chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Infection, Rash pruritic, Rash vesicular, Vomiting
Clinical narrative: Information has been received from a medical assistant concerning a 4 year old male who on 07/28/99 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot # 631066/0446J).  On 06/16/2003 the pt was seen in the physician's office with a red, itching rash on his stomach, legs, under the arms and in the groin area that had started on 06/13/03.  Vesicles were noted on his abdomen and buttocks. The pt was diagnosed with varicella. The pt had vomiting x1 and there was no fever. The pt was treated with colloidal oatmeal bath (Aveeno), calamine lotion and Benadryl. It was unknown if the pt recovered. It was also reported that 3 other pt's were vaccinated with a dose of varicella virus vaccine live and developed varicella (WAES # 0306USA02442, 0306USA02867 & 0306USA02868).  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a MA concerning a 46 month old white male with no known drug allergies who on 08/22/00 was vaccinated with a dose of varicella virus vaccine live (Lot # 634501/0537K).  On 06/06/03 the pt was seen in the physician's office with about 8-10 very itchy lesions and vesicles in the groin area for 4 days. It was reported that the symptoms started on 06/03/03.  The pt was diagnosed with varicella. There was no fever. The pt was treated with colloidal oatmeal bath (Aveeno), calamine lotion and Benadryl. It was noted that the pt's sibling had similar symptoms. It was unknown if the pt recovered. No product quality complaint was involved. It was also reported that 3 other pt's were vaccinated with a dose of varicella virus vaccine live and developed varicella (WAES # 0306USA02442, 0306USA02866 & 0306USA02868).  Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a MA concerning a 7 year old female who on 09/16/96 was vaccinated with a first dose of varicella virus vaccine live. On 09/16/96 the pt was also vaccinated with a first dose of MMRII. On 06/19/03 the pt was seen in the physician's office with a "typical" presentation of chickenpox that began on 06/12/03.  It was described as an itching rash spreading to her back, underarms, legs, stomach, face and hairline (everywhere). A physician exam identified vesicles and an "impression" was made of varicella. There was no fever. The pt was treated with Aveeno baths, calamine lotion and Benadryl. It was also reported that 3 other pt's were vaccinated with a dose of varicella virus vaccine live and developed chickenpox (WAES # 0306USA02442, 0306USA02866 & 0306USA02867).  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a child who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the child developed breakthrough chickenpox. It was reported that the pt's mother called the physician's office about her child being given the vaccine and then was exposed to another child with chickenpox and the child who was immunized developed chickenpox.  It was also reported that another child was vaccinated with a dose of varicella virus vaccine live and developed chickenpox like rash (WAES # 0308USA02579).  It was also reported that a 9 month old pt was inadvertently vaccinated with a dose of hepatitis A virus vaccine inactivated (WAES # 0306USA02947).  Additional information is expected.
Age: 4.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a nurse concerning a 4 year old female with no past medical history and no known drug allergies who on 5/10/00 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 632616/1688J). There was no illness at the time of vaccination. Concomitant vaccinations that day included a third dose of hepatitis B virus vaccine (lot # 635269/0423K) given IM in the left arm and a first dose of MMR (lot # 634036/1711J) given SC in the right arm. On 6/6/03, also reported as 6/12/03, the patient was treated at the physician's office for a varicella breakthrough, described as approximately 20 varicella lesions on her neck and torso. The outcome was reported as recovered. No other details were provided. Unspecified medical attention was sought. There was no product quality complaint. No laboratory data or diagnostic tests were reported. The reporter also indicated that 2 other patients experienced breakthrough varicella. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 12 month old female twin who on 6/13/03, two weeks ago, was exposed to her mother who had herpes zoster. On 6/17/03 the patient was vaccinated IM with a dose of varicella virus vaccine live. On 6/26/03 the patient started to developed generalized vesicles all over her body with at least 50 lesions. The physician was going to speak to the parents to see if they wished to pursue a lab culture of the vesicle. No additional information was available. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved. It was also reported that the patient's twin sister was vaccinated with a dose of varicella vaccine live and developed the same reaction. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from an unknown receptionist at a physician's office concerning a 6 year old patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed a mild case of varicella. Unspecified medical attention was sought. No additional information is available . No product quality complaint was involved. It was also reported that a 4.5 year old female was vaccinated with a dose of varicella virus vaccine live and developed a full blown 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 licensed practical nurse concerning a patient who in 1996 was vaccinated with a dose of varicella virus vaccine live. It was reported that the mother of the child reported to the physician that the child developed chicken pox in 1999 following exposure to another unvaccinated sibling who had developed chicken pox after being exposed to the disease in school. The nurse noted that their office had no record of this event and could offer no further information on the matter. No medical attention was sought. No product quality complaint was involved. No further information is expected. It was also reported that the patient's sibling was vaccinated with a dose of varicella virus vaccine live and developed a varicella like rash.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 12 month old female twin who on 6/13/03, two weeks ago, was exposed to her mother who had herpes zoster. On 6/17/03, the patient was vaccinated IM with a dose of varicella virus vaccine live. On 6/26/03 the patient started to develop generalized vesicles all over her body with at least 50 lesions. The physician was going to speak to the parents to see if they wished to pursue a lab culture of the vesicle. No additional information was available. Unspecified medical attention was sought and no treatment was required. No product quality complaint was involved. It was also reported that the patient's twin sister was vaccinated with a dose of varicella vaccine live and also developed the same reaction. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse concerning a 6 year old female with an allergy to amoxicillin who on 4/14/03 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot # 644571/1160M). There was no illness at the time of vaccination. Concomitant medications include cetirizine hydrochloride. The patient presented to the physician's office on 6/2/03 with a varicella break through described as 10 lesions. No other details were provided. Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that on 6/29/03 the patient developed a varicella-like rash on her back and neck with approximately 16 lesions. The outcome was reported as recovered. The reporter also indicated that 2 other patients experienced breakthrough varicella. No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 9 year old male with no past medical history and no known drug allergies who on 11/18/96 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 617695/0776D). There was no illness at the time of vaccination. On 6/12/03 the patient presented to the physician's office with a varicella breakthrough, described as approximately 20 varicella lesions on his face, back, arms, head, and genital area. The area was pruritic. The outcome was reported as recovered. No other details were provided. Unspecified medical attention was sought. There was no product quality complaint. There were lab data or diagnostic tests reported. The reporter also indicated that 2 other patients experienced breakthrough varicella. No additional information is expected.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Malaise, Pharyngitis, Rhinitis
Clinical narrative: Information has been received from a nurse practitioner concerning a Caucasian 49 year old female patient with hypertension and no known drug allergies who on 6/11/03 at 10:30 was vaccinated SC with a 0.5ml first dose of varicella virus vaccine live (lot # 644250/1153M). It was noted that there was no illness at the time of vaccination. Concomitant therapy included betaxolol HCl and hydrochlorothiazide. On 6/28/03 the patient developed 13 lesions and she also complained of cold like symptoms. It was noted at the time of the report she was recovering, and she had a total of 16 lesions which are starting to heal. Follow up information indicated that on 7/3/03, the patient had several more pox appear, but did not feel unwell. It was noted that the patient recovered on 7/7/03. Unspecified medical attention was sought. No further information is available.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner concerning a Caucasian 49 year old female patient with hypertension and no known drug allergies who on 6/11/03 at 10:30 was vaccinated SC with a 0.5ml first dose of varicella virus vaccine live (lot # 644250/1153M). It was noted that there was no illness at the time of vaccination. Concomitant therapy included betaxolol HCl and hydrochlorothiazide. On 6/28/03 the patient developed 13 lesions and she also complained of cold like symptoms. It was noted at the time of the report she was recovering, and she had a total of 16 lesions which are starting to heal. Follow up information indicated that on 7/3/03, the patient had several more pox appear, but did not feel unwell. It was noted that the patient recovered on 7/7/03. Unspecified medical attention was sought. No further information is available.
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Blister, Drug ineffective, Erythema, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old white female patient with no known drug allergies and no past medical history who on 6/16/03 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live (lot # 644247/0019N). Concomitant therapy included Streptococcus pneumoniae vaccine and HIB conjugate hepatitis B vaccine. Illness at the time of vaccination included fever and fussiness for 24 hours. On 6/28/03 the patient developed 15 varicella lesions and had a temperature of 101.4 F on 6/29/03. There was no treatment given. Follow up information indicated that the patient developed a rash for four days, of a red round area with blister in the center, which scabbed over. There were about 15-20. Additional follow up information indicated that the patient recovered on 7/1/03. No further information is expected.
Age: 1.0
Sex: F
Vaccine: HBHEPB, PNC, VARCEL
Symptoms: Rash, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old white female patient with no known drug allergies and no past medical history who on 6/16/03 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live (lot # 644247/0019N). Concomitant therapy included Streptococcus pneumoniae vaccine and HIB conjugate hepatitis B vaccine. Illness at the time of vaccination included fever and fussiness for 24 hours. On 6/28/03 the patient developed 15 varicella lesions and had a temperature of 101.4 F on 6/29/03. There was no treatment given. Follow up information indicated that the patient developed a rash for four days, of a red round area with blister in the center, which scabbed over. There were about 15-20. Additional follow up information indicated that the patient recovered on 7/1/03. No further information is expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse and a nurse practitioner concerning an 8 year old male child with no past medical history who on 12/27/96 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 620620/1107D). There was no illness at the time of vaccination. There was no concomitant medication. On 6/29/03 (also reported as 7/1/03) the patient broke out in 80-100 varicella lesions/vesicles and developed a fever. It was reported that the patient developed breakthrough chicken pox. Unspecified medical attention was sought and no treatment was required/provided. No laboratory diagnostic tests were performed. Subsequently, the patient recovered. No further information is expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Infection, Laboratory test abnormal, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old Caucasian male with no past medical history who on 10/25/95 was vaccinated with a first dose of varicella virus vaccine live (SC), in the left arm. There was no illness at the time of vaccination. On 6/20/03 the patient developed a fever and fluid filled vesicles, about 20 to 30. The patient was diagnosed with chicken pox. The patient sought medical attention. The patient was treated with acyclovir 800 mgm QID for 5 days, acetaminophen and colloidal oatmeal. The symptoms resolved in 5 to 7 days. it was reported that the patient had a positive titer for varicella IgM. It was noted that the patient had been exposed to varicella many times when he was younger but never developed varicella. No further information is expected.
Age: 11.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blister, Drug ineffective, Infection, Rash macular
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old white female with no past medical history who on 11/9/95 was vaccinated with a first dose of varicella virus vaccine live (site unknown). Concomitant therapy that day included a first dose of hepatitis B virus vaccine and a Mantoux Test. On 6/25/03 the patient developed multiple macules, vesicles few scabbed on trunk, arms, legs. The patient had a doctors visit and received symptomatic treatment. There were no other relevant laboratory or diagnostic tests and the patient was not hospitalized. It was reported that the patient recovered. It was also noted that the patient did not experience any adverse events following prior vaccinations. No further information is expected.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Headache, Infection, Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old adult female with no known medical history and no known allergies who on 6/17/03 at 14:00 was vaccinated SC in the left upper arm with a first dose of varicella virus vaccine live (lot # 643588/0804M). There was no concomitant medication. There was no illness at the time of vaccination. There were no adverse events following prior vaccination. The patient presented today, 15 days after vaccination, on 7/2/03, (also reported as 7/3/03) with a single, red, hot, itchy, hard not at the injection site that was 5cm in diameter and a 99.1 F temperature. On 7/7/03, it was noted that the patient reported she had a temperature of 100.0, a headache and had broken out in chicken pox. On 7/7/03, it was observed that the patient had scattered pustules on the face, chest, axilla, and back in various stages of healing. It was also noted that the approximate number of pustules on her face was 8; axilla, 4 on each; back, 20; and chest, 6. She was not allowed to be in the work place. On 6/2/03, a varicella titer was negative. Medical attention was sought. Treatment included acetaminophen, ice or diphenhydramine HCl cream as needed. On 7/11/03, the patient was allowed to return to work, the spots were dry, scabbed and vanishing. It was noted that the patient recovered. No further information is expected.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Laboratory test abnormal, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 22 year old adult female with no known medical history and no known allergies who on 6/17/03 at 14:00 was vaccinated SC in the left upper arm with a first dose of varicella virus vaccine live (lot # 643588/0804M). There was no concomitant medication. There was no illness at the time of vaccination. There were no adverse events following prior vaccination. The patient presented today, 15 days after vaccination, on 7/2/03, (also reported as 7/3/03) with a single, red, hot, itchy, hard not at the injection site that was 5cm in diameter and a 99.1 F temperature. On 7/7/03, it was noted that the patient reported she had a temperature of 100.0, a headache and had broken out in chicken pox. On 7/7/03, it was observed that the patient had scattered pustules on the face, chest, axilla, and back in various stages of healing. It was also noted that the approximate number of pustules on her face was 8; axilla, 4 on each; back, 20; and chest, 6. She was not allowed to be in the work place. On 6/2/03, a varicella titer was negative. Medical attention was sought. Treatment included acetaminophen, ice or diphenhydramine HCl cream as needed. On 7/11/03, the patient was allowed to return to work, the spots were dry, scabbed and vanishing. It was noted that the patient recovered. No further information is expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, VARCEL
Symptoms: Drug ineffective, Infection, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old Caucasian male patient with an allergy to amoxicillin, no other concurrent conditions and no past medical history who on 9/27/02, was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 641594/0200M). Concomitant vaccination included a dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid and a dose of poliovirus vaccine. There were no chronic medications. There was no illness at the time of vaccination. On 7/1/03, the patient developed a mild to moderate varicella rash. There was no fever and no other symptoms. Unspecified medical attention was sought, but no treatment was required and no laboratory tests were performed. It was noted that therapy with varicella virus vaccine live was discontinued. On 7/8/03, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a pharmacist concerning an 11 year old patient who in approximately 1994, when the child was a toddler, was vaccinated with a dose of varicella virus vaccine live. On approximately 7/3/03 the patient developed chicken pox with a fever. The number of lesions and the location of the lesions were not provided. The case was reported as more than a mild case of chicken pox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash, Skin ulcer
Clinical narrative: Information has been received from a nurse concerning a 13 year old white male who on 6/6/00 was vaccinated with a dose of varicella virus vaccine live (lot # 16875 - invalid). The patient was evaluated by a physician and it was noted that on 6/15/03 the patient developed a generalized rash of approximately 50 lesions that lasted 2 days. No fever was noted. No complications were noted. The patient was not hospitalized. The outcome is recovered. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 42 month old Caucasian male with no past medical history or allergies, who on 1/16/01 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot 632376/1684J). Concomitant therapy, that same day, included a first dose of MMR (lot # 634415/0258K) given SC in the right thigh, a fourth dose of diphtheria toxoid/pertussis vaccine/teta (lot # 092A2) given IM in the left lateral thigh, a third dose of poliovirus vaccine (lot # R1251-2) given SC in the right thigh, a fourth dose of HIB conjugate vaccine (ACTHIB) (lot # 622363A) given IM in the left lateral thigh and a third dose of hepatitis B vaccine, recomb (lot # 3344A2) given IM in the left lateral thigh. There was no illness at the time of vaccination. The patient's mother reported that the patient had chicken pox on 6/16/03 with 3 on face and 3 on back. It was reported that the patient had an uneventful recovery. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: DTPHIB, HEP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white male with no known drug allergies and no past medical history who on 2/17/98 was vaccinated IM in the left lower thigh with a first dose of varicella virus vaccine live (Lot # 621191/1549D). There was no illness at the time of vaccination. Concomitant vaccinations that day included a first dose of MMR (lot # 621288/1010E) administered SC in the right lower thigh, a third dose of hepatitis B virus vaccine (lot # 623069/0158E) administered IM in the right lower thigh, a fourth dose of diphtheria toxoid (+) Haemophilus B conjugate vaccine (+) pertussis vaccine (+) tetanus toxoid (batch # 439 192) administered IM in the left lower thigh, and a third dose of poliovirus vaccine (batch # T0816-2) administered SC in the right lower thigh. On 6/30/03 the mother reported that her child had chicken pox. It was described as lots of pox on back, arms, upper legs, and face. There were no adverse events following prior vaccinations of the patient or his siblings. Follow up information indicated that the child had an uneventful recovery. The pox on the back, upper arms, neck, and chest lasted about 1 week. He also had a low grade temperature in the evenings. There were no lasting effects from the disease. The outcome was reported as recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a consumer concerning her 12 month old daughter who has no pertinent medical history, who "about two weeks ago" (approximately 25Jun2003) was vaccinated with a dose of varicella virus vaccine live. It was noted the lot number was not provided. There was no concomitant medication. The mother reported her daughter started to develop a rash a few days after receiving the vaccine. The mother reported the rash was all over her daughter's body and has gotten worse. It was noted the rash has not gone away, and the pt has seen her Dr. It was noted treatment has not been required, but unspecified blood work was performed. There was no product quality complaint involved. Follow up information that was received from the physician via returned correspondence stated , "We did not diagnose here with chickenpox or adverse reaction to vaccine". Unspecified medical attention was sought. No further information is expected.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a 35 year old Hispanic female licensed practical nurse with an allergy to procaine hydrochloride (NOVOCAIN) who on 31Jul2001 was vaccinated SC in the right arm with a second dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that titers determined in January 2003 and February 2003 were negative. The reporter indicated that there was no adverse event. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. No further information is expected.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning a 38 y/o female employee with mild asthma and no known drug allergies who on 23Jun2003 was vaccinated SC with a dose of varicella virus vaccine live. Concomitant therapy included albuterol prn. On 08Jul2003 the pt developed a breakthrough rash all over her trunk and down one let. The vesicles were reported as painful, but not itchy. No other information was provided. No laboratory data or diagnostic studies were done. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 5 y/o male with no medical history who on 03May1999, was vaccinated SQ in the right arm with the first dose of 0.5mL dose of dose of varicella virus vaccine live. Concomitant vaccinations on that same day included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) and inactivated poliovirus vaccine. There was no illness at the time of vaccination. The RN reported that on 10Jul2003, the pt developed chickenpox characterized by a vesicular rash of 50-75 lesions mostly on his back and chest. It was noted that the pt's grandfather had shingles two weeks before he developed chickenpox. Unspecified medical attention was sought, but no treatment was required and no laboratory/diagnostic tests were performed. At the time of this report, the pt recovered from the chickenpox. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a licensed practical nurse concerning a male who on 01Jul2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced "fever" and "varicella lesions". The pt was not hospitalized. The patient received "symptomatic treatment". Unspecified medical attention was sought. There was no product quality complaint. No additional information was provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, PNC, VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning a 12 month old white female pt with no known  allergies who on 16Jun2003 at 10:00AM was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. Concomitant therapy included measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) Haemophilus B conjugate vaccine (+) hepatitis B vaccine recombinant (yeast) and Streptococcus pneumoniae vaccine (PREVNAR). Illness at the time of vaccine was bilateral otitis media, sinusitis and an upper respiratory infection. On 25Jun2003 (previously reported as "several days later") the mother of the child called and stated that the pt developed a rash on the diaper area, behind the ears and on various parts of the body. The lesions were described as "some red bumps" with white centers.  The child's grandmother stated that it was chickenpox (also reported as "grandmother states it appeared to look like the beginning stages of chicken pox"). It was noted that the number of lesions were not documented. The child was given acetaminophen (Tylenol), diphenhydramine HC1 (Benadryl) and prescription drug therapy (unspecified) for treatment. The nurse mentioned that the office did not see the child, regarding rash, (also reported as unspecified medical attention was sought) The nurse indicated that it was unknown if the pt had recovered, that the mother didn't call back and there was no number to call the pt. No additional pt information was provided. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning a young child who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed zoster. Unspecified medical attention was sought.  Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a laboratory technician in a physician's office concerning a 9 y/o male who in 1995 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that in approximately March 2003 the pt developed a moderate case of breakthrough varicella. It was noted that the pt recovered. Follow up information indicated that the pt missed one week of school. He had a fever for one week and it took him two weeks to recover. The reporter also indicated that the pt's sibling had a similar experience after vaccination with a dose of varicella virus vaccine live. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a child patient who in approximately 1999 was vaccinated with a dose of varicella virus vaccine live. On 11Jul2003, the reporter stated that the pt now has full blown chickenpox. Unspecified medical attention was sought and the pt's parent spoke with the reporting physician. At the time of the report the pt was not recovered. a product quality complaint was not involved. Additional information has been requested.
Age: 1.83
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Cough, Pyrexia, Rash papular, Vomiting
Clinical narrative: Information has been received from a consumer concerning her 21 month old white daughter with no medical history who on 20Jun2003 was vaccinated SC in the right anterior thigh with a first 0.5ml dose of varicella virus vaccine live. Concomitant vaccination the same day included a third 0.5 ml dose of Streptoccocus pneumoniae vaccine (PREVNAR) given IM in the left anterior thigh and a fourth 0.5 ml dose of alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) given IM in the right anterior thigh. There was no illness at the time of vaccination. the reporter indicated that the child had a fever of 103 degrees for "a week after the vaccination". the child also developed a "horrible cough" that made her vomit. The reporter also believed that the child "has chickenpox now". the child's fever decreased after the first week, but she was still coughing. The child was taken to the ER on 21Jun2003  but was not admitted. The child was also taken to the physician two times since being vaccinated. The child was treated with acetaminophen (TYLENOL), guaifenesin (ROBITUSSIN) and azithromycin(ZITHROMAX) and had two breathing treatments to treat the adverse reactions including fever and cough. A chest X-ray was performed but no results were reported. At the time of the report, the patient had not recovered. The reporter also noted that she is 23 weeks pregnant but did not report any adverse reactions for herself. Follow up information from the physician indicated that the pt was see in the office on 14Jul2003 because of 2 "red bumps" one on her forehead and one on her back which developed on 13Jul2003. The diagnosis was "papules" most likely insect bites. The physician reported that there was no history of cough or vomiting. No further information is expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nursing assistant concerning her 11 year old daughter with no allergies and a history of viral meningitis at the age of 15 months who in 1995 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. In 2002, the pt developed chickenpox. The pt was covered from head to toe with lesions. The pt was seen at the clinic by a physician and treated with acetaminophen (TYLENOL), diphenhydramine hydrochloride (BENADRYL) and oatmeal baths. One and a half weeks later, the chickenpox subsided and the pt recovered. It was noted that prior to this, the pt had been exposed to many children with chickenpox and had no symptoms. A product quality complaint was not involved. Follow up information from a medical office indicated the pt had no pre-existing allergies, birth defects or medical conditions and was vaccinated on 26Feb1999 SC in the right arm with the first dose of varicella virus vaccine live. Illness at the time of vaccination included herpetic gingivitis and an upper respiratory infection. On 18Jun2002 at 15:11, the pt had an episode of varicella. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 12 y/o female no medical history who on 25May1995 was vaccinated SC in the left arm with the first dose of varicella virus vaccine live. There was no known illness at the time of vaccination. On 09Jun2003 the pt developed a fever. The RN reported that on 10Jun2003, the pt broke out in a rash, had approximately 50-75 lesions and experienced intense itching. The pt was treated with hydroxyzine HC1 (ATARAX) for the intense itching. As of 11Jul2003, the pt had no other problems related to varicella virus vaccine live. At the time of this report, the outcomes were unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 4 y/o male pt with eczema and no known drug allergies who on 05May2000 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. Concomitant vaccination the same day included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) given SC in the right thigh. Other comcomitant therapy included pimcrolimus (ELIDEL) as needed for eczema. There was no illness at the time of vaccination. On 03Jul2003 the pt experienced varicella. The physician reported the pt was seen in the office on 09Jul2003 for an itchy rash that started on the face then lower extremities, upper extremities and lower back. More than 150 lesion were noted with less on the trunk. It was noted that the patient was treated with hydroxyzine hydrochloride (ATARAX). Subsequently the patient recovered. There was no product quality complaint involved. No further information is expected.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning a 17 month old female pt with no relevant medical history who in December 2002 was vaccinated SC with a dose of varicella virus vaccine live "0.5 ml/once". There was no concomitant medication. On 15Jul2003, "as of today", the pt  broke out with several vesicles on her chest and back. There was no relevant diagnostic laboratory data. It was noted that the child has several siblings and "so far none of them have contracted the chickenpox". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 12 year old female patient was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Several months post vaccination, the pt developed full blown chickenpox. Unspecified medical attention was sought, but no treatment was required. Subsequently the pt recovered. A product quality complaint was not involved. The reporter also mentioned a second pt that developed chickenpox post vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a woman in a physician's office concerning a 7 y/o male pt with  no allergies or medical history who on 17Mar1997 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live. Concomitant vaccination on the same day included a first doseSC in the left thigh of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was noted that the pt has right otitis media (ROM) at the time of vaccination and was put on "Amox". The reporter indicated that the mother called to report that the child was exposed to chickenpox and did not received the vaccine at one year of age. On 11Jul2003 the reporter noted that to date no other problems had been reported. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 8 year old male who in approximately 2001, 1-2 years ago, was vaccinated with a dose of varicella virus vaccine live. On 14Jul2003, the physician spoke with the parent after the pt "started with symptoms". It was reported that the pt had a mild case of varicella. Unspecified medical attention was sought and no treatment was required. A lot number was not available because a dr covering for the child's physician did not have the chart. No further pt information was available. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a female child patient who  was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. Approximately one year pose vaccination, the pt developed full blown chickenpox. Unspecified medical attention was sought but no treatment was required. Subsequently, the pt recovered. A product quality complaint was not involved. The reporter also mentioned a second pt that developed chickenpox post vaccination with varicella virus vaccine live. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a company representative concerning a female who was vaccinated as a small child with a dose of varicella virus vaccine live. Subsequently the pt contracted chickenpox. It was unknown if medical attention was sought. No other information was available. No product quality complaint was involved. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning her 41 year old Asian female who works with computers with no allergies and no medical history who on 21Jun2003 was vaccinated IM with a first dose of varicella virus vaccine live. There was no concomitant medication. ON 01Jul2003, 8-10 days after the initial vaccination, the pt developed a rash, swelling at the site and 3 blisters on her chest. On 07Jul2003 the pt was seen in the physician's office and the physician noted healing of the blisters, and some swelling at the vaccine site with scabbing. No treatment was needed. The pt recovered and it was reported that the pt is now "fine". On 24Jul2003 the pt was vaccinated with a second dose of varicella virus vaccine live with no reaction noted. There was no product quality complaint was involved. No further information is not expected.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a certified medical assistant concerning a 13 year old male patient with no past medical history who on 30MAY2003 was vaccinated subcutaneously with a first dose of varicella virus vaccine live. There was no concomitant medication. Subsequently in 2003, the patient developed 20 spots on his face. Unspecified medical attention was sought, but no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse RN concerning her adult daughter who was vaccinated with the first dose of varicella virus vaccine live. The RN reported hat her daughter developed a rash about one month after being vaccinated. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 2.5
Sex: F
Vaccine: VARCEL
Symptoms: Folliculitis, Rash, Rash erythematous, Rash papular, Rash pustular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 month old white female who on 13DEC2001 was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant therapy on 12DEC2001 included a first dose in the left arm of measles-mumps-rubella vaccine. On 24JUN2003 the patient developed a rash. Upon an office visit on 26JUN2003, it was noted that the patient had erythema papules with one pustule. The pustule was located on the patient's trunk. The papules were located on the patient's left leg, right forehead, and back and abdomen. It was also noted that the patient was in the hot tub and the physician was questioning the diagnosis of varicella breakthrough or hot tub folliculitis. The outcome was reported as recovered. The reporter also indicated that one other patient developed lesions after being vaccinated with a dose of varicella virus vaccine live. No further information is expected.
Age: 2.5
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 month old white female who on 13DEC2001 was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant therapy on 12DEC2001 included a first dose in the left arm of measles-mumps-rubella vaccine. On 24JUN2003 the patient developed a rash. Upon an office visit on 26JUN2003, it was noted that the patient had erythema papules with one pustule. The pustule was located on the patient's trunk. The papules were located on the patient's left leg, right forehead, and back and abdomen. It was also noted that the patient was in the hot tub and the physician was questioning the diagnosis of varicella breakthrough or hot tub folliculitis. The outcome was reported as recovered. The reporter also indicated that one other patient developed lesions after being vaccinated with a dose of varicella virus vaccine live. No further information is expected.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received form a health care worker concerning a 15 month old patient who on 27JUN2003 was vaccinated intramuscularly with a dose of varicella virus vaccine live. On 14JUL2003, 17 days later, the patient developed 4 vesicles on the chest and spots were seen on the chest. The patient was afebrile and eating and drinking well. Unspecified medical attention was sought and no treatment was required. No additional information was available. No product quality complaint was involved. Additional information has been requested
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Pruritus, Pyrexia, Rash
Clinical narrative: Information has been received from a medical receptionist concerning a 12 month old white male with no allergies and no relevant medical history who on 09JUL2003 was vaccinated with a subcutaneous first dose of varicella virus vaccine live in the right arm. Concomitant therapy on 09JUL2003 included a subcataneous first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) in the left arm. Previously reported as no concomitant medication. On approximately 19JUL2003, " a few days later", the patient developed a "low grade fever", for one week. On 19JUL2003, he woke up with a rash on his stomach and blisters on one arm. The patient was treated with diphenhydramine hydrochloride (benadryl) for the itch and acetaminophen (tylenol) for the fever. Subsequently, the patient recovered. A product quality complaint was not involved. Unspecified medical attention was sought. No further information was available. No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 08JUL2003 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On approximately 19JUL2003 the patient developed 12 chicken pox and a temperature of 104 degrees. It was noted that the child "was not exposed to anyone with chickenpox". No lab diagnostic studies were performed. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. The reporter indicated that "doctor would like lot 0599M check". 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. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Urticaria
Clinical narrative: Information has been received from a physician concerning a female in her 20s who was vaccinated SC with a dose of varicella virus vaccine live. Concomitant medications included levothyroxine sodium (SYNTHROID), rabeprazol sodium (ACEPHEX), and ehinylestradiol + norgestimate (ORTHO TRI-CYCLEN). Subsequently, approximately 2 years ago, the patient broke out into hives on the injection area after administration. No additional treatment was incorporated to correct condition. Unspecified medical attention was sought. The outcome was reported as recovered. Follow up information indicated that on the evening of the injection the patient developed urticaria (diffuse) and significant erythema and induration at the injection site. The outcome was reported as recovered. No additional information is available.