chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 27-AUG-1998 was vaccinated with a dose of Varivax. Subsequently, on 09-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 12-MAY-1999 was vaccinated with a dose of Varivax. Subsequently on 08-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 20-MAY-1999 was vaccinated with a dose of Varivax. Subsequently, on 18-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 30-JUL-1999 was vaccinated with a dose of Varivax. Subsequently, on 16-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 21-SEP-1999 was vaccinated with a dose of Varivax. Subsequently, on 23-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 15-OCT-1999 was vaccinated with a dose of Varivax. Subsequently, on 08-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 09-NOV-1999 was vaccinated with a dose of Varivax. Subsequently, on 18-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 13-DEC-1999 was vaccinated with a dose of Varivax. Subsequently, in March 2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. Thee was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 01-MAR-2000 was vaccinated with a dose of Varivax. Subsequently, on 18-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 06-APR-2000 was vaccinated with a dose of Varivax. Subsequently, on 15-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 27-APR-2000 was vaccinated with a dose of Varivax. Subsequently, on 20-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 07-AUG-2000 was vaccinated with a dose of Varivax. Subsequently, on 21-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 01-SEP-2000 was vaccinated with a dose of Varivax. Subsequently, on 27-FEB-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 21-SEP-2000 was vaccinated with a dose of Varivax. Subsequently, on 21-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 17-OCT-2000 was vaccinated with a dose of Varivax. Subsequently, on 23-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 10-MAY-2001 was vaccinated with a dose of Varivax. Subsequently, on 26-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 26-FEB-2002 was vaccinated with a dose of Varivax. Subsequently, on 13-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 26-AUG-1999 was vaccinated with a dose of Varivax. Subsequently, on 28-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 30-JAN-1997 was vaccinated with a dose of Varivax. Subsequently, on 15-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 6 year old patient who was vaccinated with a dose of Varivax. "Last year", the patient developed shingles. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a 10-year-old male who was vaccinated with a dose of Varivax. Subsequently, the patient experienced "a lot of soreness in the arm after injection". Unspecified medical attention was sought and the physician indicated that everything was fine after ibuprofen and a cold pack. No further information was available at the time of this report. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Body temperature, Pruritus, Rash, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 month old male who on 03-AUG-2006 was vaccinated in the left arm with a first dose of Varivax (lot # 652803/0262F). Concomitant vaccination on the same day included a fourth dose in the right thigh of PREVNAR (lot # B08651E), a first dose in the right arm of MMRII (lot # 653751/0499F), and a first dose of VAQTA (lot # 653616/0201F). The patient was seen on 24-AUG-2006 by the physician for a rash times two days. There was no fever. The patient was possibly itchy. The lesions were noted to have started on 22-AUG-2006. There were vesicular lesions on the buttocks, hands, a few on the trunk, and one on the right ear. Ears, nose and throat were clear. The neck was supple without nodes. Chest was clear to auscultation and percussion. The heart had a regular rhythm without murmur. The abdomen was normal. Mild varicella after vaccine was noted. No further information is expected.
Age: 1.2
Sex: M
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 month old male who on 03-AUG-2006 was vaccinated in the left arm with a first dose of Varivax (lot # 652803/0262F). Concomitant vaccination on the same day included a fourth dose in the right thigh of PREVNAR (lot # B08651E), a first dose in the right arm of MMRII (lot # 653751/0499F), and a first dose of VAQTA (lot # 653616/0201F). The patient was seen on 24-AUG-2006 by the physician for a rash times two days. There was no fever. The patient was possibly itchy. The lesions were noted to have started on 22-AUG-2006. There were vesicular lesions on the buttocks, hands, a few on the trunk, and one on the right ear. Ears, nose and throat were clear. The neck was supple without nodes. Chest was clear to auscultation and percussion. The heart had a regular rhythm without murmur. The abdomen was normal. Mild varicella after vaccine was noted. No further information is expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Diabetes mellitus, Rash maculo-papular, Rash vesicular
Clinical narrative: Information has been received from a pediatric office concerning an 8 year old female who on 18-AUG-1999 was vaccinated in the left arm with a first dose of Varivax (lot # 631168/0710J). Subsequently the patient developed about 15-16 spots of macular papular vesicular lesions over the body. All lesions were in different stages; 5-6 over the face, 4-5 over right arm, 1-2 over left arm and 2 over medial thighs. At the time of the report, the "disease was in progress". Additional information included the following adverse experiences: diabetes 02-FEB-2006. The patient's immunization history was provided and included: first, second and third doses of ACEL-IMUNE and first, second and third doses of HIBTITER on 24-SEP-1998, 23-APR-1999 and 04-JUN-1999, respectively; first and second doses of poliovirus vaccine inactivated (unspecified) on 24-SEP-1998 and 23-APR-1999 and a first dose of hepatitis B virus vaccine (manufacturer unknown) on 15-JUL-1998 and a second and third dose of hepatitis B virus vaccine on 19-AUG-1998 (lot #624815/1221E) and 04-JUN-1999 (lot #630470/0213J), respectively. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning an 8 year old male who, "6 years ago," in approximately 2000, was vaccinated with a dose of Varivax. "Two years after receiving the vaccination," in approximately 2002, the patient developed a severe case of varicella, which resulted in the patient being hospitalized. The number of lesions was not specified. The length of the hospitalization was unknown. It was noted that the event improved. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Eye swelling, Sneezing, Throat irritation, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male who was vaccinated with Varivax on approximately 23-AUG-2006. Within a minute after varicella administration, the patient experienced sneezing, swollen eyes, itchy throat and hives. The patient was seen by the physician on 30-AUG-2006 and most of the patient's symptoms were gone. No laboratory tests were performed. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her sister, a 12 year old female who was vaccinated with Varivax. After the first dose of Varivax, the patient "broke out in chickenpox spots all over; there were quite a few." The consumer stated that the patient was taken back to the physician for follow-up. The patient's chickenpox spots persisted. No further information is available.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Diet refusal, Fatigue, Pyrexia, Varicella
Clinical narrative: Information has been received from a physician concerning his 10 year old granddaughter who has no known allergies or pertinent medical history, who on 08-AUG-1997 was vaccinated with a dose of Varivax. There was no concomitant medication. ON 23-AUG-2006 the patient developed a breakthrough case of chickenpox. The rash was described by the patient's mother to be at least 20 pox, which progressed from papular to vesicular mostly on the torso (groin are) and scalp. The patient complained of itching, developed a low grade fever, was tired, and "did not eat". The patient presented to the physician's office and was prescribed ATARAX which was not needed, topical hydrocortisone cream and 4 teaspoons qid for 5 days of acyclovir suspension. The patient was also advised to use AVEENO bath. On 06-SEP-2006 the patient recovered. It was also reported that both the patient's father and grandfather are physicians. There was no product quality complaint involved. The patient's sister (WAES # 0609USA00973) had a similar experience after vaccination with Varivax. Additional information from the nurse indicated that no further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Anorexia, Body temperature increased, Fatigue, Pyrexia, Rash papular
Clinical narrative: Information has been received from a physician concerning his 7 year old granddaughter who has no known allergies or pertinent medical history who on 20-SEP-2000 was vaccinated with a dose of Varivax. There was no concomitant medication. On 05-SEP-2006 the patient developed a breakthrough case of chickenpox. The rash was described by the patient's mother as 8 pox with progressed from papular to vesicular. It was reported that the patient also had a low grade fever of 99.2, was tired and lost her appetite. It was reported that the patient did not see a physician, though bother her father and grandfather are physician's, and that she did not receive any medication. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient's sister (WAES # 0609USA00942) had a similar experience following vaccination with Varivax. Additional information from the nurse indicated that there is no further information available
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Varicella
Clinical narrative: Information has been received from a physician concerning his 7 year old granddaughter who has no known allergies or pertinent medical history who on 20-SEP-2000 was vaccinated with a dose of Varivax. There was no concomitant medication. On 05-SEP-2006 the patient developed a breakthrough case of chickenpox. The rash was described by the patient's mother as 8 pox with progressed from papular to vesicular. It was reported that the patient also had a low grade fever of 99.2, was tired and lost her appetite. It was reported that the patient did not see a physician, though bother her father and grandfather are physician's, and that she did not receive any medication. At the time of the report the patient had not recovered. There was no product quality complaint involved. The patient's sister (WAES # 0609USA00942) had a similar experience following vaccination with Varivax. Additional information from the nurse indicated that there is no further information available
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 10-year-old male with a milk allergy and a history of reactive airways disease who on 26-OCT-1996 was vaccinated SC in the left arm with a first 0.5mL dose of Varivax (Lot # 617695/0776D). There was no illness at the time of vaccination. Concomitant therapy that day included a first dose of MMR (Lot # 618613/0469D) administered SC> There were no other concomitant medication. On 05-SEP-2006 the patient presented to the physician's office with an itchy rash all over his body (face, back, and groin area). He was treated with BENADRYL and CALAMINE LOTION. The patient's itchy rash persisted. There were no lab diagnostic studies performed. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 05-SEP-2006 the patient developed 100-200 lesions on his face, back, chest, and groin. He was given symptomatic treatment. The outcome was recovered. No additional information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Rash erythematous, Rash papular, Varicella
Clinical narrative: Information has been received from a physician concerning a 7 year old female, with no medical history and no allergies, who on 26-JUN-2007 was vaccinated once with a 0.5 ml dose of Varivax (Lot# 635207/0075K). There was no concomitant medication. It was noted that the patient had a possible exposure in school to varicella. on 05-SEP-2006 the patient experienced greater than 50 lesions initially appearing on her abdomen which had then spread to her body. The appearance of the rash was an erythematous papular rash progressing to pustules in various stages. No other systemic symptoms were noted. The patient was diagnosed clinically with breakthrough varicella, but was not laboratory confirmed. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The reporter expressed concern about the lot. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot let the requirements and was released. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Rash erythematous, Rash papular, Varicella
Clinical narrative: Information has been received from a physician concerning a 10-year-old female with no pertinent medical history or allergies, who on 26-JUN-2006 was vaccinated with a second 0.5 ml dose of Varivax (lot# 635207/0075K). It was noted that the first dose of the vaccine had been given 5 to 6 years earlier. There was no concomitant medication and it was reported that the vaccine had been stored at the correct temperature. On 05-SEP-2006, possibly following exposure to varicella at school, the patient experienced a breakthrough rash, less than 50 lesions. The rash was described as erythematous and papular and progressing to pustules. Unspecified medical attention was sought and the patient was clinically diagnosed with varicella; no laboratory or diagnostic studies were performed. At the time of the report the patient had not recovered. No product quality complaint was involved. The reporter requested more information on the lot number. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an 8 year old female, with no medical history and no allergies, who on 26-JUN-2000 was vaccinated once with a 0.5 ml dose of Varivax (Lot# 635207/0075K). There was no concomitant medication. On 05-SEP-2006 the patient presented with breakthrough rash with more than 50 lesions. It was noted that the patient was still developing more. At the time of the report the patient had not 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. The reporter expressed concern about the lot. A lot check was requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements and was released by the regulatory agency. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 12 month old patient on an unspecified date was vaccinated SC with a 0.5 ml first dose of Varivax. Subsequently, in the last year, the patient developed a breakthrough case of "mild" chickenpox. Medical attention was sought and unspecified therapy was used. Subsequently the patient recovered. No further information was available There was no product quality complaint involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received fro a consumer concerning her 6 year old female daughter who on 13-APR-2001 was vaccinated with a dose of Varivax (lot # 635192/1133K). About eleven days ago, on approximately 27-AUG-2006 the patient developed chickenpox. About 9 days after the first lesions developed, all of the lesions seemed to clear. Eleven days from when the rash first started, more lesions seemed to form. The lesions were found on her face, back and stomach. No other symptoms were noted. Medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from the mother of a 32 month old male with no pertinent medical history or drug reactions/allergies, who, in March 2005, was vaccinated with Varivax. Additional vaccines (not specified) were given). On 02-SEP-2006, the boy experienced chicken pox. The patient developed 10 lesions. There was no fever or any other symptoms. No laboratory testing was performed. The patient had not recovered. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 9-year-old male who in approximately 1998, "eight years ago" at "the age of one year", was vaccinated SC with a 0.5mL dose of Varivax. On approximately 02-SEP-2006, the patient developed 50-100 lesions. The patient did not have a fever. The physician did not mention location of lesions and did not provide the lot number. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a 0.5 ml dose of Varivax on an unspecified date. Subsequently, a few months after vaccination, the patient developed chickenpox. Unspecified medical attention was sought. No outcome status was reported. no product quality complaint was involved. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old black female with no allergies or medical history who on 24-APR-2006 and28-JUN-2006 was vaccinated SC in the left upper arm with a two doses adult series of Varivax (lot numbers 649734/0789R and 652552/0022F respectively).There was no illness at the time of vaccination. on 31-AUG-2006, the patient tested negative for seroconversion for varicella at less than 0.91. At the time of the report, the patient had not recovered. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the nurse who reported that there was no adverse event. It was noted that the patient had a hepatitis B surface antibody screen of less than 3.0 mU/mL and inconsistent with immunity. The patient's vaccination status with hepatitis B virus vaccine was not known.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a 30-year-old adult black female with an allergy to fish who on 10-NOV-2000 and 11-DEC-2000 was vaccinated with the first (SC in the right upper arm) and second (SC in the left upper arm) adult doses of Varivax (lot # 635204/0072K). There was no illness at the time of vaccination. In September 2006, the patient tested for seroconversion to varicella. Medical attention was sought. There was no product quality complaint involved. There were no other adverse events. No additional information is expected.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her 15-year-old daughter who on an unspecified date was vaccinated subcutaneously with a second 0.5 ml dose of Varivax. Subsequently, the patient experienced chickenpox two weeks after vaccination. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. It was reported that the patient recovered after 5 days. No product quality complaint was involved. The patient's siblings also had adverse experiences following vaccination (WAES# 0609USA04120 and 0609USA04903). Additional information has been requested.
Age: 1.4
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Blister, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 16 month old white male, with a history of eczema and no known drug allergies, who on 01-SEP-2006 was vaccinated with a first dose of Varicella (Lot# 653434/0563F). Concomitant vaccination, administered on the same day, included a first dose of Hib conj vaccine (Lot# 652867/0084F). There was no illness at the time of vaccination. "A few days after the vaccination", on approximately 03-SEP-2006, the patient developed 8 clear to yellow blisters on his face and trunk. It was reported that the patient also experienced a low-grade fever for a few days. At the time of the report the patient was recovering. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a health professional indicated that on 12-SEP-2006 the patient developed 20-30 vesicles on his face legs and trunk. It was noted that TYLENOL and calamine was to be given. Subsequently the patient recovered. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old male who, "at age one, about 7 years ago", in approximately 1999, was vaccinated with a 0.5 ml dose of Varivax. In the "past couple of days", on approximately 10-SEP-2006, the patient developed chickenpox. The number of lesions was unknown. Unspecified medical attention was sought. No product quality complaint was involved.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a male child ranging in age from 6 to 12, who in the past 2 weeks was vaccinated subcutaneously with a second dose of Varivax. Following vaccination the child experienced a hard nodule from his elbow to his upper arm, as well as redness and warmth around the injection site. Medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a pharmacist concerning an 8-year-old patient who was vaccinated with a dose of Varivax. Subsequently the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint. No other information was known. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Incorrect route of drug administration, Injection site reaction, Mean cell haemoglobin, Streptococcal identification test negative
Clinical narrative: Information has been received from a physician concerning a 5 year old male with asthma who on 01-FEB-2002 was vaccinated in the right arm with a 0.5 mL IM first dose of Varivax (lot # 640090/1147L). There was no illness at the time of vaccination. On 10-APR-2006 the patient developed shingles at the injection site on the right arm. A doctors visit was required. On approximately 10-APR-2006 a CBC was performed, the patient's MCH was low at 25.8 pg. A strep test was negative. A urinalysis was performed, the results were not reported. The patient was treated with acyclovir (ZOVIRAX). On 17-APR-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Urine analysis
Clinical narrative: Information has been received from a physician concerning a 5 year old male with asthma who on 01-FEB-2002 was vaccinated in the right arm with a 0.5 mL IM first dose of Varivax (lot # 640090/1147L). There was no illness at the time of vaccination. On 10-APR-2006 the patient developed shingles at the injection site on the right arm. A doctors visit was required. On approximately 10-APR-2006 a CBC was performed, the patient's MCH was low at 25.8 pg. A strep test was negative. A urinalysis was performed, the results were not reported. The patient was treated with acyclovir (ZOVIRAX). On 17-APR-2006 the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a pharmacist concerning a male who was vaccinated with a dose of Varivax. Subsequently the patient developed a generalized mild rash 10 days after vaccination. No other symptoms were noted. No additional information was available. Unspecified medical attention was sought. There was no product complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: Information has been received from a medical assistant concerning an approximately 5-year-old female who was with a dose of Varivax. The medical assistant reported that the patient subsequently experienced an adverse event. The medical assistant also reported that the patient's sibling developed a red, itchy rash after being vaccinated with Varivax (WAES #0607USA00676). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 28-month-old male with no pertinent medical history and no drug reactions/allergies who in approximately May 2005, between 12 and 15-months of age, was vaccinated SC with a 0.5mL dose of Varivax. There was no concomitant medication. On 28-AUG-2006 the patient developed a low fever and vesicular lesions on his left thigh. Over the next week, the child developed hundreds more lesions (almost all of which were fluid filled). The lesions seemed to follow multiple dermatomes on the left thigh and buttock, with some lesions crossing midline. The physician felt that this was an atypical presentation of shingles. The patient was hospitalized and has not been released. The outcome was reported as recovering. No other information was available. There was no product quality complaint. Follow up information received from a healthcare worker indicated that the physician had no additional information to add to this report. The reporter considered the event to be an other important medical event. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a child who in approximately August 2006, was vaccinated with Varivax. In approximately September 2006, the patient developed a rash approximately 24 lesions. Follow up information indicated that the school nurse did not have any more details, and would not have any more information. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning an elderly patient who on 18-SEP-2006 was vaccinated with Varivax instead of Zostavax. The "mix-up" occurred when the pharmacy sent up the Varivax instead of the Zostavax that had been ordered and it was administered to the patient. No additional information was provided.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse (R.N.) her 16-year-old son who was vaccinated with a second dose of Varivax. Subsequently, the patient experienced cellulitis. No further information was available at the time of this report. The patient's sisters also had adverse experiences following vaccination (WAES# 0609USA02450 and 0609USA04903). Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with no known drug allergies, who, on 18-NOV-1998, was vaccinated subcutaneously in the left arm with a dose of Varivax. There was no concomitant medication. On 15-SEP-2006 the patient presented to the doctor's office with varicella 10 to 20 lesions, clear pustules, no fever. Patient outcome was not reported. No further information is available.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female with no known drug allergies who on 02-AUG-2006 was vaccinated with Varivax (Lot #652078/0940R) 0.5 mL subcutaneously. Concomitant therapy included lisinopril and "water pill" (therapy unspecified). On 21-AUG-2006 the patient developed a red, raised rash to the arms, legs, chest and face. Subsequently, the patient recovered from the red, raised rash to the arms, legs, chest and face. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a pharmacist concerning an adult female employee who "about a month ago" on approximately 19-AUG-2006 was vaccinated with her first dose of Varivax and experienced a generalized rash. She missed one week of work but had since returned to work. As of 19-SEP-2006, the patient's rash resolved and no lesions were present. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male who on 13-NOV-2002 was vaccinated with Varivax. In December 2002, the patient experienced shingles. Subsequently, the patient recovered from shingles. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a school nurse concerning a 4 year old male who was vaccinated with Varivax. On approximately 14-SEP-2006, the patient experienced breakthrough chickenpox with red dots on his ankles. The patient sought unspecified medical attention. No treatment was recommended. No further information available.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning her 15-year-old daughter who on an unspecified date was vaccinated with a second dose of Varivax. Subsequently, the patient experienced cellulitis after vaccination. It was unspecified if medical attention was sought. No outcome was reported. The patient's sibling also had adverse experiences following vaccination (WAES# 0609USA04120 and 0609USA02450). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a female employee who was vaccinated "in the past" with Varivax by another health care professional. In 2006 a recent varicella titer was negative for seroconversion. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who in September 2006 was vaccinated with a dose of Varivax instead of a dose of Zostavax. The patient had no symptoms. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a medical assistant concerning an 8 year old male with an allergy to amoxicillin who on 06-OCT-1998 was vaccinated in the right arm with a first dose of Varivax (Lot# 626970/0850H) (diluent LOT # 627257/0926H). There was no illness at the time of vaccination. On 11-SEP-2006 the patient had no fever. It was reported that "several classmates" were sent home with chickenpox. On 20-SEP-2006 the patient recovered. No further information was available. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Abdominal pain, Body temperature increased, Headache, Inappropriate schedule of drug administration, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female with a swelling reaction to procaine hydrochloride (Novocain) who on 30-AUG-2006 in the morning was vaccinated with a 0.5 mL SC first dose of Varivax (lot # 652630/0247F). Concomitant vaccination that day included a SC second dose of MMR II (lot # 649759/0383R), a first dose of Daptacel (lot # C2491AA) and a fifth dose of Engerix-B (lot # AHBUB258BA). There was no illness at the time of vaccination. On 08-SEP-2006 the patient developed more than 50 lesions and itching. It was reported that she developed a generalized chickenpox rash over her entire body, in hair and mouth. She had a fever, headache and abdominal pain. The patient went to the emergency room but was not admitted. Subsequently, the patient recovered. There was no product quality complaint involved. It was reported that prior to vaccination the patient had a varicella titer that was negative. Additional information is not expected.
Age: 27.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Pyrexia, Seroconversion test negative, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 27 year old female with a swelling reaction to procaine hydrochloride (Novocain) who on 30-AUG-2006 in the morning was vaccinated with a 0.5 mL SC first dose of Varivax (lot # 652630/0247F). Concomitant vaccination that day included a SC second dose of MMR II (lot # 649759/0383R), a first dose of Daptacel (lot # C2491AA) and a fifth dose of Engerix-B (lot # AHBUB258BA). There was no illness at the time of vaccination. On 08-SEP-2006 the patient developed more than 50 lesions and itching. It was reported that she developed a generalized chickenpox rash over her entire body, in hair and mouth. She had a fever, headache and abdominal pain. The patient went to the emergency room but was not admitted. Subsequently, the patient recovered. There was no product quality complaint involved. It was reported that prior to vaccination the patient had a varicella titer that was negative. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of Varivax. Subsequently the patient experienced an injection site reaction which was reported to be a "severe local reaction". No specifics of the reaction were known. Unspecified medical attention was sought. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Injection site reaction, Ultrasound scan
Clinical narrative: Information has been received through a pregnancy registry from a physician and a 28 year old white female with no known allergies or pertinent medical history and a history of one full-term birth and no history of birth defects, stillbirth, or miscarriage who on 25-JUL-2006 and 22-AUG-2006 was vaccinated with a first and second dose of VARIVAXx (lot# 653360/0361F) respectively. Concomitant therapy included ZYRTEC and FLOVENT. It was noted that the patient was not tested for varicella antibodies before vaccination. Subsequently, "right after the second dose," the patient discovered that she was pregnant. The date of her last menstrual period was 14-JUL-2006 and her estimated date of delivery is 22-MAY-2007. It was reported that an ultrasound was performed, results were not provided. On an unspecified date in approximately July 2006 the patient developed a local reaction at the vaccination site. No further information was available. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2007;5/16/2008. Follwup information was received froma aregistered nurse indicted that the patient had a normal pregnancy and delivery. The patient and the baby were both doing well. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning a female who's daughter was vaccinated with a dose of Varivax on 19-APR-1996. It was reported that the patient's daughter developed chickenpox on 02-APR-2006 (WAES# 0604USA00617) which she then transmitted to her. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in the third grade who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in the fourth grade who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in the second grade who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in kindergarten who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in the first grade who was vaccinated with a dose of Varivax. On 01-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a  health professional concerning a patient in kindergarten or first grade who was vaccinated with a dose of Varivax. On 02-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in kindergarten or first grade who was vaccinated with a dose of Varivax. On 02-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in Kindergarten or first grade who was vaccinated with a dose of Varivax. On 02-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in the sixth grade who was vaccinated with a dose of Varivax. On 31-MAR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in the sixth grade who was vaccinated with a dose of Varivax. On 05-APR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in kindergarten who was vaccinated with a dose of Varivax. On 01-APR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in eighth who was vaccinated with a dose of Varivax. Subsequently the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a patient in eighth grade who was vaccinated with a dose of Varivax. Subsequently the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in seventh grade who was vaccinated with a dose of Varivax. Subsequently the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in second grade who was vaccinated with a dose of Varivax. Subsequently the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in first grade who was vaccinated with a dose of Varivax. On 10-APR-2006 the patient experienced chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a patient in sixth grade who was vaccinated with a dose of Varivax. On 18-APR-2006 the patient experienced chickenpox. Additional information has been requested.