chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 year-old male patient who was vaccinated in another state (according to the patient's parent) with a dose of varicella virus vaccine live (Lot number not available). The reporter noted the patient now (17-Dec-2003) has chicken pox. No additional information was provided. There was no product quality complaint reported. Follow-up information was received from a licensed practical nurse who reported the patient was seen in the physician office when he was visiting the area. The licensed practical nurse reported that there were no laboratory or diagnostic tests performed in the physician office. She indicated that no further information is available. Unspecified medical attention was sought. No additional information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Rash pustular
Clinical narrative: Information has been received from a registered nurse concerning a 10 year-old female patient with no known allergies who on 09-Oct-1997 was vaccinated in the left deltoid with a first dose of varicella virus vaccine live (Lot #623510/0694E). The registered nurse indicated the patient's mother reported that the patient has chicken pox with classic pustules on her trunk, which have been spreading for several days. It was noted the patient was not seen by the physician and there were not tests performed. The reporter noted, the patient is getting better at this point. Follow-up information received from the registered nurse reported the patient recovered with no problem. No other information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a licensed practical nurse concerning a female employee who in April 2003 was vaccinated with a first dose of varicella virus vaccine live (lot #643536/0801M). On 12-May-2003 the patient was vaccinated with a second dose of varicella virus vaccine live. On 03-Dec-2003 a titer was drawn and revealed that the client had failed to seroconvert. Unspecified medical attention was sought and it was unknown if a prescription drug was required. A product quality complaint was not involved. The nurse also reported another female employee who had a similar experience after therapy with varicella virus vaccine live (WAES #0312USA02283). Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a consumer concerning her 7 year old white daughter with no past medical history who on 04-Sep-1997 was vaccinated with a first dose in the left thigh (lot 622748/0422EE) of varicella virus vaccine live. It was also reported that the patient "had prior Varivax 9/1/1996". Concomitant therapy included multi-vitamins (unspecified). On 17-Dec-2003 the patient broke out in a varicella rash. On the morning of 18-Dec-2003 the mother counted about 35 chicken pox lesions. The child's doctor prescribed acyclovir for treatment. No product quality complaint was involved. Follow up information from a physician indicated that the patient had a mild rash consistent with varicella and that the patient recovered. No labs or diagnostic tests were done. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician's assistant concerning a 22 year old Caucasian female cardio technician with no allergies and no past medical history who on 21-Dec-1995 and 30-Jan-1996 was vaccinated with a first and second 0.5 ml dose of varicella virus vaccine live, respectively. Subsequently, the reporter was performing a pre-employment physical on the patient. On 16-Dec-2003, a varicella titer was negative for IgG antibody. On 16-Dec-2003, the patient was positive for rubella IgG antibody and measles IgG antibody. Unspecified medical attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Blister, Drug ineffective, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old female who on 28-May-1999 was vaccinated SC with a 0.5 ml first dose of varicella virus vaccine live. Concomitant vaccinations on the same day included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a third dose of HIB conj vaccine (OMP) (manufacturer unknown), a third dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, and a third dose of poliovirus vaccine inactivated (IPOL). On 15-Dec-2003, the patient developed breakthrough chickenpox with less than 50 lesions and a low grade fever. No diagnostic laboratory tests were performed. Unspecified medical attention was sought and a prescription drug was not required. It was noted that therapy with varicella virus vaccine live was "discontinued." A product complaint was not involved. Follow-up information including an "official shot record" was received from the registered nurse which indicated that on 15-Dec-2003 the patient developed a rash on her trunk and back which was noted to be "coming in crops." The patient had a slight fever and a runny nose. Lesions were present and one had a blister and one had a scab. The patient reported itching. The patient was instructed on varicella. The official shot record indicated that on the 11-Nov-1997 and 20-Jan-1998 the patient received a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and on 06-Aug-2003 received a third 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). On 20-Jan-1998 and 31-Mar-1998 the patient received a first and second dose of HIB conj vaccine (OMPC) (manufacturer unknown). On 20-Jan-1998, 31-Mar-1998, and 06-Aug-2003 the patient received at first, second, and fourth dose of poliovirus vaccine inactivated (IPOL). On 20-Jan-1998, 31-Mar-1998, and 06-Aug-2003, the patient received a first, second, and fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. On 06-Aug-2003 the patient received a second dose of measles mumps rubella vaccine and a first dose of hepatitis A virus vaccine inactivated (manufacturer unknown). Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash, Rhinorrhoea, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old female who on 28-May-1999 was vaccinated SC with a 0.5 ml first dose of varicella virus vaccine live. Concomitant vaccinations on the same day included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, a third dose of HIB conj vaccine (OMP) (manufacturer unknown), a third dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, and a third dose of poliovirus vaccine inactivated (IPOL). On 15-Dec-2003, the patient developed breakthrough chickenpox with less than 50 lesions and a low grade fever. No diagnostic laboratory tests were performed. Unspecified medical attention was sought and a prescription drug was not required. It was noted that therapy with varicella virus vaccine live was "discontinued." A product complaint was not involved. Follow-up information including an "official shot record" was received from the registered nurse which indicated that on 15-Dec-2003 the patient developed a rash on her trunk and back which was noted to be "coming in crops." The patient had a slight fever and a runny nose. Lesions were present and one had a blister and one had a scab. The patient reported itching. The patient was instructed on varicella. The official shot record indicated that on the 11-Nov-1997 and 20-Jan-1998 the patient received a first and second dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown) and on 06-Aug-2003 received a third 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown). On 20-Jan-1998 and 31-Mar-1998 the patient received a first and second dose of HIB conj vaccine (OMPC) (manufacturer unknown). On 20-Jan-1998, 31-Mar-1998, and 06-Aug-2003 the patient received at first, second, and fourth dose of poliovirus vaccine inactivated (IPOL). On 20-Jan-1998, 31-Mar-1998, and 06-Aug-2003, the patient received a first, second, and fourth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. On 06-Aug-2003 the patient received a second dose of measles mumps rubella vaccine and a first dose of hepatitis A virus vaccine inactivated (manufacturer unknown). Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus, Skin ulcer
Clinical narrative: Information has been received from a mother, and Occupational Therapist, concerning her eight year-old son, who at the age of one year was vaccinated with a dose of varicella virus vaccine live. The mother reported that her son was diagnosed with chicken pox on 11-Dec-2003. She also reported that her son was afebrile, had 15 lesions on his body and 10 on his head. I was noted the patient had been taking diphenhydramine hydrochloride (Benadryl) and had been using "lotion" to decrease the itching. No additional information was available. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a licensed practical nurse concerning a female employee who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the patient failed to seroconvert. The nurse also report another female employee who had a similar experience after therapy with varicella virus vaccine live (WAES #0312USA02131). Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Infection, Pyrexia, Rash vesicular, Skin ulcer
Clinical narrative: Information has been requested from a physician concerning a 37-year-old (also reported as 35) male emergency room employee with no medical history and no known varicella zoster virus exposure who on 01-Dec-2003 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 17-Dec-2003 the patient developed chickenpox with greater than 250 lesions (also reported as 150-300) all over his body (also reported as occurring 19 days post vaccination). The lesions were vesicular with a red ring around them. It was noted that the patient also had a fever. Unspecified medical attention was sought and no treatment was required. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Feeling abnormal, Malaise, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 12-year-old white female with no allergies and no medical history who on 05-Dec-2003 at 14:25 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot # 645045/0208N). There was no concomitant medication. There was no illness at the time of vaccination. On 05-Dec-2003, within five minutes of vaccination, the patient stated that her arm "felt weird," itched, and a small red area was noted. The patient was offered diphenhydramine hydrochloride (Benadryl) as needed. Unspecified medical treatment was sought and a prescription drug was not required. A product quality complaint was not involved. Follow-up information was received from the registered nurse which indicated that on 05-Dec-2003 at 14:40, the patient complained of the injection site feeling "weird" and that it itched. The patient denied difficulty breathing or lip/tongue swelling. The patient was observed for 15 minutes and there was no change. On 22-Dec-2003 the mother called stating that the patient never broke out in a rash, but felt ill. No diagnostic laboratory tests were performed. The patient recovered from the itching and the arm feeling weird on 05-Dec-2003. Subsequently, the patient recovered from feeling ill. It was noted that neither the patient or her sibling had any adverse reactions following prior vaccination. No further information is expected. The nurse also reported that the patient's 3-year-old brother developed chickenpox on 19-Dec-2003 (WAES #0401USA00004). It was noted that the vaccinated sibling had no symptoms and that the disease was currently in the local schools and community. It was also noted that the patient's physician never saw the brother.
Sex: U
Vaccine: VARCEL
Symptoms: Cellulitis, Infection, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated on 17-Jul-1996 with a dose of varicella virus vaccine live. The patient was recently exposed to a wild-type virus and developed a breakthrough case of chickenpox. There were not many lesions present but the lesions were larger than usual. The physician reported that the patient's case of chicken pox was mild. The patient also developed a cellulitis of the left arm which consisted of a zone of redness 3 cm across. The patient was treated with amoxicillin (+) clavulanate potassium (Augmentin) po and had since recovered. According to the reporter, the location where the varicella virus vaccine live was administered was not indicated in the patient's chart. Unspecified medical attention was sought. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner concerning a 7-10 year old white male who was vaccinated with a dose of varicella virus vaccine live. In November 2003, "years after vaccination" the patient developed breakthrough varicella lesions. The case was mild and required no treatment and no hospitalization. The patient was seen by a physician to diagnose. Subsequently, the patient recovered. Additional information has been requested.
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 white male with no known medical history or allergies who on 14-Jun-1995 was vaccinated with a first dose of varicella virus vaccine live (lot #608655/0417B). On 17-Oct-2003 the patient developed varicella, which required a doctor's visit. Subsequently the patient recovered. No further information is expected.
Age: 3.08
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 37 month old white female with no medical history and no allergies who on 13-Nov-2001 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (lot #639128/0567L). On 13-Nov-2001 the patient was also vaccinated subcutaneously in the right arm with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #639570/0698L). There was no illness at the time of vaccination. On 22-Dec-2003 the patient developed a moderate case of the chicken pox. Unspecified medical attention was sought and no treatment was required. Subsequently, the patient recovered. No product quality complaint was involved. No further information is expected.
Age: 6.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Abdominal pain upper, Diarrhoea, Drug ineffective, Infection, Pain
Clinical narrative: Information has been received from a registered nurse concerning a six year-old white male patient with reactive airway disease and allergies (date of onset unknown) who on 26-Aug-1998 was vaccinated with a dose of varicella virus vaccine live (Lot #624722/1325E). Concomitant vaccines administered on 26-Aug-1998 included a fourth dose of HIB conj vaccine (CRM 197) (HIBTITER) (lot number M195RF), and a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #625227/159E). The registered nurse reported that the patient experienced breakthrough chickenpox after receiving varicella virus vaccine live. Additional information from the registered nurse indicated that the event onset was on 31-Oct-2003 at an unknown time. She also indicated the patient was seen on the day number three (03-Nov-2003) after the first eruption with vesicular lesions all over his trunk and scalp. The nurse reported the patient did not have a tympanic temperature or upper respiratory symptoms, but he did complain of some stomach ache and had some diarrhea on day number one, as well as "LL pain" times 2-3 hours, and itching. The registered nurse reported there were no laboratory or diagnostic tests performed, and the patient had no known reactions from prior vaccinations. It is unknown as to whether the patient was ill at the time of vaccination. The patient recovered, however the exact date of recovery is unknown. The registered nurse reported, "she does not really have any additional information". There was no product quality complaint reported. Unspecified medical attention was sought. The registered nurse also mentioned that several pediatric patients also had a similar experience following vaccination with varicella virus vaccine live. No additional information is expected.
Age: 6.0
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a six year-old white male patient with reactive airway disease and allergies (date of onset unknown) who on 26-Aug-1998 was vaccinated with a dose of varicella virus vaccine live (Lot #624722/1325E). Concomitant vaccines administered on 26-Aug-1998 included a fourth dose of HIB conj vaccine (CRM 197) (HIBTITER) (lot number M195RF), and a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #625227/159E). The registered nurse reported that the patient experienced breakthrough chickenpox after receiving varicella virus vaccine live. Additional information from the registered nurse indicated that the event onset was on 31-Oct-2003 at an unknown time. She also indicated the patient was seen on the day number three (03-Nov-2003) after the first eruption with vesicular lesions all over his trunk and scalp. The nurse reported the patient did not have a tympanic temperature or upper respiratory symptoms, but he did complain of some stomach ache and had some diarrhea on day number one, as well as "LL pain" times 2-3 hours, and itching. The registered nurse reported there were no laboratory or diagnostic tests performed, and the patient had no known reactions from prior vaccinations. It is unknown as to whether the patient was ill at the time of vaccination. The patient recovered, however the exact date of recovery is unknown. The registered nurse reported, "she does not really have any additional information". There was no product quality complaint reported. Unspecified medical attention was sought. The registered nurse also mentioned that several pediatric patients also had a similar experience following vaccination with varicella virus vaccine live. No additional information is expected.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a female health care student in her early twenties who in 2001 was vaccinated with a first and second dose of varicella virus vaccine live. The reporter indicated that the patient now shows a negative titer. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Rash maculo-papular, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 9 year-old white male patient with reactive airway disease, who on 22-Dec-1995 vaccinated with a dose of varicella virus vaccine live (Lot number reported as unknown). On 17-Dec-2003 the patient experienced 20-30 macular, papules and one scabbed lesion on arms and trunk. The patient was treated with symptomatic care. The reporter mentioned the patient's sibling had chicken pox two weeks prior. It was noted that the patient has two siblings. The registered nurse reported the patient recovered. It was noted that no laboratory or diagnostic tests were performed. It was also noted, that it is unknown as to whether the patient had an illness at the time of vaccination, and unknown whether he had adverse events following prior vaccinations. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Infection, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male who on 18-Jan-1997 was vaccinated with a dose of varicella virus vaccine live (lot #619273/1357D). Subsequently, the patient developed a case of breakthrough varicella/chicken pox with a fever of 99.9 degrees F, pruritis, and a pox-like rash all over his back, chest, arms and legs. Unspecified medical attention was sought and the patient was treated symptomatically with calamine and diphenhydramine (Benadryl). No product quality complaint was involved. On 10-Feb-2004 the registered nurse reported that she does not remember who the patient was. The patient was not seen in the office. The nurse had received a phone call from the patient's mother reporting break through chicken pox. No additional details of the adverse event can be provided. It was also reported by "someone in the office" that a 4 year old female was diagnosed with breakthrough varicella "10 days ago". There was no vaccination information available for this patient. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, Ocular hyperaemia
Clinical narrative: Information has been received from a radiology technician concerning a female who on 29DEC2003 splashed (also described as "sprayed") varicella virus vaccine live into her right eye. It was noted that the eye was red. Treatment included eye irrigation at an eye wash station x 20 minutes. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a physician concerning a 13-month old female who on 25-Nov-2003 was vaccinated with a 0.5 ml first dose of varicella virus vaccine live (lot #646239/0592N). There as no concomitant medication. On 16-Dec-2003 the patient developed chickenpox. It was noted that prescription drug treatment was not required. Subsequently, the patient recovered from chickenpox. No further information is expected.
Age: 6.0
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old female with no past medical history and no known drug allergies who on 07Dec1998 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a dose of Hib conj vaccine (manufacturer unknown) and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There were no other concomitant medication. On 29Dec2003 the pt developed 35 pox. The pt experienced itching but no fever and her mother noted that she was active. No treatment was provided. Unspecified medical attention was sought. There was no product quality complaint. No laboratory or diagnostic tests were performed. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 20 year old adult white female with no known drug allergies who on 03Jan03 and 10Feb03 was vaccinated SC in the left arm with the first and second doses of varicella virus vaccine live. There was no known illness at the time of vaccination. Concomitant therapy that day included a dose of (ENGERIX B) administered IM in the right deltoid. No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection, Infection transmission via personal contact
Clinical narrative: Information has been received from a RN concerning a 3 year old male who's 12 year old female sibling was vaccinated with a dose of varicella virus vaccine live on 05Dec2003. On 19Dec2003 the pt developed chickenpox. It was also noted that the disease was currently in the local schools and community. The pt's vaccinated sibling had no symptoms. Additional information was received from the RN which indicated that the pt broke out in chickenpox on 19Dec2003. The reporter indicated that the pt's pediatrician said that it was from the vaccines. It was noted that the pt and his sibling had no adverse events following prior vaccination. Follow up information was received from the RN who indicated that the pt did not received varicella virus vaccine live. The pt contracted chickenpox allegedly from his sister who received the vaccine. It was noted that the pt was never seen at the Doctors office. No further information is expected. The reporter also indicated that the pt's 12 year old sister had an adverse experience after therapy with varicella virus vaccine live.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a medical assistant concerning a 9 year old female who on 27Nov98 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox. The pt was see at the doctors office by the physician and no fever was noted. There was no product quality complaint involved. The reporter indicated that two other pt's had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a medical assistant concerning an 11 year old male who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced chickenpox. It was reported that six of his classmates came down with chickenpox and as a result the pt developed chickenpox. He was covered from head to toe with lesions. He was seen by the physician and prescribed acyclovir (ZOVIRAX) and ibuprofen (ADVIL). There was no product quality complaint involved. The reporter indicated that the pt's brothers and two other pt's had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old male who on 30Jul1998 was vaccinated with a dose of varicella virus vaccine live. It was reporter that the school the pt attends had a chickenpox breakout. On approximately 13Nov03 and had approximately 25 to 50 lesions with some pustules already scabbed over. Treatment with cephalexin (KEFLEX) for any secondary infection was given. As of 19Nov03 the pt was recovering. There was no product quality complaint involved.  The reporter indicated that the pt's brother's and two other pt's had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old male who on 27Oct2000 was vaccinated with a dose of varicella virus vaccine live. The school the pt attends had a chickenpox breakout and on approximately 13Nov03 the pt broke out with five to seven chickenpox lesions. Unspecified medical attention was south and as of 19Nov03, the pt was recovering. There was no product quality complaint involved. The reporter indicated that the pt's brothers and two other patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning a 20 year old female employee who on 16Feb1999 and 22Mar1999 was vaccinated with a first and second dose of varicella virus vaccine live. One lot number was reported to be 628694/1663H, however the dose corresponding to this lot number was not specified. It was reported that the pt had an inconclusive low titer to varicella despite the two dose and that there was a vaccine failure. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old white male who on 16Aug2000 was vaccinated in the RQ with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that the pt's father called the office to report that the pt had red pimples with vesicles consistent with the chickenpox. They began on 30Dec2003, were on the trunk, head and back and were itchy. The pt was not seen in the office, but chickenpox protocol advice was given. No labs or diagnostic tests were done. Follow up information from the doctors office indicated that the pt recovered with no problems. No additional information is expected.
Age: 5.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer concerning her 5 year old white son with a penicillin allergy and a history of varicella exposure from his brother on 16Nov03 who on 19Jul1999 was vaccinated IM with a first dose of varicella virus vaccine live. Concomitant therapy included a first dose of IM of measles-mumps-rubella vaccine. There was no illness at the time of vaccination. On 30Nov03, at 08:00, the pt broke out in chickenpox. It was reported that there were about 150 lesions. There were no diagnostic tests or labs done. Subsequently, the pt recovered on 04Dec2003. Additional information has been requested.
Age: 1.83
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a RN concerning a 22 month old pt with no medical history and no allergies who on 03Feb03 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 27Dec2003 the pt began development of symptoms of herpes zoster. The symptoms were described as being a seeping, oozing rash that started on the left hand and traveled up the arm and shoulder and went to the midline. The rash was described as being "without itch" and the pt did not have a fever. Medical attention was sought and the pt was written a prescription for acyclovir for treatment and was instructed to follow up as needed. No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN  concerning a 10 year old white male student with a history of chronic otitis media who on 05Feb1998 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live. At the time of vaccination the pt had a left otitis media and was started on sulfamethoxazole (+) trimethoprim (BACTRIM). There were no adverse events following prior vaccinations. On 30Dec03 the pt presented to the physician's office with a history of a blister type rash that had started at 08:00. He also had vomiting and diarrhea x2 days. He was afebrile. The pt had over 100 lesions that were primarily located on his torso. He was diagnosed with chickenpox and treated with diphenhydramine (BENADRYL) and acetaminophen (TYLENOL), PRN. Treatment also included isolate and no aspirin. No diagnostic lab tests were performed. There were no noted complications. On 06Jan2004 the pt recovered and returned to school. No product quality complaint was involved. No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 6 year old female pt who on 16Jul99 was vaccinated with a dose of varicella virus vaccine live. On 05Jan04 the pt experienced breakthrough case of mild chickenpox. The pt had 12-15 lesions, itchy rash and no treatment. It was noted that the outcome was not recovered at the time of the report. The physician also indicated that there is another chickenpox breakthrough case but he did not have any information at the time of the report. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a RN concerning a 9 year old female pt with no allergies and no past medical history who on 19Jul1995 was vaccinated in the left leg with first dose of varicella virus vaccine live. Concomitant vaccination on 19Jul95 included a first dose in the right leg of Hib conj vaccine (PROHIBIT). There was no illness at the time of vaccination. On 19Jul95, a tuberculin purified protein derivative was place and had a negative result. On 26Dec03, the pt was evaluated by a physician and had multiple vesicles and papules on her trunk, back and scalp. The pt recovered seven days after the outbreak. No other laboratory tests were performed. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 4 year old female who two years ago, in approximately 2002, was vaccinated with a dose of varicella virus vaccine live. On 06Jan2004, it was reported that the pt now has a slight varicella virus. Unspecified medical attention was sought. No additional information was provided. The physician may not be contacted. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 5 year old female pt who in approximately January 2003, was vaccinated with a dose of varicella virus vaccine live. One year later on approximately 06Jan2004, the pt developed a viral rash with a few vesicular lesions. Unspecified medical attention was sought. At the time of the report, the experience has not abated. A product quality complaint was not involved. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 25Jun1997 was vaccinated with a single 0.5ml dose of varicella virus vaccine live. On 05Jan04 it was reported that recently the pt broke out with chickenpox. Her body was covered with lesions, especially on her chest. Unspecified medical attention was sought and the patient was being treated with diphenhydramine (BENADRYL) and colloidal oatmeal bath (AVEENO). It was reported that the pt has not recovered. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of varicella virus vaccine live and also developed chickenpox. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from an occupational health nurse concerning a 31 year old female employee with no known allergies and no pertinent medical history who in 2001 was vaccinated with a first and second dose of varicella vaccine live. A titer was drawn in December 2003 and it was noted that the pt failed to seroconvert. The reporter also indicated that the pt was vaccinated at another facility. Unspecified medical attention was sought and it was unknown if treatment was required. A product quality complaint was not involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 11Jul2000 was vaccinated with a varicella virus vaccine live. On 26Dec2003 the pt was diagnosed with shingles. The pt sought unspecified medical attention. It was noted that the pt was not hospitalized. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Nasal congestion
Clinical narrative: Information has been received from a physician concerning her son who on 22Dec1999 was vaccinated with a dose of varicella virus vaccine live. On approximately 07Jan2004 the pt developed a chickenpox like rash of about 100 pox and mild nasal congestion. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Nasal congestion, Rash vesicular
Clinical narrative: Information has been received from a physician concerning her 9 year old daughter who on 03JUL1997 was vaccinated with a dose of varicella virus vaccine live. On 07JUN2004, the physician reported that her daughter developed a chickenpox like rash with about 80 pox and nasal congestion over the last 48 hours. No medical attention was sought and a prescription drug was not required. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a certified medical assistant concerning a male patient who was vaccinated with a dose of varicella virus vaccine live. Two weeks post vaccination, the patient developed hives on his trunk. Unspecified medical attention was sought, but prescription drug treatment was not required. Within five days, the hives resolved. A product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash maculo-papular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a male patient between the age of 5 and 11 years old who was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live. Subsequently, the patient developed breakthrough varicella. The case was mild with few lesions. The lesions started out maculopapular and slowly became vesicular. Unspecified medical attention was sought, but prescription drug treatment was not required and laboratory tests were not performed. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. The reporter also mentioned three other patients who each developed breakthrough varicella post vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a mother concerning her 8 year old daughter with no medical history who, at 12 months of age, was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant therapy. The patient's mother reported that her daughter subsequently developed a mild case of breakthrough varicella characterized by 19 lesions. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. Subsequently, the patient recovered. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash macular, Rash pruritic, Viral infection
Clinical narrative: Information has been received from a registered nurse RN concerning a 12 year old female with no pertinent medical history and no known allergies who on 06JAN2004 was vaccinated with the first dose of varicella virus vaccine live. The RN reported that on 08JAN2004, the patient developed breakthrough chickenpox characterized by a somewhat itchy rash with macular vesicles on her face, back arms and legs. The patient was noted to be afebrile. Unspecified medical attention was sought, but it was unknown if treatment was required. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old white female with a history of asthma who on 07FEB2000 was vaccinated in the "RQ" with a second dose of varicella virus vaccine live. There was no illness at the time of vaccination. ON 18DEC2003 the patient presented to the office with a red raised rash on her back, chest, face and eyes. It was noted that her brother had shingles three weeks ago. The patient was diagnosed with chickenpox. The patient was sent to an eye doctor due to pox in the eye. No diagnostic laboratory tests were performed. Subsequently, the patient recovered (date of recovery was not available). No further information is expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash erythematous, Rash pruritic, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old white male with a history of premature birth (35 weeks) and asthma who on 13MAR2000 was vaccinated SC in the LQ with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that on 30DEC2003 the patient's father called the office and reported an outbreak of varicella at his son's daycare. The patient had tow red spots on his chest and complained of itchiness. On 31DEC2003 the patient had a few more spots consistent with varicella. Some had scabbed over. No diagnostic laboratory tests were performed. The nurse indicated that the patient recovered with no incident. No further information is expected.
Age: 3.5
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a registered nurse concerning a 46 month old male who on 08FEB2001 was vaccinated with a dose of varicella virus vaccine live. The RN reported that a titer drawn on 17DEC2003 revealed the patient failed to seroconvert. Unspecified medical attention was sought, but it was unknown if treatment was required. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a health professional concerning a 14 year old  male child with no known medical history or allergies who on 19FEB2003 at 13:00  was vaccinated SC in the deltoid  with a first dose of varicella virus vaccine live (lot # 642994/0566M). The patient's three siblings were vaccinated the same day. He presented on 01NOV2003 completely covered with chickenpox. It was reported that two of his siblings (WAES #0311USA01047 and 0401USA00639) also developed chickenpox. The reported expressed a concern with the lot. Unspecified medical attention was sought. There was no product quality complaint involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Follow-up information indicated that the on 02-Nov-2003 (previously reported on 01-Nov-2003) the patient broke out into a rash which had now spread. No fever, cough or vomiting were noted. He denied headache or abdominal pain. The patient's sister (0401USA00639) had chickenpox for a few weeks and his littler brother (0311USA01047) also had chickenpox. No mouth lesions were noted. Small vesicular lesions in various stages were noted, classic appearing pox. The patient was given hydroxyzine hydrochloride (Atarax) (10mg/5cc) 2 teaspoons every 6 hours prn. Subsequently the patient recovered. The patient received additional vaccinations on 22-Jan-2003 at 13:17 which included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live which was given SC in the thigh, a first dose of diphtheria toxoid (+) tetanus toxoid given IM in the thigh, a first dose of poliovirus vaccine inactivated (unspecified) which was given SC in the deltoid and a first dose of hepatitis virus vaccine (unspecified) given IM in the thigh. No further information is expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Drug ineffective, Pruritus, Pyrexia, Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a health professional concerning an 11 year old female who on 19FEB2003 at 13:00 was vaccinated SC in the deltoid with a first dose of varicella virus vaccine live. The patient's three siblings were vaccinated the same day. On approximately 30SEP2003 she had full blown chickenpox and was treated with acyclovir. It was reported that two of her siblings  (WAES#0311USA01047 and 0401USA005383) also developed chickenpox. The reporter expressed a concern with the lot. Unspecified medical attention was sought. There was no product quality complaint involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released.  Follow-up information indicated that the patient was seen on 08-Jun-2003 and she developed a rash and fever on 07-Jun-2003 (previously reported as approximately 03-Sep-2003), some cough and minimal runny nose were noted. It was noted that all the patient's vaccinations were up to date and she had no immune disorders. Lesions were classic dew drop appearance and disseminiated throughtout her body with a few in her oral cavity and oral pharynx. No secondary infection was noted. Lesions were in various stages and were vesicular in nature, because of the severity of her rash and her age the patient was started on acyclovir 800 mg QID for 5 days. She was also given hydroxyzine hydrochloride (Atarax) 25mg q 6 hours for itching. Subsequently the patient recovered. The patient received additional vaccinations on 22-Jan-2003 at 13:37 which included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live which was given SC in the thigh, a first dose of diphtheria toxoid (+) tetanus toxoid given IM in the thigh, a first dose of poliovirus vaccine inactivated (unspecified) which was given SC in the deltoid and a first dose of hepatitis virus vaccine (unsepcified) given IM in the thigh. No further information is expected.