chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL, HEPA, MMR, PNC, VARCEL
Symptoms: Varicella post vaccine, Varicella zoster virus serology positive
Clinical narrative: 2/24/09REPORTED TO PEDIATRICIAN ABOUT HIGH FEVER. TYLENOL NOT WORKING. BY 2/28/09 FEVER HIT 103.7. TESTED POSITIVE FOR STREP AT URGENT CARE CENTER. HOSPITALIZED ON 3/4/09 FEVER, RASH, BLISTERS, NOS STOP CRYING. DIAGNOSED WITH POST VACCINE CHICKENPOX. READMITTED ON 3/20/09 BANGING HIS HEAD, PULLING HAIR OUT, WEAKNESS ON RIGHT SIDE OF BODY, LOSS OF MOTOR SKILLS ON RIGHT SIDE, EXCESSIVE DROOLING,, FEVER, ENLARGED LIVER, CONSTIPATION, KIDNEY PROBLEMS, HIGH BLOOD PRESSURE(170/107). CURRENTLY IN PEDIATRIC INTENSIVE CARE UNIT  4/6/09 MR received for DOS 3/4-7/09 with DX: post vaccine varicella breakthrough.  Pt presented  with 10 day  hx of fever, coryza, diffuse rash and b/l upper and lower extremity swelling/edema.  PE (+) for erythematous tonsils, shotty lymphadenopathy, b/l tibial/foot/hand edema, diffuse maculopapular rash on trunk and extremities with several papular lesions. Recent strep pharyngitis dx on abx.  Pt had increased BPs during admission. Cont tx with abx. Sx not c/w Kawasaki.  4/16/09 Received ER admission beginning 3/20/09-5/9/09.  DIAGNOSIS: Impetigo.  Pruritis.  Rash.  Irritability.  Dysphagia.  Cardiac arrest. HTN.  SIADH. Fever. pt still hospitalized as of 4/8/09 and record not available. Pt returned to ER 3/20/09 for abnormal behavior-head banging, irritability and hair pulling.  Seen by PCP to be evaluated for ear infection and enlarged lymph nodes noted on exam. Fever x 1-2 days, sleeping poorly, inconsolable. PE (+) for tender irritated scab behind R ear from recent chicken pox, face flushed, petechiae lateral to R eye. Impression:  Skin infection 2' to scratching at healing chicken pox. Admitted to ID for R sided ear and facial pruritis, unimproved with Benadryl+Atarax. Given Valium-still restless and agitated. Still admitted as of 4/28/09.  6/4/09 Hospital records received DOS 3/20/09 to 5/9/09.  DIAGNOSIS: Impetigo.  Pruritis.  Rash.  Irritability.  Dysphagia.  Cardiac arrest. HTN.  SIADH. Fever. Post vaccination: Irritable, scratching face, pulling out hair. Decreased activity. Upon examination presents with rash and itching. Nervous and anxious.  System based hospital course:  CV - HDS with tachycardia. Patient coded with successful resusitation. Renal - Hypertension Pulmonary - Required intubation. Pulmonary function gradually improved and became stable. ID - Multiple antibiotics followed by resolution of infections. GI - Elevated LFT's. Hepatomegaly.  FEN - Intitially NPO. IVF changed to NS when concern for intracranial pathology. No electrolyte abnormalities. Foley catheter placed and later d/c'd. NJ feedings followed by G-tube placement. Hyponatremia, SIADH, placed on D50.9NS with improvement. NEURO/CNS - Significant mental status changes with discoordinate movement and truncal ataxia. Decreased use of right hand. Gradual improvement of mentation and motor skills. GU - Urinary retention of unknown etiology. HEME - Hematocrit and Hemoglobin dropped - considered iatrogenic.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Full blood count normal, Gait disturbance, Haemoglobin normal, Injection site pain
Clinical narrative: Received Flu vaccine on 3/12/09.  Had R leg pain starting on 3/18 and fever on 3/17.  Seen in the office on 3/19 and noted to be walking slowly on toes, mainly wanting to be carried every where. On exam he had pain in hip with internal and external rotation, but no tenderness.  CBC and ESR normal.  I suspect he has transient synovitis.  I called home today - a couple days after I saw him he was fine to 2 days.  since that time he has intermittently c/o hip pain.  Never as severe as on 3/19.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphocyte percentage increased, Monocyte count increased, Neutrophil percentage decreased, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: Received Flu vaccine on 3/12/09.  Had R leg pain starting on 3/18 and fever on 3/17.  Seen in the office on 3/19 and noted to be walking slowly on toes, mainly wanting to be carried every where. On exam he had pain in hip with internal and external rotation, but no tenderness.  CBC and ESR normal.  I suspect he has transient synovitis.  I called home today - a couple days after I saw him he was fine to 2 days.  since that time he has intermittently c/o hip pain.  Never as severe as on 3/19.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Synovitis, White blood cell count normal
Clinical narrative: Received Flu vaccine on 3/12/09.  Had R leg pain starting on 3/18 and fever on 3/17.  Seen in the office on 3/19 and noted to be walking slowly on toes, mainly wanting to be carried every where. On exam he had pain in hip with internal and external rotation, but no tenderness.  CBC and ESR normal.  I suspect he has transient synovitis.  I called home today - a couple days after I saw him he was fine to 2 days.  since that time he has intermittently c/o hip pain.  Never as severe as on 3/19.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Pt got vaccinated with MCV4 (MENACTRA) 3/24/09, returned 3 days later with swelling and pruritus of injection site.  She was treated with Benadryl.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Urticaria
Clinical narrative: Moderate to severe hives, relieved by antihistamine; severe itching, redness and swelling at injection site for 24 hours.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Urticaria
Clinical narrative: Severe hives on ankles and lower leg, relieved by antihistamine. Itching at injection site for 24 hours.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Anti-thyroid antibody positive, Autoimmune thyroiditis, Blood thyroid stimulating hormone decreased, Chills, Headache
Clinical narrative: 8/08-High fever-102, chills, body aches, mild headache. Soreness in arm. Symptoms lasted 48hrs, although fever lowered to 100 on 2nd day.11/08-palpitations, hypertension(hyperthyroid sx), found to have subacute lymphocytic thyroiditis 3/26/09.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Hypertension, Iodine uptake decreased, Pain, Pain in extremity, Palpitations
Clinical narrative: 8/08-High fever-102, chills, body aches, mild headache. Soreness in arm. Symptoms lasted 48hrs, although fever lowered to 100 on 2nd day.11/08-palpitations, hypertension(hyperthyroid sx), found to have subacute lymphocytic thyroiditis 3/26/09.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Pyrexia, Thyroxine free normal, Tri-iodothyronine free normal, Ultrasound thyroid normal
Clinical narrative: 8/08-High fever-102, chills, body aches, mild headache. Soreness in arm. Symptoms lasted 48hrs, although fever lowered to 100 on 2nd day.11/08-palpitations, hypertension(hyperthyroid sx), found to have subacute lymphocytic thyroiditis 3/26/09.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Anorexia, Asthenia, Chills, Headache, Injection site induration
Clinical narrative: Hard,painful, hot to the touch, egg sized knot @ injection site. Fever up to 100.8, chills, body aches,generalized weakness headache,nausea, loss of appetite,24hrs after received vaccine.Today is my 4th day, symptoms are a little better.
Age: 56.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site papule, Injection site warmth, Nausea, Pain, Pyrexia
Clinical narrative: Hard,painful, hot to the touch, egg sized knot @ injection site. Fever up to 100.8, chills, body aches,generalized weakness headache,nausea, loss of appetite,24hrs after received vaccine.Today is my 4th day, symptoms are a little better.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Childhood disintegrative disorder, Convulsion, Cyanosis, Dyskinesia, Dysphagia
Clinical narrative: Patient received shots Dec. 29th, seizures started that weekend following, progressed into 5-10 daily, mostly rt. sided jerking turning blue and eyes gazing off occuring mostly when tired or stimulated by light, loss of motor skills on rt. side, neurological problems, breathing and swallowing problems. Developing normal until this time. Can no longer roll over, laugh, smile, decreased muscle tone and all over function. Physical therapy currently. On Keppra and Topamax and just discontinued Trileptal. Due to meds she is lethargic and requires constant daily care. Being treated by Dr. neurology. They have little hope for meds because they have not controlled her seizures at all. We have lost the daughter we had and her wonderful personality. We have no doubt her immunizations have changed our lives forever. I have not worked for over 1 month due to seizure activity. No seizures disorders on either side of family, normal pregnancy c-section at 38 1/2 weeks. 4 EEGs spinal tap, MRI performed with no known cause.  4/6/09 ER record received for DOS 1/31/09 with dx: possible focal seizures. Pt presented with increased intesity and length of shaking/jerking episodes of the R arm which pt has been experiencing. Began at age 5 weeks. PE WNL with jerking of the R arm noted. D/C for outpt f/u. Lab 4/24/09 MR received for ER visit 2/3/09 and admission DOS 3/4-6/2009 with D/C DX:  Seizures. Pt with increasing frequency and severity of seizures which began 1/4/09. Mainly R-sided jerking with post-ictal tiredness.  11 seizures day prior to admission. PE (+) for hypotonia and decreased movement orn R side. D/C to f/u as outpt. Follow-up: Being investigated now. Seizures following DTaP--PENTACEL vaccine. She is delayed, physically, socially and speech delays. Received Occupational, Physical and speech therapy. Could write pages on the hell we've been through. Has been confirmed her vaccines caused her seizures. Call if any questions, no time to write everything that I need to say.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Dyspnoea, Electroencephalogram, Gaze palsy, Hypotonia, Lethargy
Clinical narrative: Patient received shots Dec. 29th, seizures started that weekend following, progressed into 5-10 daily, mostly rt. sided jerking turning blue and eyes gazing off occuring mostly when tired or stimulated by light, loss of motor skills on rt. side, neurological problems, breathing and swallowing problems. Developing normal until this time. Can no longer roll over, laugh, smile, decreased muscle tone and all over function. Physical therapy currently. On Keppra and Topamax and just discontinued Trileptal. Due to meds she is lethargic and requires constant daily care. Being treated by Dr. neurology. They have little hope for meds because they have not controlled her seizures at all. We have lost the daughter we had and her wonderful personality. We have no doubt her immunizations have changed our lives forever. I have not worked for over 1 month due to seizure activity. No seizures disorders on either side of family, normal pregnancy c-section at 38 1/2 weeks. 4 EEGs spinal tap, MRI performed with no known cause.  4/6/09 ER record received for DOS 1/31/09 with dx: possible focal seizures. Pt presented with increased intesity and length of shaking/jerking episodes of the R arm which pt has been experiencing. Began at age 5 weeks. PE WNL with jerking of the R arm noted. D/C for outpt f/u. Lab 4/24/09 MR received for ER visit 2/3/09 and admission DOS 3/4-6/2009 with D/C DX:  Seizures. Pt with increasing frequency and severity of seizures which began 1/4/09. Mainly R-sided jerking with post-ictal tiredness.  11 seizures day prior to admission. PE (+) for hypotonia and decreased movement orn R side. D/C to f/u as outpt. Follow-up: Being investigated now. Seizures following DTaP--PENTACEL vaccine. She is delayed, physically, socially and speech delays. Received Occupational, Physical and speech therapy. Could write pages on the hell we've been through. Has been confirmed her vaccines caused her seizures. Call if any questions, no time to write everything that I need to say.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC
Symptoms: Lumbar puncture, Motor dysfunction, Nervous system disorder, Nuclear magnetic resonance imaging, Personality change
Clinical narrative: Patient received shots Dec. 29th, seizures started that weekend following, progressed into 5-10 daily, mostly rt. sided jerking turning blue and eyes gazing off occuring mostly when tired or stimulated by light, loss of motor skills on rt. side, neurological problems, breathing and swallowing problems. Developing normal until this time. Can no longer roll over, laugh, smile, decreased muscle tone and all over function. Physical therapy currently. On Keppra and Topamax and just discontinued Trileptal. Due to meds she is lethargic and requires constant daily care. Being treated by Dr. neurology. They have little hope for meds because they have not controlled her seizures at all. We have lost the daughter we had and her wonderful personality. We have no doubt her immunizations have changed our lives forever. I have not worked for over 1 month due to seizure activity. No seizures disorders on either side of family, normal pregnancy c-section at 38 1/2 weeks. 4 EEGs spinal tap, MRI performed with no known cause.  4/6/09 ER record received for DOS 1/31/09 with dx: possible focal seizures. Pt presented with increased intesity and length of shaking/jerking episodes of the R arm which pt has been experiencing. Began at age 5 weeks. PE WNL with jerking of the R arm noted. D/C for outpt f/u. Lab 4/24/09 MR received for ER visit 2/3/09 and admission DOS 3/4-6/2009 with D/C DX:  Seizures. Pt with increasing frequency and severity of seizures which began 1/4/09. Mainly R-sided jerking with post-ictal tiredness.  11 seizures day prior to admission. PE (+) for hypotonia and decreased movement orn R side. D/C to f/u as outpt. Follow-up: Being investigated now. Seizures following DTaP--PENTACEL vaccine. She is delayed, physically, socially and speech delays. Received Occupational, Physical and speech therapy. Could write pages on the hell we've been through. Has been confirmed her vaccines caused her seizures. Call if any questions, no time to write everything that I need to say.
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion, Demyelination, Guillain-Barre syndrome, Laboratory test, Neuropathy peripheral
Clinical narrative: Seizures - non-epileptic, began July 2007 - Dec. 2008; Diagnosed Guillain-Barre Syndrome - March 2009 (onset was three weeks after 2nd Gardasil Injection.  Has peripheral neuropathy in both lower legs and feet as result. Treatment was begun 2009) Myelin Sheath Degeneration - diagnosed March 2009
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Saliva analysis
Clinical narrative: Seizures - non-epileptic, began July 2007 - Dec. 2008; Diagnosed Guillain-Barre Syndrome - March 2009 (onset was three weeks after 2nd Gardasil Injection.  Has peripheral neuropathy in both lower legs and feet as result. Treatment was begun 2009) Myelin Sheath Degeneration - diagnosed March 2009
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bedridden, Convulsion, Demyelination, Dyspnoea, Gait disturbance
Clinical narrative: Seizures - non-epileptic, began July 2007 - Dec. 2008; Diagnosed Guillain-Barre Syndrome - March 2009 (onset was three weeks after 2nd Gardasil Injection.  Has peripheral neuropathy in both lower legs and feet as result. Treatment was begun 2009) Myelin Sheath Degeneration - diagnosed March 2009
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Gastrointestinal disorder, Guillain-Barre syndrome, Hair metal test abnormal, Hypophagia, Irritability
Clinical narrative: Seizures - non-epileptic, began July 2007 - Dec. 2008; Diagnosed Guillain-Barre Syndrome - March 2009 (onset was three weeks after 2nd Gardasil Injection.  Has peripheral neuropathy in both lower legs and feet as result. Treatment was begun 2009) Myelin Sheath Degeneration - diagnosed March 2009
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Joint swelling, Migraine, Neuropathy peripheral, Pain in extremity, Rash
Clinical narrative: Seizures - non-epileptic, began July 2007 - Dec. 2008; Diagnosed Guillain-Barre Syndrome - March 2009 (onset was three weeks after 2nd Gardasil Injection.  Has peripheral neuropathy in both lower legs and feet as result. Treatment was begun 2009) Myelin Sheath Degeneration - diagnosed March 2009
Age: 21.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Swelling face, Urine aluminium increased, Weight decreased, Wheelchair user
Clinical narrative: Seizures - non-epileptic, began July 2007 - Dec. 2008; Diagnosed Guillain-Barre Syndrome - March 2009 (onset was three weeks after 2nd Gardasil Injection.  Has peripheral neuropathy in both lower legs and feet as result. Treatment was begun 2009) Myelin Sheath Degeneration - diagnosed March 2009
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TD, FLUX, HEP, PPV, TD, TYP
Symptoms: Nuclear magnetic resonance imaging, Unevaluable event
Clinical narrative: I went with my physician husband to receive routine immunizations.  A "tech" administered the injections not writing down which was given, where, a total of 4:  HEP B, TD, Pneumovax & Typhoid.  I am a registered nurse and questioned non documentation of which injection was given where, or if they could be given together.  I was assured by him that he was properly trained.  He was not a medical person, only trained on the job!  I left to go home with my husband.  When I returned home, I felt warm + sluggish + could not do any normal business- No hunger, just panic within 2 1/2 my temp went form 99.6 to over 106.5 My husband took me later to hospital, very seriously ill I today have problems with walking any lengths & fevers, & memory problems.  I now live alone & cannot afford Rx's, doctors visits, or hospital visits, as my insurance stopped.  I need HELP!  I also have severe problems in my right knee & can not push body pressure on it without help.  Because of unsteadiness from this I fell in my bathroom + had to have brain surgery.  Also, exacerbate congenital spinal stenosis- Not able to work at all.  I used to go to Dr for increase BP & fevers & aches, but no longer can afford this I have very little money.  I do feel that I have been tossed aside I have written about this once before, to no reply.  Please help me.  My right knee was the worst & still is.  I have no health insurance + must suffer.  This is not your fault.  I am a victim of the times + sad.  Have to use cane.  Need help to buy groceries/sister.  Must be in bed with illness and fevers up to 102.5 at any given time.  I am 60 years old + since this happened I am going steadily down hill.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TD, FLUX, HEP, PPV, TD, TYP
Symptoms: Activities of daily living impaired, Arthropathy, Balance disorder, Body temperature increased, Decreased appetite
Clinical narrative: I went with my physician husband to receive routine immunizations.  A "tech" administered the injections not writing down which was given, where, a total of 4:  HEP B, TD, Pneumovax & Typhoid.  I am a registered nurse and questioned non documentation of which injection was given where, or if they could be given together.  I was assured by him that he was properly trained.  He was not a medical person, only trained on the job!  I left to go home with my husband.  When I returned home, I felt warm + sluggish + could not do any normal business- No hunger, just panic within 2 1/2 my temp went form 99.6 to over 106.5 My husband took me later to hospital, very seriously ill I today have problems with walking any lengths & fevers, & memory problems.  I now live alone & cannot afford Rx's, doctors visits, or hospital visits, as my insurance stopped.  I need HELP!  I also have severe problems in my right knee & can not push body pressure on it without help.  Because of unsteadiness from this I fell in my bathroom + had to have brain surgery.  Also, exacerbate congenital spinal stenosis- Not able to work at all.  I used to go to Dr for increase BP & fevers & aches, but no longer can afford this I have very little money.  I do feel that I have been tossed aside I have written about this once before, to no reply.  Please help me.  My right knee was the worst & still is.  I have no health insurance + must suffer.  This is not your fault.  I am a victim of the times + sad.  Have to use cane.  Need help to buy groceries/sister.  Must be in bed with illness and fevers up to 102.5 at any given time.  I am 60 years old + since this happened I am going steadily down hill.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TD, FLUX, HEP, PPV, TD, TYP
Symptoms: Fall, Feeling hot, Gait disturbance, Memory impairment, Panic reaction
Clinical narrative: I went with my physician husband to receive routine immunizations.  A "tech" administered the injections not writing down which was given, where, a total of 4:  HEP B, TD, Pneumovax & Typhoid.  I am a registered nurse and questioned non documentation of which injection was given where, or if they could be given together.  I was assured by him that he was properly trained.  He was not a medical person, only trained on the job!  I left to go home with my husband.  When I returned home, I felt warm + sluggish + could not do any normal business- No hunger, just panic within 2 1/2 my temp went form 99.6 to over 106.5 My husband took me later to hospital, very seriously ill I today have problems with walking any lengths & fevers, & memory problems.  I now live alone & cannot afford Rx's, doctors visits, or hospital visits, as my insurance stopped.  I need HELP!  I also have severe problems in my right knee & can not push body pressure on it without help.  Because of unsteadiness from this I fell in my bathroom + had to have brain surgery.  Also, exacerbate congenital spinal stenosis- Not able to work at all.  I used to go to Dr for increase BP & fevers & aches, but no longer can afford this I have very little money.  I do feel that I have been tossed aside I have written about this once before, to no reply.  Please help me.  My right knee was the worst & still is.  I have no health insurance + must suffer.  This is not your fault.  I am a victim of the times + sad.  Have to use cane.  Need help to buy groceries/sister.  Must be in bed with illness and fevers up to 102.5 at any given time.  I am 60 years old + since this happened I am going steadily down hill.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TD, FLUX, HEP, PPV, TD, TYP
Symptoms: Pyrexia, Sluggishness, Spinal column stenosis, Surgery
Clinical narrative: I went with my physician husband to receive routine immunizations.  A "tech" administered the injections not writing down which was given, where, a total of 4:  HEP B, TD, Pneumovax & Typhoid.  I am a registered nurse and questioned non documentation of which injection was given where, or if they could be given together.  I was assured by him that he was properly trained.  He was not a medical person, only trained on the job!  I left to go home with my husband.  When I returned home, I felt warm + sluggish + could not do any normal business- No hunger, just panic within 2 1/2 my temp went form 99.6 to over 106.5 My husband took me later to hospital, very seriously ill I today have problems with walking any lengths & fevers, & memory problems.  I now live alone & cannot afford Rx's, doctors visits, or hospital visits, as my insurance stopped.  I need HELP!  I also have severe problems in my right knee & can not push body pressure on it without help.  Because of unsteadiness from this I fell in my bathroom + had to have brain surgery.  Also, exacerbate congenital spinal stenosis- Not able to work at all.  I used to go to Dr for increase BP & fevers & aches, but no longer can afford this I have very little money.  I do feel that I have been tossed aside I have written about this once before, to no reply.  Please help me.  My right knee was the worst & still is.  I have no health insurance + must suffer.  This is not your fault.  I am a victim of the times + sad.  Have to use cane.  Need help to buy groceries/sister.  Must be in bed with illness and fevers up to 102.5 at any given time.  I am 60 years old + since this happened I am going steadily down hill.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, TYP, YF, HEP, HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Discomfort, Joint effusion, Joint stiffness, Joint swelling, Pain
Clinical narrative: Initial report received on 12 March 2009 from a health professional.  A female patient, whose age and medical history were unknown, received YF-VAX (lot number not reported) on an unspecified date.  Illness at the time of vaccination and vaccinations in the four weeks prior were all unknown.  On 11 March 2009, approximately two weeks after immunization, the patient experienced joint pain in both knees as well as swelling.  The patient was to be evaluated by a physician later that day.  The patient had not recovered.  No other information was available at the time of the report.  Follow up information was received on 16 March 2009 from a health care professional.  Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious.  A 42 year old female patient received intramuscular left deltoid injection of ADACEL (lot number C3058AA), subcutaneous right arm injection of IPOL (lot number B0475), intramuscular left deltoid injection of MENACTRA (lot number U2726AA), intramuscular right deltoid injection of TYPHIM VI (lot number B0706-2), a subcutaneous left arm injection of YF VAX (lot number UF432AA), intramuscular left deltoid injection of HAVRIX (manufacturer GSK, lot number AHAVB285AB), ENGERIX B (manufacturer GSK, lot number AHBVB518AA) on 27 February 2009 at 11:00 AM.  On 11 March 2009 at 08:10 PM, the patient noted stiffness of the right knee.  The next morning the patient noted stiffness and swelling in both knees.  The patient noticed stiffness in the medial aspect of the feet without swelling.  The patient had discomfort when ambulating.  On 12 March 2009 the patient took Ibuprofen 600 mg every 8-12 hours without improvement.  On 13 March 2009 the patient's symptoms increased.  The patient's instep/ankle area had mild swelling with an increase in pain during ambulation.  The patient continued to use Ibuprofen 600 mg every 6-8 hours with leg elevation.  The patient did not have a fever, chills, rash, warmth, or erythema.  The patient had 2-3 cm bilateral bursal effusions at knees without tenderness.  The patient was instructed to seek medical attention 13 March 2009.  List of Documents held by Sender: none.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, TYP, YF, HEP, HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Arthralgia, Joint effusion, Joint stiffness, Joint swelling, Musculoskeletal stiffness
Clinical narrative: Initial report received on 12 March 2009 from a health professional.  A female patient, whose age and medical history were unknown, received YF-VAX (lot number not reported) on an unspecified date.  Illness at the time of vaccination and vaccinations in the four weeks prior were all unknown.  On 11 March 2009, approximately two weeks after immunization, the patient experienced joint pain in both knees as well as swelling.  The patient was to be evaluated by a physician later that day.  The patient had not recovered.  No other information was available at the time of the report.  Follow up information was received on 16 March 2009 from a health care professional.  Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious.  A 42 year old female patient received intramuscular left deltoid injection of ADACEL (lot number C3058AA), subcutaneous right arm injection of IPOL (lot number B0475), intramuscular left deltoid injection of MENACTRA (lot number U2726AA), intramuscular right deltoid injection of TYPHIM VI (lot number B0706-2), a subcutaneous left arm injection of YF VAX (lot number UF432AA), intramuscular left deltoid injection of HAVRIX (manufacturer GSK, lot number AHAVB285AB), ENGERIX B (manufacturer GSK, lot number AHBVB518AA) on 27 February 2009 at 11:00 AM.  On 11 March 2009 at 08:10 PM, the patient noted stiffness of the right knee.  The next morning the patient noted stiffness and swelling in both knees.  The patient noticed stiffness in the medial aspect of the feet without swelling.  The patient had discomfort when ambulating.  On 12 March 2009 the patient took Ibuprofen 600 mg every 8-12 hours without improvement.  On 13 March 2009 the patient's symptoms increased.  The patient's instep/ankle area had mild swelling with an increase in pain during ambulation.  The patient continued to use Ibuprofen 600 mg every 6-8 hours with leg elevation.  The patient did not have a fever, chills, rash, warmth, or erythema.  The patient had 2-3 cm bilateral bursal effusions at knees without tenderness.  The patient was instructed to seek medical attention 13 March 2009.  List of Documents held by Sender: none.
Age: 42.0
Sex: F
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, TYP, YF, HEP, HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Pain
Clinical narrative: Initial report received on 12 March 2009 from a health professional.  A female patient, whose age and medical history were unknown, received YF-VAX (lot number not reported) on an unspecified date.  Illness at the time of vaccination and vaccinations in the four weeks prior were all unknown.  On 11 March 2009, approximately two weeks after immunization, the patient experienced joint pain in both knees as well as swelling.  The patient was to be evaluated by a physician later that day.  The patient had not recovered.  No other information was available at the time of the report.  Follow up information was received on 16 March 2009 from a health care professional.  Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious.  A 42 year old female patient received intramuscular left deltoid injection of ADACEL (lot number C3058AA), subcutaneous right arm injection of IPOL (lot number B0475), intramuscular left deltoid injection of MENACTRA (lot number U2726AA), intramuscular right deltoid injection of TYPHIM VI (lot number B0706-2), a subcutaneous left arm injection of YF VAX (lot number UF432AA), intramuscular left deltoid injection of HAVRIX (manufacturer GSK, lot number AHAVB285AB), ENGERIX B (manufacturer GSK, lot number AHBVB518AA) on 27 February 2009 at 11:00 AM.  On 11 March 2009 at 08:10 PM, the patient noted stiffness of the right knee.  The next morning the patient noted stiffness and swelling in both knees.  The patient noticed stiffness in the medial aspect of the feet without swelling.  The patient had discomfort when ambulating.  On 12 March 2009 the patient took Ibuprofen 600 mg every 8-12 hours without improvement.  On 13 March 2009 the patient's symptoms increased.  The patient's instep/ankle area had mild swelling with an increase in pain during ambulation.  The patient continued to use Ibuprofen 600 mg every 6-8 hours with leg elevation.  The patient did not have a fever, chills, rash, warmth, or erythema.  The patient had 2-3 cm bilateral bursal effusions at knees without tenderness.  The patient was instructed to seek medical attention 13 March 2009.  List of Documents held by Sender: none.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Crying, Irritability, Pyrexia, Rash, Urticaria
Clinical narrative: Fever of 103.5 at 0130 in the AM on the day after the shot, that would not go down w/ Tylenol, Motrin or tepid baths.  Fever stayed around for 3 days, then he got a rash.  The rash is slightly raised, non circular pinkish areas that cover his back, arms, chest and stomach.  Patient is also very very irritable and at times inconsolable which is not a normal behavior for him.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Culture throat negative, Eye pain, Flushing, Haematocrit normal, Haemoglobin normal
Clinical narrative: Initial report received from a health care professional on 13 March 2009. The reporter stated that two of his patients "got the Flu" after receiving FLUZONE; however information was received for only one patient. An elderly female patient had received FLUZONE SV 2008-2009 (lot number, route/site of administration not reported) on 16 October 2008 and an unspecified amount time later she developed the "flu". On 09 March 2009, the patient had laboratory testing performed for Influenza virus A & B IGG, IGM, and IGA ABS with the following results: Influenza A: IgG (4.94), IgM (1.09), IgA (1.4) and Influenza B: IgG (3.38), IgM (<0.80), IgA (<0.80). Reference ranges - (<0.80 = negative); (0.80 - 1.20 = Equivocal); (>1.20 - positive). According to the laboratory report received, "This test(s) was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by (the laboratory). This test should not be used for diagnosis without confirmation by other medically established means." The patient's recovery status was not reported. No additional information was provided at the time of the report. Follow-up information received 17 March 2009 from a health care professional. The reporter confirmed that patient had been 74-years-old at the time of the event. The patient had received an intramuscular right deltoid injection of FLUZONE on 16 October 2008 and 140 days later, she developed sinus congestion; aching behind eyes, red pharynx and her face was flushed. She had no adenopathy and her lungs were clear. Laboratory test results had been positive for influenza A and B and additional labs revealed Hgb (14.1), Hct (42), WBC (3,300) and platelets (151,000); Diff: PMN (70.3), Lymph (23), Prolymphs (6.3). A throat culture grew normal flora. The patient had no pre-existing illnesses or medical conditions and no illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE. The patient was recovering as of 17 March 2009. It had been previously reported that a second patient had developed the "Flu" after receiving FLUZONE; however new information received noted that the second patient had not received an influenza vaccination prior to contracting the flu. No additional information was provided at the time of the report. Documents held by sender: Lab titers.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza serology positive, Pharyngeal erythema, Platelet count normal, Sinus congestion
Clinical narrative: Initial report received from a health care professional on 13 March 2009. The reporter stated that two of his patients "got the Flu" after receiving FLUZONE; however information was received for only one patient. An elderly female patient had received FLUZONE SV 2008-2009 (lot number, route/site of administration not reported) on 16 October 2008 and an unspecified amount time later she developed the "flu". On 09 March 2009, the patient had laboratory testing performed for Influenza virus A & B IGG, IGM, and IGA ABS with the following results: Influenza A: IgG (4.94), IgM (1.09), IgA (1.4) and Influenza B: IgG (3.38), IgM (<0.80), IgA (<0.80). Reference ranges - (<0.80 = negative); (0.80 - 1.20 = Equivocal); (>1.20 - positive). According to the laboratory report received, "This test(s) was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by (the laboratory). This test should not be used for diagnosis without confirmation by other medically established means." The patient's recovery status was not reported. No additional information was provided at the time of the report. Follow-up information received 17 March 2009 from a health care professional. The reporter confirmed that patient had been 74-years-old at the time of the event. The patient had received an intramuscular right deltoid injection of FLUZONE on 16 October 2008 and 140 days later, she developed sinus congestion; aching behind eyes, red pharynx and her face was flushed. She had no adenopathy and her lungs were clear. Laboratory test results had been positive for influenza A and B and additional labs revealed Hgb (14.1), Hct (42), WBC (3,300) and platelets (151,000); Diff: PMN (70.3), Lymph (23), Prolymphs (6.3). A throat culture grew normal flora. The patient had no pre-existing illnesses or medical conditions and no illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE. The patient was recovering as of 17 March 2009. It had been previously reported that a second patient had developed the "Flu" after receiving FLUZONE; however new information received noted that the second patient had not received an influenza vaccination prior to contracting the flu. No additional information was provided at the time of the report. Documents held by sender: Lab titers.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: White blood cell count decreased
Clinical narrative: Initial report received from a health care professional on 13 March 2009. The reporter stated that two of his patients "got the Flu" after receiving FLUZONE; however information was received for only one patient. An elderly female patient had received FLUZONE SV 2008-2009 (lot number, route/site of administration not reported) on 16 October 2008 and an unspecified amount time later she developed the "flu". On 09 March 2009, the patient had laboratory testing performed for Influenza virus A & B IGG, IGM, and IGA ABS with the following results: Influenza A: IgG (4.94), IgM (1.09), IgA (1.4) and Influenza B: IgG (3.38), IgM (<0.80), IgA (<0.80). Reference ranges - (<0.80 = negative); (0.80 - 1.20 = Equivocal); (>1.20 - positive). According to the laboratory report received, "This test(s) was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by (the laboratory). This test should not be used for diagnosis without confirmation by other medically established means." The patient's recovery status was not reported. No additional information was provided at the time of the report. Follow-up information received 17 March 2009 from a health care professional. The reporter confirmed that patient had been 74-years-old at the time of the event. The patient had received an intramuscular right deltoid injection of FLUZONE on 16 October 2008 and 140 days later, she developed sinus congestion; aching behind eyes, red pharynx and her face was flushed. She had no adenopathy and her lungs were clear. Laboratory test results had been positive for influenza A and B and additional labs revealed Hgb (14.1), Hct (42), WBC (3,300) and platelets (151,000); Diff: PMN (70.3), Lymph (23), Prolymphs (6.3). A throat culture grew normal flora. The patient had no pre-existing illnesses or medical conditions and no illness at the time of vaccination. She had not received any other vaccines within four weeks of receiving FLUZONE. The patient was recovering as of 17 March 2009. It had been previously reported that a second patient had developed the "Flu" after receiving FLUZONE; however new information received noted that the second patient had not received an influenza vaccination prior to contracting the flu. No additional information was provided at the time of the report. Documents held by sender: Lab titers.
Sex: M
Vaccine: DTAP
Symptoms: Convulsion, Pyrexia, Rash, Respiration abnormal
Clinical narrative: Initial report received on 19 March 2009 from a consumer who is the patient's parent. A male patient had received DTaP when he was an infant (manufacturer, lot number, route/site and date of administration not reported) and an unspecified amount of time later (reported as "approximately 1985 - 1986"), he experienced a seizure, serious fever, breathing (type of breathing not reported) and a rash. According to the reporter, the primary care provider documented from 1985 - 1986 that the patient could not tolerate the Pertussis vaccine and "gave prt doses" due to the reported event. The reporter further reported that their niece experienced serious seizures following DTP vaccination (captured in case 2009-01150). No additional information was provided at the time of the report. The reporter for this case is the same as for case numbers 2009-00841 and 2009-01150.
Sex: F
Vaccine: DTAP
Symptoms: Convulsion
Clinical narrative: Initial report received on 19 March 2009 from a consumer who is the patient's aunt.  A female patient had received a DTP vaccine (manufacturer, lot number, route/site and date of administration not reported) and an unspecified amount of time later, she experienced a seizures.  The reporter's son had also experienced a seizure following DTP vaccination when he was an infant (captured in case 2009-01149).  No additional information was provided at the time of the report.  The reporter for this case is the same as for case numbers 2009-00841 and 2009-01149.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site cellulitis, Myalgia, Nausea, Pain in extremity
Clinical narrative: Cellulitis R upper arm injection site. Headache, nausea, myalgias, arm pain, itching. Prescription for hydrocodone and prednisone given.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus
Clinical narrative: Cellulitis R upper arm injection site. Headache, nausea, myalgias, arm pain, itching. Prescription for hydrocodone and prednisone given.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site haematoma, Oedema peripheral
Clinical narrative: Right leg thigh red and swollen over entire lateral thigh from knee to hip.  Treatment per Dr. > ice and watch for further developments 3-30-09 I spoke with patients father this morning at 0945.  He stated that patients leg is much improved.  The swelling and redness have resolved and she only has a small bruising at the injection site.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Vaccinated 3/9/09 - on 3/14/09 mother noted fine red rash on face, abdomen, neck trunk & upper legs, No treatment.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Blister, Pyrexia, Scab, Varicella
Clinical narrative: Mother brought patient to the clinic on 3/23/09 to be evaluated by RN. Child was "covered" in pox. Some were still in the vesicule stage, but most were crusted over. Mother stated that outbreak started on 3-20-09 (3 days after vaccination) mother stated that patient may have had low grade temp at onset of illness. Spoke with mother by phone on 3/25/09. Stated all vesicules now crusted.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Redness and swelling LUD.  Warm to touch.  Soreness X2days.  Mother states applied ice and gave TYLENOL for low-grade fever X1day.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness & swelling on arm - right side.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever (102 degrees) multiple muscle aches, mild nausea was seen and released from ER 3/25/09 still has muscle aches & erythema around injection site today but no pain.  He feels much better.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called 2 days after vaccine to say that vaccine site " reddened and raised" (erythema) starting about half dollar in size and moving "to a much larger one, going" in a band halfway around her arm". Little c/o pain. Ice decreased erythema, small in size now.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain, Pruritus
Clinical narrative: Site reaction, large area of redness and swelling at site. (baseball size) + pain+ itch + fever 102-103 degrees, 5x within 6 hours of injection. Resolved over next 48 hours.
Age: 11.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Pyrexia
Clinical narrative: Site reaction, large area of redness and swelling at site. (baseball size) + pain+ itch + fever 102-103 degrees, 5x within 6 hours of injection. Resolved over next 48 hours.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Malaise, Throat irritation
Clinical narrative: Morning after immunizations, child had red, swollen left deltoid.  Also c/o HA & burning throat & not feeling well.  Parent took child to Dr. on Fri, 3-20-09, & she was given antibiotic.  Unsure if reaction was R/T immunization.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Initial information was received from a health care professional on 09 October 2008. A 35 year old pregnant female with no reported obstetric history received a right deltoid injection of ADACEL (lot number C2767AA) on 22 September 2008. It was not known whether the patient experienced any adverse events. The patient's date of her last menstrual period was 05 September 2008. The patient's estimated date of confinement was not reported. No further information was provided. Follow-up information was received 15 December 2008 from a health care professional who stated that they had no additional information regarding this patient and provided the contact information for the patient's OB/GYN. Follow-up information was received from another health care professional on 19 March 2009. The patient had not been vaccinated at that facility, and the reporter had no information regarding vaccination. The patient had begun care at the facility on 10 October 2008, and per the reporter the patient's due date was 10 October 2009. No additional information was provided. Follow up information was received from another health care professional on 23 March 2009. The patient had a miscarriage on 14 October 2008. No further information was provided. Based upon this new information received, this case meets seriousness criteria and has been upgraded to serious. Documents held by sender: None.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Computerised tomogram normal, Convulsion, Crying, Electroencephalogram normal, Grimacing
Clinical narrative: This case was received on 23 March 2009 from a health care professional. A 4 month old female patient received ACT-HIB lot number UF516AA (Sanofi Pasteur SA lot number B0426-1) in the left thigh, DAPTACEL (lot number C3000AA) in the left thigh, IPOL (lot number B0009-2) in the right thigh, and PREVNAR (lot number D21053) in the right thigh on 11 February 2009 at 4:15 PM. On 12 February 2009 at 22:00 the patient was brought to the emergency room after she began crying, "stiffened up", grimacing, and "made strange faces". The patient was sent home and was not seen by a pediatric neurologist until the following day. The patient was then admitted to pediatric intensive care unit and hospitalized for four days. The patient was diagnosed with clinical seizure activity which was believed to be a result of the vaccinations. The physician advised the patient's family to follow an alternate vaccination schedule. The patient had an EEG (electroencephalogram) and CT scan (Computed tomography) to rule out seizure which were both negative. The patient's recovery status was not reported. List of Documents held by Sender: none.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Intensive care, Musculoskeletal stiffness
Clinical narrative: This case was received on 23 March 2009 from a health care professional. A 4 month old female patient received ACT-HIB lot number UF516AA (Sanofi Pasteur SA lot number B0426-1) in the left thigh, DAPTACEL (lot number C3000AA) in the left thigh, IPOL (lot number B0009-2) in the right thigh, and PREVNAR (lot number D21053) in the right thigh on 11 February 2009 at 4:15 PM. On 12 February 2009 at 22:00 the patient was brought to the emergency room after she began crying, "stiffened up", grimacing, and "made strange faces". The patient was sent home and was not seen by a pediatric neurologist until the following day. The patient was then admitted to pediatric intensive care unit and hospitalized for four days. The patient was diagnosed with clinical seizure activity which was believed to be a result of the vaccinations. The physician advised the patient's family to follow an alternate vaccination schedule. The patient had an EEG (electroencephalogram) and CT scan (Computed tomography) to rule out seizure which were both negative. The patient's recovery status was not reported. List of Documents held by Sender: none.