chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Cardiac stress test, Computerised tomogram, Computerised tomogram normal, Echocardiogram, Electroencephalogram
Clinical narrative: Syncope 24 hours post injection,no warning signs,hit head on door frame,hospitalized 4days for cardiac,neuro,testing.All negative findings. 11/27/07 Reviewed hospital medical records which reveal patient experienced a sudden loss of consciousness & fell in doctor's office where patient works.  Sustained a laceration of occiput & was dizzy afterward.  Admitted 10/10-10/13/2007.  Neuro, neurosurgery & cardio consults done.  No recurrent symptoms but continued w/mild dizziness at d/c to home w/neuro f/u for outpatient EEG. FINAL DX: syncope, likely secondary to vasovagal event; mild concussion; scalp laceration./
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Head injury, Laboratory test, Spinal X-ray, Syncope
Clinical narrative: Syncope 24 hours post injection,no warning signs,hit head on door frame,hospitalized 4days for cardiac,neuro,testing.All negative findings. 11/27/07 Reviewed hospital medical records which reveal patient experienced a sudden loss of consciousness & fell in doctor's office where patient works.  Sustained a laceration of occiput & was dizzy afterward.  Admitted 10/10-10/13/2007.  Neuro, neurosurgery & cardio consults done.  No recurrent symptoms but continued w/mild dizziness at d/c to home w/neuro f/u for outpatient EEG. FINAL DX: syncope, likely secondary to vasovagal event; mild concussion; scalp laceration./
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: pt complained of HA and fever and sore arm
Age: 1.3
Sex: F
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Computerised tomogram normal, Convulsion, Electroencephalogram normal, Full blood count normal, Metabolic function test normal
Clinical narrative: seizures x 2 the day after immunizations.  11/05/2007 MR received for DOS 9/25-26/2007 with DX: probable provoked seizures 2' to immunizations.  Child presented to ER after an episode of irritability follwed by  becoming rigid, back arching, extension of extremities, eyes rollling back and subsequent limpness. Event was preceded by low grade fever. Child had shallow respirations and was poorly responsive for 5-10 minutes. Upon arrival to ER pt was fine but had a 2nd episode in the ER with apnea, unresponsive limpness x1 minute.  Admitted for observation with no further episodes.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain
Clinical narrative: Patient was administered the pneumovax 23 this past Monday and after about 24 hours was having pain in her upper left ar and then the pain spreed down her arm to her lower back.  She went to her physican and he told her that she had cellulitus and was given Keflex 500mg 1bid for 10 days
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Patient called me on the morning of 10/20/2007 to report that her left deltiod was inflamed, red, hot and sore. This occurred late last night and had not progressed since then. Area affected was about palm-sized around the area where the shot was administered and was localized. She felt fine otherwise and didn't have any chest tightness, hives or breathing problems. I instructed her to take benadryl as directed on the box, ibuprofen, and to ice the area periodically throught the day. I will follow up tomorrow morning.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: Pt experienced itching sensation and hives on face, neck, and back.  Also dizziness without syncope.  Pt was placed in position of comfort, seen by in-house physician, ordered and given 50mg of benadryl IM in opposite arm as flu shot, was observed for 40 minutes. Pt stated feeling better, hives and itching resolved.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Blood test, Lethargy, Pruritus, Rash
Clinical narrative: MMR was administered with known ear infection.  Antibiotics (amoxycillin) started same day as MMR.  Severe rash started on the 10th day.  Spread to entire body.  Lethargic.  Mild itching of face and eyes.  Doctor visit immediately after rash started; Benadryl (OTC) prescribed; 2nd day rash was worse; went to hospital for blood work to rule out measles.  5th day, doctor confirmed results that rash was due to an allergic reaction to the MMR vaccine.  Rash began to clear up the on 4th day, but took 4 weeks to completely fade away.  (note: also used baking soda during bath on 2 occasions)
Age: 1.3
Sex: F
Vaccine: DTAPH, HIBV, MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Expressive language disorder, Febrile convulsion, Intelligence test
Clinical narrative: Patient HAD A VERY BAD COLD IMMEDIATELY AFTER GETTING THOSE VACCINATIONS.  FURTHER, A FEW WEEKS LATER SHE SUFFERED A FEBRILE SEIZURE WHICH LED TO HER HOSPITALIZATION FOR 4 DAYS. Patient HAD ALREADY BEEN TALKING AT THE TIME OF THE SEIZURE.  HOWEVER, ALL SPEECH WAS LOST, BEHAVIOR CHANGED, AND SHE HAS BEEN DIAGNOSED WITH AUTISM AND HAVE BEEN UNDER THE CARE OF A NEUROLOGIST, OCCUPATIONAL THERAPIST AND SPEECH THERAPIST FROM THAT TIME ON.    10/30/07 Reviewed pcp medical records which included vax records.  F/u visit of 9/30/05 reveals patient in hospital for seizure 9/25/05.  EEG to be repeated. By visit of 2/23/06, concerned for autism due to no eye contact, lack of speech, developmental delays & dare devil behaviors.  Referred to developmental pediatrics for early intervention.  Referred for hearing eval.  1/25/08 Reviewed ER medical records of 9/25/2005 which reveal patient experienced shaking & eyes rolling.  Tx w/antiseizure meds & transferred to higher level of care.   FINAL ER DX: convulsions. 3/5/08 Reviewed hospital medical records. FINAL DX: new onset seizures.  Admit of 9/25-9/27/2005 reveals patient experienced tonic-clonic seizure x 1-2 min followed by unresponsiveness.  Seen in outlying ER & transferred here.  Neuro consult done.  Tx w/Pb.  No further seizures during hospital stay.  D/C to f/u w/pcp.
Age: 1.3
Sex: F
Vaccine: DTAPH, HIBV, MMR, VARCEL
Symptoms: Nasopharyngitis
Clinical narrative: Patient HAD A VERY BAD COLD IMMEDIATELY AFTER GETTING THOSE VACCINATIONS.  FURTHER, A FEW WEEKS LATER SHE SUFFERED A FEBRILE SEIZURE WHICH LED TO HER HOSPITALIZATION FOR 4 DAYS. Patient HAD ALREADY BEEN TALKING AT THE TIME OF THE SEIZURE.  HOWEVER, ALL SPEECH WAS LOST, BEHAVIOR CHANGED, AND SHE HAS BEEN DIAGNOSED WITH AUTISM AND HAVE BEEN UNDER THE CARE OF A NEUROLOGIST, OCCUPATIONAL THERAPIST AND SPEECH THERAPIST FROM THAT TIME ON.    10/30/07 Reviewed pcp medical records which included vax records.  F/u visit of 9/30/05 reveals patient in hospital for seizure 9/25/05.  EEG to be repeated. By visit of 2/23/06, concerned for autism due to no eye contact, lack of speech, developmental delays & dare devil behaviors.  Referred to developmental pediatrics for early intervention.  Referred for hearing eval.  1/25/08 Reviewed ER medical records of 9/25/2005 which reveal patient experienced shaking & eyes rolling.  Tx w/antiseizure meds & transferred to higher level of care.   FINAL ER DX: convulsions. 3/5/08 Reviewed hospital medical records. FINAL DX: new onset seizures.  Admit of 9/25-9/27/2005 reveals patient experienced tonic-clonic seizure x 1-2 min followed by unresponsiveness.  Seen in outlying ER & transferred here.  Neuro consult done.  Tx w/Pb.  No further seizures during hospital stay.  D/C to f/u w/pcp.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Developed a boil area appx. 3-4inchs diameter, area surrounding boil, hot to touch, tight, raised off arm(right, extremly itchy, 3rd day after vaccine given, developed swollen area which is progrssivly getting larger, constant generalized joint pain.  Difficulty ambulating, getting out of bed, tylenol, motrin, naproxen, no effect.  lymph nodes under arm, up neck under throat, painful not enlarged.  generalized skin itchy all over, all the time. Had difficulty breathing 2-3 days after given shot.  Sometimes feel dizziness, lightheaded, fatigue all the time.  Usual flu like symptoms, chills, sweating, high temp.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Furuncle, Gait disturbance, Hyperhidrosis, Influenza like illness, Lymph node pain
Clinical narrative: Developed a boil area appx. 3-4inchs diameter, area surrounding boil, hot to touch, tight, raised off arm(right, extremly itchy, 3rd day after vaccine given, developed swollen area which is progrssivly getting larger, constant generalized joint pain.  Difficulty ambulating, getting out of bed, tylenol, motrin, naproxen, no effect.  lymph nodes under arm, up neck under throat, painful not enlarged.  generalized skin itchy all over, all the time. Had difficulty breathing 2-3 days after given shot.  Sometimes feel dizziness, lightheaded, fatigue all the time.  Usual flu like symptoms, chills, sweating, high temp.
Age: 34.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Pruritus generalised, Skin tightness, Skin warm, Swelling
Clinical narrative: Developed a boil area appx. 3-4inchs diameter, area surrounding boil, hot to touch, tight, raised off arm(right, extremly itchy, 3rd day after vaccine given, developed swollen area which is progrssivly getting larger, constant generalized joint pain.  Difficulty ambulating, getting out of bed, tylenol, motrin, naproxen, no effect.  lymph nodes under arm, up neck under throat, painful not enlarged.  generalized skin itchy all over, all the time. Had difficulty breathing 2-3 days after given shot.  Sometimes feel dizziness, lightheaded, fatigue all the time.  Usual flu like symptoms, chills, sweating, high temp.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT RECEIVED PNEUMOVAX RIGHT DELTOID ON 10/18/07.  NOTED SWELLING, TENDERNESS, AND "RED" SPOTS APPROX. ONE INCH BELOW INJECTION SITE ON 10/20/07.
Age: 20.0
Sex: M
Vaccine: FLUX
Symptoms: Asthenia, Blood test, Chills, Culture urine negative, Dizziness
Clinical narrative: 3:00 pm headache,  4:30 high fever and chills,along with hands and feet feeling numb, 6:00 throwing up,weak and dizzy,  7:00 pm lips swollen, face swollen and shallow labored breathing and a fever of 103 F, called primary care physician on call and recommended immediate transport to emergency room.
Age: 20.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Hypoaesthesia, Hypoventilation, Lip swelling, Pyrexia
Clinical narrative: 3:00 pm headache,  4:30 high fever and chills,along with hands and feet feeling numb, 6:00 throwing up,weak and dizzy,  7:00 pm lips swollen, face swollen and shallow labored breathing and a fever of 103 F, called primary care physician on call and recommended immediate transport to emergency room.
Age: 20.0
Sex: M
Vaccine: FLUX
Symptoms: Swelling face, Vomiting
Clinical narrative: 3:00 pm headache,  4:30 high fever and chills,along with hands and feet feeling numb, 6:00 throwing up,weak and dizzy,  7:00 pm lips swollen, face swollen and shallow labored breathing and a fever of 103 F, called primary care physician on call and recommended immediate transport to emergency room.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Blood culture, Computerised tomogram, Convulsion, Culture urine
Clinical narrative: Around two hours after flu shot, patient experienced a seizure that lasted approximately two minutes.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Blood immunoglobulin G, Diarrhoea, Fatigue, Full blood count, Headache
Clinical narrative: Vomiting, nausea, headaches, extreme tiredness, fatigue, diarreha, mild grade fever, muscle aches, stiff neck, pain in calves, quads, and hips.  10/26/07 At request of CDC, f/u started.  T/C to parent to check recovery status of patient.  Spoke w/father/reporter who stated patient is unchanged since s/s first developed 2-3 days s/p vaccination.  Has been f/u in ID clinic at hospital.  No diagnosis made.  Awaiting neurology f/u.  10/26/07 Received t/c from pcp.  Agreed w/info received from parent.  Has referred to neuro but doubts GBS.  Provided NIP contact info. Letter faxed to request med records. 11/6/07 Reviewed vax record from pcp & VAERS database updated w/same. Outpatient ID clinic report of 10/15/07 reveals patient experienced  vomiting, diarrhea & fatigue 3 days s/p vaccine.  This lasted approx 10 days & the fatigue, intermittent HA, sore throat, difficulty sleeping & leg pain  persisted beyond that.  Seen in clinic on 10/15/2007.  Had not be able to attend school or participate in sports.  Had traveled out of the country approx 1 month prior to onset of current illness.  Rheum clinic reports of 10/11/07 reveal left knee pain x 4 mos duration.  Exam revealed marked crepitus of left knee s/o tenderness.  X-rays & MRI  were requested.  Referred to Ortho clinic.  No additional records available. FINAL DX: chronic fatigue of unknown etiology, probable nonspecific post infectious immune process.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Helicobacter pylori identification test, Monocyte count, Musculoskeletal stiffness, Myalgia, Nausea
Clinical narrative: Vomiting, nausea, headaches, extreme tiredness, fatigue, diarreha, mild grade fever, muscle aches, stiff neck, pain in calves, quads, and hips.  10/26/07 At request of CDC, f/u started.  T/C to parent to check recovery status of patient.  Spoke w/father/reporter who stated patient is unchanged since s/s first developed 2-3 days s/p vaccination.  Has been f/u in ID clinic at hospital.  No diagnosis made.  Awaiting neurology f/u.  10/26/07 Received t/c from pcp.  Agreed w/info received from parent.  Has referred to neuro but doubts GBS.  Provided NIP contact info. Letter faxed to request med records. 11/6/07 Reviewed vax record from pcp & VAERS database updated w/same. Outpatient ID clinic report of 10/15/07 reveals patient experienced  vomiting, diarrhea & fatigue 3 days s/p vaccine.  This lasted approx 10 days & the fatigue, intermittent HA, sore throat, difficulty sleeping & leg pain  persisted beyond that.  Seen in clinic on 10/15/2007.  Had not be able to attend school or participate in sports.  Had traveled out of the country approx 1 month prior to onset of current illness.  Rheum clinic reports of 10/11/07 reveal left knee pain x 4 mos duration.  Exam revealed marked crepitus of left knee s/o tenderness.  X-rays & MRI  were requested.  Referred to Ortho clinic.  No additional records available. FINAL DX: chronic fatigue of unknown etiology, probable nonspecific post infectious immune process.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Pain, Pyrexia, Red blood cell sedimentation rate, Vomiting
Clinical narrative: Vomiting, nausea, headaches, extreme tiredness, fatigue, diarreha, mild grade fever, muscle aches, stiff neck, pain in calves, quads, and hips.  10/26/07 At request of CDC, f/u started.  T/C to parent to check recovery status of patient.  Spoke w/father/reporter who stated patient is unchanged since s/s first developed 2-3 days s/p vaccination.  Has been f/u in ID clinic at hospital.  No diagnosis made.  Awaiting neurology f/u.  10/26/07 Received t/c from pcp.  Agreed w/info received from parent.  Has referred to neuro but doubts GBS.  Provided NIP contact info. Letter faxed to request med records. 11/6/07 Reviewed vax record from pcp & VAERS database updated w/same. Outpatient ID clinic report of 10/15/07 reveals patient experienced  vomiting, diarrhea & fatigue 3 days s/p vaccine.  This lasted approx 10 days & the fatigue, intermittent HA, sore throat, difficulty sleeping & leg pain  persisted beyond that.  Seen in clinic on 10/15/2007.  Had not be able to attend school or participate in sports.  Had traveled out of the country approx 1 month prior to onset of current illness.  Rheum clinic reports of 10/11/07 reveal left knee pain x 4 mos duration.  Exam revealed marked crepitus of left knee s/o tenderness.  X-rays & MRI  were requested.  Referred to Ortho clinic.  No additional records available. FINAL DX: chronic fatigue of unknown etiology, probable nonspecific post infectious immune process.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactic reaction, Face oedema, Swelling face, Urticaria generalised
Clinical narrative: Information has been received from an agency concerning a 14 year old female with no medical history, who on 23-AUG-2007 was vaccinated in the left arm with a first dose of Gardasil (Lot# 658558/1061U). There was no concomitant medication. There were no illnesses at the time of the vaccination. On 23-AUG-2007 within 12 hours of the vaccination the patient developed an anaphylactic type 1 reaction with face oedema, swelling face and generalised urticaria. The patient was hospitalized. The patient recovered on an unspecified date. The anaphylactic reaction, face oedema, swelling face, and generalised urticaria were considered to be life threatening. The VAERS ID number was 288955. A standard lot check investigation was performed. 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 for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Anaphylactoid reaction, Face oedema, Swelling face, Urticaria
Clinical narrative: Information has been received from an agency concerning a 14 year old female with no medical history, who on 23-AUG-2007 was vaccinated in the left arm with a first dose of Gardasil (Lot# 658558/1061U). There was no concomitant medication. There were no illnesses at the time of the vaccination. On 23-AUG-2007 within 12 hours of the vaccination the patient developed an anaphylactic type 1 reaction with face oedema, swelling face and generalised urticaria. The patient was hospitalized. The patient recovered on an unspecified date. The anaphylactic reaction, face oedema, swelling face, and generalised urticaria were considered to be life threatening. The VAERS ID number was 288955. A standard lot check investigation was performed. 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 for Biologics Evaluation and Research and was released. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaemia, Bacterial infection, Body temperature increased, Dehydration, Dermatitis
Clinical narrative: 8/5/07 Started to get shingles. 8/07/07 Went to doctor. He said it was the worse case of shingles he saw and also a green infection. Called an ambulance to his office and took me to the hospital for 5 days.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fungal infection, Herpes zoster, Hyperlipidaemia, Hypokalaemia, Impetigo
Clinical narrative: 8/5/07 Started to get shingles. 8/07/07 Went to doctor. He said it was the worse case of shingles he saw and also a green infection. Called an ambulance to his office and took me to the hospital for 5 days.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise, Myalgia, Red blood cell sedimentation rate increased, Renal failure, Sepsis
Clinical narrative: 8/5/07 Started to get shingles. 8/07/07 Went to doctor. He said it was the worse case of shingles he saw and also a green infection. Called an ambulance to his office and took me to the hospital for 5 days.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Superinfection, Syncope
Clinical narrative: 8/5/07 Started to get shingles. 8/07/07 Went to doctor. He said it was the worse case of shingles he saw and also a green infection. Called an ambulance to his office and took me to the hospital for 5 days.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Infection, Skin infection
Clinical narrative: 8/5/07 Started to get shingles. 8/07/07 Went to doctor. He said it was the worse case of shingles he saw and also a green infection. Called an ambulance to his office and took me to the hospital for 5 days.
Age: 0.4
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Diarrhoea, Haematochezia, Occult blood positive, Stool analysis normal
Clinical narrative: Developed diarrhea 10/7/07 >5 x 1 day. guaiac positive. Stool studies pending.
Age: 0.4
Sex: M
Vaccine: RV5, DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Culture stool, Diarrhoea, Occult blood positive
Clinical narrative: Developed diarrhea 10/7/07 >5 x 1 day. guaiac positive. Stool studies pending.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Asthenia, Crying, Headache, Nausea, No reaction on previous exposure to drug
Clinical narrative: Patient has felt weak, nauseated and has broken out in hives repeatedly since she received her immunizations 3 days ago. She was given 4 shots in the same day, TDAP, HEP A, HPV, and Meningococcal. She has not had an allergic reaction to any previous immunizations, nor has she had hives or rashes as reactions to any substance in the past. At the outbreak of the hives we have treated her with the maximum dose of Benadryl which has controlled the rash temporarily, however, it has returned twice. On the third day she began complaining of a severe headache, so bad she began to cry uncontrollably. We gave her ibuprofen and within an hour her headache had improved.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Patient has felt weak, nauseated and has broken out in hives repeatedly since she received her immunizations 3 days ago. She was given 4 shots in the same day, TDAP, HEP A, HPV, and Meningococcal. She has not had an allergic reaction to any previous immunizations, nor has she had hives or rashes as reactions to any substance in the past. At the outbreak of the hives we have treated her with the maximum dose of Benadryl which has controlled the rash temporarily, however, it has returned twice. On the third day she began complaining of a severe headache, so bad she began to cry uncontrollably. We gave her ibuprofen and within an hour her headache had improved.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Nausea, Pain in extremity, Rash erythematous, Urticaria
Clinical narrative: Patient has felt weak, nauseated and has broken out in hives repeatedly since she received her immunizations 3 days ago. She was given 4 shots in the same day, TDAP, HEP A, HPV, and Meningococcal. She has not had an allergic reaction to any previous immunizations, nor has she had hives or rashes as reactions to any substance in the past. At the outbreak of the hives we have treated her with the maximum dose of Benadryl which has controlled the rash temporarily, however, it has returned twice. On the third day she began complaining of a severe headache, so bad she began to cry uncontrollably. We gave her ibuprofen and within an hour her headache had improved.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: Patient has felt weak, nauseated and has broken out in hives repeatedly since she received her immunizations 3 days ago. She was given 4 shots in the same day, TDAP, HEP A, HPV, and Meningococcal. She has not had an allergic reaction to any previous immunizations, nor has she had hives or rashes as reactions to any substance in the past. At the outbreak of the hives we have treated her with the maximum dose of Benadryl which has controlled the rash temporarily, however, it has returned twice. On the third day she began complaining of a severe headache, so bad she began to cry uncontrollably. We gave her ibuprofen and within an hour her headache had improved.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Asthenia, Crying, Headache, Nausea, No reaction on previous exposure to drug
Clinical narrative: Vaccinated afternoon of October 18, 2007.  Client experienced slight sore arms after vaccinations that evening.  On the 19th, at approximately 6pm client developed a raised red rash starting at her ears and immediately and quickly working down the rest of her body (hives.) Parent administered benadryl.  Rash improved.  On Oct. 20th the rash appeared at approximately 24 hrs later in the same matter as the day before.  Benadryl was administered and rash disappeared.  On Oct 21st, experienced a severe headache and nausea. Ibuprofen was administered and ice pack applied to neck.  Rash reappeared the same as the previous days and Benadryl was given.  Oct 22, child went to school but came home in the middle of day due to nausea, headache, and blurred vision.  Parent reports child did not develop fever at anytime. All symptoms are intermittant.  Other times child feels normal.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: Vaccinated afternoon of October 18, 2007.  Client experienced slight sore arms after vaccinations that evening.  On the 19th, at approximately 6pm client developed a raised red rash starting at her ears and immediately and quickly working down the rest of her body (hives.) Parent administered benadryl.  Rash improved.  On Oct. 20th the rash appeared at approximately 24 hrs later in the same matter as the day before.  Benadryl was administered and rash disappeared.  On Oct 21st, experienced a severe headache and nausea. Ibuprofen was administered and ice pack applied to neck.  Rash reappeared the same as the previous days and Benadryl was given.  Oct 22, child went to school but came home in the middle of day due to nausea, headache, and blurred vision.  Parent reports child did not develop fever at anytime. All symptoms are intermittant.  Other times child feels normal.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Headache, Nausea, Pain in extremity, Rash erythematous, Urticaria
Clinical narrative: Vaccinated afternoon of October 18, 2007.  Client experienced slight sore arms after vaccinations that evening.  On the 19th, at approximately 6pm client developed a raised red rash starting at her ears and immediately and quickly working down the rest of her body (hives.) Parent administered benadryl.  Rash improved.  On Oct. 20th the rash appeared at approximately 24 hrs later in the same matter as the day before.  Benadryl was administered and rash disappeared.  On Oct 21st, experienced a severe headache and nausea. Ibuprofen was administered and ice pack applied to neck.  Rash reappeared the same as the previous days and Benadryl was given.  Oct 22, child went to school but came home in the middle of day due to nausea, headache, and blurred vision.  Parent reports child did not develop fever at anytime. All symptoms are intermittant.  Other times child feels normal.
Age: 12.0
Sex: F
Vaccine: HEPA, HPVX, MEN, TDAP, HEPA, HPV4, MNQ, TDAP
Symptoms: Vision blurred
Clinical narrative: Vaccinated afternoon of October 18, 2007.  Client experienced slight sore arms after vaccinations that evening.  On the 19th, at approximately 6pm client developed a raised red rash starting at her ears and immediately and quickly working down the rest of her body (hives.) Parent administered benadryl.  Rash improved.  On Oct. 20th the rash appeared at approximately 24 hrs later in the same matter as the day before.  Benadryl was administered and rash disappeared.  On Oct 21st, experienced a severe headache and nausea. Ibuprofen was administered and ice pack applied to neck.  Rash reappeared the same as the previous days and Benadryl was given.  Oct 22, child went to school but came home in the middle of day due to nausea, headache, and blurred vision.  Parent reports child did not develop fever at anytime. All symptoms are intermittant.  Other times child feels normal.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Anxiety, Chest discomfort, Dysphonia, Dyspnoea
Clinical narrative: within 1 1/2 hours she began having trouble breathing, tightness, bad stomach pain, felt very hot, very tired - wanted to go to sleep right then, became hoarse, very anxious, felt like she could cry  - she used an inhaler to help with her breathing, she has exercise induced asthma
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Feeling hot
Clinical narrative: within 1 1/2 hours she began having trouble breathing, tightness, bad stomach pain, felt very hot, very tired - wanted to go to sleep right then, became hoarse, very anxious, felt like she could cry  - she used an inhaler to help with her breathing, she has exercise induced asthma
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Disorientation, Dizziness, Feeling abnormal, Malaise
Clinical narrative: I received the shot at about 11 a.m. on  11/20/07 at the office of my son's pediatrician; my 20-month son received it too.  Hours after the shot I started to fell dizziness, weak, like vomiting and this continued until the next day (today). Today, around mid day I vomited my hands shaked for most of the day as if I had drank a high dosage of caffine. I feel very weak and spacey/disoriented. My son seems to be okay. My ex, my son's father also received the shot at the same time that my son and I did. He says that he has felt fine. Today, I had to rest for part of the day because I did not feel well.  If this feeling continues tomorrow morning, I will go in to see a doctor. I have had the shot before but have not had this reaction. I don't know why I am feeling this way this time, I was not ill before I received it.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Tremor, Vomiting
Clinical narrative: I received the shot at about 11 a.m. on  11/20/07 at the office of my son's pediatrician; my 20-month son received it too.  Hours after the shot I started to fell dizziness, weak, like vomiting and this continued until the next day (today). Today, around mid day I vomited my hands shaked for most of the day as if I had drank a high dosage of caffine. I feel very weak and spacey/disoriented. My son seems to be okay. My ex, my son's father also received the shot at the same time that my son and I did. He says that he has felt fine. Today, I had to rest for part of the day because I did not feel well.  If this feeling continues tomorrow morning, I will go in to see a doctor. I have had the shot before but have not had this reaction. I don't know why I am feeling this way this time, I was not ill before I received it.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient developed redness/swelling at site of injection with progression of swelling/redness to elbow and shoulder-non-circumferential.  patient also had bone "achiness" for 3 days.  Redness and swelling improved in about 1 week.  No other symptoms.  Patient back to baseline.
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Body temperature increased, Culture negative, Irritability, Otitis media acute, Pyrexia
Clinical narrative: EXTREAM FUSSINESS GREATER THAN 6 HOURS TEMP TO 102 18 HOURS LATER.  12/03/2007 MR received for DOS 10/16-18/2007 with DX: fussiness. Mother reported inconsolable crying with vomiting after receiving vax.  Child was found to be tachycardic (HR 166) and was admitted for post-immunization reaction, increased fussiness, emesis. Child developed a fever of 102 after admission and was txd with abx.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: wrong age appropriate vaccine given to age of child.  This vaccine is not lisenced for this child's age.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: Reddened area,size of softball, warm to touch and swollen at site injection.  Further states she used cold wash cloths the day of injection and warm the next day.  Parent called physician and was instructed to use ice to site with Benadryl and Tylenol for symptom relief. Initial notice to clinic on 10/19/07. On 10/22/07 mother states child lethargic all weekend with headache.  Improved this morning and able to attend school.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Renal failure
Clinical narrative: Information has been received from a pharmacist concerning a 21 year old female who on 12-MAR-2007 was vaccinated with a dose of Gardasil, injection (form), 0.5 ml. Concomitant  therapy included metformin, drospirenone (+) ethinyl ethinyl estradiol (YASMIN), levofloxacin (LEVAQUIN) and naproxen. On 10-OCT-2007 after being vaccinated with her third dose of Gardasil, the patient experienced renal failure and was hospitalized. Unspecified medical attention was sought. The outcome of the event was not reported. renal failure was considered to be immediately life-threatening. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Electroencephalogram normal
Clinical narrative: Information has been received from a medical assistant (M.A) concerning a 16 year old female patient who on 02-JUL-2007 was vaccinated with a first dose of Gardasil. Patient came back to the office on 03-JUL-2007 and said that she had experienced seizure like activity. The physician had done an electroencephalography (EEG) on 23-JUL-2007 and did a second electroencephalography (EEG) on 21-SEP-2007 and both came back negative. No further information was available. The patient recovered on an unknown date. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Clinical narrative: Information has been received from a physician concerning a 1 year old patient, who on an unspecified date, was vaccinated with a dose of Rotateq. Subsequently, the patient was hospitalized for the intussusception (unknown dates and length of hospitalization). The treatment the patient received in the hospital was unspecified. The physician did not associate the intussusception with Rotateq. The patient sought medical attention, "by exam". No other symptoms or treatment were reported. The patient was recovering. There was no product quality complaint. Additional information has been requested.  10/25/07 Patient demographics provided by CDC. 11/16/07 Reviewed hospital medical records which reveal patient experienced bilious vomiting x 1 day.  Admitted 10/9-10/14/2007.  Unable to reduce IS w/BE.  Surgery consult.  OR for laparotomy, reductionof ileo-colic IS, resection of 12 cm ileum for Meckles diverticulum & appendectomy.  Progressed well & d/c to home FINAL DX: Intussusception & Meckles diverticulum, surgically reduced. Records faxed to CDC. 12/11/07 Reviewed vax record from pcp.  VAERS database updated w/same. Record faxed to CDC.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: Information has been received from a registered nurse concerning two patients who were vaccinated with Rotateq PO (dose not reported). The nurse reported that two patients who had received Rotateq subsequently developed blood in their stool. Upon internal review blood in the stool was determined to be an other important medical event. Additional information has been requested to obtain patient identifiers.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Crying, Intussusception, Pain
Clinical narrative: Information has been received from a physician concerning an 8 week old male who received his first dose of oral Rotateq. On an unspecified date, he was seen in the physician's office after he had developed sudden bouts of crying and appeared to be in pain. At the time of this report, the physician was awaiting the results of unspecified test but he suspects a diagnosis of intussusception. It is reported that the patient has not recovered. A product quality complaint was not reported. No further information was available. Upon internal review it was determined that intussusception was an other important medical event. Additional information has been requested.  10/23/07 Patient demographics provided by CDC./ss 10/23/2007 Reviewed hospital medical records which reveal patient experienced emesis x 2, diarrhea, irritability, decreased oral intake x 1 week.  Seen by pcp & KUB obtained c/w IS.  Confirmed by BE as outpatient & sent to outlying hospital but they were unable to do the BE for reduction.  Transferred to higher level of care.  Repeat KUB revealed distended bowel but no IS.  Admitted 9/7-9/8/07 for observation s/p reduction. Had recurrent IS s/s.  US of abdomen confirmed IS within transverse colon recurred & air contrast enema successfully reduced.  Surgical consult done. FINAL DX: Intussusception, enema reduced. Records faxed to CDC. 11/30/07 Reviewed hospital ER records which reveal patient seen 9/6/07 with intermittent emesis, watery stools & poor appetite x 4 days.  BE revealed IS & patient transferred to higher level of care.  Records faxed to CDC.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Barium enema, Diarrhoea, Enema administration, Flatulence, Intussusception
Clinical narrative: Information has been received from health professionals concerning a 7 month old male who received his first dose on 17-APR-2007, second dose 20-JUN-2007, and a third dose, 2 ml oral 21-AUG-2007, of Rotateq (lot #655866/1110F; 56385/0030U; 656381/0875U respectively). Concomitant vaccines included Hib conj vaccine (lot#'s53523/0063U and 654679/1126F respectively), PREVNAR (lot #'s B08691F; B08690H; and B58845F respectively), and PEDIARIX (lot #'s AC21B096A; AC21B114CA; and AC21B124AA respectively). On 11-SEP-2007, the patient's mother phoned the office reporting that the patient had developed a fever, loose stools, was gassy, and was screaming every 1 1/2 hours at night. He was seen in the office and stool samples on 12-SEP-2007 were negative for Rota virus. The reporter stated that he continued to experience symptoms "on and off over the next couple of weeks." He was seen in the office again on 04-OCT-2007, after developing loose stools with mucous and low grade fever "on and off". On 05-OCT-2007, he was hospitalized and underwent an x-ray with barium enema "which cleared the intussusception". He was seen in the office in follow up to his hospitalization and reportedly was "doing fine". The reporter stated "the admission to the hospital and enema administration was intervention to prevent serious criteria". No product quality complaint was reported. The patients experiences were considered to be other important medical events by the reporter. This is one of two reports from the same source. Additional information has been requested.  10/23/07 Patient demographics provided by CDC. 10/23/07 Recieved contrast enema report from CDC which reveals patient had ileocolic IS at hepatic flexure & was successfully reduced. 10/23/07 Received vax record from pcp & VAERS database updated w/same.  12/4/07 Received ER medical records which reveal patient experienced irritability, fever & distended abdomen.  BE reduced IS but transferred to higher level of care for continued observation. FINAL ER DX: Intussusception.  Records faxed to CDC. 12/7/07 Reviewed hospital medical records which reveal patient experienced abdominal discomfort for approx 1 month starting w/ulcerations in mouth & throat & progressed to nightly abdominal pain, large amounts of gas, low grade fever intermittently.  PCP tested for rotavirus which was neg.  Initially had increased WBC.  GI consult done as outpatient 1 week prior to admit who dx GERD, tx w/antacid & antibiotic.  Transferred from outlying ER s/p BE revealed IS.  Admitted 10/6 & d/c same day.  To f/u w/PCP & have GI small bowel series done as outpatient.  FINAL DX: abdominal pain, possible formula intolerance, unlikely intussusception.  Records faxed to CDC.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Mucous stools, Pyrexia, Rotavirus test negative, Screaming
Clinical narrative: Information has been received from health professionals concerning a 7 month old male who received his first dose on 17-APR-2007, second dose 20-JUN-2007, and a third dose, 2 ml oral 21-AUG-2007, of Rotateq (lot #655866/1110F; 56385/0030U; 656381/0875U respectively). Concomitant vaccines included Hib conj vaccine (lot#'s53523/0063U and 654679/1126F respectively), PREVNAR (lot #'s B08691F; B08690H; and B58845F respectively), and PEDIARIX (lot #'s AC21B096A; AC21B114CA; and AC21B124AA respectively). On 11-SEP-2007, the patient's mother phoned the office reporting that the patient had developed a fever, loose stools, was gassy, and was screaming every 1 1/2 hours at night. He was seen in the office and stool samples on 12-SEP-2007 were negative for Rota virus. The reporter stated that he continued to experience symptoms "on and off over the next couple of weeks." He was seen in the office again on 04-OCT-2007, after developing loose stools with mucous and low grade fever "on and off". On 05-OCT-2007, he was hospitalized and underwent an x-ray with barium enema "which cleared the intussusception". He was seen in the office in follow up to his hospitalization and reportedly was "doing fine". The reporter stated "the admission to the hospital and enema administration was intervention to prevent serious criteria". No product quality complaint was reported. The patients experiences were considered to be other important medical events by the reporter. This is one of two reports from the same source. Additional information has been requested.  10/23/07 Patient demographics provided by CDC. 10/23/07 Recieved contrast enema report from CDC which reveals patient had ileocolic IS at hepatic flexure & was successfully reduced. 10/23/07 Received vax record from pcp & VAERS database updated w/same.  12/4/07 Received ER medical records which reveal patient experienced irritability, fever & distended abdomen.  BE reduced IS but transferred to higher level of care for continued observation. FINAL ER DX: Intussusception.  Records faxed to CDC. 12/7/07 Reviewed hospital medical records which reveal patient experienced abdominal discomfort for approx 1 month starting w/ulcerations in mouth & throat & progressed to nightly abdominal pain, large amounts of gas, low grade fever intermittently.  PCP tested for rotavirus which was neg.  Initially had increased WBC.  GI consult done as outpatient 1 week prior to admit who dx GERD, tx w/antacid & antibiotic.  Transferred from outlying ER s/p BE revealed IS.  Admitted 10/6 & d/c same day.  To f/u w/PCP & have GI small bowel series done as outpatient.  FINAL DX: abdominal pain, possible formula intolerance, unlikely intussusception.  Records faxed to CDC.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 74 year old male with no medical history who was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included aspirin. On 05-SEP-2007 it was reported that the patient developed shingles. Unspecified medical attention was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the physician who stated that the patient had an outbreak of herpes zoster after vaccination. At the time of report the patient was not recovered. The patient's experience was considered to be an other important medical event by the reporter. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood count, Blood test, Full blood count normal, Genital pain, Genital swelling
Clinical narrative: Friday day of shot shot was given in afternoon extreme nervousness 08-11-2007, 08-12-2007, 08-13-07, 08-14-2007} woke up with anal + vaginal rash - swollen doctor gynecology appointment Rx Estrogen: 08-17-2007 doctor - shins + arms tingling - Rx Val: 08-30-2007 doctor - swollen right leg - stop Estrogen; 09-08-2007 both legs swollen - knees to ankles - gums swollen in my mouth; 09-08-2007 tongue swollen; 09-12-2007 doctor - Rx BLM suspension first mouthwash; 09-15-2007 left big toe swollen; 09-18-2007 doctor - throat and tongue swollen - Rx Nystatin; 09-19-2007 doctor; 09-24-2007, 10-03-2007; doctor - oral surgeon 10-05-07 doctor ENT.  10/30/07 Received pcp medical records which reveal patient not seen by MD on day of vax.  RTC 8/17 with c/o nervous, genital soreness & swelling, incontinence, rectal irritation, tingling of arms & legs x 1 day.  Injection site w/swelling & warmth.  RTC 8/30 with c/o leg edema & aching but no edema evident on exam.  RTC 9/12, 9/18, 9/19 w/tongue swelling x 4 days w/blisters, pain & difficulty swallowing.  Exam revealed swollen tongue w/white patches. Tx w/nystatin.  10/3/07 continues to c/o sore throat but exam is WNL.  Referred to ENT & otolaryngeal surgeon. FINAL DX: atrophic vaginitis; UTI; glossodynia; anxiety reaction. 11/16/07 Received oral surgeon medical records which reveal patient experienced swollen & painful tongue x 2 wks when seen on 9/24/07.  Exam WNL.  Returned 10/3 w/increased s/s.  Exam still WNL. 11/27/07 Reviewed otolaryngology & neurotology clinic notes of 10/5/07 reveal dx of pharyngitis; sensorineural hearing loss & tinnitus.  Return to clinic of 10/18/07 & added dx of atypical glossodynia. Per 60 day follow up: I have extreme nervousness, a constant swollen tongue & (achy gums sometimes) and trouble staying asleep. I have't had any help or results with my doctor so I just suffer and I am really depressed. Can you help me? I need to see a doctor. Do you have any suggestions? 1/12/2010 Center of tongue on top still burning and swollen. Nervous and anxiety. Trouble going to sleep and staying asleep. Follow-up Information 21-NOV-2007: I have been to an oral surgeon  2 time - 10-3-07, 9-24-07, a Ear Nose and Throat (ENT) 2 time - 10-5-07, 10-18-07, an ophthalmologist for red eyes - 11-02-07 almost every weeks since to. Dr - 10-03-07, 10-22-07, 11-07-07, 11-13-07. I've had all kinds of blood test but 5 no end to a solution. My tongue, left big toe are swollen and sore. Plus my back had a pinched nerve for the last week. I have an allergy test set for 11-28-07 I have even quit drinking a acup of tea in the morning to calm my nerves a little. I haven't felt good since 2 hrs after I received the Zostavax injection for shingles. Do you know of anything to help me. I feel just awful