chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Skin ulcer
Clinical narrative: Information has been received from a nurse concerning a 6.5 year-old white male who on 14-Jan-1998 was vaccinated with a dose of varicella virus vaccine live (lot #623130/0568E). The reporter indicated that on 20-May-2003 the patient developed a generalized rash with less than 50 lesions. It was noted that the rash was documented and evaluated by a physician. The patient also developed a fever which had a duration of three days. The highest temperature was 100. It was indicated that the patient did not have a cough. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practicioner concerning an 8 yo female with no medical history and no allergies who on 05Apr1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. The pt had otitis media at the time of vaccination but was afebrile. Concomitant medication included amoxicillin (+) clavulanate (AUGMENTIN) for "otitis media at the time of visit". It was noted that the pt "broke out in chickenpox post vaccination" with varicella virus vaccine live. On 18May2003 (previously reported as 19May2003) the pt presented to the office with a rash that was reported as varicella with about 20 lesions on her chest, arms, and back and had a fever of 103.2. Unspecified symptomatic treatment was required for the varicella as needed. No diagnostic tests were performed. Subsequently, the pt recovered. There was no product quality complaint involved. No further information is expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 year old male who on 29Apr1996 was vaccinated with a dose of varicella virus vaccine live. On 28May2003 the pt presented to the doctor's office with a mild case of chickenpox. The pt had red spots on his chest, arms, and neck and had a maximum fever of 102 degrees. The physician indicated that the "usual treatment for client such as anti-pyretic, anti itch medicine recommended as needed". Varicella DFA lab tests were taken and the results were positive. The outcome was reported as not recovered. Unspecified medical attention was sought. Treatment was required for the mild case of chickenpox. There was no product quality complaint. The physician also indicated that he had three cases of break through chickenpox post vaccination with varicella virus vaccine live last year. All three cases were vaccinated in 1995. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 30 y/o female pt who on 24Mar2003 was vaccinated with a second dose of varicella virus vaccine live. Subsequently in 2003, the pt wanted to conceive, her physician checked her IgG titer for varicella and it was negative. Unspecified medical attention was sought. A product quality complaint was not 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 RN concerning a 7 y/o male with no medical history and no allergies who in approximately April 2003, 4 to 6 weeks ago at another practice, was vaccinated with a dose of varicella virus vaccine life. There was no concomitant medication . On 27May2003 the pt was seen for his first visit in the physician's office with lesions and a papular rash that had appeared that morning. The pt was diagnosed with varicella and treated with triamcinolone cream 0.025% bid to qid as needed for itching. On 27May2003 it was reported that the pt had not recovered. It was also reported that the pt's mother might be pregnant and was probably in her first trimester. The reporter noted that the mother wondered if her son was contagious. No product quality complaint was involved. It was also noted that the pt's 8 y/o sister was vaccinated with a dose of varicella virus vaccine live and developed varicella. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child pt's who in approx. 1995 were each vaccinated with a dose of varicella virus vaccine live. In approx. 2003 the pt's developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chickenpox outbreak. The reporter notified the elementary school parent's of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 pt's were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated pt's was a 7 y/o pt who on 29Sep1998 was vaccinated with a dose of varicella virus vaccine live. On 03Feb2003, the pt developed chickenpox.  The previously vaccinated pt's included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other patients that developed chickenpox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer and a school nurse concerning 41 child pt's who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approx. 2003, the pt's developed mild cases of chickenpox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the follow up information from the nurse indicated that 13 of the reported 41 pt's were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chickenpox have recovered. One of the previously vaccinated pt's was a 9 y/o pt in the third grade with extensive allergies who on 02Jun98 was vaccinated with a dose of varicella virus vaccine live. On 28Feb2003, the pt developed chickenpox. The reporter noted that this case of chickenpox was not mild. The pt had been vaccinated in a different state.  The previously vaccinated pt's included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chickenpox. The other pt's that developed chickenpox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 27 month old white male with no past medical history and no known drug allergies who on 02Mar2002, also reported as 21Mar2002, was vaccinated SC in the thigh with a first dose of varicella virus vaccine live. There was not illness at the time of vaccination. There was no concomitant medication. On 03Jun2003, also reported as 02Jun2003, the pt presented to the dr's office with a chickenpox rash. No fever was noted. It was reported that no treatment was required at that time. No other information was provided. There was no product quality complaint. The outcome was reported as not recovered. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations of the pt or his siblings. Follow  up information indicated that the pt recovered. No further information is expected.
Age: 12.0
Sex: F
Vaccine: DPP, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 12 y/o white female with a history of anxiety who on 26Jul1996 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live. Concomitant vaccinations on the same day included a second dose SC in the left arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (MSD), a fourth dose PO of oral poliovirus vaccine and a fifth dose IM on the left thigh of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid. There was no other concomitant medication. It was noted that the pt had a urinary tract infection at the time of vaccination. The reporter indicated that the pt developed breakthrough varicella after being vaccinated in the past. It was noted that the pt was seen the week of 19May2003 and was covered with lesions. The pt was seen by a dermatologist and a zanc smear was positive for varicella. The patient was treated with diphenhydramine hydrochloride (BENADRYL) and acetaminophen (TYLENOL) as needed. It was also indicted that a prescription drug was required. The symptoms have not completely resolved and at the time of the report, the pt had not recovered. Follow up information from a medical office indicated that the onset of the adverse event was 26May2003. It was noted that there were no other problems to date related to the varicella experience. It was also reported that the pt began taking escitalopram oxalate (LEXAPRO) on 01May2003 for anxiety. Additional information has been requested. The nurse also reported a similar experience in a male child after vaccination with a dose of varicella virus vaccine live. It was noted that the children attended the same school and the reporter notified the school of the children's status.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning a 2 year old male with no medical history who on 19Feb2003, was vaccinated SC in the left arm with a 0.5 mL dose of varicella virus vaccine live. There was no concomitant therapy. On 05Mar2003, the pt developed several vesicles surrounding the injection site on his left arm. No treatment was required. On 05Apr2003, the pt developed two firm papules at the injection site. At the time the pt was seen by the physician and was treated with a course of unspecified antibiotics which "did nothing". On 04Jun2003, the pt developed "brownish colored bumps" near the injection site with no vesicles. No laboratory tests were performed. The physician noted that the pt was a normal host, without immunosuppression and without known exposure to wild chickenpox. At the time of this report the pt had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received on 04Jun2003 from a RN concerning a female hospital employee who possibly in the past few weeks was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt's unvaccinated child had developed varicella after being exposed in day care (noted to be unknown if it was transmission or live virus exposure) The child had broken out with lesions. Subsequently, the mother "broke out with lesions, but the mother's lesions did not look the same. One lesion reportedly looked like varicella but other lesions were atypical. She had a total 20 lesions. She started with symptoms on 20May2003 to 26May2003. The mother again broke out on 02Jun2003 and saw her doctor. It was noted that the mother received no treatment. It was also reported that the pt had two other vaccinated children who developed varicella. Additional information had been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from RN concerning a 6 y/o male with no known allergies who on 20Jul1998 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. There was no concomitant medication.  On 31May2003 the pt started breaking out in a chicken pox rash and now has full blown chicken pox. The mother counted over 100 lesions. He also had a fever as well. Medical attention was sought and no treatment was required. No diagnostics studies were performed. No product quality complaint was noted. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 y/o male who on 07Aug1997 was vaccinated with a dose of varicella virus vaccine live. On 04Jun2003 it was reported that "several days ago" the pt developed a rash which was determined to be breakthrough chicken pox with less than 50 lesions on the neck, chest, leg and groin. Medical attention was sought and the pt was treated with diphenhydramine hydrochloride (BENADRYL) and colloidal oatmeal bath (AVEENO). No additional information was provided. No diagnostics studies were performed. No product quality complaint was involved. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a consumer concerning an adult female in her late twenties with no medical history in 2002 was vaccinated with a second dose of varicella virus vaccine live. The patient received her first dose of varicella virus vaccine live in 2002. There was no concomitant mediation. The reporter indicated that a titer was drawn in the end of May 2003 and was negative. Unspecified medical attention was sought. No treatment was required for the event. It was also noted that it was unknown if the patient was pregnant. A product quality complaint was not involved. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician and a registered nurse (RN) concerning a 32-month-old white male with no medical history who on 22-Oct-2001, was vaccinated SC in the right thigh with the first dose of varicella virus vaccine live (Lot #639128/0567L). There was no illness at the time of vaccination. The physician reported that on 05-Jun-2003, the patient had a moderate outbreak. The RN clarified that the moderate outbreak was a pruritic rash that started on the patient's arms and was eventually all over. The patient was seen by the physician on the same day. On 12-Jun-2003, the patient's pruritic rash resolved. The patient's brother also developed a papular rash and pruritis after being vaccinated with the first dose of varicella virus vaccine live (WAES #0306USA01066). Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from the mother of a 14 month old male with no medical history and no allergies who on 29MAY2003 was vaccinated subcutaneously with a 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On 05JUN2003, 7 days post vaccination, the mother reported that her son developed varicella breakthrough with 12 varicella like lesions. He was experiencing a "mild" varicella reaction and his pediatrician had recommended oatmeal bath as a form of treatment. No diagnostic studies were performed. At the time of report, 05JUN2003, it was reported that the patient was still recovering. No product quality complaint was involved.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 11 year white female student on 22FEB2001, was vaccinated in the left arm with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. The physician reported that on 27MAY2003, the patient developed varicella disease. It was unknown if medical attention was sought. Subsequently, the patient recovered. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Unintended pregnancy
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received through the pregnancy registry from a nurse practitioner and a 32 year old female, G3, PO, with a past medical history of having three therapeutic abortions and herpes genitalis treated with acyclovir, who in June, 2002 and on 04APR2003, was vaccinated with a first and subcutaneously 0.5ml second dose of varicella virus vaccine live, respectively. There was no local reaction at the vaccination site and there were no symptoms of varicella or herpes zoster post vaccination. The patient's LMP was 21APR2003. According to the patient's health care provider she became pregnant on 05MAY2003. In March 2002 and March 2003 the patient was tested for varicella antibodies the results of which were negative. On 25NOV2003 at 31 weeks, and on 02DEC2003 the patient had an ultrasound which showed a slight increase in anmniotic fluid. On 31DEC2003 the patient was started on pantoprazole sodium (PROTONIX) or famotidine for heartburn. On 07JAN2004 the ultrasound was normal and it was reported that the increase in amniotic fluid had resolved. No amniocentasis was performed. Routine tested was reported as "all normal". It was reported that during the pregnancy the patient was positive for both B-strept and chlamydia. On 08JAN2004, at 37 weeks and 3 days from her LMP, the patient delivered a live born, normal 6lb, 13oz male. There were no complications during labor or delivery. There were no congenital anomalies or features of congenital varicella zoster syndrome. The fetus was healthy without any known problems secondary too vaccination. On that same day it was noted that the pantoprazole sodium (Protonix) or famotidine was discontinued. Additional information is not expected.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 18 month old male with no medical history and no known documented allergies who was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 06JUN2003 the patient was seen in the physician's office for a routine visit. It was reported that he had lesions on his ribcage that "may be shingles". It is not known when the lesions started. No treatment was required. At the time of report 06JUN2003, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician and a registered nurse RN concerning a 5 year old male with no medical history who on 04DEC2000, was vaccinated SC in the right arm with the first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The physician reported that on 05JUN2003, the patient had moderate outbreak. The RN clarified that the moderate outbreak was an itchy papular rash that started on the patient's neck, back and trunk. The patient was seen by the physician on that same day. In June 2003, a week and a half later, the patient's itchy papular rash resolved. The patient's brother also developed a pruritic rash after being vaccinated with the first dose of varicella virus vaccine live. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 month old white male with no medical history and no allergies who on the morning of 29MAY2003 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live. The patient had a mild upper respiratory infection and a rectal temperature of 99.1 degrees at the time of vaccination. On 07JUN2003 the patient developed a fever of 100 degrees F (rectal) that lasted through 09JUN2003. On 08JUN2003 the child broke out/erupted with small yellow, clear fluid filled blisters on small red patches initially on his trunk and then they quickly spread to his extremities. There were over 50 pox on his trunk alone. His behavior was reported as "fine". On 09JUN2003 the mother of the patient had also reported that he had developed a chicken pox rash with lesions with yellow fluid filled pustules on top of a red area. Most of the lesions were raised but there were some that appeared flat. Some lesions had already popped and were crusting over. The mother reported that they started in the lower abdominal area, went to the torso and neck and then scattered down the arms and legs. She counted the lesions and stopped at 50 and just said "there are more than 50". No diagnostic lab tests were performed. Unspecified medical attention was sought and no treatment was required. Subsequently, the patient recovered. No product quality complaint was involved. No further information is 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 and a physician concerning a 8 year old white male student who on 18JUL1997 was vaccinated in the left arm with a first dose of varicella virus vaccine live. On 28MAY2003, the patient broke out with chickenpox. On 28MAY2003, the patient was seen by a physician in the office and was treated with acyclovir 1000mg per day for 5 days. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a consumer regarding a 5 year old white male who on 26AUG1998 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that a child at the day care center where his children go had developed chickenpox over the past two to three weeks. The reporter believed that the child may have been previously vaccinated. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional information was received from a physician which indicated that on 05MAY2003 the doctor's office was called and it was reported that the child had vesicular lesions on the chest, back and axilla. The patient was diagnosed with mild breakthrough varicella which lasted four to six days. The consumer also reported up to nine other children at the day care center that had similar reactions after being vaccinated with a dose of varicella virus vaccine live. He also indicated that the cases were mild, however he did not know that two of the cases were not mild. No further information is expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning an 8 year old white male who on 09MAR1998, was vaccinated with a dose of varicella virus vaccine live. The nurse reported that on 30MAY2003, the patient developed a generalized rash characterized by less than 50 lesions. The patient was noted to be afebrile with no cough. It was unknown if medical attention was sought. On 05JUN2003, the patient recovered from generalized rash. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a 5 year old white male who on 02AUG1999 was vaccinated with a dose of varicella virus vaccine live. On 03JUN2003 the patient developed a generalized rash with less than 50 lesions. There was no localization at the injection site and the patient did not have a cough or a fever. Unspecified medical attention was sought. Additional information has been requested.
Age: 3.5
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning an approximately 42 month old caucasian male with no past medical history who on 07SEP2000 was vaccinated with a first dose of varicella virus vaccine live, in the left arm. There was no illness at the time of vaccination. In March 2003 the patient developed "<20 pink papular lesions on skin, no fever, no malaise: other than lesions child appears well (as per mother 09JUL2003 via telephone). There were no relevant diagnostic laboratory tests. It was reported that the patient recovered 5 days after onset of rash. It was also reported that up to nine other children in the patient's day care center had also developed chicken pox after being vaccinated with a dose of varicella virus vaccine live. No further information is expected.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer regarding a 4 to 6 year old child who may have been vaccinated with a dose of varicella virus vaccine live. The reporter indicated that a child at the day care center where his children go had developed chickenpox over the past two to three weeks. The reporter believed that the child may have been previously vaccinated. It was unknown if medical attention was sought. A product quality complaint was not involved. The consumer also reported up to nine other children at the day care center that had similar reactions after being vaccinated with a dose of varicella virus vaccine live. He also indicated that the cases were mild, however he did not know that two of the cases were not mild. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. The physician was informed that the patient had an immediate severe reaction, described as an immediate 10-15cm wheal, upon injection. It was noted that the reaction responded to dephenhydramine HCL (benadryl). Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Diarrhoea, Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male patient with no past medical history who on 17DEC1998 was vaccinated with a first dose of varicella virus vaccine live, SC, in the left leg. Concomitant therapy that day included a first dose of measles virus vaccine live+ mumps virus vaccine live + rubella virus vaccine live (second generation), SC, in the right leg, and a third dose of oral poliovirus vaccine. There was no illness at the time of vaccination. Subsequently, the patient "came down with chickenpox" .On 07JUN2003, the patient developed a fever of 99.9F, diarrhea and greater than 75 lesions (also reported as "spots") on face and trunk. The patient was seen in the office on 09JUN2003. The physician told the mother to give symptomatic treatment of diphenhydramine HCL (benadryl), acetaminophen (Tylenol) and oatmeal baths. On 11JUN2003, the patient was reportedly "beginning to recovery" and had "no other symptoms related to varicella exposure." It was also reported that this child was exposed to other children with chickenpox. At the time of this report one other patient was reported to have a similar experience. Additonal information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a first dose of varicella vaccine live. Subsequently, the patient developed a "mild rash" with about 20 lesions. Medical attention was sought and no treatment was required. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female patient who was vaccinated with varicella virus vaccine live. Subsequently, the patient "came down with chickenpox". On 09JUN2003 "she began feeling tired and had a low grade fever and started breaking out on 10JUN2003. The patient reportedly had 50 to 75 lesions. The doctor told the mother to give diphenhydramine HCl (benadryl), acetaminophen (tylenol) and oatmeal bath. On 11JUN2003, the patient was reportedly "beginning to recovery." It was also reported that this child was exposed to other children with chickenpox. At the time of this report one other patient was reported to have a similar experience. Additional information has been requested.
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 white male with reactive airways disease who on 05AUG1998 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine. There was no illness at the time of vaccination. It was reported that on 09JUN2003 the patient was exposed to shingles "2 weeks ago", broke out in a rash, came into the physician's office and was diagnosed with chickenpox. No diagnostics were performed. On 16JUN2003 the patient recovered. No further information is expected.
Age: 3.6
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a consumer regarding a3 year old (also reported as a 5 year old)  male with a history of craniosynostosis (also reported as having no medical history ) who on 29OCT1998 was vaccinated in the arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that a child at the day care center where his children go had developed chickenpox over the past two weeks. The reporter believed that the child may have been previously vaccinated. It was unknown if medical attention was sought. A product quality complaint was not involved. follow up information was received from a physician which indicated that on 12MAY2003 the patient had "typical case varicella although mild after vaccination on 29OCT1998." The physician also reported a "varicella type rash on skin difficulty." The patient recovered on 19MAY2003. The consumer also reported up to nine other children at the day care center that had similar reactions after being vaccinated with a dose of varicella virus vaccine live. He also indicated that the cases were mild, however he did know that two of the cases were not mild. No further information is expected.
Age: 3.4
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 41 month old male who on 08JUL2001 was vaccinated with a first dose of varicella virus vaccine live. On 12JUN2003 (also reported as 11JUN2003), the patient developed chicken pox with small vesicular bumps over his body. Medical attention was sought and the patient was not treated with any prescription medication. The reporter was not sure if the patient had recovered; he had not been back to the office since 11JUN2003. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old white female with no allergies or medical conditions who on 24AMAY2000 was vaccinated with a 0.5ml second dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. The reporter noted that the patient was immunized at a health department before she became their patient. On 24MAY2003 the patient's mother noticed two small fluid filled spots on the abdomen and by 25MAY2003 it "spread to about a dozen vesicles," was "itchy on trunk and extremities" and the patient was "uncomfortable from itching." The patient was diagnosed with "chickenpox post vaccine" and it was also noted that she had been exposed to varicella about three weeks prior to breakout. Prescription drug treatment was not required and the patient was "treated only symtomatically for varicella." The symptom was still being treated and she was expected to recover. The outcome was reported as uknown. There were no diagnostic tests or laboratory results. Follow up information received from the registered nurse indicated that on 24MAY2003 the patient started with two "vesicle looking spots" on the belly and within 24 hours had spread to "about a dozen vesicles on a red base (belly and extremities)." The patient's mother was instructed to treat symtomatically for varicella. On 06JUN2003 the patient recovered without complication. No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female patient who on 31JUL1998 was vaccinated with a first dose of varicella virus vaccine live. On 10JUN2003, the patient developed "itchy red spots" on her "entire body". Subsequently, the patient recovered. No further information is required.
Age: 1.75
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 21 month old male patient with no relevant medical history and no known allergies who on 04OCT2002 was vaccinated with a dose of varicella virus vaccine live. Other concomitant medications included amoxicillin for 7 days for bilateral ear infection. On 15JUN2003, the patient developed 150 to 200 lesions on trunk and extremities, some clusters, no blisters, a few on the neck were "pimple like" and he was afebrile. On 16JUN2003, the patient "was seen in the office". It was noted that three weeks ago "he had close contact, hugging with a boy who had been vaccinated and had 7 to 8 lesions" (there was no further information on the other boy at this time). The patient was treated with diphenhydramine HCL (benadryl) and calamine + camphor+ pramoxine hydrochloride (Aveeno) baths as needed. it was also noted that the patient had not recovered. Medical attention was sought. There was no product quality complaint involved. The nurse also reported on another patient who had been vaccinated with varicella virus vaccine live and developed 7-8 lesions. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning her 12 month old daughter with no allergies or medical history who on 05JUN2003 at 5:00pm was vaccinated SC in the arm with a 0.5ml dose of varicella virus vaccine live. Concomitant vaccination on the same day at 5:00p.m included a dose in the arm of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation). There was no other concomitant medication. There was no illness at the time of vaccination. The reporter indicated that he kept her daughter home from day care on 17JUN2003 because the child had several red lesions on her body including her legs, neck and torso for a total of about ten. The lesions were described as a "red rash-like bump with no vesicle." Unspecified medical attention was sought and no treatment was required. There  were no diagnositc tests or laboratory results. A product quality complaint was not involved. Additional information was received from the pharmacist which indicated that on 15JUN2003 the child developed a chickenpox like rash with about ten red spots that faded in three days. The pharmacist noted that she was told by her physician that the child was contagious and needed to be kept home form daycare until the event resolved. It was also reported that the child had a fever of 101 degrees Fahrenheit. Subsequently, the child recovered. No further information is expected.
Age: 5.0
Sex: F
Vaccine: MMR, OPV, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 year old white female patient with no pre-existing allergies or medical conditions, who on 03MAR1999 was vaccinated SC with a first dose of varicella virus vaccine live. Concomitant therapy administered on 03MAR1999 included a first dose of measles mumps rubella vaccine administered SC, and a third dose of oral poliovirus vaccine. The physician noted the patient had no known illness at the time of vaccination. On 04JUN2003 at 10:00 AM (also reported as 07JUN2003), the patient developed shingles. The physician also described the event as varicella zoster rash to the L2 dermatome. According to the physician the patient was not hospitalized, and no treatment was required. The physician indicated acetaminophen (TYLENOL) was used for pain control. The physician declined participation in varicella zoster identification program due to the lack of lesions for sampling. According to the physician the patient is now "fine" and has recovered (also reported by the physician as 20JUN2003-improving). There was no product quality complaint reported. Unspecified medical attention was sought. No additional information is expected.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 29 year old male who was vaccinated with a first 1x dose of varicella virus vaccine live. Subsequently the pt developed a fever, a headache and approximately 15 lesions. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health department RN concerning a 9 year old male with an unknown medical history who at 12 months of age was vaccinated with a dose of varicella virus vaccine live. It was unknown if the pt was on concomitant therapy. On 06/18/03 it was reported that the pt was exposed to another child with chicken pox and "now" has a mild case himself.  Unspecified medical attention was sought and no treatment was required. It was unknown if diagnostic studies were performed.  No other information was provided. No product quality complaint was involved. On 08/01/03 it was reported that there was no information on this child and that the "form" was sent to the parent to complete. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash papular, Rhinorrhoea, Skin ulcer
Clinical narrative: Information has been received from a female reporter concerning a 12 month old white male with no known drug allergies and no past medical history who on 06/12/03 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (reported lot # 0074M).  There was no illness at the time of vaccination. Concomitant vaccinations that day included a first dose of MMRII (Lot # 644709/1179M) administered SC in the left arm. On approximately 06/17/03, about 5 days later, the pt returned to the office with 15-20 papular lesions, a low grade fever and slight, clear nasal drainage. No other symptoms were noted. No treatment was required. No product quality complaint was involved. Follow up information indicated that on 06/18/03 the pt presented with a fever, a clear runny nose, and 15-20 papular lesions. Unspecified medical attention was sought. The outcome was reported as unknown. The outcome was reported as recovered. No further information is expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer who is the father of a 9 year old female who in 1997 was vaccinated with a dose of varicella virus vaccine live. On 06/18/03, the pt "developed about 15 chickenpox sores". It was noted that the pt was away on vacation at this time and had not seen her doctor. It was also noted that the "pt's friend had chickenpox about 2 weeks ago, and was also already vaccinated". The pt's father had no additional information to provide. There was no product quality complaint involved. The caller also reported on another pt who had been vaccinated with varicella virus vaccine live and developed chickenpox (WAES # 0306USA02707).  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner concerning a "4-5 year old" male who in April 2003, was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. Subsequently, in approximately June 2003, the pt developed over 30 lesions and a fever. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). A product quality complaint was not involved. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection transmission via personal contact
Clinical narrative: Information has been received from a physician concerning a 41 year old white father with no known drug allergies who's 12 month old daughter was vaccinated with a dose of varicella virus vaccine live "one week ago", on approximately 06/12/03.  There was no illness at the time of vaccination. On 06/19/03 the father developed herpes zoster. The physician is not certain if the zoster was transmitted from the vaccine. No other information was given.  Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a physician indicated that the adverse event onset was 06/16/03.  It was noted that the "pt is father of child immunized within 2 weeks prior to presentation of zoster". The reporter indicated that no additional data was available. It was noted that the pt recovered.  No additional information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old male with an unknown medical history who on 04/11/00 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 634504/1768J).  It was unknown if the pt was on concomitant medication. On 06/13/03 the pt was seen in the physician's office with a 2 day history of a "typical" presentation of a red, itchy rash, some vesicles under the arms, groin area, legs and stomach. The pt was diagnosed with varicella. There was no fever. The pt was treated with colloidal oatmeal bath (Aveeno) and calamine lotion.  It was unknown if diagnostic tests were performed. It was unknown if the pt recovered. No product quality complaint was noted. It was also reported that 3 other pt's were vaccinated with a dose of varicella virus vaccine live and developed varicella (WAES # 0306USA02866 through 0306USA02868).  Additional information has been requested.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a LPN concerning a 21 month old white male with no pertinent medical history who on 09/27/02 was vaccinated SC with a first dose of varicella virus vaccine live (Lot # 635795/0778L).  On 06/05/03 the pt broke out in classic varicella rash. The LPN reported that the pt presented to the clinic "1 week later", and was treated with Zyrtec and Omnicef (start dates, and doses unknown) for impetigo. The LPN reported that the duration of the pt's varicella was 1 week and the date of recovery was 06/12/03.  The health professional indicated the pt is still being treated.  Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 year old female pt with no relevant medical history and no known allergies who on 02/09/98 was vaccinated in the left arm with a SC (previously reported as IM) first dose of varicella virus vaccine live (Lot # 624447/1419E). Concomitant therapy on 02/09/98 included a SC first dose in the left arm of MMRII (Lot # 321490/1230E). There was no illness at the time of vaccination. On 06/17/03, the pt complained of a sore throat and developed a varicella rash described as maculo papular with vesicles. On 06/18/03, the pt was diagnosed with chickenpox and had approximately 150 lesions (previously reported as "about 40 lesions"). No throat culture was done. Unspecified medical attention was sought. Subsequently, the pt recovered. There was no product quality complaint involved. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. On approximately 06/13/03, "within the last week", the pt may have possibly developed zoster. The pt was not treated. No additional information is available at this time. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a RN concerning a male pt who was vaccinated with a dose of varicella virus vaccine live and developed 7-8 lesions. It was noted that there was no further information available at this time. The nurse also reported on another pt who had been vaccinated with varicella virus vaccine live and developed 150-200 lesions (WAES # 0306USA02150).  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a consumer concerning a pt who was vaccinated with a dose of varicella vaccine live virus. On approximately 06/04/03, "about 2 weeks ago", the pt developed chickenpox. It was noted that the reporter had no additional information to provide. The caller also reported on another pt who had been vaccinated with varicella virus vaccine live and developed chickenpox (WAES # 0306USA02323).  Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received on 06/23/03 from a physician concerning a male child with no past medical history who was vaccinated with a dose of varicella virus vaccine live (site unknown) (0.5mL), SC. There was no concomitant medication. Subsequently the pt "broke out with a few lesions." The reporting physician was concerned "because his pt, a heart transplant recipient, will be in contact with this child". The pt sought unspecified medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Pharyngolaryngeal pain, Rhinorrhoea
Clinical narrative: Information has been received on 06/23/03 from a consumer concerning his 4 year old daughter with no known allergies who "2 weeks ago" was vaccinated with varicella virus vaccine live (site unknown). There was no concomitant medication. Subsequently, the pt developed a sore throat, runny nose and had "about 5 lesions that look like chickenpox." The pt sought unspecified medical attention. There were no lab tests performed. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Infection, Pruritus, Rash
Clinical narrative: Information has been received from a woman in a doctor's office concerning a 6 year old male with no known drug allergies who on 08/07/97 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on the same day included a dose of MMRII. The reporter indicated that a rash was noted on 06/02/03.  The reporter noted "reported/seen in our office 06/04/03." The pt had itching and less than 50 lesions on the neck, chest, leg and groin. The pt subsequently recovered. No further information is expected.