chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included allergy to Penicillin (PCN) (rash) and Codeine (fever). The patient had no current illnesses and other medications and the patient's prior vaccinations was not reported. On 22-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # L043214, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included BOOSTRIX dose number: 1, vaccinated date: 22-SEP-2016, intramuscularly in the right arm, lot # 7RJ9B; (dose, frequency and lot expiration date unknown) and MENACTRA dose number: 1, vaccinated date: 22-SEP-2016, intramuscularly in the right arm, lot # U5390AA; (dose and lot expiration date unknown). On 22-SEP-2016, the patient fainted (syncope). The outcome of syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Blood electrolytes normal, Generalised tonic-clonic seizure
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient's had no current illnesses and medical history. The patient's prior vaccinations was not reported. The patient other medications included Acetaminophen, Bupropion SR, Desmopressin Acetate, Hydroxyzine, Methylphenidate ER, Pediatric Multivit Gummy, Prazosin, Sertraline, Sertraline HCL. On 22-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M007764 and expiration date: 30-JAN-2018, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included FLUVIRIN dose number: 1, vaccinated date: 22-SEP-2016, intramuscularly in the left arm, lot # 168702 (dose, frequency and lot expiration date unknown). On 24-SEP-2016 at 10 am, the patient had generalised tonic-clonic seizure without incontinence and the patient was seen emergency room (ER), the patient PE and blood electrolytes were normal. The outcome of blood electrolytes normal and generalised tonic-clonic seizure was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Fall, Hypertonia, Loss of consciousness, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 655676) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses, other medications and medical history. Information on the patient's prior vaccinations and lab data were not reported. On 27-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M020103 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included first dose of BOOSTRIX, lot# 542F3, (Manufacturer: GlaxoSmithKline) and first dose of MENACTRA lot# U5410AA, (Manufacturer: Sanofi Pasteur), intramuscularly in the right arm (dose, frequency and lot expiration date were not reported) for prophylaxis. On 27-SEP-2016 after vaccination patient experienced loss of consciousness for approximately one minute, fell forward onto tile floor, brief tonic contraction followed by mild limb shaking then regained consciousness. The patient required an emergency room (ER) visit.  The outcome of fall, hypertonia, loss of consciousness and tremor was reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 655743) on 02-MAY-2017. This spontaneous report 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 the other medications were not reported. On 13-SEP-2016 the patient was vaccinated with the third dose of GARDASIL 9 lot # M007764 (expiration date: 30-JAN-2018) (dose and frequency were not reported), intramuscularly in the left arm for prophylaxis. On 13-SEP-2016, the patient blacked out and complained of dizziness and lightheadedness. The patient lowered to ground and was unresponsive for 5 seconds approximately and then responsive. The outcome of dizziness, and loss of consciousness was reported as recovered. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included Diabetes Type 1. The patient had no current illnesses. The patient's other medications and prior vaccinations were not reported. On 28-SEP-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M024261 and expiration date: 30-JUL-2018, intramuscularly in the right arm (dose and frequency unknown) and second dose of VAQTA lot # M011839, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapy included MENVEO dose number 3; vaccinated date: 28-SEP-2016, intramuscularly in the right arm, lot # M16014; (dose, frequency and lot expiration date unknown). It was reported that only diluent (product preparation error) of MCV MENVEO was administered.
Sex: M
Vaccine: HPV9
Symptoms: Myalgia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 22 year old male patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On 12-SEP-2016, the patient was vaccinated with first dose of GARDASIL 9, intramuscularly in the left arm (dose, frequency, lot number and lot expiration date unknown) for prophylaxis and the same day patient had soreness in muscle. The outcome of myalgia was still persisting (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
Symptoms: Erythema, Pruritus, 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 # 656052) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included tachycardia. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 26-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M009378, via unknown route in the right arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 26-SEP-2016, via unknown route in the right arm, lot# U5390AA; dose and expiration date unknown). On 27-SEP-2016, the patient experienced erythema, skin warm and pruritus which required ER (Emergency room) visit. Patient experienced a mild reaction which was 9x9 cm, red circular and warm to touch. There was no pain except slight itching. Cold compress was given as treatment. Diphenhydramine was prescribed for itching. The outcome of erythema, skin warm and pruritus 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: HPV9
Symptoms: Dizziness, 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 # 656136) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's medical history included type 1 diabetes mellitus. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 23-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # M013636 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. Patient was fine when she got the injection. Patient went to get off the table and felt dizzy then nauseated. On the same day, the patient experienced dizziness and nausea for about 20 minutes. Patient's grandfather helped her sit down on the chair and patient slumped over. Doctor came to the room and got the patient to lay down on the bed. Patient felt, dizzy, faint and nauseated. Patient was given time to feel better before leaving. The outcome of dizziness and nausea was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Gastritis, Headache, Loss of personal independence in daily activities, Migraine
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 # 656155) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included pollen allergies and panic attacks. Information on other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 20-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M009378, (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 20-SEP-2016, intramuscularly in the left arm, lot# U1565AA; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 20-SEP-2016, intramuscularly in the left arm, lot# U5282BB; dose and expiration date unknown), and FLUZONE (dose number: 8, vaccinated date: 20-SEP-2016, intramuscularly in the right arm, lot# UI684AC; dose and expiration date unknown). On 21-SEP-2016, the patient experienced dizziness, nausea, migraine, headache (triggered the first migraine) and gastritis which lasted for 5 days. Patient missed five days of school and had two office visits for evaluation and one emergency room visit for migraine abortant therapy. Patient continued having gastritis. The outcome of dizziness, nausea, migraine, headache and gastritis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: 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 # 656155) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient's medical history included pollen allergies and panic attacks. Information on other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 20-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M009378, (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 20-SEP-2016, intramuscularly in the left arm, lot# U1565AA; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 20-SEP-2016, intramuscularly in the left arm, lot# U5282BB; dose and expiration date unknown), and FLUZONE (dose number: 8, vaccinated date: 20-SEP-2016, intramuscularly in the right arm, lot# UI684AC; dose and expiration date unknown). On 21-SEP-2016, the patient experienced dizziness, nausea, migraine, headache (triggered the first migraine) and gastritis which lasted for 5 days. Patient missed five days of school and had two office visits for evaluation and one emergency room visit for migraine abortant therapy. Patient continued having gastritis. The outcome of dizziness, nausea, migraine, headache and gastritis was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 656511) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old male patient. The patient's concurrent illness and medical history were reported as none. The patient's prior vaccinations, concomitant therapies and other medications were not reported. On 30-SEP-2016, the patient was vaccinated with third dose of GARDASIL 9 (dose, frequency, lot # and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. On 01-OCT-2016, patient had fever of 39.2 degree Celsius (C) and headache. The outcome of headache and pyrexia was unknown. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, 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 # 656692) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient's concurrent illnesses, lab data and medical history were not reported. Information on the patient's prior vaccinations and other medications were not reported. On 12-AUG-2016, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # M013636, expiry date:15-FEB-2018 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included ADACEL intramuscularly in the left arm, lot # UI568AA, MENACTRA intramuscularly in the left arm, lot # U5416AA and FLUZONE intramuscularly in the right arm, lot # UT5598KA, (Manufacturer: Sanofi Pasteur) (dose, frequency, route, injection site, lot expiration date were not reported) for prophylaxis. On 12-AUG-2016, post vaccination patient was fainted immediately. The outcome of immediate post-injection reaction and syncope was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cellulitis, Injection site pruritus, 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 # 656943) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. Information on patient's other medications and prior vaccinations were not reported. Patient's medical history had no known allergies. Patient's current illnesses included allergic rhinitis. On 15-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 15-AUG-2015, through needle and syringe in the left arm, lot# U5260; dose and expiration date unknown). On 18-AUG-2016, the patient experienced cellulitis, injection site warmth, injection site swelling and injection site pruritus. Left deltoid area was swollen, itchy and warm to touch. Patient developed cellulitis in the left arm and was placed on Keflex for 7 days and hydrocortisone 2.5 % cream. The outcome of cellulitis, injection site warmth, injection site swelling and injection site pruritus was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 22.0
Sex: M
Vaccine: FLU3, HPV9, PNC13
Symptoms: Continuous positive airway pressure, Injection site pain, Injection site swelling, Malaise, 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 # 656977) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 22 year old male patient with prophylaxis. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 26-SEP-2016, the patient was vaccinated with the second dose GARDASIL 9 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUVIRIN (vaccinated date: 26-SEP-2016, intramuscularly in the right arm, lot# 1620201; dose and expiration date unknown) and PREVNAR 13 (vaccinated date: 26-SEP-2016, intramuscularly in the right arm, lot# M16562; dose and expiration date unknown). On unknown dates, the patient experienced injection site pain, pyrexia, pain, malaise and injection site swelling. Patient took Automatic Positive Airway Pressure (APAP) BENADRYL, Non steroidal anti-inflammatory drug (NSAIDS) or Automatic Positive Airway Pressure (APAP) and application of ice pack to area was recommended by the physician assistant (PA). The outcome of the events injection site pain, pyrexia, pain, malaise and injection site swelling were reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 22.0
Sex: M
Vaccine: FLU3, HPV9, PNC13
Symptoms: 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 # 656977) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 22 year old male patient with prophylaxis. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 26-SEP-2016, the patient was vaccinated with the second dose GARDASIL 9 (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapies included FLUVIRIN (vaccinated date: 26-SEP-2016, intramuscularly in the right arm, lot# 1620201; dose and expiration date unknown) and PREVNAR 13 (vaccinated date: 26-SEP-2016, intramuscularly in the right arm, lot# M16562; dose and expiration date unknown). On unknown dates, the patient experienced injection site pain, pyrexia, pain, malaise and injection site swelling. Patient took Automatic Positive Airway Pressure (APAP) BENADRYL, Non steroidal anti-inflammatory drug (NSAIDS) or Automatic Positive Airway Pressure (APAP) and application of ice pack to area was recommended by the physician assistant (PA). The outcome of the events injection site pain, pyrexia, pain, malaise and injection site swelling 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: M
Vaccine: HPV9, MNQ
Symptoms: Injection site nodule, Injection site pruritus, Injection site warmth, Wheezing
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657108) on 02-MAY-2017. This spontaneous report refers to a 11 year old male patient with prophylaxis. The patient had no concurrent illnesses. The patient's medical history included asthma and allergic rhinitis. Information on the patient's prior vaccinations was not reported. The patient's other medications included Zyrtec 10mg, Singulair 5mg, Advair 115mcg inhaler. On 03-OCT-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M020103 (dose, frequency, and lot expiration dates were not reported), intramuscularly in the right arm for prophylaxis.  Other suspect therapies included MENVEO batch/lot # M16002, dose 1, intramuscularly in the left deltoid for prophylaxis. On 03-OCT-2016, a golf ball size knot was observed where MENVEO was administered (l.deltoid). The patient woke up on 04-OCT-2016 and the knot was 3.5 inches in diameter, which was itchy  and warm to touch and wheezing was also reported on the same day. The outcome of injection site nodule, wheezing, injection site warmth and injection site pruritus 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: 11.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Decreased appetite, 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 # 657121) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient had no concurrent illnesses, lab data and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 03-OCT-2016 the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the right arm, lot # M018810 with expiry date: 28-MAY-2018 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included second dose of FLUARIX QUADRIVALENT intramuscularly in the left arm, lot# 579KX, manufacturer: glaxoSmithKline (dose, frequency and lot expiration date were not reported) for prophylaxis. On 03-OCT-2016, the patient experienced syncope, PCP evaluated fluids and food and the patient didn't eat (decreased appetite) for 5 hours. The outcome of decreased appetite and syncope was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Loss of personal independence in daily activities, Mydriasis, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 657298) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient had no known concurrent illnesses and information about the patient's other medications was not reported. On 05-OCT-2016, the patient was vaccinated with GARDASIL 9 dose 1 (Unspecified dosage and lot number), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with HAVRIX dose 1 (Unspecified dosage and lot number) in the left arm, MENACTRA dose 1 (Unspecified dosage and lot number) in the left arm, FLUZONE Quadrivalent dose 6 (Unspecified dosage and lot number) in the right arm and ADACEL dose 1 (Unspecified dosage and lot number) in the right arm, via intramuscular route for prophylaxis. On the same day, the patient had not eaten and the registered nurse (RN) gave the patient crackers to eat while drawing the vaccines. HAVRIX and FLUZONE Quadrivalent were given first and MENACTRA, ADACEL and GARDASIL 9 were given last, in that order. The patient immediately experienced a post-injection reaction, felt dizzy after the last vaccine and was not able to see well, pallid color. The registered nurse put a cool cloth on the patient's neck and called the patient's mom to support her. Both the eyes of the patient were dilated before slumping in faint in the chair. The registered nurse retrieved the ice pack and had called another nurse for water. The patient revived in less than a minute and was supported by her mother and the registered nurse, to a lying position. Her activities of daily living was impaired. After 5 minutes, the patient was sitting, sipping water and after 10 minutes, she was talking and stated that she felt better. The patient stayed in the office for 15 more minutes, before the mother walked her out to the car. The color of the face returned, the patient stated that she felt better and was still sipping water. The patient was asking to stay out of school for the rest of the day and was making her mother state that she must be fully recovered. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Posture abnormal, Syncope, Visual impairment
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 # 657298) on 02-MAY-2017. This spontaneous report refers to a 11 year old female patient. The patient had no known concurrent illnesses and information about the patient's other medications was not reported. On 05-OCT-2016, the patient was vaccinated with GARDASIL 9 dose 1 (Unspecified dosage and lot number), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with HAVRIX dose 1 (Unspecified dosage and lot number) in the left arm, MENACTRA dose 1 (Unspecified dosage and lot number) in the left arm, FLUZONE Quadrivalent dose 6 (Unspecified dosage and lot number) in the right arm and ADACEL dose 1 (Unspecified dosage and lot number) in the right arm, via intramuscular route for prophylaxis. On the same day, the patient had not eaten and the registered nurse (RN) gave the patient crackers to eat while drawing the vaccines. HAVRIX and FLUZONE Quadrivalent were given first and MENACTRA, ADACEL and GARDASIL 9 were given last, in that order. The patient immediately experienced a post-injection reaction, felt dizzy after the last vaccine and was not able to see well, pallid color. The registered nurse put a cool cloth on the patient's neck and called the patient's mom to support her. Both the eyes of the patient were dilated before slumping in faint in the chair. The registered nurse retrieved the ice pack and had called another nurse for water. The patient revived in less than a minute and was supported by her mother and the registered nurse, to a lying position. Her activities of daily living was impaired. After 5 minutes, the patient was sitting, sipping water and after 10 minutes, she was talking and stated that she felt better. The patient stayed in the office for 15 more minutes, before the mother walked her out to the car. The color of the face returned, the patient stated that she felt better and was still sipping water. The patient was asking to stay out of school for the rest of the day and was making her mother state that she must be fully recovered. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain upper, Injection site erythema, Injection site pain, Injection site pruritus, 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 # 657688). This spontaneous report refers to a 12 year old male patient. Information on patient's current illnesses, medical history and other medications was not reported. The patient's medical history included allergic rhinitis. The patient's prior vaccinations include Tdap, dose 1, (unknown date at 11:00) and influenza (seasonal), dose 7, (unknown date at 11:00) with reaction local cellulitis. On 29-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M017983, dose 2, route: unknown in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX Quadrivalent lot # E97K2, dose 9, route: unknown in the left arm. The patient had vaccine allergy and allergenic triggers include an unknown source. Presentation included injection site reaction and this problem has not been previously evaluated and treated. The last clinic visit was 1 day(s) ago. Symptoms included rash, swelling, warmth, pain and the reaction was located on the left upper extremity. The patient described the pain as aching and onset was gradual. The patient described the symptoms as moderate in severity. Associated symptoms do not include malaise, irritability, drowsiness, arthralgia's, myalgia's, anorexia, nausea, vomiting, diarrhea, lightheadedness, palpitations, chest pain or syncope. The patient was not currently being treated for the problem. Two to four hours after administration of the vaccine, noticed heat, soreness, redness was about the size of a half dollar previous day, next morning during school it progressed in size. Patient has been putting ice pack on it. Around 09:00, patient saw a school nurse and did not have a temperature of fever, he put an ice pack on it. The patient had no fevers or vomiting or difficulty breathing but has a mild stomach ache, he thinks it was something he ate at lunch that day. Otherwise patient had good energy, appetite, urination and bowel movements are within normal limits. Pain starts when the patient moves it, with writing and touching it. Feels like a sore muscle and a little itchy at the top and still feels very hot. Phone Note on 30-SEP-2016, stated that patient received the HPV and flu vaccine the previous day. In the past, he developed cellulitis to one of his arms where he received a vaccine. The area was swollen and red. Patient's mother drew a circle to the reddened area and the redness has now spread beyond the marking. He was having pain to his arm but had no fever and still was able to move his arm. He was at school and called his mother with 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.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Myalgia, 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 # 657688). This spontaneous report refers to a 12 year old male patient. Information on patient's current illnesses, medical history and other medications was not reported. The patient's medical history included allergic rhinitis. The patient's prior vaccinations include Tdap, dose 1, (unknown date at 11:00) and influenza (seasonal), dose 7, (unknown date at 11:00) with reaction local cellulitis. On 29-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M017983, dose 2, route: unknown in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX Quadrivalent lot # E97K2, dose 9, route: unknown in the left arm. The patient had vaccine allergy and allergenic triggers include an unknown source. Presentation included injection site reaction and this problem has not been previously evaluated and treated. The last clinic visit was 1 day(s) ago. Symptoms included rash, swelling, warmth, pain and the reaction was located on the left upper extremity. The patient described the pain as aching and onset was gradual. The patient described the symptoms as moderate in severity. Associated symptoms do not include malaise, irritability, drowsiness, arthralgia's, myalgia's, anorexia, nausea, vomiting, diarrhea, lightheadedness, palpitations, chest pain or syncope. The patient was not currently being treated for the problem. Two to four hours after administration of the vaccine, noticed heat, soreness, redness was about the size of a half dollar previous day, next morning during school it progressed in size. Patient has been putting ice pack on it. Around 09:00, patient saw a school nurse and did not have a temperature of fever, he put an ice pack on it. The patient had no fevers or vomiting or difficulty breathing but has a mild stomach ache, he thinks it was something he ate at lunch that day. Otherwise patient had good energy, appetite, urination and bowel movements are within normal limits. Pain starts when the patient moves it, with writing and touching it. Feels like a sore muscle and a little itchy at the top and still feels very hot. Phone Note on 30-SEP-2016, stated that patient received the HPV and flu vaccine the previous day. In the past, he developed cellulitis to one of his arms where he received a vaccine. The area was swollen and red. Patient's mother drew a circle to the reddened area and the redness has now spread beyond the marking. He was having pain to his arm but had no fever and still was able to move his arm. He was at school and called his mother with 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.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: 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 # 657688). This spontaneous report refers to a 12 year old male patient. Information on patient's current illnesses, medical history and other medications was not reported. The patient's medical history included allergic rhinitis. The patient's prior vaccinations include Tdap, dose 1, (unknown date at 11:00) and influenza (seasonal), dose 7, (unknown date at 11:00) with reaction local cellulitis. On 29-SEP-2016, the patient was vaccinated with GARDASIL 9 lot # M017983, dose 2, route: unknown in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX Quadrivalent lot # E97K2, dose 9, route: unknown in the left arm. The patient had vaccine allergy and allergenic triggers include an unknown source. Presentation included injection site reaction and this problem has not been previously evaluated and treated. The last clinic visit was 1 day(s) ago. Symptoms included rash, swelling, warmth, pain and the reaction was located on the left upper extremity. The patient described the pain as aching and onset was gradual. The patient described the symptoms as moderate in severity. Associated symptoms do not include malaise, irritability, drowsiness, arthralgia's, myalgia's, anorexia, nausea, vomiting, diarrhea, lightheadedness, palpitations, chest pain or syncope. The patient was not currently being treated for the problem. Two to four hours after administration of the vaccine, noticed heat, soreness, redness was about the size of a half dollar previous day, next morning during school it progressed in size. Patient has been putting ice pack on it. Around 09:00, patient saw a school nurse and did not have a temperature of fever, he put an ice pack on it. The patient had no fevers or vomiting or difficulty breathing but has a mild stomach ache, he thinks it was something he ate at lunch that day. Otherwise patient had good energy, appetite, urination and bowel movements are within normal limits. Pain starts when the patient moves it, with writing and touching it. Feels like a sore muscle and a little itchy at the top and still feels very hot. Phone Note on 30-SEP-2016, stated that patient received the HPV and flu vaccine the previous day. In the past, he developed cellulitis to one of his arms where he received a vaccine. The area was swollen and red. Patient's mother drew a circle to the reddened area and the redness has now spread beyond the marking. He was having pain to his arm but had no fever and still was able to move his arm. He was at school and called his mother with 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.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Limb mass
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 658089). This spontaneous report refers to a 13 year old female patient. Information on patient's current illnesses, medical history, other medications and prior vaccinations was not reported. On 05-OCT-2016, the patient was vaccinated with GARDASIL 9 (dose, route and lot # not reported) for prophylaxis. On the same day, the patient had lump on arm. The outcome of the event limb mass was unknown. The causality assessment of the event limb mass 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: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness, Fatigue, Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 658858) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old male patient. The patient's medical history included Autistic spectrum disorder, sensory integration disorder, epilepsy, tic disorder and sleep disorder. Information on current illness, concomitant medications and prior vaccinations were not reported. Other medications included Escitalopram, Olanzapine  and Vyvanse. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M009378 dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included FLUZONE (Manufacturer: Sanofi Pasteur, lot # UI625AB, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 08-OCT-2016, the patient had headache, dizziness and was tired. On 09-OCT-2016, the patient was still dizzy and had stiffness in the neck during the day and there was an onset of fever (pyrexia) in the evening. On 10-OCT-2016, the patient was still suffering from fever and also had photophobia, neck pain, frontal headache and malaise. On an unspecified date, the patient underwent polymerase chain reaction test which showed negative results for streptococcus DNA. The outcome of all the events were reported as not recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Neck pain, Photophobia, Polymerase chain reaction, Pyrexia, Streptococcus test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 658858) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old male patient. The patient's medical history included Autistic spectrum disorder, sensory integration disorder, epilepsy, tic disorder and sleep disorder. Information on current illness, concomitant medications and prior vaccinations were not reported. Other medications included Escitalopram, Olanzapine  and Vyvanse. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M009378 dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included FLUZONE (Manufacturer: Sanofi Pasteur, lot # UI625AB, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the left arm for prophylaxis. On 08-OCT-2016, the patient had headache, dizziness and was tired. On 09-OCT-2016, the patient was still dizzy and had stiffness in the neck during the day and there was an onset of fever (pyrexia) in the evening. On 10-OCT-2016, the patient was still suffering from fever and also had photophobia, neck pain, frontal headache and malaise. On an unspecified date, the patient underwent polymerase chain reaction test which showed negative results for streptococcus DNA. The outcome of all the events were reported as not 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, MNQ, TDAP
Symptoms: Rash, Rash erythematous, Swelling face
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 # 658866) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old female patient. The patient's medical history included no drug allergies, narcolepsy and eczema. The patient had no current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 27-SEP-2016, the patient was vaccinated with GARDASIL 9 dose 1, lot # L02602 via intramuscular route in the left arm for prophylaxis. Other suspect therapies included BOOSTRIX (Manufacturer: GlaxoSmithKline, Vaccinated date: 27-SEP-216 lot # H549F (dose and lot expiration date unknown) via intramuscular route in the right arm and MENACTRA (Manufacturer: Sanofi Pasteur, Vaccinated date: 27-SEP-216 lot # U5415AA (dose and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. On 28-SEP-2016, the patient's mother noticed rash on face and facial swelling. She applied hydrocortisone cream. On 29-SEP-2016, swelling resolved. But, still some red rash on forehead and under eyes per mother. No physician visit during that time. The outcome of rash and swelling face was reported as recovered/resolved. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dizziness, Fatigue, Impaired driving ability, Loss of personal independence in daily activities, Nausea
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 16 year old male patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On Monday 26-SEP-2016, the patient was vaccinated with third dose of GARDASIL 9, lot # M009378, intramuscularly in the left arm (dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included MENACTRA dose number: 2, vaccinated date: 26-SEP-2016, intramuscularly in the right arm, lot # U5390AA; (dose, frequency and lot expiration date unknown). On Tuesday 27-SEP-2016, the patient experienced activities of daily living impaired and patient woke up dizzy nauseated, fatigued and unable to drive. On Wednesday the patient felt same. On Friday patient sent home from school and was still dizzy. The outcome of dizziness, nausea, impaired driving ability, fatigue and activities of daily living impaired was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Local reaction
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 # 659172) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 05-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M003659, (dose, frequency and lot expiration date were not reported) intramuscularly in the left arm for prophylaxis. Other suspect therapies MENVEO (dose number: 1, vaccinated date: 05-OCT-2016, intramuscularly in the left arm, lot# M16004; dose and expiration date unknown) which required ER (emergency room) visit. On 06-OCT-2016, the patient experienced injection site erythema, local reaction, injection site warmth and injection site pain. Localized reaction was observed on the left upper arm (redness, warmth and tenderness). The outcome of injection site erythema, local reaction, injection site warmth and injection site pain was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 9.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Musculoskeletal pain, Oedema
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 # 659190) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 9 year old male patient. The patient's medical history included allergy to bee sting. Patient's other medications included gummy bits vitamins. Information on prior vaccinations were not reported. The patient had no concurrent illnesses. On 10-OCT-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # M018810 (dose, frequency and lot expiration date were not reported), via unknown route in the left arm for prophylaxis. Other suspect therapies included FLUZONE Quadrivalent (dose number: 1, vaccinated date: 10-OCT-2016, intramuscularly in the right arm, lot# UI657AA; dose and expiration date unknown). On 11-OCT-2016, the patient experienced cellulitis, pain in extremity, pain, oedema, musculoskeletal pain, vaccination complication and erythema. Patient's right arm/shoulder developed cellulitis which was a possible reaction to the vaccine. The outcome of erythema, cellulitis, pain in extremity, pain, oedema and musculoskeletal pain was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.