chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9
Symptoms: Dysphonia, Dyspnoea, Throat tightness, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657322) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder (ADHD). Information on current illnesses, concomitant mediations and prior vaccinations were not reported. Other medications included vyvanse. On 03-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # 1045700, dose number 1 (dose, frequency and lot expiration date were not reported) via intramuscular route in the right arm for prophylaxis. On 04-OCT-2016, the patient experienced difficulty breathing, hoarseness to voice with sensation of throat closing and generalized urticarial rash. The patient was taken to emergency room. The outcome of all 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: F
Vaccine: FLU4, HPV9
Symptoms: Blood pressure immeasurable, Hyperhidrosis, Nausea, Pulse absent, 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 # 658022) on 02-MAY-2017. This spontaneous report refers to a 19 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 07-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # M021407 (dose, dose number, frequency, lot expiration dates and site were not reported), intramuscularly for prophylaxis. Other suspect therapies included FLUZONE batch/lot # UI690AB, intramuscularly for prophylaxis. On 07-OCT-2016, the patient became diaphoretic, nauseated and fainted. Her pulse and BP were undetectable by both manual and mechanical means for about 10 minutes, though she was alert the entire time. She was alert within seconds of fainting and was back to normal within 20 minutes of onset of symptoms. The EMS was called to the location, they checked her vitals and assessed whether she was conscious. They were onsite for 10 minutes before releasing her with no concerns. The outcome of blood pressure immeasurable, syncope, pulse absent, 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.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 658266) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient. The patient's medical history included asthma. The patient's concurrent illnesses and lab data were reported as none. The patient's other medication and prior vaccinations were not reported. On 19-SEP-2016, the patient was vaccinated with GARDASIL 9 (unknown route) in the left arm, lot # M017983 (dose number and lot expiration date were not reported) for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (site: right arm, route: unknown, lot # U5468AA, manufacturer: Sanofi Pasteur; dose number and lot expiration date were not reported) and MENACTRA (site: right arm, route: unknown, lot # U5416AA, manufacturer: Sanofi Pasteur; dose number and lot expiration date were not reported) for prophylaxis. On an unknown date, the patient developed swelling and erythema (14.5 cm x 15.5 cm) in his deltoid. The outcome for the events injection site erythema and injection site swelling were reported as not 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: HPV9
Symptoms: Erythema, Pruritus, 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 # 658315) 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 07-OCT-2016 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the right arm, lot # L037554 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 09-OCT-2016, the patient experienced redness, mild swelling and itching. The outcome of erythema, pruritus and swelling was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, IPV, MENB, MNQ, VARCEL
Symptoms: Extra dose administered, 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 # 658403) on 02-MAY-2017. This spontaneous report refers to a 16 year old male patient. The patient had no medical history and concurrent illnesses. The patient's other medication was reported as none. Information on the patient's prior vaccinations was not reported. On 31-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # M018810 (lot expiration date was not reported) and VARIVAX (dose number: 2, subcutaneously in the right arm, lot # M005973, 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 # CM37R, manufacturer: GlaxoSmithKline; lot expiration date was not reported), TRUMENBA (dose number: 1, intramuscularly in the right arm, lot # M95612, manufacturer: Pfizer/Wyeth; lot expiration date was not reported) and MENVEO (dose number: 2, intramuscularly in the left arm, lot # M15164, manufacturer: Novartis; lot expiration date was not reported) for prophylaxis. On an unknown date as per foreign record, the patient missed dose number 4 of IPV (Inactivated Polio vaccine) on 06-JUL-2009 which was to be administered at age 9. IPV given on 31-AUG-2016, was not needed. No adverse symptoms/events reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 658523) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient with prophylaxis. The patient's medical history included 1 episode of syncope. Information on current illnesses, concomitant conditions and prior vaccinations were not reported. On 11-OCT-2016, the patient was vaccinated with GARDASIL 9 dose 3, lot # L048054 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. Other suspect therapies included influenza virus vaccine (unspecified) (Manufacturer: Glaxosmithkline, lot # TS5F3 (dose number, dose and lot expiration date unknown) via intramuscular route in the left arm) for prophylaxis. On the same day, post vaccination patient's mother and grandmother were in the room and reported that patient experienced immediate post injection reaction and looked pale and began to stiffen his arms and then appeared to lose consciousness. Mother called for help and patient was moved to lie down on exam table. He was reportedly unconscious for a few seconds. The nurse practitioners were called into the room immediately after this occurred and the patient was awake and talking but appeared pale. The pulse ox, blood pressure, respiratory rate and heart rate were taken and all within normal limits. EMS was called and patient was taken to closest emergency department. 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: F
Vaccine: HPV9, MENB
Symptoms: Chest X-ray, Dyspnoea, Electrocardiogram, Pain in extremity, Paraesthesia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old female. The patient's other medications included ELAVIL, STRATTERA and PERIACTIN. The patient's medical history, current illnesses and prior vaccinations were not reported. On 20-SEP-2016, with first second dose of GARDASIL 9, lot # M009362, intramuscularly in the right arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included TRUMENBA dose number: 1, vaccinated date: 20-SEP-2016, intramuscularly in the left arm, lot # M37316; (dose and expiration date unknown). The lab data include: EKG (electrocardiogram) and CXR (chest x-ray). On 21-SEP-2016, the patient was with fever, shortness of breath (SOB), rash and pain in left arm and the patient also had tingling in hands and feet, had chest x-ray and electrocardiogram. The patient was treated with BENADRYL 25 mg, IM (intramuscular) and DECADRON 4mg, IM (intramuscular). Placed on oxygen saturation/2L. On an unknown date, the patient was taken by the Emergency Medical Services (EMS) to emergency department (ED). The outcome of chest x-ray, rash, pyrexia, paraesthesia, pain in extremity, electrocardiogram and dyspnoea 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, MENB
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old female. The patient's other medications included ELAVIL, STRATTERA and PERIACTIN. The patient's medical history, current illnesses and prior vaccinations were not reported. On 20-SEP-2016, with first second dose of GARDASIL 9, lot # M009362, intramuscularly in the right arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included TRUMENBA dose number: 1, vaccinated date: 20-SEP-2016, intramuscularly in the left arm, lot # M37316; (dose and expiration date unknown). The lab data include: EKG (electrocardiogram) and CXR (chest x-ray). On 21-SEP-2016, the patient was with fever, shortness of breath (SOB), rash and pain in left arm and the patient also had tingling in hands and feet, had chest x-ray and electrocardiogram. The patient was treated with BENADRYL 25 mg, IM (intramuscular) and DECADRON 4mg, IM (intramuscular). Placed on oxygen saturation/2L. On an unknown date, the patient was taken by the Emergency Medical Services (EMS) to emergency department (ED). The outcome of chest x-ray, rash, pyrexia, paraesthesia, pain in extremity, electrocardiogram and dyspnoea 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.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 659155) on 02-MAY-2017. This spontaneous report 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 11-AUG-2016 the patient was vaccinated with GARDASIL 9 (dose, dose number, frequency and lot expiration dates were not reported), route: unknown in the right arm for prophylaxis. Other suspect therapies included ADACEL batch/lot # U5476AA, intramuscularly in the left arm and MENACTRA batch/lot # U5179AA, route: unknown in the right arm for prophylaxis. On 11-AUG-2016, the patient passed out in clinic hallway hitting head on the wall after the vaccination. The patient was not conscious for less than a minute. A cool wash cloth was applied to the patient's neck. The patient was assisted to the exam room and was monitored for 30 minutes. The patient was alert and orient. The outcome of head injury and loss of consciousness 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: FLU4, HPV9, MNQ, TDAP
Symptoms: Cold sweat, Pallor, Posture abnormal, Staring, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 659199) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient with prophylaxis. The patient had no concurrent illnesses. The patient was on Rifampin prophylaxis at about age 6. Information on the patient's prior vaccinations and other medications were not reported. On 11-OCT-2016 the patient was vaccinated with GARDASIL 9 lot # M017983 (dose, dose number, frequency, lot expiration dates were not reported), intramuscularly, site: unknown for prophylaxis. Other suspect therapies included MENACTRA batch/lot # U5410AA, intramuscularly, site: unknown, INFLUENZA VIRUS VACCINE (UNSPECIFIED) batch/lot # 79PE5, intramuscularly, site: unknown and BOOSTRIX batch/lot # 7RJ98, intramuscularly, site: unknown for prophylaxis. On 11-OCT-2016, after the 4th vaccine (GARDASIL-9) the patient slumped and started to shake (tremor) with open eyes staring ahead for a few brief seconds. So, MD was summoned by MA. The patient was laid down to relax, and on examination her BP was 90/60 (units unspecified) with a HR 58/min. she was further advised to lie down. She admitted that she didn't eat her lunch for which she was given a hard candy to lick. After 10 minutes, her cold, clammy hands became warm and there was a return of color to her pale lips. She was able to sit up and eventually walk to the bathroom on her own after about 25 minutes. She was discharged to return in 1-2 weeks to discuss and likely workup the episode, to rule out (R/O) syncope Vs seizures Vs postural hypotension Vs neurogenic shock. The outcome of cold sweat, tremor, staring, skin warm and pallor was reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Blood pressure abnormal, Dizziness, Hyperhidrosis, 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 # 659451) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses. The patient medical history included asthma, allergic rhinitis and atopic dermatitis. Information on the patient's prior vaccinations and other medications were not reported. On 14-OCT-2016 the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # U5415AA (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day 4 minutes after post vaccination of GARDASIL 9 the patient became sweaty, dizzy, fainted and his airway, breathing and circulation were intact. The patient was oriented to person, place and time but had initial blood pressure of 74/45 that improved after 15 minutes of lying down to 105/65. The outcome of blood pressure abnormal, dizziness, hyperhidrosis 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.
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site pain, Insomnia, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 659474) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 25 year old female patient. The patient current illness included pain. Information on the patient's prior vaccinations and medical history were not reported. Other medications include flonase and antifungal Shampoo. On 05-OCT-2016 the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm (dose, frequency, lot # and expiration date were not reported) for prophylaxis, she had pain when the injection was given. On 11-OCT-2016, the patient had headache, stiff neck, muscle spasms and insomnia. The patient required an emergency room (ER) visit. The outcome of headache, injection site pain, insomnia, muscle spasms and musculoskeletal stiffness was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: FLU4, HPV9, MEN
Symptoms: Erythema, Local reaction, Pain in extremity, 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 # 659920) on 02-MAY-2017. This spontaneous report 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 14-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M018810 (dose, frequency and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUARIX QUADRIVALENT batch/lot # J97D2, intramuscularly in the right arm and MENOMUNE-A/C/Y/W-135 batch/lot # U5390AA, intramuscularly in the right arm for prophylaxis. On 16-OCT-2016, the patient experienced local reaction to right arm with pain, swelling and redness. The outcome of erythema, peripheral swelling, pain in extremity and local reaction was reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Myalgia, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 659927) on 02-MAY-2017. This spontaneous report refers to a 25 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 17-OCT-2016, the patient was vaccinated with the second dose of GARDASIL 9 (dose, frequency, lot and lot expiration dates were not reported), intramuscularly in the left arm for prophylaxis. On 17-OCT-2016, the patient first reported over sensitive muscles which was achy at around 7:30 (AM/PM unspecified), Fever started at around 11:30 PM and has continued till the morning of the date/time reported. The outcome of myalgia, pyrexia and 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Fall, Fear, Hyperventilation
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 # 660365) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 10-OCT-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the left arm, lot # U5288AA (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL and MENACTRA. On 10-OCT-2016, the patient experienced dizzy, stiff, rolled his eyes, became pale  and fell on exam table. The patient was scared, hyperventilation and held his mom. After about 30 minutes of rest, the patient felt better and left. The outcome of dizziness, pallor, musculoskeletal stiffness, hyperventilation, fear, fall and eye movement disorder was reported as recovered/resolved. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Musculoskeletal stiffness, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 660365) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 10-OCT-2016 the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the left arm, lot # U5288AA (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL and MENACTRA. On 10-OCT-2016, the patient experienced dizzy, stiff, rolled his eyes, became pale  and fell on exam table. The patient was scared, hyperventilation and held his mom. After about 30 minutes of rest, the patient felt better and left. The outcome of dizziness, pallor, musculoskeletal stiffness, hyperventilation, fear, fall and eye movement disorder 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: Axillary mass, Injection site rash, Swelling, Tenderness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 662626) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 24-OCT-2016 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M026306 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 25-OCT-2016 the patient experienced axillary swelling, tenderness and bumpy rash at injection site. The patient required emergency room visit. The outcome of axillary mass, tenderness and injection site rash 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: 13.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Inappropriate schedule of drug administration
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 # 662816) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 31-OCT-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the right arm, lot # M026306 (dose, frequency and lot expiration date were not reported) for prophylaxis. On same day the patient was vaccinated with ENGERIX-B (Pediatric/Adolescent) too early, vaccination was not due until 20-DEC-2016. The outcome of inappropriate schedule of drug administration was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Skin warm, Tenderness, Testicular pain, Testicular 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 # 663474) on 02-MAY-2017. This spontaneous report refers to a 12 year old male patient. The patient's medical history included penicillin allergy. The patient's other medication included multi-vitamin. The patient's concurrent illnesses was reported as none. Information on the patient's prior vaccinations was not reported. On 04-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (lot # M020103, site: right arm, route: unknown; lot expiration date was not reported). The patient's mother called a month after the event occurred and stated that she did not want anymore GARDASIL 9 vaccinations for the patient. The patient experienced swelling of the testicles with pain in the area on the same day of vaccination. The area was tender, warm (to touch) and red. The outcome for the events erythema, testicular swelling, testicular pain, tenderness and skin warm were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Infectious mononucleosis, Mononucleosis heterophile test positive, Oropharyngeal pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 664550) 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 14-SEP-2016 the patient was vaccinated with the first dose GARDASIL 9 lot # M011840 (dose, frequency and lot expiration dates were not reported), intramuscularly in the right arm  for prophylaxis. On 18-SEP-2016, the patient experienced fatigue and sore. On 19-SEP-2016 the patient was diagnosed with infectious mononucleosis and mononucleosis heterophile test positive. The patient visited the emergency room. The outcome of fatigue, oropharyngeal pain, mononucleosis heterophile test positive and infectious mononucleosis 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: 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 concerning a 22 year old female patient with food allergy. Other medication included tanshinone(skin medication from China). Current illnesses and prior vaccinations were not provided. On 17-NOV-2016 the patient was vaccinated with GARDASIL 9 (strength, dose, and expiration date unknown, lot # M030380, intramuscular in the left arm) for prophylaxis. After vaccination, the patient experienced fever to 102.7 degrees Fahrenheit and headache overnight. By morning she was feeling better and temperature was down to 100.1 degrees Fahrenheit. The outcome of headache and pyrexia was reported as recovered. The causality between the events and GARDASIL 9 was unknown.   Additional information is not expected since no further information could be requested from the agency.
Sex: M
Vaccine: HPV9
Symptoms: Epistaxis, Eye movement disorder, Face injury, Fall, Seizure like phenomena
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 668629). This spontaneous report refers to a 12 year old male patient. The patient had no current illnesses and other medications. The patient's medical history included headache. On 21-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M009378, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, patient's mother stated that patient fell off the exam table approximately one minute after receiving GARDASIL 9 vaccine. Patient's nose began to bleed as he fell directly on his face. Another nurse saw the patient have seizure like movements, shaking extremities and eyes rolling back in his head. Blood Pressure (BP) was 104/60 (units not specified), Heart Rate (HR): 50-60 (units not specified), oxygen saturation: 99-100 %, room air. Patient was sent to emergency department (ED) by ambulance. 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: Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 668629). This spontaneous report refers to a 12 year old male patient. The patient had no current illnesses and other medications. The patient's medical history included headache. On 21-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # M009378, dose 2, intramuscularly in the left arm for prophylaxis. On the same day, patient's mother stated that patient fell off the exam table approximately one minute after receiving GARDASIL 9 vaccine. Patient's nose began to bleed as he fell directly on his face. Another nurse saw the patient have seizure like movements, shaking extremities and eyes rolling back in his head. Blood Pressure (BP) was 104/60 (units not specified), Heart Rate (HR): 50-60 (units not specified), oxygen saturation: 99-100 %, room air. Patient was sent to emergency department (ED) by ambulance. 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.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, 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. This report refers to an 11 year old male patient. The patient's medical history included cardiac operation (at the age of 2). The patient's concurrent condition included tinea corporis on the left cheek. The patient had no other medications or prior vaccinations. On 28-NOV-2016, the patient was vaccinated with the 1st dose of GARDASIL 9 (lot # M007764, expiration date unknown) intramuscularly in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (batch# H549F, intramuscular, in the left arm) and MENVEO (batch# M15166, intramuscular, in the right arm). On 28-NOV-2016, about 1 hour after getting the meningitis vaccine, his right shoulder became swollen, red, hot, and he also had pain when trying to move his arm. The outcome of the events were unknown. The causality assessment was not reported.    Additional information is not expected as no further information can be obtained from the Agency.
Sex: M
Vaccine: HPV9
Symptoms: Erythema, 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 # 669490). This spontaneous report as refers to a 11 year old male patient. Information on patient's current illnesses, medical history and other medications was not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636 (expiry date: 15-FEB-2018), intramuscularly in the right arm for prophylaxis. On an unknown date, the patient had redness and swelling to his right arm after vaccination. 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: Abdominal pain, Crying, Dizziness, Nausea, Nervousness
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 # 671391). This spontaneous report refers to a 14 year old male patient. The patient had no current illnesses and information on patient's medical history, other medications and prior vaccinations were not reported. On 18-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M016193 (expiry date: 24-APR-2018), dose 1, intramuscularly in the left arm for prophylaxis. On the same day, after vaccine was administered, the patient experienced abdominal pain, dizziness, nausea and broke out in hives in trunk area. Patient was given diphenhydramine 25 mg, intramuscular (IM) RA. Patient was shaky, nervous and crying after 1 hour of observation and rash decreased by 80 %. The patient felt better and went home with his father. The outcome of the events was reported as not 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: Tremor, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 671391). This spontaneous report refers to a 14 year old male patient. The patient had no current illnesses and information on patient's medical history, other medications and prior vaccinations were not reported. On 18-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M016193 (expiry date: 24-APR-2018), dose 1, intramuscularly in the left arm for prophylaxis. On the same day, after vaccine was administered, the patient experienced abdominal pain, dizziness, nausea and broke out in hives in trunk area. Patient was given diphenhydramine 25 mg, intramuscular (IM) RA. Patient was shaky, nervous and crying after 1 hour of observation and rash decreased by 80 %. The patient felt better and went home with his father. The outcome of the events was reported as not recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Culture urine, Full blood count, Hyperhidrosis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 674402) under the Freedom of Information Act referring to a 26 year old female with no current illness and no medical history. On 07-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot # L036301, expiration date not provided), dose 2, in the right arm (route unknown). The patient experienced chills and sweats 8 hours after getting vaccine. Lab data included: full blood count (CBC), culture urine (urine C & S) (results not provided). The patient recovered from the events on an unknown date. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Age: 22.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (HA# 675506) under the Freedom of Information Act referring to a 22 year old male patient with no current illness and history of ADD (attention deficit/hyperactivity disorder), multiple allergies treated with unspecified allergy shots, and prior vaccinations (unspecified dates and types). On 19-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018), intramuscularly in the left arm. Concomitant therapy included atomoxetine hydrochloride (STRATTERA). On 20-DEC-2016, the patient experienced hives in the trunk area. She was treated in the emergency room and received cetirizine hydrochloride (ZYRTEC) and was to force fluids. There was no lab data. The outcome of urticaria was reported as recovered. Additional information is not expected as no further information can be obtained from the local regulatory authority.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Nephrolithiasis, Pelvic 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, concerning a 16 year old female patient. No concurrent conditions, medical history or concomitant therapies were reported. On 19-OCT-2016, the patient was vaccinated with a first dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On 05-NOV-2016, the patient experienced nephrolithiasis and severe pelvic pain. She was taken to the emergency room (ER) on 07-NOV-2016 and was diagnosed with kidney stones. Second dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported) was administered on 27-DEC-2016 and the same symptoms appeared on 01-JAN-2017, but the patient was not taken to the ER at that time. The outcome of nephrolithiasis and pelvic pain was unknown. Causality assessment was not provided. Additional information is not expected, because no further information can be obtained from the regulatory authority.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Chest X-ray, Chest discomfort, Electrocardiogram, Laboratory test, Painful respiration
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 (Agency# 676931) form the patient's father referring to a 17.0 year old female patient. She had no current illness and had environmental allergies. Also she had seizures and prior vaccinations before. On 03-JAN-2017, the patient was vaccinated with first dose of GARDASIL 9(lot # M017983, 1 dose form, intramuscular, injection site unknown) for prophylaxis. Other suspect therapies included second dose of BOOSTRIX (GLAXOSMITHKLINE) (Intramuscular, lot# Z9Z4Y, injection site unknown) and second dose of MENACTRA (SANOFI PASTEUR) (Intramuscular, lot# U5415AA, injection site unknown). On the same day, approximately 1 hour after having vaccines, the patient's father called and said patient was having tightness in her chest and it hurt to breathe. She was advised to visit emergency room and after a delay, her father brought her to emergency room for eval. The patient experienced chest x-ray, laboratory test and electrocardiogram. The outcome of events was reported as unknown.The causality between GARDASIL 9 and events was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Local swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency number 681495) under the Freedom of Information Act. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient with no current illnesses and no medical history. No information regarding the patient's prior vaccinations was provided. On 01-FEB-2017, the patient was vaccinated at the private doctor's office/hospital with the third dose of GARDASIL 9 lot number M028323, intramuscularly in the left arm, (dose and expiration date were not provided) for prophylaxis. There were no concomitant medications reported. On 02-FEB-2017, the patient experienced a stiff neck with swelling and pain. The patient sought medical attention via visiting emergency room and was referred for physical therapy. It was also stated that in case pain continued an x-ray would be ordered. The outcome of local swelling, neck pain and musculoskeletal stiffness was unknown at the time of the report. The relatedness between the adverse events and therapy with GARDASIL 9 was not provided. Additional information is not expected as no follow up can be obtained from the local regulatory authority.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning an 11 year old female patient. Other medications, current illnesses, medical history and prior vaccinations were not provided. On 09-FEB-2017 the patient was vaccinated with GARDASIL 9 (strength, dose, and expiration date unknown, lot # L037554, intramuscular in the right arm), MENVEO (strength, dose, and expiration date unknown, lot # M15167, intramuscular in the left arm) and FLUARIX QUADRIVALENT(strength, dose, and expiration date unknown, lot # C54L5, intramuscular in the left arm) for prophylaxis. On 09-FEB-2017, the patient experienced syncope episode. The outcome of the event was reported as recovered. The causality between the event and all suspect vaccines was not reported. Additional information is not expected since no further information could be requested from the agency.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Information was received on 10-MAY-2017 from the Freedom for Information Act received from private facility via the Food and Drug Administration concerning an 11 year old male patient. Concurrent conditions included constipation. No concomitant medications or medical history was reported. On 15-FEB-2017, the patient received his second dose of GARDASIL 9 (lot M032650, expiration unknown) intramuscularly in the left arm for prophylaxis. On 16-FEB-2017, the patient experienced headache, fever and vomiting. Subsequently the patient recovered on an unknown date. The causality was not reported. Additional information is not expected.
Sex: M
Vaccine: ANTH, HPV9, JEV1, SMALL, TYP, ANTH, HPV9, JEV1, SMALL, TYP
Symptoms: Chest X-ray, Chest pain, Full blood count, Laboratory test, Metabolic function test
Clinical narrative: This spontaneous report as received from a facility via the Food and Drug Administration under the Freedom for Information Act and refers to a 21 year old male patient. No concomitant medication, medical history or concurrent conditions reported. On 21-FEB-2017 the patient was vaccinated with GARDASIL 9 lot # M037770, no expiration reported, dose 2, intramuscular in the right arm for prophylaxis. Other suspect therapies included ACAM2000, (lot VV03019C, no expiration reported) via unknown route in the left arm, BIOTHRAX (lot FAV487, no expiration reported) intramuscularly in the right arm, IXIARO (lot JEV15L07E, not expiration reported) intramuscularly in the right arm and TYPHIM VI (lot M1287, no expiration reported) intramuscularly in the right arm. On 22-FEB-2017, 2 days after onset of therapy, the patient experienced chest burning and pain centrally and across both pectoral muscles, myalgia, metabolic function test, laboratory test, full blood count and chest x-ray (no test results reported). It was reported that the patient  had an emergency visit. The outcome of chest pain, myalgia, metabolic function test, laboratory test, full blood count and chest x-ray is unknown. The causality was not reported. Additional information is not expected.
Sex: M
Vaccine: ANTH, HPV9, JEV1, SMALL, TYP, ANTH, HPV9, JEV1, SMALL, TYP
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a facility via the Food and Drug Administration under the Freedom for Information Act and refers to a 21 year old male patient. No concomitant medication, medical history or concurrent conditions reported. On 21-FEB-2017 the patient was vaccinated with GARDASIL 9 lot # M037770, no expiration reported, dose 2, intramuscular in the right arm for prophylaxis. Other suspect therapies included ACAM2000, (lot VV03019C, no expiration reported) via unknown route in the left arm, BIOTHRAX (lot FAV487, no expiration reported) intramuscularly in the right arm, IXIARO (lot JEV15L07E, not expiration reported) intramuscularly in the right arm and TYPHIM VI (lot M1287, no expiration reported) intramuscularly in the right arm. On 22-FEB-2017, 2 days after onset of therapy, the patient experienced chest burning and pain centrally and across both pectoral muscles, myalgia, metabolic function test, laboratory test, full blood count and chest x-ray (no test results reported). It was reported that the patient  had an emergency visit. The outcome of chest pain, myalgia, metabolic function test, laboratory test, full blood count and chest x-ray is unknown. The causality was not reported. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Crying, Gait disturbance, Immediate post-injection reaction, Injection site erythema, Injection site pain
Clinical narrative: Immediately following the vaccine, patient began limping and crying. Was limping until bed time. Woke up on 5/21 still limping. 5/22 developed warm to the touch visibly red thigh. The whole thigh area is visibly swollen, red and warm and is still painful.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Immediately following the vaccine, patient began limping and crying. Was limping until bed time. Woke up on 5/21 still limping. 5/22 developed warm to the touch visibly red thigh. The whole thigh area is visibly swollen, red and warm and is still painful.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Incorrect route of drug administration, Pain, Pyrexia, Vaccination site inflammation, Weight bearing difficulty
Clinical narrative: Both MMR and Varicella vaccines were administered intramuscularly instead of subcutaneously as recommended. The following symptoms occurred within 12 hours: Inflammation in upper thighs at vaccination site. Low grade fever. Painful to touch and unwillingness to bear weight on legs.
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: This spontaneous retrospective pregnancy report as received on 04-MAY-2017  from a registered nurse which refers to a female patient of unknown age. The reporting nurse stated that the patient, at unspecified times, received first and second doses in GARDASIL immunization series.  The registered nurse stated that at unspecified time patient became pregnant and delivered baby and patient is now seeking to complete the GARDASIL immunization.  (The lot number and expiration date of the first and second dose of the vaccine was not reported.)    The reporting nurse refused to answer questions about experience and did not report any adverse effects to patient or baby. No further information was provided. Additional information is not expected as the reporter did not give permission to contact her.