chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Influenza B virus test, Influenza virus test negative, Lethargy, 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 # 629937) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included asthma exercise induced and recurrent urinary tract infection. The patient had no concurrent illnesses. The patient's concomitant therapies were not reported. The patient's other medications included OTC cold preparation (did not get details of specific ingredients). On 18-MAR-2016 the patient was vaccinated with third dose of GARDASIL 9 lot # L016428 (expiration date: 30-JUL-2017) (dose and frequency were not reported), via intramuscular route, in the left arm for prophylaxis. On 19-MAR-2016, the patient developed sudden onset of fever and lethargy which last over one week. The patient also had decreased appetite, cough, headache and shortness of breath. The patient's lab data included influenza A and B virus test negative. The patient had visited emergency room. The outcome of cough, pyrexia, lethargy, influenza B virus test, influenza A virus test negative, headache, dyspnoea and decreased appetite were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Drooling, Hypertonia, 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 # 630121). This spontaneous report refers to a 13 year old female patient. The patient had no current illnesses and medical history. Information on patient's other medications was not reported. On 21-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiry date: 17-OCT-2017), dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient experienced hypertonia (also reported as hyper tonic), prolonged syncope, drooling and was referred to emergency room. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 630155). This spontaneous report refers to a 17 year old female patient. Information on patient's concurrent illnesses, medical history and other medications were not reported. On 30-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L016429 (expiry date: 09-AUG-2017), intramuscularly for prophylaxis. On the same day, the patient also vaccinated with VARIVAX lot # L020002, intramuscularly and MENACTRA lot # U5037AA, intramuscularly for prophylaxis. On 30-MAR-2016, the patient began to exit mobile clinic setting within 5 minutes of receiving three vaccines and experienced syncope at 15:57. The outcome of the event syncope was reported as recovered. The causality assessment of the event syncope 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, MNQ, TDAP
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 (VAERS # 630234). This spontaneous report refers to a 11 year old male patient. Patient's current illnesses included cold with symptoms of cough and nasal congestion. The patient's medical history included asthma. On 29-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L019297 (expiry date: 18-AUG-2017), dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # 59TN9R, dose 1, intramuscularly in the left arm and MENACTRA lot # U5187AA, dose 1, intramuscularly in the right arm for prophylaxis. On 30-MAR-2016, the patient developed hives covering his entire body, 24 hours after receiving vaccinations. The outcome of the event urticaria was reported as recovered. The causality assessment for the event urticaria with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MEN
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient had no medical history and current illnesses. The patient's other medications and prior vaccinations were not reported. On 04-APR-2016, the patient was vaccinated with third dose of GARDASIL 9 intramuscularly in the left arm (dose, frequency, lot number and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENOMUNE (dose number: 2, vaccinated date: 04-APR-2016, intramuscularly in the left arm, (lot number; dose and expiration date unknown)). On 06-APR-2016, the patient experienced redness, swelling and warm to touch. The outcome of erythema, swelling and skin warm was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Pain, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 630436). This spontaneous report refers to a 18 year old female patient. Information on the patient's medical history, prior vaccinations and other medications were not reported. The patient had no concurrent illnesses. On 05-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (expiry date: 19-OCT-2017) dose 1, intramuscular in the left arm for prophylaxis. On the same day, the patient was also vaccinated with VAQTA lot # L032749, dose 1, intramuscular route in the left arm, VARIVAX lot # L035129, dose 2, Subcutaneous route in the right arm and MENACTRA batch/lot# U5179AA, dose 2, intramuscular route in the right arm for prophylaxis. On 05-APR-2016, the patient experienced extreme stomach pains (upper) with vomiting, body aches, lightheaded, generalized weakness and feverish. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, VARCEL
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 # 630436). This spontaneous report refers to a 18 year old female patient. Information on the patient's medical history, prior vaccinations and other medications were not reported. The patient had no concurrent illnesses. On 05-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (expiry date: 19-OCT-2017) dose 1, intramuscular in the left arm for prophylaxis. On the same day, the patient was also vaccinated with VAQTA lot # L032749, dose 1, intramuscular route in the left arm, VARIVAX lot # L035129, dose 2, Subcutaneous route in the right arm and MENACTRA batch/lot# U5179AA, dose 2, intramuscular route in the right arm for prophylaxis. On 05-APR-2016, the patient experienced extreme stomach pains (upper) with vomiting, body aches, lightheaded, generalized weakness and feverish. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Chest pain, Dysphagia, Headache, Throat tightness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient had no current illnesses and other medications and the patient's prior vaccinations were not reported. The patient's medical history included new daily onset of headaches, dysmenorrhea, acne and history of kidney problems. On 19-APR-2016, the patient was vaccinated with the third dose of GARDASIL 9, lot # L044475, intramuscular in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. On 20-APR-2016, the patient experienced intense headache, chest pain, tight throat with difficulty swallowing. On an unknown date, the patient had an emergency room (ER) visit. The outcome of chest pain, throat tightness, headache and dysphagia was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: 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 (HA #632837) and refers to a 14 year old female patient. Current illness was reported as Vaccine appt. History was reported as no known allergies (NKA). Lab data was none. No details about other medications and prior vaccination was provided. On 08-APR-2016 the patient was vaccinated with GARDASIL 9 lot # L040164, dose 2, via unknown route in the left arm for prophylaxis (strength and dosing detail unknown). On an unknown date the patient experienced pain. The outcome of pain was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 633695) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient's medical history included pollen allergy and obesity. Information on current illness, concomitant medications, lab data and prior vaccinations were not reported. Other medications included Sudafed Children's Nasal Decongestant. On 25-APR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L044475, dose number 2 through intramuscular route (dose, frequency and lot expiration date unknown) in the right arm for prophylaxis. Other suspect therapies included MENVEO (Manufacturer: Novartis, vaccinated date: 25-APR-2016, dose number 1, lot # M15068, (dose, frequency and lot expiration date unknown), intramuscular, left arm) for prophylaxis. On an unspecified date, it was reported that the patient administered an incorrect product formulation. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Body temperature increased, Cold sweat, Feeling abnormal, Oropharyngeal pain, 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 # 633752). This spontaneous report refers to a 13 year old female patient. The patient had no concurrent illnesses and medical history. Information on patient's other medications was not reported. On 28-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L018351, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, patient was also vaccinated with BOOSTRIX lot # 9NA32, dose 1, intramuscularly in the right arm and meningococcal conjugate vaccine (unspecified) lot # U5186AA, dose 1, via intradermal route in the right arm for prophylaxis. On 28-APR-2016, shortly after receiving vaccinations, the patient was feeling bad, her throat hurt and very clammy, PO 100 degree F, P 101 (units not reported), respiratory and cardiovascular (N). Patient laid down and symptoms eventually started to resolve and syncope recovered. Patient was given benadryl because of throat as precaution. After 20 minutes vitals were stable. 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: HEPA, HPV9
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 # 633976). This spontaneous report refers to a 15 year old female patient. The patient's concurrent illnesses was not reported. The patient's medical history included anxiety. On 02-MAY-2016 the patient was vaccinated with GARDASIL 9 lot # L043213, dose 4, intramuscularly in the left arm for prophylaxis. Other suspect therapies included HAVRIX (lot # 25DM2, dose 3, intramuscularly in the right arm, vaccination date: 02-MAY-2016). On 02-MAY-2016, the patient had an extra dose administration and no events were reported. The outcome for extra dose administration was reported as recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.
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 under the Freedom of Information Act (VAERS # 634018). This spontaneous report refers to a 9 year old male patient. Patient had no concurrent illnesses, medical history and other medications. On 27-APR-2016, the patient was vaccinated with (GARDASIL 9) lot # L043213, dose 1, route: unknown in the right arm for prophylaxis. On the same day, the patient went to school after receiving vaccine at office and two hours later he had hives (urticaria) on various parts of his body. The patient required emergency room visit. The outcome of the event urticaria was reported as unknown. The causality assessment of the event urticaria with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 634101). This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses and medical history. Information on patient's other medications was not reported. On 29-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L016428 (expiry date: 30-JUL-2017), dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U5209AA, dose 2, intramuscularly in the left arm and MENVEO lot # A15068, dose 2, intramuscularly in the right arm for prophylaxis. On 29-MAR-2016, patient's left arm became red, was hot to touch and a raised area was formed at injection site in the size of baseball. The patient did not run a fever and symptoms disappeared in 5 days. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, 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 # 634115). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses and information on medical history was not reported. Patient's other medication included albuterol, zyrtec, flonase and advair HFA. On 02-MAY-2016, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX lot # E735A, dose 6, intramuscularly in the right arm and MENVEO lot # A15077AA, dose 1, intramuscularly in the left arm for prophylaxis. On 02-MAY-2016, after receiving vaccines patient complained of lightheadedness dizziness which lasted approximately 5 minutes. Patient laid on the exam table with legs propped up and a cup of water was given. The outcome of the event dizziness was reported as recovered. The causality assessment for the event dizziness 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, MNQ, TDAP
Symptoms: Erythema, Swelling, 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 # 634157). This spontaneous report refers to a 11 year old male patient. Patient's current illnesses included unspecified inflammation issues. Patient's other medications included ADACEL and MENVEO and HPV9 (Human Papillomavirus) 9 valent. Information on patient's medical history was not reported. On 02-MAY-2016, the patient was vaccinated with GARDASIL 9 (dose, lot #, route and site not reported) for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (dose, lot #, route and site not reported) and MENVEO (dose, lot #, route and site not reported). On 03-MAY-2016, the patient experienced localized hives, swelling and redness. Patient was given benadryl and benadryl cream was applied on the area. 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: HPV9
Symptoms: Computerised tomogram head normal, Electroencephalogram normal, Neurological examination normal, Psychogenic seizure
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient had no medical history and current illnesses. The patient's other medications and prior vaccinations were not reported.  On 09-NOV-2015, third dose of GARDASIL 9, intramuscularly (dose, frequency, lot number and lot expiration date were not reported) for prophylaxis. Lab data included: Normal EEG (electroencephalogram) and neurology evaluation, normal head CT (computerised tomogram). On 01-DEC-2015, patient underwent neurological examination normal, electroencephalogram, computerised tomogram head normal and had pseudoseizures. The patient's parents requested report to be submitted. On an unknown date, patient had emergency room (ER) visit. The outcome of neurological examination normal and psychogenic seizure were reported as unknown.  Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no current illnesses. The patient's other medications, medical history and prior vaccinations were not reported. On 03-MAY-2016, the patient was vaccinated with third dose of GARDASIL 9, lot # L043213, route of administration: unknown, in the left arm, prn (dose, lot number and lot expiration date were not reported) for prophylaxis. Telephone call (TC) from patient's mother on 04-MAY-2016 stated that the patient developed only fever with a temperature 101.6 =>102.5 and no other symptoms. The outcome of fever was reported as unknown. 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: Computerised tomogram head normal, Electroencephalogram normal, Psychogenic seizure
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On 22-OCT-2015, the patient was vaccinated with the second dose of GARDASIL 9, lot # L014415, intramuscular in the right arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Lab data included: Normal EEG and neurology evaluation; Negative head CT. On 09-NOV-2015, the patient underwent electroencephalogram normal, computerized tomogram head normal and had pseudoseizures and the patient's parents requested report to be submitted. On an unknown date patient had emergency room (ER) visit. The outcome of electroencephalogram normal, psychogenic seizure and computerized tomogram head normal was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fall, Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 18 year old male patient. The patient had no current illnesses and medical history. The patient's prior vaccinations were not reported. The patient had no other medications and was reported patient denied any medications. On 04-MAY-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # L044475, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included TRUMENBA (dose number: 1, vaccinated date: 04-MAY-2016, intramuscularly in the right arm, lot # M37314; dose and expiration date unknown). On 04-MAY-2016, the patient walked out to lobby and suddenly fainted, falling backwards from standing position and striking floor. The outcome of fall and syncope were not reported. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient had no current illnesses and patient's other medications and prior vaccinations were not reported. The patient's medical history included neurofibromatosis and scoliosis. On 02-MAY-2016, the patient was vaccinated with the third dose of GARDASIL 9, lot # L038917, intramuscular in the right arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BEXSERO dose number: 1, vaccinated date: 02-MAY-2016, intramuscularly in the left arm, lot # 151301D, (dose, frequency and expiration date unknown). On an unknown date, the patient was unable to extend his left arm fully at the shoulder, when he moves the arm he experiences shooting pains down the arm and had pain in extremity. The outcome of pain, movement disorder and pain in extremity was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, PPV, TDAP
Symptoms: Fatigue, Nausea, Pain, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient's medical history included diabetes. The patient had no current illnesses and prior vaccinations were not reported. The patient's concomitant therapy included insulin for diabetes. On 11-MAY-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L048459, intramuscularly in the right arm (dose, frequency and lot expiration date were not reported) for prophylaxis and PNEUMOVAX dose number: 1, lot # L021367, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 11-MAY-2016, intramuscularly in the right arm, lot # U5228BA; dose and expiration date unknown) and ADACEL (dose number: 1, vaccinated date: 11-MAY-2016, intramuscularly in the left arm, lot# U5378AA; dose and expiration date unknown). On 13-MAY-2016, the patient experienced left arm swollen (peripheral swelling), hot (skin warm), body aches (pain), fatigue and nausea. The patient was offered to see MD (Doctor of medicine). The patient's mother preferred to monitor at home and would continue with Motrin prn and ice to arm. The patient was advised to call back if worsens or new symptoms develop. The outcome of peripheral swelling, pain, nausea, fatigue and skin warm was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, 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 # 636451) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 24 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were reported as none. Information on patient's prior vaccination was not reported. On 28-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L048459, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 18-MAY-2016, the patient noticed 1/4 inch welt, on her left deltoid arm, just 1/2 inch below under the tattoo. The outcome of injection site urticaria was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Peripheral swelling, 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 (HA #636557) and refers to a 11 year old female patient. Patient had no current illnesses and medical history was none. No details about lab data, other medications and prior vaccinations were provided. On 19-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L048459, dose 1, intramuscular in the left arm for prophylaxis (strength and dosing detail unknown). Other suspect therapy included BOOSTRIX. On 20-MAY-2016, approximately 24 hours after the injection the patients arm became swollen from the shoulder to the elbow and was warm to the touch. The outcome of skin warm and peripheral swelling was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's current illnesses, medical history and prior vaccinations were not reported. The patient's concomitant therapy included omeprazole, melatonin, focalin, Zyrtec, Prozac, multivitamin and kristalose. On 18-MAY-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # l048459, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. On 19-MAY-2016, the patient had noted soreness and swelling at injection site the day after receiving vaccine and experienced injection site erythema and injection site nodule. Peak at day 5 with knot and pain at site. The patient was seen in office on day 6 of symptoms - mild pink erythema, fullness but no warmth, pain or knot with no fever. The patient had examination and was normal. The patient was treated with ibuprofen and Benadryl prn. The patient was advised to return if worsens or new symptoms occur. On an unknown date, the patient had an emergency room (ER) visit. The outcome of injection site erythema, injection site swelling, injection site pain and injection site nodule were not reported. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 637567). This spontaneous report refers to a 27 year old male patient. The patient's concurrent illnesses and other medications were not reported. The patient's medical history included HIV. On 01-MAR-2016, the patient was vaccinated with GARDASIL 9 (lot#, frequency and route were not reported) for prophylaxis. On 27-MAY-2016, the patient experienced injection site pain and injection site swelling. The spot on arm where the patient received the GARDASIL 9 vaccine became painful months after vaccination and is swollen up and there is a bump there now. It was painful for a few days after vaccination but now months later the area has swollen up. The patient had an emergency visit. The outcome of injection site pain and injection site swelling were reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Consciousness fluctuating, Immediate post-injection reaction, Loss of consciousness, Nausea, Posture abnormal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638225). This spontaneous report refers to a 16 year old male patient. The patient and his mother denied to report concurrent illnesses, medical history and other medications. On 06-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # L044475, dose 3, intramuscularly in the left arm and VARIVAX, lot # L046887, dose 3, Subcutaneously in the left arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included HAVRIX (lot # Z5DM2, dose 3, intramuscularly in the left arm). Immediately after shot given, patient became nauseated, fainting slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5 mins. On 06-JUN-2016, the patient experienced immediate post-injection reaction, syncope, nausea and loss of consciousness. 911 was called, oxygen administered, vital signs taken blood pressure 120/60, pulse 74 and respiration rate was 20. Patient was kept under observation until paramedic arrive. The patient had an emergency visit. The outcome of immediate post-injection reaction, syncope, nausea and loss of consciousness were reported as unknown.  Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL, HEPA, HPV9, VARCEL
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638225). This spontaneous report refers to a 16 year old male patient. The patient and his mother denied to report concurrent illnesses, medical history and other medications. On 06-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # L044475, dose 3, intramuscularly in the left arm and VARIVAX, lot # L046887, dose 3, Subcutaneously in the left arm for prophylaxis. On the same day, the patient was vaccinated with other suspect therapies included HAVRIX (lot # Z5DM2, dose 3, intramuscularly in the left arm). Immediately after shot given, patient became nauseated, fainting slumping down and totally lost consciousness for 10 seconds and in and out of consciousness for 5 mins. On 06-JUN-2016, the patient experienced immediate post-injection reaction, syncope, nausea and loss of consciousness. 911 was called, oxygen administered, vital signs taken blood pressure 120/60, pulse 74 and respiration rate was 20. Patient was kept under observation until paramedic arrive. The patient had an emergency visit. The outcome of immediate post-injection reaction, syncope, nausea and loss of consciousness were reported as unknown.  Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Cardiac murmur, Feeling jittery, Heart rate decreased, Hypoaesthesia, Nausea
Clinical narrative: This spontaneous report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638240). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses and medical history were not reported. On 06-JUN-2016, the patient was vaccinated with GARDASI 9, dose 2 (route and lot# not reported), for prophylaxis. On an unknown date, shortly after HPV #2 vaccine, the patient had an episode of nausea, jitteriness, and numbness/tingling in lower extremities. Patient needed to lay down and nearly had emesis. He was noted to have a low resting heart rate in the 50s-60s and a cardiac murmur. The duration was 15-20 minutes. A similar episode occurred in this patient following the HPV # 1, although he also received HepA, Tdap, and MENVEO concurrently. The outcome of cardiac murmur, paraesthesia, nausea, hypoaesthesia, heart rate decreased and feeling jittery was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638240). This spontaneous report refers to a 12 year old male patient. The patient's concurrent illnesses and medical history were not reported. On 06-JUN-2016, the patient was vaccinated with GARDASI 9, dose 2 (route and lot# not reported), for prophylaxis. On an unknown date, shortly after HPV #2 vaccine, the patient had an episode of nausea, jitteriness, and numbness/tingling in lower extremities. Patient needed to lay down and nearly had emesis. He was noted to have a low resting heart rate in the 50s-60s and a cardiac murmur. The duration was 15-20 minutes. A similar episode occurred in this patient following the HPV # 1, although he also received HepA, Tdap, and MENVEO concurrently. The outcome of cardiac murmur, paraesthesia, nausea, hypoaesthesia, heart rate decreased and feeling jittery was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 638288) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Patient's medical history included infant gastroesophageal reflux. Patient's historical drug included dacryocystocele (OD). Information on the patient's concurrent illnesses, lab data and other medications were reported as none. Information on patient's prior vaccination was not reported. On 27-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot# M007728, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was vaccinated with BOOSTRIX lot/batch# KJ4MS, via intramuscular route, in the left arm and MENVEO lot# M15098, via intramuscular route, in the right leg for prophylaxis (dosage and expiry date unspecified). On 27-MAY-2016, itching began at the injection site after the vaccination. Patient had redness, swelling and pain with the hard lump at injection site. It continued till one week and currently patient had a small lump at the injection site. The outcome of injection site erythema, injection site swelling, injection site pruritus, injection site pain, injection site mass and injection site induration was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 638288) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Patient's medical history included infant gastroesophageal reflux. Patient's historical drug included dacryocystocele (OD). Information on the patient's concurrent illnesses, lab data and other medications were reported as none. Information on patient's prior vaccination was not reported. On 27-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot# M007728, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was vaccinated with BOOSTRIX lot/batch# KJ4MS, via intramuscular route, in the left arm and MENVEO lot# M15098, via intramuscular route, in the right leg for prophylaxis (dosage and expiry date unspecified). On 27-MAY-2016, itching began at the injection site after the vaccination. Patient had redness, swelling and pain with the hard lump at injection site. It continued till one week and currently patient had a small lump at the injection site. The outcome of injection site erythema, injection site swelling, injection site pruritus, injection site pain, injection site mass and injection site induration was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Pain, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 639234). This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses and information on patient's medical history and other medications were not reported. On 08-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with meningococcal conjugate vaccine (unspecified), batch/lot # A15076A, dose 1, intramuscularly in the left arm and BOOSTRIX batch/lot # 541S7, dose 1, intramuscularly in the left arm for prophylaxis. On 09-JUN-2016, the patient experienced swelling, redness and pain when his left arm moved and it was warm to touch. Patient was given cold compress, benadryl prn for itching and ibuprofen prn for 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: 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 # 639234). This spontaneous report refers to a 11 year old male patient. The patient had no concurrent illnesses and information on patient's medical history and other medications were not reported. On 08-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L044475, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with meningococcal conjugate vaccine (unspecified), batch/lot # A15076A, dose 1, intramuscularly in the left arm and BOOSTRIX batch/lot # 541S7, dose 1, intramuscularly in the left arm for prophylaxis. On 09-JUN-2016, the patient experienced swelling, redness and pain when his left arm moved and it was warm to touch. Patient was given cold compress, benadryl prn for itching and ibuprofen prn for 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Skin discolouration, 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 # 639575) 0n 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Patient's medical history include allergic to amoxicillin. Information on the patient's concurrent illnesses and other medications were reported as none. Information on patient's prior vaccinations were not reported. On 20-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot/batch# L04475, via intramuscular route, in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was vaccinated with MENACTRA lot/batch# U5216AA, dose 1, via intramuscular route, in the left arm and ADACEL lot/batch# C4713AA, via intramuscular route, in the left arm for prophylaxis (dosage and expiry date unspecified). On 20-MAY-2016, the patient had hives on trunk, arms, legs. Initially on 23-MAY-2016, the patient was treated with Benadryl. On 23-MAY-2016, patient was given hydroxyzine for rash improvement for purple areas. Patient was advised to have a recheck up with allergy consultant. The outcome of skin discolouration, rash and urticaria was reported as not recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Cellulitis, 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 # 640009) on 18-APR-2017. This spontaneous report refers to a 24 year old female patient. The patient's concurrent condition included cold (sore throat, coughing) and other medications included Sertraline and Lutera. Information about the patient's medical history was not reported. On 16-JUN-2016, the patient was vaccinated with GARDASIL 9, dose 3 (unspecified dosage and lot #) via unspecified route in the left arm for prophylaxis. On 17-JUN-2016, the patient experienced injection site erythema and injection site swelling. The patient had a large red swelling on the arm, that received the injection and the swelling was reported to have grown rapidly to reach from the shoulder to elbow. The patient required an emergency room visit, where the doctor diagnosed it as cellulitis and prescribed antibiotics. The outcome of the events was unknown. The causality assessment for the events with respect to GARDASIL 9 was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Cellulitis, Injection site rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640539) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. Information about the patient's concurrent illnesses, prior vaccinations and other medications were not reported. The patient's medical history included no known drug allergies (NKDA). On 06-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # 1020015 (dosage, frequency and dose number were unspecified) in the right arm via unspecified route for prophylaxis. On the same day, patient was vaccinated with BOOSTRIX lot # 9NA32, (dosage, frequency and dose number were unspecified) in the left arm via unspecified route for prophylaxis and MENACTRA lot # U5058AB, (dosage, frequency and dose number were unspecified) in the left arm via unspecified route for prophylaxis. On 07-JUN-2016, the patient experienced cellulitis of upper limb and injection site rash in arm deltoid - 4.5 cm x 7.5 cm in diameter with irregular borders. The patient was treated with Cefdinir 250 mg/5 ml oral suspension, at a dose of 8 ml per day orally, with meals for 10 days. The outcome of the events was unknown. The causality assessment for the events cellulitis and injection site rash 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: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Fatigue, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 640991). This spontaneous report refers to a 17 year old male patient. The patient had blood work attempt at this visit and no concurrent illnesses were reported. The patient's medical history was not reported. On 24-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # M009362, dose 3, intramuscularly in the left arm for prophylaxis. Other suspect therapies included TRUMENBA (lot # M37316, dose 1, intramuscularly in the right arm, vaccination date: 24-JUN-2016). On the same day of vaccination, the patient experienced dizziness, injection site pain and fatigue. Patient's blood work was attempted and failed, after the patient had shots, the patient experienced dizzy lightheaded, next day very fatigued, right arm hurt from injection site to shoulder. The outcome of dizziness, injection site pain and fatigue were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient had no current illnesses. The patient's other medications and prior vaccinations were not reported. The patient's medical history included longitudinal melanonychia. On 29-JUN-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L024993, intramuscular in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL dose number: 1, vaccinated date: 29-JUN-2016, intramuscularly in the right arm, lot# U5292AA; dose and expiration date unknown) and MENACTRA dose number: 1, vaccinated date: 29-JUN-2016, intramuscularly in the right arm, lot# U5216AA; dose and expiration date unknown). And the same day approximately after 2 minutes of GARDASIL 9 vaccination, the patient got off tablet felt dizzy and passed out. The outcome of dizziness and was loss of consciousness reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.