chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Contusion, Headache, Hypoaesthesia, Limb discomfort
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 # 627834) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Information on the patient's other medications and prior vaccinations were not reported. The patient's medical history included allergic to nuts and peanuts. Patient had no concurrent illnesses. On 10-MAR-2016, the patient was vaccinated in office with the first dose of GARDASIL 9 lot # L019297, via intramuscular route, in the left arm for prophylaxis (dosage unspecified). From 11-MAY-2016, patient had aches and joint pains. Patient did not have fever and URI symptoms post vaccination. Post vaccination days patient's leg was hurting a little bit to walk, but on next day the leg pain was gone and has not come back since then, but the arms have gotten worse. Next week, post vaccination patient played (played on Tuesday and Wednesday) in the volleyball tournament. After she finished playing volleyball, she had numbness starting from her armpits down to her forearms. Her fingers had sensation. The numbness lasted until she fell asleep. When she woke up next morning she could feel her arms, but they did hurt very badly. The discomfort was present on both the arms. Patient had a mild headache at least every other day since vaccination. In the week of vaccination, she did not eat any new foods or nut containing foods. She stayed home (on monday) after practice because of the discomfort. Patient had a spontaneous bruise on her right knee (noticed on Sunday). The bruise on her right knee has gotten bigger, but does not remember hitting knee, as there was no volleyball practice during that time, she played last volleyball was on the 10-MAY-2016 for a routine practice which was uneventful and prior to getting Gardasil vaccine. Patient's mother had given her Tylenol and not ibuprofen for bruise. No tests ordered for the patient but advised for an evaluation to infectious disease specialist. The outcome of loss of personal independence in daily activities, sensory disturbance, pain in extremity, pain, limb discomfort, hypoaesthesia, headache, contusion and arthralgia 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.
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 627834) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Information on the patient's other medications and prior vaccinations were not reported. The patient's medical history included allergic to nuts and peanuts. Patient had no concurrent illnesses. On 10-MAR-2016, the patient was vaccinated in office with the first dose of GARDASIL 9 lot # L019297, via intramuscular route, in the left arm for prophylaxis (dosage unspecified). From 11-MAY-2016, patient had aches and joint pains. Patient did not have fever and URI symptoms post vaccination. Post vaccination days patient's leg was hurting a little bit to walk, but on next day the leg pain was gone and has not come back since then, but the arms have gotten worse. Next week, post vaccination patient played (played on Tuesday and Wednesday) in the volleyball tournament. After she finished playing volleyball, she had numbness starting from her armpits down to her forearms. Her fingers had sensation. The numbness lasted until she fell asleep. When she woke up next morning she could feel her arms, but they did hurt very badly. The discomfort was present on both the arms. Patient had a mild headache at least every other day since vaccination. In the week of vaccination, she did not eat any new foods or nut containing foods. She stayed home (on monday) after practice because of the discomfort. Patient had a spontaneous bruise on her right knee (noticed on Sunday). The bruise on her right knee has gotten bigger, but does not remember hitting knee, as there was no volleyball practice during that time, she played last volleyball was on the 10-MAY-2016 for a routine practice which was uneventful and prior to getting Gardasil vaccine. Patient's mother had given her Tylenol and not ibuprofen for bruise. No tests ordered for the patient but advised for an evaluation to infectious disease specialist. The outcome of loss of personal independence in daily activities, sensory disturbance, pain in extremity, pain, limb discomfort, hypoaesthesia, headache, contusion and arthralgia 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.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 628397) on 18-APR-2017. This spontaneous report refers to a 14 year old female patient. The patient had no known concurrent illnesses and historical conditions. Information about the patient's other medications was unknown. On 08-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L023230 (Expiration date: 28-JUL-2017) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA lot # U5178AA, dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day after the vaccine was administered, the patient's mother stated that the problem began on the left arm, at the injection site and then extended to shoulder and wrist of the same arm. The patient required an emergency room visit after the injection site became red, hot, hard, swollen, painful and itchy over the course of few days, following vaccination. The patient's mother stated that, after 4-5 days post-vaccination, these symptoms went away and there were no residual symptoms. The outcome of the events was reported as recovered. 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, MNQ
Symptoms: 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 # 628397) on 18-APR-2017. This spontaneous report refers to a 14 year old female patient. The patient had no known concurrent illnesses and historical conditions. Information about the patient's other medications was unknown. On 08-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L023230 (Expiration date: 28-JUL-2017) dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was vaccinated with MENACTRA lot # U5178AA, dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day after the vaccine was administered, the patient's mother stated that the problem began on the left arm, at the injection site and then extended to shoulder and wrist of the same arm. The patient required an emergency room visit after the injection site became red, hot, hard, swollen, painful and itchy over the course of few days, following vaccination. The patient's mother stated that, after 4-5 days post-vaccination, these symptoms went away and there were no residual symptoms. The outcome of the events was reported as recovered. 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.
Age: 18.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: 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 # 629103) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 18 year old female patient. The patient had no medical history, concurrent illnesses and other medications. Information on the patient's prior vaccinations was not reported. On 15-FEB-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L045711 (dose number: 3, lot expiration date unknown) for prophylaxis. On the same day, the patient was also vaccinated with BEXSERO (dose number: 1, intramuscularly in the right arm, lot # 151301D, manufacturer: Novartis, lot expiration date unknown) and MENACTRA (dose number: 2, intramuscularly in the right arm, lot # U5180AA, manufacturer: Sanofi Pasteur, lot expiration date unknown) for prophylaxis. On 17-FEB-2016, the patient experienced localized rash at injection site in the right deltoid area. The outcome for the event injection site rash was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Borrelia test negative, Epistaxis, Fatigue, Headache, Hypersomnia
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 # 629447) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 15 year old male patient. The patient's medical history included none except allergy to cortisone. The patient's concurrent illnesses and other medications were reported as none. Information on the patient's prior vaccinations was not reported. On 23-NOV-2015, the patient was vaccinated with GARDASIL 9 (unknown route and site )(dose number, lot# and expiration date were not reported.) for prophylaxis. On 01-DEC-2015, the patient experienced excessive fatigue, nosebleed, headaches and nausea. The patient slept for more than 13 hours straight through several times per week. Sometimes the patient also slept more than 20 hours straight through. The patient's lab data included mononucleosis heterophile test, lab test for Lyme and all other lab tests whose results were negative or inconclusive. The outcome for the events borrelia test negative, nausea, headache, fatigue, mononucleosis heterophile test negative, laboratory test normal, hypersomnia and epistaxis 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.
Sex: M
Vaccine: HPV9
Symptoms: Laboratory test normal, Mononucleosis heterophile test negative, Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 629447) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 15 year old male patient. The patient's medical history included none except allergy to cortisone. The patient's concurrent illnesses and other medications were reported as none. Information on the patient's prior vaccinations was not reported. On 23-NOV-2015, the patient was vaccinated with GARDASIL 9 (unknown route and site )(dose number, lot# and expiration date were not reported.) for prophylaxis. On 01-DEC-2015, the patient experienced excessive fatigue, nosebleed, headaches and nausea. The patient slept for more than 13 hours straight through several times per week. Sometimes the patient also slept more than 20 hours straight through. The patient's lab data included mononucleosis heterophile test, lab test for Lyme and all other lab tests whose results were negative or inconclusive. The outcome for the events borrelia test negative, nausea, headache, fatigue, mononucleosis heterophile test negative, laboratory test normal, hypersomnia and epistaxis 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: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Discomfort, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
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 # 629598) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 13 year old female patient. The patient's historical drug included Keflex and Penicillin. The patient's concurrent illnesses included pharyngitis with no fever. The patient's other medications and prior vaccinations were not reported. On 18-MAR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the right arm, lot # L020015 (dose number: 2, lot expiration date:16-AUG-2017) for prophylaxis. On the same day, the patient experienced immediate tingling of arm and numbness in fingers which was resolved 24 hours later. The patient had residual discomfort and felt transient weakness 10 days later. The patient's lab data was reported as none. The outcome of the events was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Rash, Rash erythematous, Rash pruritic
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 # 629780) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient's concurrent illness and medical history were reported as none. The patient's concomitant therapies, other medications and prior vaccinations were not reported. On 24-FEB-2016 the patient was vaccinated with first dose of GARDASIL 9 lot # L020015, lot expiration date 16-AUG-2017(dose and frequency were not reported), via intramuscular route, in the right arm for prophylaxis. Two weeks post vaccination with first dose of GARDASIL, the patient developed an itchy red rash on both hands. The rash was still present on 07-MAR-2016. The patient's hands were red with rash and itchy but otherwise he was well. The outcome of rash erythematous and rash pruritic 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.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Unevaluable 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 # 630284) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old female patient. The patient's medical history, concurrent illnesses and other medications was reported as none. Information on the patient's prior vaccinations was not reported. On 16-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L044475 (lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX (dose number: 1, intramuscularly in the left arm, lot # 9N74F, manufacturer: GlaxoSmithKline, lot expiration date was not reported) and MENVEO (dose number: 1, intramuscularly in the left arm, lot # M15068, manufacturer: Novartis, lot expiration date was not reported) for prophylaxis. On 18-MAR-2016, drug administered to patient of inappropriate age was reported. The event required emergency room (ER) visit. The outcome for the event was reported as recovered.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pruritus, Injection site rash, 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 # 630291) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 10 year old male patient. The patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 04-APR-2016, the patient was vaccinated with GARDASIL 9) intramuscularly in the left arm, lot # L040164 (dose number: 2; lot expiration date was not reported) for prophylaxis. On 04-APR-2016, while the patient was checking out of the office, he notified the staff that he had experienced rash at the injection site which was itchy, slightly warm to touch and flat lacey pattern was noted. The doctor was notified and the injection site was assessed. The patient's vital signs were stable and he had no difficulty breathing. The rash was fading at the time the patient was leaving. The outcome for the events injection site pruritus, injection site warmth and injection site rash 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: Arthralgia, Heart rate increased, Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 23 year old female patient. The patient had no other medications, current illnesses, medical history and the patient's prior vaccinations was not reported. On 01-APR-2016, the patient was vaccinated with third dose of GARDASIL 9, lot # L024993, intramuscularly in the left arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis. And on the same day, the patient had fever 102, fast heart rate, muscle pain, pain in left elbow, and numbness in left little and right fingers. All symptoms were resolved when she got up on 02-APR-2016 Saturday morning. The outcome of myalgia and fever 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, MENB, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 17 year old female patient with prophylaxis. The patient had no current illnesses, medical history and other medications it was reported that patient's mother instructed on use of ibuprofen (if not contraindicated for patient) at home to help with any swelling and discomfort beyond the redness and heat that may occur. The patient's prior vaccinations was not reported. On 04-APR-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L026602, 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: 04-APR-2016, intramuscularly in the left arm, lot # U5228BB; (dose and expiration date unknown) and TRUMENBA dose number: 1, vaccinated date: 04-APR-2016, intramuscularly in the right arm, lot # M37315; (dose and expiration date unknown). On 04-APR-2016, the patient had experienced small amount of heat felt on right deltoid injection site cold compress was placed and 2 minutes later noticed redness and heat at the left deltoid front injection site. Cold compress was placed. The outcome of injection site erythema and injection site warmth 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: HPV9
Symptoms: Face injury, 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 # 630362) on 18-APR-2017. This spontaneous report refers to a 14 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 29-MAR-2016 the patient was vaccinated with the second dose of GARDASIL 9 lot # L044475 (dose, frequency and lot expiration date were not reported), intramuscularly in the left arm for prophylaxis. On 29-MAR-2016, the patient fainted   while walking to the door after vaccination and hit her face on the floor. The patient was responsive after about a minute and no abnormal movements were observed and her vital signs were normal. She was alert, oriented and became pink within another minute. The patient visited emergency room. The outcome of face injury and syncope was reported as recovered. The causality assessment was unknown. Additional information is not expected from  the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site urticaria, 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 # 630503) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old female patient. The patient's medical history, concurrent illness, prior vaccination, concomitant therapy and other medication was not reported. On 25-MAR-2016, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly in the left arm, lot # L043213 (dose, frequency and lot expiration date were not reported) for prophylaxis.  On the same day, the patient was also vaccinated with second dose of MENVEO(intramuscularly in the left arm, lot# M15067; dose, frequency and lot expiration date were not reported) for prophylaxis. The patient passed out after blood was drawn and vaccination. On 26-MAR-2016 (24 hours later), patient developed localized hives on the left upper arm down to the elbow. The patient was given Benadryl and Claritin orally and hydrocortisone topically. The patient had visited the emergency room. The outcome for the events injection site urticaria and loss of consciousness were unknown. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness, Tinnitus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 630594). This spontaneous report refers to a 18 year old female patient. The patient had no concurrent illnesses or medical history. Information on the patient's prior vaccinations and other medications were not reported. On 07-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L024993 (expiry date: 17-OCT-2017), dose 1, intramuscular in the right arm, HAVRIX batch/lot# P3A42, dose 1, intramuscular route in the left arm and MENACTRA batch/lot# U5216AA, dose 1, intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient complained of dizziness and ringing in the ears. The outcome of dizziness and tinnitus was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Blood glucose decreased, Dizziness, Fall, 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 # 630856). This spontaneous report refers to a 12 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder (ADHD). The patient had no concurrent illnesses. Information on the patient's prior vaccinations was not reported. The patient's other medication included metadate CD 50 (1 cap, every morning) and methylphenidate 10 (1 tab, every afternoon). On 06-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (expiry date: 19-OCT-2017), dose 2, intramuscular route in the left arm for prophylaxis. On the same day, the patient felt lightheaded, went down but did not lose consciousness. The patient's vital signs were checked and was within normal limits, glucose was low at 64 even though patient had eaten. The patient complained of left sided achiness for two days after the shot. The outcome of the events was reported as recovered. The causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site pain, 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 # 630955). This spontaneous report refers to a 15 year old female patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations and other medications were not reported. On 09-APR-2016, the patient was vaccinated with GARDASIL 9 lot # L028082 (expiry date: 18-SEP-2017), dose 3, intramuscular route in the left arm for prophylaxis (dosage unspecified). On an unknown date, the patient complained of soreness at injection site, swelling at injection site, fever at injection site and the patient's arm was red. The outcome of erythema, injection site warmth, injection site swelling and injection site pain was unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 631105) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient had no medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 07-APR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L023230, Expiration date: 28-JUL-2017, (dose, dose number unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, vaccinated date: 07-APR-2016, lot # U5241AA, (dose, dose number a lot expiration date unknown) via intramuscular route in the left arm) and MENACTRA (Manufacturer: Sanofi Pasteur, vaccinated date: 07-APR-2016, lot # U5180AA, (dose, dose number a lot expiration date unknown) via intramuscular route in the left arm) for prophylaxis. On the same day, the patient experienced episodes of syncope. Lasted 5-10sec without any ill effect. The patient's father reported that patient had similar episodes of syncope in the past with administration of ear piercing. The patient consulted Neurosurgeon. The outcome of syncope was reported as recovered/resolved. The 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: Pallor, Presyncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 631154) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning  a 12 year old female patient. The patient had no medical history/concurrent illnesses. Information on patient's concomitant medications, lab data and prior vaccinations were not reported. On 12-APR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # K026247, dose number 1 (dose, frequency and lot expiration date unknown)  via intramuscular route in the right arm,for prophylaxis. Other suspect therapies included MENVEO (Manufacturer: Novartis, Vaccinated date: 12-APR-2016, dose number 1, lot # A15068 via intramuscular route in the right arm) and BOOSTRIX (Manufacturer: Glaxosmithkline, Vaccinated date: 12-APR-2016, dose number 1, lot # B54KE via intramuscular route in the left arm) for prophylaxis. On the same day, after one minute post vaccination the patient became pale and had near syncope. Cool wet paper towels were applied to her forehead and she was fanned. She was given a cup of water and when she was feeling better, she was moved to the table to lay down. Her blood pressure was 78/40 - > 90/62 - >100/70.  She was monitored for 45 minutes and was asymptomatic prior to leaving office. The outcome of the events were reported as recovered/resolved. The Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
Symptoms: Blood creatine phosphokinase, CSF cell count, CSF culture, CSF glucose, CSF protein
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 # 631267) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old male patient. The patient had no medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 31-MAR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L026602, Expiry date: 19-OCT-2017, dose number 2 (dose and frequency unknown) via intramuscular route in the left arm for prophylaxis.  Other suspect therapies included TRUMENBA (Manufacturer: Pfizer/Wyeth, Vaccinated date: 31-MAR-2016, lot # M37315, dose number 2 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 04-APR-2016, the patient experienced headache, nausea, vomiting, photosensitivity reaction, bilateral leg weakness, left axillary lymphadenopathy with associated axillary pain. The patient underwent lipase test, urine analysis, laboratory test, gram stain, full blood count, CSF protein, CSF glucose, CSF culture, CSF cell count and blood creatinine phosphokinase. The outcome of all the events were reported as recovered/resolved. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
Symptoms: Full blood count, Gram stain, Headache, Laboratory test, Lipase
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 # 631267) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old male patient. The patient had no medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 31-MAR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L026602, Expiry date: 19-OCT-2017, dose number 2 (dose and frequency unknown) via intramuscular route in the left arm for prophylaxis.  Other suspect therapies included TRUMENBA (Manufacturer: Pfizer/Wyeth, Vaccinated date: 31-MAR-2016, lot # M37315, dose number 2 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 04-APR-2016, the patient experienced headache, nausea, vomiting, photosensitivity reaction, bilateral leg weakness, left axillary lymphadenopathy with associated axillary pain. The patient underwent lipase test, urine analysis, laboratory test, gram stain, full blood count, CSF protein, CSF glucose, CSF culture, CSF cell count and blood creatinine phosphokinase. The outcome of all the events were reported as recovered/resolved. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
Symptoms: Lymphadenopathy, Muscular weakness, Nausea, Photosensitivity reaction, Urine analysis
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 # 631267) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old male patient. The patient had no medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 31-MAR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L026602, Expiry date: 19-OCT-2017, dose number 2 (dose and frequency unknown) via intramuscular route in the left arm for prophylaxis.  Other suspect therapies included TRUMENBA (Manufacturer: Pfizer/Wyeth, Vaccinated date: 31-MAR-2016, lot # M37315, dose number 2 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 04-APR-2016, the patient experienced headache, nausea, vomiting, photosensitivity reaction, bilateral leg weakness, left axillary lymphadenopathy with associated axillary pain. The patient underwent lipase test, urine analysis, laboratory test, gram stain, full blood count, CSF protein, CSF glucose, CSF culture, CSF cell count and blood creatinine phosphokinase. The outcome of all the events were reported as recovered/resolved. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MENB
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 # 631267) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old male patient. The patient had no medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 31-MAR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L026602, Expiry date: 19-OCT-2017, dose number 2 (dose and frequency unknown) via intramuscular route in the left arm for prophylaxis.  Other suspect therapies included TRUMENBA (Manufacturer: Pfizer/Wyeth, Vaccinated date: 31-MAR-2016, lot # M37315, dose number 2 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 04-APR-2016, the patient experienced headache, nausea, vomiting, photosensitivity reaction, bilateral leg weakness, left axillary lymphadenopathy with associated axillary pain. The patient underwent lipase test, urine analysis, laboratory test, gram stain, full blood count, CSF protein, CSF glucose, CSF culture, CSF cell count and blood creatinine phosphokinase. The outcome of all the events were reported as recovered/resolved. The 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 cellulitis, Injection site pain, Injection site papule, Injection site pruritus, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 631562) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old female patient. The patient had no medical history, concurrent illnesses and other medications. Information on the patient's prior vaccinations was not reported. On 12-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L024993 (frequency and lot expiration date unknown), BOOSTRIX (dose number: Unknown, intramuscularly in the left arm, lot# B4SD9; manufacturer: GlaxoSmithKline, frequency and lot expiration date unknown) and MENACTRA (dose number: 1, intramuscularly in the right arm, lot# U5185BA; manufacturer: Sanofi Pasteur, frequency and lot expiration date unknown) for prophylaxis. On 13-APR-2016, the patient developed injection site reaction with swelling and pain over the left deltoid area which was followed by intense itching and development of papular eruptions within an area of 8 cm around the injection sites. It was diagnosed as cellulitis of the deltoid area. The outcome for the events injection site cellulitis, injection site swelling, injection site reaction, injection site pruritus, injection site pain and rash papular were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nausea, 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 # 632044) on 18-APR-2017. This spontaneous report refers to a 15 year old female patient. Patient had no concurrent illnesses. The patient's medical history included asthma. Information on the patient's prior vaccinations and other medications were not reported. On 25-NOV-2015 the patient was vaccinated with the first dose of GARDASIL 9 lot # L032737, intramuscularly in the left arm for prophylaxis. On 27-NOV-2015 the patient experienced nausea, headache, hives. The patient was treated with BENADRYL at home. The outcome of headache, urticaria and nausea was reported as recovered. The causality assessment was not reported. Additional information is not expected from  the agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Anxiety, Chest discomfort, Dizziness, Epistaxis, Nodule
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 # 632045) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 16 year old male patient. The patient had no current illnesses. Information on pertinent medical history, concomitant medications and prior vaccinations were not reported. On 28-MAR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L020015, dose number 3 (dose, frequency and lot expiration date unknown) via unspecified route in the right arm for prophylaxis. On an unknown date, the patient experienced anxiousness, nodules, nose bleed, dizziness and chest discomfort/tightness. The outcome of all the events were reported as recovered/resolved. The outcome of the events were reported as recovered. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Erythema, Pain in extremity, Peripheral 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 # 632360) on 18-APR-2017. This spontaneous report as received from a regulatory authority refers to a 17 year old female patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 18-APR-2016, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly in the right arm, lot # L043213, (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BEXSERO intramuscularly in the left arm, lot # 153701, manufacturer: Novartis, (dose, frequency and lot expiration date were not reported) for prophylaxis. On 18-APR-2016, the patient experienced arm red, tenderness, swollen and painful and advised to take Motrin over the counter Benadryl and cool compresses. The outcome of erythema, tenderness, peripheral swelling and pain in extremity was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperhidrosis, Loss of consciousness, Pallor, Tremor, Urinary incontinence
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 14 year old female patient with prophylaxis. The patient had no current illnesses, other medications, medical history and lab data. The patient's prior vaccinations was not reported. On 19-APR-2016, the patient was vaccinated with GARDASIL 9, lot # L048237, intramuscular in the right arm, (dose number, dose, frequency, and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 19-APR-2016, intramuscularly in the left arm, lot # 943Z5; (dose number, dose and expiration date unknown) and MENACTRA vaccinated date: 19-APR-2016, intramuscularly in the right arm, lot # U5172BA; (dose number, dose and expiration date unknown). And on the same day 5 minutes after vaccines were administered, the client (patient) had a change in facial color to pallor and became diaphoretic, the patient lost consciousness and began to shake and also was incontinent of urine. The patient responded after about 45 seconds to her name and was oriented to time and place. Cold compresses were applied. The patient's parent was informed that the patient would be ok with plenty of fluids and adequate nutrition. The outcome of hyperhidrosis, loss of consciousness, urinary incontinence, tremor and pallor 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: FLUN4, HPV9, MNQ, TDAP
Symptoms: Incorrect product formulation administered, Product reconstitution quality issue
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 # 632631) on 18-APR-2017. This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses were unknown and other medications included adderall xr 20mg, trazodone 100mg, guanfacine 3mg. The patient had no known allergies in the past. On 16-MAR-2016 the patient was vaccinated with GARDASIL 9 lot # L018351 (dose, dose number, frequency and lot expiration date were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included ADACEL lot # U5267AA, intramuscularly in the left arm, FLUMIST QUADRIVALENT lot # FL2115, route: intranasal and MENVEO lot # A15071, dose 1, intramuscularly in the left arm for prophylaxis. On 16-MAR-2016, the physician prescribed MENVEO to patient, but there is a possibility that the patient had only received the diluent and not the vaccine (product reconstitution quality issue). The outcome of product reconstitution quality issue was unknown. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, IPV, MNQ
Symptoms: Abdominal pain upper, Diarrhoea, Hepatic enzyme increased, Vomiting
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 18 year old male patient with prophylaxis. The patient other medications included PPD. The patient had no current illnesses and medical history. The patient's prior vaccinations were not reported. On 21-APR-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L037339, (route of administration unknown) in the left arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA dose number: 2, vaccinated date: 21-APR-2016, (route of administration unknown in the left arm, lot # U5186AA; (dose and expiration date unknown), HAVRIX (dose number: 1, vaccinated date: 21-APR-2016, (route of administration unknown) in the right arm, lot # F4KR5; (dose and expiration date unknown) and IPOL dose number: 5, vaccinated date: 21-APR-2016, (route of administration unknown in the right arm, lot # K1513; (dose and expiration date unknown). Lab data include: elevated liver enzymes. On 23-APR-3016, approximately 35 hours after vaccine the patient had severe vomiting, stomach cramping (upper), and some diarrhea and had hepatic enzyme increased. After 5 hours the patient went to emergency room (ER) and received anti-nausea and cramping medicine and as well as fluids. After 4 hours in ER, the patient recovered rapidly. The outcome of diarrhoea, hepatic enzyme increased, abdominal pain upper and vomiting 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: Dyspnoea, Rash, Rash pruritic
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient had no other medications and medical history. The patient had no current conditions and reported that they were aware at time of injection. The patient's prior vaccinations was not reported. On 26-JAN-2016, the patient was vaccinated with GARDASIL 9, lot # L037339, intramuscularly, (dose number, dose, frequency, and lot expiration date were not reported) for prophylaxis. Lab data included: history of reaction 3+ months later. On 26-JAN-2016, 1 day after onset of therapy the patient experienced rash, rash pruritic and dyspnoea. The outcome of rash, rash pruritic and dyspnoea 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: Arthralgia
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 # 633554) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 19 year old female patient. The patient had no past medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 20-APR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L045711, dose number 1 (dose and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 21-APR-2016, the patient experienced joint pain in wrist and knee lasting at least 4 days. The outcome of the event was not reported. The causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Erythema, Flushing, Respiration abnormal, 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 (HA #633727) and refers to a 13 year old female patient. Current illnesses were reported as none. No details about medical history, lab data, prior vaccination and other medications were provided. On 28-APR-2016 the patient was vaccinated with GARDASIL 9 lot # L026602, dose 2, via unknown route in the left arm for prophylaxis (strength and dosing detail unknown). On 28-APR-2016, the patient experienced swelling, redness, flushing, abdominal pain, diminished air movement, wheezing. The events were treated with BENADRYL, Prednisone and Albuterol. The outcome of abdominal pain, wheezing, swelling, respiration abnormal, flushing and erythema was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.