chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Client's Mother reported that client began having "severe" headache with vomiting and a temp. of 102.5 within 24 hours of receiving a Tdap. Client was taken to her physician on 11/20/09 afternoon and treated with Zofran for  the N/V. Bloodwork was drawn at this visit. By Sat. 11/21/09, the Mother reports that the client was still nauseated, but not vomiting. Client still had a headache at this time. Mon. 11/23/09 the client's Mother reported that client had improved long enough on Sunday, the 22, to have a small meal. By 5:00 PM Sunday, it was reported that the client had begun to experience symptoms again: fever, headache, and nausea. After another follow-up phone call, the parent left a voice message stating that the client was "just starting to feel better" stating that client was still feeling weak, but the headache, fever, and N/V were gone. "It has been a really long 11 days" The Mother stated that she felt after talking with others that this was a vaccine reaction and that she plans to seek payment for an E.R. visit for hydration, 3 M.D. office visits, and the Motrin and Tylenol that were useed to help her recover.
Age: 35.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Hormone level abnormal
Clinical narrative: I had a miscarriage. My hormone levels were progressing normally until I received the vaccine at which time they began to drop leading to a miscarriage on 11/26/09. 12/3/2009 OB records, pregnant patient with EDC 7/15/2010, hx of infertility, c/o's vaginal bleeding, sudden decrease of HCG levels and rt sided pelvic pain, had spontaneous AB 11/26/2009.
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abasia, Asthenia, Blepharospasm, Blood test abnormal, Computerised tomogram normal
Clinical narrative: Severe headache to begin with, then 1 week later head twitching, neck pain, numbness back and arms as well as lips, cheeks and eyes.  Dizzy.  Cheeks became swollen.  On Saturday couldn't walk due to weakness and a feeling of paralysis and SOB. Starting last Saturday, eye started twitching. 3 ER visits at hospital, PCP 3 times.  Had multiple blood work done, MRI, CT Scan, X rays. Everything is normal except blood work indicating slight inflammation. Has Neuro appt on December 9th.
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Dizziness, Dyspnoea, Headache, Hypoaesthesia, Hypoaesthesia facial
Clinical narrative: Severe headache to begin with, then 1 week later head twitching, neck pain, numbness back and arms as well as lips, cheeks and eyes.  Dizzy.  Cheeks became swollen.  On Saturday couldn't walk due to weakness and a feeling of paralysis and SOB. Starting last Saturday, eye started twitching. 3 ER visits at hospital, PCP 3 times.  Had multiple blood work done, MRI, CT Scan, X rays. Everything is normal except blood work indicating slight inflammation. Has Neuro appt on December 9th.
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Hypoaesthesia oral, Inflammation, Muscle twitching, Neck pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Severe headache to begin with, then 1 week later head twitching, neck pain, numbness back and arms as well as lips, cheeks and eyes.  Dizzy.  Cheeks became swollen.  On Saturday couldn't walk due to weakness and a feeling of paralysis and SOB. Starting last Saturday, eye started twitching. 3 ER visits at hospital, PCP 3 times.  Had multiple blood work done, MRI, CT Scan, X rays. Everything is normal except blood work indicating slight inflammation. Has Neuro appt on December 9th.
Age: 37.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Paralysis, Swelling face, X-ray normal
Clinical narrative: Severe headache to begin with, then 1 week later head twitching, neck pain, numbness back and arms as well as lips, cheeks and eyes.  Dizzy.  Cheeks became swollen.  On Saturday couldn't walk due to weakness and a feeling of paralysis and SOB. Starting last Saturday, eye started twitching. 3 ER visits at hospital, PCP 3 times.  Had multiple blood work done, MRI, CT Scan, X rays. Everything is normal except blood work indicating slight inflammation. Has Neuro appt on December 9th.
Age: 1.07
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 1.07
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Blood test, Chest X-ray, Convulsion, Cyanosis, Feeling hot
Clinical narrative: Febrile seizure.
Age: 1.07
Sex: F
Vaccine: FLUX(H1N1), FLU(H1N1)
Symptoms: Pyrexia, Staring
Clinical narrative: Febrile seizure.
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Hypoaesthesia, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Pt states next day, numbness in forehead and side of face into neck, generalized weakness, "tingling" from mid-spine up.  States symptoms come and go.  Not any worse.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Injection site appeared like a "spider bite" with a red ring around the injection spot.  This developed into a mild rash all over the arm the vaccine was administered in and a small rash on the other arm as well.  The rash never itched but is unsightly for the patient.  The patient says that the injection spot is still tender and feels as if there is a capsule under her skin.
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dysphonia, Dyspnoea, Oral discharge, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Hoarse throat and pain trouble breathing and discharge from chest nose and throat (green).
Age: 49.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Streptococcal bacteraemia
Clinical narrative: Hoarse throat and pain trouble breathing and discharge from chest nose and throat (green).
Age: 1.06
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Pyrexia
Clinical narrative: Fever, coughing.
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Arthralgia, Dyspnoea, Erythema, Mobility decreased, Oedema peripheral
Clinical narrative: Patient reports soreness following administration of the vaccine, which continued into the weekend.  Along with the soreness was redness and swelling of the right arm and fingers.  On Wednesday, Thursday, and Friday of the following week, patient states it felt like his arm was "broken" and had limited mobility in the right arm and wrist.  In addition, he experienced pain the right hip and leg (mainly the joints).  He also stated he had shortness of breath (excercise induced - walking) for approximately 2 days.  Treatment of the symptoms included ice therapy and use of ointment for joint/arthritis pain.  As of today, day fifteen following administration of the 3rd dose of Twinrix, patient states he is "getting better, but still has tenderness in his right elbow and has not gained full strength in the right arm yet."  Patient is in the process of setting up an appointment to see his primary care physician.
Age: 63.0
Sex: M
Vaccine: HEPAB
Symptoms: Pain, Tenderness
Clinical narrative: Patient reports soreness following administration of the vaccine, which continued into the weekend.  Along with the soreness was redness and swelling of the right arm and fingers.  On Wednesday, Thursday, and Friday of the following week, patient states it felt like his arm was "broken" and had limited mobility in the right arm and wrist.  In addition, he experienced pain the right hip and leg (mainly the joints).  He also stated he had shortness of breath (excercise induced - walking) for approximately 2 days.  Treatment of the symptoms included ice therapy and use of ointment for joint/arthritis pain.  As of today, day fifteen following administration of the 3rd dose of Twinrix, patient states he is "getting better, but still has tenderness in his right elbow and has not gained full strength in the right arm yet."  Patient is in the process of setting up an appointment to see his primary care physician.
Age: 6.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Discomfort, Mobility decreased, Synovitis, Weight bearing difficulty
Clinical narrative: Clinical findings and symptoms compatible with transient synovitis of the left hip.  Onset with discomfort and difficulty with weight bearing; no fever and no other musculoskeletal or constitutional features.  Symptoms gradually improving over the course of the following week, though not yet fully resolved.  Currently with a mild decrease in internal rotation of the left hip.
Age: 3.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Violent vomiting followed by 4 days of diarrhea.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash erythematous
Clinical narrative: I got red spots on my back and left arm and they hurt and itched.  Today is 12/1 and I have a few more and they itch and hurt and are red.  Have done nothing so far because I am not sure what to do.  I have to be careful about medications I TAKE.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Dizziness, Hypokinesia, Musculoskeletal pain, Pain in extremity
Clinical narrative: Received flu shot high in upper left arm. Within 2 hours, had shoulder/joint pain and couldn't move arm. Pain radiates down arm. 4 days after shot, major dizziness and vertigo.  Pain in arm is still present.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Vertigo
Clinical narrative: Received flu shot high in upper left arm. Within 2 hours, had shoulder/joint pain and couldn't move arm. Pain radiates down arm. 4 days after shot, major dizziness and vertigo.  Pain in arm is still present.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Anaphylactic reaction, Chest discomfort, Discomfort, Dyspnoea, Throat irritation
Clinical narrative: Anaphylaxis: scratchy throat, tight chest, wheezing and SOB, overall discomfort sensation:  Treated with albuterol MDI on own, then given Neb of albuterol and Benadryl 25 mg IM x1.  Watched for 3 hrs.  Given Prednisone Taper the next day as still had sx overnight and into the next day.12/9/2009 PCP records for 11/2/2009, c/o's chest tightness, SOB, scratchy throat, tx: Albuterol, Benadryl and prednisone .
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Wheezing
Clinical narrative: Anaphylaxis: scratchy throat, tight chest, wheezing and SOB, overall discomfort sensation:  Treated with albuterol MDI on own, then given Neb of albuterol and Benadryl 25 mg IM x1.  Watched for 3 hrs.  Given Prednisone Taper the next day as still had sx overnight and into the next day.12/9/2009 PCP records for 11/2/2009, c/o's chest tightness, SOB, scratchy throat, tx: Albuterol, Benadryl and prednisone .
Age: 41.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Muscle contractions involuntary
Clinical narrative: Fasciculations of muscles - started first in deltoid where injected, since spread to face, abdominal muscles.
Age: 9.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Aphasia, Blood test, Chest X-ray, Electrocardiogram, Loss of consciousness
Clinical narrative: Patient stopped talking in mid sentence and became unresponsive.  She then collapsed to the floor (passed Out).  she was out for about 30 seconds.  Noticed a tingling in her feet.  She was transported to the ER via ambulance.  They did EKG, Chest X-Ray, Blood work and a few other tests.  No treatment given besides keep an eye on her for the next couple of days.
Age: 9.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Paraesthesia, Syncope, Unresponsive to stimuli
Clinical narrative: Patient stopped talking in mid sentence and became unresponsive.  She then collapsed to the floor (passed Out).  she was out for about 30 seconds.  Noticed a tingling in her feet.  She was transported to the ER via ambulance.  They did EKG, Chest X-Ray, Blood work and a few other tests.  No treatment given besides keep an eye on her for the next couple of days.
Age: 3.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain, Pyrexia, Rash, Urticaria
Clinical narrative: Presents to ED on 11/25/09 @ 1727.  Mother stated that reaction began in the morning but did not know what time.  Initial vitals 38.8 °C (101.8°F)    Temp Source TYMPANIC -LM TYMPANIC -    Pulse 140  Resp 32 BP 99/57 mmHg    SpO2 98 % -LM   Patient presents with fever and rash on his upper proximal extremities. The rash is consistent with hives but is non-puritic, but painful. Patient observed in the ED until 19:18 11/25/09.  Patient given acetaminophen 15 mg/kg/dose and diphenhydramine 1 mg/kg/dose orally in the ED. Vitals at discharge are as follows:  BP 100/50 | Pulse 130 | Temp 97.7 | Resp 20 | Wt 15.6 kg | SaO2 99%.  Discharged home with Benadryl for use as needed and to follow up with PCP.
Age: 1.36
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Nausea, Pyrexia, Somnolence, Vomiting
Clinical narrative: N/V, Fever, remained drowsey and I put him to bed early.
Age: 0.79
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Irritability, Pyrexia, Rhinorrhoea
Clinical narrative: Extreme fussiness (11/30/2009 until Now), Runny Nose (11/30/2009 until Now) , Fever (12/1/2009 at 8:31 AM and 10:07 PM)
Age: 31.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Back pain
Clinical narrative: Persistent lower back pain x 3 days (so far).  OTC's taken for pain.
Age: 21.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Oedema peripheral
Clinical narrative: Swelling of arm and fingers in the arm the shot was given.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Abasia, Acute disseminated encephalomyelitis, Asthenia, Autonomic nervous system imbalance, Blood culture negative
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Blood test normal, C-reactive protein increased, CSF glucose normal, CSF oligoclonal band absent, CSF protein normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Chest X-ray normal, Clonus, Convulsion, Coordination abnormal, Dyspnoea
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Electrocardiogram abnormal, Encephalomyelitis, Fatigue, Gait disturbance, Headache
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Hyperreflexia, Lethargy, Lumbar puncture normal, Mental status changes, Muscle twitching
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Neck pain, Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging normal, Pain in extremity, Palpitations
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Pyrexia, Spinal X-ray normal, Tachycardia, Thyroid function test normal, 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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Urinary tract infection, Urine analysis abnormal, White blood cell count 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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Acute disseminated encephalomyelitis, Asthenia, Body temperature increased, Chills, Computerised tomogram
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Convulsion, Electrocardiogram, Headache, Hyperreflexia, Laboratory test
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Lethargy, Lumbar puncture, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Scan brain
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Tachycardia
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Abasia, Acute disseminated encephalomyelitis, Asthenia, Autonomic nervous system imbalance, Body temperature 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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: CSF oligoclonal band absent, Chills, Clonus, Convulsion, Coordination abnormal
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4, MNQ, TDAP, HPV4
Symptoms: Dyskinesia, Fatigue, Headache, Hemicephalalgia, Hyperreflexia
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. A 17 year old female with PANMIST DM allergy and with no known medical history was vaccinated with a first dose of GARDASIL vaccine (lot# 661766/0652X) in the right arm (route not reported) on 27-May-2009. Concomitant vaccinations included a first dose of ADACEL (lot# reported as C3068AA) and a first dose of MENACTRA (lot# reported as U2869AA). On 04-Jun-2009, the patient experienced acute disseminated encephalomyelitis, abasia, asthenia, autonomic nervous system imbalance, clonus, convulsion, coordination abnormal, fatigue, headache, hyperreflexia, lethargy, mental status changes, pyrexia, tachycardia, body temperature increased and chills. Seven days after immunization, the patient started mental status changes with fever (104), headache, lethargy, inability to walk, discoordination, signs of autonomic instability. The patient went to emergency room. Two events of brief seizure with mouth pulling to the left separated by 30 minutes occurring on one day about 1 mouth following onset of symptoms. Fatigue, intermittent tachycardia, left-sided headache and general weakness have persisted, although improved over the past 3 months. She was diffuse, symmetric hyperreflexia in all extremities with 1 beat clonus of the right ankle. Diagnosis of ADEM was made. No treatment was given. The listing indicated that one or more of the events required hospitalization (05-JUN-2009 and 13-JUL-2009) and was considered to be immediately life-threatening. The originally reporting source was not provided. The VAERS ID# is 356939. No further information is available. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released.