chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Piloerection, Posture abnormal, Tremor, Unresponsive to stimuli, 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 # 643505). This spontaneous report refers to a 16 year old male patient. The patient had no current illnesses, medical history and other medications. On 15-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L016428 (expiry date: 30-JUL-2017), dose 3, route : unknown in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5187AA, dose 2, route: unknown in the left arm. On 15-JUL-2016, patient's parent stated that after GARDASIL 9 shot was administered to patient's right arm, their son's eyes shifted to the right and froze, then his arms went stiff, bent into his chest with his fists closed. His head tilted to the right and he got highly visible goose bumps all over his arms and legs. He was unresponsive to voice prompts, his eyes remained open and he shook a little. The nurse laid him back on the bed. They tried to talk to him, but he was still unresponsive. Within a few minutes, patient immediately came to senses and started to sit up frantically, not knowing what just happened. The nurse asked him some questions, to which he answered one incorrectly, she had him lay back down and they explained what happened to him. Then patient said that he didn't feel very good and nurse put an alcohol pad near his nose to help with his nausea. Then before he could sit up quick enough, he vomited all over himself. When he got completely upright, the nurse gave him a trash can and he vomited some more in it. After sitting and laying and drinking sips of water, along with cold wet towels on his forehead and neck, the nurse asked him to stand and sit in the chair directly across from bed. He did so very slowly and after sitting for a few minutes, he vomited again in the trash can about 3 or 4 times. Prior to this visit, patient had not been sick and hasn't been sick with anything since the winter time and that was just a mild cold. He did have a small bowl of froot loops about an hour and a half prior to the visit. Once home, patient walked very slowly to get inside. Patient's parents cleaned him up and he immediately laid on the couch and fell asleep. He has no temperature but is extremely lethargic. He complained of slight headache and nausea. It was almost 16:00 on 15-JUL-2016, at the time of report. The outcome of all the events was reported as 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: 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 # 643637) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 14-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L026602 (expiration date: 19-OCT-2017) (dose and frequency were not reported), route: unknown, in the left arm for prophylaxis. On 14-JUL-2016, after administration of vaccine, the patient experienced syncope. The patient's BP was 98/50 (units unspecified) and after 15 minutes the patient's BP was rechecked and was found to be 92/60 (units unspecified). The outcome of syncope was reported as recovered. The causality assessment was unknown. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Seizure, 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 # 643720) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old male patient. Information on the patient's concurrent illnesses, medical history, lab data, other medications and prior vaccinations were not reported. On 08-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M011117, dose 1, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with MENACTRA lot/batch # U5282AB, dose 2, intramuscularly in the right arm and TRUMENBA lot/batch # M37315, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day, after 4 hours of vaccination at 15:00 (also reported as 1500) patient had syncope and brief seizure. Patient took clonazepam prior to vaccination for anxiety. The outcome of seizure and syncope 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, MNQ, TDAP
Symptoms: Dizziness, 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 # 643773) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. Information on patient's medical history and lab data were reported as none. Patient had no concurrent illness. On 18-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M004116, dose 1, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with BOOSTRIX lot/batch # H5495, dose 1, intramuscularly in the right arm and MENVEO lot/batch # M15122, dose 1, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day, the patient had dizziness and fainted. The outcome of the events were 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: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient's medical history included mild intermittent asthma. The patient had no current illnesses and the patient's prior vaccinations was not reported. The other medications included albuterol inhaler prn (when necessary) and loratadine prn. On 13-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L014415 and lot expiration date: 25-JUL-2017, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number: 1, vaccinated date: 13-JUL-2016, intramuscularly in the left arm, lot # 4EK53; (dose and lot expiration date unknown), MENACTRA dose number: 1, vaccinated date: 13-JUL-2016, intramuscularly in the right arm, lot # U5186AA; (dose and lot expiration date unknown) and HAVRIX dose number: 2, vaccinated date: 13-JUL-2016, intramuscularly in the left arm, lot # 49LH2; (dose and lot expiration date unknown). On 13-JUL-2016, the patient experienced dizziness, vomiting, nausea and fever for 2 days after vaccines administration. The patient's mother used Ibuprofen and Tylenol to treat fever for the patient. The fever resolved on 15-JUL-2016. The outcome of dizziness, vomiting, fever and nausea 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
Symptoms: Syncope, Vaccination site pallor
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccianitons were not reported.  On 09-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M007764, (route of administration unknown) in the left arm (dose, frequency and expiration date unknown) for prophylaxis and the same day when the vaccination was pricked and removed the vaccination site appeared pale. It was reported that after receiving the entire shot of vaccination the patient fainted (syncope) (fainting time was reported as < 5 seconds). The patient was rested and had 100 % recovery (the outcome of the events syncope and pallor were not reported). Causality assessment was not reported. Lot number M007764 was invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast). Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient's current conditions included, as per the patient's mother the patient had no energy, dizzy, lightheaded and had some chest palpations. Chest discomfort started last Thursday and other symptoms were ongoing through most of the summer months. The patient's medical history included Bicuspid aortic valve, the patient was seen by pediatric cardiology, last evaluation was done in December 2014, and the aortic valve on echo appeared normal and had no restrictions. The patient was advised to follow up in 3 years (2017). The patient other medications included Hx (history) of large amount of caffeine consumption. The patient prior vaccinations was not reported. On 19-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L024993 and expiration date: 17-OCT-2017, intramuscularly in the left arm (dose and frequency unknown) for prophylaxis and the same day patient felt dizzy after 15 minute of vaccine administration. The patient was instructed to lie down and vital signs (VS) obtained. Vital signs were stable. The patient was given water and ammonia inhalant. The patient dizziness 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: Cellulitis, 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 # 644087). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses, medical history, prior vaccinations and other medications were not reported. On 18-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L037554, dose 2, unknown route in the right arm, BOOSTRIX batch/lot # 2729X, dose 2, unknown route in the left arm and MENVEO batch/lot # M15078, dose 2, unknown route in the left arm for prophylaxis. On the same day, the patient had injection site erythema and injection site swelling of approximately 12cm x 10cm, in the left upper arm and further reported that it was very warm to touch for 2 days. The patient also had cellulitis (onset date: 18-JUL-2016) and was prescribed cephalexin. The outcome of cellulitis, injection site warmth, injection site swelling and injection site erythema 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: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema multiforme, Rash
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient's other medications, current illnesses, medical history and prior vaccinations were not reported. On 12-JUL-2016, the patient was vaccinated with GARDASIL 9, lot # M009116, intramuscularly in the left arm (dose number, dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included MENACTRA vaccinated date: 12-JUL-2016, intramuscularly in the left arm, lot # U5390AA; (dose number, dose, frequency and lot expiration date unknown), BOOSTRIX vaccinated date: 12-JUL-2016, intramuscularly in the right arm, lot # 2E9JG; (dose number, dose, frequency and lot expiration date unknown) and HAVRIX vaccinated date: 12-JUL-2016, intramuscularly in the right arm, lot # C90A2; (dose number, dose, frequency and lot expiration date unknown). On 21-JUL-2016, the patient experienced erythema multiforme and rash involving bilateral thighs. The outcome of erythema multiforme and rash 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, MENB, MNQ
Symptoms: Activated partial thromboplastin time, Chest X-ray, Chest discomfort, Crying, Dyspnoea
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 # 644534) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 13-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M007764 (expiration date: 30-JAN-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included TRUMENBA (manufacturer: pfizer/wyeth) batch/lot # M68769, dose 1, intramuscularly in the right arm and MENACTRA batch/lot # U5180AA, dose 2, intramuscularly in the right arm for prophylaxis. On 13-JUL-2016, at 21:00 hrs the patient experienced muscle aches (myalgia) and twitching (muscle twitching). By 23:15 hrs, the patient was crying in pain and had chest discomfort. The patient had shortness of breath (dyspnoea) and chest x-ray, troponin, prothrombin time, metabolic function test, full blood count, electrocardiogram and activated partial thromboplastin time. The patient visited the emergency and was given IVF and NSAIDS. The outcome of chest x-ray, troponin, prothrombin time, myalgia, muscle twitching, metabolic function test, full blood count, electrocardiogram, dyspnoea, crying, chest discomfort and activated partial thromboplastin time was reported as recovered. The causality assessment was unknown.  Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Electrocardiogram, Full blood count, Metabolic function test, Muscle twitching, Myalgia
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 # 644534) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 13-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M007764 (expiration date: 30-JAN-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included TRUMENBA (manufacturer: pfizer/wyeth) batch/lot # M68769, dose 1, intramuscularly in the right arm and MENACTRA batch/lot # U5180AA, dose 2, intramuscularly in the right arm for prophylaxis. On 13-JUL-2016, at 21:00 hrs the patient experienced muscle aches (myalgia) and twitching (muscle twitching). By 23:15 hrs, the patient was crying in pain and had chest discomfort. The patient had shortness of breath (dyspnoea) and chest x-ray, troponin, prothrombin time, metabolic function test, full blood count, electrocardiogram and activated partial thromboplastin time. The patient visited the emergency and was given IVF and NSAIDS. The outcome of chest x-ray, troponin, prothrombin time, myalgia, muscle twitching, metabolic function test, full blood count, electrocardiogram, dyspnoea, crying, chest discomfort and activated partial thromboplastin time was reported as recovered. The causality assessment was unknown.  Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain, Prothrombin time, Troponin
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 # 644534) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 13-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M007764 (expiration date: 30-JAN-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included TRUMENBA (manufacturer: pfizer/wyeth) batch/lot # M68769, dose 1, intramuscularly in the right arm and MENACTRA batch/lot # U5180AA, dose 2, intramuscularly in the right arm for prophylaxis. On 13-JUL-2016, at 21:00 hrs the patient experienced muscle aches (myalgia) and twitching (muscle twitching). By 23:15 hrs, the patient was crying in pain and had chest discomfort. The patient had shortness of breath (dyspnoea) and chest x-ray, troponin, prothrombin time, metabolic function test, full blood count, electrocardiogram and activated partial thromboplastin time. The patient visited the emergency and was given IVF and NSAIDS. The outcome of chest x-ray, troponin, prothrombin time, myalgia, muscle twitching, metabolic function test, full blood count, electrocardiogram, dyspnoea, crying, chest discomfort and activated partial thromboplastin time was reported as recovered. The causality assessment was unknown.  Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Presyncope
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 # 644689). This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations and other medications were not reported. On 25-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M014929, dose 1, intramuscular route in the right arm, BOOSTRIX batch/lot # 73D7R, dose 1, intramuscular route in the left arm and MENVEO batch/lot # M15078, dose 1, intramuscular route in the right arm for prophylaxis. On the same day, after receiving the vaccinations, the patient had a vasovagal response. The outcome of presyncope 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: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Altered state of consciousness, Eye movement disorder, Muscle contractions involuntary, Seizure
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 # 645215) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. The patient's medical history included allergic to Amoxicillin and Cefzil. Information on the patient's prior vaccinations were not reported. Patient's had no illness and no medications were taken. Patient was not alcoholic and drug or tobacco user. Information on patient's other medication was reported as none. On 27-JUL-2016, the patient was vaccinated with GARDASIL 9 dose 2, intramuscularly, in the left arm for prophylaxis (dosage, lot and expiry date unspecified). On the same day the patient was also vaccinated with HEPATITIS A VACCINE, INACTIVATED dose 2, intramuscularly, in the left arm for prophylaxis (dosage, lot and expiry date unspecified). On 27-JUL-2016, after five to ten minutes of vaccination, patient felt like passing out. Her eyes trolled up into her head and her hands curled inward. Nurse informed that the patient had a seizure and her parent helped her to laid back on the table. The nurse put a cooling pack on patient's forehead. Later nurse informed that patient had a seizure and lasted less than for 30 seconds. As the patient had a seizure, she was checked by a doctor again before she left the clinic. The outcome of all the events were 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.
Age: 13.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema
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 # 645253) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. Information on the patient's concurrent illnesses, medical history, lab data and prior vaccinations were not reported. Patient's other medication included Fluticasone. On 20-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L026602, dose 2, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with VARIVAX lot # M002064, dose 2, intramuscularly in the right arm for prophylaxis (dosage unspecified). On 21-JUL-2016, the patient had erythematous (7cm x 5cm), edematous nodule at injection site started in the next morning after the vaccination. The outcome of injection site erythema, injection site oedema and injection site nodule was unknown. 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, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On 26-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M004116 and lot expiration date: 12-OCT-2017, (route of administration unknown) in the left arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number: 1, vaccinated date: 26- JUL-2016, (route of administration unknown) in the right arm, lot # Z924Y; (dose and lot expiration date unknown) and MENVEO dose number: 1, vaccinated date: 26- JUL-2016, (route of administration unknown) in the right arm, lot # M15098; (dose and lot expiration date unknown). On 26-JUL-2016, the patient experienced syncopal event. The outcome of 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: HPV9, MNQ
Symptoms: Vaccination site induration, Vaccination site pallor, 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 # 645269) 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, lab data and prior vaccinations were not reported. The patient's other medications included multivitamin. The patient's medical history included allergy to amoxicillin. On 29-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L019297 with expiration date: 18-AUG-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included first dose of MENACTRA intramuscularly in the left arm, lot # US186AA (dose, frequency and lot expiration date were not reported) for prophylaxis.  On 30-JUN-2016, the patient experienced 9 centimeter induration warm local blanching surrounding vaccination area. The outcome of injection site induration, injection site reaction, injection site warmth and pallor 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: HEPA, HPV9, MNQ
Symptoms: Immediate post-injection reaction, Musculoskeletal stiffness, Nausea, Pallor, Posture abnormal
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 # 645537). This spontaneous report refers to a 16 year old female patient. Information on the patient's prior vaccinations was not reported. The patient had no concurrent illnesses, medical history and other medications. The patient played simple sports and was very healthy. On 29-JUL-2016, the patient was vaccinated with GARDASIL 9 dose 1, intramuscular route in the right arm for prophylaxis (dosage, lot # unspecified) and the patient was also vaccinated with MENACTRA dose 2, intramuscular route in the left arm and VAQTA dose 2, intramuscular route in the left arm for prophylaxis (dosage, lot # unspecified). On the same day, almost immediately after GARDASIL 9 vaccine, the patient fainted. The patient was sitting on the exam table, therefore was caught by the patient's mother wen she fell forward. The nurse, who vaccinated, helped position the patient on her back on the table. Nurses and doctors came in after. The patient had some stiffened muscles from fainting. The patient came back around shortly after nurse rubbed her closed eyelid. The patient was very pale and was given water, juice and a nutria-grain bar. The patient had some nausea on drive home after waiting a bit before leaving clinic. The outcome of loss of consciousness, syncope, pallor, nausea and musculoskeletal stiffness 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: HEPA, HPV9, MNQ
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 # 645537). This spontaneous report refers to a 16 year old female patient. Information on the patient's prior vaccinations was not reported. The patient had no concurrent illnesses, medical history and other medications. The patient played simple sports and was very healthy. On 29-JUL-2016, the patient was vaccinated with GARDASIL 9 dose 1, intramuscular route in the right arm for prophylaxis (dosage, lot # unspecified) and the patient was also vaccinated with MENACTRA dose 2, intramuscular route in the left arm and VAQTA dose 2, intramuscular route in the left arm for prophylaxis (dosage, lot # unspecified). On the same day, almost immediately after GARDASIL 9 vaccine, the patient fainted. The patient was sitting on the exam table, therefore was caught by the patient's mother wen she fell forward. The nurse, who vaccinated, helped position the patient on her back on the table. Nurses and doctors came in after. The patient had some stiffened muscles from fainting. The patient came back around shortly after nurse rubbed her closed eyelid. The patient was very pale and was given water, juice and a nutria-grain bar. The patient had some nausea on drive home after waiting a bit before leaving clinic. The outcome of loss of consciousness, syncope, pallor, nausea and musculoskeletal stiffness 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: DTAP, HPV9, MEN
Symptoms: Abdominal pain upper, Anxiety, Cyanosis, Depression, 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 # 645562). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations and other medications were not reported. On 29-JUL-2016, the patient was vaccinated with GARDASIL 9 dose 1, unknown in the left arm, meningococcal polysaccharide vaccine (unspecified)(manufacturer unknown) dose 1, unknown route in the right arm and diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (manufacturer unknown) dose 1, unknown route in the right arm for prophylaxis (dosage and lot # unspecified). On the same day, the patient had a syncopal episode followed by tonic/clonic seizure like activity which lasted between 3-5 minutes. When the patient came out of it, her body and face were white and lips were purple. The patient had no recollection of what had taken place. The next 36 hours the patient reported significant stomach pain, extreme fatigue, dizziness, anxiety and depression. The outcome of abdominal pain upper, tonic clonic movements, syncope, seizure like phenomena, pallor, fatigue, dizziness, depression, cyanosis and anxiety 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: DTAP, HPV9, MEN
Symptoms: Fatigue, Pallor, Seizure like phenomena, Syncope, Tonic clonic movements
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 # 645562). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations and other medications were not reported. On 29-JUL-2016, the patient was vaccinated with GARDASIL 9 dose 1, unknown in the left arm, meningococcal polysaccharide vaccine (unspecified)(manufacturer unknown) dose 1, unknown route in the right arm and diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (manufacturer unknown) dose 1, unknown route in the right arm for prophylaxis (dosage and lot # unspecified). On the same day, the patient had a syncopal episode followed by tonic/clonic seizure like activity which lasted between 3-5 minutes. When the patient came out of it, her body and face were white and lips were purple. The patient had no recollection of what had taken place. The next 36 hours the patient reported significant stomach pain, extreme fatigue, dizziness, anxiety and depression. The outcome of abdominal pain upper, tonic clonic movements, syncope, seizure like phenomena, pallor, fatigue, dizziness, depression, cyanosis and anxiety 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: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Hypotonia, Immediate post-injection reaction, Muscle twitching, Unresponsive to stimuli
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 # 645731) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient had no concurrent illnesses. The patient medical history included no known allergies (NKA) and weight in 3rd %. Information on the patient's prior vaccinations, lab data and other medications were not reported. On 01-AUG-2016 the patient was vaccinated with first dose of GARDASIL 9 via intramuscularly in the right arm, lot # L044475 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included third dose of MENVEO (Manufacturer: Novartis) intramuscularly in the left arm, lot # M15070 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 01-AUG-2016 at 10:25am, post vaccination of GARDASIL 9 and immediately after MENVEO patient started to go limp and did not respond to name (unresponsive to stimuli). Twitched and laid down on the table. Within a minute the patient opened his eyes and became alert. The patient was admitted to feeling dizzy prior to episode. The provider was notified immediately and came in to assess the patient. The patient blood pressure (BP) was 98/40, patient drank water and ate and advised to wait in office for 15 minutes. After 15 minutes patient left with his mother and stated that he felt better. The outcome of dizziness, hypotonia, immediate post-injection reaction, muscle twitching and unresponsive to stimuli was reported as recovered/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
Symptoms: Asthenia, Dizziness, Headache, Malaise, Pallor
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On 28-JUL-2016 at 4 pm, the patient was vaccinated with third dose of GARDASIL 9, lot # L043214, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. The patient was fine until 3 am on 29-JUL-2016 and same day, the patient experienced fever, headache, malaise, dizziness, vomiting, weakness, asthenia, dizziness, pale and orthostatic in office. There was some improvement in patient with ibuprofen and ZOFRAN. The patient was sent to home with instructions to go to emergency room (ER) if the persistent symptoms get worsened. On an unknown date, the patient had an emergency room (ER) visit. Lab data reported as decline lab work today. The outcome of asthenia, vomiting, pyrexia, pallor, malaise, headache and dizziness 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: HPV9
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On 28-JUL-2016 at 4 pm, the patient was vaccinated with third dose of GARDASIL 9, lot # L043214, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. The patient was fine until 3 am on 29-JUL-2016 and same day, the patient experienced fever, headache, malaise, dizziness, vomiting, weakness, asthenia, dizziness, pale and orthostatic in office. There was some improvement in patient with ibuprofen and ZOFRAN. The patient was sent to home with instructions to go to emergency room (ER) if the persistent symptoms get worsened. On an unknown date, the patient had an emergency room (ER) visit. Lab data reported as decline lab work today. The outcome of asthenia, vomiting, pyrexia, pallor, malaise, headache and dizziness 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: HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Nervousness, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 23 year old female patient. The patient's medical history included low blood sugar. The patient's other medications included Aviane. The patient's current illnesses and prior vaccinations were not reported. On 01-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L043214, intramuscular in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. And same day, the patient passed out, felt shaky, sweating and patient was alert but not responsive. The outcome of hyperhidrosis, unresponsive to stimuli, nervousness and loss of consciousness 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: Hypersensitivity, 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 # 645845) 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 the other medications were not reported. On 25-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M005714 (expiration date: 03-OCT-2017) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included ADACEL batch/lot # U5316AA, dose 1, intramuscularly in the left arm and MENVEO batch/lot # A15079, dose 1, intramuscularly in the right arm for prophylaxis. On an unknown date the patient experienced swelling, redness pain to the left deltoid. The patient had allergic reaction, complained of swelling, redness, pain at the injection site, left deltoid. The patient was afebrile and had no vomiting or diarrhea (v/d). The outcome of hypersensitivity, injection site swelling, injection site pain and injection site erythema 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient had no current illnesses. The patient's other medications, medical history and prior vaccinations were not reported. On 22-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L019297 and expiration date: 18-AUG-2017, (route of administration unknown) in the right arm (dose and frequency and unknown) for prophylaxis. Other suspect therapies included ADACEL dose number: 1, vaccinated date: 22-JUL-2016, (route of administration unknown) in the left arm, lot # C4713AA; (dose and frequency unknown) and MENACTRA dose number: 1, vaccinated date: 22-JUL-2016, (route of administration unknown) in the right arm, lot # U5180AA; (dose and frequency unknown). Incorrect product storage was reported as there was a fridge temperature discrepancy. The vaccine for children (VFC) fridge minimum temperature went down to 31. The patient had no illness or Injury. Patient does need to be revaccinated and appointment was scheduled on 15-AUG-2016. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness
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 # 646036) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male 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-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. On an unknown date (also reported as 10 seconds after) after receiving the injection, patient lost consciousness for about 6 seconds. Regained his consciousness with no interventions and had no further symptoms for 30 minutes. The patient said that he didn't eat in the morning, juice and crackers were given and he felt much better. The outcome of loss of consciousness 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, VARCEL
Symptoms: Blood pressure decreased, Hyperhidrosis, Pallor, Visual impairment
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 18 year old male patient. The patient had no other medications, current illnesses and medical history. The patient's prior vaccinations was not reported. On 02-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L023230 and expiration date: 28-JUL-2017, intramuscularly in the left arm (dose and frequency and unknown) for prophylaxis and other suspect therapy included VARIVAX lot # L026408 and expiration date:15-JUL-2017, subcutaneously in the left arm (dose and frequency and unknown) for prophylaxis and the same day within 3-5 minutes of the first dose of GARDASIL 9 administered, the patient experienced pale, sweaty, could not see and blood pressure dropped. The outcome of blood pressure decreased, visual impairment, pallor and hyperhidrosis 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: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blindness, Blood pressure decreased, Hyperhidrosis, 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 # 646070) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient had no concurrent illnesses, lab data and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included oral contraceptives. On 02-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly in the left arm, lot # L023230, expiry date: 28-JUL-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included second dose of MENACTRA intramuscularly in the right arm, lot # US186AA (Manufacturer: Sanofi Pasteur), (dose, frequency and lot expiration date were not reported) for prophylaxis. On 02-AUG-2016, 15 minutes after vaccination of GARDASIL 9 and MENACTRA patient stated that she couldn't see, became pale, sweaty and pressure dropped but did not completely faint. The outcome of blindness, blood pressure decreased, dizziness, hyperhidrosis and pallor 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
Symptoms: Axillary mass
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 19 year old female patient. The patient had no other medications, current illnesses and medical history. The patient's prior vaccinations was not reported. On 11-JUL-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M004116 and expiration date: 12-OCT-2017, intramuscularly in the left arm (dose and frequency unknown) for prophylaxis. On 30-JUL-2016, the patient found lump in left axilla. On 02-AUG-2016, the patient came to office and was treated with BACTRIM DS one tablet twice a day for 10 days. The outcome of axillary mass 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
Symptoms: Injection site cellulitis, Rash
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient's medical history reported as prior HPV (severe allergy to previous dose or component vaccine). The patient had no current illnesses. The patient other medications and prior vaccinations were not reported. On 02-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9, lot number # M011840, (route of administration unknown) in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included MENACTRA vaccinated date: 02-AUG-2016, in the left arm, lot # U5260AA; (route of administration, dose number, dose, frequency and lot expiration date unknown). On 03-AUG-2016, the patient experienced moderate rash < 14 days and cellulitis to injection site. The outcome of rash and injection site cellulitis 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: 14.0
Sex: M
Vaccine: HPV9
Symptoms: 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 # 646385) on 02-MAY-2017. This spontaneous report refers to a 14 year old male patient. The patient had no concurrent illnesses, medical history and other medications. On 02-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M009116 dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On 03-AUG-2016, the patient experienced headache, fever and body aches. 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: U
Vaccine: HEPA, HPV9
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, 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 ID-646404). This spontaneous report refers to a patient of unknown age and gender. The patient had no concurrent illnesses. The patient's medical history included developmental delay. The patient had the condition "weakness predates vaccine". Information on patient's other medications was not reported. On 29-JUL-2016 the patient was vaccinated with GARDASIL 9 lot # L026602 dose 2 (unspecified dosage), intramuscular in the left arm for prophylaxis and VAQTA dose 1 (unspecified dosage) lot # L015460 (expiration date: 20-JUL-2017), intramuscularly in the left arm. On 01-AUG-2016, he patient had minor swelling and complained of pain in upper left deltoid injection site, numbness and tingling in the left hand. The patient was taken to emergency room. The outcome of hypoaesthesia, paraesthesia, injection site swelling and injection site pain was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.