chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: ANTH
Symptoms: Vomiting
Clinical narrative: Subject reports that approx 5 hours after immunization, she experienced malaise and fatigue. Her symptoms progressed to stomach pain and nausea, vomiting and diarrhea at 10 hours after immunization. 20 hours after immunization symptoms included body aches, joint aches, fever, chills, headache and continued nausea, diarrhea, malaise and fatigue.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Electrocardiogram normal, Syncope
Clinical narrative: Subject reports that three days after receiving the ANTHRAX vaccine she felt chest pain and fainted for approximately 30 seconds. Subject was taken to ER by her friend (who has witnessed the event). Test preformed included EKG, blood work (specific tests unknown) chest x-ray and urine pregnancy tests which were all negative. She reports she was discharged from the ER to return home. No further episodes or additional complaints.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Urine human chorionic gonadotropin negative
Clinical narrative: Subject reports that three days after receiving the ANTHRAX vaccine she felt chest pain and fainted for approximately 30 seconds. Subject was taken to ER by her friend (who has witnessed the event). Test preformed included EKG, blood work (specific tests unknown) chest x-ray and urine pregnancy tests which were all negative. She reports she was discharged from the ER to return home. No further episodes or additional complaints.
Sex: M
Vaccine: ANTH
Symptoms: Cardiac flutter
Clinical narrative: Recd via e-mail: Subject has a latex allergy and received the anthrax vaccine. Subject is requesting information regarding whether the vaccine is made/stored in nitrile.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Gait disturbance, Myalgia, Pain in extremity
Clinical narrative: Soreness of muscle, left leg, from mid-calf to behind the knee. Soreness caused limping. Subsequently within 3 days, pain lessened, no longer limping.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pain at injection site, itching at injection site, swelling at injection site, redness at injection site, warmth at injection site, 5cm x 7cm area.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Activities of daily living impaired, Convulsion, Hepatobiliary scan, Irritable bowel syndrome, Laboratory test
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female with no medical history or drug allergy who was vaccinated with the first, the second and the third dose (lot # 660393/0067X) of GARDASIL on 04-FEB-2008, 16-APR-2008 and 18-AUG-2008 respectively.  There was no concomitant medication.  On 21-FEB-2008 the patient started to experience nausea, headache and stomach pain.  On 01-MAY-2008 the patient had the same symptoms.  On 03-SEP-2008 the patient experienced nausea, stomach pain and fever and the patient never recovered from that time on because the same symptoms kept coming back and the stomach pain became very severe that now she was out of school.  The patient was brought to the emergency room on 29-SEP-2008, but she was not admitted in the hospital.  The patient was currently experiencing severe stomach pain.  The physician had referred the patient to a neurologist but it would be 3 months before she could get an appointment.  The patient performed X-rays and blood work.  Nausea, headache, stomach pain and fever were considered to be disabling since they resulted in the patient being out of school.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Nausea, Oesophagogastroduodenoscopy, Pain, Streptococcal identification test negative, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female with no medical history or drug allergy who was vaccinated with the first, the second and the third dose (lot # 660393/0067X) of GARDASIL on 04-FEB-2008, 16-APR-2008 and 18-AUG-2008 respectively.  There was no concomitant medication.  On 21-FEB-2008 the patient started to experience nausea, headache and stomach pain.  On 01-MAY-2008 the patient had the same symptoms.  On 03-SEP-2008 the patient experienced nausea, stomach pain and fever and the patient never recovered from that time on because the same symptoms kept coming back and the stomach pain became very severe that now she was out of school.  The patient was brought to the emergency room on 29-SEP-2008, but she was not admitted in the hospital.  The patient was currently experiencing severe stomach pain.  The physician had referred the patient to a neurologist but it would be 3 months before she could get an appointment.  The patient performed X-rays and blood work.  Nausea, headache, stomach pain and fever were considered to be disabling since they resulted in the patient being out of school.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Abdominal pain upper, Activities of daily living impaired, Blood test, Headache, Nausea
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female with no medical history or drug allergy who was vaccinated with the first, the second and the third dose (lot # 660393/0067X) of GARDASIL on 04-FEB-2008, 16-APR-2008 and 18-AUG-2008 respectively.  There was no concomitant medication.  On 21-FEB-2008 the patient started to experience nausea, headache and stomach pain.  On 01-MAY-2008 the patient had the same symptoms.  On 03-SEP-2008 the patient experienced nausea, stomach pain and fever and the patient never recovered from that time on because the same symptoms kept coming back and the stomach pain became very severe that now she was out of school.  The patient was brought to the emergency room on 29-SEP-2008, but she was not admitted in the hospital.  The patient was currently experiencing severe stomach pain.  The physician had referred the patient to a neurologist but it would be 3 months before she could get an appointment.  The patient performed X-rays and blood work.  Nausea, headache, stomach pain and fever were considered to be disabling since they resulted in the patient being out of school.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Pyrexia, Vaccine positive rechallenge, X-ray
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female with no medical history or drug allergy who was vaccinated with the first, the second and the third dose (lot # 660393/0067X) of GARDASIL on 04-FEB-2008, 16-APR-2008 and 18-AUG-2008 respectively.  There was no concomitant medication.  On 21-FEB-2008 the patient started to experience nausea, headache and stomach pain.  On 01-MAY-2008 the patient had the same symptoms.  On 03-SEP-2008 the patient experienced nausea, stomach pain and fever and the patient never recovered from that time on because the same symptoms kept coming back and the stomach pain became very severe that now she was out of school.  The patient was brought to the emergency room on 29-SEP-2008, but she was not admitted in the hospital.  The patient was currently experiencing severe stomach pain.  The physician had referred the patient to a neurologist but it would be 3 months before she could get an appointment.  The patient performed X-rays and blood work.  Nausea, headache, stomach pain and fever were considered to be disabling since they resulted in the patient being out of school.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Abdominal pain, Activities of daily living impaired, Convulsion, Diagnostic procedure, Disability
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female with no medical history or drug allergy who was vaccinated with the first, the second and the third dose (lot # 660393/0067X) of GARDASIL on 04-FEB-2008, 16-APR-2008 and 18-AUG-2008 respectively.  There was no concomitant medication.  On 21-FEB-2008 the patient started to experience nausea, headache and stomach pain.  On 01-MAY-2008 the patient had the same symptoms.  On 03-SEP-2008 the patient experienced nausea, stomach pain and fever and the patient never recovered from that time on because the same symptoms kept coming back and the stomach pain became very severe that now she was out of school.  The patient was brought to the emergency room on 29-SEP-2008, but she was not admitted in the hospital.  The patient was currently experiencing severe stomach pain.  The physician had referred the patient to a neurologist but it would be 3 months before she could get an appointment.  The patient performed X-rays and blood work.  Nausea, headache, stomach pain and fever were considered to be disabling since they resulted in the patient being out of school.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Laboratory test, Malaise, Nausea, Thinking abnormal, Vaccine positive rechallenge
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female with no medical history or drug allergy who was vaccinated with the first, the second and the third dose (lot # 660393/0067X) of GARDASIL on 04-FEB-2008, 16-APR-2008 and 18-AUG-2008 respectively.  There was no concomitant medication.  On 21-FEB-2008 the patient started to experience nausea, headache and stomach pain.  On 01-MAY-2008 the patient had the same symptoms.  On 03-SEP-2008 the patient experienced nausea, stomach pain and fever and the patient never recovered from that time on because the same symptoms kept coming back and the stomach pain became very severe that now she was out of school.  The patient was brought to the emergency room on 29-SEP-2008, but she was not admitted in the hospital.  The patient was currently experiencing severe stomach pain.  The physician had referred the patient to a neurologist but it would be 3 months before she could get an appointment.  The patient performed X-rays and blood work.  Nausea, headache, stomach pain and fever were considered to be disabling since they resulted in the patient being out of school.  Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4
Symptoms: Metal poisoning
Clinical narrative: Information has been received from a consumer concerning her daughter, a 13 year old female with no medical history or drug allergy who was vaccinated with the first, the second and the third dose (lot # 660393/0067X) of GARDASIL on 04-FEB-2008, 16-APR-2008 and 18-AUG-2008 respectively.  There was no concomitant medication.  On 21-FEB-2008 the patient started to experience nausea, headache and stomach pain.  On 01-MAY-2008 the patient had the same symptoms.  On 03-SEP-2008 the patient experienced nausea, stomach pain and fever and the patient never recovered from that time on because the same symptoms kept coming back and the stomach pain became very severe that now she was out of school.  The patient was brought to the emergency room on 29-SEP-2008, but she was not admitted in the hospital.  The patient was currently experiencing severe stomach pain.  The physician had referred the patient to a neurologist but it would be 3 months before she could get an appointment.  The patient performed X-rays and blood work.  Nausea, headache, stomach pain and fever were considered to be disabling since they resulted in the patient being out of school.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Abdominal pain, Activities of daily living impaired, Asthenia, Blindness, Bone pain
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Chest pain, Dizziness, Electrocardiogram normal, Fall, Flank pain
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Headache, Hyperaesthesia, Hypoaesthesia, Incoherent, Musculoskeletal pain
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Myalgia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Blindness, Blood test, Computerised tomogram, Drug screen, Dysarthria
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Electrocardiogram, Headache, Hypersomnia, Pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Arthralgia, Blindness, Bone pain, Computerised tomogram normal, Dizziness
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Headache, Hypersomnia, Hypoaesthesia, Incoherent, Laboratory test normal
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP, HPV4, TTOX
Symptoms: Myalgia, Pain, Vision blurred
Clinical narrative: Information has been received from a consumer concerning her daughter, a 24 year old female with allergy to nuts who in the afternoon October 2008 (also reported as in December 2008) was vaccinated with the first dose of GARDASIL, IM, 0.5ml.  Concomitant therapy included tetanus toxoid.  At 02:00 the patient complained of body pain that got worse and worse.  The very next morning the patient came to the house at 6:00AM and collapsed on her floor, complaining of severe pain in her joints, flesh and bones.  The patient stated "this is the worse pain ever."  The patient could not stand to be touched or moved without having severe pain.  The patient also had muscle pain and bone pain.  The patient was a nursing student and did not go to class that day.  The patient slept for 7 days before recovering.  During that time, if the patient was awake, she complained of lots of pain, including a headache.  The patient was given TYLENOL for the headache.  The patient also experienced dizziness and lightheadedness.  Since that time, there had been progressive problems in her condition.  A few days ago (on approximately 20-FEB-2009) while the patient was in her nursing class she lost her vision, her vision then became blurry, developed left side pain and numbness and a pain attack.  The patient was speaking incoherently.  (The following day the patient she was in her head saying "help me out of the class, something is wrong" but the other students told her that they were not able to understand her.)  The patient was taken to the hospital (emergency room), she was not admitted.  She had undergone multiple diagnostic tests.  All results had come back negative.  The patient continued to complain of pain that came on and then faded, and then came on again and then faded.  Sometimes the whole body was in pain, including thoracic area, chest, arm, leg, sometimes it was just left-sided pain.  The patient was told not to receive any additional doses of GARDASIL by her physician.  The patient's events were considered to be disabling.  Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: MMR
Symptoms: Autism, Unresponsive to stimuli
Clinical narrative: Information has been received from a consumer concerning her 20 month old son with penicillin allergy who on approximately November 2004 was vaccinated with MMR II (Lot not reported). On approximately January 2005 the patient was not responding to his name and did not turn around to look anyone. The patient saw many doctors and was diagnosed with autism (unspecified tests had done). The consumer reported that the patient had speech therapy, social skills classes and other types of interventions which had made him improve drastically, but he was still autistic. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Headache
Clinical narrative: Information has been received from a physician concerning a female patient who in August 2008, was vaccinated with a dose of GARDASIL (Lot not reported).  In approximately February 2009, the patient told her doctor she experienced seizure and headaches.  At the time of reporting the outcome of the patient was unknown.  Upon internal review, seizure was considered to be an Other Important Medical Event.  Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Haematology test, Hypersensitivity, Lip swelling, Oedema peripheral, Pruritus generalised
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with purple cornflower allergy and no pertinent medical history, who in August 2008, was vaccinated with 0.5 ml of the third dose of GARDASIL. Concomitant therapy included birth control (unspecified). On 25-FEB-2009 the patient experienced hives all over her body and swollen hands, feet and lips. She was taken to emergency room and given prednisone 10 mg and "hydroxydine" 25 mg. On 26-FEB-2009 she was taken back to the hospital where she was admitted over night and released on 27-FEB-2009. She still has not recovered completely and still had break outs. Additional information has been requested.  3/13/09-records received from PCP severe allergic reaction to gardasil vaccine, on 2/18/09 hives, 2/22/09 seen in ED and again on 2/23/09 for 24 observation . Follow-up 3/8/09-when antihistamine wears off spots occur mostly on arms hands feet and thighs, rash is less and less. 4/6/09-records received for ED visit 2/22/09-C/O skin rash 3 days ago, generalized, urticarial rash. Assessment:allergic reaction-acute secondary to vaccine. 4/8/09-records received for DOS 2/23/09-ED Observation, C/O generalized itching times 5 days. DX:acute allergic reaction. Follow-up: Pt has had 2 additional breakouts since this report. 1. NOV 17, 09 > Broke out in hives all over body. 2. Sept 20, 09 > Broke out in hives all over body. Susceptible to allergic reactions since the vaccine not before.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash, Urticaria, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with purple cornflower allergy and no pertinent medical history, who in August 2008, was vaccinated with 0.5 ml of the third dose of GARDASIL. Concomitant therapy included birth control (unspecified). On 25-FEB-2009 the patient experienced hives all over her body and swollen hands, feet and lips. She was taken to emergency room and given prednisone 10 mg and "hydroxydine" 25 mg. On 26-FEB-2009 she was taken back to the hospital where she was admitted over night and released on 27-FEB-2009. She still has not recovered completely and still had break outs. Additional information has been requested.  3/13/09-records received from PCP severe allergic reaction to gardasil vaccine, on 2/18/09 hives, 2/22/09 seen in ED and again on 2/23/09 for 24 observation . Follow-up 3/8/09-when antihistamine wears off spots occur mostly on arms hands feet and thighs, rash is less and less. 4/6/09-records received for ED visit 2/22/09-C/O skin rash 3 days ago, generalized, urticarial rash. Assessment:allergic reaction-acute secondary to vaccine. 4/8/09-records received for DOS 2/23/09-ED Observation, C/O generalized itching times 5 days. DX:acute allergic reaction. Follow-up: Pt has had 2 additional breakouts since this report. 1. NOV 17, 09 > Broke out in hives all over body. 2. Sept 20, 09 > Broke out in hives all over body. Susceptible to allergic reactions since the vaccine not before.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Lip swelling, Oedema peripheral, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 14 year old daughter with purple cornflower allergy and no pertinent medical history, who in August 2008, was vaccinated with 0.5 ml of the third dose of GARDASIL. Concomitant therapy included birth control (unspecified). On 25-FEB-2009 the patient experienced hives all over her body and swollen hands, feet and lips. She was taken to emergency room and given prednisone 10 mg and "hydroxydine" 25 mg. On 26-FEB-2009 she was taken back to the hospital where she was admitted over night and released on 27-FEB-2009. She still has not recovered completely and still had break outs. Additional information has been requested.  3/13/09-records received from PCP severe allergic reaction to gardasil vaccine, on 2/18/09 hives, 2/22/09 seen in ED and again on 2/23/09 for 24 observation . Follow-up 3/8/09-when antihistamine wears off spots occur mostly on arms hands feet and thighs, rash is less and less. 4/6/09-records received for ED visit 2/22/09-C/O skin rash 3 days ago, generalized, urticarial rash. Assessment:allergic reaction-acute secondary to vaccine. 4/8/09-records received for DOS 2/23/09-ED Observation, C/O generalized itching times 5 days. DX:acute allergic reaction. Follow-up: Pt has had 2 additional breakouts since this report. 1. NOV 17, 09 > Broke out in hives all over body. 2. Sept 20, 09 > Broke out in hives all over body. Susceptible to allergic reactions since the vaccine not before.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Headache
Clinical narrative: Information has been received from a physician assistant concerning a female patient who on an unknown date was vaccinated with the second dose of GARDASIL (Lot number was not available). Subsequently, the patient experienced a day long seizures and severe headaches after receiving her second dose of GARDASIL. The patient was currently seeing a neurologist but was not yet recovered. On an unspecified date, a magnetic resonance imaging (MRI) was performed (results was not provided). Additional information has been requested.  04/14/2009  Neurology records received for eval of dysphasia, dizziness, H/A from 11/14/08-3/23/09. Pt had recently presented to ER on 11/10/08 with c/o chest pain upon inspiration.  Initially thought to be asthma by parent and tx with nebs. Pt developed tachycardia and became frightened. Dx with anxiety and tx with Ativan in ER and D/c. The next day pt was difficult to arouse and was feeling dizzy. Parent noted pt was having problems with speech, halting and with problems expressing self which continued throughout the day in addition pt very sleepy.  On 11/12/08 pt developed H/A which has continued on/off until 11/14/08 appt.  PE (+) for halting speech with stuttering quality. DTRs 1-2 in UEs and 3+ in LEs. DX: Dysphasia-etiology unclear.  Sent for MRI. Started on Topamax 1/12/09. Pt presented again 1/6/09 with several episodes of fogginess, cognitive sluggishness, falling asleep and H/A. Reports increased menstrual cramps. DX:  H/A and altered mental status. ? migraine variant.  Started on Topamax 1/12/09. Parent reports pt falling during skating practice with H/A and later H/A, neck pain, back pain, muscle and joint pain. Tx with medrol dosepak.  By 3/2009 having frequent H/A often preceeded by neck pain, back pain with fogginess.  2nd opinion neuro consult 3/18/09. PE WNL except (+) trigger point pain of trapezius. Etiology of sx unknown. ? seizure despite normal EEG.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Bradycardia, Hypotonia, Pallor, Respiratory rate decreased, Syncope
Clinical narrative: Initial report received 23 February 2009 from a health care professional. A 4-year-old female patient had received a third dose intramuscular left deltoid injection of FLUZONE 2008-2009, lot number U2809AA on 04 December 2008 at 12:15 hours, and within 10 minutes, the patient experienced a syncopal episode where she became pale, limp and unresponsive with bradycardia and a low respiratory rate. The patient remained unresponsive until EMS arrived at the physician's office. The patient was stimulated with sternal rub and oxygen by mask and taken to the emergency room. She was admitted overnight for observation and released the next day. The patient had no past medical history and had not been taking any concomitant medications. The patient recovered from the event. This patient has two brothers who each experienced a syncopal event post vaccination with FLUZONE which have been captured in case numbers 2008-03955 and 2009-00670. The reporter for this case is the same as for case numbers 2008-03955 and 2009-00670. Documents held by sender: None
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Unresponsive to stimuli
Clinical narrative: Initial report received 23 February 2009 from a health care professional. A 4-year-old female patient had received a third dose intramuscular left deltoid injection of FLUZONE 2008-2009, lot number U2809AA on 04 December 2008 at 12:15 hours, and within 10 minutes, the patient experienced a syncopal episode where she became pale, limp and unresponsive with bradycardia and a low respiratory rate. The patient remained unresponsive until EMS arrived at the physician's office. The patient was stimulated with sternal rub and oxygen by mask and taken to the emergency room. She was admitted overnight for observation and released the next day. The patient had no past medical history and had not been taking any concomitant medications. The patient recovered from the event. This patient has two brothers who each experienced a syncopal event post vaccination with FLUZONE which have been captured in case numbers 2008-03955 and 2009-00670. The reporter for this case is the same as for case numbers 2008-03955 and 2009-00670. Documents held by sender: None
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Initial report received 23 February 2009 from a health care professional. An eight-year-old male patient with no past medical history, had received an injection of FLUZONE 2008-2009, lot number U2758AA on 13 October 2008 and moments after vaccination, he experienced syncope. The event did not require an emergency room visit. The event lasted a few seconds and the patient recovered. This patient has a brother and sister who each experienced a syncopal event post vaccination with FLUZONE which have been captured in case numbers 2008-03955 and 2009-00669. The reporter for this case is the same as for case numbers 2008-03955 and 2009-00669. Documents held by sender: None.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Anaphylactoid reaction
Clinical narrative: Initial report received on 27 February 2009 from a physician. A 4-year-old female patient, whose past medical history was not provided, had received a dose of DAPTACEL on an unspecified date. The lot number, route and site of administration were not provided. At an unspecified amount of time later, the patient experienced what "sounded like an anaphylactic type reaction." At the time of this report, the physician was not at his office and did not known the specifics of the reaction. It was not reported whether the patient required hospitalization. The patient did recover (date not provided). Documents held by sender: None.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Asthma exercise induced, Chills, Condition aggravated, Cyanosis, Electroencephalogram normal
Clinical narrative: 4-21 - 4-22-08 was in hospital for syncopal episode. She had normal EEG recording. Was referred for evaluation of a 2 months Hx of spells. First in 2/2/08 - Felt chills, hands & face turned white with corresponding perioral cyanosis. Tachycardic with sweaty palms. Episode free for 3 mo. 4/14/09-records received for DOS 4/21/08-referred for evaluation of 2 month history of spells beginning 2/08, C/O feeling chilled to face and hands turned white with corresponding perioral cyanosis, tachycardic, sweaty palms. Seen in ED with normal EKG, CBC, chemistires. Out of country travel and upon return increase in spells. Syncope.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Hyperhidrosis, Pallor, Syncope, Tachycardia
Clinical narrative: 4-21 - 4-22-08 was in hospital for syncopal episode. She had normal EEG recording. Was referred for evaluation of a 2 months Hx of spells. First in 2/2/08 - Felt chills, hands & face turned white with corresponding perioral cyanosis. Tachycardic with sweaty palms. Episode free for 3 mo. 4/14/09-records received for DOS 4/21/08-referred for evaluation of 2 month history of spells beginning 2/08, C/O feeling chilled to face and hands turned white with corresponding perioral cyanosis, tachycardic, sweaty palms. Seen in ED with normal EKG, CBC, chemistires. Out of country travel and upon return increase in spells. Syncope.
Age: 1.1
Sex: F
Vaccine: HBHEPB
Symptoms: Erythema, Rash papular
Clinical narrative: Red raised spots that started on torso and spreading to her legs.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: DIARRHEA AND VOMITING
Age: 29.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Dysgeusia, Lymphadenopathy, Malaise, Oedema peripheral, Pain in extremity
Clinical narrative: Pt c/o pain and swelling in L arm the next morning after receiving a Tdap in this arm.  States lymph nodes swollen and just felt ill with a bad taste in mouth.  States pain 7 on a scale of 0-10 yesterday and 5 and 1/2 today.  States did not see an MD or take anthing for the sx.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized on 11/27/2008 for COPD exacerbation. Vaccination took place on 10/04/2007. According to physician, the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request. 3/11/09-records received for DOS 11/27-12/2/08 DC DX: COPD exacerbation. Admitted with increased shortness of breath and cough. Chest tightness. Chills