chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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 no allergies or medical conditions who in 2000, at 12 months of age, was vaccinated SC with a 1st dose of 0.5ml of varicella virus vaccine live. There was no illness at the time of vaccination. On 7/1/05, the pt presented with a rash which the reporter dx'd as a mild case of breakthrough. The pt was not febrile. A product quality complaint was not involved. Follow-up info was received from the physician who reported that on 6/24/05, the pt had a rash consistent with atypical varicella post/vax. Subsequently, the pt recovered. No diagnostic lab tests were performed. It was noted that neither the pt nor her sibling had any adverse events following prior vaccination. No further info is expected.
Age: 1.07
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a physician concerning a 17 month old male pt who on 1/28/05 was vaccinated with varicella virus vaccine live. On 6/29/05, the pt experienced a mild case of breakthrough chicken pox. It was noted that he was afebrile. There was no product quality complaint reported. The pt is recovering. Follow-up info received from the physician reported that there are no additional details regarding the adverse event or pt's outcome. The pt sought unspecified medical attention. No additional info is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a physician concerning her oldest child (child has 4 younger siblings) who, at the age of 3, was vaccinated, SC with a 0.5ml dose of varicella virus vaccine live. In February or March, 2005, the pt broke out with chickenpox during a school outbreak, developing about 40 lesions but no other symptoms. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that the pt's 2 siblings also developed chickenpox (WAES0509USA02318 and WAES0509USA02319). Additional info has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning an 8 year old male, with no medical history and no allergies, who on 7/14/98 was vaccinated with a SC 1st dose in the left thigh of varicella virus vaccine live. There was no illness at the time of vaccination. It was reported that on 7/1/05, the pt developed a rash, with 80 lesions, scattered over his body. The pt was taken to the ER. He was afebrile and was given symptomatic treatment only. It was reported that the pt was recovering. No product quality complaint involved. Follow-up info from a health professional indicated that the pt's mother called the office on 7/5/05 and stated that she had a physician friend check the pt's rash that started on 7/3/05 and dx'd it as varicella. It was noted that there were approximately 80 vesicles on his back and chest with no fever. The lesions were all crusted over and the pt recovered on 7/5/05. Additional info is not expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Pyrexia
Clinical narrative: Info has been received from an RN, who is the mother, concerning her 28 year old daughter, who was vaccinated with 2 doses of varicella virus vaccine live. She was 18 years old (approximately 1995). It was reported that on 7/2/05, the pt had a "mild" breakthrough case of varicella with a mild fever. At the time of the adverse event reporting, the pt was recovering. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional info has been requested.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature decreased, Drug ineffective, Infection, Pruritus, Rash vesicular
Clinical narrative: Info has been received from an RN concerning a 7 year old male with an allergy to azithromycin (Zithromax) and no pertinent medical history who on 7/31/99 was vaccinated, SC in the left deltoid with a 0.5ml 1st dose of varicella virus vaccine live. Concomitant vaccination on the same day included a 1st dose in the left thigh of MMRII. There was no other concomitant medication. There was no illness at the time of vaccination. On 6/29/05, the pt experienced a rash with some filled vesicles. A questionable unknown exposure was noted. He was treated with Benadryl. Aveeno Bath and calamine lotion. On 7/31/05, the pt had many lesions on his face, scalp and extremities with itching. He was afebrile, alert and not ill. Unspecified medical attention was sought. No diagnostic lab studies were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Follow-up info was received from the RN who reported that on 6/29/05, the pt developed breakthrough chickenpox with a rash and itching. The pt was last seen for this on 7/1/05 and subsequently recovered. No further info is expected. 05/16/2008 Information has been received from a registered nurse concerning a 7-year-old male with an allergy to ZITHROMAX and no pertinent medical history who on 31-JUL-1999 at 10:50 AM was vaccinated SC in the left deltoid (also report IM in the left thigh) with a 0.5 ml first dose of VARIVAX (Oka/Merck) (lot # 631067/0447J). Concomitant vaccination on the same day included a first dose in the left thigh of MMR II (MSD). There was no other concomitant medication . There was no illness at the time of vaccination. On 29-JUN-2005, the patient experienced a rash with some filled vesicles. A questionable unknown exposure was noted. He was treated with BENADRYL ELIXIR, AVEENO BATH, and calamine lotion. On 01-JUL-2005, the patient had many lesions on his face, scalp, and extremities with itching. He was afebrile, alert, and not ill. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow-up information was received from the registered nurse who reported that on 29-JUN-2005, the patient developed break through chickenpox with a rash and itching. Symptomatic treatment was provided. The patient was last seen for this on 01-JUL-2005 and subsequently recovered. No further information is expected.
Age: 1.25
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Info has been received from an RN concerning a 7 year old male with an allergy to azithromycin (Zithromax) and no pertinent medical history who on 7/31/99 was vaccinated, SC in the left deltoid with a 0.5ml 1st dose of varicella virus vaccine live. Concomitant vaccination on the same day included a 1st dose in the left thigh of MMRII. There was no other concomitant medication. There was no illness at the time of vaccination. On 6/29/05, the pt experienced a rash with some filled vesicles. A questionable unknown exposure was noted. He was treated with Benadryl. Aveeno Bath and calamine lotion. On 7/31/05, the pt had many lesions on his face, scalp and extremities with itching. He was afebrile, alert and not ill. Unspecified medical attention was sought. No diagnostic lab studies were performed. At the time of the report, the pt was recovering. A product quality complaint was not involved. Follow-up info was received from the RN who reported that on 6/29/05, the pt developed breakthrough chickenpox with a rash and itching. The pt was last seen for this on 7/1/05 and subsequently recovered. No further info is expected. 05/16/2008 Information has been received from a registered nurse concerning a 7-year-old male with an allergy to ZITHROMAX and no pertinent medical history who on 31-JUL-1999 at 10:50 AM was vaccinated SC in the left deltoid (also report IM in the left thigh) with a 0.5 ml first dose of VARIVAX (Oka/Merck) (lot # 631067/0447J). Concomitant vaccination on the same day included a first dose in the left thigh of MMR II (MSD). There was no other concomitant medication . There was no illness at the time of vaccination. On 29-JUN-2005, the patient experienced a rash with some filled vesicles. A questionable unknown exposure was noted. He was treated with BENADRYL ELIXIR, AVEENO BATH, and calamine lotion. On 01-JUL-2005, the patient had many lesions on his face, scalp, and extremities with itching. He was afebrile, alert, and not ill. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. At the time of the report, the patient was recovering. A product quality complaint was not involved. Follow-up information was received from the registered nurse who reported that on 29-JUN-2005, the patient developed break through chickenpox with a rash and itching. Symptomatic treatment was provided. The patient was last seen for this on 01-JUL-2005 and subsequently recovered. No further information is expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Info has been received from a health professional concerning a 11 year old healthy female with Down's Syndrome who on 1/17/96 was vaccinated with a dose of varicella virus vaccine live. On 7/3/05, the pt experienced 50 lesions on her back, chest, groin and face described as itchy fluid filled blisters. She was afebrile. Treatment was symptomatic and the pt is recovering. No product quality complaint was involved. Follow-up info has been received which indicated that the pt's condition resolved. Additional info is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a physician concerning an approximately 2 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced breakthrough varicella with 3 small patches of lesions. These lesions became infected with Staph, however, it was reported that the family members all have a Staph infection and infected the child. Unspecified medical attention was sought. The physician reported that the girl was recovering as 7/6/05. Additional info has been requested.
Age: 41.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Pyrexia
Clinical narrative: Info has been received from a health professional concerning a 40 year old white female with no history of chickenpox and no allergies who on 5/5/05 was vaccinated SC in the right arm with a 0.5ml, 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. The nurse called the pt to schedule the 2nd dose  and the woman said she had developed slight fever and localized rash that looked like chickenpox. The nurse reported that the reaction sounded very mild and lasted only a few days. The pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info indicated that the pt called to schedule the 2nd dose of vaccine and reported that she had a mild case of chickenpox during the week after receiving the vaccine, on approximately 5/11/05. She said she had a few spots and a slight temperature. The nurse did not know the number of spots or the exact temperature. No labs were done. The pt recovered. Additional info is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from an RN concerning a pt who was vaccinated, SC, with a 0.5ml dose of varicella virus vaccine live and experienced breakthrough from the vaccination. There was no product quality complaint reported. No further info was available regarding the adverse event or the pt's outcome. The pt sought unspecified medical attention. No further info is available.
Age: 1.1
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Infection, Infection transmission via personal contact
Clinical narrative: Info has been received from a health professional concerning a 16 month old white female, with no medical history and no allergies, who, "at 13 month of age", on 1/13/2004, was vaccinated with a 1st SC dose in the right arm of varicella virus vaccine live. Concomitant vaccine administered on the same day, included a 4th IM dose in the left thigh of Prevnar. There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that, in July 2005, the pt developed a case of breakthrough with about 50 lesions and no fever. Unspecified medical attention was sought. No product quality complaint was involved. No further information was provided. Follow-up info from a person from a pediatric office indicated that the rash started two weeks ago, on 4/13/04 (also reported as July 2005 at 13:15, with exposure to chickenpox. It was described as a blistery rash all over. It was relieved by a baking soda bath. The rash re-appeared yesterday and was described as pruritic with approximately 50 tear drop vesicles in different stages, erythematous, based on her head, back, scalp, trunk and pelvis. The pt had no fever and was otherwise well. It has reported that the pt's symptoms were treated with clinical care and subsequently recovered. Additional info is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Info has been received from a health professional concerning a child who was vaccinated with a 0.5ml, SC, dose of varicella virus vaccine live. Subsequently, the pt experienced a full blown case of chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Follow-up info from a health professional noted that the report she gave was hearsay and that they have never had a case of breakthrough at the clinic. Additional info is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Info has been received from a health professional concerning a 7 year old (previously reported as 4 year old) white male with no allergies or medical conditions who on 4/4/02, was vaccinated SC, in the left deltoid with a 0.5ml 1st dose of varicella virus vaccine live. There were no concomitant medications and no illness at the time of vaccination. On 4/7/05, the pt experienced breakthrough chickenpox. No labs or diagnostic tests were performed. Unspecified medical attention was sought. No product quality complaint was involved. No other info was available at this time. Follow-up info indicated that the pt recovered in April 2005, 2 weeks later. The pt's sibling (WAES0507USA02233) also developed breakthrough chickenpox after vaccination with varicella virus vaccine live. Additional info 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 who, in approx. 2001, at 12 months of age, was vaccinated with a dose of varicella virus vaccine live. On 5/4/05 the pt had a mild case of breakthrough. This case was verified by the nurse, but she was not seen by a doctor. The mother used over the counter medications to make the child comfortable. Unspecified medical attention was sought and the child recovered. No product quality complaint was involved. Additional info has been requested.
Age: 37.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Malaise, Pyrexia, Rash papular, Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a physician concerning a 37 yr old white male with a history of inflammatory bowel disease and inflammatory arthritis who on 14Jun05 was vaccinated SC with a first 0.5ml dose of varicella virus vaccine live. Concomitant medications the same day included a first dose of hep A virus vaccine inactivated (manf unk) and a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. Recently, in approx 2005, the pt developed several dozen lesions. Unspecified medical attention was sought. No product quality complaint was involved. The pt is recovering. Follow up information from the physician indicated that on 04Jul05 the pt began with vesicular skin lesions, LG temp and malaise. He was seen in the office on 06Jul05 and  had several dozen vesicular and papular on trunk. Diagnosis was disseminated zoster. It was noted that the pt was off the leflunomide (Arava) since Feb 2005 and had ana shot. It was also noted that his last etanercept (Enbrel) was 20 days before vaccines. The pt recovered. The physician felt that the disseminated zoster was an other important medical event (OMIC). No additional information was provided.
Age: 1.33
Sex: F
Vaccine: DTAP, HBHEPB, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 16 month old white female with "aszma" who on 18May05 at 15:00PM was vaccinated SC in the left deltoid with a first dose of varicella virus vaccine live (lot 649481/0764P). Concomitant vaccinations given on the same day included: the second dose of diphtheria toxoid (+) pertussis acellular 3 component vaccine (+) tetanus toxoid (Infanrix) (lotDTPA620A9) given intramuscularly in the left thigh, the second dose of Hib conj hep B vaccine (lot646451/0560N) given IM in the right thigh, the first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 647113/0346P) given SC in the right deltoid, the second dose of  pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR) (lot A67182A) given IM in the right thigh and the second dose of poliovirus vaccine inactivated (Ipol) (lot X1038) given IM in the left thigh. There was no known illness at the time of vaccination. In the evening of 24May05 the pt developed a low grade fever and on 25May05 the pt was seen at the health dept with approx 10 vesicle lesions on her neck, chest, and arms. The pt was diagnosed with varicella disease (noted to be possible vaccine induced). The family was advised to consider the child contagious for at least 4-5 days until all of the areas were scabbed over. No further information was available at the time of this report.  The reporter also noted the pt's previous immunization record: the first dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, poliovirus vaccine given on 05Oct04, the first dose of poliovirus vaccine inactivated (unspecified) given on 05Oct04, the first dose of hep B virus vaccine (unspecified) (+) Hib vaccine (unspecified) given on 05OCT04 and the first dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (PREVNAR) given on 05Oct04. The nurse also reported three siblings of the girl who had adverse experiences (WAES0507USA03557, 0507USA03558, and 0507USA03559). Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a health professional concerning a child between the age of 6 and 8 yrs old who at 12 months old, was vaccinated with a 0.5ml, SC dose of varicella virus vaccine live. It was reported that the pt experienced breakthrough chickenpox with less than 50 lesions and if there was a fever it was very mild. 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 she didn't recall any other information. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male with no allergies or medical conditions who on 17Jul96 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. There was no illness at the time of vaccination. On 06Jun05, the pt was seen in a doctor's office for multiple varicella lesions on the trunk and head. The pt was treated with diphenhydramine hydrochloride (Benadryl) and calamine. Subsequently, the pt recovered in mid June 2005. No diagnostic lab tests were performed. Additional information is not expected.
Age: 1.12
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 19 month old male, of unk race, with no medical history and no allergies, who on 07Dec04 was vaccinated with a SC first dose in the right arm of varicella virus vaccine live (lot 649281/0656P). Concomitant vaccines included a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar), hep B vaccine, recomb (manf unk) and a dose of poliovirus vaccine. There was no illness at the time of vaccination. On 02Jun05 the pt experienced 10-20 papular lesions on his trunk and thighs. Symptomatic treatment was given. It was reported that the pt recovered on approx mid Jun 2005. There were no lab or diagnostic tests performed. Unspecified medical attention was sought. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 9 yr old male pt with Attention Deficit Disorder, developmental delay and a history of reactive airways disease, who on 30Jun98 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (lot 625476/0645H). There was no concomitant medication. It was noted that the pt was not ill at the time of vaccination. On 02Jun05 the pt developed 30 plus papular lesions. He was seen by the physician and given symptomatic treatment. There were no lab test performed. The pt recovered in mid June 2005. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer
Clinical narrative: Information has been received from a health professional concerning a 15 month old white male, with an azithromycin (Zithromax) allergy, who on 11Jul05, at 10:30AM, was vaccinated with a first SC dose of varicella virus vaccine live (lot 648554/0584P). There was no illness at the time of vaccination and no adverse events following prior vaccination. It was reported that the pt developed a rash on his back, described as a cluster of bumps with a white center, the day after receiving his varicella virus vaccine live vaccination, on 12Jul05. It was noted that the pt did not have a fever. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a woman working in a physician's office indicated that the day after receiving varicella virus vaccine live, on 12Jul05, the pt developed about 10 raised, red lesions with white centers extending from the base of the right scapula extending to the middle of his back. Follow up information from a woman working in a physician's office indicated that they had no further information. Additional information is not expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Condition aggravated, Drug ineffective, Eczema, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 yr old female who on 18Jan00 was vaccinated with a dose of varicella virus vaccine live. On 26May05 the pt experienced breakthrough chickenpox. At that time, the pt was in the midst of an episode of eczema. This resulted in a severe rash on the pt's face, trunk and neck. The pt was hospitalized and treated with antibiotics. Subsequently, the pt recovered. There was no product quality complaint involved. Follow up information from the physician indicated that he did not give the original vaccine and he has no additional information to provide. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cellulitis, Dermatitis bullous, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 36 yr old female with no pertinent medical history and no drug reactions or allergies who on 20Jun05 was vaccinated with a dose of varicella virus vaccine live (lot 647712/0983P). On 05Jul05 the pt called the office because she had a swollen deltoid with a red area of 3cm. She also had a couple pox marks on her deltoid. The experience began on 04Jul05. It was diagnosed as a bad cellulitis and she was prescribed antibiotics, diphenhydramine hcl (Benadryl) and cold compresses. The pt recovered on an unk date. No product quality complaint was involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Influenza like illness, Injection site erythema, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a health professional concerning a 36 yr old female with no pertinent medical history and no drug reactions or allergies who on 20Jun05 was vaccinated with a dose of varicella virus vaccine live (lot 647712/0983P). On 05Jul05 the pt called the office because she had a swollen deltoid with a red area of 3cm. She also had a couple pox marks on her deltoid. The experience began on 04Jul05. It was diagnosed as a bad cellulitis and she was prescribed antibiotics, diphenhydramine hcl (Benadryl) and cold compresses. The pt recovered on an unk date. No product quality complaint was involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 36 yr old female with no pertinent medical history and no drug reactions or allergies who on 20Jun05 was vaccinated with a dose of varicella virus vaccine live (lot 647712/0983P). On 05Jul05 the pt called the office because she had a swollen deltoid with a red area of 3cm. She also had a couple pox marks on her deltoid. The experience began on 04Jul05. It was diagnosed as a bad cellulitis and she was prescribed antibiotics, diphenhydramine hcl (Benadryl) and cold compresses. The pt recovered on an unk date. No product quality complaint was involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cellulitis, Dermatitis bullous, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 36 yr old white female teacher, who on 20Jun05 at 10:00AM was vaccinated with a first 0.5ml SC dose of varicella virus vaccine live (lot647712/0983P). One week ago on approx 07Jul05, the pt broke out with a rash at the injection site. The pt also had swelling and pain at the inj site. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 01Jul05 the pt experienced a pox like lesion in the site of vaccination, with induration, redness and pain in the local area. It was also reported that the pt experienced a low grade fever and flu like symptoms. It was noted that the pt was seen in the office, but did not require treatment to prevent a serious outcome. It was reported that the pt recovered. The reporter had no further information regarding the pt's experience. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Influenza like illness, Injection site erythema, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 36 yr old white female teacher, who on 20Jun05 at 10:00AM was vaccinated with a first 0.5ml SC dose of varicella virus vaccine live (lot647712/0983P). One week ago on approx 07Jul05, the pt broke out with a rash at the injection site. The pt also had swelling and pain at the inj site. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 01Jul05 the pt experienced a pox like lesion in the site of vaccination, with induration, redness and pain in the local area. It was also reported that the pt experienced a low grade fever and flu like symptoms. It was noted that the pt was seen in the office, but did not require treatment to prevent a serious outcome. It was reported that the pt recovered. The reporter had no further information regarding the pt's experience. Additional information is not expected.
Age: 37.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 36 yr old white female teacher, who on 20Jun05 at 10:00AM was vaccinated with a first 0.5ml SC dose of varicella virus vaccine live (lot647712/0983P). One week ago on approx 07Jul05, the pt broke out with a rash at the injection site. The pt also had swelling and pain at the inj site. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a health professional indicated that on 01Jul05 the pt experienced a pox like lesion in the site of vaccination, with induration, redness and pain in the local area. It was also reported that the pt experienced a low grade fever and flu like symptoms. It was noted that the pt was seen in the office, but did not require treatment to prevent a serious outcome. It was reported that the pt recovered. The reporter had no further information regarding the pt's experience. Additional information is not expected.
Age: 1.27
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Fluid retention, Pyrexia, Rash vesicular, Rhinorrhoea
Clinical narrative: Information has been received from a RN concerning a 15 month old healthy female pt with no allergies, who on 01Jul05 was vaccinated with varicella virus vaccine live (lot 648319/0441P). The nurse reported that the pt was seen in the physician's office with a rash from head to toe. The events were reported to have started on 12Jul05. The nurse described the majority of lesions as fluid filled. The pt also had a runny nose, cough, and fever. The pt was prescribed diphenhydramine (Benadryl) and guaigenesin (Robitussin). At the time of this report the pt was not recovered. There was no product quality complaint reported. Additional information has been requested.
Age: 1.27
Sex: F
Vaccine: VARCEL
Symptoms: Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 15 month old healthy female pt with no allergies, who on 01Jul05 was vaccinated with varicella virus vaccine live (lot 648319/0441P). The nurse reported that the pt was seen in the physician's office with a rash from head to toe. The events were reported to have started on 12Jul05. The nurse described the majority of lesions as fluid filled. The pt also had a runny nose, cough, and fever. The pt was prescribed diphenhydramine (Benadryl) and guaigenesin (Robitussin). At the time of this report the pt was not recovered. There was no product quality complaint reported. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neck pain, Pruritus, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 14 year old white female pt who may have been vaccinated with a dose of varicella virus vaccine live. It was noted that  the pt was not ill at the time of vaccination. The pt's mother called the physician's office to report that the pt had received the vaccine years ago but the physician was not sure that the pt had received it. Within the past week, on approx 11Jul05, the pt had a high fever, neck pain, and a rash all over her body with greater than 100 lesions. At the time of the report, the parent was going to take the pt to a hospital. Unspecified medical attention was sought. A product quality compliant was not involved. Follow up information was received from a physician who reported that he did not care for the pt and did not have details. He indicated that the mother of the pt was unsure when the pt was exposed to varicella, but there were some modified varicella cases in the area. It was noted that the pt was vaccinated nine to ten years ago. The pt was healthy with no past medical history. The pt presented with a high fever, numerous spots, many lesions, a severe headache, and a stiff neck. In the ER, the pt was diagnosed with anterior cervical adenopathy and varicella. The pt has subsequently recovered. Additional information was received from a physician who indicated that the child was vaccinated with varicella virus vaccine live when she was younger and just recently developed chickenpox. He indicated that there was no adverse event. Further information received from the physician indicated that the pt had developed varicella, not modified varicella as previously reported. She had greater than 100 lesions, fever, pruritis, vaginal/vulvar pain, and pruritis. She required anti viral therapy. It was noted that she recovered on 22Jul05. No additional information is expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin ulcer, Vaginal pain, Viral infection
Clinical narrative: Information has been received from a physician concerning a 14 year old white female pt who may have been vaccinated with a dose of varicella virus vaccine live. It was noted that  the pt was not ill at the time of vaccination. The pt's mother called the physician's office to report that the pt had received the vaccine years ago but the physician was not sure that the pt had received it. Within the past week, on approx 11Jul05, the pt had a high fever, neck pain, and a rash all over her body with greater than 100 lesions. At the time of the report, the parent was going to take the pt to a hospital. Unspecified medical attention was sought. A product quality compliant was not involved. Follow up information was received from a physician who reported that he did not care for the pt and did not have details. He indicated that the mother of the pt was unsure when the pt was exposed to varicella, but there were some modified varicella cases in the area. It was noted that the pt was vaccinated nine to ten years ago. The pt was healthy with no past medical history. The pt presented with a high fever, numerous spots, many lesions, a severe headache, and a stiff neck. In the ER, the pt was diagnosed with anterior cervical adenopathy and varicella. The pt has subsequently recovered. Additional information was received from a physician who indicated that the child was vaccinated with varicella virus vaccine live when she was younger and just recently developed chickenpox. He indicated that there was no adverse event. Further information received from the physician indicated that the pt had developed varicella, not modified varicella as previously reported. She had greater than 100 lesions, fever, pruritis, vaginal/vulvar pain, and pruritis. She required anti viral therapy. It was noted that she recovered on 22Jul05. No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a female who in 2002 was vaccination with a first and second dose of varicella virus vaccine live, four to five weeks apart. It was reported that when the pt's varicella antibody titer was tested recently, the level came back undetectable. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a five year old female patient who was vaccinated once, at the age of one year (approximately July 2001) with a 0.5 ml SC dose of varicella virus vaccine live. The physician reported that last week (approximately 7/7/2005) (also reported as recently) the patient came into the office with a severe case of chicken pox. The patients body was covered with lesions. It was reported that the patient also had a cough. A chest X ray was done and the results were normal. The physician prescribed Keflex for the patient. At the time the event was reported, the patient was recovering. There was no product quality complaint reported. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a woman working in a physicians office concerning a 5 year old white female, with no medical history and no allergies, who on 7/19/2000 was vaccinated with a first dose in the right thigh of varicella virus vaccine live (lot 632724/0087K). It was noted that the patient was well at the time of vaccination and there were no adverse events following prior vaccinations. On 6/29/2005 the patient was infected with varicella. It was noted that a full recovery was expected without the need for a follow up. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. Additional information is not expected.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a health professional concerning a 28 year old healthy female who on 12/11/1998 and on 1/30/1999 was vaccinated with varicella virus vaccine live. It was reported that the patient had a negative titer for varicella. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old male with eczema who on 5/16/2002 was vaccinated with a dose of varicella virus vaccine live (lot 638361/0564L). There was no concomitant medication. It was reported that the patient used topical triamcinolone when needed for his eczema. In the evening, on 7/13/2005, the patient developed a rash. It was reported that on 7/13/2005 the school notified the patients mother regarding cases of chickenpox in the school. On 7/14/2005 the patient was seen by the physician who confirmed the rash as atypical varicella. No treatment was ordered. At the time of the report the patient's outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male patient with severe poison ivy was exposed to chickenpox, natural varicella which his sister had contracted, approximately two days before he was vaccinated on 6/24/2005 with a dose of varicella virus vaccine live, as a post exposure prophylaxis measure. Concomitant therapy included steroids liquid prednisone (manufacturer unknown). It was noted about 10 days later, on approximately 4/4/2005 he experienced a mild varicella rash. It was described as a raised non vesicular rash on his neck, face, arms, lower abdomen and legs. he had very few spots, under 50. There was no product quality complaint reported. No other information was available regarding the patients outcome. The patient sought unspecified medical attention. Follow up information was received from the registered nurse which reported that the patient recovered. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a child who was vaccianted with a dose of varicella virus vaccine live. Subsequently the patient developed breakthrough chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Dermatitis bullous, Drug ineffective, Pyrexia, Skin ulcer
Clinical narrative: Information has been received from a registered nurse concerning a health 29 year old male with no pre existing allergies, birth defects, or medical conditions who on 8/4/2004 was vaccinated subcutaneously in the left deltoid with a 0.5ml first dose of varicella virus vaccine live (lot 646676/0711N). There was no illness at the time  of vaccination. There was no concomitant medication. A few days later, the patient developed a full blown case of chickenpox characterized by head to toe lesion and a fever of 101F. Medical attention was sought and he was treated with anti viral medication. It was reported that the patient recovered on an unknown date. On Product quality complaint was involved. Follow up information received from a registered nurse indicated that on 7/22/2004, the patient had a varicella titer drawn which showed no protection against chickenpox. It was noted that on 8/22/2004 at 5:00 PM after mowing the grass the patient began breaking out with vesicles resembling chicken pox. He came to employee health on 8/24/2004 with a temperature of 100.4 degrees. Vesicles on the scalp and right chest were noted. The patient was sent for lab work with showed negative varicella tests on 8/24/2004 and protection against chickenpox on 8/30/2004. The physician diagnosed him with varicella. The outcome was reported as recovered on 8/30/2004. Additional information has been requested.
Age: 29.0
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a health 29 year old male with no pre existing allergies, birth defects, or medical conditions who on 8/4/2004 was vaccinated subcutaneously in the left deltoid with a 0.5ml first dose of varicella virus vaccine live (lot 646676/0711N). There was no illness at the time  of vaccination. There was no concomitant medication. A few days later, the patient developed a full blown case of chickenpox characterized by head to toe lesion and a fever of 101F. Medical attention was sought and he was treated with anti viral medication. It was reported that the patient recovered on an unknown date. On Product quality complaint was involved. Follow up information received from a registered nurse indicated that on 7/22/2004, the patient had a varicella titer drawn which showed no protection against chickenpox. It was noted that on 8/22/2004 at 5:00 PM after mowing the grass the patient began breaking out with vesicles resembling chicken pox. He came to employee health on 8/24/2004 with a temperature of 100.4 degrees. Vesicles on the scalp and right chest were noted. The patient was sent for lab work with showed negative varicella tests on 8/24/2004 and protection against chickenpox on 8/30/2004. The physician diagnosed him with varicella. The outcome was reported as recovered on 8/30/2004. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old patient who on 4/4/2002, at 36 months of age, was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Lot 641267/1294L). On 7/7/2005 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available at this time. The patient's sibling WAES0507USA01061, also developed breakthrough chickenpox after vaccination with varicella virus vaccine live (lot 641267/1294L). Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Bacterial infection, Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 yr old female who on 13Jul98 was vaccinated with a dose of varicella virus vaccine live (lot625372/0057H). On 16Jul05 the pt developed breakthrough varicella with about 10 lesion on the trunk. The pt was also diagnosed with having impetigo. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). At the time of the report the pt was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 30 yr old female employee who in 1998 was vaccinated with a dose of varicella virus vaccine live (lot632510/0694E). On 20Jun05 a titer was taken and it did not show seroconversion. Unspecified medical attention was sought. It was reported that no symptoms were present. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a RN concerning a 13 yr old male with no pertinent medical history and no drug reactions/allergies who on 22Mar96 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot612226/1501B). On 18Jul05 the pt presented with a chickenpox vesicular rash, approx 100 lesion, mainly on the trunk of the body. No fever was noted. The child was treated with oral diphenhydramine hydrochloride (Benadryl) as needed. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. Follow up information received from a RN indicated that the outcome was reported as recovered. No additional information is expected.
Age: 1.01
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Bacterial infection, Dry skin, Pruritus, Rash maculo-papular, Rhinorrhoea
Clinical narrative: Information has been received from a woman in a physicians office concerning a 34 month old male with no known medical history or allergies who on 19Aug03 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot645052/0204N). Concomitant vaccination that day included a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot645146/0060N) in the right thigh. There was no illness at the time of vaccination. On 27Jun05 at 11:20am the pt was seen in the office with greater than 50 lesions throughout his entire body. The pt complained of red, raised bumps all over his body for one week with watery discharge and slight crusty, dryness. The pt had increased itching and a slightly runny nose. The pt was afebrile and rapid strep was positive. Treatment included anti itch cream and diphenhydramine hydrochloride (Benadryl). There was no product quality complaint involved. The pt's vaccination history included: A first, second, third and fourth dose in the left thigh of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (Daptacel) on 16Oct02 (U0583DA), 03Jan03 (lotU0849DA), 05Mar03 (lotU0852AA), and 28Oct03 (lot C1606AA), respectively. A first, second and third dose in the right thigh of hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine on 16Oct02 (lot643661/0723M), 03Jan03 (lot643884/0741M) and 28Oct03 (645708/0284N), respectively. A first, second and third dose in the left thigh of poliovirus vaccine inactivated (Ipol) on 16Oct02 (lot W0063), 03Jan03 (lotW0332), 28Oct03 (lotX0148), respectively. A first, second, third and fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197)(PREVNAR) on 16Oct02 (lot489-752) in the right thigh, 03Jan03 (lot 485-991) in the right thigh, 05Mar03 (lot 490-909) in the right thigh, and 19Aug03 (lot 491-193) in the left thigh. Additional information is not expected.