chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster, Rash, Viral infection
Clinical narrative: Information has been received from a nurse concerning a 35 month old male with no pre-existing allergies, birth defects, or medical conditions who on 5/23/03 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot # 644569/1158M). There was no illness at the time of vaccination. On 4/11/05 at 8:45 AM, at almost 3 years old, the patient developed a severe case of shingles involving the whole right upper and lower arm, also involving the thumb, index finger, and half of the ring finger. It was noted that the child had a rash for 3 days before presenting to the office on 4/11/05. The rash was described as multiple vesicles and papules along a strip from the right shoulder and down the right arm all the way, involving the thumb and index finger. The pediatrician had a culture done and it was positive for VZV. The pediatrician prescribed acyclovir. No additional information was reported. The outcome was reported as not recovered. There was no product quality complaint. Follow up information received from a registered nurse indicated that the patient had recovered on 4/18/05. No additional information is expected.
Age: 1.05
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pruritus
Clinical narrative: Info has been received from an RN concerning a 31 month old male, with no pertinent medical history and no known drug reactions/allergies, birth defects, or medical conditions, who on 9/4/03 was vaccinated, SC in the left thigh, with a 1st dose of varicella virus vaccine live. On 4/11/05, also reported as 4/5/05, the pt developed scattered varicella lesions on the trunk and upper extremities. It was previously reported that the pt experienced varicella breakthrough, which began on his face only. When seen by the doctor, he had 12 lesions scattered on his side and back. He also had itching but was afebrile. Benadryl and Aveeno baths were prescribed. No relevant diagnostic tests or lab studies were performed. Medical attention was sought. No product quality complaint was involved. There was no illness at the time of the vaccination. The pt recovered. Additional info is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 yr old female, with no known allergies, who on 29Nov01 was vaccinated with a dose of varicella virus vaccine (route and Lot # unk). On 12Apr05 the pt experienced full blown case of chickenpox. Outcome not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 0.6
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal
Clinical narrative: Info has been received from an RN concerning a 8 month old female twin, with a healthy pertinent medical history born prematurely at 28 weeks and no known drug reactions/allergies, who in June, 2004, was vaccinated in another country with a dose of varicella virus vaccine live. A varicella lab diagnostic studies was performed on 4/1/05, which came back negative. Outcome unknown. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info was received from an RN indicating that the pt was vaccinated again on 4/19/05. The reporter also noted that the pt's twin sister was vaccinated with a dose of varicella virus vaccine live and had a negative titer. Additional info has been requested.
Age: 1.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Inflammation, Rash macular, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning a healthy 6 yr old white female student who on 20Dec99 was vaccinated IM with a dose of varicella virus vaccine live (lot6320421360J). Concomitant vaccination given on the same day included: the fourth dose of Hib conj vaccine (crm197) (Hibtiter) (lot 520253A) given IM. On 22Mar05 the pt developed large macules with an inflammatory process around them; they were on her torso, neck and both arms. She was diagnosed with chicken pox. She was home from school for a week. The student recovered. No product quality complaint was involved. Additional information is not expected.
Age: 1.04
Sex: M
Vaccine: HEP, IPV, VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 41 month old white male with eczema and no allergies who on 15Nov02 was vaccinated SC in the right thigh with the first dose (0.5mL) of varicella virus vaccine live (lot 643529/0598M). Concomitant vaccinations on the same day included the third IM dose of hep B virus vaccine rHBsAg (yeast) (lot 543757/0781M) and the third IM dose of poliovirus vaccine inactivated (lot W0010). There was illness at the time of vaccination. The RN reported that on 10Apr05, the pt presented to the ER with scattered lesions on his trunk, face and groin. A diagnosis of chickenpox rash was made. The pt was not hospitalized. No treatment or lab/diagnostic tests were required and the pt was released from the ER. Subsequently, the pt recovered from his chickenpox rash. Additional information is not expected.
Age: 1.29
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 8 yr old female with no medical history and no allergies, who on 10Feb98 was vaccinated with a 0.5ml SC first dose in the right thigh of varicella virus vaccine live (lot 622969/0423E). There was no illness at the time of vaccination. It was reported that the pt started with scattered lesions yesterday, on 13Apr05 and was seen in the office today with 20 classic varicella lesions on her trunk and abdomen. No fever was noted. The pt's status was reported as not recovered. There were no laboratory or diagnostic test performed. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that on 14Apr05 the pt experienced 20 scattered classic varicella lesions on trunk and abdomen. Symptomatic relief was given and the pt was afebrile. Subsequently the pt recovered. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a healthy 10 yr old white male who on 17Jun98 at 9:30 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 624724/1327E). There was no concomitant medication and there was no illness at the time of vaccination. On 02Apr05, the pt experienced break through chickenpox. It was not a mild case but a full blown case of chickenpox. A product quality complaint was not involved. Follow up information was received from the physician who reported that on 02Apr05, the pt broke out with a full blown pox rash with greater than 50 lesions and a fever for a couple days. No diagnostic lab tests were performed. Subsequently, on an unspecified date, the pt recovered. There were no adverse events following prior vaccination. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular, Rhinorrhoea, Skin ulcer
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 6 yr old female who on 07Jul99 was vaccinated SC with a first dose of varicella virus vaccine live. On 13Apr05, the pt presented with about 30 vesicular lesions and a runny nose. Hydroxyzine hydrochloride (Atarax) was prescribed for itching. No other symptoms were noted. At the time of the report the pt was recovering. A product quality complaint was not involved. Follow up information was received from the licensed visiting nurse who reported that on 12Apr05, the pt had times 24 hrs positive itchy vesicles which were two to three mm on the scalp. The pt also had rhinorrhea. Subsequently, on an unspecified date, the pt recovered. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Malaise
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt experienced mild breakthrough and looked kind of sick. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a medical assistant concerning an 11 yr old black male with no pre-existing allergies, birth defects or medical conditions, who on 30Mar05 at 2:30PM was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 649482/0765P). There was no illness at the time of vaccination. There was no concomitant medication. On 09Apr05 in the AM the pt broke out with full blown chicken pox. There were no relevant diagnostic tests or lab data. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Skin ulcer
Clinical narrative: Information has been received from a worker in a physician's office concerning a 25 month old female with a history of shingles exposure (grandmother) who on 25Feb04 at 14:00, was vaccinated SC in the left arm with the first dose of varicella virus vaccine live (647261/1134N). It was reported that on 04Apr05, the pt developed about 18 lesions on her belly. No other symptoms were noted. Medical attention was not sought. In April 2005, the pt's lesions resolved. No further information is available.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 12 month old white female with no pre-existing allergies, birth defects, or medical conditions who on 29Mar05 at 10:30AM was vaccinated in the right leg with a first dose of varicella virus vaccine live (lot 648319/0441P). There was no illness at the time of vaccination. On 16Apr05 the pt developed approx 5 to 6 varicella lesions which were characterized as mild and widely scattered. She was see in the physician's office and checked by the doctor. Unspecified medical attention was sought. There pt did not have a fever and there were no other problems. The outcome was reported as recovered. There was no product quality complaint. There were no relevant diagnostic tests or lab data. There were no adverse events following prior vaccinations at the pt or her siblings. No additional information is expected.
Age: 1.22
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Face oedema, Hand-foot-and-mouth disease, Pyrexia, Rash
Clinical narrative: Information has been received from a medical assistant concerning a healthy 14 month old white female with no allergies or medical history who on 13Apr05 was vaccinated in the right arm with an expired first dose of varicella virus vaccine live (lot 642052/0108P). Concomitant vaccination on the same day included first dose in the left arm of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 649514/0777P). There was no concomitant medication. Over the weekend of 16Apr05 and 17Apr05, the pt developed a rash, fever, and a swollen face. Diphenhydramine hydrochloride (Benadryl) was prescribed and the pt was to be seen by the physician on 18Apr05. At the time of the report, the pt had not recovered. A product quality complaint was not involved. Additional information was received from the medical assistant who indicated that on 18Apr05 the pt's mother called the office and reported that the child had a swollen face, rash all over her body. and a low grade fever. The pt was seen on 18Apr05 and diagnosed with probable hand-foot and mouth. It was unk if the pt recovered. No further information is expected.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 7 yr old Caucasian female, with no known allergies, who on 02Jul98 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 1547E). There was no illness at the time of vaccination. On 03Mar05 the pt experienced rash upon visit consistent with chicken pox. No relevant diagnostic tests or lab studies were performed. Subsequently, on 13Mar05, the pt recovered. No additional information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a RN concerning a 9 yr old white female, with known pre-existing allergies, birth defects, and medical conditions reported, who on 03Feb00 was vaccinated with a first dose of varicella virus vaccine live (route and lot #unk). There was no illness at time of vaccination. There was no concomitant medication. On 23Mar05 the pt experienced rash on trunk, legs, ears, chin. It was also reported that the pt was very itchy, a couple have crusted over, and exposed approx 2 wks ago. Subsequently the pt recovered on 01Apr05. No relevant diagnostics and lab studies were performed. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 4 yr old white male, with penicillin allergy and a history of asthma, who on 09Oct01 was vaccinated (unk route) in the right thigh with a first dose of varicella virus vaccine live (lot 639432/0787L). There was no illness at the time of vaccination. There were no relevant diagnostic test or lab studies performed. On 20Mar05 the pt experienced rash and lesions and was diagnosed with chickenpox. Subsequently, the pt recovered on 30Mar05. No additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Herpes zoster, Pyrexia
Clinical narrative: Information has been received from a RN concerning a 11 yr old white female who on 10Nov95 was vaccinated (route unk) in left thigh with a second dose of varicella virus vaccine live (lot 610250/0746B). The mom indicated that on 08Mar05 she had a case of shingles. Subsequently, on 23Mar05 the pt broke out in rash and fever. The report indicated that Mom knows it is varicella. No relevant diagnostic tests or lab studies were performed. Subsequently, the pt recovered on 01Apr05. No additional information has been requested.
Age: 1.6
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash pruritic, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 9 yr old white male with cerebral palsy, who on 27DEC96 was vaccinated (route unk) with a first dose of varicella virus vaccine (lot unk). There was no illness at the time of the vaccination. On 02Mar05, the mom indicated that her son had lesions on torso, face and genital area. He was also itchy with no fever. The report indicated that there was an outbreak of chicken pox at the school. Subsequently, the pt recovered on 12Mar05. No additional information has been requested.
Age: 1.27
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Erythema
Clinical narrative: Information has been received from a certified medical assistant concerning a 9 yr old white male who on 06Jan98 was vaccinated in the right thigh (route unk) with a second dose of varicella virus vaccine live (lot 0158B). Subsequently the pt experienced red bumps. The report indicated that the pt has a younger brother (DOB 28Jul04) who contracted them from two other brothers and varicella was given because of age. Additional information has been requested.
Age: 0.46
Sex: M
Vaccine: HBHEPB, IPV, MMR
Symptoms: Agitation, Erythema, Medication error, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 18 month old male who on 12Apr04 (previously reported as 28Jan05) was vaccinated SC in the left arm with a dose of varicella virus vaccine live (lot 647527/1183N). Concomitant vaccination that day included an IM dose of Hib conj hep B vaccine (lot 646188/0450N) in the right thigh and an IM dose of poliovirus vaccine inactivated (Ipol) (lot E0706) in the left thigh. It was reported that on 10Aug04 (previously reported as 28Jan05) the pt was vaccinated with an SC dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot647671/1188N). On 04May05 (previously reported as 07Feb05) the pt developed breakthrough varicella with 40 plus lesions on his torso, thighs, scalp and legs. The pt's rash was described as vesicular on his torso and scalp. The doctor stated previously that on 09Feb05 it became angry/turned bright red. It was also reported that the pt experienced five days of a fever. Unspecified medical attention was sought. It was reported that while on therapy the pt's adverse events improved. It was previously reported that on 15Feb05 the pt was considered to be recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 0.46
Sex: M
Vaccine: HBHEPB, IPV, MMR
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 18 month old male who on 12Apr04 (previously reported as 28Jan05) was vaccinated SC in the left arm with a dose of varicella virus vaccine live (lot 647527/1183N). Concomitant vaccination that day included an IM dose of Hib conj hep B vaccine (lot 646188/0450N) in the right thigh and an IM dose of poliovirus vaccine inactivated (Ipol) (lot E0706) in the left thigh. It was reported that on 10Aug04 (previously reported as 28Jan05) the pt was vaccinated with an SC dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot647671/1188N). On 04May05 (previously reported as 07Feb05) the pt developed breakthrough varicella with 40 plus lesions on his torso, thighs, scalp and legs. The pt's rash was described as vesicular on his torso and scalp. The doctor stated previously that on 09Feb05 it became angry/turned bright red. It was also reported that the pt experienced five days of a fever. Unspecified medical attention was sought. It was reported that while on therapy the pt's adverse events improved. It was previously reported that on 15Feb05 the pt was considered to be recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Condition aggravated, Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning an approx 6 yr old male who on 05Aug99 was vaccinated with a dose of varicella virus vaccine live. In 2004 the pt developed chickenpox and again in Feb 2005. It was reported that the lesions in Feb 2005 were located on the pt's scalp and trunk. Unspecified medical attention was sought. Treatment included loratadine (Claritin) and bacitracin zinc (+) neomycin sulfate (+) polymyxin B sulfate (Neosporin). 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: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash papular, Rash pruritic, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 36 month old female with no known medical history or allergies who on 25Mar03 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (lot0966). There was no concomitant medication. On 17Apr05 the pt developed breakthrough chickenpox with itchy papular lesions on her face and arms, then on her neck and buttocks. On 19Apr05 the pt was seen in the office. Treatment included calamine lotion and diphenhydramine hydrochloride (Benadryl). There was no product quality complaint involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Headache, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 9 yr old white male who was vaccinated with a dose of varicella virus vaccine live. On 16Apr04 the pt broke out in bumps with a headache and a temperature. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 12 month old female who was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. One month after vaccination, the pt developed break through chicken pox with about 10 lesions and a low grade fever. Unspecified medical attention was sought. The adverse event improved at the time of the report, the pt was recovering. A product quality complaint was not involved. Additional information was received from the RN who indicated that the pt was unk. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a RN concerning a female pt who was vaccinated with a dose of varicella virus vaccine live.  A couple of years later, the pt contracted chicken pox. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a LPN concerning a female who was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. The LPN reported that in Apr 2005, the pt developed a rash. Unspecified medical attention was sought, but no prescription drug treatment was required. At the time of this report, the outcome was unk. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 5 year old female, with "moderate to severe" asthma and no drug reactions/allergies reported, who in 1999 was vaccinated with a dose of varicella virus vaccine. Concomitant therapy included montelukast sodium and fluticasone propionate (Flovent) (also reported an "Slovent"). On 4/19/05, the pt experienced mild case of varicella with 25 lesions. No known lab diagnostic studies were performed. Unspecified medical attention was sought. No product quality complaint was involved. The reporter also noted that the pt took montelukast sodium and experienced an adverse event. Additional info has been requested.
Age: 1.02
Sex: F
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 5 yr old white female, with no medical history and no allergies, who on 31Jan01 was vaccinated with a 0.5ml SC first dose in the left leg of varicella virus vaccine live (lot 636571/0928K). Concomitant vaccines administered on the same day included a third IM dose in the right leg of poliovirus inactivated (Ipol), a first IM dose in the right leg of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 637423/1512K) and a first IM dose in the left leg of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR). There was no illness at the time of vaccination and no adverse events following prior vaccinations. It was reported that the pt as brought into the office on 16Apr05 complaining of leg pain. The pt was brought back into the office on 10Apr05 with the same complaint. The physician then diagnosed the pt with herpes zoster and prescribed acyclovir. It was noted that as of last evening the physician did not have any follow up on the pt. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that the onset of severe right thigh pain was 15Apr05. The pt experienced continuous pain over 2-3 days. Then there was an onset of a rash on her right calf. A Tzanck smear of the right calf showed no evidence of malignancy and the cell findings were consistent with a herpes cytopathic effect. The pt responded to acyclovir. It was reported that on 21Apr05 the pt recovered. Additional information is not expected.
Age: 1.94
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Info has been received from a physician concerning her 6 year old son with no pre-existing allergies or medical conditions, who in at approximately 2 years of age (approximately September, 1999), was vaccinated with a dose of varicella virus vaccine live. The pt was not ill at the time of his vaccination. In June, 2004 (exact date not specified), the pt developed varicella disease, which was described as a mild case of breakthrough varicella with approximately 40-50 lesions (also previously reported as 25 lesions). The reporter also noted that her son had a low-grade fever. It was reported that there was an "outbreak" at his school. He recovered in approximately 10 days. There were no diagnostic or lab tests performed. No additional info is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from an LPN concerning her niece, a 6 year old female, who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced mild case of varicella. The nurse reported that her nephew also experienced a mild case of varicella after vaccination. Additional info has been requested.
Age: 1.02
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Cellulitis, Drug ineffective, Scar, Viral infection
Clinical narrative: Info has been received from a physician concerning a 5 year old white male student who on 12/18/00 was vaccinated with a 1st dose of varicella virus vaccine live. Concomitant vaccination included a 4th dose of Hib-Titer, given in the left thigh. There were no other concomitant medications. On 3/16/05, the pt developed severe chickenpox. He had greater than 114 lesions in his left arm alone. Unspecified medical attention was sought. The pt also had cellulitis on the dorsum of his right foot requiring oral antibiotics. It resolved well, but the pt does have significant scaring. It was reported that the pt subsequently recovered. There was no product quality complaint involved. The physician considered the pt's severe chickenpox and cellulitis to be other important medical events. No further info is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Info has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional info has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from an LPN concerning a 4 year old male with no medical history or allergies who on 8/30/01 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. There was no illness at the time of vaccination. The LPN reported that on 4/20/05, the pt developed breakthrough characterized by a rash consisting of 50 lesions. No fever or other symptoms were noted. The pt was seen on 4/21/05, but no lab/diagnostic tests were performed. Subsequently, the pt recovered. Additional info is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Sepsis, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 5 yr old male described as a normal healthy child with no significant medical history except a speech delay, no allergies and no known or recent exposure to varicella who on 28Sep00 was vaccinated in the leg (side unk) with a first dose of varicella virus vaccine live. There was no concomitant medication. On 21Apr05 the pt presented to the office shingles on his right shoulder. The child had no other complaints. A vesicular fluid specimen was obtained from on of the child's lesions which will be submitted for PCR analysis through the VZV ID Program. At the time of the report the specimen was refrigerated in a sterile container until instructions were available as to where to send the sample. No other lab tests were done. Follow up information indicated that the pt had a rash that was zoster-like, but was otherwise well. No complications were noted. The distribution of lesions was on the right shoulder, but the number of lesion were not counted. The adequate vesicular swab specimen was collected on 21Apr05 and was received on 06May05. The results of the PCR analysis revealed that the specimen contained the wild type varicella zoster virus. Follow up information was received from the physician which indicated that the pt recovered prior to 18May05. Additional information is not expected.
Age: 1.49
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash pruritic, Skin ulcer
Clinical narrative: Information has been received from a LPN concerning a 6 yr old white male with no medical history who on 28Apr00 was vaccinated SC with a 0.5mL first dose in the right arm of varicella virus vaccine live (lot632619/1861J) (also reported as Lot 1816J). There was no concomitant therapy. The LPN reported that on 19Apr05 the pt developed lesions all over body on his torso, head, under axilla, in the underwear area and face. The pt was noted to be afebrile. On 21Apr05, the pt was seen in the physician's office. No lab/diagnostic tests were performed and the pt was treated with diphenhydramine HC1 (Benadryl). At the time of this report the pt's lesions persisted. Follow up information from a licensed practical nurse indicated that on 19Apr05 the pt experienced a itchy rash with vesicles and scabs in different stages all over his torso, arms and legs. It was reported that the pt recovered. Additional information is not expected.
Age: 1.04
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with no known medical history or allergies who on 12/10/1999 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. Concomitant vaccination that day included an IM first dose of hepatitis B vaccine, recomb Engerix B in the left arm. There was no illness at the time of vaccination. On 4/11/2005 the patient developed a few vesicles and blisters on abdomen, back and groin. Unspecified medical attention was sought and symptomatic treatment included Avena Aveeno bath and diphenhydramine hydrochloride Benadryl. No relevant diagnostic test were performed. There were no adverse events following prior vaccination. Subsequently, the patient recovered. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTP, IPV, MMR, VARCEL
Symptoms: Injection site pain, Medication error
Clinical narrative: Info has been received from an RN concerning a 4 year old Caucasian male with no pertinent medical history and no drug allergies who on 4/21/05 was vaccinated, SC in the left lower thigh, with the 1st 0.5ml dose of varicella virus vaccine live. Concomitant therapy included DTAP, poliovirus vaccine inactivated and MMRII. The varicella virus vaccine live had expired on 4/17/05. It was reported that the pt experienced no adverse reaction but the RN did report slight soreness at the site on the day of administration, which only lasted for one day. Unspecified medical attention was sought. The RN noted that the pt's mother declined re-vaccination and no other problems were noted. No product quality complaint was involved. Additional info is not expected.
Age: 1.4
Sex: F
Vaccine: DTP, PPV, VARCEL
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Information has been received from a RN concerning a 16 month old female who on 30-JUL-03 was vaccinated SC with a first dose of 0.5ml VARIVAX (Merck). Concomitant vaccinations given on that same day included a fourth dose of PNEUMOVAX 23 (manf unspecified) and a fourth dose of DTP (manf unk). Almost immediately after the injection the patient experienced hives and redness around the injection site. Unspecified medical attention was sought, no diagnostic or laboratory tests were performed. The RN reported that the patient has recovered. The reporter included an immunization summary: first, second and third doses of DTP given on 13-MAY-02, 17-JUL-02 and 26-SEP-02, respectively; first, second, third and fourth doses of Hib conj vaccine (unspecified carrier) on 25-APR-02, 13-MAY-02, 17-JUL-02 and 26-SEP-02, respectively; the first, second, and third doses of hep B virus vaccine rHBsAg (yeast) (manf unspecified); given on 06-MAR-02, 08-APR-02 and 03-DEC-02, respectively; the first, second and third doses of poliovirus vaccine inactivated (unspecified) given on 13-MAY-02, 17-JUL-02 and 26-SEP-02, respectively; and the first, second and third doses of pneumococcal 23v polysaccharide vaccine (manf unspecified) given on 13-MAY-02, 17-JUL-02 and 26-SEP-02, respectively. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a pt who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 4/22/05, the pt developed mild breakthrough varicella. Unspecified medical attention was sought and at the time of this report, the outcome was unknown. Additional info has been requested.
Age: 1.09
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from an RN concerning a 6 year old white female with no known medical history or allergies who in the PM of 8/13/99, was vaccinated, SC in the right upper arm with 0.5ml, 1st dose of varicella virus vaccine live. Concomitant vaccination that day included a 1st dose of MMRII. The RN reported that the morning of 4/21/05 (also reported as 4/28/05), the pt developed chickenpox, it was reported that the mother phoned the office, but the pt was not seen. It was also noted that the pt "had recent exposure". Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the pt had recovered. Additional info is not expected.
Age: 1.31
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 5 year old female with no known medical history or allergies who on 3/15/01, was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. On approximately, 4/12/05, the pt developed breakthrough chickenpox with lesions that lasted 24 hours on her back. On 4/12/05, the pt was seen in the office. Treatment included calamine lotion and Benadryl. On 4/18/05, the pt was seen in the office, her lesions had resolved. There was no product quality complaint involved. Additional info has been requested.
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a physician concerning a 6 year old male who on 10/29/99, was vaccinated with a dose of varicella virus vaccine live. On 4/22/05, the pt developed breakthrough varicella with 3 lesions after being exposed to another previously vaccinated classmate that contracted chickenpox. Unspecified medical attention was sought. A product quality complaint was not involved. No further info is available. The physician who also reported that one female child and approximately 6 other children developed breakthrough varicella after vaccination with varicella virus vaccine live.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from an LPN concerning her nephew, an 8 year old male, who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced mild case of varicella. The nurse reported that he niece also experienced a mild case of varicella after vaccination. Additional info has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 6 year old Hispanic male, who developed a rash to penicillin, who, on 4/22/05, was vaccinated with a 1st dose in the left deltoid of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that on 4/25/05, the pt presented with about 100 vesicular lesions and no other symptoms. At the time of the report, the pt was recovering. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Follow-up info from a health professional indicated that on 4/23/05, the pt broke out in about 100 vesicles on his trunk, arms and face one day after vaccination with varicella virus vaccine live. It was reported that the pt recovered within 2 weeks. Additional info is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash papular, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 yr old Asian male with no medical history who on 12Oct98 was vaccinated SC with a dose of varicella virus vaccine live. There was no concomitant therapy and no illness at the time of vaccination. The physician reported that in March 2005, the pt developed breakthrough. Unspecified medical attention was sought, but no lab/diagnostic tests were performed. At the time of this report, the pt was recovering. Follow up information indicated that the child presented in the office on 23Mar05 with papules and vesicles all over the body. There were over 100 lesions and some were in the scabbing stage. The diagnosis was breakthrough varicella with an onset date of 23Mar05. The pt recovered on 30Mar05. The pt's sister (WAES0505USA01974) also developed varicella after vaccination with varicella virus vaccine live. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a RN concerning a 12 month old female who over the past year was vaccinated SC with a dose of 0.5ml varicella virus vaccine live. Almost immediately after the injection, the pt experienced hives around the injection site. Unspecified medical attention was sought. The RN reported that the pt has recovered. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 4 yr old pt who in 2000 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt experienced breakthrough chickenpox with 10 lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that she did not have access to any information that the letter was asking for. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Skin ulcer
Clinical narrative: Information has been received from a consumer concerning a 9 yr old male who was vaccinated with a dose of varicella virus vaccine live. On 23Apr05 the pt experienced 4 chickenpox like lesions. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 yr old female child with no medical history or allergies who was vaccinated on 11Nov97 at another practice with the first dose of varicella virus vaccine live (lot unavailable). There was no illness at the time of vaccination. The physician reported that on 06May05 the pt developed cases of mild breakthrough varicella (with few vesicles). The physician described it as clinical varicella. The pt's present status was reported as recovered. The physician also noted that the pt's unvaccinated father also developed varicella. No product quality complaint was involved. The physician also reported that the pt's sister also developed varicella (associated WAES0505USA02237). Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 or 9 yr old male who sometime in the late 1990's was vaccinated with a dose of varicella virus vaccine live. Subsequently, on an unspecified date the pt developed full blown chickenpox. Unspecified medical attention was sought. At the time of this report the pt's present status was not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Info has been received from a physician concerning a 24 month old male pt who was vaccinated with a dose of varicella virus vaccine live. The physician reported that the pt developed zoster on the arm and was treated with acyclovir. It was noted that zoster improved and the pt improved and the pt recovered from the zoster on an unknown date. There was no product quality complaint reported. Unspecified medical attention was sought. Additional info has been requested.
Age: 1.5
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster, Infection
Clinical narrative: Info has been received from a physician concerning an 18 month old pt who "12 months ago", in 4/04, was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt "developed zoster on the trunk, just one dermatome". Unspecified medical attention was sought. It was reported that the pt's adverse experience resolved on it's own, and at the time of the report, the pt was recovered. There was no product quality complaint involved. Additional info has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Laboratory test abnormal
Clinical narrative: Info has been received from a health professional concerning a 21 year old female, that had chickenpox when younger, but had a titer drawn on 1/13/05, which was negative. The pt indicated that she has no pertinent medical history and has no drug allergies. On 2/15/05, she was vaccinated in the right arm with a 1st dose of varicella virus vaccine live. The pt stated that she was not taking any other medications. The health professional reported that on 2/15/05, the pt developed a 45mm swelling and redness of the right arm. The pt indicated that she did not call the office when her arm swelled. Just tried not to touch it. The pt also reported that it took about 1 1/2 weeks, on approximately 2/25/05, to recover post/vax. Unspecified medical attention was sought. No produce quality complaint was involved. Additional info has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 37 month old male with no medical history and no allergies, who on 14MAr03 was vaccinated with a 0.5ml dose of varicella virus vaccine live (lot 0936). There was no concomitant medication. It was reported that the pt came into the office on 26Apr05 with a mild case of varicella. He had a rash and no lesions. The pt's status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 yr old female who in approx 2000, between the ages of 12 and 15 months, was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed breakthrough varicella. The number of lesions was not reported. Unspecified medical attention was sought. It was not reported if treatment was necessary. There was no product quality complaint involved. Additional information has been requested.
Age: 1.55
Sex: M
Vaccine: DTAPH, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Skin ulcer
Clinical narrative: Info has been received from a physician concerning an 18 month old male who on 4/18/05 was vaccinated with a SC, 0.5 ml dose, in the left thigh, of varicella virus vaccine live. Concomitant vaccine, administered on the same day, included DTAP. It was reported that on 4/27/05, the pt spiked a high fever and began to have seizures. The pt was transported via ambulance to the hospital this morning, on 4/28/05, at 05:00 AM. The fever on arrival at the ER was 103F. The pt experienced several additional seizures at the hospital. The report said the child presented with febrile seizures and lesions on his back. One of the lesions was oozing. A spinal tap was done and the CSF was normal. The pt remains hospitalized on IV fluids and acetaminophen. The pt's status was reported as not recovered. No product quality complaint was involved. No other info was provided. Additional info has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from a physician concerning a 9 year old male who was vaccinated with a dose varicella virus vaccine live as a child at another physician's office. Subsequently, the pt developed chickenpox, less than 50 lesions which had crusted over. Unspecified medical attention had been sought. At the time of this report, the pt was recovering. No product quality complaint was involved. Additional info has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 10 year old male who in approximately 1996, between the ages of 12 and 15 months, was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt developed breakthrough varicella. The number of lesions was not reported. Unspecified medical attention was sought. It was not reported if treatment was necessary. There was no product quality complaint involved. Additional info has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning his son who was vaccinated with a dose of varicella virus vaccine live. It was reported that the pt developed a mild breakthrough case. Unspecified medical attention was sought. No other info was provided. Additional info has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician and a nurse practitioner concerning a 9 yr old male who on 04Dec96, at one year of age, was vaccinated one time SC with a 0.5ml dose of varicella virus vaccine live (lot 620614/1106D). There was no concomitant medication. On 25Apr05 the pt was seen in the physician's office with varicella lesions primarily on the trunk and also around the eyes. The physician reported that a varicella test was performed. The pt fully recovered with no treatment at one week. No product quality complaint was involved. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Medication error
Clinical narrative: Information has been received from a health professional concerning an approx 26 yr old female pt who 2-3 years ago in approx 2002 or 2003 was vaccinated with varicella virus vaccine live. The pt believes that she received two doses at the same time using two different injection sites. A recent titer did not show seroconversion. Unspecified medical attention was sought. It was reported that the pt had no symptoms at the present time. There was no product quality complaint involved. Additional information has been requested.