chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 5.5 yr old female with no allergies or medical conditions who on 23Feb01 was vaccinated in the left anterior thigh with a second dose of varicella virus vaccine live (lot636360/1334K). Concomitant vaccination on the same day included a second dose in the right anterior thigh of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot633822/1168K). There was no illness at the time of vaccination. On 30Oct05, the pt was seen in the office for scattered lesions for five days (starting approx 25Oct05) involving the scalp, abdomen, and extremities. One lesion on the abdomen was infected. The pt was treated with mupirocin (Bactroban). It was noted that the pt's mother had shingles two weeks prior and the pt's sibling and had lesions and was examined by a physician. Additional information is not expected.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 12 yr old pt who a long time ago was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. Recently, in approx Nov 2005, the pt experienced a full blown case of chickenpox. It was noted that the pt improved but the current status is unk. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning her 14 yr old son who at the age of 12 on 13Nov00 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. Two years later, on 28Mar02, the pt experienced a full blown case of chickenpox. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning an 8 yr old female who, as an infant, was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. In the spring in approx Apr 2005, the pt had classic appearing herpes zoster involving the left back, fifth rib area. It was not cultured. The pt was treated with oral acyclovir. It was reported that the pt recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a health professional concerning an 11 yr old female who as an infant, was vaccinated with a 0.5ml SC dose of varicella virus vaccine live. In the summer in approx Jul 2005, the pt had classic appearing herpes zoster involving the right breast area around to the posterior back. It was not cultured. The pt was treated with oral acyclovir. It was reported that the pt recovered. No product quality complaint was involved. No other information was provided. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 5 yr old male who on his 12 month visit, in approx 2001, was vaccinated with a dose of varicella virus vaccine live. Recently, in 2005, the pt experienced breakthrough varicella of about fifty lesions or less with no fever. Subsequently, the pt recovered. No treatment was given. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: HEP, HIBV, VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 yr old white female with no known medical history or allergies who on 27Dec99 was vaccinated in the right thigh with a first dose of varicella virus vaccine live (lot630408/0293J). Concomitant vaccination that day included a third dose of hep B vaccine, recomb (Engerix B) (lot ENG2356A2) in the right thigh and a fourth dose of Hib conj vaccine (lot03585S) in the left thigh. On 21Aug05 the child developed a rash all over her body. She was brought into the office on 22Aug05. She was diagnosed with chickenpox. Treatment consisted of diphenhydramine hydrochloride (Benadryl), oatmeal baths and calamine lotion prn. The pt recovered within one week. No lab diagnostic tests were performed. There was no product quality complaint involved. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Medication error, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 yr old white female who on 28Jan03 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot 641162/0797M). There was no concomitant medication. It was noted that the vaccine was stored in a refrigerator inadvertently. A few days after vaccination, on approx 31Jan03, the pt developed a break through case of chickenpox. Lesions were on her face and it was less than 50 lesions. Unspecified medical attention was sought. Subsequently, the pt recovered. A product quality complaint was not involved. Follow up information was received from the physician's office which indicated that the pt had chickenpox, just a few, in Feb 2003. The pt recovered on an unspecified date. No further information is expected. It was reported that the pt's female sibling also developed breakthrough chickenpox after therapy with varicella virus vaccine live. (WAES0511USA02330).
Age: 2.0
Sex: F
Vaccine: FLUX, HEPA, VARCEL
Symptoms: Erythema, Injection site reaction, Skin disorder, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 26-month-old female who on 10/26/2005, was vaccinated SC in the right thigh with a 0.5 mL dose of varicella virus vaccine live (oka/Merck) (lot #65117/0428R). Concomitant vaccination on the same day included a dose in the left thigh of influenza virus vaccine (unspecified) (lot #U1743IA) and a first dose in the left thigh of hepatitis A vaccine (inactive) (manufacturer unknown) (Havrix) (lot #AHAVA018BA). There was no illness at the time of vaccination. On 11/09/2005, the patient developed two lesions at the injection site. It was noted that the patient's mother, who had a history of chickenpox, was pregnant and it was unknown if she had chickenpox at that time. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the registered nurse who reported that the mother called on 11/09/2005 and stated that her daughter had red spots on the right upper thigh which were hard. The patient did not have a fever. The reporter was not able to provide any further information. No further information is expected.
Age: 1.13
Sex: M
Vaccine: DTP, HIBV, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning an approximately 7-year-old white male who on 10/22/1999 was vaccinated SC in the left arm with a 0.5 Ml dose of varicella virus vaccine live (Oka/Merck) (lot #63116801710J). Concomitant vaccination on the same day included an IM fourth dose in the left thigh of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot #912A2), a SC first dose in the right arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl LyNN) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot #63116b/0710J), a SC third dose in the right thigh of Poliovirus vaccine inactivated (Vero) (IPOL) (Lot #P0040-2), and an IM third dose in the left thigh of Hib conj vaccine (tet Toxoid) (ACTHIB) (lot #412353A). In approximately November 2005, the patient developed a case of break through chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that she was unable to contact the family for further details. No further information is expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a woman working in a physician's office concerning a 9 year old white female who on 01/11/1997 was vaccinate with a subcutaneous first dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot#620617/1105D). Subsequently the patient was diagnosed with chickenpox and has since recovered. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 4 year old female who, "on her 12 month visit", in approximately 2002, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Recently", in 2005, the patient experienced breakthrough varicella of about fifty lesions or less with no fever. Subsequently, the patient recovered. No treatment was given. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a health professional concerning a 6-year-old white male student who on 10/13/2000 at 10:00 AM was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot #635452/0768K). It was noted that the patient had a rash at the time of vaccination. On 10/03/2005 at 2:00 PM the patient developed chickenpox. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site rash, Rash
Clinical narrative: Information has been received from a physician concerning an adult female nurse who on 10/11/2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 10/17/2005, the patient developed lesions on her face and at the injection site. It was reported that she came back to work but there was no present status reported. additionally, it was reported that a patient was exposed to another nurse who subsequently developed an adverse experience (WAES#0511USA03072). No product quality complaint was involved. Follow-up information has been obtained regarding the results of the VZV identification program. The specimen was obtained on 11/11/2005 from a vesicular lesion, the VZV DNA was amplified. The strain identified was wild-type. There was no further information at the time of this report. Additional information has been requested.
Age: 1.07
Sex: F
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a mother and a worker in a physician's office concerning a 5-year-old white female with no medical history or allergies, who on 04/04/2001, was vaccinated SC in the right thigh with the first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot #6363661340K). Concomitant vaccinations on that same day included the first SC dose in the right thigh of measles virus vaccine live (Enders-Edmonston) (+)mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot #637256/1381K), the third IM dose in the left thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) (Lot #473347) and the third SC dose in the left thigh of poliovirus vaccine inactivated (Vero) (IPOL) (Lot #T0559). Illness at the time of vaccination included a runny nose and a right middle ear effusion. The patient's mother reported that on 11/11/05, her daughter was sent home from school because she was diagnosed with chickenpox. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. Subsequently, the patient's chickenpox resolved. Additional information is not expected.
Age: 1.13
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a medical assistant concerning a 7-year-old female patient with no allergies, who on 09/23/1999 at another physician's office, was vaccinated with varicella virus vaccine live (Oka/Merck). On 11/09/2005 the patient developed a rash with less than 30 lesions on her trunk and arms with itching. She presented to the physician's office on 11/10/2005 and is reported to have a chicken-pox breakthrough. It was noted that her brother had shingles 10 days ago (approximately 11/01/2005) There was no product quality complaint reported. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a consumer, who is the father, concerning his 5 year old son, who has no allergies or pertinent medical history and who on 07/10/2001 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot #637979/1899K). Other vaccine therapy administered on the same day, 07/10/2001, included a first dose of measles virus vaccine live  (+) mumps virus vaccine live (+) rubella virus vaccine life  (Lot #637433/0149L). Concomitant therapy included hydroxyzine hydrochloride and cetirizine hydrochloride (Zyrtec). On 11/11/2005(also reported as 11/14/2005), the patient developed a chicken pox rash and has about 30 lesions. It was noted that the patient saw the school nurse. The father also reported that there were four other students in his sons class that have chicken pox. At the time of this reporting the adverse event did not improve and the patient's outcome is not recovered. There was no laboratory studies performed. There was no product quality complaint reported. Follow up information was received from a registered nurse at the physicians office who reported that there was no known adverse reaction following the vaccine. The registered nurse mentioned that the patient developed possible varicella, though the patient was not seen in the clinic. The registered nurse mention that the physician's office had a phone call from the patient's mother and that the office answered questions about varicella. The patient recovered on an unspecified date. The registered nurse also mentioned that the patient's siblings, a 10 year old female (0601USA00320) and seven year old female (0601USA00321) developed similar events following vaccination with varicella virus vaccine live. No additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 2-year-old female, who in 2001 was vaccinated with a dose of varicella virus live (Oka/Merck). The physician reported that on 11/10/2005, the patient developed breakthrough varicella characterized by less than 20 lesions on her chest. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who on 10/23/1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On 11/12/2005, the patient started erupting in an itchy rash. On 11/14/2005, he was seen in the physician's office and he still had an itchy rash that was red, scabbing and spreading on his left axilla, chest and both arms that was vesicular and papular. The physician diagnosed the rash as chickenpox. Treatment included diphenhydramine hydrochloride (Benadryl) and Avena (Aveeno Bath). At the time of the report the patient's out come was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12-month-old white female with no allergies or medical history, who on 11/01/2005 at approximately 14:00 PM was vaccinated SC in the right leg with first dose of varicella virus vaccine live (Oka/Merck) (lot #651177/0428R). Concomitant vaccination at the same time included a SC first dose in the left leg of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot #649699/0775P). There was no illness at the time of vaccination. The patient experienced approximately 15 lesions on her arms, legs, and diaper area. Unspecified medical attention was sought. No other information was available regarding the adverse event or the patient's outcome. A product quality complaint was not involved. Follow up information was received from the nurse who reported that four days after vaccination, on 11/05/2005, the patient had diffuse rash over the whole body that began to fade by day five and six. The patient had no fever and not other symptoms. The patient was considered recovered. No diagnostic laboratory test were performed. No further information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Medication error
Clinical narrative: Information has been received from a physician concerning an approximately 6-year-old female, who on 01/28/2003 was vaccinated SC with a 0.5 mL dos of varicella virus vaccine live (lot #641162/0797M). It was noted that the vaccine was stored in a refrigerator inadvertently. She was exposed to the wild type varicella in July 2005. A couple of weeks later she developed chickenpox on the face, head, and a few on the back. It was noted to be a mild case. Unspecified medical attention was sought. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested. It was reported that the patient's female sibling also developed break through chickenpox after therapy with varicella virus vaccine live (WAES #0511USA01850).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 12-year-old white male with no allergies or medical conditions, who on 02/20/1998, was vaccinated SC in the left outer arm with a first 0.5 Ml dose of varicella virus vaccine live (Oka/Merck) (Lot #622850/0537E). Concomitant vaccination on the same day included a SC second dose in the right outer arm of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot #620879/0283E), a fifth IM dose in the right deltoid of diphtheria toxoid (+) Pertussis vaccine (Unspecified) (+) tetanus toxoid (lot #448 451), and a forth oral dose of poliovirus vaccine inactivated (Vero) (IPOL) (lot #0766H). There was no illness at the time of vaccination. In approximately November 2005, the patient developed a case of break through chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up information was received from the registered nurse who reported that in the AM of 11/09/2005, the patient's entire body was covered with lesions in various stages. It was a very severe rash and the patient had a low grade fever for three to four days. The duration was 10 to 12 days. He had a doctor appointment on 11/09/2005 and was treated with calamine (+) camphor (+) pramoxine hydrochloride (Aveeno) cream and bath, diphenhydramine hydrochloride (Benadryl), and children's chewable aspirin. He missed five to six days of school. It was noted that he had two younger siblings (6 and 9 years) who were vaccinated with varicella virus vaccine live (Oka/Merck) on the same day as the patient and did not experience illness. The patient was diagnosed with chickenpox. The patient recovered 10 to 12 days after onset. No diagnostic laboratory test were performed. Neither the patient nor his siblings had any adverse events following prior vaccination.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Skin hyperpigmentation
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 1-year-old health male with no allergies who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (dose, date and lot number not reported). There was no concomitant mediation. Subsequently, 3-4 weeks after vaccination (date unspecified) the patient experienced zoster-type rash from his left buttock down his leg to his ankle. Unspecified medical attention was sought, no diagnostic or laboratory tests were performed. At the time of this report the lesions were described as post inflammatory hyperpigmented. The patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Gait disturbance, Infection, Pain, Pyrexia
Clinical narrative: Info has been received from a physician concerning a 2 year old male who "one year ago" in 2004 was vaccinated with a dose of varicella virus vaccine live. Concomitant vaccination "most likely" included a dose of MMRII. Subsequently, the pt presented with mild leg pain and a limp. An x-ray was taken, results not reported. The pt returned 2 days later with what appeared to be poison ivy. He then returned 3 days later, after the original complaint. He "still" had a fever. A culture was taken which showed that the pt had the varicella zoster virus. It was reported that the pt had 3 lesions in a line and lesions down his calf to the side of his foot. The pt was not hospitalized. The pt was treated with acyclovir (unspecified). After taking one day of acyclovir (unspecified), the pt "appeared to be" uninfected and was not limping. Additional info has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Info has been received from a physician concerning a 3 year old male who at 1 year of age was vaccinated with a dose of varicella virus vaccine love. Concomitant vaccination "most likely" included a dose of MMRII. Subsequently, the pt developed a classic distribution of zoster down his leg. Unspecified medical attention was sought. The pt had no hospitalizations. It was reported that the pt had healed when he presented to the office, but he had a rash for about a week. No medicines were administered. It was reported that the pt had full resolution. Additional info has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from a dental hygienist concerning her 13 month old son who on approximately 10/16/05, was vaccinated with a dose of varicella virus vaccine live. The dental hygienist reported that in 11/05, her son developed chickenpox. Unspecified medical attention was sought and the pt was referred to an infectious disease physician. At the time of this report, the outcome was unknown. Additional info has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning an 11 year old male who was vaccinated SC, with a 0.5ml dose of varicella virus vaccine live. The physician reported that on 10/19/05, the pt developed breakthrough chickenpox characterized by 45 lesions and a temperature. Unspecified medical attention was sought. On 11/16/05, the pt completely recovered from the breakthrough chickenpox after unspecified therapy. Additional info has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 2 year old pt who in 12/94, was vaccinated with a dose of varicella virus vaccine live. The RN reported that in approximately 11/05, the pt presented to the physician's office with mild breakthrough chickenpox. At the time of this report, the outcome was unknown. No further info is available.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Infection transmission via personal contact, Pyrexia
Clinical narrative: Info has been received from a physician concerning a 39 year old female nurse with no verified history of varicella, who was in contact with an adult female healthcare worker who was vaccinated with a dose of varicella virus vaccine live. On 10/17/05, the healthcare worker experienced an adverse experience. The pt was exposed to the healthcare worker on 10/20/05. At the time of exposure, the pt was taking the following medications: hydrochlorothiazide (+)losartan potassium, sertraline hydrochloride (Zoloft), unspecified therapy and hormonal contraceptives (unspecified). The pt had never been vaccinated with a dose of varicella virus vaccine live but on 11/7/05 (previously reported an 11/10/05), the pt developed a generalized chickenpox rash characterized by 19-20 small vesicles on erythematous base. The lesions were distributed on the pt's head, face, chest and abdomen. It was noted that the pt also had an enlarged posterior cervical mass. A VZV culture was taken from a vesicle on 11/11/05 and determined to be BgL (+) wild type. It was reported that the pt recovered. Additional info is not expected.
Age: 1.23
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Drug ineffective, Infection, Vomiting
Clinical narrative: Info has been received from a health professional concerning an 8 year old white female student who on 11/24/98 at 11:17 AM was vaccinated in the left arm with varicella virus vaccine live (lot 625475/0644H). It was noted that she had a diaper rash at the time of vaccination. On 10/31/05, the pt developed vomiting and diarrhea. The symptoms continued and the pt presented to the physician's office on 11/8/05. Additional info has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Info has been received from a CMA concerning a healthy 11 year old white male pt with no allergies, who on 7/8/96 was vaccinated, SC, in the left arm with a dose of varicella virus vaccine live (lot 608666/0392B). On 11/15/05, he was prescribed acetaminophen (Tylenol) for symptomatic and supportive care. There was no product quality complaint reported. There was no other info available regarding the adverse event or the pt's outcome. Follow-up info indicated that the pt recovered on 11/23/05. No additional info is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 6 year old male who on 8/17/01 was vaccinated with an 0.5 mL dose of varicella virus vaccine live (lot 630975/1601K). The physician reported that on 10/25/05, the pt developed breakthrough chickenpox characterized by less than 50 lesions. No fever was noted. Unspecified medical attention was sought, but no treatment was ordered. Subsequently, the pt's breakthrough chickenpox resolved. Additional info is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Info has been received from an RN concerning a 5 year old male pt with no allergies and no pertinent medical history, who immigrated from another country, who on 8/1/05 was vaccinated with a dose of varicella virus vaccine live. On 8/18/05, the pt had a titer drawn which showed varicella antibody response failure. It was also noted that the same child was vaccinated with a 2nd, IM, dose of MMRII (lot 649241/0032R) on 7/18/05 and failed to seroconvert for mumps. There was no illness at the time of vaccination and no adverse events following prior vaccination. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional info is not expected.
Age: 1.01
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Dermatitis bullous, Eye swelling, Irritability, Pyrexia
Clinical narrative: Info has been received from an RN concerning a 12 month old Caucasian male who on 11/11/05 was vaccinated, SC, one time with 0.5 ml dose of varicella virus vaccine live (lot 646439/0551R). Concomitant vaccinations given on the same day included: a 4th dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj. vaccine (CRM197) (Prevnar lot 308636D) given, IM, in the left thigh; the 1st dose of MMRII (lot 649755/0380R) given, SC, in the right thigh. On 11/14/05, around 08:00, the pt developed his 1st varicella lesion. He was seen in the physician's office on 11/17/05 and he had 50-100 varicella lesions and a fever of 100.5F. It was reported that the pt had increased irritability and that his left eye was swollen from a lesion. The physician prescribed acyclovir 200 daily for 5 days and azithromycin (Zithromax) 200mg for 3 days. The pt was reported to be recovered at the time of this report. No product quality complaint was involved. Additional info is not expected.
Age: 1.44
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 7 year old male student who on 8/4/99 was vaccinated with a dose of varicella virus vaccine live. It was reported that on 11/8/05, the pt developed red spots with a flat base on each cheek, three to the chest and 6-8 on his back. Medical attention was not sought. In 11/05, the pt's red spots received. Additional info is not expected.
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin ulcer
Clinical narrative: Info has been received from a physician concerning a white female with a history of recurrent ear infections who on 11/7/05, was vaccinated, SC, with the 1st 0.5 mL dose of varicella virus vaccine live (lot 650223/0426R). Concomitant vaccinations given on that same day included the 4th, IM, dose of Prevnar (lot A98341H) and the 1st, IM, dose of influenza virus whole virion 3v vaccine inactivated (Fluzone) (lot U1743KA). The pt developed a red, bumpy (raised lesions) rash at the injection site that did not appear to be classic chickenpox. Unspecified medical attention was bought and the physician was trying to determine if the pt should be isolated. No lab/diagnostic tests were performed. Subsequently, the pt's rash resolved. Additional info is not expected.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Info has been received from a health professional concerning a 39 year old adult female who was vaccinated with two 2 dose series of varicella virus vaccine live. Titers after each series have been negative. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info indicated that the pt was vaccinated with 2 doses of varicella virus vaccine live, in another country. She was then vaccinated, SC, in the left arm with a 3rd dose (lot 648551/0286P) and 4th dose (lot 648317/0439P) of varicella virus vaccine live on 3/3/05 and 4/6/05, respectively. The pt did not seroconvert. The second antibody test was negative. This is all the info available. Additional info is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Info has been received from a physician concerning a male who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced rash. Additional info has been requested.
Age: 0.3
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC, VARCEL
Symptoms: Crying, Injection site haemorrhage, Medication error
Clinical narrative: Info has been received from a health professional concerning a 4 month old male with no past medical history, who on 11/18/05 at 12:00, was inadvertently vaccinated, SC, in the right thigh with a 0.5 ml first dose of varicella virus vaccine live (lot 650221/0431R). The pt was also inadvertently vaccinated, SC, in the left thigh with a first dose of MMRII (lot 647646/0990P). Other concomitant vaccinations included: a 1st dose of Pediarix (lot AC21A013A) given in the right thigh, a 1st dose of Prevnar (lot A56117H) given, IM, in the left thigh and a 1st dose of Hib conj vaccine (lot 649023/0368P) given IM in the left thigh. There was no illness at the time of vaccination. Subsequently, the pt developed bleeding at one of the injection sites. The nurse had to apply pressure and the baby was screaming. There was no product quality complaint involved. Follow-up info was received indicating that the pt had recovered and that no adverse effects were reported as of 1/3/06. Additional info is not expected.
Age: 0.99
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 9 year old male with no known medical history or allergies who on 11/15/96 was vaccinated, in the left thigh, with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 11/18/05, the pt developed mild breakthrough chickenpox characterized by approximately 50 lesions in various stages. It was noted that the pt had felt "lousy" for 1 week prior to breakthrough. The pt was seen in the doctor's office. No lab diagnostic tests were performed. The pt was discharged from the doctor's office to home with symptomatic treatment and isolation for the duration of the rash. On 11/30/05, the pt recovered. There was no product quality complaint involved. Additional info is not expected.
Age: 1.01
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 6 year old black male with asthma, who on 7/12/00 was vaccinated, SC, in the left arm with a 0.5 mL first dose of varicella virus vaccine live (lot 632276/1454J). Concomitant vaccination included a 3rd dose of Hep-B virus vaccine rHBsAg (yeast) (lot 635516/0426K) given, IM, in the right thigh and a 3rd dose of (IPOL) (lot R0444) given, SC, in the right thigh. Concomitant therapy included fluticasone propionate (Flovent). On 11/1/05, the pt developed fine bumps which were dx'd as chickenpox. It was reported that the rash involved 25 lesions. Unspecified medical attention on was sought. Subsequently, the pt recovered. There was no product quality complaint involved. No further info is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 5 year old female who in 2001 was vaccinated with a dose of varicella virus vaccine live. The RN reported that on 11/21/05, the pt developed "lots" of varicella lesions. The pt was noted to be afebrile. Unspecified medical attention was sought, but no lab/diagnostic tests or treatments was required. At the time of this report, the pt was recovering. Additional info has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from a health professional concerning a pt who was vaccinated, SC, with a 0.5ml dose of varicella virus vaccine live. Subsequently, the pt experienced chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from an RN concerning a 10 year old male who on 9/1/98 was vaccinated with a dose of varicella virus vaccine live (lot 626961/0848H). The RN reported that on approximately 11/15/05, the pt developed breakthrough chickenpox characterized by about 60 lesions and a fever of 101.9F. Unspecified medical attention was sought. In 11/05, the pt's chickenpox resolved. No further info is available.
Age: 1.27
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from an RN concerning a 4 year old healthy female with no medical history or allergies who on 3/4/02 was vaccinated with a dose of varicella virus vaccine live (lot 637957/1882K). The RN reported that on 11/3/05, the pt developed a fever of 101F. On 11/4/05, the pt developed 40 pox. By 11/6/05, the pt's pox were noted to be drying. On 11/8/05, the pt's pox resolved. Additional info is not expected.
Age: 1.51
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin ulcer
Clinical narrative: Info has been received from a physician concerning an 18 month old male with no known medical history or allergies who on 11/5/05 was vaccinated with, SC, 0.5 ml dose of varicella virus vaccine live (lot 651178/0427R). Concomitant vaccinations the same day included a dose of MMRII. On 11/20/05, the pt experienced a rash. He was seen in the office on 11/23/05 with 6 lesions. No treatment was required. At the time of the report, the pt had not recovered. There was no product quality complaint involved. Additional info has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: info has been received from a physician concerning a 15 month old white female with no known medical history or allergies and was born full term, who on 11/3/05 was vaccinated, SC, with a 0.5 mL dose of varicella virus vaccine live. Sixteen days later, on 11/19/2005, the pt developed a mild case of chickenpox. Unspecified medical attention was sought. No lab diagnostic tests were performed. Subsequently, the pt recovered. There was no illness at the time of vaccination. The pt did not experience any adverse events following prior vaccinations. There was no product quality complaint involved. Additional info is not expected.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Info has been received from a CMA concerning a 32 year old white female pharmacist with no medical history or allergies who on 3/3/98 and 4/21/98 was vaccinated, IM, in the left arm with a 1st and 2nd 0.5 mL dose of varicella virus vaccine live (lot 624782/0052H). There was no illness at the time of vaccination. A titer was done recently (date unspecified) and the result was below the seroconversion limit. Unspecified medical attention was sought and no symptoms were noted. A product quality complaint was not involved. Additional info was received from the CMA who reported that there was no adverse event. The reporter was told by the pt's OB/GYN of a low varicella titer and recommended re-vaccination. The pt had no adverse events following prior vaccination. No further info is expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pneumonia, Pyrexia
Clinical narrative: Info has been received from an RN concerning a 46 month old white female with a tracheostomy who on 12/19/03 was vaccinated, SC, with a 1st dose of varicella virus vaccine live (lot 641596/0767M). There was no illness at the time of vaccination. Concomitant therapy included dornase alfa (Pulmozyme), ipratropium bromide (Atrovent), and tobramycin sulfate (Tobra) via a nebulizer prn. On 11/14/05, the pt had a temperature of 102.8 for 1-2 days and had less than 50 lesions. It was noted that the pt had pneumonia first and then developed chickenpox. The pt totally recovered on 11/18/05 and is now fine. Additional info has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Headache, Infection, Pyrexia
Clinical narrative: Info has been received from a CMA concerning a healthy 11 year old male pt with no allergies, who on 3/27/98 was vaccinated with a dose of varicella virus vaccine live. On 11/16/05, the pt developed 20-30 lesions, fever (103.2F) and headache. He was treated with Tylenol and supportive care. There was no product quality complaint reported. There was no other info available regarding the adverse event or the pt's outcome. Additional info has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a school student who was vaccinated with a dose of varicella virus vaccine live. The nurse reported that her student developed break through varicella after vaccination. It was noted that all of the children in the school except one had been vaccinated (80 per grade from K through 8th). The case was reported to be mild and the child did not return to school until all the pox had crusted. The child did not have the normal stages of chickenpox and the pox healed quickly. Additional info has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 4 year old male with asthma who on 1/25/05 was vaccinated, SC, with a 0.5ml dose of varicella virus vaccine live (lot 641151/1181L). Concomitant therapy included fluticasone propionate (Flovent). On 11/14/05, the pt experienced a breakthrough case of 10 lesions and no fever. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
Age: 1.51
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 10 year old male with no medical history and no allergies who on 5/21/97 was vaccinated with a 1st 0.5ml dose of varicella virus vaccine live. Concomitant medication included a 5th dose of DTAP. On 11/18/05, the pt started with an itchy rash. He was seen in the office on 11/20/05 with 10 lesions, some vesicles and papules and some scabbed over. The pt was afebrile. He was treated with Benadryl and calamine lotion. Subsequently, the pt recovered. No product quality complaint was involved. Follow-up info indicated that the pt was seen in the office with chicken pox on 11/20/05, after having an itchy rash for 2 days duration, since 11/18/05. The pt had scattered papules, many scabbed and some near vesicles. There were about 40 lesions. It was noted that 3 classmates had chicken pox. The pt was sent home with recommendation for symptomatic treatment and isolation for the duration of the rash. The pt recovered on 11/26/05. The pt's sibling had chicken pox after vaccination with varicella virus vaccine live. Additional info is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning an 8 year old female with no known medical history or allergies who on 11/2/98 was vaccinated, SC, in the left arm with a 1st 0.5 ml dose of varicella virus vaccine live (lot 62775/1245H). There was no concomitant medications or illness at the time of vaccination. On 11/25/05, the pt started to experience lesions. On 11/29/05, she was seen in the office with some lesions scabbed over. She also developed 2 new lesions on her back for a total of about 30 lesions. No treatment was required. At the time of the report, the pt was recovering. There was no product quality complaint involved. Follow-up info indicated that on 11/27/05 (previously reported as 11/25/05), the pt experienced scabs, blisters and dried lesions on her face, scalp and trunk, more than 30 were noted. Subsequently, the pt recovered. No further info is expected.
Age: 1.21
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an RN concerning a 10 year old white male who on 3/1/96 was vaccinated with a dose of varicella virus vaccine live. It was noted that the pt was not vaccinated at the reporter's office. On 11/17/05, the pt had a mild case of chickenpox. The pt recovered on 11/20/05. No further info is expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 12-year-old female who in approximately 1993 at 12 to 18 months of age, was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On approximately 11/22/2005, the patient presented with a case of chickenpox. She had 24 lesions located mainly on her trunk. Unspecified medial attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 1.14
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a healthcare professional concerning a 45-month-old female twin with no other pertinent medical history or allergies, who on 03/20/2003 was vaccinated subcutaneously in the right leg with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot #64115/0793M). There was no concomitant medication. On 11/27/2005, the patient broke out in red papules, she presented to the physicians' office on 11/28/2005 with red papules on face and new lesions on her legs, no fever. The patient was treated with acetaminophen (Tylenol), calamine lotion, diphenhydramine hydrochloride (Benadryl) and fluids. There was no information provided regarding the present status of the patient. No product quality complaint was involved. The patient's twin sister was also vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed an adverse reaction (WASE#0512USA00118). Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 or 9 year old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 11/22/2005, the patient developed breakthrough with more than 50 lesions. Besides the external lesions she had lesions in her mouth and down her throat. Unspecified medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 21 year old female who on 11/18/2005, was vaccinated subcutaneously with a 0.5ml of varicella virus vaccine live (Oka/Merck) (lot #651175/0423R). On 11/19/2005, the patient developed several vesicular lesions on her forehead, 24 hours post vaccination. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a 16-year-old black female student, who on 12/18/1997 was vaccinated in the right arm with the first dose of varicella virus vaccine live (Oka/Merck). The physician reported that in the middle of November 2005, the patient developed breakthrough chickenpox characterized by 20 varicella lesions on her body. The physician did not see the patient in her office, but unspecified attention was sought. At the time of this report, the outcome was unknown.
Age: 1.14
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a healthcare professional concerning a 45-month-old female twin with no other pertinent medical history or allergies who on 03/20/2003, was vaccinated subcutaneously in the right leg with a 0.5 ml dos of varicella virus vaccine live (Oka/Merck) (lot #64115/0793M). There was no concomitant medication. On 11/27/2005, the patient broke out in red papules, she presented to the physician's office on 11/28/2005 , with red papules on her face, forehead, trunk, upper and lower extremities and did not have a fever. The patient was treated with acetaminophen (Tylenol), calamine lotion, diphenhydramine hydrochloride (Benadryl) and fluids. There was no information provided regarding the present status of the patient. No product quality complaint was involved. The patient's twin sister was also vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed an adverse reaction (WASE# 0512USA00001). Additional information has been requested.