chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: DTP, HIBV, IPV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Information has been received from a mother concerning her 15 month old daughter with no pertinent past medical history who on 05/05/03 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a dose of MMRII, poliovirus vaccine (manufacturer unknown), DTP vaccine, Hib conj vaccine (manufacturer unknown) and one other vaccine that the "caller is not sure of name".  On 05/05/03 the pt developed a fever that lasted for 3 days. On 05/08/03 the pt developed a rash on her arm. No lab diagnostic studies were performed. No medical attention was sought. There was no product quality complaint. Follow up information from the mother indicated that "the adverse reaction ended up to be from the MMR".  Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician who is the parent of a male child who in 1997 was vaccinated with a dose of varicella virus vaccine live. Recently, he developed a "mild form of the disease after being exposed to his younger brother, whom had not had the vaccine in the US and contracted chickenpox here (possibly following exposure at school)".  It was noted that the pt required no treatment and he recovered "quickly and fully".  Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN who is the cousin of a 6 year old male child who on 01/15/98 was vaccinated with a dose of varicella virus vaccine live.  In the "spring of 2002", the child developed a mild case of chickenpox. It was noted that "everything resolved without sequelae". Unspecified medical attention was sought. There was no product quality complaint reported. The RN also reported on another sibling who experienced a similar reaction (WAES # 0305USA01701).  Additional information has been requested.
Age: 31.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a physician concerning a 31 year old male with no medical history and no allergies who on 04/25/03 was vaccinated SC with a dose of varicella virus vaccine live. There was no concomitant medication. On approximately 05/05/03, 10-14 days after vaccination, the pt developed a mild varicella-form rash. No other symptomology was reported. No diagnostic studies were performed. Unspecified medical attention was sought and it was reported that no treatment was required. Subsequently, the pt recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 18 month old male pt who on 12/09/02 was vaccinated with a dose of varicella virus vaccine live (Lot # 641983/0291M).  Concomitant vaccination included a dose of MMRII (Lot # 643500/0633M) and a dose of Hib conj vaccine (manufacturer unknown) (Lot # 480701).  On 05/19/03, the pt developed symptoms of chickenpox. Unspecified medical attention was sought and the pt was to be seen by the physician. Treatment was not required. A product quality complaint was not involved.  Additional information is not available.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Rash pruritic
Clinical narrative: Information has been received from a RN concerning a 5 year old white male with no past medical history and no known drug allergies who on 04/13/99 was vaccinated SC on the right arm with a first dose of varicella virus vaccine live (Lot # 628697/1838H).  There was no illness at the time of vaccination. Concomitant therapy that day included a first dose in the left arm of MMRII (Lot # 627184/1580H) and a first dose of tuberculin purified protein derivative (Batch # 25110-11). There were no problems following vaccination. On 05/14/03 the pt was seen in the office with midly pruritic lesions in the underware area and on the head. It was noted that the rash was in four stages: tiny papules, larger papules, watery blisters, and scabbing and scabbed over lesions. No prescription therapy was required. It was not known if there was a known exposure. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 05/13/03 the pt developed less than 50 lesions. There was a small amount of itching. No fever was reported. Diagnostic tests and lab work was "not done". It was noted that the pt recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Condition aggravated, Dermatitis atopic
Clinical narrative: Information has been received from a physician concerning a child pt with a history of eczema who was vaccinated SC with a first 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. A few days post vaccination, a rash broke out on the face and neck area. The pt was seen by a dermatologist and was diagnosed with atopic dermatitis. Lab tests were not performed. The reporting physician was not sure if varicella virus vaccine live caused this because the pt had a history of eczema. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Erythema, Infection
Clinical narrative: Information has been received from a medical assistant concerning a 32 month old white male pt with no medical history who on 10/09/01 was vaccinated in the left upper arm with a first dose of varicella virus vaccine live (Lot # 638242/0563L) (Lot #  for diluent: 640357/0832L). There was no illness at the time of vaccination.  On 05/16/03 (previously reported as 05/14/03) the pt developed a "chickenpox outbreak" described as "small, red, vesicular bumps on entire body". There was no relevant diagnostic lab data completed. Subsequently the pt recovered in June 2003.  No further information is expected.
Age: 1.6
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from the physician concerning an 18 month old pt who was vaccinated with a dose of varicella virus vaccine live and was diagnosed with herpes zoster. It was noted that the child was not hospitalized. Unspecified medical attention was sought. No further information was provided. Follow up information on 05/22/03 revealed that "the child would not be coming in for a specimen". Additional information is requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Infection, Rash papular, Rash pruritic
Clinical narrative: Information has been received from office staff concerning an 8 year old female pt with "ADHD" and an allergy to "Dexadryn" who on 04/01/01 in the AM was vaccinated SC in the right arm with a first dose of varicella virus vaccine live.  There was no concomitant medication.  On 05/19/03, in the AM, the pt's throat was red but the throat culture was negative. On 05/19/03, in the PM (previously reported as 05/20/03), the pt developed a "varicella rash/chickenpox" with "nearly 100 lesions" on her face, arms, ears, trunk, hands, fingers, legs, back and buttocks, also described as mild "itching, multiple lesions" that were all papular and non vesicular. On 05/20/03, "next AM", vesicules with fluid were scabbed. A throat culture was "negative for strep" (previously reported as no relevant diagnostic lab data). It was noted that the physician recommended diphenhydramine HCL (Benadryl) every 6 hours. Calamine lotion was applied for itching.  It was also noted that this case was 22 months after the vaccine and was not a vaccine reaction. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, the pt recovered. No further information is expected.
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse concerning a child who on 26-Jan-1996 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included Hib conj vaccine (manufacturer unknown). Subsequently, the child developed a mild case of chickenpox. It was noted that there were no hospitalization or complications", no treatment was required and "patients were often not seen by the nurse, but were reported by parents as explanation of an absence". It was also noted that the child was part of "six cases that took place over the last school year (from 9/02 to present)". Unspecified medical attention was sought. There was no product quality complaint involved. At the time of this report the child was 9 year of age. The nurse also reported that five other children developed mild chickenpox (WAES #0305USA02461), (WAES #0305USA02459), (WAES #0305USA02458), (WAES#0304USA02457) and (WAES #0305USA02460). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 47 month-old male patient with no known drug allergies who on 01-Aug-2002 was vaccinated subcutaneously in the right upper arm with a first dose of varicella virus vaccine live (Lot number 642680/0479M). on 01-Aug-2002 concomitant therapy included an intramuscular fifth dose in the left arm of diptheria toxoid (+) pertussis vaccine (+) tetanus toxoid  (batch #541T9) (Infanrix), a subcutaneous second dose in the right arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (639984/1383L), and a subcutaneous fourth dose in the left arm of poliovirus vaccine (IPOL) (batch #U0908). On 19-May-2003, the patient developed a generalized vesicular rash of 20-30 lesions. On 21-May-2003, the patient was seen in the office and was diagnosed with chickenpox. It was noted that no other symptoms were noted and no treatment was required. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint reported. No further information is expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Laboratory test abnormal, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 44-month-old female with burkitt's lymphoma and no known drug allergies who sometime in 2000 was vaccinated with a first dose of varicella virus vaccine live. Concomitant therapy included chemotherapy for the burkitt's lymphoma. This included cyclophosphamide, "adnamyai", piperacillin sodium (+) tazobactam sodium, acyclovir, sulfamethoxazole (+) trimethoprim (Bactrim), vincristine sulfate, granulocyte colony stimulating factor (unspecified), methorexate, tobramycin, vancomycin, and cytarabine (ARA-C). In May 2003, the child subsequently developed what was diagnosed as chickenpox (exact date unknown), and was hospitalized for treatment with acyclovir as a precaution due to her concurrent burkkitt's lymphoma. It was noted that four weeks prior, the patient was exposed to family who had "natural chickenpox". The physician indicated that the patient is currently doing well, and has not developed any complications. The physician obtained 2 swab specimens (DFA positive) on 20-May-2003 in viral transport media, and has submitted them for PCR analysis. The results of the PCR analysis revealed that the specimen contained the wild-type varicella zoster virus. It was noted that the specimen was obtained on 20-May-2003 and sent to the laboratory on 22-May-2003. The source of the specimen was a lesion and the type was a vesicle. The specimen arrived in the laboratory on 23-May-2003. The results indicated that  VZV DNA was amplified and the VZV strain identification showed wild-type. Additional follow up information indicated that the patient did recover. It was noted that the patient was newly diagnosed with Burkitt's lymphoma. The patient developed varicella during hospitalization for treatment of burkitts lymphoma. The distribution of lesions was on the face, scalp, shoulders, and upper extremities. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash erythematous, Rash papular, Rash pruritic, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 26-year-old white male patient with insulin dependent mellitus who at 11:00 am on 25-Apr-2003 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (643529/0598M). It was reported that the patient called the primary care physician's office "soon thereafter", on 09-May-2003 and reported a two day history of an itchy rash, "under 50 lesions". The event onset was reported as 07-May-2003. In follow-up the licensed practical nurse reported the patient was being married and he "broke out in chicken pox". It was also noted the patient had multiple raised erythematous papules on his face, neck, abdomen, and back. The licensed practical nurse reported the patient was evaluated by the primary care physician and physician assistant. It was noted the physician had the patient "treat" with calamine lotion (therapy unspecified), and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) baths. It was noted the patient did not have any illnesses at the time of vaccination, and no laboratory tests were performed. The licensed practical nurse reported patient's outcome is unknown. There was no product quality complain involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a child who on 11MAY1998 was vaccinated with a dose of varicella virus vaccine live, only. There was no concomitant medication. Subsequently , the child developed a mild case of chickenpox. It was noted that there was no hospitalization or complications, no treatment was required and patients were often not seen by the nurse, but were reported by parents as explanation of an absence. It was also noted that the child was part of six cases that took place over the last school year from 09/02 to present. Unspecified medical attention was sought. There was no product quality complaint reported. At the time of this report the child was 9 years of age. The nurse also reported that five other children developed mild chickenpox.
Sex: U
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a child who on 16MAY2000 was vaccinated with a dose of varicella virus vaccine live. On 16MAY2000 concomitant therapy included diphtheria toxoid/pertussis vaccineteta, poliovirus vaccine and measles virus vaccine live+mumps virus vaccine live+rubella virus vaccine live, respectively. Subsequently , the child developed a mild case of chickenpox. It was noted that there was no hospitalization or complications", no treatment was required and patients were not seen by the nurse , but were reported by parents as explanation of an absence. It was also noted that th child was part of six cases that took place over the last school year from 9/02 to present. Unspecified medical attention was sought. There was no product quality complaint reported. At the time of this report the child was 9 years of age. The nurse also reported that five other children developed mild chickenpox. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old patient who on 26JUL2001 was vaccinated iwth a dose of varicella virus vaccine live. On 26JUL2001 concomitant therapy included diphtheria toxoid/pertussis vaccineteta, poliovirus vaccine and measles virus vaccine live+mumps virus vaccine live+rubella virus vaccine live, respectively. Subsequently , the child developed a mild case of chickenpox. It was noted that there was no hospitalization or complications", no treatment was required and patients were not seen by the nurse , but were reported by parents as explanation of an absence. It was also noted that the child was part of six cases that took place over the last school year from 9/02 to present. Unspecified medical attention was sought. There was no product quality complaint reported. At the time of this report the child was 9 years of age. The nurse also reported that five other children developed mild chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a child who on 18JUN1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently , the child developed a mild case of chickenpox. It was noted that there was no hospitalization or complications", no treatment was required and patients were not seen by the nurse , but were reported by parents as explanation of an absence. It was also noted that th child was part of six cases that took place over the last school year from 9/02 to present. Unspecified medical attention was sought. There was no product quality complaint reported. At the time of this report the child was 12 years of age. The nurse also reported that one sibling and four other children developed mild chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a child who on 18JUN1996 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Subsequently , the child developed a mild case of chickenpox. It was noted that there was no hospitalization or complications", no treatment was required and patients were not seen by the nurse , but were reported by parents as explanation of an absence. It was also noted that the child was part of six cases that took place over the last school year from 9/02 to present. Unspecified medical attention was sought. There was no product quality complaint reported. At the time of this report the child was 10 years of age. The nurse also reported that four other children developed mild chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection, Vomiting
Clinical narrative: Information has been received from a registered school nurse concerning a child in her school between the ages of 6 and 9 years old with an unknown medical history who was vaccinated with a dose of varicella virus vaccine live. It was uknown if the child was on concomitant medication. On 20MAY2003, it was reported that within the last 3 weeks the child developed a fairly severe case of chickenpox with a fever, vomiting a lots of pox. It was unknown if diagnositics studies were performed. Unspecified medical attention was sought and it was unknown if any treatment was required. No product quality complaint was involved. It was also reported that 7 other children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chickenpox. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Malaise, Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a certified medical assistant and a 24 year old female veterinarian with no past medical history who on 28MAR2003 at 13:30 was vaccinated subcutaneously on the right with a second dose of varicella virus vaccine live. There was no concomitant medication. Approximately two weeks post vaccination in April 2003, the patient developed a low grade fever and a raised rash at the infection site that was approximately 3 centimeters in diameter. The patient described the rash as a localized injection site reaction with 2 to 3 lesions that never became wheeping. On 10APR2003 the patient experience3d malaise and the rash was still present. On 15APR2003 the patient was feeling better, but the injection site was itching and the rash had gone down to 0.5 cm in diameter. Hives were also reported. Unspecified medical attention was sought. Treatment included topical and oral over the counter dephenhydramine hydrochloride (benadryl) and ibuprofen (Motrin). As of 23MAY2003, the patient felt fine and had recovered from the malaise and itching. The rash had resolved in a few days. The patient also recovered from the hives. The doctor did not want to give the patient a booster because of this adverse experience and it was noted that the therapy was discontinued. A product quality complaint was not involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a certified medical assistant and a 24 year old female veterinarian with no past medical history who on 28MAR2003 at 13:30 was vaccinated subcutaneously on the right with a second dose of varicella virus vaccine live. There was no concomitant medication. Approximately two weeks post vaccination in April 2003, the patient developed a low grade fever and a raised rash at the infection site that was approximately 3 centimeters in diameter. The patient described the rash as a localized injection site reaction with 2 to 3 lesions that never became wheeping. On 10APR2003 the patient experience3d malaise and the rash was still present. On 15APR2003 the patient was feeling better, but the injection site was itching and the rash had gone down to 0.5 cm in diameter. Hives were also reported. Unspecified medical attention was sought. Treatment included topical and oral over the counter dephenhydramine hydrochloride (benadryl) and ibuprofen (Motrin). As of 23MAY2003, the patient felt fine and had recovered from the malaise and itching. The rash had resolved in a few days. The patient also recovered from the hives. The doctor did not want to give the patient a booster because of this adverse experience and it was noted that the therapy was discontinued. A product quality complaint was not involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 9-year old white female child with no medical history and no allergies who on 22-Aug-1995 was vaccinated with one 0.5 ml dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that the patients' sibling had no adverse events following prior vaccination. On 19-May-2003 the patient developed a breakthrough rash with cluster of 5-10 scattered vesicular lesions on the right side of her chest below the right nipple. Unspecified medical attention was sought and it was reported that no treatment was required. No diagnostic tests were performed. On approximately 02-Jun-2003, two weeks later, the patient recovered. No product quality complaint was involved. It was also noted that the patient's 8 year old sister was vaccinated with a dose of varicella virus vaccine live and developed a breakthrough rash with 10-20 lesions on her trunk and upper extremities (WAES #0304USA02917). No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white male with no medical history and no allergies who on 25-Aug-1999 was vaccinated (previously reported as subcutaneously with a first dose of varicella virus vaccine live (lot # not available). It was unknown if the patient was ill at the time of vaccination. Neither the patient nor his sister had an adverse event following prior vaccinations. There was no concomitant medication. On 18-May-2003 the patient developed a varicella rash. It was reported that the patient contracted chicken pox/varicella and was "into a clinic setting with objective diagnosis of varicella". No other symptoms were noted. Medical attention was sough and the patient was being treated with acyclovir (ZOVIRAX) suspension. No diagnostic studies were performed. Subsequently, on an unknown date, the patient recovered. No product quality complaint was involved.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Unintended pregnancy
Clinical narrative: Information has been received from a 27 year old female, through the pregnancy registry for varicella virus vaccine live, with no allergies or other pertinent medical history who on 21-Mar-2003 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The patient reported that on 02-Apr-2003, she developed chickenpox. The patient did not seek medical attention and simply took acetaminophen (Tylenol). On 08-Apr-2003, the patient recovered from the chickenpox. On approximately 12-Apr-2003, the patient became pregnant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Nonspecific reaction
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in 1998 was vaccinated with varicella virus vaccine live. On 27-May-2003 it was reported that the patient "now has a titer with not immune results." The patient sought unspecified medical attention. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pharyngolaryngeal pain
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 27-May-1997 was vaccinated with varicella virus vaccine live (site unknown). On 13-May-2003 the patient presented with a one day history of sore throat. She had no rash, headache, or fever. Laboratory evaluation was notable for a negative rapid strep test, a negative throat culture, a VZV IgG antibody of 6.1 with 1.1 or greater indicating immunity, and a VZV Ab IgM, EIA of 0.93 which was withing the equivocal range of 0.91-1.09. Her sore throat "self resolved within a couple days." It was noted that she never developed any clinical signs or symptoms of varicella. It was also reported that the patient's brother was exposed to natural varicella in April 2003, and developed symptoms on 23-Apr-2003 (WAES #0304USA02850). Subsequently, her two brothers also developed symptoms (WAES #0304USA02848 and 0305USA02849). All were previously vaccinated. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a female patient who on 10-Apr-2002 and 16-May-2002 was vaccinated with a first and second dose of varicella virus vaccine live. On 27-May-2003 it was reported that the patient "now" has a negative titer. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female 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 live. There was no concomitant medication. On 27-May-2003 the patient was seen for the first time in the physician's office with lesions and a papular rash that had appeared that morning. The patient was diagnosed with varicella and treated with triamcinolone cream 0.025% bid to qid as needed for itching. On 27-May 2003 it was reported that the patient had not recovered. It was also reported that the patient's mother might be pregnant and probably in her first trimester. The reporter noted that the mother was concerned regarding contagiousness. No product quality complaint was involved. It was also noted that the patient's 7 year old brother was vaccinated with a dose of varicella virus vaccine live and developed varicella (WAES #0306USA00129). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 26 year old female medical student with no medical history and no allergies who on 01-Jul-1998 and 14-Feb-2001 was vaccinated with a first and second dose of varicella virus vaccine live. Concomitant therapy included "nodette". It was reported that the patient received 2 doses of the vaccine within a 3 year interval. During the week of 19-May-2003 the patient had a titer drawn which was reported as negative. Medical attention was sought and no treatment was required. No product quality complaint was involved. On 17-Jul-2003 information was received from the physician who reported that there was no adverse vaccine experience, he noted that he had simply called to get advice from the company about using varicella virus vaccine live. No further information is expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed a severe case of chicken pox with a rash that was described as being so severe that they had to send the child to a dermatologist for diagnosis. The reporter could not say when or if the child had been immunized previously. No product quality complaint was involved. On 05-Jun-2003 it was reported by a physician that the patient's two cousins who are siblings now have chicken pox following exposure to the patient. The chicken pox was "considered mild" and no hospitalization was required. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection transmission via personal contact
Clinical narrative: Information has been received from a licensed practical nurse concerning a child who on 27-May-2003 was vaccinated with a dose of varicella virus vaccine live. On 28-May-2003, the patient's sibling developed varicella. Unspecified medical attention was sough. There was no product quality complaint involved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Headache, Infection, Pharyngitis, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 10 year old white male with no past medical history who on 12-Aug-1997 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot #633680/0086E). Concomitant therapy that day included measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live, diphteria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (unspecified). There were also no other medications at the time of immunization. There were no significant illness at the time of immunization or immediately before or after immunization. On 08-May-2003 the patient was sent home from school with a fever and frontal headache. That evening he developed a pruritic rash which started on his upper torso. In the office, he had a vesiculopapular rash on his face, scalp, torso, and extremities that ultimately totaled about 50 to 100 lesions and group A streptococcal pharyngitis. The patient reportedly had a varicella infection. His VZV IgG antibody was 2.0 with 1.1 or greater indicating immunity and his VZV Ab IgM, EIA was .18 which was well within the negative reference range. The patient was treated with a 10 day course of cefasorxil (Duricef). On 04-Jun-2003 the patient returned for a follow-up visit. He had a few scabbed lesions remaining on his head and upper torso. His VZV IgG had increased to 4.6 and his VZV Ab IgM, EIA had increased to 2.50 which was also well within the positive reference rang of greater than 1.1. The patient reportedly recovered. I was noted that the patient did not experience any adverse events following prior vaccinations. It was reported that the patient's brother had been exposed to natural chicken pox in April 2003, and on 23-Apr-2003 had developed symptoms (WAES #0305USA02850). Subsequently, the patient's other siblings also developed symtpoms (WAES #0304USA2704, and WAES #0305USA02849). All were previously vaccinated. No further information is expected.
Age: 10.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash pruritic, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 10 year old white male with no past medical history who on 12-Aug-1997 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot #633680/0086E). Concomitant therapy that day included measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live, diphteria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine inactivated (unspecified). There were also no other medications at the time of immunization. There were no significant illness at the time of immunization or immediately before or after immunization. On 08-May-2003 the patient was sent home from school with a fever and frontal headache. That evening he developed a pruritic rash which started on his upper torso. In the office, he had a vesiculopapular rash on his face, scalp, torso, and extremities that ultimately totaled about 50 to 100 lesions and group A streptococcal pharyngitis. The patient reportedly had a varicella infection. His VZV IgG antibody was 2.0 with 1.1 or greater indicating immunity and his VZV Ab IgM, EIA was .18 which was well within the negative reference range. The patient was treated with a 10 day course of cefasorxil (Duricef). On 04-Jun-2003 the patient returned for a follow-up visit. He had a few scabbed lesions remaining on his head and upper torso. His VZV IgG had increased to 4.6 and his VZV Ab IgM, EIA had increased to 2.50 which was also well within the positive reference rang of greater than 1.1. The patient reportedly recovered. I was noted that the patient did not experience any adverse events following prior vaccinations. It was reported that the patient's brother had been exposed to natural chicken pox in April 2003, and on 23-Apr-2003 had developed symptoms (WAES #0305USA02850). Subsequently, the patient's other siblings also developed symtpoms (WAES #0304USA2704, and WAES #0305USA02849). All were previously vaccinated. No further information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Headache, Infection, Listless, Pharyngitis
Clinical narrative: Information has been received from a physician concerning a 5 year old white male with no past medical history who on 16-Jun-1999 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot # 628697/183H). There was no illness at the time of vaccination. There was no other immunization concomitantly or any other concomitant medication within three months of receiving varicella virus vaccine live. On 09-May-2003 the patient presented to the doctor's office. The patient reportedly "had not been well for a couple for days." The patient had a tactile fever, listlessness, slightly sore throat, and frontal headache. On the evening of 08-May 2003 he developed a pruritic rash on his torso. In the office, he had a one day history of vesiculopapular rash on his torso and head ultimately totaling about 5 to 10 lesions and group A strepococcal pharyngitis. The patient reportedly had a varicella infection. The patient's VZV IgG antibody was 5.4 with 1.1 greater indicating immunity and his VZV Ab IgM, EIA was 1.72 which was wel. within the positve range of greater than 1.1. The patient was treated with a 10 day course of cefradroxil (Duricef). The patient recovered in May 2003. It was noted that the patient did not experience any other adverse events following previous vaccinations. It was reported that the patient's brother had been exposed to natural chicken pox in April 2003, and on 23-Apr-2003 had developed symptoms (WAES #0305USA02850). The patient's other siblings also developed symptoms (WAES #0305USA02704 and WAES #0304USA02848). All were previously vaccinated. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rash pruritic, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 5 year old white male with no past medical history who on 16-Jun-1999 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot # 628697/183H). There was no illness at the time of vaccination. There was no other immunization concomitantly or any other concomitant medication within three months of receiving varicella virus vaccine live. On 09-May-2003 the patient presented to the doctor's office. The patient reportedly "had not been well for a couple for days." The patient had a tactile fever, listlessness, slightly sore throat, and frontal headache. On the evening of 08-May 2003 he developed a pruritic rash on his torso. In the office, he had a one day history of vesiculopapular rash on his torso and head ultimately totaling about 5 to 10 lesions and group A strepococcal pharyngitis. The patient reportedly had a varicella infection. The patient's VZV IgG antibody was 5.4 with 1.1 greater indicating immunity and his VZV Ab IgM, EIA was 1.72 which was wel. within the positve range of greater than 1.1. The patient was treated with a 10 day course of cefradroxil (Duricef). The patient recovered in May 2003. It was noted that the patient did not experience any other adverse events following previous vaccinations. It was reported that the patient's brother had been exposed to natural chicken pox in April 2003, and on 23-Apr-2003 had developed symptoms (WAES #0305USA02850). The patient's other siblings also developed symptoms (WAES #0305USA02704 and WAES #0304USA02848). All were previously vaccinated. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Infection, Pyrexia, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 8 year old white male with no past medical history who on 12-Aug-1997 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot #622680/0086E). The patient was reportedly healthy at the time of immunization, on no medications, and did not have any significant illnesses prior to or after immunization. I was also noted that the patient did not receive any other vaccinations that day or in the year of 1997. After exposure to one known child with natural varicella at his school in April 2003, the patient was evaluated in the office on 25-Ap-2003 with a two day history of fever, frontal headache, and a vesiculopapular rash scattered on his face, scalp, torso, and groin that ultimately totaled about 50 to 100 lesions. The patient reportedly had a varicella infection. Laboratory . That evening he developed a pruritic rash which started on his upper torso. In the office, he had a vesiculopapular rash on his face, scalp, torso, and extremities that ultimately totaled about 50 to 100 lesions. The patient reportedly had a varicella infection. Laboratory evaluation showed a rapid strep test that was positive, a throat culture with growth of group A streptococcus, a VZV IgG antibody was 2.0 with 1.1 or greater indicating immunity and his VZV Ab IgM, EIA was 0.18 which was well within the negative reference range. The patient was treated with a 10 day course of amoxicillin for streptococcal pharyngitis and was advised to stay home from school until the rash crusted/resolved. The patient returned to the doctor's office on 16-May-2003 for follow-up and convalescent antibody titers.  The patient's rash was resolving with a few scabbed lesions remaining on his forehead and scalp. His VZV IgG antibody had increased to 5.2 and his VZV Ab IgM, EIA had increased to 2.93 which was within the positive reference range of greater than 1.1. The patient reportedly recovered in May 2003. It was noted that the patient did not have any adverse events following prior vaccinations. It was reported that the patient subsequently infected his father (who was not vaccinated) and his two brothers and sister who both had been immunized with varicella virus vaccine live. It was reported that the patient's other siblings also developed symptoms (WAES #0305USA02704, WAES #0304USA02848 and 0304USA02849). All were previously vaccinate. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 8 year old white male with no past medical history who on 12-Aug-1997 was vaccinated with a first dose of varicella virus vaccine live (site unknown) (SC) (lot #622680/0086E). The patient was reportedly healthy at the time of immunization, on no medications, and did not have any significant illnesses prior to or after immunization. I was also noted that the patient did not receive any other vaccinations that day or in the year of 1997. After exposure to one known child with natural varicella at his school in April 2003, the patient was evaluated in the office on 25-Ap-2003 with a two day history of fever, frontal headache, and a vesiculopapular rash scattered on his face, scalp, torso, and groin that ultimately totaled about 50 to 100 lesions. The patient reportedly had a varicella infection. Laboratory . That evening he developed a pruritic rash which started on his upper torso. In the office, he had a vesiculopapular rash on his face, scalp, torso, and extremities that ultimately totaled about 50 to 100 lesions. The patient reportedly had a varicella infection. Laboratory evaluation showed a rapid strep test that was positive, a throat culture with growth of group A streptococcus, a VZV IgG antibody was 2.0 with 1.1 or greater indicating immunity and his VZV Ab IgM, EIA was 0.18 which was well within the negative reference range. The patient was treated with a 10 day course of amoxicillin for streptococcal pharyngitis and was advised to stay home from school until the rash crusted/resolved. The patient returned to the doctor's office on 16-May-2003 for follow-up and convalescent antibody titers.  The patient's rash was resolving with a few scabbed lesions remaining on his forehead and scalp. His VZV IgG antibody had increased to 5.2 and his VZV Ab IgM, EIA had increased to 2.93 which was within the positive reference range of greater than 1.1. The patient reportedly recovered in May 2003. It was noted that the patient did not have any adverse events following prior vaccinations. It was reported that the patient subsequently infected his father (who was not vaccinated) and his two brothers and sister who both had been immunized with varicella virus vaccine live. It was reported that the patient's other siblings also developed symptoms (WAES #0305USA02704, WAES #0304USA02848 and 0304USA02849). All were previously vaccinate. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning an 8 year old white female with no medical history and no allergies who on 02-May-1996 was vaccinated with on 0.5 ml dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 19-May 2003 the patient developed a breakthrough rash with 10-20 lesions on her trunk and upper extremities. Unspecified medical attention was sought and it was reported that no treatment was required. On approximately 02-Jun-2003, two weeks later, the patient recovered. No product quality complaint was involved. It was also noted that the patient's 9 year old sister was vaccinated with a dose of varicella virus vaccine live and developed a breakthrough rash with 5-10 scattered lesions on the right side of her chest (WAES #0304USA02590). No further information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10 year-old male patient with no relevant medical history who in 1998 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 27-May 2003, the patient developed varicella described as "lesions on his face". On 28-May-2003, he was seen in the office and was moderately covered with at least 50 lesions, and had a fever. Treatment included acetaminophen (Tylenol) and "comfort measure". Medical attention was sought. There was no product quality complaint involved. No further information was available at this time. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site oedema, Injection site rash
Clinical narrative: Information has been received from a registered nurse concerning a 34 year-old female patient with a history of Hepatitis A and Psoriasis who on 21-May-2003 at approximately 15:00 was vaccinated subcutaneously in the right upper arm with a first dose of varicella virus vaccine live (lot number 642877/0416M). There was no illness at the time of vaccination. On 21-May-2003, the patient developed "some swelling at injection site". On 29-May-2003, the patient developed a "very mild rash" described as a rash at the injection site on her back and abdomen and a duration of 4 days. No treatment was required. There was no relevant diagnostic laboratory data. Unspecified medical attention was sought. Subsequently, the patient recovered from the rash at the injection site. There was no product quality complaint involved. No other information was provided. Additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of varicella virus vaccine live. On approximately 15-May-2003. "approximately 2 weeks ago", the patient developed a mild case of chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No additional information was provided at this time. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 11-year-old white male with a cefaclor (CECLOR) allergy and no medical history who on 06-Aug-1996 was vaccinated in the right arm with a first dose of varicella virus vaccine live (lot #616997/1656B). Concomitant vaccination on the same day in the left arm included a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot 3613410/0103D). There was no other concomitant medication. There was no illness at the time of vaccination. The reporter indicated that the patient developed "breakthrough varicella" after being vaccinated in the past. It was noted that the symptoms started a few days before being seen on 27-May-2003 and included "several lesions." The patient was treated with diphenhydramine hydrochloride (Benadryl) and acetaminophen (Tylenol) as needed. It was also indicated that a prescription drug was required. The symptoms had not completely resolved and at the time of the report, the patient had not recovered. Follow-up information from the registered nurse indicated that the patient developed many scattered varicella lesions the trunk. There were no diagnostic tests or laboratory results. It was noted that the patient recovered (also reported as unknown). Follow-up information from the registered nurse indicated that as of 11-Jul-2003 there were no other problems to date related to the varicella experience. No further information is expected. The nurse also reported a similar experience in a female child after vaccination with a dose of varicella virus vaccine live (WAES #0306USA00402). It was noted that the children attended the same school and the reporter notified the school of the children's status.