chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 21 month old female, that was exposed to an adult who had chickenpox about 3 weeks ago, who was vaccinated with a 0.5 ml dose of varicella virus vaccine live. On 06-AUG-2005 the patient developed 11 red bumps on her abdomen, a low grade fever and a grumpy mood. It was reported that the patient was recovering. Unspecified attention was sought. No product quality complaint was involved. No other information was provided. The patient's twin sister experienced 5 red bumps on her abdomen following vaccination with varicella virus vaccine live (WAES0508USA01774). Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a company representative concerning a male twin who was vaccinated with a 0.5mL dose of varicella virus vaccine live. On approximately 18-JUL-2005, the patient was exposed to his father who had chickenpox. Subsequently, the boy developed a mild case of varicella after the exposure. No other information was available. The outcome was reported as recovering. There was no product quality complaint. It was also noted that the patient's brother developed varicella (WAES0508USA02064). No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Viral infection
Clinical narrative: Information has been received from a nurse concerning a female patient who was vaccinated "12 - 15 months ago" (2004), with varicella virus vaccine live. The nurse reported that recently, on 04-AUG-2005, the patient developed a breakthrough case of varicella with about 20 lesions and fever. She was treated with acyclovir (ZOVIRAX) and the adverse event improved. The patient's present status at the time of report was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Laboratory test abnormal, Malaise
Clinical narrative: Information has been received from a registered nurse concerning a healthy 43 year old white female phlebotomist, with allergies to sulfa, cimetidine (TAGAMET) and acetaminophen (+) oxycodone (PERCOCET), who on 18-JUL-2005, at 3:30 PM, was vaccinated with a first subcutaneous dose in the right arm of varicella virus vaccine live (Lot# 9376606). There was no concomitant medication. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was noted that the patient had a varicella titer prior to vaccination 18-JUL-2005 and it was less than 0.91. On approximately 05-AUG-2005 or 07-AUG-2005, the patient experienced a generalized rash and malaise. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Follow-up information from a health professional indicated that on 07-AUG-2005, in the AM, the patient developed a generalized skin rash, described as being similar to chickenpox. The patient was treated with acyclovir. Follow-up information from a health professional indicated that on 22-AUG-2005 the patient recovered. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Viral infection
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 4 year old male who on 20-FEB-2002 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live. There was no concomitant therapy. The CMA reported that on 08-AUG-2005, the patient presented to the physician's office with 15 - 20 varicella lesions. The patient was noted to be afebrile and was treated with cephalexin (KEFLEX) to prevent infection. AT the time of this report, the patient was recovering from the varicella. Additional information has been requested.
Age: 1.75
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a physician concerning a 21 month old female, that was exposed to an adult who had chickenpox about 3 wks ago who was vaccinated with a 0.5ml dose of varicella virus vaccine live. On 06Aug05 the pt developed only 5 red bumps on her abdomen and no other symptoms. It was reported that the pt was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The pt's twin sister experienced 11 red bumps on her abdomen, a low grade fever, and a grumpy mood following vaccination with varicella virus vaccine live (WAES0508USA01560). Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pruritus, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 2 yr old female with no pertinent medical history and no allergies who on 15Nov04 was vaccinated with a dose of varicella virus vaccine live (lot650227/1110P). There was no concomitant medication. On 05Aug05 the pt experienced breakthrough. It was noted that she had 20 lesions around her lower trunk and upper leg. She did not have a fever and the lesions were described as not very itchy. Most of the lesions were crusted over but two were vesicular. The child was given hydroxyzine hydrochloride (Atarax). It was noted that there was no known exposure to chickenpox there were no lab tests performed. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash pruritic
Clinical narrative: Information has been received from a health professional concerning a 15 yr old white male with attention deficit/hyperactivity disorder who was vaccinated with a dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 06Apr05 the pt developed an itchy rash. On 07Apr05 the pt was seen in the office and diagnosed with post Varicella. Supportive care was ordered. No diagnostic tests were performed. Neither the pt or his siblings experienced adverse events following prior vaccination. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 35 month old pt who on 22May03 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccine administered with varicella virus vaccine live included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 26Apr05 the pt experienced chickenpox, described as mild with only 10 to 15 skin lesions. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from pharmacist concerning a pt who was vaccinated with a dose of varicella virus vaccine live. The pharmacist reported that a titer was drawn, which was low, indicating that the pt failed to seroconvert. Unspecified medical attention was sought. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a health professional concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, two weeks later, the pt experienced a generalized rash. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 yr old male pt who on 29Aug00 was vaccinated with varicella virus vaccine live. On an unspecified date in June 2005, the pt developed breakthrough varicella. The breakthrough was described as less than 50 lesions and no temp. It was unk as to whether lab studies were performed. The adverse event improved and the pt recovered on an unspecified date. There was no product quality complaint reported. The pt sought unspecified medical attention. The reporter mentioned that the pt's sister (WAES0508USA02097) had a similar experience of breakthrough varicella following vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 yr old white male with no known medical history or allergies who on 20Dec01 was vaccinated SC in the right leg with a 0.5mL dose of varicella virus vaccine live (lot638495/1904K). There was no concomitant medication. There was no illness at the time of vaccination. On 16Aug05 the pt developed 20 or more chickenpox. It was later reported that the pt developed breakthrough varicella with greater than 20 lesions on his chest, left arm and legs. Unspecified medical attention was sought. There were no laboratory diagnostic tests performed. At the time of the report the pt had not  yet recovered. There was no adverse events following prior vaccination. There was no product quality complaint involved. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 yr old white male with no known medical history or allergies who on 20Dec01 was vaccinated SC in the right leg with a 0.5mL dose of varicella virus vaccine live (lot638495/1904K). There was no concomitant medication. There was no illness at the time of vaccination. On 16Aug05 the pt developed 20 or more chickenpox. It was later reported that the pt developed breakthrough varicella with greater than 20 lesions on his chest, left arm and legs. Unspecified medical attention was sought. There were no laboratory diagnostic tests performed. At the time of the report the pt had not  yet recovered. There was no adverse events following prior vaccination. There was no product quality complaint involved. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a female in the pediatrician's office concerning a 4-year-old male with no medical history who on 20-Dec-2001 was vaccinated subcutaneously in the right leg with a dose of varicella virus vaccine live (Oka/Merck) (lot# 638495/1904K). There was no illness at the time of vaccination. On 10/AUG-2005 the patient experienced breakthrough varicella characterized by greater than 20 lesions on the chest, left arm and legs. The patient was seen by a physician. Subsequently, the patient recovered from breakthrough varicella. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a female in the pediatrician's office concerning a 4-year-old male with no medical history who on 20-Dec-2001 was vaccinated subcutaneously in the right leg with a dose of varicella virus vaccine live (Oka/Merck) (lot# 638495/1904K). There was no illness at the time of vaccination. On 10/AUG-2005 the patient experienced breakthrough varicella characterized by greater than 20 lesions on the chest, left arm and legs. The patient was seen by a physician. Subsequently, the patient recovered from breakthrough varicella. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a company representative concerning a male twin who was vaccinated with a 0.5mL dose of varicella virus vaccine live. On approx 18Jul05, the pt was exposed to his father who had chickenpox. Subsequently, the boy developed a mild case of varicella after the exposure. No other information was available. The outcome was reported as recovering. There was no product quality complaint. It was also noted that the pt's brother developed varicella (WAES0508USA01561). No additional information is expected.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 yr old female pt who on 07Dec97 was vaccinated with a dose of varicella virus vaccine live. On an unspecified date in June 2005, the pt developed breakthrough varicella. The breakthrough presented as a full blown case of chickenpox. It was unk as to whether lab studies were performed. The adverse event improved and the pt recovered on an unspecified date. There was no product quality complaint reported. The pt sought unspecified medical attention. The reporter mentioned that the pt's brother (WAES0506USA02032) had a similar experience of breakthrough varicella following vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on 25Jul05 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live (lot 1029). On 10Aug05 the pt presented with hives on her arms, legs and trunk. The pt was treated with over the counter diphenhydramine hydrochloride (Benadryl). At the time of the report the pt had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a physician indicated that the pt was unable to be located Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 16Dec98 was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt has developed chickenpox. Later this morning, on 11Aug05 the pt was being seen in the office. On 11Aug05, the physician's office submitted 3 swabs for PCR analysis for the pt who had developed breakthrough. No product quality complaint was involved. Follow up information received on 29Sep05 reported that the pt's VZV results from testing on 11Aug05 showed wild type VZV. Additional follow up information was received from the VZV ID program which confirmed that a specimen was obtained from the pt on 14Aug05 and the source was a lesion. The specimen was sent to the lab on 15Aug05 and it arrived in the lab on 16Aug05. The results showed that VZV was amplified and the VZV strain identified was wild type. No additional information has been requested. The pt's brother experienced severe shingles, iritis and eye droop following vaccination with varicella virus vaccine live (WAES0508USA02122).
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 yr old male with no medical history who in 1999 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The physician reported that in August 2005, the pt developed a typical case of breakthrough characterized by less than 50 lesions. Unspecified medical attention was sought and the pt was noted to be afebrile. At the time of this report, the outcome was unk. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning his 4 yr old daughter who was vaccinated at 12 months of age with a dose of varicella virus vaccine live. Subsequently, the pt developed a very mild case of chickenpox. One pox on her chest became infected and she was treated with oral antibiotics. No other complications were noted. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pharyngolaryngeal pain, Pyrexia, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 10 yr old white female with no allergies or medical history who on 07May98 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot624449/1422E). There was no concomitant medication. On 08Aug05 the pt experienced varicella lesions to her entire body. It was noted that this was seven years after vaccine administration. She presented to the physician's office on 10Aug05 with the lesions described as a rash on her face, a fever sore throat and the lesions all over her body. No labs or diagnostic tests were done. Unspecified prescription drug treatment was given for the varicella and it is still being treated. Outcome of the sore throat is unk. The pt's varicella was considered an other important medical event  (OMIC) by the reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 10 yr old white female with no allergies or medical history who on 07May98 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot624449/1422E). There was no concomitant medication. On 08Aug05 the pt experienced varicella lesions to her entire body. It was noted that this was seven years after vaccine administration. She presented to the physician's office on 10Aug05 with the lesions described as a rash on her face, a fever sore throat and the lesions all over her body. No labs or diagnostic tests were done. Unspecified prescription drug treatment was given for the varicella and it is still being treated. Outcome of the sore throat is unk. The pt's varicella was considered an other important medical event  (OMIC) by the reporter. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old male who on 21Jun99 was vaccinated with a dose of varicella virus vaccine. On 12May05, the pt presented with a case of breakthrough varicella with less than 50 lesions and no fever. Unspecified medical attention was sought. The pt recovered on his own and no treatment was needed. A product quality complaint was not involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 yr old female who on 23Nov99 was vaccinated with a dose of varicella virus vaccine live. On 13May05, the pt presented with a case of breakthrough varicella with less than 50 lesions and no fever. Unspecified medical attention was sought. The pt recovered on her own and no treatment was needed. A product quality complaint was not involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Information has been received from a physician concerning a 4 yr old female with a seizure disorder who on 02Aug05 was vaccinated with a dose of varicella virus vaccine live. On 12Aug05 the pt developed injection site redness, induration and swelling. No vesicular lesions or crusting were present. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 32 yr old white female non smoker with no known medical history or allergies who was vaccinated with a first and second dose of varicella virus vaccine live (lot0893J) on 13Sep99 and 26Oct1999, respectively. Recently a titer was drawn and the pt failed to seroconvert. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information from the physician indicated that the on 01Jul05 the pt had a titer, VZV AB IgG, drawn which had a negative result of 0.14. There was no adverse event. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a nurse concerning a female pt who on 07May98 was vaccinated with a dose of varicella virus vaccine live. On 10Aug05, the pt developed break through chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 11 year old black female with no medical history who on 28-MAY-1998 was vaccinated in the right arm with a first dose of varicella virus vaccine live (Oka/Merck)(lot # 624644/1329E). There was no illness at the time of vaccination. Concomitant therapy on an unknown date was reported as a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD), a dose of poliovirus vaccine and a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. "Now", on approximately 15-AUG-2005, the patient has experienced full blown chicken pox with greater than 50 lesions. She is being treated with hydroxyzine hydrochloride (ATARAX) and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO). No additional information is available. No product quality complaint was involved. Follow-up information indicated that on 13-AUG-2005, at 15:00, the patient developed distorted vesicles diffusely over the body. Some vesicles were dried and some still oozing. It was reported that on 20-AUG-2005 the patient recovered. The chickenpox was considered an other important medical event (OMIC) by the reporter. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from an immunization official concerning an adult female patient who, several years ago, received an adult two dose vaccination SC, each dose 0.5 mL of varicella virus vaccine live (Oka/Merck). It was noted that a recent titer was done and does not show seroconversion. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 36-month-old white female patient with no pre-existing allergies or medical conditions, who on 17-JUL-2003 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot# 645049/0198N). Concomitant vaccine therapy included a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot # 645406/0133N) administered SC in the right thigh. The patient was not ill at the time of vaccination. As per the patient's mother, on 05-AUG-2005 the patient started with one possible chickenpox on her hand. As of 08-AUG-2005 the patient had about 28-30 lesions over her body. She did not have a fever. It was noted that none of the lesions were infected at the time of the report. It was also noted that the patient had not been to the physician's office. It was noted that the patient's mother feels it is a breakthrough case of chickenpox. There were no relevant diagnostic studies or tests performed. The patient recovered. No additional information is expected.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pruritus, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 31 month old white female, with no known drug allergies, who on 04-FEB-2004 was vaccinated with a subcutaneous first dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot# 647242/0895N). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 10-AUG-2005 the patient experienced a new itchy, vesicular rash noted to be small chickenpox on her mid-body with more new lesions on the next day. It was noted that there was no fever and the patient did not seem ill. Medical attention was not sought. Follow-up information from a woman working at a physician's office indicated that on 11-AUG-2005 the patient experienced small vesicles of chickenpox on her skin. It was reported that the patient recovered. Additional information is no expected.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a nurse practitioner concerning a 37-year-old white female who in 2003 was vaccinated with a dose of VARIVAX (Oka/Merck). Subsequently, a titer did not show seroconversion. No other information was noted. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information from the nurse practitioner indicated that the patient has received VARIVAX (Oka/Merck) two times and titers on 24-APR-2000 and 10-AUG-2005 have been negative. Additional information is not expected.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 24-year-old female healthcare worker, with no known allergies and no pertinent medical history, who in July 2005 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot# 647242/0895N) and on an unspecified date in August 2005 with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 651040/0211R). There was no concomitant medication. Shortly after the second vaccination, during the week of 08-AUG-2005 (exact data unknown) the patient developed a case of breakthrough. She had about 15 lesions, some crusted over while others are vesicular lesions. there was no fever or itching present. Most of the breakthrough lesions were on the arm where the varicella virus vaccine live (Oka/Merck) was given. the patient did not improve and was not recovered at the time of this report. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain
Clinical narrative: Information has been received from a nurse practitioner concerning a 35 year old female with no medical history or allergies who on 15-AUG-2005 was vaccinated in the arm with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 15-AUG-2005 the patient's arm "hurts a little bit". The patient reported that she does not know if she is currently pregnant and asked the nurse if it was okay to have the vaccine if she was trying to get pregnant. there were no labs done, but she sought medical attention with the nurse who administered the vaccine. No product quality complaint was involved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash macular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old male with Chiari malformation and a history of recurrent febrile convulsions who on 22-APR-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 640156/0978L). There was no concomitant medication. On 11-AUG-2005 the patient experienced varicella lesions. He presented to the office on 14-AUG-2005 with 30 varicella lesions, 20 of these lesions were vesicular and 10 were maculopapular. The patient did not have a fever. Treatment included diphenhydramine hcl (BENADRYL) for the itching. No other information was available. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6-year-old healthy female who in August 2000, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The physician reported that on 15-AUG-2005, the patient developed mild breakthrough characterized by a few lesions. Unspecified medical attention was sought. Subsequently, the patient recovered from the mild breakthrough. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning an 18 year old female with seasonal allergies and no known drug allergies/reactions who was vaccinated with a first, second, and third dose of varicella virus vaccine live (Oka/Merck) on 24-NOV-1996, 28-JUL-2004, and 12-AUG-2005 (lot# 651043/0215R), respectively. Concomitant therapy included fexofenadine hydrochloride (ALLEGRA). the patient's titer was negative on 27-APR-2005. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Viral infection
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a 0.5ml dose SC of varicella virus vaccine live (Oka/Merck). On 09-AUG-2005, the patient came to the office with 15-20 varicella lesions that started that day. He did not have fever. He was given diphenhydramine hcl (BENADRYL) to stop the itching. No product quality complaint was involved. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HBHEPB, VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old female, with no known allergies, and with a history of a urinary tract infection and reactive airways disease who on 05-NOV-2005 was vaccinated with a first dose in the right thigh of varicella virus vaccine live (Oka/Merck) (Lot# 640468/0796L). Concomitant vaccine administered on the same day included a third dose in the right thigh of HIB conj-hepatitis B vaccine (COMVAX) (Lot# 640084/1133L). There was no illness at the time of vaccination. It was reported that the patient was seen in the office on 11-AUG-2005 with breakthrough chickenpox. Subsequently, the patient 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. Follow-up information from a health professional indicated that on 10-AUG-2005 the patient broke out with a rash, and on 11-AUG-2005 was seen at the office and diagnosed with chickenpox. the patient was treated with diphenhydramine hydrochloride (BENADRYL), calamine lotion, and oatmeal baths. It was reported that the patient recovered in one week. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received from physician and a registered nurse concerning the registered nurse's 7-year-old daughter who in approximately 1999, at 12-months-old, was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 628244/1343H). The child was exposed to chickenpox in the summer of 2005. On 10-AUG-2005, the patient developed a full-blown case of chickenpox with over 100 lesions/vesicles. A fever was noted. Acyclovir was prescribed. Subsequently, the patient fully recovered. No further information is available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Viral infection
Clinical narrative: Information has been received from a physician concerning a 11-year-old healthy female with no allergies who on 24-JUN-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 07-AUG-2005 the patient developed breakthrough varicella, described as less than 50 lesions and a slight fever. The patient was treated with anti-itch medicine. No further information was available. Subsequently, the patient recovered from breakthrough varicella. There were no laboratory studies performed. There was no product quality complaint reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 14-JAN-1999 was vaccinated with a dose of varicella virus vaccine live (Lot# 628037/1252H). It was reported that on 22-JUL-2005 the patient was seen in the office with breakthrough chickenpox. Subsequently the patient recovered. The patient's brother experienced chickenpox following vaccination with varicella virus vaccine live (WAES0508USA03161). Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Viral infection
Clinical narrative: Information has been received from a physician concerning a 30 month old male who on 03-FEB-2004 was vaccinated with a dose of varicella virus vaccine live (Lt# "0201H"). It was reported that on 08-AUG-2005 the patient was treated at the emergency room with cephalexin (KEFLEX) for full blown chickenpox with a fever of 104.7 degrees F. It was noted that the patient was not admitted to the hospital. Subsequently, the patient recovered. The patient's sister experienced chickenpox following vaccination with varicella virus vaccine live (WAES0508USA03160). Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 11 year old female who in 1996 was vaccinated with a dose of varicella virus vaccine live. It was reported that "several weeks ago", in approximately July 2005, the patient had 50-100 "sack field" lesions. It was noted that the patient's sibling had been vaccinated with varicella virus vaccine live. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 12-year-old patient who on 03-AUG-2005 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Lot# 647242/0895N) and on an unspecified date in August 2005 with a second dose of varicella virus vaccine live. The RN reported that on 15-AUG-2005 the patient developed a rash. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Pruritus
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 18-year-old white female who on 26-JUL-2005 at 15:30 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot# 647951/0892P). On 11-AUG-2005 to 14-AUG-2005 the patient complained of a headache and itching (Itching also reported to have began on 15-AUG-2005). It was reported that her mother noticed pox on 14-AUG-2005. On 17-AUG-2005 the patient was seen by a physician and had approximately 20 lesions on her body. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a male who in August 2005 was vaccinated SC with a 3.5 mL dose of varicella virus vaccine live (Oka/Merck). The physician reported that in August 2005, the patient developed a case of full blown chickenpox characterized by approximately 300-500 lesions. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health care professional concerning a female patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient did not seroconvert. It was noted that at the time of the report the patient had not recovered. No other information was provided.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Rhinorrhoea
Clinical narrative: Information has been received from a nurse practitioner (NP) and registered nurse (RN) concerning a 32-year-old female who with no allergies who on 21-JUL-2005 was vaccinated SC in the left upper arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot #649740/0221R). Concomitant therapy included albuterol. There was no illness at the time of vaccination. The NP reported that on 11-AUG-2005, the patient developed a rash characterized by about 50 lesions on her trunk and extremities. On 15-AUG-2005, the patient also developed a low fever and runny nose. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. On 19-Aug-2005, the patient's vesicular rash resolved. At the time of this report, the outcome of the patient's low fever and runny nose was unknown. No other information is available.
Age: 1.12
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact, Pyrexia
Clinical narrative: Info has been received from an RN concerning a 7 year old white female with seasonal allergies and no pre-existing allergies, birth defects or medical conditions. and no known drug allergies who on 6/8/99 at 14:00 was vaccinated SC in the left arm with a 0.5ml, 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. There was no concomitant medications. On 8/19/05, at 09:00, also reported as 8/20/05, the pt presented to the physician's office with a 102 fever, a papular vesicular rash and complained of not feeling well and feeling "very lethargic". It was noted that the child was exposed to chickenpox and shingles in the community. No treatment for chickenpox was given, but the child was placed on Zyrtec at the time of the visit. Unspecified events following prior vaccinations. The outcome was reported as recovered on 8/27/05. No additional info is expected.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a physician and a mother concerning her approximately 18-year-old daughter (also reported as 19-year-old) with no allergies who in approximately 1999 (at 12 years of age) was vaccinated subcutaneously with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient "showed no immunity to the vaccine" following that dose. The patient was vaccinated with a second dose of varicella virus vaccine (Oka/Merck) on 25-JUN-2005. Concomitant therapy included ethinyl estradiol/Norgestimate (ORTHO TRI-CYCLEN LO). On 25-Jun-2005 the patient developed a "softball size induration at the injection site" characterized by a 3 inch diameter red, swollen circle which lasted until 29-JUN-2005. Medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 1.45
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Info has been received from a health professional concerning a 19 month old male with no known medical history or allergies who on 6/29/05 was vaccinated with a SC dose of varicella virus vaccine live (lot 646666/0066R). There was no concomitant medication. On 8/21/05, the pt broke out in a rash with approximately 30 lesions. On 8/22/05, the pt was seen by the physician. He was given acyclovir (Zovirax), 6 tsp. QID for 5 days. No lab or diagnostic tests were performed. At the time of the report, the pt was still on medication. There was no product quality complaint involved. The pt's rash with approximately 30 lesions was considered to be an Other Important Medical Event by the reporter. Additional info has been requested.
Age: 1.06
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 4 year old white male no allergies or medical history who on 8/15/02 was vaccinated with a dose of varicella virus vaccine live at a shot clinic. Concomitant medication given on the same day at the shot clinic included: a dose of hepatitis B virus vaccine rHBsAg (yeast), a dose of MMRII and a dose of poliovirus vaccine inactivated. No illness was known at the time of vaccination. On 8/20/05, the pt was seen in the office with a mild case of chickenpox characterized by a generalized skin rash of less than 100 lesions noted trunkcally with mild upper respiratory symptoms (cough). No fever or other symptoms were noted. No diagnostic or lab tests were performed. It was noted that the symptoms started on the morning of 8/19/05. The pt was treated with Tylenol and Benadryl as needed. At the time of the report, the adverse event had not improved. A product quality complaint was not involved. Additional info has been requested.
Age: 0.98
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been received from a woman at a pediatrician's office concerning a 13-month-old male with no allergies or medical history who on 27-JUN-2005 was vaccinated in the right leg with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 649276/0899P). concomitant vaccination on the same day included a first dose in the left leg of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 648967/0232R). On 09-AUG-2005, the patient had greater than 60 lesions all over the upper body. There was a questionable fever at home. The adverse reaction was described as variant varicella. "OVX - 10-AUG-2005" was noted. The patient's vaccination administration and screening record indicated that the patient received in the left thigh a first, second, and third dose of diphtheria toxoid (+) pertussis acellular Biken, vaccine (+) tetanus toxoid (TRIPEDIA) on 26-AUG-2004 (lot # C1700AA), 26-OCT-2004 (lot # C204AA), and 04-JAN-2005 (C2103AA). The patient received a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) on 09-SEP-2004 (lot # 647482/0026P) in the right anterior thigh and 15-NOV-2004 (lot # 649039/0356P) in the left thigh. The patient received a first and second dose of poliovirus vaccine inactivated (Vero) (IPOL) on 09-SEP-2004 (lot # X1038) in the left anterior thigh and 26-OCT-2004 (lot # X1191) in the left thigh. The patient received a first, second, third, and fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRMC 97) (PREVNAR) on 26-AUG-2004 (lot # 495-707) in the left thigh, 15-NOV-2004 (lot # A67180A) in the right thigh, 04-JAN-2005 (lot # A74400E) in the right thigh, and 27-JUN-2005 (lot # A94440B) in the left thigh. Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Drug ineffective, Infection, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 3-year-old patient who was vaccinated with a 0.5 mL dose of VARIVAX (Oka/Merck).  The RN reported that on approximately 23-MAY-2005, the patient developed a mild case of breakthrough chickenpox characterized by about 20 lesions. Unspecified medical attention was sought. Subsequently, the patient recovered from mild breakthrough chickenpox.  Follow-up info from the RN indicated that she was unable to remember details regarding this particular patient.  Additional information is not expected.  This is in follow-up to report(s) previously submitted on 5/12/2006.  Information has been received from a registered nurse concerning a 16-month-old female who on the morning of 19-NOV-2004 was vaccinated SC in the right arm with the first 0.5 mL dose of VARIVAX (Oka/Merck) (Lot #647717/0192P).  The RN reported that on 01-APR-2005 (also reported as approximately 23-MAY-2005), the patient developed a mild case of breakthrough chickenpox characterized by about 20 lesions.  The patient had a fever of 100.7F which lasted 1 1/2 days.  Unspecified medical attention was sought.  There were no other complications noted.  Subsequently, the patient recovered from mild breakthrough chickenpox.  Additional information is not expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 3-year-old patient who was vaccinated with a 0.5 mL dose of VARIVAX (Oka/Merck).  The RN reported that on approximately 23-MAY-2005, the patient developed a mild case of breakthrough chickenpox characterized by about 20 lesions. Unspecified medical attention was sought. Subsequently, the patient recovered from mild breakthrough chickenpox.  Follow-up info from the RN indicated that she was unable to remember details regarding this particular patient.  Additional information is not expected.  This is in follow-up to report(s) previously submitted on 5/12/2006.  Information has been received from a registered nurse concerning a 16-month-old female who on the morning of 19-NOV-2004 was vaccinated SC in the right arm with the first 0.5 mL dose of VARIVAX (Oka/Merck) (Lot #647717/0192P).  The RN reported that on 01-APR-2005 (also reported as approximately 23-MAY-2005), the patient developed a mild case of breakthrough chickenpox characterized by about 20 lesions.  The patient had a fever of 100.7F which lasted 1 1/2 days.  Unspecified medical attention was sought.  There were no other complications noted.  Subsequently, the patient recovered from mild breakthrough chickenpox.  Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an NP concerning a 10 year old male who in 10/97, was vaccinated, SC with a 0.5 mL dose of varicella virus vaccine live (lot 624063/0958F). "Recently", in approximately 8/05, the pt presented with chickenpox with about 40 lesions. The pt was not experiencing a fever or any other illness. Unspecified medical attention was sought. There was no product quality complaint involved. Additional info has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 9 year old male with no medical history who on 6/22/59, at 3 years of age, was vaccinated, SC, with a 0.5 mL dose of varicella virus vaccine live (Lot 629901/0116J). There was no illness at the time of vaccination. The physician reported that on 8/18/05, the pt presented to the office with chickenpox characterized by lesions all over his body. No lab/diagnostic tests were performed. As of 8/22/05, the pt was noted to be recovering as his lesions persisted, but he had no fever and felt fine. Additional info has been requested.