chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: M
Vaccine: VARCEL
Symptoms: Conjunctivitis, Dermatitis bullous, Fatigue, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 41 year old male, with no medical history and no allergies, who, three weeks ago, on approximately 1/31/2006 was vaccinated with a dose of varicella virus vaccine live. there was no concomitant medication. It was reported that the patient came into the office with approximately 50 varicella like lesions, described as pseudovesicular on the anterior and posterior trunk, neck, and proximal lower extremities that were bilateral and diffuse, that appeared on 2/18/2006. The patient also had fatigue and left eye conjunctivitis. It was noted that the patient was to see an ophthalmologist. VZV cultures were done on the patients lesions by the physician. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. The patients reaction was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Abortion, Unintended pregnancy
Clinical narrative: Information has been received through the manufacturer pregnancy registry from a health professional concerning a 17 year old female who on 1/20/2006 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (lot 648303/0218R). It was noted that the patient may be pregnant. The reporter did not have confirmation that the patient was pregnant. No symptoms were noted. Follow up information indicated that the pregnancy was terminated. No additional information was available. Upon internal review, pregnancy termination was considered to be an other important medical event (OMIC). No additional information was available.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain, Oedema
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old male with asthma and a Naproxen allergy who on 1/20/2006 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). there was no concomitant medication. On 1/21/2006 within 24 hours, the patient experienced swelling, redness and pain in the site and went down the patients arm to the wrist. Unspecified medical attention was sought. It was noted that the patient was unable to work for 3 days, Three or four days later, the symptoms subsided and the patient recovered. No product quality complaint was involved. Swelling, redness and pain at the site and went down the patients arm to the wrist were considered to be disabling. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Information has been received from a registered nurse concerning a 68 year old male with asthma and a Naproxen allergy who on 1/20/2006 was vaccinated SC with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650453/0791P). there was no concomitant medication. On 1/21/2006 within 24 hours, the patient experienced swelling, redness and pain in the site and went down the patients arm to the wrist. Unspecified medical attention was sought. It was noted that the patient was unable to work for 3 days, Three or four days later, the symptoms subsided and the patient recovered. No product quality complaint was involved. Swelling, redness and pain at the site and went down the patients arm to the wrist were considered to be disabling. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: Myocarditis, Symptoms headache general start 02/16/2006 end 02/18/2006 bad headaches x 3 days (unusual for patient behind eyes, pounding pain and started in afternoon with gradual worsening until HS, no relief with two Aleve. Chest pain substernal start 2/18/2006 initial episode brief after going up flight of stairs, woke up with CP that persisted x 2-3 hours the next day. CP dull pressure. Dyspnea (shortness of breath) start 2/18/2006 initial onset after climbing flight of stairs, woke with mild dyspnea the next day that worsened with activity. chills start 2/19/2006 experienced shaking shivering and chills and alternating sensation of being hot and cold (on drive to hospital in early AM). numbness start 2/19/2006 experienced circumoral numbness and arms felt numb during drive to hospital in early arm. Nausea w/o vomiting start 2/19/2006 experienced nausea when pain at its peak and while in ER. 05/08/06-received 35 page medical record from VHC and 7 page follow-up clinic visit. Hospitalized from 2/19-2/21/06-DC DX vaccinia related myopericarditis-presented with c/o chest pain, elevated troponin level 2.6,  EKG normal, echo normal.  Follow-up Report April 14, 2006: Patient remains asymptomatic. Enclosed are medical records from hospital as well as records from his recent outpatient Cardiology evaluation at medical center.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chills, Complement factor C3 decreased, Complement factor C4 increased, Dyspnoea, Echocardiogram
Clinical narrative: Myocarditis, Symptoms headache general start 02/16/2006 end 02/18/2006 bad headaches x 3 days (unusual for patient behind eyes, pounding pain and started in afternoon with gradual worsening until HS, no relief with two Aleve. Chest pain substernal start 2/18/2006 initial episode brief after going up flight of stairs, woke up with CP that persisted x 2-3 hours the next day. CP dull pressure. Dyspnea (shortness of breath) start 2/18/2006 initial onset after climbing flight of stairs, woke with mild dyspnea the next day that worsened with activity. chills start 2/19/2006 experienced shaking shivering and chills and alternating sensation of being hot and cold (on drive to hospital in early AM). numbness start 2/19/2006 experienced circumoral numbness and arms felt numb during drive to hospital in early arm. Nausea w/o vomiting start 2/19/2006 experienced nausea when pain at its peak and while in ER. 05/08/06-received 35 page medical record from VHC and 7 page follow-up clinic visit. Hospitalized from 2/19-2/21/06-DC DX vaccinia related myopericarditis-presented with c/o chest pain, elevated troponin level 2.6,  EKG normal, echo normal.  Follow-up Report April 14, 2006: Patient remains asymptomatic. Enclosed are medical records from hospital as well as records from his recent outpatient Cardiology evaluation at medical center.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Electrocardiogram, Feeling cold, Fibrin D dimer, Headache, Hot flush
Clinical narrative: Myocarditis, Symptoms headache general start 02/16/2006 end 02/18/2006 bad headaches x 3 days (unusual for patient behind eyes, pounding pain and started in afternoon with gradual worsening until HS, no relief with two Aleve. Chest pain substernal start 2/18/2006 initial episode brief after going up flight of stairs, woke up with CP that persisted x 2-3 hours the next day. CP dull pressure. Dyspnea (shortness of breath) start 2/18/2006 initial onset after climbing flight of stairs, woke with mild dyspnea the next day that worsened with activity. chills start 2/19/2006 experienced shaking shivering and chills and alternating sensation of being hot and cold (on drive to hospital in early AM). numbness start 2/19/2006 experienced circumoral numbness and arms felt numb during drive to hospital in early arm. Nausea w/o vomiting start 2/19/2006 experienced nausea when pain at its peak and while in ER. 05/08/06-received 35 page medical record from VHC and 7 page follow-up clinic visit. Hospitalized from 2/19-2/21/06-DC DX vaccinia related myopericarditis-presented with c/o chest pain, elevated troponin level 2.6,  EKG normal, echo normal.  Follow-up Report April 14, 2006: Patient remains asymptomatic. Enclosed are medical records from hospital as well as records from his recent outpatient Cardiology evaluation at medical center.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Hypoaesthesia oral, Myocarditis, Nausea, Pain, Red blood cell sedimentation rate normal
Clinical narrative: Myocarditis, Symptoms headache general start 02/16/2006 end 02/18/2006 bad headaches x 3 days (unusual for patient behind eyes, pounding pain and started in afternoon with gradual worsening until HS, no relief with two Aleve. Chest pain substernal start 2/18/2006 initial episode brief after going up flight of stairs, woke up with CP that persisted x 2-3 hours the next day. CP dull pressure. Dyspnea (shortness of breath) start 2/18/2006 initial onset after climbing flight of stairs, woke with mild dyspnea the next day that worsened with activity. chills start 2/19/2006 experienced shaking shivering and chills and alternating sensation of being hot and cold (on drive to hospital in early AM). numbness start 2/19/2006 experienced circumoral numbness and arms felt numb during drive to hospital in early arm. Nausea w/o vomiting start 2/19/2006 experienced nausea when pain at its peak and while in ER. 05/08/06-received 35 page medical record from VHC and 7 page follow-up clinic visit. Hospitalized from 2/19-2/21/06-DC DX vaccinia related myopericarditis-presented with c/o chest pain, elevated troponin level 2.6,  EKG normal, echo normal.  Follow-up Report April 14, 2006: Patient remains asymptomatic. Enclosed are medical records from hospital as well as records from his recent outpatient Cardiology evaluation at medical center.
Age: 25.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Tremor, Troponin I increased, White blood cell count increased
Clinical narrative: Myocarditis, Symptoms headache general start 02/16/2006 end 02/18/2006 bad headaches x 3 days (unusual for patient behind eyes, pounding pain and started in afternoon with gradual worsening until HS, no relief with two Aleve. Chest pain substernal start 2/18/2006 initial episode brief after going up flight of stairs, woke up with CP that persisted x 2-3 hours the next day. CP dull pressure. Dyspnea (shortness of breath) start 2/18/2006 initial onset after climbing flight of stairs, woke with mild dyspnea the next day that worsened with activity. chills start 2/19/2006 experienced shaking shivering and chills and alternating sensation of being hot and cold (on drive to hospital in early AM). numbness start 2/19/2006 experienced circumoral numbness and arms felt numb during drive to hospital in early arm. Nausea w/o vomiting start 2/19/2006 experienced nausea when pain at its peak and while in ER. 05/08/06-received 35 page medical record from VHC and 7 page follow-up clinic visit. Hospitalized from 2/19-2/21/06-DC DX vaccinia related myopericarditis-presented with c/o chest pain, elevated troponin level 2.6,  EKG normal, echo normal.  Follow-up Report April 14, 2006: Patient remains asymptomatic. Enclosed are medical records from hospital as well as records from his recent outpatient Cardiology evaluation at medical center.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: Emergency nurse said erratic heart beat, in ER for about 2 1/2 hrs. Vaccine given and immediately had palpitations.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Nausea, Pain, Pyrexia
Clinical narrative: On 10/18 her arm was painful, red and swollen. She also had fever, body aches throughout 10/18, 10/19, 10/20 & 10/21. She was also nauseous. When she presented to me on 10/21 her arm was red and splotchy. I referred immediately to MD and called MD and he prescribed Keflex. She also went to MD that night and he confirmed Cellulitis and said Keflex ok.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash maculo-papular, Swelling
Clinical narrative: On 10/18 her arm was painful, red and swollen. She also had fever, body aches throughout 10/18, 10/19, 10/20 & 10/21. She was also nauseous. When she presented to me on 10/21 her arm was red and splotchy. I referred immediately to MD and called MD and he prescribed Keflex. She also went to MD that night and he confirmed Cellulitis and said Keflex ok.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Pain
Clinical narrative: Right arm (where shot given) starting to hurt immediately by time arrive home. Couldn't lift- ached continuously went back to Dr. He said not from shot - sent to phy therapy - arm still aches hurt to lift in certain positions.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site pain, Swelling
Clinical narrative: 48 hours after immunization redness, swelling, warm to touch, c/o pain from RA shot area to elbow.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Rash not limited to injection. Site diffuse swelling and erythema top R arm.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site swelling, Pain
Clinical narrative: Pt developed redness with swelling at site. Next day developed increasing erythema and pain extending distally to elbow. Treated with antibiotics.
Age: 23.0
Sex: F
Vaccine: TD
Symptoms: Contusion, Hypokinesia, Pain
Clinical narrative: Wed 2/22/06 bruising and pain. Thursday improved painful with movement. Friday no discomfort or pain. Pain returned Saturday with pain and movement upon movement. Muscle knot present (Pt massage site everyday but Friday). Pt saw Dr this am. Dr does not feel pt pain to be associated with any nerve damage or infection. Will have pt return if still painful with movement after one more week.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Erythema, Feeling hot, Myalgia, Swelling
Clinical narrative: Pt received Dtap in RD and IPV in right arm SQ. Upper arm swelled up and got red, hot, and sore. Began in the afternoon of 2/24/06. As of today per mom arm not as swollen or red. Condition improving.
Age: 1.0
Sex: M
Vaccine: FLU3, MMR, PNC
Symptoms: Blister
Clinical narrative: Vesicle in varies stages of healing on the body, arm, leg. No Tx.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthma, Chest discomfort, Headache, Pyrexia
Clinical narrative: Pt had fever, headache, tightness with breathing, asthma like symptoms. Pt spoke to MD office, used albuterol inhaler and nebulizer, prednisone ordered. No hospitalization required but telephone calls, multiple time office visit.
Age: 53.0
Sex: M
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: A  c/o of a fever for a couple week.
Age: 14.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: Tdap given as a second dose per "Recommended Immunization Schedule for children & adolescents who start late or who are more than 1 month behind." As per CDC catch up schedule which says "Tdap may be substituted for any dose in a primary catch up series or as a booster if age appropriate for Tdap." No adverse events. No treatment
Age: 15.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: Tdap given as a second dose per recommended immunization scheduled for children adolescents who start late or are more than 1 month behind. Given as per catch up schedule which says, Tdap may be substituted for any dose in a primary catch up series oar as a booster if age appropriate for Tdap. No adverse event. No treatment.
Age: 16.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP
Symptoms: Unevaluable event
Clinical narrative: Tdap given as a second dose per recommended immunization schedule for children adolescents who start late or are more than 1 month behind. Given as per catch up schedule which says Tdap may be substituted for any dose in a primary catch up series or as a booster if age appropriate for Tdap. No adverse event. No treatment.
Age: 48.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site rash, Injection site warmth, Tenderness
Clinical narrative: Pt received vaccine 2/24/06. Next day 2/25/2006 around 6:00 pm, she noticed erythematous rash over lateral right arm near inj site. Erythema continued spread to ant and med aspect of right arm with increased heat and tenderness. Pt treated with Keflex 500mg BID x 10d. Needs to recheck in 1 week.
Age: 48.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Rash
Clinical narrative: Recd Hep A on 2/6/06 Broke out in rash on 2/9/06 seen by personal MD on 2/10/06.
Age: 48.0
Sex: M
Vaccine: HEPA, HEPA
Symptoms: Urticaria
Clinical narrative: Recd Hep A on 2/6/06 Broke out in rash on 2/9/06 seen by personal MD on 2/10/06.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: left upper arm red, swollen, warm from shoulder through deltoid.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Chorea, Dyskinesia, Emotional disorder, Movement disorder, Stupor
Clinical narrative: Abrupt onset of movement disorder, repetitive hand tapping, shoulder jerks. less able to focus, exhibited more extreme emotions, neurologist felt movements were choreiform.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Rash papular, Rash vesicular, Skin ulcer
Clinical narrative: 4-6 vesicular papular lesions  one on scalp, few on trunk started 2 wks after vaccine.
Age: 34.0
Sex: F
Vaccine: MMR, TD
Symptoms: Medication error, Rash, Unintended pregnancy
Clinical narrative: Patient visited an urgent care facility approximately 3 weeks post-vaccination due to scattered flat rash on face and also requested pregnancy testing at that time.  Pregnancy test was positive.
Age: 26.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: L arm at injection site tender eve of injection and progressively became worse. On 3/1/06, an area of induration, redness and warmth at site measured 3"  circ with axillary lymph node involvement and much pain. Was sent to MD and was dx with cellulitis. Tx - 500mg keflex q12h for 12 days and off work for 2 days using ice packs to area prn. On 3/3/06, redness has abated as well as induration and most of the pain, but a residual lump is felt. On 3/6/06, the arm is fine - no additional complications.
Age: 26.0
Sex: F
Vaccine: PPV, TD
Symptoms: Lymphadenopathy
Clinical narrative: L arm at injection site tender eve of injection and progressively became worse. On 3/1/06, an area of induration, redness and warmth at site measured 3"  circ with axillary lymph node involvement and much pain. Was sent to MD and was dx with cellulitis. Tx - 500mg keflex q12h for 12 days and off work for 2 days using ice packs to area prn. On 3/3/06, redness has abated as well as induration and most of the pain, but a residual lump is felt. On 3/6/06, the arm is fine - no additional complications.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Hypokinesia, Pain
Clinical narrative: The injection was administered intramuscularly in the right deltoid using a 1 inch needle. The acromion process was palpated as site reference and injection given below acromion in dense portion of deltoid muscle. The site was visualized when patient presented to clinic today and was unremarkable. Patient reports pain and discomfort in right upper arm upon pressure and position changes. Pt relates discomfort to injection and has sought medical attention through two physcians. The initial provider was seen approximately one month ago and patient was treated with anti-inflammatory medication that produced no relief per patient. The second provider offered her a shoulder x- ray of which she declined.
Age: 1.12
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever as high as 102F from 3 days post innoculation to seven days post innoculation.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Abdominal pain, Anorexia, Asthenia, Back pain, Diarrhoea
Clinical narrative: Soreness at place of injection, lasting for 24 hours. Started feeling tired and weak about 6 hours after the injection. Nausea, stomach cramps - all starting 7 hours after the injection, lasting for 30 hours. Diarrhea, fever (mild)/chills, lack of appetite, general discomfort, aches, and back pain - all starting 9 hours after the injection, lasting for 50 hours. Vomited once about 16 hours after injection.   Fully recovered 3 days after injection.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Discomfort, Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: Soreness at place of injection, lasting for 24 hours. Started feeling tired and weak about 6 hours after the injection. Nausea, stomach cramps - all starting 7 hours after the injection, lasting for 30 hours. Diarrhea, fever (mild)/chills, lack of appetite, general discomfort, aches, and back pain - all starting 9 hours after the injection, lasting for 50 hours. Vomited once about 16 hours after injection.   Fully recovered 3 days after injection.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, Vomiting
Clinical narrative: Soreness at place of injection, lasting for 24 hours. Started feeling tired and weak about 6 hours after the injection. Nausea, stomach cramps - all starting 7 hours after the injection, lasting for 30 hours. Diarrhea, fever (mild)/chills, lack of appetite, general discomfort, aches, and back pain - all starting 9 hours after the injection, lasting for 50 hours. Vomited once about 16 hours after injection.   Fully recovered 3 days after injection.
Age: 43.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Injection site swelling, Shoulder pain
Clinical narrative: Localized swelling in tricep (injection site) to at least twice size, duration 7 days. 4 days post injection pain and swelling in shoulder and elbow. Pain in shoulder resided 2 weeks post injection, elbow/joint/tendon pain continues and requires NSAIDs daily (currently 27 days post injection).
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Tremor
Clinical narrative: FATHER REPORTED TWO EPISODES OF "SHAKING" OF UPPER EXTEMITIES AND HEAD LASTING 10-15 SEC. NO RIGIDNESS, NO UNUSUAL EYE MOVEMENT, NO POST DROWSINESS, NORMAL BEHAVIOR FOLLOWING AND PRIOR TO EPISODE. FIRST EPISODE 2 DAYS POST VACCINE, SECOND EPISODE 1 WEEK POST VACCINE.
Age: 1.01
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: Rash, modified chicken pox diagnosis, onset of symptoms began on 2/28/06, pt treated with Atarax, Tylenol, and Carbofed.
Age: 1.04
Sex: F
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: MMR, Varivax, Prevnar and HIB given on 2-27-06.  Parents reported that child developed vesicular rash over torso, arms and legs and low grade fever on 3-3-06. Treated with Tylenol and Benadryl.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Blister, Erythema, Oedema, Pain, Rash macular
Clinical narrative: Left arm and back later that day, hurt slight puffy, heating pad applied 20 min. Next day blotchy, tender, redness lower left triceps area, left upper back with 2 blisters almost burn like.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Left arm and back later that day, hurt slight puffy, heating pad applied 20 min. Next day blotchy, tender, redness lower left triceps area, left upper back with 2 blisters almost burn like.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Redness, swelling, hot to touch from shoulder to elbow. Treated with Ice, Ibuprofen.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Swelling, Heat, redness from shoulder to elbow. Redness and puffiness down in to axillary area. Treated with Ibuprofen and Ice.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: Swelling and redness at site, Warm to touch. Swelling from shoulder to Elbow, TX with Ibuprofen ice.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Left arm red, swollen 3" diameter tx with Ibuprofen/ice.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Skin ulcer
Clinical narrative: Pt presented to office on 3/4/06 with a history of vesicles for 3 x 4d duration. No fever. Generalized lesion >100 scattered over body. Aveeno, Benadryl, Calamine. No ASA, Isolation. vaccine administered 01/20/1998, adverse event onset 03/01/2006.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Local reaction (3 patients in 1 month with local reaction).
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis right leg 6cm x 5cm, Keflex 250 mg 1 tsp TID x 10d.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, DTAP, IPV
Symptoms: Cellulitis, Injection site reaction, Red blood cell abnormality
Clinical narrative: Cellulitis right leg 6cm x 5cm, Keflex 250 mg 1 tsp TID x 10d.
Age: 57.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Chills, Pruritus, Urticaria
Clinical narrative: Broke out in hives on entire body from top of scalp to bottom of feet over a period of 3 days.  Dissipated 10 days after onset.  Treated with Claritin D, Cortisone, Benadryl, and Prednisone.
Age: 57.0
Sex: F
Vaccine: HEP, UNK
Symptoms: Urticaria
Clinical narrative: Broke out in hives on entire body from top of scalp to bottom of feet over a period of 3 days.  Dissipated 10 days after onset.  Treated with Claritin D, Cortisone, Benadryl, and Prednisone.
Age: 0.62
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Benign intracranial hypertension, Decreased appetite, Irritability, Laboratory test abnormal, Papilloedema
Clinical narrative: 1/30/06 6MO well visit, DTaP, Hib. 2/9/06 and 2/15/06 called with fussiness and decreased appetite since shots, 2/15/06 mom noticed right eye turning in. 2/17/06 Pediatric opthalomologist. 6 nerve palsy and papilledema. MRI NL, 2/18 ped neuro increased HC, LP with elevated pressure. Transferred care to another pediatrician
Age: 0.62
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Paralysis, Strabismus
Clinical narrative: 1/30/06 6MO well visit, DTaP, Hib. 2/9/06 and 2/15/06 called with fussiness and decreased appetite since shots, 2/15/06 mom noticed right eye turning in. 2/17/06 Pediatric opthalomologist. 6 nerve palsy and papilledema. MRI NL, 2/18 ped neuro increased HC, LP with elevated pressure. Transferred care to another pediatrician
Age: 0.62
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Benign intracranial hypertension, Strabismus
Clinical narrative: 1/30/06 6MO well visit, DTaP, Hib. 2/9/06 and 2/15/06 called with fussiness and decreased appetite since shots, 2/15/06 mom noticed right eye turning in. 2/17/06 Pediatric opthalomologist. 6 nerve palsy and papilledema. MRI NL, 2/18 ped neuro increased HC, LP with elevated pressure. Transferred care to another pediatrician
Age: 0.62
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Benign intracranial hypertension, Decreased appetite, Irritability, Laboratory test abnormal, Papilloedema
Clinical narrative: This case was reported by a physician and described the occurrence of pseudotumor cerebri in a 7 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) plus a separate injection of Haemophilus influenzae type B conjugate vaccine (Hib vaccine, unknown). On 15 September 2005 the subject received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) as the 1st dose in the diphtheria and tetanus toxoids and acellular pertussis (Dtap) vaccination series. On 15 November 2005 the subject received a dose of Infanrix as the 2nd dose in the Dtap vaccination series. On 30 January 2006 the subject received 3rd dose of Infanrix plus a separate injection of Hib vaccine. On 17 February 2006, 18 days after the receipt of Infanrix and Hib vaccine, the subject was seen at a physician's office. The mother of the subject reported to the physician that the subject's "eyes were crossing intermittently." The subject was subsequently seen by an ophthalmologist. Results of nuclear magnetic resonance imaging were normal. Result of a lumbar puncture was 205. The ophthalmologist diagnosed the subject with pseudotumor cerebri. The reporting physician stated that, "after the lumbar puncture was performed, (the subject's symptoms began to resolve. " At the time of initial reporting, 01 March 2006, the crossed eyes resolved and the pseudotumor cerebri had improved. The physician stated that she, "did not know whether Infanrix contributed to the patient's pseudotumor cerebri." Comment: Pseudotumor cerebri, was assessed as medically serious by manufacturer (OMIC).
Age: 0.62
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Paralysis, Strabismus
Clinical narrative: This case was reported by a physician and described the occurrence of pseudotumor cerebri in a 7 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) plus a separate injection of Haemophilus influenzae type B conjugate vaccine (Hib vaccine, unknown). On 15 September 2005 the subject received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) as the 1st dose in the diphtheria and tetanus toxoids and acellular pertussis (Dtap) vaccination series. On 15 November 2005 the subject received a dose of Infanrix as the 2nd dose in the Dtap vaccination series. On 30 January 2006 the subject received 3rd dose of Infanrix plus a separate injection of Hib vaccine. On 17 February 2006, 18 days after the receipt of Infanrix and Hib vaccine, the subject was seen at a physician's office. The mother of the subject reported to the physician that the subject's "eyes were crossing intermittently." The subject was subsequently seen by an ophthalmologist. Results of nuclear magnetic resonance imaging were normal. Result of a lumbar puncture was 205. The ophthalmologist diagnosed the subject with pseudotumor cerebri. The reporting physician stated that, "after the lumbar puncture was performed, (the subject's symptoms began to resolve. " At the time of initial reporting, 01 March 2006, the crossed eyes resolved and the pseudotumor cerebri had improved. The physician stated that she, "did not know whether Infanrix contributed to the patient's pseudotumor cerebri." Comment: Pseudotumor cerebri, was assessed as medically serious by manufacturer (OMIC).
Age: 0.62
Sex: F
Vaccine: DTAP, HIBV, DTAP, HIBV
Symptoms: Benign intracranial hypertension, Strabismus
Clinical narrative: This case was reported by a physician and described the occurrence of pseudotumor cerebri in a 7 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) plus a separate injection of Haemophilus influenzae type B conjugate vaccine (Hib vaccine, unknown). On 15 September 2005 the subject received diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) as the 1st dose in the diphtheria and tetanus toxoids and acellular pertussis (Dtap) vaccination series. On 15 November 2005 the subject received a dose of Infanrix as the 2nd dose in the Dtap vaccination series. On 30 January 2006 the subject received 3rd dose of Infanrix plus a separate injection of Hib vaccine. On 17 February 2006, 18 days after the receipt of Infanrix and Hib vaccine, the subject was seen at a physician's office. The mother of the subject reported to the physician that the subject's "eyes were crossing intermittently." The subject was subsequently seen by an ophthalmologist. Results of nuclear magnetic resonance imaging were normal. Result of a lumbar puncture was 205. The ophthalmologist diagnosed the subject with pseudotumor cerebri. The reporting physician stated that, "after the lumbar puncture was performed, (the subject's symptoms began to resolve. " At the time of initial reporting, 01 March 2006, the crossed eyes resolved and the pseudotumor cerebri had improved. The physician stated that she, "did not know whether Infanrix contributed to the patient's pseudotumor cerebri." Comment: Pseudotumor cerebri, was assessed as medically serious by manufacturer (OMIC).
Sex: U
Vaccine: HIBV
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib Titer vaccine (haemophilus B conjugate vaccine (Diphtheria crm 197 protein conjugate) injection) was received from a registered nurse regarding a patient, who on an unspecified date, received a third dose of Hib titer. On an unspecified date, the patient developed autism. Relevant medical history was not provided. Indication for Hib Titer vaccine was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. On an unspecified date, the patient received a third dose of Hib Titer, on an unspecified date, the patient developed autism. the patient recovery status is unknown. As of 2/22/2006, the reporter had declined  to provide any further information and indicated the patient had declined to be contacted.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Acne, Amnesia, Arthritis, Arthropathy, Blister
Clinical narrative: Skin itch in the whole body; and skin discoloration and insomnia; loss of muscular, tinnitus, weight gain, joints and muscles,acne, arthritis, amnesia, blisters, etc.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Insomnia, Muscle disorder, Pruritus, Skin discolouration, Tinnitus
Clinical narrative: Skin itch in the whole body; and skin discoloration and insomnia; loss of muscular, tinnitus, weight gain, joints and muscles,acne, arthritis, amnesia, blisters, etc.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Weight increased
Clinical narrative: Skin itch in the whole body; and skin discoloration and insomnia; loss of muscular, tinnitus, weight gain, joints and muscles,acne, arthritis, amnesia, blisters, etc.
Age: 9.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site hypersensitivity, Injection site oedema, Pruritus
Clinical narrative: pt noted redness in LOA of left deltoid in evening of 3/1/06 day of administration. Swelling noted by mother on 3/2/06 redness had increased. Today 3/3/06 color and swelling subsiding. Child c/o some itching at site. Mother gave TYELNOL x 1 last evening. Child offers no other complaints, nor does mother. Child anxious to return to her school at this time.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Headache, Pyrexia
Clinical narrative: Mother stated child woke up morning after receiving vaccine with hugh temp, but did not take it also c/o headache and stomach cramps.
Age: 35.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Injection site hypersensitivity, Injection site induration, Injection site oedema, Pruritus, Pyrexia
Clinical narrative: Swelling, redness, itching in an area about 5x3. Also area was hard. Low grade fever.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Oedema
Clinical narrative: 02/13/2006 2.5 x 4.5 cm mild erythema and swelling.
Age: 0.19
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site rash
Clinical narrative: Mom noticed on 03/05/2006, small tiny bumps on extremities where vaccines were given.  No treatment needed.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Dyskinesia, Pyrexia
Clinical narrative: 02/24 Started on Amoxicillin for ear infection and fever. 02/27 6 month well checkup received immunizations, no fever. 02/28 Fever 103, jerking.  Given Tylenol and Motrin.
Age: 0.25
Sex: F
Vaccine: PNC
Symptoms: Erythema
Clinical narrative: Left thigh red.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pruritus, Pyrexia
Clinical narrative: Left deltoid area red hot to touch, has had some fever the first day only.  Mother seems to think this was normal for him.  Child has been itching, scratching area.  DTAP 5th.  Child eating and sleeping, playing around normal.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, FLU3, PNC
Symptoms: High-pitched crying
Clinical narrative: High pitch cry - 35 minutes.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Swelling
Clinical narrative: Left thigh red and swollen.
Age: 1.22
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Urticaria
Clinical narrative: Rash started on trunk approximately 4 days after receiving one year vaccination.  Rash moved from back and stomach down to legs and arms and to the back of the neck.  Seen by doctor on 02/21/2006, doctor states hives.  Gave Zyrtec which made rash worse - started Zyrtec 02/21.  Stop given Zyrtec on 02/22/.  Rash looks like measles rash.  Fever one day of 101 degrees.  Made appointment to see Allergies.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV
Symptoms: Irritability, Pallor, Pyrexia, Screaming
Clinical narrative: Pallor, irritability, screaming.  Temperature 100.2 in ER.
Age: 25.0
Sex: F
Vaccine: RAB
Symptoms: Diarrhoea, Injection site swelling, Rash erythematous, Vomiting
Clinical narrative: Injection site noted small knot, red raised bumps in circle around injection site size of half dollar, vomited once, diarrhea since 11AM on 03/02/2006.
Age: 53.0
Sex: F
Vaccine: HEPA, PPV
Symptoms: Chills, Injection site pain, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Vaccine:  Pneumovax, given intramuscularly in right deltoid, on 02/28/2006 at 14:40.  Patient reports feeling bad starting 16:00-17:00, by 20:00 fever 101.7 degrees, chills, achy all over, then injection site very sore.  Next day arm red, swollen, warm.
Age: 67.0
Sex: F
Vaccine: HEPAB, TD, TYP
Symptoms: Joint range of motion decreased, Pain, Sensation of heaviness
Clinical narrative: Heaviness in arm after injection. Pain worsened and radiated to shoulder- no redness, bruising, swelling but decreased arm range of motion pain at deltoid but also into infraspinatous, tenes minor. NSAIDS, latab and use ice.
Age: 5.0
Sex: U
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site inflammation, Swelling
Clinical narrative: L deltoid inflamed swollen, hot to touch. No fever. Child fine otherwise per mom. Eating and playing normal. Hep A administered L deltoid.
Age: 1.22
Sex: M
Vaccine: DTAP, PNC
Symptoms: Urticaria
Clinical narrative: Developed progressive urticaria within 2 hours after immunization. He returned to the doctors office and was given oral diphenly-dramine and gradually the symptoms abated. He returned home, fully recovered.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying
Clinical narrative: Crying spell off and on for about 7 hours on day of vaccination.
Age: 1.01
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Pt developed chicken pox lesions about 8-10.
Age: 36.0
Sex: M
Vaccine: MMR, TYP
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Approx 2 1/2 hrs after vaccine administration, developed nausea/vomiting/Ha. No chest pains/SOB/Fever
Age: 0.51
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: fever 102 for 24hrs.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given an adult dose of Hepatitis A vaccine (1.0cc) rather than pediatric/adolescent dose. CDC contacted. Their response "We do not expect to see a serious reaction. Second dose (pediatric Hepatitis A) should be given in six months."
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: She was given an adult dose of Hepatitis A vaccine (1.0cc) rather than the pediatric/adolescent dose. CDC contacted. Their response "We do not expect to see a serious reaction. Second dose (pediatric Hepatitis A) should be given in six months."
Age: 26.0
Sex: M
Vaccine: RAB
Symptoms: Dizziness
Clinical narrative: "tipsy" feeling, "slightly lightheaded".
Age: 37.0
Sex: M
Vaccine: TD
Symptoms: Dizziness, Myalgia, Pain
Clinical narrative: Had Td immunizations 2/23/06. Client states on 2/24/06 lightheaded and dizzy. 2/25/06 client complained of L arm was sore and ache. Late afternoon got dry heaves. Sharp pain shot down his arm from site of injections to his knuckles. Went to bed. Got up next day no problem. No problem with arm since. Did not see PMD. Just red around injection site.
Age: 1.97
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Laboratory test abnormal, Swelling
Clinical narrative: Redness, swelling where shot was administered L thigh.
Sex: U
Vaccine: DTAPHEPBIP, HBHEPB, PNC
Symptoms: Pyrexia
Clinical narrative: Temp axillary 107 following shot.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Injection site inflammation
Clinical narrative: 20x16 cm area of erythema and inflammation, warmth at injection site L lateral thigh
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Pt developed severe case of chicken pox. Rx Zonimax 20 mg bid
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Decreased appetite, Gastritis, Pyrexia, Rash, Vomiting
Clinical narrative: On 2-27-2006 12:00 am approx high 103F fever, body disconform. 6:00am-vomit of last dinner food, high fever 103 F and vomit, small dark red dots over abdominal area and inflammation. Fever. Children Motrin and Tylenol phedanoz supp 12.5mg. Symptoms until 2/28/06. Child doesn't want to eat.
Age: 1.06
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash on back
Age: 71.0
Sex: F
Vaccine: TD
Symptoms: Blister, Erythema, Musculoskeletal stiffness
Clinical narrative: Blister at injection site, redness-to elbow into neck, stiffness.
Age: 0.24
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Crying, Erythema, Pyrexia, Rash, Rash papular
Clinical narrative: Mother reported rash on arms & face and uncontrollable crying about 4 hrs after imms. Taken to ER -- Temp 99.0(R);  given Tylenol 1/2 tsp po at ER. Crying ceased. ER Clinician noted fine pinpoint papules on cheeks, between eyebrows, mildly erythematous...subsided greatly once pt ceased crying.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Shoulder pain, Skin nodule
Clinical narrative: Approximately 9 hours after receiving vaccine, patient complained of pain in left shoulder.  A large, red, hard raised bump was noted.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Computerised tomogram normal, Convulsion, Electroencephalogram abnormal, Immunoglobulin therapy
Clinical narrative: Two weeks after the flu shot, started having generalized mycloinc seizures and generalized convulsive seizures.  Three different anticonvulsants were tried, then IVIg was given to the patient. She is still having seizures not as many, but she must wear a helmet all the time. We are down to less than 5 a day. 3/31/2010 Follow up: The seizures stopped, but it is hard to tell if she has any mental deficis at this time.
Age: 3.0
Sex: F
Vaccine: FLU3
Symptoms: Myoclonic epilepsy
Clinical narrative: Two weeks after the flu shot, started having generalized mycloinc seizures and generalized convulsive seizures.  Three different anticonvulsants were tried, then IVIg was given to the patient. She is still having seizures not as many, but she must wear a helmet all the time. We are down to less than 5 a day. 3/31/2010 Follow up: The seizures stopped, but it is hard to tell if she has any mental deficis at this time.
Age: 0.01
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Mother is Hispanic and responded to the wrong patient's name. I had the information on another patient. When I asked her about his size she said the baby was being followed by doctor. I gave her the VIS and told her that since this was the babies second set of immunizations that he would have had these before. No adverse effects noted at this time. The infant was in the health department for two hours after receiving the immunizations.
Age: 29.0
Sex: M
Vaccine: TD
Symptoms: Cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Pt stated injection site started becoming red and warm to the touch 1 day post injection and lasted for 2 days. Seen by civilian provider and was diagnosed with cellulitis. Patient given Keflex 1 pill QID x 7 days.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Coma, Crying, Hypotonia
Clinical narrative: After my son recieved his shots, he cried for only a few seconds then he just went limp- into a comatose state.  Noone could get him to respond and this lasted for approximately 10 minutes.  Finally the nurses went to undress him, and he oped his eyes a little.  After about 5 minutes of poking him, talking to him, etc.  He finally came back around. 20 minutes later he was smiling again and acting like himself.  No treatment was adminstered.
Age: 31.0
Sex: F
Vaccine: HEPA, IPV, MEN, TYP, YF
Symptoms: Injection site erythema, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: 2/21/06 5:30 AM noted welt and redness at yellow fever vaccine site; 2/22/06 5:30AM diffuse rash and pruritus; 3/1/2006 Afebrile T=98.2; 3/1/06 Treated with Zyrtec and Benadryl
Age: 57.0
Sex: F
Vaccine: YF
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: 2/21/06 received YF vax by Thursday morning she noticed red, raised, 5mm diameter bumps about 3-4 around waist and 4 cm each shin.  She denies any respiratory symptoms. She states that bumps are very "itchy", looked like "flea bites" and resolved by Sunday 2/26.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Rash macular, Swelling
Clinical narrative: Mother stated the child was noted to have a slightly swollen left leg on Saturday night with blotches of red also noted above the knee. Mother reported this finding to the advise nurse on Sunday then she was given advise to medicate the child with Benadryl and apply a cold compress to the area and an appointment was made to follow up on monday of which if improved she was told to cancel, however mother did notice improve ment and still wanted the child seen. Slight swelling remained as did the slight redness patient did not complain of and discomfort and no new treatment was given.
Age: 34.0
Sex: M
Vaccine: HEPAB, TD, TYP
Symptoms: Face oedema, Urticaria
Clinical narrative: Patient developed hives starting on the evening of 3/8/06 which worsened and involved facial and lip swelling by the early morning of 3/10 requiring and emergency room visit. He was given IV medications and sent home with a medrol dose pack and continues taking antihistamines in addition to the oral steriods. He reports he continues with some hives but it is greatly improved and continues to improve. Patient reported he went home immediately aftr receiving the vaccine and had no other known exposures.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: High-pitched crying, Pyrexia, Swelling
Clinical narrative: Crying (loud high-pitched)for 4 hours, swollen left thigh. Parent gave Tylenol 0.6ml at 1430 for temp of 101.5.
Age: 0.12
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Brain oedema, Nervous system disorder, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of brain swelling in a 6 week old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. The subject's medical history included allergic reaction to eye drops. Concurrent medications included paracetamol (Tylenol). On 29 May 2003, the subject received 1st dose of Infanrix (lot DTPA594A2). On 29 May 2003, the subject also received inactivated poliomyelitis virus vaccine (IPOL lot 94030), 7 valent pneumococcal conjugate vaccine (Prevnar lot 492-588), and combination haemophilus influenzae type B conjugate/hepatitis B vaccine (Comvax lot 0641M). On 30 May 2003, 1 day after vaccination with Infanrix, the subject experienced brain swelling, fever and neurologic developmental delay. The events were considered to be disabling to require clinical intervention (OMIC). The mother of the subject reported that after 29 May 2003, the subject, "has never received vaccines with pertussis, but rather diphtheria and tetanus toxoids vaccines to complete the series." The subject is seeing a "child neurologist." At the time of initial reporting, 02 March 2006, the brain swelling and fever had resolved and the neurologic developmental delay was ongoing.