chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: HPV4, HPV4, HPV4
Symptoms: Vasculitis
Clinical narrative: Information has been received from a registered nurse concerning her 17 year old daughter with attention deficit disorder and an allergy to over-the-counter cold preparations, who on 04-MAR-2008 at 16:30 was vaccinated with a third dose of Gardasil. Concomitant therapy included ADDERALL TABLETS. On 05-MAR-2008, eight hours post vaccination the patient experienced a high fever, hallucinations, severe back pain, severe headache, skin sensitivity, nausea and vomiting and was hospitalized. It was reported that the patient tolerated the first and second doses of Gardasil well. At the time of the report, the patient had not recovered. No product quality complaint was involved. The high fever, hallucinations, severe back pain, severe headache, skin sensitivity, nausea and vomiting were considered to be disabling. Additional information has been requested.  4/10/2008 MR received for ER visit 3/5/2008 with DX: Primary DX: R Flank Pain.  Additional DX: Fever-unknown origin. Pt presented to ER from MD's office with fever, chills, sudden onset R sided flank pain, nausea and vomiting. Pt reports fatigue and weakness as well. PE (+) for tenderness at the R CVA, fever, and pain.  D/C home in improved condition.    5/13/2008 MR received for DOS 3/6-8/2008 with no clear D/C DX.  Rheumatology Impression is: Back pain that is probably of a systemic problem. ID consult Impression: Fever and infection of the back, r/o sacroilitis, r/o vertebral osteomyelitis, r/o non-infectious etiology. Pt presented unable to walk 2' to back pain. Pain is localized to SI joint area. 5/06/2008 MR received for ER visit 3/10/2008 with DX: Headache. Pt presented following D/C from inpt stay with worsening h/a assoc with neck and back pain.  07/21/2008 MR received from Allergy/Immunology consult dated 3/12/2008 to 6/20/2008 with DX: Gardasil induced vasculitis. On the evening of the 3rd Gardasil vax pt awoke with fever, feeling delusional with aching chills. Pt continued to have fevers, excrutiating headaches and back pain which worsened following LP. PE (+) for glassy eyes, dehydration, unable to stand, diffuse weakness.  Pulse increased from 50 to 90 upon standing. Started on Prednisone with 80-90% improvement. Seen again 6/20/08 with improvment of sx of vasculitis.  Reports post-exercise exhaustion.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA
Symptoms: Biopsy skin, Biopsy skin abnormal, Hyperplasia, Lymphadenectomy, Nodule
Clinical narrative: Information has been received from a licensed practical nurse, concerning an 11 year old female patient with seasonal allergies, who on 04-JAN-2008 was vaccinated IM, with the first dose, 0.5 of Gardasil (lot #657868/0523U).  Concomitant therapy included ZYRTEC.  On 23-JAN-2008 the patient developed a small node on her left clavicle, and was afebrile.  On 25-JAN-2008, she was seen in the office with a supraclavicular lesion.  On 08-FEB-2008, a biopsy and removal of the node was performed as outpatient at the hospital.  The biopsy revealed a "benign reactive hyperplastic node."  The patient recovered from the events (date and duration not specified).  On 05-MAR-2008, the second dose, 0.5 ml, IM, of Gardasil (lot # 658556/1060U) was administered.  The reporter considered the events to be serious as an other important medical event.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, HEPA
Symptoms: Hyperplasia, Lymphadenopathy
Clinical narrative: Information has been received from a licensed practical nurse, concerning an 11 year old female patient with seasonal allergies, who on 04-JAN-2008 was vaccinated IM, with the first dose, 0.5 of Gardasil (lot #657868/0523U).  Concomitant therapy included ZYRTEC.  On 23-JAN-2008 the patient developed a small node on her left clavicle, and was afebrile.  On 25-JAN-2008, she was seen in the office with a supraclavicular lesion.  On 08-FEB-2008, a biopsy and removal of the node was performed as outpatient at the hospital.  The biopsy revealed a "benign reactive hyperplastic node."  The patient recovered from the events (date and duration not specified).  On 05-MAR-2008, the second dose, 0.5 ml, IM, of Gardasil (lot # 658556/1060U) was administered.  The reporter considered the events to be serious as an other important medical event.  Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paralysis
Clinical narrative: Information has been received from a physician, via a company representative, regarding a set of triplets (age not specified), who on an unknown date was vaccinated with a dose of Gardasil (lot # not reported). Subsequently "one of the triplets" (a female) experienced some form of "paralysis." No further details were provided. The outcome of the events was not specified. Upon internal review, "some form of paralysis" was considered to be serious as an other important medical event. No further information is available.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Information has been received from a nurse, concerning a female patient (age not specified), who on an unknown date was vaccinated with the second dose of Gardasil (lot # not reported).  Subsequently the patient had a seizure.  She was seen by a neurologist, who said the seizure was because of the Gardasil.  Upon internal review, had a seizure was considered to be serious as an other important medical event.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: PNC
Symptoms: Abnormal behaviour, Head banging, Headache, Neck pain
Clinical narrative: This case was considered medically important for the events of possible behavior disorder and head banging. Information regarding Prevenar was received from a healthcare professional regarding a 5-year-old male patient who presented with a history of intentionally hitting his head against walls and other objects, possible behavior disorder and experienced neck pain and headaches. The patient received the third dose on 24-Jun-2003. Relevant medical history was not provided. Concomitant medications were not reported. The reporter noted the patient is currently being assessed (but has not been diagnosed) for a possible behavior disorder with a history of intentionally hitting his head against walls and other objects. Additionally the patient has experienced neck pain and headaches. No treatment was reported. The patient's outcome is unknown. No additional information was available at the time of this report.
Age: 17.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis requiring 2 doses of epinephrine, Benadryl and ER transport.
Age: 31.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Asthenia, Feeling hot, Muscle spasms, Tremor
Clinical narrative: My legs were cramping, my whole body was shaky.  My face felt like it was burning up.  I felt really weak, no energy.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Electroencephalogram, Loss of consciousness, Muscle contracture, Syncope
Clinical narrative: Patient was walking on a treadmill as he often does.  Patient grabbed left side of chest and said "mama" and collapsed.  He was unconscious and constricted.  Incident happened on 2-5-08 about 5:30.  Mother took to ER at 18:03.  Accuv-102 et EEG.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Contusion, Headache, Injection site erythema, Injection site mass
Clinical narrative: Bruise left shoulder, soreness, body aches, chills, fever, HA.  Same day bump at site (redness) at 1800.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia
Clinical narrative: Bruise left shoulder, soreness, body aches, chills, fever, HA.  Same day bump at site (redness) at 1800.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: About a day after immunizations, patient developed an area of red induration, which by day 3 was approximately 3" round area of induration.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Throbbing pains from left shoulder to mid upper left arm.
Age: 26.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Rash
Clinical narrative: Throbbing pains from left shoulder to mid upper left arm.
Age: 18.0
Sex: F
Vaccine: HEP, HPV4
Symptoms: Confusional state, Dizziness, Erythema, Feeling abnormal, Pruritus generalised
Clinical narrative: At 4:30PM on 3/7/08, patient experienced dizziness, slight confusion and "fogginess".  At 7:00PM on 3/7/08 patient related "itching and redness all over".  She took a dose of oral Benadryl that evening and was able to sleep.  On 3/12/08 itching and generalized redness is still present, concentrating at the knee area.
Age: 1.09
Sex: M
Vaccine: HEPAB, HIBV, MMRV, PNC
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Misadministration - Twinrix given to a 13 month old instead of Ped Hep A #1 and Ped Hep B #1 - no adverse event.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Chest discomfort, Dysphonia, Dyspnoea, Wheezing
Clinical narrative: Patient showed in our clinic on 3/18/08 approximately 10:35am - 10:40am with mom complaining of breathing/hoarseness and difficulty of breathing and tightness of chest.  Was wheezing some (was given Varicella vaccine in trailer behind clinic around 10 minutes ago.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Erythema, Injection site induration, Rash macular, Swelling
Clinical narrative: Soft tissue swelling of thigh, including the knee.  Some induration at the site of injection.  Mild redness/blotchiness.  Benadryl given by mom (approximately 1mg/kg x 3 doses).  On follow up visit next day, decreased swelling, induration, redness and discomfort.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pruritus
Clinical narrative: No fever; 10 vesicles, itchy.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash, Varicella
Clinical narrative: Fever x 3 days followed by extensive varicella rash.
Age: 45.0
Sex: F
Vaccine: TYP
Symptoms: Influenza like illness, Nausea, Pyrexia
Clinical narrative: Flu like symptoms 5 days after last tablet.  Fever x 4 days.  Nausea x 2 weeks.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Autism spectrum disorder, Febrile convulsion, Full blood count, Laboratory test normal, Pyrexia
Clinical narrative: Seizure within 24 hours - (about 12 hrs) post vaccination on acellular DPT & IPV.  With 104-105 fever.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Urine analysis
Clinical narrative: Seizure within 24 hours - (about 12 hrs) post vaccination on acellular DPT & IPV.  With 104-105 fever.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. stated her arm started to hurt around 6pm.  She thought nothing of it.  Wed AM her arm was red & swollen.  Pt was examined on 3-13-08 - 3pm.  Her Lt upper arm was red with severe swelling.  Area very warm, tender to touch.  Pt started on steroids therapy x several days.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pt. stated her arm started to hurt around 6pm.  She thought nothing of it.  Wed AM her arm was red & swollen.  Pt was examined on 3-13-08 - 3pm.  Her Lt upper arm was red with severe swelling.  Area very warm, tender to touch.  Pt started on steroids therapy x several days.
Age: 1.3
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Developed varicella rash 12 days after receiving Varivax vaccine.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: 4" raised induration on left lateral thigh (upper).
Age: 29.0
Sex: M
Vaccine: TYP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Psoriatic arthropathy
Clinical narrative: Pt is taking Etanercept (Immunosuppressing med) for psoriatic arthritis but was vaccinated by medic yesterday with Typhoid. PA was not aware of this patient as he was seeing patients during sickcall. Pt presented today with sore left shoulder and decreased ROM but no infection observed today only. Pt has hot compress and quarters. Pt doing well otherwise with stable vitals.
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: 34 y/o male given anthrax vaccine prior to deployment. Presents at clinic, 48 hrs after with Redness, Swelling, Pruritis, Pain, Warm to touch to right arm. On exam redness/induration is 15cm x 12cm on Right upper Arm and is warm to touch. No systemic issues. Will treat with Ice Pack, Motrin 800mg, and Benadryl per conversation with Dr (Allery/Imunizations) at Medical Center. Manufacturer (Bioport Corporation).
Age: 34.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site warmth
Clinical narrative: 34 y/o male given anthrax vaccine prior to deployment. Presents at clinic, 48 hrs after with Redness, Swelling, Pruritis, Pain, Warm to touch to right arm. On exam redness/induration is 15cm x 12cm on Right upper Arm and is warm to touch. No systemic issues. Will treat with Ice Pack, Motrin 800mg, and Benadryl per conversation with Dr (Allery/Imunizations) at Medical Center. Manufacturer (Bioport Corporation).
Age: 55.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Blood product transfusion, Chest discomfort, Guillain-Barre syndrome, Hepatic enzyme abnormal, Hypoaesthesia
Clinical narrative: 14-15 days after receiving vaccines she started having tingling in right hand and foot. Next day same thing on left side. Also some numbness in extremities.  Gradually got worse over the next several days.  Felt like "electricity shooting out".  Numbness also went up her back. Went to MD on Feb 12. Blood tests ordered.Liver enzymes were elevated so Hepatitis blood tests done.  On Feb 15 brain MRI done which showed nothing.  Next day, Feb 16 went to ER because of increased tightening of muscles in chest (diaphram area). Dr.'s focused on heart and gallbladder.  She and husband went home and started looking up things on internet.  Found symptoms of Guillain Barre which fit perfectly so the next day (Sunday, Feb 17) drove to the ER there so she could see a neurologist.  A spinal tap was done and another test on a special machine which confirmed diagnosis of Guillain Barre. She was hospitalized that night until Friday the 22nd.  There she received large daily doses of immune globulin.  As of March 18, she is feeling better.  The tingling and numbness is still there but is decreased.  Dr. told her it should be gone by 6 months. 4/4/08 Reviewed hospital medical records of 2/17-2/22/08. FINAL DX: Guillain Barre syndrome Records reveal patient experienced progressive weakness, numbness & tingling of both right upper & lower extremity x 9 days followed by same on left side x 8 days with gait disturbance & balance difficulty x 2 days.  Had chest tightening x 4-5 days w/progressive fatigue & SOB.  Exam revealed distal sensory loss, areflexia, markedly weak hamstring muscles.  Admitted for IVIG x 4-5 doses.  Neuro consult done. Progressed & d/c w/continued home health PT.  7/11/08 Reviewed PCP medical records of 2/12-6/19/2008. FINAL DX: Guillain Barre syndrome, resolving Records of 2/12/08 reveal patient experienced weakness, pain, decreased appetite, LBP, LUQ abdominal pain & numbness of hands, feet & tongue for approx 2 wks. Appearance was extremely tired & stressed.  DTRs diminished or absent in LEs.   Follow-up: Still having some tingling in fingertips and toes -off and on. Happens more when she exercises. States it is about only 5% of what is was in the beginning.  Still has tingling and numbness in fingers and toes on both sides of body but states is 50-75% less than in the beginning. Also occasional feelings of "electricity" mostly around nose area. She believes it all will be gone within 2 more months.
Age: 55.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Lumbar puncture, Muscle tightness, Nuclear magnetic resonance imaging brain normal, Paraesthesia
Clinical narrative: 14-15 days after receiving vaccines she started having tingling in right hand and foot. Next day same thing on left side. Also some numbness in extremities.  Gradually got worse over the next several days.  Felt like "electricity shooting out".  Numbness also went up her back. Went to MD on Feb 12. Blood tests ordered.Liver enzymes were elevated so Hepatitis blood tests done.  On Feb 15 brain MRI done which showed nothing.  Next day, Feb 16 went to ER because of increased tightening of muscles in chest (diaphram area). Dr.'s focused on heart and gallbladder.  She and husband went home and started looking up things on internet.  Found symptoms of Guillain Barre which fit perfectly so the next day (Sunday, Feb 17) drove to the ER there so she could see a neurologist.  A spinal tap was done and another test on a special machine which confirmed diagnosis of Guillain Barre. She was hospitalized that night until Friday the 22nd.  There she received large daily doses of immune globulin.  As of March 18, she is feeling better.  The tingling and numbness is still there but is decreased.  Dr. told her it should be gone by 6 months. 4/4/08 Reviewed hospital medical records of 2/17-2/22/08. FINAL DX: Guillain Barre syndrome Records reveal patient experienced progressive weakness, numbness & tingling of both right upper & lower extremity x 9 days followed by same on left side x 8 days with gait disturbance & balance difficulty x 2 days.  Had chest tightening x 4-5 days w/progressive fatigue & SOB.  Exam revealed distal sensory loss, areflexia, markedly weak hamstring muscles.  Admitted for IVIG x 4-5 doses.  Neuro consult done. Progressed & d/c w/continued home health PT.  7/11/08 Reviewed PCP medical records of 2/12-6/19/2008. FINAL DX: Guillain Barre syndrome, resolving Records of 2/12/08 reveal patient experienced weakness, pain, decreased appetite, LBP, LUQ abdominal pain & numbness of hands, feet & tongue for approx 2 wks. Appearance was extremely tired & stressed.  DTRs diminished or absent in LEs.   Follow-up: Still having some tingling in fingertips and toes -off and on. Happens more when she exercises. States it is about only 5% of what is was in the beginning.  Still has tingling and numbness in fingers and toes on both sides of body but states is 50-75% less than in the beginning. Also occasional feelings of "electricity" mostly around nose area. She believes it all will be gone within 2 more months.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: NO ADVERSE REATIONS NOTED AT THIS TIME
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMR
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 27.0
Sex: M
Vaccine: ANTH, FLUN3, SMALL, TYP
Symptoms: Carbuncle, Dermatitis, Rash maculo-papular
Clinical narrative: Presente to the Medical Clinic on 3/18/08 with c/o rash times 2-3 days. MD evaluated and noted maculopapular lesions 20-30 on back and abdomen and carbuncle to the occipital ridge posterior scalp. Diagnosed with dermatitis probably rash due to smallpox reaction per MD and carbuncle. Given Cephalexin and Benadryl. RTC if worse.
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: 10-15 red papules, some w/ vesiculopapular centers, different stages, on midtrunk/lower back/buttocks.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Rash macular
Clinical narrative: 3 DAYS AFTER ADMINISTRATION OF HEPATITIS A VACCINE (LATERAL RT THIGH) LOCAL ERYTHEMA REACTION WAS NOTED AROUND THE VACCINATION SITE WHICH SPEAD INTO MACULAR RASH TO THE LOWER AND ALSO THE OPPOSITE EXTREMITY.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Pain in extremity, Skin warm
Clinical narrative: EVENING OF PNEUOCOCCAL INJECTION ARM STARTED PAINING. NEXT DAY PAIN WAS SO BAD UNABLE TO LIFT ARM. TODAY ARM IS UPPER INNER ASPECT WAS RED AND WARM TO THE TOUCH.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient was given a DTaP on 03-12-2008. Patient seen in office on 03-19-2008 with 4cm X 6cm redness and mild swelling on Left deltoid.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: PT REPORTED TO MEDICAL CENTER ON 16 MAR 2008 FOR PAIN AND SWELLING AT THE INJECTION SIGHT.  PT STATES THAT MC GAVE HIM MOTRIN FOR PAIN.  PT REPORTED TO ISC FOR EVALUATION ON 17 MAR 2008 WITH IMPROVED SX'S SINCE STARTING THE MOTRIN WITH LESS EDEMA AND ERYTHEMA.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Abdominal pain upper, Injection site erythema, Malaise, Nausea, Pain
Clinical narrative: 3/15/08 LARGE RED RAISED AREA TO LEFT UPPER UNDER ARM APPROX SIZE 1.5". 3/17/08 AT 9:30PM HAD NAUSEA, STOMACH ACHE, 11:30PM VOMITING 4:30 VOMITING. 3/18/08 VOMITING, MALAISE, ACHES, PETECHIAE TO FACE. 3/19/08 ACHES, MALAISE. VISIT WITH DOCTOR AND PRESCRIBED BENADRYL.
Age: 13.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Petechiae, Vomiting
Clinical narrative: 3/15/08 LARGE RED RAISED AREA TO LEFT UPPER UNDER ARM APPROX SIZE 1.5". 3/17/08 AT 9:30PM HAD NAUSEA, STOMACH ACHE, 11:30PM VOMITING 4:30 VOMITING. 3/18/08 VOMITING, MALAISE, ACHES, PETECHIAE TO FACE. 3/19/08 ACHES, MALAISE. VISIT WITH DOCTOR AND PRESCRIBED BENADRYL.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Heart rate, Lethargy, Malaise, Pallor
Clinical narrative: CLIENT RECEIVED GARDASIL VACCINE DOSE NUMBER TWO. AFTER TWO MINUTES CLIENT VERBALIZED NOT FEELING WELL. SHE BECOME PALE AND LETHARGIC. AMMONIA INHALANT WAS USED AND CLIENT GIVEN SIPS OF WATER. PULSE RATE AT 70BPM. SHE VERBALIZED FEELING BETTER AFTER TEN MINUTES.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Induration, Myositis, Nuclear magnetic resonance imaging abnormal
Clinical narrative: About 24 hrs post vaccination patient had edema, localized redness, heat, and affected area was hard to the touch.  Patient also had cellulitis.  A heating pad was applied to the area and vancomycin 1.9 gm load, 1.5 gm q24hr was started. 5/13/08-records received for DOS 3/15-3/19/08-DC DX: Coronary artery disease with myocardial ischemia. Congestive heart failure with left ventricular systolic dysfunction, ejection fraction of 39%. Paroxysmal atrial fibrillation. Cellulitis of left deltoid area. Acute renal failure. presented to ED with witnessed syncope. C/O light-headednes, generalized weakness, diarrhea, macular rash on legs.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Oedema, Skin warm
Clinical narrative: About 24 hrs post vaccination patient had edema, localized redness, heat, and affected area was hard to the touch.  Patient also had cellulitis.  A heating pad was applied to the area and vancomycin 1.9 gm load, 1.5 gm q24hr was started. 5/13/08-records received for DOS 3/15-3/19/08-DC DX: Coronary artery disease with myocardial ischemia. Congestive heart failure with left ventricular systolic dysfunction, ejection fraction of 39%. Paroxysmal atrial fibrillation. Cellulitis of left deltoid area. Acute renal failure. presented to ED with witnessed syncope. C/O light-headednes, generalized weakness, diarrhea, macular rash on legs.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Blood product transfusion, Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Bilateral ascending weakness of legs starting approximately 2 weeks after administration of Hepatitis A vaccine.  Weakness progressed and diagnosed with Guillain-Barre Syndrome at Hospital.  Treated with IVIG with mild residual symptoms. 5/20/08 Reviewed hospital records for 2/28-2/29/2008 & 3/3-3/8/2008 admissions and outpatient clinic notes of 2/25-3/17/2008. FINAL DX: Guillain-Barre syndrome & Type 1 diabetes mellitus 2/28-2/29 Records reveal patient experienced foot drop, ankle inversion. abnormal gait , wanting to be carried, hand weakness approx 1 mo prior to admission.  Exam on 2/28 revealed broad based gait, LE weakness, difficulty standing from sitting, muscle atrophy more in LEs.  3/3-3/8 Records reveal patient had been readmitted for IVIG x 5 doses. Neuro consult done.  Areflexic. Improved & d/c to home  Outpatient clinic notes for ortho 2/25/08 who referred immediately for neuro eval on same date.  No definite dx at that time.  PT eval done 3/17 reveals pt w/continued LE weakness, tripping & falls, bilateral ankle pronation, unable to go up/down stairs w/o support.
Age: 1.31
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Blood culture, C-reactive protein, Chest X-ray normal, Differential white blood cell count, Febrile convulsion
Clinical narrative: Received Dtap and Varivax on 3-4-2008.  Patient went to ER via ambulance on 3-14-2008. Triage assessment states Fever x 1 day (102.3 @ home). Febrile seizure. Per mom lasted 5 min. Pt turned blue. Pt now alert. Tested ordered are: CXR, CBC w/diff, CRP, UA, RSV and influenza screen & blood cultures.  CXR neg, UA normal, negative RSV & influenza A & B, CRP 1.3, blood cultures pending.  Dx Acute febrile illness and Febrile seizure. Pt had follow up appointment 3-15.  Dr ordered strep screen, all negative. Note- patient had prior febrile seizure on 2-8-2008. Had gone to ER and dx given was influenza and febrile seizure.
Age: 1.31
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Full blood count, Influenza serology negative, Pyrexia, Urine analysis normal, Virus serology test
Clinical narrative: Received Dtap and Varivax on 3-4-2008.  Patient went to ER via ambulance on 3-14-2008. Triage assessment states Fever x 1 day (102.3 @ home). Febrile seizure. Per mom lasted 5 min. Pt turned blue. Pt now alert. Tested ordered are: CXR, CBC w/diff, CRP, UA, RSV and influenza screen & blood cultures.  CXR neg, UA normal, negative RSV & influenza A & B, CRP 1.3, blood cultures pending.  Dx Acute febrile illness and Febrile seizure. Pt had follow up appointment 3-15.  Dr ordered strep screen, all negative. Note- patient had prior febrile seizure on 2-8-2008. Had gone to ER and dx given was influenza and febrile seizure.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect route of drug administration
Clinical narrative: The Patient was given .1 ml of Influenza Virus Vaccine intradermally.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: No adverse reaction
Clinical narrative: NO ADVERSE EVENT OCCURRED.
Age: 16.0
Sex: U
Vaccine: HPV4
Symptoms: Condition aggravated, Eczema
Clinical narrative: Patient with severe eczema, Severe flare up requiring oral steroids 2 days after administration.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, RV5
Symptoms: Wrong drug administered
Clinical narrative: I inadvertantly gave an influenza shot instead of a pneuococcal shot, to a 4 month old child.  The syringes look very similar, and are pre-filled.  The error was noticed as I went to enter the shots into the computer, after my clinic, at approximately 1500.  CDC was contacted RE: any possible adverse reactions, as well as, the parent, my supervisor, and adminstration.  A detailed report was put into Webcident.  Parent was also instructed to bring the child back to the hosptial for the pnuemococcal shot.  Immunization opportunities offered.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Burning sensation, Cough, Headache, Pain
Clinical narrative: Fever, Coughing, Body Ache, Headache.  Pt c/o burning sensation on top portion of body two days after vaccination.  Also, upper torso abdominal pain to LU quadrant for 1.5 days.  Headache, "all over" throbbing.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Fever, Coughing, Body Ache, Headache.  Pt c/o burning sensation on top portion of body two days after vaccination.  Also, upper torso abdominal pain to LU quadrant for 1.5 days.  Headache, "all over" throbbing.
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. presents with redness, swelling, raised warm area around site and extending down 3-4 inches of arm - denies pain.
Age: 17.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Injection site erythema, Local reaction
Clinical narrative: After administering the vaccines, patient's left FA had a localized reddened area the R deltoid site did as well.  Pt denied pain, no swelling noted.  Dr. assessed the sites.  Pt remained in the office for an additional 30 minutes for observation.  Both sites became less reddened, pt was sent home.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: At age 5 pt was to received a DTaP, and received a Boostrix instead.  She had no reaction at all.
Age: 0.5
Sex: F
Vaccine: HIBV, RV5
Symptoms: Pallor, Rash erythematous, Rash maculo-papular
Clinical narrative: Patient had erythematous, blanching facial rash.  Macular papular extended from face, to chest, abdomen & back.  Prescribed Benadryl and follow-up in 3 days.
Age: 1.9
Sex: M
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: Large local reaction 7 cm.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Pallor, Rash maculo-papular
Clinical narrative: Macular papular blanching rash to torso 14 days after MMR.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 days post vaccine, arm red and swollen around injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature, Headache, Heart rate increased
Clinical narrative: Pneumovax administered at 1030A 3/11/08.  Pt states that at 250pm had rapid heart rate and severe headache which lasted 4 hrs.  Felt like when she had atrial fib.  In past, pt had atril fib ablation by cardiologist.  T 99.6 felt "OK" when reported event to Dr. office at 1140AM 3/11/08.
Sex: F
Vaccine: HPV4
Symptoms: Incorrect dose administered, Myalgia
Clinical narrative: Information has been received from a company representative concerning a female who in December 2007, was vaccinated intramuscularly with the first dose of GARDASIL. In January 2008, the patient was vaccinated with the second dose of GARDASIL. Subsequently, the patient experienced inappropriate schedule of vaccine administered. Also the patient has experienced muscle pain since the second. The patient's inappropriate of vaccine administered and muscle pain persisted. No further information is available.
Age: 21.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Skin burning sensation
Clinical narrative: Information has been received from a physician concerning a 21 year old white female, with type 1 diabetes and depression, who was vaccinated with a first and second dose of RECOMBIVAX HB. On 25-JUL-2006 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB. Concomitant  vaccine administered on 25-JUL-2006 included a pediatric dose of VAQTA. There was no illness at the time of vaccination. No product quality complaint was involved. No other information was provided. Follow-up information from the medical assistant indicated that in December 2006, at 4:00 p.m. the she was vaccinated with a dose in the thigh of RECOMBIVAX HB. It was reported that the she experienced burning for a moment or two, which then went away. It was noted that the she was fine after she washed it with water. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Dermatitis allergic, Dizziness, Myalgia, Nausea
Clinical narrative: Information has been received from a medical assistant concerning a 35 year old white female, who abuses tobacco, who on 02-JAN-2007 was inadvertently vaccinated intramuscularly in the left deltoid with a pediatric 0.5 ml first dose of RECOMBIVAX HB (Lot# 652881/0105F). On 02-JAN-2007 the patient received a second pediatric 0.5 ml dose of RECOMBIVAX HB (Lot# 652881/0105F) There was no illness at the time of vaccination and no adverse events following prior vaccination. On 03-JAN-2007, at 8:30 p.m., the patient stated she went to the emergency room with dizziness, nausea, confusion and pruritus. The emergency department chart indicated that the patient had muscle soreness in both legs and felt shakey. It was reported that the history and presentation was consistent with an acute allergic dermatitis. The reporter noted that the reaction was due to a side affect of RECOMBIVAX HB. There was no evidence of upper airway stridor, loss of voice, or trouble swallowing prior to the exam. The symptoms were rated at the emergency department as merely annoying. No nasal congestion and no symptoms of conjunctivitis. The patient denied rash. There was no fever, chills, sweats, or chest pain. The primary diagnosis was an allergic reaction. Upon discharge the patient was instructed to arrange for a follow-up appointment in one day or immediately if the symptoms got worse. Subsequently the patient recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Tremor
Clinical narrative: Information has been received from a medical assistant concerning a 35 year old white female, who abuses tobacco, who on 02-JAN-2007 was inadvertently vaccinated intramuscularly in the left deltoid with a pediatric 0.5 ml first dose of RECOMBIVAX HB (Lot# 652881/0105F). On 02-JAN-2007 the patient received a second pediatric 0.5 ml dose of RECOMBIVAX HB (Lot# 652881/0105F) There was no illness at the time of vaccination and no adverse events following prior vaccination. On 03-JAN-2007, at 8:30 p.m., the patient stated she went to the emergency room with dizziness, nausea, confusion and pruritus. The emergency department chart indicated that the patient had muscle soreness in both legs and felt shakey. It was reported that the history and presentation was consistent with an acute allergic dermatitis. The reporter noted that the reaction was due to a side affect of RECOMBIVAX HB. There was no evidence of upper airway stridor, loss of voice, or trouble swallowing prior to the exam. The symptoms were rated at the emergency department as merely annoying. No nasal congestion and no symptoms of conjunctivitis. The patient denied rash. There was no fever, chills, sweats, or chest pain. The primary diagnosis was an allergic reaction. Upon discharge the patient was instructed to arrange for a follow-up appointment in one day or immediately if the symptoms got worse. Subsequently the patient recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a health professional concerning a patient who, "a number of years ago," was vaccinated with a dose of RECOMBIVAX HB. Subsequently the patient experienced a reaction. Additional information is not expected.
Age: 0.11
Sex: M
Vaccine: FLU3, HEP
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 11 month old male who was vaccinated with his third dose of RECOMBIVAX HB. Concomitant therapy that day included the frost dose of FLUZONE. Ten minutes post vaccination the child developed hives on his face, chest and extremities. Medical attention was obtained. Treatment was 3/4 teaspoon of BENADRYL. The final outcome was unknown at the time of this report. No further is available. No associated quality complaint report.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B test negative
Clinical narrative: Information has been received from a 33-year-old licensed practical nurse concerning with mild asthma, sulfa allergy, and intrauterine contraceptive device insertion who in 1993 was vaccinated with RECOMBIVAX HB. There was no concomitant medication. In 2003, her titer level was 11. On 17-JAN-2007, the patient had a low titer of less than 3. Unspecified medical attention was sought. No symptoms were noted. No additional information to report. There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Hepatitis B test negative
Clinical narrative: Information has been received from a registered nurse concerning a 65-year-old male who on 30-JAN-2006(Lot # 651434/0504R), 02-MAR-2006 (Lot # 651494/0504R), and 03-JUL-2006 (Lot # 650889/0143R) was vaccinated with his first, second, and third doses of RECOMBIVAX HB. One year later (2007), the patient experienced negative titers. No additional information to report. There was no product quality complaint involved. It was noted that the reporter "would like a trace for the lot numbers provided". A standard lot check investigation was performed for Lot # 651494/0504R and Lot # 650889/0143R. All in-process quality checks for the lot numbers in question were satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released. This is one of three cases from the same source. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 12-APR-2006 (Lot # 651494/0504R), 19-JUL-2006 (Lot # 651464/0504R), and 19-OCT-2006 (Lot # 650889/0143R) was vaccinated with the first, second, and third doses of RECOMBIVAX HB. Subsequently, the patient's titers were negative. Dates for the titers were not provided, but it was noted that a titer was done "recently." No further information available. There was no product quality complaint. It was noted that the reporter "would like a trace for the lot numbers provided". A standard lot check investigation was performed for Lot # 651494/0505R and Lot # 650889/0143R. All in-process quality checks for the lot numbers in question were satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released. Additional information has been requested.
Age: 52.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: Information has been received from a registered nurse concerning an approximately 54-year-old patient who on 25-JAN-2006 (Lot # 651494/0504R), 22-FEB-2006 (Lot # 651494/0504R), and 26-JUL-2006 (Lot # 650889/0143R) was vaccinated with the first, second, and third dose of RECOMBIVAX HB. Titers conducted one year later in approximately 2007 (exact date not provided) were found to be negative. No additional information to report. There was no product quality complaint involved. It was noted that the reporter "would like a trace for the lot numbers provided". A standard lot check investigation was performed for Lot # 651494/0504R and Lot # 650889/0143R. All in-process quality checks for the lot numbers in question were satisfactory. The lots met the requirements of the Center for Biologics Evaluation and Research and were released. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HEP
Symptoms: Hypoaesthesia, Muscular weakness, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 44 year old white male physical education teacher, with no medical history and who's family history included a father who was allergic to sulfite or sulfa, who on 17-OCT-2006, at 3:15., was vaccinated with a first dose in the left deltoid of RECOMBIVAX HB (Lot# 653786/0107F). There was no illness at the time of vaccination. On 19-OCT-2006, at 8:00 a.m., the patient developed numbness in his left thumb which lasted until about 26-OCT-2006. There were no laboratory or diagnostic tests performed. Medical attention was sought. Follow-up information from a registered nurse indicated that after the vaccination with RECOMBIVAX HB in October, within a short time, on 17-OCT-2006, the patient had pain that started in his neck and radiated into his arm. He went to his family physician. The patient needed VICODIN to sleep. It was noted that the patient did not remember an injury. In October, he had weakness in his arm. His physician recommended that he go to neurologist or to an immunologist. The patient did not go either the neurologist or the immunologist. It was noted that the patient was not going to received more vaccinations. At the time of the report the patient said he had been experiencing left thumb into wrist weakness, that it was not rehabilitated prior to the injection, and that his feeling and grasp was up to 75% out of 100%. The patient's experiences were considered to be other important medical events by the reporter. The patient experienced brachial plexus neuritis and tightness between his fourth and fifth vertebrae following with a dose of MMR II (WAES# 0611USA01644). Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis A antibody negative, Hepatitis B test negative
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old nurse female employee with no known medical history on allergies, who received three doses of RECOMBIVAX HB. The patient "currently" has a negative hepatitis B titer. Unspecified medical attention was sought. Follow up information indicated the patient had negative antibodies. It is not known "which series she received". No additional information is expected.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Aura
Clinical narrative: Information has been received from a certified medical assistant concerning a 19-year-old female with allergic reaction to antibiotics and a history of seizures who was vaccinated with her first dose of RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included CARBATROL and NEURONTIN. Subsequently the day after vaccination, the patient experienced a pre-seizure visual aura with no accompanying seizure. It was noted that the patient never had a seizure with this aura, the date and duration of the aura was unclear. Subsequently, the patient recovered from pre-seizure visual aura. The series was not continued. The patient's medications at the time of this event were unknown. Additional information to report. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning an approximately 69 year old female with haemodialysis, hypertension and diabetes and no known allergies who in 2003 was vaccinated with 3 dose series of RECOMBIVAX HB and failed to seroconvert. The registered nurse reported that the patient's antibody blood test result that was drawn on 05-FEB-2007 was 7 but should be 10. Unspecified attention was sought. No product quality complaint was involved. Further information has been received from the nurse who reported that the patient received four doses of RECOMBIVAX HB in 2003. The patient had been vaccinated with hep b NOV 04, 2002 Lot # 0036M, on 06-DEC-2006 Lot#/0036M, on 06-JAN-2003, Lot # 0036 and on 07-MAY-2003 Lot # 0918M. The nurse noted that she did not known if these doses were for the first or second series for RECOMBIVAX HB. The patient was vaccinated on 24-JUL-2002 with pneumococcal vaccine lot # 1051L and vaccinated against influenza 22-OCT-2002, 03-OCT-2003 ( Lot # 765413), 08- Nov-2004, 10-OCT-2005 (Lot # U1777AA) and on 06-NOV-2006 with lot 2F601211. Additional information not expected.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B test negative, Vaccination failure
Clinical narrative: Information has been received from a health professional concerning a 40 year old white female nurse who on 29 DEC 2006 at 10:35 was vaccinated with a fourth dose of RECOMBIVAX HB (yeast intramuscularly into the deltoid). The patient received a third dose of RECOMBIVAX HB (yeast on 19-APR-2006). Concomitant therapy included LIPITOR. The patient was expected to received a second series in MAR 2007. The patient did not seroconvert. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Laboratory test, Rheumatoid arthritis
Clinical narrative: Information was received from a consumer concerning her mother a 67 year old female with no known medical history or allergies who on 16-NOV-1990 was vaccinated with a 1 milliliter third dose of RECOMBIVAX HB. On 18-NOV-1990 the patient developed rheumatoid arthritis. Laboratory diagnostic studies performed, "blood work" results not reported. It was not known if the vaccine was given intravenously or intradermally. The patient's arthritis persisted. The patient was not hospitalized. The patient was not recovered. There was no product quality involved. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Incorrect dose administered
Clinical narrative: Information has been received regarding a case in litigation concerning patient who on 13-MAY-1994 at the age of 10 weeks, was vaccinated in the right thigh with a 0.25 ml dose of Recombivax HB (lot # 607023/0301W). Concomitant vaccination included a dose of TRIPEDIA (lot # #C51043) given in the right thigh, an oral dose of ORIMUNE (lot # 0688L) and a dose of Hib (unspecified carrier) (manufacturer unknown) (lot # MISOKL) in the right thigh. On an unspecified date the patient experienced an unspecified adverse event. Medical records received indicate that the patient's vaccination history includes: 0.5 ml dose of Recombivax HB given in the left upper thigh on 12-JUL-1994 (lot # 611785/0539A) and the right thigh on 14-OCT-1994 (lot # 611785/0539A or "0539P") ; dose of TRIPEDIA given in the right thigh on 12-JUL-1994 (lot # 4K51154) and in the left thigh on 14-OCT-1994 (lot # 4W1169); a dose of DTaP (+) HIB (+) tetanus toxoid (lot # 386987 given in the left thigh on 14-APR-1995; oral doses of ORIMUNE on 12-JUL-1994 (lot # 0700H) and 14-OCT-1994 (lot #073M); a dose of HIB (unspecified carrier) (manufacturer unknown) given in the left thigh on 12-JUL-1994 (lot # MOO5KA) ; a dose of HIB (lot # 609541/0787A or "0787H" given in the right thigh on 14-OCT-1994; a dose of MMR II (lot # 609876/0481A) given in the left arm on 14-APR-1995. No further information was provided.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Vaccination failure
Clinical narrative: Information has been received from a registered nurse concerning a 57 year old male with no past medical history or allergies who in 1991 was vaccinated with a full series of RECOMBIVAX HB (Lot # 655810/1022F) IM. In 1992, the patient had a documented, positive hepatitis b antibody titer. After blood exposure, at the end of 2006, blood work indicated a negative hepatitis b titer. On 29-DEC-2006, the patient was re-immunized with RECOMBIVAX HB. A follow-up titer was negative. No adverse experience was related to this event.  Unspecified medical attention was sought. Additional information has been received from the registered nurse who stated that the patient had a full dose series of RECOMBIVAX HB in 1991. The titer was done in 1992 and was noted as reactive. In December 2006, the patient was involved in a BBP exposure and was retested. The testing came back negative and at that time patient was given a booster dose of RECOMBIVAX HB. No further information is expected.
Age: 0.2
Sex: M
Vaccine: DTAPH, HEP, HIBV, IPV, PNC
Symptoms: Flushing, Rash macular
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 week old white male who on 14-FEB-2007 was vaccinated with the first dose of RECOMBIVAX HB (Lot # 653268/0223F) in the right thigh. Concomitant therapy included pneumococcal conj vaccine (unspecified), poliovirus vaccine, Hib conj vaccine (unspecified carrier) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 14-FEB-2007 the patient developed facial flushing with macules. Subsequently, the patient recovered within 10 to 15 minutes without intervention. Additional informtion has been requested.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old female with no known drug reaction/allergies or pertinent medical history who was vaccinated with RECOMBIVAX HB. There was no concomitant medication. Subsequently the patient developed a rash. The physician felt that rash may have been related to therapy with RECOMBIVAX HB. The product quality complaint unit was not involved. Additional information has been requested.