chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 647861) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 09-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L026602, expiration date: 19-OCT-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included MENACTRA intramuscularly in the left arm, lot # U5228BA (dose, frequency and lot expiration date were not reported) and ADACEL intramuscularly in the left arm, lot # UI565AA (dose, frequency and lot expiration date were not reported) for prophylaxis. On 12-AUG-2016, the patient experienced red, swollen and painful in left arm from shoulder to elbow. The outcome of injection site erythema, injection site swelling and injection site pain was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 647900) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history included febrile seizures, that happened at the age of 7 months, which were non vaccine related. The patient's other medications included Benadryl and zyrtec (taken for seasonal allergies). The patient had no concurrent illnesses. On 12-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M007764 (Expiration date: 30-JAN-2018) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # 542F3 dose 1 (unspecified dosage) and MENVEO lot # M15079 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 14-AUG-2016, the patient's mother called to report that the patient experienced a 2 hour episode of felling dizzy and also reported blackening vision (visual impairment), which occurred several times. The patient then went to bed and had no further occurrence that day. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Arthralgia, Burning sensation, Headache, Hypersensitivity, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648025) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses and medical history. Information about the patient's other medications and prior vaccinations were not reported. On 15-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L043214 dose 3 (unspecified dosage) via an unknown route in the left arm and MENACTRA lot # U5282BB (unspecified dose and dosage) via an unknown route in the right arm, for prophylaxis. On the same day, after the administration of the vaccines, the patient's mother called and reported that the patient had experienced fever of 102-103 degrees, joint pain and burning sensation in the hand. The patient also had headache, hypersensitivity and serum sickness. The patient had no cough or upper respiratory infection and no rash. The patient required an emergency room visit. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Serum sickness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648025) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses and medical history. Information about the patient's other medications and prior vaccinations were not reported. On 15-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L043214 dose 3 (unspecified dosage) via an unknown route in the left arm and MENACTRA lot # U5282BB (unspecified dose and dosage) via an unknown route in the right arm, for prophylaxis. On the same day, after the administration of the vaccines, the patient's mother called and reported that the patient had experienced fever of 102-103 degrees, joint pain and burning sensation in the hand. The patient also had headache, hypersensitivity and serum sickness. The patient had no cough or upper respiratory infection and no rash. The patient required an emergency room visit. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Dizziness, Hypotonic-hyporesponsive episode
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648570) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no other medications. Information about the patient's concurrent illnesses and medical history were not provided. On 15-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M007764 (Expiration date: 30-JAN-2018) dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5392AA, dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis, BEXSERO lot # 156701, dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis and HAVRIX lot # LN749, dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, after receiving vaccination, the patient started to feel dizzy and light-headed. While waiting for the arrival of a cot, the patient had hypotonic-hypo responsive reaction, which lasted for approximately 1 minute. The patient was then, lowered to the cot and he became alert immediately after. The patient drank juice and laid down for approximately 10 minutes, until he felt better. The patient then sat on the side of the cot and stood up, with no further signs and symptoms. The patient was advised to eat and take rest after leaving. The outcome of dizziness and hypotonic-hypo responsive episode was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648906) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient's concurrent illnesses was unknown and medical history was reported as none. Information on the patient's prior vaccinations and other medications were not reported. On 13-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the left arm, lot # M001840 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 13-AUG-2016, 60 seconds post vaccination the patient got fainted. The patient did not required any medical treatment. He awoke with no memory of the previous events after about 6 seconds of being passed out. The outcome of loss of consciousness and syncope was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Fall, Gaze palsy, Limb injury, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 649024) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no allergies or previous medical history, as on the screening questionnaire. The patient had no concurrent illnesses and other medications. On 23-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (Expiration date: 19-OCT-2017) dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # Z9244 dose 6 (unspecified dosage), in the right arm, HAVRIX lot # 97KL2 dose 3 (unspecified dosage), in the right arm and MENVEO lot # M15068 dose 2 (unspecified dosage), in the left arm, via intramuscular route, for prophylaxis. On 23-AUG-2016, after receiving immunizations, the patient had an episode of syncope. The patient had stood up, her eyes rolled to the back of her head and then, she fainted. The patient fell backwards, hitting her right arm and possibly her head too. She laid on the floor and a pillow was placed under her head. The patient was given juice and ice was applied to her right arm. She was observed for 20 minutes and waited for 10 more minutes in the waiting room. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood test normal, Chest pain, Dyskinesia, Dyspnoea, Electroencephalogram
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 649026) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient's medical history included mood and anxiety  disorder. The patient's other medications included Hydroxyzine HCL, 50 mg (1 tablet, 3 times a day). Information about the patient's concurrent illnesses were not reported. On 22-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714 (Expiration date: 03-OCT-2017) dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5259AA dose 2 (unspecified dosage), in the right arm and TRUMENBA lot # M74089 dose 1 (unspecified dosage), in the left arm via intramuscular route, for prophylaxis. On 22-AUG-2016, the patient experienced involuntary movements (dyskinesia) and was referred to the neurology department. The patient also experienced, chest pain and shortness of breath. The patient required an emergency room visit. She underwent normal blood test and was referred to do an electroencephalogram (EEG). The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Presyncope, Seizure like phenomena
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 649739). This spontaneous report refers to a 15 year old female patient. The patient had no current illnesses and medical history. Patient's other medications included claritin 10 mg prn, ibuprofen 200 mg prn, claritin D 12 hour prn and aleve 220 mg prn. On 22-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M023169, dose 2, intramuscularly in the left arm for prophylaxis. Patient tolerated the injection well and approximately 5 minutes after vaccine administration, she had a vaso-vagal response/seizure-like activity in the waiting room. Patient was assisted to supine position on the floor with her feet up on a chair. Vitals were assessed and patient was alert and oriented. Lab data included blood pressure: 90/60 (units unspecified), heart rate (HR): 75 (units unspecified), oxygen saturation (O2): 100 %. Patient was assisted to a patient care room with her mother and sister where doctor assessed and evaluated the patient. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 651145) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses, medical history and other medications. On 02-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L036301 dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U5486AA dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis and MENACTRA # U5462AA dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. The order of vaccine administration was such that, ADACEL was given first and few minutes later, the patient was given GARDASIL 9 and MENACTRA. On the same day, immediately after vaccination, the patient experienced lightheadedness, nausea and hyperhidrosis. The patient then, collapsed to the ground and woke up, a few minutes later. Cool pack was placed on the patient's neck and he was given fluids. The patient recovered well, approximately 15-20 minutes later. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Muscular weakness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-651249). This spontaneous report refers to a 14 year old female patient. Information on patient's medical history and other medications was not reported. The patient had no current illnesses. On 10-MAR-2014, the patient was vaccinated with GARDASIL 9 lot # H020301, dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. After vaccination, the patient had muscular weakness from head to toe for 2 weeks. The outcome of muscular weakness was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653219) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information about the patient's other medications and prior vaccinations were not reported. On 17-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M007764 (Expiration date: 30-JAN-2018) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # Z9Z4Y dose 1 (unspecified dosage) and MENACTRA lot # U5390AA dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced left hand and right lower leg paraesthesia, which lasted for three days after vaccination (approximately till 20-AUG-2016). The outcome of paraesthesia was reported as recovered. The causality assessment for paraesthesia was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653360) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's concurrent illnesses, medical history and other medications were reported as none. Information on the patient's prior vaccinations was not reported. On 14-SEP-2016 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # M007764, expiration date: 30-JAN-2018 (dose and frequency were not reported) for prophylaxis. On 14-SEP-2016, five minutes after receiving GARDASIL 9 the patient experienced vasovagal syncopal episode occurred in the office. The outcome of syncope was reported as recovered/resolved without difficulty. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 19.0
Sex: M
Vaccine: HPV9, VARCEL
Symptoms: Erythema, Pain, Pruritus, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653367) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 19 year old male patient. The patient's concurrent illnesses and prior vaccinations were not reported. The patient's medical history included allergic to vancomycin and gastrooesophageal reflux disease (GERD). Other medications included omeprazole. On 22-AUG-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # M009362 (dose, frequency and lot expiration date were not reported) and also vaccinated with the second dose of VARIVAX subcutaneous in the right arm, lot # L049534 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 26-AUG-2016, the patient experienced achy, red, warm to touch, itchy and no fever. Doctor prescribed antibiotic to the patient. The outcome of erythema, skin warm, pruritus and pain was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Maculopathy, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653634) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old male patient. The patient concurrent illnesses included recovering from viral illness, no fever. Information on the patient's medical history, prior vaccinations and other medications were not reported. On 17-AUG-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included HAVRIX intramuscularly in the left arm, lot # GP75A (dose, frequency and lot expiration date were not reported) for prophylaxis. On 19-AUG-2016, the patient complained of difficulty in seeing from right eye. Ophthalmologist diagnosed the patient with maculopathy of right eye and recommended for observation. The patient required emergency room visit. The outcome of maculopathy and visual impairment was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653844) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient's medical history included allergy to bee stings, otherwise unremarkable. The patient had no concurrent illnesses and other medications. On 14-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M021407 (Expiration date: 30-APR-2018) dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BEXSERO lot # M15124, dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 16-SEP-2016, the patient experienced injection site swelling, redness and the skin was warm to touch. The patient required an emergency room visit. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Asthenia, Blood glucose, Blood iron, Blood test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653904) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history included anxiety, depression, attention deficit hyperactivity disorder (ADHD) and allergies to- Zithromax and Cipro. The patient had no concurrent illnesses and the patient's other medications included Focalin XR-20 mg (l x daily), Celexa-20 mg (1 x daily) and Zantac-150mg (2 x daily). On 26-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 dose 3 (unspecified dosage) via an unknown route in the left arm, for prophylaxis. On 27-AUG-2016, patient experienced symptoms including severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, hypo aesthesia and hyper aesthesia. The patient required an emergency room visit. Several tests were run, such as- fasting blood glucose test, thyroid function test, full/complete blood count, electroencephalogram (EEG), electrocardiogram (EKG), computerised tomogram head (CT scan), X-rays, borrelia test, urine tests, blood test and blood iron test. The symptoms were said to have persisted for 3 weeks without any relief or diagnosis. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test, Chest pain, Computerised tomogram head, Decreased appetite, Electrocardiogram
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653904) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history included anxiety, depression, attention deficit hyperactivity disorder (ADHD) and allergies to- Zithromax and Cipro. The patient had no concurrent illnesses and the patient's other medications included Focalin XR-20 mg (l x daily), Celexa-20 mg (1 x daily) and Zantac-150mg (2 x daily). On 26-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 dose 3 (unspecified dosage) via an unknown route in the left arm, for prophylaxis. On 27-AUG-2016, patient experienced symptoms including severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, hypo aesthesia and hyper aesthesia. The patient required an emergency room visit. Several tests were run, such as- fasting blood glucose test, thyroid function test, full/complete blood count, electroencephalogram (EEG), electrocardiogram (EKG), computerised tomogram head (CT scan), X-rays, borrelia test, urine tests, blood test and blood iron test. The symptoms were said to have persisted for 3 weeks without any relief or diagnosis. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Electroencephalogram, Eye pain, Fatigue, Full blood count, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653904) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history included anxiety, depression, attention deficit hyperactivity disorder (ADHD) and allergies to- Zithromax and Cipro. The patient had no concurrent illnesses and the patient's other medications included Focalin XR-20 mg (l x daily), Celexa-20 mg (1 x daily) and Zantac-150mg (2 x daily). On 26-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 dose 3 (unspecified dosage) via an unknown route in the left arm, for prophylaxis. On 27-AUG-2016, patient experienced symptoms including severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, hypo aesthesia and hyper aesthesia. The patient required an emergency room visit. Several tests were run, such as- fasting blood glucose test, thyroid function test, full/complete blood count, electroencephalogram (EEG), electrocardiogram (EKG), computerised tomogram head (CT scan), X-rays, borrelia test, urine tests, blood test and blood iron test. The symptoms were said to have persisted for 3 weeks without any relief or diagnosis. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperaesthesia, Hypoaesthesia, Myalgia, Night sweats, Thyroid function test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653904) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history included anxiety, depression, attention deficit hyperactivity disorder (ADHD) and allergies to- Zithromax and Cipro. The patient had no concurrent illnesses and the patient's other medications included Focalin XR-20 mg (l x daily), Celexa-20 mg (1 x daily) and Zantac-150mg (2 x daily). On 26-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 dose 3 (unspecified dosage) via an unknown route in the left arm, for prophylaxis. On 27-AUG-2016, patient experienced symptoms including severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, hypo aesthesia and hyper aesthesia. The patient required an emergency room visit. Several tests were run, such as- fasting blood glucose test, thyroid function test, full/complete blood count, electroencephalogram (EEG), electrocardiogram (EKG), computerised tomogram head (CT scan), X-rays, borrelia test, urine tests, blood test and blood iron test. The symptoms were said to have persisted for 3 weeks without any relief or diagnosis. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Urine analysis, X-ray
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653904) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history included anxiety, depression, attention deficit hyperactivity disorder (ADHD) and allergies to- Zithromax and Cipro. The patient had no concurrent illnesses and the patient's other medications included Focalin XR-20 mg (l x daily), Celexa-20 mg (1 x daily) and Zantac-150mg (2 x daily). On 26-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011840 dose 3 (unspecified dosage) via an unknown route in the left arm, for prophylaxis. On 27-AUG-2016, patient experienced symptoms including severe headaches, fatigue, muscle pain, joint pain, numbness in feet, eye pain, chest pain, night sweats, loss of appetite, weakness, hypo aesthesia and hyper aesthesia. The patient required an emergency room visit. Several tests were run, such as- fasting blood glucose test, thyroid function test, full/complete blood count, electroencephalogram (EEG), electrocardiogram (EKG), computerised tomogram head (CT scan), X-rays, borrelia test, urine tests, blood test and blood iron test. The symptoms were said to have persisted for 3 weeks without any relief or diagnosis. The outcome of the events was reported as unknown. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction, Loss of consciousness, Muscle twitching
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654485) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old male patient. Information on the patient's other medications, lab data and prior vaccinations were not reported. Information on patient's current illness was reported as none. The patient's medical history included allergic to eggs, milk, peanuts, cats and dogs. On 20-SEP-2016, the patient was vaccinated with GARDASIL 9 lot/batch# M11407, dose 1, via unknown route, in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with BEXSERO lot/batch#  156801A, dose 1, via unknown route, in the right arm and VAQTA lot# M022924 (expiration date: 24-JAN-2018) dose 1, via unknown route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 20-SEP-2016, immediately after vaccination the patient became lightheaded and his head was lowered. Patient was pale and lost consciousness. Patient felt like he was going through a time wrap and he had twitching for about 5 seconds. Patient rested about 5 minutes, his head was raised (patient was in an exam table). Patient started talking and interacting. The outcome of the events were reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654485) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old male patient. Information on the patient's other medications, lab data and prior vaccinations were not reported. Information on patient's current illness was reported as none. The patient's medical history included allergic to eggs, milk, peanuts, cats and dogs. On 20-SEP-2016, the patient was vaccinated with GARDASIL 9 lot/batch# M11407, dose 1, via unknown route, in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with BEXSERO lot/batch#  156801A, dose 1, via unknown route, in the right arm and VAQTA lot# M022924 (expiration date: 24-JAN-2018) dose 1, via unknown route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 20-SEP-2016, immediately after vaccination the patient became lightheaded and his head was lowered. Patient was pale and lost consciousness. Patient felt like he was going through a time wrap and he had twitching for about 5 seconds. Patient rested about 5 minutes, his head was raised (patient was in an exam table). Patient started talking and interacting. The outcome of the events were reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 654787) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's concurrent illness and medical history were reported as none. The patient's concomitant therapies, prior vaccinations and other medications were not reported. On 20-SEP-2016 the patient was vaccinated with GARDASIL 9 (dose number, dose, frequency, lot #, lot expiration date, route of administration and site of administration were not reported) for prophylaxis. On 20-SEP-2016, the patient fainted with jerking. The outcome of dyskinesia and syncope were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site erythema, Injection site inflammation, Injection site scar, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 656003) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included epilepsy. The patient had no concurrent illness. The patient's concomitant therapies and prior vaccinations were not reported. The patient's other medications included Trileptal, Lamictal and Banzel. On 27-SEP-2016 the patient was vaccinated with second dose of GARDASIL 9 lot # M009378 (dose, frequency and lot expiration date were not reported) via intramuscular route in the left arm for prophylaxis. Other suspect therapy which was given on the same day included FLUZONE QUADRIVALENT (intramuscularly in the left arm, lot# UT5686KA; dose, dose number and expiration date were not reported) for prophylaxis. The patient had warm, erythematous, inflamed skin covering 6 cm x 5 cm around the injection site and on BCG scar (left deltoid). The patient's father reported that these symptoms began on 28-SEP-2016. The patient was seen in the office on 29-SEP-2016. The patient visited the emergency room. The outcome of the events were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Blister
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 656048) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient's medical history was reported as none. The patient had no concurrent illnesses. The patient's concomitant therapies, prior vaccinations and other medications were not reported. On 22-SEP-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M018810, lot expiration date 28-MAY-2018 (dose and frequency were not reported) via intramuscular route, in the left arm for prophylaxis. The patient reported that he had blister on 23-SEP-2016, the day after the shot. The outcome of blister was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 656504)on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concomitant therapies, concurrent illnesses, prior vaccinations and medical history were not reported. The patient's other medications included kids gummy bear multivitamins and lactobacillus probiotic. On 16-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L026602, lot expiration date 19-OCT-2017 (dose and frequency were not reported) via intramuscular route in the right leg for prophylaxis. Other suspect therapies which were given on the same day included first dose of ADACEL (intramuscularly in the left arm, lot# U5267AA; dose and expiration date unknown) and first dose of MENACTRA (intramuscularly in the right arm, lot# U5392AB; dose and expiration date unknown) for prophylaxis. On 16-SEP-2016, patient was fainted after vaccination. The patient was treated with 2L of oxygen, orange juice and crackers. The patients blood pressure was 98/60 (units not provided). The outcome of syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site pain, Middle insomnia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 656714) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's concomitant therapies, concurrent illnesses, prior vaccinations, other medications and medical history were not reported. On 26-SEP-2016 the patient was vaccinated with second dose of GARDASIL 9 lot # M021407, lot expiration date 30-APR-2018 (dose and frequency were not reported) via unknown route, in the left arm for prophylaxis. Other suspect therapy which were given on the same day included first dose of FLUARIX QUADRIVALENT (in the left arm, lot# 53T43; dose, route of administration and expiration date unknown) for prophylaxis. On 26-SEP-2016, the patient had left upper arm pain which increased overnight and woke the patient from sleep. The patient had die to level of pain. The parent gave ice and ibuprofen. The pain continued for more than 48 hours, which slowly resolved. The outcome of injection site pain and sleep disorder were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Blindness, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 656786) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old female patient. The patient's concurrent illnesses and medical history were reported as none. The patient's other medications included Adderall XR. The patient's concomitant therapies and prior vaccinations were not reported. On 26-SEP-2016 the patient was vaccinated with second dose of GARDASIL 9 lot # M016193, lot expiration date 24-APR-2018 (route of administration: unknown, dose: not reported) in the left arm for prophylaxis. On 26-SEP-2016, the patient experienced loss of vision for about one and half hours. The outcome of blindness and vision blurred were reported as recovered. Causality assessment was not reported.     Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657328) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 27-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included first dose of ADACEL intramuscularly in the right arm, lot # U5459AC and MENACTRA intramuscularly in the left arm, lot # U5272AA, Manufacturer: Sanofi Pasteur (dose, frequency and lot expiration date were not reported) for prophylaxis. On 29-SEP-2016, the patient experienced redness and warmth 10x10 centimeter in the left shoulder and redness and warmth 10x4 centimeter in the right shoulder. The patient required an emergency room (ER) visit. The outcome of injection site erythema and injection site warmth was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Erythema, Fatigue, Injection site erythema, Pain, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657402) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concurrent illnesses and lab data were not reported. Information on the patient's prior vaccinations and other medications were not reported. The patient's medical history included seasonal allergies. On 26-SEP-2016, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # M018810 with expiration date: 28-MAY-2018 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included eleventh dose of FLUZONE intramuscularly in the left arm, lot # UI673AA, Manufacturer: Sanofi Pasteur (dose, frequency and lot expiration date were not reported) for prophylaxis. On 27-SEP-2016, the patient experienced pain, redness, swelling 3 inches in diameter, tenderness to touch, reddened area at site, fatigue, urinary incontinence, warm to touch  and indurated at site of vaccination. The outcome of erythema, fatigue, induration, injection site erythema, pain, skin warm, swelling, tenderness and urinary incontinence was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Tenderness, Urinary incontinence, Vaccination site induration, Vaccination site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657402) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concurrent illnesses and lab data were not reported. Information on the patient's prior vaccinations and other medications were not reported. The patient's medical history included seasonal allergies. On 26-SEP-2016, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # M018810 with expiration date: 28-MAY-2018 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included eleventh dose of FLUZONE intramuscularly in the left arm, lot # UI673AA, Manufacturer: Sanofi Pasteur (dose, frequency and lot expiration date were not reported) for prophylaxis. On 27-SEP-2016, the patient experienced pain, redness, swelling 3 inches in diameter, tenderness to touch, reddened area at site, fatigue, urinary incontinence, warm to touch  and indurated at site of vaccination. The outcome of erythema, fatigue, induration, injection site erythema, pain, skin warm, swelling, tenderness and urinary incontinence was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV9
Symptoms: Fatigue, Headache, Immediate post-injection reaction, Nausea, Oropharyngeal pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657488) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 03-OCT-2016, the patient was vaccinated with GARDASIL 9  (injection site, route, dose, frequency, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) Manufacturer: unknown (injection site, route, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On the same day post vaccination the patient experienced severe headache immediately, nausea, vision issue, sore throat and fatigue. The outcome of fatigue, headache, immediate post-injection reaction, nausea, oropharyngeal pain and visual impairment was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLUX, HPV4, FLUX, HPV9
Symptoms: Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657488) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 03-OCT-2016, the patient was vaccinated with GARDASIL 9  (injection site, route, dose, frequency, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) Manufacturer: unknown (injection site, route, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On the same day post vaccination the patient experienced severe headache immediately, nausea, vision issue, sore throat and fatigue. The outcome of fatigue, headache, immediate post-injection reaction, nausea, oropharyngeal pain and visual impairment was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.