chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site rash, Injection site warmth, Pyrexia
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.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a male patient who in 1999 in vaccinated a 0.5 ml dose of Varivax. On 18-JAN-2007 the patient experienced a breakthrough case of chickenpox. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Oral soft tissue disorder, Rash papular, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old white male with no known medical history who on 23-JUL-1997 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 622969/0423E). On 19-JAN-2007 it was reported that the patient "now" has chickenpox with greater than 50 lesions and was being treated with acyclovir. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information from the registered nurse indicated that on 19-JAN-2007 the patient developed classic varicella lesions on his face and trunk, erythematous papules with clear vesicles. A lesion was noted on the roof of his mouth and one on the outer left ear canal. The patient was prescribed acyclovir and mupirocin (BACTROBAN) for the lesion on the ear. The patient was diagnosed within 24 hours of the outbreak and new lesions appeared for up to 4 days. Subsequently the patient recovered. The reporter considered the chickenpox and acyclovir treatment an other important medical event. No further information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old white male with no known medical history who on 23-JUL-1997 was vaccinated SC in the left thigh with a first dose of Varivax (lot # 622969/0423E). On 19-JAN-2007 it was reported that the patient "now" has chickenpox with greater than 50 lesions and was being treated with acyclovir. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information from the registered nurse indicated that on 19-JAN-2007 the patient developed classic varicella lesions on his face and trunk, erythematous papules with clear vesicles. A lesion was noted on the roof of his mouth and one on the outer left ear canal. The patient was prescribed acyclovir and mupirocin (BACTROBAN) for the lesion on the ear. The patient was diagnosed within 24 hours of the outbreak and new lesions appeared for up to 4 days. Subsequently the patient recovered. The reporter considered the chickenpox and acyclovir treatment an other important medical event. No further information is expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a 14 year old female who on 18-JAN-2007 was vaccinated with Varivax (Lot 655066/1143F). Subsequently the patient developed cellulitis. The patient sought unspecified medical attention. Patient outcome was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Body temperature increased, Rash papular, Rash vesicular, Teething
Clinical narrative: Information has been received from a registered nurse concerning a 21 month old female with no known allergies or medical history who on 29-MAR_2006 was vaccinated SC in the left thigh with a 0.5 mL first dose of Varivax (lot # 646670/0627R). Concomitant vaccination on the same day in the right thigh included a fourth dose of PREVNAR. On 22-JAN-2007, the patient presented to the office with approximately 10 lesions, small red bumps on the breast, back, buttocks, and stomach. The child also had a low grade temperature for two days. The patient was also noted to be teething. The nurse stated that no treatment was required, just TYLENOL as needed for fever. The patient was to be isolated from day care for one week. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that the patient was seen in the office on 22-JAN-2007. The mother noted a small red pimple-like bump on the center of the stomach in the AM of 21-JAN-2007. More were noted on the day of the visit. She had 10 papules with near vesicles on the trunk. She was advised of signs and symptoms and was in isolation for 7 days. She was to follow-up prn. The patient recovered on 31-JAN-2007. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Scab, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with no known allergies and a history of clubfoot at birth who on 05-JUN-1997 was vaccinated SC in the left thigh with a 0.5 mL first dose of Varivax (lot # 621071/1552D). There was no concomitant medication. On 22-JAN-2007, the patient presented to the office with chickenpox on the extremities and face and a scabbed lesion on the scalp. There were no frank vesicles. The child felt tired and ill five days prior (17-JAN-2007) and began the outbreak two days prior (20-JAN-2007). No treatment was required. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the nurse who reported that the patient was seen in the office by a physician on 22-JAN-2007 for three days of an itchy rash (started on 19-JAN-2007). He had five red bumps on his extremities and face, some scabs, one scabbed lesion on his scalp, and no frank vesicles. Isolation was advised. The patient recovered on an unspecified date. It was reported that the patient's sibling had a similar experience after therapy with Varivax (WAES # 0702USA00765).
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 0.5 ml dose of Varivax. Subsequently, the patient experienced shingles. Unspecified medical attention was sought. No additional information was provided. There was no product quality complaint involved.
Age: 1.32
Sex: M
Vaccine: FLUX, HEP, HIBV, PPV, VARCEL
Symptoms: Injection site vesicles, Varicella, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her 16 month old "perfectly healthy" son with no known allergies who on 10-JAN-2007 was vaccinated in the left arm with a first dose of Varivax (Merck) (Lot #655065/1142F, product circular 7999915) (lot # also reported as "M9108"). Concomitant therapy included influenza virus vaccine (unspecified), Hib conj vaccine (unspecified carrier), hepatitis B virus vaccine (unspecified) and pneumococcal vaccine (unspecified). On 17-JAN-2007, the patient developed chicken pox around his mouth, eyes, chest, arms, and stomach. The patient's mother indicated that her son's condition was getting "worse and worse" since getting the vaccine. The patient sought medical attention and was treated with antibiotics (not further specified). As of 22-JAN-2007, the patient had not recovered. The product quality complaint unit is not involved. Additional information has been requested.  Additional information from a health care professional indicated that the patient had no past medical history and had no illness at the time of vaccination. It was reported that on 20-JAN-2007 the patient developed several vesicles at the injection site and on his face. Medical attention was sought, there were no lab tests performed. The patient recovered on 22-JAN-2007. It was reported that the patient and his sibling had no adverse events following prior vaccination. No further information was provided. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Seroconversion test positive, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a registered nurse concerning an adult male healthcare professional who on an unspecified date was vaccinated subcutaneously with a 0.5 ml dose of Varivax. He had a positive seroconversion shortly after his vaccination. Recently, a second titer was taken and the result was negative. No other symptoms were reported. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 3-year-old male with no pertinent medical history and no drug reactions or allergies who in approximately 2005 (at the age of 12 to 15 months) was vaccinated with Varivax. Subsequently, the patient experienced breakthrough varicella and had approximately 30 lesions. 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. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Pyrexia, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male with no allergies or medical history who on 01-DEC-1998 was vaccinated SC with a 0.5 mL dose of Varivax (lot # "613881/1257A"). There was no concomitant medication. On 23-JAN-2007, the patient developed approximately 10 lesions and a low grade fever. It was that the patient had breakthrough varicella. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. It was also reported that the patient's sister had a similar experience after therapy with Varivax (Oka/Merck).
Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature, Pyrexia, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female with no allergies or medical history who on 01-DEC-1998 was vaccinated SC with a 0.5 mL dose of Varivax (lot # "613881/1257A"). There was no concomitant medication. On 22-JAN-2007, the patient had approximately 30 lesions and a low grade fever. It was noted that the patient had break through varicella. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. It was also reported that the patient's brother had a similar experience after therapy with Varivax (WAES # 0701USA04042).
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female who on 11-JAN-2007 was vaccinated with Varivax (lot # not provided). On 15-JAN-2007, the patient experienced breakthrough varicella rash after receiving Varivax. The nurse reported that the patient had approximately 50 lesions or more. The patient outcome was not reported. There was no product quality complaint.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 18 year old female who on 19-JAN-2006 was vaccinated with a second dose of Varivax. On 20-JAN-2007, within 24 hours of vaccination, the patient experienced redness, swelling and a hard nodule at the injection site. Unspecified medical attention was sought. No product quality complaint was involved.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning a 5 year old male who's brother was vaccinated "on the left" with a dose of Varivax (lot # 638568/1888K). On 21-JAN-2006 the patient developed chickenpox. The patient was never vaccinated with Varivax and the physician believed that the chickenpox was a result of transmission from the patient's brother. It was not known if medical attention was sought. The patient's outcome was not reported. There was no product quality complaint involved. It was reported that the patients brother (WAES# 0701USA01706) developed an adverse event after vaccination with Varivax (lot 3 638568/1888K). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female who in July 2006, was vaccinated with her second dose of Varivax on its recommended schedule. Subsequently, in July 2006, the patient experienced a lot titer. No symptoms were reported. No further information to report. There was no product quality complaint involved. No additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 5-year-old male with no pertinent medical history and no previous drug reactions/allergies who on 14-JUN-2002 was vaccinated subcutaneously with his first dose of 0.5 ml of Varivax "(Lot # 639373/1206L)". Concomitant therapy included acyclovir, 200 mg daily for five days. On 24-JAN-2007, eighteen hours post vaccination, the patient was seen in the doctor's office with a rash on his face and complaints of itching. The varicella rash was described as having less than 50 lesions on his neck face, trunk and legs. The lesions on his neck, face, and trunk were erythematous papules; the lesions on his legs are tiny clear vesicles. The patient was afebrile. Unspecified medical attention was sought. No laboratory or diagnostic testing was performed. There was no product complaint involved. The patient reportedly recovered on 26 JAN 2007. Additional information is not expected.
Age: 1.6
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who on 01-MAY-2003 was vaccinated with Varivax (Lot # 642991/0489M). On 25-JAN-2007 the patient developed chickenpox on her abdomen. Concomitant medication includes TYLENOL. The reporter did not know the exact number of lesions or if the patient had a fever. The patient had been exposed to a child with chickenpox at daycare. The patient is currently taking BENADRYL for itching. At the time of the report the patient was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. additional information has been received from the registered nurse who stated that the mother of the child called on 25-JAN-2007 stating that the patient developed chickenpox. The patient was feeling itchy and so mother asked the medicine for that. The mother was recommended to give BENADRYL 1-1.5 tea spoon every 6 hours for itching. It was unknown about the patient's status. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female with no drug reactions or allergies who was vaccinated with a dose of Varivax. Subsequently, 24 hours after vaccination, the patient experienced a localized rash on her legs described as vesicles. Subsequently, the patient recovered 2 days later. Unspecified medical attention was sought. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a pharmacist concerning herself, a 34 year old female who in approximately 1995 (also reported as 1997) was vaccinated with two doses of Varivax. On 15-JAN-2007, the patient had her titers checked which came back low at 0.8 (units not provided). The patient did not seek medical attention. As of 26-JAN-2007, the patient's outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male with no allergies or medical history who on 26-JUN-1998 was vaccinated SC in the right arm with a first dose of Varivax (lot # 625047/1574E). Concomitant vaccination on the same day included a SC first dose of MMR (lot # 623743/0505H). There was no illness at the time of vaccination. On 18-JAN-2007, the patient's mother stated that the child had one red spot on his face. By 19-JAN-2007, he had about 60 all over his body. They were itchy and slight painful. The patient recovered on an unspecified date. No diagnostic laboratory tests were performed. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 11 year old white male who on 29-APRI-1998 was vaccinated in the left arm with a dose of Varivax. On 19-NOV-2006, the patient broke out with chickenpox. There was no illness at the time of vaccination. Subsequently, the patient recovered from chickenpox. It was also reported in the patient's record of immunizations that he received the following vaccinations: a first, second, and third dose of hepatitis B virus vaccine (manufacturer unknown) on 11-OCT-1995, 07-NOV-1995, and 17-JUL-1996;l a first, second, third and fourth dose of diphtheria toxoid (+) Hib conj vaccine (unspecified carrier) (+) pertussis vaccine (unspecified) (+) tetanus toxoid on 08-DEC-1995, 09-FEB-1996, 26-APR-1996, and 10-JAN-1997; a first, second, and third dose of IPOL on 08-DEC-1995, 09-FEB-1996, and 26-APR-1996; and a first dose of MMR on 10-JAN-1997. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 7 year old white male with one sister who was vaccinated with a dose of Varivax per immunization schedule (immunization history not available). On 14-NOV-2006 the patient presented to a physician's office with chicken pox. The outcome was unknown. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male who on 21-OCT-1999 was vaccinated with a first dose of Varivax. On 19-JAN-2007 the patient reported to the physician's office with pink papules on trunk and face, vesicular lesions. It was reported that none of the lesions were crusted over and the symptoms began the night before (18-JAN-2007) with sore throat and fever. The patient was diagnosed with chickenpox and was treated with supportive care. The patient outcome was reported as recovered. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 9-year-old male who on 25-SEP-2000 was vaccinated with his first dose of Varivax. On 17-DEC-2006, the patient experienced 10 to 12 vesicular lesions. On 21-DEC-2006 (Day 5), it was noted during an office visit that the 10 to 12 lesions were mostly broken open with scabs. Treatment was not specified. It was noted that there were reports of chicken pox in school. Subsequently, the patient recovered. It was also reported that the patient's sister experienced vesicular rash (WAES # 0701USA04729), and had also been vaccinated with Varivax. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 9-year-old female who on 06-MAY-1999 was vaccinated with her first dose of Varivax. ON 01-JAN-2007 the patient experienced approximately 50 itchy lesions. On 03-JAN-2007 (day 3) it was noted during an office visit that the lesions were in various stages throughout the body, some crusted over. It was noted that a sibling had been diagnosed with chickenpox last week. Treatment was not specified. Subsequently, the patient recovered. It was also noted that the patient's brother experienced vesicular rash (WAES # 0701USA04728), and had also been vaccinated with Varivax. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: VARCEL
Symptoms: Enterovirus infection, Exposure to communicable disease, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male on 19-JAN-2001 was vaccinated with a first dose of Varivax. The registered nurse reported that the patient's mother called the office to report that the patient developed chicken pox after in school exposure. The patient was seen in the office on 21-DEC-2006 and diagnosed with with enterovirus versus dermatitis. The patient presented with pinpoint rash over the body after a bath. There were 25-30 spots with central whiteheads and reddening around them. The outcome was reported as recovered. Additional information has been requested. This is in follow-up to report (s) perviously submitted on 5-16/2007.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female who 27-OCT-1999 was vaccinated with a first dose of Varivax. The registered nurse reported that on 05-JAN-2007, the patient reported to the office with a 2 day history with a lesion under the nose that was spreading and itchy. The patient had 4-5 lesions on the face that were crusted over. The patient also had a couple of lesions on her arms. The total number of lesions was reported as 20 on the torso, arms, and legs. The outcome was reported as recovered. It was also noted that the patient's sibling had an AE after vaccination with varicella virus vaccine (WAES # 0701USA04732). Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular, Scab, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male who on 12-JAN-2001 was vaccinated with Varivax. The registered nurse reported that on 05-JAN-2007, the patient reported to the office with a 2 day history with a lesion under the nose that was spreading and itchy. The patient had 4 to 5 lesions on the face that were crusted over and also had a couple of lesions on the arm. The patient had a total of 20 lesions on the torso arms, and legs. The patient outcome was reported as recovered. It was also reported that the patient's sibling had an AE after vaccination with Varivax (WAES# 0701USA04731). Additional information has been requested. 02/11/2010 In follow-up information it was reported that the patient presented to the office (21-DEC-2006) with a 2 day history of red, raised rash. There were 10 lesions on the chest and back. The lesions on the upper back were crusted over. The patient currently had 30-40 lesions on chest, back and inguinal area. The patient received supportive care. The outcome was reported as recovered. No further information is available.
Age: 1.1
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash erythematous, Rash pustular, Scab
Clinical narrative: Information has been received from a health professional concerning a 9 year old white male (65 pounds, 50 inches) with no pre-existing allergies, birth defects, or medical conditions who on 07-JAN-1999 was vaccinated SC in the left arm with a first dose of Varivax (Lot# 628246/1655H). There was no illness at the time of vaccination. That same day the patient was also vaccinated with MMR (lot # 628895/1541H) subcutaneous in the right arm. On 15-JAN-2007 at 9:30AM the patient started with a few red bumps and then progressed to a total of 15. The location was right clavicle area/shoulder and upper arm in various stages of red pustulae with center scabs. No relevant drug tests or lab data were required. The patient recovered on 24-JAN-2007 (also reported as the rash lasted for 3 days). Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea
Clinical narrative: Information has been received from a 34 year old female who "three weeks ago", on 08-JAN-2007 was vaccinated with Varivax. On 08-JAN-2007 the patient experienced nausea. The patient reported that she was nauseous for about two weeks. The patient did not seek medical attention. Subsequently, the patient recovered from nausea. There was no product quality complaint. No further information is available.
Age: 82.0
Sex: M
Vaccine: VARCEL
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 82-year-old patient who was vaccinated with a dose of Varivax instead of Zostavax. No additional information to report. There was no product quality complaint involved. It was noted 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. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 3 year old male who in approximately 2005, at "12 months of age", was vaccinated with a dose of Varivax. Subsequently the patient experienced breakthrough chicken pox. Unspecified medical attention was sought and the patient recovered. It was noted that the physician was not sure if she will give a booster dose. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Inappropriate schedule of drug administration, Pyrexia, Rash pruritic, Varicella
Clinical narrative: Information has been received from a health professional concerning a 6-year-old female with reactive airways disease, with no history of drug reactions or allergies, who on 17-JUL-2001 (Lot # 635451/1143K) and 23-AUG-2003 was vaccinated intramuscularly with the first and second doses of Varivax. Concomitant therapy included albuterol inhaler. On 28-JAN-2007, the patient experienced approximately 50 lesions on her body. It was noted that the patient's father recently had chicken pox. On 29-JAN-2007 the patient was seen in the doctor's office for an itchy rash she developed the previous day. The rash started on her chest and progressed to her face and back. The parent reported that she had a low grade temperature, which when measured was 99.9, while in the office. The patient had 60-70 red papules on her face, chest, back, arms and legs. Several scabbed areas over some vesicular. The patient was sent home to isolation. The patient was prescribed symptomatic relief with baths and acetaminophen (TYLENOL). No laboratory or diagnostic studies were performed. The outcome was unknown at the time of this report. There was no product quality complaint involved. Additional information is not expected. Information has been received from a healthcare professional concerning a 6-year-old female with reactive airwas disease, with no history of drug reactions or allergies, who on 17-JUL-2001 (lot # 635451/1143K) and 23-AUG-2003 was vaccinated intramuscularly with the first and second doses of VARICELLA virus vaccine live (Oka/Merck). It was noted that the patient's father recently had chicken pox. On 29-JAN-2007 the patient was seen in the doctor's office for an itchy rash she developed the previous day. The rash started on her chest and progressed to her face and back. The parent reported that she had a low grade temperature, which when measured was 99.9, while in the office. The patient had 60-70 red papules on her face, chest, back, arms and legs. Several scabbed areas over some vesicular. The patient was sent home to isolation. The patient was prescribed symptomatic relief with baths and TYLENOL. No laboratory or diagnostic studies were performed. The outcome was unknown at the time of this report. The was no product quality complain involved. Additional information is not expected. This is one of several reports from the same source.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic, Scab, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male with reactive airways disease, a pertinent history of pneumonia, and no drug reactions or allergies, who on 04-AUG-1999 was vaccinated, intramuscularly, with the first dose of Varicella (Lot #1545H). On 31 Jul 2002 a second dose of Varivax (Lot #0376L), was administered. Concomitant therapy included VENTOLIN (albuterol). On 27-JAN-2007 the patient developed less than 50 chicken pox lesions. The patient's father recently had chickenpox. Unspecified medical attention was sought. At the time of the report the patient was not recovered. There was no product quality complaint. There was no lab diagnostic studies performed. Additional information has been requested. 02/11/2010 Follow up information received from a registered nurse who reported that hte patient was seen on 29 JAN 2007 with a two day history of an itchy rash that started on the face and spread to his back. There was some scabbing. Thirst to forty lesions were presented on face, chest, legs and back. Some new vesicles were present. Treatment included isolation until all lesions were scabbed and Avenno baths. At the time of reporting the outcome was unknown. The lot # for the 04-AUG-1999, first dose of VARIVAX was initially reported as lot # 628011/1545M. Follow up information indicated the associated number as Lot # 629263/03083. The patient's six year old siblikng (WAES# 0705USA01699), developed chickenpox after their first dose of VARIVAX. This is one of several reports received from the same source. Additional information is not expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an approximately 10 year old male with Sickle Cell disease, who in approximately 2000, 6-7 years ago, was vaccinated with 0.5 ml of Varivax (Merck). Subsequently the patient experienced "a mild breakthrough" of about ten lesions of a varicella type rash after receiving Varivax (Merck). At the time of the report the patient was not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. Follow-up information via phone call indicated that no further information was known regarding the patient. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physical therapist concerning a 1 year old female who on 19-JAN-2007 was vaccinated with a dose of Varivax. On 29-JAN-2007 the patient experienced a chickenpox outbreak. The outcome was not reported. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a consumer concerning her 8 year old daughter with no allergies or medical history who on 15-MAR-2002 was vaccinated with a dose of Varivax. There was no concomitant medication. On 30-JAN-2007, the patient developed a breakthrough case of chickenpox. The lesions were red with a white center. There were approximately 20 lesions. The reporter stated that she probably would not take her daughter to the physician's office. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 1.82
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a female, with no pertinent medical history who on 04-NOV-2004 was vaccinated with Varivax. There was no concomitant therapy. Recently, the patient experienced chicken pox. The nurse had no further information on the development or number of pox/lesions present. The patient was vaccinated but not seen in the office for this case. It was noted that the patient sought medical attention. The patient was recovering. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain, Pruritus
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no known drug or food allergies who on 30-NOV-2004 was vaccinated in the right thigh with a 0.5 mL dose of Varivax (lot # 649268/0647F). There was no concomitant therapy. In June 2005, the patient experienced vesicular lesions/chicken pox. On 27-JAN-2007 the patient developed shingles/herpes zoster described as 6-7 vesicular lesions on her back only. The patient felt itchy with a pain level of 1 out of 10. There was no recent exposure to chicken pox. Her maximum temperature was 97.6 degrees Fahrenheit. There was no fluorescent antibody testing or PCR performed. The patient recovered. No further information is available. It was reported that two older siblings developed chicken pox after Varivax (WAES0703USA02158).
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician (the patient) concerning a 35 year old female with asthma and allergies to aspirin and codeine who in 1996 was vaccinated with 2 doses of Varivax (lot#'s not reported). On 23-NOV-2004 (lot# 647534/0625P) and 07-FEB-2005 (lot#649644/1050P) the patient received 1 dose of Varivax. Concomitant therapy included albuterol and pre-natal vitamins (unspecified). Sometime in 2004, the patient experienced a negative titer after receiving the 2 doses. In November 2005, the patient again experienced a negative titer after receiving 2 doses. Unspecified medical attention was sought. The outcome was not reported. No product quality complaint. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 10 year old male patient who at "8 years of age" was vaccinated with the first dose of 0.5 mL of Varivax and after a couple of years "10 years old" was diagnosed with the shingles. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male who on 18-MAY-2005 was vaccinated with Varivax. On 28-JAN-2007, the patient developed chicken pox with a rash less than 50 pox. The rash is located on both arms and was diagnosed by the physician. No treatments were prescribed and the patient is reported to be recovering at home. No diagnostic laboratory tests were performed. There was no product quality complaint. No further information is expected.
Age: 15.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: No reaction on previous exposure to drug, Varicella, Varicella post vaccine, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 15-year-old female who developed a non-specific rash after she was prescribed ZITHROMAX in 1997, who on 22-JAN-2007 had a well exam (which was normal and the patient was considered healthy0 and was vaccinated SC in the arm with her second (booster) dose of Varivax (lot # 654128/1147F). Concomitant vaccination included a first dose of BOOSTRIX. There was no illness at the time of vaccination. The patient received her first dose of Varivax on 27-SEP-2002. Five days after the second vaccination, on 27-JAN-2007, the patient's mother called the office and said that the patient had developed breakthrough which was described as 100 lesions, symptomatic treatment was discussed. The patient was examined on 29-JAN-2007 in the office and she had diffuse fluid-filled 1/2 cm blisters on her entire body (with 1-3 inch space between the lesions). A CBC, immunoglobulin panel and varicella titer were all ordered but at the time of the report the patient had not yet gone to the lab. On an unspecified date the patient recovered. It was reported that the patient had not had any adverse events following prior vaccination. No additional information to report. There was no product quality complaint involved. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the vaccine VZV strain. The sample of the lesion was collected on 02-FEB-2007 and taken from an unspecified source. PCR results were provided: the isolated virus was positive for wild-type varicella. Additional information is not expected.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 17-JAN-2007 was vaccinated, subcutaneously, with a dose of Varivax (Lot# 635452/0768K). On 23-JAN-2007 the patient experienced multiple skin lesions of the face, trunk, extremities and buttocks. Some of the lesions were red, papular, some vesicular. Patient was afebrile. Outcome of the event was unknown at the time of the report. No further information is available.
Age: 69.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 69 year old female who on 23-JAN-2007 was vaccinated with a dose of Varivax instead of a dose of Zostavax. The physician stated that the error occurred because the individual who gave the vaccine knew it was the varicella strain and she knew that Varivax was varicella and forgot about the Zostavax that was new to their practice. No medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 1.75
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 21-month-old patient who in March 2005, was vaccinated subcutaneously with a 0.5 ml dose of Varivax. On 29-DEC-2006, the patient experienced mild chicken pox. The patient presented with attenuated macules bulle. some of which were scabbed over. Lesions were two to four inches in diameter at maximum. Also noted were areas of hyperpigmentation and dry skin. After these resolved, some areas became hypopigmented. The reporter noted that 20% of the papules became vesicles and scabs; and concluded that if this was a case of chickenpox, it was very mild. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. The outcome of the time of this report was recovering. No additional information to report. There was no product quality complaint involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with a history of a grade 4 splenic rupture and no known allergies, who on 25-FEB-1997 was vaccinated SC with a first dose of Varivax (lot # 620622/1342D). There was no concomitant medication. There was no illness at the time of vaccination. On 03-FEB-2007 the patient broke out with 15-20 itchy, erythematous papules most prominent on the trunk, some were reported to have a "dewlike substance" centrally. The patient was seen in the office on 04-FEB-2007, the patient had no fever. No treatment was provided. There were no lab studies performed. It was reported that the patient had four classmates who had chickenpox within the last couple of weeks. On 05-FEB-2007 the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash papular, Rash vesicular, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8year old autistic male with no known allergies who on 07-MAY-1999 was vaccinated SC in the left thigh with a 0.5 ml first dose of Varivax (lot # 629254/1849H). There was no concomitant medication. On 03-FEB-2007 the patient developed chickenpox. It was reported that there were 20 to 25 lesions scattered across the body. The lesions were described as excoriated, raised, erythematous papules, the patient also had several clear vesicles on the back. The patient was seen in the office on 05-FEB-2007. There was no fever reported and unspecified symptomatic treatment was started. The patient was instructed to remain in isolation for the duration of the vesicular rash. No lab studies were performed. On an unspecified date the patient recovered. There was no product quality complaint involved. Additional information has been requested. The patient's brother (WAES # 0701USA03740) recently had the same experience after vaccination with Varivax.
Age: 1.14
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 8 year old male who, three years ago, in 2004, was vaccinated with a SC 0.5ml dose of Varivax. On 05-FEB-2007 the patient experienced shingles. Unspecified medical attention was sought. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2007. Information has been received from a physician concerning an 8 year old male with no medical history or allergies who on 20-APR-1999 was vaccinated SC with a 0.5 mL dose of VARIVAX vaccine (Merck). On 05-FEB-2007, the patient experienced shingles. Unspecified medical attention was sought. Additional information has been received from the physician who reported that on 03-FEB-2007 (previously reported as 05-FEB-2007) the patient developed shingles on the right side of the chest along the dermatome. It was assumed that the patient has since recovered. No further information is expected.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9-year-old male with a antibiotic allergy (CEFZIL)) who on 05-FEB-2007 was vaccinated with Varivax (Lot # 655069/1145F). Concomitant therapy on that day included Vaqta. On 06-FEB-2007, the patient experienced 4.5 cm swelling at injection site with redness; it was also warm to the touch. The patient's mother had been applying cool compresses. The patient was seen by a physician, treatment was not specified. The outcome at the time of this report was not recovered. There was no additional information to report. There was no product quality complaint involved. No additional information is expected.
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Myalgia, Pyrexia, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician's assistant concerning a 21-year-old male with no pertinent medical history and no drug allergies or reactions, who in 1998 was vaccinated with Varivax. Last week (approximately 01-JAN-2007) the patient experienced chicken pox and had fever, myalgia and his entire body was covered with lesions. The patient was in the emergency and at his physician's office and was diagnosed with chicken pox. No diagnostic studies or laboratory tests were performed. Treatment was acyclovir. At the time of this report, the patient had not recovered completely. It was also noted that the patient's mother had shingles in the last week and a half. No additional information to report. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Varivax (Lot # 654520/1152F) instead of Zostavax. The reporter states that this was a staff error and not product confusion. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 75 year old female who on 05-FEB-2007 was vaccinated with a dose of Varivax instead of a dose of Zostavax. It was not known how the mistake was made. There was no report of any adverse reaction. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a certified medical assistant concerning a child who on an unspecified date was vaccinated with a dose of Varivax (Merck). Subsequently the patient developed shingles after vaccination. It was reported that this occurred "a while ago." Unspecified medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Follow-up information was received from the medical assistant on 09-NOV-2007. She reported that she did not have any further information because she cannot identify the patient. Additional information is not available.