chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Hypotension, Vomiting
Clinical narrative: Information has been received from a health professional concerning a 31 yr old female described as healthy with no known drug reactions or allergies who was vaccinated with a dose of varicella virus vaccine live (lot 649272/0653P). Concomitant vaccination included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot648671/1070P) and a dose of tetanus toxoid. On 06Jun05 the pt vomited and developed low blood pressure. Subsequently, on 06Jun05, the pt recovered from her adverse experiences. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 4 yr old white male who on 02Aug02 was vaccinated with a first SC dose of varicella virus vaccine live (lot642640/0308M). On 23May05 the pt experienced papular vesicles plus excoriations. Medical attention was not sought. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 2 yr old white male who on the morning of 19Feb05 was vaccinated with the first SC dose of varicella virus vaccine live (lot647270/1103N). The physician reported that in 2005, the pt developed 10-15 lesions and a fever. Medical attention was not sought. The pt was noted to have recovered from the lesions and fever three days after the symptoms began. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 5 yr old male who on 24Aug01 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot 05006). On 06Jun05 the pt presented with a painful linear rash that looked like zoster. It was reported that the rash on the pt's chest, went around to his back and stopped at the midline. The rash started as vesicles which scabbed over, but new vesicles were forming at the time of the report. Unspecified medical attention was sought. The pt was prescribed acyclovir and pain medication. At the time of the report the pt was had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin burning sensation, Stomatitis
Clinical narrative: Information has been received from a 74 yr old female with hypertension, a history of a rash on her leg for five years and no allergies who in approx 1996 or 1997 was vaccinated with the first dose of varicella virus vaccine live. Concomitant therapy included estrogens, conjugated (Premarin) and a diuretic. It was reported on 06Jun05 that over a month ago, the pt experienced a burning rash in the right corner of her mouth. The pt described the rash as little bumps. Unspecified medical attention was sought. She had not recovered at the time of this report. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed a full blown severe case of chickenpox. No other complications were reported and the pt was still recovering at the time of the report. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 42 month old female with no known medical history or allergies who on 29Oct02 was vaccinated with a dose of varicella virus vaccine live. On 18May05 the pt developed a mild case of chickenpox breakthrough. Unspecified medical attention was sought. No treatment was given. Subsequently, the pt recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 8 yr old male who about 2 years ago in approx 2003 was vaccinated with a dose of varicella virus vaccine live. On 01Jun05, the pt presented with about 200 vesicular lesions and no other symptoms. Unspecified medical attention was sought and he was treated with over the counter diphenhydramine hydrochloride (Benadryl). At the time of the report, the pt was recovering. A product quality complaint was not involved. Follow up information was received from the physician who indicated that he had no further information to provide.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 35 yr old female who was vaccinated with a first and second dose of varicella virus vaccine live 28 days apart. As a result, three titers were given which have not converted. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information was received from a woman in a physician's office who reported that the pt was not given the vaccine at her clinic. The pt was vaccinated at another facility which the reporter had no information regarding. No further information is expected.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 yr old pt who in 1997 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox with less than 50 lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 12 yr old pt who in Feb 2005, was vaccinated with a dose of varicella virus vaccine live. It was reported that 24 days following the vaccination, in approx Mar 2005, the pt experienced a rash with 50 lesion and a low grade fever. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Fluid retention, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a RN concerning a healthy nine year old female pt, who on 09Jun00 was vaccinated with a dose of varicella virus vaccine live (lot630678/0426J). On 02Jun05 the pt developed a rash on her abdomen and legs, which then spread to her lower extremities. The rash was described as water filled vesicles and itchy. The suggested treatments were avena (AVEENO bath), diphenhydramine (Benadryl), and calamine lotion. At the time of this report the pt's outcome is recovering. There was no product quality complaint reported. The pt sought medical attention. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a consumer concerning her 41 month old son with multi cystic kidney disease and no allergies who on 07Jun05 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The mother reported that on 08Jun05 her son developed a rash on his buttock. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the pt's rash persisted. No further information is available.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 13 month old female patient adopted from another country who has tinea corporas and a mild developmental delay, who on 5/23/2005 was vaccinated IM with a first dose of varicella virus vaccine live (lot 647763/0191P) and on 6/10/2005 at approximately 17:00 she developed a diffuse rash, which started in the neck area and worked it's way up to the scalp area and down the body. There was no illness at the time of vaccination. The physician reported that there were some very small vesicles, one of which he was able to pop and scrape if needed. The patient was treated with topical econazole 1% and multivitamin with fluoride. A specimen was collected on an unspecified date (approximately May 2005 for PCR analysis and the PCR results showed positive varicella but it was unable to be typed. Therefore it is unknown whether the varicella was wild type or vaccine type. It was noted that the patient did not have adverse events following prior vaccination. There was no product quality complaint reported. The patient recovered on an unspecified date. No additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old female with no medical history who on 6/18/1999, at one year of age, was vaccianted SC in the left arm with the first dose of varicella virus vaccine live (lot 629141/1836H). There was no illness at the time of vaccination. It was also noted that on 6/30/1999, the patient was vaccinated SC in the right arm with the first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 628894/1546H). The NP reported that on 6/3/2005, the patient developed a mild case of breakthrough varicella characterized by less than 25 lesions. ON 6/6/2005, a culture of a trunk lesion was positive for varicella Zoster virus DNA. Otherwise, the patient was not noted to be ill. Unspecified medical attention was sought, but no treatment was required. In June 2005, the patient subsequently recovered from the breakthrough varicella. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Viral infection
Clinical narrative: Information has been received from a mother concerning her 8 year old daughter, who is asthmatic and on albuterol, who was vaccianted with a dose of varicella virus vaccine live. It was reported that the patient sat next to a child in her class who was not vaccianted and apparently came to school for 2 days with active chickenpox. At the end of May 2005, the patient experienced itching and broke out with approximately 30 to 40 spots that resembled little mosquito bites. The patient was seen by a physician who diagnosed the chickenpox. The rash went away within 48 hours and was described as mild. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash erythematous, Viral infection
Clinical narrative: Information has been received from a mother concerning her 7 year old daughter who was vaccinated with a dose of varicella virus vaccine live. It was reported that on 5/21/2005 the patient developed a mild case of breakthrough chickenpox while sitting next an unvaccinated child. The patient had less than 15 red raised areas that resembled bug bites, 1 behind her ear, 2 under her arms, a couple on her belly, and 1 on her bottom. it was noted that the mother felt it was hard to tell that she even had chickenpox. It was noted that patient saw a physician who diagnosed the chickenpox. On 5/21/2005 the patient had a fever and by 5/24/2005 she was recovered. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Erythema, Pyrexia, Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 15 month old female, with no medical history, who on 5/18/2005, at 3:30pm, was vaccianted with a subcutaneous first dose in the upper right deltoid of varicella virus vaccine live (lot 649481/0764P). Concomitant vaccines administered on the same day included a first subcutaneous dose in the upper left posterior arm of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 647113/0346P) and a first intramuscular dose in the upper left vastus of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (lot A65652K). At the time of vaccination it was noted that the patient was well and fever free, the patient had no problems after last shot, the patient has never had a convulsion, there were no children in the home who were no immunized, the patient had no problems with her immune system, no one around the child was taking cortisone or prednisone, the patient had no received blood products within the past year, no one around the patient had cancer, leukemia, AIDS virus, or lymphoma, the patient was not allergic to eggs, neither the patient or anyone in the family was allergic to neomycin, streptomycin, gelatin, or bakers yeast, and that the patient has no allergies. In approximately May 2005, the patient experienced break through chickenpox, described as mild with less than 50 lesions. It was reported that the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that the patients mother called on 6/1/2005 and said that her child has had two rashes since 5/18/2005. One was 2-3 days after the immunizations with a fever, that was no measured by a thermometer. It was reported that the patient now has pinpoint red dots on her back and face with no fever. It was noted that it was recommended to the mother that the child had varicella, and to consider the rash contagious until the lesions crusted and healed. The reporter noted that child had possible vaccine acquired varicella disease. Subsequently, the patient recovered. The patients sibling experienced break through chickenpox following vaccination with varicella virus vaccine live (WAES0506USA01918). Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a registered nurse concerning her male nephew who was vaccinated with a dose of varicella virus vaccine live on an unknown date. Subsequently, the patient developed a case of breakthrough chicken pox, Unspecified medical attention was sought. There was no additional information provided at the time of this report. No product quality complaint was involved. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old male with no known medical history or allergies who on 3/19/2002 was vaccianted SC with a 0.5 ml dose of varicella virus vaccine live (lot 639127/1237L). Concomitant vaccination that day included as SC first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 640792/1381L). On 6/2/2005 the patient developed a few spots. On 6/3/2005, the patient was seen in the office with 6-8 pox on the abdomen. On 6/10/2005 the patient had a total of 12 pox. No treatment was needed. There were no laboratory diagnostic tests performed. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a child who a year or so ago was vaccinated with a dose varicella virus vaccine live. The physician reported that in June 2005, the patient developed chickenpox. Unspecified medical attention was sought and at the time of this report the patient was noted to be recovering from the chickenpox. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 6 year old male with no medical history or allergies who on 5/10/00 was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 6/9/05, the pt developed chickenpox characterized by a widespread rash all over his body. Unspecified medical attention was sought and the pt was treated with acyclovir. At the time of this report, the pt was recovering from the chickenpox. Additional info has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a male who was vaccinated with a dose of varicella virus vaccine live. The physician reported that in 2004, the pt developed breakthrough characterized by five pox on his skin. It was unknown if medical attention was sought. At the time of this report the outcome was unknown. The  physician also reported that another pt could not sleep at night while taking montelukast sodium. No further info is available.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 3 year old white female with eczema who on 10/15/04, was vaccinated SC in the right arm with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. There were no concomitant medication. Subsequently, on 6/6/05 (also reported as 6/7/05)., she experienced a mild case of chickenpox. The pt was not hospitalized. The varicella lesions have subsequently resolved. Follow-up info received from a physician indicated that the child was seen on 6/8/05 with a 2 day history of papular eruptions on her trunk and extremities. The papules were excuriated and some were possibly infected vesicles. Some were noted to be crusting. The child was prescribed estrogens, conjugated (Premarin) cream prn for the adhesions. There were no relevant diagnostic test of lab data noted. There were no adverse events following prior vaccinations. She was noted to visit the physician's office 2 times. The outcome was reported as recovered. There were no adverse events following prior vaccinations of the pt or her siblings. It was noted that the child's 4 month old sibling was hospitalized with a fever and suspected varicella at the time of onset of the pt's lesions. The sibling was without lesions or serologic evidence of varicella. No additional info is expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning an approximately 5 year old pt, "who was entering kindergarten", who on 5/18/05 was vaccinated with a dose of varicella virus vaccine live. In approximately May 2005, the pt experienced breakthrough chickenpox described as mild with less than 50 lesions. It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. The pt's sibling experienced breakthrough chickenpox following vaccination with varicella virus vaccine live. Additional info has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a health professional concerning a 13 year old white female, with no medical history and no allergies, who on 4/20/05, was vaccinated with a 1st dose of varicella virus vaccine live (Lot # "0859P") (also reported as Lot # "08594"). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 5/6/05, the pt experienced chickenpox breakthrough, during a middle school breakout, described as a mild generalized rash with a few mild scattered lesions, 20 bumps, with no fever. There was no treatment. It was noted that the pt had no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Age: 1.76
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Fatigue, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a health professional concerning a 10 year old white male, with no medical history and no allergies, who on 5/31/96 was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 4/13/05 (also reported as 4/13/99) the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a rash, moderate, generalized, mild, with a few scattered lesions, feeling of fatigue and weak, and a fever of 100.4 for 4 days. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No further info was provided. Additional info is not expected.
Age: 1.56
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a health professional concerning an 8 year old white female who on 3/3/98 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 4/14/05, the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a generalized rash, with a moderate case of pox, lesions mild to severe and no fever. There were no complications. It was noted that the pt was out of school for 5 days. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a health professional concerning a 10 year old black male, with no medical history and no allergies, who on 6/12/00, was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 4/15/05, the pt experienced chickenpox breakthrough, during a middle school outbreak. Described as a generalized mild rash with a fever of 99.8 for 3 days. There were no complications. It was noted that there were no lab test. It was reported that the pt recovered on 4/18/05 without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Age: 1.34
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact, Pyrexia
Clinical narrative: Info has been received from a health professional concerning a 9 year old white male, with pre-existing sinusitis, who on 12/10/96 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 4/19/05, the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a generalized rash with moderate to severe lesions and fever of 100.2 for 2 days. There were no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 10 year old white female, with no medical history and no allergies who on 1/12/96 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 5/1/05, the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a mild generalized rash with no fever. It was reported that the pt recovered with no hospitalization. Unspecified medical attention was sought. No produce quality complaint was involved. No other info was provided. Addition info is not expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a health professional concerning a 9 year old white female, with no medical history and no allergies, who on 9/17/96 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 5/3/05, the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a moderate outbreak with a mild generalized rash. It was noted that the pt was febrile via mother's palpation. It was reported that the pt recovered without hospitalization. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. no product quality complaint was involved. No other info was provided. Additional info has been requested.
Age: 1.54
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 9 year old female who on 3/20/97 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccinations. It was reported that on 1/18/05, the pt experienced chickenpox breakthrough described as a generalized, moderate generalized chickenpox rash, during a middle school outbreak, with 200 tiny blisters on her scalp and body. It was noted that the pt was afebrile. There were no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a health professional concerning a 12 year old diabetic white male who on 4/20/05 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 5/7/05, the pt experienced mild generalized chickenpox breakthrough rash, during a middle school outbreak, described as a mild with no fever. There were no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a health professional concerning a 10 year old white male, with no medical history and no allergies, who on 2/23/95 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 4/13/05, the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a generalized, moderate rash with no fever. There were no complications. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 5 year old female who on 1/19/01 was vaccinated with a 2nd dose of varicella virus vaccine live. The physician reported that on 6/10/05, the pt developed a mild case of breakthrough varicella. The pt was noted to be afebrile and did not have many lesions. Unspecified medical attention was sought. At the time of this report, the pt had recovered. There was no product quality complaint involved. Additional info has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a person working a physician's office concerning an 8 year old male, with no medical history and no allergies, who on 11/20/97 was vaccinated with a SC, 1st dose, in the right anterior thigh of varicella virus vaccine live. Concomitant vaccine administered on the same day included a 1st, SC, dose in the left anterior thigh of MMRII. There was no illness at the time of vaccination. It was reported that on 6/1/05, the pt was seen for a rash described as greater that 25 lesions on various areas of his upper body in the form of red bumps, some with vesicles, some with scabs and some urticaria. The dx was a varicella variant. Subsequently, the pt recovered. Additional info is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a woman at a physician's office concerning a 6 year old male student with no pre-existing allergies or medical conditions who on 5/7/01 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 5/30/05, the pt developed >52 lesions; he was seen in the physician's office on 6/2/05 and was dx'd with questionable varicella. An immunization record was received and it was noted that the pt had received the following immunizations in the previous 6 years; poliovirus vaccine given 5/7/99, 7/19/99 and 3/3/00 and polio vaccine IPOL, given in the R arm on 6/4/04; DTP given on 5/7/99, 7/19/99, 10/28/99, 10/19/00 and Tripedia on 6/4/04, given in the left arm; MMRII given 6/13/00 and 6/4/04 given in the left arm; Hib vaccine given on 5/7/99, 7/19/99, 10/19/00; Prevnar given on 6/13/00, 10/19/00. The outcome of the adverse experience was not reported. Additional info has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a CMA concerning a 9 year old white female who on 7/26/96 was vaccinated, SC, with a dose of varicella virus vaccine live. On 5/19/05, the pt was seen in the physician's office and was dx'd with chickenpox. Treatment included calamine lotion and OTC ibuprofen (Motrin). The pt was reported to be recovering as of 5/19/05. There was no further info provided at the time of this report. Additional info has been requested.
Age: 1.97
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning an 11 year old healthy white female pt with no pertinent medical history, who on 11/14/95 was vaccinated, SC, in the right arm, with a 1st dose of varicella virus vaccine live. There was no concomitant medication. On 6/1/05, she pt had an onset of red itch bumps which started on her head and back, by 1/3/05, bumps were everywhere on her body. The physician confirmed the dx of breakthrough chicken pox in the physician office on 6/3/05. It was reported that the child had more than 35 pox on her body that were itchy and some were fluid filled. There was no fever present. It was reported that the pt recovered. No further info was available regarding the adverse event. There was no product quality complaint reported. No additional info is expected.
Age: 3.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Info has been received from a CMA concerning a 43 month old female pt with no allergies or pertinent medical history, who on 11/12/02 was vaccinated, SC in the right arm once with a 0.5mL dose of varicella virus vaccine live. Concomitant vaccine therapy included a dose of MMRII, in the left arm. On 6/11/05, the pt experienced 15 papules on the trunk, arms and back. It was reported that the adverse experience was improved after receiving Benadryl. It was reported that the pt recovered on 6/17/05. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional info is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pharyngolaryngeal pain, Pyrexia, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 7 yr old white female student with no pre-existing allergies or medical conditions, who on 07Nov00 was vaccinated SC in the left arm with the first 0.5mL dose of varicella virus vaccine live (lot634515/0540K). There were no concomitant medications and there was no illness at the time of vaccination. The physician reported that on 10Jun05 (previously reported as 11Jun05), the pt developed a classic case of chickenpox characterized by a sore throat and fever for 2-3 days. It was also noted that the pt's chickenpox lesions were in various stages.  A doctor's visit was required, but no treatment was given. It was reported that the pt recovered as of 17Jun05. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 yr old white female student with no pre-existing allergies or medical conditions, who on 07Nov00 was vaccinated SC in the left arm with the first 0.5mL dose of varicella virus vaccine live (lot634515/0540K). There were no concomitant medications and there was no illness at the time of vaccination. The physician reported that on 10Jun05 (previously reported as 11Jun05), the pt developed a classic case of chickenpox characterized by a sore throat and fever for 2-3 days. It was also noted that the pt's chickenpox lesions were in various stages.  A doctor's visit was required, but no treatment was given. It was reported that the pt recovered as of 17Jun05. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 yr old female who on 21Feb97 was vaccinated with a dose of varicella virus vaccine live (620626/1400D). On 13Jun05 the pt developed 50 lesions described as moderate chickenpox, with lesions in the mouth and vagina and a fever of 101.4. Unspecified medical attention was sought. It was reported that there was no recent exposure to chickenpox. The pt's present status was unk. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, Unintended pregnancy
Clinical narrative: Information has been received from a physician through a pregnancy registry concerning a female who was vaccinated in 2000 with two doses of varicella virus vaccine live six months apart. Subsequently a titer was checked and was negative. Unspecified medical attention was sought. On 06Jun05, the mother was picking up her four year old from daycare and was exposed to chickenpox. On 09Jun05 she was vaccinated with another dose of varicella virus vaccine live while pregnant. Unspecified medical attention was sought. On 10Jun05 she was induced and vaginally delivered a healthy baby boy. The mother was given after delivery. As of 14Jun05, the infant was five days old and had been breast feeding for five days. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Condition aggravated, Dermatitis bullous, Eczema, Irritability, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 18 month old male with a history of eczema and no allergies, who on 23Nov04 was vaccinated with a 0.5ml dose in the right lower thigh of varicella virus vaccine live (Lot0345p). There were no concomitant medications. Last night, on 14Jun05 the pt presented with possible breakthrough varicella rash which the physician felt was worsened by the child's history of eczema. The physician thought it was eczema herpeticum. It was reported that the physician obtained a scraping of the lesion. The pt began on acyclovir yesterday. Follow up information from a physician indicated that on 12Jun05 the pt experienced hundreds of vesicles then excoriations and undilated ulcerations that were distributed on his face, elbows and knees in an eczematous distribution. It was reported that the pt also experienced a maximum temp of 100, fussiness, and eczema herpeticum. It was noted that a rash did not occur at the site of injection post vaccination, and that the pt did not have a recent exposure to chickenpox or shingles. The specimen arrived in the lab on 15Jun05 and VZV DNA was not amplified, B globin DNA was amplified and the interpretation was that it was an adequate specimen but no VZV was identified negative. The pt's status was reported as recovered. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 18 month old male with a history of eczema and no allergies, who on 23Nov04 was vaccinated with a 0.5ml dose in the right lower thigh of varicella virus vaccine live (Lot0345p). There were no concomitant medications. Last night, on 14Jun05 the pt presented with possible breakthrough varicella rash which the physician felt was worsened by the child's history of eczema. The physician thought it was eczema herpeticum. It was reported that the physician obtained a scraping of the lesion. The pt began on acyclovir yesterday. Follow up information from a physician indicated that on 12Jun05 the pt experienced hundreds of vesicles then excoriations and undilated ulcerations that were distributed on his face, elbows and knees in an eczematous distribution. It was reported that the pt also experienced a maximum temp of 100, fussiness, and eczema herpeticum. It was noted that a rash did not occur at the site of injection post vaccination, and that the pt did not have a recent exposure to chickenpox or shingles. The specimen arrived in the lab on 15Jun05 and VZV DNA was not amplified, B globin DNA was amplified and the interpretation was that it was an adequate specimen but no VZV was identified negative. The pt's status was reported as recovered. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a woman in a pediatric office concerning a 27 month old white male who on 01Sep03 was vaccinated with a first IM dose of varicella virus vaccine live (lot 1158N). On 15Apr05 the pt was diagnosed with varicella. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 18 month old female with no allergies or medical history who on 15Jan05 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot649271/0652P). There was no illness at the time of vaccination. On 13Jun05 the pt developed a rash. On 14Jun04 the pt presented to the office with 20-30 scattered papules, some with vesicular heads, consistent with chickenpox. Symptomatic treatment was provided. There was no product quality complaint involved. Follow up information indicated that the pt was seen in the office and it was noted that there were approx 20-30 scattered papules and some were vesicular heads. Diagnosis was varicella and the onset date was 14Jun05. The child was afebrile. No other labs or diagnostic tests were done. The pt recovered. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Myalgia, Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning her 6 yr old white grandson with no allergies or medical conditions who, at one year of age, was vaccinated with a dose of varicella virus vaccine. There was no illness at the time of vaccination. Recently the pt had a case a break through chickenpox. He had more than 50 lesions all over his body and a fever of 102. He was sick for seven days and was given a medication by his doctor but the name of the medication was not known. The nurse reported that there was a mild outbreak in the pt's school. Subsequently, the pt recovered from breakthrough chickenpox.  A product quality complaint was not involved. Follow up information was received from a consumer who  reported that on 18Feb05 at 17:00 the pt had a full chickenpox outbreak with more than 50 pox and a high fever of 103 degrees along with vomiting and bodyaches. Clinical observation by the pt's primary care physician was required. The pt recovered on 25Feb05. No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a RN concerning her 6 yr old white grandson with no allergies or medical conditions who, at one year of age, was vaccinated with a dose of varicella virus vaccine. There was no illness at the time of vaccination. Recently the pt had a case a break through chickenpox. He had more than 50 lesions all over his body and a fever of 102. He was sick for seven days and was given a medication by his doctor but the name of the medication was not known. The nurse reported that there was a mild outbreak in the pt's school. Subsequently, the pt recovered from breakthrough chickenpox.  A product quality complaint was not involved. Follow up information was received from a consumer who  reported that on 18Feb05 at 17:00 the pt had a full chickenpox outbreak with more than 50 pox and a high fever of 103 degrees along with vomiting and bodyaches. Clinical observation by the pt's primary care physician was required. The pt recovered on 25Feb05. No further information is expected.
Age: 1.37
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 year old Caucasian female with attention deficit disorder and no drug allergies who on 24Nov98 was vaccinated with a dose of varicella virus vaccine live (lot 626966/1054H). Concomitant vaccination given on the same day included the fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot0939790) given IM in the left vastus lateralis (LVL) and the fourth dose of Hib conj vaccine (CRM197) (Hibtiter) (lot M240RL) given IM in the LVL. There was no illness at the time of vaccination. Concomitant therapy included sertraline HC1 (Zoloft), clonidine and amphetamine aspartate/amephetamine SO4/dex (Adderall tablets). On 13Jun05 (previously reported as 11Jun05) the pt developed breakthrough chickenpox characterized by a lot of pox on her chest, back and perineal area. Unspecified medical attention was sought. No lab or diagnostic tests were performed. The pt was reported to be in active recovery as of 17Jun05. The reporter also noted that the pt had received the following vaccinations on 14Jul98: the first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot625314/1681E) given SC in the LVL and the third dose of poliovirus vaccine inactivated (IPOL) (lot U0903) given IM in the RL. No product quality complaint was involved. The nurse also reported that the pt's brother developed breakthrough chickenpox (associated WAES0506USA02915). Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a consumer concerning her son a 13 year old male with no known medical history or allergies who on 13Aug96 was vaccinated SC in the left deltoid with a first dose of varicella virus vaccine live (lot617073/1662B). There was no concomitant medication. On 06Jun05 the pt developed a classic course of varicella. Unspecified medical treatment was sought. No lab diagnostic tests were performed. On approx 14 Jun05 the pt recovered. There was no product quality complaint involved. Follow up information from a physician indicated that the pt's vaccination history included: a first, second, third and fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid on 07Apr92, 12Jun92, 08Aug92 and 10Aug93 respectively; a dose of diphtheria toxoid (+) pertussis acellular 4 component vaccine (+) tetanus toxoid (Acel-Imune) (lot 386911) on 07Feb96 in the left deltoid; a first, second, and third dose of poliovirus vaccine live oral on 07Apr92, 12Jun92, and 10Aug93 respectively; a dose of poliovirus vaccine live oral (lot 0736A) on 07Feb96; a first and second dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 14May93 and 24Jul97 (lot 620094/1334D; in the left arm) respectively; a first, second, third and fourth dose of HIB vaccine (unsp) on 07Apr92, 12Jun92, 08Aug92, and 14May93, respectively; a first, second and third dose of hep B virus vaccine (unsp) on 23Feb94, 23Mar94 and 19Aug94, respectively a first dose of BCG vaccine on 05Mar05; a first and second dose of tuberculin purified protein derivative (Tubersol) on 18Aug97 (lot246311) in the left forearm and 23Jun03 (lot C1430A8); a first, second, and third dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) on 12Nov01 (lot U0707AA), 20Nov02, and 20Oct03, respectively. Additional information has been requested.
Age: 0.83
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Medication error, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 yr old female who on 10Jun99 was vaccinated with a dose of varicella virus vaccine live. On 13Jun05 the pt experienced a case of breakthrough. It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 2 yr old male who on 09Feb04 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot647520/1106N). On 06Jun05 the pt developed chickenpox lesions. Additional information is not expected.
Age: 0.96
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a mother concerning her 9 yr old white daughter who around Sep 1996, was vaccinated with a dose of varicella virus vaccine live. On 09Jun05 the pt experienced chickenpox, described as a bad case with hundreds of pox. It was reported that it was 2 outbreaks, first a big one and then, when they healed, a second smaller one. It was noted that the pt also had a fever for 3 days. Additional information has been requested.
Age: 1.26
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician's assistant (PA) concerning a 6 yr old male who on 04May00 was vaccinated SC (631073/0450J). The PA reported that on 15Jun05, the pt presented to the office with a case of varicella characterized by several hundred lesions on his back, trunk, face and a few on his extremities. The pt was also noted to have a low grade fever. The pt was treated with ibuprofen and at that time of this report was recovering from the varicella. Additional information has been requested.