chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL, HPV9, MNQ, TDAP
Symptoms: Erythema, Immediate post-injection reaction, Pruritus, Rash, Throat tightness
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 # 655585) on 02-MAY-2017. This spontaneous report refers to a 12 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 08-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M004116 (expiration date: 12-OCT-2017) (dose, dose number and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX batch/lot # 54L57, dose 1, intramuscularly in the right arm and MENACTRA batch/lot # U5216AA, dose 1, intramuscularly in the left arm for prophylaxis. On 08-AUG-2016, the patient complained of lightheadedness, skin pale, nausea and vomiting. The patient was laid flat with elevated feet and was made to turn to his side after his vomiting stopped. The patient was offered sports drink and Pretzels. His BP was 124/82, HR 62, R 16 and T 97.2 orally. The patient was discharged home with his mother after he was able to ambulate and denied further complaints. The outcome of dizziness, vomiting, pallor and nausea was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL, HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Skin abrasion, 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 # 655585) on 02-MAY-2017. This spontaneous report refers to a 12 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 08-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M004116 (expiration date: 12-OCT-2017) (dose, dose number and frequency were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX batch/lot # 54L57, dose 1, intramuscularly in the right arm and MENACTRA batch/lot # U5216AA, dose 1, intramuscularly in the left arm for prophylaxis. On 08-AUG-2016, the patient complained of lightheadedness, skin pale, nausea and vomiting. The patient was laid flat with elevated feet and was made to turn to his side after his vomiting stopped. The patient was offered sports drink and Pretzels. His BP was 124/82, HR 62, R 16 and T 97.2 orally. The patient was discharged home with his mother after he was able to ambulate and denied further complaints. The outcome of dizziness, vomiting, pallor and nausea was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site pain, Injection site urticaria, 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 # 657249) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patients medical history was reported as none. The patient had no current illnesses. The patient's other medications included omeprazole 20 mg, essential daily multivitamin and daily probiotic. The patient's concomitant therapies and prior vaccinations were not reported. On 30-SEP-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M011840, lot expiration date 01-FEB-2018 (dose and frequency were not reported) via intramuscular route, in the left arm for prophylaxis. On 01-OCT-2016, the patient had welt in the immunization area which was 2-3 inches long, 1/2 inch wide and raised by 1/2 inch. The area was rock hard and very tender but not redness and no warmth to touch. As of 05-OCT-2016, the welt was almost gone, but the arm was still sore. The outcome of urticaria, injection site swelling, injection site reaction, injection site pain and injection site induration was reported as recovered. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 657348) 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 and current illnesses were reported as none. The patient's concomitant therapies, other medications and prior vaccinations were not reported. On 06-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M018810 (dose, frequency and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapies which were given on the same day included BOOSTRIX (intramuscularly in the right arm, lot# 7RJ9B; dose number, dose and expiration date was unknown) and MENVEO (intramuscularly in the right arm, lot# M15167; dose number, dose and expiration date was unknown) for prophylaxis. On 06-SEP-2016, the patient experienced dizziness and light headedness for 3 minutes. The patient's blood pressure was 107/70 (units not provided) and hemoglobin level was ordered. The outcome of dizziness was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Headache, Injection site swelling, Laboratory test, Nausea, Vertigo
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 # 658525) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient's medical history included migraine. Information on concomitant medications, current illnesses and prior vaccinations were not reported. Other medications included Periactin 4 mg, every bed time (qhs) had been taking for the past 2 years. On 21-SEP-2016, the patient was vaccinated with GARDASIL 9 dose 2, lot # M021407 (expiry date unknown) via intramuscular route in the left arm for prophylaxis. Other suspect therapies included FLUARIX Quadrivalent (Manufacturer: Glaxosmithkline, Vaccinated date: 21-SEP-2016, lot # 37PK4 (dose and lot expiry date unknown) via intramuscular route in the right arm) for prophylaxis. On 24-SEP-2016, the patient developed nausea, vomiting, vertigo and headache. Vertigo, nausea and headache were continued for 2.5 weeks. On 10-OCT-2016, the patient noted swelling on left shoulder at the site of GARDASIL 9 vaccine administration. It was reported that the patient was undergoing laboratory tests at the time of report. The outcome of all the events were reported as not recovered/not resolved. The causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: 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 # 658525) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient's medical history included migraine. Information on concomitant medications, current illnesses and prior vaccinations were not reported. Other medications included Periactin 4 mg, every bed time (qhs) had been taking for the past 2 years. On 21-SEP-2016, the patient was vaccinated with GARDASIL 9 dose 2, lot # M021407 (expiry date unknown) via intramuscular route in the left arm for prophylaxis. Other suspect therapies included FLUARIX Quadrivalent (Manufacturer: Glaxosmithkline, Vaccinated date: 21-SEP-2016, lot # 37PK4 (dose and lot expiry date unknown) via intramuscular route in the right arm) for prophylaxis. On 24-SEP-2016, the patient developed nausea, vomiting, vertigo and headache. Vertigo, nausea and headache were continued for 2.5 weeks. On 10-OCT-2016, the patient noted swelling on left shoulder at the site of GARDASIL 9 vaccine administration. It was reported that the patient was undergoing laboratory tests at the time of report. The outcome of all the events were reported as not recovered/not resolved. The causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Ovarian cyst
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 # 658717) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 12 year old female patient. Information on pertinent medial history, concurrent illnesses, lab data and prior vaccinations were not reported. On 18-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M007764, Expiry date: 30-JAN-2018, dose 1 via intramuscular route in the right arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, Vaccinated date: 18-AUG-2017, dose number 1, lot # C4990AA via intramuscular route in the left arm), HAVRIX (Manufacturer: Glaxosmithkline, Vaccinated date: 18-AUG-2017, dose number 2, lot # CL2R5 via intramuscular route in the right arm) and MENACTRA ((Manufacturer: Sanofi Pasteur, Vaccinated date: 18-AUG-2017, dose number 1, lot # U5392AB via intramuscular route in the left arm) for prophylaxis. On an unspecified date, the parent called the clinic and stated that her daughter had an ovarian cyst and she believed it was from the GARDASIL 9. The outcome of the event was not reported. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Syncope, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 658766) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old male patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 29-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # L024993, Expiry date: 17-OCT-2017, dose 1 via intramuscular route in the left arm for prophylaxis.  Other suspect therapies included HAVRIX (Manufacturer: Glaxosmithkline, Vaccinated date: 29-SEP-2016, lot # F3J75 via intramuscular route in the right arm) BOOSTRIX (Manufacturer: Glaxosmithkline, Vaccinated date: 29-SEP-2016, lot # 2729X via intramuscular route in the left arm) and MENVEO (Manufacturer: Novartis, Vaccinated date: 29-SEP-2016, lot # M15077A via intramuscular route in the right arm) for prophylaxis. On the same day, right after receiving HPV vaccination the patient experienced immediate post injection reaction and became dizzy and fainted. Patient  became unresponsive for about 4 secs, but immediately became responsive after laid on floor with feet elevated. The outcome of the events were 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: HEP, HEPA, HPV9, IPV, MMR, TDAP
Symptoms: Axillary pain, Cellulitis
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 # 659296) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient with prophylaxis. The patient had no concurrent illnesses. The patient's medical history included allergic to pork product. Information on the patient's prior vaccinations and other medications were not reported. On 27-SEP-2016 the patient was vaccinated with GARDASIL 9 lot # M020103 (dose, dose number, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included MMR II) lot # K018990 (dose, dose number, frequency and lot expiration dates were not reported), subcutaneously in the left arm, BOOSTRIX batch/lot # EC9A9, intramuscularly in the right arm, IPOL batch/lot # M14771M, intramuscularly in the right arm, HAVRIX batch/lot # ED72D, intramuscularly in the left arm and ENGERIX-B batch/lot # M020103, intramuscularly in the right arm for prophylaxis. On 05-OCT-2016, the patient experienced cellulitis and right axillary fold and pain. The patient visited the emergency room and was started with a 10 day course of Bactrim and was advised to return to the pediatrician on 13-OCT-2016. The treatment plan at that time was to continue and finish the 10 day course of Bactrim, to shower twice daily and to return if no improvement was seen or if the symptoms worsen. The outcome of cellulitis and axillary pain 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: DTAP, FLUX, HPV9, MEN
Symptoms: Fall, Head injury, Headache, Syncope, 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 # 659453) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 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 14-OCT-2016 the patient was vaccinated with GARDASIL 9 (dose, frequency, route, injection site, lot and expiration date were not reported) for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown), meningococcal polysaccharide vaccine (unspecified) (manufacturer unknown) and influenza virus vaccine (unspecified) (manufacturer unknown) (dose, frequency, route, injection site, lot and expiration date were not reported) for prophylaxis. On 14-OCT-2016 the patient was allowed to leave office immediately after vaccination and fainted within 10 minutes in hallway while she was leaving office and got head hit on floor. The patient was brought back into physician's office for observation. The patient had back of head sore but not swelling. Vomited approximately after 2 hours and 3 hours after she felt down. The outcome of head injury, headache 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.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Dizziness, Headache, Nausea, Phonophobia
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 # 660641) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's medical history included dysmenorrhoea, attention deficit/hyperactivity disorder (ADHD) and environmental allergies. Other medications included SPRINTEC. The patient's concurrent illnesses and prior vaccinations were not reported. On 19-OCT-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the right arm, lot # M017983 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 20-OCT-2016, after waking up the patient had bitemporal headache, nausea, lightheadedness, abdominal pain, associated with photophobia and phonophobia. No fever or emesis before vaccination. Reports had similar symptoms plus fever and emesis after first GARDASIL 9 shot was received. The patient required emergency room visit. The outcome of abdominal pain, vomiting, pyrexia, photophobia, phonophobia, nausea, headache and dizziness was unknown. 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: Photophobia, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 660641) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient's medical history included dysmenorrhoea, attention deficit/hyperactivity disorder (ADHD) and environmental allergies. Other medications included SPRINTEC. The patient's concurrent illnesses and prior vaccinations were not reported. On 19-OCT-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the right arm, lot # M017983 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 20-OCT-2016, after waking up the patient had bitemporal headache, nausea, lightheadedness, abdominal pain, associated with photophobia and phonophobia. No fever or emesis before vaccination. Reports had similar symptoms plus fever and emesis after first GARDASIL 9 shot was received. The patient required emergency room visit. The outcome of abdominal pain, vomiting, pyrexia, photophobia, phonophobia, nausea, headache and dizziness 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
Symptoms: Arthralgia, Insomnia, Myalgia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 660689). This spontaneous report refers to a 12 year old female patient. Information on patient's current illnesses, medical history, other medications and prior vaccinations was not reported. On 05-MAY-2014, the patient was vaccinated with GARDASIL 9 batch/lot # J008423, dose 3, route: unknown in the left arm for prophylaxis. On an unknown date since last vaccine, the patient experienced insomnia, muscle and joint pain. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Electrocardiogram normal, 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 # 660872). This spontaneous report refers to a 16 year old female patient. The patient had no medical history and other medications. Information on patient's current illnesses was unknown. On 20-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # L040054, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENVEO lot # A16002, dose 2, intramuscularly in the left arm and FLUZONE QUADRIVALENT lot # UI678AC, dose 1, intramuscularly in the right arm. On 21-OCT-2016, the patient experienced lightheadedness, headache and mild fever, temp: 100.6 (units not reported). Lab data included electrocardiogram (EKG): normal. The outcome of the events was reported as unknown. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 661017). This spontaneous report refers to a 14 year old female patient. Information on patient's current illnesses, medical history and other medications was not reported. Patient's prior vaccination included GARDASIL 9, dose 1, (unknown date) 14:00 and patient had dizziness. On 20-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M028323, dose 2, route: unknown in the right arm for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX QUADRIVALENT lot # BM577, route: unknown in the left arm. On 20-OCT-2016, patient passed out after vaccinations. Blood Pressure (BP) after resting was 106/58 (units not reported). The outcome of the event was reported as recovered. The causality assessment for the event with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Nausea, Skin warm
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 # 661733) on 02-MAY-2017. This spontaneous report refers to an 18 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-OCT-2016 the patient was vaccinated with the second dose of GARDASIL 9 lot # M028323 (dose, frequency and lot expiration dates were not reported), intramuscularly in the right arm for prophylaxis. On 26-OCT-2016, the patient reported warm, lightheaded, nauseous and sweaty. The outcome of dizziness, skin warm, nausea and hyperhidrosis was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Head injury, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 662351) on 02-MAY-2017. This spontaneous report refers to a 13 year old female patient. The patient had no concurrent illnesses. The patient's medical history included seasonal allergy. Information on the patient's prior vaccinations was not reported. The patient's other medications included Zyrtec 10mg. On 26-OCT-2016 the patient was vaccinated with the third dose of GARDASIL 9 lot # L040054 (dose, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. On 26-OCT-2016, after vaccination the patient began to walk towards the elevator, then she passed out and reportedly hit her head on the carpet. The patient came back, she was put in a chair and was given water. She felt ok and wanted to leave and went down in the elevator. Again she began to feel dizzy. The patient was taken to the exam room 20. They laid down the patient, gave water, cool compression and a lollipop. The patient's mom requested the doctor to examine. Her pulse was 70 (units unspecified), she was alert and interactive. She was advised to remain horizontal for about 10 minutes, then to sit up for about 5 minutes. She was asked to leave if feeling better. Nurses were advised to check on patient at intervals described. The outcome of dizziness, loss of consciousness and head injury was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, 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 # 662999) 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 and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 06-OCT-2016 the patient was vaccinated with the second dose of GARDASIL 9 via unknown route and site, lot # M021407 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 07-OCT-2016, 24 hours after receiving vaccination the patient experienced stomachache and nausea lasted approximately for about 36 hours. The outcome of abdominal pain upper and nausea was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Chills, Injection site rash, 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 # 663635) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to an 18 year old male patient. The patient's concurrent illnesses included stomach pain with greasy food. The patient had no pertinent medical history or other medications. On 18-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L007560, expiration date: 15-JUN-2017, intramuscularly in the left arm and MENACTRA (manufacturer: Sanofi Pasteur) dose number 2, lot # U5172AA, intramuscularly in the right arm for prophylaxis. On 19-AUG-2016, the patient experienced injection site rash on left deltoid, with chills and had pain all over the body. The events required an emergency room visit. The outcome of all 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.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Arthralgia, Back pain, Blood test normal, Hypoaesthesia, 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 # 666649). This spontaneous report refers to a 16 year old female patient. The patient had no current illnesses. The patient's medical history included left ventricle non-compaction cardiomyopathy and amoxicillin allergy. Patient's other medications included depo-provera and aspirin. On 06-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 (expiry date: 07-DEC-2017), dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with FLUZONE QUADRIVALENT lot # UT5636JA, dose 4, intramuscularly in the left arm. On 16-OCT-2016, approximately at 09:00-09:30, the patient had numbness in both legs and feet with pins and needles, back pain, hip pain, moderate swelling in feet and had no discoloration. On 17-OCT-2016 at 09:00, the patient went to emergency room (ER) with severe pain and they questioned guillain-barre syndrome (GBS). A spinal tap was going to be performed, however, her symptoms improved and it was not done. Patient was given pain medication for two days. On 20-OCT-2016, patient visited the doctor (primary provider) who drew her blood for tests and blood work was within normal limits as per patient's mother report and doctor also questioned GBS. Over the next one and half weeks the symptoms gradually resolved and patient became normal which was reported by patient's mother who also provided the summary of events. 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: FLU4, HPV9
Symptoms: Paraesthesia, Peripheral 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 # 666649). This spontaneous report refers to a 16 year old female patient. The patient had no current illnesses. The patient's medical history included left ventricle non-compaction cardiomyopathy and amoxicillin allergy. Patient's other medications included depo-provera and aspirin. On 06-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 (expiry date: 07-DEC-2017), dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with FLUZONE QUADRIVALENT lot # UT5636JA, dose 4, intramuscularly in the left arm. On 16-OCT-2016, approximately at 09:00-09:30, the patient had numbness in both legs and feet with pins and needles, back pain, hip pain, moderate swelling in feet and had no discoloration. On 17-OCT-2016 at 09:00, the patient went to emergency room (ER) with severe pain and they questioned guillain-barre syndrome (GBS). A spinal tap was going to be performed, however, her symptoms improved and it was not done. Patient was given pain medication for two days. On 20-OCT-2016, patient visited the doctor (primary provider) who drew her blood for tests and blood work was within normal limits as per patient's mother report and doctor also questioned GBS. Over the next one and half weeks the symptoms gradually resolved and patient became normal which was reported by patient's mother who also provided the summary of events. 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: M
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA # 667450) under the Freedom of Information Act and concerns a 16 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-NOV-2016, the male patient was given an extra dose of GARDASIL 9 injection, intramuscular, in his left arm, lot number L043214 (dose reported as 3.0 (no units specified)) (strength, dose and expiration date were not reported) for prophylaxis. The patient was suppose to receive MENACTRA but instead received GARDASIL 9. He had already completed the human papillomavirus (HPV) (as reported) series (No dates reported.) The patient had no signs and symptoms of adverse reaction. The causality between the events and therapy with GARDASIL 9 was not reported. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Neck pain, Pain, Skin warm, Swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency# 667451) under the Freedom of Information Act referring to a 21 year old female patient. There were no current illnesses or history. On 18-NOV-2016 the patient was vaccinated with GARDASIL 9 (dose, route, lot# and expiration date were unknown) for prophylaxis. On the same day, the patient experienced neck ache, swelling immediately and had been warm and painful to touch (code by agency as immediate post-injection reaction, skin warm, peripheral swelling, pain in extremity and neck pain). The outcome of the events and causality were not reported. The agency considered the events to be non-serious. Additional information is not expected since no further information could be obtained from the Agency.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act and refers to a 13-year-old male patient. The patient had not current illnesses or medical history. There was no information about the patient's concomitant therapies provided. On 28-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # reported as M027983, dose was not reported), intramuscularly in the left arm. The patient was vaccinated at public health clinic/ hospital. On 28-NOV-2016, the patient experienced syncope after vaccine administration. The outcome of syncope was reported as recovered, on an unknown date. The relatedness between the event and GARDASIL 9 was not provided. Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Chest pain, Chills, Cough, Headache, Hypoaesthesia
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# 673020), concerning a 13 years old male patient. The patient's medical history included vocal cord paralysis and gastrostomy tube in approximately 2003 (reported as "at 2 months old"). The patient had no concurrent conditions and no history of allergies. On 15-DEC-2016, the patient was vaccinated with his third dose of GARDASIL 9, lot # M023169, intramuscularly in the left arm, for prophylaxis (expiration date was unknown).  On the same date, he was also vaccinated with his second dose of MENACTRA, lot # U5410AA, intramuscularly in the right arm, as well for prophylaxis (expiration date was unknown). There were no concomitant medications. On 16-DEC-2016 (also reported as "1 day after vaccine administration"), the patient awoke with nausea, numbness in legs, chest pain, tactile fever, chills, cough, rhinorrhea and left fronto-pariental headache. A rapid flu test was performed with negative results. At the time of reporting, the patient had recovered from the events. The causality assessment between the events and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the regulatory authority.
Age: 13.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Influenza virus test negative, Nausea, Pyrexia, Rhinorrhoea
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# 673020), concerning a 13 years old male patient. The patient's medical history included vocal cord paralysis and gastrostomy tube in approximately 2003 (reported as "at 2 months old"). The patient had no concurrent conditions and no history of allergies. On 15-DEC-2016, the patient was vaccinated with his third dose of GARDASIL 9, lot # M023169, intramuscularly in the left arm, for prophylaxis (expiration date was unknown).  On the same date, he was also vaccinated with his second dose of MENACTRA, lot # U5410AA, intramuscularly in the right arm, as well for prophylaxis (expiration date was unknown). There were no concomitant medications. On 16-DEC-2016 (also reported as "1 day after vaccine administration"), the patient awoke with nausea, numbness in legs, chest pain, tactile fever, chills, cough, rhinorrhea and left fronto-pariental headache. A rapid flu test was performed with negative results. At the time of reporting, the patient had recovered from the events. The causality assessment between the events and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the regulatory authority.
Age: 26.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Altered state of consciousness, Asthenia, Fatigue, Gait disturbance, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#  679014)  under the Freedom of Information Act (FOI) regarding a 26 year old male patient. On 16-DEC-2016,  the patient was vaccinated with GARDASIL 9 intramuscular in the left arm, lot # M011117, for prophylaxis (dosage schedule and expiration date were not reported). Other suspect and concomitant medications were not provided. Sore throat symptoms appeared about 8 hours after injection. Over 24 hours later (16:12 hours on 17-DEC-2016), symptoms persist and were stronger. No other flu-like symptoms were present. The pain/soreness felt more like a physical injury than from a flu infection. Phlegm/mucus of some sort also appeared a day after injection but was subsiding fast. No treatment administered. Lab data: not applicable Other medications: none Current illnesses: none History: none prior vaccinations. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 26.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nausea, Pain in extremity, Pallor, Tinea capitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#  679014)  under the Freedom of Information Act (FOI) regarding a 26 year old male patient. On 16-DEC-2016,  the patient was vaccinated with GARDASIL 9 intramuscular in the left arm, lot # M011117, for prophylaxis (dosage schedule and expiration date were not reported). Other suspect and concomitant medications were not provided. Sore throat symptoms appeared about 8 hours after injection. Over 24 hours later (16:12 hours on 17-DEC-2016), symptoms persist and were stronger. No other flu-like symptoms were present. The pain/soreness felt more like a physical injury than from a flu infection. Phlegm/mucus of some sort also appeared a day after injection but was subsiding fast. No treatment administered. Lab data: not applicable Other medications: none Current illnesses: none History: none prior vaccinations. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 26.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Oropharyngeal pain, Pain, Productive cough, Secretion discharge
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#  679014)  under the Freedom of Information Act (FOI) regarding a 26 year old male patient. On 16-DEC-2016,  the patient was vaccinated with GARDASIL 9 intramuscular in the left arm, lot # M011117, for prophylaxis (dosage schedule and expiration date were not reported). Other suspect and concomitant medications were not provided. Sore throat symptoms appeared about 8 hours after injection. Over 24 hours later (16:12 hours on 17-DEC-2016), symptoms persist and were stronger. No other flu-like symptoms were present. The pain/soreness felt more like a physical injury than from a flu infection. Phlegm/mucus of some sort also appeared a day after injection but was subsiding fast. No treatment administered. Lab data: not applicable Other medications: none Current illnesses: none History: none prior vaccinations. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 26.0
Sex: M
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nausea, Pain in extremity, Pallor, Paraesthesia, Tinea capitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#  679014)  under the Freedom of Information Act (FOI) regarding a 26 year old male patient. On 16-DEC-2016,  the patient was vaccinated with GARDASIL 9 intramuscular in the left arm, lot # M011117, for prophylaxis (dosage schedule and expiration date were not reported). Other suspect and concomitant medications were not provided. Sore throat symptoms appeared about 8 hours after injection. Over 24 hours later (16:12 hours on 17-DEC-2016), symptoms persist and were stronger. No other flu-like symptoms were present. The pain/soreness felt more like a physical injury than from a flu infection. Phlegm/mucus of some sort also appeared a day after injection but was subsiding fast. No treatment administered. Lab data: not applicable Other medications: none Current illnesses: none History: none prior vaccinations. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Altered state of consciousness, Asthenia, Fatigue, Gait disturbance, Hypoaesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#679014)  under the Freedom of Information Act (FOI) regarding a 14 year old female patient. On 20-JAN-2017, the patient was vaccinated with GARDASIL 9, intramuscular in the right arm for prophylaxis (dosage schedule, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On the same date, the total arm experienced pain/numbness and tingling in right arm (side of injection), she was very tired and fatigue that still had not gone away. Nauseous that still had not gone away. She had general weakness, cannot walk down the hall without needing to stop and rest and feeling like she was going to pass out. she still had not gotten better and was very, very pale. Lab data: none, cannot get ahold of doctor until tomorrow Other medications: none Current illnesses: no History: none prior Vaccinations. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nausea, Pain in extremity, Pallor, Tinea capitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#679014)  under the Freedom of Information Act (FOI) regarding a 14 year old female patient. On 20-JAN-2017, the patient was vaccinated with GARDASIL 9, intramuscular in the right arm for prophylaxis (dosage schedule, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On the same date, the total arm experienced pain/numbness and tingling in right arm (side of injection), she was very tired and fatigue that still had not gone away. Nauseous that still had not gone away. She had general weakness, cannot walk down the hall without needing to stop and rest and feeling like she was going to pass out. she still had not gotten better and was very, very pale. Lab data: none, cannot get ahold of doctor until tomorrow Other medications: none Current illnesses: no History: none prior Vaccinations. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Oropharyngeal pain, Pain, Productive cough, Secretion discharge
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#679014)  under the Freedom of Information Act (FOI) regarding a 14 year old female patient. On 20-JAN-2017, the patient was vaccinated with GARDASIL 9, intramuscular in the right arm for prophylaxis (dosage schedule, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On the same date, the total arm experienced pain/numbness and tingling in right arm (side of injection), she was very tired and fatigue that still had not gone away. Nauseous that still had not gone away. She had general weakness, cannot walk down the hall without needing to stop and rest and feeling like she was going to pass out. she still had not gotten better and was very, very pale. Lab data: none, cannot get ahold of doctor until tomorrow Other medications: none Current illnesses: no History: none prior Vaccinations. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Nausea, Pain in extremity, Pallor, Paraesthesia, Tinea capitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA#679014)  under the Freedom of Information Act (FOI) regarding a 14 year old female patient. On 20-JAN-2017, the patient was vaccinated with GARDASIL 9, intramuscular in the right arm for prophylaxis (dosage schedule, lot number and expiration date were not reported). Other suspect and concomitant medications were not provided. On the same date, the total arm experienced pain/numbness and tingling in right arm (side of injection), she was very tired and fatigue that still had not gone away. Nauseous that still had not gone away. She had general weakness, cannot walk down the hall without needing to stop and rest and feeling like she was going to pass out. she still had not gotten better and was very, very pale. Lab data: none, cannot get ahold of doctor until tomorrow Other medications: none Current illnesses: no History: none prior Vaccinations. Additional information is not expected as no follow-up can be obtained from the agency.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness, 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 (HA# 673248), concerning a 15 years old male patient. The patient's concurrent illnesses included rhinitis. The patient had no known drug allergies ("NKDA"). On 16-DEC-2016, the patient was vaccinated with his first dose of GARDASIL 9, lot # M024261, intramuscularly in the left arm, for prophylaxis (expiration date was unknown).  On the same date, he was also vaccinated with a dose of FLUARIX QUADRIVALENT, lot # 9D325, intramuscularly in the right arm, as well for prophylaxis (expiration date was unknown). Concomitant therapies included cetirizine hydrochloride(ZYRTEC) and fluticasone propionate(FLONASE).   On the same date, the patient went to the check out area and passed out. The patient was examined by the provider, he did not hit his head and had vasovagal response. It was also reported that the patient did not eat breakfast on that day. No laboratory tests were performed. At the time of reporting, the patient had recovered from the loss of consciousness and the presyncope. The causality assessment between loss of consciousness, presyncope and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the regulatory authority.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA# 673497), concerning a 13 years old female patient. The patient had no concurrent conditions or medical history. On 13-DEC-2016, the patient was vaccinated with her first dose of GARDASIL 9, lot # M017983, intramuscularly in the left arm, for prophylaxis (expiration date was unknown). Concomitant medications were not reported. On 15-DEC-2016, the patient experienced hives on "truck" and below elbows, but nothing near the injection site. At the time of reporting, the outcome of urticaria was unknown. The causality assessment between urticaria and GARDASIL 9 was not provided. Additional information is not expected as no further information can be obtained from the regulatory authority.