chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Depressed level of consciousness, Feeling abnormal, Injection site reaction, Local reaction, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 585807) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old female patient. Patient had no pertinent medical history and current illnesses. Other medications and prior vaccinations were not reported. On 10-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # K026247 dose 1, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENVEO dose number: 1, (vaccinated date: 10-JUL-2015, intramuscularly in the right arm, lot# A15009; dose and expiration date unknown) and BOOSTRIX dose number: 1, (vaccinated date: 10-JUL-2015, intramuscularly in the right arm, lot# 2224P; dose and expiration date unknown). Patient stated she did not feel good, the color drained from her face and she almost passed out. On 10-JUL-2015, the patient experienced feeling abnormal, pallor, loss of consciousness, local reaction and injection site reaction. The outcome of feeling abnormal, pallor, loss of consciousness, local reaction and injection site reaction were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Abdominal discomfort, Abdominal pain, Arthralgia, Asthenia, Autoimmune disorder
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: 586144) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old male patient. Patient had no pertinent medical history and current illnesses. Other medications and prior vaccinations were not reported. On 15-APR-2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis. Other suspect therapies included hepatitis a virus vaccine (+) hepatitis b virus vaccine (manufacturer unknown) (site : left arm). On 16-APR-2015, the patient experienced abdominal discomfort, weight decreased, tremor, syncope, skin disorder, seizure like phenomena, pain, myalgia, muscular weakness, inflammation, head discomfort,  fatigue, chest pain, blood test normal, autoimmune disorder, asthenia, arthralgia, activities of daily living impaired and abdominal pain and required an emergency visit. Lab data: Bloodwork came back generally normal and diagnosis was difficult. Doctor thought that there was autoimmune response to Gardasil vaccine causing unexplained pain or inflammation. Checked permanently disabled because till date day to day activities have proved nearly impossible and reaction is debilitating. The outcome of abdominal discomfort, weight decreased, tremor, syncope, skin disorder, seizure like phenomena, pain, myalgia, muscular weakness, inflammation, head discomfort, fatigue, chest pain, blood test normal, autoimmune disorder, asthenia, arthralgia, activities of daily living impaired and abdominal pain was reported as not recovered. Causality was not reported. The Agency considered the case to be serious due to disabling. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Blood test normal, Chest pain, Fatigue, Head discomfort, Inflammation
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: 586144) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old male patient. Patient had no pertinent medical history and current illnesses. Other medications and prior vaccinations were not reported. On 15-APR-2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis. Other suspect therapies included hepatitis a virus vaccine (+) hepatitis b virus vaccine (manufacturer unknown) (site : left arm). On 16-APR-2015, the patient experienced abdominal discomfort, weight decreased, tremor, syncope, skin disorder, seizure like phenomena, pain, myalgia, muscular weakness, inflammation, head discomfort,  fatigue, chest pain, blood test normal, autoimmune disorder, asthenia, arthralgia, activities of daily living impaired and abdominal pain and required an emergency visit. Lab data: Bloodwork came back generally normal and diagnosis was difficult. Doctor thought that there was autoimmune response to Gardasil vaccine causing unexplained pain or inflammation. Checked permanently disabled because till date day to day activities have proved nearly impossible and reaction is debilitating. The outcome of abdominal discomfort, weight decreased, tremor, syncope, skin disorder, seizure like phenomena, pain, myalgia, muscular weakness, inflammation, head discomfort, fatigue, chest pain, blood test normal, autoimmune disorder, asthenia, arthralgia, activities of daily living impaired and abdominal pain was reported as not recovered. Causality was not reported. The Agency considered the case to be serious due to disabling. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Myalgia, Pain, Seizure like phenomena
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID: 586144) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old male patient. Patient had no pertinent medical history and current illnesses. Other medications and prior vaccinations were not reported. On 15-APR-2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis. Other suspect therapies included hepatitis a virus vaccine (+) hepatitis b virus vaccine (manufacturer unknown) (site : left arm). On 16-APR-2015, the patient experienced abdominal discomfort, weight decreased, tremor, syncope, skin disorder, seizure like phenomena, pain, myalgia, muscular weakness, inflammation, head discomfort,  fatigue, chest pain, blood test normal, autoimmune disorder, asthenia, arthralgia, activities of daily living impaired and abdominal pain and required an emergency visit. Lab data: Bloodwork came back generally normal and diagnosis was difficult. Doctor thought that there was autoimmune response to Gardasil vaccine causing unexplained pain or inflammation. Checked permanently disabled because till date day to day activities have proved nearly impossible and reaction is debilitating. The outcome of abdominal discomfort, weight decreased, tremor, syncope, skin disorder, seizure like phenomena, pain, myalgia, muscular weakness, inflammation, head discomfort, fatigue, chest pain, blood test normal, autoimmune disorder, asthenia, arthralgia, activities of daily living impaired and abdominal pain was reported as not recovered. Causality was not reported. The Agency considered the case to be serious due to disabling. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Skin disorder, Syncope, Tremor, Weight decreased
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: 586144) on 04-APR-2017. This spontaneous report was received from a regulatory authority concerning a 18 year old male patient. Patient had no pertinent medical history and current illnesses. Other medications and prior vaccinations were not reported. On 15-APR-2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis. Other suspect therapies included hepatitis a virus vaccine (+) hepatitis b virus vaccine (manufacturer unknown) (site : left arm). On 16-APR-2015, the patient experienced abdominal discomfort, weight decreased, tremor, syncope, skin disorder, seizure like phenomena, pain, myalgia, muscular weakness, inflammation, head discomfort,  fatigue, chest pain, blood test normal, autoimmune disorder, asthenia, arthralgia, activities of daily living impaired and abdominal pain and required an emergency visit. Lab data: Bloodwork came back generally normal and diagnosis was difficult. Doctor thought that there was autoimmune response to Gardasil vaccine causing unexplained pain or inflammation. Checked permanently disabled because till date day to day activities have proved nearly impossible and reaction is debilitating. The outcome of abdominal discomfort, weight decreased, tremor, syncope, skin disorder, seizure like phenomena, pain, myalgia, muscular weakness, inflammation, head discomfort, fatigue, chest pain, blood test normal, autoimmune disorder, asthenia, arthralgia, activities of daily living impaired and abdominal pain was reported as not recovered. Causality was not reported. The Agency considered the case to be serious due to disabling. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, 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 # 588336) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 12 year old male patient. The patient's other medication and concurrent illness were not reported. Patient's pertinent medical history included ODD, ADD (Attention deficit/hyperactivity disorder) and behavioral disorder. On 28-JUL-2015, the patient was vaccinated with first dose of GARDASIL 9 lot/batch# K011562, intramuscularly in the left arm (dose, frequency and expiration date were not provided) for prophylaxis. On 28-JUL-2015, within 15 minutes of injection, patient had complaint of numbness over suprasternal area then had pain. Patient's VS remained normal and physical exam. Didn't resolve after 1 hour sent to ED. The patient required emergency room visit. The outcome of events hypoaesthesia and pain was unknown. Causality assessment for the events hypoaesthesia and pain with respect to GARDASIL 9 was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Seizure
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589302) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 26 year old female patient. The patient's other medications was not provided. Patient's pertinent medical history and concurrent illness were reported as no documentation noted. On 08-JUN-2015, the patient was vaccinated with first dose GARDASIL 9, lot # K026246, intramuscularly in the left arm (dose, frequency and expiration date were not provided), for prophylaxis. Patient did not have any allergic reaction in the office. Patient left and went to the bus stop and experienced a seizure on 08-JUN-2015. Patient had a follow up with neurology department, they could not conifirm if the event was due to the vaccine. The patient required emergency room visit. The outcome of seizure was reported as recovered. Causality assessment for the event seizure with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 589600). This spontaneous report refers to an 11 year old male patient. The patient had no concurrent illnesses and medical history. The patient's other medications included VENTOLIN HFA 90 mcg PRN. On 11-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9 lot # L007495, intramuscularly in the right leg for prophylaxis. On 11-AUG-2015, the patient was vaccinated with first dose of MENACTRA, intramuscularly (lot# U15172AA) in the right leg and BOOSTRIX intramuscularly in the left leg (lot# 95L3P). On 11-AUG-2015, the patient experienced nausea, pallor and lightheaded dizziness. Blood pressure was 96/42, fluids and snack were given in the office. BP rechecked in 15 minutes was 100/62. The outcome of nausea, pallor and dizziness were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9
Symptoms: Blood test normal, Confusional state, 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 # 590151). This spontaneous report refers to a 15 year old male patient. The patient had no concurrent illnesses and medical history. The patient had no other medications. The physician misinformed that HPV vaccine was required for school. On 11-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 dose 1, batch # k026248, intramuscularly in the right arm for prophylaxis. On 14-AUG-2015, the patient experienced pyrexia, had high fever between 102 to 105 F for over 2 days and vomited a few times. The patient's blood test was normal. The patient was taken to the emergency room (ER) on 16-AUG-2015. The patient was in confusional state in the morning of 17-AUG-2015 and an ambulance was called. The outcome of blood test normal, vomiting, pyrexia and confusional state were reported as not recovered. The causality assessments for the events blood test normal, vomiting, pyrexia and confusional state with respect to GARDASIL 9 was not provided by the reporter. Agency consider the events to be life threatening. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Fall, Heart rate decreased, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 590410). This spontaneous report refers to a 11 year old male patient. Information on the patient's concurrent illnesses, medical history and other medications were not reported. On 13-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # L004014, dose 1, intramuscular in the right arm for prophylaxis (dosage and expiry date unspecified) and on the same day, the patient was also vaccinated with MENVEO batch # A15016, dose 1, intramuscular in the left arm for prophylaxis (dosage and expiry date unspecified). On 13-AUG-2015, after administration of the vaccine, the patient experienced pallor, decreased heart rate and fall. The patient looked pale and began falling forward. The patient was placed on an exam table with legs extended for 3-4 seconds. The patient received medical attention from the physician after 2-3 seconds. The patient's heart rate dropped to 40-50 beats per minute after 5-7 seconds. Heart rate and breathing was normal after 10-15 seconds. The patient was alert and responding through the whole incident. The patient was given pedialyte with no problems. After 5 minutes the patient was sitting up and after 10 minutes the patient left. The outcome of heart rate decreased, fall and pallor was unknown. The causality assessment for the events heart rate decreased, fall and pallor with respect to GARDASIL 9 was not provided by the reporter. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: 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 # 591208). This spontaneous report refers to a 16 year old female patient. Information on patient's medical history, other medications and prior vaccinations were not reported. The patient had no concurrent illnesses. On 10-AUG-2015, the patient was vaccinated with GARDASIL 9 lot # K026246, dose 2, intramuscular in the right arm for prophylaxis and on the same day, the patient was also vaccinated with MENVEO batch # A14120, dose 2, intramuscular in the left arm for prophylaxis. On 15-AUG-2015, 5 days after receiving GARDASIL 9, the patient experienced injection site pain (soreness in the right deltoid muscle). The outcome of injection site pain was reported as not recovered. The causality assessment for the event injection site pain 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: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Vaccination site abscess, Vaccination site warmth
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591322) on 04-APR-2017. This spontaneous report was received from a regulatory authority refers to a 22 year old female patient. The patient had no concurrent illness. The patient's pertinent medical history were reported as none. On 19-AUG-2015, the patient was vaccinated with the second dose of GARDASIL 9 lot # L000610, intramuscular in the right arm (dose and frequency were not reported) for prophylaxis. Concomitant therapies included DEPO-PROVERA. On 21-AUG-2015, 3 days after onset of therapy the vaccine site was red, hot and had abscess under the skin. Patient had received GARDASIL 9 previously but never had this response. The outcome of events injection site erythema, vaccination site warmth and vaccination site abscess was unknown. Causality assessment for the events site erythema, vaccination site warmth and vaccination site abscess with respect to GARDASIL 9 was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Computerised tomogram head normal, Fall, Head injury, Laceration, Loss of consciousness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591580) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 15 year old female patient. The patient's medical history included acne and seizure disorder. Patient had no current illnesses. Prior vaccinations were not reported. On 31-JUL-2015, the patient was vaccinated with GARDASIL 9 lot # L014198, intramuscularly in the left arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Concomitant therapies included doxycycline (manufacturer unknown), tretinoin (manufacturer unknown) and sulfacetamide (manufacturer unknown). Patient developed loss of consciousness within a minute of vaccine administration and resulted in fall from exam table and hit the head and had lacerations. Lab data reveal that the patient underwent a CT scan for brain and the results were normal. On 31-JUL-2015, patient underwent computerised tomogram head normal, developed loss of consciousness, laceration, head injury and also had a fall which required an ER visit. The outcome of computerised tomogram head normal, loss of consciousness, laceration, head injury and fall were reported as recovered/resolved. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: HPV9
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Lip 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 # 591612) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 11 year old female patient with prophylaxis. The patient's, concurrent illness, other medications, medical history and prior vaccinations were not reported. On 07-AUG-2015, the patient was vaccinated with GARDASIL 9 (route of administration and site was reported as unknown) (dose, frequency and lot number and expiration date were not reported) for prophylaxis. And on the same day, the patient experienced arm pain (also reported as pain in extremity), numbness of neck, mouth, cheek (also reported as hypoaesthesia) and swollen lip on left side. The outcome of hypoaesthesia, pain in extremity and lip swelling was reported as recovered. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Induration, Rash, Rash erythematous, 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 # 591723) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 12 year old male patient with prophylaxis. The patient's other medications included FLONASE. The patient's current illness included nasal congestion. The patient's medical history and prior vaccinations was not reported. On 25-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the right arm, lot # L011846 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 5, vaccinated date: 25-AUG-2015, intramuscularly in the left arm, lot# C4690BA; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 25-AUG-2015, intramuscularly in the left arm, lot# U5185BA; dose and expiration date unknown). On 26-AUG-2015, the patient experienced left arm red, indurated 4 cm diameter red rash on arm and urticaria on forearms and legs. On an unknown date the patient underwent emergency room (ER) visit. The outcome of erythema, urticaria, rash erythematous and induration was reported as unknown. Causality assessment was not reported. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Aphasia, Confusional state, Disorientation, Pyrexia, 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 # 591845) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 18 year old male patient with prophylaxis. The patient's other medications, concurrent illness and patient's medical history were not reported. On 29-JUL-2015, the patient was vaccinated with the second dose of GARDASIL 9 lot # L011846 (route of administration and site was reported as unknown) (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 29-JUL-2015, lot# U4923BA; route of administration, site, dose and lot expiration date was reported as unknown).  Patient started having fever with a temperature of 100.8 at 8pm and was shaking. The patient was given ADVIL, he went to sleep and woke up at 1 am on 29-JUL-2015 shaking even more with a temperature of 101.2. After 10 min the patient did not respond, couldn't talk and then patient was taken to the emergency, his fever reached 104 degrees, the patient was confused and he didn't know his name, where he was and he was not recognizing anyone. He recovered around 4:30 am. The outcome of aphasia, unresponsive to stimuli, tremor, pyrexia, disorientation and confusional state was reported as recovered. Lab tests performed were reported as normal. Additional information is not expected from the Agency as follow up information cannot be obtained.
Age: 18.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Unresponsive to stimuli
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 591845) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to an 18 year old male patient with prophylaxis. The patient's other medications, concurrent illness and patient's medical history were not reported. On 29-JUL-2015, the patient was vaccinated with the second dose of GARDASIL 9 lot # L011846 (route of administration and site was reported as unknown) (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included MENACTRA (dose number: 1, vaccinated date: 29-JUL-2015, lot# U4923BA; route of administration, site, dose and lot expiration date was reported as unknown).  Patient started having fever with a temperature of 100.8 at 8pm and was shaking. The patient was given ADVIL, he went to sleep and woke up at 1 am on 29-JUL-2015 shaking even more with a temperature of 101.2. After 10 min the patient did not respond, couldn't talk and then patient was taken to the emergency, his fever reached 104 degrees, the patient was confused and he didn't know his name, where he was and he was not recognizing anyone. He recovered around 4:30 am. The outcome of aphasia, unresponsive to stimuli, tremor, pyrexia, disorientation and confusional state was reported as recovered. Lab tests performed were reported as normal. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain, Alanine aminotransferase increased, Arthritis, Aspartate aminotransferase increased, C-reactive protein increased
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 # 595747) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concomitant therapies, concurrent illness, other medications and medical history were not reported. The patient had joint problems when he was 4 years old starting about 10 days of DTAP was given on 22-JUL-2008 and the joint symptoms were resolved after 5-6 months and the patient had no problems in between. On 01-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 01-AUG-2015, intramuscularly in the right arm, lot# C4690BA; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 01-AUG-2015, intramuscularly in the right arm, lot# U5155AA; dose and expiration date unknown). On 11-AUG-2015, the patient had reactivation of arthritis with foot pain, knee effusion, chills, fever (also reported as pyrexia), myalgia, abdominal pain, weight loss (also reported as weight decreased), serum ferritin increased, red blood cell sedimentation rate increased, prothrombin time prolonged, pain in extremity, the patient condition was aggravated, C-reactive protein increased, joint fluid was drained, alanine aminotransferase, aspartate aminotransferase increased. On 20-AUG-2015 CRP (C-reactive protein) was 24.87, ESR (erythrocyte sedimentation rate) was 63, ferritin was high, elevated protime, slightly elevated ALT (alanine aminotransferase) and AST (aspartate aminotransferase). On 01-SEP-2015 the patient was hospitalized with abdominal pain overnight. The patient was seen in rheumatology and knee effusion was drained. The outcome of the events abdominal pain, alanine aminotransferase increased, arthritis, aspartate aminotransferase increased, C-reactive protein increased, chills, condition aggravated, joint effusion, joint fluid drainage, myalgia, pain in extremity, prothrombin time prolonged, pyrexia, red blood cell sedimentation rate increased, serum ferritin increased and weight decreased was reported as not recovered. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Chills, Condition aggravated, Joint effusion, Joint fluid drainage, Myalgia
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 # 595747) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concomitant therapies, concurrent illness, other medications and medical history were not reported. The patient had joint problems when he was 4 years old starting about 10 days of DTAP was given on 22-JUL-2008 and the joint symptoms were resolved after 5-6 months and the patient had no problems in between. On 01-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 01-AUG-2015, intramuscularly in the right arm, lot# C4690BA; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 01-AUG-2015, intramuscularly in the right arm, lot# U5155AA; dose and expiration date unknown). On 11-AUG-2015, the patient had reactivation of arthritis with foot pain, knee effusion, chills, fever (also reported as pyrexia), myalgia, abdominal pain, weight loss (also reported as weight decreased), serum ferritin increased, red blood cell sedimentation rate increased, prothrombin time prolonged, pain in extremity, the patient condition was aggravated, C-reactive protein increased, joint fluid was drained, alanine aminotransferase, aspartate aminotransferase increased. On 20-AUG-2015 CRP (C-reactive protein) was 24.87, ESR (erythrocyte sedimentation rate) was 63, ferritin was high, elevated protime, slightly elevated ALT (alanine aminotransferase) and AST (aspartate aminotransferase). On 01-SEP-2015 the patient was hospitalized with abdominal pain overnight. The patient was seen in rheumatology and knee effusion was drained. The outcome of the events abdominal pain, alanine aminotransferase increased, arthritis, aspartate aminotransferase increased, C-reactive protein increased, chills, condition aggravated, joint effusion, joint fluid drainage, myalgia, pain in extremity, prothrombin time prolonged, pyrexia, red blood cell sedimentation rate increased, serum ferritin increased and weight decreased was reported as not recovered. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Pain in extremity, Prothrombin time prolonged, Pyrexia, Red blood cell sedimentation rate increased, Serum ferritin increased
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 # 595747) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concomitant therapies, concurrent illness, other medications and medical history were not reported. The patient had joint problems when he was 4 years old starting about 10 days of DTAP was given on 22-JUL-2008 and the joint symptoms were resolved after 5-6 months and the patient had no problems in between. On 01-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 01-AUG-2015, intramuscularly in the right arm, lot# C4690BA; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 01-AUG-2015, intramuscularly in the right arm, lot# U5155AA; dose and expiration date unknown). On 11-AUG-2015, the patient had reactivation of arthritis with foot pain, knee effusion, chills, fever (also reported as pyrexia), myalgia, abdominal pain, weight loss (also reported as weight decreased), serum ferritin increased, red blood cell sedimentation rate increased, prothrombin time prolonged, pain in extremity, the patient condition was aggravated, C-reactive protein increased, joint fluid was drained, alanine aminotransferase, aspartate aminotransferase increased. On 20-AUG-2015 CRP (C-reactive protein) was 24.87, ESR (erythrocyte sedimentation rate) was 63, ferritin was high, elevated protime, slightly elevated ALT (alanine aminotransferase) and AST (aspartate aminotransferase). On 01-SEP-2015 the patient was hospitalized with abdominal pain overnight. The patient was seen in rheumatology and knee effusion was drained. The outcome of the events abdominal pain, alanine aminotransferase increased, arthritis, aspartate aminotransferase increased, C-reactive protein increased, chills, condition aggravated, joint effusion, joint fluid drainage, myalgia, pain in extremity, prothrombin time prolonged, pyrexia, red blood cell sedimentation rate increased, serum ferritin increased and weight decreased was reported as not recovered. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Weight decreased
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 # 595747) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 11 year old male patient. The patient's concomitant therapies, concurrent illness, other medications and medical history were not reported. The patient had joint problems when he was 4 years old starting about 10 days of DTAP was given on 22-JUL-2008 and the joint symptoms were resolved after 5-6 months and the patient had no problems in between. On 01-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in the left arm, lot # K026247 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included ADACEL (dose number: 1, vaccinated date: 01-AUG-2015, intramuscularly in the right arm, lot# C4690BA; dose and expiration date unknown) and MENACTRA (dose number: 1, vaccinated date: 01-AUG-2015, intramuscularly in the right arm, lot# U5155AA; dose and expiration date unknown). On 11-AUG-2015, the patient had reactivation of arthritis with foot pain, knee effusion, chills, fever (also reported as pyrexia), myalgia, abdominal pain, weight loss (also reported as weight decreased), serum ferritin increased, red blood cell sedimentation rate increased, prothrombin time prolonged, pain in extremity, the patient condition was aggravated, C-reactive protein increased, joint fluid was drained, alanine aminotransferase, aspartate aminotransferase increased. On 20-AUG-2015 CRP (C-reactive protein) was 24.87, ESR (erythrocyte sedimentation rate) was 63, ferritin was high, elevated protime, slightly elevated ALT (alanine aminotransferase) and AST (aspartate aminotransferase). On 01-SEP-2015 the patient was hospitalized with abdominal pain overnight. The patient was seen in rheumatology and knee effusion was drained. The outcome of the events abdominal pain, alanine aminotransferase increased, arthritis, aspartate aminotransferase increased, C-reactive protein increased, chills, condition aggravated, joint effusion, joint fluid drainage, myalgia, pain in extremity, prothrombin time prolonged, pyrexia, red blood cell sedimentation rate increased, serum ferritin increased and weight decreased was reported as not recovered. Causality assessment was not reported. The agency considered the case to be serious due to hospitalization. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, TDAP
Symptoms: Aggression, Computerised tomogram head normal, Confusional state, Crying, Generalised tonic-clonic seizure
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 608421). This spontaneous report refers to a 20 year old female patient. The patient's other medications included SPRINTEC. On 29-OCT-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in right arm, lot # L004014 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUARIX and ADACEL given on same day intramuscularly in the left arm. Immediately after vaccinating with GARDASIL 9, the patient was not feeling well, then had approximately 10 seconds of generalized tonic-clonic seizure activity and became unresponsive to stimuli. The patient woke up about 30 seconds later in confusional state and was mildly combative (also reported as aggressive). The patient was diaphoretic with bad headache. The patient also experienced paraesthesia, malaise, immediate post-injection reaction, loss of consciousness, hyperhidrosis and crying. The patient's nuclear magnetic resonance imaging brain and computerised tomogram head was normal. Blood pressure was 160/94; P:88; Oxygen saturation: 84%. After drinking water and applying oxygen, the conditions were improved, blood pressure was 129/84; P:66; Oxygen saturation: 99%. The patient had tingling in hands, pounding H/A weepy and was confused. The patient was sent to emergency room. The outcome of aggression, unresponsive to stimuli, paraesthesia, nuclear magnetic resonance imaging brain normal, malaise, loss of consciousness, immediate post-injection reaction, hyperhidrosis, headache, generalised tonic-clonic seizure, crying, confusional state and computerised tomogram head normal was reported as unknown. Causality assessment was not provided. The agency considered the case to be serious as the patient was hospitalized due to the events aggression, unresponsive to stimuli, paraesthesia, nuclear magnetic resonance imaging brain normal, malaise, loss of consciousness, immediate post-injection reaction, hyperhidrosis, headache, generalised tonic-clonic seizure, crying, confusional state and computerised tomogram head normal. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, TDAP
Symptoms: Headache, Hyperhidrosis, Immediate post-injection reaction, Loss of consciousness, Malaise
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 # 608421). This spontaneous report refers to a 20 year old female patient. The patient's other medications included SPRINTEC. On 29-OCT-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in right arm, lot # L004014 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUARIX and ADACEL given on same day intramuscularly in the left arm. Immediately after vaccinating with GARDASIL 9, the patient was not feeling well, then had approximately 10 seconds of generalized tonic-clonic seizure activity and became unresponsive to stimuli. The patient woke up about 30 seconds later in confusional state and was mildly combative (also reported as aggressive). The patient was diaphoretic with bad headache. The patient also experienced paraesthesia, malaise, immediate post-injection reaction, loss of consciousness, hyperhidrosis and crying. The patient's nuclear magnetic resonance imaging brain and computerised tomogram head was normal. Blood pressure was 160/94; P:88; Oxygen saturation: 84%. After drinking water and applying oxygen, the conditions were improved, blood pressure was 129/84; P:66; Oxygen saturation: 99%. The patient had tingling in hands, pounding H/A weepy and was confused. The patient was sent to emergency room. The outcome of aggression, unresponsive to stimuli, paraesthesia, nuclear magnetic resonance imaging brain normal, malaise, loss of consciousness, immediate post-injection reaction, hyperhidrosis, headache, generalised tonic-clonic seizure, crying, confusional state and computerised tomogram head normal was reported as unknown. Causality assessment was not provided. The agency considered the case to be serious as the patient was hospitalized due to the events aggression, unresponsive to stimuli, paraesthesia, nuclear magnetic resonance imaging brain normal, malaise, loss of consciousness, immediate post-injection reaction, hyperhidrosis, headache, generalised tonic-clonic seizure, crying, confusional state and computerised tomogram head normal. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HPV9, TDAP
Symptoms: Nuclear magnetic resonance imaging brain normal, Paraesthesia, 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 # 608421). This spontaneous report refers to a 20 year old female patient. The patient's other medications included SPRINTEC. On 29-OCT-2015 the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly in right arm, lot # L004014 (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included FLUARIX and ADACEL given on same day intramuscularly in the left arm. Immediately after vaccinating with GARDASIL 9, the patient was not feeling well, then had approximately 10 seconds of generalized tonic-clonic seizure activity and became unresponsive to stimuli. The patient woke up about 30 seconds later in confusional state and was mildly combative (also reported as aggressive). The patient was diaphoretic with bad headache. The patient also experienced paraesthesia, malaise, immediate post-injection reaction, loss of consciousness, hyperhidrosis and crying. The patient's nuclear magnetic resonance imaging brain and computerised tomogram head was normal. Blood pressure was 160/94; P:88; Oxygen saturation: 84%. After drinking water and applying oxygen, the conditions were improved, blood pressure was 129/84; P:66; Oxygen saturation: 99%. The patient had tingling in hands, pounding H/A weepy and was confused. The patient was sent to emergency room. The outcome of aggression, unresponsive to stimuli, paraesthesia, nuclear magnetic resonance imaging brain normal, malaise, loss of consciousness, immediate post-injection reaction, hyperhidrosis, headache, generalised tonic-clonic seizure, crying, confusional state and computerised tomogram head normal was reported as unknown. Causality assessment was not provided. The agency considered the case to be serious as the patient was hospitalized due to the events aggression, unresponsive to stimuli, paraesthesia, nuclear magnetic resonance imaging brain normal, malaise, loss of consciousness, immediate post-injection reaction, hyperhidrosis, headache, generalised tonic-clonic seizure, crying, confusional state and computerised tomogram head normal. Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HEPA, HPV9
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Heart rate decreased, Pallor
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS # 611371) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient's concomitant therapies, concurrent illness and prior vaccinations were not reported. The patient's medical history included leber's congenital amaurosis and other medications included clonidine. On 19-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # L013429 dose 1, intramuscularly in the right arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included VAQTA (dose number: 1, vaccinated date: 19-NOV-2015, intramuscularly in the left arm, lot# L002717; dose and expiration date unknown) and FLUZONE (dose number: 1, vaccinated date: 19-NOV-2015, intramuscularly in the left arm, lot# UI443AD; dose and expiration date unknown). On 19-NOV-2015 the patient became lightheaded/pale/weak, heart rate dropped to 40's, blood pressure dropped to 64/40, vomited within 10 minutes, asthenia and dizziness. All the events have occurred within a few minutes before administration of vaccine. The outcome of asthenia, vomiting, pallor, heart rate decreased, dizziness and blood pressure decreased was reported as recovered/resolved. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.
Sex: F
Vaccine: FLU3, HEPA, 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 (VAERS # 611371) on 04-APR-2017. This spontaneous report as received from a regulatory authority refers to a 14 year old female patient. The patient's concomitant therapies, concurrent illness and prior vaccinations were not reported. The patient's medical history included leber's congenital amaurosis and other medications included clonidine. On 19-NOV-2015, the patient was vaccinated with GARDASIL 9 lot # L013429 dose 1, intramuscularly in the right arm (dose, frequency and lot expiration date were not reported) for prophylaxis. Other suspect therapies included VAQTA (dose number: 1, vaccinated date: 19-NOV-2015, intramuscularly in the left arm, lot# L002717; dose and expiration date unknown) and FLUZONE (dose number: 1, vaccinated date: 19-NOV-2015, intramuscularly in the left arm, lot# UI443AD; dose and expiration date unknown). On 19-NOV-2015 the patient became lightheaded/pale/weak, heart rate dropped to 40's, blood pressure dropped to 64/40, vomited within 10 minutes, asthenia and dizziness. All the events have occurred within a few minutes before administration of vaccine. The outcome of asthenia, vomiting, pallor, heart rate decreased, dizziness and blood pressure decreased was reported as recovered/resolved. Causality assessment was not reported.  Additional information is not expected from the Agency as follow up information cannot be obtained.