chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a physician and L.P.N. concerning an 84 year old female who on 12-DEC-2006 was inadvertently vaccinated with a 0.5 ml dose of Varivax (lot 3 654813/1088F) instead of Zostavax. Unspecified medical attention was sought. This was reported to be staff error and not product confusion. The administering L.P.N. stated that the office stopped carrying Varivax on an earlier date and she did not realize that they started carrying it again. The L.P.N. said that she grabbed the vaccine out of the freezer, saw varicella on the bottle and thought it was Zostavax. After administering the vaccine the L.P.N. saw the brand name of the vaccine on the bottle. The patient has not had any adverse experiences. There was no product quality complaint involved. No additional information was provided. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a 46 year old female who on an unspecified date had a varicella titer drawn which was negative, then on 29-NOV-2006 was vaccinated with a first dose of Varivax. On an unspecified date post vaccination, the patient developed a rash. It was reported that the client had 35 pox on unspecified locations on her body. Unspecified medical attention was sought. At the time of the report the patient's recovery status was unknown. There was no product quality complaint involved. No further information is available.
Age: 78.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse from the health department concerning a 78 year old female who on 13-DEC-2006 was vaccinated with a dose of Varivax for the prevention of shingles instead of Zostavax. There was no adverse experience related to this event. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain, Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a 24 year old female volunteer with unknown medical history who on 06-NOV-2006 was vaccinated SC in the left deltoid with a 0.5 ml first dose of Varivax (lot 3 651280/0408R). It was unknown if there was illness at the time of vaccination. Two days after the injection, on 08-NOV-2006 she experienced soreness, redness and pox marks (also reported as fluid filled vesicles) across her chest and abdomen. She did not have a fever. The patient recovered spontaneously 10 days later on 18-NOV-2006 (also reported as on an unknown date) and the pox crusted over. It was reported that the patient's symptoms were observed by a relative who is a nurse, not by clinic personnel. There were no labs performed. There was no product quality complaint involved. It was unknown if the patient had any adverse experiences following prior vaccination. No further information was available. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 18-year-old male with an amoxicillin allergy (rash following amoxicillin) who on 17-NOV-1997 was vaccinated with a dose of Varivax. There was no concomitant medication. No illness at the time of vaccination. On 27-NOV-2006 the patient had a reported temperature of 102 and his first outbreak was reported on 29-NOV-2006. Subsequently, the patient recovered on 02-DEC-2006. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a nine year old male who on 15-JUL-1998 was vaccinated with Varivax. There was no concomitant medication. On 15-NOV-2006 the patient was seen in the doctor's office and diagnosed with varicella. The patient recovered from the varicella on an undisclosed date. No further information is available.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a school medical assistant concerning a 12-year-old male who in approximately 1985, at the age of 12 months, was vaccinated with a dose of Varivax. On approximately 10-DEC-2006, the patient developed varicella disease. No medical attention was sought. There was not known. There was no other information to report. No additional information is expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 8-year-old female with no pertinent medical history and no drug reaction or allergies who on 25-MAR-1999 was vaccinated subcutaneously with a dose of Varivax. Concomitant therapy included polyethylene glycol 3350 (MIRALAX) (Lot #629541/1894H). There was no illness at the time of vaccination. On 12-DEC-2006 the patient experienced 10 lesions that were flat and maculopapular; one of two lesions were slightly vesicular. No fever was noted. The patient was examined again on 17-Dec-2006 and was observed to have approximately 25 lesions, some of which were vesicular. Unspecified medical attention was sought. The patient was treated with diphenhydramine (BENADRYL) and Aveeno Bath. The patient's lesions persisted. There were no lab studies performed. There was no other information to report. Follow-up information was received in which a nurse noted that the 10 lesions were located behind the ears, stomach, chin, and arm. The lesions were described as flat, red, macules with a "pimple-like center;" one or two appeared to be slightly vesicular. There was no illness at the time of vaccination. On 17-DEC-2006, the patient recovered. No additional information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old female who in approximately October 2005 was vaccinated with one dose of Varivax. Subsequently, the patient was diagnosed with shingles. There was no product quality complaint. Unspecified medical attention was sought. The outcome was recovered. There was no further information to report. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Pharyngolaryngeal pain, Pyrexia, Rash, Rash papular, Varicella
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 13 year old male, with no pertinent medical history, drug reactions or allergies, who on 02-FEB-1995 was vaccinated with VARIVAX (Merck). On approximately 18-DEC-2006 the patient complained of a sore throat, fever, rash and small papules on his face, back and chest. Some of the papules were open, but none were fluid filled. The physician diagnosed the patient with mild case of chickenpox. There was no concomitant therapy. The final outcome was unknown at the time of this report. Unspecified medical attention was sought. There was no product quality complaint. There wwere no lab diagnostic studies performed. Additional information has been requested.  No further information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Dizziness, Headache, Pneumonia, Pyrexia, Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old male with no known drug allergies, hay fever and urethral stenosis, who on 27-SEP-1999 was vaccinated SC in the right arm with a first dose of Varivax (lot # 630414/0302J). On 18-NOV-2006 the patient experienced a frontal headache and dizziness. On 19-NOV-2006 the patient presented to the emergency department with a fever and rash which started on his legs. The rash spread to his face, back, chest and all extremities. The patient's palms and oral mucosa were spared. The rash was reported to be reddened area 1 1/2 to 2 1/2 cm in diameter with blister like centers, the patient also complained of itching. The rash was also reported to be spotty and palpable. The patient also had a cough and muscle/joint pain. The patient was discharged in stable condition with a diagnosis of chickenpox. It was reported that on an unspecified date the patient's 6 year old sister had rash and pneumonia. Information received on 20-DEC-2006 contained the following adverse experience: concussion at the age of 2. No additional information was provided. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: FLU3, PNC, VARCEL
Symptoms: Body temperature decreased, Decreased appetite, Irritability, Skin lesion, Varicella
Clinical narrative: Information has been received from a medical assistant concerning a 13 month old female with reactive airways disease and a history of frequent ear infections, who on 27-NOV-2006 was vaccinated SC in the leg (also reported as thigh) with a first dose of Varivax (lot # 654610/1049F). Concomitant vaccination included a fourth dose of Prevnar (lot # B08681F) given IM in the leg (also reported as thigh) and a first dose of Fluzone (lot # U2220BB) given IM in the leg (also reported as thigh). Concomitant medication included loratadine (CLARITIN0. There was no illness at the time of vaccination. On approximately 09-DEC-2006 the patient was seen in the physician's office for an unspecified reason, on the same date as a 4 month old infant with active varicella. On 13-DEC-2006 (also reported as 11-DEC-2006) the patient came in to the office with less than one dozen spots of varicella crops and crusted lesions visible on her trunk, in her mouth and on her lips. The patient was fussy, had a decreased appetite and had a low temperature (also reported as afebrile). It was reported that there were a few lesions with a honey colored crust and a few with the classic tear drop shaped blisters. It was reported that there was an "active outbreak" in this country. The patient was noted to have a laceration to the top of her phrenulum. The patient was treated with amoxicillin (AMOXIL) for prophylaxis. It was reported that the patient and her sibling had not had any adverse events followed prior vaccination (previously reported as the patient has experienced soreness and fever after previous vaccination with DTaP. No labs tests were performed, just a physical exam by the physician. Subsequently, on an unspecified date the patient recovered. No further information was available. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthma, Drug hypersensitivity, Eczema, Pruritus, Rash generalised
Clinical narrative: Information has been received from a consumer concerning her 4 year old daughter with food allergies, environmental allergies, a penicillin allergy, eczema and asthma who on 10-NOV-2006 was vaccinated SC with a 0.5 ml dose of Varivax (product circular # 7999915). Concomitant therapy included montelukast sodium. Subsequently, "2 1/2 to 3 weeks after the shot", on approximately 28-NOV-2006 the patient developed "itching and rashes all over her body." Unspecified medical attention was sought. There were no labs performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with a hernia, congenial diaphragmatic hernia (CDH) and a history of patent ductus arteriosus (PDA) who on 10-JUN-1999 was vaccinated with Varivax. It was unknown if there were any illnesses at the time of vaccination. On 25-NOV-2006, the patient developed 25-30 lesions on neck and trunk and the appearance of a classic varicella rash. The patient required a doctor visit. Symptomatic treatment included unspecified over-the-counter therapy. No diagnostic testing was performed. The patient recovered. No further information is available.
Age: 0.75
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Rash, Scab
Clinical narrative: Information has been received from a registered nurse concerning a 9 month old male with no medical history or allergies who on 01-MAR-2001 was vaccinated with a first dose of Varivax (lot # 635461/1246K). There was no concomitant medication. There was no illness at the time of vaccination. On 03-DEC-2006 the patient developed a rash described as "25 scabbed papular." There were no blisters, they were all scabbed. Medical attention was sought. Treatment was symptomatic. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 1.4
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male with no medical history or allergies who on 03-OCT-1995 was vaccinated with a first dose in the right arm of Varivax (lot # 608655/0417B). Concomitant therapy vaccination that day included a first dose in the left arm of MMR II (lot # 615839/0885B). There was no illness at the time of vaccination. On 27-NOV-2006 the patient developed a fever of 104 and lesions on face, trunk, and buttocks with a total of 75. Medical attention was sought. No laboratory diagnostic tests were performed. Treatment was symptomatic. Subsequently, the patient recovered. The patient did not experience any adverse events following prior vaccination. There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test abnormal, Vaccination failure, Varicella
Clinical narrative: Information has been received from a consumer concerning his daughter, who was one of seven children in grades 1 and 2 (combined) who reportedly had chickenpox, including her daughter. The reporter noted that her daughter had been previously vaccinated with Varivax on an unspecified date. In December 2006, the daughter developed a papular rash on her face, trunk, back and genitalia, which was confusingly not vesicular, but in different stages. The rash first appeared on her daughter around Christmas. At the time of this report the rash not shown any scabs. His daughter was afebrile, active, and felt perfectly fine otherwise. The reporter communicated she felt that clearly there seems to be some failure of the vaccine suggesting the need for a booster or another wild variant strain not covered by the vaccine. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Eye pruritus, Injection site pain, Lymphadenopathy, Rash maculo-papular
Clinical narrative: Information has been received from a physician and a physician's assistant from employee health, concerning a 62 year old female with a sulfa allergy who on 13-NOV-2006 was vaccinated subcutaneously in the right upper arm with her first dose of Varivax (lot # reported as "09078"). At the time of vaccination, the patient had allergic rhinitis. Subsequently, ten days post immunization, on 23-NOV-2006, the patient's developed a dry maculopapular rash (5-6 lesions) over her torso/head; rhinorrhea, pruritic eyes, slight generalized arthralgias, injection site soreness, anterior node cervical lymphadenopathy. No laboratory or diagnostic tests were performed. It was reported that the symptoms lasted approximately 13-14 days; the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Rhinitis allergic, Rhinorrhoea
Clinical narrative: Information has been received from a physician and a physician's assistant from employee health, concerning a 62 year old female with a sulfa allergy who on 13-NOV-2006 was vaccinated subcutaneously in the right upper arm with her first dose of Varivax (lot # reported as "09078"). At the time of vaccination, the patient had allergic rhinitis. Subsequently, ten days post immunization, on 23-NOV-2006, the patient's developed a dry maculopapular rash (5-6 lesions) over her torso/head; rhinorrhea, pruritic eyes, slight generalized arthralgias, injection site soreness, anterior node cervical lymphadenopathy. No laboratory or diagnostic tests were performed. It was reported that the symptoms lasted approximately 13-14 days; the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vaccination failure, Varicella
Clinical narrative: Information has been received from a medical assistant and a physician concerning an 11 year old 7 month old female who on 14-JAN-1998 was vaccinated with a dose of Varivax. On 24-DEC-2006, the patient developed a fever and more than 250 lesions which was described by the physician as a "full blown" case of chickenpox. The patient was seen by a physician and the examination revealed many lesions that were all in stages including teardrops to crusts. The child was fully alert and in no distress. The patient had lesions in her mouth and scalp, which her lungs were clear and there was no cough. There was mild itching and used diphenhydramine hydrochloride (BENADRYL) and oatmeal baths. The physician also reported, "child appears well and doesn't seem to be having any complications of chickenpox, but seems to be a vaccine failure". At the time of the report, the had not recovered. No product quality complaint was involved. It was reported that the patient's sister was also previously vaccinated with a dose of Varivax and developed chickenpox (WAES# 0701USA01186). Additional information was received on 13-FEB-2007 and indicated that the patient recovered completely. It was also noted that the patient did not have any pre-existing allergies, birth defects or medical conditions and no diagnostic or laboratory tests were performed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Excoriation, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a female, five years of age, who on 02-FEB-2004 was vaccinated with Varivax (Lot # 646535/0575N). In 2007 the patient experienced breakthrough chickenpox. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. 02/11/2010 Information has been received from a registered nurse concerning a 4 year old female with no pre exisitng allergies, medical conditions or present illness, who on 02-FEB-2004, at 6pm, was vaccinated with the first doses of both VRIVAX (lot # 646535/0575X) and MMR II (Lot # 645909/0622N). The patient was seen on 2 JAN 2007 with a history of an itchy rash which began the previous day 01 JAN 2007 at 11:05AM. The patient presented with multiple erythematous papules all over her trunk, greater on the right side than the left. Most lseions were excoratied. Two lesions on the back were vesicular. The patient was prescribed ecyclovic 200 mg PO A5, for five days, and isolation until all lesions were crusted. The patient was recovered on 09 JAN 2007. There was no product quality complaint. There were no lab diagnositic studies performed. No further information is expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a female, five years of age, who on 02-FEB-2004 was vaccinated with Varivax (Lot # 646535/0575N). In 2007 the patient experienced breakthrough chickenpox. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. 02/11/2010 Information has been received from a registered nurse concerning a 4 year old female with no pre exisitng allergies, medical conditions or present illness, who on 02-FEB-2004, at 6pm, was vaccinated with the first doses of both VRIVAX (lot # 646535/0575X) and MMR II (Lot # 645909/0622N). The patient was seen on 2 JAN 2007 with a history of an itchy rash which began the previous day 01 JAN 2007 at 11:05AM. The patient presented with multiple erythematous papules all over her trunk, greater on the right side than the left. Most lseions were excoratied. Two lesions on the back were vesicular. The patient was prescribed ecyclovic 200 mg PO A5, for five days, and isolation until all lesions were crusted. The patient was recovered on 09 JAN 2007. There was no product quality complaint. There were no lab diagnositic studies performed. No further information is expected.
Age: 1.05
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a 15 month old male who in September 2006, was vaccinated subcutaneously with Varivax (Oka/Merck), as well as MMR II (MSD), and other unidentified vaccinations. On around 23-NOV-2006 the patient developed shingles, which was believed to be a result of the Varivax vaccine (Oka/Merck), the patient received in SEP 2006. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning female nurse who in 2003 was vaccinated with two doses of Varivax. On 13-DEC-2006, the patient's titers were less than 0.91. No additional information to report. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a physician and L.P.N. concerning a 70 year old female homemaker who on 12-DEC-2006 at 14:39 was inadvertently vaccinated IM in the left deltoid with a 0.5 ml first dose of Varivax (lot # 654813/1088F) instead of Zostavax. Unspecified medical attention was sought. This was reported to be staff error and not product confusion. The administering L.P.N. stated that the office stopped carrying Varivax on an earlier date and she did not realize that they started carrying it again. The L.P.N. said that she grabbed the vaccine out of the freezer, saw varicella on the bottle and thought it was Zostavax. After administering the vaccine the L.P.N. saw the brand name of the vaccine on the bottle. The patient has not had any adverse experiences. There was no product quality complaint involved. No additional information was provided. Additional information received indicated that the patient was vaccinated with a first dose of Zostavax (lot # 652966/1211F) on 14-DEC-2006 at 14:31. There was no illness at the time of vaccination. There were no lab tests performed. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Antibody test, Antibody test negative
Clinical narrative: Information has been received from a pharmacist concerning a patient greater than 38 years old, who on 31-JAN-2002 finished the Varivax series. Subsequently the patient had a titer value of 0.58. It was reported that a value of less than 0.91 is considered negative. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Nausea, Pyrexia
Clinical narrative: Information has been received from a consumer concerning her 18 year old daughter with a history of unspecified allergies, who on 02-JAN-2007 was vaccinated with Varivax (Merck), and subsequently, on 03-JAN-2007, developed fever, diarrhea and nausea. Concomitant therapy included fexofenadine hydrochloride (ALLEGRA). The patient's fever and diarrhea and nausea persisted, and were not recovered at the time of this report. Lab diagnostic studies were not performed. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash maculo-papular
Clinical narrative: Information has been received from a 38 year old female registered nurse who, on 18-DEC-2006, as part of her employees health vaccine administration, was vaccinated with Varivax (Merck). On the evening of 18-DEC-2006 the patient experienced a fever of 104', big red spots and 100 blisters on her belly area. The nurse reported that the fever lasted three days. Six days later, on approximately 23-DEC-06, the nurse reported that the blisters had dried up and she was recovered. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 7-year-old male who on 08-SEP-2000 was vaccinated with Varivax. On 03-JAN-2007 the patient experienced chickenpox. Unspecified medical attention was sought. It was reported that the patient was recovering at the time of this report. No additional information to report. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 13-year-old male who in 1996 was vaccinated with a 0.5 ml dose of Varivax. Recently, the patient experienced a break through case; he had 50 to 250 lesions on the trunk and the rest of body. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 16-JUL-2001 was vaccinated SC in the left arm with a first dose of Varivax (lot # 638248/0496L). On 01-JAN-2007 the patient experienced a rash that was papular for 3 days, then a varicella rash all over the body. There are several hundred (50-249) that were continuing to break out at the time of the office visit on 04-JAN-2007. The patient had recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. Follow-up information was received from a health professional, who reported that the child had no medical conditions, pre-existing allergies, or illness at the time of vaccination on 16-JUL-2001. On 04-JAN-2007 the patient presented with numerous poxs, approximately 100-250 spots. Supportive treatment included oatmeal baths, diphenhydramine hydrochloride for itching, and acetaminophen for increased temperatures. Seven to ten days post onset, approximately 11-JAN-2007, the patient was recovered. No further treatment was necessary. No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Incorrect route of drug administration, Scab, Skin lesion
Clinical narrative: Information has been received from a health professional concerning a 4 year old female with no allergies or medical history who on 25-FEB-2003 was vaccinated IM in the left arm with a first dose of Varivax (lot # 643820/0864M). There was no concomitant medication and no illness at the time of vaccination. On 28-DEC-2006 the patient experienced numerous erythematous lesions about 1 cm in size scattered over the trunk, face and limbs. Some are papular while others have a central clear vesicles. There is a scabbed/crusted over lesion on the back. There are less than 50 lesions entirely. No labs were done. It was unknown if medical attention was sought. The patient recovered. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Rash pruritic, Varicella
Clinical narrative: Information has been received from a healthcare worker concerning a 7-year-old male with no pertinent medical history or allergies who on 02-OCT-2000 (also reported as 20-OCT-2000) was vaccinated in the arm with a 0.5 mL dose of Varivax (Lot #635452/0768K). Concomitant therapy included MMR II. There was no illness at the time of vaccination. On 09-JAN-2007 at 09:00, the patient experienced a generalized, scattered papular rash which was itchy for 4-5 days. Unspecified medical attention was sought. The patient was diagnosed with chicken pox. No diagnostic studies or lab tests were performed. On 16-JAN-2007 the patient recovered. No additional information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 9-year-old female with drug hypersensitivity to diphenhydramine (Benadryl) and a history of chicken pox in June 1994 and cleft palate repair who on 03-MAY-1999 was vaccinated subsequently with a 0.5 mL first dose of Varivax (Lot # 630037/0290J). There was no concomitant medication. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. On 28-JUL-2003, the patient experienced shingles and was seen in the emergency room. She was told to rest. No diagnostic studies were performed. Subsequently, the patient recovered from shingles. No additional information to report. There was no product quality complaint. No additional information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Upper respiratory tract infection, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 24-month-old female with no history of drug reactions or allergies no pre-existing medical conditions who on 19-MAY-2005 was vaccinated subcutaneously in the left deltoid with a 0.5 ml dose of Varivax (Lot # 649270/0987P). Concomitant therapy included brompheniramine maleate/pseudoephedrine DM (DIMETAPP); it was also indicated that there were no concomitant medications at the time of vaccination. There was no illness at the time of vaccination. On 24-MAY-2006, the patient experienced an upper respiratory infection; on 04-JUN-2006 (also reported as 03-JUN-2006) she experienced varicella rash with a total of 15 to 20 pink, papulo-vesicular lesions on both forearms and two on her face. There were no additional symptoms. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. There were no adverse events following prior vaccinations. No additional information is expected.
Age: 1.0
Sex: F
Vaccine: HEPA, PNC, VARCEL
Symptoms: Irritability, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 12-month-old female with restrictive airway disease, and no history of drug reactions or allergies, who on 19-DEC-2006 was vaccinated with one 0.5 ml subcutaneous dose of Varivax (Lot # 654025/0802F) in the left thigh. Concomitant medication included a first Vaqta Lot # 656495/1029F) in the left thigh and a third Prevnar (Lot # B08646K). There was no illness at the time of vaccination. On 31-DEC-2006, she became "cranky," and, on 02-JAN-2007 the patient experienced a varicella rash with approximately 15 lesions in different stages on her trunk. There were no laboratory or diagnostic studies performed. Outcome was reported as recovered. No additional information to report. There was no product quality complaint. There were no adverse events following prior vaccinations. No additional information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a medical assistant concerning a female who on an unspecified date was vaccinated with a dose of Varivax. Subsequently, the patient developed a mild case of chickenpox "two weeks ago" approximately 15-DEC-2006. it was unspecified if medical attention was sought. No outcome information was reported. It was also reported that the patient's sister developed a "full blown" case of chickenpox after Varivax (WAES# 0701USA00227). Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 12 year old female with no medical history or allergies who on 21-AUG-2006 was vaccinated in the left arm with a second dose of Varivax (lot # 652807/0266F). Illness at the time of vaccination included a "local reaction". On 23-AUG-2006 at 17:00 the patient developed a golf sized bump with redness, swelling warmth and tenderness on the posterior left upper arm. She also developed swelling and redness from the left elbow up to the shoulder area with itching and discomfort. There was no fever or drainage. Medical attention was not sought. No laboratory diagnostic tests were performed. The patient recovered on an unspecified date. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 12 year old female with no medical history or allergies who on 21-AUG-2006 was vaccinated in the left arm with a second dose of Varivax (lot # 652807/0266F). Illness at the time of vaccination included a "local reaction". On 23-AUG-2006 at 17:00 the patient developed a golf sized bump with redness, swelling warmth and tenderness on the posterior left upper arm. She also developed swelling and redness from the left elbow up to the shoulder area with itching and discomfort. There was no fever or drainage. Medical attention was not sought. No laboratory diagnostic tests were performed. The patient recovered on an unspecified date. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Information has been received from a physician concerning a 3-year-old male with a history of rash occurring twice on the left upper leg with no additional pertinent medical history and no history of drug reactions or allergies who on 16-AUG-2004 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (Lot # 648320/0115P). There was no concomitant medication. Subsequently, the patient experienced shingles on his left upper leg. There was noted to be about 20 lesions with itching and pain. The child's mother reported that this is the third time her child had such a rash in the same area. No laboratory or diagnostic studies were performed. The outcome at the time of this report was recovering. There is no additional information to report. There was no product quality complaint involved.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning her 8-year-old daughter who on 17-MAR-1999 was vaccinated subcutaneously in the left arm with a 0.5 ml dose of Varivax (Lot # 629249/1845H). Concomitant medication on that day was MMR (Lot # "121408/03"). On 02-JAN-2007 (previously reported as 03-JAN-2007), the patient experienced a breakthrough of approximately 50 lesions of varicella rash. It was noted that this was a "mild case" of varicella disease. The outcome was reported as recovered. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved. No additional information is expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Herpes zoster, Laboratory test, Rash vesicular
Clinical narrative: Information has been received from two physicians concerning a 4 year old male (birth date reported as 30-APR-2002 and 20-APR-2002) with no known allergies or pertinent medical history who on 19-MAY-2003 at one year of age, was vaccinated in the left thigh with a dose of Varivax (lot # 644091/1066M). There was no concomitant medication. On 30-DEC-2006 (also reported as 03-JAN-2007) the patient developed a zoster like rash on the lower left leg and another rash above the lower left buttock (the rash was also described as vesicular and developed on the left side from the midline of the back, down the left buttock and down the left crossing numerous dermatomes) (the physician was unsure if this was zoster). Medical attention was sought, a pediatrician (not the reporting physician) was seen on day 6 or 7 of the rash, the rash was described as "getting better", and the patient was treated with acyclovir. It was also reported that the patient was referred to a dermatologist and zoster was diagnosed. On approximately 05-JAN-2007 testing was done and the patient had a negative varicella IgM titer, and a varicella anticomplement immunogluorescence (ACIF) was greater than 1/2256. The patient's immune system was evaluated and found to be "normal." On 11-JAN-2007 the patient was considered recovered when examined by the dermatologist. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old female with seasonal allergies, congestion, pyloric stenosis (diagnosed in January 2003), a cefdinir (OMNICEF) hypersensitivity and a history of tubes (in 2004), who on 18-NOV-2003 was vaccinated SC with a 0.5 ml dose of Varivax (lot # 646140/0539N). Concomitant vaccination included a first dose of ProQuad (lot # 640788/1180M) given SC. Concomitant therapy included cetirizine hydrochloride (ZYRTEC). There was no illness at the time of vaccination. On 10-JAN-2007 the patient experienced an unspecified amount of lesions and red papules on the trunk. The patient was afebrile. Medical attention was sought, the patient was seen in the office on 11-JAN-2007 and was diagnosed with chickenpox. There were no lab studies performed. The patient was treated with oral diphenhydramine hydrochloride (BENADRYL) capsules and calamine (+) zinc oxide (CALAMINE LOTION) topically as needed. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided.  The patient's vaccination history also included a second dose of MMR (lot # 655063/0861F) given SC on 18-NOV-2006. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a nurse practitioner concerning a female child who was vaccinated subcutaneously with a 0.5ml dose of Varivax. One day later, the child experienced an initial varicella-like injection site reaction from which she recovered. No laboratory or diagnostic studies were performed. Unspecified medical attention was sought. There is no additional information to report. There was no product quality complaint involved. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Blood immunoglobulin G normal, Blood immunoglobulin M, Drug exposure during pregnancy
Clinical narrative: Information has been received through the Merck pregnancy registry from a physician concerning an 18-year-old white female with no drug reactions/allergies and with a history of chickenpox (therefore the patient had immunity to varicella) who on 10-OCT-2006 was inadvertently vaccinated SC with a 0.5mL dose of Varivax (Lot # 654082/0916F) when she was 19 weeks pregnant. Concomitant therapy that day included a dose of influenza virus vaccine (unspecified). Titers showed the patient had a prior immunity to varicella. It was noted that the physician ordered Varivax, and the nurse administered it. It was "just human error". Unspecified medical attention was sought. There was no product quality complaint. Follow up information indicated that a the LMP=07-MAY-2006 (EDD=04-MAR-2007). On 25-JUL-2006, an ultrasound was obtained to "check dates". On 22-SEP-2006, a MSAFB was obtained, and showed "neg NTD, OS, Trils". On 18-OCT-2006, an ultrasound showed a 20.6 week male. The patient had no previous pregnancies, no full-term deliveries, and no pre-term births. There was no birth defects with any other pregnancy; no still birth or miscarriage in any previous pregnancy. The patient was not tested for varicella antibodies before vaccination with VZV containing vaccine. A liveborn male infant was born on 18-FEB-2007 (weight 7 pounds 2 ounces; 38 weeks from LMP). The infant was normal. There was no complications or abnormalities. There was no complications during pregnancy. There were no complications during labor/delivery. There were no infections or illnesses during pregnancy. There were no concurrent medical conditions. There was no feature of congenital varicella zoster syndrome. Diagnostic tests during pregnancy included: "varicella zoster IgG=3.61 (positive IgG Ab=31.10); IgM=0.30 (0-0.90 Neg)". Other medication used during the pregnancy included: "PNV" and ferrous sulfate from December 2006 325mg daily for anemia. No additional information is expected.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular, Scab
Clinical narrative: Information has been received from a nurse concerning a 6 year old female with no known allergies and a history of sinus hydronephrosis and pyonephrosis who on 23-AUG-2001 was vaccinated with a first dose of Varivax. On 12-JAN-2007 the patient presented to the doctor's office with chicken pox. She had an itchy vesicular rash on her right abdomen, under the right arm, on the right and left upper thighs and on the right ankle. Some lesions are scabbed. The child was afebrile, not vomiting and had no other symptoms. At the time of this report the patient had not recovered. Unspecified medical attention was sought. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 7 year old male who, in 2000, at one year of age, was vaccinated with Varivax. In December of 2006 the patient experienced "breakthrough". The number of lesions was not specified. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 11-year-old female who was vaccinated with Varivax; date not provided. In December 2006, the patient experienced "breakthrough." The number of lesions was not specified. Unspecified medical attention was sought. There was no additional information available. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella
Clinical narrative: Information has been received from a physician concerning an 11-year-old female with no pertinent medical history who on 23-JUL-1996 was vaccinated with her first dose of Varivax. There was no concomitant medication. On 12-DEC-2006, it was noted that the patient's mother had shingles and it was unknown if the mother had been vaccinated with Varivax. On 26-DEC-2006, 14 days after the mother had shingles, the patient experienced "breakthrough," with an unspecified number of lesions. Unspecified medical attention was sought. The patient was "fine" at the time of this report. No additional information was available. There was no product quality complaint involved. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 78-year-old female patient, with no pertinent medical history, who was vaccinated on 11-JAN-2007 intramuscularly (previously reported as subcutaneously) with a 0.5 ml dose of Varivax instead of Zostavax. No adverse event was reported. No additional information to report. There was no product quality complaint involved. Follow-up information was received from a physician on 25-JAN-2007 indicating that the reason for the medication error was her office's "check out sheet" and an inexperienced nurse. The office has now implemented changes to reduce errors, has reeducated the administering nurse, and the check-out sheet has been amended (now grouped by pediatric and adult vaccines). The physician stated there was no confusion due to the vaccine's packaging. The patient will be vaccinated with Zostavax in the next month. At the time of this report, the patient has not had any issues since vaccination.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G increased, Blood immunoglobulin M increased, Herpes virus infection
Clinical narrative: Information has been received from a physician concerning a 2-year-old male with no pertinent medical history and no history of drug reactions or allergies, who in November 2006, was vaccinated with Varivax. Subsequently, the patient experienced multiple herpetic lesions in the groin, IGG and IGM titers were elevated. Medical attention was sought, and treatment included DENVIR. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no pertinent medical history who on 28-MAY-2003 was vaccinated SC with a 0.5 mL dose of Varivax. There was no concomitant medication. On 12-JAN-2007 the patient developed a varicella rash on her torso and right leg, and she had a temperature of 100.5 degrees Fahrenheit and complained of itchiness. There were about 10 lesions. The patient was instructed to use calamine lotion and take therapy with diphenhydramine hydrochloride (BENADRYL) at night. On 16-JAN-2007 the physician followed up with the patient, and the patient was recovering. She no longer had a temperature but had developed 3 additional lesions under her right eye and ear. No lab diagnostics were performed. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Body temperature increased, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a physician assistant concerning a 10 year old female with no allergies or medical history who on 22-APR-2002 was vaccinated with a first dose of Varivax without any problems and on 16-JAN-2007 was vaccinated SC in the left deltoid with a 0.5 mL second dose of Varivax (lot # 654131/1150F). Concomitant vaccination on the same day included a dose of Gardasil in the other arm. There was no illness at the time of vaccination. On 17-JAN-2007, the patient developed an injection site rash. The rash was described as a cellulitis that was swollen, warm, and tender to the touch. The patient was seen in the office on 18-JAN-2007 and the cellulitis was determined to be 4 cm in diameter and reported to be larger than it was on 17-JAN-2007. The patient had a fever of 102 degrees Fahrenheit on 18-JAN-2007. Unspecified medical attention was sought and the patient was told to take Benadryl and to use a warm compress. No diagnostic laboratory tests were performed. At the time of the report the patient had not recovered. Follow-up information was received from the physician assistant who reported that on 17-JAN-2007, the patient had red, indurated, warm cellulitis of the left upper extremity around the injection site. It was greater than four inches in diameter with a central vesicle. Her temperature was 102.5. She was treated with Rocephin and Augmentin. The patient recovered on 19-JAN-2007. The patient's experiences were considered to be disabling and other important medical events by the reporter. No further information is expected.