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 an 11 year old female patient. The patient had no current illnesses and medical history. The patient's other medications and prior vaccinations were not reported. On 25-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M005714 and expiration date: 03-OCT-2017, intramuscularly in the left arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included ADACEL dose number 1; vaccinated date: 25-JUL-2016, intramuscularly in the right arm, lot # U1567AA; (dose, frequency and lot expiration date unknown) and MENACTRA dose number 1; vaccinated date: 25-JUL-2016, intramuscularly in the right arm, lot # U5244AA; (dose, frequency and lot expiration date unknown). On 25-JUL-2016, the patient fainted  for 1 minute after injection. 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: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 7 year old female patient. The patient had no other medications, medical history and current illnesses and the patient's prior vaccinations was not reported. On 25-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # L024993 and expiration date: 17-OCT-2017, in the right thigh (reported as right leg) (route of administration, dose and frequency unknown) for prophylaxis. It was reported that the drug was administered to patient of inappropriate age. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MENB, MNQ
Symptoms: Hypoacusis, Loss of consciousness, 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 # 645284). This spontaneous report refers to a 17 year old female patient. The patient had no current illnesses and information on patient's medical history, other medications and prior vaccinations was not reported. On 28-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M011840, dose 3, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with VAQTA lot # M021124, dose 2, intramuscularly in the left arm; MENACTRA lot # U367SAA, dose 2, intramuscularly in the left arm and BEXSERO lot # 1151501, dose 1, intramuscularly in the right arm. On 28-JUL-2016, the patient and her mother were instructed to wait for 10-15 minutes in the waiting room following vaccinations. The patient went to the waiting room to wait and sat next to her mother. The patient reported at that time that she felt fine and a few minutes later her mother came to the door yelling for assistance. The patient was found slumped over on chair and appeared unconscious, she was lowered to the floor by the staff. At that time, patient became conscious and was stating that she could not hear. The patient was allowed to rest lying on the floor with ice pack. The patient reported that she was feeling better and sat up to drink a cup of water. She was alert and oriented (person, place and date/time) at that time. The patient then stood and rested in the chair for additional five minutes. The patient reported that she was feeling fine and her mother wanted to take her to get something to eat. Nurse walked the patient and mother to the car and patient appeared to have recovered from the episode at that time. The outcome of the events was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 and VAQTA 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: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Anxiety, 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 # 645700). This spontaneous report refers to a 12 year old female patient. Information on the patient's concurrent illnesses, medical history, prior vaccinations and other medications were not reported. On 25-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L043214, dose 1, intramuscular route in the right arm, MENACTRA batch/lot# U5282BB, dose 1, intramuscular route in the right arm and BOOSTRIX batch/lot# LZ972, dose 1, intramuscular route in the left arm for prophylaxis. On the same day, after vaccinations, the patient had syncope that lasted for more than 30 minutes and anxiety. The patient was sent to emergency room (ER) via EMS for observation/treatment. Follow-up from ER: the nurse reported that, the patient was treated for anxiety and was discharged. The outcome of anxiety and syncope 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, Oedema, Pain
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient medical history included hyperlipidemia and obesity. The patient current condition included ankle sprain. The patient's other medications and prior vaccinations were not reported. On 26-JUL-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M003659, intramuscularly in the right arm (dose frequency and lot expiration date unknown) for prophylaxis. On 27-JUL-2016, the patient experienced erythema, pain and oedema. On an unknown date the patient had an emergency room (ER) visit. The outcome of erythema, pain and oedema 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: U
Vaccine: HPV9
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 21 year old patient (unspecified gender). The patient had a medical history of Cefaclor allergy. The patient had no current illnesses. The patient's other medications and prior vaccinations were not reported. On 26-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M007728, intramuscularly in the right arm (dose frequency and lot expiration date unknown) for prophylaxis. On the same day after 30 minutes of receiving GARDASIL 9 vaccine, the patient complained of lightheadness followed by syncopal episode with loss of consciousness (LOC) approximately for 10 seconds and was associated with diaphoresis. The patient had a rapid recovery over the course of supine position for approximately 15 minutes. The patient was monitored for 40 minutes before discharging to home. The outcome of hyperhidrosis, syncope and dizziness was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Presyncope, 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 # 646845) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient with prophylaxis. The patient's medical history included obesity. Information on patient's other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 08-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # M011117, intramuscularly in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 08-AUG-2016, intramuscularly in the left arm, lot# TX34X; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 08-AUG-2016, intramuscularly in the left arm, lot# U5187AA; dose and expiration date unknown). On the same day, the patient experienced immediate post-injection reaction, syncope and presyncope. Syncopal episode was consistent with vasovagal, immediately upon administration of GARDASIL 9 which was short after administration of BOOSTRIX. The outcome of immediate post-injection reaction, syncope and presyncope 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: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, 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 # 647041) on 02-MAY-2017. This spontaneous report refers to a 12 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations and the other medications were not reported. On 29-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L023230 (expiration date: 28-JUL-2017) (dose and frequency were not reported), intramuscularly in the right arm for prophylaxis. Other suspect therapies included VAQTA lot # K019560 (expiration date: 02-JUN-2017) (dose and frequency were not reported), dose 1, intramuscularly in the left arm, ADACEL batch/lot # U5247BA, dose 1, intramuscularly in the left arm and MENACTRA batch/lot # U5178AA, dose 1, intramuscularly in the right arm for prophylaxis. On 06-AUG-2016, the patient experienced rash on the left upper back which spread to the right upper back. On 08-AUG-2016, the patient presented to the clinic with his father with the above complaints. On examination, redness was observed on his right upper back. The patient was treated with ZYRTEC, BENADRYL and some cream (unspecified trade/generic). The outcome of erythema and rash 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: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood pressure decreased, Gaze palsy, Immediate post-injection reaction, Pallor, 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 # 647076) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 11 year old male patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On an unknown date the patient was vaccinated with GARDASIL 9, lot # U5282BD, dose number 1 (dose, frequency and lot expiration date unknown) via unknown route in the right arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, lot # U5209AA, dose number 1 (dose, frequency and lot expiration date unknown) via unknown route in the left arm) and MENACTRA (Manufacturer: Sanofi Pasteur, lot # L023230, dose number 1 (dose, frequency and lot expiration date unknown) via unknown route in the right arm) for prophylaxis. On an unknown date, immediately after vaccination the patient became pale, had a fixed gaze, and his arms an upper body shook. The episode lasted approximately for 2 seconds. There was no loss of consciousness. His blood pressure went down from 99/60 to 76/33, but after resting for 5 minutes and drinking 2 cups of water it went up to 96/33, heart rate 55- all NNL. 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.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 647140) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. The patient concurrent illnesses included dizziness after vaccination. The patient's medical history and other medications were reported as none. Information on the patient's prior vaccinations was not reported. On 01-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the right arm, lot # M005714, expiration date: 03-OCT-2017 (dose and frequency were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX intramuscularly in the right arm, lot # 1345D9 (dose, frequency and lot expiration date were not reported) and MENVEO intradermal in the left arm, lot # M15143 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 01-AUG-2016, the patient experienced dizziness during vaccination. The outcome of dizziness was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blister
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 # 647217) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient had no concurrent illnesses and lab data. The patient's medical history included peanut allergy, allergies seasonal, asthma, antinuclear antibody (ANA). The patient's other medications included valacyclovir 500mg once in a day (qd), SINGULAIR 10mg qd, loratadine 10mg qd. Information on the patient's prior vaccinations were not reported. On 09-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L038503 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included second dose of MENACTRA intramuscularly in the right arm, lot # U5416AA, manufacturer: Sanofi Pasteur (dose, frequency and lot expiration date were not reported) for prophylaxis. On 10-AUG-2016, the patient experienced blister. The outcome of blister was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Condition aggravated, Seizure
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 # 647331) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 14 year old female patient. The patient's medical history included Catamenial seizures. The patient had no current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. Other medications included Lamotrigine 125mg twice daily. On 09-AUG-2016 the patient was vaccinated with GARDASIL 9 dose number 1, lot # M011840 (dose and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included HAVRIX (Manufacturer: GlaxoSmithKline, Vaccinated date: 09-AUG-2016, dose number 1, lot # CL2R5 (dose and lot expiration date unknown) via intramuscular route in the left arm) for prophylaxis. On 10-AUG-2016, the patient had two seizures, one at 9:30AM and another at 5:55PM. Patient has known seizures, and patient's mother stated that seizures were different. The patient required an emergency room visit. The outcome of seizure 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.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 647427) on 02-MAY-2017. This spontaneous report refers to a 12 year old male patient. The patient's medical history included allergic rhinitis, asthma and attention deficit hyperactivity disorder (ADHD). The patient had no concurrent illnesses and the patient's other daily medications included FLONASE, Montelukast and VYVANSE. On 07-JUN-2016, first dose of the vaccine GARDASIL 9 was given. On 09-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # L038503 (unspecified expiration date and dosage), intramuscularly in the left arm for prophylaxis. On 10-AUG-2016 (am), the patient experienced urticaria from waist up. The patient was prescribed with oral BENADRYL. The outcome of urticaria was reported as recovered. The causality assessment for urticaria was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Head injury, Pallor, 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 # 647452) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old female patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications and prior vaccinations were not reported. Other medications included Tuberculin purified protein derivative diluted APLISOL 5TU/0.1ml left forearm intradermal. On 11-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # M013636, Expiry date: 15-FEB-2018, dose 1 via intramuscular route in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (Manufacturer: GlaxoSmithKline, Vaccinated date: 11-AUG-2016, lot # 7RJ9B, dose number 1, via intramuscular route in the left arm) for prophylaxis. On the same day at 12:55pm, patient noted at doorway of room-patient became pale and stated that she thought she was fainted and hit head against room door. She did not remember leaving bed to get to door. The doctor examined for injury. Pulse and blood pressure were taken immediately and while lying down, standing up and sitting at 5min, 10min and 15 min after the event. The outcome of 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.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Head injury, Hyperhidrosis, Malaise, Pallor, 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 # 647462) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old female patient. The patient's medical history and lab data was reported as none. The patient's current illness included wisdom teeth removal on 10-AUG-2016. The patient's other medications included MOTRIN. The patient's concomitant therapies and prior vaccinations were not reported. On 11-AUG-2016, the patient was vaccinated with second dose of GARDASIL 9 lot # M011117, lot expiration date 07-DEC-2017 (dose: not reported) via intramuscular route, in the left arm for prophylaxis. Other suspect therapy which were given on the same day, included second dose of MENACTRA (intramuscularly in the right arm, lot# U5259AA; dose and expiration date were not reported) for prophylaxis. On the same day while standing in the waiting room with her mother, the patient started to fell unwell. She told her mother that she did not feel good and collapsed hitting the back of her head on the floor but did not lose consciousness. She was immediately awake and interactive but slightly pale and sweaty. The patient was taken to the treatment room and was given some Gatorade to drink and was made to lie back after which the vital signs were checked. The vital signs were 113/83 (Lab test and units not provided), heart rate 76 (units not provided), respiratory rate 16 (units not provided) and Oxygen saturation 96% on room air. The patient felt better and departed from the clinic on her own volition. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dysarthria, Headache, Hyperhidrosis, Hypersomnia, Urinary incontinence
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 # 647546) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old male patient. The patient had no concurrent illnesses. The patient's medical history included migraine, anxiety and attention deficit/hyperactivity disorder (ADHD). Other medications included phenobarbital, CONCERTA, IMITREX and propranolol. Information on the patient's prior vaccinations was not reported. On 03-AUG-2016, Wednesday evening the patient was vaccinated with the first dose of GARDASIL 9 via unknown route in the left arm, lot # M007764, expiration date: 30-JAN-2018 (dose and frequency were not reported) for prophylaxis. On 05-AUG-2016 (Friday) the patient had slurred speech, sweating and headache. The patient had urinated on himself while sleeping and had slept all the day. The outcome of dysarthria, urinary incontinence, hypersomnia, hyperhidrosis and headache was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9, MEN, TDAP, VARCEL
Symptoms: Injection site erythema, 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 # 647601) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 13 year old male patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications, lab data and prior vaccinations were not reported. On 09-AUG-2016 the patient was vaccinated with GARDASIL 9 (dose, lot #, expiration date unknown) via intramuscular route and VARIVAX dose number 2, (dose, frequency and lot expiration date unknown) via subcutaneous route in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (Manufacturer: GlaxoSmithKline, Vaccinated date: 09-AUG-2016 (dose, dose number, frequency, lot # and lot expiration date unknown) intramuscularly), MENOMUNE-A/C/Y/W-135 (Manufacturer: Sanofi Pasteur, Vaccinated date: 09-AUG-2016 (dose, dose number, frequency, lot # and lot expiration date unknown) intramuscularly) for prophylaxis. On 12-AUG-2016, post vaccination with VARIVAX the patient experienced injection site erythema, injection site swelling and injection site pruritus. The outcome of all the events were unknown. The Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Amnesia, Cardiac monitoring, Computerised tomogram head, Echocardiogram, Electrocardiogram
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 # 647677) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient's medical history included seasonal allergy. The patient's concurrent illnesses and other medications reported as not applicable. Information on the patient's prior vaccinations was not reported. On 10-FEB-2016, the patient was vaccinated with the second dose of GARDASIL 9 subcutaneous in the right arm (dose, frequency, lot # and lot expiration date were not reported) for prophylaxis. On 11-MAR-2016 (Friday), the patient blacked out at play practice, couldn't remember anything before or after, lab date included: head scan (computerised tomogram head), EKG (electrocardiogram), MRI w/contrast (scan with contrast), EEG (electroencephalogram) w/video 72 hour, EEG (electroencephalogram) 48 hour, heart monitor (echocardiogram) and nuclear magnetic resonance imaging. On Saturday did same thing 3 more times. The patient was taken to emergency room (ER) on Sunday and diagnosed with seizures. The outcome of amnesia, seizure, scan with contrast, nuclear magnetic resonance imaging, loss of consciousness, electroencephalogram, electrocardiogram, echocardiogram and computerised tomogram head was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Electroencephalogram, Loss of consciousness, Nuclear magnetic resonance imaging, Scan with contrast, Seizure
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 # 647677) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient's medical history included seasonal allergy. The patient's concurrent illnesses and other medications reported as not applicable. Information on the patient's prior vaccinations was not reported. On 10-FEB-2016, the patient was vaccinated with the second dose of GARDASIL 9 subcutaneous in the right arm (dose, frequency, lot # and lot expiration date were not reported) for prophylaxis. On 11-MAR-2016 (Friday), the patient blacked out at play practice, couldn't remember anything before or after, lab date included: head scan (computerised tomogram head), EKG (electrocardiogram), MRI w/contrast (scan with contrast), EEG (electroencephalogram) w/video 72 hour, EEG (electroencephalogram) 48 hour, heart monitor (echocardiogram) and nuclear magnetic resonance imaging. On Saturday did same thing 3 more times. The patient was taken to emergency room (ER) on Sunday and diagnosed with seizures. The outcome of amnesia, seizure, scan with contrast, nuclear magnetic resonance imaging, loss of consciousness, electroencephalogram, electrocardiogram, echocardiogram and computerised tomogram head was reported as not recovered/not 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: Lymphadenopathy
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 ID-647870). This spontaneous report refers to a 42 year old female patient. The patient's historical conditions included heart murmur and Attention deficit hyperactivity disorder (ADHD). The patient's other medications included STRATTERA, PROAIR HFA and Vitamins. The patient had no current illnesses. On 02-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L043214 dose 1 (unspecified dosage), via unknown route in the left arm for prophylaxis. On 09-AUG-2016, the patient experienced lymphadenopathy. 1 lymph node was identified with 1 inch diameter at the left axilla which was non tender and mobile with no redness. The outcome of lymphadenopathy was unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Dyspnoea, Headache
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 # 647902) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient's medical history included scoliosis. The patient's concurrent conditions included dysmenorrhea, fatigue and backache. Information about the patient's other medications and prior vaccinations were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M004116 (Expiration date: 12-OCT-2017) dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BEXSERO lot # 151501 dose 1 (unspecified dosage) in the left arm and MENACTRA lot # U5260AA dose 2 (unspecified dosage) in the right arm via intramuscular route, for prophylaxis. On 11-AUG-2016 (pm), the patient was seen in the clinic with complaints of headache, diarrhoea, nausea and shortness of breath. The patient was referred to the emergency department and she underwent blood test and computerised tomogram (CT scan). She was later discharged home. The outcome of the events was reported as not 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: 16.0
Sex: F
Vaccine: HPV9, MENB, MNQ
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 # 647902) on 02-MAY-2017. This spontaneous report refers to a 16 year old female patient. The patient's medical history included scoliosis. The patient's concurrent conditions included dysmenorrhea, fatigue and backache. Information about the patient's other medications and prior vaccinations were not reported. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # M004116 (Expiration date: 12-OCT-2017) dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with BEXSERO lot # 151501 dose 1 (unspecified dosage) in the left arm and MENACTRA lot # U5260AA dose 2 (unspecified dosage) in the right arm via intramuscular route, for prophylaxis. On 11-AUG-2016 (pm), the patient was seen in the clinic with complaints of headache, diarrhoea, nausea and shortness of breath. The patient was referred to the emergency department and she underwent blood test and computerised tomogram (CT scan). She was later discharged home. The outcome of the events was reported as not 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: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, C-reactive protein, Chills, Decreased appetite, Full blood count
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 # 648023) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old male patient. The patient's concurrent illnesses, other medications and medical history were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 10-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # M011848 (dose and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. On 11-AUG-2016, patient had a fever of 104 within about 12 hours after GARDASIL injection. The patient also had tingling of hands, subjecting weakness, chills, loss of appetite, headache and muscle aches. The patient's lab tests included Erythrocyte Sedimentation rate: 6 (units not provided), C-Reactive protein: 5.1 (units not provided), Complete Blood count and comprehensive metabolic panel. The patient had visited the emergency room. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Metabolic function test, Myalgia, Paraesthesia, 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 # 648023) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old male patient. The patient's concurrent illnesses, other medications and medical history were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 10-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # M011848 (dose and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. On 11-AUG-2016, patient had a fever of 104 within about 12 hours after GARDASIL injection. The patient also had tingling of hands, subjecting weakness, chills, loss of appetite, headache and muscle aches. The patient's lab tests included Erythrocyte Sedimentation rate: 6 (units not provided), C-Reactive protein: 5.1 (units not provided), Complete Blood count and comprehensive metabolic panel. The patient had visited the emergency room. The outcome of the events were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Red blood cell sedimentation rate normal
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 # 648023) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old male patient. The patient's concurrent illnesses, other medications and medical history were reported as none. The patient's concomitant therapies and prior vaccinations were not reported. On 10-AUG-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # M011848 (dose and lot expiration date were not reported) via intramuscular route, in the left arm for prophylaxis. On 11-AUG-2016, patient had a fever of 104 within about 12 hours after GARDASIL injection. The patient also had tingling of hands, subjecting weakness, chills, loss of appetite, headache and muscle aches. The patient's lab tests included Erythrocyte Sedimentation rate: 6 (units not provided), C-Reactive protein: 5.1 (units not provided), Complete Blood count and comprehensive metabolic panel. The patient had visited the emergency room. The outcome of the events 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: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648106) on 02-MAY-2017. This spontaneous report was received from a regulatory authority concerning a 7 year old female patient. The patient had no pertinent medical history/current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 10-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L043214, dose number 1 (dose, frequency and lot expiration date unknown) via intramuscular route in the left leg for prophylaxis. On an unknown date, GARDASIL 9 inadvertently given to patient (drug administered to patient of inappropriate age) and no adverse effect was noted. Mother advised to watch the patient. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Headache, Hyperacusis, Neck pain, Oropharyngeal pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-648160). This spontaneous report refers to a 12 year old male patient. Information on patient's other medications was not reported. The patient had no current illnesses and historical conditions. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (expiration date: 19-OCT-2017), dose 1 (unspecified dosage) and VAQTA lot # M002268 dose 2 (unspecified dosage) intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with ADACEL lot # U5315AA, dose 1 and MENACTRA lot # U5415AA, dose 1 intramuscularly in the right arm for prophylaxis. On 16-AUG-2016, patient experienced dizziness, fever with a temperature of 102 F, hands hurt, sore throat, neck pain, noise sensitivity and headache. On the same day, the patient also had streptococcus test negative. The patient was taken to emergency room. The outcome of all the events was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Pain in extremity, 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 ID-648160). This spontaneous report refers to a 12 year old male patient. Information on patient's other medications was not reported. The patient had no current illnesses and historical conditions. On 10-AUG-2016, the patient was vaccinated with GARDASIL 9 lot # L026602 (expiration date: 19-OCT-2017), dose 1 (unspecified dosage) and VAQTA lot # M002268 dose 2 (unspecified dosage) intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with ADACEL lot # U5315AA, dose 1 and MENACTRA lot # U5415AA, dose 1 intramuscularly in the right arm for prophylaxis. On 16-AUG-2016, patient experienced dizziness, fever with a temperature of 102 F, hands hurt, sore throat, neck pain, noise sensitivity and headache. On the same day, the patient also had streptococcus test negative. The patient was taken to emergency room. The outcome of all the events was reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Gait disturbance, Pain in extremity, Rash, Streptococcus test negative, Throat tightness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648229) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concurrent illnesses included clavicle pain and sore throat. The patient's historical condition included seasonal allergies. Information on the patient's prior vaccinations and other medications were not reported.  On 12-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # M009378 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 13-AUG-2016, the patient woke up at 8 am with leg pain and experienced some difficulty in walking. At 7.30 pm the patient developed some bumps and his mom felt those were hives, child's throat was tight and was given with 4 tablespoons of BENADRYL. Spoke with doctor at 9:10 pm and the doctor recommended emergency room (ER) visit. The patient's mom called 911. Paramedics felt that the child was fine and no further symptoms. The patient's lab data included streptococcus culture and the result was found to be negative. The outcome of rash was resolved. The outcome of gait disturbance, pain in extremity, streptococcus test negative, throat tightness and urticaria was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648229) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concurrent illnesses included clavicle pain and sore throat. The patient's historical condition included seasonal allergies. Information on the patient's prior vaccinations and other medications were not reported.  On 12-AUG-2016, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # M009378 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 13-AUG-2016, the patient woke up at 8 am with leg pain and experienced some difficulty in walking. At 7.30 pm the patient developed some bumps and his mom felt those were hives, child's throat was tight and was given with 4 tablespoons of BENADRYL. Spoke with doctor at 9:10 pm and the doctor recommended emergency room (ER) visit. The patient's mom called 911. Paramedics felt that the child was fine and no further symptoms. The patient's lab data included streptococcus culture and the result was found to be negative. The outcome of rash was resolved. The outcome of gait disturbance, pain in extremity, streptococcus test negative, throat tightness and urticaria was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dysphagia, Fatigue, Full blood count normal, Malaise, Myalgia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648242) on 02-MAY-2017. This spontaneous report refers to an 18 year old male patient. The patient had no concurrent illnesses. The patient's medical history included allergy: sesame seeds, seasonal allergy and hyperhidrosis. Information on the patient's prior vaccinations was not reported. The patient's other medications included TAVIST. On 01-AUG-2016 the patient was vaccinated with the first dose of GARDASIL 9 lot # M005714 (expiration date: 03-OCT-2017) (dose and frequency were not reported), intramuscularly, site: unknown for prophylaxis. On 10-AUG-2016, the patient experienced fatigue, malaise, myalgias, dysphagia and full blood count normal. The patient's lab data included normal CBC. The outcome of dysphagia, myalgia, malaise, full blood count normal and fatigue was unknown. The causality assessment was not reported. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Confusional state, Crying, Hallucination, Mydriasis
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 # 648367). This spontaneous report refers to a 13 year old female patient. The patient's concurrent illnesses was reported as none and medical history included asthma. On 08-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L043213, dose 1, intramuscularly in the right arm for prophylaxis. On 09-JUN-2016, the patient experienced confusional state, mydriasis, hallucination and crying hysterically. The patient had an emergency room visit. The outcome of confusional state, mydriasis, hallucination and crying hysterically, were reported as unknown. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 20.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Chest pain, Dyspnoea, Mobility decreased, Pain, 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 # 648581) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 20 year old male patient. The patient's other medications, concurrent illness and pertinent medical history were not reported. On 09-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L011846, expiration date: 16-JUN-2017, dose 3, intramuscularly in the left arm and BEXSERO (manufacturer: Novartis) lot # 153701, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient came to the emergency room during the pm time, was unable to move arm, had left sided swelling and pain with throat closed up. The patient had heavy breathing and was given Benadryl and epinephrine. The patient was seen again on 10-AUG-2016 and was having chest pain and heavy breathing. The outcome of dyspnoea, throat tightness, swelling, pain and movement disorder was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 20.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Throat tightness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648581) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 20 year old male patient. The patient's other medications, concurrent illness and pertinent medical history were not reported. On 09-AUG-2016 the patient was vaccinated with GARDASIL 9 lot # L011846, expiration date: 16-JUN-2017, dose 3, intramuscularly in the left arm and BEXSERO (manufacturer: Novartis) lot # 153701, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient came to the emergency room during the pm time, was unable to move arm, had left sided swelling and pain with throat closed up. The patient had heavy breathing and was given Benadryl and epinephrine. The patient was seen again on 10-AUG-2016 and was having chest pain and heavy breathing. The outcome of dyspnoea, throat tightness, swelling, pain and movement disorder was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 648584) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient had no concurrent illnesses and was not under use of any other medications. The patient's medical history included allergy to amoxicillin. On 09-AUG-2016 the patient was vaccinated with GARDASIL 9, dose 1, lot#: L022602 (invalid), intramuscularly in the right deltoid, ADACEL dose 1, lot#: U5264AA, intramuscularly in the left deltoid and MENACTRA dose 1, lot#: U5228BA, intramuscularly in the left deltoid for prophylaxis. On 10-AUG-2016, in the morning, the patient experienced redness and a small swelling of left deltoid which increased in size. The patient visited physician's office on 12-AUG-2016. The left deltoid had an area of redness, swelling and tenderness within 6 inches x 4 inches (onset reported as: 10-AUG-2016). Treatment was provided with KEFLEX and cool compresses. The outcome of all the events was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.