chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.58
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning an 8 year old female with no medical history, who on 02/04/1999 was vaccinated subcutaneously with a 0.5ml of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 11/26/2005, the patient experienced breakthrough varicella. She presented to the office on 11/30/2005, with two crusted lesions on her head that were itchy and red. Patient had no fever or other symptoms. No labs were done and the patient subsequently recovered on 12/01/2005. No product quality complaint was involved. Additional information has been requested.
Age: 1.26
Sex: F
Vaccine: FLU3, HBHEPB, VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a 15-month-old white female with no known allergies or medical history, who on 11/18/2005 was vaccinated subcutaneously in the right with a first dose of varicella virus vaccine live (Oka/Merck) (lot #646669/626R). Concomitant vaccination on the same day included an intramuscular third dose in the right thigh of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (lot #652710/0695R) and an intramuscular first dose in the left thigh of influenza virus split virion 3v vaccine inactivated (Fluzone) (lot #U1765BA). There was no other concomitant medication. There was no illness at the time of vaccination. The mother called the office to report that the child developed three vesicular lesions at the injection site on 11/29/2005. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow-up information was received from the registered nurse who reported that the child's mother called the office in the morning on 11/29/2005 to report that the patient had redness at the injection site initially and had "bubbly bumps" that were very small. The mother was instructed to monitor the symptoms and was told it was "probably just a reaction." The patient recovered on an unspecified date.
Age: 1.24
Sex: M
Vaccine: FLU3, HBHEPB, VARCEL, FLU3, HBHEPB, VARCEL
Symptoms: Laboratory test abnormal, Pain, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a health professional concerning a 14 month old white male, with no medical history and no allergies, who on 11/11/2005 was vaccinated with a 0.5 ml subcutaneous first dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot #646669/0626R). Concomitant vaccine administered on the same day included a third intramuscular dose in the right conj-hepatitis B vaccine (MSD) (Lot #652498/0643R), and a first intramuscular dose in the left thigh of influenza virus split virion 3v vaccine inactivated (Fluzone) (Lot #U1767CA). There was no illness at the time of vaccination. It was reported that, on 11/15/2005, the patient's mother notified the reporter that on 11/13/2005 (previously reported on 11/14/2005) the child developed a fever of 103.4 F and extreme pain when the child tried to us the leg in which the vaccine was given. The mother was advised to give the child over-the-counter ibuprofen. The patient was seen in the office on 11/16/2005 and the fever was down to 99.6. On 11/18/2005, the fever and leg pain had resolved, but the child did develop a mild red rash on his trunk. At the time of the report the patient was recovering. The reporter assumed that the child had since recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that no treatment was provided except for ibuprofen and warm compresses. It was reported that the patient recovered. Additional information is not expected.
Age: 1.24
Sex: M
Vaccine: FLU3, HBHEPB, VARCEL, FLU3, HBHEPB, VARCEL
Symptoms: Difficulty in walking, Pyrexia, Red blood cell sedimentation rate increased, Vaccination complication
Clinical narrative: Information has been received from a health professional concerning a 14 month old white male, with no medical history and no allergies, who on 11/11/2005 was vaccinated with a 0.5 ml subcutaneous first dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot #646669/0626R). Concomitant vaccine administered on the same day included a third intramuscular dose in the right conj-hepatitis B vaccine (MSD) (Lot #652498/0643R), and a first intramuscular dose in the left thigh of influenza virus split virion 3v vaccine inactivated (Fluzone) (Lot #U1767CA). There was no illness at the time of vaccination. It was reported that, on 11/15/2005, the patient's mother notified the reporter that on 11/13/2005 (previously reported on 11/14/2005) the child developed a fever of 103.4 F and extreme pain when the child tried to us the leg in which the vaccine was given. The mother was advised to give the child over-the-counter ibuprofen. The patient was seen in the office on 11/16/2005 and the fever was down to 99.6. On 11/18/2005, the fever and leg pain had resolved, but the child did develop a mild red rash on his trunk. At the time of the report the patient was recovering. The reporter assumed that the child had since recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that no treatment was provided except for ibuprofen and warm compresses. It was reported that the patient recovered. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 09/13/2000 was vaccinated with a 0.5 ml subcutaneous first dose of varicella virus vaccine live (Oka/Merck) (Lot #634496/0535K). There was no concomitant medication. On 11/29/05, the patient developed a vesicular rash of 15 lesions on her trunk and legs after exposure to other children with chicken pox. It was reported that the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that the patient had multiple vascular lesions on her trunk and buttock. Approximately 15 lesions were noted on 12/01/2005. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse (RN) concerning an 8-year-old white male with attention deficit/hyperactivity disorder (ADHD) and no known allergies who on 09/11/1998 was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Lot #625477/0653H). Concomitant therapy included Atomoxetine HCL (Strattera), carbamazepine (Tegretol) and fluoxetine HCL (Prozac). Vaccines given on or within four weeks of varicella virus vaccine live included a dose of hepatitis B virus vaccine rHBSAG (yeast) (manufacture unknown) (exact date not reported). There was no illness at the time of vaccination. The RN reported that on 11/26/2005, the patient developed a skin rash. On 11/29/2005, the patient presented to the physician's office with a generalized skin rash which was sparse with vesicles with a slightly erythematous base, some of which had ruptured. The appearance was consistent with early or a mild case of chickenpox as per the physician's exam. No laboratory or diagnostic tests were performed. At the time of this report, the patient was recovering from the chickenpox. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 12 year old white male with no known medical history or allergies who on 06/12/1998 was vaccinated subcutaneously with a first dose of varicella virus vaccine live(lot #625378/0066H). There was no illness at the time of vaccination. On 11/14/2005, the patient developed a breakthrough case of varicella. It was noted that there were between 50 and 249 lesions. The patient had a fever of 104.0 F for one day. The patient's outcome was recovered. It was unknown if the patient had a reliable history of chickenpox. Medical attention was not sought. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 9 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Within the last 6 months", the patient developed a breakthrough case of varicella. Unspecified medical attention was sought. Treatment included either ibuprofen (Motrin) or acetaminophen (Tylenol). No laboratory diagnostic tests were performed. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 36 month old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Within the last 6 months", the patient developed a breakthrough case of varicella. Unspecified medical attention was sought. Treatment included either ibuprofen (Motrin) or acetaminophen (Tylenol). No Laboratory diagnostic test were performed. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection, Otitis media
Clinical narrative: Information has been received from a consumer concerning her son a 3 yr old male (currently 6 years old) with borderline low immunity and a history of multiple ear infections who in approx 2000 was vaccinated around his first birthday without incident with a dose of varicella virus vaccine live. In 2002 the pt developed a case of shingles while hospitalized for an unrelated ear infection. It was noted that the pt's shingles did not prolong his hospital visit. The rash was on his arm and was not properly diagnosed until he was discharged from the hospital and see by his own doctor at a follow up visit. It was unclear if he had any other varicella infection prior to the shingles. It was unk if testing was done on the shingles three years ago when it happened. The pt's outcome was recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Information has been received from a registered nurse concerning an approximately 17 month old female who in May 2005, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In October 2005, the patient presented to the office with singles on her face, chin and neck. On 10/11/2005 swabs and slides were obtained from a papule lesion. The specimen was adequate. On 10/12/2005, the VZV DNA sample was amplified and the VZV strain was identified as vaccine type. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning an 8 yr old white female who on 30Jan98 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination on the same day included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was noted that the vaccinations were not given at the reporter's office. On 25Nov05, the pt's mother called the office and reported that the child had spots. An appt was made in the office and on 26Nov05 the pt was seen. She had spots on her chest, back, face, and head. She was treated with diphenhydramine hydrochloride (Benadryl) and subsequently recovered. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 6 yr old female who on 10Jul01 was vaccinated with a SC first dose in the right arm of varicella virus vaccine live. On 02Nov05 the pt experienced chickenpox disease post vaccination, described as a mild case with 25-30 lesions that were mostly on the trunk, back and chest. It was noted that the pt's mother had shingles 2 weeks prior. It was reported that the pt recovered on 22Nov05. Medical attention was not sought. Additional information is not expected. The pt's brother experienced a runny nose and skin lesions following vaccination with varicella virus vaccine live (WAES0512USA00454).
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rhinorrhoea, Skin ulcer
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 12 yr old male, with high functioning autism, who on 31Oct96 was vaccinated with a first SC dose in the left arm of varicella virus vaccine live (lot618233/0781D). On 19Nov05 the pt started with runny nose with no fever. It was reported that there were lesions mostly on the trunk, chest and back with a few lesions on the face, arms and legs. There were greater than 100 lesions. Subsequently the pt recovered. Medical attention was not sought. Additional information is not expected. The pt's sister experienced chickenpox disease post vaccination following vaccination with varicella virus vaccine live (WAES0512USA00453).
Age: 1.11
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash erythematous, Rash papular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 4 yr old white female who on 23Apr02 was vaccinated with a SC dose in the right thigh of varicella virus vaccine live (lot639778/0981L). Concomitant vaccine administered on the same day included a SC dose in the left thigh of measles-mumps-rubella vaccine (lot641023/1485L). It was reported that on 26Nov05, in the morning, the pt experienced clustered erythematous papules, and possibly some vesicles, on her labia. There were also scattered papules on her trunk with a few scabbed over, and several papules or scabbed lesions on her face, neck and forehead. The pt was treated with diphenhydramine hydrochloride (Benadryl). It was reported that the pt recovered. Additional information is not expected.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Mouth ulceration, Pruritus, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 6 yr old white male with acute pharyngitis since 19Aug00 and no allergies who on 08Sep00 was vaccinated with a SC first standard dose of varicella virus vaccine live (lot 634502/0538K). Concomitant vaccine administered at the same time included a dose of measles-mumps-rubella vaccine. Concomitant therapy included cefaclor (Ceclor), PO, amoxicillin PO, and ampicillin IM all for treatment for acute pharyngitis. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 02Dec05 lesions started on the pt's face and progressed to his neck, arms and torso. The pt was afebrile, but had itching and an ulcer in his mouth. He was treated with cyproheptadine hydrochloride (Periactin) and avena (Aveeno bath). There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 02Dec05, at 10:00AM, the pt experienced breakthrough varicella, described as mild. Additional information is not expected.
Age: 1.29
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 yr old white male with acute pharyngitis since 19Aug00 and no allergies who on 08Sep00 was vaccinated with a SC first standard dose of varicella virus vaccine live (lot 634502/0538K). Concomitant vaccine administered at the same time included a dose of measles-mumps-rubella vaccine. Concomitant therapy included cefaclor (Ceclor), PO, amoxicillin PO, and ampicillin IM all for treatment for acute pharyngitis. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 02Dec05 lesions started on the pt's face and progressed to his neck, arms and torso. The pt was afebrile, but had itching and an ulcer in his mouth. He was treated with cyproheptadine hydrochloride (Periactin) and avena (Aveeno bath). There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 02Dec05, at 10:00AM, the pt experienced breakthrough varicella, described as mild. Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a consumer concerning an approx 5-12 yr old child who in approx 1996-2003 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced a mild case of chickenpox. Unspecified medical attention was sought. The pt subsequently recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash pruritic, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 11 yr old female with no known medical history who on 11Sep95 was vaccinated SC with a 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On 03Dec05 the pt presented with 60-75 vesicular lesions in varying stages over her whole body, a 102F fever and itching. The pt was treated with ibuprofen (Motrin) and diphenhydramine hydrochloride (Benadryl). At the time of the report the pt was recovering. There was no product quality complaint involved. Follow up information indicated that the pt had chickenpox. On 05Dec05 the physician's office received a phone call from the parent, symptoms and treatment were reviewed; isolated for duration of vesicles. It was noted that the pt's brother (WAES0511USA04538) had chickenpox the previous week. Subsequently the pt recovered on 15Dec05. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 11 yr old female with no known medical history who on 11Sep95 was vaccinated SC with a 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On 03Dec05 the pt presented with 60-75 vesicular lesions in varying stages over her whole body, a 102F fever and itching. The pt was treated with ibuprofen (Motrin) and diphenhydramine hydrochloride (Benadryl). At the time of the report the pt was recovering. There was no product quality complaint involved. Follow up information indicated that the pt had chickenpox. On 05Dec05 the physician's office received a phone call from the parent, symptoms and treatment were reviewed; isolated for duration of vesicles. It was noted that the pt's brother (WAES0511USA04538) had chickenpox the previous week. Subsequently the pt recovered on 15Dec05. No further information is available.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin ulcer
Clinical narrative: Information has been received from a RN and a physician concerning a 10 yr old female pt with reactive airways disease and environmental allergies who on 22Apr96 was vaccinated SC with varicella virus vaccine live (lot 610251/0747B). Concomitant therapy included montelukast sodium, budesonide and allergy injections. On 02Dec05 the pt had several lesions on her abdomen and itching. On 05Dec05, she was seen by the physician and had around 20-30 lesions mainly on her trunk, in her mouth and on her scalp with itching. No treatment was ordered. There was no further information available regarding the adverse event. The pt is recovered. There was no product quality complaint reported. No additional information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning her 10 yr old neice who nine years ago in 1996 was vaccinated with a dose of varicella virus vaccine live. In Nov 2005, the pt experienced a mild case of breakthrough chickenpox. Subsequently, the pt recovered on an unk date. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.19
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning an 8 yr old white female, with no known medical history and no known allergies who on 23Apr98 was vaccinated with a dose of varicella virus vaccine live. On 03Dec05 the pt experienced 30-40 lesion mostly from the waist up with a few on her legs. It was noted that half of the lesions did blister and scab over. At the time of the report the pt was still breaking out in new lesions. It was reported that it was unk if the pt had recovered at this time. The pt was treated with home care. There were no lab or diagnostic tests performed. Medical attention was not sought. Follow up information from a health professional indicated that the pt had no new lesions since 06Dec05 and the pt wanted to go back to school. The pt was reported as recovered on 07Dec05. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash maculo-papular, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 4 yr old female who on 23Jul02, at one year of age, was vaccinated SC in the left arm with the first 0.5mL dose of varicella virus vaccine live (lot641277/1297L). There was no illness at the time of vaccination. The RN reported that on 07Dec05, the pt developed 15 macular papular lesions, 2-3 which were pus filled, and a mild fever. The RN indicated that the pt had been exposed to chickenpox. Unspecified medical attention was sought. At the time of this report, the pt was recovering from her events. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 yr old male with no reported history and no allergies who was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate (Advair). On 03Dec05 the pt experienced a breakthrough case of chickenpox. He had a fever, stomach ache and a rash that developed into lesions. No lab tests were done. At the time of this report the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 3 yr old female who at one year of age, in 2003, was vaccinated with a dose of varicella virus vaccine live. In Dec 2005, the pt experienced a severe case of chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Medication error
Clinical narrative: Information has been received from a pharmacist concerning a 33 yr old female who in 2001 was vaccinated with two doses of varicella virus vaccine live. In 2005 the pt presented with negative antibody titers. The pharmacist stated that there may have been some question as to whether the proper dosing schedule was used in 2001. Unspecified medical attention was sought. At the time of the report the pt had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 yr old female who on 12Jul00 was vaccinated with a 0.5mL dose of varicella virus vaccine live (lot632726/0088K). The physician reported that on 08Dec05, the pt presented to his office with a breakthrough case of chickenpox characterized by six lesions. At the time of this report, the pt was recovering. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye disorder, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning an approx 2.5 year old female who in approx June 2004, was vaccinated SC with a dose of varicella virus vaccine live. On 09Dec05 it was reported that the pt recently developed a vesicular rash that involved one of her eyes. Unspecified medical attention was sought. There was no product quality complaint involved. Vesicular rash was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 0.83
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 10 month old male who on 02May96 was vaccinated with a SC dose of varicella virus vaccine (lot616995/1499B). On 10Dec05 the pt developed less than 50 lesions and he had a fever. There was no other treatment other than diphenhydramine hydrochloride (Benadryl). It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a RN concerning an 8 yr old male with no medical history or drug allergies who on 17Aug98 was vaccinated SC in the left thigh with a 0.5mL dose of varicella virus vaccine live (lot 626688/0650H). Concomitant therapy included a dose of measles-mumps-rubella vaccine. On 09Dec05 the pt developed a fever and a varicella rash. He was seen in the physician's office on 10Dec05. There was no fever noted at the physician's office. No treatment was prescribed. It was reported that the pt fully recovered. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 yr old female who on 18Aug97 was vaccinated with a 0.5mL dose of varicella virus vaccine live (lot 622969/0423E). There was no concomitant medication. On 13Dec05 the pt developed a mild case of breakthrough varicella (less than 50 lesions). She did not have a fever. No other details were given. The outcome was reported as recovering. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 3 and 1/2 year old pt who at 23 months of age was vaccinated with a dose of varicella virus vaccine live. The child was exposed to chicken pox at the day care center one week prior to the doctor's visit on 12/12/05. The physician noted that the pt did not appear ill and did not have a fever and reported that it appeared to be a very mild case. Additional information has been requested.
Age: 1.35
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pruritus, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning an 11 yr old white male who has no pre-existing allergies or medical conditions, who on 01Jan96 was vaccinated with a first dose of varicella virus vaccine live. The pt was not ill at the time of vaccination. On 04Dec05 the pt's mother called to report that the pt has approx 100 lesions on his body with itching. It was reported that a girl in the pt's class had chickenpox and exposed the whole class. It was also reported that 8 or 9 children in the class have come down with varicella. There were no laboratory tests performed. The pt recovered on 12Dec05. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 44 month old white female with no known history or drug allergies who on 04/14/2003 was vaccinated subcutaneously in the left thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot #644565/1149M). Concomitant vaccination the same day included a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistra RA 27/3) (MSD) (lot #644644/1080M) given SC in the left thigh. On 12/11/2005, the patient developed 3 to 4 spots and on 12/12/2005 she had approximately 18 lesions. Some of the lesions were blistering and scabbed over and some were itchy. The patient's mom treated her with home care over the counter products. Subsequently she recovered. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Abdominal pain, Skin ulcer
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 6-year-old white male with asthma and no known drug allergies who on 06/20/2000, was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication and there was no illness at the time of vaccination. On 12/07/2005, the patient was seen in the physician's office with lesions on his leg, some scabbed over. On 12/09/2005, he complained of abdominal pain, no fever. Subsequently, the patient recovered as of 12/12/2005. Additional information is not expected.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Information has been received from a health professional concerning her 36-48 month old daughter who, "when she was 15 months old", in approximately 2002, was vaccinated once with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). In December 2004, the patient experienced a mild case of breakthrough varicella with less than 30 lesions. It was reported that she had no fever but the lesions were itchy. The patient was given an oatmeal bath. Subsequently, the patent recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 7-8 year old male who, "when he was 15 months old", in approximately 1998, was vaccinated once with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 12/13/2005, the patient came into the office with breakthrough varicella with less than 50 lesions. The patient had no fever and no treatment was given. At the time of the report the patient was recovering. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. Additional information has been request.
Age: 1.06
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse (R.N.) and a physician concerning a 13-month-old female with a history of a patent foramen ovale (PFO), macrocephaly (without shunts) and mild congential valvular pulmonary stenosis who on 08/09/2004, was vaccinated subcutaneously in the left thigh with the first dose of varicella virus vaccine live (Oka/Merck) (lot #649739/0121R). Concomitant vaccinations given on the same day included: the first dose of measles virus live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot #649672/0774P) given subcutaneously in the left thigh and the fourth dose of Hib conj vaccine (tet Toxoid) (ACTHIB) (lot #UE562AA) given intramuscularly in the right thigh. There was no illness at the time of vaccination. It was reported that 8 days after vaccination, on 08/17/2005, the patient developed lesions. Medical attention was sought and the patient was seen by a physician on 08/19/2005. At the time of the office visit, the patient had less than 50 lesions and she was diagnosed with breakthrough varicella. It was reported that the patient recovered as of 08/26/2005. No product quality complaint was involved. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a female from a physician's office concerning an 11-year-old male student who in 1996 was vaccinated with a dose of varicella virus vaccine live.  It was unknown if there was any illness at the time of vaccination.  On 10-DEC-2005 the patient developed multiple lesions in various stages, and had a lesion on his left eye.  The patient was seen in the physician's office, he was referred to an ophthalmologist and treated with routine calamine lotion and diphenhydramine hydrochloride.  Subsequently, the patient recovered on an unknown date.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5-year-old white male with no known drug allergies who on 22-OCT-2001 was vaccinated with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  On 30-NOV-2005, the patient's parents called the office to report that the patient had several areas on his chest with lesions.  There was no fever.  On 07-DEC-2005, the patient recovered.  No diagnostic laboratory tests were performed.  Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 10-year-old patient who in 2001 or 2002 was vaccinated with a dose of varicella virus vaccine live.  In November 2005, the patient developed a case of break through case of chickenpox.  The patient had bumps on the body.  Unspecified medical attention was sought.  A product quality complaint was not involved.  It was also noted that the patient's 12-year-old sibling had a similar reaction after vaccination with varicella virus vaccine live (WAES 0601USA00310).  It was noted that each patient received vaccine from a different lot number.
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from an infectious disease control nurse concerning a grade school age child who was vaccinated between 1999 and 2000 with a dose of varicella virus vaccine live.  In approximately November 2005 (through December 2005), the patient developed varicella.  It was unknown if medical attention was sought.  No outcome was reported.  No product quality complaints were involved.  This is one of several reports from the same source.  It was reported that there was an outbreak of varicella in a school. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a male child around 7 years old who in 2000 was vaccinated with a dose of varicella virus vaccine live.  In November 2005, the patient experienced a mild case of chickenpox.  The patient had lesions on his trunk and back.  Subsequently, the patient recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: IPV, VARCEL
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 4 year old male with asthma who on January 25, 2002 was vaccinated with a fist subcutaneous dose in the left thigh of varicella virus vaccine live (Oka/Merck) ( Lot #641151/1181L). Concomitant vaccine administered on the same day included a third subcutaneous dose in the left arm of poliovirus vaccine inactivated (Vero) (IPOL) (lot #T1390). The patient had mild asthma and a yeast diaper rash at the time of vaccination. It was reported that on November 13, 2005, the patient developed what appeared to be chickenpox lesions. with not more than 10 lesions. Symptomatic treatment was given for mild itching. Subsequently, the patient recovered. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 35-year-old female, who is 13 weeks pregnant with twins and allergic to penicillin, who on 03-MAY-2001 was vaccinated with a dose of varicella virus vaccine live and with a follow-up vaccination, "shortly after", with a dose of varicella virus vaccine live.  There was no concomitant medication.  Today, on 19-DEC-2005 the patient found out that the vaccine was not protecting her from the virus and that she was now susceptible to the virus.  It was reported that the patient had not recovered.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old white male, with non-remarkable medical history and no allergies, who on 24-SEP-2002 was vaccinated once with a 0.5 ml intramuscular dose of varicella virus vaccine live (640556/0258M.  There was no concomitant medication.  On 16-DEC-2005 the patient experienced breakthrough varicella covering his trunk and body.  Unspecified medical attention was sought.  No product quality complaint was involved.  No other information was provided.  Follow-up information from a health professional indicated that no further information was available.  Follow-up information from a health professional indicated that on 19-DEC-2005 the patient experienced varicella lesions.  The patient was treated with diphenhydramine hydrochloride and oat.  Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 22-month-old white male with a history of gastroesophageal reflux as an infant (no treatment now) and with no drug reactions/allergies.  It was also noted that the child was underweight (per the physician), noted to be in the less than third percentile for weight while in the fifth percentile for height.  On 03-MAR-2005, the patient was vaccinated SC in the left thigh with a first 0.5 ml dose of varicella virus vaccine live (0984P).  There was no illness at the time of vaccination.  There was no concomitant medication.  On 15-DEC-2005 the patient experienced a diffuse rash over his trunk, back, abdomen and lower extremities.  He was also noted to have a fever for 2 days.  The physician ordered only symptomatic treatment if/as needed, including fluids, rest and acetaminophen as needed.  The physician does not know the number or type lesions or how high the child's temperature was.  At the time of the report, the patient was comfortable, without other complications, and was noted to be recovering.  There was no product quality complaint.  Follow up information indicated that on 15-DEC-2005 the patient developed chickenpox.  The patient has since recovered.  There were no relevant diagnostic tests or laboratory data.  No additional information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 10-year-old male who in approximately 1996, around his first birthday, was vaccinated with a dose of varicella virus vaccine live.  On 15-NOV-2005 the patient developed breakthrough as part of a mild outbreak in school.  The child was noted to have 5 lesions and missed 1 week of school.  The boy had mild to low grade fevers and no other symptoms mentioned.  The outcome was reported as recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 4-year-old female who, in approximately 2002, around her first birthday, was vaccinated with a dose of varicella virus vaccine live.  On 06-DEC-2005, the patient developed breakthrough, noted to be 12 to 15 lesions.  The child was out of school for 2 weeks but it was unknown what the outcome was.  Unspecified medical attention was sought.  The outcome was reported as recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 7 and 1/2 year old male who in approximately 1999, at 12-months-old, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On December 19,2005, the patient presented to the office with a case of breakthrough chickenpox and a low grade fever. No further information was available. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a female pt, who about two years ago (approx 2003) was vaccinated twice with varicella virus vaccine live. She reported that her titers have not shown antibodies. The pt did not provide any further information regarding the adverse event or her outcome. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from an employee health nurse concerning a 31 yr old female certified nursing assistant with an allergy to levofloxacin (Levaquin), no history of chickenpox,  and who had an initial titer on 09Aug05 which returned a result of 1.2 eu/ml, who on 24Aug05 was vaccinated SC with a 0.5mL first dose in the left arm of varicella virus vaccine live (lot9103907) and a second SC 0.5mL dose in the left arm of varicella virus vaccine live (lot 9103907) on 28Sep05. There was no concomitant medication. There was no illness at the time of vaccination. On 14Dec05 she had a titer drawn, which returned on 21Dec05 as negative. The nurse reported that negative is defined by the laboratory as less than 15 eu/mL and the employee was 8.7 eu/ml. No ELISA units were specified in the measurement. The employee is presently well and has been well. There was no product quality complaint reported. Unspecified medical attention was sought. Follow up information indicated that no additional information was available. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a six year old male pt with no allergies and no pertinent medical history, who on 08Sep00 was vaccinated SC with 0.5mL varicella virus vaccine live. There was no concomitant medication. On 21Dec05 the pt experienced breakthrough varicella. There were no lab studies performed. The adverse event did not improve and the pt's outcome is not recovered. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pruritus
Clinical narrative: Information has been received from a physician concerning a 15-year-old with no pertinent medical history and no allergies, who on December 06,2005, was vaccinated subcutaneously with a 0.5 ml does of varicella virus vaccine live (Oka/Merck) (lot #646536/0550R). There was no concomitant medication. About 7-10 days later, on approximately December 12,2005, the patient developed general pox eruptions with more than 50 lesions with itching. Unspecified medical attention was sought. It was reported that he was treated with diphenhydramine hydrochloride (Benadryl). The patient's status was unspecified by the reporter. No product quality complaint was involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 7 year old female who at one year of age, in 1999, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In December 2005, the patient experienced a mild case of chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning an 11 year old male who at one year of age, in 1995, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In December 2005, the patient experienced a mild case of chickenpox. Unspecified medical attention was sought. No Product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received form a physician concerning a 6-year-old male who on was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live.  Subsequently, on approximately 16-DEC-2005, the child developed a severe case of chickenpox.  The child had lesions all over his body, including his mouth and scalp.  Unspecified medical attention was sought.  The outcome was recovering.  It was noted that there was an outbreak of chickenpox at the child's elementary school.  There was no product quality complaint involved.  Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a health professional concerning a 9 year old white male with no known history who on 10/30/97 was vaccinated with a 2nd dose of varicella virus vaccine live. There was no concomitant medication. On 12/13/05, the pt developed red lesions over his body and a low-grade temp. On 12/14/05, some lesions were scabbing over and new lesions were appearing. On 12/16/05, no new lesions were developing, he was afebrile and it was reported that one of his classmates was dx'd with chickenpox. Additional info has been requested.
Age: 1.59
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning an 11 year old male with no allergies or medical conditions who on 6/6/98 was vaccinated, SC in the right arm with a 1st dose of varicella virus vaccine live (lot 617072/1661B). There was no illness at the time of vaccination. On 12/22/05, the pt experienced a rash on the face. The rash progressed and the child was seen in the office on 12/23/05. The dx was post Varivax varicella. No labs were done. Outcome was not reported. Additional info has been requested.