chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 581310) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 15 year old female patient. The patient's concomitant medications, pertinent medical history, concurrent illnesses, prior vaccinations were not reported. On 09-JUN-2015, the patient was on a nurse visit to receive the HPV vaccine. Vaccine GARDASIL 9 lot # K026247 dose number 2, (dose, frequency, lot expiration date unknown) was administered intramuscularly in the left arm for prophylaxis. On the same day, about 2 min after the administration patient's mother came out of the room yelling for help. When nurse entered the room the patient passed out in her chair. The nurse assured patient's mother that this can happen with HPV vaccines. Patient waited for about 10 more minutes in the room while the clinical staff continued to check on her. Patient walked out of the office feeling well. The outcome of loss of consciousness was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, 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 # 581372) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old male patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 04-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left leg, lot # L007495 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 04-JUN-2015 the patient became light headed immediately after vaccine was administered, even thought patient was given juice prior to vaccine administration. The patient became very pale and nauseated, although did not vomit. The patient continued to lay in supine position with legs elevated for 20 minutes. After 20 minutes, the patient sat up for another 5 minutes and then left the office without another incident. The outcome of dizziness, pallor, nausea 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.
Sex: M
Vaccine: HPV9
Symptoms: Fall, Head injury, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 583504). This spontaneous report refers to a 15 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 22-JUN-2015 at 16:25, the patient was vaccinated with GARDASIL 9 lot/ batch # K025247, dose 1, intramuscularly in the left arm for prophylaxis. Doctor gave vaccination to the patient and left room 5 minutes later. Patient was alone in the room on exam table and staff heard him fall. Patient was found on the floor with head hit and passed out. Juice and crackers were given to the patient and he recovered after 20 minutes. The outcome of the events fall, loss of consciousness and head injury was reported as recovered. The causality assessment of the events fall, loss of consciousness and head injury 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
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: dizziness; headache; pyrexia; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 583646) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient's medical history included allergy, percutaneous nephrolithotomy (PCN) and headache. Other medications were reported as FLONASE, multivitamins, melatonin and VENTOLIN inhaler. On 26-JUN-2015,  the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026247, dose number 1, intramuscularly in the left arm for prophylaxis. On 26-JAN-2016, the patient experienced dizziness, pyrexia and headache. The outcome of dizziness, pyrexia and headache were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Headache, Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 583654). This spontaneous report refers to a 12 year old female patient. The patient had no concurrent illness and medical history. Information on the patient's prior vaccinations and other medications were not reported. On 24-JUN-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, dose 1 via intramuscular route in the left arm for prophylaxis (dosage unspecified). On 24-JUN-2015, the patient experienced headache, injection site pain, vomiting (1 emesis), pyrexia (temperature measurement oral: 102-101) and nausea. The patient felt better later in the afternoon on 25-JUN-2015. The outcome of headache, injection site pain, vomiting, pyrexia and nausea was reported as recovered. The causality assessment for the events headache, injection site pain, vomiting, pyrexia and nausea 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: HEP, HIBV, HPV9, IPV, PNC13
Symptoms: Drug administered to patient of inappropriate age
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 # 583738) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 72 year old male patient. The patient's medical history included bone marrow transplant recipient. The patient's other medications included CYMBALTA, XARELTO, ZOVIRAX, pluragestic patches and FLOMAX. The patient had no concomitant therapies and concurrent illness. On 28-MAY-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # K026246 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included PREVNAR 13, PEDVAXHIB, ENGERIX-B and IPOL. On an unknown date the drug administered to patient of inappropriate age was reported. The outcome of drug administered to patient of inappropriate age was reported as recovered/resolved. Causality assessment was not reported.   Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Dizziness, Feeling hot, Hyperhidrosis, Retching
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 # 583938) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's historical drug included allergies to amoxicillin. The patient's concomitant therapies and concurrent illness were not reported. On 29-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L001312 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA. On 29-JUN-2015, the patient first became dizzy, then dizziness was resolved after 2 minutes. The patient again became dizzy, felt like bubbles in throat, abdominal pain, felt hot, started sweating, and started heaving. The outcome of abdominal pain, throat irritation, retching, hyperhidrosis, feeling hot and dizziness was 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: Throat irritation
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 # 583938) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient. The patient's historical drug included allergies to amoxicillin. The patient's concomitant therapies and concurrent illness were not reported. On 29-JUN-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L001312 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX and MENACTRA. On 29-JUN-2015, the patient first became dizzy, then dizziness was resolved after 2 minutes. The patient again became dizzy, felt like bubbles in throat, abdominal pain, felt hot, started sweating, and started heaving. The outcome of abdominal pain, throat irritation, retching, hyperhidrosis, feeling hot and dizziness was 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
Symptoms: Chills, Headache, Nausea, 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 # 584055) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old male patient. The patient's concurrent illness included child was healthy. The patient's concomitant therapies and medical history were not reported. On 29-JUN-2015 the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the left arm, lot # L014198 (dose, frequency and lot expiration date were not reported) for prophylaxis. On 29-JUN-2015, the patient experienced chills, pyrexia (101.4), nausea and headache. The outcome of events chills, pyrexia, nausea and headache 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 erythema, Vaccination site nodule, Vaccination site pain, 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 # 584657). This spontaneous report refers to a 11 year old female patient. Information on the patient's concurrent illnesses, medical history, other medications and prior vaccinations were not reported. On 01-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # L001312, dose 2, (route reported as: needle and syringe, not specified further) in the left arm for prophylaxis (dosage unspecified). On 02-JUL-2015, the patient experienced injection site erythema, vaccination site swelling, vaccination site pain and vaccination site nodule (tender). The outcome of injection site erythema, vaccination site swelling, vaccination site pain and vaccination site nodule was unknown. The causality assessment for the events injection site erythema, vaccination site swelling, vaccination site pain and vaccination site nodule with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Swelling face
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 584850). This spontaneous report refers to a 14 year old male patient. The patient's medical history included ataxia and PDD. The patient had no concurrent illnesses. Information on the patient's prior vaccinations and other medications were not reported. On 02-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # K026246, dose 1 via intramuscular route in the left arm for prophylaxis (dosage unspecified). On the same day, the patient was also vaccinated with MENACTRA batch/lot # U5082BA, dose 1 via intramuscular route in the right arm for prophylaxis (dosage unspecified). On 03-JUL-2015, the patient experienced injection site swelling, injection site pain and injection site erythema at the left arm site, then progressed to erythema and swelling of left jaw. The patient required emergency room (ER) visit and was given Keflex at ER. The outcome of erythema, injection site swelling, injection site pain, injection site erythema and swelling was reported as recovered. The causality assessment for the events erythema, injection site swelling, injection site pain, injection site erythema and 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: F
Vaccine: HPV9, MENB, PNC13, VARCEL
Symptoms: Herpes zoster
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 # 584882). This spontaneous report refers to a 16 year old female patient. Information on the patient's concurrent illnesses and other medications were not reported. Patient had no known drug allergies. On 30-JUN-2015 the patient was vaccinated with GARDASIL 9 lot # L001312, dose 1, route: unknown in the left arm and VARIVAX lot # K015993, subcutaneously in the left arm for prophylaxis. On the same day, the patient was also vaccinated with TRUMENBA lot # J29203, dose 1, route: unknown in the left arm and PREVNAR 13 lot # L58154, dose 1, route: unknown in the right arm for prophylaxis. On 02-JUL-2015, the patient experienced herpes zoster (shingles) after chicken pox vaccination last week. Patient was given acyclovir 80 mg tablet and acyclovir 5% external ointment as treatment. The outcome of the event herpes zoster was unknown. The causality assessment for the event herpes zoster with respect to GARDASIL 9 and VARIVAX was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Malaise, 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 # 585010). This spontaneous report refers to a 10 year old male patient. The patient had no concurrent illnesses as per the patient's mother. Information on the patient's medical history and other medications were not reported. On 08-JUL-2015, the patient was vaccinated with GARDASIL 9 batch# K02647, dose 2 via intramuscular route in the right thigh (leg) for prophylaxis (dosage unspecified). On 08-JUL-2015, the patient experienced malaise and pallor. The patient reported that he was "not feeling well" and became pale in color after administration. The patient was instructed to lie down for 30 minutes, eat, drink and ambulate prior to leaving the clinic. The outcome of malaise and pallor was reported as recovered. The causality assessment for the events malaise and pallor with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Muscle contractions involuntary, 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 # 585400) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old female patient. The patient had no other medications. The patient's medical history and current illnesses were not reported. On 09-JUL-2015, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly in the left arm, lot # L001312 (dose, frequency and lot expiration date were not reported) for prophylaxis. On the same day after the patient was given second dose of GARDASIL 9 she felt normal, no dizziness and the patient was moved to chair from examination table so the patient's brother could get his vaccines. Patient had no complaints and sibling finished with vaccines. And the patient complained of dizziness, she then immediately fainted and her body had muscle contractions. And then patient immediately opened her and was assisted her to examination table to lie down, propped knees with pillow. Placed a cool cloth on forehead of the patient and she was offered orange juice. Blood pressure was checked (BP) 112/76 and allowed to rest for 15 minutes. The patient felt better and had no further complaints. Blood pressure (BP) was rechecked 100/61. Patient was assisted to sitting position in which she sat for 3 minutes before she was bought to standing position. She still felt no further symptoms and was recommended her to walk slowly with assistance. The patient had food when arrived to home and she was called up for any further questions or concerns. The patient's mom and patient verbalized understanding. The outcome of dizziness and syncope was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Abnormal behaviour, Cough, Feeling abnormal, Headache, Immediate post-injection reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 585988) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. Information on patient's medical history, concurrent conditions and concomitant therapies were not reported. Other medications were also not reported. On 14-JUL-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported), lot # K026246, dose number 1, intramuscularly in the right arm for prophylaxis. Immediately after getting injected, the patient developed  runny nose and went for lunch with family. Approximately 20 minutes later, the patient developed dry cough/tickle to the back of throat lasting approximately 45 minutes, and faced no issues with breathing, sob,swelling of lips, nose, mouth, tongue, eyes, nose and throat. After having lunch, the patient went home and approximately one and a half hours later, the patient complained to his mother he just didn't feel well and felt 'shaky on the inside' and also felt clingy. The patient requested his mother to lay down with him/sitting on mother's lap which was totally out of character for patient. On 14-JUL-2015,the patient experienced abnormal behaviour, throat irritation, rhinorrhoea, nervousness, nausea, malaise, immediate post-injection reaction, headache, feeling abnormal and cough. The mother telephoned to report this concern and discussed the issue with the doctor and requested that the patient be taken for evaluation. The patient was checked by the doctor and the patient c/o of HA, foggy headedness, sniffles, and some nausea. The patient was advised to take Benadryl every 4-6 hours and was asked to return in the morning if the patient was still foggy headed and there was no improvement. If new conditions appeared or worsened, the patient was asked to visit ER (Emergency room) STAT. The family voiced their understanding and the patient was discharged at 5 pm. The outcome of abnormal behaviour, throat irritation, rhinorrhoea, nervousness, nausea, malaise, immediate post-injection reaction, headache, feeling abnormal and cough 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: Malaise, Nausea, Nervousness, Rhinorrhoea, Throat irritation
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 # 585988) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old male patient. Information on patient's medical history, concurrent conditions and concomitant therapies were not reported. Other medications were also not reported. On 14-JUL-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported), lot # K026246, dose number 1, intramuscularly in the right arm for prophylaxis. Immediately after getting injected, the patient developed  runny nose and went for lunch with family. Approximately 20 minutes later, the patient developed dry cough/tickle to the back of throat lasting approximately 45 minutes, and faced no issues with breathing, sob,swelling of lips, nose, mouth, tongue, eyes, nose and throat. After having lunch, the patient went home and approximately one and a half hours later, the patient complained to his mother he just didn't feel well and felt 'shaky on the inside' and also felt clingy. The patient requested his mother to lay down with him/sitting on mother's lap which was totally out of character for patient. On 14-JUL-2015,the patient experienced abnormal behaviour, throat irritation, rhinorrhoea, nervousness, nausea, malaise, immediate post-injection reaction, headache, feeling abnormal and cough. The mother telephoned to report this concern and discussed the issue with the doctor and requested that the patient be taken for evaluation. The patient was checked by the doctor and the patient c/o of HA, foggy headedness, sniffles, and some nausea. The patient was advised to take Benadryl every 4-6 hours and was asked to return in the morning if the patient was still foggy headed and there was no improvement. If new conditions appeared or worsened, the patient was asked to visit ER (Emergency room) STAT. The family voiced their understanding and the patient was discharged at 5 pm. The outcome of abnormal behaviour, throat irritation, rhinorrhoea, nervousness, nausea, malaise, immediate post-injection reaction, headache, feeling abnormal and cough 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: HEPA, HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Seizure, Syncope, Tearfulness
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 # 586178) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient with prophylaxis. Information on patient's medical history were not reported. The patient had no concurrent illnesses. On 26-JUN-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026246 dose number 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included VAQTA (dose, frequency and lot expiration date were not reported), lot # K012457 (vaccinated date: 26-JUN-2015, dose number 1, dose, frequency and lot expiration date were not reported) intramuscularly in the right arm, BOOSTRIX lot # C4713AA, (vaccinated date: 26-JUN-2015, dose number 1, dose, frequency and lot expiration date were not reported) intramuscularly in the left arm and MENACTRA lot # U5021AA (vaccinated date: 26-JUN-2015, dose number 1, dose, frequency and lot expiration date were not reported) intramuscularly in the left arm. Other medications: Patient reported no medications at the time of the visit. Patient became unconscious shortly after the vaccines were administered. Patient fell off the exam table and parent picked him up and placed him on the table. Nursing responded to exam room and found patient unconscious and incontinent of urine. On 26-JUN-2015, the patient experienced fall, urinary incontinence, tearfulness, syncope, seizure and loss of consciousness. Vital signs were stable. Emergency 911 was initiated and patient was taken to ED (Emergency department) by ambulance. Patient had regained consciousness prior to ambulance arrival. Patient was tearful but alert and oriented. The outcome of fall, urinary incontinence, tearfulness, syncope, seizure and loss of consciousness were reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 586178) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient with prophylaxis. Information on patient's medical history were not reported. The patient had no concurrent illnesses. On 26-JUN-2015, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # K026246 dose number 1, intramuscularly in the right arm for prophylaxis. Other suspect therapies included VAQTA (dose, frequency and lot expiration date were not reported), lot # K012457 (vaccinated date: 26-JUN-2015, dose number 1, dose, frequency and lot expiration date were not reported) intramuscularly in the right arm, BOOSTRIX lot # C4713AA, (vaccinated date: 26-JUN-2015, dose number 1, dose, frequency and lot expiration date were not reported) intramuscularly in the left arm and MENACTRA lot # U5021AA (vaccinated date: 26-JUN-2015, dose number 1, dose, frequency and lot expiration date were not reported) intramuscularly in the left arm. Other medications: Patient reported no medications at the time of the visit. Patient became unconscious shortly after the vaccines were administered. Patient fell off the exam table and parent picked him up and placed him on the table. Nursing responded to exam room and found patient unconscious and incontinent of urine. On 26-JUN-2015, the patient experienced fall, urinary incontinence, tearfulness, syncope, seizure and loss of consciousness. Vital signs were stable. Emergency 911 was initiated and patient was taken to ED (Emergency department) by ambulance. Patient had regained consciousness prior to ambulance arrival. Patient was tearful but alert and oriented. The outcome of fall, urinary incontinence, tearfulness, syncope, seizure and loss of consciousness were reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Arthralgia, Crying, Fatigue, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 586286). This spontaneous report refers to a 13 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 17-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot # not reported), dose 1, subcutaneously in the left arm for prophylaxis. Patient experienced pain at injection site, 5 hours following injection but no redness. She had really bad headache and body aches during later afternoon at 16:00. By 17:00, patient experienced terrible nausea, joint pain, tingling, extreme skin sensitivity, pain when breathing deeply and low grade fever. Nurse was called and ibuprofen was given. Symptoms worsened over course of the night and progressed to high fever (not measured but extremely hot to mother's touch all over her body even with ibuprofen), horrible joint pain, dry heaves (small amount of vomit), terrible nausea, tingling in hands, period type pain and cramps in abdomen and lower back, horrible headache, pain would migrate around body, worsening causing her to sob (as she never cries). Patient was better by morning but still had headache and body aches. On third day out, she was better but exhausted and has body aches and headache still. Symptoms worsened when she was fatigued (went and did something for a few hours yesterday afternoon and when got home had headache and body aches). It was stated as "Not sure if I'm remembering all of them, but this is as accurate as I can remember". The outcome of the events was reported as not 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.
Sex: F
Vaccine: HPV9
Symptoms: Hyperaesthesia, Injection site pain, Muscle spasms, Nausea, Pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 586286). This spontaneous report refers to a 13 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 17-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot # not reported), dose 1, subcutaneously in the left arm for prophylaxis. Patient experienced pain at injection site, 5 hours following injection but no redness. She had really bad headache and body aches during later afternoon at 16:00. By 17:00, patient experienced terrible nausea, joint pain, tingling, extreme skin sensitivity, pain when breathing deeply and low grade fever. Nurse was called and ibuprofen was given. Symptoms worsened over course of the night and progressed to high fever (not measured but extremely hot to mother's touch all over her body even with ibuprofen), horrible joint pain, dry heaves (small amount of vomit), terrible nausea, tingling in hands, period type pain and cramps in abdomen and lower back, horrible headache, pain would migrate around body, worsening causing her to sob (as she never cries). Patient was better by morning but still had headache and body aches. On third day out, she was better but exhausted and has body aches and headache still. Symptoms worsened when she was fatigued (went and did something for a few hours yesterday afternoon and when got home had headache and body aches). It was stated as "Not sure if I'm remembering all of them, but this is as accurate as I can remember". The outcome of the events was reported as not 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.
Sex: F
Vaccine: HPV9
Symptoms: Painful respiration, Paraesthesia, Pyrexia, Retching, 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 # 586286). This spontaneous report refers to a 13 year old female patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 17-JUL-2015, the patient was vaccinated with GARDASIL 9 (lot # not reported), dose 1, subcutaneously in the left arm for prophylaxis. Patient experienced pain at injection site, 5 hours following injection but no redness. She had really bad headache and body aches during later afternoon at 16:00. By 17:00, patient experienced terrible nausea, joint pain, tingling, extreme skin sensitivity, pain when breathing deeply and low grade fever. Nurse was called and ibuprofen was given. Symptoms worsened over course of the night and progressed to high fever (not measured but extremely hot to mother's touch all over her body even with ibuprofen), horrible joint pain, dry heaves (small amount of vomit), terrible nausea, tingling in hands, period type pain and cramps in abdomen and lower back, horrible headache, pain would migrate around body, worsening causing her to sob (as she never cries). Patient was better by morning but still had headache and body aches. On third day out, she was better but exhausted and has body aches and headache still. Symptoms worsened when she was fatigued (went and did something for a few hours yesterday afternoon and when got home had headache and body aches). It was stated as "Not sure if I'm remembering all of them, but this is as accurate as I can remember". The outcome of the events was reported as not 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.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: 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 # 586656) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 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 21-JUL-2015,  the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot # L006547, dose number 1, intramuscularly in the left arm for prophylaxis. On 21-JUL-2015, the patient experienced syncope. The outcome of syncope was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Dysarthria
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 # 586784) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 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 10-MAR-2015, the patient was vaccinated with GARDASIL 9 dose number 1, lot # K006960, (dose, frequency and lot expiration date were not reported) intramuscular for prophylaxis. On 10-MAR-2015, the patient experienced dysarthria. Patient experienced slurred speech which was noted the patient herself, her mother, teachers and peers. This lasted till evening while going to sleep. Patient woke up fine the next day. The outcome of dysarthria was reported as recovered/resolved. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Pallor, Tension, 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 # 587844). This spontaneous report refers to a 20 year old female patient. The patient's medical history was reported as fainting with vaccines. The patient had no concurrent illness and other medications. On 24-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # L000610, dose 1 via intramuscular route in the left arm for prophylaxis (dosage unspecified). On 24-JUL-2015, the patient experienced malaise, unresponsive to stimuli, tension and pallor. The patient had eaten and had something to drink, she also had juice and candy at the vaccination center. After vaccine was given, 5 minutes later the patient stated that, she felt ill. The patient was pale, body became very tense for about 10 seconds during which the patient did not answer/respond and she drank water. The patient was able to move, sit and stand. The patient color was improved. The patient felt well enough to leave the vaccination center 35 minutes after vaccination. The patient was also examined by the physician while she was at the vaccination center. Initial blood pressure was 131/74 HR 71 after the onset of the symptoms and blood pressure was 130/74 HR 54 before leaving the vaccination center. The outcome of the events malaise, unresponsive to stimuli, tension and pallor was reported as recovered. The causality assessment for the events malaise, unresponsive to stimuli, tension and pallor with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP
Symptoms: Skin abrasion, 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 # 587924) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 13 year old male patient with prophylaxis. Patient's current illness and medical history were reported as none. Patient's other medication was reported as unknown. Patient's concurrent therapies was not reported. On 30-JUL-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L004741 (dose, frequency and expiration were not reported) intramuscularly, in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 30-JUL-2015, intramuscularly in the right arm, lot/batch# 92458; dose, frequency and expiration date unknown), MENACTRA (dose number: 1, vaccinated date: 30-JUL-2015, intramuscularly in the left arm, lot/batch# U5020AA; dose, frequency and expiration date unknown) and HAVRIX (dose number: 1, vaccinated date: 30-JUL-2015, intramuscularly in the left arm, lot/batch# 77D7L; dose, frequency and expiration date unknown). On 30-JUL-2015, at 4:03p.m. patient fainted in hallway and causing an abrasion beside his left eye. Wet paper towels applied to face. Patient's legs was elevated. Cold pack to abrasion beside left eye. BP was reported as 114/70. The outcome of skin abrasion and syncope was reported as recovered. Causality assessment for the events skin abrasion and syncope with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blood glucose normal, Defaecation urgency, Dizziness, Haemoglobin normal, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 587925) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient with prophylaxis. The patient's current illness and medical history were not reported. The patient's other medications include DIFFERIN 0.1% External Cream; Minocycline Hcl 50 mg capsules; Cetirizine Hcl 5 g/5ml syrup. On 29-JUL-2015, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the left arm, lot # K026246 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 2, vaccinated date: 29-JUL-2015, intramuscularly in the right arm, lot # U4986CA; dose and expiration date unknown). On 29-JUL-2015, the patient had syncopal episode following vaccination and she was seated and stated that she felt tingly, dizzy, vision changes and then had brief LOC (loss of consciousness) which was witnessed by mother and MA (medical administration) staff. On the same day, she then immediately needed to use the bathroom to have bowel movement and felt nauseous and was pale. She was then seen by the provider in the bathroom appeared pale and advised to take deep breaths. She was then taken to exam room and laid down and improved. BS (blood glucose) and HGB (hemoglobin) tested were normal on the same day. She stated that she only had caffeine/coffee in the AM (morning). The patient episode was c/w (consistent with) syncope, verbal education provided, drink fluids and f/u (follow up) prn. Patient was at baseline during the time of discharge. The outcome of blood glucose normal, visual impairment, syncope, pallor, nausea, haemoglobin normal, dizziness and defaecation urgency was reported as recovered/resolved. Lab data: Fasting glucose: 109mg/d; HGB (Haemoglobin): 14.0g/dl. 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, MNQ
Symptoms: Nausea, Pallor, Paraesthesia, Syncope, Visual impairment
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 587925) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient with prophylaxis. The patient's current illness and medical history were not reported. The patient's other medications include DIFFERIN 0.1% External Cream; Minocycline Hcl 50 mg capsules; Cetirizine Hcl 5 g/5ml syrup. On 29-JUL-2015, the patient was vaccinated with the third dose of GARDASIL 9 intramuscularly in the left arm, lot # K026246 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 2, vaccinated date: 29-JUL-2015, intramuscularly in the right arm, lot # U4986CA; dose and expiration date unknown). On 29-JUL-2015, the patient had syncopal episode following vaccination and she was seated and stated that she felt tingly, dizzy, vision changes and then had brief LOC (loss of consciousness) which was witnessed by mother and MA (medical administration) staff. On the same day, she then immediately needed to use the bathroom to have bowel movement and felt nauseous and was pale. She was then seen by the provider in the bathroom appeared pale and advised to take deep breaths. She was then taken to exam room and laid down and improved. BS (blood glucose) and HGB (hemoglobin) tested were normal on the same day. She stated that she only had caffeine/coffee in the AM (morning). The patient episode was c/w (consistent with) syncope, verbal education provided, drink fluids and f/u (follow up) prn. Patient was at baseline during the time of discharge. The outcome of blood glucose normal, visual impairment, syncope, pallor, nausea, haemoglobin normal, dizziness and defaecation urgency was reported as recovered/resolved. Lab data: Fasting glucose: 109mg/d; HGB (Haemoglobin): 14.0g/dl. 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: 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 # 588106) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 18 year old female patient. The patient's concomitant therapies, concurrent illness and medical history were not reported. On 31-JUL-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # L000610 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA. On 31-JUL-2015, the patient fainted while he was sitting in chair but no harm was caused. Two other nurses came and assisted the patient. The patient was carried to the exam table and her legs were lifted up. The patient was made to drink water and orange juice, then the patient felt better and was dismissed after 30 minutes. The outcome of syncope was reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 588394). This spontaneous report refers to a 16 year old female patient with abdominal pain and chronic irritable bowel syndrome. The patient's medical history included rhinitis allergic, juvenile osteochondrosis of foot and syncope. Other medications included dicyclomine. On 08-JUL-2015 the patient was vaccinated with GARDASIL 9 lot # L001312, intramuscular in the left arm for prophylaxis. Other suspect therapies included MENVEO given on the same day intramuscularly in the left arm. On an unknown date, approximately 2 1/2 weeks post injection, the patient experienced injection site erythema, injection site swelling, injection site induration at the site of both injections and was taken to emergency room. No fever was reported. Diameter of swelling was 3 cm of firmness. The patient was instructed to take ibuprofen and apply ice packs. He was asked to notify MD if the symptoms were not better or worsen. The outcome of injection site erythema, injection site swelling and injection site induration was reported as recovered. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.