fever, and headache after receiving 1st dose of SHINGRIX vaccine.
Sex: F
Vaccine: PPV
Symptoms: Chills, Disorientation, Gait disturbance, Hyperhidrosis, Injection site pain
Clinical narrative: I received a PNEUMOVAX 23 injection on 9/6/2018 at 1 p.m. By 9 p.m. I was disoriented, sweating, fever, chills, hallucinating, severe muscle pain in arm where injection was given-muscle pain extended from shoulder to forearm, and to scapula. Severe muscle weakness in that arm as well. The entire left arm was hot, and felt like it should have been bloody and blistered; but it looked normal. I live alone and was unable to do any activities for 36 hours, except crawl to the bathroom and try to keep water down. Sleep was the only activity that I was able to tolerate. I have never had any reaction to vaccines before this. I am a healthy, active, 69 year old female.
Sex: F
Vaccine: PPV
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: I received a PNEUMOVAX 23 injection on 9/6/2018 at 1 p.m. By 9 p.m. I was disoriented, sweating, fever, chills, hallucinating, severe muscle pain in arm where injection was given-muscle pain extended from shoulder to forearm, and to scapula. Severe muscle weakness in that arm as well. The entire left arm was hot, and felt like it should have been bloody and blistered; but it looked normal. I live alone and was unable to do any activities for 36 hours, except crawl to the bathroom and try to keep water down. Sleep was the only activity that I was able to tolerate. I have never had any reaction to vaccines before this. I am a healthy, active, 69 year old female.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Visual impairment
Clinical narrative: Patient was administered a SHINGRIX vaccine on 09/11/18 and a few hours after receiving the vaccine she reported impaired vision, describe to us as "crossed eyes" and sensitivity to light as she was driving her vehicle. She had to pull over and wait several minutes and put on sunglasses to continue her drive but still reported some difficulty seeing. She reported to us that she had seen her ophthalmologist approximately 3 months ago and they reported no significant issues with her vision.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Poor quality sleep, Pyrexia
Clinical narrative: Adverse reaction to vaccination. Got first SHINGRIX shot on 2 September at approximately Noon. Went through day normally. Then, at about 2-3 AM on the morning of 3 September, was woken up due to pain in arm where shot was, chills and body aches. Took TYLENOL PM which helped somewhat but had a restless night because of this and slept a good amount during the day on 3 September. Continued to have chills and significant body aches through the day even though taking TYLENOL. Toward end of day took Ibuprofen which helped more. Took my temperature during the day and did not register fever but rest of symptoms felt like I had a fever. Slept good the evening of 3 September, although took TYLENOL PM to be sure, and next day was generally OK but pain in arm persisted, less each day, for the next 2 days.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, Vaccination complication
Clinical narrative: Adverse reaction to vaccination. Got first SHINGRIX shot on 2 September at approximately Noon. Went through day normally. Then, at about 2-3 AM on the morning of 3 September, was woken up due to pain in arm where shot was, chills and body aches. Took TYLENOL PM which helped somewhat but had a restless night because of this and slept a good amount during the day on 3 September. Continued to have chills and significant body aches through the day even though taking TYLENOL. Toward end of day took Ibuprofen which helped more. Took my temperature during the day and did not register fever but rest of symptoms felt like I had a fever. Slept good the evening of 3 September, although took TYLENOL PM to be sure, and next day was generally OK but pain in arm persisted, less each day, for the next 2 days.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever, nausea and headache with GARDASIL 2nd dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Lethargy, Pyrexia, Tremor
Clinical narrative: I had severe shivering twelve hours after receiving my second dose of SHINGRIX 50 MCG (IM) Sngdse vl10pl. The shivering was uncontrollable, causing me to bite down on my tongue several times. My whole body shook. I also felt feverish and lethargic. The shivering went away after about one hour of resting. Now on day two after the injection I still feel, not myself, energy wise.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Systemic inflammatory response syndrome
Clinical narrative: Systemic inflammatory response syndrome.
Sex: M
Vaccine: PNC13
Symptoms: Chills, Headache, Nausea, Pyrexia, Somnolence
Clinical narrative: I received an injection of PREVNAR 13 for immunization against pneumonia. I experienced chills, fever, headaches, nausea, vomiting and feeling sleepy.
Sex: M
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: I received an injection of PREVNAR 13 for immunization against pneumonia. I experienced chills, fever, headaches, nausea, vomiting and feeling sleepy.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: 2nd dose of SHINGRIX fever 101F after 12hrs of injection.
Age: 1.25
Sex: M
Vaccine: MMR
Symptoms: Measles post vaccine, Pyrexia
Clinical narrative: Spiked a 105 degree fever, broke out in full measles rash, sent to hospital after unable to lower fever.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Influenza like illness, Injection site pain, Injection site rash
Clinical narrative: Flu like symptoms, headache, sore muscles and joints, lethargic, stuffy nose, painful injection site with rash at site of injection.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Nasal congestion
Clinical narrative: Flu like symptoms, headache, sore muscles and joints, lethargic, stuffy nose, painful injection site with rash at site of injection.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Herpes zoster
Clinical narrative: Severe chest pain similar to heart attack then 20 hours later shingles reappeared on back.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Expired flu vaccine given -injection in box removed and administered-expiration date not checked prior to administration.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Body temperature increased, Headache, Injection site pain
Clinical narrative: Headache. Low grade temp 100. Very sore arm (injection site) also led up to my shoulder. Stomachache. Shoulder is better the next day. Stomach seems to require food. Arm is about the same.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a female patient, age and medical history not provided. In 2014 the patient was inoculated with ZOSTAVAX vaccine for routine adult health maintenance and the prevention of shingles at a pharmacy. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015 the patient was treated at a health center for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information was requested.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUL-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.