chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HPV9, MENB
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient's other medications, current illnesses, medical history and prior vaccinations were not reported. On 31-MAY-2016, the patient was vaccinated with third dose of GARDASIL 9 lot # L04574, in the left arm (route of administration, dose, frequency and lot expiration date unknown) for prophylaxis. Other suspect therapies included TRUMENBA dose number 1; vaccinated date: 31-MAY-2016, in the right arm, lot # M37315; (route of administration, dose, frequency and lot expiration date unknown). And the same day 3 hours after injection, the patient had a fever increased to 103 degrees Fahrenheit with body aches and lethargy. The outcome of lethargy, pyrexia and pain 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: Cellulitis, Injection site erythema, Injection site pruritus, Injection site swelling, 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 # 642024) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Patient's medical history included intermittent asthma, body mass index (BMI) 99%, Attention deficit hyperactivity disorder (ADHD), autism, obsessive-compulsive disorder (OCD), anxiety, picking and self-mutilation. Patient's concurrent illness included upper respiratory tract infections (URI) and neg rapid and patient had no fever. Patient's other medication included Clonidine. Information on the patient's prior vaccinations were not reported. On 03-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L024993, dose 2, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day at 2:17pm, the patient was also vaccinated with MENACTRA lot/batch # U5244AA, dose 2, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On the same evening, after the vaccination with MENACTRA at 02:17pm, the patient developed local itchiness, started scratching site over next day and continued scratching, he developed swelling and redness at the injection site. Patient's mother took him to the emergency room on 04-JUN-2016 night. Patient was diagnosed with cellulitis and local reaction. On 03-JUN-2016, patient complained of stuffy nose and sore throat. On 06-JUN-2016, patient's mother presented the swelling on patient's right arm. Other immunization were up to date for age including 2015 flu, TDaP and MENACTRA. HPV and MCV was due. HPV#3 was due on OCT-2016. In follow up, local vaccine reaction and cellulitis were reported. The outcome of all the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Nasal congestion, Oropharyngeal pain, Peripheral swelling, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642024) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Patient's medical history included intermittent asthma, body mass index (BMI) 99%, Attention deficit hyperactivity disorder (ADHD), autism, obsessive-compulsive disorder (OCD), anxiety, picking and self-mutilation. Patient's concurrent illness included upper respiratory tract infections (URI) and neg rapid and patient had no fever. Patient's other medication included Clonidine. Information on the patient's prior vaccinations were not reported. On 03-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L024993, dose 2, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day at 2:17pm, the patient was also vaccinated with MENACTRA lot/batch # U5244AA, dose 2, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On the same evening, after the vaccination with MENACTRA at 02:17pm, the patient developed local itchiness, started scratching site over next day and continued scratching, he developed swelling and redness at the injection site. Patient's mother took him to the emergency room on 04-JUN-2016 night. Patient was diagnosed with cellulitis and local reaction. On 03-JUN-2016, patient complained of stuffy nose and sore throat. On 06-JUN-2016, patient's mother presented the swelling on patient's right arm. Other immunization were up to date for age including 2015 flu, TDaP and MENACTRA. HPV and MCV was due. HPV#3 was due on OCT-2016. In follow up, local vaccine reaction and cellulitis were reported. The outcome of all the events was reported as recovered. The causality assessment for 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: F
Vaccine: HEPA, HPV9
Symptoms: Abdominal pain, Arthralgia, Cognitive disorder, Colonoscopy, Endoscopy
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 # 642027) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Information on the prior vaccinations were not reported. Information on the patient's concurrent illnesses and medical history were reported as none. Patient's other medications included PRILOSEC, SINGULAIR, Albuterol, ADDERALL, SYMBICORT. Patient's lab data included colonoscopy, endoscopy, multiple therapists, x-rays. Patient visited an orthopedic. On 21-JUN-2016, the patient was vaccinated with GARDASIL 9 lot/batch# 0459AE, dose 1, intramuscularly, in right leg for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with VAQTA dose 1, intramuscularly, in unknown site for prophylaxis (dosage, lot and expiry date unspecified). On 12-AUG-2012, after the vaccination, the patient had abdominal pain, Joint pain, headaches, nausea, visual disturbances, hot flashes, cognitive memory issues and patient could not sleep. The patient had been to many doctors. The outcome of the events were reported as not recovered. The patient required emergency room visit. 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: F
Vaccine: HEPA, HPV9
Symptoms: Headache, Hot flush, Insomnia, Memory impairment, 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 # 642027) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Information on the prior vaccinations were not reported. Information on the patient's concurrent illnesses and medical history were reported as none. Patient's other medications included PRILOSEC, SINGULAIR, Albuterol, ADDERALL, SYMBICORT. Patient's lab data included colonoscopy, endoscopy, multiple therapists, x-rays. Patient visited an orthopedic. On 21-JUN-2016, the patient was vaccinated with GARDASIL 9 lot/batch# 0459AE, dose 1, intramuscularly, in right leg for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with VAQTA dose 1, intramuscularly, in unknown site for prophylaxis (dosage, lot and expiry date unspecified). On 12-AUG-2012, after the vaccination, the patient had abdominal pain, Joint pain, headaches, nausea, visual disturbances, hot flashes, cognitive memory issues and patient could not sleep. The patient had been to many doctors. The outcome of the events were reported as not recovered. The patient required emergency room visit. 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: F
Vaccine: HEPA, HPV9
Symptoms: Visual impairment, X-ray
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 # 642027) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Information on the prior vaccinations were not reported. Information on the patient's concurrent illnesses and medical history were reported as none. Patient's other medications included PRILOSEC, SINGULAIR, Albuterol, ADDERALL, SYMBICORT. Patient's lab data included colonoscopy, endoscopy, multiple therapists, x-rays. Patient visited an orthopedic. On 21-JUN-2016, the patient was vaccinated with GARDASIL 9 lot/batch# 0459AE, dose 1, intramuscularly, in right leg for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with VAQTA dose 1, intramuscularly, in unknown site for prophylaxis (dosage, lot and expiry date unspecified). On 12-AUG-2012, after the vaccination, the patient had abdominal pain, Joint pain, headaches, nausea, visual disturbances, hot flashes, cognitive memory issues and patient could not sleep. The patient had been to many doctors. The outcome of the events were reported as not recovered. The patient required emergency room visit. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Presyncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642045) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 16 year old male patient. Information on the patient's concurrent illnesses, medical history and lab data were reported as not applicable. Information on the patient's prior vaccinations were not reported. Patient's other medication included KARIVA (birth control pill). On 06-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M004116, dose 1, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with included HAVRIX lot/batch # 4P9M9, dose 1, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient had vasovagal reaction. The outcome of the event  presyncope was reported as recovered. The causality assessment for the event presyncope with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HEPA, 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 # 642051) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old male patient. Information on the patient's lab data and prior vaccinations were not reported. Information on the patient's concurrent illnesses, other medications and medical history were reported as none. On 11-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L019297, dose 3, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with VAQTA lot # L015460, dose 2, intramuscularly in the left arm for prophylaxis (dosage unspecified). The patient was administered the drug at an inappropriate age and patient had no symptoms. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Antinuclear antibody negative, Arthralgia, Back pain, Erythema nodosum, Full blood count 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 # 642098) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were reported as none. Information on the patient's prior vaccination were not reported. Patient's lab data included normal complete blood picture (CBC) and comprehensive Metabolic Panel (CMP) and a negative antinuclear antibody (ANA) test. Patient had a slightly elevated sedimentation rate. On 15-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L048459, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On 18-JUN-2016, the patient developed erythema nodosum rash on the legs, with joint pain leading to back pain. The outcome of the events were reported as not recovered. The patient required emergency room visit. The causality assessment for 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: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Metabolic function test normal, Rash, Red blood cell sedimentation rate increased
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 # 642098) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 15 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were reported as none. Information on the patient's prior vaccination were not reported. Patient's lab data included normal complete blood picture (CBC) and comprehensive Metabolic Panel (CMP) and a negative antinuclear antibody (ANA) test. Patient had a slightly elevated sedimentation rate. On 15-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # L048459, dose 1, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On 18-JUN-2016, the patient developed erythema nodosum rash on the legs, with joint pain leading to back pain. The outcome of the events were reported as not recovered. The patient required emergency room visit. The causality assessment for 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: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Dyspnoea, Fatigue, Myalgia, 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 # 642143) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old female patient. Information on the patient's medical history and prior vaccinations were not reported. Information on the patient's concurrent illnesses and lab data were reported as none. Patient's other medication included BENZACLIN, topically for acne (start date: 03-JUN-2016). On 03-JUN-2016, the patient was vaccinated with GARDASIL 9 lot # M003659, dose 3, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with TRUMENBA lot/batch # M95612, dose 1, intramuscularly in the left arm and MENACTRA lot/batch # US272AA, dose 2, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day patient complained of shortness of breath upon standing. On 04-JUN-2016, patient had fatigue and muscle hurting. On 05-JUN-2016, patient woke up with urticarial lesions in the trunk and in extremities. Patient was seen in the urgent care and was given SOLU-MEDROL injection and oral steroids for 5 days. The outcome of the events were reported as recovered. The patient required emergency room visit. 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: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain upper, Headache, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642318) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. Patient had no concurrent illness. Information on the patient's lab data and prior vaccinations were not reported. The patient's medical history included attention Grave's disease, oppositional defiant disorder (ODD), attention deficit/hyperactivity disorder (ADHD), anxiety and asthma. Patient's other medication included ZOLOFT, FOCALIN, Trazodone, SYNTHROID and TRI-SPRINTEC. On 30-JUN-2016 the patient was vaccinated with GARDASIL 9 lot # L038917, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient had vomiting, headache, stomach, cramps and low grade Fever all lasted for three days. The outcome of abdominal pain upper, vomiting, pyrexia and headache was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Unevaluable event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642383) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and prior vaccinations were not reported. On 19-OCT-2015, the patient was vaccinated with GARDASIL 9 lot # M003659, dose 3, intramuscularly in the left arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with included FLUARIX lot/batch # 2F5P4, intramuscularly in the left arm for prophylaxis (dose number, dosage and expiry date unspecified). On an unknown date the patient had unevaluable event. The outcome of the event was unknown. The causality assessment for the event with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Headache, Muscle twitching, Nausea, Syncope
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 16 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 07-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. And same day the patient had syncope with leg twitching after 5 minutes of vaccine administration and also complained of nausea and headache remainder of day. The outcome of muscle twitching, syncope, nausea and headache 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, MEN, TDAP
Symptoms: Abdominal pain upper, Feeding disorder, Injection site erythema, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 642969). This spontaneous report refers to a 11 year old male patient with prophylaxis. The patient had no current illnesses and information on patient's prior vaccinations was not reported. The patient's medical history included attention deficit/hyperactivity disorder (ADD), seizure, insomnia, depression, constipation, asthma and migraines- followed by specialists. The patient's other medications included VYVANSE, vitamin D3, valproic acid, trazodone, SINGULAIR, buspirone, DEPAKOTE, fluoxetine and guanfacine. On 08-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714 (expiry date: 03-OCT-2017), dose 2, intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # US278AA, dose 2, intramuscularly in the left arm and MENOMUNE lot # US259AA, dose 2, intramuscularly in the right arm. On 08-JUL-2016, the patient complained of erythema, pain at injection site and had difficulty in eating and drinking due to stomach pain. On 10-JUL-2016, the patient was seen in the emergency room (ER) and was followed up in the office and improvement was noted on 11-JUL-2016. 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: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643546). This spontaneous report refers to a 14 year old female patient. Information on the patient's concurrent illnesses, medical history and prior vaccinations were not reported. The patient had no other medications. On 14-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M007764 (expiry date: 30-JAN-2018), dose 1, intramuscular route in the left arm for prophylaxis. On the same day, the patient fainted three times after vaccine administration. The outcome of 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.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Erythema, Gait disturbance, Joint swelling, Macule, Peripheral swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643552). This spontaneous report refers to a 14 year old female patient. The patient's medical history included SP MVA, left VIth cranial nerve palsy (resolving) and left scapula fracture (resolving). Information on the patient's concurrent illnesses, prior vaccinations and other medications were not reported. On 12-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 (expiry date: 07-DEC-2017), dose 1, intramuscular route in the left arm and VAQTA lot# M002268, dose 1, intramuscular route in the left arm for prophylaxis. On an unknown date, the patient developed joint swelling and red middle fingers around the proximal interphalangeal (PIP) joints. The patient felt better the next day, however her feet were puffy and had difficulty walking. The same morning, the patient had rash on arms and legs: scattered macules and rest of the rash were spidery which were improving and lighter in color, at the time of the report. The patient underwent a visual inspection. The outcome of erythema, rash, peripheral swelling, macule, joint swelling and gait disturbance was 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: 14.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: 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 # 643552). This spontaneous report refers to a 14 year old female patient. The patient's medical history included SP MVA, left VIth cranial nerve palsy (resolving) and left scapula fracture (resolving). Information on the patient's concurrent illnesses, prior vaccinations and other medications were not reported. On 12-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 (expiry date: 07-DEC-2017), dose 1, intramuscular route in the left arm and VAQTA lot# M002268, dose 1, intramuscular route in the left arm for prophylaxis. On an unknown date, the patient developed joint swelling and red middle fingers around the proximal interphalangeal (PIP) joints. The patient felt better the next day, however her feet were puffy and had difficulty walking. The same morning, the patient had rash on arms and legs: scattered macules and rest of the rash were spidery which were improving and lighter in color, at the time of the report. The patient underwent a visual inspection. The outcome of erythema, rash, peripheral swelling, macule, joint swelling and gait disturbance was 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: 15.0
Sex: M
Vaccine: HEPA, HPV9
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 # 643575).This spontaneous report refers to a 15 year old male patient. Information on the patient's concurrent illnesses, medical history, prior vaccinations and other medications were not reported. On 14-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M011117 (expiry date: 07-DEC-2017), dose 1, unknown route in the right arm and HAVRIX lot/batch # 2PC5H, dose 1, unknown route in the right arm for prophylaxis. On the same day, the patient experienced dizziness, but did not faint. The outcome of dizziness was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling, 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 # 643626). This spontaneous report refers to a 11 year old male patient. The patient's medical history included asthma and allergies. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 12-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M004116 (expiry date: 12-OCT-2017), dose 1, intramuscular route in the left arm and MENACTRA batch/lot# U5244AA, dose 1, intramuscular route in the right arm for prophylaxis. On the same day, the patient's right deltoid was red and swollen to a diameter of 5cm. The reaction was a local reaction. The outcome of injection site erythema, local reaction and injection site swelling was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MENB, MNQ, VARCEL
Symptoms: Dizziness, Hypoaesthesia oral, Lip swelling, Swollen tongue
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 16 year old male patient. The patient's medical history included essential HTN (hypertension) and obesity. The patient had no current illnesses. The patient's other medications included Lisinopril and patient's prior vaccinations was not reported. On 15-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9 lot # M007764 and expiration date: 30-JAN-2018, intramuscularly in the left arm (dose and frequency unknown) for prophylaxis, with second dose of VARIVAX lot # M007287, subcutaneously in the right arm arm (dose, frequency and lot expiration date unknown) for prophylaxis and with a first dose of VAQTA lot # M009377 and expiration date 17-JUN-2017, intramuscularly in the left arm arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included BEXSERO dose number 1; vaccinated date: 15-JUL-2016, intramuscularly in the right arm, lot # 154101; (dose, frequency and lot expiration date unknown) and MENVEO dose number 1; vaccinated date: 15-JUL-2016, intramuscularly in the right arm, lot # 154101, (dose, frequency and lot expiration date unknown).   On 15-JUL-2016, after 10-15 minutes of vaccine administration the patient became dizzy and started to complain that his lips and tongue had swollen and felt numb. The patient's vitals were normal. At the time of examination the patient had no swelling. The patient received 50 mg of Benadryl. After 20 minutes the patient felt fine and was discharged to home. The patient had no hives, cough or wheezing. The outcome of hypoaesthesia oral, dizziness, swollen tongue and lip swelling was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Feeling hot, 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 # 643674) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Information on the patient's lab data, other medications and prior vaccinations were not reported. Patient had no concurrent illness and medical history. On 15-JUL-2016, the patient was vaccinated with GARDASIL 9 lot/batch# L0432103, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On 16-JUL-2016, the patient had swelling, redness, warmth. The outcome of the events were unknown. The causality assessment for 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: Abdominal pain upper, Glassy eyes, Loss of consciousness, Pallor, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643676) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. Information on the patient's lab data, other medications and prior vaccinations were not reported. Information on the patient's concurrent illnesses and medical history were reported as none. On 18-JUL-2016, the patient was vaccinated with GARDASIL 9 dose 2, in the left arm for prophylaxis (route, dosage, lot and expiry date unspecified). On the same day, the patient's stomach started hurting and she passed out. Patient's vitals were checked. She was given with orange juice and crackers. She vomited. Her eyes looked very glazed for a short period of time and she was white and pale. Wet cloth was put on patient's head and was checked her reflexes and eyes. She got her colour back and she was fine. The outcome of the events  was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MEN, MENB
Symptoms: Dizziness, Loss of consciousness, Posture abnormal
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 17 year old male patient. The patient had no other medications, current illnesses and medical history. The patient's prior vaccinations was not reported. On 19-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M005714 and expiration date: 03-OCT-2017, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. Other suspect therapies included TRUMENBA dose number 1; vaccinated date: 19-JUL-2016, intramuscularly in the right arm, lot # M74089, (dose, frequency and lot expiration date unknown) and MENOMUNE-A/C/Y/W-135 dose number 1; vaccinated date: 19-JUL-2016, intramuscularly in the left arm, lot # U5O58AC, (dose, frequency and lot expiration date unknown). On 19-JUL-2016, after patient had received three vaccines, he stated that he felt dizzy, had loss of consciousness and slumped over in chair. The patient was held upright for approximately 10 seconds until he came around and was able to respond to the questions. The patient was assisted to lying position and ice was applied to his back of neck. After lying for a few a minutes, the patient sat up and ate a granola bar which his grandmother gave and drank a juice. The patient was observed for approximately 10 more minutes until he stated he felt better and patient left the office. The outcome of loss of consciousness, dizziness and posture abnormal was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Differential white blood cell count normal, Eye pain, Headache, Lip swelling, Metabolic function test 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 # 643876) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included minocycline 100 mg. On 07-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M004116 with expiration date: 12-OCT-2017 (dose and frequency were not reported) for prophylaxis. On the same day post vaccination of GARDASIL 9 the patient experienced eye pain and swelling of lips. On 09-JUN-2016, the patient experienced severe headache with migraine like features of photophobia, mild nuchal rigidity, nausea, vomiting, inability to keep anything down, streptococcus test negative, metabolic function test normal and differential white blood cell count normal. The patient required an emergency room (ER) visit. The outcome of blood culture negative, differential white blood cell count normal, eye pain, lip swelling, metabolic function test normal, migraine, nausea, nuchal rigidity, photo phobia, streptococcus test negative and vomiting 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: Migraine, Nausea, Nuchal rigidity, Photophobia, 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 # 643876) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included minocycline 100 mg. On 07-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M004116 with expiration date: 12-OCT-2017 (dose and frequency were not reported) for prophylaxis. On the same day post vaccination of GARDASIL 9 the patient experienced eye pain and swelling of lips. On 09-JUN-2016, the patient experienced severe headache with migraine like features of photophobia, mild nuchal rigidity, nausea, vomiting, inability to keep anything down, streptococcus test negative, metabolic function test normal and differential white blood cell count normal. The patient required an emergency room (ER) visit. The outcome of blood culture negative, differential white blood cell count normal, eye pain, lip swelling, metabolic function test normal, migraine, nausea, nuchal rigidity, photo phobia, streptococcus test negative and vomiting 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: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 643876) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient. The patient had no concurrent illnesses and medical history. Information on the patient's prior vaccinations were not reported. The patient's other medications included minocycline 100 mg. On 07-JUN-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # M004116 with expiration date: 12-OCT-2017 (dose and frequency were not reported) for prophylaxis. On the same day post vaccination of GARDASIL 9 the patient experienced eye pain and swelling of lips. On 09-JUN-2016, the patient experienced severe headache with migraine like features of photophobia, mild nuchal rigidity, nausea, vomiting, inability to keep anything down, streptococcus test negative, metabolic function test normal and differential white blood cell count normal. The patient required an emergency room (ER) visit. The outcome of blood culture negative, differential white blood cell count normal, eye pain, lip swelling, metabolic function test normal, migraine, nausea, nuchal rigidity, photo phobia, streptococcus test negative and vomiting 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: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site discomfort
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644294). This spontaneous report refers to a 17 year old female patient. Information on the patient's concurrent illnesses, medical history, prior vaccinations and other medications were not reported. On 14-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M005714 (expiry date: 03-OCT-2017), dose 1, intramuscular route in the left arm for prophylaxis. On 15-JUL-2016, the patient experienced injection site discomfort for a week. The patient had no swelling or redness and the injection site was not warm to touch. The outcome of injection site discomfort 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: 6.0
Sex: F
Vaccine: HPV9
Symptoms: Dyskinesia, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 644686). This spontaneous report refers to a 6 year old female patient. The patient had no concurrent illnesses, historical conditions or other medications. Information on the patient's prior vaccinations was not reported. On 25-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L014415 (expiry date: 25-JUL-2017), dose 1, intramuscular route in the left arm for prophylaxis. On the same day, within one minute post vaccination, the patient's body jerked and she passed out. The patient was laid down and within 30 seconds, she woke up. The patient's vital signs were stable 108/50 (units unspecified) and pulse was 60 (units unspecified). The outcome of dyskinesia 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.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Loss of consciousness, 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 # 644752). This spontaneous report refers to a 11 year old female patient. The patient had no concurrent illnesses or historical conditions. Information on the patient's prior vaccinations and other medications were not reported. On 26-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L043214, dose 1, intramuscular route in the right arm, ADACEL lot/batch# UI543AA, dose 1, intramuscular route in the left arm and MENVEO lot/batch# M15076A, dose 1, intramuscular route in the left arm for prophylaxis. On the same day, the patient passed out and urinated. The outcome of loss of consciousness and urinary incontinence 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, MNQ, TDAP
Symptoms: Loss of consciousness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old female patient. The patient had no other medications, current illnesses, medical history and prior vaccinations. On 27-JUL-2016, the patient was vaccinated with GARDASIL 9, lot # L024993 and expiration date: 17-OCT-2017, intramuscularly in the right arm (dose number, dose and frequency unknown) for prophylaxis. Other suspect therapies included ADACEL dose number 1; vaccinated date: 27-JUL-2016, intramuscularly in the left arm, lot # U5406AA; (dose, frequency and lot expiration date unknown) and MENACTRA dose number 1; vaccinated date: 27-JUL-2016, intramuscularly in the right arm, lot # U5460AB; (dose, frequency and lot expiration date unknown). On 27-JUL-2016, the patient left the office after getting vaccinated and passed out near the elevator. She quickly came to and the patient's mother brought her back into the office. The outcome of loss of consciousness 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: HEPA, HPV9
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient. The patient's other mediations, current illnesses, medical history and prior vaccinations were not reported. On 13-JUL-2016, the patient was vaccinated with first dose of GARDASIL 9, lot # M005714 and expiration date: 03-OCT-2017, intramuscularly in the right arm (dose and frequency unknown) for prophylaxis. Other suspect therapy included HAVRIX dose number 1; vaccinated date: 13-JUL-2016, intramuscularly in the right arm, lot # 7447G, (dose, frequency and lot expiration date unknown). It was reported that the adult formula GARDASIL 9 was given to patient. The outcome for drug administered to patient of inappropriate age was reported as recovered.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Hypersensitivity, Lip oedema, Tongue 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 # 645115) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old male patient. Information on the patient's other medications and prior vaccinations were not reported. Patient had no concurrent illness, lab data and medical history. On 22-JUL-2016 at 10:10 am, the patient was vaccinated with GARDASIL 9 lot/batch# M0041116, dose 2, intramuscularly in the left arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with HAVRIX lot/batch# ED72D, dose 2, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). Patient's mother stated that at the time of vaccination patient did not suffer from any allergies or illness. At 2:00pm patient's mother called the facilities and notified that her son had edema in lips and tongue. Patient received medical assistance at 4:00pm on the same day. After the patient was evaluated he was diagnosed with an allergic reaction due to vaccine administration. Patient was given BENADRYL and SOLU-MEDROL intravenously. The outcome of the events was reported as recovered. The patient required emergency room visit. The causality assessment for the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 645141) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. Information on the patient's medical history, other medications and prior vaccinations were not reported. Information on patient's current illness was reported as none.  On 19-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # L037554, dose 1, via unknown route in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day the patient was also vaccinated with ADACEL lot/batch # U5264AA, dose 1, via unknown route in the left arm and MENACTRA lot/batch # U52441979, dose 1, via unknown route in the right arm for prophylaxis (dosage and expiry date unspecified). On 20-JUL-2016, the patient had redness, it was hot and swollen right shoulder. The outcome of injection site erythema, injection site warmth and injection site swelling was reported as recovered. The causality assessment for 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: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling hot, Flushing, 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 # 645149) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Information on the patient's concurrent illnesses and other medications were reported as none. Patient's medical history was reported as nuts. Information on the patient's lab data and prior vaccination were not reported. On 21-JUL-2016, the patient was vaccinated with GARDASIL 9 lot # M007764, dose 1, intramuscularly in the right arm for prophylaxis (dosage unspecified). On the same day the patient was also vaccinated with included BOOSTRIX lot/batch # KJ4M, dose 6, intramuscularly in the left arm and MENVEO lot/batch # M15124, dose 1, intramuscularly in the right arm for prophylaxis (dosage and expiry date unspecified). On the same day, after the vaccination patient sat for approximately 15 minutes with no issues. When patient stood up she flushed, felt hot and also complained of headache. Cool compress was applied, water was given to her and patient laid down for approximately 15 minutes with no further issues. Patient was given with foods. She stated that she had not eaten in a while. Mother was present in the room. Patient left the facility with no more further issues and no complaints. The outcome of feeling hot, headache and flushing was reported as recovered. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.