chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Pain
Clinical narrative: Daughter had the GARDASIL vaccination on Monday. That night she felt nauseous, dizzy and thought she was going to throw up. She went to school on Tuesday and felt terrible. The symptoms really kicked in on Wednesday and she stayed home from school. She didn't eat anything and just was in so much pain. Thursday she tried to go to school and made it a half day before coming home. Called the GI doc, she recommended ZANTAC. We tried that, no relief. Burning stomach pain, nausea, dizziness still happened. She is trying to go to school today but she really feels awful. This was her final dose. She had a milder form of this with her first two, but nothing like this.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Syringe issue
Clinical narrative: Following pneumococcal conjugate vaccine PREVNAR 13 injection attending nurse went to place the safety device on the needle. The lure lock snapped breaking in half; empty syringe one end and separated needle the other end. No injury and reported Nurse Manager and retained in Biohazard Bag.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642389) 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 other medications and prior vaccinations were not reported. Information on the patient's other medication and medical history was reported as none. Patient's concurrent illnesses included fasting (also reported as none). On 07-JUL-2016, the patient was vaccinated with GARDASIL 9 lot/batch# L0026602, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On 07-JUL-2016, patient fainted 5 minutes after the vaccination, immediately assessed by family nurse practitioner (FNP), vital sign was stable and oxygen was given to her. Patient was monitored in lying and sitting position for 15 minutes each. Patient was in stable condition at last. The outcome of immediate post-injection reaction and syncope 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.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642391) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. Information on the patient's prior vaccinations were not reported. The patient's medical history included celiac disease and anxiety. Patient's other medication included LEXAPRO, SEASONALE OCP (Oral contraceptive pill). Information on patient's lab data was reported as none. On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L048459, dose 2, via unknown route, in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with TRUMENBA lot/batch # M68769, dose 1, via unknown route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 05-JUL-2016, after two hours of the vaccination patient developed erythema, pain and swelling at Injection site. Patient also had soreness in proximal cervical spine and generalized myalgia and fever. Patient was prescribed with cephalexin 500mg, three times a day for 5 days and Prednisone 20mg for 5 days. The outcome of injection site erythema, fever, neck pain, myalgia, injection site swelling and injection site pain was reported as recovered/resolved. 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.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Spinal 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 # 642391) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 18 year old female patient. Information on the patient's prior vaccinations were not reported. The patient's medical history included celiac disease and anxiety. Patient's other medication included LEXAPRO, SEASONALE OCP (Oral contraceptive pill). Information on patient's lab data was reported as none. On 05-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L048459, dose 2, via unknown route, in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with TRUMENBA lot/batch # M68769, dose 1, via unknown route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 05-JUL-2016, after two hours of the vaccination patient developed erythema, pain and swelling at Injection site. Patient also had soreness in proximal cervical spine and generalized myalgia and fever. Patient was prescribed with cephalexin 500mg, three times a day for 5 days and Prednisone 20mg for 5 days. The outcome of injection site erythema, fever, neck pain, myalgia, injection site swelling and injection site pain was reported as recovered/resolved. 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: F
Vaccine: HEPA, HPV9
Symptoms: Dyskinesia, Fall, Injury, 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 # 643519) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included amoxicillin. The patient had no current illnesses. The patient's other medications, concomitant therapies and prior vaccinations were not reported. On 12-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M003659 (dose, frequency, lot expiration date, route and site of administration were unknown) for prophylaxis. Other suspect therapy which was given on the same day included first dose of HAVRIX (lot# 4P9M9; dose, route of administration, site of administration and expiration date were unknown) for prophylaxis. On 12-JUL-2016, while sitting on a medical bed the patient passed out and fell off causing injuries. The patient's head was jerking while she was unconscious. The nurse walked away, turning her back away from her and not monitoring her after vaccination. The patient had visited emergency room. The outcome of dyskinesia, loss of consciousness, injury and fall is unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Local reaction, 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 # 643542). This spontaneous report refers to a 11 year old male patient. The patient had no concurrent conditions or historical conditions. Information on the patient's prior vaccinations and other medications were not reported. On 19-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659 (expiry date: 20-SEP-2017), dose 1, intramuscular route in the left arm and MENACTRA batch/lot# U5529AA, dose 1, intramuscular route in the right arm for prophylaxis. On 20-JUN-2016,  the patient experienced localized reaction, with increased swelling and redness(erythema). The patient was prescribed diphenhydramine and hydro cortisone 2.5% cream. The outcome of erythema, swelling and local reaction was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Pyrexia, Trismus
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 # 643545). This spontaneous report refers to a 17 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 12-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M007764 (expiry date: 30-JAN-2018), unknown route in the left arm and MENACTRA batch/lot# U5392AA, unknown route in the left arm for prophylaxis (dose # and dosage unspecified). On 13-JUL-2016, 16 hours after vaccinations, the patient developed fever  and inability to open mouth "lock Jaw", which lasted 45-60 mins. Hot compress was used and the jaw released after 15 min. The same happened again at 2 am, the patient went back to sleep and woke up again 3 am with locked jaw (3am - 4am). The patient's jaw would lock up about 2-3 times every hour. The patient woke up at 7 am and was better and had no fever. The outcome of pyrexia and trismus 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: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Rash, 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 # 643727) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and lab data were reported as none. Information on patient's prior vaccination was not reported. On 15-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 2, intramuscularly in the right arm for prophylaxis (dosage unspecified). On 17-JUL-2016, about 48 hours after receiving the second HPV vaccination, patient broke out with urticarial rash on legs and arms. The outcome of urticaria was unknown. The causality assessment for the event urticaria with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Lip swelling, Rash pruritic, 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 # 643789) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old female. The patient's medical history included allergic peanuts and eczema. Patient's current illness included body rash and itching. Information on the patient's other medications and prior vaccinations were not reported. On 18-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L013429, dose 1, via unknown route, in the left arm for prophylaxis (dosage unspecified). On 18-JUL-2016, the patient had whelps, itchy rash, swollen lips. On 19-JUL-2016, patient took Decadron, 8mg, via intramuscular route. The outcome of lip swelling, urticaria and rash pruritic 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: F
Vaccine: HPV9, MNQ
Symptoms: Ear pain, 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 # 644070). This spontaneous report refers to a 17 year old female patient. The patient had no concurrent illnesses, historical conditions or other medications at the time of report. Information on the patient's prior vaccinations was not reported. On 08-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L037554, dose 4, intramuscular route in the right arm and MENVEO batch/lot# A15097, dose 2, intramuscular route in the left arm for prophylaxis. On the same day, the patient had pain behind both the ears and rash on both ears, which lasted for 12 days. The outcome of ear pain and rash 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: Blister, Erythema, Oedema peripheral
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 # 644071). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses, medical history, other medications and prior vaccinations were not reported. On 18-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (expiry date: 19-OCT-2017), dose 1, intramuscular in the right arm, BOOSTRIX batch/lot# 7B222, dose 1, intramuscular route in the left arm and MENVEO batch/lot# M15097, dose 1, intramuscular route in the left arm for prophylaxis. On 19-JUL-2016, the patient had oedema peripheral and erythema in the left arm and 1.5 cm bulla along the outside edge of the area of oedema peripheral and erythema towards the edge where the band aid was. The outcome of blister, oedema peripheral and erythema was unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, 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 # 644571). This spontaneous report refers to a 12 year old female (also reported as male) patient. The patient had no current illnesses and medical history. Information on patient's other medications was not reported. On 22-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L028083 (expiry date: 03-SEP-2017), dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # US288BA, dose 1, intramuscularly in the left arm and MENACTRA lot # US390AA, dose 1, intramuscularly in the right arm. On 22-JUL-2016, patient slumped over in her chair shortly following administration of the HPV vaccine. She was alert and oriented but did not know where she was. Patient was transferred from the immunization room to the treatment room and was placed in supine position with her lower extremities slightly elevated and a blanket was placed over her. Vitals were taken shortly after the event at 12:30: blood Pressure (BP): 102/64 (units not reported), heart rate (HR): 84 (units not reported) and oxygen saturation (Sp O2): 98 (units not reported) and was reassessed 10 minutes after at 12:40: blood Pressure (BP): 112/68 (units not reported), heart rate (HR): 72 (units not reported) and oxygen saturation (Sp O2): 97 (units not reported). Results were forwarded to the nurse practitioner (NP) on site whom the patient met shortly and was released by NP. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter.       Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Blood iron, Borrelia test, Dizziness postural, Laboratory test, 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 # 644591). This spontaneous report refers to a 15 year old female patient. The patient had no current illnesses and medical history. Patient's other medications included zoloft and abilify. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9 dose 2, (route and lot # not reported) for prophylaxis. On 19-JUN-2016, the patient experienced extreme leg pain, heart palpitations and was dizzy when standing. Doctor tested the patient for lyme disease, other tick borne diseases, thyroid problems, iron levels and some other tests. The outcome of the events was unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Palpitations, Thyroid function test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644591). This spontaneous report refers to a 15 year old female patient. The patient had no current illnesses and medical history. Patient's other medications included zoloft and abilify. On 14-JUN-2016, the patient was vaccinated with GARDASIL 9 dose 2, (route and lot # not reported) for prophylaxis. On 19-JUN-2016, the patient experienced extreme leg pain, heart palpitations and was dizzy when standing. Doctor tested the patient for lyme disease, other tick borne diseases, thyroid problems, iron levels and some other tests. The outcome of the events was unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Dizziness postural, Nausea, Pain, 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 # 644611). This spontaneous report refers to a 26 year old female patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations was not reported. The patient's other medications included norethindrone acet-ethinyl est (MICROGESTIN) 1-20 MG-MCG oral tablet. On 22-JUL-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route, lot #, site of administration unspecified). On 22-JUL-2016, the patient had tingling in extremities, slight nausea and dizziness upon standing. The symptoms progressed to mid-grade fever, aches and joint pain  and vomiting. The outcome of arthralgia, vomiting, pyrexia, paraesthesia, pain, nausea and dizziness postural was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: 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 # 644611). This spontaneous report refers to a 26 year old female patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations was not reported. The patient's other medications included norethindrone acet-ethinyl est (MICROGESTIN) 1-20 MG-MCG oral tablet. On 22-JUL-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose, route, lot #, site of administration unspecified). On 22-JUL-2016, the patient had tingling in extremities, slight nausea and dizziness upon standing. The symptoms progressed to mid-grade fever, aches and joint pain  and vomiting. The outcome of arthralgia, vomiting, pyrexia, paraesthesia, pain, nausea and dizziness postural 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, MNQ, VARCEL
Symptoms: No adverse event, Wrong drug 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 # 644613). This spontaneous report refers to a 11 year old female patient. The patient had no medical history. Information on the patient's concurrent illnesses, prior vaccinations and other medications were not reported. On 21-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L007560 (expiry date: 15-JUN-2017), dose 1, intramuscular route in the right arm, VARIVAX lot # L043620, dose 2, subcutaneous route in the left arm, MENACTRA batch/lot# U5560AA, dose 1, intramuscular route in the right arm and DAPTACEL batch/lot# C478AA, dose 6, intramuscular route in the left arm for prophylaxis. Wrong drug was administered to the patient. The nurse inadvertently drew up and administered DAPTACEL instead of Tdap. No adverse events or problems noted with patient. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Headache, Syncope, 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 # 645374) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient's medical history, concurrent illnesses and other medications were reported as none. Information on the patient's prior vaccinations was not reported. On 28-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (route: needle and syringe (not specified), site: right arm, lot# and lot expiration date were not reported) for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (route: needle and syringe (not specified), site: left arm, manufacturer: Sanofi Pasteur; dose number, lot# and lot expiration date were not reported) and MENACTRA (route: needle and syringe (not specified), site: right arm, manufacturer: Sanofi Pasteur, dose number: 1 ; lot # and lot expiration date were not reported) for prophylaxis. On 28-JUL-2016, the patient was told that she might feel woozy and was asked to sit for a minute after vaccinations. The nurse administered the vaccines and left the room. The patient sat for about 5 minutes and decided she was able to walk. So, she walked down the hall. As the bill was being payed, the patient collapsed. A few nurses went to the patient and one sent for a doctor. The patient was faced down. When the patient's head was lifted, her eyes were open but unresponsive. She laid there for about another 2 minutes before the nurses helped her walk to the trauma room where they placed her on a bed and kept a wet paper towel on her forehead. They also gave her a little bottle of water and some ibuprofen. The patient sat there for about 20 minutes and then the doctor came to check. The doctor examined the patient's rib and asked if she had headaches. The doctor then told the patient that fainting was not uncommon after vaccines were given and the patient was asked to contact the doctor if the patient felt dizzy the next day or anything happened  The doctor also instructed the patient to take plenty of fluids. The patient left and felt dizzy off and on with headaches off and on for the remainder of the day. The outcome for the events unresponsive to stimuli, syncope, headache, dizziness and face injury were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 645421) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient's medical history, concurrent illnesses, other medications and prior vaccinations were not reported. On 28-JUL-2016, the patient was vaccinated with GARDASIL 9 (unknown route) in the left arm, lot # L037554 (dose number 2: lot expiration was not reported) for prophylaxis. On 28-JUL-2016, 5 minutes post vaccination, the patient experienced dizziness. The nurse applied cold compression to the patient's forehead and asked the patient to sit with his head between knees. After 5 minutes, the patient sat up and drank 6 ounces of orange juice and 4 ounces of water. The patient then experienced headaches with continued dizziness. The nurse placed a mat on the floor where the patient laid down. After 10 minutes, the patient recovered completely. The outcome for the events headache and dizziness 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: HEPA, HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, 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 # 645509). This spontaneous report refers to a 19 year old female patient. The patient's medical history included seasonal allergies. The patient's concurrent illnesses was reported as "physical". Information on the patient's prior vaccinations and other medications were not reported. On 20-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L043213 dose 2, unknown route in the left arm and MENVEO batch/lot# M15068, dose 2, unknown route in the right arm and HAVRIX batch/lot# 9927T, dose 1, unknown route in the left arm for prophylaxis. On 21-JUL-2016, the patient had 5.5 X 2.5 inch area of injection site induration, injection site erythema and injection site warmth in right deltoid. The outcome of injection site erythema, injection site warmth and injection site induration was unknown. 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: Dizziness, Loss of consciousness, Pallor, 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 # 646494) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concurrent illnesses and prior vaccinations were not reported. The patient's medical history included attention deficit/hyperactivity disorder (ADHD). The patient's other medications included Adderall 20mg, capsule. On 04-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the right arm, lot # M007764, expiration date: 30-JAN-2018 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included HAVRIX, BOOSTRIX and MENACTRA. On 04-AUG-2016, few seconds after receiving vaccination the patient felt lightheaded, fainted and face turned white. Lips turned white and patient was made to have crackers and juice. The outcome of dizziness, syncope, pallor and 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, MNQ, TDAP
Symptoms: Seizure like phenomena
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 646618) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's medical history included asthma, underweight and rhinitis allergic. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 02-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the left arm, lot # M011117, expiration date: 07-DEC-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA. On 02-AUG-2016, the patient had seizure like activity and it was unclear if that was psychogenic event triggered by stress/fear of vaccine versus syncopal episode w/tonic clonic movements. The outcome of seizure like phenomena was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Injection site pain, 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 # 646795) on 02-MAY-2017. This spontaneous report refers to a 18 year old female patient. The patient's medical history was reported as none. The patient's had no concurrent illnesses. The patient's other medications and prior vaccinations were not reported. On 25-JUL-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L037554 (dose number: 3; lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with BEXSERO (dose number: 1, intramuscularly in the right arm, lot # 153701, manufacturer: Novartis; lot expiration date was not reported) and HAVRIX (dose number: 2, intramuscularly in the left arm, lot # TS343, manufacturer: GlaxoSmithKline; lot expiration date was not reported) for prophylaxis. On 08-AUG-2016, the patient called the health department and complained of pain at injection site (right arm) and generalized body aches. The patient neither experienced fever nor swelling or redness at the injection site. The patient reported of pain primarily at injection site (right arm) since vaccination. The patient reports no range of motion (ROM) limitations. VFC (Vaccine for Children) on-call nurse was called who then advised the patient that pain at injection site could be common which may take time to resolve and generalized body aches may or may not be related to vaccination. The nurse advised the patient to contact the office back if there were any other questions or concerns or if she would develop other symptoms. Patient voiced understanding. The outcome for the events pain, pyrexia, injection site swelling, injection site pain and injection site erythema was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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-647203). This spontaneous report refers to a 12 year old male patient. The patient had no current illnesses, historical conditions and other medications. On 08-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M011840 dose 1, via unspecified route in the left arm for prophylaxis.  On the same day, the patient was vaccinated with ADACEL dose 1 (unspecified dosage), via unspecified route in the right arm and MENACTRA dose 1 (unspecified dosage), via unspecified route in the left arm for prophylaxis. Several minutes after the vaccination, the patient fainted for a few seconds while she was walking. The outcome of 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.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, 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-647210). This spontaneous report refers to a 11 year old female patient. Information on patient's current conditions, historical conditions and other medications was not reported. On 03-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L016429 dose 1 (unspecified dosage), via unknown route in the right arm for prophylaxis. On the same day the patient was vaccinated with ADACEL dose 1 (unspecified dosage), via unknown route in the left arm for prophylaxis. After vaccinations, the patient felt lightheaded, had syncope and passed out. The outcome of dizziness, syncope 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: HEPA, HPV9, MEN, TDAP
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness, 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 # 648454) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses and medical history. Information about the patient's other medications and prior vaccinations were not reported. On 18-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M016193 (Expiration date: 24-APR-2018) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U5406AA dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis, VAQTA lot # M015290 dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis and MENOMUNE-A/C/Y/W-135 lot # U5513AB dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient lost consciousness for about 10 seconds, immediately after the injection and slid down into the chair. The patient's extremities became stiff within 10 seconds, he became alert and was asking what had happened. The patient had also become pale and diaphoretic. The patient had eased into the floor in lying position to recover and the patient's mother was also present. He drank some water and was eager to leave. The patient walked out of the clinic at 2.40 pm. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MEN, TDAP
Symptoms: 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 # 648454) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses and medical history. Information about the patient's other medications and prior vaccinations were not reported. On 18-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M016193 (Expiration date: 24-APR-2018) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U5406AA dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis, VAQTA lot # M015290 dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis and MENOMUNE-A/C/Y/W-135 lot # U5513AB dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient lost consciousness for about 10 seconds, immediately after the injection and slid down into the chair. The patient's extremities became stiff within 10 seconds, he became alert and was asking what had happened. The patient had also become pale and diaphoretic. The patient had eased into the floor in lying position to recover and the patient's mother was also present. He drank some water and was eager to leave. The patient walked out of the clinic at 2.40 pm. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Diarrhoea, Dizziness, 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 # 648488). This spontaneous report refers to a 12 year old female patient. The patient's concurrent illnesses and medical history were reported as none. The patient's other medications were not reported. On 17-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 (expiry date:07-DEC-2017), dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient felt dizzy, nauseated status post vaccination. Patient was placed in supine position and given water, symptoms subsided. Patient left clinic with mother in ambulatory condition. Mother called the next day stating patient still felt nauseated/dizzy/headache & was experiencing some diarrhea. The outcome of diarrhoea, nausea, headache and dizziness 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: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Face injury, Fall, Lip injury, Neurological examination normal, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648563) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no concurrent illnesses, other medications and had no known allergies. On 18-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L045711 dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENOMUNE-A/C/Y/W-135 lot # U5416AA dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient fainted after the injection was administered and fell down, hitting the face against the floor, causing a face injury and cutting of the lip. The patient had not eaten since 11:00 am. The neurological examination of the patient was reported to be normal. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, 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 # 648565) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included syncope after a dental procedure. The patient's current illnesses and other medications were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 18-AUG-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # M011840, lot expiration date 01-FEB-2018 (dose and frequency were not reported) via intramuscular route, in the right arm for prophylaxis. Other suspect therapies which were given on the same day included BOOSTRIX (dose number: 1, intramuscularly in the left arm, lot# 324Z7; dose and expiration date were unknown) and MENVEO (dose number: 1, intramuscularly in the right arm, lot# M15124; dose and expiration date were unknown) for prophylaxis. On the same day, about 10 minutes after vaccination, patient felt light headed and was presyncopal. Patient was placed on a bed and was given some water and graham crackers. The patient felt better after about an hour and was discharged home. The outcome of dizziness and presyncope were reported as recovered. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Hypotonic-hyporesponsive episode, 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 # 648567) on 02-MAY-2017. This spontaneous report refers to a 17 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. The patient's other medications included Insulin. On 25-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 batch/lot # M01117 (dose, frequency and lot expiration dates were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5259AA, intramuscularly in the right arm, ADACEL batch/lot # U5298AA, intramuscularly in the left arm and TRUMENBA (manufacturer- Pfizer/Wyeth) batch/lot # M74089, intramuscularly in the left arm for prophylaxis. On 25-JUL-2016, after receiving last vaccine, the patient experienced a hypotonic-hyporesponsive reaction. After which she vomited several times. The patient was given juice and was monitored for 15 minutes before being walked to the car by nurse. The outcome of hypotonic-hyporesponsive episode and vomiting was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Allergy to vaccine, Chest X-ray normal, Chest pain, Dyspnoea, Electrocardiogram 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 # 648591) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient's medical history included seizure disorder (released by neurology February 2014) and heart murmur (released by cardiology 2011). The patient's other medication included QUAR for allergy season and Ventolin inhaler (PRN). The patient's concurrent illnesses was reported as none. Information on the patient's prior vaccinations was not reported. On 11-AUG-2016 at 14:30, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose number: 3, batch/lot # M011840; route: unknown; site: left arm; lot expiration date was not reported). On 12-AUG-2016 at 05:00, the patient developed fever (101.3 - 101.6). On the same day at 07:00, the patient developed chest pain and shortness of breath. The patient required emergency room (ER) visit. Chest x-ray, electrocardiogram (EKG) and urine analysis were performed with normal results. The patient was told that she was allergic to immunization. The outcome of the events 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: Pyrexia, Urine analysis 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 # 648591) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient's medical history included seizure disorder (released by neurology February 2014) and heart murmur (released by cardiology 2011). The patient's other medication included QUAR for allergy season and Ventolin inhaler (PRN). The patient's concurrent illnesses was reported as none. Information on the patient's prior vaccinations was not reported. On 11-AUG-2016 at 14:30, the patient was vaccinated with GARDASIL 9 for prophylaxis (dose number: 3, batch/lot # M011840; route: unknown; site: left arm; lot expiration date was not reported). On 12-AUG-2016 at 05:00, the patient developed fever (101.3 - 101.6). On the same day at 07:00, the patient developed chest pain and shortness of breath. The patient required emergency room (ER) visit. Chest x-ray, electrocardiogram (EKG) and urine analysis were performed with normal results. The patient was told that she was allergic to immunization. The outcome of the events 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: Headache, Nausea, 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 # 648787) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. The patient's medical history included twin birth and chronic disease of tonsils and adenoids. The patient's concurrent illness and other medications were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 18-AUG-2016 the patient was vaccinated with third dose of GARDASIL 9 lot # M020103 (dose, frequency, route of administration and lot expiration date were not reported) in the left arm for prophylaxis. On 19-AUG-2016, the patient experienced fever, severe headache, aches and nausea for 2 days. The patient had symptomatic treatment at home. The mother of the patient requested VAERS report to be filled as these did not occur after previous two vaccines. The outcome of headache, pyrexia, pain and nausea were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Feeling abnormal, Injection site reaction, Mass, 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 # 648795) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included attention deficit/hyperactivity disorder and epilepsy. The patient's concurrent illness was reported as none. The patient's other medication included Quillivant XR suspension. The patient's concomitant therapies and prior vaccinations were not reported. On 16-AUG-2016 the patient was vaccinated with second dose GARDASIL 9 lot # M003659, lot expiration date 20-SEP-2017 (dose and frequency were not reported) via intramuscular route, in the right arm for prophylaxis. On 17-AUG-2016, the patient had a weird felling in the whole right arm and then localized in the right upper arm. A lump developed on 18-AUG-2016 and the patient had continued pain and stinging. The patient also had mild erythema. The outcome of erythema, pain, limb mass, injection site reaction and feeling abnormal 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: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Peripheral swelling, Pruritus, Tenderness
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 # 649491) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications, lab data and prior vaccinations were not reported. On 02-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M005714, dose 3, intramuscularly in the left arm for prophylaxis (dosage unspecified). On 03-AUG-2016, the patient had redness, swelling and itching on the right deltoid after vaccination. It was tender to touch. No discharge or blood was noted. Patient took Clindamycin. The outcome of erythema, tenderness, pruritus and peripheral swelling 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.