chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Injection site erythema, Rash macular
Clinical narrative: MOTHER WAS CHECKING OUT AT THE FRONT DESK APPROX. 5 MINUTES AFTER THE ADMINISTRATION OF THE INJECTIONS AND NOTED BLOTCHES APPEARING ON PATIENT'S SCALP. THE RECEPTIONIST CALLED ME UP TO THE DESK TO CHECK ON HIM. I NOTICED SEVERAL SEPARATE DEFINITE BLOTCHES ON HIS SCALP.  HE WAS MOVED BACK INTO AN EXAM ROOM AND THE DOCTOR WAS CALLED RIGHT IN TO CHECK ON HIM.  WHILE DOCTOR WAS  EXAMINING HIS SCALP I NOTED RED BLOTCHES APPEARING ON HIS NECK. PATIENT'S CLOTHING WAS REMOVED FOR FURTHER EXAMINATION.  THE INJECTION SITES WERE NOTED TO HAVE REDNESS AROUND THEM.  THE RIGHT PRESENTED GREATER THAN THE LEFT.  DOCTOR CONTINUED TO MONITOR THE PATIENT. NO MEDICATION INTERVENTIONS WERE USED. DOCTOR CONSULTED WITH ANOTHER DOCTOR. THE BLOTCHES DISAPPEARED AFTER APPROX 15-20 MINUTES.  HIS FEET TURNED BRIGHT RED AFTER THE BLOTCHES DISAPPEARED.  NO EDEMA WAS NOTED.  THE REDNESS DISAPPEARED WITHIN MINUTES AND WAS DISCHARGED HOME WITH NO FURTHER REACTIONS.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Rash papular
Clinical narrative: Developed papular/vesicular rash with erythematous base on face, thorax, back and arms. Treated with Benadryl OTC 25mg, cold compress, taped baths.
Age: 18.0
Sex: M
Vaccine: DT, MEN
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Low grade temp(101), mild headache, myalgia
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema, Pyrexia
Clinical narrative: Fever began on 6/27 and cont'd on 6/28 as high as 102. Afebrile on 6/29/03. Significant swelling and redness of left leg began 6/28. Erythema extended from below groin to well demarcated area under knee.  Mod. edema of ant quadricep muscle. No tenderness at insertion site of needle or any red throughout muscle tissue.  On 6/30 went to ER for worsening of tenderness and swelling.
Age: 39.0
Sex: M
Vaccine: SMALL
Symptoms: Chest pain, Headache, Pain
Clinical narrative: Pt received small pox vax 04/03, 7-10 days later pt complained of body aches, headache and substernal chest pain. Chest pain described as mild, lasting for 2 days (etiology unknown). Pt did not report at that time of his symptoms. After return to states saw civilian MD for episode in April 2003 for pt's symptoms at that time. During outprocessing 07/23/03 pt informed MD.
Age: 22.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Skin ulcer
Clinical narrative: Afebrile. Multiple erythematous lesions on chest. No induration. No vesicles. One lesion right upper back with central pustule. Dx: possibility generalized vaccinia reaction.
Age: 23.0
Sex: F
Vaccine: HEPAB, MEN, SMALL, TTOX, SMALL
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: 7/25/03: Eczematous flat topped papules elbows, knees, dorsal aspect both hands symmetrically (3-8mm diameter). Colescent on elbows, some urticarial qualities. 2 sm erosions on elbows, no vesicles or bullae. Temp 99.6. Headache. (2-7 days post vaccination red: 7/24 red palms-painful). 7/20 nausea, chills.
Age: 23.0
Sex: F
Vaccine: HEPAB, MEN, SMALL, TTOX, SMALL
Symptoms: Rash papular
Clinical narrative: 7/25/03: Eczematous flat topped papules elbows, knees, dorsal aspect both hands symmetrically (3-8mm diameter). Colescent on elbows, some urticarial qualities. 2 sm erosions on elbows, no vesicles or bullae. Temp 99.6. Headache. (2-7 days post vaccination red: 7/24 red palms-painful). 7/20 nausea, chills.
Age: 23.0
Sex: F
Vaccine: HEPAB, MEN, SMALL, TTOX, SMALL
Symptoms: Dermatitis, Dermatitis bullous, Purpura, Rash erythematous, Rash papular
Clinical narrative: 7/25/03: Eczematous flat topped papules elbows, knees, dorsal aspect both hands symmetrically (3-8mm diameter). Colescent on elbows, some urticarial qualities. 2 sm erosions on elbows, no vesicles or bullae. Temp 99.6. Headache. (2-7 days post vaccination red: 7/24 red palms-painful). 7/20 nausea, chills.
Age: 52.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Abdominal pain, Nausea
Clinical narrative: Experienced high blood pressure 16-18 weeks after vaccination.  Existing risk factors of diabetes and overweight being treated with lifestyle changes including dietary and exercise.  No past history of HBP.  First noted several months after vaccination.  Also suffered a motor vehicle accident around the same time, has recently been on medical leave for accident. 6/13-she was in a car accident, and went to a urgent care center. No HBP at that time. 6/17-she visited her personal physician for back pain. No HBP at that time. 6/28-follow up visit to personal physician's office for back pain. No HBP. (She had called her physician a few times between visits for pain). 7/15-follow up visit to physician's office for back pain and headache. BP taken thrice, all ranging around 170-100 (172/100; 170/102). Physician ordered labwork and they were drwn the same day. 7/22-another doctor's appointmen. The physician's office could not find her chart-lab results are unknown. She's unsure as to what tests were ordered. She was put on medication-Atenolol 50mg. 7/23-stress test done. She lasted 2 minutes on the treadmill before she was stopped with a systolic of 220.
Age: 52.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Back pain, Headache, Hypertension
Clinical narrative: Experienced high blood pressure 16-18 weeks after vaccination.  Existing risk factors of diabetes and overweight being treated with lifestyle changes including dietary and exercise.  No past history of HBP.  First noted several months after vaccination.  Also suffered a motor vehicle accident around the same time, has recently been on medical leave for accident. 6/13-she was in a car accident, and went to a urgent care center. No HBP at that time. 6/17-she visited her personal physician for back pain. No HBP at that time. 6/28-follow up visit to personal physician's office for back pain. No HBP. (She had called her physician a few times between visits for pain). 7/15-follow up visit to physician's office for back pain and headache. BP taken thrice, all ranging around 170-100 (172/100; 170/102). Physician ordered labwork and they were drwn the same day. 7/22-another doctor's appointmen. The physician's office could not find her chart-lab results are unknown. She's unsure as to what tests were ordered. She was put on medication-Atenolol 50mg. 7/23-stress test done. She lasted 2 minutes on the treadmill before she was stopped with a systolic of 220.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Unevaluable event
Clinical narrative: Patient received vaccines on 7/21. Patient expired during the night of 7/22-23. Do not know if expired before or after midnight of 7/22.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Balance disorder, Difficulty in walking, Disturbance in attention, Dysarthria
Clinical narrative: Tremors, Optic Uveitis, swallowing problems, hard to breathe, speech slurred, very hard to keep my thoughts, itching, numbness, burning in arms, legs, and face, swollen tongue, difficult to walk and drive, felt I was unbalanced, kept on falling, alot of pain, felt like my neck was broken, very weak in muscles, quick to fatigued, couldn't keep warm.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Dysphagia, Dyspnoea, Fall, Fatigue, Pruritus
Clinical narrative: Tremors, Optic Uveitis, swallowing problems, hard to breathe, speech slurred, very hard to keep my thoughts, itching, numbness, burning in arms, legs, and face, swollen tongue, difficult to walk and drive, felt I was unbalanced, kept on falling, alot of pain, felt like my neck was broken, very weak in muscles, quick to fatigued, couldn't keep warm.
Age: 43.0
Sex: F
Vaccine: RAB
Symptoms: Skin burning sensation, Tongue oedema, Tremor, Uveitis
Clinical narrative: Tremors, Optic Uveitis, swallowing problems, hard to breathe, speech slurred, very hard to keep my thoughts, itching, numbness, burning in arms, legs, and face, swollen tongue, difficult to walk and drive, felt I was unbalanced, kept on falling, alot of pain, felt like my neck was broken, very weak in muscles, quick to fatigued, couldn't keep warm.
Age: 2.0
Sex: M
Vaccine: IPV
Symptoms: Fall
Clinical narrative: Kept falling after vaccination; had penicillin shot after vaccination to try to kill virus. Had incision to drain penicillin.
Age: 0.32
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Coma, Cyanosis, Diarrhoea, Laboratory test abnormal
Clinical narrative: 1-2 minute episode turning blue, apnea with stiffness of upper extremities. Not responsive; no tonic-clonic activity, no fever, no choking. Did not require CPR. Normal activity since admitted two hours to event and CXR; patchy infiltrates. Discharge summary states diarrhea, apnea. msv
Age: 0.32
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Musculoskeletal stiffness
Clinical narrative: 1-2 minute episode turning blue, apnea with stiffness of upper extremities. Not responsive; no tonic-clonic activity, no fever, no choking. Did not require CPR. Normal activity since admitted two hours to event and CXR; patchy infiltrates. Discharge summary states diarrhea, apnea. msv
Age: 29.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: + erythema with minimal edema to left arm. Swelling is noncircumferential, close to capsule.
Age: 27.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Injection site erythema, Injection site oedema, Malaise, Pyrexia
Clinical narrative: Moderate local reaction to Anthrax #5. Moderate edema/erythema (11 x 11cm) to posterior right humerous. Also fever (99.5 degrees F.) and malaise. Treated with Motrin 800 mg PO TID #20 and ice to local site.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Gastrointestinal disorder, Headache, Pain
Clinical narrative: Fatigue, headache, body aches, GI distress on 1st day after immunization. On 7/12/03 pt had fever and body aches with headaches. Extremity weakness. Resolved after 14 days.
Age: 60.0
Sex: F
Vaccine: TD
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Quarter size red elevated macular rash around injection site, slightly irregular. Pt given bactroban, Augmentin XR, Elocon
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Serious erythema and soft tissue swelling occurred within 1 hour, got worse, went to ER 2/4/03 7 PM. Rx IM Benadryl.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Eyelid oedema, Pruritus, Urticaria
Clinical narrative: 1410 PM Symptoms: hives over upper body, eyelids swollen, pruritis severe, brought back to clinic by mom. 1415: 0.2ml epinephrine per MD's order after exam. 1418: 0.7 ml Benadryl per MD's order after exam. 1420: hives clearing up, no problems breathing. 1430:  itching gone, redness almost gone. 14:45 Client no longer scratching, hives almost gone, no problems breathing, drawing on paper at this time. 1500 follow up call-mother states "he is sleeping and isn't having any problems". Prescriptions written by MD and explained by nurse when to give as prescribed starting at 1800, next dose; to go to ER if any other problems arise.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever for one week (7 days) 100.5 with Tylenol-highest was 102.6 with Tylenol and Motrin. Rash for 10 days - saw private MD.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Feeling hot, Injection site erythema, Injection site induration, Tenderness
Clinical narrative: Menomune administered on 7/1/03. Pt developed area of redness and tenderness by 7/2/03. Area firm and warm, but not indurated. Already on Augmentin 875 BID for infected cyst behind right ear, which was begun on 7/1/03. Pt applying ice and taking 600-800 mg ibuprofen. Area 4 cm in circumference.
Age: 22.0
Sex: F
Vaccine: TTOX
Symptoms: Fall, Loss of consciousness
Clinical narrative: Plasma donor was given Tetanus Toxoid (05.ml) in left deltoid approx 1 PM on 7/23/03. After 15 minutes follow-up with LPN to check for any symptoms of allergic reaction, donor fell and had LOC for 1-2 seconds. Donor stated she bumped back of head when she fell backwards. No lumps or bleeding noted. At 1:20 PM BP 82/60, P 72, R 20 (lying). 1:25 PM P 68, BP 102/64, R 20 (lying). 1:30 PM P 72, BP 94/60, R 20 (sitting). 1:42 PM P 76, BP 92/60, R 20 (sitting). 1:45 PM P 72, BP 98/60, R 20. Donor did not eat or drink fluids since 7 AM. Prior to donation P 74, BP 116/64. Donor given peanut butter crackers and water during reaction. No hives, rash, SOB or CP noted.
Age: 68.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Injection site red, itchy, swollen
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Pain
Clinical narrative: Child developed redness and swelling of right thigh which persisted for 3 days. Did see MD who advised it probably was due to vaccine and to watch. On 7/23/03 mother contacted health department and reported redness, swelling gone but child still has swollen area in groin 1" long and tender to touch. To see MD again for recommendations on 7/24/03.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site mass
Clinical narrative: Left leg developed lump (hard) size of nickel.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 22 x 17cm area of light redness and induration of left thigh. No fever. No pain with palpitation of area. No inguinal lymphadenopathy. Treated with topical ice only.
Age: 12.0
Sex: M
Vaccine: TD
Symptoms: Feeling hot, Injection site erythema, Tenderness
Clinical narrative: Site was 6 cm x 6cm, warm, red, tender to touch. Benadryl.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness and induration of left thigh within 24 hours after vaccines given. No fever or drainage from injection sites. Treated initially as cellulitis, but was not responsive to antibiotics.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: 8-9 cm area of swelling, redness in left medial thigh appeared 2 days after given DTaP #5, PV #4 in left anterior medial thigh.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Malaise, Myalgia
Clinical narrative: 5 inch round indurated area tender with erythema at injection site. Accompanying malaise and generalized myalgias.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Unconsolable crying started at about 13:30, continued until 18:30 on 07/23/2003.  Mom treated patient with Tylenol.  No other treatments prescribed after being seen by doctor.  No other significant findings by doctor.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Agitation, Crying
Clinical narrative: Unconsolable crying started and continued until 18:30 on 07/23/2003.  Mother treated patient with Tylenol.  No other treatment prescribed after being seen by physician.  No other significant findings by physician.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Hypoaesthesia, Paraesthesia, Tremor
Clinical narrative: Tingling/numbness left arm with tremor-especially index finger of left.  Presently still symptoms.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Fever of 103-treat with Tylenol
Age: 1.6
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Musculoskeletal stiffness, Rash
Clinical narrative: Few spots of rash noted prior to event.  Family at restaurant and child had a stiffening spell (?seizure?).  By the time child was carried to car by father to go to ER, child was back to normal.  No medical care obtained.  No further events.  No fever.
Age: 1.4
Sex: M
Vaccine: DTAP, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: Shots given around 11:00am.  Fever started around 17:00.  Convulsions around 05:00am that night.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Oedema peripheral, Pruritus
Clinical narrative: 07/17/2003: Immunizations. 07/19/2003: Right arm swelling, slightly itchy
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema (4 x 8 cm), induration (3 x 3 cm) surrounding injection site.
Age: 4.8
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Blister, Cellulitis, Erythema, Feeling hot, Injection site pain
Clinical narrative: Left arm from shoulder to elbow-red, swollen, hot to touch with several blisters in this area.  Complained of pain and tenderness at this site. MD Dx as cellulitis.
Age: 4.8
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Oedema
Clinical narrative: Left arm from shoulder to elbow-red, swollen, hot to touch with several blisters in this area.  Complained of pain and tenderness at this site. MD Dx as cellulitis.
Age: 4.8
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Left arm from shoulder to elbow-red, swollen, hot to touch with several blisters in this area.  Complained of pain and tenderness at this site. MD Dx as cellulitis.
Age: 4.8
Sex: M
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site warmth
Clinical narrative: Left arm from shoulder to elbow-red, swollen, hot to touch with several blisters in this area.  Complained of pain and tenderness at this site. MD Dx as cellulitis.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Erythema, Pyrexia, Rash papular
Clinical narrative: Fever x 2 days (documented 40.2 rectal).  Rash erythema, papules on face, chest right thigh nonblanching.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Localized redness and swelling to left deltoid
Age: 51.0
Sex: M
Vaccine: HEP
Symptoms: Anorexia, Hepatitis A, Hepatitis C virus, Hyperhidrosis, Nausea
Clinical narrative: Nausea, loss of appetite, night sweats started 07/18/2003.
Age: 1.3
Sex: M
Vaccine: HIBV
Symptoms: Abasia, Hypokinesia, Somnolence
Clinical narrative: Slept longer than usual.  Floppy, unable to site, unable to walk "wouldn't move".
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Left upper, outer arm swelling, redness, warmth.  Began evening of vaccination 07/21/2003 and still present 07/23/2003.  Swelling appears to be resolving.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Oedema
Clinical narrative: Left thigh red and swollen.  Cold compress and Tylenol or Ibuprofen as needed.
Age: 1.49
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Developed generalized rash and fever.  Visited ER with diagnosis or urticaria made, dipher and prelone given.
Age: 2.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Erythema, Oedema, Screaming, Somnolence
Clinical narrative: Continuous crying > 3 hours.  Redness and swelling on most of upper right thigh.  Increased drowsiness.  Patient advised per doctor to use 1/2 tsp Tylenol every 4 hours, 1/2 tsp. Benadryl every 6 hours.
Age: 0.6
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Anorexia, Body temperature increased, Contusion, Injection site swelling
Clinical narrative: Temperature 104F; injection sites raised - larger than the size of a quarter on both legs.  Injection sites on right leg - purple in color also.  Decreased appetite and fluid intake parents using Motrin every 6-8 hours when needed.
Age: 53.0
Sex: F
Vaccine: TD, DT
Symptoms: Erythema, Muscular weakness, Oedema, Pain, Paraesthesia
Clinical narrative: Patient complained of pain ever since Td administered to right deltoid on 04/03/2003.  Complained of pain, tingling, weakness in right upper arm.  (+) red, swollen right after administration.
Age: 53.0
Sex: F
Vaccine: TD, DT
Symptoms: Asthenia, Pain, Paraesthesia
Clinical narrative: Patient complained of pain ever since Td administered to right deltoid on 04/03/2003.  Complained of pain, tingling, weakness in right upper arm.  (+) red, swollen right after administration.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Oedema
Clinical narrative: Left upper extremity swelling, erythema.  Treated with Keflex 125mg by mouth three times a day for 10 days.  07/14/2003.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Got up this am c/o hurting- left thigh with 5cm x 4 1/2 cm. Redness around DTaP injection site T98.5 Note: Shots given in legs- mother's request
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Febrile convulsion, Malaise
Clinical narrative: Received immunizations on 07/18/2003 around 12:30pm on 07/19/2003. Told dad he didn't feel good. Five minutes later found in bedroom having febrile seizure.  T101.9
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Erythema, Pyrexia, Respiratory distress, Screaming, Tachycardia
Clinical narrative: Child developed wheezing by mother's history 24 hours after injection. Had panting respirations also redness of leg where injected. Seen in office next day. No wheezing noted. Temp 100.5 mild tachycardia. 12 hour crying. Leg no longer red.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Wheezing
Clinical narrative: Child developed wheezing by mother's history 24 hours after injection. Had panting respirations also redness of leg where injected. Seen in office next day. No wheezing noted. Temp 100.5 mild tachycardia. 12 hour crying. Leg no longer red.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hive like rash head to toe. Sporadic an arms legs and face confluent or chest.
Age: 0.9
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Erythema, Feeling hot, Injection site pain, Oedema, Urticaria
Clinical narrative: 07/18/2003 pt behind on immunization due to recurrent OM. Received DTaP #2, IPV #2 left leg, Comax (Hep B #3/HIB #2) and Prevnar #1 in right leg. Child with 50 cent red wheal with IPV initially, but later that night whole left leg red, hot, swollen. Pt very upset, leg very painful to touch.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Fall, Syncope
Clinical narrative: Syncopal episode. Fell off exam table and hit head. Taken to ER.
Age: 0.4
Sex: U
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Feeling hot, Injection site erythema, Injection site oedema, Pyrexia
Clinical narrative: Fever, sites red, warm- LT is quarter size 1/2 size. Red swollen RT (DTaP- HIB) dime size red rash on face and back a little. No redness before.
Age: 34.0
Sex: U
Vaccine: RAB
Symptoms: Chills, Feeling hot, Headache, Injection site erythema, Injection site mass
Clinical narrative: Red, hard, hot infected are 3" diameter. Fever, chills day after, massive headache.
Age: 34.0
Sex: U
Vaccine: RAB
Symptoms: Pyrexia
Clinical narrative: Red, hard, hot infected are 3" diameter. Fever, chills day after, massive headache.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Apnoea, Blood glucose increased, Crying
Clinical narrative: child received Immunization (6wks) sched. on 7/24/03 P.M. in the evening had 20 min. episode of unconsolable crying & apnic episode of 30 sec. brought to E.R., admitted overnight for observation, then discharged
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Injection site inflammation, Lymphadenopathy, Oedema, Pain
Clinical narrative: Take evaluation Day 7 (7/7/03): 10mm pustule, mininal erythema.  Adverse Event Active Surveillance interview Day 29 (7/29/03): Pt reports on Day 9 (7/9/03) left deltoid area became swollen, sore and inflamed beyond the size of the Op-Site (9.5cm X 8.5 cm).  The underarm/axilla along bicep was sore with palpable lymph nodes.  Afebrile.  Pt reports slow and spontaneous recovery over period of 5-7 days.
Age: 34.0
Sex: F
Vaccine: SMALL
Symptoms: Palpitations, Rash pustular
Clinical narrative: Take evaluation Day 7 (7/7/03): 10mm pustule, mininal erythema.  Adverse Event Active Surveillance interview Day 29 (7/29/03): Pt reports on Day 9 (7/9/03) left deltoid area became swollen, sore and inflamed beyond the size of the Op-Site (9.5cm X 8.5 cm).  The underarm/axilla along bicep was sore with palpable lymph nodes.  Afebrile.  Pt reports slow and spontaneous recovery over period of 5-7 days.
Age: 46.0
Sex: M
Vaccine: ANTH, SMALL
Symptoms: Chills, Myalgia
Clinical narrative: MYALGIA/CHILLS AFTER VACCINATION WITH BOTH ANTHRAX AND SMALLPOX VACCINE--TX WITH DIPHENHYDRAMINE AND IBUPROFEN
Age: 33.0
Sex: F
Vaccine: SMALL
Symptoms: Erythema, Injection site reaction, Rash
Clinical narrative: Received Smallpox vaccination on 06/26/2003.  Uneventful course after vaccination.  Scab remained intact on day 28 check.  On day 33, scab continues to be intact and a faint red rash has developed on patient's abdomen.  She was to be seen by family physician on 07/29/03.  Unable to contact as of yet today to determine treatment and or diagnosis of rash.
Age: 44.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site vesicles, Vaccination complication
Clinical narrative: Pt. presented with blisters at vaccination site.  Dressing applied after picture taken.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Eye irritation, Lacrimation increased, Urticaria
Clinical narrative: 12:25 client returned to clinic with itching, tearing eyes, whealts noted on all extremites.in moderate distress yet alert, responsive, and scratching.  Gave benedryl and 12:38 vital signs stable.
Age: 30.0
Sex: F
Vaccine: HEPA, TD, TYP
Symptoms: Rash, Urticaria
Clinical narrative: Patient repoted a rash that started on her arms, spread to her hands .Rash started on 7/24/03, and patient called 0n 7/29, still repoting rash and hives now.I advised she been be seen by a health care provided to evaluate and treat
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Head discomfort, Headache, Nausea
Clinical narrative: Did not want to get shot.  Ask mother to stand near, vaccine given.  approx 5 min later at the check out area, she was found lying flat on back.  Had bump on back of head size of golf ball.  Is lying flat-got up and c/o nausia, H/A and dizzyness. Lay pt back down with feet up, no better, called 911. 7/28/03 spoke with sister, child sent home and is OK.  Mother to call me back.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Oral mucosal blistering
Clinical narrative: Had immunizations 7/15/03.  7/16 started blisters in mouth oral mucosa, and lips.  In health department  7/17/03, refered to private doc.
Age: 5.0
Sex: M
Vaccine: DTAP, HEP, IPV, MMR
Symptoms: Erythema, Oedema peripheral, Pyrexia, Tenderness
Clinical narrative: Patient came in on 7/30/03 AM L Deltoid area very swollen, red, tende and warm to touch.  Says child has complained of high fever that are relieved by Tylenol but return.  Referred to clinic for provider visit. 7/30/03 AM. NKA allergies- no previous history of adverse reactions.
Age: 1.3
Sex: M
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash vesicular
Clinical narrative: small vessicular rash on neck, back, angle of left eye and arm.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Child received vaccines listed below approximately 11am. Mom called about 4pm to state that the child had what appeared to be hives over body. Treated with Benadryl. Child appeared at the after hours clinic and MD disagreed with the 'hive' diagnosis and felt that uticaria was more likely.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC
Symptoms: Injection site rash, Urticaria
Clinical narrative: Patient developed urticarial rash both around injection site (in approximately 8 cm diameter circumscribed area) and on torso.
Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC, HBHEPB, PNC, HBHEPB, PNC
Symptoms: Cough, Gait disturbance, Hypoaesthesia, Insomnia, Pyrexia
Clinical narrative: A nurse reported that a 12 month old male received a third injection of Prevnar in the right thigh and a third dose of Comvax in the left thigh on 6/19/03. The child had no relevant medical history. There were no concomitant medications. Approximately one week post-immunization, the reporter indicated the mother contacted the physician's office reporting that the child had developed a tic (eye blinking) and an abnormal gait. The child was examined by a neurologist and "everything came back normal." As of 7/18/03, the "tic was gone and the child was walking better." This event was considered medically important (OMIC). Follow up on 08/14/2003: "Additional information received on 08/01/2003 and 08/07/2003 provided additional adverse event information, product lot numbers and sites of administration, and recovery status.  A nurse reported that a male received a third injection (0.5mL) of Prevnar in the right thigh and a third dose of Comvax in the left thigh on 06/19/2003.  The child had no relevant medical history.  There were no concomitant medications.  On 06/25/2003, approximately one week post-immunization, the reporter indicated the mother contacted the physician's office reporting that the child had developed a tic (eye blinking) and an abnormal gait.  On 07/01/2003, the reporter stated the child was "fine."  On 07/02/2003, he developed a "funny" walk and nonstop blinking.  He was examined by his PCP and subsequently referred to a pediatric neurologist.  A "workup" and evalution for lyme disease were performed; the results were negative.  He recovered without medical intervention.  This event was considered medically important (OMIC).  Information regarding this event has been forwareded to the manufacturer of the concomitantly administered vaccine."
Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC, HBHEPB, PNC, HBHEPB, PNC
Symptoms: Gait disturbance, Muscle twitching, Tic
Clinical narrative: A nurse reported that a 12 month old male received a third injection of Prevnar in the right thigh and a third dose of Comvax in the left thigh on 6/19/03. The child had no relevant medical history. There were no concomitant medications. Approximately one week post-immunization, the reporter indicated the mother contacted the physician's office reporting that the child had developed a tic (eye blinking) and an abnormal gait. The child was examined by a neurologist and "everything came back normal." As of 7/18/03, the "tic was gone and the child was walking better." This event was considered medically important (OMIC). Follow up on 08/14/2003: "Additional information received on 08/01/2003 and 08/07/2003 provided additional adverse event information, product lot numbers and sites of administration, and recovery status.  A nurse reported that a male received a third injection (0.5mL) of Prevnar in the right thigh and a third dose of Comvax in the left thigh on 06/19/2003.  The child had no relevant medical history.  There were no concomitant medications.  On 06/25/2003, approximately one week post-immunization, the reporter indicated the mother contacted the physician's office reporting that the child had developed a tic (eye blinking) and an abnormal gait.  On 07/01/2003, the reporter stated the child was "fine."  On 07/02/2003, he developed a "funny" walk and nonstop blinking.  He was examined by his PCP and subsequently referred to a pediatric neurologist.  A "workup" and evalution for lyme disease were performed; the results were negative.  He recovered without medical intervention.  This event was considered medically important (OMIC).  Information regarding this event has been forwareded to the manufacturer of the concomitantly administered vaccine."
Age: 1.0
Sex: M
Vaccine: HBHEPB, PNC, HBHEPB, PNC, HBHEPB, PNC
Symptoms: Gait disturbance, Tic
Clinical narrative: A nurse reported that a 12 month old male received a third injection of Prevnar in the right thigh and a third dose of Comvax in the left thigh on 6/19/03. The child had no relevant medical history. There were no concomitant medications. Approximately one week post-immunization, the reporter indicated the mother contacted the physician's office reporting that the child had developed a tic (eye blinking) and an abnormal gait. The child was examined by a neurologist and "everything came back normal." As of 7/18/03, the "tic was gone and the child was walking better." This event was considered medically important (OMIC). Follow up on 08/14/2003: "Additional information received on 08/01/2003 and 08/07/2003 provided additional adverse event information, product lot numbers and sites of administration, and recovery status.  A nurse reported that a male received a third injection (0.5mL) of Prevnar in the right thigh and a third dose of Comvax in the left thigh on 06/19/2003.  The child had no relevant medical history.  There were no concomitant medications.  On 06/25/2003, approximately one week post-immunization, the reporter indicated the mother contacted the physician's office reporting that the child had developed a tic (eye blinking) and an abnormal gait.  On 07/01/2003, the reporter stated the child was "fine."  On 07/02/2003, he developed a "funny" walk and nonstop blinking.  He was examined by his PCP and subsequently referred to a pediatric neurologist.  A "workup" and evalution for lyme disease were performed; the results were negative.  He recovered without medical intervention.  This event was considered medically important (OMIC).  Information regarding this event has been forwareded to the manufacturer of the concomitantly administered vaccine."
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Visual acuity reduced
Clinical narrative: Received Hep B at 5 PM 7/29 within 5-10 minutes nausea, sweaty, dizziness all night. One episode of "not seeing very well" 30 minutes after vaccination.
Age: 2.4
Sex: F
Vaccine: PNC
Symptoms: Cough, Eye irritation, Sneezing, Urticaria
Clinical narrative: Within about 15 minutes, had onset of hives on lower right eyelid, itchy eyes, cough and sneezing. Size of hives rapidly progressive. No wheeze/lip swelling/facial swelling. Did not develop hives elsewhere (with ?hurt lower left eyelid). Given po Benadryl and SQ epi in office.
Age: 14.0
Sex: M
Vaccine: TD
Symptoms: Convulsion, Dizziness
Clinical narrative: Pt approximately 20 minutes after vaccine was light headed, had seizure for 5 seconds. Pt was still in office.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abdominal pain, Feeling hot, Headache, Injection site oedema, Pain
Clinical narrative: Elevated fever of 104.3 within 12 hours of vaccine administration-left arm swelling, warm to touch and pain-complained of abdominal pain, vomited x1, headache-was seen by MD 7/24/03-MD stated ?virus versus vaccine reaction.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Elevated fever of 104.3 within 12 hours of vaccine administration-left arm swelling, warm to touch and pain-complained of abdominal pain, vomited x1, headache-was seen by MD 7/24/03-MD stated ?virus versus vaccine reaction.
Age: 47.0
Sex: F
Vaccine: TD
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: Immediate pain in left arm, increased pain when scrum injected in. Decreased ROM with pain. Inability to move arm for 2 months. Still in physical therapy.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Child was fine while sitting in room about 4-5 minutes after shot; she wandered away from me while I was making appointment. I heard a loud band and looked over and saw pt laying on the floor on her back, feet towards me, her eyes were open.
Age: 1.7
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: Fever temperature 104.2 degrees F., decreased activity.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Large area of redness, swelling left thigh.
Age: 1.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Injection site oedema, Injection site warmth, Pain
Clinical narrative: Swelling, heat, tenderness of right thigh lasting 5 days. Subcut nodule (about 1 cm) remains.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Left leg swollen, red and hot where imz were given. Tx Augmentin or Cefzil depending on insurance coverage and Benadryl 1/2 tsp Motrin 1 tsp every 6 hours. F/U if fever or rapid expansion of erythema.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: IMMUNIZATIONS GIVEN SAME DAY PATIENT EXPIRED FROM SIDS. NO ADVERSE REACTION NOTED TO IMMUNIZATION.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Rash maculo-papular
Clinical narrative: on 7/25 mom reported that patient had red knot to LAT day after inj of DTaP.  States patient doing fine now, no symptoms, fever, knot gone.
Age: 0.5
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Diarrhoea, Head discomfort, Screaming, Vomiting
Clinical narrative: Baby was sick for 1-1/2 weeks, then violently ill for almost a week with severe vomiting, diarrhea, and painful head (would wake up screaming & touching his head).  Recovered immediately upon receiving a religious priesthood blessing, but wealthly parents have a lawyer to handle all future medical care.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Anorexia, Cyanosis, Dehydration, Diarrhoea, Gastroenteritis
Clinical narrative: From initial information received on Jul 25, 2003 from manufacturer (A0417640A) regarding an adverse event occurring in the USA, it was reported by the patient's mother that a two month old female received her first dose of diptheria and tetanus toxoids and acellular pertussis vaccine, hepatitis B vaccine, 7- valent pneumococcal conjugate vaccine, haemophilus influenza type b conjugate vaccine, and inactivated poliomyelitis virus vaccine on Nov 01, 2002. On Nov 02, 2002, the patient experienced "heavy" vomiting with the "inability to keep down fluids", lethargy, diarrhea and "heavy" urination. The patient was hospitalized for seven days. The events resolved. The mother reported that the patient's physician considered the events to be caused by pertussis vaccine, and the pertussis immunization series was discontinued.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Insomnia, Lethargy, Somnolence, Vomiting
Clinical narrative: From initial information received on Jul 25, 2003 from manufacturer (A0417640A) regarding an adverse event occurring in the USA, it was reported by the patient's mother that a two month old female received her first dose of diptheria and tetanus toxoids and acellular pertussis vaccine, hepatitis B vaccine, 7- valent pneumococcal conjugate vaccine, haemophilus influenza type b conjugate vaccine, and inactivated poliomyelitis virus vaccine on Nov 01, 2002. On Nov 02, 2002, the patient experienced "heavy" vomiting with the "inability to keep down fluids", lethargy, diarrhea and "heavy" urination. The patient was hospitalized for seven days. The events resolved. The mother reported that the patient's physician considered the events to be caused by pertussis vaccine, and the pertussis immunization series was discontinued.
Age: 0.08
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC, DTAP, HEP, HIBV, IPV, PNC
Symptoms: Diarrhoea, Lethargy, Pollakiuria, Vomiting
Clinical narrative: From initial information received on Jul 25, 2003 from manufacturer (A0417640A) regarding an adverse event occurring in the USA, it was reported by the patient's mother that a two month old female received her first dose of diptheria and tetanus toxoids and acellular pertussis vaccine, hepatitis B vaccine, 7- valent pneumococcal conjugate vaccine, haemophilus influenza type b conjugate vaccine, and inactivated poliomyelitis virus vaccine on Nov 01, 2002. On Nov 02, 2002, the patient experienced "heavy" vomiting with the "inability to keep down fluids", lethargy, diarrhea and "heavy" urination. The patient was hospitalized for seven days. The events resolved. The mother reported that the patient's physician considered the events to be caused by pertussis vaccine, and the pertussis immunization series was discontinued.
Age: 0.3
Sex: M
Vaccine: DPP, HBPV, DTAP, HIBV, IPV, PNC
Symptoms: Insomnia, Irritability, Joint range of motion decreased
Clinical narrative: Pt's mother called 8 hours after 4 immunizations given, reporting absence of movement in both legs. Baby usually squirms and kicks, but failed to demonstrate leg movement. Described them as "limp" even in response to pulling. Did curl toes to stroking soles. Sent to ER for evaluation, began spontaneous leg movements by time MD saw pt (about 10 PM). By Mom's phone report, seems recovered today.
Age: 0.3
Sex: M
Vaccine: DPP, HBPV, DTAP, HIBV, IPV, PNC
Symptoms: Hypokinesia
Clinical narrative: Pt's mother called 8 hours after 4 immunizations given, reporting absence of movement in both legs. Baby usually squirms and kicks, but failed to demonstrate leg movement. Described them as "limp" even in response to pulling. Did curl toes to stroking soles. Sent to ER for evaluation, began spontaneous leg movements by time MD saw pt (about 10 PM). By Mom's phone report, seems recovered today.
Age: 22.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Infection transmission via personal contact, Rash, Skin ulcer
Clinical narrative: No history of acute, chronic, or exfoliative skin conditions. Seen by NP on 6/9/03, had vaginal lesion, tested for herpes. Lab at Medical Center showed viral isolate. Sent to Lab where vaccinia was identified. Between 5/12 and 5/16/03 had contact sexual contact with smallpox vaccinee. State patient had bandaid covering site. He removed the bandaid but pt did not touch the site. He covered the site with a new bandaid and did not wash his hands. Approximately two weeks after contact notices lesion in vaginal area. Self treated with warm compresses and after MD visit 6/9/03, was put on doxycycline BID. No other sexual contacts after this contact. No other lesions occurred, no h/o herpes. Is feeling very well. Has never received the smallpox vaccine. Notified this case. Name given by this case cannot be found in their records.
Age: 22.0
Sex: F
Vaccine: SMALL, SMALL
Symptoms: Infection transmission via personal contact, Laboratory test abnormal, Skin ulcer
Clinical narrative: No history of acute, chronic, or exfoliative skin conditions. Seen by NP on 6/9/03, had vaginal lesion, tested for herpes. Lab at Medical Center showed viral isolate. Sent to Lab where vaccinia was identified. Between 5/12 and 5/16/03 had contact sexual contact with smallpox vaccinee. State patient had bandaid covering site. He removed the bandaid but pt did not touch the site. He covered the site with a new bandaid and did not wash his hands. Approximately two weeks after contact notices lesion in vaginal area. Self treated with warm compresses and after MD visit 6/9/03, was put on doxycycline BID. No other sexual contacts after this contact. No other lesions occurred, no h/o herpes. Is feeling very well. Has never received the smallpox vaccine. Notified this case. Name given by this case cannot be found in their records.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Convulsion
Clinical narrative: It was reported by the pt's parent that a four year old female pt received IPOL< a fifth dose of Infanrix and a dose of MMR II on an unspecified date in January 2002. The lot numbers, routes and sites were not reported. Later that same day, the pt experienced four seizures within a 24 hr period. On an unspecified date, the pt was seen by a physician and prescribed an unspecified anticonvulsant. The parent reported that the pt had no further seizures, however, she continued to take the anticonvulsant as of 7/14/03. Reportedly, the pt recovered from this event. Seriousness criteria-other medically significant (OMIC).
Age: 0.65
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Condition aggravated, Heart disease congenital, Trisomy 21
Clinical narrative: This subject is an 11 month old male, who died on 3/23/03 from congenital heart disease while enrolled in a Phase IV Daptacel study. The subject received two doses of study vaccine; the last dose prior to the event was given on 11/26/02. The subject had a pre-existing congenital heart disease and Down's syndrome and died 356 days post-immunization. The event of congenital heart disease was reported by the investigator as unrelated to the study vaccine. No autopsy performed. Case is closed.  Follow up on 08/12/2003: "This is a 10.5 month old male seen for evaluation.  The patient has Down's syndrome and was diagnosed by fetal echo to have a permeative atrial ventricular canal.  Initially the patient was placed on digoxin and Lasix but subsequently developed pulmonic stenosis, so these were discontinued.  The patient had an initial cardiac cetherization on 09/10/2002.  This revealed a permeative atrial-ventricular canal with a moderate left-to-right shunt and some right-to-left shunt and a TOR pressure drop across the pulmonic valve.  The patient had pulmonary artery pressures which were twice normal and modestly elevated pulmonary vascular resistance.  Subsequently, the patient on 09/26/2002, had a pulmonary artery band performed for a MD.  Postoperative course was complicated by severe postoperative respiratory syndrome with problems necessitating prolonged intubation secondary to tracheal stenosis.  In addition, the patient had post pericardiotomy syndrome which was treated with ibuprofen without complication.  The patient recently had repeat cardiac catherization on 01/16/2003, which confirmed the above diagnosis.  The patient is presently scheduled for surgery on 02/27/2003. This would consist of having resection of his tracheal ________ by MD and a Glen procedure by another MD.  Since the patient's last evaluation one month ago, there been no symptoms of feeding difficulties, respiratory difficulties, increasing stridor or syncope noted.  Mother states that the patient did have some breathing problems for approximately four or five days after catherization secondary to his intubation.  However, subsequently he has not had inspiratory or expiratory stridor.  Follow up on 04/14/04: "After a medical review of the case, a new version of the report has been generated to add the adverse event term "condition aggravated", and to correct the interval between the date of immunization and the fatal outcome, from 356 to 117 days."
Age: 1.29
Sex: F
Vaccine: DTAP, MMR, PNC, UNK
Symptoms: Acidosis, Hepatic necrosis, Hepatitis, Renal failure, Respiratory failure
Clinical narrative: This subject is a one year old female, who was admitted to the hospital due to systemic inflammatory response syndrome while enrolled in a Phase IV Daptacel study. The subject received one dose of Daptacel vaccine: along with other pediatric vaccines on 3/17/03. The subject developed symptoms 65 days post immunization and was admitted to the hospital three days later 5/25/03. The subject was transferred from hospital to another hospital on 5/26/03 with the diagnosis of acute respiratory failure, presumed streptococcal sepsis and hepatitis. While at hospital, the pt expired on 5/31/03 with a diagnosis of SIRS, acidosis and acute liver necrosis. The event of systemic inflammatory response syndrome was reported by the investigator as unrelated to the study vaccine. No autopsy was performed. Follow up on 04/21/04: "New version created to place Infanrix into pt's history screen." Medical Records received on 8/05/2003 states kidney failure and thrombocytopenia.
Age: 1.29
Sex: F
Vaccine: DTAP, MMR, PNC, UNK
Symptoms: Sepsis, Thrombocytopenia
Clinical narrative: This subject is a one year old female, who was admitted to the hospital due to systemic inflammatory response syndrome while enrolled in a Phase IV Daptacel study. The subject received one dose of Daptacel vaccine: along with other pediatric vaccines on 3/17/03. The subject developed symptoms 65 days post immunization and was admitted to the hospital three days later 5/25/03. The subject was transferred from hospital to another hospital on 5/26/03 with the diagnosis of acute respiratory failure, presumed streptococcal sepsis and hepatitis. While at hospital, the pt expired on 5/31/03 with a diagnosis of SIRS, acidosis and acute liver necrosis. The event of systemic inflammatory response syndrome was reported by the investigator as unrelated to the study vaccine. No autopsy was performed. Follow up on 04/21/04: "New version created to place Infanrix into pt's history screen." Medical Records received on 8/05/2003 states kidney failure and thrombocytopenia.