chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, 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 # 647850) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder (ADHD) and tourette syndrome. The patient's other medications included Guanfacine and Focalin XR. The patient's concurrent illnesses was reported as none. Information on the patient's prior vaccinations was not reported. On 02-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right deltoid, lot # M007764 (lot expiration date: 30-JAN-2018) for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (dose number:1, intramuscularly in the left deltoid, lot # U1567AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) and MENACTRA (dose number:1, intramuscularly in the left deltoid, lot # U5416AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On 07-AUG-2016, the patient noticed red circles with induration (area: 2.5 x 2 inch diameter) on the left deltoid. The patient developed swelling on the left deltoid which was mildly itchy. On 08-AUG-2016, the patient visited the office and the area was treated with cool compresses and hydrocortisone cream. The outcome for the events injection site erythema, injection site swelling, injection site pruritus and injection site induration were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 647863) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 19 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-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L043214, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with BOOSTRIX lot/batch # 7RJ9B, dose 1, intramuscularly in the left arm and MENACTRA lot/batch # U5416AA, dose 1, intramuscularly in the right arm. On the same day, within 5 minutes of vaccination patient felt dizzy and briefly lost consciousness. Patient's sister helped her on the floor. Within a few minutes she was sitting in a chair and was feeling better. 911 was called and emergency responders were there within 15 minutes. They put her through an assessment and she was checked out. Patient refused for further treatment and was cleared to go on her way. The outcome of dizziness and loss of consciousness 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: M
Vaccine: HEPA, HPV9
Symptoms: Death, Headache, Intracranial aneurysm, Loss of consciousness, 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 # 648057) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient's concurrent illnesses and medical history was reported as none. Other medications included doxycycline. On 26-JUL-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M004116, (route: unknown) in the left arm and VAQTA lot # M002268, dose 1, (route: unknown) in the left arm for prophylaxis. On 30-JUL-2016, the patient awoke with severe headache and vomiting, went unconscious (loss of consciousness) and found to have a cerebellar aneurysm (intracranial aneurysm). The patient died on 31-JUL-2016. It was unknown if an autopsy was performed. The events headache, vomiting, loss of consciousness and intracranial aneurysm led to death (outcome of these events were reported as not recovered). Causality assessment was not provided. The case was serious as these events led to death. An investigation into the manufacture of lot# M004116 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Additional information is not expected as the initial information was from the agency and we could not do follow up with the agency.; Reported Cause(s) of Death: headache; Intracranial aneurysm; Loss of consciousness; Vomiting.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Haemoglobin normal, Immediate post-injection reaction, 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 # 648088) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's medical history was reported as none. The patient had no concurrent illnesses. The patient's prior vaccinations, other medications and concomitant therapies were not reported. On 17-AUG-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # M021407, lot expiration date 30-APR-2018 (dose and frequency were not reported) via intramuscular route in the left arm for prophylaxis. Other suspect therapy which were given on the same day, included first dose of MENVEO (intramuscularly in the left arm, lot# M15147; dose and expiration date unknown) for prophylaxis. On the same day, immediately after receiving the vaccines the patient had syncopal episode and fell on the floor. The patient's hemoglobin level was 10.8 (units not provided), blood pressure prior to the event was 108/66 (units not provided) and after event was 121/75 (units not provided) and heart rate prior to the event was 78 (units not provided) and after the event 93 (units not provided). The outcome of fall, syncope, immediate post-injection reaction and haemoglobin normal 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: 4.0
Sex: M
Vaccine: DTAP, HPV9, IPV, MMR
Symptoms: Drug administered to patient of inappropriate age, No adverse event
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 # 648105) on 02-MAY-2017. This spontaneous report refers to a 4 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 10-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L043214 (dose, frequency and lot expiration dates were not reported) intramuscularly, in the left leg for prophylaxis. Other suspect therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live) (manufacturer unknown), dose 2, subcutaneously in the right leg, INFANRIX, dose 6, intramuscularly in the left leg and poliovirus POLIOVIRUS VACCINE INACTIVATED (UNSPECIFIED) (manufacturer unknown), dose 4, intramuscularly in the left leg for prophylaxis. On an unknown date it was reported that GARDASIL 9 was inadvertently given to the patient and no adverse effects were noted. The patient's mom was advised to watch the patient. The outcome of drug administered to patient of inappropriate age and no adverse event was reported as recovered. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Immediate post-injection reaction, Malaise, 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 # 648107) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient had no medical history and concurrent illnesses. The patient's other medications and prior vaccinations were not reported. On 16-AUG-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right deltoid, lot # M009378 (dose number: 3, lot expiration date was not reported) and MENACTRA (dose number: 2, intramuscularly in the left deltoid, lot # U5392AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On the same day immediately post vaccination, the patient did not feel well and had a syncopal episode. The episode lasted for 10-15 seconds. The patient then became alert and oriented and returned to baseline. The patient's lab data was reported as none. 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: HEPA, HPV9
Symptoms: Dyskinesia, Generalised tonic-clonic seizure, Laboratory test 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 # 648206) on 02-MAY-2017. This spontaneous report refers to a 12 year old female patient. The patient's medical history included asthma and she had no concurrent illnesses. Information about the patient's prior vaccinations and other medications were not reported. The patient's normal routine labs were received on 10-AUG-2016. On 13-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 (Expiration date: 07-DEC-2017) dose 1 (unspecified dosage) via an unknown route in the right arm for prophylaxis. On the same day, the patient was also vaccinated with HAVRIX lot # J3GT5, dose 1 (unspecified dosage) via an unknown route in the left arm for prophylaxis. On the same day, 10 minutes after the administration of the vaccines, the patient had tonic-clonic seizure for about 10 seconds, then continued to experience jerk movements for 30 minutes. The patient required an emergency room visit and also underwent laboratory test, for which the results were 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: M
Vaccine: HPV9
Symptoms: Culture, Influenza like illness, Mononucleosis heterophile test negative, Muscular weakness, 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 # 648289) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included heart murmur, asthma, allergies, migraine, gastrointestinal issues and lactose intolerance. The patient's concurrent illnesses were reported as none. The patient's prior vaccinations, concomitant therapies and other medications were not reported. On 15-AUG-2016 the patient was vaccinated with fourth dose of GARDASIL 9 lot # M005714, lot expiration date 03-OCT-2017 (dose and frequency were not reported) via intramuscular route, in the left arm for prophylaxis. On 16-AUG-2016, the patient felt flu like symptoms, weakness in legs, nausea and shaky. The rapid strep test and mono spot test were negative. The nasal culture was pending. The outcome of the events were unknown. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Streptococcus test negative, 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 # 648289) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's medical history included heart murmur, asthma, allergies, migraine, gastrointestinal issues and lactose intolerance. The patient's concurrent illnesses were reported as none. The patient's prior vaccinations, concomitant therapies and other medications were not reported. On 15-AUG-2016 the patient was vaccinated with fourth dose of GARDASIL 9 lot # M005714, lot expiration date 03-OCT-2017 (dose and frequency were not reported) via intramuscular route, in the left arm for prophylaxis. On 16-AUG-2016, the patient felt flu like symptoms, weakness in legs, nausea and shaky. The rapid strep test and mono spot test were negative. The nasal culture was pending. The outcome of the events were unknown. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MENB
Symptoms: Nodule, 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 # 648846) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 03-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # M011840 (dose, frequency and lot expiration date were not reported) and also vaccinated with the first dose of VAQTA intramuscularly in the left arm, lot # M011116, expiration date: 17-JUN-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included TRUMENBA intramuscularly in the right arm, lot # M95612 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 04-AUG-2016, the patient experienced pain with knot in vaccinated arm. The outcome of nodule and pain in extremity was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648850) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 17-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M011840 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO intramuscularly in the right arm, lot # M15097 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 17-AUG-2016, the patient experienced syncope. The outcome of syncope was reported as recovered/resolved. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Rash, Secretion discharge
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 # 649004) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient had no concurrent illnesses. The patient's medical history included bilateral sensorineural hearing loss and had no known drug allergies (NKDA). The patient's other medications included Adderral and Claritin. On 20-JAN-2016 the patient was vaccinated with GARDASIL 9 lot # L011846, expiration date: 16-JUN-2017, dose 1, intramuscularly in the right arm and MENACTRA (manufacturer: Sanofi Pasteur) lot# U5172AA dose 1, intramuscularly in the left arm for prophylaxis. On an unknown date the patient experienced rash on the right arm.  On 18-APR-2016, the patient was again vaccinated with GARDASIL 9. The patient stated there was a rash with drainage to the left arm. The outcome of rash was reported as recovered/resolved. The patient reported to the provider's office on 18-AUG-2016. 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: Rash generalised
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 # 649200) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old male patient. The patient's medical history and concurrent illnesses were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. The patient's other medications included Strattera and Risperidone. On 15-AUG-2016 the patient was started on ampicillin and Retin-A. On 23-AUG-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # M009378 (dose, frequency and lot expiration date were not reported) via intramuscular route in the right arm for prophylaxis. On 24-AUG-2016, the patient experienced rash all over the body. The outcome of rash generalised was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Anxiety, Injection site pain, Loss of consciousness, 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 ID-649211). This spontaneous report refers to a 12 year old male patient. The patient had no current illnesses and medical history. Information on patient's other medications was not provided. On 24-AUG-2016 at 13:00, the patient was vaccinated with GARDASIL 9 lot # L014198 dose 1 (unspecified dose), intramuscularly in the left arm for prophylaxis. 30 seconds later, the patient verbalized that it was painful at the injection site. The patient dropped his head. He had loss of consciousness and posture abnormal. An attempt was made to wake up the patient and got epinephrine injection from the cabinet. The patient woke up with anxiety asking "what happened?". He was given Benadryl 1 table spoon. The patient was monitored for 15 minutes. The patient was alert and was oriented pleasant, ambulating out of the clinic at 13:05. 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: HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, 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 # 649505). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses was reported as unknown and medical history was not reported. On 24-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included MENACTRA (lot # US180AA, dose 1, intramuscularly in the right arm) and ADACEL (lot # US316AA, dose 1, intramuscularly in the left arm). On an unknown date, the patient experienced pain in right arm and musculoskeletal stiffness. The outcome of pain in extremity and musculoskeletal stiffness 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, MNQ
Symptoms: Disorientation, Dizziness, Gait disturbance, Loss of consciousness, Muscular weakness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 649709) 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 lab data, other medications and prior vaccinations were not reported. Patient's medical history included asthma. Information on the patient's concurrent illnesses reported as none. On 24-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M018810, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with included MENACTRA lot/batch # U5390AA, dose 1, intramuscularly in the right left arm for prophylaxis (dosage and expiry date unspecified). On the same day, patient blacked out for a moment. Patient was disoriented, felt dizzy, muscle stiffness and weakness. Patient also had difficulty in walking. The outcome of all the events were reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Musculoskeletal stiffness
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 # 649709) 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 lab data, other medications and prior vaccinations were not reported. Patient's medical history included asthma. Information on the patient's concurrent illnesses reported as none. On 24-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M018810, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with included MENACTRA lot/batch # U5390AA, dose 1, intramuscularly in the right left arm for prophylaxis (dosage and expiry date unspecified). On the same day, patient blacked out for a moment. Patient was disoriented, felt dizzy, muscle stiffness and weakness. Patient also had difficulty in walking. The outcome of all the events were reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Fatigue, Headache, Peripheral swelling, 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 # 649951) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old male patient. The patient had no concurrent illnesses or medical history. The patient's other medications included PROAIR HFA and lactase. On 24-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M016193, expiration date: 24-APR-2018, dose 1, intramuscularly in the right arm, TRUMENBA (manufacturer: Pfizer/Wyeth) lot # M77Z8Z, dose 1, intramuscularly in the left arm and MENACTRA (manufacturer: Sanofi Pasteur) lot # U5416AA, dose 2, intramuscularly in the left arm for prophylaxis. On the evening of 24-AUG-2016, the patient started to experience low grade fever, headache and fatigue. On 25-AUG-2016 the patient's left arm was red, swollen and headache, fatigue continued. On 26-AUG-2016, the left arm redness, headache and fatigue continued. The events required an emergency room visit. The outcome of all the events 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: 4.0
Sex: U
Vaccine: HPV9
Symptoms: 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 # 650106). This spontaneous report refers to a 4 year old patient of unknown gender. The patient's concurrent illnesses and medical history were not reported. On 27-JUN-2016, the patient was vaccinated with GARDASIL 9, lot # M005714 (expiry date: 03-OCT-2017), via unknown route (site: unknown) for prophylaxis. The patient received a wrong vaccine in error. The outcome of the wrong drug administration was reported as unknown. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Muscle twitching, 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 ID-650380). This spontaneous report refers to a 11 year old male patient. The patient had no current illnesses. Information on patient's other medications and historical conditions was unknown. On 08-JUN-2015 the patient was vaccinated with GARDASIL 9 lot # L001312 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. The patient was also vaccinated with BOOSTRIX dose 1 (unspecified dosage) and MENACTRA)dose 1 (unspecified dosage) in the in the right arm, intramuscularly for prophylaxis. Approximately 10 hours after vaccination on the same day, the patient's mother stated that the patient was vomiting and had muscle twitching. The patient was taken to emergency room. The urgent care provider was unsure which vaccine could have caused reaction since all the three vaccines were administered on the same day. The outcome of muscle twitching and vomiting 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: HPV9, TDAP
Symptoms: Erythema, Headache, Pain in extremity, Peripheral swelling, 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 # 650832) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 19 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 31-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M007764 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL intramuscularly in the right arm, lot # US264AA(dose, frequency and lot expiration date were not reported) for prophylaxis. On 31-AUG-2016, the patient experienced fever 101 F (Fahrenheit), headache, arm redness, swelling and pain. The patient required emergency room visit. The outcome of erythema, pyrexia, peripheral swelling, pain in extremity and headache was reported as recovered/resolved.  Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: 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 # 650853) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no concurrent illnesses or medical history. On 08-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M003659 dose 2, intramuscularly in the left arm for prophylaxis. On 09-AUG-2016, the patient experienced injection site pain and injection site swelling which continued over 1.5 weeks then slowly decreased. The outcome of injection site pain and injection site swelling was reported as recovered/resolved. Causality assessment was not reported.       Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: 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 # 650854) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient had no concurrent illnesses. The patient's medical history included nocturnal enuresis. The patient's other medications included desmopressin 0.2 mg every night (qhs). On 08-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M014929 dose 1, intramuscularly in the left arm for prophylaxis. On 28-AUG-2016, the patient experienced swelling which continued to grow at the time of evaluation. There was no pain or erythema. The outcome of swelling was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MENB
Symptoms: Erythema, Injected limb mobility decreased, Injection site erythema, Injection site pain, Rash erythematous
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 # 651178) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient's medical history, concurrent illnesses, other medications and lab data were reported as none. Information on the patient's prior vaccinations was not reported. On 17-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L037554 (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 left arm, lot # 153701, manufacturer: Novartis; lot expiration date was not reported) for prophylaxis. On 18-AUG-2016 at 16:26, the patient's grandmother called and reported that the patient's left upper arm was very sore. The patient could hardly move due to the red rash which had raised to one dollar in size and the patient was not feverish. The area had reddened to the front outer aspect of left forearm well below the injection site. The signs and symptoms had started since the previous day. The patient was advised to seek medical care and required emergency room (ER) visit on 19-AUG-2016 at 16:56. The patient was prescribed Zyrtec (10mg, orally, daily) for 3 days and was asked to follow up with primary physician. The outcome for the events erythema, rash, pain and injected limb mobility decreased was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Headache, Nausea, 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 # 651258) on 02-MAY-2017. This spontaneous report refers to a 17 year old male patient. The patient's medical history included migraine, which had occurred once, in 2014. The patient had no concurrent illnesses and other medications. On 06-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L036301 dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced headache, nausea and fever of 100.8, which started 1 hour after vaccine administration. The patient was taking ibuprofen with relief. The symptoms were still present during evaluation on 08-SEP-2016. The outcome of the events was reported as unknown. The causality assessment for the events was not reported.      Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, 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 # 651261) 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 eggs allergy, rhinitis allergic, asthma, dermatographism and chronic urticaria. Other medications included zachtor, periactin, flonase, singulair, albuterol and qvar. The patient had no concurrent illnesses and prior vaccinations were not reported. On 17-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M007764, expiration date: 30-JAN-2018 (dose and  frequency were not reported) for prophylaxis. Other suspect therapies included MENVEO. On 17-AUG-2016 (also reported as 10-AUG-2016) the patient's right upper arm became redness, warmth, itchiness and pain for about 2 days. Redness progressively spread down to elbow area. The patient required emergency room visit. The outcome of injection site erythema, injection site warmth, injection site pruritus and injection site 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: Drug administered at inappropriate site
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 # 651277) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 09-AUG-2016, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # L045700 (dose, frequency and lot expiration date were not reported) for prophylaxis. On an unknown date the patient was vaccinated in a incorrect site for an intramuscular injection. The site was approximately 4 inches below deltoid. The outcome of drug administered at inappropriate site was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Blood glucose normal, Dizziness, Muscle tightness, Paraesthesia, Tinnitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-651299). This spontaneous report refers to a 15 year old female patient. The patient had no medical history, current illnesses and other medications. On 29-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M009378 dose 1 (unspecified dosage), via unknown route in the left arm for prophylaxis. On the same day, the patient began feeling lightheaded, ears ringing, tingling in arms and jaw tight. The patient's blood glucose was normal. The events lasted for 10 minutes before resolving. On an unknown date, the patient's random blood glucose was 111 (units unspecified) and blood pressure was 110/70 (in supine and sitting positions) with unspecified units. 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: F
Vaccine: FLU4, HPV9
Symptoms: Cellulitis, Erythema, Pain, Skin warm, Ultrasound scan 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 ID-651439). This spontaneous report refers to a 11 year old female patient. The patient had no medical history and current illnesses. Other medications included Prevacid. On 18-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M009378 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with FLUZONE dose 5 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On 19-AUG-2016, the day after 1st dose of GARDASIL 9 was given, the patient's mother noticed a dime sized red spot that steadily increased in size and warmth. The patient also experienced cellulitis, pain and had an ultrasound scan. On day 8, the patient was taken to emergency room and was treated with Augmentin for cellulitis. On day 11, the patient returned with increased pain. Cellulitis was improved. Ultrasound scan of the area showed swelling with no focal collection of fluids. Severe pain lasted for approximately 10 days. The outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Headache, 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 # 651541) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 22 year old female patient.  Information on the patient's pertinent medical history, concurrent illnesses, prior vaccinations and other medications were not reported. On 06-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 via an unknown route in the left arm, lot # M016193, Expiry date: 24-APR-2018 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX via unknown route in the right arm, lot# GS22H, manufacturer: glaxosmithkline (injection site, dose, frequency and lot expiration date were not reported) for prophylaxis. On 07-SEP-2016 at 08:30am, student called and reported that she experienced fever and headache. On 08-SEP-2016, at 02:45pm registered nurse (RN) called student, student reported that she was feeling better with no fever or headache. The outcome of headache and pyrexia was reported as recovered/resolved. The Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Hypersensitivity, Oral mucosal eruption, Pain, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 651591) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses. The patient's medical history included asthma and nut allergy. Information on the patient's prior vaccinations was not reported. The patient's other medications included Flovent 44 and Ventolin. On 26-MAY-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L038917 (dose, frequency and lot expiration dates were not reported), route: unknown in the right arm for prophylaxis. On 01-JUN-2016 (also reported as 4 days after vaccination), the patient experienced painful rash on chin and mouth, swelling around chin, testicular swelling, pain/itching (erythema), and wheezing. Two days later, the patient experienced red, painful rash on lower cheeks and chin and rash on chest. The patient was diagnosed with allergy reaction and was treated with Benadryl. Wheezing was managed with inhalers. The outcome of erythema, wheezing 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
Symptoms: Rash, Rash erythematous, Swelling face, Testicular swelling, Wheezing
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 # 651591) on 02-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient had no concurrent illnesses. The patient's medical history included asthma and nut allergy. Information on the patient's prior vaccinations was not reported. The patient's other medications included Flovent 44 and Ventolin. On 26-MAY-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L038917 (dose, frequency and lot expiration dates were not reported), route: unknown in the right arm for prophylaxis. On 01-JUN-2016 (also reported as 4 days after vaccination), the patient experienced painful rash on chin and mouth, swelling around chin, testicular swelling, pain/itching (erythema), and wheezing. Two days later, the patient experienced red, painful rash on lower cheeks and chin and rash on chest. The patient was diagnosed with allergy reaction and was treated with Benadryl. Wheezing was managed with inhalers. The outcome of erythema, wheezing 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: F
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Eye movement disorder, Musculoskeletal stiffness
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 # 651736) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included depressed mood. The patient's concurrent illnesses, prior vaccinations and concomitant therapies were not reported. The patient's other medications were reported as none. On 01-SEP-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L043214 (dose, frequency, route of administration and lot expiration date were not reported) in the left arm for prophylaxis. Other suspect therapy which were given on the same day included MENACTRA (in the right arm, lot# U5462AA; dose, route of administration and expiration date unknown) for prophylaxis. On 01-SEP-2016, the patient's experienced body stiffness and her eyes rolled back for 5 seconds. The patients then felt dizzy and she was asked to lay down and the vitals were taken. The outcome of the events 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: Dizziness, Loss of consciousness, Nausea, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653076) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included exercise induced asthma. The patient was not taking any medications during the time of vaccination. On 13-SEP-2016 the patient was vaccinated with GARDASIL 9 batch/lot#: M021407, dose 1, intramuscularly in the left arm for prophylaxis. On the same day approximately 1 minute after vaccination, the patient felt nauseous, saw black spots, started swaying and passed out. The outcome of events 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: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Posture abnormal, Tonic clonic movements
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 653757) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient's concurrent illnesses included mild runny nose for greater than 24 hours. The patient's medical history included seasonal allergies. On 13-SEP-2016 the patient was seated on exam table and was vaccinated with GARDASIL 9 lot # L043213 dose 2, intramuscularly in the left deltoid for prophylaxis. Approximately 2 minutes later patient slumped onto table and as he was being placed in supine position and began to have tonic-clonic movements which lasted approximately less than 5 seconds and then stopped. The patient was responsive but tired and was kept in supine position for 15 to 20 minutes after event. The patient felt fine afterwards and was discharged home with vitals stable. The outcome of fatigue and tonic clonic movements 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, MENB, MNQ, TDAP
Symptoms: Injection site erythema
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 # 654540) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses or medical history. On 12-SEP-2016 the patient was vaccinated with GARDASIL 9 batch#: M021407, in the left arm BOOSTRIX (manufacturer: GlaxoSmithKline) lot#: EC9A9 in the right arm, MENACTRA (manufacturer: Sanofi Pasteur) in the left arm  and TRUMENBA (manufacturer: Pfizer/Wyeth) lot#: N16808 in the right arm via needle and syringe (not specified) for prophylaxis. On the same day post vaccination, the patient's mother reported that the patient experienced redness from injection site to elbow on the right arm. There were no other symptoms. On 13-SEP-2016, the next day, injection site erythema had resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: No adverse event
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 # 654913) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 19 year old female patient. The patient had no concurrent conditions and medical history. Information on concomitant medications, lab data and prior vaccinations were not reported. On 17-SEP-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # 019287 (dose number, dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included second dose of MENACTRA (Manufacturer: Sanofi Pasteur) lot # U5410AA (dose, frequency, lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. On the same day, it was reported that the drug administered to patient of inappropriate age. The outcome of drug administered to patient of inappropriate age was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.