chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse RN concerning a 12 year old female who on 09FEB2004 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. There was no concomitant therapy. The RN reported that on 01MAR2004, the patient developed a rash. Unspecified medical attention was sought, but no treatment or laboratory/diagnostics test were done. At the time of this report, the outcome was unknown.  The RN also reported that the pts sibling developed a fever after being vaccinated with varicella virus vaccine live. Additional info has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Alpha 1 foetoprotein increased, Blood human chorionic gonadotropin positive, Delivery, Drug exposure during pregnancy, Ultrasound scan normal
Clinical narrative: Information has been received from a certified nurse midwife through a Merck pregnancy registry for varicella virus vaccine live concerning a 16 year old female with a urinary tract infection, no history and no allergies who on 17JUL2003 was vaccinated with varicella virus vaccine live (lot 641991/0323M). Concomitant therapy included nitrofurantoin early in the pregnancy for the UTI and vitamins. It was reported that the patient later found out she was pregnant. Her LMP was 01JUL2003 and her expected date of delivery is 08APR2004. It was reported that there was no indication of problems with the pregnancy, 4 ultrasounds were normal and a urine pregnancy test was done. It was noted that the patient did have an "elevated AFP, alpha fetus protein". Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.  Follow up information from a nurse practitioner indicated that the patient had a history of 1 pregnancy that resulted in full term birth. There was no local reaction, varicella symptoms or herpes zoster symptoms post vaccination. On 3/12/2004, 37 weeks from LMP, the patient delivered a female infant weighing 5lb 12oz. It was reported that the infant was normal. There were no congenital anomalies and there were no complications. It was reported that at 10 days of age the infant was seen by a physician for followup on jaudice. It had resolved and there were no other concerns. The infant was subsquently vaccinated with hepatitis b vaccine (manufacturer unknown) and experienced adverse events (WAES 0601USA00985) Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received form a consumer concerning a 7 year old male who was vaccinated with a dose of varicella virus vaccine live. The consumer reported that in the first week of March 2004, the patient developed a mild case of chickenpox with lesions on the inner thigh, back of arm and trunk. It was noted that the patient was not seen or diagnosed by a physician. No treatment was required. At the time of this report, the outcome was unknown. Additional info has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 2 year old male who was vaccinated at 1 year of age, with a dose of varicella virus vaccine live. The physician reported that the patient subsequently developed a chickenpox like rash with less than 50 lesions. Unspecified medical attention was sough, but no treatment was required. At the time of this report, the outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a patient with no pertinent medical history who was vaccinated with varicella virus vaccine live at a young age. The child developed a mild case of chicken pox shortly after being vaccinated and a second mild case more recently after a trip. No labs or diagnostic studies were performed and not treatment was required. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Nasal congestion, Rash vesicular, Rhinorrhoea, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 16 month old male patient with a history of asthma who on 28OCT2003 was vaccinated with a dose of varicella virus vaccine live (lot 646232/0543N). Concomitant therapy included measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (lot 645405/0132N) given in the left thigh on 28OCT2003, other concomitant medication included levalbuterol hydrochloride and budesonide. On 24FEB2004 the patient experienced "breakthrough". He developed a vesicular rash. He was treated with acyclovir, diphenhydramine hydrochloride and calamine lotion. It was noted that the patient had a runny nose about one week before the lesions appeared. No lab diagnostic studies were performed. No product quality complaint was involved. Additional information has been requested.  Follow up information On 11/25/2003 the patient was vaccinated in the left thigh with a first dose of influenza virus whole virion 3v vaccine inactivated (Fluzone). At the time of vaccination it was noted that the patient had a developmental delay was physically well and was being followed by GI, Pulmonary, neurology, opthamalogy, ENT and Ortho.  Follow up information from the registered nurse indicated that the patient saw pulmonologist on 02/24/2004 and the patient history of cold URI and was congested. The patient had a rash and a vesicle was noted and varicella was questioned. The patient was instructed to go to the ER if respiratory distress was noted. The patient was started on acyclovir BID, which was discontinued on 02/27/2004. It was reported that the patient recovered in 2 weeks. No further information is available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female patient with no pertinent medical history and no known allergies who on 22SEP1998 was vaccinated with a dose of varicella virus vaccine live. On 04MAR2004 the patient presented with varicella at the panty line, right shoulder and on her side. There was not treatment. The nurse reported that the patient experienced "chicken pox break through thru post vaccination with varicella virus vaccine live. It was noted at the time of the report that the patient was not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a public health care nurse concerning a patient who on 10AUG1999 was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed chickenpox breakthrough. It was noted that this case was part of 4 cases of chickenpox breakthrough on of which was "mild" and the other three "regular chickenpox". Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned three other patients who developed chickenpox breakthrough experienced similar reactions (WAES0403USA01867, WAES0403USA01868, WAES0403USA01869.  Subsequently, the reporter mentioned two additional patients who developed breakthrough varicella. Additional information is not expected.
Age: 3.5
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an approximately 42 month old female who at "one year of age" was vaccinated with varicella virus vaccine live. Subsequently the patient developed a rash. The patient sought unspecified medical attention. The patient required no treatment for the symptoms. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning her niece who on 04JAN1999 was vaccinated with a dose of varicella virus vaccine live. It was reported that the child had a mild case of chicken pox break out. Unspecified medical attention was sought. The patient recovered. No product quality complaint was involved.  The patient's sister was also vaccinated with varicella virus vaccine live and got chicken pox and another patient was vaccinated with varicella virus vaccine live and got shingles. Additional information has been requested.  This is in follow up to report previously submitted on 05/14/2004, information has been received from a health professional concerning her 10 year old neice with no allergies or medical history who on 01/04/1999 was vaccinated SC in the left leg with a first dose of varicella virus vaccine live (lot 624724/1127E). There was no illness at the time of vaccination. Follow up information indicated that the child broke out with chicken pox on 01/28/2004. She was moderately covered with pox and was out of school for 1 week. There were no labs or diagnostic test done. She recovered fully on approximately 02/04/2004. The patients sister (WAES0403USA00669) was also vaccinated with varicella virus vaccine live (lot 624724/1127E) and got chicken pox and another patient (WAES0402USA01796) was vaccinated with varicella virus vaccine live (lot 624724/1327E) and got shingles. Additional information is not expected.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health professional concerning her niece who on 04JAN1999 was vaccinated SC in the left leg with a dose of varicella virus vaccine live (lot 624724/1327R). There was no illness at the time of vaccination. Subsequently the patient had a mild case of chicken pox break through two weeks after her sister. Unspecified medical attention was sought. The patient recovered. No product quality complaint was involved. The patient's sister was also vaccinated with varicella virus vaccine live and developed chicken pox and another patient was vaccinated with varicella virus vaccine live and developed shingles. Additional information has been requested  Follow up information frim a health care professional indicated that the child broke out with chicken pox 1 week after her sibling, on Feb 4 2004, and that she was heavily covered with pox. No labs or diagnostic test were done. She was out of school one week and recovered fully on approximately 02/11/2004. The patients sister (WAES0403USA00668) was vaccinated with varicella virus vaccine live (lot 624734/1327E) and developed chicken pox and another patient (WAES0402USA01796) was vaccinated with varicella virus vaccine live (lot 624724/1327E) and developed shingles.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 12 month old female who on 27FEB2004 was vaccinated with a subcutaneous dose of varicella vaccine, 0.5ml/once. There was no concomitant medication. On 08MAR2004, 9 days later, the patient broke out with chickenpox, less than 30 lesions. There were no diagnostic laboratory tests performed. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.  Follow up information has been received from a physician concerning a 12 month old female patient with no relevant meddical history who on 2/27/2004 was vaccinated with a subcutaneous dose of varicella virus vaccine live 0.5 ml. An illness at the time of vaccination was bilateral otitis media with effusion. On 3/08/2004, 9 days later, the patient broke out with chickenpox. Subsequently, the patient recovered. No further information is expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Laboratory test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 33 year old "healthy" female who on 19NOV1999 and 09DEC1999 was vaccinated with doses of varicella virus vaccine live. A varicella titer on 05MAR2004 was determined to be "equivocal". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 1.04
Sex: M
Vaccine: IPV, MMR, PNC, VARCEL
Symptoms: Rash vesicular, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a male patient who was vaccinated with a dose of VARIVAX. Other suspect vaccination administered at the same time included a dose of MMR II. Concomitant vaccines administered along with the previously mentioned vaccines included a dose of poliovirus vaccine inactivated and an dose of pneumococcal conj vaccine. The registered nurse reported the patient broke out in hives, however it was not reported where the hives occurred on the body. The registered nurse reported that initially the patient was treated with acyclovir because the physician though the hives were chicken pox. It was noted the patient was then treated with diphenhydramine. It was noted that therapy with the vaccines was discontinued. The adverse event abated, and the patient recovered. There was no product quality complaint reported. Additional information has been requested. This is in follow-up to report(s) previusly submitted on 5/14/2004. Information has een received from a registered nurse concerning a male patient who was vaccinated with a dose of VARIVAX (Merck) (Lot# 547269/1101N). Other suspect vaccination administered at the same time included a dose of MMR II (Lot #  646740/0822N). Concomitant vaccines administered along with the previously mentioned vaccines included a dose of IPOL (unspecified) and a dose of PREVNAR. The registered nurse reported the patient broke out in hives, however it was not reported where the hives occurred on the body. The registered nurse reported that initially the patient was treated with ACYCLOVIR because the physician thought the hives were chicken pox. It was noted the patient was treated with BENADRYL. It was noted that therapy with the vaccines was discontinued. The adverse event abated, and the patient recovered. There was no product quality complaint reported. Follow-up information was received from a registered nruse who is also the patient's mother which reports more detailed information of the event experienced by her son. a 12-month-old male with no pre-existing allergies or medical conditions, who on 19-FEB-2004 was vaccinated in the left thigh with a 0.5 mL dose of VARIVAX (Merck) (Lot# 647269/1101N). Other suspect vaccine therapy administered on the same day, 18-FEB-2004, included a 0.5 dose of MMR II (Lot# 646740/0822N) in the left thigh. Concomitant vaccines administered along with the previously mentioned vaccines included a 0.5 mL dose in the right thigh of PREVNAR (Lot # 495-888) and a 0.5 mL dose IPOL (Lot W1233) in the right thigh. The patient was not ill at th time of vaccination. On 19-FEB-2004, reported as last Thursday, the patient developed a rash on his face that comes and goes. It was mentioned that he has received immunizations prior to this. The reporter thought that the rash could be an allergic reaction to something, possibly immunization. There were no laboratory studies performed. It was menttioned that the patient recovered on "10-FEB-2004". No additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Cough, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 4 year old female who "at 1 year of age " was vaccinated with varicella virus vaccine live. Subsequently the patient developed a rash, cough and fever. The patient sough unspecified medical attention. The patient required no treatment for symptoms. Additional information has been requested.
Age: 1.48
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old female patient who in September 29, 1998, was vaccinated in the right thigh with a first dose of varicella virus vaccine live (lot number 526962/0849H). On 08MAR2004, the patient developed a typical chickenpox rash also described a varicella rash. It was noted that the child reported to the office on 09MAR2004. The physician described the rash as "probably 50-100 lesions", spread all over the body, including the torso, face, arms and legs and the lesions were "a bit more than other breakthrough cases" he had seen. The patient had a fever of 103 which resolved prior to the office visit. It was also noted that the parents of the child were educated on chickenpox care but there was no specific treatment. Unspecified medical treatment sought. There was no product quality complaint. Additional information has been requested.  Follow up information Subsequently on approximately 03/12/2004, approximately 5 days after the patient recovered. Unspecified medical treatment sought. There was no product quality complaint involved. No further information is requested.
Age: 26.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 26 year old male patient who on 29SEP1999 was vaccinated with a dose of varicella virus vaccine live. On 09MAR2004, the patient developed 20-30 pimples on his abdomen and groin. No other symptoms were noted. The patient's mother reported that her son had been exposed to another child with chickenpox last week. It was noted that the child was vaccinated by another HCP. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Pyrexia, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old female who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the patient developed breakthrough chickenpox. She was reported to have 10 pox and a little fever. Unspecified medial attention was sought. No other information was available. There was no product quality complaint. The reporter also indicated that the patient's sister developed and adverse event after vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 1.28
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Herpes zoster, Pain, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a health care professional concerning a 7 year old female who on 08Oct1997 was vaccinated with a dose of varicella virus vaccine live. On 07Mar2004 the pt experienced shingles that were red and itchy and painful. She also reported a sore throat and a fever. The pt did not go to the hospital nor receive any treatment. The reporter also indicated that another pt experienced adverse reactions following vaccination with chickenpox. Additional information has been requested.  This is in follow up to report previously submitted on 05/14/2004, information has been received from a health care professional concerning a 7 year old female with asthma (diagnosed at 2 years old) who on 10/08/1997 was vaccinated in the left upper leg with a first dose of varicella virus vaccine live (lot 624340/0962E) There was no illness at the time of vaccination. follow up information indicated that on 03/01/2004 the patient broke out on her left arm with bumps that started out as red dots. The dots turned into blisters and were in a linear pattern down her forearm. The patient indicated that they itched very bad, and were painful to the touch. After about a week, the dots started to fade. The physician indicated that it was mild shingles. It was noted that the patient had never had the chickenpox disease. The outcome was reported as recovered. The reporter also indicated that another patient experienced adverse reaction following vaccination with chickenpox (WAES0403USA01393). No further information is expected.
Age: 1.28
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia
Clinical narrative: Information has been received from a health care professional concerning a 7 year old female who on 08Oct1997 was vaccinated with a dose of varicella virus vaccine live. On 07Mar2004 the pt experienced shingles that were red and itchy and painful. She also reported a sore throat and a fever. The pt did not go to the hospital nor receive any treatment. The reporter also indicated that another pt experienced adverse reactions following vaccination with chickenpox. Additional information has been requested.  This is in follow up to report previously submitted on 05/14/2004, information has been received from a health care professional concerning a 7 year old female with asthma (diagnosed at 2 years old) who on 10/08/1997 was vaccinated in the left upper leg with a first dose of varicella virus vaccine live (lot 624340/0962E) There was no illness at the time of vaccination. follow up information indicated that on 03/01/2004 the patient broke out on her left arm with bumps that started out as red dots. The dots turned into blisters and were in a linear pattern down her forearm. The patient indicated that they itched very bad, and were painful to the touch. After about a week, the dots started to fade. The physician indicated that it was mild shingles. It was noted that the patient had never had the chickenpox disease. The outcome was reported as recovered. The reporter also indicated that another patient experienced adverse reaction following vaccination with chickenpox (WAES0403USA01393). No further information is expected.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Chills, Erythema, Fatigue, Headache, Night sweats
Clinical narrative: Information has been received from a RN concerning a 23 year old "healthy" female who was vaccinated with a dose of varicella virus vaccine live (643597/0895M). There were no other  concomitant  vaccinations given. There were no illness at the time of vaccination. Twenty two and a half days later the pt developed a flat, red rash. Unspecified medical attention was sought and it was unknown if any treatment was given. No product quality complaint was involved. Additional information has been requested.  Follow up information On 03/08/2004 at approximately 0800 the patient developed a severe headache that progressed to fatigue, night sweats, and chills. On 3/9/2004 at 1800 the patient developed the first signs of a rash that was itchy, flat or slight rasied. On 3/10/2004 the patient developed approximately 11 lesions on the abdomen, back, left leg and arms. Her temperature was 99.1. Unspecified medical attention was sought. She was much better after one week. On 3/23/2004 she was back to work. It was reported that the patient recovered and no specific treatment was required. No diagnostic lab test were performed. No product quality complaint was involved. It was noted that there was a possible secondary spread to a co worker. No other information is expected.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Pyrexia, Rash, Rash erythematous, Skin ulcer
Clinical narrative: Information has been received from a RN concerning a 23 year old "healthy" female who was vaccinated with a dose of varicella virus vaccine live (643597/0895M). There were no other  concomitant  vaccinations given. There were no illness at the time of vaccination. Twenty two and a half days later the pt developed a flat, red rash. Unspecified medical attention was sought and it was unknown if any treatment was given. No product quality complaint was involved. Additional information has been requested.  Follow up information On 03/08/2004 at approximately 0800 the patient developed a severe headache that progressed to fatigue, night sweats, and chills. On 3/9/2004 at 1800 the patient developed the first signs of a rash that was itchy, flat or slight rasied. On 3/10/2004 the patient developed approximately 11 lesions on the abdomen, back, left leg and arms. Her temperature was 99.1. Unspecified medical attention was sought. She was much better after one week. On 3/23/2004 she was back to work. It was reported that the patient recovered and no specific treatment was required. No diagnostic lab test were performed. No product quality complaint was involved. It was noted that there was a possible secondary spread to a co worker. No other information is expected.
Age: 1.42
Sex: F
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a registered nurse concerning a 17 month old female who on 26Feb2004 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that on 10Mar2004 the mother called the physician's office and stated that her daughter had developed a mild case of chickenpox. Unspecified medical attention was sought and no treatment was required. A product quality complaint was not involved. Additional information has been requested.
Age: 1.06
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a consumer who is the mother of a 9 year old male pt with no relevant medical history and no allergies who on 30Sep1994 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 10Mar2004, this past Wednesday night, the pt developed chickenpox. There was no treatment required. There were no laboratory diagnostic tests performed. It was noted that the pt saw the physician at the clinic. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.  This is in follow up to report previously submitted on 05/14/2004, information has been received from a nurse practitioner concerning a 9 year old male patient with no relevant medical history and no allergies who on 10/20/1995 (previously reported as 09/30/1994) was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. The patients mother reported that on 03/10/2004, this past Wednesday night, the patient developed chickenpox. On 3/11/2004 the patient was seen at the clinic with an apparent varicella infection. There was no treatment required. There were no lab diagnostic test performed. It was noted that the patient saw a physician at the clinic. The reporter mentioned that the patient did not experience an adverse reaction to the vaccine. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is requested.
Age: 1.07
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Body temperature decreased, Drug ineffective, Erythema, Viral infection
Clinical narrative: Information has been received from a nurse practitioner concerning a pt who in 1996 was vaccinated with a dose of varicella virus vaccine live (lot number 620620/1107D). Subsequently, the child developed over 200 lesions. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. This is in follow up to report previously submitted on 05/14/2004 information has been received from a nurse practitioner concerning an 8 year old patient with no allergies and no relevant medical history who on 11/25/1996 was vaccinated subcutaneously with a firse dose of varicella virus vaccine live (lot # 620620/1107D). Concomitant medication included amphetamine asparate (-) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (Adderall). There was no illness at the time of vaccination. On Mar 12 2004, the patient developed varicella (previously reported as child developed over 200 lesions). It was noted on physicial exam that the patient was alert and cooperative, temperature was 96.4, his skin had erythematous clear filled vesicles on the face and abdomen, ENT was clear, lungs were clear and abdomen was soft. It was also noted theat the child was exposed to chickenpox in school on 3/02/2004. The treatment plan included acyclovir 600 mg QID x 5 days, avenno bath and diphenhydramine HCL (Benadryl) as needed. There were no other lab diagnostic tests performed. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, the patient recovered on 03/17/2004. No further information has been requested.
Age: 5.0
Sex: M
Vaccine: DTP, MMR, OPV, VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 06Jul99 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the pt had a serious breakthrough of varicella. The pt was seen at the office on 08Mar2004 and had many lesions on the face, trunk and extremities. The pt was treated with diphenhydramine hydrochloride (Benadryl) and ibuprofen (Advil). It was noted that the physician already reported the event to the health dept. A product quality complaint was not involved. Additional information has been requested. This is in follow up to report previously submitted on 5/14/2004 information has been received from a physician concerning a 10 year old male who on 07/08/1999 was vaccinated in the right arm with a dose of varicella virus vaccine live (lot # 629615/0310J). Concomitant vaccinations on the same day included a second dose in the left arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 627426/0540J), a fifth dose in the right arm of diphtheria toxoid (-) pertussis vaccine (unspecified) (-) tetanus toxoid (lot 464-301), and a fourth oral dose of poliovirus vaccine inactivated (unspecified) (lot 0800X). The reporter indicated that the patient had a serious break through of varicella. The patient was seen at the office on 03/08/2004 and had many lesions on the face, trunk and extremities. The patient was treated with diphenhydramine hydrochloride (Benadryl) and ibuprofen (Advil). It was noted that the physician already reported the event to the health department. A product quality complaint was not involved. Follow up information was received from a woman in the physicians office who indicated that the patient was diagnosed with varicella on 3/1/2004. Subsequently, the patient recovered. No further information is expected.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis bullous
Clinical narrative: Information has been received from a RN concerning a 31 month old female with no past medical history and no known drug allergies who on 14Aug2003 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 20Jan04 the pt presented to the physician's office with varicella like lesions on her eyelid. The lesions were treated with an ocular antibiotic to prevent secondary infection. The lesion on the eyelid has since resolved, but the child's mother has reported that more lesions have developed in other places "over the last month". No other information was available. Unspecified medical attention was sought. No lab diagnostic studies were performed. There was no product quality complain. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Infection, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 27Jul1998 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live. 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) given in the left arm. On 02Mar2004 the pt developed chickenpox lesions greater than 57 with 17 scabbed over. Only a slight fever was noted at onset. The end of the virus was 11Mar2004 and the pt recovered. No further information is available.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a certified medical assistant concerning a 15 year old female pt with no past medical history and no allergies who on 02Sep95 was vaccinated with a dose of varicella virus vaccine live. On 09Feb2004 the pt developed chickenpox. The pt was seen with red papules and small vesicle points at the first visit to the physician's office. About 4 days later, the condition was a little improved. It was noted that the office did run tests which came out positive for chickenpox. The rash occurred on the facial body, and upper extremities. It was noted that the pt recovered. No product quality complaint was involved. Additional information has been requested.
Age: 0.86
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Drug ineffective, Erythema, Rash vesicular, Skin ulcer, Viral infection
Clinical narrative: Information has been received from a physician concerning a 6 year old male who in 1998 was vaccinated with a dose of varicella virus vaccine live. It was reported that "he has developed" chickenpox with more than 100 lesions. The child was not hospitalized and the nurse stated that this case of chickenpox was uneventful. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information has been requested.  **This Is in follow up to report previously submitted on 5/14/2004 information has been received from a nurse concerning a 6 year old male with no allergies or medical history who, at a well check up on 06/22/1998 was vaccinated SC in the right arm with a first dose of varicella virus vaccine live (lot 62538000060H). Concomitant therapy that day included a first dose SC in the left arm of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 621993/0026H). it was reported that he has developed chickenpox with more than 100 lesions. The child was not hospitalized and the nurse stated that this case of chickenpox was uneventful. Unspecified medical attention sought. No produce quality complaint was involved. Follow up information from the nurse indicated that on 03/04/2004 at 9:50, mom reported that there were red bumps all over. The child was seen by the physician who described them as vesicular puttules lesions with erythema in differing stages of development on trunk and face. Treatment included Aveeno, Diphenhydramine HCL (Benadryl), calamine lotion and no ASA, isolate. The patients mother called on 3/5/2004 to report that the child had over 100 lesions all over the body. The report indicated that the treatment was the same. No lab or diagnostic test were done. The patient recovered on 3/10/2004 (also reported as 3/14/2004) and returned to school on 3/11/2004. Additional information is not expected.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a health care professional concerning a 7 year old pt who on 15Oct1997 was vaccinated with a dose of varicella virus vaccine live. On 10Mar2004 the pt was diagnosed with chickenpox. The pt had lesions on his trunk, back, bottom, and legs. No fever was noted. The child was given diphenhydramine hydrochloride (Benadryl) to treat his chickenpox. Unspecified medical attention was sought. There was no product quality complaint. The outcome was reported as not recovered. The reporter also indicated that another pt experienced adverse reactions following vaccination with chickenpox (WAES0403USA01037). Additional information has been requested.  ** Follow up information indicated that the child was exposed to chickenpox by his cousin on 3/8/2004. On 3/9/2004, bumps on the childs back, legs, and stomach were noticed. The child was brought to the physicians office on 03/10/2004, and the physician verified that the child had the chickenpox with less than 20 lseions. There were no relevant diagnostic test or lab data. Additional follow up information indicated that the patient recovered on 3/17/2004. No further information is expected.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective
Clinical narrative: Information has been received from a female doctor of philosophy with asthma who was vaccinated with two doses of varicella virus vaccine live. Concomitant therapy included albuterol. Subsequently the pt did not seroconvert. The pt sought unspecified medical attention. There was no product quality complaint involved.  The pt also reported that she had received doses of hepatitis B virus vaccine rHBsAg (yeast) and subsequently had a negative titer WAES0403USA00992). No further information is expected.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Viral infection
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 13Nov97 was vaccinated with a 0.5ml dose of varicella virus vaccine live. There was no concomitant medication. The physician indicated that on 01Mar2004, the pt experience chickenpox with fewer than 20 varicella lesions. The pt was treated with over the counter diphenhydramine hydrochloride (Benadryl). Subsequently, the pt recovered. A product quality complaint was not involved. No further information is expected. Follow up information from the physician ws received who indicated tha on 3/1/2004, the patient was seen for probable varicella. No diagnostic lab test were performed.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a licensed practical day care nurse who received a call concerning a 5 year old healthy female who in 2002 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 12Mar2004 the pt developed a  mild macro-papular rash.  Unspecified medical attention attention was sought. No diagnostic test or treatment was required. No product quality complaint was involved.  Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Platelet count increased
Clinical narrative: Information has been received from a doctor of pharmacy concerning her 13 month old healthy daughter who on 02Mar2004 or 03Mar2004 was vaccinated with varicella virus vaccine live. Concomitant therapy the same day included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR) and tuberculin purified protein derivative (PPD Tine Test). On 13Mar2004 a blood test showed elevated levels of white cells, red cells, and platelets. The pt sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from physician concerning a male pt who in Jan2002, was vaccinated with a dose of varicella virus vaccine live. On 17Mar2004, the pt presented to the office with 50 lesions. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a male pt who in September 1997 was vaccinated with varicella virus vaccine live.  On 03/11/04 the pt's mother called the MD's office stating that her son had chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved. It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0403USA01664, 0403USA01645, 0403USA01646, 0403USA01647).  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a female pt who in September 1996 was vaccinated with varicella virus vaccine live. On 03/12/04 the pt's mother called the MD's office and reported that her daughter had gotten a few spots of chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved.  It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine (WAES # 0403USA01611, 0403USA01645, 0403USA01646 & 0403USA01647).  Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a male pt who in May 2000 was vaccinated with varicella virus vaccine live. On 03/15/04 the pt was seen in the office with five lesions. It was reported that the pt had a breakthrough case of chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved.  It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0403USA01611, 0403USA01644, 0403USA01646 & 0403USA01647).  Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a male pt who in October 1998 was vaccinated with varicella virus vaccine live. On 03/11/04 the pt was seen in the MD's office with 50 chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved. It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0403USA01611, 0403USA01644, 0403USA01645, 0403USA01647).  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a physician concerning a female pt who in Feb 00 was vaccinated with varicella virus vaccine live.  On 03/04/04 the pt was seen in the MD's office with three chickenpox. The pt sought unspecified medical attention. There was no product quality complaint involved.  It was also reported that four other pt's developed chickenpox after being vaccinated with varicella virus vaccine live (WAES # 0403USA01611, 0403USA01644, 0403USA01645, 0403USA01646).  Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Rash, Viral infection
Clinical narrative: Information has been received from a public health professional concerning a female with a concurrent condition of "cryptogenic infantile spasm (West's syndrome)" who in 1995 was vaccinated with a dose of varicella virus vaccine live. In 1999, the pt developed a mild case of varicella. On 03/04/04 the pt developed rash with a "limited number of lesions involving several dermatomes". The reporter also mentioned two other pt's who were residents of the same long-term care facility: a 16 year old male who was vaccinated with varicella virus vaccine live and developed varicella rash (WAES # 0403USA01096) and a 13 year old female who developed varicella through secondary transmission (WAES # 0403USA01097).  Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Infection, Rash
Clinical narrative: Information has been received from a physician concerning a 27 year old Indian female with no allergies and no medical conditions who on 12/01/03 was vaccinated "IM" with a 0.5mL first dose of varicella virus vaccine live (Lot # 646230/0541N).  There was no illness at the time of vaccination. There was no concomitant medications. On 12/17/03 the pt experienced varicella infection (skin rash) "from the vaccination". Unspecified medical attention was sought. It was reported that no prescription drug treatment was required, the pt was not hospitalized and the experience was not life threatening. It was also reported that the pt recovered. No product quality complaint was involved. The pt's daughter (WAES # 0402USA01530) also developed chickenpox. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a public health nurse concerning a pt who on 08/11/99 was vaccinated with a dose of varicella virus vaccine live (Lot # 629612/0284J).  Subsequently, the pt developed chickenpox breakthrough. It was noted that this case was part of 4 cases of chickenpox breakthrough one of which was "mild" and the other three were "regular chickenpox". Unspecified medical attention was sought. There was no product quality complaint involved.  The reporter also mentioned three other pt's who developed chickenpox breakthrough and experienced similar reactions (WAES # 0403USA00650, 0403USA01868, 0403USA01869).  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a public health nurse concerning a pt who in August 00 was vaccinated with a dose of varicella virus vaccine live (Lot # 632727/0089K).  Subsequently, the pt developed chickenpox breakthrough. It was noted that this case was part of 4 cases of chickenpox breakthrough one of which was "mild" and the other three were"regular chickenpox". Unspecified medical attention was sought. Subsequently, all cases resolved. There was no product quality complaint involved. The reporter also mentioned three other pt's who developed chickenpox breakthrough and experienced similar reactions (WAES # 0403USA00650, 0403USA01867, 0403USA01869).  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Infection
Clinical narrative: Information has been received from a public health nurse concerning a pt who in September, 2000 was vaccinated with a dose of varicella virus vaccine live (Lot # 632727/0089K).  Subsequently, the pt developed chickenpox breakthrough. It was noted that this case was part of 4 cases of chickenpox breakthrough one of which was "mild" and the other three were "regular chickenpox". Unspecified medical attention was sought. Subsequently, all cases resolved. There was no product quality complaint involved. The reporter also mentioned three other pt's who developed chickenpox breakthrough and experienced similar reactions (WAES # 0403USA00650, 0403USA01867, 0403USA01868).  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, PNC, VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Information has been received from a RN concerning a 4 year old female who on 07/31/00 was vaccinated with a first dose of varicella virus vaccine live in her left anterior thigh (Lot # 634495/0534K).  Concomitant suspect therapy that same day included a first dose of MMRII given in her right anterior thigh (Lot # 12681C Invalid). Other concomitant therapy that same day included a second dose of Prevnar (Lot # 480-970) given in the left anterior thigh. On 01/15/04 the pt was "diagnosed by MD".  The adverse event was not otherwise specified. There were no lab or diagnostic tests performed. The nurse also reported that the pt may have been vaccinated with improperly stored varicella virus vaccine live. It was noted that the pt was not recovered. Unspecified medical attention was sought. The reporter also mentioned other pt's who may have been vaccinated with improperly stored varicella virus vaccine live (WAES # 0403USA02038, 0403USA02039, 0403USA02040).  These pt's included three other children in the same daycare who reported having chickenpox within the same time period (WAES # 0403USA02038, 0403USA02039).  Another child in the same daycare also reported having chickenpox within the same time period, but had not previously received varicella virus vaccine live. Additional information has been requested.