chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Adverse reaction
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 # 620617). This spontaneous report refers to an 11 year old female patient. The patient's concurrent illnesses and medical history were not reported. On 18-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L011846, via unknown route in the right arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included ADACEL (lot # U5214AA, via unknown route in the left arm) and MENACTRA (lot # U5185BA, via unknown route in the right arm). On 20-JAN-2016, the patient experienced adverse reaction. The patient had a reaction and wanted to know what else to do besides ice. The patient called on 20-JAN-2016 at 11 am and was told to use ADVIL / TYLENOL. Patient called her mom on 21-JAN-2016, said that adverse reaction was on right arm. The outcome of adverse reaction was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, 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 # 620910). This spontaneous report refers to a 16 year old female patient. The patient's concurrent illnesses was reported as none and medical history was not reported. Patient's historical drug included Amoxicillin. On 26-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L028083, dose 1, intramuscularly in the right arm for prophylaxis. Patient received HPV 9 in right deltoid. Patient remained on the exam table in a laying position for 5 minutes and in room for 10 minutes post vaccination. On the same day of vaccination, patient felt faint and mother assisted patient to table. Patient experienced loss of consciousness for 1 second approximately. Blood Pressure was taken, juice and crackers given. Patient remained for observation and provider examined prior to release. Chart alert placed. The outcome of dizziness and loss of consciousness was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9, MNQ, VARCEL
Symptoms: Dyskinesia, Fall, Moaning, Pain, 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 # 621499). This spontaneous report refers to a 17 year old male patient. The patient's concurrent illnesses and medical history were not reported. In patient's prior vaccinations, it was reported that patient's sibling had GARDASIL 9, dose 1, and experienced dizziness and nausea. On 01-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L016428, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included VARIVAX (lot # L030159, dose 2, subcutaneously in the right arm), MENVEO (lot # M15066, dose 1, intramuscularly in the left arm) and FLUZONE (lot # UI431AA, dose 1, intramuscularly in the left arm). After the last injection, GARDASIL 9, patient stated "Ouch, that one hurt" and then fell backwards onto the table. Patient started to have movements and head shaking, along with moaning. Provider notified, vitals taken, EMS (emergency medical service) notified at 12:25 PM. Patient was monitored until EMS arrived at 12:29 PM. Patient was then transported to Medical Centre via 911. On the same day of vaccination, the patient was diagnosed with dyskinesia, tremor, pain, moaning and fall. The outcome of dyskinesia, tremor, pain, moaning and fall were reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Dizziness, Tuberculin 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 # 621516) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old female patient. Information on the patient's concurrent illnesses, lab data, medical history and prior vaccinations were not reported. Patient's other medication reported as TB skin test. On 01-FEB-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L023230, via intramuscular route, in the left arm for prophylaxis (dosage unspecified). On the same day the patient was vaccinated with FLUZONE lot/batch # UI505AA, dose 7, via intramuscular route, in the right arm and MENVEO lot/batch # M14136, dose 2, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 01-FEB-2016, after GARDASIL 9 and MCV 4 vaccine was given patient started feeling lightheaded and dizzy. Patient laid on the floor with legs up and ice was applied to the neck. After 5 minutes of laying down, patient sat on the chair. Patient started feeling the same symptoms again. The patient again laid down on the floor for five minutes and she felt better. TP skin test was given to her. The outcome of dizziness was reported as recovered. Causality assessment was not provided.     Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Fall, Head injury, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #621566) and refers to a 11 year old female patient. Patient's current illness, history and other medication was reported as none. On 01-FEB-2016 the patient was vaccinated with GARDASIL 9, lot # L014415, dose 1, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). On 01-FEB-2016, 20 min after vaccination patient was asked if she was ok. Both patient and her mother stated she was fine. The patient walked out while they were scheduling her next follow up appointment in the front office. Patient fainted, fell and hit her head on the counter on her way down. The outcome of fall, syncope and head injury was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Irritability, 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 (HA #621623) and refers to a 14 year old female patient. No details about current illnesses, medical history, prior vaccination and other medications were provided. Lab data was reported as none. On 26-JAN-2016 the patient was vaccinated with GARDASIL 9, lot # L019297, intramuscular for prophylaxis (strength and dosing detail unknown). On 26-JAN-2016, the patient experienced light headedness, headache, sore throat and irritability. The outcome of the events were reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MENB
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Headache, 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 ID-621975). This spontaneous report refers to a 17 year old female patient. The patient's medical history included allergic rhinitis and dysmenorrhea. The patient's other medications were not reported. The patient had no current illnesses. On 24-NOV-2015 the patient was vaccinated with GARDASIL 9 (lot # 1011846) dose 3 (unspecified dose), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with BEXSERO dose 1 (unspecified dose) (in the left arm) and FLUZONE (unspecified dose) in the right arm intramuscularly for prophylaxis. On 28-NOV-2015, 5 days after onset of therapy the patient experienced decreased appetite, weight decreased, vomiting, pain in extremity, nausea, headache, progressive and persistent fatigue and diarrhoea. The patient had leg pains within in 2 days after vaccinating with BEXSERO and persisted till 04-FEB-2016. The patient lost weight of approximately 7 kg due to anorexia from the date of vaccination to 04-FEB-2016. The outcome of the events was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9, MENB
Symptoms: Pain in extremity, Vomiting, 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 ID-621975). This spontaneous report refers to a 17 year old female patient. The patient's medical history included allergic rhinitis and dysmenorrhea. The patient's other medications were not reported. The patient had no current illnesses. On 24-NOV-2015 the patient was vaccinated with GARDASIL 9 (lot # 1011846) dose 3 (unspecified dose), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with BEXSERO dose 1 (unspecified dose) (in the left arm) and FLUZONE (unspecified dose) in the right arm intramuscularly for prophylaxis. On 28-NOV-2015, 5 days after onset of therapy the patient experienced decreased appetite, weight decreased, vomiting, pain in extremity, nausea, headache, progressive and persistent fatigue and diarrhoea. The patient had leg pains within in 2 days after vaccinating with BEXSERO and persisted till 04-FEB-2016. The patient lost weight of approximately 7 kg due to anorexia from the date of vaccination to 04-FEB-2016. The outcome of the events was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Lethargy, 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 # 622150) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included depression and affective disorder. The patient had no known drug allergies. The patient's current illnesses were reported as none and concomitant medications were not reported. The patient's other medications included ZOLOFT, SEROQUEL, DEPAKOTE and COGENTIN. On 04-FEB-2016 the patient was vaccinated approximately at 10:15 am with first dose of GARDASIL 9 lot # L020015 (dose and frequency were not reported and lot expiration date was reported as 16-AUG-2017), via intramuscular route, in the right arm for prophylaxis. On the same day at 12:11pm, the foster home staff called to report that patient was lethargic and was non responsive to the questions asked by the staff. The patient also vomited twice. The foster home staff was advised to call 911. The patients visited the emergency room. The outcome of lethargy, vomiting and unresponsive to stimuli was reported as unknown. Causality assessment of the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Injection site reaction, Local reaction
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 # 622176) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old female patient. The patient had no medical history or concurrent illnesses. The patient's other medications included birth control medications. Information on the patient's prior vaccinations was not reported. On 08-FEB-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L018351 (dose number: 2, frequency and lot expiration date unknown) and FLUARIX (dose number: 2; intramuscularly in the left arm, lot# 3L9LD, manufacturer: GlaxoSmithKline, frequency and lot expiration date unknown) for prophylaxis. On the same day, post vaccination, the patient called and had presented to the office with reaction on the left (L) deltoid. The PNP was notified and the patient was assessed. It was determined to be a local reaction. The patient was given BENADRYL at the office and was asked to do cold compression at home. The patient was asked to call if there were any questions or concerns. The patient required emergency room (ER) visit. The outcome for the event injection site reaction 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: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: Dizziness, Dyskinesia, Loss of consciousness, 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 # 622215) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old female patient. The patient's medical history was reported as none. The patient's concurrent illness included otitis media. The patient's concomitant medication was not reported. On 09-FEB-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L018351 (dose, frequency and lot expiration date were not reported), via intramuscular route, in the right arm for prophylaxis. The patient was vaccinated with other suspect therapies on the same day included MENACTRA (dose number: 2, intramuscularly in the left arm, lot# U5179AA; dose and expiration date unknown) and FLUZONE (dose number: not reported, intramuscularly in the right arm, lot# U1443AB; dose and expiration date unknown) for prophylaxis. On 09-FEB-2016, the patient felt 'lightheaded' and sat down on a chair. On the same day the patient was turned pale, lost consciousness and had jerking movement of extremities for 5-10 seconds. The patient was made to lay down on an examining table and she received blow by oxygen. The patient regained consciousness after 5 minutes. The patient continued to be in supine position for the next 10 minutes. The patient drank coconut juice (4oz). The patient's vitals were stable. The patient was self ambulated out of the clinic without any incident. The patient stated that she had not eaten nor drank since the previous night. The outcome of dizziness, pallor, loss of consciousness and dyskinesia were reported as recovered. Causality assessment for the events were not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: 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 # 622252) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included keratosis pilaris. Information on the patient's concurrent illnesses was reported as none. Patient's other medication and prior vaccination were not reported. Information on patient's lab data was reported as not applicable. On 08-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L036245, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with ADACEL lot/batch # U5263AA, via intramuscular route, in the left arm, FLUZONE lot/batch # UI455AD, via intramuscular route, in the right arm and MENACTRA lot/batch # U5272AA, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On 09-FEB-2016, the patient had rashes on her arm, hand and abdomen. The outcome of rash was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 19.0
Sex: F
Vaccine: HPV9, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, 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 ID-622727) This spontaneous report refers to a 19 year old female patient. The patient's other medications included Ativan, Celexa and Prevacid. The patient's medical history included obesity and mood disorder. The patient had no current illnesses. On 10-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L037339 dose 2 (unspecified dose), intramuscularly in the left arm for prophylaxis and VARIVAX (lot # L020000) dose 2, subcutaneously in the left arm for prophylaxis. Following the vaccinations, the patient experienced injection site erythema, injection site swelling and injection site pain in the upper posterior left arm which progressed to a larger area with more pain and warmth over the two days. The patient had central area (2x3cm of induration with spreading redness about 6x10 cm) with warmth at the injection site and pain. The patient was taken to emergency room. She was treated for possible cellulitis with clindamycin for 7 days. The outcome of injection site erythema, injection site warmth, injection site swelling, injection site pain and injection site induration was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Body temperature increased, Malaise, 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 ID-622742). This spontaneous report refers to a 17 year old male patient. The patient's medical history included PCN (Penicillin) and Amoxicillin allergy. The patient had no current illnesses and other medications. On 11-FEB-2016 the patient was vaccinated with GARDASIL 9 (lot # L19297) dose 1 (unspecified dose), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA dose 1 (unspecified dose), in the left arm, TRUMENBA dose 1 (unspecified dose), in the left arm and FLUARIX QUADRIVALENT dose 1 (unspecified dose), in the right arm, intramuscularly for prophylaxis. On 12-FEB-2016, the patient had nausea after breakfast. He attempted to follow normal routine for school. At 11:00, nausea increased and the patient was not feeling well. He experienced malaise and body temperature was increased (102.8) (unspecified units). He was placed on medical isolation to rest in room, placed on clear liquid diet and was administered with Tylenol 650 mg for every 4 hours. The patient was encouraged to oral fluid intake. The patient was monitored. On 13-FEB-2016, at 07:00, he was afebrile and no c/o voiced. The patient's vital signs were stable and returned to normal stable. The outcome of the events was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU3, HPV9
Symptoms: Aggression, Headache, Vision blurred
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 622962). This spontaneous report refers to a 15 year old male patient. Information on patient's current illnesses was not reported. The patient's medical history included attention deficit/hyperactivity disorder (ADHD), cough variant asthma and migraine. Patient's other medications included concerta 36 mg and ventolin HFA. On 10-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L019297 (expiry date: 18-AUG-2017), dose 3, intramuscularly in the left arm for prophylaxis. On the same day, patient was also vaccinated with FLUZONE lot # U5304AB, dose 8, intramuscularly in the left arm for prophylaxis. On 12-FEB-2016, the patient experienced combative, blurred vision and headache. 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: FLUN4, HEPA, HPV9, MNQ
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Pallor, Retching
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 # 623050) on 18-APR-2017. This spontaneous report refers to a 17 year old female patient. Information about the patient's other medications was unknown and the patient had no concurrent illnesses and historical conditions. On 15-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L019297 dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA lot # U5185BA dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis, HAVRIX lot # 32DZ5 dose 2 (unspecified dosage), intramuscularly in the left arm for prophylaxis and FLUMIST lot # FL2117, dose 1 (unspecified dosage), via intranasal route for prophylaxis. On 15-FEB-2016, the patient stated she was feeling faint, dry heaved 5 times, turned completely pale, had an immediate post-injection reaction and suddenly started feeling hot, immediately following the GARDASIL 9 administration. Cool and moistened paper towels were placed on the back of the patient's neck. The patient's blood pressure was taken and found to be 68/49 and after 7 minutes, the test was repeated to show a rebound of 86/72. The patient was monitored for 15 minutes before releasing from the clinic in good condition. The patient was reported to have been walking on her own without any further incident. The outcome of the events 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.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Antinuclear antibody negative, Blood thyroid stimulating hormone normal, Borrelia test negative, C-reactive protein normal, Differential white blood cell count normal
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 # 623147) on 18-APR-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. The patient's other medications included two prior HPV 4 vaccines and not HPV 9. On 13-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L017407 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUZONE lot # UI443AC, dose 7 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 05-FEB-2016, the patient experienced uncontrollable right hand muscle twitching and tremors that progressed to leg and shoulder twitching, because of which the patient required an emergency room visit. On the same day, the patient's C-reactive protein test, differential white blood cell count, electroencephalogram, full blood count, metabolic function test, brain nuclear magnetic resonance imaging and the free thyroxine 4 test were found to be normal. The Borrelia test, antinulclear antibody titer (ANA) and streptococcus test was found to be negative. On an unknown date, the patient also had Lyme disease antibody test, antistreptolysin O titer (ASO), antinulclear antibody titer (ANA), thyroid-stimulating hormone test the results of which were found to be normal. The outcome of the events was reported as not 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.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Electroencephalogram normal, Full blood count normal, Metabolic function test normal, Muscle twitching, Nuclear magnetic resonance imaging brain normal
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 # 623147) on 18-APR-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. The patient's other medications included two prior HPV 4 vaccines and not HPV 9. On 13-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L017407 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUZONE lot # UI443AC, dose 7 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 05-FEB-2016, the patient experienced uncontrollable right hand muscle twitching and tremors that progressed to leg and shoulder twitching, because of which the patient required an emergency room visit. On the same day, the patient's C-reactive protein test, differential white blood cell count, electroencephalogram, full blood count, metabolic function test, brain nuclear magnetic resonance imaging and the free thyroxine 4 test were found to be normal. The Borrelia test, antinulclear antibody titer (ANA) and streptococcus test was found to be negative. On an unknown date, the patient also had Lyme disease antibody test, antistreptolysin O titer (ASO), antinulclear antibody titer (ANA), thyroid-stimulating hormone test the results of which were found to be normal. The outcome of the events was reported as not 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.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Streptococcus test negative, Thyroxine free normal, 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 # 623147) on 18-APR-2017. This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. The patient's other medications included two prior HPV 4 vaccines and not HPV 9. On 13-JAN-2016, the patient was vaccinated with GARDASIL 9 lot # L017407 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUZONE lot # UI443AC, dose 7 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On 05-FEB-2016, the patient experienced uncontrollable right hand muscle twitching and tremors that progressed to leg and shoulder twitching, because of which the patient required an emergency room visit. On the same day, the patient's C-reactive protein test, differential white blood cell count, electroencephalogram, full blood count, metabolic function test, brain nuclear magnetic resonance imaging and the free thyroxine 4 test were found to be normal. The Borrelia test, antinulclear antibody titer (ANA) and streptococcus test was found to be negative. On an unknown date, the patient also had Lyme disease antibody test, antistreptolysin O titer (ASO), antinulclear antibody titer (ANA), thyroid-stimulating hormone test the results of which were found to be normal. The outcome of the events was reported as not 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.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Blood test, Chest X-ray, Computerised tomogram head, Dizziness, Drug screen
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 # 623454) on 18-APR-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses, medical history and other medications. On 17-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L036245, dose 2 (unspecified dosage and units), intramuscularly in the right arm for prophylaxis. On the same day, patient was vaccinated with FLUARIX QUADRIVALENT lot # GZ72T, (unspecified dose, dosage and units) intramuscularly in the right arm for prophylaxis and MENVEO lot # A15069, dose 2 (unspecified dosage and units) intramuscularly in the left arm for prophylaxis. On 22-FEB-2016, the patient experienced somnolence, loss of consciousness, hyporesponsive to stimuli and dizziness. On the same day, patient had also undergone blood test, chest x-ray, computerized tomogram head without contrast, drug screen and electrocardiogram (EKG). Urine analysis test was also performed. The results of the tests were not reported. The patient required an emergency room visit, after found passed out on the bathroom floor at school. The patient was minimally responsive, sleepy but arousable, when found by a fellow student. The patient reported to have been dizzy and lightheaded before going to the bathroom and does not have recollection after passing out. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Electrocardiogram, Hyporesponsive to stimuli, Loss of consciousness, Somnolence, 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 # 623454) on 18-APR-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses, medical history and other medications. On 17-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L036245, dose 2 (unspecified dosage and units), intramuscularly in the right arm for prophylaxis. On the same day, patient was vaccinated with FLUARIX QUADRIVALENT lot # GZ72T, (unspecified dose, dosage and units) intramuscularly in the right arm for prophylaxis and MENVEO lot # A15069, dose 2 (unspecified dosage and units) intramuscularly in the left arm for prophylaxis. On 22-FEB-2016, the patient experienced somnolence, loss of consciousness, hyporesponsive to stimuli and dizziness. On the same day, patient had also undergone blood test, chest x-ray, computerized tomogram head without contrast, drug screen and electrocardiogram (EKG). Urine analysis test was also performed. The results of the tests were not reported. The patient required an emergency room visit, after found passed out on the bathroom floor at school. The patient was minimally responsive, sleepy but arousable, when found by a fellow student. The patient reported to have been dizzy and lightheaded before going to the bathroom and does not have recollection after passing out. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Nodule, 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 # 623531) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 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 29-DEC-2015 the patient was vaccinated with the second dose of GARDASIL 9 lot # L017407, (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On 14-JAN-2016, the patient experienced swelling, no redness, warmth and nodule. On 15-JAN-2016, no redness or warmth were observed on examination and the patient was informed to take Motrin, Benadryl and cool compress. On 18-JAN-2016 the patient was given Augmentin. On 01-FEB-2016 after completing medication the patient still had a knot and mild swelling. The patient was required emergency visit. The outcome of nodule and swelling 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: Chest 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 # 624152). This spontaneous report refers to a 12 year old male patient. The patient had no concurrent conditions, no allergies or chronic medical concerns. Information on the patient's prior vaccinations and other medications were not reported. On 01-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L011846 (expiry date: 16-JUN-2017) dose 2, intramuscular route in the right arm (deltoid) for prophylaxis (dosage unspecified). On the same day, the patient return to clinic approximately 40 minutes later and complained of right sided chest pain. MD evaluated the patient and the patient was stable. The EMS transported the patient to ED/ER for further evaluation. The outcome of chest pain 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
Symptoms: Dizziness, Nausea, Pyrexia, 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 # 624172). This spontaneous report refers to a 17 year old male patient. The patient's medical history included intermittent asthma. Information on the patient's concurrent illnesses, prior vaccinations and other medications were not reported. On 20-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L020015 (expiry date:16-AUG-2017), dose 3, intramuscular route in the left arm for prophylaxis. On 21-FEB-2016, the patient complained of vomiting, pyrexia, nausea and dizziness. The symptoms lasted on and off for 6 hours. The symptoms improved after taking a dose of TYLENOL and fluids. The outcome of dizziness, vomiting, pyrexia and nausea 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: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Nausea, Pain, 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 # 624625) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 17 year old male patient. The patient's medical history, other medications and concurrent illnesses were not reported. Information on the patient's prior vaccinations was not reported. On 08-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right deltoid, lot # L016428, expiration date: 30-JUL-2017 (frequency unknown) for prophylaxis. The patient was fine and was concerned about the soreness. Then (on the same day) the patient was also vaccinated with MENACTRA (dose number: 2, site: left deltoid, route: unknown, lot# U5179AA; manufacturer: Sanofi Pasteur, frequency and lot expiration date unknown) for prophylaxis. As the vaccination was being completed, the patient complained of feeling nauseous. The personnel who administered the vaccine stood in front of the patient who was sitting on the edge of the exam table and the patient fainted. The patient was caught and his head was supported then the patient was laid back on the table. The other MA's were called to the exam room and when they came back, the patient was sitting up. The patient was asked to lay back down and was kept in the exam room for 10 minutes. The patient stated that he was feeling fine and spoke to the doctor. The doctor advised to keep the patient a little longer and made sure to release him when he was fine. The patient was able to leave home on his own with this mother. The outcome for the events pain, syncope 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: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Dizziness, Immediate post-injection reaction, Loss of consciousness, 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 (HA #624772) and refers to a 11 year old female patient. Patient's  current illnesses, medical history and other medications were reported as none. On 03-FEB-2016, the patient was vaccinated with GARDASIL 9, lot # L016429, dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with BOOSTRIX and MENACTRA administered on 03-FEB-2016, intramuscular for prophylaxis. On 03-FEB-2016, after receiving 3 vaccines patient immediately felt faint. She was immediately laid on her back on the table. There was a slight loss of consciousness, but upon MD coming in the room seconds later the patient had eyes open and confused as to what had happened. Patient was laid down on the table until she was able to tolerate sitting up. Once able to do this the patient tolerated water and pretzels and was feeling better but still slightly nauseous. She was ambulated to the car with mother and sister. The outcome of the events were reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-624985). This spontaneous report refers to a 10 year old male patient. The patient had the history of fainting with blood draws/need sticks. The patient had no current illnesses and other medications. On 02-MAR-2016 the patient was vaccinated with GARDASIL 9 lot # L019297 dose 1 (unspecified dosage), intramuscular in the right arm for prophylaxis. Approximately 2 minutes after vaccination, the patient had syncopal episode lasting approximately for 15-20 seconds. The patient had loss of consciousness. The patient was sitting in a chair, no injury occurred. The patient regained consciousness immediately after ammonia inhalants were given. The patient's vital signs were stable. No ongoing effects were noted. The outcome of loss of consciousness and syncope was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: 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 # 625061) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old male patient. The patient's concomitant therapies and medical history were not reported. The patient's current illness and other medications was reported as none. On 08-FEB-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L045711 (dose, frequency and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which was given on the same day included first dose of TRUMENBA (via intramuscular route, in the left arm, lot# M13065; dose and expiration date unknown). On 09-FEB-2016, the patient's father called and stated that patient experienced redness and tenderness about the size of a softball in the left deltoid/upper arm, around the area where the patient got vaccinated 2 days before. The patient was not able to raise his arm normally. The patient had no fever and no other treatments were ordered. Medical consultation was recommended to the patient's father and to call back if condition worsens, to which the patient's father agreed. The patient visited the emergency room. The outcome of injection site erythema, peripheral swelling, mobility decreased and injection site warmth 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, MNQ, TDAP
Symptoms: Injection site discomfort, 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 # 625521) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. The patient's medical history included rhinitis allergic and eczema. The patient's health condition was reported to be well. The patient's concomitant therapies were not reported and other medications included metafolbic. On 01-MAR-2016, the patient was vaccinated with second dose of GARDASIL 9 (dose, frequency and lot were not reported) via unknown route in the right arm for prophylaxis. Other suspect therapies which were vaccinated on the same day, included second dose of ADACEL (via unknown route, in the right arm, lot, dose and expiration date unknown) and second dose of MENACTRA (via unknown route,in the left arm, lot# U5180AA; dose and expiration date unknown) for prophylaxis. On 02-MAR-2016, the patient was presented with swelling on both arms around the deltoid. The swelling was hot to touch and bit uncomfortable but the patient said he did not feel any pain. The patient was well and alert in the office. The patient visited the emergency room. The outcome of injection site discomfort, injection site warmth and injection site swelling 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
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 # 626269) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 13 year old female patient. The patient's medical history included drug allergies to penicillin (PCN), sulfa (sulfonamide) and codeine. The patient's concurrent illnesses were reported as none. The patient's other medication and prior vaccinations were not reported. On 24-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L019297, lot expiration date: 18-AUG-2017 (frequency not reported) and HAVRIX (dose number:1, intramuscularly in the left arm, lot# 49LH2, manufacturer: GlaxoSmithKline, frequency and lot expiration date were not reported) for prophylaxis. On 24-FEB-2016 1 hour post vaccination, the patient developed hives. On 29-FEB-2016, the patient still had hives with no other symptoms. The patient referred to an allergist. The event required emergency room (ER) visit. The outcome for the event urticaria 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
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
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 # 626495) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 26 year old female patient. The patient's medical history included asthma (mild). The patient had no concurrent illness. The patient's other medication was reported as none. Information on the patient's prior vaccinations was not reported. On 04-FEB-2016, the patient was vaccinated with GARDASIL 9 (route, site, lot #, dose number, frequency and lot expiration date were not reported) for prophylaxis. On 05-FEB-2016, the patient experienced moderate to severe shoulder/arm pain and had limited range of motion due to pain. The outcome for the events joint range of motion decreased, pain in extremity and musculoskeletal pain 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
Symptoms: Dizziness, 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 # 626694). This spontaneous report refers to a 26 year old male patient. The patient's medical history included anxiety, post-traumatic stress disorder and no known drug allergies (NKDA). The patient had no concurrent illnesses. Information on the patient's prior vaccinations was not reported. The patient's other medications include escitalopram (10 mg, daily), allegra (180 mg, daily), flonase (50 mcg, PRN). On 10-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L016429 (expiry date: 09-AUG-2017) dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient stated that about 20 minutes after leaving clinic, he noted dizziness and lightheadedness. Nausea and vomiting started about 25 minutes later and the patient also reported minor headache. The patient denied having any side effects to vaccines in past. The patient denied redness/swelling in arm. The patient denied any shortness of breath (SOB). The patient denied any vision changes or ringing in ears. The patient was given Zofran ODT 4 mg when returned to clinic with side effects. The outcome of dizziness, vomiting, nausea and headache was reported as recovered. The causality assessment for the events dizziness, vomiting, nausea and headache with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered
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 # 627378) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to an 18 year old female patient. The patient's medical history, concurrent illnesses and other medications were not reported. Information on the patient's prior vaccinations was not reported. On 10-MAR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, batch/lot# K010215 (dose number: 4, frequency and lot expiration date unknown) for prophylaxis. The patient received an extra dose of GARDASIL 9. Additional information is not expected from the Agency as follow up information cannot be obtained.