chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been receiverd from a physician's office concerning a 3 year old male who in 1998 was vaccinated with varicella virus vaccine live (site unknown). On approximately 05/04/01, the pt developed "full-fledged chicken pox". the pt sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a female child who was vaccinated with varicella virus vaccine live. Subsequently, the pt experienced a rash at the injection site and no other symptoms. The pt sought unspecified medical attention. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site reaction, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female with no known drug allergies and no past medical history who on 03/30/2001 at 4pm was vaccinated SC in the left upper arm with a first dose of varicella vaccine. There was no illness at the time of vaccination. There was no concomitant medication. It was noted that the pt received MMR vaccine on 02/27/2001. On 04/13/2001 at 10pm, the pt experienced two watery blister lesions on the left upper arm close to the injection site. Unspecified medical attention was sought. No treatment was given. The lesions dried and scabbed after 5-6 days. The pt has recovered. Additional info has been received from a registered nurse who reports the pt had blood work prior to the first vaccination which showed a negative varicella antibody. On 05/14/2001 at 4:30 pm, the pt received a second dose SC in the left upper arm of varicella vaccine. There was no illness at the time of vaccination. There was no concomitant medication. on 05/15/2001, the following day, the pt had a 50 x 50mm injection site reaction that was described as itchy, red and swollen. Benadryl was given and the pt recovered in five days.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 29 year old female with no known drug allergies and no past medical history who on 03/30/2001 at 4pm was vaccinated SC in the left upper arm with a first dose of varicella vaccine. There was no illness at the time of vaccination. There was no concomitant medication. It was noted that the pt received MMR vaccine on 02/27/2001. On 04/13/2001 at 10pm, the pt experienced two watery blister lesions on the left upper arm close to the injection site. Unspecified medical attention was sought. No treatment was given. The lesions dried and scabbed after 5-6 days. The pt has recovered. Additional info has been received from a registered nurse who reports the pt had blood work prior to the first vaccination which showed a negative varicella antibody. On 05/14/2001 at 4:30 pm, the pt received a second dose SC in the left upper arm of varicella vaccine. There was no illness at the time of vaccination. There was no concomitant medication. on 05/15/2001, the following day, the pt had a 50 x 50mm injection site reaction that was described as itchy, red and swollen. Benadryl was given and the pt recovered in five days.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 28 year old female employee with a serum varicella virus antibody < than 10 on 05/30/1995 who was vaccinated SC in the right arm with a first and second dose of varicella vaccine on 06/05/1995 and 07/17/1995 respectively. On 09/21/1995, lab evaluation revealed varicella zoster virus antibody of 10. On 01/11/2001, lab evaluation revealed varicella zoster virus antibody <than 10. No adverse experiences were noted. Medical attention was sought. Additional info has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female who on 07/20/1998 was vaccinated SC in the left thigh with a first dose of varicella vaccine. On 04/02/2001, the pt developed chicken pox. The rash described as papulovesicular lesions, different sizes, mostly on trunk, less on extremities, itchy. It lasted one week.
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a male physician who was vaccinated with varicella vaccine. Subsequently, the pt "failed to seroconvert according to the commercially available anti-varicella antibody test." Unspecified medical attention was sought. Additional info has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a nurse practitioner concerning a 30 year old female who in 1995 or 1996 was vaccinated with varicella vaccine. In 2000, lab evaluation revealed that the pt did not seroconvert. Unspecified medical attention was sought. Additional info has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a female who in approximately 2000 was vaccinated with varicella vaccine. "Recently" in 2001, the pt was titered and did not show seroconversion. No further details were provided. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Headache, Herpes zoster, Infection, Pain
Clinical narrative: Information has been received from a physician concerning a healthy white 6 year old male (the physician's cousin) with no significant medical history including no history of immunosuppression, chickenpox or recent varicella or herpes zoster exposure who on 3/19/95 was vaccinated with a 1st dose of varicella virus vaccine live (lot 1:29B-invalid lot). There was no concomitant medication and no illnesses at the time of vaccine administration. It was noted that no rash occurred at the injection site or elsewhere within 42 days of vaccination. On 4/28/01, the pt developed herpes zoster along the right trigeminal nerve. Follow-up information received from the same physician, indicated that on 4/29/01, the pt began with a headache in the right temple. By 4/30/01, the pt developed a pustular rash over his right eyebrow, initially thought to be poison ivy, which spread over ophthalmic/right trigeminal distribution. The pt also experienced vomiting, itching and pain rated "7" on a scale of 0-10. On 5/3/01, the pt was followed-up and dx'd with shingles. The pt had a positive ophthalmic exam for herpes zoster. On 5/4/01, a vesicle specimen was obtained by the reporting physician. Seven days into the illness, the pt was reported to have what his parent thought was varicella pox on his body. On 5/24/01, the specimen was sent to the lab for identification. Follow-up information received on 6/7/01, from the lab, indicated that the preliminary polymerase chain reaction (PCR) results from this episode's specimen were VZV positive. In further follow-up from 6 20/01, PCR analysis of the vesicular specimen on 5/29/01 had identified the presence of Oka/Vaccine VZV. On 7/11/01, the physician reported that an ophthalmologist had treated the pt with valacyclovir HCI Valtrex and "several" eye drops, including vitarabine (Vira-A) and trifluridine (Viroptic). The pt's mother told the physician that the pt had developed 15-20 lesions in a generalized distribution on his body after developing the herpes zoster. The physician had not view this rash, however, the pt's mother had photographed the trigeminal nerve herpes zoster, which the physician stated was "truly a heinous picture". On 5/21/01, the pt recovered from the chickenpox. He also recovered from the herpes zoster lesions, but facial scarring remained. The reporting physician considered the chickenpox and herpes zoster to be non-serious. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Scar, Vomiting
Clinical narrative: Information has been received from a physician concerning a healthy white 6 year old male (the physician's cousin) with no significant medical history including no history of immunosuppression, chickenpox or recent varicella or herpes zoster exposure who on 3/19/95 was vaccinated with a 1st dose of varicella virus vaccine live (lot 1:29B-invalid lot). There was no concomitant medication and no illnesses at the time of vaccine administration. It was noted that no rash occurred at the injection site or elsewhere within 42 days of vaccination. On 4/28/01, the pt developed herpes zoster along the right trigeminal nerve. Follow-up information received from the same physician, indicated that on 4/29/01, the pt began with a headache in the right temple. By 4/30/01, the pt developed a pustular rash over his right eyebrow, initially thought to be poison ivy, which spread over ophthalmic/right trigeminal distribution. The pt also experienced vomiting, itching and pain rated "7" on a scale of 0-10. On 5/3/01, the pt was followed-up and dx'd with shingles. The pt had a positive ophthalmic exam for herpes zoster. On 5/4/01, a vesicle specimen was obtained by the reporting physician. Seven days into the illness, the pt was reported to have what his parent thought was varicella pox on his body. On 5/24/01, the specimen was sent to the lab for identification. Follow-up information received on 6/7/01, from the lab, indicated that the preliminary polymerase chain reaction (PCR) results from this episode's specimen were VZV positive. In further follow-up from 6 20/01, PCR analysis of the vesicular specimen on 5/29/01 had identified the presence of Oka/Vaccine VZV. On 7/11/01, the physician reported that an ophthalmologist had treated the pt with valacyclovir HCI Valtrex and "several" eye drops, including vitarabine (Vira-A) and trifluridine (Viroptic). The pt's mother told the physician that the pt had developed 15-20 lesions in a generalized distribution on his body after developing the herpes zoster. The physician had not view this rash, however, the pt's mother had photographed the trigeminal nerve herpes zoster, which the physician stated was "truly a heinous picture". On 5/21/01, the pt recovered from the chickenpox. He also recovered from the herpes zoster lesions, but facial scarring remained. The reporting physician considered the chickenpox and herpes zoster to be non-serious. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with varicella vaccine. It was noted that the physician "has seen zoster occuring in the same appendage at the vaccine was given." Unspecified medical attention was sought. Follow-up info has been received from a physician who states in the last year he has seen 3-4 cases of herpes zoster in children who have received varicella vaccine. He reports that they were all at the site of injection and that all of the children had uncomplicated recoveries from the herpes zoster. Additional info is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician's office concerning a 10 year old female who in 2000 was vaccinated with varicella vaccine. On approximately 05/04/2001 the pt developed "full-fledged chicken pox." The pt sought medical attention. Additional info has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from an RN concerning a "middle school aged boy" who was vaccinated with varicella virus vaccine live. Subsequently, the pt developed a mild case of chickenpox (a few lesions). Unspecified medical attention was sought. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Herpes zoster, Infection, Pain, Pruritus
Clinical narrative: Information has been received from an ER physician and a nurse in a pediatrician's office concerning a 4 year old male with no known allergies who was noted to be a normal healthy child without immunosuppression. On 5/3/01, the pt was vaccinated with 1 dose of varicella virus vaccine live (site unknown). Concomitant vaccinations that same day included 1 dose of MMRII. Other vaccinations that day included, 1 dose of diphtheria toxoid/pertussis vaccine/teta and 1 dose of poliovirus vaccine. On 5/7/01, the pt developed a herpes zoster-like rash at the site of the varicella virus vaccine live injection. On 5/10/01, the physician reported that the rash "now" involved the chest, armpit area and a small area on the back. It was also reported that the child had some lesions on the right arm and right chest. The rash was slightly itchy. The pt had no fever and otherwise felt fine. The pt was seen in the ER and treated with acyclovir (Zovirax) and was released from the ER with the child to see his pediatrician 2 days later. A nurse in the pt's pediatrician's office stated that the pediatrician agreed with the dx of herpes zoster and described the herpes zoster along the right T4 dermatome. In addition to the Zovirax, the pt was treated with cetirizine hydrochloride (Zyrtec) and prophylactically with Zithromax. It was noted that the pt did have itching and pain. The nurse planned to contact the pt's mother to discover if any dried lesions were available and will also attempt to obtain information about previous exposure to wild type virus. The nurse was unable to provide lot numbers for the varicella virus vaccine live or the MMRII that the pt received because they were not given at this office. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from an LPN concerning a 6 year old pediatric male pt with a history of tonsillectomy, adenoidectomy and no known allergies who in 2001 (initially reported as "6/8/01") was vaccinated with varicella virus vaccine live (dosage and lot number not provided). On 5/10/01, the pt presented to his physician's office with symptoms described as "multiple red, itchy, blisters, some crusted over red base, on face, and one on the trunk". The child had no fever. On follow-up, it was reported by the LPN that on an initial office visit on 5/9/01 as a new pediatric pt, the child's mother had reported that the child had been vaccinated at another unspecified physician's office on 6/8/98 with (1st dose) of varicella virus vaccine live (dosage and lot number not provided). The pt had presented to his current physician's office with symptoms described as "multiple red, itchy, blisters, some crusted over red base, on face and one on the trunk". The child had no fever. Subsequently, the pt was dx'd with varicella. No further information was available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from an RN concerning a pt who on 8/13/00 was vaccinated with varicella virus vaccine live (site unknown) (lot 631471/1347J). The pt developed chickenpox the week of 4/23/01. It was unknown if the pt sought medical attention. Also reported was another pt (WAES01042688) who was vaccinated and experienced similar events. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a LPN concerning a 6 year old male with no past medical history who on 10/20/95 was vaccinated with varicella virus vaccine live (069297/0437B) in the thigh. There were no illnesses at the time of vaccination. The LPN stated that the pt "now has chickenpox". In follow-up, the LPN reported that on 5/8/01, the pt "broke out with chickenpox with 20-40 spots". The LPN reported that the pt recovered from his experience on 5/13/01. Unspecified medical attention was sought. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Malaise, Pruritus, Pyrexia
Clinical narrative: Information has been received from an NP concerning a 2 year old male with no known drug allergies who on 5/4/01 was vaccinated with varicella virus vaccine live. On 5/9/01, the pt developed lesions. On 5/11/01, the pt was seen in his physician's office with 100 lesions on face and trunk, with a temperature of 101F, malaise and itch. The pt had been exposed to another child at school who had varicella more than 2 weeks prior to the pt's eruptions. On 5/11/01, diphenhydramine HCI (Benadryl) was ordered as needed. Additional information has been requested.
Age: 1.7
Sex: M
Vaccine: DTAP, IPV
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Patient was brought in to clinic by his father.  He had been given his 18 month immunizations 2 days prior and had a 10cm x 12cm area of redness,swelling and warm to touch on his left leg.  Father was instructed to ice the area and to return to clinic if no improvement.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Rash erythematous
Clinical narrative: Patient was brought in to the clinic approximately 48 hours after receiving his immunizations.  He had a 10cm x 10cm erythamatous, warm to touch raised rash on his left leg that was blanchable, non-tender.  He was prescribed antihistamines and instructed to ice the site.  Return to clinic if problem persists.
Age: 1.04
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Injection site mass
Clinical narrative: Mother of patient stated that child had a dime sized lump on her right leg four days after receiving immunizations.  The lump grew to about a quarter size within 11 days post immunization.  No heat, pain or edema. Gave parent another VIS and instructed to monitor the area.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Feeling hot, Oedema peripheral
Clinical narrative: On 5/15/02 received DTaP. had recent illness had fever prior to shot, but now afebrile. Arm is less swollen than it was , a bit warm - 3 inch erythema.
Age: 0.17
Sex: F
Vaccine: VARCEL
Symptoms: Anorexia, Crying, Diarrhoea, Eczema, Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 week old female pt with no known allergies or past medical history who on 11/20/2000 was vaccinated with a first dose of varicella vaccine. It was reported that the child had "borderline RSV" at the time of vaccination. On 11/22/2000, two days after vaccination, the child developed a rash and lost her appetite. On approx. 12/11/2000, three weeks after administration of the vaccine, the pt developed two chicken pox lesions, one on her leg and one large lesion on her stomach. The child was also covered from head to toe with eczema. It was noted that the office where the child received the vaccination denied tat the child received varicella vaccine but the mother was sure she signed for it. The nurse reported that when the child got the rash, she was treated with oral steroids. There were no lab tests performed. The rash resolved, the steroids were stopped and the rash returned. No other info was available. Follow-up info has been received from a licensed practical nurse who reports the child had borderline RSV at the time of vaccination. The pt's mother reports the night after the shot the child's legs were sore, she had a loss of appetite and continuous cries of pain. By that weekend the child continued to scream in pain, a rash broke out and her bathing products began to burn her skin. The pt was treated with cream, Benadryl. It was noted that the child had an allergic reaction to the treatment. The mother tried different detergents, soaps, formulas and baths and nothing seemed to change. The treatment would work for a few days then quit. It was also reported that the pt's sleep was affected, she had diarrhea from the shot until April 2001, gland swell and break outs, and her right eye seeps with breakouts. Follow-up info has been received from a licensed practical nurse who reports that there is no change in the pt's condition. Follow-up info has been received indicating that the pt has not been seen in the doctor's office since 06/14/2001. It was reported  that she did have allergy testing done at another doctor's office. Additional info has been reported.  Additional follow up information was received from a physician on 04Apr2002. He reported that the child seemed to develop atopic dermatitis after vaccination, for which he evaluated her. Diagnostic testing was positive for food allergy. Additional information has been requested.
Age: 0.17
Sex: F
Vaccine: VARCEL
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 week old female pt with no known allergies or past medical history who on 11/20/2000 was vaccinated with a first dose of varicella vaccine. It was reported that the child had "borderline RSV" at the time of vaccination. On 11/22/2000, two days after vaccination, the child developed a rash and lost her appetite. On approx. 12/11/2000, three weeks after administration of the vaccine, the pt developed two chicken pox lesions, one on her leg and one large lesion on her stomach. The child was also covered from head to toe with eczema. It was noted that the office where the child received the vaccination denied tat the child received varicella vaccine but the mother was sure she signed for it. The nurse reported that when the child got the rash, she was treated with oral steroids. There were no lab tests performed. The rash resolved, the steroids were stopped and the rash returned. No other info was available. Follow-up info has been received from a licensed practical nurse who reports the child had borderline RSV at the time of vaccination. The pt's mother reports the night after the shot the child's legs were sore, she had a loss of appetite and continuous cries of pain. By that weekend the child continued to scream in pain, a rash broke out and her bathing products began to burn her skin. The pt was treated with cream, Benadryl. It was noted that the child had an allergic reaction to the treatment. The mother tried different detergents, soaps, formulas and baths and nothing seemed to change. The treatment would work for a few days then quit. It was also reported that the pt's sleep was affected, she had diarrhea from the shot until April 2001, gland swell and break outs, and her right eye seeps with breakouts. Follow-up info has been received from a licensed practical nurse who reports that there is no change in the pt's condition. Follow-up info has been received indicating that the pt has not been seen in the doctor's office since 06/14/2001. It was reported  that she did have allergy testing done at another doctor's office. Additional info has been reported.  Additional follow up information was received from a physician on 04Apr2002. He reported that the child seemed to develop atopic dermatitis after vaccination, for which he evaluated her. Diagnostic testing was positive for food allergy. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 21 month old male with no past medical history who on 07/24/2000 was vaccinated with the first dose of varicella vaccine SC in the right leg. Concomitant therapy that day included second dose of MMR SC in the right leg, a fourth dose of Hib-TITER IM in the left leg and the fourth dose of Tripedia IM in the left leg. It was unknown if the pt had an illness at the time of vaccination. On 04/25/2001 the pt developed chicken pox. The pt sought unspecified medical attention. Additional info has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Cough, Otitis media, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female w/no part medical history who on 08/11/00 was vaccinated with the first dose  of varicella virus vaccine live, subcutaneously in the right arm. Concomitant therapy that day included the second dose of MMRII subcutaneously in the left arm and the first dose of hepatitis A vaccine  (inactive), in the left leg. Other concomitant therapy included one dose of alum, potassium (+0 diptheria toxoid (+) pertussis vaccine (+) tetanus toxoid (Tripedia) and one dose of poliovirus vaccine inactivated. There was no illness at the time of vaccination. In 03/01, the pt developed bilateral otitis media, cough  and a new rash outbreak the pt sought unspecified medical attention. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The pt developed redness and increased temperature, and erythema of left lower extremity following the injection of DTaP and IPV. Lasted for 2-3 weeks.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Body temperature increased, Injection site erythema
Clinical narrative: The pt developed redness and increased temperature, and erythema of left lower extremity following the injection of DTaP and IPV. Lasted for 2-3 weeks.
Age: 0.25
Sex: F
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Apnoea, Cyanosis, Petechiae, Pyrexia, Sudden infant death syndrome
Clinical narrative: Per F/U 7/5/02, autopsy DX: SIDS. The pt was last known alive by her mother at 06:45 on 5/12/02. She states she bottle-fed the pt 4 oz of Enfamil with Iron at 06:45. She also gave the pt Children's Tylenol (dosage unk). She states she fell asleep with the pt resting face up on her chest and wrapped in a receiving blanket. When she awoke at 11:15 and saw the pt's lips were blue, she yelled to her mother to call the hospital. At 11:16, the pt's grandmother iniated CPR. EMS responded and arrived at 11:19. The pt was without respirations or discernible heart beat. Pt was given oxygen via bag-valve mask and CPR was continued during transport. Arrived in ER at 11:24. At ER, advanced life support were iniated but unsuccessful. MD made the death decision at 11:47 hours. The pt's mother was present at the time of death. A low-grade temperature had been present since the immunizations. Final pathologic findings: scattered petechial hemorrhages of the lungs, heart and thymus.
Age: 11.0
Sex: F
Vaccine: HEP
Symptoms: Blindness, Headache, Insomnia, Medication error, Pain
Clinical narrative: Information has been received from a licensed practical nurse who is the mother of an approximately 11 year old female child with no past medical history, who in approximately 1993 or 1994 was vaccinated with the third dose of hepatitis B vaccine recombinant (yeast). There was no concomitant medication and no known allergies. The mother reported that starting the next day, following vaccination, the child began having headaches, which became more severe as time went on. She also experienced aches and pains all over her body and missed almost a year of school. It was also reported that the child sleeps poorly and is losing her eyesight. At the time of this report, the child continued to experience the aches and pains. The mother reported that the child use to be a very active, healthy child until she had the vaccination. She has been to numerous doctors over the years. The mother also reported that about one week after vaccination was given, she found out the child had received a recalled lot of vaccine. The child is reported to be still doing poorly. Upon internal review, the events of blindness, headaches and pain were considered to be other important medical events. Additional information has been requested.
Age: 2.6
Sex: M
Vaccine: PNC
Symptoms: Bacterial infection, Fungal infection, Gastrointestinal haemorrhage, Haemoglobin decreased, Meningitis
Clinical narrative: Information has been received from an investigator concerning a male child with a history of acute myeloid leukemia who received his 4th dose of Prevnar on 10/17/96 as part of a post-marketing safety surveillance trial. Approx. 2 years, post vax, at 31 months of age, he developed sepsis. Culture revealed Streptococcus pneumoniae serotype 19F. Sepsis was considered to be an "Other Medically Important Event". The Medical Monitor and Investigator's assessment of the relatedness between septicemia streptococcal (expected per the package insert) and Prevnar was unknown. Additional information was received on 5/6/02. The child had a history of bleeding episodes since 14 months of age. A probable dx of acute megaloblastic leukemia was made and the child was treated with standard induction chemotherapy including intrathecal cytarabine. He was re-admitted to the hospital on 11/15/98 for his 2nd course of chemotherapy and was febrile. Blood culture grew penicillin resistant Streptococcus pneumoniae. A repeat blood culture on 11/16/99 was negative. He was afebrile and was started on chemotherapy. "Stormy" hospital course was complicated by Streptococcus viridans sepsis and he was transferred to another facility because of increased respiratory distress. He developed a right pleural effusion which grew Aspergillus. His respiratory condition improved and the child was transferred back to the hospital facility. He was discharged on 1/1/99 and died at home. Both the investigator and medical monitor's assessments were unknown. Per F/U 5/28/02 autopsy: COD ureteral and GI bleeding, Aspergillos meningitis and pneumonia and myelodysplasia/pre-leukemia.
Age: 2.6
Sex: M
Vaccine: PNC
Symptoms: Myeloid leukaemia, Pleural effusion, Pyrexia, Respiratory distress, Sepsis
Clinical narrative: Information has been received from an investigator concerning a male child with a history of acute myeloid leukemia who received his 4th dose of Prevnar on 10/17/96 as part of a post-marketing safety surveillance trial. Approx. 2 years, post vax, at 31 months of age, he developed sepsis. Culture revealed Streptococcus pneumoniae serotype 19F. Sepsis was considered to be an "Other Medically Important Event". The Medical Monitor and Investigator's assessment of the relatedness between septicemia streptococcal (expected per the package insert) and Prevnar was unknown. Additional information was received on 5/6/02. The child had a history of bleeding episodes since 14 months of age. A probable dx of acute megaloblastic leukemia was made and the child was treated with standard induction chemotherapy including intrathecal cytarabine. He was re-admitted to the hospital on 11/15/98 for his 2nd course of chemotherapy and was febrile. Blood culture grew penicillin resistant Streptococcus pneumoniae. A repeat blood culture on 11/16/99 was negative. He was afebrile and was started on chemotherapy. "Stormy" hospital course was complicated by Streptococcus viridans sepsis and he was transferred to another facility because of increased respiratory distress. He developed a right pleural effusion which grew Aspergillus. His respiratory condition improved and the child was transferred back to the hospital facility. He was discharged on 1/1/99 and died at home. Both the investigator and medical monitor's assessments were unknown. Per F/U 5/28/02 autopsy: COD ureteral and GI bleeding, Aspergillos meningitis and pneumonia and myelodysplasia/pre-leukemia.
Age: 2.6
Sex: M
Vaccine: PNC
Symptoms: White blood cell count decreased
Clinical narrative: Information has been received from an investigator concerning a male child with a history of acute myeloid leukemia who received his 4th dose of Prevnar on 10/17/96 as part of a post-marketing safety surveillance trial. Approx. 2 years, post vax, at 31 months of age, he developed sepsis. Culture revealed Streptococcus pneumoniae serotype 19F. Sepsis was considered to be an "Other Medically Important Event". The Medical Monitor and Investigator's assessment of the relatedness between septicemia streptococcal (expected per the package insert) and Prevnar was unknown. Additional information was received on 5/6/02. The child had a history of bleeding episodes since 14 months of age. A probable dx of acute megaloblastic leukemia was made and the child was treated with standard induction chemotherapy including intrathecal cytarabine. He was re-admitted to the hospital on 11/15/98 for his 2nd course of chemotherapy and was febrile. Blood culture grew penicillin resistant Streptococcus pneumoniae. A repeat blood culture on 11/16/99 was negative. He was afebrile and was started on chemotherapy. "Stormy" hospital course was complicated by Streptococcus viridans sepsis and he was transferred to another facility because of increased respiratory distress. He developed a right pleural effusion which grew Aspergillus. His respiratory condition improved and the child was transferred back to the hospital facility. He was discharged on 1/1/99 and died at home. Both the investigator and medical monitor's assessments were unknown. Per F/U 5/28/02 autopsy: COD ureteral and GI bleeding, Aspergillos meningitis and pneumonia and myelodysplasia/pre-leukemia.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Blood pressure decreased, Body temperature decreased
Clinical narrative: Temperature of 103 on day 5/7/02. Temperature of 94 degrees at 23:00 on 5/7/02; felt cold all over. Went to ER, temp of 96; BP 71/35 at 00:55 on 5/8/02. At 05:00, Temp of 98; BP 104/51 on floor.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Platelet count decreased, Thrombocytopenic purpura
Clinical narrative: Idiopathic thrombocytopenic purpura. Admitted to hospital on 05/07/2002. Annual report follow up adds: This child has been followed at hospital for chronic ITP.
Age: 1.25
Sex: M
Vaccine: DTAP, HBHEPB, HIBV, IPV
Symptoms: Autism
Clinical narrative: Autism A 60-day follow up report received 6/23/2003 adds: Autism. Speech disability. Digestive problems. Dilated pupils. Light, sound, taste sensitivity. Social problems relatedness. Sleep disorder. Inability to properly metabolize foods. I've asked this before. What is the CDC-VAERS doing about this. Still, no recall of thimerasol-containing vaccines, so children will continue to get poisoned, and some vaccines are still manufactured with it. The drug companies come out smelling like a rose while thousands of children and their families got screwed! Stop monitoring and do something. Please, have them stop sending thimerasol-containing vaccines to third world countries now. Order vials still on the shelves in the US recalled now!
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV
Symptoms: Body temperature increased, Convulsion, Sepsis
Clinical narrative: Seizure that evening associated with temperature of 102 degrees, axillary. Duration of seizure estimated at 20-30 minutes per father.
Age: 1.0
Sex: M
Vaccine: HBHEPB, MMR, PNC
Symptoms: Erythema, Pyrexia, Rash
Clinical narrative: The pt developed single flat red area on upper arm on 03/29 but on 03/30, rash spread to legs, highly irritable and feverish. On 03/31, rash turned purplish red, low grade fever. By 04/01/2002, rash peaked, low grade fever continued. On 04/02, he improved and by the next day, rash was gone. Rash was systemic on trunk, face and groin areas.
Age: 0.6
Sex: M
Vaccine: HIBV, PNC
Symptoms: Agitation, Flushing, Gait disturbance
Clinical narrative: The pt was given Prevnar vaccine on left leg. Baby began crying, skin turned red color and was limping. Immediately recovered. Skin color returned to pink. Went to MD for evaluations and all were within normal limits. A follow up report received 5/28/2002 adds: No site reaction.
Age: 1.2
Sex: M
Vaccine: DTAP, HBHEPB, PNC
Symptoms: Pyrexia
Clinical narrative: The pt developed fever of greater than or equal to 105 deg. F at 1 1/2 days post vaccination.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Screaming
Clinical narrative: Four hours following vaccination, pt developed inconsolable screaming for 3 1/2 hours.
Age: 0.6
Sex: F
Vaccine: DTAP, PNC
Symptoms: Fontanelle bulging, Pyrexia
Clinical narrative: The pt developed bulging fontenelle and fever four days after vaccination.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Electroencephalogram abnormal, Hypertonia, Hypotonia, Infantile spasms, Staring
Clinical narrative: Episodes of staring, deviation of eyes, and clonic activity of arms and legs which began 48 hours after second series of immunizations. Child was hospitalized and EEG revealed hypsarrhythmia, consistent with infantile spasms. CT scan of brain and CSF evaluation negative. Infant was treated with ACTH injections.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Strabismus
Clinical narrative: Episodes of staring, deviation of eyes, and clonic activity of arms and legs which began 48 hours after second series of immunizations. Child was hospitalized and EEG revealed hypsarrhythmia, consistent with infantile spasms. CT scan of brain and CSF evaluation negative. Infant was treated with ACTH injections.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Urticaria
Clinical narrative: The pt developed hives and redness over trunk, arms and legs. Treated with Benadryl and resolved.
Age: 1.3
Sex: F
Vaccine: MEA
Symptoms: Cough, Cystitis, Pharyngitis, Pyrexia, Rash
Clinical narrative: The pt developed high fever of 104 deg F on 09/23/1998 lasted for 24 hrs. Then it dropped to 100.6-101 deg. F. over 3-4 days. Pt developed rash on arms and upper trunk. Atypical measles reaction to vaccine. Developed bladder infection on 09/28/1998 and fever returned. Also cold-like symptoms with wheezing and coughing.
Age: 1.3
Sex: F
Vaccine: MEA
Symptoms: Rhinitis, Wheezing
Clinical narrative: The pt developed high fever of 104 deg F on 09/23/1998 lasted for 24 hrs. Then it dropped to 100.6-101 deg. F. over 3-4 days. Pt developed rash on arms and upper trunk. Atypical measles reaction to vaccine. Developed bladder infection on 09/28/1998 and fever returned. Also cold-like symptoms with wheezing and coughing.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: The pt developed 9cm x 7cm of red, warm to touch, and firm area on left deltoid. Duricef 500/5 prescribed by physician.
Age: 0.08
Sex: M
Vaccine: VARCEL
Symptoms: Dyskinesia, Pyrexia, Rash
Clinical narrative: The pt developed fever, mild rash and shaking/jerking in middle of sleep.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: The pt developed redness in right deltoid and warm and tender to touch. Diagnosed with local reaction to DTaP and advised Motrin prn.
Age: 7.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: The pt developed fever for 1-2 days and broke out in chicken pox on 05/14/2002.
Age: 8.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: Approximately 8-10 mins after receiving immunization, pt vomited once. She reported feeling scared and nauseated just before shot. Pt laid down in clinic wiht cool wet towel on forehead for about 20 mins. Mother stated another sibling ahd "stomach flu like nausea" earlier in the week. Pt went home, declined physician follow-up.
Age: 4.7
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site reaction, Rash
Clinical narrative: Pt's mother first noticed on 03/14/2002pm while putting child in tub, swollen, painful and red right deltoid. Next day on 03/15 rash started on neck and across top of shoulder. Seen the physician on 03/15 and diagnosed as skin infection. Keflex po x 14 days. Child denies any pain on 03/15.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: The pt developed red, swelling, warm and tender to touch area on the DTaP injection site. Mother applied ice pack and gave Ibuprofen. Pt seen in clinic 2 days post immunization.
Age: 1.4
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: The pt developed extremely swollen, red, and hard right thigh started off within four hours after vaccination that progressed over next 2 days. Given Tylenol. Child limping left leg also red in the small area.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: The pt developed chicken pox.
Age: 22.0
Sex: U
Vaccine: HEP
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: The pt complained of swollen, hard arm at injection site. Improved next day post onset of symptoms.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: The mother noted large red area on leg (11 1/2 x 8 cm with 4x3 central area of induration). Cool compresses, and Augment ES seen next day with area larger but central clearing and overall less erythema and induration.
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: The pt received Hep A vaccination on 05/06/2002 and developed urticarial rash (arms, legs, and trunk).
Age: 1.2
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Infection
Clinical narrative: The pt developed varicella lesions on waist on 05/09/2002 spreading to extremities on 05/10/2002. Afebrile, lesions were papular to vesicular and pruritic. Approx. 100 lesions noted.
Age: 1.08
Sex: M
Vaccine: DTAP, HBHEPB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: 6 X 9 cm, area of erythema with induration on right thigh lateral thigh
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Rash pruritic
Clinical narrative: The pt developed itchy rash on legs about four days after HBV #3. Referred to student health services physician.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: The pt developed pain, swelling and erythema at DTaP injection site approximately 12 hrs after vaccination. Treated with ibuprofen.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: The pt developed red with mild swelling approx 10 cm in diameter on right deltoid injection site area. Advised to give Tylenol or Motrin and apply warm compresses. Child voices no complaint of pain or discomfort, good range of motion.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Pt is stp varivax and presented w/mild varicella a few years later. Diagnosis based on clinical exam.
Age: 0.2
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: The pt developed redness, swelling and tender at DTaP injection site two hours post vaccination.
Age: 1.7
Sex: M
Vaccine: DTAP, HEP
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: The pt developed cellulitis on left leg.
Age: 23.0
Sex: F
Vaccine: MMR, TD
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: The pt developed redness, warmth and swelling (4"x6") on left arm after the vaccine administration. Pt grimacing when arm touched. Pt states that symptoms started 4 days post vaccination. Pt was able to move arm some how with less pain.
Age: 7.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Rash vesicular
Clinical narrative: 50 kids broke out w/chickenpox this past month at the pt's school. Pt got Varivax on 5-9-02 and broke out with approximately 379 pox by 5-17-02.
Age: 0.3
Sex: M
Vaccine: DTAP, HEP, HIBV, OPV
Symptoms: Crying, Screaming
Clinical narrative: The pt developed screaming, inconsolable cry for 2 1/2-3 hours.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Asthenia, Chills, Dizziness, Headache, Injection site erythema
Clinical narrative: The pt reports that seven days after 1st doses of Hep A and Hep B and again 2nd dose 7 days after she began experiencing hard chills (temp. not taken), headache, enlargement and tenderness in submandibular lymph nodes, neck, extreme weakness, dizziness, aching in bones. Onset of symptoms 05/05, worst day was 05/07. On 05/10 left arm at site raised, reddened and tender to touch 7 x 8 cm.
Age: 52.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pain, Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: The pt reports that seven days after 1st doses of Hep A and Hep B and again 2nd dose 7 days after she began experiencing hard chills (temp. not taken), headache, enlargement and tenderness in submandibular lymph nodes, neck, extreme weakness, dizziness, aching in bones. Onset of symptoms 05/05, worst day was 05/07. On 05/10 left arm at site raised, reddened and tender to touch 7 x 8 cm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema
Clinical narrative: 3 inches total erythema around injection site left deltoid area. Started on  Keflex (150mg/5 ml) 1 1/2 tsp X 10 d for  cellulitis.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The pt developed 2" x 2" area on left deltoid with erythema and warmth.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site haemorrhage, Injection site vesicles, Injection site warmth
Clinical narrative: 5" X 6" slightly warm, ecchymotic area with a small blister.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large, red and swollen local reaction extending beneath arm and hot to touch.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extremely large, red and swollen area that was tender to touch.
Age: 2.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cellulitis, Injection site reaction
Clinical narrative: Right thigh infection at injections site.
Age: 81.0
Sex: M
Vaccine: TD
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt complained of redness, swelling and warmth to right upper arm and deltoid area. Treated with Keflex and Benadryl.
Age: 1.7
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: 102F-103F fever and a severe total body rash lasting for over 2 weeks.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Abasia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling of left leg (front and back) from knee to underwear. Area feels tight and warm. Tender to touch and unable to bear weight. Area of redness about the size of a quarter around the IPV injection site.
Sex: U
Vaccine: DTAP, HEP, HIBV, IPV
Symptoms: Hypersensitivity, Pruritus, Pyrexia, Urticaria
Clinical narrative: Pt had symptoms of hives all over body, high temperature and itching for 4 days. Treated with Benadryl and Oraphed 7.5mg bid. Severe allergic reaction to vaccines.
Age: 8.0
Sex: M
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Pt presented at approx. 15:30 for PPD reading. Mother states she noticed a rash on his right arm, mild erythema at injection site; no pain, no shortness of breath and no other symptoms at this time. Reassured and advised if increased redness or pain to return to clinic or go to ER.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: 7 days, post vax, developed rash, redness on perimeters and raised with clear centers; some fluid filled in appearance which lasted 96 hours. 8 days, post vax, fever to 101F (ax), lasting approx. 72 hours. Treated symptoms with Tylenol and Motrin.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Skin ulcer
Clinical narrative: Information has been received from a physician concerning three children who are 12 months old who are vaccinated with varicella virus vaccine live. Subsequently 2 wks after the vaccine, the pt developed shingles. No further details were provided. Unspecified medical attention was sought. Additional information has been requested.