chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 621281) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 15 year old female patient. The patient's medical history included hypertriglyceridemia, eczema and myopia. The patient had no known allergies (NKA) and current illnesses. Information on concomitant medications and prior vaccinations were not reported. Other medications include Amitriptyline 50 mg, Desowen 0.05% cream, Ibuprofen 200 mg. On 21-JAN-2016, the patient was vaccinated with GARDASIL 9 injection, dose number 1 (dose, frequency, lot number and lot expiration date unknown) via intramuscular route in the right arm for prophylaxis. On 22-JAN-2016, the patient developed soreness and redness at the injection site (injection site erythema), injection site warmth, injection site pruritus, injection site pain and quarter size swelling at the injection site. Treated with ice and ibuprofen. The symptoms lasted more than a week after injection. 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: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 621897) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old male patient. The patient's medical history included food allergy to sesame seeds. The patient had no concurrent illnesses or other medications. Information on the patient's prior vaccinations was not reported. On 04-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L028083 (lot expiration date unknown) for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX (dose number: 1, intramuscularly in the left arm, lot# KP95K, manufacturer: GlaxoSmithKline, lot expiration date unknown), HAVRIX (dose number: 2, intramuscularly in the left arm, lot# 7447G, manufacturer: GlaxoSmithKline, lot expiration date unknown) and (MENACTRA (dose number: 1, intramuscularly in the right arm, lot# U5272AA, manufacturer: Sanofi Pasteur, lot expiration date unknown) for prophylaxis. On an unspecified date, the patient experienced an unevaluable adverse event. The outcome of the event 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
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, 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 # 621991) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old male patient. The patient had no known allergy in the past. The patient's concurrent illnesses was reported as none. The patient's other medication and prior vaccinations were not reported. On 27-JAN-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L027282 (dose number: 3, lot expiration date: 21-SEP-2017) for prophylaxis. On 28-JAN-2016, the patient developed redness around the injection site which was also hot and hard. The redness kept expanding downward and partially around the arm with vague borders (approximately 16cm long, 11cm wide) and swelling. The injection site was warm to touch. The patient had cellulitis in injection site. Status post immunization: Cephalexin 500mg (bid, orally for 10 days) was given. The outcome of the events was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Dyspnoea, Gait disturbance, 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 # 622325) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 12 year old male patient. The patient's medical history included amoxicillin allergy. The patient had no concurrent illness. Information on the patient's prior vaccinations was not reported. On 08-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm (lot# and expiration date were not reported) for prophylaxis. On the same day, the patient experienced difficulty in breathing, difficulty in walking, dizziness and nausea. The patient had called the clinic to report about the experiences and the nurse said that it was normal. The patient did not see the vaccine (GARDASIL 9) on his list. The outcome for the events dyspnoea, nausea, dizziness and gait disturbance 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: FLUN4, HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Altered state of consciousness, Dizziness, Hyperhidrosis, 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 # 622409) on 18-APR-2017. This spontaneous report refers to a 11 year old male patient with prophylaxis. The patient's medical history, concurrent illness and other medication were reported as none. Information on the patient's prior vaccinations was not reported. On 11-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L048237 (lot expiration date was not reported) and VARIVAX (dose number:1, subcutaneously in the left arm, lot# L017146, lot expiration date was not reported) for prophylaxis. On the same day, the patient was also vaccinated with FLUMIST QUADRIVALENT (dose number:1, route: intranasal, manufacturer: Medimmune; lot # and lot expiration date were not reported), MENACTRA (dose number:1, intramuscularly in the right arm, lot# U5172BA, manufacturer: Sanofi Pasteur; lot expiration date was not reported), BOOSTRIX (dose number:7, intramuscularly in the left arm, lot# XE2DJ, manufacturer: GlaxoSmithKline; lot expiration date were not reported) and HAVRIX (dose number:1, intramuscularly in the right arm, lot# 44Z9H, manufacturer: GlaxoSmithKline; lot expiration date was not reported) for prophylaxis. On 11-FEB-2016, the patient (student) experienced lightheadedness and was mildly diaphoretic. The patient then felt like he was "going to black out" so he was placed in reverse trendelenberg position. The patient's blood pressure (BP) was 92/64 (units unspecified). After 5 minutes the patient felt better and his BP was 102/78 (units unspecified). The patient gradually recovered and returned to normal within 15 minutes. The patient had near syncope episode. The outcome for the events hyperhidrosis, dizziness and presyncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Fall, Posture abnormal, 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 # 622510) on 18-APR-2017. This spontaneous report refers to a 12 year old female patient. The patient's medical history included allergy to peanuts, attention deficit hyperactivity disorder (ADHD) and acne. The patient's current illness included right eye discomfort and other medications included Concerta with a dose of 18mg and frequency of once a day. On 06-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L036245, (unspecified dose and dosage) intramuscularly in the left arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5260AA, (unspecified dose and dosage) intramuscularly in the right arm for prophylaxis, BOOSTRIX lot # KJ4MS, (unspecified dose and dosage) intramuscularly in the left arm for prophylaxis and FLUZONE lot # UI431AD, (unspecified dose and dosage) intramuscularly in the right arm for prophylaxis. On the same day after the vaccine was administered, the patient fell back on the exam chair after standing, eyes rolled back, had some tremors and had an abnormal posture by leaning to the side. The events lasted less than 30 seconds. The patient's vital signs were taken immediately after that and were found to be within normal ranges. The patient was given water and a candy sucker. She sat and waited approximately for 30 minutes, after which the vital signs were taken again and were found to be normal.  She was escorted to the parking lot, and was reported to have walked and felt fine. She had no complaints while leaving the facility. The outcome of the events was reported as recovered. The causality assessment for the events with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Abdominal pain, Fatigue, Laboratory test, Lymph node pain, 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 # 623541) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. The patient's medical history and other medications was reported as none. The patient had no concurrent illnesses. The patient's concomitant therapies and prior vaccinations were not reported. On 12-NOV-2015, the patient was vaccinated with first dose of GARDASIL 9 (dose, frequency and lot # were not reported) via intramuscular route, in the right arm for prophylaxis.  Other suspect therapies which were given on the same day included ADACEL (dose number: 1, intramuscularly in the left arm; lot#, dose and expiration date was unknown) and MENOMUNE (dose number: 1, intramuscularly in the left arm; lot#, dose and expiration date was unknown) for prophylaxis. On 13-NOV-2015, patient experienced migraine, nausea, abdominal pain, fatigue and lymphatic pain. The patient also had swollen lymph nodes in neck, clavicle and arm pit. The patient had visited the emergency room. On 19-NOV-2015, the pediatrics started performing several tests, including checking for lymphomas, tick borne illnesses, flea borne illnesses. The outcome of the events were reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MEN, TDAP
Symptoms: Migraine, 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 # 623541) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. The patient's medical history and other medications was reported as none. The patient had no concurrent illnesses. The patient's concomitant therapies and prior vaccinations were not reported. On 12-NOV-2015, the patient was vaccinated with first dose of GARDASIL 9 (dose, frequency and lot # were not reported) via intramuscular route, in the right arm for prophylaxis.  Other suspect therapies which were given on the same day included ADACEL (dose number: 1, intramuscularly in the left arm; lot#, dose and expiration date was unknown) and MENOMUNE (dose number: 1, intramuscularly in the left arm; lot#, dose and expiration date was unknown) for prophylaxis. On 13-NOV-2015, patient experienced migraine, nausea, abdominal pain, fatigue and lymphatic pain. The patient also had swollen lymph nodes in neck, clavicle and arm pit. The patient had visited the emergency room. On 19-NOV-2015, the pediatrics started performing several tests, including checking for lymphomas, tick borne illnesses, flea borne illnesses. The outcome of the events were reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Oropharyngeal pain, Throat tightness
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient medical history included asthma, environmental allergies, allergic rhinitis and overweight. The patient's other medications included ASMANEX 220 mcg, inhalation 1, inhalation BID; Albuterol prn; Fluticasone 50 mcg, actual 1 spray each nare daily; Loratadine 10 mg, oral, qhs; SINGULAIR 5 mg, oral qhs. The patient prior vaccinations included dizziness-Gardasil 9 1 11.00-Patient. The patient had no current illnesses. On 24-FEB-2016, the patient was vaccinated with second dose of GARDASIL 9, lot # L016428, intramuscularly in the left arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis, And the same day, the patient experienced dizziness, fatigue, lightheadedness, sensation of sore/tight throat. Heart rate (HR) and Blood pressure (BP) were normal for patient age, good air exchange of all lung fields. Oropharynx examination benign was done. Resolved after 25 minutes, tolerated sips water without difficulty. The outcome of throat tightness, fatigue, dizziness and oropharyngeal pain was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Feeling hot
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 # 623620) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient. The patient had a history of allergy to penicillin and cefzil. The patient had received two prior doses of HPV vaccine. The patient had no concurrent illnesses. The patient concomitant therapies and other medications were not reported. On 24-FEB-2016 the patient was vaccinated with third dose of GARDASIL 9 lot # L016429, lot expiration date 09-AUG-2017(dose and frequency were not reported) via intramuscular route, in the left arm for prophylaxis. On 24-FEB-2016, during HPV vaccination in a school based clinic held in the cafeteria, the patient complained of feeling dizzy and feeling hot after looking at the needle when HPV injection was given. The patient was then lowered to the floor. Cool wash cloth was applied to the forehead and vital signs were taken. The patient's blood pressure and pulse rate was found to be 105/72 (units not provided) and 72 (units not provided) respectively. The patient's skin colour was good. The patient did not have breakfast and was offered juice and crackers and bottle of cold water. The patient was assisted to sitting position and the parent was notified by the school nurse. The patient was able to stand after 30 minutes and was ambulated to the school nurse's office. The outcome of dizziness and feeling hot 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: M
Vaccine: HPV9
Symptoms: Oral papilloma
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 # 623998) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 26 year old male patient. The patient has no medical history and concurrent illness. The patient's other medication included Losartan. The patient's prior vaccinations were not reported. On 24-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, frequency, route and site of administration, site, lot # and lot expiration date were not reported) for prophylaxis. On 25-FEB-2016, the next day morning after vaccination, the patient woke up with thousands of tiny warts on his lip. The outcome for the event oral papilloma was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Vaccination site induration, Vaccination site pain, Vaccination site rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 624371). This spontaneous report refers to a 21 year old female patient. The patient had no concurrent illnesses and no know drug allergies (NKDA). Information on the patient's prior vaccinations was not reported. The patient's other medications included sprintec. On 01-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L027282 (expiry date: 21-SEP-2017), dose 1, route reported as needle and syringe (not specified further) in the left arm for prophylaxis. Approximately on 05-FEB-2016, 4 days post shot, the patient had vaccination site rash. On 10-FEB-2016, the patient developed a 2-3 cm hard lump, vaccination site induration and vaccination site pain (4 out of 10). The outcome of injection site mass, vaccination site rash, vaccination site pain and vaccination site induration 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: 18.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Balance disorder, Feeling abnormal, Headache, 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 # 624387). This spontaneous report refers to a 18 year old female patient. Information on the patient's medical history, prior vaccinations and other medications were not reported. The patient had no concurrent illnesses. On 27-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L025737 (expiry date: 28-JUL-2017), dose 2, intramuscular route in the left arm for prophylaxis and the patient was also vaccinated with TRUMENBA batch/lot# J29203, dose 2, intramuscular route in the right arm for prophylaxis. On the same day, 1 and a half hour after vaccinations, the patient had sever headache with vomiting, the patient felt "foggy" and unsteady for 2 days. The patient required emergency room visit. The outcome of the events was reported as not recovered, however by day 3 the patient was getting better. 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: Dizziness, Nausea, Pallor, Pruritus, 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 # 624550) on 18-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. The patient's concomitant therapies, concurrent illnesses, prior vaccinations, other medications and medical history were not reported. On 18-FEB-2016 the patient was vaccinated with third dose of GARDASIL 9 lot # L036245 (dose, frequency and lot expiration date was not reported) via intramuscular route, in the left arm for prophylaxis. On 18-FEB-2016, patient had felt light headed, pale and queasy. On the next day patient developed rash that looked like hives, raised bumps and itchy. The outcome of dizziness, urticaria, pruritus, pallor and nausea was reported as recovered.Causality assessment was not reported.    Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Drooling, Loss of consciousness, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-624993). This spontaneous report refers to a 12 year old male patient. The patient had no current illnesses, historical conditions and other medications. On 01-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L018351 dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with ADACEL (unspecified dosage) intramuscularly in the right arm and MENACTRA dose 1, (unspecified dosage), intramuscularly in the left arm for prophylaxis. After receiving the three vaccinations, the patient experienced drooling, tremor and loss of consciousness. The patient was sitting in the seat and was attempted to lower to the floor while his mother was holding him. She yelled for smelling salt. Ammonia salt was cracked and by then, the patient had already started responding to his mom. The patient stated that he was scared of getting the shot and started to phase out again but his mom yelled his name and he responded. Oxygen therapy was started and MD (Doctor of medicine) was notified. The patient's mother proceeded to inform that this happens whenever he receives vaccines or has blood work done. She stated that she forgot to inform about this situation. She was asked to inform about this condition before the next vaccine so that the patient can be made to lay down for vaccines. Oxygen saturation was at 98-99% with and without the oxygen. The patient asked for water, tolerated well and left. The outcome of drooling, tremor and loss of consciousness was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 12.0
Sex: F
Vaccine: HPV9
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 ID-625305). This spontaneous report refers to a 12 year old female patient. The patient's current illnesses, historical conditions and other medications were not reported. On 15-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L045711 dose 3 (unspecified dosage), intramuscularly in the left arm for prophylaxis. The patient's father reported that on 16-FEB-2016, the patient had injection site erythema, injection site warmth and injection site swelling (in the left deltoid). Ice and ibu were applied and the swollen area was red/pink. It measured 130 mm x 100 mm. The patient stated that the condition was getting better. The outcome of injection site erythema, injection site warmth and injection site swelling was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 625329) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old female patient. The patient's historical drugs included Amoxicillin. The patient's concurrent illnesses included polycystic kidney disease and autosomal dominant plantar warts. The patient did not have any short term illness. On 15-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L011846, expiration date: 16-JUN-2017 for prophylaxis. On the same day, the patient was also vaccinated with BOOSTRIX (dose number: 1, intramuscularly in the right arm, lot# 2729X, manufacturer: GlaxoSmithKline, lot expiration date unknown) and MENVEO (dose number: 1, intramuscularly in the left arm, lot# M14130, manufacturer: Novartis, lot expiration date unknown) for prophylaxis. On 15-FEB-2016, after reaching home post vaccinations, the patient's injection site became red, raised, hot to touch and itchy. On 18-FEB-2016, the patient and her mother had visited the office to complain about these symptoms of the vaccination site. The patient had taken Tylenol/Ibuprofen alternately as needed and the patient also tried some Benadryl. The patient's other medications also included Melatonin. The vaccination site was getting better but was still 3 inches by 3.75 inches red and slightly raised but cool and much less itchy. The outcome for the events injection site erythema, injection site warmth, injection site swelling and injection site pruritus was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, TYP
Symptoms: Condition aggravated, Eye pain, Fatigue, Headache, Migraine
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 17 year old female patient with prophylaxis. The patient's medical history included migraines and it was reported that as per patient's mother, patient had migraines and has a family history of severe migraines. The patient had no other medications and current illnesses. The patient's prior vaccinations was not reported. On 29-FEB-2016, the patient was vaccinated with third dose of GARDASIL 9, lot # L037339, intramuscularly in the right arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis. Other suspect therapies included HAVRIX (dose number: 1, vaccinated date: 29-FEB-2016, intramuscularly in the left arm, lot # P3A42; dose and expiration date unknown) and VIVOTIF (BERNA) (dose number: 1, vaccinated date: 29-FEB-2016, orally, lot # 3003106; dose and expiration date unknown). On an unknown date, the client's (patient) mother called up to report that patient felt extremely tired (fatigue) and nauseous. As per patient mother, the patient complained off a headache and her eyes was hurting (eye pain) and had blind spot in one of her eyes. The patient's mother reported that patient had frequent migraines and had condition aggrevated. The outcome of condition aggravated, nausea, fatigue, headache, eye pain, visual field defect and migraine were reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, TYP
Symptoms: Nausea, Visual field defect
Clinical narrative: This spontaneous report as received from a regulatory authority refers to a 17 year old female patient with prophylaxis. The patient's medical history included migraines and it was reported that as per patient's mother, patient had migraines and has a family history of severe migraines. The patient had no other medications and current illnesses. The patient's prior vaccinations was not reported. On 29-FEB-2016, the patient was vaccinated with third dose of GARDASIL 9, lot # L037339, intramuscularly in the right arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis. Other suspect therapies included HAVRIX (dose number: 1, vaccinated date: 29-FEB-2016, intramuscularly in the left arm, lot # P3A42; dose and expiration date unknown) and VIVOTIF (BERNA) (dose number: 1, vaccinated date: 29-FEB-2016, orally, lot # 3003106; dose and expiration date unknown). On an unknown date, the client's (patient) mother called up to report that patient felt extremely tired (fatigue) and nauseous. As per patient mother, the patient complained off a headache and her eyes was hurting (eye pain) and had blind spot in one of her eyes. The patient's mother reported that patient had frequent migraines and had condition aggrevated. The outcome of condition aggravated, nausea, fatigue, headache, eye pain, visual field defect and migraine were reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Malaise, Nausea, Pallor, Skin discolouration, Visual impairment
Clinical narrative: This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient's current illnesses, other medications, medical history and prior vaccinations were not reported. On 13-FEB-2016, first dose of GARDASIL 9, lot # L020015, (route of administration: unknown) in the right arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis and a second dose of VAQTA lot # L039659, (route of administration: unknown) in the left arm, (dose, frequency, and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 13-FEB-2016, in the left arm, lot # U5264AA; (route of administration, dose and expiration date unknown) and MENACTRA dose number: 1, vaccinated date: 13-FEB-2016, in the right arm, lot # U5185BA; (route of administration, dose and expiration date unknown). The patient and his parents confirmed that the patient had breakfast before visit, granola bar, bag of cookies and juice were given to patient prior to vaccine administration. Patient waited in a room for monitoring after immunizations. On the same day (13-FEB-2016) at 9:20 am, patient's mother informed front desk that patient was not feeling well. In examination room patient stated that he felt nauseous, 'saw different colors' and per patient's mother the patient looked "green" and pale. Patient had stated that he felt better. Juice box were already given. The patient was examined by Medicine of Doctor (MD) and stated that he had no loss of consciousness and cleared for discharge at 09:25 am. The outcome of malaise, visual impairment, skin discoloration, pallor and nausea 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: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Muscle spasms, Muscle twitching
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 # 625752) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 16 year old male patient. The patient's medical history and concurrent illnesses were reported as none. The patient's other medication included Aleve. Information on the patient's prior vaccinations was not reported. On 19-FEB-2016, the patient was vaccinated with the first dose of GARDASIL 9 in the right arm (unknown route), lot # L016429 (expiration date: 09-AUG-2017) and MENACTRA (dose number: 2, in the left deltoid (unknown route), lot# U5187AA, manufacturer: Sanofi Pasteur; lot expiration date was not reported) for prophylaxis. On 21-FEB-2016, the patient complained of twitching or muscle spasm in the left arm and since then the patient was having frequent muscle spasm in left arm for 3 days. On 24-FEB-2016, the patient visited the office and the twitching or muscle spasm in the left arm was still occurring. The events required emergency room (ER) visit. The outcome for the events muscle spasms and muscle twitching were reported as not recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal pain upper, 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 # 626283) on 18-APR-2017. This spontaneous report which refers to a 24 year old male patient. The patient's medical history included gastrooesophageal reflux disease (GERD), sensorineural hearing loss of left ear and was at risk for exposure to HIV. The patient's other medication included Nexium and Tums. The patient had no concurrent illness. Information on the patient's prior vaccinations was not reported. On 01-MAR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L045711 (dose number: 2, lot expiration date was not reported) for prophylaxis. On 02-MAR-2016, the patient woke up with 'incredible nausea' and stomach cramps. The patient took Zofran which gave no improvement. On 03-MAR-2016, the symptoms were still present but milder, so the patient started taking Truvada for HIV prophylaxis after which nausea and stomach cramps worsened. On 05-MAR-2016, the patient stopped Truvada. On 09-MAR-2016, the patient still had nausea which was milder and stomach cramps had fully resolved. The patient required emergency room (ER) visit. The outcome for the event abdominal pain upper and nausea 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, MNQ
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 # 626702). This spontaneous report refers to a 15 year old female patient. The patient had no known concurrent illnesses or historical conditions. Information on the patient's prior vaccinations and other medications were not reported. On 08-MAR-2016, the patient was vaccinated with GARDASIL 9 lot # L023230 (expiry date: 28-JUL-2017), dose 1, intramuscular route in the right arm for prophylaxis and the patient was also vaccinated with MENVEO batch/lot# 15036, dose 1, intramuscular route in the left arm for prophylaxis. On the same day, the patient's deltoid area of arm was red, hot and swollen 5 inch by 3 inch area and the patient went back to clinic 48 hours after vaccine. The outcome of injection site erythema, injection site warmth and injection site swelling was unknown. 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, 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 # 626765). This spontaneous report refers to a 11 year old male patient. The patient's medical history included attention deficit/hyperactivity disorder (ADHD). Information on the patient's prior vaccinations was not reported. The patient had no acute concurrent illnesses. The patient's other medications included KEFLEX. On 24-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L016428 (expiry date: 30-JUL-2017), dose 1, intramuscular route in the right arm for prophylaxis and the patient was also vaccinated with MENACTRA batch/lot # U5180AA, dose 1, intramuscular route in the left (deltoid) arm for prophylaxis. On the same day, the patient experienced injection site warmth, injection site swelling and injection site erythema on left deltoid area where vaccine was administered. The patient was place on antibiotics for treatment. The outcome of injection site erythema, injection site warmth and injection site swelling was unknown. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 626907). This spontaneous report refers to a 14 year old female patient. The patient's medical history included scoliosis. The patient had no concurrent illnesses and no known allergies. Information on the patient's prior vaccinations was not reported. The patient's other medications included fluticasone and singulair. On 14-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L025737 (expiry date: 28-JUL-2017), dose 1, intramuscular route in the right arm and VAQTA lot # L015460 (expiry date: 20-JUL-2017), dose 1, intramuscular route in the left arm for prophylaxis. On the same day, the patient had initial stabbing pain, which lasted for 3 days and the patient slept through it and was unable to go to school due to pain (activities of daily living impaired). The patient also had sharp pain that radiated down the arm  which lasted 3 days. The patient took ibuprofen without relief. No swelling, red/warm or fever noted. The outcome of the events was reported as recovered. The causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Injection site rash, 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 # 626949). This spontaneous report refers to a 25 year old female patient. The patient's medical history included inguinal lymphadenopathy and hives due to morphine. Information on the patient's concurrent illnesses, prior vaccinations and other medications were not reported. On 02-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L016428 (expiry date: 30-JUL-2017), dose 1, intramuscular route in the left arm for prophylaxis and FLUARIX QUADRIVALENT lot/batch # 33FF2, intramuscular route in the right arm for prophylaxis. On the same day, the patient had rash on left upper arm (injection site rash) and also had rash on lower and upper back after the 1st dose of GARDASIL 9. The patient reported these events on 09-MAR-2016, when she went to take the second vaccine dose. The outcome of the events was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Erythema, Induration, Pain in extremity
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 626960). This spontaneous report refers to a 16 year old male patient. The patient's medical history included autism and attention deficit/hyperactivity disorder (ADHD). The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 29-FEB-2016 the patient was vaccinated with GARDASIL 9 lot # L045711, dose 2, unknown route in the left arm, MENVEO batch/lot# A1053, dose 2, unknown route in the right arm and TRUMENBA batch/lot# M13065, dose 1, unknown route in the left arm for prophylaxis. On 02-MAR-2016, the patient had 3cm induration and erythema in the left arm with arm pain. The outcome of the events was reported as recovered. The causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV9, MENB, MNQ
Symptoms: Abnormal behaviour, Crying, Fatigue
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 # 626962). This spontaneous report refers to a 16 year old male patient. The patient's medical history included RAD. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 17-DEC-2015, the patient was vaccinated with GARDASIL 9 lot # L014415 (expiry date: 25-JUL-2017), dose 2, unknown route in the right arm, FLUMIST Quadrivalent batch/lot # FJ2099, intranasal route, TRUMENBA batch/lot # L13514, dose 1, unknown route in the left arm and MENACTRA batch/lot # U5172BA, dose 2, unknown route in the left arm for prophylaxis. On the same day, as per the patient's mother, the patient had abnormal behavior in the night, he cried for hours for no reason and was very fatigued. The patient's mother further stated that the patient seemed better the next day but was still tired. The outcome of abnormal behaviour, fatigue and crying 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: 12.0
Sex: F
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, 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 # 627275) on 18-APR-2017. This spontaneous report was received from a regulatory authority concerning a 12 year old female patient. The patient had no past medical history and current illnesses. Information on concomitant medications and prior vaccinations were not reported. On 14-MAR-2016, the patient was vaccinated with GARDASIL 9 injection, lot # L014198, Expiry date: 05-SEP-2017, dose number 2 (dose and frequency unknown) via intramuscular route in the left arm for prophylaxis. Other suspect therapies included ADACEL (Manufacturer: Sanofi Pasteur, Vaccinated date: 14-MAR-2016, lot # U5263AA, dose number 2 (dose, frequency, lot expiry date unknown) via intramuscular route in the right arm), MENACTRA (Manufacturer: Sanofi Pasteur, Vaccinated date: 14-MAR-2016, lot # U5180AA, dose number 2 (dose, frequency, lot expiry date unknown) via intramuscular route in the left arm) and FLUMIST (Manufacturer: Medimmune, Vaccinated date: 14-MAR-2016, lot # FL2117, dose number 2 (dose, frequency, lot expiry date unknown) via intranasal route) for prophylaxis. On 15-MAR-2016, About 5 inches down the arm from the Left Deltoid area where vaccines were administered the patient developed redness, warm to touch and pain at the injection site. The outcome of the events were not reported. The 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: FLUN4, HPV9, MENB, MNQ, TD
Symptoms: Blood bilirubin increased, Jaundice, Splenomegaly
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 # 627547) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 20 year old male patient. The patient had no medical history, concurrent illnesses and other medications. Information on the patient's prior vaccinations was not reported. On 03-MAR-2016, the patient was vaccinated with GARDASIL 9 intramuscularly in the left arm, lot # L045711 (dose number: 3, lot expiration date unknown) for prophylaxis. On the same day, the patient was also vaccinated with TENIVAC (dose number: 2, intramuscularly in the right arm, lot # C4736CA, manufacturer: Sanofi Pasteur, lot expiration date unknown), FLUMIST QUADRIVALENT (route: intranasal, lot # FL2112, manufacturer: MedImmune; dose, frequency and lot expiration date unknown), TRUMENBA (dose number: 2, intramuscularly in the left arm, lot # M37315, manufacturer: Pfizer/Wyeth, lot expiration date unknown) and MENACTRA (dose number: 3, intramuscularly in the right arm, lot # U5180AA, manufacturer: Sanofi Pasteur, lot expiration date unknown) for prophylaxis. On 05-MAR-2016, the patient was seen at Emergency Room (ER) for jaundice. The patients lab test showed elevated bilirubin level and was diagnosed with enlarged spleen. On 07-MAR-2016, the patient went to the office for recheck-up and a repeat of the lab tests was ordered. The outcome of the events was 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: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Eye movement disorder, Headache, Musculoskeletal stiffness, Pyrexia, 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 # 627811) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old female patient. The patient had no medical history, concurrent illness and other medications. Information on the patient's prior vaccinations was not reported. On 14-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L013429, expiration date: 21-JUL-2017 for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (dose number: 1, intramuscularly in the left arm, lot # U4875AA, manufacturer: Sanofi Pasteur, lot expiration date unknown), HAVRIX (dose number: 2, intramuscularly in the right arm, lot # 49LH2, manufacturer: GlaxoSmithKline, lot expiration date unknown) and MENACTRA (dose number: 1, intramuscularly in the left arm, lot # U5058AD, manufacturer: Sanofi Pasteur, lot expiration date unknown) for prophylaxis. On 14-MAR-2016, post vaccinations, the patient became stiff, unresponsive, her eyes rolled back but she recovered immediately. The patient's mother was encouraged to follow-up with Primary Medical Doctor (PMD). During the follow-up call, the patient's mother reported that 12 to 24 hours post vaccinations, the patient developed the symptoms of headache, rash on the left arm and fever 100.5. The patient returned to school on 17-MAR-2016, but still had rash on the left arm. The events required emergency room (ER) visit. The outcome of all the events was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 627811) on 18-APR-2017. This spontaneous report was received from a regulatory authority which refers to a 11 year old female patient. The patient had no medical history, concurrent illness and other medications. Information on the patient's prior vaccinations was not reported. On 14-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L013429, expiration date: 21-JUL-2017 for prophylaxis. On the same day, the patient was also vaccinated with ADACEL (dose number: 1, intramuscularly in the left arm, lot # U4875AA, manufacturer: Sanofi Pasteur, lot expiration date unknown), HAVRIX (dose number: 2, intramuscularly in the right arm, lot # 49LH2, manufacturer: GlaxoSmithKline, lot expiration date unknown) and MENACTRA (dose number: 1, intramuscularly in the left arm, lot # U5058AD, manufacturer: Sanofi Pasteur, lot expiration date unknown) for prophylaxis. On 14-MAR-2016, post vaccinations, the patient became stiff, unresponsive, her eyes rolled back but she recovered immediately. The patient's mother was encouraged to follow-up with Primary Medical Doctor (PMD). During the follow-up call, the patient's mother reported that 12 to 24 hours post vaccinations, the patient developed the symptoms of headache, rash on the left arm and fever 100.5. The patient returned to school on 17-MAR-2016, but still had rash on the left arm. The events required emergency room (ER) visit. The outcome of all the events was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.