chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 14-Nov-1997 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed "mild breakthrough" with "less than 50 lesions". It was noted that the patient was part of 7 children reported, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions (WAES #0312USA00884), (WAES #0312USA00885), (WAES #0312USA00886), (WAES #0312USA00887), (WAES #0312USA00888) and (WAES #0312USA00889). Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 6 year-old Asian male patient with a concurrent condition of eczema who on 02-Jun-1998 was vaccinated SC in the arm with a first dose of varicella virus vaccine live. The physician reported that recently the patient came to the office with 60-70 lesions, a fever of 101 degrees, and itching. The physician reported the patient had chicken pox disease with crops of vesicles intermittent became generalized. The onset of the chicken pox was reported as 24-Nov-2003. The physician noted the vesicles appeared in stages. There were no laboratory or diagnostic studies performed. The patient recovered on 01-Dec-2003. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 6 year-old Asian male patient with a concurrent condition of eczema who on 02-Jun-1998 was vaccinated SC in the arm with a first dose of varicella virus vaccine live. The physician reported that recently the patient came to the office with 60-70 lesions, a fever of 101 degrees, and itching. The physician reported the patient had chicken pox disease with crops of vesicles intermittent became generalized. The onset of the chicken pox was reported as 24-Nov-2003. The physician noted the vesicles appeared in stages. There were no laboratory or diagnostic studies performed. The patient recovered on 01-Dec-2003. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 16 year old white female with no medical history and no allergies who on 21JUL1997 was vaccinated with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 17NOV2003 the patient developed chicken pox and a clinical diagnosis of varicella was made. It was reported that she had varicella like lesions that appeared all over her body.Unspecified medical attention was sought. No diagnostic lab tests were performed. No product quality complaint was involved. It was also reported that another patient was vaccinated with a dose of varicella vaccine live and developed chicken pox. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a male child who was vaccinated with a dose of varicella virus vaccine live. The nurse practitioner indicated that her staff nurse received information from a mother that her child's doctor diagnosed her son as six days post recovery from shingles which the pt developed after vaccination. All of the lesions were dried and covered and the doctor stated that the child could return to school. A varicella zoster virus identification specimen was not performed. It was unknown if a prescription drug was required. A product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 5 year old Caucasian female pt with no allergies and no past medical history who on 11FEB1998 was vaccinated in the right arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination.  There was no concomitant medication. Subsequently, the patient was "exposed to disease (varicella virus vaccine live). On 13JAN2003, the patient "came down with disease" . Medial attention was not sought and laboratory testes were not performed. Subsequently,the patient recovered. The reporter also mentioned three other patients who had similar experiences following vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 6 year old female patient with no allergies and no past medical history who on 22SEP1998 was vaccinated in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the patient was exposed to chickenpox at school. On 11NOV2003, the patient "came down with the disease". Medical attention was not sought and laboratory tests were not performed.  Subsequently, the patient recovered. The reporter also mentioned three other patients who had similar experiences following vaccination with varicella virus vaccine live. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a white female patient with no allergies, no past medical history and no adverse events following prior vaccination who on 29JUL1999 was vaccinated in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The patient was exposed to chickenpox at school. Subsequently, the patient "came down with disease". Medical attention was not sought and laboratory tests were not performed. Subsequently the patient recovered. The reporter also mentioned three other patients who had similar experiences following vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a woman in a medical office concerning a 8 year old white male patient with no allergies, no past medical history and no adverse events following prior vaccinations who on 06AUG1999 was vaccinated in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Subsequently, the patient was exposed to chickenpox. In November, the patient "broke out with disease". Medical attention was not sought and laboratory tests were not performed. Subsequently, the patient recovered. The reporter also mentioned three other patients who had similar experiences following vaccination with varicella virus vaccine live. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a pediatric patient who in 1999 was vaccinated with a dose of varicella virus vaccine live. In 2003 the patient had a "mild breakthrough" . Subsequently,the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. On 21JAN2004 it was reported that the patient was unknown. No further information is expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 08APR1999 was vaccinated with a dose of varicella virus vaccine live. On 12NOV2003 the patient presented with a mild case of chickenpox and there was no treatment required. There was no product quality complaint involved. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female who on 17APR1996 was vaccinated with a dose of varicella virus vaccine live. It was noted that the vaccination was given by another health care provider. There was no known illness at the time of vaccination. The reporter indicated that on 28NOV2003 the patient presented at her practice with a mild case of chickenpox. A prescription drug was not required. A product quality complaint was not involved. Follow up information was received from a registered nurse which indicated that on 28NOV2003 at 1:00 pm. the patient  presented with a varicella rash at the office seven and a half years after receiving the vaccine. The patient subsequently recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a patient with a history of known exposure to "wildtype varicella" who was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live. Subsequently, the patient developed varicella, and was "briefly hospitalized". It was noted that the "doctors were certain that wildtype varicella was the infectious agent based on clinical studies." Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. On 16JAN2004 it was reported by the nurse manager that she could not recall who the patient was and without a name or a date of birth it would be impossible to determine who the patient was in this report. No further information is expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female who, at 2 years old, was vaccinated with a dose of varicella virus vaccine live. On 01DEC2003 it was reported that the patient "recently" developed 10-15 varicella breakthrough lesions. It was reported that she was exposed to the wild type varicella at school and that there had been an "outbreak of wild virus of varicella" in the school district. No testing was done. It was unknown if medical attention was sought. No product quality complaint was involved. It was also reported that the patient's brother and female cousin was vaccinated with a dose of varicella virus vaccine live and also developed varicella breakthrough lesions. It was also reported that 12-14 children were vaccinated with a dose of varicella virus vaccine and developed varicella. The nurse also reported that she did not keep separate charts and that she was unable to answer the questions asked. No further information is expected.
Age: 13.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a woman in a pediatrician's office concerning a 13 year old white male with Down's syndrome and "acquired hypothyroid" who on 08JAN1998 was vaccinated with a first dose of varicella virus vaccine live, in the right arm and a second dose of measles virus vaccine live + mumps virus vaccine live+ rubella virus vaccine live, in the left arm. There was no illness at the time of vaccination. On 18NOV2003 the patient developed a "diffuse vesicular rash on arms, legs and trunk." There were no relevant diagnostic tests or laboratory data. The patient recovered on 26NOV2003. No further information is expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from an office staff member on behalf of a physician concerning an 11 year old white male who on 05JUN1995 was vaccinated with a first dose of varicella virus vaccine live. On 14NOV2003 the patient developed clinical varicella. Unspecified medical attention was sought. No diagnostic tests were performed. Subsequently, the patient recovered. No product quality complaint was involved. It was also reported that another patient was vaccinated with a dose of varicella virus vaccine live and developed chicken pox. No further information is expected.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Otitis media, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old white female with gastroesophageal reflux disease (GERD), a left ear infection, poor weight gain and failure to thrive who on 24NOV2003 at a well child visit was vaccinated intramuscularly in the right arm with a first dose of varicella virus vaccine live. Concomitant vaccination included a fourth dose of pneumococcal vaccine. There was no other concomitant medication. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 30NOV2003 the patient developed full blown varicella lesions over his entire body that appeared like a "full slam natural illness". There was no fever. It was suspected that the patient had a natural exposure but there was no history of such. It was reported that the patient also being treated with amoxicillin for an ear infection. Unspecified medical attention was sought and no treatment was required. No diagnostic tests were performed. It was reported that the patient was still ill. It was also noted that all work-up "to date" for the patient's failure to thrive was negative. No product quality complaint was involved. Follow up information indicated that on 30NOV2003, the patient developed full blown varicella illness and left otitis and "no adverse events". It was reported that the scars were healing well and the patient did not develop cellulitis. No hospitalization or even repeated office visits were noted. The patient recovered in December 2003. No  further information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male who, at 12 months old, was vaccinated with a dose of varicella virus vaccine. On 01DEC2003 it was reported that the patient "recently" developed 10-15 varicella breakthrough lesions. It was reported that he was exposed to the wild type varicella at school and that there had been an "outbreak" of wild virus of varicella in the school district. No testing was done. It was unknown if medical attention was sought.  No product quality complaint was involved. It was also reported that the patient's sister and female cousin were vaccinated with a dose of varicella virus vaccine live and also developed varicella breakthrough lesions. It was also reported that 12-14 children were vaccinated with a dose of varicella virus vaccine live and developed varicella. The nurse also reported that she did not keep these charts separate and was unable to answer the questions asked. No further information is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female who in September 1997, at another physician's office was vaccinated " a little early" with a dose of varicella virus vaccine live. On 01DEC2003 it was reported that the patient "recently" developed 20-25 varicella breakthrough lesions. It was unknown if medical attention was sought. it was also noted that the school district had an outbreak of "wild virus of varicella" and that no testing was done. No product complaint was involved. It was also reported that the patient's female cousin and male cousin were vaccinated with a dose of varicella virus vaccine and also developed varicella  breakthrough lesions. The nurse also reported that she did not keep these charts separate and was unable to answer the questions asked. No further information is expected.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pain, Viral infection
Clinical narrative: Information has been received from a physician concerning a 13 month old female with no allergies, medical history, or history of chickenpox or chickenpox/herpes zoster exposure who on 12SEP2003 was vaccinated in the right arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was noted that the patient was vaccinated at 12 months of age and at "15-months" of age the patient developed a case of zoster. The reporter also indicated that a rash did not occur at the site of injection or elsewhere within 42 days of vaccination. Unspecified medical attention was sought and it was unknown if treatment was required. It was noted that the patient had not been back into the office. A product quality complaint was not involved. Follow up information was received from a registered nurse which indicated that on 27OCT2003 the patient was diagnosed with shingles and was started on acyclovir. The patient's maximum temperature was 97.4. On a pain scale of 0 to 10, with 10 being the most, pain was noted to be an 8. No diagnostic laboratory tests, including a direct fluorescent antibody or polymerase chain reaction, were performed. The patient recovered on 25NOV2003. It was also noted that the patient and her siblings had no adverse events following prior vaccination. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 1 year old female who on 17NOV2003 was vaccinated with varicella virus vaccine live. On 27NOV2003 the patient developed "full blown case of chicken pox." The patient sought unspecified medical attention. It was also reported that another patient developed chickenpox after being vaccinated with varicella virus vaccine live. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a male who was vaccinated with a dose of varicella virus vaccine live. The reporter is unsure if the patient was vaccinated with the vaccine or not. Subsequently the patient developed a chicken pox break out. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received form a health professional concerning a 4 year old female with no known medical history who on 18JUL2000 was vaccinated in the left arm with a first dose of varicella virus vaccine live. Concomitant vaccination the same day included a third dose of hepatitis b virus vaccine given into the left arm and a first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live given in the right arm. There was no illness at the time of vaccination. On 27NOV2003 the patient broke out with mild varicella. Subsequently, the patient recovered. No further information is expected.
Age: 1.9
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 23 month old normal healthy male child with no immunosuppression and no allergies who on 12/12/02 (also reported as 2001) was vaccinated in the left arm SC with a dose of varicella virus vaccine live (lot # 643540/0604M). There was no concomitant medications. There was no recent exposure to chicken pox or shingles. The child did not have a rash post vaccination. On 12/1/03 the patient experienced shingles in the left arm, which was the same site as the injection of vaccine. It was reported that there was no known recent exposure to varicella. The shingles are in dermatomes C5, C6, and C7. The physician indicated that the child appears to have pain from the lesions, but no other signs or symptoms. A specimen was collected from one of the shingles lesions. The hospital found it to be positive for varicella zoster virus (VZV). A sample will be sent for PCR analysis. Follow up information indicated that the results were of vaccine OKA strain. Additional follow up information indicated that the patient had a history of vesicoureteric reflux and was s/p a ureteric implantation. It was reported that on 12/3/03 the patient got a rash described as herpes zoster shingles on the left arm covering C5, C6, and 7 dermatomes. There were multiple papulovesicular lesions. On 12/03/03 a vesicular specimen was obtained and sent for PCR analysis. It was an adequate specimen and VZV DNA was amplified and showed vaccine type strain. The patient's experience was ongoing. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning her 4 year old grandson who on 12/3/98 was vaccinated with a dose of varicella virus vaccine live. On 12/20/01 the patient developed a mild case of chicken pox. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint. The physician also indicated that 3 other children experienced chicken pox after being vaccinated with a dose of varicella virus vaccine live. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a child who was vaccinated with varicella virus vaccine live. Subsequently, the patient developed chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information indicated that this was not a reaction. No further information is expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning her friend's 7 year old grandson who was vaccinated with a dose of varicella virus vaccine live. Three years later, the patient developed shingles. Unspecified medical attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on approximately 11/28/03, last week was vaccinated with a first dose of varicella virus vaccine live and in December 2003, now has approximately 24 varicella-like lesions on her body. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male child who on 3/28/96 was vaccinated with a dose of varicella virus vaccine live (lot # 612214/1124B). On 12/4/03, yesterday, the patient broke out in a mild case of chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that this case was part of 16 cases of chicken pox reported at a school, 4 of which had been previously vaccinated with varicella virus vaccine live. The reporter also mentioned three other children who were siblings and experienced similar reactions. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on 10/27/98 was vaccinated with a dose of varicella virus vaccine live. On 10/17/03 the patient developed a severe case of chicken pox. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint. The physician also indicated that three other children experienced chicken pox after being vaccinated with a dose of varicella virus vaccine live. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 6 year old male who in June 1998 was vaccinated with a dose of varicella virus vaccine live. On 10/28/03 the patient developed a case of chicken pox (severity unknown). Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint. The physician also indicated that 3 other children experienced chicken pox after being vaccinated with a dose of varicella virus vaccine live. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 7 year old female who in June 1998 was vaccinated with a dose of varicella virus vaccine live. On 10/29/03, the patient developed a mild case of chicken pox. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint. The physician also indicated that 3 other children experienced chicken pox after being vaccinated with a dose of varicella virus vaccine live. Additional information has been requested.
Age: 46.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 46 year old male who in March 2000 completed the adult schedule of varicella virus vaccine live (lot # 631071/1002J). A recent titer did not show seroconversion. No other information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a child who was vaccinated several years ago with a dose of varicella virus vaccine live. Subsequently, the patient had a breakthrough case. The physician also mentioned who are her children and who experienced similar reactions. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a 33 year old female student with Crohn's disease and post-traumatic stress disorder who on 3/14/03 and 4/11/03 was vaccinated with the first and second doses of varicella virus vaccine live, respectively. There was no concomitant therapy. The physician reported that, in 2003, after two doses of varicella virus vaccine live the patient did not seroconvert as confirmed by a negative titer. The physician also noted that the patient had no adverse reaction. Unspecified medical attention was sought. Subsequently, a third dose of varicella virus vaccine live was given and the patient was noted to have a positive titer. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Infection, Rash macular, Rash pustular
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old white female who on 10/6/03, at 16:15, was vaccinated SC in the left arm with the first dose of varicella virus vaccine live (lot # 643593/0868M). Concomitant vaccinations on that same day and time included the fourth dose IM in the right arm of pneumococcal 4 6B 9V 14 18C 19F 23F conjugate vaccine (PREVNAR)(lot # 493472). There was no illness at the time of vaccination. The RN reported that on 10/21/03, the patient developed a mild case of chicken pox. On 10/23/03, the patient presented to the office with a rash characterized by small clear pustules and macules in different stages of evolution mostly on the extremities, although there was also one on her trunk. Subsequently, the patient recovered from the chicken pox. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning an 8 year old female with no known medical history who on 9/11/00 was vaccinated SC in the right leg with a second dose of varicella virus vaccine live (lot # 634850/0762K). Concomitant vaccination the same day included a second dose of MMR. There was no illness at the time of vaccination. On 12/1/03, the patient developed lesions; 10-15 scattered erythema nearly vesicular lesions, was itchy and afebrile. No laboratory or diagnostic tests were performed. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a female who on 5/13/03 was vaccinated with varicella virus vaccine live. On 11/29/03 the patient developed a mild case of chicken pox. It was noted that the patient's father had broke out with shingles the same day that she broke out with chicken pox. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed mild breakthrough with less than 50 lesions. It was noted that the patient was part of 7 children reported, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 8/5/96 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed mild breakthrough with less than 50 lesions. It was noted that the patient was part of 7 children reported, 4 males and 3 female, some of which are siblings who were vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 9/4/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed mild break through with less than 50 lesions. It was noted that the patient was part of 7 children reported, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed mild breakthrough with less than 50 lesions. It was noted that the patient was part of 7 children, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned six other patients who were vaccinated with varicella virus vaccine live and experienced similar reactions. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection, Radiation injury
Clinical narrative: Information has been received from a RN concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed "mild breakthrough" with "less than 50 lesions". It was noted that the pt was part of 7 children reported, 4 male and 3 female, some of which were siblings who were vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned 6 other pt's who were vaccinated with varicella virus vaccine live and experienced similar reactions (WAES # 0311USA02872, 0312USA00884, 0312USA00885, 0312USA00886, 0312USA00887, 0312USA00888).  Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 10 year old male child who on 10/09/95 was vaccinated with a dose of varicella virus vaccine live (Lot # 609285/0430B). Subsequently, between the dates of 10/06/03 to 12/04/03, the child developed a "mild case of chickenpox breakthrough" that was diagnosed by a physician. Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that this case was part of 16 cases of chickenpox reported at a school, 4 of which had been previously vaccinated with varicella virus vaccine live. The reporter also mentioned three other children who experienced similar reactions (WAES # 0312USA00810, 0312USA01002 & 0312USA01003), two of which were siblings, respectively.  Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 7 year old female child who on 12/03/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, between the dates of 10/06/03 to 12/04/03, the pt developed a "mild case of chickenpox break thru". It was noted that this case was part of 16 cases of chickenpox reported at a school, 4 of which had been previously vaccinated with varicella virus vaccine live.  The reporter also mentioned three other children who experienced similar reactions (WAES # 0312USA00810, 0312USA01001 & 0312USA01003) two of which were siblings respectively.  Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning an 8 year old female child who on 01/09/97 was vaccinated with a dose of varicella virus vaccine live. Subsequently, between the dates of 10/06/03 to 12/04/03, the pt developed a "mild case of chickenpox break thru". It was noted that this case was part of 16 cases of chickenpox reported at a school, 4 of which had been previously vaccinated with varicella virus vaccine live.  The reporter also mentioned three other children who experienced similar reactions (WAES # 0312USA00810, 0312USA01001 & 0312USA01002), two of which were siblings respectively. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 15 year old male who on 11/20/03, was vaccinated with the first dose of varicella virus vaccine live. The physician reported that on 12/03/03 the pt developed a rash consisting of 5-7 lesions on his trunk. The physician considered the rash to be a mild form of chickenpox. Unspecified medical attention was sought, but it was unknown if treatment was required. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Herpes zoster, Infection
Clinical narrative: Information has been received from a physician concerning an otherwise healthy 12 year old male with no allergies or history of chickenpox who in August 1999 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The physician reported that in approximately October 2003, the pt developed extensive severe herpes zoster in one dermatome in which an isolate grew varicella zoster virus (VZV). Unspecified medical attention was sought. It was noted that the pt had not had a recent exposure to chickenpox. On 10/28/03, a vesicle lesion was obtained and sent to the lab for analysis. Subsequently recovered from the severe herpes zoster. Results from PCR testing revealed that the pt had wild-type VZV infection. The physician also reported that another pt had died from VZV infection after being possibly exposed to someone who had been vaccinated with varicella virus vaccine live (WAES # 0312USA01394).  No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician who is the mother of a pt who was vaccinated "several years ago" with a dose of varicella virus vaccine live. Subsequently, the pt "had a breakthrough case" with 150 lesions and "no fever".  It was noted that the child had to stay home from school. The physician also mentioned (WAES # 0312USA00828) who also was her child and (WAES # 0312USA01109) who experienced similar reactions. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician concerning her 7 year old white son with no past medical history and no known drug allergies who on 09/13/96 was vaccinated with a first dose of varicella virus vaccine live (Lot # 616497/0416E). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose of MMRII (Lot # 618391/0890D). Subsequently, the pt developed "breakthrough disease" with 150 lesions and "no fever". It was noted that the child had to stay home from school. Follow up information received from a physician indicated that the child was immunized for chickenpox and developed chickenpox (approximately 100 lesions) on 11/16/03 at 8:00AM.  The outcome was reported as recovered on 11/21/03.  No relevant diagnostic tests or lab data were obtained. There were no adverse events following prior vaccinations of the pt.  The physician also mentioned the pt's sibling (WAES # 0312USA01108) and one other child (WAES # 0312USA00828) experienced similar reactions. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pain, Pruritus, Rash
Clinical narrative: Information has been received from a health professional concerning a 4 year old female with no pertinent medical history who on 06/07/00 was vaccinated with a dose of varicella virus vaccine live (Lot # 634842/1867J).  There was no concomitant medication.  The child came into the office on 12/10/03 and reported that two days ago, on 12/08/03, she developed 1 or 2 pimples on her chest. On 12/10/03 they were also on her abdomen and the number increased to 6-7. She also had some in her groin and a couple on her arms. It was reported that they itch and hurt. No labs or diagnostic test were performed. No product quality complaint was involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a consumer concerning her 7 year old son who on 03/04/97 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included montelukast sodium and Zyrtec. On 10/04/03 the pt broke out with one small spot on his arm and has since spread over his body.  The pt's mother reported that this was an outbreak of chickenpox. Unspecified medical attention was sought. As of 10/08/03, the pt had not recovered and was still resting at home. There was no product quality complaint involved. Follow up information from the health care professional indicated that the pt got active chickenpox in the fall of 2003. He had been vaccinated at 12-13 months of age. No unusual reaction to the vaccine and no serious chickenpox was reported.  The reporter also indicated that the pt's brother (WAES # 0310USA01194) had similar experience following exposure to varicella vaccine live. No further information is expected.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 37 year old male with no reported medical history or allergies who on 08/21/95 and 10/04/95 was vaccinated with first and second doses of varicella virus vaccine live (Lot # 608589/0416B). The physician indicated that the pt's wife had shingles and the pt presented to the MD's office a "couple days later" on 12/10/03 with a varicella-like rash on the trunk of his body. The pt was treated with "Zovrax".  A product complaint was not involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 6 year old male who on 09/16/98 was vaccinated with a first dose of varicella virus vaccine live (Lot # 627330/1052H).  On 12/01/03 the pt had "50 vesicles in different stages all over." A MD visit was required and the pt was treated with Aveeno, Benadryl, Calamine and Tylenol. No diagnostic tests were performed. Subsequently, the pt recovered. Additional information is not expected.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 35 year old female with no allergies who on 08/17/01 and on 10/12/01 was vaccinated with a first (Lot # 638811/0498L) and second dose (Lot # 639432/0787L) of varicella virus vaccine live, respectively. Concomitant therapy included "birth control pill". Subsequently, it was reported that the pt "twice failed to seroconvert."  On 11/29/03 a titer drawn showed that the pt failed to seroconvert. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning an approximately 32 year old female with no past medical history who on 10/31/97 (Lot # 623131/0801E) and on 12/08/97 (invalid Lot # 623890/0701E for this product) was vaccinated with varicella virus vaccine live. There was no concomitant medication. In 2000, the pt tested negative for antibodies. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a RN concerning a 13 year old white male who was vaccinated with a dose of varicella virus vaccine live. On 11/26/03 the pt had multiple scattered macules and pustules on the face and trunk. A MD's visit was required and the pt was treated with calamine and given symptomatic care. No diagnostic tests were performed. Subsequently, the pt recovered.  Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a woman in a medical office concerning a 5 year old white male who on 08/11/99 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination.  On 12/05/03, the pt developed approximately 15 red, round, raised areas on his chest, leg, head and arm.  It was noted to be itchy. The areas were in all different stages of development. Medical attention was not sought. At the time of the report, the pt outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Blister, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a LPN concerning a 12 month old white female with eczema and no known allergies or other medical history who on 10/22/03 at 10:30AM was vaccinated in the right arm with a first dose of varicella virus vaccine live (Lot # 645579/0440N). Concomitant therapy that day at 10:30AM included a first dose of MMRII (Lot # 641627/0666N) administered in the left thigh, a dose of Prevnar (Batch # 493266) administered in the left thigh, and a first dose of Fluzone (Batch # L11097AA) administered in the right thigh. On 10/29/03 the pt developed a rash with blisters on her legs, arms and abdomen. Some of the blistered were raised. The child was also noted to have a low grade fever. The outcome was reported as recovered. There were no relevant diagnostic tests or lab data. The reporter also reported another pt's adverse experience (WAES # 0311USA01477).  No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning her 4 year old granddaughter with no past medical history who "before she was 12 months old" was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 12/11/03 the pt broke out in chickenpox, described as "pretty mild and does not include a fever." The pt was considered as not recovered. There was no product quality complaint involved. There were no relevant diagnostic tests or lab data. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 45 month old female who on 02/16/01 was vaccinated SC in the left thigh with a second dose of varicella virus vaccine live (Lot  # 636360/1334K).  On 12/02/03 the pt's symptoms began, she developed "20+ scattered papules and vesicles, itchy". It was reported that she was afebrile. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a CMA concerning an 11 year old "healthy" white female with an allergy to Zithromax who on 07/13/98 was vaccinated in the left arm with a first dose of varicella virus vaccine. Concomitant vaccine therapy included a first dose given in the right arm of MMRII (Lot # 638359/0163L). There were "no routine medications". There was no illness at the time of vaccination. On 12/05/03 the pt developed a moderate to mild case of chickenpox with vesicles/lesions that were widespread. The pt had no fever. The pt was told to watch for other symptoms but none occurred. There were no diagnostic lab tests performed. Unspecified medical attention was sought and no treatment was required. On 12/16/03 the pt recovered. There was no product quality complaint involved.  No further information is expected.