chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Infection, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female with no known drug allergies and a history of seizures at 38 hours of age that was treated with phenobarbitol for 6 months who on 05-Aug-2003 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot #644248/1145M). On 05-Aug-2003 the patient was also vaccinated with a dose of poliovirus vaccine (manufacturer unknown). There was no illness at the time of vaccination. On 19-Aug-2003 (also reported as 18-Aug-2003) the patient developed chicken pox with about 20-25 lesions located on her trunk. Symptomatic treatment was provided and the patient was treated with a prescription drug. No diagnostic tests were performed. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician who is the father of a male who at "15 months of age" was vaccinated subcutaneously with a dose of varicell virus vaccine live 0.5 ml. In approximatel July 2003, "within the last month or two", the patient "broke out with chicken pox". It was noted that this "was more than a mild case" and that the child had "at least 50 lesions on the head alone, but no scarring." Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned other patients (WAES #0308USA02392) and one sibling (WAES #0308USA02391) who experienced a similar reaction with varicella virus vaccine live. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a female patient with a history of chickenpox who in approximately 2003 was vaccinated with a dose of varicella virus vaccine live (lot # not provided). The patient subsequently developed shingles. It was not known what treatment was provided or if the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter indicated a similar experience with another patient. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician who is the father of a male who at 15 months of age was vaccinated SC with a dose of varicella virus vaccine live 0.5ml. In approximately July 2003, within the last month or two, the patient broke out with chicken pox. It was noted that this was more than a mild case and that the child had at least 50 lesions on the head alone, but no scarring. Unspecified medical attention was sought. There was no product quality complaint. The reporter also mentioned other patients who experienced a similar reaction with varicella virus vaccine live. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 6/27/96 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that on 7/1/03 the patient developed a mild case of chicken pox with about 75 lesions. The patient was sick for about three or four days and subsequently recovered. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 10 year old white female patient who on 5/23/95 was vaccinated with a dose of varicella virus vaccine live. On 8/22/03, it was reported that the child recently developed full blown chicken pox. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the health care facility indicated that per mom, the patient developed chicken pox on 9/2/03. The patient recovered in 1 week. It was also reported that on 3/21/95 the patient was vaccinated IM with a fourth dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (TRIPEDIA). No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated against chicken pox with a dose of varicella virus vaccine live. Recently, in approximately 2003, the patient developed lesions after being exposed to a person who had chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from the reporter indicated patient not known. No further information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a male who in approximately 1993 was vaccinated with a dose varicella virus vaccine live. Subsequently, the patient's titer for varicella is negative. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available at the time of the report. Additional information is requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician who is the father of a female who at 15 months of age was vaccinated SC with a dose of varicella virus vaccine live 0.5ml. In approximately July 2003, within the last month or two, the patient broke out with chicken pox. It was noted that this was more than a mild case. Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned other patients and one sibling who experienced a similar reaction with varicella virus vaccine live. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Information has been received from a woman in a physician's office concerning a 3 year old female with no medical history who on 12/18/00, was vaccinated SC in the left leg with the first dose of varicella virus vaccine live, 0.5ml (lot # 635451/1143K). There was no illness at the time of vaccination. It was reported that in July 2003, the patient developed an on and off fever (x 2-3 weeks) with the onset of red spots all over her body (x 2-3 days). Medical attention was not sought and no laboratory/diagnostic tests were performed. In July 2003, the patient's red spots resolved. At the time of this report, the outcome of the patient's fever was unknown. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Swelling, Tenderness
Clinical narrative: Information has been received from a certified medical assistant concerning her 35 month old son with seasonal allergy and no past medical history, who on 8/11/03 in the PM was vaccinated IM, also reported as SC, in the left deltoid with a 25 gauge 5.8 needle with a first dose of varicella virus vaccine live (lot # 645171/0330N). There was no illness at the time of vaccination. Concomitant therapy included a dose of Streptococcus pneumoniae vaccine at the same site in the left arm in a different syringe. There were no other concomitant medications. On 8/11/03 the patient's arm became swollen near the shoulder and was tender for a few days. No treatment was required. Unspecified medical attention was sought. The outcome was reported as recovered on 8/14/03. There was no product quality complaint. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female employee who in October 2002, was vaccinated with a first dose of varicella virus vaccine live. She experienced an injection site reaction with swelling and numbness of her upper arm area. The physician reported that the patient did not show it anyone, and she did not treat it. There was no prescription drug required. The physician also reported the patient did not return for the second injection. The physician indicated there was no additional information available at the time and reported that he or his staff would call back with it. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 17 year old black male student who on the morning of 04AUG2003 was vaccinated subcutaneously in the right arm with a 0.5ml first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 19AUG2003, the patient developed a rash described as vesicular lesions on the trunk and extremities and pustular on his chest and back. He also had a fever of 102 degrees for 3 days. The rash cleared in about 9 to 10 days. At the time of report, on 26AUG2003, the physician reported that he would not give the second vaccine and he would draw a titer. Unspecified medical attention was sought and no prescription drug was required. Subsequently, the patient recovered. It was reported that in October 2003 the patient is to have a varicella IgG antibody titer done. No product quality complaint was involved. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a child who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient's mother called the physician's office to report that her child developed a chicken pox-like rash more than 2 months after receiving the vaccine. The parent asked if the patient was considered contagious. The parent also called the physician's office about her child being given the vaccine and then was exposed to another child with chicken pox and the child who was immunized developed chicken pox. The patient was not seen to confirm. On 10/20/03 it was reported that the adverse event had been reported long after the parent called. The physicians office had no idea who the patient was. It was also reported that another child was vaccinated with a dose of varicella virus vaccine live and developed breakthrough chicken pox. It was also reported that a 9 month old patient was inadvertently vaccinated with a dose of hepatitis A virus vaccine inactivated. No further information is expected.
Age: 1.8
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 22 month old white female with an amoxicillin allergy who on 10/11/02, was vaccinated SC in the left thigh with the first dose of varicella virus vaccine live (lot # 638816/1236L). Concomitant vaccinations on that same day included MMR. There was no illness at the time of vaccination. The RN reported that on 8/25/03, the patient developed a mild breakthrough varicella rash and a low grade fever. No other symptoms were reported. Unspecified medical attention was sought and no laboratory/diagnostic tests were performed. In 2003, the patient recovered from the breakthrough varicella rash and low grade fever. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Unintended pregnancy, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 y/o female who on 22Aug03 was vaccinated with a dose of varicella virus vaccine live. On 26Aug03 the pt went to the ER because of nausea and vomiting. The ER discovered that the pt was pregnant. The pt's LMP was 15Jul03. No prescription drug or treatment was required. No product quality complaint was involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Injection site rash, Pain, Pruritus
Clinical narrative: Information has been received from a physician concerning a 30 y/o white female with no relevant medical history who was vaccinated  on 07Oct02 on "7A-3P days" SC in the left upper arm with a first dose of varicella virus vaccine live.  There were no concomitant medications. There was no illness at the time of vaccination.  Subsequently the patient developed a localized rash around the injection site. It was noted that when the pt returned for the second varicella vaccine on 20Dec2002, she stated that she had a "local reaction" which included pain, redness and itching. On 25Sep2002 varicella zoster antibody results were "not immune". It was noted by physician that it was a "very small reaction" but the pt did not want to get the second vaccine in the series. There was no treatment required. Unspecified medical attention was sought.  There was no product quality complaint involved. It was also noted that the rash did go away after a few days and the pt recovered. Follow up information indicated that the pt received a second dose of varicella virus vaccine live "without adverse experience". No further information is expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from licensed practical nurse, and a physician concerning an 11 year old male patient with asthma and no allergies who on 09Aug03 was vaccinated with a dose of varicella virus vaccine live. Concomitant medication included fluticasone propionate (-) salmeterol xinafoate (advair) and albuterol (therapy unspecified). On 26Aug2003 (also reported as yesterday) the pt developed chickenpox (also reported as rash). It was noted that he was seen in the office today, 27Aug2003 (also reported as same day) with about 20 poxes (also reported as 3 lesions on the face, 3 on the calf and 5 on the trunk). He was treated with calamine lotion (therapy unspecified), no other treatment was necessary and no fever. There was no product quality complaint involved. It was also noted that the pt had not recovered. Unspecified medical attention was sought. Additional information information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 37 y/o female pt with no medical history who four years ago (approx 1999) was vaccinated with 2 doses of varicella virus vaccine live. There was no concomitant medication. The RN reported that "recently" the pt had a blood test conducted and was found to "have negatives titers". The reporter indicated the pt had immunizations done at her primary care physician, and her records have been requested. No additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. Follow-up information was received from a RN who reported that the pt is a prospective employee, and any additional information about the pt cannot be provided.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Balance disorder, Coordination abnormal, Fall, Pyrexia, Rash papular
Clinical narrative: Information has been received from a physician concerning a 12 month old white male pt who on 22Jul2003 was vaccinated in the right thigh with a first dose of varicella virus vaccine live. Concomitant therapy was also administered on 22Jul2003 included a dose of Streptococcus pneumoniae vaccine (Prevnar) and a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) in the left thigh. On 15Aug2003 (also reported by physician as 17Aug2003 the pt developed a fever which continued to 17Aug2003. On 15Aug2003 he also developed a lack of balance, falling down, and red papular eruptions on trunk. It was noted that on 20Aug2003 the pt became slightly ataxic. The physician reported that as of 27Aug2003 the pt was seen at the physician's office and was reported to have a mild ataxic gait (also reported as still has some ataxia). It was noted that the adverse event did not abate. The physician reported that he did not have a lot of time to offer information because he was seeing patients. There was no treatment required for the adverse event. There was no product quality complaint involved. Follow up information from the physician reported that he had referred the pt to a neurologist at a children's medical center, and the pt was seen on 28Aug2003. On an unspecified date in approximately Aug 2003 the following diagnostic tests were performed.: computed axial tomography (CAT) scan of the head was normal, West Nile serology was negative, Epstein-Barr Virus serology was negative, HV17 and VMA on his urine was negative. The physician reported a "clinical recovery over 3-4 days after neurology consult". The physician reported that the pt had no adverse events following prior vaccinations. Additionally he reported that "handouts on varicella virus vaccine live and  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) were given to mom". Unspecified medical attention was sought. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 24 month old female who on 16Aug2002 was vaccinated SC in the right thigh with a dose of varicella virus vaccine live. Concomitant therapy on 16Aug2002 included a third dose in the left thigh of poliovirus vaccine (IPOL). There was no illness at the time of vaccination. ON 22Au03, (previously reported as this year in 2003) the child developed a rash in her genital area which the physician diagnosed as chickenpox. It was noted the child also "spiked a 103 degree fever for one day on 25Aug03. It was noted that there were no relevant laboratory diagnostic studies performed however, laboratory data performed on 16Aug2002 was a mantoux test. It was also noted that the doctor "treated the rash symptomatically" but the child was "not prescribed anything for the rash". "At this time" 27Aug2003, the rash stopped progressing but did not fully disappear. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available.  Follow up information indicated that the pt had recovered. No further information is expected.
Age: 0.33
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a company representative concerning a 16 week old female  who was vaccinated SC with a dose of varicella virus vaccine live. 8 days post vaccination the pt developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint involved. It was noted that the physician may not be contacted. No other information was available.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning an 18 month old female pt  who in approx. Feb.2003, was vaccinated with a dose of varicella virus vaccine live. On 28Aug2003 the pt was brought into the office with a mild breakthrough of varicella. No further treatment was necessary, and it was indicated that it was a mild case. The number of lesions was not reported. It was noted that the pt recovered with sequelae. No product quality complaint was involved.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dizziness, Febrile convulsion, Pyrexia, Restlessness, Sleep disorder
Clinical narrative: Information has been received from a mother who is a RN concerning her four year old (also reported as 5 year old) white son who has not significant medical history or allergies, who on 19Jun2003 at approx. 11:30AM was vaccinated SC in the arm with a first dose of varicella virus vaccine live. Additional therapy administered SC in the arm on the same day, 19Jun2003, at approx. 11:30AM included a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The pt's mother reported that a few days before 10Jul2003, her son complained if dizziness on and off. On 10Jul2003, he developed vomiting and fever and on 07Aug2003 he again had a high fever, and he also had a febrile seizure. On 22Aug2003 the pt again had a febrile seizure and was taken to the ER where a computed axial tomograph (CAT) scan and blood work  were done. On 26Aug2003 the pt's had his last recorded fever. Since approx. 26Aug2003 (reported as last Tuesday), The pt's mother indicated her son has been "feeling better", which she described as, "he does not lay his head down everywhere anymore". The pt's mother also stated that the pt had also been "very restless throughout this time falling asleep only by 1AM or so". The mother reported that three other siblings had no untoward reactions to varicella virus vaccine live. The mother reported that she also suspects that the events are related to varicella virus vaccine live. It was reported that the adverse event abated, and prescription medication was required. The mother also reported that the pt had no rashes or other symptoms. There was no product quality complaint reported.   Follow up information was received from the office manager via a telephone conversation, and indicated the pt was not sick at the time he received the vaccinations. The office manager reported that the route of the vaccine administration  was "the normal way", and indicated she had a hard time reading the physician's handwriting. The office manager indicated that at the time of the telephone conversation the physician was out of the office but that he may be able to provide more details. Additional information received from the physician on 23Sep2003 reported that the pt's fever and headache onset was 10Jul2003 through 12Jul2003. The physician also reported that on 07Aug2003 the pt had a temp of 103 and experienced a brief febrile seizure, again on 22Aug2003 the pt had a temp reported as 102.5 and he had another brief febrile seizure. It was noted that from "mid July to Sept" the pt complained of dizziness and slept poorly. The pt's outcome is reported recovered on approx. 01Sep2003. Additional information was received from the physician, who reported that "as of today" 07Oct 2003 the pt is no longer restless and no more vomiting. The physician reported the pt is completely recovered. Unspecified medical attention was sought. Upon internal review, febrile seizure was determined to be an other important medical event.(OMIC)No further information is expected.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a mother who is a RN concerning her four year old (also reported as 5 year old) white son who has not significant medical history or allergies, who on 19Jun2003 at approx. 11:30AM was vaccinated SC in the arm with a first dose of varicella virus vaccine live. Additional therapy administered SC in the arm on the same day, 19Jun2003, at approx. 11:30AM included a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The pt's mother reported that a few days before 10Jul2003, her son complained if dizziness on and off. On 10Jul2003, he developed vomiting and fever and on 07Aug2003 he again had a high fever, and he also had a febrile seizure. On 22Aug2003 the pt again had a febrile seizure and was taken to the ER where a computed axial tomograph (CAT) scan and blood work  were done. On 26Aug2003 the pt's had his last recorded fever. Since approx. 26Aug2003 (reported as last Tuesday), The pt's mother indicated her son has been "feeling better", which she described as, "he does not lay his head down everywhere anymore". The pt's mother also stated that the pt had also been "very restless throughout this time falling asleep only by 1AM or so". The mother reported that three other siblings had no untoward reactions to varicella virus vaccine live. The mother reported that she also suspects that the events are related to varicella virus vaccine live. It was reported that the adverse event abated, and prescription medication was required. The mother also reported that the pt had no rashes or other symptoms. There was no product quality complaint reported.   Follow up information was received from the office manager via a telephone conversation, and indicated the pt was not sick at the time he received the vaccinations. The office manager reported that the route of the vaccine administration  was "the normal way", and indicated she had a hard time reading the physician's handwriting. The office manager indicated that at the time of the telephone conversation the physician was out of the office but that he may be able to provide more details. Additional information received from the physician on 23Sep2003 reported that the pt's fever and headache onset was 10Jul2003 through 12Jul2003. The physician also reported that on 07Aug2003 the pt had a temp of 103 and experienced a brief febrile seizure, again on 22Aug2003 the pt had a temp reported as 102.5 and he had another brief febrile seizure. It was noted that from "mid July to Sept" the pt complained of dizziness and slept poorly. The pt's outcome is reported recovered on approx. 01Sep2003. Additional information was received from the physician, who reported that "as of today" 07Oct 2003 the pt is no longer restless and no more vomiting. The physician reported the pt is completely recovered. Unspecified medical attention was sought. Upon internal review, febrile seizure was determined to be an other important medical event.(OMIC)No further information is expected.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 6 y/o who on 15Jun98 was vaccinated SC with a dose of varicella virus vaccine live. On 24Jul2003, 2 weeks after exposure to a 4 year old child who on 11Jul2003 was diagnosed with shingles (also reported as a child with chickenpox and a child who had chickenpox illness in April 2000), the pt was seen at the physician's office and was found to have a mild case of chicken pox. No treatment was required. No product quality complaint was involved. It was also reported that 3 other children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chicken pox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 8 y/o 8 who on 15Jun98 was vaccinated with a dose of varicella virus vaccine live. On 24Jul2003, 2 weeks after exposure to a 4 year old child who on 11Jul2003 was diagnosed with shingles (also reported as a child with chicken pox and a child who had chicken pox illness in April 2000), the pt was seen at the physician's office and was found to have a mild case of chicken pox. No treatment was required.  No product quality complaint was involved. It was also reported that 3 other children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chicken pox. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 4 y/o who on 27Mar00 was vaccinated with a dose of varicella virus vaccine live. On 24Jul2003, 2 weeks after exposure to a 4 year old child who on 11Jul2003 was diagnosed with shingles (also reported as a child with chicken pox and a child who had chicken pox illness in April 2000), the pt was seen at the physician's office and was found to have a mild case of chicken pox. No treatment was required.  No product quality complaint was involved. It was also reported that 3 other children were vaccinated with a dose of varicella virus vaccine live and developed a mild case of chicken pox. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: DPP, HIBV, MMR, VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 7 y/o Asian male in "good health" and with no allergies or medical history who on 10Oct1998 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live during a well check up. Concomitant vaccinations on the same day included measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) an IM fourth dose in the left thigh of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid, and an IM fourth dose in the right thigh of Hib conj vaccine (HIBTITER). It was noted that the pt was not taking any chronic medications. The nurse reported that this previously immunized child presented on 02Sep2003 with a one day history of a new onset of lesions and severe itching. ON examination there were 91 lesions, mainly on the torso and the rest of the upper body, scanty on the extremities, and none on the mucosa. There was no fever on examination and none reported by the parents. There was no known exposure to community chicken pox. The parents reported that iphenhydramine hydrochloride (Benadryl) was not helping. The pt was prescribed  cetirizine hydrochloride (Zyrtec) and recommended calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) bath and calamine lotion. NO diagnostic or laboratory tests were performed. It was noted that the pt had no adverse events following prior vaccination. At the time of the report the pt had not recovered.  A product quality complaint was not involved.  Follow up information was received from the RN which indicated that on 02Sep2003 the pt presented to the clinic with a blister type rash times three days, starting in the AM of 31Aug2003. Approx. 91 lesions were counted, primarily on the upper torso. The pt recovered from the blister type rash and lesions on 05Sep2003 at which time he returned to school. Follow up was received which indicated that there was no additional information. No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Pharyngitis, Rash maculo-papular
Clinical narrative: Information has been received from a RN concerning a 6 y/o male pt with no allergies and no past medical history who on 13Jul98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. Illness at the time of vaccination included pharyngitis. There was no concomitant medication. On 01Sep2003 the pt developed a rash that included approx. 500 to 700 maculopapular lesions described as "insect bite like lesions" on his face, chest, back, arms and legs. Laboratory tests were no performed and treatment was not required. Subsequently, the patient recovered. The reporter noted that therapy with varicella virus vaccine live was discontinued on 13Jul1998. A product quality complaint was not involved.  Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 6 y/o female with no relevant medical history and no known allergies who  on 11Jul97 between 8:30AM -12PM was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 11Jul97, between 8:30AM-12PM, concomitant medication included a SC first dose in the right arm ofmeasles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) an IM fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) and an IM fourth dose of Hib conj vaccine. There were no other concomitant medications.   There was no illness at the time of vaccination. The father of the child reported that on 12May03, the pt had developed chickenpox after receiving the chickenpox vaccine. There was no relevant diagnostic or laboratory tests performed. It was noted that the male sibling "had more pox" than the female. It was also noted that the pt had a "mild case". The pt did not see a physician and she was not hospitalized (previously reported as unspecified medical attention was sought). Subsequently, the pt recovered.  There was no product quality complaint involved. No further information was available. No further information is expected. The reporter also mentioned that a male sibling experienced a similar reaction after vaccination with varicella virus vaccine live.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a RN concerning a 29 y/o female pt with no known food or medication allergies, previous "ppd-MANTOUX" test on 05Aug2003 and no other medical history who on 15Aug2003 was vaccinated SC in her left arm with a first dose of varicella virus vaccine live. The vaccination was administered for school. Other therapy administered on 15Aug2003 at a different clinic included a dose of tuberculin purified protein derivative. There were no other concomitant medications. ON 31Aug2003, the pt reported having a varicella like rash beginning on her back and spreading into a generalized rash on much of her body. It was noted the rash worsened by 03Sep2003. The RN reported that the pt described the rash as itchy and she had been scratching a lot since it began. It was noted there were approximately 20-30 lesions which appeared maculopapular, some with formed vesicles and crusted, and were over various parts of her body. The RN also reported that the rash developed on the pt's left arm and spread to her face, neck, arm and now most of her body. The RN reported the pt's outcome as not recovered, and no treatment was required for the adverse event. There was no product quality complaint reported. Follow up information was received from the RN, and medical progress records which reported that the pt did go to a physician, and she received a prescription for acyclovir 200 mg/ 1 five times a day for 5-7 days, the pt didn't remember how many days. It was noted the rash resolved in 2-3 days after starting the oral acyclovir. The pt has been completely relieved of the rash and is reported as recovered. It was noted in the medical progress record that  the pt had "negative titers" on 09Sept2003. It was also noted the pt did not have a previous history of reactions to vaccinations. The medical progress records noted the pt was to return to the clinic on 11Sep2003 for follow up vaccination of hep B. On 11Sep2003 the pt returned to the clinic and the RN provided her with information about the need for the second dose of varicella virus vaccine live. The pt stated she is hesitant to get the second dose of varicella virus vaccine live and knows that serology can be done to check the antibody. On 11Sep2003 at 14:00PM the pt was vaccinated IM in the left deltoid with a second dose of hep B virus vaccine rHBsAg (yeast) (Engerix B). Unspecified medical attention was sought. Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received form a nurse and a medical assistant concerning a 36 year old white male who on 11AUG2003 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 23AUG2003 the pt developed a temperature of unknown degree and the next day, on 24AUG2003, broke out in 100-120 spots. The majority of the spots were on his chest and back. 20 on his face and the rest on his arms and legs. The report indicated that this was a "severe" case of chickenpox breakthrough. The pt was treated with calamine lotion and is "now healing" , with only a few crusty spots left. Follow up information indicated that the pt became covered with 100-120 pox with the majority being on the trunk. There were approximately 20 on the face and the remaining were on arms and legs. On 31AUG2003 all the pox were scabbed over. It was noted that the patient recovered. No additional information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 9y/o male no known relevant medical history and no known allergies who on 11Jul1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. There were no concomitant medications. There was no illness at the time of vaccination. The father of the child reported that on 12May2003, the pt developed chickenpox after receiving the chickenpox vaccine, also described as "peppered with pox". There were no relevant diagnostic or laboratory tests performed. It was noted that he "had more pox than the female. It was also noted that the pt did not see a physician and was not hospitalized (previously reported as unspecified medical attention was sought). Subsequently, the patient recovered. There was no product quality complaint involved. No further information was available. No further information is expected. The reporter also mentioned that a female sibling experienced a similar reaction after vaccination with varicella virus vaccine live.
Age: 1.83
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash maculo-papular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 22-month old female who on 04-May-2003 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (lot #644724/0074N). The nurse indicated that the patient developed a breakthrough case of chickenpox. On 29-Aug-2003 the patient began to experience a maculopapular rash and ran a low grade fever. The patient presented to the office on 02-Sep-2003 and most of the lesions were scabbed over. The child had a total of about 40 lesion. Unspecified medical attention was sought. It was noted that a prescription drug was not required and that the event abated. A product quality complaint was not involved. Follow-up was received from the registered nurse which indicated that no further information was available. No further information is expected.
Age: 3.75
Sex: M
Vaccine: DTAPH, IPV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 45-month-old white male child with a history of reactive airway disease in October 2000 who on 21 Dec-200 was vaccinated SC in the anterior lateral right thigh with a first dose of varicella virus vaccine live (Lot #636573/0930K). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose in the right lateral thigh of pneumococcal 4 6B 9V 14 18 C 19F conj vaccine (CRM 197) (Prevnar) (Batch #472048), a fourth dose in the left lateral thigh of diptheria toxoid (+) Hib conj cavvine (tet toxoid) (+) pertussis acellular Biken vaccine (+) tetatnus toxoid (Tribibit) (Batch #UA5537A), a first dose in the left anterior deltoid of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #636656/1278K), and a third dose in the "left anterior lateral" of poliovirus vaccine inactivated (unspecified) (manufacturer unknown) (Batch #T04B4). Subsequently, the patient broke out with chickenpox. The severity of the chickenpox was unknown. The outcome was reported was not recovered. Unspecified medical attention was sought. There was no product quality complaint. No other information was available. Follow up information indicated that on 03-Sep-2003 at 9:15 Am the patient was confirmed to have chickenpox. Subsequently, the patient recovered from chickenpox. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccinations of the patient or his siblings. The reporter also indicated that one other patient was vaccinated with a dose of varicella virus vaccine live and developed chickenpox (WAES #0309USA00887). No further information is expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Drug ineffective, Pneumonia, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning her 24-month old daughter with asthma who was vaccinated with a dose of varicella virus vaccine live "at the appropriate age". Concomitant therapy included montelukast sodium (MSD) 4 mg daily for the treatment of asthma. The reporter indicated that the child had been taking montelukast sodium (MSD). "4mg PRN and then started taking it daily". It was noted when the child started taking the montelukast sodium (MSD) on a daily basis, the child developed chickenpox with bruising and pneumonia. "The doctor thought that it may be from the" montelukast sodium (MSD). The montelukast sodium (MSD) was discontinued and the symptoms resolved. No hospitalization was required. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Hypoaesthesia, Injection site induration, Pyrexia
Clinical narrative: Information has been received from a 31 year old female with a penicillin allergy who on 28AUG2003 was vaccinated in the left upper arm with a second dose of varicella virus vaccine live. There was no concomitant medication. Subsequently, the patient experienced a low grade fever of 99 degrees Fahrenheit. She had some numbness in left arm for three days and a small bump at the injection site for three days. At the time of the report, the patient did not have soreness or any bump at the site. The reporter also noted that she may be pregnant but could not confirm that she was pregnant thus far. She also indicated that she had not notified her physician. The patient did not seek medical attention, no diagnostic studies were performed, and no prescription drug was required. The patient subsequently recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a male child who on 02AUG2002 was vaccinated with a dose of varicella virus vaccine live. Since then, the child has experienced several recurrences of breakthrough chickenpox. The report indicated that the child was not hospitalized. Unspecified medical attention was sought. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse RN concerning a 29 year old female with no allergies who on 08AUG2003 was vaccinated SC with the first dose of (0.5ml) of varicella virus vaccine live. The RN reported that on 22AUG2003 the patient presented to the Emergency Room ER with a rash all over her body. The patient was treated with acetaminophen, Tylenol, and diphenhydramine HCl, Benadryl, and was released. It was unknown if laboratory diagnostic tests were performed. On 08SEP2003, the patient presented to the office to receive the second dose of  varicella virus vaccine live. At that time, the patient was recovering, but some of the rash remained. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old white male child with reactive airway disease who on 03APR2000 was vaccinated SC with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 04SEP2003 the patient was seen in the doctor's office with mild chickenpox disease. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. No other information was available. Follow up information indicated that on 04SEP2003 at 9:30AM varicella was confirmed. The patient recovered. The reporter indicated that the child was not vaccinated in her office. No relevant diagnostic tests or laboratory data was reported. There was no adverse events following prior vaccinations of the patient or his siblings. The reporter also indicated that one other patient was vaccinated with a dose of varicella virus vaccine live and developed chickenpox. No further information is expected.
Age: 3.7
Sex: F
Vaccine: DTAP, HIBV, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 44 month old Hispanic female who was born at 34 weeks (premature) with no pertinent medical history and no known drug allergies who on 28MAR2001, also reported as "approximately one year ago", was vaccinated SC, also reported as IM, in the left thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant therapy included a first dose of measles- mumps-rubella vaccine administered SC in the right thigh, a first dose of tuberculin purified protein derivative administered in intradermally in the left forearm, a fourth dose of Hib conj vaccine (tet toxoid) administered IM in the left thigh, a third dose of poliovirus vaccine inactivated administered IM in he left thigh, a a fourth dose of diphtheria toxoid + pertussis acellular Biken vaccine+ tetanus toxoid administered IM in the right thigh. There were no other concomitant medications. On 03SEP2003 the patient developed shingles. The blisters were noted to be on the child's scalp and forehead, ad have been crusted over without any treatments. No lab diagnostic studies were performed. Unspecified medical atttention was sought. There was no product quality complaint. There were no adverse events following prior vaccinations. It was noted that the patient recovered. Follow up information from the physician indicated that the eruption "followed perfectly along the dermatome." Additional follow up information indicated that on 03SEP2003, the blister appeared anteriorly on the right side of the patient's forehead/scalp. It was noted that there were approximately 2 dozen lesions form the patient's right forehead into the scalp area, abruptly stopping at the midline. It was reported as itchy. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. No fever was noted. The pain was noted to be a 2 (with 0 being the least and 10 being the most). There were no other systemic symptoms. The outcome was reported as recovered. No relevant diagnostic tests or laboratory data were reported. There were no adverse events following prior vaccinations. There was no history of chickenpox. There was no recent exposure to chickenpox or herpes zoster. No direct flourescent antibody was done. No specimen was collect for PCR. No photo was taken. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a nurse concerning a 4 year old white female who on 03APR2000 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 31AUG2003 the patient developed a rash and was seen by a physician. She was diagnosed with a mild case of chickenpox. No laboratory work was done. the patient recovered on 05SEP2003. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received concerning a 12 month old white female who on 18DEC2002 was vaccinated in the left leg with a "second dose" of varicella virus vaccine live. On 01AUG2003 the patient experienced a rash. It was reported that there was no itching and no fever. Subsequently, the patient recovered. Additional information has been requested.