chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous, Viral infection
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 03/02/01 was vaccinated with varicella virus vaccine live. About a week or later the pt developed a rash on her left buttock, back and left leg. The rash was described as raised red papules that were like insect bites. The rash was not at all vesicular in nature. The physician reported that the rash resolves completely within a week or so, but returns up to twice a yr. No Tx was required. The physician had no other available information. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 4 year old black female pt with no pre-existing medical conditions, who on 03/21/2001 was vaccinated SQ in the RA with 1st dose of varicella virus vaccine, live. On 06/11/2004, the pt developed  a case of chickenpox. It was not reported if medical attention was sought. There were no lab or diagnostic tests performed. The pt recovered. No additonal information is expected.
Age: 1.03
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Erythema, Pruritus, Rash papular, Viral infection
Clinical narrative: Information has been received form a RN concerning a 6 year old Caucasian female pt who on 01/15/1999 was vaccinated SQ with 2nd 0.5ml dose of varicella virus vaccine, live. There  was no illness at the time of vaccination. There were no concomitant therapies. On 05/27/04, the pt started to breakout with some spots. By 05/28/2004, the spots covered her entire body and there was lots of itching. On 05/28/2004, the pt was seen in the office to verify chickenpox. The pt had widespread red papules and clear vesicles on red bases. Several of the lesions had central crusting. The pt was diagnosed with chickenpox. RX drug tx was not required. On 06/06/04, the pt recovered. Additional information is not requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Erythema, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a health professional concerning a 6 year old white female with no past medical history and no known drug allergies who on 07May02 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 640821/1438L). There was no illness at the time of vaccination. There was no concomitant medication. On 02Jun04 the pt developed some red spots on her legs, over entire body by (03Jun04). The pt was seen in the office on 03Jun04 with vesicular eruption over body and was diagnosed with chickenpox. The pt was treated symptomatically. The pt recovered without complication. Follow up information indicated that on 02Jun04 the pt noticed a few small spots on her legs. By 03Jun04, the spots had spread to her trunk and were blister like on a red base. She was seen in the office on 03Jun04, and chickenpox was verified. The pt recovered without complication on 13Jun04. There were no relevant diagnostic tests or lab data. It was also noted that the pt's vaccinated brother subsequently developed chicken pox (WAES0406USA02003). No further information is expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Erythema, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 8 yr old white male with no past medical history and no known drug allergies who on 07May02 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot 640821/1438L). There was no illness at the time of vaccination. On 03Jun04 the pt's mother noticed some small vesicles on red base on arms/legs. Subsequently, the pt was seen in the doctor's office and was diagnosed with chicken pox. The pt was treated symptomatically and recovered without complication. Follow up information indicated that on 03Jun04, the pt came home from school with about 5 vesicle like spots on his torso with a red base. He was seen in the office and chickenpox was diagnosed. The pt recovered without complications on 13Jun04. It was noted that the pt's vaccinated sister had developed chicken pox the day before (WAES0406USA02003). No further information is expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning an 8 year old white female who was vaccinated with varicella virus vaccine live. Subsequently the pt was diagnosed with chickenpox breakthrough. The pt had less than fifty lesions and only two crusted. The duration was reported as two days and the pt had a fever for one day. There was no product quality complaint involved. Follow up information indicated that on 11Jun04 at 10:30AM the pt developed a very slight case of chickenpox. Additional information has been requested.
Age: 1.06
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a RN concerning an 18 month old biracial female who on 08Jan04 was vaccinated with a dose of varicella virus vaccine live (lot 646361/0572N). Subsequently, the pt developed a rash that a pediatrician diagnosed as zoster with about 5 blisters on the backside of the pt's waist on the left side. The entire area was the size of a dime. The mother noted that there was no apparent rash or chickenpox following the administration of the vaccine. The physician believed the zoster rash was a result of the vaccine. The pt was prescribed antiviral medication but did not yet get the prescription filled because they were just seen in the office. A product quality complaint was not involved. Follow up information was received from a physician who indicated that the pt allegedly had the varicella virus vaccine live at one year of age. On 21Jun04, the pt was seen with classic shingles on the trunk and back. No further information is expected.
Age: 1.98
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Nasal congestion, Pyrexia, Rash, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 35 month old white male pt who on 18Mar03 in the AM was vaccinated in the left deltoid with a first dose of varicella virus vaccine live (lot 643129/0570M). Concomitant vaccination on 18Mar03 in the AM included a third dose in the right deltoid of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar) (lot 491185). On 17Mar04, the pt developed a rash, temp and congestion. The pt presented at the physician's office with a fever and a rash consisting of a few lesions. The reporter noted atypical varicella through vaccine and breakthrough. The pt was treated with acetaminophen (Tylenol), ibuprofen (Motrin) and increased fluids. Subsequently, the pt recovered. A product quality complaint was not involved. The reporter also mentioned two of the pt's brothers were vaccinated with varicella virus vaccine live and subsequently developed breakthrough (WAES0406USA02726 and 0406USA02727). Additional information is not expected.
Age: 1.98
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a RN concerning a 35 month old white male pt who on 18Mar03 in the AM was vaccinated in the left deltoid with a first dose of varicella virus vaccine live (lot 643129/0570M). Concomitant vaccination on 18Mar03 in the AM included a third dose in the right deltoid of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (crm197) (Prevnar) (lot 491185). On 17Mar04, the pt developed a rash, temp and congestion. The pt presented at the physician's office with a fever and a rash consisting of a few lesions. The reporter noted atypical varicella through vaccine and breakthrough. The pt was treated with acetaminophen (Tylenol), ibuprofen (Motrin) and increased fluids. Subsequently, the pt recovered. A product quality complaint was not involved. The reporter also mentioned two of the pt's brothers were vaccinated with varicella virus vaccine live and subsequently developed breakthrough (WAES0406USA02726 and 0406USA02727). Additional information is not expected.
Age: 1.54
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a health professional concerning an 18 month old white male with no known medical history who on 09Jun04 was vaccinated IM with a first dose of varicella virus vaccine live (lot 647093/0886N). Concomitant vaccination the same day included a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 646707/0815N) given IM, a fourth dose of Hib conj vaccine (lot 647150/0717N) given IM and a fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot U1027BA) given IM. There was no illness at the time of vaccination. On 19Jun04 the pt broke out with several pox and developed chicken pox. Unspecified medical attention was sought. There were laboratory or diagnostic tests performed. No product quality complaint involved. Follow up information from the RN indicated that the pt subsequently recovered. It was reported that the pt or his sibling did not experience adverse events following prior vaccination. No further information is available.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a health professional concerning a 27 year old healthy female who on 08/06/1999 and 09/08/1999 was vaccinated with doses of varicella virus vaccine live. An antibody titer done the week of 06/13/04 was negative. Unspecified medical attention was sought. No product quality complaint was involved. Additional informtion has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 year old patient who on 07/09/1997 was vaccinated with a dose of varicella virus vaccine live. On 06/22/2004, the pt presented with chickenpox. The pt had a severe breakout with lesions covering the entire body including the genital area. Unspecified medical attention was sought. No product quality complaint was involved. It was also noted that the pt's grandmother has a case of shingles. The physician also reported that he had another case that was not related to this case in any way concerning a 4 year old child who had a very mild breakthrough case of chickenpox last week (vaccination hx unknown). Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Viral infection
Clinical narrative: Information has been recieved from a physician concerning a 11 year old male student with no medical Hx who on 07/07/1995 was vaccinated SQ in the LA with the 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 06/21/04, the pt developed breakthrough chickenpox characterized by approximately 20 vesicles and a temp of 102.5 F. Medical attention was sought and the pt was treated with acyclovir (400 mg PO QID x 5 days). On 06/30/2004, the pt recovered from the breakthrough chickenpox. Additional information is not expected.
Age: 0.97
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous, Rash
Clinical narrative: Information has been received by a physician concerning a female who in 09/2003 was vaccinated with varicella virus vaccine, live. Subsequently, " in a couple of weeks" the child developed a peculiar rash on the buttocks. It was believed to  have been the same side in which the immunization was administered. The rash " reappeared about every two months" the pt was considered not to be recovered. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from an RN concerning a 5 year old female with no pre existing allergies, birth defects, or medical conditions who on  12/30/99 was vaccinated SQ with a 1st dose of varicella virus vaccine live. At the time of vaccination the pt has resolving OM and was being treated with amoxicillin. On 06/23/2004, the pt was brought to the physicians office with a rash that had developed that morning. Upon exam, the physician believed the rash to be caused by varicella. There were 13 lesions located about the groin, back, and trunk and a few more may be developing. No evidence of URI, cough or fever was present. No specific Tx was indicated. No product quality complaint was involved. There were no adverse events following prior vacciantions of the pt or siblings. Follow up information received from a RN indicated that on 06/23/2004. the child was seen in the office with scattered lesions appearing over the course of the morning. There was no evidence of an URI, fever or cough. Tx included symptomatic relief and standard varicella precautions. The outcome was reported as recovered. No additonal information is expected.
Age: 1.04
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash pustular
Clinical narrative: Information has been received from a LVN concerning a 12 month old Hispanic female with no known allergies who on 06/11/04 was vaccinated SQ in the LL with the 1st dose of varicella virus vaccine, live. Concomitant vaccinations on that same day included a dose of MMR. There was no illness at the time of vaccination. The LVN reported that on 06/19/2004, the pt developed a fever of 103 F. On 06/22/04, the pt developed a pustular rash and on 06/23/04 developed 45 vesicular lesions that were widely disseminated on her arms, legs, and trunk. Unspecified medical attention was sought, but no Tx was required. On 06/25/2004, the pt recovered from her events. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a RN concerning a 12 year old male with asthma, NKDA, and many environmental allergies and past medical Hx of varicella exposure from his brother ( pt had no outbreak) who in 02/1995 at 3 years old was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. Illness at the time of vaccination included Pneumonia and Reflex sympathetic dystrophy. Prior therapy included steroids (NOS) . On 06/09/04 the pt had a titer drawn which showed he is not immune. It was noted that the pt had no outbreak of chickenpox. It was also noted that the pt was currnetly on an unspecified asthma medication. Unspecified  medical attention was sought, but no Tx was required. AT the time of this report the outcome was unknown. The RN also reported that the pt's brother developed chickenpox after being vaccinated with varicella virus vaccine., live. (WAES 0406USA02564). No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a company rep concerning a pt who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that he may have a vaccine failure. No product quality complaint was involved. No further information is available.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a woman in a physician's office concerning a 7 yr old white male student with no medical history who on 11Aug98 was vaccinated in the left leg with the first dose of varicella virus vaccine live (lot 626956/0837H). There was no illness at the time of vaccination. The woman reported that on 19Jun04. The pt developed vesicles on his trunk, legs and arms. The pt was not seen in the office and no lab/diagnostic tests were performed. Subsequently, the pt recovered with no problems. Additional information is not expected.
Age: 1.12
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old healthy white male with no pre-existing allergies, birth defects, or medical conditions who on 5/5/00 was vaccinated SC in the right thigh with a frist dose of varicella virus vaccine live (lot #632619/1861J). There was no illness at the time of vaccination. On 6/23/04, the patient developed a rash on his face. He presented to the office on 6/24/04 with 20 lesions all over his body. The physician indicated in the chart that this was consistent with chicken pox. No other information was available. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 6/24/04 the patient developed a scattered rash on his face that was consistent with varicella. The patient was afebrile. Symptomatic relief was noted. The outcome was reported as recovered. There were no relevant diagnostic tests or laboratory results. No further information is expected.
Age: 1.06
Sex: M
Vaccine: MMR, OPV, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 5 year old male with no known medical history who on 9/9/99 was vaccinated SC with the first dose of varicella virus vaccine live (lot # 629142/1837H). Concomitant vaccinations on that same day included the first dose of MMR (lot # 628900/1357H) and the first dose of poliovirus vaccine live oral (lot # 458433). There was no illness at the time of vaccination. It was reported that on 6/10/04, the patient developed a rash. On 6/11/04, the patient was diagnosed with a case of full blown chicken pox. Unspecified medical attention was sought and the patient was treated with Acyclovir. No laboratory/diagnostic tests were performed. As of 6/15/04, the patient was noted to be recovering. Subsequently, the patient recovered from the chicken pox. No further information is available.
Age: 1.28
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 26 month old male patient who on 7/17/03 was vaccinated wtih a dose of varicella virus vaccine live. On 6/24/04, the patient presented with 15 to 20 vesicular lesions that were widely disseminated. No other symptoms were reported. Unspecified medical attention was sought, but treatment was not required. A product quality complaint was not involved. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 8 year old white male with no allergies or medical history who on 4/29/97 was vaccinated in the left thigh with a first dose of varicella virus vaccine live (lot # 619268/1336D). On 6/23/04 the patient presented for a well child exam and had a varicella rash. There were no labs or diagnostic tests done. The recovery status was unknown. Follow up information indicated that the patient recovered with no problems. Additional information is not expected.
Age: 1.16
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old female who on 7/16/99 at 12:00 PM was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot # 628697/1838H). On 5/10/04, the patient developed less than 50 lesions. Subsequently, the patient recovered. There were no adverse events following prior vaccinations of the patient or her siblings. No further information is expected.
Age: 1.27
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a licensed professional nurse concerning a 7 year old male with allergies to penicillin and amoxil who on 12/15/97 at 11"30 was vaccinated in the left arm with a first dose of varicella virus vaccine live (lot # 623655/0807E). There were no adverse events following prior vaccinations with the patient or sibling. On 5/10/04, the patient developed under 50 lesions. Subsequently, the patient recovered. No further information is expected.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician and follow up from a registered nurse concerning a 26 year old female with no known pre-existing allergies or medical conditions, who on 6/9/04 at 10:00 AM was vaccinated SC in the left arm with a 0.5ml first dose of varicella virus vaccine live (lot # 648043/1345N). It was noted that the patient had no known illness at the time of vaccination. Subsequently, 2-2.5 weeks later at 10:00 AM on 6/24/04, the patient presented to the clinic and had developed 8-10 lesions on her arms, legs, and chest, which appeared like chicken pox. Verbal instructions for chicken pox care were given to the patient. She was told to return to the clinic if necessary. There were no signs or symptoms of acute distress. No laboratory tests were performed. It was noted that the patient did not have adverse events following prior vaccination. There was no product quality complaint involved. Unspecified medical attention was sought. No additional information is expected.
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Pt returned 15-20 minutes after DTaP/IPV/MMR with diffuse erythema and urticaria, EPI and Benadryl given.
Sex: F
Vaccine: RAB
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Migraine, Vomiting
Clinical narrative: Chills, sweats, migraine HA, vomiting, diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Immun. given 5/18/05. Today presents to clinic with redness, swelling and localized reaction 7cm x 9cm left thigh.
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis
Clinical narrative: Cellulitis upper left deltoid 10x6cm. Tx: Augmentin ES 600 1 1/2 po bid x 10 days. Motrin 200mg q 6h prn.
Age: 1.25
Sex: F
Vaccine: DTAPH, PNC
Symptoms: Urticaria
Clinical narrative: Hives on total body including ears. Pt mother called describing hives appearing about 5 hrs after shots given. WE sent pt to ER. Tx with Benadryl there and at home.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Otitis media, Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a 30 month old female with no medical history who on 12/12/02 was vaccinated SC in the left arm with the first dose of varicella virus vaccine live (lot # 641155/0793M). Concomitant vaccinations on that same day included the first dose SC in the right arm MMR (lot # 642182/0774M). There was no illness at the time of vaccination. The NP reported that on 6/18/04, the patient developed approximately 11 raised pink lesions on her back, face, and right hand. Unspecified medical attention was sought and a diagnosis of chicken pox was made. The patient was treated with diphenhydramine HCl for the chicken pox and amoxicillin for a concurrent otitis media. Subsequently the patient's chicken pox resolved, however, at the time of this report, the outcome of the otitis media was unknown. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Erythema, Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old white female with no medical history and no allergies who on 4/24/98 was vaccinated with a first dose of varicella virus vaccine live (lot # 624450/1423E). Concomitant medications the same day included a first dose of hepatitis B virus vaccine (lot # 623680/0747E) and a second dose of MMR (lot # 620880/0476E). On 6/8/04, the patient was seen with a mild case of chicken pox. It was noted that the patient had been exposed 2 weeks prior to her outbreak. The patient was treated with diphenhydramine and colloidal oatmeal baths. No product quality complaint was involved. Follow up information indicated that the patient's chicken pox started on 6/7/04. She presented to the office on 6/8/04 with an itchy rash with individual erythematous lesions. There was a cluster on buttock area near L4-L5 that spreads out towards the left and right hip. There were also scattered lesions on both upper this and lesions in the lower back area that have a vesicle appearance. The patient was instructed with in home care and was instructed to stay out of school until all lesions have scabbed over. No labs or diagnostic tests were done. It was reported that the patient recovered. It was also reported that two other patients were vaccinated with a dose of varicella virus vaccine live and developed chicken pox (WAES0406USA02749 and 0406USA02750). Additional information is not expoected.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning 6 year old male with no past medical history who on 3/23/99 at 12:04 PM was vaccinated with a first dose of varicella virus vaccine live (lot # 628697/1838H), IM in the left arm. There was concomitant medication or illness at the time of vaccination. Subsequently, the patient developed mild case of chicken pox. On 5/1/04, the patient developed less than 50 lesions. It was noted that the patient had no fever. The patient recovered on 5/7/04. It was noted that the patient did not experience any adverse events following prior vaccinations. No product quality complaint was involved. It was also reported that other patients had a similar experience (WAES0406USA02563). Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 yr old white male with no known medication allergies who was vaccinated with a dose of varicella virus vaccine live. The RN reported that approx one year after being vaccinated, the pt developed a mild case of chickenpox. Unspecified medical attention was sought, but no treatment or lab/diagnostic testing was required. Subsequently, the pt recovered. The RN also reported that the pt's brother had a negative titer after being vaccinated with varicella virus vaccine live (WAES0406USA02249). Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Mouth ulceration, Rash, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning an 8 year old female patient who was vaccinated with a dose of varicella virus vaccine live. On 6/21/04, the patient presented with chicken pox all over her body, including in her mouth. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 1.36
Sex: F
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 7 year old female pt who on 18Mar98 was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant vaccination the same day included a fourth dose of Hib conj vaccine (Crm197) (Hibtiter) (lot M260RT) given in the right thigh and a fourth dose of diphtheria toxoid (+) pertussis acellular vaccine (+) tetanus toxoid (Tripedia) (lot 7891824) given in the left thigh. There was no illness at the time of vaccination. On 28Jun04, the reporter stated the pt now has chickenpox. Unspecified medical attention was sought, but the pt was not hospitalized and treatment was not required. A product quality complaint was not involved. Follow up information from the nurse indicated that on 25Jun04 at 10AM the pt began with varicella lesions. Subsequently the pt recovered. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 9 year old female who in 1996 was vaccinated with a dose of varicella virus vaccine live. On 28Jun04 the physician reported that in Jan 2004, the pt had a mild case of chicken pox breakthrough and she has a mild case of chickenpox now. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a RN concerning a pt who on 24Apr98 was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. No additional information is available.
Age: 1.03
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Cough, Drug ineffective, Nasal congestion, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old healthy white male with no pre-existing allergies, birth defects, or medical conditions who on 30Jun1998 was vaccinated with a first dose of varicella virus vaccine live (lot not available). Concomitant therapy included a first dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no illness at the time of vaccination. On 24Jun04 the pt presented to the office with a few spots. On 25Jun04, he presented to the office again with 30-40 lesions on his trunk. They were itchy vesicular lesions and he had a cough and congestion. There was no treatment. Unspecified medical attention was sought. There was no product quality complaint. There were no relevant diagnostic tests or lab data. Follow up information received from a RN indicated that the pt developed a clinical case of varicella on 24Jun04 with approx 30-40 lesions, cough, congestion, and no fever. The pt was exposed to varicella 2 weeks prior. The outcome was reported as recovered. No additional information is expected.
Age: 1.98
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Drug ineffective, Nasal congestion, Rash, Upper respiratory tract infection, Viral infection
Clinical narrative: Information has been received from a RN concerning a 38 month old white male who in the morning of 18Mar03 was vaccinated in the left deltoid with the first dose of varicella virus vaccine live (lot 643129/0570M). Concomitant vaccinations on that same day and time included the third dose in the right deltoid of pneumococcal 4 6B 9V 18C 19F 23F conj vaccine (crm197) (Prevnar) (lot 491185). The RN reported that on 17Mar04, the pt presented to the physician's office with a rash and an upper respiratory infection characterized by congestion. The pt was noted to be afebrile. A diagnosis of breakthrough was made. The pt was treated with acetaminophen (Tylenol), ibuprofen (Motrin) and increased fluids. Subsequently, the pt recovered from the URI and breakthrough and was noted to be doing well. The RN also reported that two of the pt's brothers developed breakthrough after being vaccinated with varicella virus vaccine live (WAES0406USA02067 and 0406USA02727). Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Drug ineffective, Pyrexia, Rash papular, Viral infection
Clinical narrative: Information has been received from a RN concerning a 5 yr old white male who on 18Mar03 was vaccinated in the right deltoid with the first dose of varicella virus vaccine live (lot 643821/0865M).  On 26May04 the pt presented at the physician's office with a fever and a papular rash with vesicles on his trunk and legs. The pt was reported as having breakthrough. The pt was treated with acetaminophen (Tylenol), ibuprofen (Motrin) and increased fluids. No product quality complaint was involved. Follow up information indicated that the pt was afebrile.  It was also reported that pt's two brothers  were vaccinated with a dose of varicella virus vaccine live and developed breakthrough  (WAES0406USA02067 and 0406USA02726). Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Blister, Drug ineffective, Rash pruritic, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 yr old Caucasian male pt with a history of iron deficiency who on 09Feb00 was vaccinated with a dose of varicella virus vaccine live (lot 631170/0713J). Concomitant vaccination on 09Feb00 included a dose of diphtheria toxoid (+) pertussis acellular 4 component (+) tetanus toxoid (Acel Immune) (lot 466925). Illness at the time of vaccination included cold symptoms and otitis media. On 23Jun04, the pt developed an itchy rash at his waist line. By the following day, the pt had vesicles with crusts there as well as on the groin, shoulders, behind the ears and in his axillae. Subsequently in June 2004, the pt presented to the medical office. It was noted that the pt had a breakthrough case of 100 to 150 chickenpox lesions. On 08Jul04, the pt was seen again and was fine. The reporter indicated the pt had recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a RN concerning a 13 year old male student with no allergies and no past medical history who on 06/27/1995 was vaccinated SQ in the LA with a first dose  of varicella virus vaccine live. There was no illness at the time of vaccination. There was no concomitant medication. On 06/22/2004, the pt developed a random lesion or pimple but, on 06/27/04, became full blown  with over 100 lesions on the face, stomach, back, and a few on the extremities. The pt was afebrile per the mother. Unspecified medical attention was sought, but the pt was out of town and had not been seen by the physician. The pt was treated with calamine + camphor + pramoxine hydrochloride ( Aveeno) soap and diphenhydramine hydrochloride ( Benadryl). The pt was healing well and recovered on 07/08/2004. There was no known exposure to chicken pox. A product quality complaint was not involved. Addtional information is expected.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a  RN concerning a 5 year old female with no medical Hx and no allergies who on 10/22/1999 was vaccinated SQ in the LA with a first dose of varicella virus vaccine live. There was no concomitant medication. On 06/11/2004, the pt was seen with a mild case of chicken pox. It was reported that there were several cases at her day care. The pt was treated with diphenhydramine hydrochloride (Benadryl_ and colloidal oatmeal bath (Aveeno). No product quality complaint was involved. F
Age: 1.02
Sex: F
Vaccine: HEP, IPV, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received form a RN concerning a 3 year old female with no medical Hx and no allergies who on 08/24/2001, was vaccinated SQ in the LA with a first dose of varicella virus vaccine, live. Concomitant vaccines that day included a 3rd dose IM in the RA of Hepatitis B virus vaccine rHBsAg (yeast) and a 3rd dose IM in the LA of poliovirus vaccine inactivated. There was no other concomitant medication. On 06/25/2004. the pt's mother called the office and reported that her child had chicken pox. The pt was treated with diphenhydramine  (Benadryl) and colloidal oatmeal baths (Aveeno). No product quality complaint was involved. Follow up information indicated that the pt's sibling had chicken pox on 06/11/04 and the mother called the office 06/25/2004 to report that the pt now had chicken pox. There were no labs or diagnostic tests performed and the pt recovered.  It was also reported that the two other pt's were vaccinated with a  dose of varicella virus vaccine live and developed chicken pox (WAES0406USA02545) and the pt sister, (WAES 0406USA02749).  Additonal information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live. On 6/29/04, the patient presented to the physician with breakthrough chicken pox. A product quality complaint was not involved. The reporter also mentioned a second patient who developed chicken pox post vaccination with varicella virus vaccine live (WAES0407USA01590). Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash papular, Viral infection
Clinical narrative: Information has been received from a NP concerning a white male patient with "unknown or  none known  or remembered" medical history or allergies who was vaccinated with a dose of varicella virus vaccine, live. On approximately 02/26/2004, "over the last 3 weeks", the pt developed breakthrough chicken pox. The child is between the ages of 6-10 years old and the rash was described as papulovesicular and erythematous. The child had an average of 30 lesions. The reporter did not have any additional infomation or lot numbers of the vaccine. Unspecified medical attention was sought. There was no product quality complaint . Follow up information received from a NP indicated that the child had a chickenpox outbreak and recovered after 2 weeks. There were no relevant diagostic tests or lab data. The reporter also mentioned 2 other pts who experienced adverse events (WAES 0403USA01629). No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Medication error, Rash
Clinical narrative: Information has been received from a RN concerning a child who was vaccinated with varicella virus vaccine, live ( also mentioned in f/u information as "several children" had developed a rash subsequent to reviewing the vaccine). It was also reported that the vaccine was exposed to multiple temperature elevations beginning 04/01/04. There were reportedly temps as high as - 1.3C(29.66 F). Follow up information received from a health department RN reported that the vaccines were determined to be safe by a health dept immunization representative. It was noted that the immunization rep had determined that the varicella virus vaccine live was stored at the recommended temperatures and the problem was related to the thermometer and the placement of the thermometer, not the freezer. It was noted that no vaccine was discarded. No product quality complaint involved. The reporter mentioned the following varicella virus vaccine live lot numbers 647763/0191P, 641710/0452N, 647259/1137N, but did not specify the lot that was used to  vaccinate the child. Unspecified medical atterntion was sought. No additonal information is expected.
Age: 1.04
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a licensed practical nurse concerning her 5 year old grandson who in approximately August 1999 at 13 months of age, was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. In the end of May 2004, the patient developed a mild breakthrough case of varicella. Unspecified medical attention was sought. It was noted that therapy with varicella virus vaccine live was discontinued. Subsequently, the patient recovered. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a female nurse who on 06/10/04 was vaccianted with a dose of varicella virus vaccine, live. On 06/22/04,  the pt developed a rash described as urticaria all over her body. In areas such as her elbows, she had groups of lesions that appeared to form one lesion. Unspecified medical Tx was sought. A product quality complaint was not involved. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a LPN concerning a 3 year old male pt with an allergy to amoxicillin who on 05/06/2003 was vaccinated with a dose of varicella virus live vaccine live. On 06/26/2004 the pt presented to the physicians office with a severe case of chicken pox described as over 100 lesions in multiple stages over the entire body. The pt's mother reported the lesions started in the morning of 06/26/2004. Medical attention was sought. The pt recovered on an unspecified date. No product quality complaint was involved. No additional information is expected.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Injection site rash, Injection site vesicles, Photophobia
Clinical narrative: Information has been received from a health professional concerning a 26 year old white female patient (previously reported as male) with no known allergies or medical history who on 6/10/04 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 648300/0075P). Concomitant vaccination included a SC dose of MMR (lot # 646886/0949N) given on 5/27/04. Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. WIthin fourteen days of vaccination, the patient developed a varicella like rash of about 20 spots around the site of injection. Within four days the spots were healed and mostly gone. Unspecified mediacl attention was sought and no treatment was required. There was no product quality complaint involved. Follow up information from the registered nurse indicated that the afternoon of 6/24/04, 14 days after vaccination with varicella virus vaccine live, the patient developed 10-15 tiny vesicles at the injection site and over her torso. It was also reported that the patient felt tired, developed a low grade fever, and experienced a headache, heat intolerance and photophobia. On 6/28/04, within four days of adverse event onset, all symptoms resolved. On 8/23/04, the patient was vaccinated with a second dose of varicella virus vaccine live and had no reaction at all. It was also reported that on 5/12/04 the patient was vaccinated with an IM second dose of hepatitis B vaccine (lot # 646144/0469N). It was noted that the patient recovered on 6/28/04. No further information is available.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 26 year old white female patient (previously reported as male) with no known allergies or medical history who on 6/10/04 was vaccinated SC with a first dose of varicella virus vaccine live (lot # 648300/0075P). Concomitant vaccination included a SC dose of MMR (lot # 646886/0949N) given on 5/27/04. Concomitant therapy included hormonal contraceptives (unspecified). There was no illness at the time of vaccination. WIthin fourteen days of vaccination, the patient developed a varicella like rash of about 20 spots around the site of injection. Within four days the spots were healed and mostly gone. Unspecified mediacl attention was sought and no treatment was required. There was no product quality complaint involved. Follow up information from the registered nurse indicated that the afternoon of 6/24/04, 14 days after vaccination with varicella virus vaccine live, the patient developed 10-15 tiny vesicles at the injection site and over her torso. It was also reported that the patient felt tired, developed a low grade fever, and experienced a headache, heat intolerance and photophobia. On 6/28/04, within four days of adverse event onset, all symptoms resolved. On 8/23/04, the patient was vaccinated with a second dose of varicella virus vaccine live and had no reaction at all. It was also reported that on 5/12/04 the patient was vaccinated with an IM second dose of hepatitis B vaccine (lot # 646144/0469N). It was noted that the patient recovered on 6/28/04. No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: Information has been received from a health professional concerning an 11 year old male who a few years ago, in approximately 2002, was vaccinated with a dose of varicella virus vaccine live. It was reported that the child now has a mild outbreak of chicken pox. Unspecified medical attention was sought, but no treatment was provided. No product quality complaint was involved. It was reported that there were many cases, possibly 50 in the area. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient experienced an adverse event reaction. It was unknown if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Malaise, Pyrexia, Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 42 year old white female employee with no known history or allergies who on 6/15/04 was vaccinated SC in the upper arm with a first dose of varicella virus vaccine live (lot # 647253/1060N). Concomitant medications included vitamins. There was no illness at the time of vaccination. On 6/30/04 the patient had one lesion on her face and then her breast. On 7/1/04, she had lesions on her back, a headache, general malaise and felt feverish but had no temperature. Unspecified medical attention was sought and the patient was treated with acetaminophen. There was no product quality complaint involved. Follow up information indicated that on 6/30/04 the patient developed a rash on her face, breast, neck and back and complained of itching. The patient broke out in new lesions through 7/4/04. On 7/6/04, labs were drawn for Varicella Zoster IGG/IGM, however no results were reported. Subsequently, the patient recovered. No further information is expected.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site vesicles, Rash, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 18 year old female who on 6/15/04 was vaccinated in the left deltoid with a first dose of varicella virus vaccine live (lot # 645575/0436N). There was no illness at the time of vaccination. On 6/28/04, the patient experienced atypical chicken pox with vesicular lesions around the injection site. On 6/30/04, the patient's parent called the office to report that she had raised bumps under her breast and on her back. Unspecified medical attention was sought and no treatment was suggested. There was no product quality complaint involved. Follow up information indicated that the patient experienced blisters on her arms, legs, and abdomen. A local reaction, 2cmx2cm was noted at the injection site. Subsequently, the patient recovered. No further information is available.