chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC, DTAP, HEP, HIBV, PNC
Symptoms: Cardiac arrest, Respiratory disorder, Sudden infant death syndrome
Clinical narrative: Information has been received from an investigator concerning a 15 month old male who received his first injection of Prevnar, his second injection of Recombivax-HB, and his third injection of Hib-Titer and Infanrix vaccines on 08/07/00. The child was found in his crib one morning not breathing and in cardiac arrest. The child was taken to a local emergency room where a heartbeat was re-established following a long code. The child was placed on a ventilator, but was unresponsive to light and painful stimuli. The patient was removed from the ventilator and died due to "SIDS-LIKE SYNDROME" on 01/11/01. Both the investigator and the medical monitor agree that this event was not related to vaccine administration. NOTE: This report is being submitted in a 15-day time frame as requested by FDA. F/U received on 4/25/02 from the study investigator contained autopsy results. The reported cause of death has been changed from "Sids-like syndrome" to "cardiorespiratory failure (cardio-respiratory arrest) secondary to possible sepsis, etiology unknown" as found upon autopsy. The investigator considered the event not related to vaccine administration.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Contusion, Petechiae, Platelet count decreased, Platelet production decreased, Pyrexia
Clinical narrative: On 02/14/01, the mother noticed the patient was really sluggish with fever. On 02/15/01, the patient began bruising by just touching things. On 02/16/01, the patient saw the MD. the patient was admitted to the hospital diagnosed with severe ITP crisis. The patient had severe petechiae all over his body. The patient was given 2 rounds of gamaglobin. Discharged on 02/19/01, from the hospital. The MD said he was unsure if S/P vaccines or maybe vaccine overload. He will be followed up in 1 year. The 60 day follow-up states the mother says that the child still has bruising and feeling sluggish. Lab was done 1 week ago (platelet count 70,000). Has appointment in Aug. with pediatric oncologist. If platlet count is still low will do bone marrow aspiration. The follow up received on 6/2/01 states "our first OV with pt was 2/16/0. Pt has not been given any vaccinations in this office."
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Sluggishness, Thrombocytopenic purpura
Clinical narrative: On 02/14/01, the mother noticed the patient was really sluggish with fever. On 02/15/01, the patient began bruising by just touching things. On 02/16/01, the patient saw the MD. the patient was admitted to the hospital diagnosed with severe ITP crisis. The patient had severe petechiae all over his body. The patient was given 2 rounds of gamaglobin. Discharged on 02/19/01, from the hospital. The MD said he was unsure if S/P vaccines or maybe vaccine overload. He will be followed up in 1 year. The 60 day follow-up states the mother says that the child still has bruising and feeling sluggish. Lab was done 1 week ago (platelet count 70,000). Has appointment in Aug. with pediatric oncologist. If platlet count is still low will do bone marrow aspiration. The follow up received on 6/2/01 states "our first OV with pt was 2/16/0. Pt has not been given any vaccinations in this office."
Age: 6.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abnormal behaviour, Autism, Speech disorder
Clinical narrative: After watching some past videos, I believe my child had a reaction to the MMR vaccine he was given on 12/11/95. By the following December of 1996, we were having his hearing tested, due to an obvious language delay. Within months, we learned he had autism. He was officially dx'd as autistic in 10/98. There was a noticeable difference in behavior by 12/25/95 and we make reference on tape of how sick he had been earlier thus making me believe now, that he had a reaction. 60 day follow-up states the pt still has autism and he has been tested for heavy metals and the level of mercury is 8.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Anuria, Asthenia, Bacterial infection, Cerebral infarction, Hypotension
Clinical narrative: Information has been received from a physician concerning an adult female who was vaccinated on 11/15/90. In January 2001, the patient experienced pneumococcal sepsis. The patient was admitted to the hospital on approximately 01/19/01. She was diagnosed with pneumococcal sepsis of 9N followed by pneumothorax. The patient was placed on a ventilator for one week. She experienced kidney shut down. She experienced no urinary output for 36 hours. Blood pressure was 30/0. There was a secondary diagnosis of lupus. The patient was receiving large doses of Prednisone. The patient was very weak. An anticipated date of discharge was unknown. The patient's symptoms persisted at the time of the report, and she remained hospitalized. It was reported she would require extensive rehabilitation. No further information is available. Follow-up from a physician concerning an adult female "in her 30's" who in 11/99 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629633/1993H). The pt had received pneumococcal vaccine 23 polyvalent (Pnu-Imune, lot 285908) on 11/15/90. On approx. 1/17/01, the pt was seen as an outpt for wheezing and asthma and was treated with pulse steroids. On approx. 1/19/01, she was admitted to the hospital with bacterial sepsis. She was very hypotensive in the ER with a systolic blood pressure in the 30's. She was treated with dobutamine and dopamine. The pt's symptoms persisted at the time of the report and she remained hospitalized. It was reported she would require extensive rehabilitation. Follow-up was received which indicated she was extubated and discharged to a nursing rehabilitation facility on approx. 2/13/01. The pt was improving very slowly with no use of her legs at this point and only functional use of her upper extremities. The bacterial sepsis was found to be secondary to S. pneumoniae type 9N. No further information is available.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Hypoxia, Pneumothorax, Renal failure, Sepsis, Systemic lupus erythematosus
Clinical narrative: Information has been received from a physician concerning an adult female who was vaccinated on 11/15/90. In January 2001, the patient experienced pneumococcal sepsis. The patient was admitted to the hospital on approximately 01/19/01. She was diagnosed with pneumococcal sepsis of 9N followed by pneumothorax. The patient was placed on a ventilator for one week. She experienced kidney shut down. She experienced no urinary output for 36 hours. Blood pressure was 30/0. There was a secondary diagnosis of lupus. The patient was receiving large doses of Prednisone. The patient was very weak. An anticipated date of discharge was unknown. The patient's symptoms persisted at the time of the report, and she remained hospitalized. It was reported she would require extensive rehabilitation. No further information is available. Follow-up from a physician concerning an adult female "in her 30's" who in 11/99 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629633/1993H). The pt had received pneumococcal vaccine 23 polyvalent (Pnu-Imune, lot 285908) on 11/15/90. On approx. 1/17/01, the pt was seen as an outpt for wheezing and asthma and was treated with pulse steroids. On approx. 1/19/01, she was admitted to the hospital with bacterial sepsis. She was very hypotensive in the ER with a systolic blood pressure in the 30's. She was treated with dobutamine and dopamine. The pt's symptoms persisted at the time of the report and she remained hospitalized. It was reported she would require extensive rehabilitation. Follow-up was received which indicated she was extubated and discharged to a nursing rehabilitation facility on approx. 2/13/01. The pt was improving very slowly with no use of her legs at this point and only functional use of her upper extremities. The bacterial sepsis was found to be secondary to S. pneumoniae type 9N. No further information is available.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Information has been received from a physician concerning an adult female who was vaccinated on 11/15/90. In January 2001, the patient experienced pneumococcal sepsis. The patient was admitted to the hospital on approximately 01/19/01. She was diagnosed with pneumococcal sepsis of 9N followed by pneumothorax. The patient was placed on a ventilator for one week. She experienced kidney shut down. She experienced no urinary output for 36 hours. Blood pressure was 30/0. There was a secondary diagnosis of lupus. The patient was receiving large doses of Prednisone. The patient was very weak. An anticipated date of discharge was unknown. The patient's symptoms persisted at the time of the report, and she remained hospitalized. It was reported she would require extensive rehabilitation. No further information is available. Follow-up from a physician concerning an adult female "in her 30's" who in 11/99 was vaccinated with pneumococcal vaccine 23 polyvalent (lot 629633/1993H). The pt had received pneumococcal vaccine 23 polyvalent (Pnu-Imune, lot 285908) on 11/15/90. On approx. 1/17/01, the pt was seen as an outpt for wheezing and asthma and was treated with pulse steroids. On approx. 1/19/01, she was admitted to the hospital with bacterial sepsis. She was very hypotensive in the ER with a systolic blood pressure in the 30's. She was treated with dobutamine and dopamine. The pt's symptoms persisted at the time of the report and she remained hospitalized. It was reported she would require extensive rehabilitation. Follow-up was received which indicated she was extubated and discharged to a nursing rehabilitation facility on approx. 2/13/01. The pt was improving very slowly with no use of her legs at this point and only functional use of her upper extremities. The bacterial sepsis was found to be secondary to S. pneumoniae type 9N. No further information is available.
Age: 3.0
Sex: M
Vaccine: PNC
Symptoms: Gait disturbance, Injection site induration, Injection site pain, Pyrexia, Urticaria
Clinical narrative: Temperature of 102F since injection on 1/9/01 and leg pain. Small amount of induration on left upper thigh but no erythema. Walks with limp. Had hives in office on 1/11/01.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Bacterial infection, Diarrhoea, Erythema, Injection site erythema, Injection site pain
Clinical narrative: One day, post vax, fever started, swollen glands. Peak fever of 105F on 1/26/01 but glands better. Vomiting and diarrhea for 3 days. On 1/26/01, testicles/leg/thigh were bright red and swollen from knee to groin and tender. Redness traveled up to chest. Advised to be seen at local clinic. Started on Duricef because of questionable infection from injection site on right leg. Had temperature 103F and was given ibuprofen. On 1/29/01, still fussy with increased sleeping but doing better. Occasional runny stool, tolerating liquids and leg is better; no red streaking. Scrotum still slightly streaked but swelling down. On 2/1/01, 9 days, post vax, rash started with red splotches on legs and back; fever to 101-102F, lasting intermittently, for 3 days.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site swelling, Irritability, Lymphadenopathy, Pyrexia, Rash maculo-papular
Clinical narrative: One day, post vax, fever started, swollen glands. Peak fever of 105F on 1/26/01 but glands better. Vomiting and diarrhea for 3 days. On 1/26/01, testicles/leg/thigh were bright red and swollen from knee to groin and tender. Redness traveled up to chest. Advised to be seen at local clinic. Started on Duricef because of questionable infection from injection site on right leg. Had temperature 103F and was given ibuprofen. On 1/29/01, still fussy with increased sleeping but doing better. Occasional runny stool, tolerating liquids and leg is better; no red streaking. Scrotum still slightly streaked but swelling down. On 2/1/01, 9 days, post vax, rash started with red splotches on legs and back; fever to 101-102F, lasting intermittently, for 3 days.
Age: 1.3
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Scrotal oedema, Scrotal pain, Vomiting
Clinical narrative: One day, post vax, fever started, swollen glands. Peak fever of 105F on 1/26/01 but glands better. Vomiting and diarrhea for 3 days. On 1/26/01, testicles/leg/thigh were bright red and swollen from knee to groin and tender. Redness traveled up to chest. Advised to be seen at local clinic. Started on Duricef because of questionable infection from injection site on right leg. Had temperature 103F and was given ibuprofen. On 1/29/01, still fussy with increased sleeping but doing better. Occasional runny stool, tolerating liquids and leg is better; no red streaking. Scrotum still slightly streaked but swelling down. On 2/1/01, 9 days, post vax, rash started with red splotches on legs and back; fever to 101-102F, lasting intermittently, for 3 days.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Blood culture, C-reactive protein increased, Culture urine, Granulocyte percentage, Leukocytosis
Clinical narrative: Child had fever of 103F, the same day. Was evaluated in office on 2/16/01 and had leukocytosis on that day. Her WBC were 27,000. A blood culture, urine culture/analysis and CRP were done. She received Rocephin IM on 2/16/01 and 2/17/01. On 2/19/01 her WBC were 8.9.
Age: 3.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Urine analysis normal, White blood cell count
Clinical narrative: Child had fever of 103F, the same day. Was evaluated in office on 2/16/01 and had leukocytosis on that day. Her WBC were 27,000. A blood culture, urine culture/analysis and CRP were done. She received Rocephin IM on 2/16/01 and 2/17/01. On 2/19/01 her WBC were 8.9.
Age: 2.0
Sex: M
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Pyrexia, Viral infection
Clinical narrative: ER visit on 1/30/01 at 19:00. Temperature was 105.9F (R). Doctor state may be from viral infection. He did have Advil on 1/29/01 and 1/30/01 for low-grade fever. Had temperature increase until 2/2/01 with no other symptoms.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Nausea, Oral mucosal blistering, Vomiting
Clinical narrative: Pt reports having a headache X 2 days, then nausea and vomiting X 1 day. Pt reports she was afebrile. Pt also reports an outbreak of fever blisters. Pt feel weak now. Pt encouraged to see MD for continued weakness.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Chest pain, Pericarditis
Clinical narrative: Approx. 2 days, post vax, the pt reached down to pick up child and felt a popping sensation. Resulted in pericarditis possibly. Fluid between lung and chest wall (left). Signs and symptoms continued: Hurts when you supine. Placed on steroids and Vioxx. Pain through my rib cage on left side. Amoxicillin on 2/20/01.
Age: 71.0
Sex: F
Vaccine: HEPA, IPV, TTOX, TYP
Symptoms: Angioneurotic oedema, Injection site erythema, Injection site oedema, Injection site warmth, Pruritus
Clinical narrative: The pt reports that within 24 hours the left arm was swollen, hot and red from the elbow to the shoulder, "one huge hive" and extreme itching. The family MD was not available and the Pt went to the ER. Treated with Prednisone and Atarax for itching.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTP, MMR, VARCEL
Symptoms: Blister, Drug ineffective, Headache, Infection, Pharyngolaryngeal pain
Clinical narrative: The pt was diagnosed with Varicella on 4/25/00, sore throat, headache, fever, blisters (2) on trunk, (1) on arm exposed to chicken pox 10 days prior.  (Clusters of blisters) more than 20.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTP, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: The pt was diagnosed with Varicella on 4/25/00, sore throat, headache, fever, blisters (2) on trunk, (1) on arm exposed to chicken pox 10 days prior.  (Clusters of blisters) more than 20.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTP, MMR, VARCEL
Symptoms: Decreased appetite, Headache, Infection, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: The pt was diagnosed with Varicella on 4/25/00, sore throat, headache, fever, blisters (2) on trunk, (1) on arm exposed to chicken pox 10 days prior.  (Clusters of blisters) more than 20.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR, VARCEL, DTP, MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: The pt was diagnosed with Varicella on 4/25/00, sore throat, headache, fever, blisters (2) on trunk, (1) on arm exposed to chicken pox 10 days prior.  (Clusters of blisters) more than 20.
Age: 31.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: 24 hours post vax, the pt developed hives on her neck, stomach, and thighs. Treated with Benadryl.
Age: 1.5
Sex: F
Vaccine: DTAP, HEP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site oedema, Pruritus
Clinical narrative: On 2/6/01 the pt's right thigh developed swelling and redness, an area of bruising and some itching. No apparent discomfort, bruising, rash or reddened area is raised right thigh swelling. Mom states also hx of eczema. Advised to try cool compresses to right thigh. Also advised to consult with physician.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Alopecia, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: One day post vax the pt's left upper arm was red, hard, with quarter-sized lump and warm to the touch. Swelling, warmth and the hardness progressed. On 2/5/01 the left upper arm redness and swelling was the size of 3 silver dollars, still warm, hard. No fever was noted. On 2/7/01, mom noticed the child's hair was falling out in clumps.
Age: 41.0
Sex: M
Vaccine: RAB
Symptoms: Arthralgia, Fatigue, Nausea, Pruritus, Urticaria
Clinical narrative: The pt experienced itching skin on 2/2/01 and that evening started to break out in hives. States took 2 doses of Benadryl with some relief. States by 2/3/02 morning the whole body was covered with hives and went to the ER. Was given 2 steroid shots and sent home with 3 day supply of steroid medicine. Called on 2/6/01 and the pt states welts are still there, joints are sore, tired with some nausea. Advised to call family MD or go to ER. MD's office prescribed steroid medication. On 2/9/01 pt is better.
Age: 0.5
Sex: F
Vaccine: DTAP, IPV
Symptoms: Crying, Cyanosis, Decreased appetite, Pyrexia
Clinical narrative: The pt experienced a high fever for 3 days ranging from 103-105. The pt also experienced a poor appetite, irritability, crying, spells for 4 days. "Would turn blue especially around the mouth and extremities shock.
Age: 1.3
Sex: F
Vaccine: DTAP, HBHEPB, MMR
Symptoms: Eye oedema, Injection site erythema, Oedema peripheral, Urticaria
Clinical narrative: The pt experienced swollen eyes, rash with welts from waist up. The feet were swollen redness to the left leg. ER administered Benadryl and Motrin.
Age: 1.8
Sex: U
Vaccine: DTAP, HIBV, IPV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema
Clinical narrative: The pt experienced a swollen, red left thigh with cellulitis.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Erythema, Pyrexia, Rash papular, Skin ulcer
Clinical narrative: The pt experienced 12 hours post vax. the pt developed a fever of 103.2. No other symptoms. The fever resolved later that day and then experienced a diffuse erythematous tiny papular lesions appeared all over the body.
Age: 5.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Blister
Clinical narrative: On 2/19/01 the pt woke with one lesion. As the day progressed, more bumps appeared. The pt had 20 vesicles on trunk and non-focal lesions on body. Advised to treat with Benadryl as needed.
Age: 29.0
Sex: F
Vaccine: MMR, TD
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: The pts husband called and stated theat his wife began complaining of swollen painful glands on back of neck and behind ears. The pt saw her MD, he was unsure why the pt was having symptoms.
Age: 1.08
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: The pt experienced a light rash on stomach and back of neck and a few on the face. The pt also experienced a slight fever.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Rash, Viral infection
Clinical narrative: The pt experienced a rash on hands and feet following vax. Was told by physician it was hoof and mouth disease. The pt developed a rash on arms, chest, back and legs. The child was seen by the MD and is currently on steroids.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Infection, Rash
Clinical narrative: The pt was diagnosed with chicken pox on 2/12/01. Lesions noted on abdomen and chest, approximately 15 lesions.
Age: 65.0
Sex: F
Vaccine: DT
Symptoms: Back pain, Injection site oedema, Neck pain
Clinical narrative: The pt can't put hands to mouth and swelling at the site. The pt's neck and back hurts, no complaints prior to last night.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash maculo-papular
Clinical narrative: The pt experienced several maculo-papulo lesions on face, behind ears, trunk and arms few with vesicles, one with scab on leftl mandible. Treated with Benadryl and calamine lotion.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: The pt experienced a few pox on abdomen, back and behind right ears. Treated with Benadryl for 24 hours.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular
Clinical narrative: The pt experienced several papules, pruritic. The next day, more appeared on the scalp, ears, trunk, proximal arms, genitalia. The pt also had a case of chicken pox at 15 months of age.
Age: 4.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt developed Varicella.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: The pt experienced a full blown case of Varicella.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: The pt experienced small scattered papules all over the body. 1 small papule in mouth and 3 early scabs on trunk. Treated with Benadryl.
Age: 6.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Convulsion, Coordination abnormal, Delirium, Infection
Clinical narrative: The pt experienced seizures and a severe brain reaction, an infection and ataxia.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Eye oedema, Irritability, Pyrexia, Rash
Clinical narrative: Report from Lederle Labs (PR), report # HQ0332228AUG2000." A nurse reported that a 2 month old male received vaccines on 08/21/00. Within 30 hours, he developed a rash characterized as red and "splotchy" that started on his face and spread to his trunk and limbs. His eyes swelled shut and he developed a fever of 102 F. The infant was "very" fussy. A copy of this report has been forwarded to, Manufacturer of IPV". From additional information received on 02/23/01, it was reported that the patient was hospitalized for 2 days. Route of IPOL administration changed to subcutaneous. VAERS form initialed at the bottom "KZC 2/21/01." Information received from the reporter on 02/13/01 indicated that the infant was hospitalized for three days. He recovered. As a result of follow-up info, this event has been reclassified as serious, unlabeled.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Report from Lederle Labs (PR), report # HQ0332228AUG2000." A nurse reported that a 2 month old male received vaccines on 08/21/00. Within 30 hours, he developed a rash characterized as red and "splotchy" that started on his face and spread to his trunk and limbs. His eyes swelled shut and he developed a fever of 102 F. The infant was "very" fussy. A copy of this report has been forwarded to, Manufacturer of IPV". From additional information received on 02/23/01, it was reported that the patient was hospitalized for 2 days. Route of IPOL administration changed to subcutaneous. VAERS form initialed at the bottom "KZC 2/21/01." Information received from the reporter on 02/13/01 indicated that the infant was hospitalized for three days. He recovered. As a result of follow-up info, this event has been reclassified as serious, unlabeled.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Pt died of SIDS on 1/29/01, in the afternoon. She had no preceding symptoms was breast fed about 1 1/2 hour before the event where she was found dead in a crib. Pathologist's autopsy findings consistent with SIDS.
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Atherosclerosis, Cardiovascular disorder, Diabetes mellitus, Hypertension, Obesity
Clinical narrative: Pt was given Hep-A vaccine at 18:00-18:15. He was a chaplain with the Police Dept and was riding with a Police Officer. The Police Officer took the pt home at 23:30. States that the pt had no complaints at that time. At 02:15, the Police Dept was informed by the pt's wife that he had been sent to the hospital and died. Autopsy states cause of death as atherosclerotic cardiovascular disease. Other significant conditions: diabetes, hypertension, obesity.
Age: 58.0
Sex: M
Vaccine: HEPA
Symptoms: Unevaluable event
Clinical narrative: Pt was given Hep-A vaccine at 18:00-18:15. He was a chaplain with the Police Dept and was riding with a Police Officer. The Police Officer took the pt home at 23:30. States that the pt had no complaints at that time. At 02:15, the Police Dept was informed by the pt's wife that he had been sent to the hospital and died. Autopsy states cause of death as atherosclerotic cardiovascular disease. Other significant conditions: diabetes, hypertension, obesity.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Asphyxia, Unevaluable event
Clinical narrative: No data received. Autopsy states cause of death as probale asphyxia.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Parents found infant in crib upon arising; infant had expired.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Coma, Irritability, Pyrexia
Clinical narrative: Pt received vaccines on 2/5/01 in the PM. Did experience fussiness and low-grade fever. Was treated with Tylenol. In the AM of 2/6/01, was found unresponsive.
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Convulsion
Clinical narrative: A physician reported that a 4 month old female pt received IPOL, Acel-Imune, Hib-Titer and Prevnar vaccines on 2/16/01. Reportedly, the pt had a seizure, 24 hours, post vax, and had 4 more seizures over 2.5 days. The pt was hospitalized. From follow-up information received on 3/7/01, it was reported that the pt was hospitalized for 4 days. Additional pt, vaccine, vaccine administrator and responsible physician information was also provided.
Age: 0.25
Sex: M
Vaccine: DTAP, HIBV, IPV
Symptoms: Cyanosis, Pyrexia, Respiratory arrest
Clinical narrative: The evening of the vax, the pt developed a fever, perioral cyanosis and respiratory arrest. He was hospitalized. An electrocardiogram, electroencephalogram, ultrasound, thoracic x-ray and echocardiogram resulted in "no pathological findings". The reporter considered the events to be life threatening. The infant recovered.
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, PNC
Symptoms: Convulsion, Electroencephalogram abnormal
Clinical narrative: The pt experienced 2 seizures, total of 2 at 15 minutes apart. The 1st seizure lasted 20-30 seconds and 2nd seizure lasted 5-10 seconds.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Cognitive disorder, Confusional state, Depersonalisation, Dizziness, Dry mouth
Clinical narrative: One hour post vax, the pt became dizzy, confused, decrease in comprehension, complained of headache and neck burning, dry mouth, "Hot", had URI. The pt had fatigue and ache 1 week prior to vax. Diagnosed with disassociative reaction of unclear origin
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Feeling hot, Headache, Neck pain, Upper respiratory tract infection
Clinical narrative: One hour post vax, the pt became dizzy, confused, decrease in comprehension, complained of headache and neck burning, dry mouth, "Hot", had URI. The pt had fatigue and ache 1 week prior to vax. Diagnosed with disassociative reaction of unclear origin
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Blood disorder, Electrolyte imbalance, Hyponatraemia, Infection, Leukocytosis
Clinical narrative: This patient was admitted to the hospital, neurology consult. He had plasmapheresis 3 times. Then he was admitted to rehab at the hospital. Diagnosed with GBS, Hyponutremia, wound infect, leukocytosis, increased temperature
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This patient was admitted to the hospital, neurology consult. He had plasmapheresis 3 times. Then he was admitted to rehab at the hospital. Diagnosed with GBS, Hyponutremia, wound infect, leukocytosis, increased temperature
Age: 50.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Infection, Joint swelling, Panic reaction, Tachycardia
Clinical narrative: Pain and swelling in both wrists, pain in both ankles and also swelling in right ankle. Acceleration of Lyme symptoms, tachycardia, onset of panic attack and more.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Focal seizure, (right-sided) for about 5 minutes following influenza vaccine. Parent reports EEG done at hospital.
Age: 1.25
Sex: M
Vaccine: HIBV, PNC
Symptoms: Convulsion, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Fever, seizure-like activity, 24 hours, post vax, PCV #2 on 10/30/00. Fever, seizure-like activity, 48 hours, post vax, PCV #3 on 1/31/01.
Age: 47.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Dizziness, Dyskinesia, Heart rate increased, Immune system disorder, Muscle disorder
Clinical narrative: 2 days post vax, the pt experienced fainting, dizziness, body convulsions, loss of energy, degeneration of connective tissue, wasting of tissue, loss of mobility.
Age: 47.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Paraesthesia, Skin disorder
Clinical narrative: 2 days post vax, the pt experienced fainting, dizziness, body convulsions, loss of energy, degeneration of connective tissue, wasting of tissue, loss of mobility.
Age: 47.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Asthenia, Convulsion, Dizziness, Movement disorder, Syncope
Clinical narrative: 2 days post vax, the pt experienced fainting, dizziness, body convulsions, loss of energy, degeneration of connective tissue, wasting of tissue, loss of mobility.
Age: 47.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Collagen disorder, Dizziness, Dyskinesia, Heart rate increased, Immune system disorder
Clinical narrative: 2 days post vax, the pt experienced fainting, dizziness, body convulsions, loss of energy, degeneration of connective tissue, wasting of tissue, loss of mobility.
Age: 19.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Myelitis transverse
Clinical narrative: It was reported that a 19 year old male pt received a Fluzone SV '00-'01 vaccination on 11/22/00 at 18:00. Reportedly, by the end of December 2000, the pt developed an onset of transverse myelitis. Treatment of 5 day "burst" of IV steroids and oral steroids was given. The pt required 5 days of outpatient hospitalization. The pt's recovery status was not reported. Further information is requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Anoxia, Brain oedema, Convulsion, Lethargy, Opisthotonus
Clinical narrative: Seizures, lethargy, arching back. Autopsy gives cause of death as cerebral edema and anoxia. Other significant conditios: retinal hemorrhages and right retinal detachment.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Retinal detachment, Retinal haemorrhage
Clinical narrative: Seizures, lethargy, arching back. Autopsy gives cause of death as cerebral edema and anoxia. Other significant conditios: retinal hemorrhages and right retinal detachment.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Ageusia, CSF test abnormal, Dysgeusia, Eyelid ptosis, Feeling abnormal
Clinical narrative: On 12/31/00, pt began "feeling funny". On 1/1/01, pt started feeling tingling in hands, food tasted funny. Weakness in arms and legs on 1/3/01 and taste gone. Seen by MD on 1/2/01 with headache and congestion. No fever, no ST. MD thought it was ? allergic reaction to Prilosec. Seen by MD on 1/3/01 with ptosis and weakness. Currently recovering. Subsequently, dx'd with atypical GBS involving cranial nerves in particular. Per doc 210316, patient almost completely recovered, but still with occasional extremely tingling and scalp pain.  Follow up 07/06/2001: "Patient did not experience any illness with in 4 weeks prior to onset of GBS.  Possible URI 2 weeks prior to onset.  A final diagnosis of GBS has been made as : Demyelinating polyneuropathy poss atypical GBS."
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Headache, Muscular weakness, Nasal congestion, Paraesthesia
Clinical narrative: On 12/31/00, pt began "feeling funny". On 1/1/01, pt started feeling tingling in hands, food tasted funny. Weakness in arms and legs on 1/3/01 and taste gone. Seen by MD on 1/2/01 with headache and congestion. No fever, no ST. MD thought it was ? allergic reaction to Prilosec. Seen by MD on 1/3/01 with ptosis and weakness. Currently recovering. Subsequently, dx'd with atypical GBS involving cranial nerves in particular. Per doc 210316, patient almost completely recovered, but still with occasional extremely tingling and scalp pain.  Follow up 07/06/2001: "Patient did not experience any illness with in 4 weeks prior to onset of GBS.  Possible URI 2 weeks prior to onset.  A final diagnosis of GBS has been made as : Demyelinating polyneuropathy poss atypical GBS."
Age: 0.3
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Cellulitis, Injection site warmth, Oedema, Pyrexia, Rash
Clinical narrative: This infant started a temp on 02/15/01 of 103, rash on her right arm and neck. The rash was rough, hot, and the arm was swollen. The infant saw the doctor on 02/12/01 at 9 AM. She was admitted to the hospital on 02/15/01 in the evening, at 5 PM temp was 104.4. released on 2/18/01.  Diagnosed with cellulitis
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Agitation, Convulsion, Dyskinesia, Screaming
Clinical narrative: The vaccines were given at 10:30 AM, and the child started to cry inconsolably for 4-5 hours. During the last hour the child started to have jerking of his arms. The child was taken to the ER for evaluation. While in the ER the crying stopped, and the jerking movements decreased in frequency from every 2-3 minutes to every 5 minutes. When the crying restarted during the physician's exam the jerking movement increased. The ER physician believed that the jerking movements were seizures. The patient was given Ativan and admitted for observation. The following day the patient was seen by the neurologist and started on Phenobarbital.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Constipation, Guillain-Barre syndrome, Muscular weakness, Myelitis transverse, Neuropathy
Clinical narrative: Rapid onset of leg weakness. Transverse myelitis and Guillain-Barre like illness with persistent neuropathy. Doubts it is from vaccine. Is improving. Also diagnosed with Urinary retention and constipation.  Follow up:  Final diagnosis (+) Guillain-Barre Syndrome.  Diagnosis was made by a neurologist.  The patient did not experience any other illnesses within the 4 weeks before onset of GBS.  The patient did however experience severe subluxating joints and uneven gait before the onset of GBS.  The patient never had GBS or a related illness.  The patient has previously been vaccinated with influenza."
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Urinary retention
Clinical narrative: Rapid onset of leg weakness. Transverse myelitis and Guillain-Barre like illness with persistent neuropathy. Doubts it is from vaccine. Is improving. Also diagnosed with Urinary retention and constipation.  Follow up:  Final diagnosis (+) Guillain-Barre Syndrome.  Diagnosis was made by a neurologist.  The patient did not experience any other illnesses within the 4 weeks before onset of GBS.  The patient did however experience severe subluxating joints and uneven gait before the onset of GBS.  The patient never had GBS or a related illness.  The patient has previously been vaccinated with influenza."
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Chest pain, Discomfort, Dizziness, Dyspnoea
Clinical narrative: This patient had Pneumovax administered on 01/22/01, at approximately 1:30 PM. A few hours later the patient noticed discomfort (achy) in the left arm, became "feverish", felt "achy". She called the MD after contacting the health dept and complained of rapid heart beat, light headedness, mild sternal chest pain, slight sob. She was admitted to the hospital on 01/23/01. The patient was placed on Ancef foe cellulitis of the left upper arm and aqua-K pad. The patient's sickness dramatically improved and the patient was discharged on 01/26/01.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Heart rate increased, Hypertension, Pain, Pyrexia, Tachycardia
Clinical narrative: This patient had Pneumovax administered on 01/22/01, at approximately 1:30 PM. A few hours later the patient noticed discomfort (achy) in the left arm, became "feverish", felt "achy". She called the MD after contacting the health dept and complained of rapid heart beat, light headedness, mild sternal chest pain, slight sob. She was admitted to the hospital on 01/23/01. The patient was placed on Ancef foe cellulitis of the left upper arm and aqua-K pad. The patient's sickness dramatically improved and the patient was discharged on 01/26/01.
Age: 56.0
Sex: M
Vaccine: LYME
Symptoms: Dizziness, Hypothermia, Infection, Malaise
Clinical narrative: Received 1st shot on 3/10/99, 2nd shot on 4/8/99. In September, '99, I started feeling extremely light-headed and ill over my entire body. Temperature would drop to about 94F. Went to MD. It was so bad I couldn't function in early October, I was in the hospital for 4 days. Could find no problem. Dx'd with Lyme disease in July, 2000. Still being treated. Diagnosis in hospital was also intermitant chest pressure.  Follow up report: "According to the nurse at the doctor's office, the lot # was not recorded."
Age: 55.0
Sex: F
Vaccine: LYME
Symptoms: Arthralgia, Asthenia, Fatigue, Influenza like illness
Clinical narrative: I went to the MD for a blood pressure check on 5/5/99 and received Lymerix vaccine, Lot LY12069. The 2nd one was given on 6/16/99, lot LY120A9. I was in bed the rest of the day with flu-like symptoms. I am starting therapy again at the hospital on 11/28/00, 2nd time. I lost the use of my hands and strength in arms. All my joints hurt. Have had 2 years of MD visits. 60 day follow up states patient experienced fatigue.
Age: 59.0
Sex: F
Vaccine: LYME
Symptoms: Arthritis
Clinical narrative: The pt developed arthritis in September of 1997. The pt was in a testing group for a vaccine for Lyme Disease.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Abasia, Antisocial behaviour, Aphasia, Autism, Constipation
Clinical narrative: Lost language, lost eye contact within weeks. Lack of further language and social development. Had a significant development regression that began 14-15 months of age. Developed odd, repetitive behaviors and self-stimulatory behavior. Developed chronic constipation at 14 months of age. By 9/16/98, pediatrician thought he was Autistic and he was sent to another doctor and another, who dx'd him with Autism. Doctor's exam showed he was unable to walk, had few words. Treatment: Secretin infusions; nutritional/vitamin supplements; ABA (Lovass Discrete Trial Program 40-55 hours per week); Auditory integration therapy; Greenspan Floortime Therapy; Speech therapy; Occupational therapy; Gluten and Casein Free Diet.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Psychomotor hyperactivity
Clinical narrative: Lost language, lost eye contact within weeks. Lack of further language and social development. Had a significant development regression that began 14-15 months of age. Developed odd, repetitive behaviors and self-stimulatory behavior. Developed chronic constipation at 14 months of age. By 9/16/98, pediatrician thought he was Autistic and he was sent to another doctor and another, who dx'd him with Autism. Doctor's exam showed he was unable to walk, had few words. Treatment: Secretin infusions; nutritional/vitamin supplements; ABA (Lovass Discrete Trial Program 40-55 hours per week); Auditory integration therapy; Greenspan Floortime Therapy; Speech therapy; Occupational therapy; Gluten and Casein Free Diet.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Cardiac failure congestive, Cardiovascular disorder, Dyspnoea, Injection site induration, Injection site oedema
Clinical narrative: Post vaccination this patient's arm was swollen, problems breathing, about 7 days post vaccination. On 11/06, patient went to the hospital for congestive heart failure, arm was red and swollen big as a grapefruit. The patient had vaccination on Friday. On Saturday, red arm, and breathing problems. Friday hard, fine breathing. Monday, saw a doctor was sent to the hospital for ischemia, blockage of blood flow, tissue damage, ex- clot tissue basically dead tissue. Tissue damage as a result of seeing myocardial infarction tissue. The 60 day follow-up states that the pt says that he is disabled since this incident. Pt has had a previous "heart attack" 13 years prior to this incident.
Age: 55.0
Sex: M
Vaccine: HEP
Symptoms: Myocardial infarction
Clinical narrative: Post vaccination this patient's arm was swollen, problems breathing, about 7 days post vaccination. On 11/06, patient went to the hospital for congestive heart failure, arm was red and swollen big as a grapefruit. The patient had vaccination on Friday. On Saturday, red arm, and breathing problems. Friday hard, fine breathing. Monday, saw a doctor was sent to the hospital for ischemia, blockage of blood flow, tissue damage, ex- clot tissue basically dead tissue. Tissue damage as a result of seeing myocardial infarction tissue. The 60 day follow-up states that the pt says that he is disabled since this incident. Pt has had a previous "heart attack" 13 years prior to this incident.
Age: 39.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Fibromyalgia, Gastrointestinal disorder, Headache, Influenza like illness, Large intestine perforation
Clinical narrative: This patient has headache, body aches, flu-like symptoms, bowel problems; patient also reports same symptoms post 4th shot 01/08/00. Diagnosed with perforated colon 4/14/2000, corrective surgery performed. Also diagnosed with fibromyalgia. Follow up:  Patient did not recover from adverse event.  Patient experiences extreme fatigue, joint aches, headahces, arthritis in spine.  Hyper allergenic, continuing intestinal problems.  Patient's current duty status is full duty, however approximately 60 days of work has been missed.  The patient has not been evaluated by a physician or health care provider for this event.  Patient did not receive any further shots since reported event."
Age: 39.0
Sex: M
Vaccine: ANTH, MEN
Symptoms: Pain
Clinical narrative: This patient has headache, body aches, flu-like symptoms, bowel problems; patient also reports same symptoms post 4th shot 01/08/00. Diagnosed with perforated colon 4/14/2000, corrective surgery performed. Also diagnosed with fibromyalgia. Follow up:  Patient did not recover from adverse event.  Patient experiences extreme fatigue, joint aches, headahces, arthritis in spine.  Hyper allergenic, continuing intestinal problems.  Patient's current duty status is full duty, however approximately 60 days of work has been missed.  The patient has not been evaluated by a physician or health care provider for this event.  Patient did not receive any further shots since reported event."
Age: 1.5
Sex: M
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Diarrhoea, Pyrexia, Upper respiratory tract infection, Vomiting
Clinical narrative: This child had a fever of 103 F axillary approximately 12 hours after his shots; duration approximately 36 hours developed vomiting 2 days later with loose diarrheal stools 24 hours after vomiting. Diagnosed with URI and RADM on 02/02/01.
Age: 0.6
Sex: M
Vaccine: DTAP, HEP, HIBV, PNC
Symptoms: Feeling hot, Hypotonia, Loss of consciousness
Clinical narrative: Two days after this infant had his vaccines, he awoke from a nap (was in grandmothers lap) suddenly back "limp", with loss of consciousness. No tonic-clonic activity. No apnea of cyanosis. The infant felt hot, but no documented fever. This lasted  1-2 minutes, normal afterwards. Neg exam by me shortly after the episode. No problems since the episode.
Age: 63.0
Sex: M
Vaccine: LYME
Symptoms: Arthritis, Polyarthritis, Rheumatoid arthritis
Clinical narrative: Report 2001004896-1 describes polyarthritis in a 63 year old male who received Lyme disease vaccine (Lymerix). On unspecified dates, the vaccinee received Lymerix vaccine. As of 02/20/01, the outcome of the event was unknown. Human leukocyte antigen (HLA) typing by polymerase chain reaction PCR was negative for HLA-DR4. The adverse event of "arthritis" does not meet ICH serious criteria, but is be submitted as an expedited report by special FDA request per the 06/28/00 letter. The most recent info was received on 09/18/2001. The vaccinee was last seen by the physician on 04/20/2001. At that time, the vaccinee continued to experience polyarthritis which was treated with methotrexate. The follow-up info received on 09/18/2001 states that human leukocyte antigen typing by polymerase chain reaction was negative for HLA-DR4. The vaccinee was last seen by the physician on 04/20/2001. At that time, the vaccinee continued to experience polyarthritis which was treated with methotrexate. The follow up states the vaccinee was last seen by the physician on 1/21/02. At that time, the physician indicated a diagnosis of seronegative rheumatoid arthritis. This resovled with corticosteroid therapy and subsequent addition of methotrexate. He had been tapered off his steroids without difficulty. He also had advanced osteoarthritic changes of his knees and received hyaluronic acid (synvisc) in one knee without relief. However, the knees had gradulaly gotten better "on their own." Medications at that time included methotrexate 10mg weekly, Naprosyn 500mg twice daily, folic acid 3mg daily, and prevacid 30mg daily as needed. On physical examination, he had no palpable skin lesions. Joint examination revealed mild osteoarthritic changes of his hands. Otherwise, he had no palpable synovitis, erythema, tenderness or diminished range of motion in any peripheral joints. The physician's assessment was "seronegative rheumatoid arthritis. Doing well on current therapy with the exception of probable methotrexate-induced stomatitis." Folic acid therapy was discontinued and the physician prescribed folinic acid 5mg once a wee, 24 hrs after his methotrexate dose. The most recent info, received on 2/25/02, indicated that the seronegative rheumatoid arthritis and osteoarthritis persisted as of 1/21/02. Both had improved.
Age: 55.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: Report 2001004923-1 describes joint stiffness in a 55 year old male who received Lyme disease vaccine (Lymerix). The patient received his first injection of Lymerix on 11/19/99. He received his second injection of Lymerix on 12/20/99. "Within a few months" of receiving these injections, he began to experience soreness and stiffness in both wrists and the right elbow. He received no treatment for the soreness and stiffness. The stiffness and soreness persisted. The patient received his third injection of Lymerix on 11/17/00. As of 02/05/01, the soreness and stiffness in his wrists and right elbow persisted. The patient stated, "It has continued and seems chronic". The vaccine provider submitted this report directly to VAERS. The adverse event of joint stiffness and joint soreness do not meet ICH serious criteria, but is be submitted as an expedited report by special FDA the 06/28/00 letter.
Age: 53.0
Sex: M
Vaccine: LYME
Symptoms: Arthralgia, Dyspnoea, Myalgia
Clinical narrative: This patient received two of three shots while working for the forest service in Missouri. He was vaccinated with Lymerix to prevent Lyme disease. The patient started experiencing muscle aches and joint pain after his 2nd shot. He is continuing to experience similar pain off and on as well as shortness of breath.