chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site warmth
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of injection site redness in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline), VARIVAX (non-gsk). Previous and/or concurrent vaccination included MMR vaccine (non-gsk); Merck; unknown; unknown given on 12 September 2009. On 12 September 2009 the subject received 1st dose of KINRIX (.5 cc, unknown, left thigh) and 2nd dose of VARIVAX (Non-GSK) (unknown). On 15 April 2010, 7 months after vaccination with KINRIX and VARIVAX (Non-GSK), the subject experienced injection site redness, warm to touch, injection site induration approximately 7 by 10 centimeters and injection site inflammation. Both KINRIX and VARIVAX sites were inflamed and red. The subject was treated with antibiotics and BENADRYL. At the time of reporting the outcome of the experienced injection site redness, warm to touch, injection site induration and injection site inflammation was unspecified. The healthcare professional reported two other cases, see case A0855353A and A0855505A.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Blister, Injection site discomfort, Injection site erythema, Injection site pruritus
Clinical narrative: Itchiness, redness, discomfort at the site of injection and noticed a small skin blister at there too. Pt denied fever, chills, generalized skin rash, nausea, vomiting, headache, SOB after flu shot. Pt never receive flu shot and this is her first time getting flu shot.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Myalgia
Clinical narrative: Generalized myalgias involving, neck, chest, shoulders.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Heart rate increased, Lip swelling
Clinical narrative: Child was eating pizza 1hr after vaccinations, mother noticed that child's upper lip was very swollen and heart rate was slightly increaseed. No trouble breathing.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Ocular hyperaemia
Clinical narrative: 5/7/10 patient received Tdap vaccine at school at 14:00 noticed swelling at injection site and redness. 5/8/10 increased redness, swelling & warmth at injection site starting at deltoid and extending down to elbow. Parent took to ER-gave Rx for Keflex 500 mg tid x 10d. 5/10/10 sore but improved- (+) itchy, red eyes. Advise ice & BENADRYL, finish KEFLEX.
Age: 0.79
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site abscess, Injection site swelling
Clinical narrative: Site of injection is swollen and presents abscess, no treatment necessary at this point. Patient will follow up if condition is not getting better.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Child sitting on floor & fainted. Approximately 10 minutes after immunization.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash on face then all over body within hours of vaccination. Itching began 05/11/2010.
Age: 7.0
Sex: M
Vaccine: MEN, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.  Child received 2nd dose of Menactra.  Had first Menactra in 2007.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Impaired work ability
Clinical narrative: Awoke with joint pain in knees lasting through the night. Unable to work the next day and eventually subsided.
Age: 26.0
Sex: F
Vaccine: FLU(H1N1), HEPA, IPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site induration
Clinical narrative: Redenss and induration at injection site 30 x 30. No other symptoms other than sensitivity.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness
Clinical narrative: Pt passed out after recieving first dose of HPV.
Age: 28.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Abdominal discomfort, Body temperature normal, Dizziness, Flushing, Pallor
Clinical narrative: Onset of symptoms at 2 hrs after received MMR and ENGERIX B vaccines. Light headed, "swimming headed", stomach upset, dizziness and pale skin with flushing to face.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Developed pain and redness at inj site the AM after. Swelling and redness extended length of left upper arm and tenderness in armpit and numbness and tingling in hand. Developed baseball size hard area at inj site. Rx with Benadryl only. Resolved in 8-10 days.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Tenderness
Clinical narrative: Developed pain and redness at inj site the AM after. Swelling and redness extended length of left upper arm and tenderness in armpit and numbness and tingling in hand. Developed baseball size hard area at inj site. Rx with Benadryl only. Resolved in 8-10 days.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Emotional distress, Pyrexia
Clinical narrative: High fever, difficult to console.
Age: 1.01
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth, Irritability
Clinical narrative: Urticaria at injections site. Felt warm (site) to touch. Very fussy 5-4-10. 2 cm area erythema with tenderness right thigh.
Age: 0.63
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Urticaria
Clinical narrative: Child rec'd vaccinations on 4/29/10 and on 5/7/10 mom called to say child had hives on face, trunk and legs but she had bought an off brand of Tylenol with cherry flavor and thought it was the Tylenol.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Swollen on left arm of sight.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Became red on Mon evening. Wakes up and c/o pain-Redness progressed and now down to elbow.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Diarrhoea, Haematemesis, Vomiting
Clinical narrative: Vomiting and diarrhea one day. Following ROTATEQ and other 2mo vaccines. 3 days later with episode of hematemesis with BRB. No fevers.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count, Injection site induration, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Currently limited to local reaction: induration oval-70mm x 50mm-firm, hot, raised 1-2mm with central firm nodular 15 x 15 mm area-firm-not fluctuant-systemic exam otherwise negative no systemic sx.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Currently limited to local reaction: induration oval-70mm x 50mm-firm, hot, raised 1-2mm with central firm nodular 15 x 15 mm area-firm-not fluctuant-systemic exam otherwise negative no systemic sx.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Sneezing
Clinical narrative: Patient sneezed repeatedly and then her hands and feet started itching.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Lymphadenopathy, Pruritus, Rash
Clinical narrative: Client in clinic 4/21/10 for Shingles vaccine. Received ZOSTAVAX live vac. sq (LA) by RD. Given vaccination sheet/shingles. Noticed redness/scalp and itching, rash, enlarged lymph node cheek, 2 wks after vaccination 5/7/10. Went to see PCP 5/12/10 Dx Breakthrough Shingles. Placed on Valtrex tid x 7days. Ibuprofen prn-pain, f/u PCP as needed.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine breakthrough infection
Clinical narrative: Client in clinic 4/21/10 for Shingles vaccine. Received ZOSTAVAX live vac. sq (LA) by RD. Given vaccination sheet/shingles. Noticed redness/scalp and itching, rash, enlarged lymph node cheek, 2 wks after vaccination 5/7/10. Went to see PCP 5/12/10 Dx Breakthrough Shingles. Placed on Valtrex tid x 7days. Ibuprofen prn-pain, f/u PCP as needed.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Muscle twitching
Clinical narrative: Pt had involuntary twitches of body, due to receiving vaccine. Pt received BENADRYL 50mg 1mL to buttock. Twitches more in Rt leg and Lt arm. Vitals 136/93 P 83 O2 99% vitals were rechecked after 15 min BP 125/80.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia
Clinical narrative: Rt arm swelling/redness/achy/fever 2 days ago. Warm compress/MOTRIN.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness
Clinical narrative: Patient received HEP A (HAVRIX) in left deltoid & ADACEL in right deltoid .  Became light headed, gave her whiff of ammonia inhalant, cold paper towel, sat for 15 minutes, her friend drove her home.  Pulse regular - color good, walked unassisted.
Age: 40.0
Sex: F
Vaccine: PPV, TTOX
Symptoms: Discomfort, Erythema, Swelling
Clinical narrative: Discomfort, swelling, redness.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Smear site unspecified abnormal
Clinical narrative: Patient with herpes Zoster 5/10 despite 2 doses of VARIVAX (+ hx varicella per parents).
Age: 0.28
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Irritability
Clinical narrative: Irritability - inconsolable crying X 2 hrs.  Afebrile.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Crying, Dyspnoea, Eyelid oedema, Pruritus
Clinical narrative: Swelling under eyes, itching, labored breathing, crying taken to ER per parents.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Bronchitis, Chest discomfort, Cough, Fatigue, Headache
Clinical narrative: 1-1/1/2 HRS AFTER RECEIVING VACCINE DEVELOPED SORE THROAT. AS DAY PROGRESSED DEVELOPED NASAL AND SINUS CONGESTION, COUGH, HEADACHES, FATIGUE, LARYNGITIS. VOMITED X1 IN THE EVENING. HAD SORE THROAT FOR 48 HRS. SYMPTOMS PROGRESSED INTO THE CHEST: COUGH, CHEST TIGHTNESS, PRODUCTIVE COUGH OF YELLOW/TAN SPUTUM, FATIGUE. ON 05/07 DIAGNOSIS OF BRONCHITIS AND PLACED ON 5 DAY COURSE OF AZITHROMYCIN. ON 05/11 VENTOLIN INHALER QID PRESCRIBED FOR CONTINUOUS COUGH AND CHEST TIGHTNESS.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Laryngitis, Nasal congestion, Oropharyngeal pain, Productive cough, Sinus congestion
Clinical narrative: 1-1/1/2 HRS AFTER RECEIVING VACCINE DEVELOPED SORE THROAT. AS DAY PROGRESSED DEVELOPED NASAL AND SINUS CONGESTION, COUGH, HEADACHES, FATIGUE, LARYNGITIS. VOMITED X1 IN THE EVENING. HAD SORE THROAT FOR 48 HRS. SYMPTOMS PROGRESSED INTO THE CHEST: COUGH, CHEST TIGHTNESS, PRODUCTIVE COUGH OF YELLOW/TAN SPUTUM, FATIGUE. ON 05/07 DIAGNOSIS OF BRONCHITIS AND PLACED ON 5 DAY COURSE OF AZITHROMYCIN. ON 05/11 VENTOLIN INHALER QID PRESCRIBED FOR CONTINUOUS COUGH AND CHEST TIGHTNESS.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Sputum discoloured, Vomiting
Clinical narrative: 1-1/1/2 HRS AFTER RECEIVING VACCINE DEVELOPED SORE THROAT. AS DAY PROGRESSED DEVELOPED NASAL AND SINUS CONGESTION, COUGH, HEADACHES, FATIGUE, LARYNGITIS. VOMITED X1 IN THE EVENING. HAD SORE THROAT FOR 48 HRS. SYMPTOMS PROGRESSED INTO THE CHEST: COUGH, CHEST TIGHTNESS, PRODUCTIVE COUGH OF YELLOW/TAN SPUTUM, FATIGUE. ON 05/07 DIAGNOSIS OF BRONCHITIS AND PLACED ON 5 DAY COURSE OF AZITHROMYCIN. ON 05/11 VENTOLIN INHALER QID PRESCRIBED FOR CONTINUOUS COUGH AND CHEST TIGHTNESS.
Age: 7.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain upper, Blood test normal, Endoscopy upper gastrointestinal tract normal, Stool analysis normal
Clinical narrative: Stomach ache - daily every since some days are worse than others. After running tests the Dr. have tried Miralax, Pepcid & Prevacid none of them help.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Headache, Lumbar puncture, Malaise, Musculoskeletal stiffness
Clinical narrative: This was the 2nd in the HPV series of shots.  My daughter had terrible headaches and was throwing up three days after her first vaccine.  She never ran a high fever, and missed a week of school.  Three weeks to the day after her 2nd shot she began to fill ill.  Headache, body ache etc.  By the following afternoon she had a stiff neck, the "worst headache she had ever had".  We were out of town and she insisted we see a doctor instead of self treat at the hotel.  We went to a walk in center where they recorded a low grade fever (101) and because of the stiff neck and headache sent us to the ER for fear of meningitis.  My daughter was kept in the ER overnight and given morphine for the pain, had spinal fluid taken, blood tests run etc.  She was admitted to the Pediatric Ward where she remained until Tuesday, April 13th.  She was tested for Strep Throat, neurological disorders, mono, migranes etc. She was finally released when the doctors felt like we could handle her headache pain with prescriptions and then over the counter medicines.  The only thing offered us was it was "viral". The initial doctor in the PED Ward said it was her 3rd case with these symptoms - all coming in looking like meningitis initially - with no conclusions being drawn after a battery of tests.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain, Pyrexia, Viral infection, Vomiting
Clinical narrative: This was the 2nd in the HPV series of shots.  My daughter had terrible headaches and was throwing up three days after her first vaccine.  She never ran a high fever, and missed a week of school.  Three weeks to the day after her 2nd shot she began to fill ill.  Headache, body ache etc.  By the following afternoon she had a stiff neck, the "worst headache she had ever had".  We were out of town and she insisted we see a doctor instead of self treat at the hotel.  We went to a walk in center where they recorded a low grade fever (101) and because of the stiff neck and headache sent us to the ER for fear of meningitis.  My daughter was kept in the ER overnight and given morphine for the pain, had spinal fluid taken, blood tests run etc.  She was admitted to the Pediatric Ward where she remained until Tuesday, April 13th.  She was tested for Strep Throat, neurological disorders, mono, migranes etc. She was finally released when the doctors felt like we could handle her headache pain with prescriptions and then over the counter medicines.  The only thing offered us was it was "viral". The initial doctor in the PED Ward said it was her 3rd case with these symptoms - all coming in looking like meningitis initially - with no conclusions being drawn after a battery of tests.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lip swelling, Paraesthesia oral
Clinical narrative: Swollen & tingling lips.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Erythema, warmth and induration at site of vaccine injection that then spread rapidly over a day reaching 17cm by 15cm in size (R upper arm). Painful to touch.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Swollen itchy painful arm.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Hyperaesthesia, Sexual dysfunction
Clinical narrative: Head ache for 6 weeks. Belly pains for 4 weeks. Stool color 4 weeks. Sexual dysfunction, continuing. Skin on elbows ultra sensitive to any contact continuing to date.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Immediate post-injection reaction, Injection site pain, Muscle fatigue, X-ray
Clinical narrative: Sharp pain in vaccination sight and muscle fatigue.  Pain started immediately after vaccination. Muscle fatigue noticed 2 weeks later.
Age: 0.01
Sex: M
Vaccine: HIBV, PPV, RVX
Symptoms: Convulsion, Injection site erythema, Injection site induration, Injection site warmth, Opisthotonus
Clinical narrative: Inconsolable screaming, arching back, convulsing, red thigh (where injection was made), hardened spot, very warm thigh.
Age: 0.01
Sex: M
Vaccine: HIBV, PPV, RVX
Symptoms: Screaming
Clinical narrative: Inconsolable screaming, arching back, convulsing, red thigh (where injection was made), hardened spot, very warm thigh.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Child began running a fever around 102 and continued running a fever for 2-3 days.  Child also had red rash all over neck and trunk which spread to his lower body and face.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Arthralgia, Headache, Immunoglobulins abnormal, Influenza like illness, Neck pain
Clinical narrative: Flu like symptoms; sinus infection, low grade fever, headache, sore throat, joint pain, body aches, losing function of hands, severe neck pain, bilateral foot pain. Recurrent, multiple Dr. visits, autoimmune response, eventual diagnosis of rheumatoid arthritis.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Rheumatoid arthritis
Clinical narrative: Flu like symptoms; sinus infection, low grade fever, headache, sore throat, joint pain, body aches, losing function of hands, severe neck pain, bilateral foot pain. Recurrent, multiple Dr. visits, autoimmune response, eventual diagnosis of rheumatoid arthritis.
Age: 47.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Sinusitis
Clinical narrative: Flu like symptoms; sinus infection, low grade fever, headache, sore throat, joint pain, body aches, losing function of hands, severe neck pain, bilateral foot pain. Recurrent, multiple Dr. visits, autoimmune response, eventual diagnosis of rheumatoid arthritis.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Patient described pain that radiated from injection site to shoulder: as days passed, pain lessened and redness/itchiness appeared.
Age: 0.15
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site swelling
Clinical narrative: Crying, bump/swelling on left thigh.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Irritability, Rash maculo-papular
Clinical narrative: Developed 1-2 mm maculopapular rash over trunk, legs, arms, neck, face -sparing palms & soles.  Increased fussiness, no fever.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Biopsy lung abnormal, Death, Pneumonia, Pneumonia viral
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 304745) in response to a Freedom-of-Information request by GSK. Initial information received described the occurrence of death in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PREVNAR, (non-gsk) ACTHIB and (non-gsk) ROTATEQ. On 25 January 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of PREVNAR (unknown), 1st dose of ACTHIB (unknown), 1st dose of ROTATEQ (unknown). Three days later, on 28 January 2008, the onset of events was reported. The subject experienced abnormal lung biopsy, pneumonia and viral pneumonia. The subject died. An autopsy was performed. Death at the time of reporting was considered unexplained and was under investigation.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Autopsy, Blood ethanol normal, Cardiac arrest, Choking, Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 306983) via a healthcare provider in response to a request by GSK, and described the occurrence of sudden infant death syndrome in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PEDVAXHIB (Merck) and (non-gsk) PREVNAR (Wyeth Labs). On 14 November 2007 the subject received 1st dose of PEDIARIX (unknown), 1st dose of PEDVAXHIB, 1st dose of PREVNAR. On 20 November 2007, 6 days after vaccination with PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced sudden infant death syndrome and cardiac arrest. The subject arrived at the Emergency Room in cardiac arrest at 18:00 after apparently choking while being fed. The subject died on 20 November 2007 from sudden infant death syndrome. An autopsy was performed. The autopsy report revealed cause of death as sudden infant death syndrome. The subject had apparently been healthy. The parent had been lying on bed with subject feeding her with a bottle when both he and the subject apparently went to sleep. The 4-year-old sibling noticed the subject was face down in crook of parent's arm and turned the subject and woke father. Autopsy revealed a normally developed and well cared for appearing infant, no evidence of injury, no congenital or acquired condition that might explain her death was found. It was reported that: "the circumstances raise the possibility of accidental asphyxia, but it does not appear from account available that in the position described the subject's breathing would necessarily be compromised".
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 306983) via a healthcare provider in response to a request by GSK, and described the occurrence of sudden infant death syndrome in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PEDVAXHIB (Merck) and (non-gsk) PREVNAR (Wyeth Labs). On 14 November 2007 the subject received 1st dose of PEDIARIX (unknown), 1st dose of PEDVAXHIB, 1st dose of PREVNAR. On 20 November 2007, 6 days after vaccination with PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced sudden infant death syndrome and cardiac arrest. The subject arrived at the Emergency Room in cardiac arrest at 18:00 after apparently choking while being fed. The subject died on 20 November 2007 from sudden infant death syndrome. An autopsy was performed. The autopsy report revealed cause of death as sudden infant death syndrome. The subject had apparently been healthy. The parent had been lying on bed with subject feeding her with a bottle when both he and the subject apparently went to sleep. The 4-year-old sibling noticed the subject was face down in crook of parent's arm and turned the subject and woke father. Autopsy revealed a normally developed and well cared for appearing infant, no evidence of injury, no congenital or acquired condition that might explain her death was found. It was reported that: "the circumstances raise the possibility of accidental asphyxia, but it does not appear from account available that in the position described the subject's breathing would necessarily be compromised".
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Apnoea, Autopsy, Cardiopulmonary failure, Death, Epistaxis
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 307156) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of death (nos) in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PEDVAXHIB (Merck), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject's medical history included 32 week prematurity. Concurrent medications included SYNAGIS and Vitamins. On 9 February 2008 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of PEDVAXHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 25 February 2008, 16 days after vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ, the subject experienced death nos, blood in nose, apnea, absent pulse and petechial hemorrhage. The subject had been breastfed well at 03:00 hours on 25 February 2008. At approximately 06:00 hours on 25 February 2008 the subject was found with blood in nose, apneic and pulseless; 911 was called, resuscitation attempts failed. The subject was declared dead at hospital Emergency Department after failed attempt to revive her. It was reported that she was a former 32 week preemie who slept in same bed with parents. She was co-sleeping with the mother at time of cardio-pulmonary failure. The subject died on 25 February 2008. An autopsy was performed and cause of death was reported as sudden unexplained infant death in infancy. The autopsy also showed blood in nose and petechial hemorrhages, and reported a history of co-sleeping with an adult. The subject died on 25 February 2008 from death nos. An autopsy was performed and showed blood in nose and petechial hemorrhage.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Haemorrhage, Petechiae, Pulse absent, Resuscitation, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 307156) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of death (nos) in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PEDVAXHIB (Merck), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject's medical history included 32 week prematurity. Concurrent medications included SYNAGIS and Vitamins. On 9 February 2008 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of PEDVAXHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 25 February 2008, 16 days after vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ, the subject experienced death nos, blood in nose, apnea, absent pulse and petechial hemorrhage. The subject had been breastfed well at 03:00 hours on 25 February 2008. At approximately 06:00 hours on 25 February 2008 the subject was found with blood in nose, apneic and pulseless; 911 was called, resuscitation attempts failed. The subject was declared dead at hospital Emergency Department after failed attempt to revive her. It was reported that she was a former 32 week preemie who slept in same bed with parents. She was co-sleeping with the mother at time of cardio-pulmonary failure. The subject died on 25 February 2008. An autopsy was performed and cause of death was reported as sudden unexplained infant death in infancy. The autopsy also showed blood in nose and petechial hemorrhages, and reported a history of co-sleeping with an adult. The subject died on 25 February 2008 from death nos. An autopsy was performed and showed blood in nose and petechial hemorrhage.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 307157) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death (nos) in a 5-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PEDVAXHIB (Merck), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject's medical history was unknown. On 3 January 2008 the subject received 2nd dose of PEDIARIX (unknown), 2nd dose of PEDVAXHIB, 2nd dose of PREVNAR, and 2nd dose of ROTATEQ. On 14 February 2008, 42 days after vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ, the subject experienced death (nos). The subject was reported in the paper as deceased. There was no contact with the parents. The pharmacist who gave the vaccinations had remembered that the subject died and had received the vaccinations from local health unit on 3 January 2008. The subject died on 14 February 2008. Cause of death was not specified. An autopsy was performed and the report was pending.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Diarrhoea, Irritability, Vomiting projectile
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 307158) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of death (nos) in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) PEDVAXHIB (Merck), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). On 20 February 2008 the subject received unspecified dose of PEDIARIX (unknown), 1st dose of PEDVAXHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 26 February 2008, 6 days after vaccination with PEDIARIX, PEDVAXHIB, PREVNAR and ROTATEQ, the subject experienced projectile vomiting and diarrhea. She also experienced fussy and died on an unspecified date. It was reported that the subject received "1st series of vaccines" on 20 February 2008. A telephone call from her mother on 26 February 2008 reported the subject was experiencing "projectile vomiting and severe diarrhea". The pharmacist called an agency who recommended the subject see private physician now and report to nurse outcome. On 27 February 2008 a call from the subject's mother stated "her pediatrician told her that vomiting not due to Rotavirus. That it is ok to give at 4 months old". On 13 March 2008 the mother called to say subject died last evening. The mother stated "she was just fussy the past few days". The subject died from an unspecified cause on 12 March 2008. It was unknown whether an autopsy was performed.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 308149) via an unspecified source in response to a Freedom-of-Information request by GSK, and described the occurrence of sudden infant death syndrome in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACT-HIB (Sanofi Pasteur) and (non-gsk) PREVNAR (Wyeth Labs). There was no previous medical history or concurrent conditions. On 13 March 2008 the subject received 2nd dose of PEDIARIX (details unknown), 1st dose of ACTHIB, 1st dose of PREVNAR. No side effects were noted at the time of vaccination. On 14 March 2008, 1 day after vaccination with ACTHIB, PEDIARIX and PREVNAR, the subject experienced sudden infant death syndrome. The subject died on 14 March 2008 from sudden infant death syndrome. The manner of death was reported as natural. It was unknown whether an autopsy was performed. State examination was pending.
Age: 0.28
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death, Resuscitation, Sudden infant death syndrome, Unresponsive to stimuli
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 309368) via a healthcare provider in response to a Freedom-of-Information request by GSK, and described the occurrence of death (nos) in a 3-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ (Merck). The subject's medical history included 32 week prematurity, death of sibling, feeding intolerance, hypotension, indirect hyperbilirubinemia, intraventricular hemorrhage neonatal, neonatal respiratory distress syndrome, possible maternal drug use and rule out sepsis. The subject had been hospitalized in the Neonatal Intensive Care Unit from birth to 14 January 2008. There were no concomitant medications at the time of vaccination. On 7 April 2008 the subject received 1st dose of PEDIARIX (details unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. There were no adverse effects noted while in the office, and no phone calls from parents reporting problems after leaving the office. On 11 April 2008, 4 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced death (nos) and unresponsive to stimuli. The medical examiner called the reporter's office and stated that the subject had been found unresponsive on the morning of 11 April 2008. A rescue squad was unable to resuscitate the subject. The subject died on 11 April 2008. An autopsy was performed and reported the cause of death as sudden unexplained infant death associated with prior sibling death, non-standard bedding and prematurity. The autopsy revealed no evidence of trauma, disease or congenital anomaly.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Death, Drug screen negative, Gliosis, Metabolic function test normal
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 309426) in response to a Freedom of Information request by GSK and described the occurrence of sudden infant death syndrome (SIDS) in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ. Medical history/pre-existing conditions included the subject was a twin (twin A). There were no concurrent medications. On 3 April 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 6 April 2008, 3 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced SIDS and gliosis. The subject died on 6 April 2008 from SIDS. An autopsy was performed. The event was reported as unexplained death/SIDS. 12 June 2008: Autopsy was received with cause of death of SIDS. Manner of death: natural. Neuropathology report diagnosis: gliosis of the medullary nuclei. All viral polymerase chain reaction (PCR) tests were negative. Drug screen was negative. Mass spec shows no underlying metabolic disorder.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Polymerase chain reaction, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 309426) in response to a Freedom of Information request by GSK and described the occurrence of sudden infant death syndrome (SIDS) in a 2-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), (non-gsk) ACTHIB (Sanofi Pasteur), (non-gsk) PREVNAR (Wyeth Labs) and (non-gsk) ROTATEQ. Medical history/pre-existing conditions included the subject was a twin (twin A). There were no concurrent medications. On 3 April 2008 the subject received 1st dose of PEDIARIX (unknown), 1st dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. On 6 April 2008, 3 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced SIDS and gliosis. The subject died on 6 April 2008 from SIDS. An autopsy was performed. The event was reported as unexplained death/SIDS. 12 June 2008: Autopsy was received with cause of death of SIDS. Manner of death: natural. Neuropathology report diagnosis: gliosis of the medullary nuclei. All viral polymerase chain reaction (PCR) tests were negative. Drug screen was negative. Mass spec shows no underlying metabolic disorder.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Blood glucose increased, Body temperature decreased, Cardiac arrest, Cardio-respiratory arrest
Clinical narrative: This report was received from the Centers for Disease Control via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of sudden infant death syndrome in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-GSK) (Sanofi Pasteur), PREVNAR (Wyeth) and  ROTATEQ (non-GSK) (Merck). The subject's medical history included respiratory syncytial virus bronchiolitis, reportedly occurring in February 2004. Concurrent medical conditions included gastroesophageal reflux disease. Concurrent medications included TYLENOL. On 7 April 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 8 April 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced sudden infant death syndrome, cardiac arrest, body temperature decreased, cardiorespiratory arrest, unresponsive to stimuli, ventricular fibrillation and asystole. The subject had no fever. He was found unresponsive during a nap at daycare. The subject was asystolic at daycare and was unable to be resuscitated by paramedics nor by Emergency Department physician. Emergency Room medical records of 8 April 2008 reveal subject in cardiopulmonary arrest after being found unresponsive by daycare provider. No bystander cardiopulmonary resuscitation was provided. The Emergency Medical Services found the subject in ventricular fibrillation. No defibrillation was attempted, only ADRENALINE, intubation and intraosseous line. The subject was in asystole in the Emergency Room with body temperature 95 (rectal), glucose 111, unresponsive and expired. The subject died on 8 April 2008 from sudden infant death syndrome. An autopsy was performed. The autopsy report stated cause of death as sudden infant death syndrome. All laboratory findings were within normal limits.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Death, Endotracheal intubation, Laboratory test normal, Resuscitation, Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of sudden infant death syndrome in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-GSK) (Sanofi Pasteur), PREVNAR (Wyeth) and  ROTATEQ (non-GSK) (Merck). The subject's medical history included respiratory syncytial virus bronchiolitis, reportedly occurring in February 2004. Concurrent medical conditions included gastroesophageal reflux disease. Concurrent medications included TYLENOL. On 7 April 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 8 April 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced sudden infant death syndrome, cardiac arrest, body temperature decreased, cardiorespiratory arrest, unresponsive to stimuli, ventricular fibrillation and asystole. The subject had no fever. He was found unresponsive during a nap at daycare. The subject was asystolic at daycare and was unable to be resuscitated by paramedics nor by Emergency Department physician. Emergency Room medical records of 8 April 2008 reveal subject in cardiopulmonary arrest after being found unresponsive by daycare provider. No bystander cardiopulmonary resuscitation was provided. The Emergency Medical Services found the subject in ventricular fibrillation. No defibrillation was attempted, only ADRENALINE, intubation and intraosseous line. The subject was in asystole in the Emergency Room with body temperature 95 (rectal), glucose 111, unresponsive and expired. The subject died on 8 April 2008 from sudden infant death syndrome. An autopsy was performed. The autopsy report stated cause of death as sudden infant death syndrome. All laboratory findings were within normal limits.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Unresponsive to stimuli, Ventricular fibrillation
Clinical narrative: This report was received from the Centers for Disease Control via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of sudden infant death syndrome in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-GSK) (Sanofi Pasteur), PREVNAR (Wyeth) and  ROTATEQ (non-GSK) (Merck). The subject's medical history included respiratory syncytial virus bronchiolitis, reportedly occurring in February 2004. Concurrent medical conditions included gastroesophageal reflux disease. Concurrent medications included TYLENOL. On 7 April 2008 the subject received 2nd dose of PEDIARIX (details unknown), 2nd dose of ACTHIB, 2nd dose of PREVNAR, 2nd dose of ROTATEQ. On 8 April 2008, 1 day after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced sudden infant death syndrome, cardiac arrest, body temperature decreased, cardiorespiratory arrest, unresponsive to stimuli, ventricular fibrillation and asystole. The subject had no fever. He was found unresponsive during a nap at daycare. The subject was asystolic at daycare and was unable to be resuscitated by paramedics nor by Emergency Department physician. Emergency Room medical records of 8 April 2008 reveal subject in cardiopulmonary arrest after being found unresponsive by daycare provider. No bystander cardiopulmonary resuscitation was provided. The Emergency Medical Services found the subject in ventricular fibrillation. No defibrillation was attempted, only ADRENALINE, intubation and intraosseous line. The subject was in asystole in the Emergency Room with body temperature 95 (rectal), glucose 111, unresponsive and expired. The subject died on 8 April 2008 from sudden infant death syndrome. An autopsy was performed. The autopsy report stated cause of death as sudden infant death syndrome. All laboratory findings were within normal limits.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Autopsy, Cardiac arrest, Cardio-respiratory arrest, Cyanosis, Death
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 309850) in response to a Freedom-of-Information requested by GSK, and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, Sanofi Pasteur, PREVNAR, Wyeth Labs and ROTATEQ, Merck. Previous medical history included exposure to tobacco in utero and affected by an unspecified maternal condition in utero. Concurrent conditions included passive smoking. There was no other medical history or pre-existing conditions. On 4 April 2008 the subject received 1st dose of PEDIARIX (details unknown), unspecified dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. In April 2008, less than one week after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced cardiorespiratory arrest, lividity, cardiac arrest, cyanosis, livedo reticularis, mydriasis and fixed pupils. It was reported that the subject was dead on arrival at the local hospital, three days after receiving vaccinations. Emergency Room medical records of 6 April 2008 reported final diagnosis of full cardiopulmonary arrest and prehospital death of uncertain cause. The records revealed that the subject arrived in the Emergency Room asystolic with pupils fixed  and dilated, rigor mortis already present, cyanotic, mottled, early livido with cardiopulmonary resuscitation in progress. The subject died on an unspecified date in April 2008. An autopsy was performed and reported cause of death as sudden unexplained death of infant and manner of death as undetermined. The autopsy report also stated the subject's caregiver was a smoker and the subject was co-sleeping with two adults who had used alcohol and marijuana.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Livedo reticularis, Lividity, Muscle rigidity, Mydriasis, Pupil fixed
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 309850) in response to a Freedom-of-Information requested by GSK, and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, Sanofi Pasteur, PREVNAR, Wyeth Labs and ROTATEQ, Merck. Previous medical history included exposure to tobacco in utero and affected by an unspecified maternal condition in utero. Concurrent conditions included passive smoking. There was no other medical history or pre-existing conditions. On 4 April 2008 the subject received 1st dose of PEDIARIX (details unknown), unspecified dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. In April 2008, less than one week after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced cardiorespiratory arrest, lividity, cardiac arrest, cyanosis, livedo reticularis, mydriasis and fixed pupils. It was reported that the subject was dead on arrival at the local hospital, three days after receiving vaccinations. Emergency Room medical records of 6 April 2008 reported final diagnosis of full cardiopulmonary arrest and prehospital death of uncertain cause. The records revealed that the subject arrived in the Emergency Room asystolic with pupils fixed  and dilated, rigor mortis already present, cyanotic, mottled, early livido with cardiopulmonary resuscitation in progress. The subject died on an unspecified date in April 2008. An autopsy was performed and reported cause of death as sudden unexplained death of infant and manner of death as undetermined. The autopsy report also stated the subject's caregiver was a smoker and the subject was co-sleeping with two adults who had used alcohol and marijuana.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Sudden infant death syndrome
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS ID 309850) in response to a Freedom-of-Information requested by GSK, and described the occurrence of death nos in a 2-month-old female subject who was vaccinated with PEDIARIX, GlaxoSmithKline, ACTHIB, Sanofi Pasteur, PREVNAR, Wyeth Labs and ROTATEQ, Merck. Previous medical history included exposure to tobacco in utero and affected by an unspecified maternal condition in utero. Concurrent conditions included passive smoking. There was no other medical history or pre-existing conditions. On 4 April 2008 the subject received 1st dose of PEDIARIX (details unknown), unspecified dose of ACTHIB, 1st dose of PREVNAR, 1st dose of ROTATEQ. In April 2008, less than one week after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced cardiorespiratory arrest, lividity, cardiac arrest, cyanosis, livedo reticularis, mydriasis and fixed pupils. It was reported that the subject was dead on arrival at the local hospital, three days after receiving vaccinations. Emergency Room medical records of 6 April 2008 reported final diagnosis of full cardiopulmonary arrest and prehospital death of uncertain cause. The records revealed that the subject arrived in the Emergency Room asystolic with pupils fixed  and dilated, rigor mortis already present, cyanotic, mottled, early livido with cardiopulmonary resuscitation in progress. The subject died on an unspecified date in April 2008. An autopsy was performed and reported cause of death as sudden unexplained death of infant and manner of death as undetermined. The autopsy report also stated the subject's caregiver was a smoker and the subject was co-sleeping with two adults who had used alcohol and marijuana.
Age: 0.39
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Antimicrobial susceptibility test resistant, Autopsy, Bacterial test negative, Blood glucose increased, Body temperature decreased
Clinical narrative: This report was received from the Centers for Disease Control and Prevention (VAERS # 310715) via a healthcare provider in response to a Freedom-of-Information request by GSK and described the occurrence of death nos in a 4-month old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (Sanofi Pasteur), PREVNAR (Wyeth labs) and ROTATEQ (Merck). Medical history/pre-exisiting conditions included: 36 weeks by c-section; jaundice with phototherapy (16); slow initial weight gain. Past medical history: birth weight of 6.2 pounds and had slow weight gain. 50 percent for height and weight at four months. Sibling with holoprosencephaly with optic nerve dysplasia. On 17 April 2008 the subject received unspecified dose of PEDIARIX, (unknown), unspecified dose of ACTHIB, unspecified dose of PREVNAR, unspecified dose of ROTATEQ. On 17 April 2008, the subject experienced irritability and teething. On 20 April 2008, 3 days after vaccination with ACTHIB, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced death nos. Bacterial and virus culture sensitivity (c/s) were negative. Metabolic screening was within normal limits. Toxicology was negative. Vitreous glucose was 138.8 (H). The subject died from death nos. An autopsy was performed. 07 October 2008: Autopsy stated cause of death as undetermined. Pathological diagnosis: hyperglycemia, likely related to physiological stress. 07 October 2008 autopsy report stated that the subject experienced irritability with teething at time of vaccination. Infant sleeping in car seat with cluttered closet with door partially closed and baby monitor in closet. Parents bedroom (with monitor found turned off) on another floor in house. Infant was put to sleep approximately midnight, but not checked or attempted to be fed until approximately 2pm when parent entered closet for clothing. Subject was found unresponsive, damp with sweat, with blanket partially over face. The subject was dead on arrival (DOA) in emergency room with core temperature of 85. Autopsy found no traumatic injury.