chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: 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 (HA #633727) and refers to a 13 year old female patient. Current illnesses were reported as none. No details about medical history, lab data, prior vaccination and other medications were provided. On 28-APR-2016 the patient was vaccinated with GARDASIL 9 lot # L026602, dose 2, via unknown route in the left arm for prophylaxis (strength and dosing detail unknown). On 28-APR-2016, the patient experienced swelling, redness, flushing, abdominal pain, diminished air movement, wheezing. The events were treated with BENADRYL, Prednisone and Albuterol. The outcome of abdominal pain, wheezing, swelling, respiration abnormal, flushing and erythema was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Feeling 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 # 633801) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old female patient. The patient had a history of Asthma, depression and polycystic ovarian syndrome. At the time of the report patient was a little tired otherwise she had no current illnesses. Other medications included Metformin 500mg once a day, fluoxetine 20mg a day, spironolactone 50 mg a day, Lunel Fe 24. Information on lab data and prior vaccinations were not reported. On 27-APR-2015, the patient was vaccinated with GARDASIL 9, dose number 2 (dose, lot number and expiration date unknown) via intramuscular route in the left arm for prophylaxis. On the same day (also reported as 27-APR-2016), patient complained of headache, feeling a little lightheaded immediately after shot. Approximately an hour to an hour and a half after the injection, patient became very dizzy lightheaded,  chilled cold and shivering and felt as though she was having an out of body experience. She at that time also began to have diarrhea and vomiting, vomited three times. Patient felt tired and by evening symptoms slowly improved. And at this time she had no problems. The outcome of the events were 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: Feeling cold, Headache, Immediate post-injection reaction, 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 # 633801) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old female patient. The patient had a history of Asthma, depression and polycystic ovarian syndrome. At the time of the report patient was a little tired otherwise she had no current illnesses. Other medications included Metformin 500mg once a day, fluoxetine 20mg a day, spironolactone 50 mg a day, Lunel Fe 24. Information on lab data and prior vaccinations were not reported. On 27-APR-2015, the patient was vaccinated with GARDASIL 9, dose number 2 (dose, lot number and expiration date unknown) via intramuscular route in the left arm for prophylaxis. On the same day (also reported as 27-APR-2016), patient complained of headache, feeling a little lightheaded immediately after shot. Approximately an hour to an hour and a half after the injection, patient became very dizzy lightheaded,  chilled cold and shivering and felt as though she was having an out of body experience. She at that time also began to have diarrhea and vomiting, vomited three times. Patient felt tired and by evening symptoms slowly improved. And at this time she had no problems. The outcome of the events were reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site hypoaesthesia, Injection site pain, Pain, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #634007) and refers to a 17 year old female patient. The patient's medical history included allergy to Cefzil, Amoxil and Erythromycin; hypothyroidism- on Synthroid. Other medications included Clindamycin, Benzoyl peroxide gel and SYNTHROID QD. On 29-APR-2016, the patient was vaccinated with GARDASIL 9, lot#L010464, dose 4, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). On 29-APR-2016, the patient experienced numbness of arm where vaccine was given and pain of arm and down leg in the site of vaccine administration. On an unspecified date (reported as today), numbness has dissipated, but still has pain, but less which she feels especially on movement and walking. The outcome of injection site hypoaesthesia, pain in extremity and pain was reported as not recovered/not resolved (also reported as numbness has dissipated). Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Feeling abnormal, Gait disturbance, Pain, Wheelchair user
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 # 634015). This spontaneous report refers to a 11 year old female patient. The patient had no current illnesses and other medications. Patient's medical history included allergy to dairy and peanuts, asthma and lactose intolerance. On 03-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L043213, dose 3, intramuscularly in the right arm for prophylaxis. On 03-MAY-2016 at 16:38, the patient had generalized achiness and was not feeling good. Patient laid on the table with cool towel to face and sipped sprite. Blood pressure (BP): 93/55 (units not reported) and Heart Rate (HR): 81 (units not reported). At 16:46, patient was not feeling better and felt like she was going to pass out. Blood pressure (BP): 106/57 (units not reported) and Heart Rate (HR): 86 (units not reported). Patient laid down and sipped sprite. At 16:48, certified pediatric nurse practitioner (CPNP) examined patient and stated that patient has not eaten since morning and asked her to get food. Patient was sent to emergency room (ER) to be monitored for distress. At 16:49, patient's mother assisted her with walking and she was bought to the car by wheelchair. Patient looked a little perkier and had no distress. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Musculoskeletal stiffness, Pain in extremity, Vaccination site mass
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 # 634059) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old female patient. The patient had no known medical history and concurrent illness. The patient's other medication was reported as none. Information on the patient's prior vaccinations was not reported. On 28-MAR-2016, the patient was vaccinated with GARDASIL 9 in the left arm, lot # L045711 (dose number: 2, route: unknown; lot expiration date was not reported) for prophylaxis. Initially post vaccination, the patient did well. On 24-APR-2016, approximately 3 1/2 weeks later after vaccination, the patient developed redness, visible lump in the vaccinated area, arm pain and stiffness. The patient denied of bruising and the injection site had improved in the next 4 days. 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Presyncope, Unresponsive to stimuli
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 year old male patient with prophylaxis. The patient's medical history included mild asthma. The patient had no current illnesses and other medications. The patient's prior vaccinations was not reported. On 03-MAY-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L011846, intramuscularly in the right arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 03-MAY-2016, intramuscularly in the left arm, lot # 949LJ; (dose number, dose and expiration date unknown) and meningococcal conj vaccine (unspecified) (NOVARTIS) vaccinated date: 03-MAY-2016, intramuscularly in the right arm, lot # A15036; (dose number, dose and expiration date unknown). And on the same day the child (patient) was sitting in chair after his vaccinations at 11:45. As he rose he paled and fell into chair with a vasovagal response. The patient was awake but not responsive to voice commands, the patient's Hear rate (HR): 45, Respiratory rate (RR): 10 and had presyncope. The patient was not responsive to sternal rub. Called 911, at 12:58 HR was 90 and RR was 15. Emergency Medical Technician (EMT) arrived at 13:00, the patient still not responsive to voice but awake. The patient informed EMT that the patient had not eaten breakfast. Vital sign (VS) taken with Blood sugar (BS): 68, Oxygen saturation (Sats): 99 % and HR: 100. The child does not take any medications and has no significant history other than mild asthma. The patient showed moderate improvement and able to communicate at 13:20. The patient's mother declined transport to emergency department (ED) and advised to follow up as needed. The outcome of unresponsive to stimuli, presyncope and fall 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, MEN, TDAP
Symptoms: Fall, Seizure
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient current conditions included PROZAC and vitamin D. The patient's medical history included depression and hearing loss. The patient had no current illnesses and the patient's prior vaccinations was not reported. On 04-MAY-2016, the patient was vaccinated with third dose of GARDASIL 9, lot # L016429, intramuscularly in the left arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 04-MAY-2016, intramuscularly in the right arm, lot # 542F3; (dose, frequency and lot expiration date unknown) and MENOMUNE (dose number: 1, vaccinated date: 04-MAY-2016, intramuscularly in the left arm, lot # U5187AA (dose, frequency and expiration date unknown). On 05-MAY-2016, the patient's mother reported seizure occurred during school, patient dropped pencil and fell to floor from desk, had 4 convulsions, teacher let him rest for 1.5 minutes, then called his name while rubbing his back and he responded, the patient was taken to school office where he rested and his parents were contacted. The patient's mother called clinic at 2:54 PM to report incident, per provider the patient's mother was advised to take him to the local emergency department. The outcome of fall and seizure was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL, HEPA, HPV9, MNQ, VARCEL
Symptoms: Anxiety, Chills, Confusional state, Depression, Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 635057) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 18 year old female patient. The patient's medical history, other medication and concurrent illness were reported as none. The patient's concomitant therapies and prior vaccinations were not reported.  On 10-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L014415, lot expiration date 25-JUL-2017 (date and frequency were not reported), VARIVAX (dose number: 2, subcutaneously in the left arm, lo# L024251, frequency and lot expiration date unknown) and VAQTA (dose number: 1, intramuscularly in the left arm, lo# L002717, lot expiration date 02-JUN-2017; dose and frequency unknown) for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA (dose number: 1, intramuscularly in the left arm, lo# U5179AA, dose, frequency and lot expiration date unknown) for prophylaxis. On 10-NOV-2015, the patient experienced depression, anxiety, weight gain, chills, confusion and dizziness. The patient did not receive any treatment. The outcome for the events anxiety, weight increased, dizziness, depression, confusional state and chills was reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL, HEPA, HPV9, MNQ, VARCEL
Symptoms: Weight increased
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 # 635057) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 18 year old female patient. The patient's medical history, other medication and concurrent illness were reported as none. The patient's concomitant therapies and prior vaccinations were not reported.  On 10-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L014415, lot expiration date 25-JUL-2017 (date and frequency were not reported), VARIVAX (dose number: 2, subcutaneously in the left arm, lo# L024251, frequency and lot expiration date unknown) and VAQTA (dose number: 1, intramuscularly in the left arm, lo# L002717, lot expiration date 02-JUN-2017; dose and frequency unknown) for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA (dose number: 1, intramuscularly in the left arm, lo# U5179AA, dose, frequency and lot expiration date unknown) for prophylaxis. On 10-NOV-2015, the patient experienced depression, anxiety, weight gain, chills, confusion and dizziness. The patient did not receive any treatment. The outcome for the events anxiety, weight increased, dizziness, depression, confusional state and chills was reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL, HEPA, HPV9, MNQ, VARCEL
Symptoms: Anxiety, Chills, Depression, Dizziness, Fatigue
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 # 635057) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 18 year old female patient. The patient's medical history, other medication and concurrent illness were reported as none. The patient's concomitant therapies and prior vaccinations were not reported.  On 10-NOV-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L014415, lot expiration date 25-JUL-2017 (date and frequency were not reported), VARIVAX (dose number: 2, subcutaneously in the left arm, lo# L024251, frequency and lot expiration date unknown) and VAQTA (dose number: 1, intramuscularly in the left arm, lo# L002717, lot expiration date 02-JUN-2017; dose and frequency unknown) for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA (dose number: 1, intramuscularly in the left arm, lo# U5179AA, dose, frequency and lot expiration date unknown) for prophylaxis. On 10-NOV-2015, the patient experienced depression, anxiety, weight gain, chills, confusion and dizziness. The patient did not receive any treatment. The outcome for the events anxiety, weight increased, dizziness, depression, confusional state and chills was reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Muscle spasms, 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 (HA #635303) and refers to a 11 year old female patient. Patient's current illnesses, medical history, lab data and other medications were reported as non. On 06-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # L019286, dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with ADACEL and MENACTRA administered on 06-MAY-2016, intramuscular for prophylaxis. On 07-MAY-2016, the patient developed a rash on her face and also experienced muscle spasms the day following vaccination. She was also camping. The next day the rash spread to the torso. The rash was treated with increased fluids and diphenhydramine(BENADRYL). The outcome of muscle spasms and rash was reported as not recovered/not resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #635632) and refers to a 11 year old female patient. The patient's medical history and current illnesses both included von willebrand's disease and vesicoureteric reflux. Other medication included Claritin 10 mg and Potassium Citrate ER 10 MEQ. On 13-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # L023230, dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with ADACEL and MENACTRA, administered on 13-MAY-2016, intramuscularly for prophylaxis. On 16-MAY-2016, the patient experienced burning sensation at injection site. Injection site was slightly swollen, looked like pimples or blisters under skin. Patient was monitored and acetaminophen(TYLENOL) and ice was given for pain/discomfort. The outcome of injection site pain, injection site vesicles and injection site swelling was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9, 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-635635). This spontaneous report refers to a 11 year old female patient. The patient had no current illnesses, historical conditions and other medications. On 16-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # L044475, (unspecified dosage) intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with BOOSTRIX (lot # 9NA32) (unspecified dosage), intramuscularly in the left arm and MENACTRA (lot # U5187AA) unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, post vaccination, the patient had syncopal episode. Fluids were given and monitored for 15 minutes. The patient's vital signs were stable. 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.
Age: 12.0
Sex: F
Vaccine: HPV9, IPV
Symptoms: Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #635910) and refers to a 12 year old female patient with prophylaxis. Patient's current illness, medical history and lab data was reported as none. On 16-MAY-2016 the patient was vaccinated with GARDASIL 9, lot # L019297, dose 3, via unknown route in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapy included vaccination with IPOL administered on 16-MAY-2016, via unknown route for prophylaxis. On 16-MAY-2016, after the vaccination the patient got dizzy and lightheaded. The outcome of dizziness was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA # 636519) and refers to a 15 year old male patient. Patient's current illnesses, medical history and other medications were reported as none. On 20-MAY-2016 the patient was vaccinated in error with an extra dose of GARDASIL 9 lot # L048459, dose 1, intramuscular in the right arm for prophylaxis (strength and dosing detail unknown). The patient had been already vaccinated with 3 doses of GARDASIL on 12-MAY-2015, 16-JUN-2015 and 17-NOV-2015. The events extra dose administered and interchange of vaccine products were reported. The supervising MD and the patient's mother were made aware of this medication error. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9
Symptoms: Muscle twitching
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 # 636957) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 15 year old male patient. The patient's medical history included eczema and asthma. The patient had no known concurrent illnesses. The patient's other medication and lab data were reported as none. Information on the patient's prior vaccinations was not reported. On 20-APR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L018351 (dose number and lot expiration date were not reported) for prophylaxis. On 20-APR-2016, the patient felt his muscle twitching all around his body which was not treated. The outcome for the event muscle twitching was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 637015). This spontaneous report refers to a 15 year old male patient. Information on patient's current illnesses, medical history and other medications were not reported. On 25-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # M004116, dose 3, intramuscularly in the left arm for prophylaxis. On the same day, patient had a seizure and was evaluated in the office by two pediatricians who advised the patient to take a step to make sure he was ok. The outcome the event seizure was reported as recovered. The causality assessment for the event seizure 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: FLU3, HEPA, HPV9, MNQ
Symptoms: Back pain, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA # 637072) and refers to a 16 year old male patient. Patient had no current illnesses and medical history. On 09-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L013429, dose 1, intramuscularly in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with HAVRIX, MENACTRA and FLUZONE, administered on 09-MAY-2016, intramuscularly for prophylaxis. On 09-MAY-2016, right after the vaccination, the patient experienced fever with temperature 101.9 (unit unknown), body aches and chills, lack of appetite, back pain/headaches, fatigue, light sensitive. The events lasted for over 3 days. The outcome of back pain, pyrexia, photophobia, pain, headache, fatigue, decreased appetite and chills was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: FLU3, HEPA, HPV9, MNQ
Symptoms: Pain, Photophobia, 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 (HA # 637072) and refers to a 16 year old male patient. Patient had no current illnesses and medical history. On 09-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L013429, dose 1, intramuscularly in the right arm for prophylaxis (strength and dosing detail unknown). Other suspect therapies included vaccination with HAVRIX, MENACTRA and FLUZONE, administered on 09-MAY-2016, intramuscularly for prophylaxis. On 09-MAY-2016, right after the vaccination, the patient experienced fever with temperature 101.9 (unit unknown), body aches and chills, lack of appetite, back pain/headaches, fatigue, light sensitive. The events lasted for over 3 days. The outcome of back pain, pyrexia, photophobia, pain, headache, fatigue, decreased appetite and chills was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9, MEN, TDAP
Symptoms: Immediate post-injection reaction, 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 # 637214) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old male patient with prophylaxis. The patient's medical history, concurrent illnesses, other medications and prior vaccinations were not reported. On 03-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L048237 (lot expiration date not reported) for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX (dose number: 1, intramuscularly in the right arm, lot # 9NA32, manufacturer: GlaxoSmithKline, lot expiration date not reported) and MENOMUNE (dose number: 1, intramuscularly in the right arm, lot # U5186AA, manufacturer: Sanofi pasteur, lot expiration date not reported) for prophylaxis. On 03-MAY-2016, patient experienced an immediate post-injection reaction of vasovagal reaction after vaccinations. The patient's initial blood pressure (BP) was 90/50 (units unspecified) and heart rate (HR) was 45-50 (units unspecified). After 5 minutes, the patient was given crackers and water. The patient's final blood pressure (BP) was 95/61 (units unspecified) and heart rate (HR) was 73 (units unspecified). The outcome of the events immediate post-injection reaction and presyncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HEPA, HPV9, MENB, 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 # 637226) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 17 year old male patient. The patient's medical history and concurrent illnesses were reported as none. The patient's other medications was not reported. Information on the patient's prior vaccinations was not reported. On 26-MAY-2016, the patient was vaccinated with GARDASIL 9 intradermally in the left arm, lot # L043213 (dose number: 2, lot expiration was not reported) and VAQTA (dose number: 2, intramuscularly in the left arm, lot# L023936; lot expiration date: 15-MAR-2017) for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA (dose number: 2, intramuscularly in the right arm, lot# Ll3514, manufacturer: Pfizer/Wyeth; lot expiration date unknown) and MENOMUNE (dose number: 2, intramuscularly in the right arm, lot# U5228BA, manufacturer: Sanofi Pasteur; lot expiration date unknown) for prophylaxis. On 26-MAY-2016 post vaccinations, the patient fainted. The outcome for the event syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Fatigue, Gait disturbance, Joint swelling, 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 # 637228) on 18-APR-2017. This spontaneous report refers to a 14 year old female patient. The patient's medical history included Amoxicillin allergy. The patient's concurrent illness included minor rash. The patient's other medication and prior vaccinations were not reported. On 02-MAR-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (lot#, route, site, dose and lot expiration date were not reported). On 01-APR-2016, the patient had major knee swelling and fatigue. The patient's feet turned purple, she had rashes on her legs and was not able to walk on her leg and the patient underwent limb x-ray, urine analysis and blood test. The patient required emergency room (ER) visit. The outcome of the events was reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Skin discolouration, Urine analysis, X-ray limb
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 # 637228) on 18-APR-2017. This spontaneous report refers to a 14 year old female patient. The patient's medical history included Amoxicillin allergy. The patient's concurrent illness included minor rash. The patient's other medication and prior vaccinations were not reported. On 02-MAR-2016, the patient was vaccinated with GARDASIL 9 for prophylaxis (lot#, route, site, dose and lot expiration date were not reported). On 01-APR-2016, the patient had major knee swelling and fatigue. The patient's feet turned purple, she had rashes on her legs and was not able to walk on her leg and the patient underwent limb x-ray, urine analysis and blood test. The patient required emergency room (ER) visit. The outcome of the events was reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Dizziness, Dyspepsia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 25 year old male patient. The patient had no current illnesses. The patient's other medications and prior vaccinations were not reported. The patient medical history included ADHD (Attention-deficit/hyperactivity disorder), combined presentation, keratosis pilaris, major depressive order, and recurrent episode. On 25-MAY-2016, the patient was vaccinated with GARDASIL 9, (dose number, route of administration, dose, frequency, lot number and lot expiration date were not reported) for prophylaxis. On 28-MAY-2016, the patient stated that he was Feeling faint, weakness, upset stomach (burning), dyspepsia, vomiting, mild diarrhea. The outcome of asthenia, abdominal discomfort, vomiting, dyspepsia and diarrhoea were not reported. 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: Vomiting
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 25 year old male patient. The patient had no current illnesses. The patient's other medications and prior vaccinations were not reported. The patient medical history included ADHD (Attention-deficit/hyperactivity disorder), combined presentation, keratosis pilaris, major depressive order, and recurrent episode. On 25-MAY-2016, the patient was vaccinated with GARDASIL 9, (dose number, route of administration, dose, frequency, lot number and lot expiration date were not reported) for prophylaxis. On 28-MAY-2016, the patient stated that he was Feeling faint, weakness, upset stomach (burning), dyspepsia, vomiting, mild diarrhea. The outcome of asthenia, abdominal discomfort, vomiting, dyspepsia and diarrhoea were not reported. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: FLU3, HEPA, HPV9
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 # 637459) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 18 year old male patient. The patient's medical history, concurrent illnesses, other medications and prior vaccinations were not reported. On 23-MAY-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L043213 (dose number: 2; lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with HAVRIX (dose number: 2, intramuscularly in the left arm, lot # 9927T, manufacturer: GlaxoSmithKline; lot expiration date was not reported) and FLUZONE (dose number: 1, intramuscularly in the left arm, lot # U5309AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. No adverse events were reported or anticipated. However, adult dose of Hepatitis A vaccine was given to the patient (18 years old) instead of the pediatric dose. Error was found in reports which were reviewed on 24-MAY-2016. The outcome for the events was reported as recovered. 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: Abasia, Asthenia, Computerised tomogram head normal, Decreased appetite, Drug screen negative
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 # 637532) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old male patient. The patient's medical history, concurrent illnesses, other medications and prior vaccinations were not reported. On 20-APR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L044475 (dose number: 2, lot expiration date not reported) for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA (dose number: 1, intramuscularly in the right arm, lot # M37314, manufacturer: Pfizer/Wyeth, lot expiration date not reported) and MENACTRA (dose number: 2, intramuscularly in the left arm, lot # U5228BA, manufacturer: Sanofi Pasteur, lot expiration date not reported) for prophylaxis. On 20-APR-2016, post vaccination, when the patient returned home, he did not feel like eating, he did not feel that good, but he wanted to go to his basketball practice, so he went and then he felt worst. The patient's mother saw him and flushed his face. Since the patient was weak he could not even walk so his mother took him to the Emergency Room (ER) where he fainted in the parking lot. In the Emergency Room (ER), the patient was given BENADRYL (oral), 10 to15 minutes later the patient could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. Computed tomography (CT) of the patient's head, urine drug screen, Complete blood count (CBC) and comprehensive metabolic panel (CMP) were performed with normal results and the patient was then admitted to pediatrics for further evaluation and treatment. On 21-APR-2016, around 1:00 p.m. the patient did not feel well when he woke up. The patient got migraine headaches and pain in the arms at the vaccination site. The outcome of all 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.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Dyspnoea, Feeling abnormal, Flushing, Full blood count normal, Malaise
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 # 637532) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old male patient. The patient's medical history, concurrent illnesses, other medications and prior vaccinations were not reported. On 20-APR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L044475 (dose number: 2, lot expiration date not reported) for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA (dose number: 1, intramuscularly in the right arm, lot # M37314, manufacturer: Pfizer/Wyeth, lot expiration date not reported) and MENACTRA (dose number: 2, intramuscularly in the left arm, lot # U5228BA, manufacturer: Sanofi Pasteur, lot expiration date not reported) for prophylaxis. On 20-APR-2016, post vaccination, when the patient returned home, he did not feel like eating, he did not feel that good, but he wanted to go to his basketball practice, so he went and then he felt worst. The patient's mother saw him and flushed his face. Since the patient was weak he could not even walk so his mother took him to the Emergency Room (ER) where he fainted in the parking lot. In the Emergency Room (ER), the patient was given BENADRYL (oral), 10 to15 minutes later the patient could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. Computed tomography (CT) of the patient's head, urine drug screen, Complete blood count (CBC) and comprehensive metabolic panel (CMP) were performed with normal results and the patient was then admitted to pediatrics for further evaluation and treatment. On 21-APR-2016, around 1:00 p.m. the patient did not feel well when he woke up. The patient got migraine headaches and pain in the arms at the vaccination site. The outcome of all 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.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Metabolic function test normal, Migraine, Pharyngeal oedema, Rash, 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 # 637532) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old male patient. The patient's medical history, concurrent illnesses, other medications and prior vaccinations were not reported. On 20-APR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L044475 (dose number: 2, lot expiration date not reported) for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA (dose number: 1, intramuscularly in the right arm, lot # M37314, manufacturer: Pfizer/Wyeth, lot expiration date not reported) and MENACTRA (dose number: 2, intramuscularly in the left arm, lot # U5228BA, manufacturer: Sanofi Pasteur, lot expiration date not reported) for prophylaxis. On 20-APR-2016, post vaccination, when the patient returned home, he did not feel like eating, he did not feel that good, but he wanted to go to his basketball practice, so he went and then he felt worst. The patient's mother saw him and flushed his face. Since the patient was weak he could not even walk so his mother took him to the Emergency Room (ER) where he fainted in the parking lot. In the Emergency Room (ER), the patient was given BENADRYL (oral), 10 to15 minutes later the patient could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. Computed tomography (CT) of the patient's head, urine drug screen, Complete blood count (CBC) and comprehensive metabolic panel (CMP) were performed with normal results and the patient was then admitted to pediatrics for further evaluation and treatment. On 21-APR-2016, around 1:00 p.m. the patient did not feel well when he woke up. The patient got migraine headaches and pain in the arms at the vaccination site. The outcome of all 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.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Vaccination site 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 # 637532) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old male patient. The patient's medical history, concurrent illnesses, other medications and prior vaccinations were not reported. On 20-APR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L044475 (dose number: 2, lot expiration date not reported) for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA (dose number: 1, intramuscularly in the right arm, lot # M37314, manufacturer: Pfizer/Wyeth, lot expiration date not reported) and MENACTRA (dose number: 2, intramuscularly in the left arm, lot # U5228BA, manufacturer: Sanofi Pasteur, lot expiration date not reported) for prophylaxis. On 20-APR-2016, post vaccination, when the patient returned home, he did not feel like eating, he did not feel that good, but he wanted to go to his basketball practice, so he went and then he felt worst. The patient's mother saw him and flushed his face. Since the patient was weak he could not even walk so his mother took him to the Emergency Room (ER) where he fainted in the parking lot. In the Emergency Room (ER), the patient was given BENADRYL (oral), 10 to15 minutes later the patient could not breathe, his throat felt swollen and he got some rash on the neck, so he was given epinephrine shot. Computed tomography (CT) of the patient's head, urine drug screen, Complete blood count (CBC) and comprehensive metabolic panel (CMP) were performed with normal results and the patient was then admitted to pediatrics for further evaluation and treatment. On 21-APR-2016, around 1:00 p.m. the patient did not feel well when he woke up. The patient got migraine headaches and pain in the arms at the vaccination site. The outcome of all 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.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, 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 # 637562) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 26-MAY-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # M007728 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 30-MAY-2016, the patient had diarrhoea, vomiting, swollen and injection site red. On 31-MAY-2016 the patient was doing fine. The outcome of diarrhoea, vomiting, injection site swelling and injection site erythema 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: Full blood count normal, 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 # 637911) on 18-APR-2017. This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses. The patient's medical history included obesity and no known allergies were reported. Information on the patient's prior vaccinations and other medications were not reported. On 27-MAY-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # L024993 (expiration date 17-OCT-2017) (dose and frequency were not reported), intramuscularly in the right arm for prophylaxis. On 27-MAY-2016, the patient experienced fever which began within few hours of vaccination and normal complete blood count was reported. Fever was up to 103 degrees Fahrenheit which lasted 5 days and has continued to be 102-103 F on and off for 6 days. The outcome of full blood count normal and pyrexia 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
Symptoms: Fatigue, 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 # 637930) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 33 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations was not reported. Other medications included Lexapro, Mircette and Spironolactone. On 31-MAY-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the left arm (dose, frequency, lot # and expiration date were not reported). On 03-JUN-2016, the patient experienced fatigue and syncope. The outcome of fatigue and 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.