chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer, Tonsillitis, Wheezing
Clinical narrative: 11/6/01 started fever 102F range, severe HA, sore throat Sx all continued into 11/9/01. Lesions started 11/9/01, 11/9/01 3+ erythematous tonsils with petechia strep (-), bronchospasmatic cough with expiratory wheeze, fever resolved 11/10/-11/11/01. 11/9/01 started Acyclovir 600mg.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Anaphylactic reaction, Convulsion
Clinical narrative: Seizure with anaphylaxis
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site abscess
Clinical narrative: Abscess at injection site L deltoid area.
Age: 1.4
Sex: M
Vaccine: HIBV, MMR
Symptoms: Leukocytosis, Lung disorder, Otitis media, Pyrexia, Rhinorrhoea
Clinical narrative: T-102F 11/13/01. ER 11/14/01 18:00 T-105F, P 148, R 32, O2 sat 96%, course rhonchi, runny nose, pulls ears. Completed Amoxil 11/14/01. Impression: Fever, OM, Tonsillitis, Feverall 120mg supp, Rocaphin 500mg IM
Age: 1.4
Sex: M
Vaccine: HIBV, MMR
Symptoms: Tonsillitis
Clinical narrative: T-102F 11/13/01. ER 11/14/01 18:00 T-105F, P 148, R 32, O2 sat 96%, course rhonchi, runny nose, pulls ears. Completed Amoxil 11/14/01. Impression: Fever, OM, Tonsillitis, Feverall 120mg supp, Rocaphin 500mg IM
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister
Clinical narrative: Pt developed 3 vesicles on chest, 4 vesicles on back, and 1 vesicle behind ear.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Pain
Clinical narrative: Received Hepatitis B series. First shot, no reaction. Second shot, arm ached significantly. Third shot, whole body ached, felt weak in arms (resolved by next day).
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Abnormal behaviour, Convulsion
Clinical narrative: Details are unclear but he had a seizure within 2-3 days of having the immunization and also had increased temper tantrums within 1-2 week period.
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Dizziness, Pallor, Urticaria
Clinical narrative: Pt developed urticaria, dizziness and pallor 15 min after injection. He was given 2 liters IV fluid (lactated ringers) and 25mg of Benadryl with reversal after 30 minutes. He resumed activity after 8 hours.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Hypotonia, Pallor, Stupor
Clinical narrative: Hypotomic/hyporesponsive episode, pallor/floopy. Paramedics to ER. Recovered completely.
Age: 4.0
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Pt had redness and swelling noted, starting on 11/15/01 PM. It was less red in the office on 11/16/01 AM. The left upper arm and lower deltoid area was red 7cm X 10cm, with induration which had more intense redness in the center of this area (4cm X 6cm). Pt was given Benadryl, po.
Age: 10.0
Sex: F
Vaccine: HEP
Symptoms: Injection site rash
Clinical narrative: Pt had a half-dollar sized rash at the site of injection. Treated with Benadryl po with relief.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Loss of consciousness
Clinical narrative: Symptoms began about 35-37 minutes, post vax. She began to feel "funny"; legs felt weak and then passed out. She does not recall anything until waking on the ambulance. She was sent to hospital ER and kept X 5 hours. She became stable and all labs were ok. Bed rest X 48 hours.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Rash vesicular
Clinical narrative: Left arm with erythema, warmth and pustular vesicles surrounding injection site about 7-10 days later. In recovery process on antibiotic.
Age: 44.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt developed redness, swelling and heat per pt. No treatment. She never had it looked at and informed us of it today (11/21/01) and that it was better.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Hives
Age: 2.0
Sex: F
Vaccine: DTP, IPV
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: Patient came out of the room and fainted. The doctor and nurses took care of her. When she got home, she ran a fever, vomited and was very sick. The doctor's office kept on calling to check on her. He advised never to get these shots again.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site pain, Insomnia, Joint range of motion decreased, Pain
Clinical narrative: Pt had intensified wrist, finger and ankle joint pains. Her upper arm was swollen and so painful that it required ice packs. She could not lift or turn her arm or sleep (even with Dalmane and Advil) for 72 hours. Ten days post vax, her arm still hurt when she turned it and at injection site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Pt had intensified wrist, finger and ankle joint pains. Her upper arm was swollen and so painful that it required ice packs. She could not lift or turn her arm or sleep (even with Dalmane and Advil) for 72 hours. Ten days post vax, her arm still hurt when she turned it and at injection site.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Decreased appetite, Lethargy, Sleep disorder
Clinical narrative: Lethargy, slept 24-36 hours after shot. Was arrousable but would go back into deep sleep. Decreased eating secondary to sleep.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt developed hives 11/1/01. He was seen by MD and given Benadryl. The hives lasted on and off until 11/6/01. Note: Pt had eaten foods with eggs before immunizations. "No problems" per mother.
Age: 28.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Pt developed fine, pin point, red rash on face (non-raised, non-pruritic) 15 minutes after vaccination. Given Benadryl 25 mg PO at 3:33 PM. At 4 PM rash had begun to fade. Pt demanded to leave office at 4 PM, advised to go to ER if any untreated effects. Pt has been seen in office since. No further ill effects occurred after vaccination.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Pt developed miliary rash on face. He had no lymphadenopathy, fever, or any other signs of rubella.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Mother noted large area of inflammation at site of vax 24 hours after they were given. Pt had a 6 x 6.5 cm area of redness, warmth, tenderness and induration. She was started on Ilosone and Motrin.
Age: 14.0
Sex: M
Vaccine: HEPA, TTOX
Symptoms: Chills, Headache, Muscle spasms, Myalgia, Photosensitivity reaction
Clinical narrative: Wthin 12 hours post vax, pt developed a fever of 101, extreme muscle aches and spasms, chills, headache and light sensitivity. He was treated with Motrin and cool bath to bring fever down. Symptoms lasted 3 days.
Age: 14.0
Sex: M
Vaccine: HEPA, TTOX
Symptoms: Pyrexia
Clinical narrative: Wthin 12 hours post vax, pt developed a fever of 101, extreme muscle aches and spasms, chills, headache and light sensitivity. He was treated with Motrin and cool bath to bring fever down. Symptoms lasted 3 days.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Hypersensitivity, Injection site hypersensitivity, Nasopharyngitis, Pain
Clinical narrative: Later on in the day of receiving vax, pt's whole arm began to ache. One hour later, the arm began to itch below the injection site. The next day, pt felt like a cold was starting, she had a nonproductive cough which lasted 5 days. Pt saw MD on Friday 11/16 and MD said she had an allergic reaction to PPV. MD treated pt with Iophen DM liquid cough medicine and Avelox.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus
Clinical narrative: Later on in the day of receiving vax, pt's whole arm began to ache. One hour later, the arm began to itch below the injection site. The next day, pt felt like a cold was starting, she had a nonproductive cough which lasted 5 days. Pt saw MD on Friday 11/16 and MD said she had an allergic reaction to PPV. MD treated pt with Iophen DM liquid cough medicine and Avelox.
Age: 59.0
Sex: F
Vaccine: HEP, HEPA, IPV
Symptoms: Anorexia, Dizziness, Nausea
Clinical narrative: Pt developed dizziness, nausea and anorexia.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within an hour of receiving vax, pt's right arm, from injection site to elbow and 2" above injection site, became red, swollen, painful (could not lift arm) and warm. After 2 hours, pt noted to have a pink line running from armpit down to elbow. Pt was seen on 11/3/01 and given an injection of Cephalosporin and a prescription for antibiotics. She was instructed to follow up with her MD if condition worsened. On 11/5/01, the swelling and redness improved, but pt had a knot at the injection site and it was still tender to touch. Pt had a previous dose of the pneumonia 23 vax in 1994 with no reaction reported.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Joint range of motion decreased
Clinical narrative: Within an hour of receiving vax, pt's right arm, from injection site to elbow and 2" above injection site, became red, swollen, painful (could not lift arm) and warm. After 2 hours, pt noted to have a pink line running from armpit down to elbow. Pt was seen on 11/3/01 and given an injection of Cephalosporin and a prescription for antibiotics. She was instructed to follow up with her MD if condition worsened. On 11/5/01, the swelling and redness improved, but pt had a knot at the injection site and it was still tender to touch. Pt had a previous dose of the pneumonia 23 vax in 1994 with no reaction reported.
Age: 0.8
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Pt developed rash, erythema and urticaria.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: On 11/18/01, pt developed pruritic rash on face, extremities and trunk. Pt was afebrile.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Swelling face, Urticaria
Clinical narrative: Thirty minutes post vax, pt developed facial swelling and hives. She was referred to ER and treated with Prelone and Benadryl.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Ocular hyperaemia, Sneezing, Wheezing
Clinical narrative: Post vax, pt noted to be sneezing with red eyes and wheezing. Pt was treated with epi and Ventolin updraft with good results.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Discomfort, Neck pain, Oedema, Parotitis
Clinical narrative: Eight days post vax, pt presented to office with right unilateral parotitis. Pt had discomfort related to edema. Pt had questionable pain referred to mandible and right neck.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Infection, Rash
Clinical narrative: Pt developed a rash approximately 48 hours post MMR. Pt was seen in MD office on 11/16/01 with a rash consistent with German measles. The rash had started caudally. Pt was afebrile and looked good.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria, Urticaria
Clinical narrative: Pt developed localized erythema with 2 small urticarial lesions within 5 mins of receiving vax. She developed 2 additional lesions on back 15 minutes post vax. She was given 20mg Benadryl.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pruritus, Rash morbilliform
Clinical narrative: One day post vax, pt noted to have swelling at injection site. Then pt developed hives and redness which became generalized from head to feet. Pt was slightly pruritic. Conjunctivae was not involved. On 11/21/01,  pt noted to have hives at injection site and a 2 x 3 cm area of erythema along with generalized hives. The hives were somewhat morbilliform-like.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: One day post vax, pt noted to have swelling at injection site. Then pt developed hives and redness which became generalized from head to feet. Pt was slightly pruritic. Conjunctivae was not involved. On 11/21/01,  pt noted to have hives at injection site and a 2 x 3 cm area of erythema along with generalized hives. The hives were somewhat morbilliform-like.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Purpura, Pyrexia, Rash, Rash macular
Clinical narrative: On 10/20/2001 pt had rash, fever, diagnosis: fever, UTI. Treatment: Amoxil. On 10/20/2001, ER: "whelps". On 10/22/2001, pt had fever, hives, leg pain. Diagnosis: urticaria and viral illness. On 10/25/2001, pt had rash, enlarged tonsils (strep neg.). Diagnosis: viral xanthum. On 10/30/2001, pt had rash, leg aches, ASD negative, CBC-wnl, Sednate 25. Diagnosis: rash and arthralgia. Treatment: Duracef and Motrin.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash maculo-papular, Rheumatoid factor, Skin exfoliation, Urinary tract infection, Urticaria
Clinical narrative: On 10/20/2001 pt had rash, fever, diagnosis: fever, UTI. Treatment: Amoxil. On 10/20/2001, ER: "whelps". On 10/22/2001, pt had fever, hives, leg pain. Diagnosis: urticaria and viral illness. On 10/25/2001, pt had rash, enlarged tonsils (strep neg.). Diagnosis: viral xanthum. On 10/30/2001, pt had rash, leg aches, ASD negative, CBC-wnl, Sednate 25. Diagnosis: rash and arthralgia. Treatment: Duracef and Motrin.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vomiting
Clinical narrative: On 10/20/2001 pt had rash, fever, diagnosis: fever, UTI. Treatment: Amoxil. On 10/20/2001, ER: "whelps". On 10/22/2001, pt had fever, hives, leg pain. Diagnosis: urticaria and viral illness. On 10/25/2001, pt had rash, enlarged tonsils (strep neg.). Diagnosis: viral xanthum. On 10/30/2001, pt had rash, leg aches, ASD negative, CBC-wnl, Sednate 25. Diagnosis: rash and arthralgia. Treatment: Duracef and Motrin.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Arthralgia, Pyrexia, Rash, Urinary tract infection, Urticaria
Clinical narrative: On 10/20/2001 pt had rash, fever, diagnosis: fever, UTI. Treatment: Amoxil. On 10/20/2001, ER: "whelps". On 10/22/2001, pt had fever, hives, leg pain. Diagnosis: urticaria and viral illness. On 10/25/2001, pt had rash, enlarged tonsils (strep neg.). Diagnosis: viral xanthum. On 10/30/2001, pt had rash, leg aches, ASD negative, CBC-wnl, Sednate 25. Diagnosis: rash and arthralgia. Treatment: Duracef and Motrin.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Viral infection
Clinical narrative: On 10/20/2001 pt had rash, fever, diagnosis: fever, UTI. Treatment: Amoxil. On 10/20/2001, ER: "whelps". On 10/22/2001, pt had fever, hives, leg pain. Diagnosis: urticaria and viral illness. On 10/25/2001, pt had rash, enlarged tonsils (strep neg.). Diagnosis: viral xanthum. On 10/30/2001, pt had rash, leg aches, ASD negative, CBC-wnl, Sednate 25. Diagnosis: rash and arthralgia. Treatment: Duracef and Motrin.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Abnormal behaviour, Aphasia, Neurodevelopmental disorder, Social avoidant behaviour, Vaccination complication
Clinical narrative: An attorney reported that an 18 month old male received his 5th dose of Acel-Imune, 4th dose of Hib-Titer and his 3rd dose of Orimune on 10/28/1996. In 1/97, at 20 months of age, the child allegedly "began to display symptoms of neurological damage consistent with mercury poisoning" which resulted in "permanent injuries". The reporter described those symptoms as "regression of his language skills, engaging in repetitive behavior, suffering from diminished cognitive ability and becoming socially withdrawn". The reporter attributed these events to the presence of thimerosal. CANCELLED: Upon further review it was determined that this patient received Tri-Immunol vaccine. See MCN HQB948028NOV2001 which will remains the case of record.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Abnormal behaviour, Aphasia, Cognitive disorder, Drug toxicity, Neurological symptom
Clinical narrative: An attorney reported that an 18 month old male received his 5th dose of Acel-Imune, 4th dose of Hib-Titer and his 3rd dose of Orimune on 10/28/1996. In 1/97, at 20 months of age, the child allegedly "began to display symptoms of neurological damage consistent with mercury poisoning" which resulted in "permanent injuries". The reporter described those symptoms as "regression of his language skills, engaging in repetitive behavior, suffering from diminished cognitive ability and becoming socially withdrawn". The reporter attributed these events to the presence of thimerosal. CANCELLED: Upon further review it was determined that this patient received Tri-Immunol vaccine. See MCN HQB948028NOV2001 which will remains the case of record.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Social avoidant behaviour
Clinical narrative: An attorney reported that an 18 month old male received his 5th dose of Acel-Imune, 4th dose of Hib-Titer and his 3rd dose of Orimune on 10/28/1996. In 1/97, at 20 months of age, the child allegedly "began to display symptoms of neurological damage consistent with mercury poisoning" which resulted in "permanent injuries". The reporter described those symptoms as "regression of his language skills, engaging in repetitive behavior, suffering from diminished cognitive ability and becoming socially withdrawn". The reporter attributed these events to the presence of thimerosal. CANCELLED: Upon further review it was determined that this patient received Tri-Immunol vaccine. See MCN HQB948028NOV2001 which will remains the case of record.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Feeling hot, Lethargy, Myalgia, Polyarthritis
Clinical narrative: Pt was given a repeat series of Hep-B vaccine in preparation for a liver transplant. This ADR (adverse drug reaction) occurred following the 2nd injection of the repeat series. Symptoms included: fever to 102.7F, polyarthritis, warm and red knee and ankle joints, myalgias and lethargy.
Age: 58.0
Sex: F
Vaccine: HEP
Symptoms: Pyrexia
Clinical narrative: Pt was given a repeat series of Hep-B vaccine in preparation for a liver transplant. This ADR (adverse drug reaction) occurred following the 2nd injection of the repeat series. Symptoms included: fever to 102.7F, polyarthritis, warm and red knee and ankle joints, myalgias and lethargy.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Headache
Clinical narrative: Approx. 1 3/4 hours, post vax, the pt called the Pharmacy complaining of severe headache and chest tightness. The pt was counseled to take a dose of oral Benadryl if available and seek immediate medical attention at a medical facility. She was treated and released at the ER by a physician.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: On 11/9/01, pt had a red area on right arm at injection site that was painful. On 11/9/01 and 11/10/01 he had nausea and 1 episode of vomiting. On 11/10/01, he had a numb sensation on right forearm and a burning on right foot. On 11/12/01, the red area was 8cm in diameter. He also had a fever of 101.2F on 11/9/01. Pt is improving. By 11/12/01, all was resolved.
Age: 50.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Skin burning sensation, Vomiting
Clinical narrative: On 11/9/01, pt had a red area on right arm at injection site that was painful. On 11/9/01 and 11/10/01 he had nausea and 1 episode of vomiting. On 11/10/01, he had a numb sensation on right forearm and a burning on right foot. On 11/12/01, the red area was 8cm in diameter. He also had a fever of 101.2F on 11/9/01. Pt is improving. By 11/12/01, all was resolved.
Age: 66.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia
Clinical narrative: This report has not been verified by a physician or other healthcare professional.  Medical history, concurrent medications were not specified. The pt reported that he received 3 injections of Lymerix. the 1st injection was given in 1999, and the last one was given in 2000, exact dates of of IZ's not reported. In July or August of 2001, the vaccinee reportedly he began to experience burning pain in the joints of his left hand. He then experienced the burning joint pain in his left elbow, right toe, and right knee. The vaccinee reported that he has not sought medical attention for the burning joint pain persisted as of 11/14/2001. the adverse event of burning pain in the joints does not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per 06/28/2000 letter.
Age: 0.25
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Erythema, Rash macular
Clinical narrative: Immediately, post vax, infant developed "erythematous blotches" on head, neck, hands and lower legs. PMD's office closed so infant was sent to the hospital. "Fast Track".
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt had significant swelling of the arm with warmth and erythema. Left arm circumference 23 1/2cm and right arm circumference 19cm. Redness over most of upper right arm 18cm X 14cm in size.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain
Clinical narrative: The day after receiving vax, pt developed an erythematous, swollen, painful arm. He was prescribed warm compresses and elevation.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt complained of swollen and painful arm. Prescribed Benadryl by on-call MD. Improved by AM of 11/21/01.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Purpura, Pyrexia, Rash, Rash macular
Clinical narrative: Rec'd varicella 9/20 - 10 days later 9/30 pt broke out with spots on her stomach (looked like red dots above the skin. 10/7/01 red dots faded, but blotches appeared under the skin on her arms, 10/10/01 vomited for 24 hrs, 10/19/01 fever 101F,11/20/01 was seen by physician at Clinic with rash on arms and legs diagnosed with UTI, Rx Amoxil 250/5cc. 10/22/01 seen at Clinic fever for 3 days with hives. Complained of leg pains. 10/23/-10/30/01 child continued to have rash. Worse in groin and buttocks area. Skin peeled from area. 10/30/01 rash and leg pain continued. Seen at clinic pt's calves and legs looked like purpura. Grandmother made appointment with Dr for 11/8/01. Between 10/30-11/08/01 pt continued with leg pain, rashes and skin peeling, 11/8 saw Dr, rash continued on back of legs. Dr performed a multitude of blood tests. All test came back negative except for ANA (Rheumatoid/Purpura. Referred pt to a rheumatologist. 11/19/01 saw Rheumatologist. Skin continued to peel (hands and feet). Rash gone but skin dry and looks like eczema, Dr said looks like some kind of reaction. Prescribed hydrocortisone cream.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Rash maculo-papular, Rheumatoid factor, Skin exfoliation, Urinary tract infection, Urticaria
Clinical narrative: Rec'd varicella 9/20 - 10 days later 9/30 pt broke out with spots on her stomach (looked like red dots above the skin. 10/7/01 red dots faded, but blotches appeared under the skin on her arms, 10/10/01 vomited for 24 hrs, 10/19/01 fever 101F,11/20/01 was seen by physician at Clinic with rash on arms and legs diagnosed with UTI, Rx Amoxil 250/5cc. 10/22/01 seen at Clinic fever for 3 days with hives. Complained of leg pains. 10/23/-10/30/01 child continued to have rash. Worse in groin and buttocks area. Skin peeled from area. 10/30/01 rash and leg pain continued. Seen at clinic pt's calves and legs looked like purpura. Grandmother made appointment with Dr for 11/8/01. Between 10/30-11/08/01 pt continued with leg pain, rashes and skin peeling, 11/8 saw Dr, rash continued on back of legs. Dr performed a multitude of blood tests. All test came back negative except for ANA (Rheumatoid/Purpura. Referred pt to a rheumatologist. 11/19/01 saw Rheumatologist. Skin continued to peel (hands and feet). Rash gone but skin dry and looks like eczema, Dr said looks like some kind of reaction. Prescribed hydrocortisone cream.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Vomiting
Clinical narrative: Rec'd varicella 9/20 - 10 days later 9/30 pt broke out with spots on her stomach (looked like red dots above the skin. 10/7/01 red dots faded, but blotches appeared under the skin on her arms, 10/10/01 vomited for 24 hrs, 10/19/01 fever 101F,11/20/01 was seen by physician at Clinic with rash on arms and legs diagnosed with UTI, Rx Amoxil 250/5cc. 10/22/01 seen at Clinic fever for 3 days with hives. Complained of leg pains. 10/23/-10/30/01 child continued to have rash. Worse in groin and buttocks area. Skin peeled from area. 10/30/01 rash and leg pain continued. Seen at clinic pt's calves and legs looked like purpura. Grandmother made appointment with Dr for 11/8/01. Between 10/30-11/08/01 pt continued with leg pain, rashes and skin peeling, 11/8 saw Dr, rash continued on back of legs. Dr performed a multitude of blood tests. All test came back negative except for ANA (Rheumatoid/Purpura. Referred pt to a rheumatologist. 11/19/01 saw Rheumatologist. Skin continued to peel (hands and feet). Rash gone but skin dry and looks like eczema, Dr said looks like some kind of reaction. Prescribed hydrocortisone cream.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Arthralgia, Pyrexia, Rash, Urinary tract infection, Urticaria
Clinical narrative: Rec'd varicella 9/20 - 10 days later 9/30 pt broke out with spots on her stomach (looked like red dots above the skin. 10/7/01 red dots faded, but blotches appeared under the skin on her arms, 10/10/01 vomited for 24 hrs, 10/19/01 fever 101F,11/20/01 was seen by physician at Clinic with rash on arms and legs diagnosed with UTI, Rx Amoxil 250/5cc. 10/22/01 seen at Clinic fever for 3 days with hives. Complained of leg pains. 10/23/-10/30/01 child continued to have rash. Worse in groin and buttocks area. Skin peeled from area. 10/30/01 rash and leg pain continued. Seen at clinic pt's calves and legs looked like purpura. Grandmother made appointment with Dr for 11/8/01. Between 10/30-11/08/01 pt continued with leg pain, rashes and skin peeling, 11/8 saw Dr, rash continued on back of legs. Dr performed a multitude of blood tests. All test came back negative except for ANA (Rheumatoid/Purpura. Referred pt to a rheumatologist. 11/19/01 saw Rheumatologist. Skin continued to peel (hands and feet). Rash gone but skin dry and looks like eczema, Dr said looks like some kind of reaction. Prescribed hydrocortisone cream.
Age: 3.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Viral infection
Clinical narrative: Rec'd varicella 9/20 - 10 days later 9/30 pt broke out with spots on her stomach (looked like red dots above the skin. 10/7/01 red dots faded, but blotches appeared under the skin on her arms, 10/10/01 vomited for 24 hrs, 10/19/01 fever 101F,11/20/01 was seen by physician at Clinic with rash on arms and legs diagnosed with UTI, Rx Amoxil 250/5cc. 10/22/01 seen at Clinic fever for 3 days with hives. Complained of leg pains. 10/23/-10/30/01 child continued to have rash. Worse in groin and buttocks area. Skin peeled from area. 10/30/01 rash and leg pain continued. Seen at clinic pt's calves and legs looked like purpura. Grandmother made appointment with Dr for 11/8/01. Between 10/30-11/08/01 pt continued with leg pain, rashes and skin peeling, 11/8 saw Dr, rash continued on back of legs. Dr performed a multitude of blood tests. All test came back negative except for ANA (Rheumatoid/Purpura. Referred pt to a rheumatologist. 11/19/01 saw Rheumatologist. Skin continued to peel (hands and feet). Rash gone but skin dry and looks like eczema, Dr said looks like some kind of reaction. Prescribed hydrocortisone cream.
Age: 1.3
Sex: F
Vaccine: MMR
Symptoms: Convulsion, Febrile convulsion, Pyrexia, Rash
Clinical narrative: Received MMR on 11/16/2001. return to clinic on 11/19/2001 complained of rash for one week on upper extremities. Treated with Benadryl. On 11/14/2001 called AM RN, mild fever 100, took Tylenol, see on clinic at same day 2 PM with fever 101, had seizure in clinic around 2:20 PM, pt also decreased response.
Age: 1.25
Sex: F
Vaccine: HBPV, MMR
Symptoms: Coordination abnormal, Laboratory test abnormal, Pyrexia, Rash
Clinical narrative: Ataxic event lasting 30 minutes 10 days following vaccine. Developed fever and rash. Now (11/23/2001) doing well.
Sex: F
Vaccine: PNC
Symptoms: White blood cell count increased
Clinical narrative: A physician reported that her 6 month old granddaughter received Prevnar in 11/01. Two weeks, post vax, on 11/7/01, the infant developed an "elevated white count (22,000)". She was treated in the ER with IV fluids. No additional information was available as of the date of this report. This case was considered serious since the event of an elevated white blood cell count was considered "Medically Important" in this case.
Sex: M
Vaccine: PPV
Symptoms: Bacterial infection, Drug ineffective, HIV test positive
Clinical narrative: It was reported that a male pt who was HIV (+) was vaccinated with a dose of pneumococcal vaccine 23 polyvalent. The pt was also receiving monthly injections of IM, immune serum globulin. Subsequently, the pt experienced vaccine failure and approx. 1 year, post vax, he presented to the hospital with pneumococcal bacteremia. On the basis of a review of blood culture logs at the hospital microbiology lab and of the infectious disease service consultation log between 5/89 and 3/91, it was noted that the clinical course and serotype-specific functional humoral response to S. pneumoniae in 16 HIV-infected pts with pneumococcal bacteremia, and that there was no history of either pneumococcal infection or immunization in any of the 13 pts. No details about the serotype of the organism and immune status of the host were provided. It was noted that sera obtained from HIV (-) adults vaccinated with a 23-valent vaccine showed increased in vitro killing activity against certain S. pneumoniae isotypes when compared with the sera of HIV (+) pts with actual pneumococcal infections. It was noted that although serologic dx may be unreliable in HIV-infected persons, no pt tested showed serologic evidence of recent viral infection. In conclusion, the findings suggested that the high rates of cells and impaired humoral responses to S. pneumoniae rather than to increased exposure to the organism. The report did not state the outcome of the pt's experience. No further information is available.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with varicella virus vaccine live. Subsequently, 30 seconds after receiving the vaccination the pt developed a seizure. The pt had been up all night prior and had drunk large quantities of coffee. the pt was taken by ambulance to an ER but it was unknown if the pt was admitted to the hospital. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: DTAP
Symptoms: Autism, Restlessness, Sleep disorder, Upper respiratory tract infection
Clinical narrative: The child received his 4th injection of Infanrix on 10/7/99. On 11/24/99, 48 days post vax, he reportedly experienced an upper respiratory tract infection. His mother reported that he stopped sleeping at night and became very restless. He then "regressed into autism". As of 11/15/01, the autism was ongoing. Outcome of the upper respiratory tract infection was not specified. This report of autism is considered "medically Serious". The mother reported that the pt received Infanrix from lot DTPA9909AZ; however, this is not a valid not number.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Injection site oedema, Injection site warmth
Clinical narrative: The patient experienced redness, warm to touch and slight swelling at the vaccine site in an area approximately 2 1/4" x 1 1/2" approximately 30 hours.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site oedema, Vasodilation procedure
Clinical narrative: Redness, warm to touch, slight swelling under vaccine site approximately 5"x2". No fever approximately 24 hours within injection.
Age: 13.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Oedema, Pain, Pyrexia, Vasodilation procedure
Clinical narrative: Left arm swelling, pain and heat at injection site. Fever. Some better today recovery.
Age: 1.75
Sex: M
Vaccine: FLU3
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Joint range of motion decreased
Clinical narrative: Large swelling and redness left detoid. Pt complains of discomfort. Not using arm as well as usual.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Myalgia
Clinical narrative: About 1 hours after shot given, arm started (aching whole arm) and up into neck, site of where shot was given, was red and hard knot (2-3 inches) arm and neck ached all day Saturday, seemed somewhat better, but still had large, red, knot. Accidently rubbed arm against clothes dryer and arm, neck, and back around left shoulder blade started hurting like a stiff neck, used icy hot and heating pad on back and neck helped a little. Neck, back and arm are still hurting today, but a little better.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Hyperhidrosis, Pyrexia, Tachycardia
Clinical narrative: Fever, sweating, fast heart beat dizziness.
Age: 71.0
Sex: M
Vaccine: PNC
Symptoms: Arthralgia, Injection site oedema
Clinical narrative: Soreness of immunization site within 1/2 hour after injection. Pt reports inability to move arm next day. Swelling of entire arm and hand.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Headache, Malaise, Pain, Pruritus
Clinical narrative: The patient started on 11/07 with a fever and headache which progressed over 9 days with malaise, hives, itching, fever up to 102F, body aches and coughing up to 9 days after the vaccine.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Urticaria
Clinical narrative: The patient started on 11/07 with a fever and headache which progressed over 9 days with malaise, hives, itching, fever up to 102F, body aches and coughing up to 9 days after the vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: The patient felt pain after the injection and had to lie down. It was several days until the whole body pain went away.
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain, Dizziness, Muscle spasms, Pain
Clinical narrative: The patient had generalized pain, cramps, abdominal pain and dizziness for about 2 weeks.
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Ear discomfort, Ear disorder, Headache
Clinical narrative: Post vax the patient's ears started popping, she felt dizzy, her equilibrium was off all weekend, middle ear was stuffed and she had pressure in the head areas.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Asthma, Cough, Dyspnoea, Injection site hypersensitivity
Clinical narrative: Post vax the patient stated the left deltoid was itching and red. The patient was treated with Benadryl. The patient also complained of tightness in her throat, a rash and shortness of breath. The patient became anxious, stated she needs air and wheezing started. The patient was treated with Albuterol Nebulizer. The patient's coughing decreased with the nebulizer treatment. The patient's chest and back were itching. The patient experienced hives on her neck and chest. The wheezing cleared and the patient's throat was dry.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Throat tightness, Urticaria
Clinical narrative: Post vax the patient stated the left deltoid was itching and red. The patient was treated with Benadryl. The patient also complained of tightness in her throat, a rash and shortness of breath. The patient became anxious, stated she needs air and wheezing started. The patient was treated with Albuterol Nebulizer. The patient's coughing decreased with the nebulizer treatment. The patient's chest and back were itching. The patient experienced hives on her neck and chest. The wheezing cleared and the patient's throat was dry.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: The patient developed a maculo-papular rash on her face 30 minutes after her Prevnar injection. The patient was treated with Varivax, comvax, and Atarax. The patient was treated with Atarax. T
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Screaming
Clinical narrative: Inconsolable crying lasting over 3 hours, within 48 hours of vaccines.
Age: 0.08
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Screaming
Clinical narrative: Inconsolable crying within 48 hours of vaccine, lasting over 3 hours.
Age: 0.5
Sex: F
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Crying, Screaming
Clinical narrative: Inconsolable crying starting several hours after vaccines. Lasting more than 3 hours.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Screaming
Clinical narrative: Inconsolable crying, starting hours after vaccines, lasting over 3 hours.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, MMR, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Urticaria-type rash on trunk, neck and cheeks. No wheezes or angioedema. Benadryl was given.
Age: 50.0
Sex: M
Vaccine: LYME
Symptoms: Pain
Clinical narrative: The vaccine was administered in May 1999, August 1999 and May 2000. Initial pain in hips started in November 1999 and then progressed to elbows, knees, right hand. Various doctors, Celebrex and now Vioxx, plus pain pills. Hip replacement scheduled for 12/20/2001. A follow up report received 1/28/2002 adds: Left hip replaced on 12/20/2001-righth hip will also be replaced. Cartilege in both hips destroyed in 2 years since taking vaccine. Pain is terrible.
Age: 49.0
Sex: F
Vaccine: LYME
Symptoms: Pain
Clinical narrative: After having my third shot of Lymerix vaccine, I developed severe pain in my left knee, 6 weeks later it was in my right knee. It is also now located in my right hip and the top my spine in the back of my neck. PCP and orthopedic surgeon visits.
Age: 16.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Epididymitis, Pain
Clinical narrative: Mother reported to PHN on 11/19/2001 that pt developed pain in scrotal-testicle area approximately 2 weeks after MMR given. Was seen by private MD and diagnosis made of "epididymitis". Mother reported MD did not fell this episode of epididymitis and MMR was related. Approximately 1 week later, pt developed "severe" joint pain and has been seen by several physicians. Presently being treated by MD at Hospital. Mother reported that pt has had blood work done, multiple appointments and presently receiving therapy and treatment due to continued joint pain. Was encouraged to complete adverse event report or call the 1-800 number.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Fevers with slight itchy rash on trunk, arms, face and scalp.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Mother called to report hives approximately 2 hours after Hepatitis B #1 given at Health Department. Seen by MD. Hives on neck, underarms, back and stomach. Treatment: Benadryl by MD. He signed a medical contraindication for no further Hepatitis B shots.
Age: 27.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR
Symptoms: Laboratory test abnormal, Unevaluable event
Clinical narrative: Female pt, unknowingly pregnant (missed menses by 14 days), was administered MMR vaccine on 12-NOV-2001. Referred to OB and Fetal Assessment Unit for follow up.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Heart rate increased, Pyrexia, Syncope, Vasodilation procedure
Clinical narrative: Approximately 20 minutes after injection, felt faint, had "tunnel vision", face got hot; rapid pulse. Started feeling better in one hour, but felt "drained" all day. Following day, temp 99.9 (oral), on 10/07/2001, temp 98. Did not go to ER or contact Dr.
Age: 42.0
Sex: F
Vaccine: TD
Symptoms: Visual field defect
Clinical narrative: Approximately 20 minutes after injection, felt faint, had "tunnel vision", face got hot; rapid pulse. Started feeling better in one hour, but felt "drained" all day. Following day, temp 99.9 (oral), on 10/07/2001, temp 98. Did not go to ER or contact Dr.
Age: 42.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Headache, Rash
Clinical narrative: Information has been received from an RN concerning a 42 year old female health care worker with "many allergies" and sensitivities to many drugs and no significant past medical history who on 4/4/01 was vaccinated with rubella virus vaccine live (second generation) since a rubella titer "showed no immunity". There was no concomitant medication. Eleven days, post vax, on 4/15/01, the pt woke up with itching, an extreme headache and presented with a rash. Upon arrival at work, the pt was sent to the ER for evaluation. The rash was dx'd as possible rubella. Lab studies were performed and the results were unavailable at the time of the report. The pt's outcome was unknown. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: RUB, RUB
Symptoms: Headache, Laboratory test abnormal, Pruritus, Rash, Viral infection
Clinical narrative: Information has been received from an RN concerning a 42 year old female health care worker with "many allergies" and sensitivities to many drugs and no significant past medical history who on 4/4/01 was vaccinated with rubella virus vaccine live (second generation) since a rubella titer "showed no immunity". There was no concomitant medication. Eleven days, post vax, on 4/15/01, the pt woke up with itching, an extreme headache and presented with a rash. Upon arrival at work, the pt was sent to the ER for evaluation. The rash was dx'd as possible rubella. Lab studies were performed and the results were unavailable at the time of the report. The pt's outcome was unknown. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Headache, Intracranial pressure increased, Irritability, Meningitis, Musculoskeletal stiffness
Clinical narrative: Pt began to complain on 10/4/01 of headache, stomach ache, nausea and vomiting. On 10/5/01, he was seen at a walk-in clinic. He complained of a stiff neck, headache and vomiting but on 10/21/01 was seen in ER for the same complaints. Mother states she was told "allergies and emotions". Then pt started complaining of "not being able to see" and was taken to optometrist. Referred to ER with edema. He was transferred to another hospital. He has lost complete sight in right eye and partial sight in left eye.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Nausea, Neuropathy, Optic atrophy, Pneumonia, Somnolence
Clinical narrative: Pt began to complain on 10/4/01 of headache, stomach ache, nausea and vomiting. On 10/5/01, he was seen at a walk-in clinic. He complained of a stiff neck, headache and vomiting but on 10/21/01 was seen in ER for the same complaints. Mother states she was told "allergies and emotions". Then pt started complaining of "not being able to see" and was taken to optometrist. Referred to ER with edema. He was transferred to another hospital. He has lost complete sight in right eye and partial sight in left eye.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Visual field defect, Vomiting
Clinical narrative: Pt began to complain on 10/4/01 of headache, stomach ache, nausea and vomiting. On 10/5/01, he was seen at a walk-in clinic. He complained of a stiff neck, headache and vomiting but on 10/21/01 was seen in ER for the same complaints. Mother states she was told "allergies and emotions". Then pt started complaining of "not being able to see" and was taken to optometrist. Referred to ER with edema. He was transferred to another hospital. He has lost complete sight in right eye and partial sight in left eye.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Abdominal pain upper, Blindness, Headache, Musculoskeletal stiffness, Nausea
Clinical narrative: Pt began to complain on 10/4/01 of headache, stomach ache, nausea and vomiting. On 10/5/01, he was seen at a walk-in clinic. He complained of a stiff neck, headache and vomiting but on 10/21/01 was seen in ER for the same complaints. Mother states she was told "allergies and emotions". Then pt started complaining of "not being able to see" and was taken to optometrist. Referred to ER with edema. He was transferred to another hospital. He has lost complete sight in right eye and partial sight in left eye.
Age: 10.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Oedema, Vomiting
Clinical narrative: Pt began to complain on 10/4/01 of headache, stomach ache, nausea and vomiting. On 10/5/01, he was seen at a walk-in clinic. He complained of a stiff neck, headache and vomiting but on 10/21/01 was seen in ER for the same complaints. Mother states she was told "allergies and emotions". Then pt started complaining of "not being able to see" and was taken to optometrist. Referred to ER with edema. He was transferred to another hospital. He has lost complete sight in right eye and partial sight in left eye.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Abnormal behaviour, Aphasia, Neurodevelopmental disorder, Social avoidant behaviour, Vaccination complication
Clinical narrative: In January 1997, at 20 months of age, pt allegedly "began to display symptoms of neurological damage consistent with mercury poisoning which resulted in permanent injuries." The reporter described those symptoms as "regression of his language skills, engaging in repetitive behaviors, suffering from diminished cognitive ability and becoming socially withdrawn." The reporter attributed these events to the presence of thimerosal.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Abnormal behaviour, Aphasia, Cognitive disorder, Drug toxicity, Neurological symptom
Clinical narrative: In January 1997, at 20 months of age, pt allegedly "began to display symptoms of neurological damage consistent with mercury poisoning which resulted in permanent injuries." The reporter described those symptoms as "regression of his language skills, engaging in repetitive behaviors, suffering from diminished cognitive ability and becoming socially withdrawn." The reporter attributed these events to the presence of thimerosal.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, OPV, DTP, HIBV, OPV
Symptoms: Social avoidant behaviour
Clinical narrative: In January 1997, at 20 months of age, pt allegedly "began to display symptoms of neurological damage consistent with mercury poisoning which resulted in permanent injuries." The reporter described those symptoms as "regression of his language skills, engaging in repetitive behaviors, suffering from diminished cognitive ability and becoming socially withdrawn." The reporter attributed these events to the presence of thimerosal.
Sex: M
Vaccine: HEP
Symptoms: Asphyxia, Injury
Clinical narrative: Information has been received from an RN concerning a 6 day old male relative who on 11/6/01 was vaccinated with Hep-B vaccine recombinant (yeast). On 11/10/01, the child died. The cause of death was unknown. Autopsy report states child's age at time of death to be 18 days old. Cause of death is traumatic compression of head and chest due to overlaying, manner of death accidental.