chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Chills, Depressed level of consciousness, Dizziness, Muscular weakness, 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 # 588436) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient's current illnesses, medical history, other medication and prior vaccinations were not reported. On 04-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # L004741 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 04-AUG-2015, intramuscularly in the left arm, lot # C4712AA; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 04-AUG-2015, intramuscularly in the right arm, lot # U5049AA; dose and expiration date unknown), hepatitis HAVRIX (dose number: 2, vaccinated date: 04-AUG-2015, intramuscularly in the left arm, lot # 3RB2G; dose and expiration date unknown). Patient complained of dizziness and stated that "I'm going to pass out". The patient's head was lowered between legs, but patient began to slump side. FOC lowered patient to the ground with registered nurse (RN) assistance. Legs placed up on chair. Patient's eyes remained open during episode and responded to his name after 3-5 seconds and patient asked "what happened". Color began to return to face. The patient was moved back up to chair from ground at 10:15 and ice pack applied to back of neck as cold compress and water was provided. Patient complained of nausea and continued to keep his head between legs in chair. The patient began to shiver at 10:18. Granola bar was offered and patient took one bite and vomited. At 10:25, the patient continued to feel nauseous and stated that his legs felt weak. The patient was then moved to ground with legs elevated on chair. Patient pulse was 70. The patient stated that he continued to go through periods where he "feels better" and then "feels nauseous". At 10:40, 911 was called. Registered nurse (RN) came into the room. At 10:43, the patient complained of tightness in throat (throat tightness). At 10:45, 0.4 cc epinephrine was administrated in in left thigh by RN. Within 30 seconds of epinephrine, patient stated that he "feels much better" and denies tightness in throat. Patient continued to remain on ground with legs elevated and is conversing with FOC. AT 10:50, EMS (Emergency Medical Services) arrived and evaluated. FOC declined transport to hospital. EMS instructed FOC to take patient to PCP (primary care physician) as soon as possible (ASAP). FOC agrees. Patient walked out of clinic on his own at 11:30 am. The patient The outcome of pallor, vomiting, nausea, dizziness, chills, altered state of consciousness, muscular weakness, throat tightness and posture abnormal 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: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Pallor, Posture abnormal, Throat tightness, 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 # 588436) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old male patient with prophylaxis. The patient's current illnesses, medical history, other medication and prior vaccinations were not reported. On 04-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # L004741 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 04-AUG-2015, intramuscularly in the left arm, lot # C4712AA; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 04-AUG-2015, intramuscularly in the right arm, lot # U5049AA; dose and expiration date unknown), hepatitis HAVRIX (dose number: 2, vaccinated date: 04-AUG-2015, intramuscularly in the left arm, lot # 3RB2G; dose and expiration date unknown). Patient complained of dizziness and stated that "I'm going to pass out". The patient's head was lowered between legs, but patient began to slump side. FOC lowered patient to the ground with registered nurse (RN) assistance. Legs placed up on chair. Patient's eyes remained open during episode and responded to his name after 3-5 seconds and patient asked "what happened". Color began to return to face. The patient was moved back up to chair from ground at 10:15 and ice pack applied to back of neck as cold compress and water was provided. Patient complained of nausea and continued to keep his head between legs in chair. The patient began to shiver at 10:18. Granola bar was offered and patient took one bite and vomited. At 10:25, the patient continued to feel nauseous and stated that his legs felt weak. The patient was then moved to ground with legs elevated on chair. Patient pulse was 70. The patient stated that he continued to go through periods where he "feels better" and then "feels nauseous". At 10:40, 911 was called. Registered nurse (RN) came into the room. At 10:43, the patient complained of tightness in throat (throat tightness). At 10:45, 0.4 cc epinephrine was administrated in in left thigh by RN. Within 30 seconds of epinephrine, patient stated that he "feels much better" and denies tightness in throat. Patient continued to remain on ground with legs elevated and is conversing with FOC. AT 10:50, EMS (Emergency Medical Services) arrived and evaluated. FOC declined transport to hospital. EMS instructed FOC to take patient to PCP (primary care physician) as soon as possible (ASAP). FOC agrees. Patient walked out of clinic on his own at 11:30 am. The patient The outcome of pallor, vomiting, nausea, dizziness, chills, altered state of consciousness, muscular weakness, throat tightness and posture abnormal was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Depressed level of consciousness, Fall, Pallor, Tremor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 588440) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old female patient. The patient's concomitant medications, pertinent medical history, concurrent illnesses and prior vaccinations were not reported. On 15-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # K026246, (dose number, dose, frequency, lot expiration date were unknown) intramuscularly for prophylaxis. On the same day, after vaccination was given by the provider, it was noted that injection reaction in patient was pale, had some shakiness, provider gave water, patient was instructed to sit in chair to regain her composure. Patient stated that she was feeling better, stood to get more water, felt "ok", turned to sit in chair that was when she lost all color in her face, started to shake and she began to fall to the floor. The patient was then lowered to the floor, the provider was called to the room, a pillow was placed under the patient's head and was spoken to until she regained full consciousness, placing a cool wet towel to her forehead. Patient continued to lay on the floor until she was able to sit up without further reactions, then she was allowed to stand. During that process the patient regained color in her face and was talking and joking with her sister who witnessed the episode. Patient was instructed to sit until the provider felt that she could walk unassisted with her mother and sister. Patient was not injured when she was lowered to the floor. The outcome of fall, tremor and pallor was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Electroencephalogram normal, Generalised tonic-clonic seizure
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589355) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a female patient of unknown age. Patient had no current illness. Patient's other medications, concurrent therapies and medical history were not reported. Patient had HPV#2 on 01-JUN-2015, 17 days later patient had GTC seizure. On 29-JUL-2015, the patient was vaccinated with the 3rd dose of GARDASIL 9 lot # L019286 (dose, frequency and expiration date were not reported) in the left arm via unknown route for prophylaxis. 1 day later (also reported as 29-JUL-2015) patient had GTC seizure and had another GTC seizure on 03-AUG-2015. The patient required emergency room visit. The outcome of electroencephalogram normal and generalised tonic-clonic seizure was reported as not recovered. Causality assessment for the events electroencephalogram normal and generalised tonic-clonic seizure with respect to GARDASIL 9 were not provided by the reporter.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Laceration, 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 # 589378) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 17 year old male patient. Patient had no current illness. Patient's historical drug included amoxicillin. Patient's concurrent therapies and other medications were not reported. On 07-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L014198 (dose, frequency and expiration date were not reported) intramuscularly, in the left arm for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 07-AUG-2015, intramuscularly in the left arm, lot# U5068AA; dose, frequency and expiration date unknown). On 07-AUG-2015, the patient had syncope, which resulted in laceration to head. The patient required emergency room visit. The outcome of laceration and syncope was reported as recovered. Causality assessment for the events laceration and syncope with respect to GARDASIL 9 were not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained..
Age: 16.0
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 # 589519). This spontaneous report refers to a 16 year old female patient. The patient had no concurrent conditions and medical history. Concomitant medications were not reported. On 04-AUG-2015 at 13:00, the patient was vaccinated with GARDASIL 9 lot # L011846 dose 1, intramuscular in the left arm for prophylaxis. No other vaccines were given. 2 min after vaccination, the patient had 20-30 seconds syncopal episode. The outcome of syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Lymphadenopathy, 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 # 589558) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. The patient's medical history included penicillin drug rash, mild intermittent asthma, and allergic rhinitis. The patient had no other medications, current illnesses and prior vaccinations. On 16-JUL-2015, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis and on the same day after 4 hours of vaccine administration, the patient developed arm pain and axillary lymphadenopathy on the same side as injection. It was reported the patient had no fever and no fatigue. The events pain in extremity and lymphadenopathy were resolved completely in 4 days without treatment. 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: Blood glucose normal, Blood pressure decreased, Incontinence, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589856) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 12 year old female patient. The patient's concurrent illnesses and pertinent medical history were reported as none. On 06-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K026247, dose number 1, (dose, frequency and lot expiration date were not reported) intramuscularly in the right arm for prophylaxis. Other suspect therapies included ADACEL (vaccinated date: 06-AUG-2015, intramuscularly in the left arm, lot# U5214AA, dose number, dose, lot expiration date were not reported) and MENACTRA (dose number 1, vaccinated date: 06-AUG-2015, intramuscularly in the left arm, lot# U4846BA, dose, lot expiration date were not reported) for prophylaxis. On the same day, after vaccination the patient had an episode of syncope with incontinence. Syncope occurred within 10 min after receiving her vaccines. She also experienced a blood pressure decrease and pallor. Lab details: Blood glucose: 114 bedside (normal). She gradually regained normal activity after taken to exam room (Emergency room) for rest. The outcome of blood glucose normal, syncope, pallor, incontinence and blood pressure decreased were reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
Symptoms: Asthenia, Delirium, Dizziness, Malaise, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589928). This spontaneous report refers to a 14 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-AUG-2015, at approximately 2 PM, the patient was vaccinated with GARDASIL 9 lot # K026246 dose 3 (unspecified dose), intramuscular in the left arm for prophylaxis and VARIVAX lot # L015045, dose 2 (unspecified dose), subcutaneously in the left arm. Other suspect therapy included HAVRIX dose 2 (unspecified dose), intramuscularly in the right arm. At 8 PM in the evening, the patient reported that he was not feeling well. Proceeded to throw up, feel feverish. He felt weak, dizzy and delirious. At 10:00 AM on 12-AUG-2015, the temperature was 102 F and took Tylenol. No temperature was taken before. At midnight, the patient took ibuprofen. The patient's mother called primary care physician and spoke to nurse about illness. She did not take the child for treatment. He recovered and was much better as of 13-AUG-2015. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV9, VARCEL
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 # 589928). This spontaneous report refers to a 14 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 11-AUG-2015, at approximately 2 PM, the patient was vaccinated with GARDASIL 9 lot # K026246 dose 3 (unspecified dose), intramuscular in the left arm for prophylaxis and VARIVAX lot # L015045, dose 2 (unspecified dose), subcutaneously in the left arm. Other suspect therapy included HAVRIX dose 2 (unspecified dose), intramuscularly in the right arm. At 8 PM in the evening, the patient reported that he was not feeling well. Proceeded to throw up, feel feverish. He felt weak, dizzy and delirious. At 10:00 AM on 12-AUG-2015, the temperature was 102 F and took Tylenol. No temperature was taken before. At midnight, the patient took ibuprofen. The patient's mother called primary care physician and spoke to nurse about illness. She did not take the child for treatment. He recovered and was much better as of 13-AUG-2015. 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: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Vaccination site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589933) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. Patient's other medications, medical history, concurrent therapies and current illness were not reported. On 12-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L004014 (dose, frequency and expiration date were not provided) intramuscularly, in the left leg for prophylaxis. Other suspect therapies included VARIVAX (dose number: 2, vaccinated date: 12-AUG-2015, intramuscularly in the left arm, lot# K021934; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 12-AUG-2015, intramuscularly in the right arm, lot/batch# U5049AA; dose and expiration date unknown), BOOSTRIX (dose number: 5, vaccinated date: 12-AUG-2015, intramuscularly in the left arm, lot/batch# 3HG7R; dose, frequency and expiration date unknown and HAVRIX (dose number: 1, vaccinated date: 12-AUG-2015, intramuscularly in the right arm, lot/batch# XL9B7; dose, frequency and expiration date unknown. On 13-AUG-2015, patient's mother reported that the patient has a swelling the size of a softball on the right arm where the vaccine was received. The outcome of injection site swelling was reported as recovered. Causality assessment for the event injection site swelling 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, VARCEL
Symptoms: Blood pressure systolic decreased, 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 # 590033). This spontaneous report refers to a 17 year old male patient. The patient's concurrent illnesses was not reported and medical history included active airway disease. On 13-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L004014, dose 1, intramuscularly in the left arm and VARIVAX, lot# L00827, dose 2, subcutaneously in the right arm for prophylaxis. On 13-AUG-2015, the patient experienced syncope and decreased systolic blood pressure (88). Patient fainted 10 minutes after injection of GARDASIL 9 and VARIVAX. The outcome of syncope and blood pressure systolic decreased were 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
Symptoms: Dyspnoea, 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 # 590035). This spontaneous report refers to a 12 year old female patient. The patient's concurrent illnesses, prior vaccinations and medical history were not reported. On 13-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L004014, dose 1, intramuscularly in the right arm for prophylaxis. On 13-AUG-2015, the patient experienced urticaria and dyspnoea. Reports 2 hours after vaccination breaking out in welts and having difficulty breathing. Resolved after administration of BENADRYL. The outcome of urticaria and dyspnoea were 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
Symptoms: Muscle spasms, Nausea, 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 # 590078). This spontaneous report refers to a 17 year old female patient. The patient's concurrent illnesses and medical history were reported as none. On 28-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # L007560, dose 1, (route: unknown) in the right arm for prophylaxis. On 28-JUL-2015, the patient experienced nausea, muscle spasms and vomiting. The outcome of nausea, muscle spasms and vomiting were 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
Symptoms: Asthenia, Headache, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590079) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old female patient. Patient's other medication and concurrent therapies were not reported. Patient had no current illness and medical history. On 30-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L007560 (dose, frequency and expiration dates were not reported) in the left arm, via unknown route, for prophylaxis. On 31-JUL-2015, the patient had fever of 102, headache and was Weak. The outcome of asthenia, pyrexia and headache was reported as not recovered. Causality assessment for the events laceration and syncope with respect to GARDASIL 9 were 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: Dizziness, Fall, Head injury, Immediate post-injection reaction, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590165). This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses was reported as none and medical history was not reported. On 10-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with BOOSTRIX (lot# 9N74F, dose 1, intramuscularly in right arm) and MENACTRA (lot# U5155BA, dose 1, intramuscularly in right arm). Immediately patient became pale, lightheaded and had brief fainting event. He hit right side of head when he fell to floor but recovered quickly. On 10-AUG-2015, the patient experienced dizziness, immediate post-injection reaction, syncope, pallor, head injury and fall. The outcome of dizziness, immediate post-injection reaction, syncope, pallor, head injury and fall were reported as recovered. Reporter diagnosed vasovagal syncope was related to immunizations and mild head trauma was recovered fully, no serious sequelae. Causality assessment was not provided for the events dizziness, immediate post-injection reaction, pallor, head injury and fall. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590165). This spontaneous report refers to a 11 year old male patient. The patient's concurrent illnesses was reported as none and medical history was not reported. On 10-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, intramuscularly in the left arm for prophylaxis. On the same day, the patient was vaccinated with BOOSTRIX (lot# 9N74F, dose 1, intramuscularly in right arm) and MENACTRA (lot# U5155BA, dose 1, intramuscularly in right arm). Immediately patient became pale, lightheaded and had brief fainting event. He hit right side of head when he fell to floor but recovered quickly. On 10-AUG-2015, the patient experienced dizziness, immediate post-injection reaction, syncope, pallor, head injury and fall. The outcome of dizziness, immediate post-injection reaction, syncope, pallor, head injury and fall were reported as recovered. Reporter diagnosed vasovagal syncope was related to immunizations and mild head trauma was recovered fully, no serious sequelae. Causality assessment was not provided for the events dizziness, immediate post-injection reaction, pallor, head injury and fall. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590199). This spontaneous report refers to a 13 year old female patient. The patient's concurrent illnesses, prior vaccinations and medical history were not reported. On 27-JUL-2015 the patient was vaccinated with GARDASIL 9, lot # K026246, dose 3, intramuscularly in the left arm for prophylaxis. On 27-JUL-2015, the patient experienced urticaria. Patient had an emergency visit. Hives-treated with BENADRYL. The outcome of urticaria 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
Symptoms: Depressed level of consciousness, Dizziness, Nausea, Palpitations, Paraesthesia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590223). This spontaneous report refers to a 15 year old female patient. The patient's concurrent illnesses and medical history were reported as none. On 11-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L007495, dose 1, intramuscularly in the left arm for prophylaxis. On 11-AUG-2015, the patient experienced dizziness, paraesthesia, palpitations and nausea. Patient had a racing heart, dizzy, nausea, tingling in arm, she almost passed out. Patient had an emergency visit. The outcome of dizziness, paraesthesia, palpitations and nausea were 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: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: 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 # 590590). This spontaneous report refers to a 11 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 06-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K026247, route: unknown in the right arm and VARIVAX lot # L003774, subcutaneously in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U5095AA, dose: 1, route: unknown in the left arm, MENVEO lot # A15008, route: unknown in the right arm and HAVRIX lot # X22P4, route: unknown in the left arm for prophylaxis. On an unknown date, the patient had wheals over face and warms, itching. Treatment included prednisone oral (po) taper, DEPO-MEDROL OTC, BENADRYL. The outcome of the events was unknown. The causality assessment for the events with respect to the suspect therapies 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, Immediate post-injection reaction, Injection site joint pain, 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 # 590668) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 16 year old female patient. The patient's medical history included asthma. The patient's concomitant therapies and concurrent illness were not reported. On 18-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm (dose, frequency, lot # and lot expiration date were not reported) for prophylaxis. On 18-AUG-2015 the patient had Immediate urticarial with itching (pruritus), spreading and generalized reactions followed by headache and mild joint pain of the elbow and shoulder in the arm at the vaccinated site. The outcome of headache, urticaria, pruritus, injection site joint pain and immediate post-injection reaction 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: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Tongue discolouration, 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 # 590758). This spontaneous report refers to a 15 year old female patient. The patient's medical history included iron deficiency anaemia. The patient's other medications included ritalin, Concerta and Abilify. On 27-JUL-2015 the patient was vaccinated with GARDASIL 9 (lot # K026247) dose 1, intramuscular in the left arm for prophylaxis. Few hours after vaccination, the patient experienced tongue discolouration (red tongue) and approximately 6 hours after vaccination, she experienced urticaria. The patient's family called a physician on call who recommended Benadryl. The outcome of tongue discolouration and urticaria was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Fall; Head injury; Syncope; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590769). This spontaneous report refers to a 11 year old female patient. The patient had no medical history, concurrent conditions and concomitant therapies administered. On 05-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # K026246 dose 1, intramuscular in the right arm. Other suspect therapies included BOOSTRIX (dose 1 in the left arm) HAVRIX (dose 1 in the left arm) and MENVEO (dose1 in the right arm) intramuscularly. On the same day, the patient fell and hit head from fainting (syncope) and had a head injury. The patient sat for 20 minutes afterward. Alert oriented and the patient drank some water. Next day, the patient was not reachable for follow-up. The outcome of fall, syncope and head injury was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose, Electrocardiogram, Pallor, Seizure like phenomena
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 # 590781). This spontaneous report refers to a 11 year old male patient. The patient had no historical and concurrent conditions. Other medications included potentially CLARITIN and FLINTSTONE vitamin plus iron. On 17-AUG-2015 the patient was vaccinated with GARDASIL 9 lot # L019286 dose 1, intramuscular in the left arm for prophylaxis. Other suspect therapies included ADACEL (dose 1 in the right arm) and MENACTRA (dose 1 in the left arm), intramuscularly. The patient was standing by the window with his father. After the patient was immunized, his brother was vaccinated. After administration of the first vaccine, the patient went pale and appeared to be having a seizure like phenomena. The patient required emergency visit. The patient's father grabbed him to stabilize and the doctor was called for assistance. The patient was made to lie down on the exam table. Vitals were performed along with blood glucose testing and electrocardiogram. The patient was given some juice and crackers until his condition was stable and until the doctor allowed him to leave. The outcome of blood glucose, seizure like phenomena, pallor and electrocardiogram 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: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Dysphonia, Headache, Injection site induration, Injection site 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 # 590791) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's had no current illnesses, medical history, other medications and prior vaccinations.  On 12-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # L014198 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 14-AUG-2015, the patient had 2mm by 2mm induration at injection site with pain in deltoid, the patient experienced headaches, some horseness and pain in extremity. The outcome of dysphonia, pain in extremity, injection site pain, injection site induration 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.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590854) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 14 year old male patient. Patient's concurrent therapies and other medications were not reported. Patient's current illness and medical history were reported as none. On 17-AUG-2015, the patient was vaccinated with the 2nd dose of GARDASIL 9 (dose, frequency and expiration were not reported), intramuscularly in the left arm, for prophylaxis. On 17-AUG-2015, patient had Fever 103.8, headache, myalgia followed by resolution of fever and arthralgia in knees. The outcome of arthralgia, pyrexia, myalgia and headache was unknown. Causality assessment for the events arthralgia, pyrexia, myalgia and headache with respect to GARDASIL 9 were not provided by the reporter. 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: Asthenia, Crying, Delusion, Dyskinesia, Dyspnoea
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 # 590877) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient had no current illnesses, medical history and other medications. On 14-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # L019287 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 14-AUG-2015, intramuscularly in the left arm, lot  U5241AA; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 14-AUG-2015, intramuscularly in the right arm, lot# U5185BA; dose and expiration date unknown), HAVRIX (dose number: 2, vaccinated date: 14-AUG-2015, intramuscularly in the left arm, lot # 2B54R; dose and expiration date unknown). On 15-AUG-2015, the patient mother reported that the patient had a fever of 100.4 temperature and pulse was 130 in the emergency room (ER). On the same day, the patient was very weak, delusional, experienced pain in arms and legs, headache, was breathing heavily, oxygen saturation was decreased, patient's arms and legs was jerking, couldn't see nurse and her mom very well in front of her such that everyone appeared blurred and the patient was crying. The patient was back to normal to herself after 20-35 minutes of the pain medication given to patient via IV (intravenously). The patient's mom reported this on 17-AUG-2016 and stated that the patient was fine on that day. The outcome of crying, asthenia, headache, pyrexia, vision blurred, pain in extremity, oxygen saturation decreased, dyspnoea, dyskinesia and delusion 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: Headache, Oxygen saturation decreased, Pain in extremity, Pyrexia, Vision blurred
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 # 590877) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient had no current illnesses, medical history and other medications. On 14-AUG-2015, the patient was vaccinated with first dose of GARDASIL 9 intramuscularly in the right arm, lot # L019287 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 14-AUG-2015, intramuscularly in the left arm, lot  U5241AA; dose and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 14-AUG-2015, intramuscularly in the right arm, lot# U5185BA; dose and expiration date unknown), HAVRIX (dose number: 2, vaccinated date: 14-AUG-2015, intramuscularly in the left arm, lot # 2B54R; dose and expiration date unknown). On 15-AUG-2015, the patient mother reported that the patient had a fever of 100.4 temperature and pulse was 130 in the emergency room (ER). On the same day, the patient was very weak, delusional, experienced pain in arms and legs, headache, was breathing heavily, oxygen saturation was decreased, patient's arms and legs was jerking, couldn't see nurse and her mom very well in front of her such that everyone appeared blurred and the patient was crying. The patient was back to normal to herself after 20-35 minutes of the pain medication given to patient via IV (intravenously). The patient's mom reported this on 17-AUG-2016 and stated that the patient was fine on that day. The outcome of crying, asthenia, headache, pyrexia, vision blurred, pain in extremity, oxygen saturation decreased, dyspnoea, dyskinesia and delusion was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained
Sex: F
Vaccine: HPV9
Symptoms: Injection site 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 # 590905) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 03-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L000610, dose number 1, intramuscularly in the left arm for prophylaxis. On 06-AUG-2015, the patient experienced injection site pain and pain in extremity. The patient had pain at injection site with radiation to palm. Pain lasted for more than 5 days, 7/10 in intensity with normal strength and sensation. No swelling or redness was reported. The outcome of injection site pain and pain in extremity was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Pruritus, Respiratory tract congestion, Swelling face
Clinical narrative: respiratory tract congestion; swelling face; eye swelling; pruritus; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591255) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old female patient. Patient's medical history, current illness and other medications were reported as none. Patient's concurrent therapies were not reported. On 19-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L019286 (dose, frequency and expiration date were not provided) intramuscularly, in the right arm for prophylaxis. On 19-AUG-2015, 45 minutes post injection, patient had facial and eye swelling, itching and congestion and patient was given BENADRYL 25mg, got relieved in 1 hour. Symptoms were completely recovered in 3 hours. The outcome of eye swelling, swelling face, respiratory tract congestion and pruritus was reported as recovered. Causality assessment for the events eye swelling, swelling face, respiratory tract congestion and pruritus with respect to the GARDASIL 9 were 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, 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 # 591415). This spontaneous report refers to a 11 year old male patient. The patient's medical history included fecal incontinence which was well controlled. Other medication included PPD. The patient had no current illnesses. On 18-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K026246, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # C4730A, dose 1, intramuscularly in the left arm and MENVEO lot # A15008, dose 1, intramuscularly in the left arm for prophylaxis. On 20-AUG-2015, left deltoid was slightly red, swollen and warm. Patient was advised cool compress. Noted in chart and RTC if not improved in 2 to 3 days. The outcome of the events injection site erythema, injection site warmth and injection site swelling was unknown. The causality assessment for the events injection site erythema, injection site warmth and injection site swelling 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: F
Vaccine: FLU3, HPV9, MNQ
Symptoms: 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 # 591675) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 11 year old female patient. Patient's current illness and medical history were reported as none. Patient's concomitant therapies and other medication were not reported. On 24-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312 (dose, frequency and expiration date were not provided) in the right arm, via unknown route for prophylaxis. Other suspect therapies included FLUZONE (dose number: 3, vaccinated date: 24-AUG-2015, in the left arm, via unknown route lot/batch# UI423AA; dose, frequency and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 24-AUG-2015, in the left arm, via unknown route, lot/batch# U4929BA, dose, frequency and expiration date unknown). On 26-AUG-2015, the patient experienced swelling at site and warm to touch of left upper deltoid. The outcome of injection site swelling and injection site warmth was reported as recovered. Causality assessment for the events injection site swelling and injection site warmth with respect to GARDASIL 9 were 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, Syncope, Vision blurred, 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 # 591836) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's current illness, medical history, prior vaccinations and other medications were not reported. On 26-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # O011846 (dose, frequency and lot expiration date were not reported) for prophylaxis. And on the same day the patient fainted (syncope) after vaccinated with GARDASIL 9 and experienced blurred vision and complained of headache and vomited two times. Blurred vision was resolved prior leaving to office. The outcome of vision blurred, vomiting, syncope 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: HEPA, HPV9, MNQ, TDAP
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 592236). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses was not reported. The patient's medical history included attention deficit/hyperactivity disorder (ADD) and iron deficiency. Other medications included INTUNIV ER (3mg) and ZYRTEC for allergy. On 13-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K026247, dose 1, intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with ADACEL lot # U4998AA, dose 1, intramuscularly in the left arm, HAVRIX lot # X22PA, dose 1, intramuscularly in the right arm and MENVEO lot # M14125, dose 1, intramuscularly in the left arm for prophylaxis. Patient's mother emailed stating that her son's left arm was red, swollen and hot to the touch on 14-AUG-2015. Patient had a temperature of 99.0 (units not reported). The outcome of the events 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.