chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Acute leukaemia, Dermatitis bullous, Drug ineffective, Herpes zoster, Infection
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a physician concerning a 25 month old male with no history of chickenpox and no known allergies who on 06/24/03 was vaccinated with a dose of varicella virus vaccine live (Lot # unknown). The pt has had a recurring vesicular rash determined to be varicella positive. A specimen has been obtained on 10/30/03 for PCR analysis from a scab. The physician indicated that the child has had three rash outbreaks, with the last rash (patches on back, left arm and chest) occurring on approximately 10/17/03, "2 weeks ago". Unspecified medical attention was sought. There was no product quality complaint. Additional information indicated that the pt developed 3 episodes of a rash, determined to be herpes zoster. The first episode occurred on 07/16/03 as 2 discrete vesicular papular lesions on his left cheek and right lower back. The second episode occurred on 08/09/03 as 2 discrete lesions on left cheek (same spot as before) and right arm. The third episode occurred on 10/17/03 as 2 areas of erythema, 3cm in diameter. One was on the upper back and the other was on the back of the right arm. Both areas had multiple little vesicles. There were also 3 discrete papulo-vesicular lesions on his chest. The rashes did not occur at the site of injection post-vaccination. The outcome was reported as recovered. Additional follow up information received on 11/07/03 indicated that the PCR results revealed that the specimen contained the manufacturer vaccine strain virus. The specimen was obtained on 10/30/03 and sent to the lab on 10/30/03.  The source was the scab of a vesicle. VZV DNA was amplified. The VZV strain identification showed vaccine-type. B-globin was amplified. The interpretation was adequate specimen with vaccine strain.  Additional follow up information received on 22-Mar-2004 indicated that the patient was diagnosed with acute lymphocytic lekuemia (ALL) 10 days after varicella vaccine was given. Chemotherapy medication was initiated prior to 31-Oct-2003. The reporter indicated that the child was treated with acyclovir for his rashes and "is now better as far as she know." It was noted that the reporter "is going to check further to make sure the child does not have any chronic rash, but she does not think so." Information was recevied which pertained to events which occurred 10 days after vaccination with varicella virus vaccine live. This information contained the following adverse experience: ALL (acute  lymphocytic leukemia) (04-Jul-2006). Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection transmission via personal contact, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 13 year old pt who's 6 year old adopted sister was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (Lot # 644794/0334N) on 09/03/03 at 2:15PM. The 6 year old, who is being adopted into the family, received the vaccination and did not get a break through or rash or lesions. However, when she went home, the 13 year old (name, gender, and demographics were not reported) in the family got active chickenpox along with lesions on 09/15/03.  The chickenpox was described as hundreds of vesicular lesions and a temperature of 103 degrees F.  The teenager had never had varicella. It was noted to be "apparent secondary infection". The 13 year old is the biological child of the family. The biological children of the adopting family have not received any vaccinations because "the mother and father feel that vaccinations are not natural". The child has recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a RN concerning a 10 year old white female who on 08/18/95 was vaccinated SC in the left arm with a first 0.5mL dose of varicella virus vaccine live (Lot # 608667/0426B).  Subsequently the pt developed breakthrough lesions, which were mild. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the RN which indicated that the pt was an office employee's family member. The chickenpox onset was a very mild case and was not reported to the office. An office visit was not made. It was noted that the case was "hear-say" between a company representative and an office employee. The date of the event was unknown. The reporter indicated that the pt recovered. Further information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a LPN concerning a 12 month old male with no allergies or medical conditions who on 10/17/03 was vaccinated in the left anterior thigh with a first dose of varicella virus vaccine live (Lot # 644975/0472N). Concomitant vaccinations on the same day included a first dose in the right anterior thigh of MMRII (Lot # 645520/0296N) and a fourth dose in the left anterior thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar, Lot # 493261).  There was no illness at the time of vaccination. The reporter indicated that on 10/27/03 the pt had an office visit where it was noted that lesions erupted on 10/26/03 on the back, stomach, legs and arms. The child was afebrile and had greater than 50 lesions. It was unknown if the pt recovered. Follow up was received from the LPN which indicated that there was no further information. No additional information is expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 12 year old female who 3 years ago, in approximately 2000, was vaccinated with a dose of varicella virus vaccine live. On 10/31/03 the physician reported that two days ago the pt was brought in with a breakthrough varicella rash. It as noted that the pt did not have a fever but she did have 25 lesions that itched. The pt was given with acyclovir to treat the varicella.  A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Infection, Injection site mass, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a physician concerning a 12 month old Caucasian female pt with no allergies and no past medical history who on 10/21/03 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (Lot # 644249/1146M).  Concomitant vaccination on 10/21/03 included a first dose in the right thigh of MMRII (Lot # 639512/0471N) and a fourth dose in the left thigh of hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (Lot # 646074/0369N). There was no illness at the time of vaccination and there were no adverse events following prior vaccination. Ten days post vaccination on 10/31/03, the pt developed a fine, raised, red, macular rash, mostly on the abdomen and some on the legs, arms and neck with a red nodule at one injection site on the left thigh. That day, the pt returned to the medical office for a doctor visit. The pt was afebrile. The reporter noted that the adverse experience was "most likely with varicella virus vaccine live". Lab tests were not performed. Subsequently, the pt recovered. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 02/24/98 was vaccinated with a dose of varicella virus vaccine live (Lot # 622682/0181E). There was no concomitant medication. On approximately 10/29/03 the pt experienced breakthrough chickenpox. It was reported that the pt's "best friend" in school as well as the friend's siblings had chickenpox and these children were not vaccinated. The pt was seen by the physician with multiple lesions on her face, truncal was heaviest, scattered on the limb and 2 in the head. The lesions had only been out for approximately 14 hours when seen. There were papules, vesicles and 1 scab on the head and her temperature was 99.6-100. There was no other apparent cause than chickenpox. There was no treatment required and no product quality complaint involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection
Clinical narrative: Information has been received from a physician concerning a 17 year old female pt with an allergy to Ceclor and no past medical history who on 10/04/03 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Lot # 643597/0895M). Concomitant therapy included sertraline hydrochloride (zoloft). Roughly two weeks post vaccination, on approximately 10/18/03, the pt developed a "breakthrough varicelliform rash" consisting of 12 mild lesions. Unspecified medical attention was sought, but no treatment was necessary. Subsequently the pt recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a MA concerning a 18 month old white female with allergies to eggs, nuts, milk, soy and wheat who on 04/30/03 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Lot # 641787/0758M). There was no illnesses at the time of vaccination. In September 2003, the pt developed a very mild case of chickenpox.  No medical attention was sought. No diagnostic lab studies were performed.  It was also reported that in September 2003 there was an outbreak of chickenpox "in daycare". In October 2003 the pt recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a pt who "a few years ago" was vaccinated with a dose of varicella virus vaccine live. On 11/04/03 it was reported that the pt "recently" developed chickenpox. Unspecified medical attention was sought.  There was no product quality complaint involved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Pruritus, Rash
Clinical narrative: Information has been received from a RN concerning a 27 year old female who on 09/15/03 was vaccinated with a dose of varicella virus vaccine live (Lot # 644973/0195N).  The RN reported that on 09/24/03, the pt developed a case of breakthrough chickenpox characterized by 25 itchy lesions all over her body, some on her face, arm and a papular lesion on her thigh. Unspecified medical attention was sought, but it was unknown if treatment was required. Subsequently, the pt's breakthrough chickenpox and all symptoms resolved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 6 year old male who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/26/03 the pt developed chickenpox characterized by about 150 lesions. Unspecified medical attention was sought, but treatment was not required. At the time of this report, the pt was recovering with sequalae (unspecified).  The physician also reported that the pt's two brothers also developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0311USA02058 & 0311USA02059).  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a MA concerning an approximately 3.5 year old male who on 07/18/01 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced chickenpox. The pt's mother called from the ER and reported that her son was diagnosed with chickenpox. There was no product quality complaint involved. The reporter indicated that two other pt's (WAES # 0401USA00023 & 0401USA00024) had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Injection site erythema, Rash papular
Clinical narrative: Information has been received from a physician concerning a 24 month old male pt with no pertinent medical history who on 10/23/03 was vaccinated in the thigh with a dose of varicella virus vaccine live (Lot # 645044/0207N). Concomitant vaccines included Prevnar and MMRII.  The physician reported that, about 7 days (approximately 10/30/03) after varicella virus vaccine live administration the pt developed a half dollar sized red patch at the injection site with about 10 papules. No additional information was provided. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Age: 1.7
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 20 month old male pt with no known drug allergies and no history of chickenpox or recent exposure to chickenpox who on 02/19/03 was vaccinated in the left arm with a 0.5mL dose of varicella virus vaccine live (Lot # 644149/0967M). Concomitant therapy included Zyrtec. A rash did not occur at the injection site or elsewhere within 42 days of the vaccination. On 11/05/03, the pt presented to the medical office with herpes zoster and an onset date of 11/05/03 was noted. The pt had 4 crops of papular/vesicular lesions on the right thorax in the T10 dermatome. The pt's maximum temperature was 98.9 degrees. There was no pain or systemic symptoms. A photo was taken. On 11/06/03, a specimen was collected from a papule for polymerase chain reaction strain identification.  DNA was amplified and revealed vaccine-type strain. Subsequently, the pt recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning an adult health care provider "in an acute setting" who was vaccinated with a first and second dose of varicella virus vaccine live. Subsequently, there was "no demonstrated antibody titer". Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live. About a week later, the pt had a "breakthrough" with a rash that occurred on the buttocks area. Unspecified medical attention was sought and no prescription drug was required. It was reported that the pt was recovering. No product quality complaint was involved.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash pruritic
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter who was vaccinated with varicella virus vaccine live at approximately 1 years old. Subsequently the pt experienced chickenpox. It was reported as a rash that was itchy and covered her back, but she had no fever or malaise. The outcome was not known.  The pt's sister (WAES # 0311USA01815) also experienced chickenpox after vaccination with varicella virus vaccine live. This reporter also reported that a first grade child (WAES # 0311USA01817) experienced chickenpox after vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 1.4
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Herpes zoster, Infection, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 17 month old white female with seasonal allergies, no medical history, no history of chickenpox and no recent exposure to chickenpox or herpes zoster, who on 06/26/02 was vaccinated SC in the right arm with a 0.5mL first dose of varicella virus vaccine live (Lot # 640313/0967L).  On 06/26/02 the pt was also vaccinated IM in the right thigh with a third dose of hepatitis B virus vaccine rHBsAg (yeast)(+) Hib conj vaccine (Lot # 637873/1523K), a fourth dose given IM in the left thigh of Prevnar (Lot # 484871), and a first dose given SC in the left arm of MMRII (Lot # 639571/1207L).  The pt had a bilateral acute otitis media which was being treated with Omnicef at the time of vaccination. There was no other concomitant medication. There was no rash at the site of injection or elsewhere within 42 days of the vaccination.  On 12/14/02 the pt's symptoms began with a red, raised rash with vesicles to her right labia and inner thigh. It involved the L1 dermatome. The pt had no fever. The pain was rated a 4 on a scale of 1 to 10.  The rash was initially treated with hydrocortisone cream by the pt's parent with no result. On 12/16/02 the pt was seen by her physician. The pt was diagnosed with herpes zoster. She was initially treated with Zovirax by her family physician. She was then changed to Famvir by a dermatologist. Subsequently, the pt fully recovered. No product quality complaint was involved. No further information is expected.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Information has been received from a Dr of a pharmacy concerning her 15 month old white daughter with no known drug allergies and no past medical history who in the am of both 01Aug03 and 31OCt2003 was vaccinated IM in the thigh with first and second doses of varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no other concomitant medication. It was noted that in the am of both 24Oct03 and 24Nove2003 the pt was vaccinated IM in the arm with influenza virus vaccine (unspecified). There was no illness at the time of vaccination. Subsequently, in approximately Oct2003, the pt developed a slight fever. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the Dr of pharmacy which indicated that there was no adverse events from receiving the second dose of varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) three months after the first dose; however, she also reported that there was some fussiness/crankiness with both first and second doses. No diagnostic laboratory tests were performed. It was noted that there were no adverse events following prior vaccination. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: FLUX, MMR, UNK, VARCEL
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: Information has been received from a registered pharmacist concerning a 16month old male who on 06Nov03 was vaccinated with varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) , inadvertently via the IM route of administration instead of the recommended SC route. Concomitant therapy that day included influenza virus vaccine and respiratory syncytial virus vaccine. Subsequently, on 06Nov03, the pt developed a fever and increased heart rate. It was noted that the pt was not hospitalized. There was no product quality complaint involved. The pt sought unspecified medical attention. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13 year old white male with no pertinent medical history and no known drug allergies who on 11Nov96 was vaccinated with a first dose of varicella virus vaccine live, SC in the left arm. On 04Nov2003 the pt presented to the Dr's office with break through chickenpox, described as a 24 hour rash with red vesicular lesions over his trunk,arms, and body. The pt also had a mild fever and a runny nose. Medical attention was sought. The child was prescribed desloratadine (Clarinex) for treatment as needed. There was no product quality complaint. The pt recovered. No further information is expected.
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female who on 01Oct2003 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy the same day included measles virus vaccine live (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) and tuberculin purified protein derivative. Sometime between vaccination and 08Oct03 the pt experienced breakthrough, she developed red bumps and high fever. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated that two other pt's had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 12 month old white male with a history of hydroceles (surgery in July 2003) who on 15Oct2003 at noon was vaccinated SC in the left arm with a first 0.5ml dose of varicella virus vaccine live. Concomitant vaccination on the same day at noon included a third dose IM in the right arm of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR). There was no other concomitant medication. There was no illness at the time of vaccination. The reporter indicated that three weeks after vaccination the pt developed a varicella like rash. No medical attention was sought. A product quality complaint was not involved. Follow up information from the physician indicated that during the daytime on 02Nov03 the pt's mother noticed red spots on the trunk and extremities. There were a few spots on 02Nov03 and more spots appeared on 02Nov03 through 06Nov03. The pt was not scratching at it. It was noted that the pt received the varicella virus vaccine live 18 days prior to the onset of the rash . A maculopapular rash was seen on the trunk, extremities, axilla, and diaper area. No vesicles were seen. No diagnostic tests were performed. Subsequently, the pt recovered. It was also noted that the pt did not experience any adverse events following prior vaccination. No further information is expected.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 12 month old pt with an unremarkable medical history and no known drug allergies who on 22Oct2003 was vaccinated IM (also reported by physician as SC) in the left thigh with a first dose of varicella virus vaccine live. There was no concomitant medication. On 06Nov03 the pt developed a localized rash at the injection site. The physician described the rash to the left thigh, the site of the injection, to have approximately 6 small vesicles (one of which appeared crusted over). The physician reported she gave the pt acyclovir (Zovirax) ointment to treat the rash. The physician indicated it is unknown as to whether the patient recovered. It was noted the patient was not ill at the time of vaccination, had no adverse events following prior vaccinations and there were no relevant diagnostic tests or laboratory studies performed. There was no product quality complaint reported. The physician indicated there is no additional information. No additional information is expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Injection site rash, Injection site reaction, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a 33 year old female patient with a dose of varicella virus vaccine live. There was no concomitant medication. On 03Nov03 the pt developed a site reaction on her arm. The pt stated that she had a two and a half inch diameter that was swelled, bruised and itchy. The pt also developed three chickenpox on her body. Her physician recommended using an oral diphenhydramine HC1 (Benadryl), colloidal oatmeal (Aveeno bath), and icing the affected area. On 07Nov2003, the pt stated that the bruise was looking better and was less itchy. The pt was reported to be recovering with sequlae. There was no product quality complaint involved. Follow up information from a physician indicated the Caucasian pt was vaccinated on 23Oct2003 at 15:30 in the left deltoid with a first SC dose of varicella virus vaccine live. On 03Nov2003 at 08:00, the pt developed a rash at the injection site. There were no adverse events following prior vaccination. Laboratory tests were not performed. Within two weeks, the pt recovered from the rash at the injection site. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician's assistant concerning a 29 year old female who in May2003 was vaccinated with the first dose of varicella virus vaccine live. It was noted that the pt did not receive the second dose of varicella virus vaccine live. The PA reported that in 2003 the pt had a negative varicella titer. Unspecified medical attention was sought. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 6 year old white female with no pertinent medical history or allergies who on 20Aug98 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 10Nov2003 the pt presented to the office with a mild case of chickenpox that was also described as a varicella rash. The onset date was reported as 09Nov03. The pt was treated with diphenhydramine (Benadryl) and colloidal oatmeal (Aveeno) bath. No prescription drug treatment was required. No diagnostic lab tests were performed. Subsequently, the pt recovered with no further problems. No product quality complaint was involved. No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Pruritus, Rash vesicular, Viral infection
Clinical narrative: This is in follow up to report(s) previously submitted on 5/14/2004. Information has been received from a RN concerning a 9 year old male with no known allergies who on 19Feb2003 at 13:00 was vaccinated SC in the deltoid with a first dose of varicella virus vaccine live.(#642994/0566M). There was no concomitant medication.  The pt's three siblings were vaccinated the same day. Subsequently in 2003, he developed breakthrough chickenpox. It was reported that two of his siblings (WAES#0401USA00638 and 0401USA00639) also developed chickenpox. The reporter expressed concern with the lot. Unspecified medical attention was sought. There was no product quality complaint involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow-up information indicated that on 23-Oct-2003 the patient had an acute clinic visit with the onset of pruritic papule on the left temple which started on 22-Oct-2003 and progressed to his face and torso. His sister (0401USA00619) had chickenpox which lasted for two weeks. The patient was seen for a doctor's visit and his skin revealed a typical vasicular rash with erythema on his face, back, arms and torso consistent with varicella. The patient was given dophenhydramine hydrochloride (Bendaryl) (12.5 mg/5ml) 1 teaspoon every 6 hours prn, calamine lotion and oatmeal baths. Subsequently the patient recovered. Ths patient recevied additional vaccinations on 22-Jan-2003 at 13:17 which included a first dose of measles virus vaccine live (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live which was given SC in the thigh, a first dose of diphtheria toxoid (+) tetanus toxoid given IM in the thigh, a first dose of poliovirus vaccine inactivated (unspecified) which was given SC in the deltoid and a first dose of hepatitis virus vaccine (unspecifried given IM in the thigh.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an adult pt who was vaccinated with a first and second dose of varicella virus vaccine live. Subsequently, the pt had no detectable antibodies. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 9 or 10 year old female who on 13May1996 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt came into the physicians office with a rash that was found to be chickenpox. It was also noted that children at the pt's school had broken out with chickenpox. No additional information was available. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a pharmacist concerning a child who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the child developed a chickenpox-like rash after vaccination. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner and a RN concerning a 9 year old Caucasian male pt with no known drug allergies who on 06Aug96 was vaccinated SC with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 11Nov2003, the pt developed chickenpox. On 12Nov03, the pt presented for a Dr's visit with approx. 85 chickenpox bumps. No treatment was necessary. It was unknown if the pt recovered. A product quality complaint was not involved. The reporter also mentioned a female pt who developed shingles post vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Decreased appetite, Dermatitis bullous, Irritability, Nasal congestion
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 month old white female with no relevant medical history except premature birth at 35 weeks who on 24Oct03 at 1:30PM was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. There was no concomitant medication. On 11Nov03, the pt presented with a vesicular rash of about 20 lesions in a generalized desemination on her torso, low grade fever, cough and nasal congestion. There was no prescription drug required. Unspecified medical attention was sought. No other information was available. Follow up information received from a certified medical assistant indicated that on 11Nov2003 at 08:00AM 19 days post varicella vaccination, the pt developed 1-2 pox like rash. At day 20 the pt developed 20 lesions. At the doctor's appt. the pt had irritability; runny nose,  chest congestion with cough; decreased appetite. At follow up visit on 18Nov2003 the pt was improved. The outcome was reported as recovered on 18Nov2003. There were no adverse events following prior vaccinations. No additional information is expected.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 month old white female with no relevant medical history except premature birth at 35 weeks who on 24Oct03 at 1:30PM was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. There was no concomitant medication. On 11Nov03, the pt presented with a vesicular rash of about 20 lesions in a generalized desemination on her torso, low grade fever, cough and nasal congestion. There was no prescription drug required. Unspecified medical attention was sought. No other information was available. Follow up information received from a certified medical assistant indicated that on 11Nov2003 at 08:00AM 19 days post varicella vaccination, the pt developed 1-2 pox like rash. At day 20 the pt developed 20 lesions. At the doctor's appt. the pt had irritability; runny nose,  chest congestion with cough; decreased appetite. At follow up visit on 18Nov2003 the pt was improved. The outcome was reported as recovered on 18Nov2003. There were no adverse events following prior vaccinations. No additional information is expected.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN in a public health dept. who received a request for a consultation from a local preschool concerning a 45 month old who was vaccinated at age 12 months with varicella virus vaccine live. Subsequently the pt became symptomatic and was diagnosed with a case of chickenpox. It was unknown if medical attention was sought. No product quality complaint was involved. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning a male pt who was vaccinated with a first dose of varicella virus vaccine live. One week post vaccination, the pt had a breakthrough with eight bumps. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 29 month old female with no past medical history and no known drug allergies who on 19Mar2003 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live.  There was no concomitant medication. On 08Nov2003 the mother noticed a few lesions on her daughter. No treatment was required. The outcome was reported as recovered. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. There reporter also reporter one other pt who experienced an adverse event. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Malaise, Pain, Skin ulcer
Clinical narrative: Information has been received from an approx. 50 year old female nurse who in 2002 was vaccinated with a first dose of varicella virus vaccine live. Subsequently, for the following six months, the pt experienced malaise, aches, and lesions around her mouth, inside her mouth, and around her eyes. It was unknown if treatment was given. The condition had resolved. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old male with no allergies or medical history who on 30Sep1997 was vaccinated with a first dose of varicella virus vaccine live. There was no concomitant medication. The pt was recently exposed to shingles and chickenpox. Subsequently, the pt developed chickenpox with 100 to 150 lesions and without fever. Unspecified medical attention was sought and no treatment or prescription drug was required. There were no diagnostic studies performed. A product quality complaint was not involved. Follow up information was received from the licensed practical nurse which indicated that on 10Nov2003 the pt developed chickenpox. Subsequently the pt recovered. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a toddler female patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. The reporter also mentioned a male patient who developed chickenpox post vaccination with varicella virus vaccine live (WAES #311USA01416). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a school nurse concerning a teacher with a history of chickenpox and shingles who was vaccinated with a dose of varicella virus vaccine live. On approximately 24-Sep-2003, the patient developed breakthrough varicella. Subsequently, the patient recovered. The school nurse also reported breakthrough varicella in children after therapy with varicella virus vaccine live, a case of breakthrough varicella in a second grade student (WAES #0311USA01766), and a case of breakthrough varicella in a child which resulted in hospitalization (WAES #0311USA00972). It was noted that the Centers for Disease Control and Prevention and state health department were involved in surveillance. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a school nurse concerning a teacher with a history of chickenpox and shingles who was vaccinated with a dose of varicella virus vaccine live. On approximately 24-Sep-2003, the patient developed breakthrough varicella. Subsequently, the patient recovered.  It was noted that the patient also had the disease at age three. The school nurse also reported breakthrough varicella in children after therapy with varicella virus vaccine live, a case of varicella in a teacher (WAES #0311USA01765), and a case of breakthrough varicella in a child which resulted in hospitalization (WAES #0311USA00972). It was noted that the Centers for Disease Control and Prevention and state health department were involved in surveillance. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEPA, TYP, YF
Symptoms: Pharyngeal oedema, Stomatitis
Clinical narrative: Pt c/o swelling of throat and itching in mouth approx . 20min after vaccine administration.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Conjunctivitis, Infection
Clinical narrative: Information has been received from a physician concerning a 5 year old male who was vaccinated "at an unknown time in the past" with a dose of varicella virus vaccine live. Subsequently the patient developed shingles on his facial dermatones. Unspecified medical attention was sought and the patient was treated with acyclovir and anti itch eyedrops. His eyes became infected with conjuctivitis and he was treated in an outpatient department of the hospital for the conjunctivitis. There was no product quality complaint involved. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Infection
Clinical narrative: Information has been received from a physician concerning a 14 month old female who was vaccinated in approximately 2000 with a dose of varicella virus vaccine live. Concomitant vaccination included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently in approximately 2000, the patient developed ataxia. The patient's ataxia never resolved. Unspecified medical attention was sought and it was unknown if treatment was required. There was no product quality complaint involved. Upon further review, the patient's ataxia was considered to be an other important medical event. (OMIC) No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Pruritus, Rash
Clinical narrative: Information has been received from a consumer concerning her 6 year old daughter who was vaccinated with varicella virus vaccine live at approximately one year old. Subsequently the patient experienced chicken pox. It was reported as a mild itchy chicken pox rash on her face two weeks prior to her sister (WAESE 0311USA00633). She had no other symptoms. The outcome was not known. The patient's sister (WAES 0311USA0633) also experienced chicken pox after vaccination with varicella virus vaccine live. This reporter also indicated that a first grade child (WAES 0311USA01817) experienced chicken pox after vaccination with varicella virus vaccine live. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pain
Clinical narrative: Information has been received from a consumer concerning a child from a first grade class who was vaccinated with varicella virus vaccine live. Subsequently the pt experienced chickenpox. It was reported as quarter size welts which were not itchy, but painful. The child was out of school for over one week and it was unknown how the child was doing at this time.  This reporter also indicated that siblings (WAES 0311USA0063 & WAES 0311USA01815) experienced chickenpox after vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a school nurse concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live. The nurse reported that the child has been out of school for three weeks due to rashes that developed after being vaccinated. The child has been breaking out in "new crops" each week for three weeks. It was noted that therapy was "discontinued".  Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. Follow up was received from the school nurse which indicated that she had no additional information. The nurse did indicate that the pt was attending school. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 2-3 year old female pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed a mild case of chickenpox with 5-6 lesions on the chest after being exposed to another child with chickenpox. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved.  Additional information is not expected.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 20 month old male pt who was vaccinated with a dose of varicella virus vaccine live (645292/0202N). One day prior to chickenpox break through, on 11/12/03 the pt developed a fever. The pt presented to the MD office on 11/13/03, with 5-6 "pox" over torso, and some on arm and face. It was noted that the pt had no treatment. It was also noted that the pt's outcome was not recovered. The nurse also stated that the varicella virus vaccine live had a temperature exposure during a hurricane and this was the vaccine that had the break through. No product quality complaint was involved. It was noted that a female (WAES # 0401USA00731) and a male (WAES # 0401USA00732) pt from the same source, had similar experiences. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Information has been received from a health professional concerning a 3 year old male who on 11/08/03 was vaccinated with a dose of varicella virus vaccine live (Lot # not available). On 11/14/03 the pt developed shingles.  The child was not hospitalized. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a physician concerning an 8 year old male who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/26/03, the pt developed chickenpox characterized by about 35 lesions. Unspecified medical attention was sought, but treatment was not required. At the time of this report, the pt was recovering with sequalae (unspecified).  The physician also reported that the pt's two brothers also developed chickenpox after being vaccinated with varicella virus vaccine live (WAES #'s 0311USA00327 & 0311USA02059).  Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 9 year old male who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/26/03, the pt developed chickenpox characterized by about 35 lesions. Unspecified medical attention was sought, but treatment was not required. At the time of this report, the pt was recovering with sequalae (unspecified).  The physician also reported that the pt's two brothers also developed chickenpox after being vaccinated with varicella virus vaccine live (WAES #'s 0311USA00327 & 0311USA02058).  Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Infection
Clinical narrative: Information has been received from a women in a physician's office concerning a 42 month old male who on 04/24/01 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Lot # 637975/1897K).  There was no illness at the time of vaccination. On 11/10/03 the pt broke out with chickenpox. It was noted that this was a very mild case. Subsequently, the pt recovered. No labs or diagnostic tests were done.  Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a 9 year old female who 3 weeks ago, on approximately 10/28/03, was vaccinated with a dose of varicella virus vaccine live. The pt's mother called the physician's office on 11/17/03 and reported to the nurse that the child was "continuing to break out", but it was mild.  Unspecified medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. The physician also reported breakthrough varicella in two other children after therapy with varicella virus vaccine live. The office nurse reported breakthrough varicella in her children after therapy with varicella virus vaccine live. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a LPN concerning a 10 year old male who on 09/13/96 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 616867/0243D). Subsequently, the pt developed chickenpox with approximately 10 lesions. Unspecified medical attention was sought. A product quality complaint was not involved.  Follow up information was received from the LPN which indicated that on 11/15/03 the pt had an itchy rash on the arms, head and abdomen. Subsequently, the pt recovered. No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a physician (degree not specified) concerning a 6 year old white female pt with no allergies and no past medical history who on 10/19/98 was vaccinated IM in the left arm with a first dose of varicella virus vaccine live (Lot # 627332/1243H). There was no illness at the time of vaccination. There was no concomitant medication. On 11/12/03, the pt developed 10 crusted lesions on her trunk and face. Medical attention was not sought and lab tests were not performed. On 11/15/03, the pt recovered. Additional information is not expected.