chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Sepsis, Skin ulcer
Clinical narrative: Information has been received from a woman in a physicians office concerning a 34 month old male with no known medical history or allergies who on 19Aug03 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot645052/0204N). Concomitant vaccination that day included a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot645146/0060N) in the right thigh. There was no illness at the time of vaccination. On 27Jun05 at 11:20am the pt was seen in the office with greater than 50 lesions throughout his entire body. The pt complained of red, raised bumps all over his body for one week with watery discharge and slight crusty, dryness. The pt had increased itching and a slightly runny nose. The pt was afebrile and rapid strep was positive. Treatment included anti itch cream and diphenhydramine hydrochloride (Benadryl). There was no product quality complaint involved. The pt's vaccination history included: A first, second, third and fourth dose in the left thigh of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (Daptacel) on 16Oct02 (U0583DA), 03Jan03 (lotU0849DA), 05Mar03 (lotU0852AA), and 28Oct03 (lot C1606AA), respectively. A first, second and third dose in the right thigh of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine on 16Oct02 (lot643661/0723M), 03Jan03 (lot643884/0741M) and 28Oct03 (645708/0284N), respectively. A first, second and third dose in the left thigh of poliovirus vaccine inactivated (Ipol) on 16Oct02 (lot W0063), 03Jan03 (lotW0332), 28Oct03 (lotX0148), respectively. A first, second, third and fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197)(PREVNAR) on 16Oct02 (lot489-752) in the right thigh, 03Jan03 (lot 485-991) in the right thigh, 05Mar03 (lot 490-909) in the right thigh, and 19Aug03 (lot 491-193) in the left thigh. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 4 yr old female with asthma and no drug reactions/allergies who on 28Jan02 was vaccinated with a dose of varicella virus vaccine live (lot639435/0789L). On 17Jul05 the pt developed chickenpox breakthrough, described as approx 50 lesion in her vagina, mouth and all over. The child had no fever. She was treated with comfort measures as needed. Unspecified medical attention was sought. There was no product quality complaint. It was noted that the mother of the pt has cancer and was being treated with chemotherapy at the time of the report. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a health professional concerning a white 5 yr old healthy female with no allergies or medical history who on 15Jul05, at approx 9:00AM, was vaccinated in the left arm with a second dose of varicella virus vaccine live (lot 651042/0214R). There was no illness at the time of vaccination. On 16Jul05 the pt developed pink bumps on her face. Now, on approx 19Jul05 the pt had fluid filled blisters that are itchy. No treatment was prescribed at this time. Unspecified medical attention was sought. The pt is not recovered. No product quality complaint was involved. Follow up information has been received from the physician which indicated that 4 days after the vaccine, on 19Jul05, the pt developed an itchy, blistered rash. About 15 lesions in total on the face and trunk. It was noted that the pt's mother was told it was chickenpox. The pt did not come to the office for any further evaluation. No laboratory tests were performed and the pt recovered on an unk date. It was reported that the first dose of varicella virus vaccine live was received on 30Nov00. Additional information is not expected.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 34 month old pt who on 19Aug03 was vaccinated with a dose of varicella virus vaccine live (644558/1156M). Subsequently the pt experienced breakthrough. On 14Jul05 the child developed a rash that looked like bug bites. There were 100+ vesicular lesions. Unspecified medical attention was sought. Treatment was calamine lotion, baking soda baths and diphenhydramine hydrochloride (Benadryl). At the time of the report the pt was recovering. There was no product quality compliant involved. Additional information has been requested.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Medication error
Clinical narrative: Information has been received from a RN concerning a 14 month old female pt who on 19Jul05 was vaccinated with varicella virus vaccine live (lot 646675/0710N), which was expired. The pt returned for lab work, six weeks later on 13Sep05 (also reported as 23Sep05), which indicated a non immune status/titer was negative, the pt did not seroconvert. The pt was re-vaccinated on 19Oct05 with varicella virus vaccine live. The reporter mentioned no adverse reactions were observed, there were no serious criteria and medical intervention was not needed. There was no product quality complaint reported. The pt sought unspecified medical attention. No additional information has been requested.
Age: 1.53
Sex: F
Vaccine: VARCEL
Symptoms: Chronic lymphocytic leukaemia, Drug ineffective, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 9 yr old female pt, who on 09Sep97 was vaccinated SC in the right arm with a first dose with a 0.5mL dose of varicella virus vaccine live (lot622757/0348E). It was noted that the pt had no known illness at the time of vaccination. On 18Jul05 the pt presented with less than fifty lesions and no fever. The physician diagnosed clinical chicken pox (also reported as breakthrough varicella). There were multiple vesicles in various stages. The pt was treated with diphenhydramine (Benadryl) and mineral oil (+) petrolatum (Aquaphor). The pt recovered from the clinical chickenpox. There was no product quality complaint reported. Follow up information received was from a nurse at the reported responsible physician's office. She stated, the pt's chart is not in their office so it must have been years since she was seen. No other information was available regarding the adverse event or the pt's outcomes. Information received on 30Aug05 contained the following adverse experience: acute lymphocytic leukemia (All) onset 10Jun98. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash pruritic, Skin ulcer, Swelling
Clinical narrative: Information has been received from a RN concerning a 5 year old white female with no known drug allergies who on 23Apr01 was vaccinated SC with a first dose of varicella virus vaccine live (lot637671/1609K). Concomitant vaccination on the same day included a SC first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot637434/1513K). There was no illness at the time of vaccination. On 08Jul05, the pt had a rash on the entire body per her mother. It was described as very itchy. All had white centers. There were a few on the fingers which were bigger and blistered and swelled up more than the other ones did. Per the mother, all told the pt had 300 plus lesions over one week. No diagnostic lab tests were performed. The pt recovered on 15Jul05. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 26 month old male pt with no allergies or pertinent medical history, who on 11May04 was vaccinated SC with a first dose of varicella virus vaccine live (lot647521/1108N). It was varicella virus vaccine live (lot647521/1108N). It was noted the pt was not ill at the time of vaccination. On 13Jul05 a rash appeared, it was reported to be a chickenpox breakthrough. It is unk as to whether the pt had a fever. The pt presented to the office on 19Jul05 with less than 50 vesicular looking lesions. The pt's treatment was to watch for fever. There were no lab tests performed. At the time that this information was reported, the pt was not recovered. There was no product quality complaint reported. Follow up information was received from a RN who reported that the pt had been seen in the office on 19Jul05 for four suspicious spots on his leg and groin area. He had a low grade temp off and on one week prior. It was noted that he had been exposed to varicella two weeks prior. The pt recovered on 19 or 20Jul05. No additional information is expected. The reporter also mentioned that the pt's male sibling had chicken pox breakthrough following vaccination with varicella virus vaccine live (WAES0509USA01138).
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 yr old white female who on 18Sep00 was vaccinated with a first SC dose in the right arm of varicella virus vaccine live (lot 632727/0089K). It was reported that on 29Jun05 the pt developed an attenuated case of varicella while on vacation, and it was noted that it occurred two week after a known exposure. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 10 yr old white female, with no medical history and no allergies who on 24Nov95 was vaccinated with a first dose of varicella virus vaccine live (lot 610246/0444B). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that on 16Apr05 the pt experienced breakthrough chickenpox, during a middle school outbreak, that was described as mild with a total of 20 generalized bumps. The pt was afebrile. It was reported that the pt recovered. Medical attention was not sought. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 10 yr old white female, with no medical history and no allergies who was vaccinated with a first dose of varicella virus vaccine live (lot 648948/0895p). There was no illness at the time of vaccination and no adverse events following prior vaccination. In May 2005, the pt experienced breakthrough chickenpox, during middle school outbreak, described as a generalized mild rash. The pt was afebrile. There were no complications. It was reported that the pt recovered. Medical attention was not sought. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed mild breakthrough chickenpox. No other details were available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Rhinorrhoea, Sepsis, Skin ulcer
Clinical narrative: Information has been received from a physician concerning an 18 month old pt who, at 12 months of age, in approx Jan 2005, was vaccinated with a dose of varicella virus vaccine live. In July 2005, the pt experienced 30-40 lesions, a fever of 101F and a runny nose. The pt was seen in the office with the breakthrough on 19Jul05. The doctor cultured a lesion and it was positive for varicella. Unspecified medical attention was sought. No product quality complaint was involved. Outcome was unk. Additional information has been requested.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning an 18 month old pt who, at 12 months of age, in approx Jan 2005, was vaccinated with a dose of varicella virus vaccine live. In July 2005, the pt experienced 30-40 lesions, a fever of 101F and a runny nose. The pt was seen in the office with the breakthrough on 19Jul05. The doctor cultured a lesion and it was positive for varicella. Unspecified medical attention was sought. No product quality complaint was involved. Outcome was unk. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a consumer concerning her 12 month old son with no drug reactions and no allergies and with phenylketonuria who on 30Jun05 was vaccinated with a 0.5mL dose of varicella virus vaccine live. There was no concomitant medication. On 01Jul05 the pt experienced elevated blood levels. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 17 yr old male who in Sept 2004, was vaccinated with a 0.5ml dose of varicella virus vaccine live (lot647761/0097P). In varicella virus vaccine live (lot647761/0097P). In Sep2004, soon after the shot, the pt experienced a stiff neck, headache and fever. Unspecified medical attention was sought. The outcome is unk. No product quality complaint was involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Influenza like illness, Injection site erythema, Injection site mass, Injection site oedema
Clinical narrative: Information has been received from a health professional concerning a 28 yr old white female, with no reported medical history or allergies, who on 23Jun05, at 10:00AM, was vaccinated with a first dose in the left arm of varicella virus vaccine live (lot 648552/0113R). There was no illness at the time of vaccination and there were no reported adverse events following prior vaccination. It was reported that on 23Jun05 the pt developed an area about 3 inches in diameter at the injection site that was red, warm, hard and itchy for 4 days. The pt also had flu like symptoms, but it was noted that she had been flying at the same time. It was reported that the pt recovered. Medical attention was not sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 24Jun05, in the AM, the pt began to have flu like symptoms and her arm began to feel itchy. Then the site became warm and hard, about the size of a 50 cent coin. The symptoms lasted four days. On 22Jul05, at 8:45 AM the pt was vaccinated with a second dose in the right arm of varicella virus vaccine live (lot648297/0217R). It was noted that pt did not report adverse effects to the second dose of varicella virus vaccine live. Additional information is not expected.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus
Clinical narrative: Information has been received from a health professional concerning a 28 yr old white female, with no reported medical history or allergies, who on 23Jun05, at 10:00AM, was vaccinated with a first dose in the left arm of varicella virus vaccine live (lot 648552/0113R). There was no illness at the time of vaccination and there were no reported adverse events following prior vaccination. It was reported that on 23Jun05 the pt developed an area about 3 inches in diameter at the injection site that was red, warm, hard and itchy for 4 days. The pt also had flu like symptoms, but it was noted that she had been flying at the same time. It was reported that the pt recovered. Medical attention was not sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 24Jun05, in the AM, the pt began to have flu like symptoms and her arm began to feel itchy. Then the site became warm and hard, about the size of a 50 cent coin. The symptoms lasted four days. On 22Jul05, at 8:45 AM the pt was vaccinated with a second dose in the right arm of varicella virus vaccine live (lot648297/0217R). It was noted that pt did not report adverse effects to the second dose of varicella virus vaccine live. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a nurse practitioner concerning a 14 yr old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed 3 or 4 lesions. Unspecified medical attention was sought. Subsequently the pt recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.08
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 13 month old pt who on approx 19Jun05 was vaccinated with a dose of varicella virus vaccine live. On 19Jul05 the pt presented to the doctor's office with breakthrough. Thirty days post vaccination, approx 19Jul05, the pt experienced 5-6 lesions scattered around the body. The lesions were not only at the injection site. There was no fever present. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Rash maculo-papular, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 12 month old female who on 11Jul05 was vaccinated with a dose of varicella virus vaccine live (lot 648315/0072R). On 21Jul05 The pt broke out with 50 or more lesions. It was reported that most of the pox were maculopapular, but three were described as vesicular. The pt felt warm to the touch but it was unk if a fever was present. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Malaise, Rash vesicular
Clinical narrative: Information has been received from a RN concerning a 15 yr old female who was vaccinated with a dose of varicella virus vaccine live. On 08Jun05 the pt was seen at the health dept with various red spots (approx 25) behind the knees, along the waist at her back, few on her face. Initially the spots appeared as fluid filled papules then began to scab. The nurse practitioner said the spots looked "more like chiggers and the location on the body were along skin folds and underwear lines. However, it was reported that the pt was in bed all day not feeling well the day before. The parent was advised that the rash could represent varicella disease but cannot rule out other etiology such as insect bites and to consider the child contagious for at least 4-5 days until all of the area are scabbed over. The nurse also reported adverse events experienced by the child's siblings after receiving varicella virus vaccine live (WAES0507USA0715, 0507USA03558, and 0507USA03559). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning an approx 15 yr old female foster child who was vaccinated with a dose of varicella virus vaccine live. On approx 08Jun05 the pt developed a few pinpoint red spots scattered on her arms, face, and legs. The parent was advised that the symptoms could represent varicella disease but other etiologies can not be ruled out, therefore, to consider the pt contagious for 4-5 days, until all of the areas are scabbed over. No further information was available at the time of this report. The nurse also reported three siblings with adverse experiences after receiving a dose of varicella virus vaccine live (WAES0507USA03557, 0507USA03559, and 0507USA01715). Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Malaise, Rash papular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN and a mother concerning her 8 yr old daughter who was vaccinated with a dose of varicella virus vaccine live. On 08Jun05 the pt was seen at the health dept with approx 50 pinpoint red papules at differing stages scattered throughout her body. It was also noted that the girl had not been feeling well on 07Jun05. The mother was advised that the rash could represent varicella disease but other etiologies could not be ruled out, therefore, the child should be considered contagious for at least 4-5 days until all of the areas are scabbed over. The nurse also reported adverse experience of three siblings who had previously received a dose of varicella virus vaccine live (WAES0507USA01715, 0507USA03557, and 0507USA03558). Additional information has been requested.
Age: 1.16
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Cough, Dermatitis, Pyrexia, Rash
Clinical narrative: Information has been received from a RN concerning a 14 month old male with a history of a right club foot who on 18Jul05 was vaccinated SC in the left medial thigh with a first dose of varicella virus vaccine live (lot647952/0985P). Subsequently, on 22Jul05 the pt developed contact dermatitis characterized by a rash on his torso and foot (also reported as an unk number of lesions that are on his torso (front and back) as well as a blistered spot on his foot). Unspecified medical attention was sought. It was reported that he has been coughing but at the time of reporting and was febrile as well. The doctor suggested diphenhydramine hydrochloride (Benadryl), avena (Aveeno baths), dextromethorphan hydrobromide (+) guiafenesin (Robitussin DM) and acetaminophen (Tylenol) as needed. No product quality complaint was involved. Follow up information indicated that the rash had persisted for over one month before recovering on 26Aug05. Additional information is not expected.
Age: 1.16
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 14 month old male with a history of a right club foot who on 18Jul05 was vaccinated SC in the left medial thigh with a first dose of varicella virus vaccine live (lot647952/0985P). Subsequently, on 22Jul05 the pt developed contact dermatitis characterized by a rash on his torso and foot (also reported as an unk number of lesions that are on his torso (front and back) as well as a blistered spot on his foot). Unspecified medical attention was sought. It was reported that he has been coughing but at the time of reporting and was febrile as well. The doctor suggested diphenhydramine hydrochloride (Benadryl), avena (Aveeno baths), dextromethorphan hydrobromide (+) guiafenesin (Robitussin DM) and acetaminophen (Tylenol) as needed. No product quality complaint was involved. Follow up information indicated that the rash had persisted for over one month before recovering on 26Aug05. Additional information is not expected.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 20 yr old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced large red area with vesicles at the injection site. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Blister, Drug ineffective, Dysphonia, Erythema, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 4 yr old male with allergies to amoxicillin and azithromycin (Zithromax) and no medical history, who on 13Jun02 was vaccinated with a 0.5ml SC first dose in the left anterior lateral thigh of varicella virus vaccine live (lot640467/0971L). Concomitant vaccines administered on the same day included a first SC dose in the left deltoid of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot642439/0234M) and a fourth IM dose in the left anterior lateral thigh of Hib conj vaccine (Tet toxoid) (Acthib) (lotUA696AA). There was no other concomitant medication. It was reported that on 20Jul05 the pt experienced red areas and 12 blisters on his legs, arms and back with a fever of 101F. The pt was seen in the office on 22Jul05 and was diagnosed with varicella. He was treated with diphenhydramine hydrochloride (Benadryl) and acetaminophen (Tylenol). It was reported that the pt was recovering. No product quality complaint was involved. Follow up information from a health professional indicated that on 20Jul05 the pt began at the beach with a hoarse voice. The next day the pt developed red areas, possibly bug bites, as the day progressed more appeared and they started to look like blisters. There were about 12 total, on his arms, legs, cheek, and back. It was noted that the pt was scratching at the areas, and that his temp was 101. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 yr old male with allergies to amoxicillin and azithromycin (Zithromax) and no medical history, who on 13Jun02 was vaccinated with a 0.5ml SC first dose in the left anterior lateral thigh of varicella virus vaccine live (lot640467/0971L). Concomitant vaccines administered on the same day included a first SC dose in the left deltoid of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot642439/0234M) and a fourth IM dose in the left anterior lateral thigh of Hib conj vaccine (Tet toxoid) (Acthib) (lotUA696AA). There was no other concomitant medication. It was reported that on 20Jul05 the pt experienced red areas and 12 blisters on his legs, arms and back with a fever of 101F. The pt was seen in the office on 22Jul05 and was diagnosed with varicella. He was treated with diphenhydramine hydrochloride (Benadryl) and acetaminophen (Tylenol). It was reported that the pt was recovering. No product quality complaint was involved. Follow up information from a health professional indicated that on 20Jul05 the pt began at the beach with a hoarse voice. The next day the pt developed red areas, possibly bug bites, as the day progressed more appeared and they started to look like blisters. There were about 12 total, on his arms, legs, cheek, and back. It was noted that the pt was scratching at the areas, and that his temp was 101. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 15 month old female who at 12 months of age was vaccinated with a dose of varicella virus vaccine live. The physician reported that, at 15 months of age, the pt developed over 400 vesicles. It was noted that the pt had no other symptoms. Subsequently, the pt's vesicles resolved. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 yr old pt who was vaccinated with a dose of varicella virus vaccine live. In approx July 2005, recently, the pt experienced breakthrough varicella with a fever and a lot of lesions. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a LPN concerning a 39 month old female who on 08Apr03 was vaccinated in the left leg with a first dose of varicella virus vaccine live. Concomitant therapy that day included a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot644584/1014M) administered in the right leg. Vesicles started to erupt on 17Jul05. On 20Jul05 at 9:10AM, the pt developed greater than 50 papules to her face, trunk and extremities. No other symptoms were noted. Follow up information indicated that there was no known adverse sequelae at this time. No additional information is expected.
Age: 1.01
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a health professional concerning a 12 month old pt who on 30Jun05 was vaccinated with a dose of varicella virus vaccine live (lot549738/0120R). Subsequently the pt experienced breakthrough. On 13Jul05 the child developed a rash with white centers. Unspecified medical attention was sought. Treatment included calamine lotion, baking soda baths and diphenhydramine hydrochloride (Benadryl). At the time of the report the pt had not yet recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Coordination abnormal, Pyrexia, Rash papular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 12 month old male with no known medical history or allergies who on 15Jul05 was vaccinated in the left thigh with a 0.5mL dose of varicella virus vaccine live (lot649270/0987P). Concomitant vaccination that day included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 25Jul05 the pt developed lesions, a fever and ataxia. The pt's lesions were later described as a rash with papules, 2 on left arm, 2 on right arm and 4 on back. The pt's maximum temp was 101. There was no recent exposure to chickenpox. Unspecified medical attention was sought. IT was reported that the physician was going to obtain a specimen for identification. There was no product quality complaint involved. Follow up information indicated that a specimen was taken and sent to the lab on 27Jul05 (also reported as 26Jul05) from the 6 papular lesions on the pt's trunk and arms for the VZV identification program. The specimens arrived in the lab on 28Jul05 and B globin DNA was amplified from the capillary tubes. It was reported that the capillary specimen was negative for VZV, and the swab specimen was inadequate. The physician indicated that the pt did not have any vesicular lesions but she thought that the dried lesion would suffice. She stated that the pt is still ataxic but postulated that the child could have a post enterovirus ataxia. It was reported that there still has not been an LP, however that physician would share these results with the mother and neurologist. Additional information is not expected.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 41 yr old female with no known drug allergies who was vaccinated with a first and second dose of varicella virus vaccine live on 17Sep04 (lot645167/0442N) and 02Nov04 (lot648322/0117P), respectively. On 15Jul05 a titer was drawn and the pt had failed to seroconvert. It was reported that the pt had an outstanding medical history, other diagnosis, but the nurse did not state what they were. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 19 yr old female, with no pertinent medical history and no known allergies, who was vaccinated with first and second 0.5ml SC doses of varicella virus vaccine live on 18May05 and 15Jun05 respectively. Concomitant therapy included hormonal contraceptives (unspecified). It was reported that an antibody titer was drawn 2 weeks after the second dose of varicella virus vaccine live, on approx 29Jun05, with the results of some conversion, not enough. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 7 yr old male with seasonal allergies and anxiety who on 29Jul04 was vaccinated SC with a 0.5mL dose varicella virus vaccine live (lot646676/0711N). Concomitant therapy included Desloratadine (Clarinex) and escitalopram oxalate (Lexapro). The LPN reported that on 25Jul05 the pt developed a rash all over his body, but was noted to be afebrile. On 26Jul05, the pt was seen in the physician's office and a diagnosis of breakthrough chickenpox was made. No lab/diagnostic tests were performed. The pt was treated with acetaminophen (Tylenol), diphenhydramine HC1 (Benadryl) and calamine (+) pramoxine (Aveeno) baths. At the time of this report, the pt's breakthrough chickenpox persisted. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a physician concerning an 18 yr old healthy female with no drug reactions/allergies who on 12Mar97, at the age of 10, was vaccinated with a dose of varicella virus vaccine live. It was noted that the pt had a negative titer for varicella. The anti complement immunoglourescent titer for varicella was negative. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 14 month old male who was vaccinated once SC with a 0.5ml dose of varicella virus vaccine live. Last week, on approx 20Jul05, the pt experienced natural varicella. It was noted that he came into the office and had a mild case with a few lesions. No labs or diagnostic studies were done. No product quality complaint was involved. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Condition aggravated, Otitis media, Rash maculo-papular
Clinical narrative: Information has been received from a health professional concerning a 13 month old male with a history of bilateral ear tubes and no allergies who on 07Jun05 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live (lot648042/1134N). Concomitant vaccines that day included a dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR). There was no other concomitant medication. On 24Jul05 the pt experienced a raised red rash on his back, legs and arms. He was afebrile. He was seen on 26Jul05 with a diagnosis of rash and ear infection. Treatment included diphenhydramine hcl (Benadryl) for rash and azithromycin (Zithromax) for the ear infection. No labs were performed. At this time the pt had not recovered. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Herpes zoster, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician and a staff member from the pediatrician's office concerning a 7 year old white female who on 06Mar97 was vaccinated SC with a second dose of varicella virus vaccine live (617265/0566D). In May 1997, the pt experienced chickenpox. On 01Aug05 the pt was seen and diagnosed with herpes zoster. No product quality complaint was involved. Additional information has been requested.
Age: 1.59
Sex: M
Vaccine: DTAPH, IPV, VARCEL
Symptoms: Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 yr old male student with no medical history who on 25Jan00 was vaccinated in the right thigh with the first dose of varicella virus vaccine. Concomitant vaccinations on that same day included the third dose in the left thigh of poliovirus vaccine inactivated (Ipol) (lotP0904) and the fourth dose in the left thigh of diphtheria toxoid (+) Hib conj vaccine (tet toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Trihibit) (lotUA467AB/U0056DA). There was no illness at the time of vaccination. On 11Jul05, the pt developed a temp. The RN reported that on 13Jul05, at 10:00, the pt developed chickenpox characterized by between 80-100 spots. No office or hospital visits or lab/diagnostics tests were required and the pt was advised to treat the symptoms. On 20Jul05, the pt recovered from the chickenpox. The RN also reported that the pt's brother developed breakthrough after being vaccinated with varicella virus vaccine live (WAES0507USA04244). No further information is available.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 4 year old male student with an allergy to amoxicillin (AMOXIL) who on 14-AUG-2001 was vaccinated in the left arm with the first dose of varicella virus vaccine live (lot#637667/1606K). Concomitant vaccinations on that same day included the first dose in the right arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot#637834/0696L). There was no illness at the time of vaccination. The RN reported that on 15-JUL-2005, the patient developed breakthrough characterized by 60 - 100 spots. The patient was noted to be afebrile. No office or hospital visit or laboratory/diagnostic tests were required and the patient was advised to treat his symptoms. On 23-JUL-2005, the patient recovered from the breakthrough. The RN also reported that the patient's brother developed chickenpox after being vaccinated with varicella virus vaccine live (WAES0507USA04242). No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning a 1 year old female, with no medical history and no allergies, who on 13-JUL-2005 was vaccinated with a subcutaneous first dose of varicella virus vaccine live (Lot# 650226/1109P). Concomitant therapy included amoxicillin/clavulanate potassium (AUGMENTIN). On 26-JUL-2005 the patient had a breakthrough case. It was reported that the patient was recovering. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a male with no pertinent medical history and no drug reactions/allergies who on 01-OCT-1196 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Lot#617695/0776D). There was no concomitant medication, On 25-JUL-2005 the patient developed a breakthrough case of varicella. The child has about 30 lesions. No treatment was given. The outcome was reported as recovering. No lab diagnostic studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning her daughter a 5 year old female who on 11-JAN-2000 was vaccinated with a dose of varicella virus vaccine live. It was reported that "now", the patient had breakthrough chickenpox with more than 100 generalized lesions. The patient was afebrile. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with varicella virus vaccine live. The physician reported that about a year ago (approximately 2004) the patient appeared to have a case of full blown wild varicella. No testing was done. Subsequently, the patient recovered. No further information was available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Folliculitis, Viral infection
Clinical narrative: Information has been received from a physician concerning a 2 year old female who in approximately August 2003, was vaccinated with a dose of varicella virus vaccine live. In approximately August 2004, the patient developed what the physician believed to be shingles. It was reported that the patient was seen a few days later by another establishment and was diagnosed with folliculitis. The patient was treated with antibiotics. Subsequently, the patient recovered. It was noted that her older brother had not been vaccinated, but had wild chickenpox and developed shingles. There was no product quality complaint. Additional information is not expected.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 19 month old white male who on 29-DEC-2004 was vaccinated SC in the right thigh with the first dose of varicella virus vaccine live (Lot#645819/1055N). Concomitant therapy included budesonide (PULMICORT), albuterol and cetirizine HCl (ZYRTEC). The physician reported that on 21-JUL-2005 at 08:00, the patient developed a rash and diarrhea consistent with breakthrough varicella. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a female described as healthy and who has no known drug reactions or allergies who "about five years ago", in approximately 2000, was vaccinated with two doses of varicella virus vaccine live. Subsequently, "an IgG antibody test done four years was negative". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash pruritic, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male patient with no allergies or pertinent medical history, who on 17-JUL-2001 was vaccinated in the right leg (previously reported "PO") with a first dose of varicella virus vaccine live (Lot#635792/1893K). Concomitant vaccine therapy administered that day, 17-JUL-2001 included a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot # 637834/0696L) administered in the left leg. There was no other concomitant medication. The patient was not ill at the time of vaccination. On 26-JUL-2005, the patient developed breakthrough chickenpox, at least 75 lesions of the vesicular variety. He did not have a fever or chill. It was noted that the lesions were itchy but not painful. The patient recovered. There was no product quality complaint reported. Unspecified medical attention was sought.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 32 month old white female patient with no pre-existing allergies or medical conditions, who on 03-NOV-2005 was vaccinated with a first dose of varicella virus vaccine live. The patient was not ill at the time of vaccination. On 25-JUL-2005 the patient developed 50 plus multiple lesions in various stages on her trunk and arms. She was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEENO), diphenhydramine hydrochloride (BENADRYL) and mineral oil (LUBRIDERM Lotion). There were no laboratory tests performed. The patient did not have adverse events following prior vaccination. The patient recovered. No additional information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a co-workers 5 year old son who was vaccinated at the age of 18 months with a 0.5 mL SC dose of varicella virus vaccine live. Subsequently the patient developed breakthrough varicella. The patient was sick for 6 days and had over 50 lesions. Unspecified medical attention was sought. The patient subsequently recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 year old male with no medical history or allergies who on 06-SEP-2002 was vaccinated in the thigh with 0.5 mL IM (previously reported as SC) first dose of varicella virus vaccine live (lot# 643121/0548M). There was no concomitant medication. There was no illness at the time of vaccination. At 2 PM on 21-JUL-2005 the patient came to the office with a mild case of varicella (also described as breakthrough) with about 40 scattered lesions. There was no fever and did not receive any treatment. Unspecified medical attention was sought. At the time of the report the patient had recovered. There was no adverse event following prior vaccination. There was no product quality complaint involved. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 year old white female who on 07-JUN-2000 was vaccinated in the left upper arm with the first dose of varicella virus vaccine live (Lot# 632619/1861J). The NP reported that in 01-AUG-2005, the patient developed mild breakthrough varicella characterized by 20 - 30 vesicular lesions scattered among her chest and back with a few on her arms and legs. No other symptoms were noted (no fever or body aches) and the lesions were also noted to be non-pruritic. Unspecified medical attention was sought. Subsequently, the patient recovered from the breakthrough varicella. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a dose of varicella virus vaccine live. It was reported that the patient did not seroconvert after the initial vaccination, and that the physician would like to revaccinate. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Laboratory test abnormal, Rash pustular
Clinical narrative: Information has been received from a health professional concerning a 51 year old female with seasonal allergies, asthma, allergies to propoxyphene hydrochloride (DARVON) and tetanus and high cholesterol who on 02-APR-2005 was vaccinated with a first 0.5ml dose of varicella virus vaccine live. Concomitant therapy included fexofenadine hydrochloride (ALLEGRA), rosiglitazone maleate (AVANDIA), glimepiride (AMARYL), atorvastatin calcium (LIPITOR), estrogens, conjugated (PREMARIN), montelukast sodium, fluoxetine HCl (PRAZAC), ramipril (ALTACE), lorazepam (ATIVAN), metoprolol succinate (TOPROL XL TABLETS) guaifenesin (MUCINEX) and aspirin. On approximately 09-APR-2005, a week after vaccination, the patient experienced a generalized rash with pustules, blisters and oozing. The patient's condition resolved in three weeks, approximately 30-APR-2005. Treatment was unknown. It was also noted that a titer was negative. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.