chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Dizziness, Tremor
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 # 643263). This spontaneous report refers to a 12 year old female patient. The patient's concurrent illnesses was reported as runny nose. The patient had no medical history. Information on the patient's prior vaccinations and other medications were not reported. On 12-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L018351, dose 1, intramuscular route in the right arm, BOOSTRIX batch# 949LJ, dose 1, intramuscular route in the left arm and MENACTRA batch# U5187AA, dose 1, intramuscular route in the left arm for prophylaxis. On the same day, the patient was dizzy, weak and shaky for over an hour. The patient required emergency room visit. The outcome of asthenia, tremor and dizziness was reported as recovered. The 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: Abdominal pain upper, Headache, Nausea, Vomiting
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 # 643478) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included tension headache, adjustment disorder and sleep disturbances. The patient's other medication included melatonin. The patient's current illness was reported as none. The patient's concomitant therapy and prior vaccinations were not reported. On 12-JUL-2016 the patient was vaccinated with second dose of GARDASIL 9 lot # M009362 (dose, frequency and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. From 13-JUL-2016 to 15-JUL-2016, the patient had complains of nausea, vomiting (once a day), and stomach pain with headaches. The patient had no dizziness or fever present. The outcome of abdominal pain upper, vomiting and nausea 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: HEPA, HPV9, MNQ
Symptoms: Dizziness
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 # 643635) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. Information on the patient's medical history and prior vaccinations were not reported. Patient had TB PPD test. Patient's lab data included blood pressure 94/52 and oxygen saturation (O2) 99% and 98%. Information on patient's current illness was reported as none. On 15-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M009116, dose 1, intramuscularly in the right arm for prophylaxis (dosage and expiration date unspecified). On the same day the patient was also vaccinated with MENACTRA lot # U5410AA (dosage and expiration date unspecified), dose 1, via unknown route, in the left arm and VAQTA lot # M011116, dose 1, via unknown route, in the left arm for prophylaxis (dosage unspecified). On 15-JUL-2016, the patient failed right after the vaccination. Patient felt light headed for 20 minutes and was given popsicle and water. Patient rested in the room with her mother until she felt better. The outcome of dizziness was reported as recovered. The causality assessment for the event dizziness 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: Pallor, Restlessness, Throat tightness
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 # 643651) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old male patient. Information on the patient's lab data and prior vaccinations were not reported. Information on the patient's concurrent illnesses and other medications were reported as none. The patient's medical history included allergic to Augmentin, Dilaudid, morphine, sulfa, milk and tree nuts and also had a history of asthma and ulcerative colitis. On 16-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M011117, dose 1, intramuscularly in the left arm for prophylaxis (dosage unspecified). On 16-JUL-2016 at 10:30 am, patient became restless and complained of a feeling of throat closing and pallor. Benadryl was given. At 10:34 am patient was given with EPpipen 0.3 mg, intramuscularly and at 10:50 patient was transported to the hospital via paramedics. The outcome of pallor, throat tightness and restlessness was reported as recovered. The patient required emergency room visit. 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.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Fatigue, Headache, Myalgia, 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 # 643655) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. Information on the patient's concurrent illnesses and medical history were reported as none. On 13-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L026602, dose 3, intramuscularly in the left arm for prophylaxis (dosage unspecified). On 13-JUL-2016, shortly after the vaccination patient developed chills, myalgias, headache, tiredness and fever with respect to temperature maximum was 102. Symptoms lasted for one and half days. The outcome of chills, fever, myalgia, headache and fatigue was reported as recovered. The patient required emergency room visit. The causality assessment for all 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, MENB
Symptoms: Headache, Pyrexia, 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 # 643975). This spontaneous report refers to a 17 year old male patient. The patient had no current illnesses and medical history. Information on patient's other medications and prior vaccinations was not reported. On 14-JUL-2016, the patient was vaccinated with GARDASIL 9 dose 2, (route and lot # not reported) in the right arm for prophylaxis. On the same day, the patient was also vaccinated with BEXSERO dose 1, (route and lot # not reported) in the left arm for prophylaxis. On 14-JUL-2016, the patient fainted within 5 minutes of vaccine injection and had low grade fever and headache for the following 24 hours. The outcome of the events was reported as recovered. The causality assessment for all 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: F
Vaccine: HEPA, 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 # 644005). This spontaneous report refers to a 18 year old female patient. The patient had no current illnesses, medical history and other medications. On 20-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiry date: 17-OCT-2017), dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with HAVRIX lot # CM37R, dose 2, intramuscularly in the right arm for prophylaxis. On 20-JUL-2016, the patient experienced syncope. The outcome of the event syncope was reported as recovered. The causality assessment of the event syncope 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: F
Vaccine: HPV9
Symptoms: Back pain, Chills, Dizziness, Fatigue, Nausea
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 # 644064). This spontaneous report refers to a 32 year old female patient. The patient had no current illnesses and medical history. Information on patient's other medications and prior vaccinations was not reported. On 13-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (expiry date: 19-OCT-2017), dose 1, intramuscularly in the left arm for prophylaxis. On 14-JUL-2016, the patient experienced chills, lower back pain, dizziness, general fatigue and nausea. The outcome of all the events was unknown. The causality assessment for all 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: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Pallor, Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 year old female. The patient had no medical history, current illnesses and other medications and the patient's prior vaccinations was not reported. On 13-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L024993 and expiration date: 17-OCT-2017, intramuscularly in the right thigh (reported as left leg), (dose and frequency unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number: 1, vaccinated date: 13-JUL-2016, intramuscularly in the left thigh (reported as left leg, lot # 92N9B; (dose and expiration date unknown). Other suspect therapies included MENACTRA dose number: 1, vaccinated date: 13-JUL-2016, intramuscularly in the left thigh (reported as left leg), lot # US179AA; (dose and expiration date unknown). And on the same day, approximately 10 minutes after receiving first dose GARDASIL 9, the child (patient) told her mother that she felt funny and fainted into her mother's arms, the patient was pale but responsive after laying down for approximately 10 minutes with legs elevated. The patient recovered. The outcome of feeling abnormal, syncope and pallor 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: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pruritus, Vaccination 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 # 645092) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Information on the patient's other medications and prior vaccinations were not reported. Information on the patient's lab data was reported as none. Patient had no concurrent illnesses and medical history. On 26-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L043214, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with MENACTRA lot/batch # US410AA, dose 1, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On 26-JUL-2016, the patient had swelling, redness, itching at vaccination site. The outcome of injection site erythema, vaccination site swelling and injection site pruritus were unknown. The causality assessment for all 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: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
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 # 645422). This spontaneous report refers to a 3 year old female patient. The patient had no current illnesses, medical history and other medications. On 25-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiry date: 17-OCT-2017), dose 1, route: unknown, in the right leg for prophylaxis. Drug was administered to a patient of inappropriate age. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood glucose decreased, Electrocardiogram normal, 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 # 645440). This spontaneous report refers to a 16 year old female patient. The patient had no concurrent illnesses, medical history or other medications. Information on the patient's prior vaccinations was not reported. On 25-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L019297, dose 3, intramuscular route in an unknown site, TRUMENBA batch/lot# M37314, dose 1, intramuscular route in an unknown site and MENACTRA batch/lot# U5187AA, dose 2, intramuscular route in an unknown site for prophylaxis. On the same day, the patient experienced syncope 20 minutes after receiving vaccines, the patient's blood glucose decreased and the patient's electrocardiogram was normal. The patient required emergency room visit. The patient's blood pressure was 86/58 (units unspecified) and blood glucose was 68 (units unspecified). The outcome of blood glucose decreased, syncope and electrocardiogram normal was reported as recovered. The 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: Blepharospasm, Seizure, Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's medical history, current illnesses, other medications and prior vaccinations was not reported. On 26-JUL-2016, the patient was vaccinated with GARDASIL 9, lot # L043213, intramuscularly in the left arm (dose number, dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included BOOSTRIX, vaccinated date: 26-JUL-2016, intramuscularly in the right arm, lot # 9NA32; (dose number, dose, frequency and lot expiration date unknown) and BOOSTRIX and MENVEO vaccinated date: 26-JUL-2016, intramuscularly in the right arm, lot # M15078; (dose number, dose, frequency and lot expiration date unknown). And on the same day patient fainted after shot and not witnessed and had blepharospasm. The patient was fine after 15 minutes; the patient had seizure and eyes twitching reported by sister. The outcome of blepharospasm and 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.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis, Facial paresis
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 # 647192) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient's medical history and other medications were reported as none. The patient had no concurrent illnesses. Information on the patient's prior vaccinations was not reported. On 02-AUG-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm (dose number: 3, lot expiration date was not reported) for prophylaxis. On 07-AUG-2016, the patient experienced left sided facial weakness. On 09-AUG-2016, the patient was seen at the office after the symptoms worsened and was diagnosed with Bell's palsy. The patient required emergency room (ER) visit. The outcome for the events facial paralysis and facial paresis was unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
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 # 647198) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient's medical history included bee sting allergy, asthma and benign syncope. The patient's concurrent illnesses was reported as none. The patient's other medications included Epipen and Proair. Information on the patient's prior vaccinations was not reported. On 09-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L043214 (lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX (dose number:1, intramuscularly in the left arm, lot # GS5BR, manufacturer: GlaxoSmithKline ; lot expiration date was not reported) and MENACTRA (dose number:1, intramuscularly in the right arm, lot # U5260AA, manufacturer: Sanofi Pasteur ; lot expiration date was not reported) for prophylaxis. On the same day, shortly post vaccination, the patient experienced syncope. The outcome for the event 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.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Injected limb mobility decreased, 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 # 647205) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 20-JUL-2016 the patient was vaccinated with third dose of GARDASIL 9 intramuscularly in the left arm, lot # L0919297 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included first dose of BEXSERO intramuscularly in the right arm, lot # 153701, manufacturer: Novartis and second dose of HAVRIX intramuscularly in the right arm, lot # CL2R5, manufacturer: GlaxoSmithKline (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day evening the patient complained of redness, pain, swelling and limited mobility in right deltoid. Patient guardian applied ice for treatment. Except pain, all symptoms were resolved by 25-SEP-2016. The outcome of injected limb mobility decreased, injection site erythema, injection site pain and injection site swelling 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: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Urticaria
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 # 647892) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old male patient. The patient's medical history included penicillin allergy and allergy. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 15-AUG-2016 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # L043214 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO. On an unknown date the patient experienced urticaria after shots and was treated with ZYRTEC daily for 7 days. The outcome of urticaria was 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, MNQ, TDAP
Symptoms: Eyelid oedema, Lip swelling, Swelling face
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 # 648279) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history and concurrent illnesses were reported as none. The patient's other medications and prior vaccinations were not reported. On 17-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M009378 (lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX (dose number: 1;  intramuscularly in the left arm, lot # EC9A9, manufacturer: GlaxoSmithKline; lot expiration date was not reported) and MENACTRA (dose number: 1; intramuscularly in the right arm, lot # U5228BA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On 17-AUG-2016, the patient developed facial swelling of both the eyes, nose and lips. The patient's mother gave the patient a dose of Benadryl. The patient did not have any respiratory distress or other symptoms. The patient's mother declined on taking the patient to a doctor at that time. The outcome for the events eye swelling, swelling face and lip swelling was 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, MNQ, TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Pain in extremity, Pruritus
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 # 648311) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history included usage of Sulfa, amoxicillin and latex. Information about the patient's concurrent illnesses, prior vaccinations and other medications were not reported. On 11-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M004116 (Expiration date: 12-OCT-2017) dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U5378AA (unspecified dose and dosage), intramuscularly in the right arm for prophylaxis and MENACTRA lot # U5260AA dose 1 (unspecified and dosage), intramuscularly in the left arm for prophylaxis. On the same day in the evening, the patient experienced itchy arm, injection site redness (injection site erythema),  tenderness with nodule present (Injection site nodule) and pain in extremity, after being vaccinated with ADACEL, in the right deltoid. The patient was reported to have had fevers with the same vaccine, as an infant. The patient was treated with clindamycin for possible cellulitis. 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: Syncope, Tinnitus
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 # 648410) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history included allergic asthma and lipoid disorder. The patient's other medication includes tuberculin purified protein derivative (PPD). Information about the patient's concurrent illnesses was not reported. On 16-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M016193 (Expiration date: 24-APR-2018) dose 2 (unspecified dosage), intramuscularly in an unknown site for prophylaxis. On 17-AUG-2016 (also reported as 16-AUG-2016), one day after receiving the vaccination, the patient's dad reported that the patient experienced fainting and ringing in the ears. The patient was referred to otolaryngology for evaluation and treatment. 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: Injection site rash
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 # 648595) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 9 year old female patient. The patient's medical history included amox-allergies, eczema and allergic rhinitis. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 16-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011117, first dose (dose, frequency and lot expiration date were not reported) via unknown route in the right arm for prophylaxis. On 17-AUG-2016, the patient experienced injection site rash. Patient was also given Benadryl and hydrocortisone cream. The outcome of injection site rash 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, TDAP
Symptoms: Muscle twitching, Posturing, Tremor
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 # 648596) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 10 year old male patient with prophylaxis. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 09-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L026602 (dose, frequency and lot expiration date were not reported), intramuscularly (anatomical location unknown) for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 09-AUG-2016, intramuscularly, lot# Z92Z4Y; dose and expiration date unknown). On the same day, the patient experienced muscle twitching, tremor and posturing which required ER (emergency room) visit. The outcome of muscle twitching, tremor and posturing was reported as not recovered/not 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
Symptoms: Blood test, Hepatic enzyme increased, Pruritus, Urticaria
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 # 649044) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 22-JUL-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L048237, via unknown route (anatomical location unknown) for prophylaxis. On 22-JUL-2016, the patient underwent blood test and also experienced urticaria, pruritus and patient's hepatic enzyme increased which required ER (emergency room) visit. Hives followed mainly in back, buttocks, and arms. Hives also spread to neck, trunk, neck and face the next 4 weeks. The patient visited the doctor twice (08-AUG-2016 and 18-AUG-2016). The patient took antihistamin which helped a little but the hives kept coming back. On 18-AUG-2016, the patient underwent a blood test and the results indicated very elevated liver enzyme levels. The outcome of blood test, urticaria, pruritus and hepatic enzyme increased was reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
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 # 649202) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history was reported as none. The patient had no concurrent illnesses. The patient's other medications and prior vaccinations were not reported. On 23-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (site: arm, route: unknown, lot # and expiration date were not reported). On the same day, the patient had fainted. The nurse put the patient on the bed and gave her juice. The outcome for the event 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: M
Vaccine: HEPA, HPV9
Symptoms: Asthenia, Dizziness, 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 # 649791) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient had no pertinent medical history or other medications. The patient's concurrent illnesses included cough. On 29-AUG-2016 the patient was first vaccinated with GARDASIL 9 lot # L038503, dose 1, intramuscularly in the right arm and then with HAVRIX (manufacturer: GlaxoSmithKline) lot # C7252, intramuscularly in the right arm  for prophylaxis. On the same day, 15 minutes post vaccinations, the patient experienced weakness, bad headache and dizziness. The patient was transported to the emergency department for observation and was there for several hours. The patient received Tylenol for headache in clinic and treated with medication in the emergency department for headache. The outcome of all the events was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Conjunctivitis, Epistaxis
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 # 651274) on 02-MAY-2017. This spontaneous report refers to a 15 year old female patient. The patient's medical history included seasonal allergy. The patient's concurrent illnesses included conjunctivitis with no fever. The patient's other medications and prior vaccinations were not reported. On 29-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm for prophylaxis (lot # M011117, expiration date: 07-DEC-2017). On 30-AUG-2016, the patient experienced epistaxis and conjunctivitis. The outcome for the events conjunctivitis and epistaxis 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: M
Vaccine: HPV9
Symptoms: Injection site pain, Muscle spasms
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 # 651476) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's medical history, concurrent illnesses and other medications was reported as none. Information on the patient's prior vaccinations was not reported. On 29-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L043214 (dose number and lot expiration date were not reported) for prophylaxis. On the same day, the patient developed pain at the injection site (arm). The next day, the pain had worsened and persisted until the time of the report. The patient's mother noticed that the pain had subsided but the spasm still continued. The patient's lab data was reported as none. The outcome for the events muscle spasms and injection site pain were reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Electrocardiogram, Loss of consciousness, Seizure, Urine analysis
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 # 652020) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. Other medications included Vyvanse 60 mg, intuniv 4mg and Zoloft 20 mg. On 02-SEP-2016 the patient was vaccinated with third dose of GARDASIL 9 via unknown route, lot # M018810 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day 6 hours of post vaccination patient had seizure, 10 days later the patient passed out three times and did not realize that she was on the ground, patient thought she stood up. Each episode lasted about 10minutes. 2nd and 3rd episodes were 15 minutes apart. Patient received GARDASIL 4 first and second dose. The patient required an emergency room (ER) visit. The outcome of blood test, electrocardiogram, loss of consciousness, seizure and urine analysis 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
Symptoms: Aphasia, Mobility decreased, 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 # 653798) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications indicated that the patient was given a dosage of 0.5 ml with unspecified vaccine. On 09-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M004116, (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced aphasia, syncope and mobility decreased for more than 2 hours which required ER (Emergency room) visit. The outcome of aphasia, syncope and mobility decreased 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: F
Vaccine: HPV9, MNQ
Symptoms: Decreased appetite, Fatigue, Nausea, Vitamin B1 decreased, Vomiting
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 # 655904) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient had no concurrent illnesses. The patient's medical history included alpha thalassemia trait and anxiety. The patient previously had HPV-4 vaccination. On 10-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M003659 (dose, frequency and lot expiration dates were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5186AA, intramuscularly in the left arm for prophylaxis. On 01-JUL-2016, the patient reported nausea, feeling tired, episodes of vomiting, weight loss  and doesn't want to eat and the patient's mom reported low thiamine level (vitamin B1 decreased). The outcome of decreased appetite, weight decreased, vomiting, vitamin b1 decreased, nausea and fatigue was reported as not recovered/not resolved. The 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
Symptoms: Weight decreased
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 # 655904) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient had no concurrent illnesses. The patient's medical history included alpha thalassemia trait and anxiety. The patient previously had HPV-4 vaccination. On 10-JUN-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M003659 (dose, frequency and lot expiration dates were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5186AA, intramuscularly in the left arm for prophylaxis. On 01-JUL-2016, the patient reported nausea, feeling tired, episodes of vomiting, weight loss  and doesn't want to eat and the patient's mom reported low thiamine level (vitamin B1 decreased). The outcome of decreased appetite, weight decreased, vomiting, vitamin b1 decreased, nausea and fatigue was reported as not recovered/not resolved. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Blood test, Disturbance in attention, Fatigue, 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 # 656397) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 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 15-AUG-2016 the patient was vaccinated with second dose of GARDASIL 9 via an unknown route (injection site, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On 20-AUG-2016, the patient experienced sore throat and headaches as first symptoms than joint point. All over Joint pain  was persisted and gotten worse. The patient had gone to pediatric rheumatology for trouble walking raising arms. The patient still had sore throat, trouble concentrating and very fatigued. The patient was diagnosed with 3 separate orders for blood work on 12-SEP-2016, 19-SEP-2016, and 30-SEP-2016. The outcome of arthralgia, blood test, disturbance in attention, fatigue, gait disturbance, headache and mobility decreased and oropharyngeal pain was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: 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 # 656397) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 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 15-AUG-2016 the patient was vaccinated with second dose of GARDASIL 9 via an unknown route (injection site, dose, frequency, lot # and expiration date were not reported) for prophylaxis. On 20-AUG-2016, the patient experienced sore throat and headaches as first symptoms than joint point. All over Joint pain  was persisted and gotten worse. The patient had gone to pediatric rheumatology for trouble walking raising arms. The patient still had sore throat, trouble concentrating and very fatigued. The patient was diagnosed with 3 separate orders for blood work on 12-SEP-2016, 19-SEP-2016, and 30-SEP-2016. The outcome of arthralgia, blood test, disturbance in attention, fatigue, gait disturbance, headache and mobility decreased and oropharyngeal pain 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: HEPA, HPV9
Symptoms: Blood glucose, Electrocardiogram, Full blood count, Headache, Metabolic 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 # 656465) on 02-MAY-2017. This spontaneous report refers to an 18 year old female patient. The patient had no concurrent illnesses. The patient's medical history included penicillin allergy and no other medical history was reported. Information on the patient's prior vaccinations was not reported. The patient's other medications included Mirena IUD. On 22-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M011840 (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included HAVRIX lot # LN749, intramuscularly in the left arm for prophylaxis. On 22-AUG-2016 night, after vaccination, the patient experienced headache, vomiting and sore arm (pain in extremity) and experienced the same events after 2 days (25-AUG-2016). On 12-SEP-2016, the patient experienced syncope, blood glucose, urine analysis, metabolic function test, full blood count and electrocardiogram. The patient had vomiting every 2-3 days since the vaccination. On 30-SEP-2016, the patient experienced second episode of syncope. The patient visited the emergency room. She was treated with anti-nausea medications and IV fluids and was advised to take rest. The outcome of syncope, blood glucose, vomiting, urine analysis, pain in extremity, metabolic function test, headache, full blood count and electrocardiogram  was reported as not recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Pain in extremity, Syncope, Urine analysis, Vomiting
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 # 656465) on 02-MAY-2017. This spontaneous report refers to an 18 year old female patient. The patient had no concurrent illnesses. The patient's medical history included penicillin allergy and no other medical history was reported. Information on the patient's prior vaccinations was not reported. The patient's other medications included Mirena IUD. On 22-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M011840 (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included HAVRIX lot # LN749, intramuscularly in the left arm for prophylaxis. On 22-AUG-2016 night, after vaccination, the patient experienced headache, vomiting and sore arm (pain in extremity) and experienced the same events after 2 days (25-AUG-2016). On 12-SEP-2016, the patient experienced syncope, blood glucose, urine analysis, metabolic function test, full blood count and electrocardiogram. The patient had vomiting every 2-3 days since the vaccination. On 30-SEP-2016, the patient experienced second episode of syncope. The patient visited the emergency room. She was treated with anti-nausea medications and IV fluids and was advised to take rest. The outcome of syncope, blood glucose, vomiting, urine analysis, pain in extremity, metabolic function test, headache, full blood count and electrocardiogram  was reported as not recovered. The 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: Asthenia, Fatigue, Headache, Pain, 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 # 656663) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 24 year old female patient. The patient had no concurrent illnesses. The patient's medical history included attention deficit/hyperactivity disorder (ADHD), anxiety and asthma exercise induced. Information on the patient's prior vaccinations were not reported. The patients other Medications included adderall, propranolol and ventolin. On 25-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 via an unknown route in the left arm, lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day minutes after the vaccination the patient experienced subjective fever, headache, body ache, fatigue and weakness. Four hours later PCP was elevated. The patient required emergency room (ER) visit. After normal examination patient was improving slowly. The outcome of asthenia, fatigue, headache, pain and pyrexia 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: HPV9, MNQ, TDAP
Symptoms: 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 # 656669) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses. The patient's medical history included asthma. Information on the patient's prior vaccinations and other medications were not reported. On 26-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # L037554 (dose, dose number, frequency, lot expiration dates were not reported) intramuscularly, site: unknown for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5416AA, dose 1, intramuscularly in the left arm and ADACEL batch/lot # U5247, dose 1, intramuscularly in the left arm for prophylaxis. On 27-SEP-2016, the patient experienced fever 100.3 (units unspecified). The outcome of pyrexia was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Vomiting
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 # 657134) on 02-MAY-2017. This spontaneous report refers to a 14 year old female patient. The patient's medical history included attention deficit hyperactivity disorder (ADHD) and anxiety. Information about the patient's concurrent illnesses, prior vaccinations and other medications were not reported. On 07-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L018351 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On an unknown date, after the first and second doses of the vaccine, the patient experienced abdominal pain and vomiting. It was initially thought to be anxiety, but no anxiety triggers were reported and the symptoms resolved a few months after the vaccine doses. The outcome of abdominal pain and vomiting was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.