chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Abdominal discomfort, Alanine aminotransferase normal, Aspartate aminotransferase normal, Band neutrophil percentage decreased, Basophil percentage decreased
Clinical narrative: On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal, Blood chloride normal, Blood creatine phosphokinase normal
Clinical narrative: On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Blood creatinine normal, Blood glucose normal, Blood potassium decreased, Blood sodium decreased, Blood urea normal
Clinical narrative: On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: C-reactive protein increased, Carbon dioxide normal, Chills, Diarrhoea, Dyspnoea
Clinical narrative: On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Eosinophil percentage decreased, Frequent bowel movements, Full blood count normal, Gastroenteritis viral, Grip strength decreased
Clinical narrative: On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Haematochezia, Headache, Hypoaesthesia, Hypophagia, Lymphocyte percentage decreased
Clinical narrative: On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Monocyte percentage increased, Nausea, Neutrophil percentage increased, Photophobia, Protein total normal
Clinical narrative: On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pyrexia, Specific gravity urine normal, Urine ketone body present, White blood cell count normal
Clinical narrative: On day of vaccine, patient had headache, tactile fevers, chills, nausea and stomach upset. Fever persisted daily, Tmax of 105 F, responsive to acetaminophen but recurring. 5 days after vaccine, patient developed worsening diarrhea, 8-10 loose stools/day, with blood on wiping but not in toilet bowl. Has decreased oral intake but no change in urine. 7 days after vaccine, he developed numbness in both arms, like they were "going to sleep". Dad also noted progressive weakness in his grip strength. He does have photophobia with his headaches. He was short of breath yesterday and mom gave albuterol treatments with improvement. No eye/ear pain, visual changes, rhinorrhea, nasal congestion, cough, vomiting, muscle pain, joint pain. Patient was admitted to the hospital on day 8 after vaccine (today) and is thought to have viral gastroenteritis overlapping with potential vaccine reaction. Labs reported below. He is being given IV fluids with KCl and ondansetron. He is no longer reporting any paresthesias or weakness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Mass, Pain, Proctalgia
Clinical narrative: 3 days after patient received shingles vaccine, developed burning pain around base of spine. By 3 days later she developed pronounced soreness in vaginal and rectal areas. 2 days later she noticed a lump and visual redness in the above affected areas. Pain continued. Patient seen by physician 5/13/17. Diagnosed with shingles, treated with acyclovir x 7 days.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain, Vulvovaginal pain
Clinical narrative: 3 days after patient received shingles vaccine, developed burning pain around base of spine. By 3 days later she developed pronounced soreness in vaginal and rectal areas. 2 days later she noticed a lump and visual redness in the above affected areas. Pain continued. Patient seen by physician 5/13/17. Diagnosed with shingles, treated with acyclovir x 7 days.
Age: 64.0
Sex: U
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Severe pain at injection site, and could not lift arm for whole night. Went to ER - had prescribe pain killer. Subsided after 2 days.
Age: 69.0
Sex: U
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Purpura, Pyrexia
Clinical narrative: Severe shoulder pain to sternum down to elbow. Whole upper arm swollen = fever x 12 hrs. Purpura = appeared x 24 hrs.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 10-MAY-2017 from a lawyer regarding a case in litigation regarding a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 17-DEC-2009 at a medical center by an LPN as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-DEC-2009, the patient was treated by a physician at a medical center for a painful vesicular rash that was diagnosed as shingles. The patient has been prescribed acyclovir (manufacturer unknown), hydrocortisone 1% topical cream (manufacturer unknown) and  oxycodone/acetaminophen (ENDOCET) to manage persistent and excruciating symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Eyelid rash, Rash, Swelling, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 620011). This spontaneous report refers to a 12 year old female patient. Patient had no concurrent illnesses and other medications. The patient's medical history included mild grass, tree pollen and mold allergies. On 20-JAN-2016, the patient was vaccinated with GARDASIL 9 dose 2, route: unknown in the left arm for prophylaxis. On 20-JAN-2016 at 03:30, patient's parent noticed a small rash on patient's chin and a small rash with hives on her forehead. Parent spoke with the nurse at the primary care physician (PCP's) office to report the symptoms and requested the doctor be notified and to make a non-urgent call back to discuss. Patient was given BENADRYL 25 mg around 04:00 by the parent. Between 03:30 and 04:30, the rash and hives were more spotty on other areas of the face so parent administered another dose of 25 mg BENADRYL (the highest recommended dosage for patient's age). Parent then phoned the PCP again because the rash had spread to the eye area and looked swollen. Parent spoke with the PCP who recommended going to the emergency visit (ER) for further assessment. However, as parent prepared the family to leave for the ER, around 04:45, the rash appeared to be diminishing. Parent did not feel an ER visit was indicated and patient had no difficulty breathing nor any other symptoms during the event. By 05:30, the rash had decreased at least 90% and was 100% cleared by 06:30. 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: HEP, HPV9
Symptoms: Injection site pruritus, Injection site reaction, Petechiae, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #623677) and refers to a 20 year old female patient. Patient had no current illnesses and her medical history and other medications were reported as none. No details about prior vaccination and lab data was provided. On 23-FEB-2016, the patient was vaccinated with GARDASIL 9 lot # L028083, dose 1, via unknown route in the right arm for prophylaxis (strength and dosing details unknown). Other suspect therapies included vaccination with ENGERIX-B. On 23-FEB-2016, the patient experienced petechial rash and itching initially around site of injection, and then the rash spread to both arms, and now present on arms, lower back, and abdomen. The outcome of injection site reaction, pruritus, petechiae and injection site pruritus was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 12.0
Sex: F
Vaccine: FLUN4, HPV9
Symptoms: Asthma, Condition aggravated, Cough
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 (HA #623705) and refers to a 12 year old female patient. Patient's medical history included Asthma and her current illnesses and other medications were reported as none. No details about prior vaccination and lab data was provided. On 16-FEB-2016, the patient was vaccinated with GARDASIL 9, lot # L024993, dose 2, intramuscularly in the left arm for prophylaxis. Other suspect therapy included vaccination with FLUMIST. On 17-FEB-2016, one day after receiving the vaccinations patient developed cough which lead into asthma exacerbation 2-3 days later. The events required the patient for emergency room visit. The outcome of asthma, cough and condition aggravated was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9, MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #623923) and refers to a 16 year old male patient. His current illnesses and medical history was reported as none. No details about lab data, other medications and  prior vaccinations were  provided. On 26-JAN-2016, the patient was vaccinated with GARDASIL 9, lot # L016428, dose 1, intramuscularly in the left arm for prophylaxis (strength and dosing details unknown). Other suspect therapies included vaccination with PROQUAD (administered on 26-JAN-2016, subcutaneously in the left arm for prophylaxis). It was reported that vaccine licensed through age 12 year was administered to a 16 year old child. No adverse effects were experienced. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site mass, Vaccination 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 (HA #631139) and refers to a 23 year old female patient. She had no current illnesses. Her other medication included SPRINTEC. No medical history and prior vaccination details were reported. On 13-MAR-2016, the patient was vaccinated with GARDASIL 9, dose 3, intramuscular in the left arm for prophylaxis (strength and dosing details unknown). On 07-APR-2016, patient developed palpable 1-2 inch hardened lump in deltoid region of arm where vaccine was administered (left). Site was tender and painful. Noticed approximately 4 weeks following final dose in the 3 dose GARDASIL 9 vaccination series. The outcome of injection site induration, injection site pain and injection site mass was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Headache, Loss of consciousness, Presyncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #632269) and refers to a 13 year old female patient. Patient's current illnesses, medical history and lab data was reported as none. No details about other medication and prior vaccination was provided. On 18-APR-2016, the patient was vaccinated with GARDASIL 9, lot # L020015, dose 3, intramuscularly in the right arm for prophylaxis (strength and dosing detail unknown). On 19-APR-2016, one day after vaccination, patient said she got dizzy, lightheaded and passed out at school. The events required emergency room visit. Her Doctor examined and stated she had vasovagal attack and possible reaction to vaccine. On 20-APR-2016, in the morning (AM), she had headache. The outcome of dizziness, presyncope, loss of consciousness and headache was reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blood pressure decreased, Cold sweat, Pallor, Syncope
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #632534) and refers to a 11 year old male patient. His current illnesses and lab data were reported as none. Patients medical history included allergy and Attention Deficit/Hyperactivity Disorder and historical drug included INTUNIV ER. His other medication included VYVANSE. On 22-APR-2016, the patient was vaccinated with GARDASIL 9, lot # L043213, dose 1, via unknown route in the left arm for prophylaxis (strength and dosing details unknown). Other suspect therapy included vaccination with MENACTRA. On 22-APR-2016, the patient experienced syncope, cool clammy skin, pale, drop in blood pressure. The patient was transported to emergency room by monitoring vitals and with elevated feet. The outcome of the events were reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain upper, Dysgeusia, Hypophagia, Influenza A virus test negative, Influenza B virus test
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# 635211) and refers to a 11 year old female patient. Her current illnesses were reported as none. No details about medical history and prior vaccination was provided. Other medication included Loratadine prn. On 05-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L043213, dose 1, intramuscularly in the right arm for prophylaxis (strength and dosing details unknown). Other suspect therapy included vaccination with MENVEO. On 05-MAY-2016, patient experienced decreased po, fever up to 101 (unit unknown), stomach ache and body aches. Her mouth had salt water taste. The events required the patient for emergency room visit. On 06-MAY-2016, Influenza A and B test was performed and the result was negative. The outcome of events were unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Influenza virus test negative, Pain, 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 (Agency# 635211) and refers to a 11 year old female patient. Her current illnesses were reported as none. No details about medical history and prior vaccination was provided. Other medication included Loratadine prn. On 05-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L043213, dose 1, intramuscularly in the right arm for prophylaxis (strength and dosing details unknown). Other suspect therapy included vaccination with MENVEO. On 05-MAY-2016, patient experienced decreased po, fever up to 101 (unit unknown), stomach ache and body aches. Her mouth had salt water taste. The events required the patient for emergency room visit. On 06-MAY-2016, Influenza A and B test was performed and the result was negative. The outcome of events were unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Blood test, Deep vein thrombosis, Ultrasound Doppler
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 (HA #635286) and refers to a 13 year old female patient with no acute illness. The patient's medical history included cerebral palsy, Encephalopathy, seizure disorder and she was a premature baby of 30-35 weeks. Her other medications included CRYSELLE, MIRALAX, TOPAMAX, Clonidine, meloxicam and calcium. No details about prior vaccination was reported. On 01-SEP-2015, the patient was vaccinated with GARDASIL 9, lot # L000610, dose 2, intramuscularly in the left leg for prophylaxis (strength and dosing details unknown). Other suspect therapies included vaccination with FLUZONE intramuscularly in the right leg for prophylaxis. On 21-JAN-2016, the patient was seen in emergency room for DVT (deep venous thrombosis) in left leg. Deep venous thrombosis was seen in the left lower extremity from common femoral through femoral vein, including saphenous vein. It was possibly related to an unspecified contraceptive use. COUMADIN was prescribed. On 21JAN-2016, the patient underwent blood work and Venous duplex scan (Ultrasound Doppler) and results were not reported. The outcome of the events were reported as recovered/resolved. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Limb 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 (HA #637191) and refers to a 11 year old female patient. Her medical history included Asthma and Allergic rhinitis. No details about current illnesses, lab data, prior vaccination and other medications were provided. On an unknown date the patient was vaccinated with GARDASIL 9, lot # L043213, dose 1, intramuscularly in the left arm for prophylaxis (strength and dosing details unknown). Other suspect therapies included MENACTRA and ADACEL. On an unknown date the patient experienced mid left upper arm swelling, mild erythema and warmth. There was no pain and the arm felt a bit heavy and uncomfortable. No violaceous discoloration was seen. Sites of immunization were normal. The outcome of injection site erythema, limb discomfort, injection site warmth and injection site swelling was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (HA #640206) and refers to a 11 year old male patient. The patient's medical history included Amoxicillin allergy, attention deficit/hyperactivity disorder (ADHD) and anxiety. His other medications included methylphenidate 30 MG CR capsule; ZOLOFT 50 MG tablet; CHILDRENS MULTIVITAMIN PO. Patient's lab data and current illnesses were reported as none and no details about prior vaccination was provided. On 16-MAY-2016, the patient was vaccinated with GARDASIL 9, lot # L048459, dose 4, intramuscularly in the left arm for prophylaxis (strength and dosing details unknown). On 17-MAY-2016, the morning after getting vaccine the patient vomited twice. The outcome of vomiting was unknown. Causality assessment was not provided. Additional information is not expected as no follow-up can be requested from local health authority.
Sex: F
Vaccine: HPV9, MMR, TDAP
Symptoms: Injection site erythema
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 # 666655) on 02-MAY-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient had no other medications, current illnesses, medical history and the prior vaccinations was not reported. On 14-NOV-2016, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, in the right arm, lot # M018810, (dose, frequency and expiration date was not reported) and with a third dose of M-M-R II intramuscularly in the left arm, lot # M014902, (dose, frequency and expiration date were not reported) for prophylaxis. Other suspect therapies included BOOSTRIX (dose number: 1, vaccinated date: 14-NOV-2016, intramuscularly in the left arm, lot # LZ972; dose and expiration date unknown). On 16-NOV-2016, the patient had 6.5 cm red area at the site of BOOSTRIX with no fever. The patient was prescribed to take BENADRYL and had a follow up (f/u) on 17-NOV-2016. The outcome of injection site erythema 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: FLU4, HPV9
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency# 669483). Information was received regarding a 13 year old male patient. The patient's medical history was not reported. On 02-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (Strength, dose, frequency and expiration date were not reported) of lot# M028323 in the left arm, intramuscularly for prophylaxis. Other suspect therapy included FLUZONE QUADRIVALENT vaccine. There were no concomitant therapies reported. On the same day, the patient experienced dizziness and immediate post-injection reaction. Immediately after receiving GARDASIL 9 and FLUZONE QUADRIVALENT vaccines, the patient began to feel dizzy and laid down for ten minutes, drank some juice and ate a protein bar. The patient's vital signs were checked. Once, the patient felt better, he left with his mother. The outcome of the events, dizziness and immediate post-injection reaction was reported to be recovered/resolved. The causal relationship between the suspect therapy, GARDASIL 9 and the events was not reported. Additional information is not expected as no further information could be obtained from the regulatory authority.
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Pallor, Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency#). Information was received regarding a 15 year old male patient. The patient's medical history were not reported. On 29-NOV-2016, the patient was vaccinated with the third dose of GARDASIL 9 (Strength, dose, frequency and expiration date were not reported) of lot# M028323 in the left arm, intramuscularly for prophylaxis. There were no concomitant therapies reported. On 30-NOV-2016, the patient experienced dyskinesia, pallor and was unresponsive to stimuli. The outcome of the events, dyskinesia, pallor and unresponsive to stimuli was reported to be recovered/resolved. The causal relationship between the suspect therapy, GARDASIL 9 and the events was not reported. Additional information is not expected as no further information could be obtained from the regulatory authority.
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Altered state of consciousness, Asthenia, Hyperhidrosis
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 concerning a 14 year old female patient. The patient had no pertinent medical history and current illnesses. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On 18-NOV-2016, the patient was intramuscularly vaccinated with a second dose of GARDASIL 9 in the left arm, lot # M014929 (expiration date was not reported), for prophylaxis. Other suspect therapies included a first dose of MENVEO administered intramuscularly, in right arm, lot M16014 (expiration date was not reported) on the same day. On 18-NOV-2016, the patient became weak, diaphoretic and almost passed out. The patient was assisted to the laying position. Vitals were taken, juice was offered but the patient declined because she just had a smoothie. The outcome of the events was reported as recovered. The relatedness between the events and the suspect therapies was not reported. Additional information is not expected, as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, TDAP
Symptoms: Diarrhoea, 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 # 674553) on 10-MAY-2017. This spontaneous report refers to a 13 year old male patient. The patient's drug allergies included allergic to ibuprofen. There were no concurrent illnesses. On 22-DEC-2016, the patient was vaccinated with GARDASIL 9 (lot# M026306) dose 1, intramuscularly (IM) in the right arm, VAQTA (lot# M022924) dose 1, intramuscularly in the left arm, ADACEL (lot# U5278AA) dose 1, intramuscularly in the left arm, MENACTRA (lot# U5415AA) dose 1, intramuscularly in the right arm and FLUZONE (lot# UT5686MA), intramuscularly in the left arm for prophylaxis. On the same day, the patient had diarrhoea, vomiting and pyrexia. Later, the patient had an emergency visit. At the time of this report, the outcome of diarrhoea, vomiting and pyrexia was unknown. The causality of diarrhoea, vomiting and pyrexia with respect to GARDASIL 9, VAQTA, ADACEL, MENACTRA and FLUZONE was not reported. Additional information is not expected as follow up information cannot be obtained from the Agency.
Age: 17.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Chest discomfort, Chest pain, Injection site pruritus, Pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 679890) refers to a 17 years old male patient. The patient had no medical history and concurrent conditions. On 14-OCT-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # L037554, expiry date not provided) intramuscular in the left arm for prophylaxis. Other suspect therapies included MENACTRA, HAVRIX, ENGERIX-B and FLUARIX. On 15-OCT-2016, the patient experienced paraesthesia and urticaria. The outcome of the events was reported as recovered. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 17.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Paraesthesia, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 679890) refers to a 17 years old male patient. The patient had no medical history and concurrent conditions. On 14-OCT-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # L037554, expiry date not provided) intramuscular in the left arm for prophylaxis. Other suspect therapies included MENACTRA, HAVRIX, ENGERIX-B and FLUARIX. On 15-OCT-2016, the patient experienced paraesthesia and urticaria. The outcome of the events was reported as recovered. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 17.0
Sex: M
Vaccine: HPV9, FLU4, HEP, HEPA, HPV9, MNQ, FLU4, HEP, HEPA, HPV9, MNQ, HPV9
Symptoms: Chest discomfort, Chest pain, Injection site pruritus
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 679890) refers to a 17 years old male patient. The patient had no medical history and concurrent conditions. On 14-OCT-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # L037554, expiry date not provided) intramuscular in the left arm for prophylaxis. Other suspect therapies included MENACTRA, HAVRIX, ENGERIX-B and FLUARIX. On 15-OCT-2016, the patient experienced paraesthesia and urticaria. The outcome of the events was reported as recovered. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, FLU4, HPV9, MNQ
Symptoms: Loss of consciousness, Muscle twitching
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 677464) refers to a 19 years old female patient. The patient had no medical history and concurrent conditions. On 01-JAN-2017 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M007764, expiry date not provided) intramuscular in the left arm for prophylaxis. Other suspect therapies included FLUARIX and MENACTRA. No concomitant medications were reported. On 09-AUG-2017, the patient experienced loss of consciousness and muscle twitching. Relevant laboratory/diagnostic tests included: Her vital signs were checked BP 11/66 P 56 bpm. Other Medications included lorazepam and citalopram. The outcome of the events was reported as  recovered. The agency did not provide the causality assessment for the event.   Additional information is not expected since no further information can be obtained from the regulatory authority.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site reaction, Muscle swelling, Myosclerosis
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 # 677730) on 10-MAY-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old male patient.  The patient's medical history included migraines and he did not have any current illness. On 06-JAN-2017 the patient was vaccinated with GARDASIL 9 lot # M030380, intramuscular in the left arm for prophylaxis. On the same day (approximately 24 hours after vaccination), the patient noticed localized swelling within the muscle at the site of injection. There was notable absence of pain, redness, warmth or fever. There was palpable firmness deep within the muscle without any pain weakness or tenderness. He took ibuprofen at home and iced the area. He presented to the office on 11-JAN-2017 for routine check and was assessed by the physician assistant. No lab tests were performed however, area was still swollen. He has full range of motion (ROM) and no pain, tenderness or weakness was noted and there was no disability in the arm as well. Other medications included TREXIMET (it was not known when the last dose was administered). The outcome of injection site reaction, myosclerosis and muscle swelling was reported as not recovered/not resolved. The causality was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Helicobacter test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 679465) refers to a 11 years old male patient. The patient had no medical history and concurrent conditions. On 25-AUG-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M009378, expiry date not provided) intramuscular in the right arm for prophylaxis. Other suspect therapies included ADACEL and MENACTRA. No concomitant medications were reported. On 26-AUG-2016, the patient experienced abdominal pain, vomiting, red blood cell sedimentation rate normal, nausea, metabolic function test normal, helicobacter test, full blood count normal, C-reactive protein normal and antinuclear antibody negative. On 26-OCT-2016, the patient was vaccinated with 2nd dose of GARDASIL 9 (dose, lot # and expiry date was not reported) and the events became more frequent. Relevant laboratory/diagnostic tests included: CBC; CMP; ANA; ESR; CRP; H pylori and Breath test were negative. It was reported that the patient tried ZANTAC to diet modification without help. Other Medications included FLONASE; ALLEGRA. The outcome of the events was reported as not recovered/not resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Metabolic function test normal, Nausea, Red blood cell sedimentation rate normal, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 679465) refers to a 11 years old male patient. The patient had no medical history and concurrent conditions. On 25-AUG-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M009378, expiry date not provided) intramuscular in the right arm for prophylaxis. Other suspect therapies included ADACEL and MENACTRA. No concomitant medications were reported. On 26-AUG-2016, the patient experienced abdominal pain, vomiting, red blood cell sedimentation rate normal, nausea, metabolic function test normal, helicobacter test, full blood count normal, C-reactive protein normal and antinuclear antibody negative. On 26-OCT-2016, the patient was vaccinated with 2nd dose of GARDASIL 9 (dose, lot # and expiry date was not reported) and the events became more frequent. Relevant laboratory/diagnostic tests included: CBC; CMP; ANA; ESR; CRP; H pylori and Breath test were negative. It was reported that the patient tried ZANTAC to diet modification without help. Other Medications included FLONASE; ALLEGRA. The outcome of the events was reported as not recovered/not resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Helicobacter test negative
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 679465) refers to a 11 years old male patient. The patient had no medical history and concurrent conditions. On 25-AUG-2016 the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M009378, expiry date not provided) intramuscular in the right arm for prophylaxis. Other suspect therapies included ADACEL and MENACTRA. No concomitant medications were reported. On 26-AUG-2016, the patient experienced abdominal pain, vomiting, red blood cell sedimentation rate normal, nausea, metabolic function test normal, helicobacter test, full blood count normal, C-reactive protein normal and antinuclear antibody negative. On 26-OCT-2016, the patient was vaccinated with 2nd dose of GARDASIL 9 (dose, lot # and expiry date was not reported) and the events became more frequent. Relevant laboratory/diagnostic tests included: CBC; CMP; ANA; ESR; CRP; H pylori and Breath test were negative. It was reported that the patient tried ZANTAC to diet modification without help. Other Medications included FLONASE; ALLEGRA. The outcome of the events was reported as not recovered/not resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Arthralgia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) refers to a 11 years old female patient. The patient had no medical history and concurrent conditions. On 20-JAN-2017, the patient was vaccinated with 1st dose of GARDASIL 9 (lot # M023169, expiry date not provided) intramuscular for prophylaxis. Other suspect therapies included MENVEO (lot: M16076) and BOOSTRIX (lot: 7RJ9B). On 22-JAN-2017, the patient experienced arthralgia and received ibuprofen as treatment. The outcome of the event was reported as unknown. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, HPV9, MNQ
Symptoms: Injection site rash
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (Food and Drug Administration) under the Freedom of Information Act (FOI) (Agency # 681457) refers to a 11 years old female patient. The patient had no medical history and concurrent conditions. On an unknown date, the patient was vaccinated with 1st dose of GARDASIL 9 and on 31-JAN-2017, the patient was vaccinated with 2nd dose of GARDASIL 9 (lot # M024261, expiry date not provided) intramuscular in the left arm for prophylaxis. Other suspect therapies included MENVEO. Other medication included VYVANSE. On 01-FEB-2017, the patient experienced injection site rash and had an emergency visit. The outcome of the event was reported as not recovered/not resolved. The agency did not provide the causality assessment for the event. Additional information is not expected since no further information can be obtained from the regulatory authority.
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act concerning a 25 year old female patient. The patient had no pertinent medical history and current illnesses. No information regarding the patient's drug reactions or allergies and concomitant therapies was provided. On 06-FEB-2017, the patient was intramuscularly vaccinated with a second dose of GARDASIL 9 in the left arm, lot # M030380 (dose and expiration date was not reported), for prophylaxis. On the same day, the patient experienced itching and hives. The outcome of the events of itching and hives was unknown. The relatedness between the events of itching and hives and GARDASIL 9 was not reported. Additional information is not expected, as no further information can be obtained from the local regulatory authority.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Bradycardia, Dizziness, 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 concerning a 13 year old male patient. The patient's early and periodic screening diagnosis and treatment (EPSDT) check up visit was reported as well. No information regarding the patient's medical history was provided. The patient was not administered any concomitant medications. On 04-FEB-2017, the patient was vaccinated with a second dose of GARDASIL 9 in the right arm (dose, route of administration, lot# and expiration date was not reported), for prophylaxis. Subsequently, after the vaccine administration, the patient had bradycardia, was seeing black and was dizzy. No lab diagnostic studies were performed. The outcome of the events of bradycardia, visual impairment and dizziness was reported as recovered on an unknown date in 2017. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected, as no further information can be obtained from the local regulatory authority.