chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Discomfort, Dizziness, Erythema, Fall, Induration
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 # 664905) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included medication allergy to OMNICEF. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications were reported as OTC MOTRIN/TYLENOL after the vaccine(s) were administered. On 07-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L017407, intramuscularly in the right arm for prophylaxis. Other suspect therapies included FLUARIX (vaccinated date: 07-NOV-2016, intramuscularly in the right arm, lot# 3J3A9; dose and expiration date unknown). On 08-NOV-2016, the patient experienced discomfort, skin warm, skin tightness, peripheral swelling, pain in extremity, loss of consciousness, induration, fall, erythema and dizziness. Patient complained of increased pain in right arm and it was noted that there was a large area of redness/swelling/warmth to right upper extremity. Patient's skin was taut and area was swollen and painful. Patient's parent administered MOTRIN dosed by weight for pain and discomfort/swelling. Ice was also applied to the area. Patient also attended dance class per her normal schedule. Patient stated that twice during the practice she suddenly became dizzy, blacked out, and fell to the floor. Patient does not know if she lost consciousness. Her friends around her had to help her up. Patient's mother was instructed to draw a line on the skin to make sure that the redness began to subside and not spread. 36 hours after vaccine and treatment, patient reported less pain and redness had not spread beyond the line but had not subsided. Right arm continued to be swollen and red area "feels hard" per patient's mom. The outcome of discomfort, skin warm, skin tightness, peripheral swelling, pain in extremity, loss of consciousness, induration, fall, erythema and dizziness 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: FLU4, HPV9
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Skin tightness, 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 # 664905) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 13 year old female patient. The patient's medical history included medication allergy to OMNICEF. Information on patient's prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications were reported as OTC MOTRIN/TYLENOL after the vaccine(s) were administered. On 07-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L017407, intramuscularly in the right arm for prophylaxis. Other suspect therapies included FLUARIX (vaccinated date: 07-NOV-2016, intramuscularly in the right arm, lot# 3J3A9; dose and expiration date unknown). On 08-NOV-2016, the patient experienced discomfort, skin warm, skin tightness, peripheral swelling, pain in extremity, loss of consciousness, induration, fall, erythema and dizziness. Patient complained of increased pain in right arm and it was noted that there was a large area of redness/swelling/warmth to right upper extremity. Patient's skin was taut and area was swollen and painful. Patient's parent administered MOTRIN dosed by weight for pain and discomfort/swelling. Ice was also applied to the area. Patient also attended dance class per her normal schedule. Patient stated that twice during the practice she suddenly became dizzy, blacked out, and fell to the floor. Patient does not know if she lost consciousness. Her friends around her had to help her up. Patient's mother was instructed to draw a line on the skin to make sure that the redness began to subside and not spread. 36 hours after vaccine and treatment, patient reported less pain and redness had not spread beyond the line but had not subsided. Right arm continued to be swollen and red area "feels hard" per patient's mom. The outcome of discomfort, skin warm, skin tightness, peripheral swelling, pain in extremity, loss of consciousness, induration, fall, erythema and dizziness were unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: U
Vaccine: FLU4, 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 # 664969) on 02-MAY-2017. This spontaneous report was received from a regulatory authority refers to a patient of unknown age. The patient's concomitant therapies, prior vaccinations, concurrent illnesses and medical history were not reported. The patient's other medications were reported as none. On 03-NOV-2016 the patient was vaccinated with first dose of hpv GARDASIL 9 lot # M018810, lot expiration date 28-MAY-2018 (dose: not reported) (route of administration: unknown) in the left arm for prophylaxis. Other suspect therapy which were given on the same day included sixth dose of FLUARIX QUADRIVALENT (in the left arm, lot# 3HA7D; dose, route of administration and expiration date unknown) for prophylaxis. On the same day post vaccination, the patient felt syncope for two minutes. The patient had visited the emergency room. 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: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, 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 # 665200). This spontaneous report refers to a 25 year old female patient. The patient had no current illnesses and had no known allergies or medical conditions. The patient's other medications included a NEXPLANON device implanted in her left arm in September 2015 that was still in place at her vaccination appointment. On 09-NOV-2016, the patient was vaccinated with GARDASIL 9 batch/lot # M009378-P, dose 3, intramuscularly in the right arm for prophylaxis. On 10-NOV-2016 at 09:18, the patient called and reported that last night (09-NOV-2016) around 18:00, she noticed some swelling at her injection site on right deltoid that looked like a mosquito bite. Her arm hurt throughout the night and her entire arm was red (she denied a splotchy or rash-like appearance), it was swollen from her deltoid nearly halfway down to her elbow, and it itched. She reported that her right pinky was slightly tingly. The patient reported that she didn't have any reaction with either of the previous 2 doses of HPV vaccine she received. The patient was recommended to take some diphenhydramine and go to an urgent care or her primary care provider that day. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: 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 # 665200). This spontaneous report refers to a 25 year old female patient. The patient had no current illnesses and had no known allergies or medical conditions. The patient's other medications included a NEXPLANON device implanted in her left arm in September 2015 that was still in place at her vaccination appointment. On 09-NOV-2016, the patient was vaccinated with GARDASIL 9 batch/lot # M009378-P, dose 3, intramuscularly in the right arm for prophylaxis. On 10-NOV-2016 at 09:18, the patient called and reported that last night (09-NOV-2016) around 18:00, she noticed some swelling at her injection site on right deltoid that looked like a mosquito bite. Her arm hurt throughout the night and her entire arm was red (she denied a splotchy or rash-like appearance), it was swollen from her deltoid nearly halfway down to her elbow, and it itched. She reported that her right pinky was slightly tingly. The patient reported that she didn't have any reaction with either of the previous 2 doses of HPV vaccine she received. The patient was recommended to take some diphenhydramine and go to an urgent care or her primary care provider that day. The outcome of the events was reported as unknown. The causality assessment for all the events with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the agency as follow up information cannot be obtained.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Chapped lips, Injection site erythema, Lip exfoliation, Lip swelling, Oral discomfort
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID-665303). This spontaneous report refers to a 21 year old female patient. The patient's medical history included allergy to Daytrana. The patient had no current illnesses. Other medications included Vyvanse. On 08-OCT-2016, the patient was vaccinated with GARDASIL 9 lot # L036301 dose 2 (unspecified dosage), intramuscularly in the right arm for prophylaxis. A few hours after receiving the vaccination, the patient's arm became red from shoulder to elbow and her lips began to swell. She took Benadryl. On 10-OCT-2016, in the morning, her swelling had decreased but her lips were peeling and chapped. She had a burning sensation inside her mouth. The outcome of chapped lips, oral discomfort, lip swelling, lip exfoliation and injection site erythema was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Chest X-ray normal, Diarrhoea, Feeling abnormal, Hallucination, visual, Laboratory test normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 665480). This spontaneous report refers to a 13 year old female patient. The patient's current illness includes low back pain. The patient had no medical history and other medications. The patient's prior vaccinations included GARDASIL 9 dose 1 and 2, on an unknown date at 12:00 which caused fever. On 21-OCT-2016, the patient was vaccinated with GARDASIL 9 batch/lot # L0400540VFC, dose 3, route: unknown in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX QUADRIVALENT lot # 579KXOVFC, dose 6, route: unknown in the right arm. On 22-OCT-2016, the patient was taken to emergency department (ED) as she awakened in the night and complained of feeling odd, fever, vomiting and diarrhea at home. Patient's mother reported that, child complained of seeing things which were not there like lights on the clock without any light (hallucination, visual). The patient's lab tests and chest X-ray (CXR) were without concern. The child was ill on 22-OCT-2016 and was not ill on 23-OCT-2016. 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.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Malaise, 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 # 665480). This spontaneous report refers to a 13 year old female patient. The patient's current illness includes low back pain. The patient had no medical history and other medications. The patient's prior vaccinations included GARDASIL 9 dose 1 and 2, on an unknown date at 12:00 which caused fever. On 21-OCT-2016, the patient was vaccinated with GARDASIL 9 batch/lot # L0400540VFC, dose 3, route: unknown in the left arm for prophylaxis. On the same day, the patient was also vaccinated with FLUARIX QUADRIVALENT lot # 579KXOVFC, dose 6, route: unknown in the right arm. On 22-OCT-2016, the patient was taken to emergency department (ED) as she awakened in the night and complained of feeling odd, fever, vomiting and diarrhea at home. Patient's mother reported that, child complained of seeing things which were not there like lights on the clock without any light (hallucination, visual). The patient's lab tests and chest X-ray (CXR) were without concern. The child was ill on 22-OCT-2016 and was not ill on 23-OCT-2016. 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.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Musculoskeletal stiffness, Posture abnormal, 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 # 665855) on 02-MAY-2017. This spontaneous report refers to a 17 year old female patient. The patient's concurrent illnesses included concerns related to allergic rhinitis. The patient's medical history included documented allergy to amoxicillin. Information about the patient's other medications and prior vaccinations were not reported. On 11-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M030380 dose 1 (unspecified dosage), intramuscularly in the right arm for prophylaxis. On the same day, the patient was also vaccinated with MENACTRA lot # U5462A (unspecified dose and dosage), intramuscularly in the right arm and influenza FLUZONE Quadrivalent lot # UT5598JA (unspecified dose and dosage), intramuscularly in the left arm, for prophylaxis. On 11-NOV-2016, after administration of the last vaccine, GARDASIL 9, the patient immediately experienced a post-injection reaction, had dizziness and began to lean forward. Then, the nurse assisted her to lean back on the exam table. The patient then quickly had tightening of her upper extremities and lower extremities, which lasted several seconds. She then had a brief period of unresponsiveness for approximately 40-60 seconds. She slowly regained her alertness and was monitored for almost one hour in the clinic. The patient then left the pediatric primary care center (PCC) in stable condition, accompanied by her mom and younger sibling. The outcome of the events was reported as recovered. The causality assessment for the events was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Hyperhidrosis, Loss of consciousness, Muscle twitching, 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 ID-666927). This spontaneous report refers to a 24 year old female patient. The patient had no historical conditions and other medications. The patient's current illnesses were not reported. On 16-NOV-2016, the patient was vaccinated with GARDASIL 9 lot # M018810 (expiration date: 28-MAY-2018) dose 1 (unspecified dosage), intramuscularly in the left arm for prophylaxis. The patient was sitting on a chair during vaccination. After less than a minute after vaccination, the patient passed out and her head twitched for about 5 seconds. She urinated involuntarily and was diaphoretic. Ammonia capsule was placed close to her nose & she regained consciousness. An attempt was made to call 911 but the patient was then alert and oriented and hence the call was cancelled. The incident lasted for about 30 seconds. Oxygen was provided via face mask at 4L/min. The patient was alert and oriented with no signs of acute distress. After 5 minutes, she passed out again which lasted for about 10 seconds. The patient was again alert and oriented. Her vital signs were stable. PERRLA (Pupils equal, round, reactive to light and accommodation) was reported. No signs of acute distress were noted. The patient was brought to exam table to lie down with ice pack behind her neck. The patient's mother at waiting room was called inside and asked to take the patient home. The patient and her mother denied any allergies. The patient was advised to visit professional emergency physician (pep) for second shot of GARDASIL 9. She left the clinic in a stable condition with no symptoms/complaints. Emergency room warnings were given. Assistant manager called the patient in the evening to follow-up but received no answer. The outcome of the events was reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Antibody test negative, Full blood count normal, Limb mass, Lipase normal, Metabolic function test normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 669061) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 25 year old female patient. The patient's medical history included Clindamycin allergy. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications were reported as Ibuprofen, Microfestin Fe, Zofran, Prilosec, Flonase, MCG/ACT suspension and Hydrocortisone Butyr Lipo Base 0.1% Cream. On 30-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # M030380, intramuscularly in the left arm for prophylaxis. On 01-OCT-2016, the patient's antibody test was negative, urine analysis normal, metabolic function test normal, lipase normal, full blood count normal and also experienced nausea and limb mass. The patient's left arm had a lump which was noted the day after immunization. It resolved after 10 days and then recurred 4 weeks after initial immunization. Patient also noticed increased nausea for another one month starting the day after the immunization. Lab data included negative HPV titer, complete blood count (CBC), comprehensive metabolic panel (CMP), amylase, lipase and urine. The outcome of antibody test negative, urine analysis normal, nausea, metabolic function test normal, lipase normal, limb mass and full blood count normal was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Urine analysis normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 669061) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 25 year old female patient. The patient's medical history included Clindamycin allergy. Information on patient's medical history and prior vaccinations were not reported. The patient had no concurrent illnesses. Other medications were reported as Ibuprofen, Microfestin Fe, Zofran, Prilosec, Flonase, MCG/ACT suspension and Hydrocortisone Butyr Lipo Base 0.1% Cream. On 30-SEP-2016, the patient was vaccinated with the second dose of GARDASIL 9 lot # M030380, intramuscularly in the left arm for prophylaxis. On 01-OCT-2016, the patient's antibody test was negative, urine analysis normal, metabolic function test normal, lipase normal, full blood count normal and also experienced nausea and limb mass. The patient's left arm had a lump which was noted the day after immunization. It resolved after 10 days and then recurred 4 weeks after initial immunization. Patient also noticed increased nausea for another one month starting the day after the immunization. Lab data included negative HPV titer, complete blood count (CBC), comprehensive metabolic panel (CMP), amylase, lipase and urine. The outcome of antibody test negative, urine analysis normal, nausea, metabolic function test normal, lipase normal, limb mass and full blood count normal was reported as not recovered/not resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Heart rate decreased, Hypoaesthesia, Nausea, Seizure like phenomena, 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 # 670709). This spontaneous report refers to a 15 year old female patient. The patient had no current illnesses and information on patient's prior vaccinations was not reported. The patient's medical history included headache and syncope. The patient's other medications included vitamins. On 16-NOV-2016 at 14:55, the patient was vaccinated with GARDASIL 9 lot # M023169, dose 2, intramuscularly in the left deltoid for prophylaxis. Patient was instructed to lay down on bed after the injection in case of any adverse reaction. Less than one minute after leaving the exam room, post documentation of injection and visual examination, the patient's sister yelled for help. The nurse and another employee ran into patient's room and found patient demonstrating seizure like activity on table. Patient's father was at bedside talking to patient, she stopped shaking and knew who she was and who her father was. Patient stated that she felt nausea and numbness in hands. Pulse oximetry was done and O2 was 100 percent, heart rate was 40 (units unspecified). Doctor assessed the patient, heart rate dropped to 39 (units unspecified) and patient started to shake again. Doctor informed registered nurse to draw up EPI and oxygen was started on patient, 911 was called on doctor's instructions. After starting oxygen on patient her heart rate started to rise and EPI was not given on doctor's instructions. Staff and family talked to the patient and explained what they did and why. Patient was responsive and answered doctor's questions. Patient's mother was at her side at that time. Patient was transported to hospital for further evaluation when the ambulance arrived. 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.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 671092) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 11 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-OCT-2016, the patient was vaccinated with GARDASIL 9 (dose, frequency and lot expiration date were not reported) lot/batch# L028323, via unknown route in the right arm for prophylaxis. Other suspect therapies included BOOSTRIX (vaccinated date: 03-OCT-2016, intramuscularly in the left arm, lot# L2972; dose, route of administration and expiration date unknown) and MENVEO (vaccinated date: 03-OCT-2016, intramuscularly in the left arm, lot# M16005; dose, route of administration and expiration date unknown). On 07-NOV-2016, the patient experienced injection site erythema, injection site pain, injection site nodule and injection site induration. Injection nodule was 2.5 cm at injection site, hard but not fluctuant, minimal redness and was tender. The outcome of injection site erythema, injection site pain, injection site nodule and injection site induration was unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 22.0
Sex: M
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Fatigue, Injection site erythema, Injection site rash, Injection site warmth, Malaise
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency # 676606 (VAERS ID)) under the Freedom of Information Act, referring to a 22 year old male patient. The patient's other medications, current illnesses, medical history and prior vaccinations were not provided. On 27-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot # M034195, intramuscular in the right arm, dose reported as 0.0 (unit unspecified); expiration date and concentration were unknown) and BEXSERO (lot# 158701,intramuscular in the left arm, dose reported as 1.0 (unit unspecified); expiration date and concentration were unknown), both for prophylaxis. On 28-DEC-2016, the patient experienced mild rash warm, erythematous, non-indurated patch upper 11 cm x 6 cm at left deltoid upper area; also cared of nausea, fatigue, malaise. The patient reported he felt sick. The outcome of the events was reported as resolved. The causal relationship between the events and suspect therapies was not provided. The Agency considered the event was non-serious. Additional information is not expected as no further information could be obtained from the agency.
Age: 22.0
Sex: M
Vaccine: HPV9, MENB, HPV9, MENB
Symptoms: Nausea
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency # 676606 (VAERS ID)) under the Freedom of Information Act, referring to a 22 year old male patient. The patient's other medications, current illnesses, medical history and prior vaccinations were not provided. On 27-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot # M034195, intramuscular in the right arm, dose reported as 0.0 (unit unspecified); expiration date and concentration were unknown) and BEXSERO (lot# 158701,intramuscular in the left arm, dose reported as 1.0 (unit unspecified); expiration date and concentration were unknown), both for prophylaxis. On 28-DEC-2016, the patient experienced mild rash warm, erythematous, non-indurated patch upper 11 cm x 6 cm at left deltoid upper area; also cared of nausea, fatigue, malaise. The patient reported he felt sick. The outcome of the events was reported as resolved. The causal relationship between the events and suspect therapies was not provided. The Agency considered the event was non-serious. Additional information is not expected as no further information could be obtained from the agency.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Fall, Loss of consciousness, Syncope, Tooth fracture
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency # 676624 (VAERS ID)) under the Freedom of Information Act, referring to an 11 year old female patient. The patient did not have other medications, current illnesses, medical history or prior vaccinations. On 13-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot # M018810, intramuscular in the left arm, dose reported as 0.0 (unit unspecified); expiration date and concentration were unknown), MENACTRA (lot # U5392AB, intramuscular in the left arm, dose reported as 0.0 (unit unspecified); expiration date and concentration were unknown) and ADACEL (lot # U5468AA, intramuscular in the right arm, dose reported as 5.0 (unit unspecified); expiration date and concentration were unknown), all for prophylaxis. Within 1-2 minutes after last vaccine, the patient had a syncope episode and fell off the exam table hitting the tall garbage can on the way down. The patient was unconscious about 30 seconds. A doctor examined the patient, and she chipped 2 teeth. After about 15 minutes, the patient's morn took her home. At the time of reporting, the patient recovered from events. The causality between events and suspect therapies was not provided. The Agency considered the event was non-serious. Additional information is not expected as no further information could be obtained from the agency.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Crying, Fall, Head injury, Headache, Musculoskeletal stiffness
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 (Agency# 676786) referring to a 12.0 year old male patient. He had none concurrent condition, concomitant medication or medical history. On 05-JAN-2017, the patient was vaccinated with first dose of GARDASIL 9 (lot # M028323, 1 dose form, intramuscular in the left arm) for prophylaxis. Other suspect therapies included second dose of FLUARIX (lot # 4A2E2, 1 dose form, intramuscular in the right arm). On the same day, the patient and his mother walked out of exam room to head into room across hall where Sib was. Patient fainted and fell backward hitting the back of his head on the floor, where he then went into a seizure like state. Non responsive, arms and legs stiffened and started to thrash. Then he lost bladder control. Started to come to approximately a minute-2 minutes after event, where he started crying for his mom, and also asking what had happened. Primary care physician (PCP) was present the entire time and kept him down due to head injury trying to keep him from moving his head. Patient cared of head hurting but was aware of surroundings. Emergency room was visited. The outcome of events was unknown. The causality between GARDASIL 9 and events was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Seizure like phenomena, Syncope, Unresponsive to stimuli, 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 (Agency# 676786) referring to a 12.0 year old male patient. He had none concurrent condition, concomitant medication or medical history. On 05-JAN-2017, the patient was vaccinated with first dose of GARDASIL 9 (lot # M028323, 1 dose form, intramuscular in the left arm) for prophylaxis. Other suspect therapies included second dose of FLUARIX (lot # 4A2E2, 1 dose form, intramuscular in the right arm). On the same day, the patient and his mother walked out of exam room to head into room across hall where Sib was. Patient fainted and fell backward hitting the back of his head on the floor, where he then went into a seizure like state. Non responsive, arms and legs stiffened and started to thrash. Then he lost bladder control. Started to come to approximately a minute-2 minutes after event, where he started crying for his mom, and also asking what had happened. Primary care physician (PCP) was present the entire time and kept him down due to head injury trying to keep him from moving his head. Patient cared of head hurting but was aware of surroundings. Emergency room was visited. The outcome of events was unknown. The causality between GARDASIL 9 and events was not reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Crying, Dyskinesia, Fall, Head injury, Musculoskeletal stiffness
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 (Agency# 676786) referring to a 12.0 year old male patient. He had none concurrent condition, concomitant medication or medical history. On 05-JAN-2017, the patient was vaccinated with first dose of GARDASIL 9 (lot # M028323, 1 dose form, intramuscular in the left arm) for prophylaxis. Other suspect therapies included second dose of FLUARIX (lot # 4A2E2, 1 dose form, intramuscular in the right arm). On the same day, the patient and his mother walked out of exam room to head into room across hall where Sib was. Patient fainted and fell backward hitting the back of his head on the floor, where he then went into a seizure like state. Non responsive, arms and legs stiffened and started to thrash. Then he lost bladder control. Started to come to approximately a minute-2 minutes after event, where he started crying for his mom, and also asking what had happened. Primary care physician (PCP) was present the entire time and kept him down due to head injury trying to keep him from moving his head. Patient cared of head hurting but was aware of surroundings. Emergency room was visited. The outcome of events was unknown. The causality between GARDASIL 9 and events was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (agency # 676880 (VAERS ID)) under the Freedom of Information Act, referring to a 17 year old female patient. The patient's other medication included ENSKYCE. The patient did not have known current illness, and the patient did not have known allergies in history. The patient's medical histories included acute sinusitis, asthma, birth control counseling, cough, dysmenorrhea, Enc(enclosed) surveillance contraceptive uns (unspecified), encounter for immunization, herpes simplex virus (HSV) gingivostomatitis and tonsillitis, hypertrophy of tonsils alone, lymphadenitis, mononucleosis, pharyngitis-acute, unspecified sinusitis; upper respiratory tract infection (URI), and unspecified human papillomavirus (HPV) vaccine. On 04-JAN-2017, the patient was vaccinated with GARDASIL 9 (lot # M036059, intramuscular in the right arm, dose reported as 2.0 (unit unspecified); expiration date and concentration were unknown), BEXSERO (lot #158401, intramuscular in the left arm, dose reported as 0.0 (unit unspecified); expiration date and concentration were unknown) and MENVEO (lot #M16076, intramuscular in the left arm, dose reported as 1.0 (unit unspecified); expiration date and concentration were unknown), all for prophylaxis. On 04-JAN-2017, the patient was unable to raise left arm due to pain in left deltoid. The Pain began in the evening after vaccine administered earlier the day. The patient was treated with analgesics, sling and light-duty at work. The outcome of events was unknown. The causal relationship between the events and suspect therapies was not provided. The Agency considered the event was non-serious. Additional information is not expected as no further information could be obtained from the agency.
Age: 10.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Skin lesion
Clinical narrative: Fever even with Tylenol/Advil, soreness, small red spot.  4/14/2017 pain all day with fever even with meds. took him to primary Dr about 6 pm Dr prescribed antibiotic, wanted to see him the next morning.  4/15/2017 redness was worse and spreading, hot and very painful.  went to ER 4/16/2017 11am he was given morphine for pain and antibiotic, was admitted to hospital. 4/19/2017 released for hospital.
Age: 10.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Blood test abnormal, Erythema, Infection, Pain, Pyrexia
Clinical narrative: Fever even with Tylenol/Advil, soreness, small red spot.  4/14/2017 pain all day with fever even with meds. took him to primary Dr about 6 pm Dr prescribed antibiotic, wanted to see him the next morning.  4/15/2017 redness was worse and spreading, hot and very painful.  went to ER 4/16/2017 11am he was given morphine for pain and antibiotic, was admitted to hospital. 4/19/2017 released for hospital.
Age: 10.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Skin swelling, Skin warm
Clinical narrative: Fever even with Tylenol/Advil, soreness, small red spot.  4/14/2017 pain all day with fever even with meds. took him to primary Dr about 6 pm Dr prescribed antibiotic, wanted to see him the next morning.  4/15/2017 redness was worse and spreading, hot and very painful.  went to ER 4/16/2017 11am he was given morphine for pain and antibiotic, was admitted to hospital. 4/19/2017 released for hospital.
Age: 40.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Computerised tomogram, Dizziness, Face injury, Nausea, Pain in extremity
Clinical narrative: This spontaneous case, initially received on 17-May-2017 was reported by other healthcare professional and concerns a 40 years old female patient. The patient's medical history included uterine fibroids. On 01-Nov-2016, the patient administered the AFLURIA QUAD vaccine (dosage: 0.5 ml, batch number: 12949221A, route of administration: Intramuscular, expiration date: 06-Jun-2017). On 01-Nov-2016, after 4 hours of vaccination the patient experienced dizzy, nauseous with painful arm of injection, fainted, and fell on tile at work and broke left cheek in 3 different places and went to emergency room. On 08-Nov-2016, surgery was performed and titanium plates were kept in face. The outcome of the events was reported as recovered/resolved. The reporter did not provide the causality assessment of the events in relation to the influenza vaccine. This case was serious (medically significant).
Age: 40.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Surgery, Syncope
Clinical narrative: This spontaneous case, initially received on 17-May-2017 was reported by other healthcare professional and concerns a 40 years old female patient. The patient's medical history included uterine fibroids. On 01-Nov-2016, the patient administered the AFLURIA QUAD vaccine (dosage: 0.5 ml, batch number: 12949221A, route of administration: Intramuscular, expiration date: 06-Jun-2017). On 01-Nov-2016, after 4 hours of vaccination the patient experienced dizzy, nauseous with painful arm of injection, fainted, and fell on tile at work and broke left cheek in 3 different places and went to emergency room. On 08-Nov-2016, surgery was performed and titanium plates were kept in face. The outcome of the events was reported as recovered/resolved. The reporter did not provide the causality assessment of the events in relation to the influenza vaccine. This case was serious (medically significant).
Age: 40.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Dizziness, Facial bones fracture, Fall, Internal fixation of fracture, Nausea
Clinical narrative: This spontaneous case, initially received on 17-May-2017 was reported by other healthcare professional and concerns a 40 years old female patient. The patient's medical history included uterine fibroids. On 01-Nov-2016, the patient administered the AFLURIA QUAD vaccine (dosage: 0.5 ml, batch number: 12949221A, route of administration: Intramuscular, expiration date: 06-Jun-2017). On 01-Nov-2016, after 4 hours of vaccination the patient experienced dizzy, nauseous with painful arm of injection, fainted, and fell on tile at work and broke left cheek in 3 different places and went to emergency room. On 08-Nov-2016, surgery was performed and titanium plates were kept in face. The outcome of the events was reported as recovered/resolved. The reporter did not provide the causality assessment of the events in relation to the influenza vaccine. This case was serious (medically significant).
Age: 40.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: Pain in extremity, Syncope
Clinical narrative: This spontaneous case, initially received on 17-May-2017 was reported by other healthcare professional and concerns a 40 years old female patient. The patient's medical history included uterine fibroids. On 01-Nov-2016, the patient administered the AFLURIA QUAD vaccine (dosage: 0.5 ml, batch number: 12949221A, route of administration: Intramuscular, expiration date: 06-Jun-2017). On 01-Nov-2016, after 4 hours of vaccination the patient experienced dizzy, nauseous with painful arm of injection, fainted, and fell on tile at work and broke left cheek in 3 different places and went to emergency room. On 08-Nov-2016, surgery was performed and titanium plates were kept in face. The outcome of the events was reported as recovered/resolved. The reporter did not provide the causality assessment of the events in relation to the influenza vaccine. This case was serious (medically significant).
Age: 0.17
Sex: F
Vaccine: 6VAX-F, PNC10
Symptoms: Crying, Gluten sensitivity, Milk allergy
Clinical narrative: Crying without interruption over 3 hours starting 8-9 hours after vaccine. DTAP and pneumococcal vaccines administered. Given paracetamol 12 hours after. She has dairy allergy and gluten intolerance now.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (strength, dose, frequency, and route of administration were not reported; Lot number M041508 with an expiration date 09-APR-2018) for prophylaxis and despite this, the patient was also vaccinated with a dose of VARIVAX (strength, dose, frequency, and route of administration were not reported; Lot number M044349 with an expiration date 04-NOV-2018) for prophylaxis. Both vaccines reconstituted with a sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). It was reported that there was no product confusion involved and there was no adverse reaction reported. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received on 08-MAY-2017 from a licensed practical nurse regarding an 11 weeks old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The licensed practical nurse did not know why the excursions occurred but there were no further temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004967: US-009507513-1608USA012794: US-009507513-1705USA004973: US-009507513-1705USA004952: US-009507513-1705USA004965: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004960.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received on 08-MAY-2017 from a licensed practical nurse and refers to a 6 month old infant, gender unknown. There was no information about the patient's concurrent conditions, concomitant therapy or medical history provided. On 19-SEP-2016, the 6 month old infant received vaccination with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. The administered dose of vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The licensed practical nurse stated they did not know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004952: US-009507513-1705USA004967: US-009507513-1705USA004960: US-009507513-1705USA004965: US-009507513-1705USA004973: US-009507513-1608USA012794: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004942: US-009507513-1705USA004944: US-009507513-1705USA004945: US-009507513-1705USA004947: US-009507513-1705USA004948: US-009507513-1705USA004949: US-009507513-1705USA004950: US-009507513-1705USA004951: US-009507513-1705USA004953: US-009507513-1705USA004954: US-009507513-1705USA004955: US-009507513-1705USA004946: US-009507513-1705USA004956: US-009507513-1705USA004957: US-009507513-1705USA004958: US-009507513-1705USA004959: US-009507513-1705USA004964: US-009507513-1705USA004966: US-009507513-1705USA004968: US-009507513-1705USA004969: US-009507513-1705USA004970: US-009507513-1705USA004971: US-009507513-1705USA004972: US-009507513-1705USA004974: US-009507513-1705USA004975: US-009507513-1705USA004976: US-009507513-1705USA004977: US-009507513-1705USA004978: US-009507513-1705USA004979: US-009507513-1705USA004980: US-009507513-1705USA004981: US-009507513-1705USA004982: US-009507513-1705USA004983: US-009507513-1705USA004984: US-009507513-1705USA004985: US-009507513-1705USA005004: US-009507513-1705USA005005: VAQTA; US-009507513-1705USA005006: US-009507513-1705USA005007: US-009507513-1608USA012916: US-009507513-1608USA012908: VAQTA; US-009507513-1705USA004887: US-009507513-1705USA004888: RECOMBIVAX HB; US-009507513-1705USA004889: US-009507513-1705USA004890: RECOMBIVAX HB; US-009507513-1705USA004891: RECOMBIVAX HB; US-009507513-1705USA004892: RECOMBIVAX HB; US-009507513-1705USA004893: RECOMBIVAX HB; US-009507513-1705USA004894: RECOMBIVAX HB; US-009507513-1705USA004895: RECOMBIVAX HB; US-009507513-1705USA004896: RECOMBIVAX HB; US-009507513-1705USA004897: RECOMBIVAX HB; US-009507513-1705USA004898: RECOMBIVAX HB; US-009507513-1705USA004899: RECOMBIVAX HB.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a 19 year-old female patient. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. The patient received altered dosing administration schedule as she was intramuscularly vaccinated on 18-AUG-2008 and 17-DEC-2014, with the first and second dose of GARDASIL injection (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. No side effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 18-MAY-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M043306, expiration date: 24-APR-2018) diluted with sterile diluent (manufacturer unknown) (route of administration and frequency were unspecified) for prophylaxis. No adverse effects were reported.  The vaccine was exposed to a temperature range between 6 and 14 Fahrenheit degrees, for a timeframe of 1 hour and 15 minutes. There were no previous temperature excursions or a data logger involved. No product quality complaint was reported. Additional information has been requested.