chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: Immunizations on 10/02/2006 symptoms of bloody stools 12/04 surgical reduction of intussusception 12/04.  1/22/07 Received medical records from hospital which reveal patient admitted 12/4/-12/7/06 after having had bright red bloody diaper & was fussy prior to being seen in ER on 12/4/06.  GYN & surgical consults done to r/o vaginal bleeding.  US showed IS.  Air enema attempt to reduce intussusception was unsuccessful & was taken to OR whre it was reduced w/o difficulty. Continued to improve & was d/c to home w/o complications.  FINAL DX: Intussusception, surgically reduced.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intestinal gangrene, Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: 2 days after Rotateq, patient began vomiting 11/29/06 ultrasound on 12/1/06 showed signs of obstruction and . Abdomen-surgery on 12/1/06 revealed intussusception with gangrenous ascending and transverse colon-after, colectomy of involved segment  Andre-anastomosis.  Patient is doing well.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intestinal obstruction, Intussusception, Vomiting
Clinical narrative: 2 days after Rotateq, patient began vomiting 11/29/06 ultrasound on 12/1/06 showed signs of obstruction and . Abdomen-surgery on 12/1/06 revealed intussusception with gangrenous ascending and transverse colon-after, colectomy of involved segment  Andre-anastomosis.  Patient is doing well.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5, DTAP, HIBV, IPV, PNC, RV5, RV5
Symptoms: Intussusception
Clinical narrative: 2 days after Rotateq, patient began vomiting 11/29/06 ultrasound on 12/1/06 showed signs of obstruction and . Abdomen-surgery on 12/1/06 revealed intussusception with gangrenous ascending and transverse colon-after, colectomy of involved segment  Andre-anastomosis.  Patient is doing well.
Age: 1.0
Sex: F
Vaccine: DTAP, HEP, HEPA, MMRV, PNC
Symptoms: Rash papular
Clinical narrative: ProQuad received at well check up on 11/6/06. Patient presented to office on 11/27/06 with history of papular lesions 75 plus times 1 day. Afebrile
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Severe local reaction, redness swelling
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Feeling hot, Pruritus, Rash
Clinical narrative: Giavanna was brought in today by her mother because of a rash and redness at the site of the MMRV vaccination that she received on November 30, 2006. The mother said that 2 days after she received the vaccine she started having erythema at the site in her left lateral arm. It has gradually increased in size over the last 24 hours and became itchy and warm. She has no vesicular lesions. She has no other lesions on her body. Her review of systems is negative for fever or any other complaints. Physical examination:Vital Signs: Her weight is 31.25 kg or 68 3/4 pounds. Temperature 97.7 through the ear. Genera: Appearance: Comfortable in no acute distress. Skin: Exam reveals a 5x7 cm erythematous well-circumscribed warm slightly raised lesion over the lateral aspect of the left arm at the site of the previous vaccination on November 30, 2006. There are no vesicular lesions. There are no other rashes on the body. The rest of her physical exam is completely normal. Impression: Possible reaction to the MMRV vaccine. Possible superimposed secondary infection. Plan:1.  Report to vaccine adverse events reporting system. 2. Course of  Keflex (250 mg in 5 ml) 7.5 ml q 6 hours for 7-10 days, 300 ml given no refills. 3. Follow up with us if symptoms worsen or are not improving within 24 or 48 hours or any other concern or spreading of the rash or high-grade fever.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Cyst
Clinical narrative: Patient received immunizations 11/27/06. Patient reaction started 11/29/06 per moc patient had a cyst form @ site of DTAP when she was little also. 11/30/06 patient came in because of DTAP reaction. Put on Keflex, ice pads, Tylenol/Motrin PRN.
Age: 25.0
Sex: M
Vaccine: FLUN3
Symptoms: Rash, Rash macular
Clinical narrative: Patient presented with blotches and a rash on face, forearms, and chest. No rash noted on abdomen. Breath sounds equal and clear, no shortness of breath reported. Pulse 76, respirations 14, B/P 133/73 (RA). No itchiness reported. Patient given two Benadryl 25 mg each and observed for 15 minutes.
Age: 47.0
Sex: M
Vaccine: FLUN3
Symptoms: Erythema multiforme, Rash macular
Clinical narrative: Client reported he developed oval blotches on his skin on 08Nov06, the day after receiving FluMist (first time), he was in NYS and went to ER (Cortland Regional Medical Ctr) and was DX with erythema multiforme advised this clinic of event 27Nov06. Oval patches persist has F/U appt with his MD 13Dec06.
Age: 1.16
Sex: M
Vaccine: DTPHIB, HEPA, MMR, PNC
Symptoms: Blister, Pruritus, Rash papular
Clinical narrative: Several papules and vesicles in multiple stages positive puritic. Treatment calamine lotion, aveeno oatmeal, Benadryl
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Paraesthesia
Clinical narrative: Injection left deltoid with HPV vaccine, immediate pain, transient finger tingling. Pain persists with movement and pressure only, 10/27/06.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Type III immune complex mediated reaction
Clinical narrative: Pt received Zostavax on 11/17/06 on 11/17/06 she developed an Arthus reaction at the injection site.
Age: 24.0
Sex: F
Vaccine: ANTH, SMALL
Symptoms: Rash
Clinical narrative: Skin rash, mostly on sunny days.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Pruritus, Urticaria
Clinical narrative: Pt had 2 large hives at site of injection, itchy. Pt given Benadryl and hives went down.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash papular
Clinical narrative: + Papules and few vesicles scattered toes, back and feet.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Grandmother noticed 3" area of redness (slightly raised) area in deltoid area of left arm day after shot. Child said it hurt a little but it didn't stop her from doing normal activities. the mother noted that arm was warm and red 3 more days, after that was back to normal color. Denies any type reaction to previous vaccine..
Age: 2.0
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Somnolence
Clinical narrative: Raised red area around site of injection in left arm, upper remained red and raised until Sunday 10/22/06. Also reported that pt was sleepier, redness started 10/20/06. Had fever 101 eve of 10/19/06. Reported per PC with mother Motrin was given per mom.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Somnolence
Clinical narrative: Raised red area around site of injection in left arm remained red and raised until Sunday 10/22/06. Also reported that pt slept all day after the vaccine. Reported had fever 102 eve of 10/19/06. Reported per PC with mother Motrin was given.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Cellulitis reaction to vaccine pt received pneumonia and influenza vaccine in right arm on 11/03/06. Pt seen 11/06/06 with about 8"x3" RUA, DX with cellulitis, responded well to Augmentin.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site oedema
Clinical narrative: Redness and swelling of inner arm, going towards axilla. Immediate injection site. Differential here allergic reaction VS cellulitis, treated for cellulitis as a precaution. See attached clinical note.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Facial rash which was hive like in appearance appeared in face in butterfly like pattern in 5-7 minutes after vaccine given. No resp symptoms, rash after observing 30 min.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: 11/07/06 1st 12/06/06 2nd vac. No adverse effects, Accidentally  given pregnant (26 5/7 weeks) a second flu vaccine, reported per phone 12/06/06 conversation will not cause harm but is off label use so must report.
Age: 8.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Hypokinesia, Injection site oedema
Clinical narrative: Left leg swollen at injection site. Area quarter to 50 cent piece size on 11/30/06. By 12/01/2006 area enlarged and child complained of standing on right leg. Pt seen in ER.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Swelling and redness from injection site down to elbow.  Erythematous, swollen and very painful.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Headache, Nasal congestion, Pyrexia
Clinical narrative: Within 24 hours of injection started to feel tired and weak with onset of headache by evening of that same day, low grade fever with head and chest congestion lasting 4-5 days.
Age: 0.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Shoulder pain
Clinical narrative: Severe arm and shoulder pain x 5days( unable to lift arms), but continued discomfort for approx. 10 - 14 days.  Recieves flu every year first time with this reaction.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error
Clinical narrative: Tdap was given 1yr after child recieved Td. Immunization record presented at time of vaccination was incomplete. The child showed no adverse symptoms after administration.
Age: 0.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: According to Occupational Health Nurse and a incident report, patient reported he received a flu vaccine on the morning of 10-26-06; on 10-27-06 he began to experience a mild reaction of fever and hives; on 10-28-06, these symptoms increased in severity, which sent him to be seen at the doctors. He was seen, treated, and released with medication from a doctor. He has had a flu recovery to his pre-vaccine state.
Age: 0.95
Sex: M
Vaccine: HEPA, TYP
Symptoms: Pyrexia
Clinical narrative: ON THE NIGHT OF INJECTION  PT. EXPERIENCED A SLIGHT FEVER. ON THE NEXT DAY HE WAS OK ACCORDING TO PARENT.
Age: 0.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: According to the Occupational Health Nurse, patient received the flu vaccine on 11-2-06, on 11-3-06 began complaining of itching and a rash generally over body. He went to a doctor and received medication for symptoms and has made a full recovery back to his pre-vaccine state.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Epistaxis, Headache, Nasal congestion, Pharyngitis, Pharyngolaryngeal pain
Clinical narrative: Headach, Nasal congestion /bleeding, Sore throat, Burning sensation in lungs and eyes. Coldlike symptoms. Started the day after receiving Flu Vaccination. One other coworker here received the vaccination with me, experienced same symptoms. None of the other 12 people here currently sick and none of them received the flu shot.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinitis
Clinical narrative: Headach, Nasal congestion /bleeding, Sore throat, Burning sensation in lungs and eyes. Coldlike symptoms. Started the day after receiving Flu Vaccination. One other coworker here received the vaccination with me, experienced same symptoms. None of the other 12 people here currently sick and none of them received the flu shot.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Loss of consciousness, Nausea, Vomiting
Clinical narrative: About an hour after receiving the shot at a free flu shot clinic at work, I suddenly felt light-headed and passed out. After regaining conciousness, I felt nauseous and got sick twice that night. Since I passed out at work, my coworkers called an ambulance but I didn't feel bad enough to go with them.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Dysphonia, Dyspnoea, Injection site hypersensitivity
Clinical narrative: Shot area itched. The second day I had chills and a rash. The third day in the pm I experienced dizziness, difficulty breathing, nausea, and hoarseness. The fourth day in the am I still experienced dizziness and nausea. It finally went away in the afternoon. The next couple of days I have still had a feeling of lightheadedness but am able to work. I took Benedryl for the rash.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pruritus, Rash
Clinical narrative: Shot area itched. The second day I had chills and a rash. The third day in the pm I experienced dizziness, difficulty breathing, nausea, and hoarseness. The fourth day in the am I still experienced dizziness and nausea. It finally went away in the afternoon. The next couple of days I have still had a feeling of lightheadedness but am able to work. I took Benedryl for the rash.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Coma, Paraesthesia
Clinical narrative: Admitted via ER on 11/28/06 with paresthesias in both legs. Illness worsened and she now is in a coma in the neuro ICU with unknown diagnosis. On admit to ER, stated had received a flu vaccine one week earlier. Date of vaccination is estimated and not exact date. 02/01/07 records received and reviewed for DOS 11/26/06-01/23/07 DC DX: Acute disseminated encephalomyelitis Remote history of bulimina nervosa Spasticity secondary to acute dissseminated encephalomyelitis Diarrhea, chronic Respiratory failure with permanent tracheostomy, status post prolonged respiratory failure on vent previously. Methicillin resistant Staphylococcus aureus colonization, status post Baclofen pump placement for spasticity. Protein calorie malnutrition on feeds via percutaneous endoscopic gastrostomy tube. DC to long term care facility PE: positive for total paresthesia and now complete paralysis of arms and legs. No respiratory distress or chest pain. Pain in all 4 extremities. Developed respiratory distress and insufficiency, extensor posturing to deep painful stimuli, clonus and positive Babinski. Treatment included plasmapheresis and Solu-Medrol.  Developed bulbous type rash of buttocks and posterior thigh, suspect may be autoimmune.  WBC:range from 6.3-22.8, sed rate 47, ionized Ca 5.36-5.70, CRP 0.7-11.2, measles AB IGG positive ISR, mumps AB IGG positive ISR, blood culture enterococcus faecalis, pseudomonas mendocina, urine culture postive E.coli and candida albicans and pseduomonas aeruginosa, sputum culutre positive staph aureus MSRA and stenotrophomonas maltophilia, cath tip culture pseudomonas aeruginosa, herpes simplex PCR negative, Epstein Barr virus positive, CMV AB IGG 10.60, lymphocyte subset panel ABS CD4 177, CD8 998, CD3 1191, CD8 0.18, viral culture of brain negative.HIV1 negative, histoplasma antigen AG negative. Brain biopsy:intact myelin staining seems to make multiple sclerosis less likely. Vasculitis is not appreciated. A microinfarct may bet he cause although axonal staining is intact in the majority of the tissue. Macrophage infiltrates and reactive gliosis
Age: 6.0
Sex: M
Vaccine: FLU3, PPV, VARCEL
Symptoms: Fatigue, Headache, Myalgia, Neck pain, Pyrexia
Clinical narrative: Patient experienced a large local reaction extending from elbow to shoulder, myalgias, fatigue, headache, neck pain, and fever to 104.  His visit to the emergency room resulted in a full fever/sepsis workup to include lumbar puncture.  His WBC was extremely elevated at 43,000 with a predominantly left shift.  He was admitted to the hospital and started on rocephin prophylactically.  He did well in the hospital with resolution of his leukomoid reaction and no other cause for symptoms was found.  1/18/07 Received medical records which reveal patient admitted to hospital from 12/2-12/5/06 with fever & r/o meningitis after complaints of headache & neck pain.  All vax had been given in left deltoid & had also developed erythema, tenderness & warmth over left arm.  Temp was 104 on admit.  Improved significantly on antibiotics.  Headache & neck pain resolved, left arm improved & was afebrile for 24 hours prior to d/c to home on continued oral antibiotics.  When seen in clinic on 12/8 was back to baseline & WBC was 11.6, H/H 9.6/29.0  FINAL DX: immunization reaction; & respiratory syncytial virus bronchiolitis.
Age: 6.0
Sex: M
Vaccine: FLU3, PPV, VARCEL
Symptoms: Sepsis, White blood cell count increased
Clinical narrative: Patient experienced a large local reaction extending from elbow to shoulder, myalgias, fatigue, headache, neck pain, and fever to 104.  His visit to the emergency room resulted in a full fever/sepsis workup to include lumbar puncture.  His WBC was extremely elevated at 43,000 with a predominantly left shift.  He was admitted to the hospital and started on rocephin prophylactically.  He did well in the hospital with resolution of his leukomoid reaction and no other cause for symptoms was found.  1/18/07 Received medical records which reveal patient admitted to hospital from 12/2-12/5/06 with fever & r/o meningitis after complaints of headache & neck pain.  All vax had been given in left deltoid & had also developed erythema, tenderness & warmth over left arm.  Temp was 104 on admit.  Improved significantly on antibiotics.  Headache & neck pain resolved, left arm improved & was afebrile for 24 hours prior to d/c to home on continued oral antibiotics.  When seen in clinic on 12/8 was back to baseline & WBC was 11.6, H/H 9.6/29.0  FINAL DX: immunization reaction; & respiratory syncytial virus bronchiolitis.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Depressed level of consciousness, Diarrhoea, Dizziness, Fatigue, Injection site pain
Clinical narrative: 21 yo G2 P0010 EDC 4/14/07 at 21 weeks gestation came for routine prenatal care 12/5/06. Pt received Td Vaccine at approximately 1pm. Felt well before and after shot. Started feeling ill about 6pm. Reported feeling feverish with upset stomach. Vomited x 3, felt dizzy, vision blurry, and fainted. Family with her and patient stated family had difficulty arousing her and called EMS, "out x 20 minutes". Taken to  hospital and kept for 12 hours. Hit her stomach and kept for fetal evaluation. Stated had fetal sonogram and EKG done there. Had 3-4 episodes of watery diarrhea in the night. Discharged home at 6 am on 12/6/06. Now feeling tired and weak. No fever now. Injection site sore and swollen.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Injection site swelling, Malaise, Pyrexia, Stomach discomfort, Syncope
Clinical narrative: 21 yo G2 P0010 EDC 4/14/07 at 21 weeks gestation came for routine prenatal care 12/5/06. Pt received Td Vaccine at approximately 1pm. Felt well before and after shot. Started feeling ill about 6pm. Reported feeling feverish with upset stomach. Vomited x 3, felt dizzy, vision blurry, and fainted. Family with her and patient stated family had difficulty arousing her and called EMS, "out x 20 minutes". Taken to  hospital and kept for 12 hours. Hit her stomach and kept for fetal evaluation. Stated had fetal sonogram and EKG done there. Had 3-4 episodes of watery diarrhea in the night. Discharged home at 6 am on 12/6/06. Now feeling tired and weak. No fever now. Injection site sore and swollen.
Age: 21.0
Sex: F
Vaccine: TD
Symptoms: Vision blurred, Vomiting
Clinical narrative: 21 yo G2 P0010 EDC 4/14/07 at 21 weeks gestation came for routine prenatal care 12/5/06. Pt received Td Vaccine at approximately 1pm. Felt well before and after shot. Started feeling ill about 6pm. Reported feeling feverish with upset stomach. Vomited x 3, felt dizzy, vision blurry, and fainted. Family with her and patient stated family had difficulty arousing her and called EMS, "out x 20 minutes". Taken to  hospital and kept for 12 hours. Hit her stomach and kept for fetal evaluation. Stated had fetal sonogram and EKG done there. Had 3-4 episodes of watery diarrhea in the night. Discharged home at 6 am on 12/6/06. Now feeling tired and weak. No fever now. Injection site sore and swollen.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Oedema, Pain, Pyrexia
Clinical narrative: Right upper arm was edematous and "bright red", hot, painful, tactile temp.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration
Clinical narrative: Patient had a flu shot on 11/29/06. Patient returned to clinic on 12/1/06 with a hard lump on left upper arm. Patient had a local reaction.
Age: 1.26
Sex: M
Vaccine: DTAP, FLU3, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: One week after vaccines, developed fever.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Shoulder pain, Tremor
Clinical narrative: Pain in arm/shoulder where vaccination was given for at least 2 weeks after vaccination was administered.  Vibrations felt from top of shoulder down through finger tips very often - and especially during physical activity.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Hot flush, Pyrexia
Clinical narrative: FEVER, HOT FLASHES AND A TIGHT FEELING IN THE UPPER CHEST REGION.  EVENT LASTED FOR 2 HOURS.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 11/10/06  RECEIVED PHONE CALL FROM PATIENT REPORTS REDNESS,TENDERNESS, AT INJECTION SITE  WILL OBSERVE FOR NOW AND CALL WITH UPDATE 11/13/06.   REPORTS SITE IMPROVED.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: 11/10/06  PHONE CALL REPORTING REDNESS, INFLAMMATION, SWELLING NOTED TO WRIST.  AUGMENTIN 875 BID X 7 DAYS ORDERED.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure decreased, Dysphonia, Dyspnoea, Heart rate increased
Clinical narrative: MOTHER STATES SYMPTOMS STARTED ON THE 15TH OR 16TH.  HE COMPLAINED OF SORE THROAT.  MOTHER STATES HE HAD DIFFICULTY BREATHING, HOARSENESS, WHEEZING, PALENESS, WEAKNESS, A FAST HEART BEAT AND DIZZINESS.  DENIES HIVES.  HE WAS TAKEN TO ER ON 11/19.  SHE SAID HIS HEART RATE IN ER WAS 152 AND HIS BP VERY LOW.  HE WAS DIAGNOSED WITH PNEUMONIA.  HE HAD A RESPIRATORY ARREST AND THEN LATER KIDNEY FAILURE. PARENTS CAME AND REPORTED THIS TO FIRST DISTRICT BECAUSE  THE CLINIC HAD TOLD THEM TO.  THEY WERE RELUCTANT TO GIVE THEIR ADDRESS AND THEIR NAMES.  "WE HAVE BEEN THROUGH ENOUGH."  12/8/06 Received medical records from 1st hospital which reveal patient admitted 11/19/06.  Patient had 4 days of sore throat, fever, dry cough & diarrhea.  Patient continued to deteriorate, coded & expired on 11/22/06.  No autopsy was done. LABS: CXR hazy infiltrates in bilateral lung bases. CT of abdomen & pelvis WNL.  US of kidney was WNL.  CK 11, 046 & troponin 0.24. Bone marrow biopsy done was WNL.  WBC 9.21, plts 99, Na 131, elevated liver enzymes. Final Dx: acute tubular necrosis; chronic renal failure likely secondary to HIV nephropathy; HIV positive; COPD, thrombocytopenia; culture negative sepsis; hypotension; respiratory failure/hypoxia; alcoholism; tobacco abuse; seizures secondary to head trauma; depression; s/p LS operation; hypothyroidism; insomnia; and anxiety. 1/5/07 Received Death Certificate from funeral home which reveals COD as HIV/AIDS with rhabdomyalysis as a contributing factor.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Pharyngolaryngeal pain, Pneumonia, Renal failure, Respiratory arrest
Clinical narrative: MOTHER STATES SYMPTOMS STARTED ON THE 15TH OR 16TH.  HE COMPLAINED OF SORE THROAT.  MOTHER STATES HE HAD DIFFICULTY BREATHING, HOARSENESS, WHEEZING, PALENESS, WEAKNESS, A FAST HEART BEAT AND DIZZINESS.  DENIES HIVES.  HE WAS TAKEN TO ER ON 11/19.  SHE SAID HIS HEART RATE IN ER WAS 152 AND HIS BP VERY LOW.  HE WAS DIAGNOSED WITH PNEUMONIA.  HE HAD A RESPIRATORY ARREST AND THEN LATER KIDNEY FAILURE. PARENTS CAME AND REPORTED THIS TO FIRST DISTRICT BECAUSE  THE CLINIC HAD TOLD THEM TO.  THEY WERE RELUCTANT TO GIVE THEIR ADDRESS AND THEIR NAMES.  "WE HAVE BEEN THROUGH ENOUGH."  12/8/06 Received medical records from 1st hospital which reveal patient admitted 11/19/06.  Patient had 4 days of sore throat, fever, dry cough & diarrhea.  Patient continued to deteriorate, coded & expired on 11/22/06.  No autopsy was done. LABS: CXR hazy infiltrates in bilateral lung bases. CT of abdomen & pelvis WNL.  US of kidney was WNL.  CK 11, 046 & troponin 0.24. Bone marrow biopsy done was WNL.  WBC 9.21, plts 99, Na 131, elevated liver enzymes. Final Dx: acute tubular necrosis; chronic renal failure likely secondary to HIV nephropathy; HIV positive; COPD, thrombocytopenia; culture negative sepsis; hypotension; respiratory failure/hypoxia; alcoholism; tobacco abuse; seizures secondary to head trauma; depression; s/p LS operation; hypothyroidism; insomnia; and anxiety. 1/5/07 Received Death Certificate from funeral home which reveals COD as HIV/AIDS with rhabdomyalysis as a contributing factor.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: MOTHER STATES SYMPTOMS STARTED ON THE 15TH OR 16TH.  HE COMPLAINED OF SORE THROAT.  MOTHER STATES HE HAD DIFFICULTY BREATHING, HOARSENESS, WHEEZING, PALENESS, WEAKNESS, A FAST HEART BEAT AND DIZZINESS.  DENIES HIVES.  HE WAS TAKEN TO ER ON 11/19.  SHE SAID HIS HEART RATE IN ER WAS 152 AND HIS BP VERY LOW.  HE WAS DIAGNOSED WITH PNEUMONIA.  HE HAD A RESPIRATORY ARREST AND THEN LATER KIDNEY FAILURE. PARENTS CAME AND REPORTED THIS TO FIRST DISTRICT BECAUSE  THE CLINIC HAD TOLD THEM TO.  THEY WERE RELUCTANT TO GIVE THEIR ADDRESS AND THEIR NAMES.  "WE HAVE BEEN THROUGH ENOUGH."  12/8/06 Received medical records from 1st hospital which reveal patient admitted 11/19/06.  Patient had 4 days of sore throat, fever, dry cough & diarrhea.  Patient continued to deteriorate, coded & expired on 11/22/06.  No autopsy was done. LABS: CXR hazy infiltrates in bilateral lung bases. CT of abdomen & pelvis WNL.  US of kidney was WNL.  CK 11, 046 & troponin 0.24. Bone marrow biopsy done was WNL.  WBC 9.21, plts 99, Na 131, elevated liver enzymes. Final Dx: acute tubular necrosis; chronic renal failure likely secondary to HIV nephropathy; HIV positive; COPD, thrombocytopenia; culture negative sepsis; hypotension; respiratory failure/hypoxia; alcoholism; tobacco abuse; seizures secondary to head trauma; depression; s/p LS operation; hypothyroidism; insomnia; and anxiety. 1/5/07 Received Death Certificate from funeral home which reveals COD as HIV/AIDS with rhabdomyalysis as a contributing factor.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Dysgeusia, Joint range of motion decreased, Lymph node pain, Lymphadenopathy
Clinical narrative: WITHIN 1 HR OF RECEIVING THE FLULAVAL INJECTION, THE PATIENT STATED THAT SHE HAD A "METALLIC TASTE" IN HER MOUTH AND BEGAN FEELING HER LEFT ARM BEGIN TO SWELL. WITHIN 24 HOURS AFTER THE INJECTION, THE EPITROCHLEAR LYMPH NODES IN THE LEFT ARM BEGAN TO ENLARGE, BECAME PAINFUL AND HAD SUBCUTEANEOUS TISSUE SWELLING FROM THE LOWER MID ARM TO UPPER MID ARM. THE LYMPH NODES AND SUBCUTANEOUS TISSUE CONTINUED TO SWELL AND INCREASE IN SIZE AND PEAKED IN SIZE AFTER 6-7 DAYS AFTER THE INJECTION. RANGE OF MOTION TO THE LEFT ARM WAS ALSO LIMITED AND THE LYMPH NODES TO THE LEFT UNDERARM AREA WERE ALSO ENLARGED ABD PAINFUL. ON DAY 10, THE EPITROCHLEAR LYMPH NODES AND SUBCUTANEOUS TISSUE HAVE REDUCED SIGNIFICANTLY IN SIZE; ALTHOUGH, THE EPITROCHLEAR LYMPH NODE MEASURED 2 3/4 INCHES BY 1 3/4 INCHES. THE PATIENT ALSO EXPERIENCE MILD MYALGIA THROUGHOUT THIS PERIOD OF TIME.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Swelling
Clinical narrative: WITHIN 1 HR OF RECEIVING THE FLULAVAL INJECTION, THE PATIENT STATED THAT SHE HAD A "METALLIC TASTE" IN HER MOUTH AND BEGAN FEELING HER LEFT ARM BEGIN TO SWELL. WITHIN 24 HOURS AFTER THE INJECTION, THE EPITROCHLEAR LYMPH NODES IN THE LEFT ARM BEGAN TO ENLARGE, BECAME PAINFUL AND HAD SUBCUTEANEOUS TISSUE SWELLING FROM THE LOWER MID ARM TO UPPER MID ARM. THE LYMPH NODES AND SUBCUTANEOUS TISSUE CONTINUED TO SWELL AND INCREASE IN SIZE AND PEAKED IN SIZE AFTER 6-7 DAYS AFTER THE INJECTION. RANGE OF MOTION TO THE LEFT ARM WAS ALSO LIMITED AND THE LYMPH NODES TO THE LEFT UNDERARM AREA WERE ALSO ENLARGED ABD PAINFUL. ON DAY 10, THE EPITROCHLEAR LYMPH NODES AND SUBCUTANEOUS TISSUE HAVE REDUCED SIGNIFICANTLY IN SIZE; ALTHOUGH, THE EPITROCHLEAR LYMPH NODE MEASURED 2 3/4 INCHES BY 1 3/4 INCHES. THE PATIENT ALSO EXPERIENCE MILD MYALGIA THROUGHOUT THIS PERIOD OF TIME.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Hallucination, Irritability, Pyrexia
Clinical narrative: Seven hours after vaccine given patient become irritable and spiked fever to 102.2 and hallucinated worms all over the place.  Hallucinations lasted approximately 20 hours. Telephone report on 12/6 5pm: hallucinations resolved.  Spiked fever in late afternoon.
Age: 0.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 11/13/06  REPORTED INJECTION SITE SORE, PAINFUL, AND RED   AUGMENTIN 875 BID X 7 DAYS.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 10/20/06  CALLED TO REPORT THAT INJECTION SITE TENDER, RED, WARM TO TOUCH.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash erythematous
Clinical narrative: 4 days after receiving Fluogen employee starting getting fine erythemic rash on anterior and lateral aspects of thighs and lower back/c/o itchiness but no other sx.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cold sweat, Difficulty in walking, Disorientation, Dizziness, Dyskinesia
Clinical narrative: With in five minutes of administration complaint of headache, then felt faint.  I had my daughter sit down in the waiting room with her head down before we walked out.  Not thinking this had anything to do with the vaccine.  We walked out the door and she began have difficlty walking, weaving, I asked her if she was okay and she could only respond yes.  I took her arm and tried to turn her back to the Doctor's office and she collapsed on the ground.  Though, she remainded conscious her eyes were glazed and was disoriented.  It happened that another lady was leaving the office and I asked for her assitance to walk her back inside.  The nurse immediately had us put her on an exam table.  I do not think she was able to hear a blood pressure.  At this point, my daughter was extremely pale, clammy, shallow rapid breathing, weak pulse, able to anwser questions.  She stated her ears were ringing and that she had tingling in her feet.  The doctor naturally examined her as well.  They treated her with oral fluids, rest and some sugar cookies(the only thing they had). I am not sure the exact time the vaccine was administered. I believe it was around 5pm.  When we left the doctors office, it was 5:45, my daughter felt weak and was shaky (visible).  On the drive home she experienced visible muscle contractions in her arms and legs.  Legs and arms were involuntarily jerking.  This lasted approximately 10 minutes.  By 6:00pm she felt "normal".
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Gait disturbance, Headache, Hyperventilation, Pallor, Paraesthesia
Clinical narrative: With in five minutes of administration complaint of headache, then felt faint.  I had my daughter sit down in the waiting room with her head down before we walked out.  Not thinking this had anything to do with the vaccine.  We walked out the door and she began have difficlty walking, weaving, I asked her if she was okay and she could only respond yes.  I took her arm and tried to turn her back to the Doctor's office and she collapsed on the ground.  Though, she remainded conscious her eyes were glazed and was disoriented.  It happened that another lady was leaving the office and I asked for her assitance to walk her back inside.  The nurse immediately had us put her on an exam table.  I do not think she was able to hear a blood pressure.  At this point, my daughter was extremely pale, clammy, shallow rapid breathing, weak pulse, able to anwser questions.  She stated her ears were ringing and that she had tingling in her feet.  The doctor naturally examined her as well.  They treated her with oral fluids, rest and some sugar cookies(the only thing they had). I am not sure the exact time the vaccine was administered. I believe it was around 5pm.  When we left the doctors office, it was 5:45, my daughter felt weak and was shaky (visible).  On the drive home she experienced visible muscle contractions in her arms and legs.  Legs and arms were involuntarily jerking.  This lasted approximately 10 minutes.  By 6:00pm she felt "normal".
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Tinnitus, Tremor
Clinical narrative: With in five minutes of administration complaint of headache, then felt faint.  I had my daughter sit down in the waiting room with her head down before we walked out.  Not thinking this had anything to do with the vaccine.  We walked out the door and she began have difficlty walking, weaving, I asked her if she was okay and she could only respond yes.  I took her arm and tried to turn her back to the Doctor's office and she collapsed on the ground.  Though, she remainded conscious her eyes were glazed and was disoriented.  It happened that another lady was leaving the office and I asked for her assitance to walk her back inside.  The nurse immediately had us put her on an exam table.  I do not think she was able to hear a blood pressure.  At this point, my daughter was extremely pale, clammy, shallow rapid breathing, weak pulse, able to anwser questions.  She stated her ears were ringing and that she had tingling in her feet.  The doctor naturally examined her as well.  They treated her with oral fluids, rest and some sugar cookies(the only thing they had). I am not sure the exact time the vaccine was administered. I believe it was around 5pm.  When we left the doctors office, it was 5:45, my daughter felt weak and was shaky (visible).  On the drive home she experienced visible muscle contractions in her arms and legs.  Legs and arms were involuntarily jerking.  This lasted approximately 10 minutes.  By 6:00pm she felt "normal".
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Broke out with severe urticartia/hives over entire body the same night as vaccine. The hives have lasted the past 3 weeks and arent getting any better. I am being treated with antihistimines/prednizone/lotion daily.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Asthenia, CSF test abnormal, Encephalitis, Encephalopathy, Laboratory test abnormal
Clinical narrative: Sudden onset of global weakness. Pt hospitalized and diagnosed with ADEM. Specialist believes the condition may have been caused by vaccines. 01/08/07-records received and reviewed.  DOS 11/29-12/9/06- DC DX: acute disseminating encephalopathy. Began with weakness not moving all 4 limbs, PE little movement in lower limbs, hypotonic, 2+reflexes, without clonus, poor head control. Two weeks prior had respiratory illness.  Treatment included Solu Medrol. Residual neurological symptoms - weakness of extremities, mild developmental delay (motor), and vesico-uretral reflux (possibly due to urinary retention).
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Myelitis
Clinical narrative: Sudden onset of global weakness. Pt hospitalized and diagnosed with ADEM. Specialist believes the condition may have been caused by vaccines. 01/08/07-records received and reviewed.  DOS 11/29-12/9/06- DC DX: acute disseminating encephalopathy. Began with weakness not moving all 4 limbs, PE little movement in lower limbs, hypotonic, 2+reflexes, without clonus, poor head control. Two weeks prior had respiratory illness.  Treatment included Solu Medrol. Residual neurological symptoms - weakness of extremities, mild developmental delay (motor), and vesico-uretral reflux (possibly due to urinary retention).
Sex: M
Vaccine: FLU3
Symptoms: Facial palsy
Clinical narrative: On 11/28 patient contacted doctor and later visited the office. Diagnosed with Bell's Palsy affecting left side of face. Patient has history of head trauma so uncertain whether vaccine caused problem.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Persisting muscle pain at left deltoid S/P flu shot approximately 3 weeks ago.
Age: 41.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Injection site erythema, Injection site oedema, Malaise, Pain, Pyrexia
Clinical narrative: Pt states she had low grade fever, achiness approx 8 hrs after vaccine. Next pm experienced 103.6 fever, tachycardia and generalized aches. On 12/02 pt woke up vomiting, T of 102.5 still achiness. Arm red and swollen. 12/03 no fever, continued severe malaise, Today 12/10 pt has no fever, aches, arm slightly red some swelling.
Age: 41.0
Sex: F
Vaccine: FLU3, MNQ, PPV
Symptoms: Tachycardia, Vomiting
Clinical narrative: Pt states she had low grade fever, achiness approx 8 hrs after vaccine. Next pm experienced 103.6 fever, tachycardia and generalized aches. On 12/02 pt woke up vomiting, T of 102.5 still achiness. Arm red and swollen. 12/03 no fever, continued severe malaise, Today 12/10 pt has no fever, aches, arm slightly red some swelling.
Age: 44.0
Sex: M
Vaccine: ANTH, MEN, SMALL, TYP
Symptoms: Hypertension, Injection site pain, Mental impairment, Photophobia, Tinnitus
Clinical narrative: Blood pressure high, hearing ringing in ears, pain injection site, poor tolerance for bright lights, unable to comprehend words.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Feeling jittery, Pyrexia, Tremor
Clinical narrative: 3 days fever 2 weeks jittery, fine tremors not himself (can't explain it)
Age: 72.0
Sex: M
Vaccine: PPV, TD
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, Chills x 72 hours
Age: 60.0
Sex: F
Vaccine: PPV, TD
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, chills, x 72 hours
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: Pt was given Pneumovax not at our office but at another one. Symptoms were provided by pt to us. Pt was not seen in OV. Pt C/O swollen right arm from elbow to axilla, hot to touch x 3.5 days.
Age: 0.36
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: Pt received vaccines at another clinic 12/04/06. On 12/05/06 she started with fever and later developed rash on arm which spread to all extremities and face. We saw her on 12/06/06, rash appeared like erythema much for me. She also was given Tylenol on 12/04.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Irritability, Rash pruritic
Clinical narrative: Pruritic redness around neck and mild irritablilty seen in Emergency Room given Benadryl. Resolved symptoms in less than 24 hours with out worsening. Started 2-3 hours of vaccine administration. No erythema, shortness of breath, facial edema.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives and itching, erythema of skin all over body.
Age: 0.17
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Crying, Haematochezia, Intussusception
Clinical narrative: Information has been received from a physician concerning a 2 month old pt who on 11/3/06 was vaccinated with a dose of Rotavirus vaccine. On 11/25/06 the pt developed intussusception and was hospitalized. It was noted that the intussusception required surgery. At the time of the report the pt was noted to still be in the hospital and not recovered. No product quality complaint was involved. The pts experience was considered to be immediately life threatening, disabling by the reporter, and an other important medical event by the report (OMIC). Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Intussusception
Clinical narrative: Information has been received from a physician concerning a 2 month old pt who on 11/3/06 was vaccinated with a dose of Rotavirus vaccine. On 11/25/06 the pt developed intussusception and was hospitalized. It was noted that the intussusception required surgery. At the time of the report the pt was noted to still be in the hospital and not recovered. No product quality complaint was involved. The pts experience was considered to be immediately life threatening, disabling by the reporter, and an other important medical event by the report (OMIC). Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: DTAP, HBHEPB, IPV, PNC, RV5, RV5, DTAP, HBHEPB, IPV, PNC, RV5
Symptoms: Agitation, Crying, Haematochezia, Intussusception
Clinical narrative: Information has been received from a physician concerning a 2 month old pt who on 11/3/06 was vaccinated with a dose of Rotavirus vaccine. On 11/25/06 the pt developed intussusception and was hospitalized. It was noted that the intussusception required surgery. At the time of the report the pt was noted to still be in the hospital and not recovered. No product quality complaint was involved. The pts experience was considered to be immediately life threatening, disabling by the reporter, and an other important medical event by the report (OMIC). Additional information has been requested.
Age: 0.12
Sex: F
Vaccine: DTPHIB, PNC
Symptoms: Laboratory test abnormal, Neutropenia, Platelet count increased, Rhinorrhoea, Salivary hypersecretion
Clinical narrative: This is a 6 week old female who enrolled in a study, and expired on 11/06/2006 from an unk cause. The subject was vaccainted with Prevnar and CombAct-Hib which contained Hib CV, diphtheria toxoid, tetanus and whole cell pertussis on 11/3/2006. The subject was also co-enrolled in CIPRA SA 002 and began treatment with Zidovudine, Lamivudine, and Lopinavir/ritonavir on 11/3/06. On 11/3/06 the mother noticed a fever, and on 11/4/06 she gave the subject paracetamol. She reported the subjects temp on 11/3,4 and 5th as 36.4 deg C, 38.1 deg C and 38.7 deg C respectively. She reported no other symptoms. The subject seemed well according to the mother. There were no symptoms of cough or diarrhea. No rash was noticed. There was no evidence of bleeding from any site. The mother had not noticed any signs of respiratory distress or cyanosis on any of the post vaccination days. On 11/5/06, the subject was fed at 7pm. The subject woke up at 12am and the mother noticed clear fluid exuding from the mouth and nose. The mother did not notice any difficulty with breathing. She did not feel the situation was serious and she put the subject to sleep. When she checked the baby at 5am on 11/6/06 she found the subject had expired. There was no autopsy. The cause of death is unk.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Meningitis, Pyrexia, Vomiting
Clinical narrative: Vaccinated 11/17 with Influenza vaccine at time pt had temp of 101 orally, other symptoms not known. But fever resolved on 12/01/06, pt developed fever, headache, vomiting. Taken to hospital where LP C/W viral meningitis on 12/02/06 and admitted. Recovered in 1-2 days and discharged on 12/04/2006.  1/22/07 Received medical records from hospital which reveal patient admitted 12/2-12/4/06 for headache, fever & vomiting.  Treated w/antibiotics until CSF c/s neg for 48 hrs.  - FINAL DX: Meningitis, likely viral etiology.
Age: 4.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site erythema, Injection site oedema, Pain
Clinical narrative: Erythema and swelling of upper arm/shoulder, pain with arm raising.
Age: 0.18
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: Hives developed before other vaccines administered after Rotateq before other vaccines given. This is in follow-up to reports previously submitted on 1/16/2007. Information has been received from a physician and a registered nurse concerning a 9-week old male who on 29-Sep-2006, immediately after the administration of ROTATEQ, the patient developed a mild case of hives before other vaccines could be given. Unspecified medical attention was sought. There was no swelling and no respiratory distress. The patient was monitored and after about 10 minutes, the hives subsided. The patient did not need long-term care and there were no other reactions noted. It was also noted that the series of ROTATEQ was discontinued after the first dose. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash papular, Skin ulcer
Clinical narrative: Scattered clusters pruritic papules groups 3 or 4. total skin lesions 5 or 6. No fever or other symptoms.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Guillain-Barre syndrome, Laboratory test abnormal, Pain, Pyrexia
Clinical narrative: Reported death due to Guillain Barre Syndrome. Transferred to Hospital on 11/18/06 with severe pain to spinal stenosis, low grade fever, and possible Guillian Barre Syndrome. Dies at hospital. 1/8/07 Received medical records from hospital which reveal patient admitted 11/18/06-11/29/06 for LE pain with ascending paralysis & studies positive for GBS.  Treated with IVIG x 4 days. on 11/25, had PEA & coded.  Responded well initially then coded several additional times before expiring on 11/29. Consults of pulmonology & neurology included.  D/C summary indicates COD as secondary to GBS, causing severe autonomic dysfunction & cardiac arrhythmias. PMH: CHF LABS: EMG/NCS 11/20/06, c/w GBS; CT of head 11/18, showed mild atrophy; fluoroscopic LP on 11/18, revealed elevated protein, normal WBC & RBC. FINAL Dx: Guillain Barre Syndrome; CHF w/ejection fraction of 35%; aspiration pneumonia; BPH; anemia; & CAD. 1/9/07 Received copy of Death Certificate from family which reveals COD as GBS with contributing factors of CAD & spinal stenosis.
Age: 0.38
Sex: M
Vaccine: RV5
Symptoms: Haematochezia, Intussusception
Clinical narrative: Information has been received from a physician concerning a 6 month old male, with no medical history and no allergies, who was vaccinated with a first and second oral dose of rotavirus vaccine on 6/20/06 and 9/5/06, respectively. There was no concomitant medication. On 11/6/06, the pt was found to have blood in the stool. An abdominal ultrasound showed a small bowel intussusception. A barium enema was done after the ultrasound that showed no intussusception. The small bowel intussusception was found to be transient and reduced spontaneously. there was no blood in the stool on 11/13/06 and the pt was considered to be recovered by the reporter. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Upon internal review, intussusception was considered to be an other important medical event (OMIC). Additional information  has been requested.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Cerebrovascular accident
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old pt who about 4.5 weeks ago, on approx 10/26/06 was vaccinated with a 0.5ml dose of MMR II/Varicella vaccine. Ten days after receiving the shot on approx 11/5/06, the pt experienced a CVA (stroke) and was hospitalized for three weeks. The pt was released from the hospital on 11/28/06 with a feeding tube, At the time of the report, the pt was recovering. No product quality complaint was involved. The reporter considered the pts stroke to be life threatening and disabling. Additional information has been requested.