chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Speech disorder, Vision blurred
Clinical narrative: Symptoms began with headache, blurred/distorted vision, tingling sensation on left side of body, numbness in face. Proceeded to tightening of muscles on right side of body. Speech was impaired. Exhibited stroke like symptoms. Went to ER, CT scan was done. Was admitted to hospital. MRI was done following morning. Approx. 5:00 pm, was discharged and went to Medical Center. Had lumbar puncture. All tests came back fine. Was referred to another Medical Center for further testing. Still do not know what happened, no diagnosis. Nothing has come back on any of the testing.11/12 and 11/13/2009 ED, MR for DOS 10/27-10/28/2009, Pt c/o headache, blurred vision, tingling, weakness of extremities, slow speech and unsteady gait.  Neuro exam abnormal. Impression: Neurological spell.  12/1/2009 Lab test results: ASO titer: 211 IU/ml: normal.   01/12/10 MR received for DOS 10/28/09. Pt c/o numbness of L side of body and weakness, peripheral vision problems, confused, difficulty ambulating, headache, slow speech. On neurological exam: normal. Dr. considered this event as possible underlying seizure.  Pt scheduled for EEG to evaluate possible sz.
Age: 5.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Crying, Diarrhoea, Hypoaesthesia, Injection site erythema, Injection site irritation
Clinical narrative: Swelling at injection sight, redness, irritation, itching, diarrhea, leg cramps, numbness, and tingling, crying.  Took to emergency room for treatment, ice-pack on arm injection sight, and Benadryl.
Age: 5.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Injection site pruritus, Injection site swelling, Muscle spasms, Paraesthesia
Clinical narrative: Swelling at injection sight, redness, irritation, itching, diarrhea, leg cramps, numbness, and tingling, crying.  Took to emergency room for treatment, ice-pack on arm injection sight, and Benadryl.
Age: 27.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Drug exposure during pregnancy, Migraine, Pain
Clinical narrative: Migraine Headache, lasted 3 days, severe pain.  Tried Tylenol & Midrin, ice, heat, etc nothing worked.  I am pregnant so I had to wait it out.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test negative
Clinical narrative: Patient miscarried embryo.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg injection site red raised area slightly larger than a quarter. Warm to the touch.
Age: 10.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: RASH ON L ARM, SHOWN UP ON SATURDAY
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Fatigue, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Developed hard lump at injection site,about the size of 2/3 of a dollar bill. It was very painful and protruded from the arm about a half inch. Next day felt tired, feverish and gradually whole upper arm swelled up and turned red. November 8/9 the swelling began to go down but I noticed 2 little "bags" of skin on either side of the elbow that looked like they contained fluid. Dead white cells, I suspect. As of 11/11, arm back to normal size, redness almost completely gone, and skin "bags" almost gone.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Joint swelling, Oedema peripheral, Pyrexia
Clinical narrative: Developed hard lump at injection site,about the size of 2/3 of a dollar bill. It was very painful and protruded from the arm about a half inch. Next day felt tired, feverish and gradually whole upper arm swelled up and turned red. November 8/9 the swelling began to go down but I noticed 2 little "bags" of skin on either side of the elbow that looked like they contained fluid. Dead white cells, I suspect. As of 11/11, arm back to normal size, redness almost completely gone, and skin "bags" almost gone.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Confusional state, Febrile convulsion, Gaze palsy, Muscle rigidity, Pulse absent
Clinical narrative: At approximately 2100, father noticed that he felt warm, gave him a dose of ibuprofen.  The child subsequently had emesis times one around 2200.  This was nonbloody and nonbilious.  Approximately 20 minutes prior to arrival, the patient was asleep on the couch when he had an episode where his entire body went rigid, his eyes rolled back in his head, and the father was concerned that the patient did not have a pulse.  At that time, the father started CPR, however, the episode remitted spontaneously.  The patient seemed slightly confused and maybe a little bit sleepy and has gradually returned towards his baseline.  Subsequently he was transported by Ambulance for further evaluation.  Per ER note:  This likely represents a simple febrile seizure as the patient has returned to his normal baseline within a reasonable period of time.  There is no further testing or intervention needed at this point in time.
Age: 4.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Skin warm, Somnolence, Vomiting
Clinical narrative: At approximately 2100, father noticed that he felt warm, gave him a dose of ibuprofen.  The child subsequently had emesis times one around 2200.  This was nonbloody and nonbilious.  Approximately 20 minutes prior to arrival, the patient was asleep on the couch when he had an episode where his entire body went rigid, his eyes rolled back in his head, and the father was concerned that the patient did not have a pulse.  At that time, the father started CPR, however, the episode remitted spontaneously.  The patient seemed slightly confused and maybe a little bit sleepy and has gradually returned towards his baseline.  Subsequently he was transported by Ambulance for further evaluation.  Per ER note:  This likely represents a simple febrile seizure as the patient has returned to his normal baseline within a reasonable period of time.  There is no further testing or intervention needed at this point in time.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Chest discomfort, Gingival disorder, Gingival pain, Headache, Swollen tongue
Clinical narrative: Swelling on side of tongue, raw, sore gums, chest discomfort, headache.
Age: 15.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, aches
Age: 41.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Paraesthesia oral, Respiratory tract congestion, Wheezing
Clinical narrative: Shortness of breath, wheezing, congestion, tingling lips and tongue
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth, Pain
Clinical narrative: PATIENT SATES THAT BY EARLY EVENING OF INJECTION SHE WAS VERY WARM TO TOUCH HER ARM WAS WARM TO TOUCH, RED AND THROBBING.  DID NOT REST WELL THROUGH THE NIGHT AND FELT SHE MIGHT HAVE HAD LOW GRADE FEVER. LEFT ARM WAS INCREASED WARMTH AT SITE WITH 4 INCH BY 8 INCH AREA OF REDNESS.  AREA CONTINUED TO THROB WHERE FLU WAS GIVEN.   PRIVATE DOCTOR TREATED FOR CELLULITIS WITH DOXYCYCLINE 10/20/2009.  PT APPLIED COOL COMPRESSES 10/29/2009 BUT DID NOT IMPROVE.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Skin warm, Sleep disorder
Clinical narrative: PATIENT SATES THAT BY EARLY EVENING OF INJECTION SHE WAS VERY WARM TO TOUCH HER ARM WAS WARM TO TOUCH, RED AND THROBBING.  DID NOT REST WELL THROUGH THE NIGHT AND FELT SHE MIGHT HAVE HAD LOW GRADE FEVER. LEFT ARM WAS INCREASED WARMTH AT SITE WITH 4 INCH BY 8 INCH AREA OF REDNESS.  AREA CONTINUED TO THROB WHERE FLU WAS GIVEN.   PRIVATE DOCTOR TREATED FOR CELLULITIS WITH DOXYCYCLINE 10/20/2009.  PT APPLIED COOL COMPRESSES 10/29/2009 BUT DID NOT IMPROVE.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Foetal disorder, Injection site pain, Malaise
Clinical narrative: Aching, general malaise, fever for 36 hours.  Plus soreness at injection point.  Had a pap smear 10/12/2009, uterus bleeding started 10/17/2009, miscarried baby 10/30/2009.  It's my unprofessional opinion that the sickness (especially the fever) caused by the flu shot resulted the miscarriage.  The baby had, again in my unprofessional opinion, a neural defect which we think was caused by the fever.  This was the first time she ever had a flu shot.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Pain, Pyrexia, Uterine haemorrhage
Clinical narrative: Aching, general malaise, fever for 36 hours.  Plus soreness at injection point.  Had a pap smear 10/12/2009, uterus bleeding started 10/17/2009, miscarried baby 10/30/2009.  It's my unprofessional opinion that the sickness (especially the fever) caused by the flu shot resulted the miscarriage.  The baby had, again in my unprofessional opinion, a neural defect which we think was caused by the fever.  This was the first time she ever had a flu shot.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Pyrexia, Urticaria
Clinical narrative: Fever three days after vaccine administration. Urticaria 7 days after vaccine administration.
Age: 1.13
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash
Age: 26.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Soreness in arm and shoulder blade muscle tenderness in her chest. 12/08/09 Prenatal records received for DOS 10/19/09-12/01/09. G4 P1
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache
Clinical narrative: Received 2nd GARDASIL injection 10/26/2009. After injection reported headache & dizziness. Examined & observed by Dr. Given Tylenol & went home in stable condition.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Season flu vaccination given 10/9/09. Within 10 minutes pt states he began to feel dizzy and nauseated. Started vomiting 45 after shot. Reported back to OCC Health clinic 1 1/2hrs after shot was given. Observed x 2hrs then sent home with family.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Antinuclear antibody, Arthralgia, Asthenia, Blood creatine phosphokinase, Chest discomfort
Clinical narrative: Diffuse body aches/joint pain weakness, chest heaviness. Sx are on going & work up not completed to date.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Pain, Red blood cell sedimentation rate
Clinical narrative: Diffuse body aches/joint pain weakness, chest heaviness. Sx are on going & work up not completed to date.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Patient stated he became dizzy about 20-30 min after vaccine, then nauseated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Dysphonia, Fatigue, Feeling hot, Irritability, Pyrexia
Clinical narrative: Vaccine administered 11/9/09. Within 1/2 hr - 40 minutes pt became tired and very warm and irritable through out the same night. Hoarse voice and fever same night. Fever next day 11/10/09 103F. Pt's feeling much better today 11/11/09.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Computerised tomogram, Condition aggravated, Respiratory arrest, Syncope
Clinical narrative: The patient fainted and stopped breathing. she started breathing on her own. 911 was called and EMT's evaluated her. She was then transported to the hospital by her mother. I followed up with her mother and primary MD on 11/10/09. She fainted due to anxiety and vagal synope. It was determined to not be vaccine related by the hospital.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Blood uric acid, C-reactive protein, Full blood count, Joint swelling
Clinical narrative: Both knees became swollen, warm, and she couldn't bear wt on them. Was hospitalized. 11/12/09:  ED Record, Discharge Summary and Hospital records for dates of service 9/27/09 to 9/29/09.  Final Dx:  Allergic reaction to influenza shot. Assessment:  Presented with tense swelling in both knees, increased warmth, dependent edema, unable to walk.  Responded to IV steroids.  Discharged able to weight bear, although still painful.    11/13/09: Laboratory test report with duplicate records of hospital discharge summary and hospital emergency room records for dates of service 9/27/09 to 9/29/09 received. Presented with knee pain.   Labs: Sed Rate 32 and Uric Acid 6.9.  PMH: Osteoarthritis of knees and left shoulder.\rem
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Joint warmth, Red blood cell sedimentation rate, Skin warm, Weight bearing difficulty
Clinical narrative: Both knees became swollen, warm, and she couldn't bear wt on them. Was hospitalized. 11/12/09:  ED Record, Discharge Summary and Hospital records for dates of service 9/27/09 to 9/29/09.  Final Dx:  Allergic reaction to influenza shot. Assessment:  Presented with tense swelling in both knees, increased warmth, dependent edema, unable to walk.  Responded to IV steroids.  Discharged able to weight bear, although still painful.    11/13/09: Laboratory test report with duplicate records of hospital discharge summary and hospital emergency room records for dates of service 9/27/09 to 9/29/09 received. Presented with knee pain.   Labs: Sed Rate 32 and Uric Acid 6.9.  PMH: Osteoarthritis of knees and left shoulder.\rem
Age: 37.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Tremor
Clinical narrative: Dizziness, tremor.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Had seasonal flu shot in 9/25/09 - woke up next morning feeling bad + very dizzy. This lasted until about 2pm then went away.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Muscle pain at injection site.
Age: 36.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Eye swelling, Hypoaesthesia facial, Swelling face
Clinical narrative: Patient reported numbness in left side of face 15 minutes after H1N1 vaccine administered in left deltoid. Minimal swelling noted in left cheek. Vital signs taken. Patient is stable 6 hrs and left side infected red and swelling is increasing around left eye. Called 911, BENADRYL 50mg IM given in R arm-Patient in supine position, monitored vitals. Transported to EMT after sec vital
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: She was swollen, red
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Faeces discoloured, Haematochezia, Irritability, Mucous stools
Clinical narrative: Patient with very watery green bowel movements with mucous with blood x 4.  1st administration of Rotateq earlier today very irritable. These symptoms started within 1hr of administration.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Ultrasound abdomen normal
Clinical narrative: Patient with very watery green bowel movements with mucous with blood x 4.  1st administration of Rotateq earlier today very irritable. These symptoms started within 1hr of administration.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Gait disturbance, Myalgia
Clinical narrative: Weakness, muscle aches, and fatigue onset within 15 minutes. Progressed over 24 hours to unsteady gait. Started MOTRIN 400mg at 36 hours post vaccination.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Hypoaesthesia, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Received a phone call from the patient today stating that she continues to have pain in her arm. She states that she has a constant throbbing pain in her left arm over her shoulder blade and into her neck. She states that she has numbness in the evening in this distribution and in her back as well. The symptoms seem to be worse at night. She does take IBUPORFEN during the day and this seems to help some. The numbness in her arm extends to her elbow. She states that the discomfort and numbness is located a little bit more on the underside of her arm in her axillary region, than on the deltoid region. She denies any drainage or redness from the site of her Tdap. She received her Tdap on 10/20/2009 and these symptoms began on 10/21/2009. After discussion with patient, she will schedule an appointment for evaluation. Her symptoms are a bit concerning for brachial neuritis. We discussed that further testing may be necessary. She did want to have me file a report with the vaccine event reporting system and this will be done. Further direction will be given after evaluation. The patient was encouraged to call with any questions or concerns.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Radiculitis brachial
Clinical narrative: Received a phone call from the patient today stating that she continues to have pain in her arm. She states that she has a constant throbbing pain in her left arm over her shoulder blade and into her neck. She states that she has numbness in the evening in this distribution and in her back as well. The symptoms seem to be worse at night. She does take IBUPORFEN during the day and this seems to help some. The numbness in her arm extends to her elbow. She states that the discomfort and numbness is located a little bit more on the underside of her arm in her axillary region, than on the deltoid region. She denies any drainage or redness from the site of her Tdap. She received her Tdap on 10/20/2009 and these symptoms began on 10/21/2009. After discussion with patient, she will schedule an appointment for evaluation. Her symptoms are a bit concerning for brachial neuritis. We discussed that further testing may be necessary. She did want to have me file a report with the vaccine event reporting system and this will be done. Further direction will be given after evaluation. The patient was encouraged to call with any questions or concerns.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity, Physiotherapy
Clinical narrative: Pain in left arm, shoulder, neck and down neck. Began two days severely after shot called doctor on 4th and 5th day and saw doctor 8 days later. Physical therapy, pain relievers. Starting treatment.
Age: 10.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Breath sounds abnormal, Dysphonia, Heart rate irregular, Insomnia, Lymphadenopathy
Clinical narrative: Time noted above is when patient arrived home from school, actual time of onset is unknown from him being at school but according to patient symptoms started aprox two hours before arriving home.  hoarseness, red raw throat, congestion, runny nose, irregular heartbeat and breathing, difficulty sleeping, puffy face.  I had patient go to school nurse next morning to report symptoms and check for any serious issues, nurse noted no fever (as I did as well); said he did appear to have red swollen nodes and hoarseness as well as runny nose but nothing to worry over.  Symptoms persisted for 5 days maxing out at day 2 and day 3.  Gave Mucinex for noted congestion, and Motrin for ache's and to ensure no onset of fever.  Patient took cough drops to aid in sore throat.
Age: 10.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pharyngeal erythema, Respiratory tract congestion, Rhinorrhoea, Swelling face, Throat irritation
Clinical narrative: Time noted above is when patient arrived home from school, actual time of onset is unknown from him being at school but according to patient symptoms started aprox two hours before arriving home.  hoarseness, red raw throat, congestion, runny nose, irregular heartbeat and breathing, difficulty sleeping, puffy face.  I had patient go to school nurse next morning to report symptoms and check for any serious issues, nurse noted no fever (as I did as well); said he did appear to have red swollen nodes and hoarseness as well as runny nose but nothing to worry over.  Symptoms persisted for 5 days maxing out at day 2 and day 3.  Gave Mucinex for noted congestion, and Motrin for ache's and to ensure no onset of fever.  Patient took cough drops to aid in sore throat.
Age: 11.0
Sex: M
Vaccine: FLU3, FLUN(H1N1), MNQ, TDAP
Symptoms: Headache, Vomiting
Clinical narrative: Severe Headache behind his eye, felt different from his migraines.  Emesis once.  Severity of headache reduced with ibuprofen.  The next morning woke up with a mild headache again reduced with ibuprofen.
Age: 6.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red bumps all over body ad itchy. Put Aveeno anti-itch cream to alleviate itching.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at right thigh and crying non-stop
Age: 3.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Erythema, Eye swelling, Oedema mouth, Pyrexia
Clinical narrative: Swollen eyes, cheeks and mouth, fever, vomiting, redness all over face, cough, wheezing. I took her to Urgent Care and they advised that it was normal and to administer Tylenol.
Age: 3.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Swelling face, Vomiting, Wheezing
Clinical narrative: Swollen eyes, cheeks and mouth, fever, vomiting, redness all over face, cough, wheezing. I took her to Urgent Care and they advised that it was normal and to administer Tylenol.
Age: 2.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Immediate post-injection reaction, Injection site pain, Skin warm, Vomiting
Clinical narrative: Severe soreness in injection sight immediatley following for several hours. Vomiting one hour approximately after and warmness to the touch for 2 days. Ibuprofen
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Nausea, Presyncope, Vomiting
Clinical narrative: Vaso vagal event. with loss of consciousness for several minutes, nausea and vomiting, and recovery over one and one half hours.
Age: 12.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Dyspnoea, Flushing, Rash
Clinical narrative: Pt received vaccine at approx. 8:00 am. She was brought down to the nurses from her classroom by the teacher at 9:45. The pt. was complaining of coughing, trouble breathing, and her face was flush. Vitals were stable. No wheezing noted. Pt given liguid Benadryl 37.5mg PO per the HD protocol. The EMS was notified. Pt's father notified. EMS arrived at 10:05 am. Vitals stable- oxygen saturation 99%. Spotty non-raised rash developed. Pt. taken to ER by the EMS for further evaluation. Pt. remained stable.
Age: 10.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Epistaxis
Clinical narrative: Patient developed a nose bleed approx. 15 minutes after the vaccine was given. The nose bleed lasted about 5 minutes. The pt. had no other complaints or S/S at that time. Pt. held pressure to his nose. Pt. stated that he had a history of nose bleeds. Mom attempted to be reached. Spoke with mom about 2 hours later and she verified that the pt. did have a history of nose bleeds. Instructed to monitor the pt. for the rest of the evening and call with any concerns.
Age: 0.1
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Arthralgia
Clinical narrative: Consistent joint pain in back, neck, hips, knees, shoulders.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Gait disturbance, Pain, Pain in extremity, Pyrexia
Clinical narrative: 2 days after received injection, pt had fever of 103.8 degrees.  Began coughing, having runny nose, complaining of foot pain, leg pain, body aches, and difficulty walking.
Age: 5.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Rhinorrhoea
Clinical narrative: 2 days after received injection, pt had fever of 103.8 degrees.  Began coughing, having runny nose, complaining of foot pain, leg pain, body aches, and difficulty walking.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Asthenia, Diarrhoea, Oral herpes, Vomiting
Clinical narrative: One large diarrhea and, an hour later, a single incidence of vomiting.  Also, formation of a cold sore on the left corner of his lip over the course of that day.  After the diarrhea and vomiting, energy level returned, and the child was as before with the exception of the cold sore blister which has lingered for the past week.
Age: 42.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Abnormal faeces, Diarrhoea, Injection site haematoma, Injection site pain
Clinical narrative: Diarrhea several times throughout the day. No other symptoms. (Usually suffer from chronic constipation.) Nine days later continue with diarrhea, (regardless of diet) stools have been very different, ie. color, odor, consistency. Plan to go to doctor if not better by Monday, which will be almost 2 weeks. Also injection site bruised and very sore.
Age: 1.77
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Body temperature increased, Cough, Dysphonia, Ear infection, Respiratory tract congestion
Clinical narrative: Very deep, hoarse cough; congestion; and small temperature (99.6F) within 24 hours after vaccination.
Age: 1.77
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Streptococcal identification test negative
Clinical narrative: Very deep, hoarse cough; congestion; and small temperature (99.6F) within 24 hours after vaccination.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Asthma, Cough, Wheezing
Clinical narrative: Sustained coughing after went to bed in the evening and for the next 2 days; then wheezing and coughing with vomiting at night time for the following 8 days. On the 4th day, we took him to the doctor for the second time, and she diagnosed asthma.
Age: 80.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Dizziness, Nausea, Non-cardiac chest pain, Vomiting
Clinical narrative: Dizziness, Lightheadedness, Extreme Nausea, vomiting, Chest Hurting, Diarrhea
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Facial palsy, Hypoaesthesia oral
Clinical narrative: On the afternoon of 11/7/09 I developed numbness and loss of taste on the left side of my tongue.  By 11/8/09 this progressed to full left sided facial paralysis and I was diagnosed with Bell's Palsy.   12/7/09:  ED Record received for date of service 11/8/09.  Dx:  Bell's Palsy.  Presents with facial numbness, left side of tongue feels numb, left eyelid feels weak, loss of taste on L side of tongue, slight droop of left mouth noted.
Age: 25.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Eye swelling, Injection site erythema, Injection site pruritus, Injection site swelling, Sneezing
Clinical narrative: Localized itching, redness, swelling at injection site followed by hives all over body, wheezing, sneezing, swollen eyes, vomiting.
Age: 25.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Urticaria, Vomiting, Wheezing
Clinical narrative: Localized itching, redness, swelling at injection site followed by hives all over body, wheezing, sneezing, swollen eyes, vomiting.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Electroencephalogram, Grand mal convulsion, Nuclear magnetic resonance imaging
Clinical narrative: General tonic clonic seizure in patient with no prior seizure history. 11/16/2009 MR and DC summary for 11/7-11/9/2009, patient with tonic-clonic movements, postictal  urinary incontinence and confusion, foaming at the mouth and headache. Neuro consult,  Tx: IVF, Keppra  Dx New onset seizure activity GI consult for patient's recent weight loss, anorexia and constipation, recommended an EGD and Colonoscopy which patient deferred at the time
Age: 21.0
Sex: F
Vaccine: RAB
Symptoms: Hypoventilation, Pruritus, Urticaria
Clinical narrative: Hives on both arms, face, and neck, dizziness since the vaccine, shallow breathing started after the hives, itchyness. went to urgent care was put on Xylan and pred for 5 days and told not to do the third vaccine
Age: 43.0
Sex: M
Vaccine: ANTH, FLU3
Symptoms: Dizziness, Eye irritation, Respiratory distress
Clinical narrative: Initial report extracted from VAERS database via QScan FDA report on 11 March 2009 (VAERS identification number 211529). A 43-year-old male patient had received on 01 November 2003 a sixth intramuscular injection of Fluzone SV 2003-2004 USP (lot number U1098AA) and a first subcutaneous injection of Biothrax (manufacturer Bio Port, lot number FAV076). At an unspecified amount of time later on 01 November 2003, the patient felt dizzy, his eyes were burning (coded as conjunctivitis by VAERS), and he had mild respiratory distress (coded as dyspena by VAERS). The patient's blood pressure was normal and he did not require any treatments. It was not reported whether any relevant diagnostic tests or laboratory data were performed. Two hours later, the patient felt better and was considered to be recovered. No further information is expected.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Eye pruritus, Ocular hyperaemia, Speech disorder, Urticaria
Clinical narrative: This case was extracted from the databases via QScan on 11 March 2009 (reference number 213290). A 70-year-old female patient received an intramuscular injection of FLUZONE (lot number U1102AA) on 23 October 2003. The evening of vaccination, she developed itchy, red eyes which continued the following day. On 25 October 2003, two days post-vaccination, she developed hives. On 26 October 2003 she experienced impaired speech and difficulty swallowing. She presented to the hospital where she was treated with prednisone. She subsequently saw a dermatologist, and the prednisone dosage was increased. All events recovered on 03 November 2003.
Age: 94.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Condition aggravated, Cough, Death, Hypertension, Hypoxia
Clinical narrative: Initial report received on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A Versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 94 year old patient with a history of CVA, PVD, HTN, hypothyroidism, and partial gastrectomy received FLUZONE SV '2004-'2005 USP (lot number was not provided in article; however, lot number was entered according to the previous info received for the other 4 cases, U1478AA) on an unspecified date. Five days post vaccination, the patient developed a cough. Eighteen days post vaccination the patient died. According to the death certificate, causes of death were respiratory depression, hypoxia, and hypertension. Date of death was not provided. Four additional cases were mentioned in this article that was previously reported to the Company: 2004-03646, 2004-03647, 2004-03648, and 2004-03649.
Age: 94.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Respiratory depression
Clinical narrative: Initial report received on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A Versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 94 year old patient with a history of CVA, PVD, HTN, hypothyroidism, and partial gastrectomy received FLUZONE SV '2004-'2005 USP (lot number was not provided in article; however, lot number was entered according to the previous info received for the other 4 cases, U1478AA) on an unspecified date. Five days post vaccination, the patient developed a cough. Eighteen days post vaccination the patient died. According to the death certificate, causes of death were respiratory depression, hypoxia, and hypertension. Date of death was not provided. Four additional cases were mentioned in this article that was previously reported to the Company: 2004-03646, 2004-03647, 2004-03648, and 2004-03649.
Age: 94.0
Sex: U
Vaccine: FLU3, FLU3
Symptoms: Cough, Death, Hypertension, Hypoxia, Respiratory depression
Clinical narrative: Initial report received on 27 July 2009 from a literature citation. Purpose: To evaluate a possible association between influenza vaccination and four deaths and four serious illnesses among 114 recent influenza vaccinees in a long-term care facility (LTCF) and two deaths from a nearby physician's office. All had received vaccine from the same lot (Lot A). Methods Field investigation including (1) a retrospective cohort study among LTCF residents who received Lot A or other influenza vaccine, (2) review of medical records of cases of death or serious illness, (3) active surveillance of deaths among 1500 community based Lot A vaccinees and (4) laboratory testing of vaccine from available Lot A vials. Results Medical record reviews showed no common clinical syndrome or cause of death. Laboratory testing of Lot A samples revealed no evidence of tampering and no differences compared to an unrelated lot. The risk of death or hospitalization was not significantly different between persons who received Lot A Versus a comparison lot, Lot B (incidence rate ratio (IRR) = 0.9, 95%CI = 0.3-3.3). Conclusions There was no clinical or biological evidence pointing to inherent vaccine safety issues, nor was there a detectable increased risk of death or hospitalization among persons vaccinated with Lot A. Lot specific clustering of adverse events (AEs) may reflect medical events causally unrelated to vaccination. Rapid investigations of potential AEs are important to ensure vaccine safety and to maintain public and healthcare provider confidence in vaccines. A 94 year old patient with a history of CVA, PVD, HTN, hypothyroidism, and partial gastrectomy received FLUZONE SV '2004-'2005 USP (lot number was not provided in article; however, lot number was entered according to the previous info received for the other 4 cases, U1478AA) on an unspecified date. Five days post vaccination, the patient developed a cough. Eighteen days post vaccination the patient died. According to the death certificate, causes of death were respiratory depression, hypoxia, and hypertension. Date of death was not provided. Four additional cases were mentioned in this article that was previously reported to the Company: 2004-03646, 2004-03647, 2004-03648, and 2004-03649.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dysphonia, Heart rate increased, Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: This case was extracted from the VARES database via QScan on 11 March 2009 (reference number 229847). A 21-year-old female patient received received an intramuscular injection of Fluzone (lot number not reported) on 18 November 2004. Later that day, at an unspecified time, she experienced blood shot eyes, swollen throat, change in voice and elevated pulse, within 10 minutes of coughing episode. She was treated with oral Benadryl and Prednisone, and transported to the emergency room. She subsequently recovered.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Agitation, Apnoea, Convulsion, Deafness, Decreased appetite
Clinical narrative: This case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 232432). A two-year-old male patient received an intramuscular right deltoid injection of FLUZONE SV (lot U1270AA) on 12 December 2003. Within one week post-vaccination the patient's mother noted redness around the eyes, and two weeks post-vaccination he developed a rash on his face and body. Per the mother, no other symptoms were noted at that time. He was seen by his physician on 24 December 2003. He subsequently developed the following: apnea, encephalopathy, viral infection, thinking abnormal, gait abnormal, Guillain Barre Syndrome, speech disorder, abnormal vision, agitation, allergic reaction, anorexia, convulsion, deafness, dyspnea, facial edema, and fever. The events were considered to be life-threatening, and the patient was hospitalized. No additional information regarding etiology, treatment, or outcome was provided.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Encephalopathy, Face oedema, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: This case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 232432). A two-year-old male patient received an intramuscular right deltoid injection of FLUZONE SV (lot U1270AA) on 12 December 2003. Within one week post-vaccination the patient's mother noted redness around the eyes, and two weeks post-vaccination he developed a rash on his face and body. Per the mother, no other symptoms were noted at that time. He was seen by his physician on 24 December 2003. He subsequently developed the following: apnea, encephalopathy, viral infection, thinking abnormal, gait abnormal, Guillain Barre Syndrome, speech disorder, abnormal vision, agitation, allergic reaction, anorexia, convulsion, deafness, dyspnea, facial edema, and fever. The events were considered to be life-threatening, and the patient was hospitalized. No additional information regarding etiology, treatment, or outcome was provided.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Ocular hyperaemia, Pyrexia, Rash generalised, Speech disorder
Clinical narrative: This case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 232432). A two-year-old male patient received an intramuscular right deltoid injection of FLUZONE SV (lot U1270AA) on 12 December 2003. Within one week post-vaccination the patient's mother noted redness around the eyes, and two weeks post-vaccination he developed a rash on his face and body. Per the mother, no other symptoms were noted at that time. He was seen by his physician on 24 December 2003. He subsequently developed the following: apnea, encephalopathy, viral infection, thinking abnormal, gait abnormal, Guillain Barre Syndrome, speech disorder, abnormal vision, agitation, allergic reaction, anorexia, convulsion, deafness, dyspnea, facial edema, and fever. The events were considered to be life-threatening, and the patient was hospitalized. No additional information regarding etiology, treatment, or outcome was provided.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Thinking abnormal, Viral infection, Visual impairment
Clinical narrative: This case was extracted from the VAERS database via QSCAN on 11 March 2009 (reference number 232432). A two-year-old male patient received an intramuscular right deltoid injection of FLUZONE SV (lot U1270AA) on 12 December 2003. Within one week post-vaccination the patient's mother noted redness around the eyes, and two weeks post-vaccination he developed a rash on his face and body. Per the mother, no other symptoms were noted at that time. He was seen by his physician on 24 December 2003. He subsequently developed the following: apnea, encephalopathy, viral infection, thinking abnormal, gait abnormal, Guillain Barre Syndrome, speech disorder, abnormal vision, agitation, allergic reaction, anorexia, convulsion, deafness, dyspnea, facial edema, and fever. The events were considered to be life-threatening, and the patient was hospitalized. No additional information regarding etiology, treatment, or outcome was provided.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye irritation, Wheezing
Clinical narrative: This case was extracted from the database via QScan on 11 March 2009 (reference number 245661). A 50-year-old male patient, whose past medical history was not reported, had received on 14 October 2005 at 12:00 pm an intramuscular injection of FLUZONE SV 2005-2005 USP (lot number U1753AA). The route and site of administration was not reported. Approximately fours after receiving the FLUZONE at around 4:00 pm, the patient developed a wheeze, cough and eye irritation. The patient was evaluated in the emergency room and received nebulizer treatment and a prescription for MEDROL dose pack. Relevant diagnostic tests and laboratory data performed were not reported. "None" was recorded at the end of narrative. The patient recovered (date not reported). Documents held by sender: None.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Cough, Eye irritation, Oropharyngeal pain, Throat tightness
Clinical narrative: This case was extracted from VAERS via a search of QScan on 11 March 2009 (reference number 245933).  A 66-year-old female patient received an intramuscular dose of FLUZONE (lot number U1744AA) on 20 October 2005.  Within three hours of vaccination, she complained of coughing spasms, throat tightness, wheezing, blurred vision, sore throat, and "matted eyes".  She was seen by her physician, and treated with a corticosteroid shot, antihistamines, and eye drops. The event subsequently recovered.  In addition to the above events, the event "asthenia" was also reported in VAERS.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred, Wheezing
Clinical narrative: This case was extracted from VAERS via a search of QScan on 11 March 2009 (reference number 245933).  A 66-year-old female patient received an intramuscular dose of FLUZONE (lot number U1744AA) on 20 October 2005.  Within three hours of vaccination, she complained of coughing spasms, throat tightness, wheezing, blurred vision, sore throat, and "matted eyes".  She was seen by her physician, and treated with a corticosteroid shot, antihistamines, and eye drops. The event subsequently recovered.  In addition to the above events, the event "asthenia" was also reported in VAERS.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Cold sweat, Dysphonia, Dyspnoea, Pallor, Wheezing
Clinical narrative: This case was extracted from database via QScan on 11 March 2009 (reference number 246243). A 43 year old male patient received FLUZONE (lot number reported as 41771A, invalid lot number) intramuscularly on 26 October 2005. The patient woke up at 11:30 PM and his voice was unrecognizable. His voice was very hoarse, became pale, skin was cold and clammy, and he began wheezing. He was having trouble breathing and "getting his breath". The patient's symptoms were disclosed to the emergency department. The emergency department did not think the symptoms were vaccine related and the symptoms would occur 10 to 12 hours after the vaccine was administered. The patient was made as comfortable as possible. The patient's outcome was reported as a life threatening illness and disabling. No further information was reported. List of Documents held by Sender: none.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Electrocardiogram abnormal, Full blood count abnormal, Metabolic function test, Ocular hyperaemia
Clinical narrative: This case was reported from the database via QScan on 11 March 2009 (reference number 247276). A 60 year old female patient received FLUZONE (lot number U1913AA) intramuscularly on 10 November 2005. The developed shortness of breath, blood shot eyes, tingling lips, abnormal EKG, CMP, CBC on 10 November 2005. The patient had a doctor's visit or an emergency room visit. The patient was reported as recovered. No further information was provided. List of Documents held by Sender: None.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia oral
Clinical narrative: This case was reported from the database via QScan on 11 March 2009 (reference number 247276). A 60 year old female patient received FLUZONE (lot number U1913AA) intramuscularly on 10 November 2005. The developed shortness of breath, blood shot eyes, tingling lips, abnormal EKG, CMP, CBC on 10 November 2005. The patient had a doctor's visit or an emergency room visit. The patient was reported as recovered. No further information was provided. List of Documents held by Sender: None.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Amblyopia, Blood test, Computerised tomogram, Conjunctivitis, Cough
Clinical narrative: This case was extracted from VAERS via QSCAN on 11 March 2009 (reference number 247380). A 53-year-old female patient received an intramuscular injection of FLUZONE SV '2005-'2006 USP (lot number U1778AA) on an unspecified date. Within four hours of vaccination, the patient complained of blurred vision, cough, blood shot and swollen eyes, tight throat, and low-grade nausea. She was seen in the emergency room and given intravenous fluids. She underwent a CT scan and blood work (results not reported). She recovered within 24 hours of vaccination.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Face oedema, Laryngospasm, Nausea, Ocular hyperaemia
Clinical narrative: This case was extracted from VAERS via QSCAN on 11 March 2009 (reference number 247380). A 53-year-old female patient received an intramuscular injection of FLUZONE SV '2005-'2006 USP (lot number U1778AA) on an unspecified date. Within four hours of vaccination, the patient complained of blurred vision, cough, blood shot and swollen eyes, tight throat, and low-grade nausea. She was seen in the emergency room and given intravenous fluids. She underwent a CT scan and blood work (results not reported). She recovered within 24 hours of vaccination.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Vision blurred
Clinical narrative: This case was extracted from VAERS via QSCAN on 11 March 2009 (reference number 247380). A 53-year-old female patient received an intramuscular injection of FLUZONE SV '2005-'2006 USP (lot number U1778AA) on an unspecified date. Within four hours of vaccination, the patient complained of blurred vision, cough, blood shot and swollen eyes, tight throat, and low-grade nausea. She was seen in the emergency room and given intravenous fluids. She underwent a CT scan and blood work (results not reported). She recovered within 24 hours of vaccination.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Ocular hyperaemia, Wheezing
Clinical narrative: This case was extracted from the VAERS database via QScan on 11 March 2009 (reference number 247898). A 59 year old female patient received FLUZONE (lot number U1830AA) intramuscularly on 04 November 2005. That same day, the patient became short of breath, began wheezing, and coughing about three hours post vaccination and her eyes were red. The patient was brought to ER where she was given oxygen and an injection of BENADRYL. She was instructed to take an over the counter BENADRYL in the morning. The patient was recovered. List of Documents held by Sender: none.