chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed wild type varicella. The physician saw the patient at his practice on an unspecified date and on an unknown date the patient recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning 2-4 children who were vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patients developed break through varicella. The physician has seen all 2-4 patients at his practice. On an unspecified date the patient's recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from a physician concerning a 6 year old male with ADHD and a heart murmur and no known allergies who on 03-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included hepatitis A vaccine (inactive) (MSD) and influenza virus vaccine (unspecified). Other concomitant therapy included "methylphenidate hydrochloride". A few days after receiving the vaccines the patients mother stated that her son experienced itching all over his body. There was no product quality complaint and the patient sought unspecified medical attention. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Listless
Clinical narrative: Information has been received from a physician concerning a 5 year old male (40 in, 32 lb) with an allergy to beef gelatin and on other pertinent medical history who on 15-OCT-2007 was vaccinated with VARIVAX (Merck) and the flu vaccine.  Within one minute of these injections, the patient had an acute allergic reaction (erythema, sneezy, coughing and listless). Subsequently the patient went to the emergency room where he was treated with epidural, BENADRYL and unspecified steroids.  On an unspecified date, the patient recovered from the event.  Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Rash
Clinical narrative: Information has been received from a health professional concerning a 10 year old male who on 06-APR-2000 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot# 632369/1461J). On 10-DEC-2007, the patient developed a rash of less than 50 lesions on the trunk. It was noted that the patient was exposed to chickenpox by his brother. The patient's current status was unspecified. No product quality complaint was involved. No other information was provided. This is one of several reports from the same source. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis allergic
Clinical narrative: Information has been received from a mother concerning her 13-year-old daughter who had no medical history or allergies who on 08-DEC-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant therapy. The patient's mother reported that on 12-DEC-2007, her daughter developed an allergic rash all over her body. The patient was seen in the Emergency Room (ER) because of the rash. No laboratory/diagnostic tests were performed. At the time of this report, the patient's allergic rash persisted. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse who was told by the local school system that a 7 year old male was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 641155/0793M) on 10-JAN-2003. On 05-DEC-2007, the patient developed a rash on his back and abdomen, without a fever. At the time of reporting the patient's status was unknown. Additional information was received from a physician who reported that in the AM of 10-JAN-2003 the patient was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 641155/0793M). At the time of reporting the patient was recovered. (date unspecified). This is one of several reports received from the same source. (SR-1-2048401150 and 1-2049342869) Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Scar
Clinical narrative: Information has been received from a registered nurse concerning her 12-year-old daughter with a history of chickenpox (2 vesicles at 6 weeks of age) who at age 9 or 10 (in approximately 2003) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In the "spring of 2006", a few years after vaccination, the patient developed zoster on the right side with a T1 distribution. She was seen in the physician's office and was treated with acyclovir. It was reported that the zoster went down then up her right arm and lasted for several weeks. The sensitivity at the area of the zoster lasted 6 months and the daughter presently has scars at the zoster site. Subsequently, the patient recovered from zoster. No product quality complaint was involved. Additional information has been received from a woman from a physician's office stating that the patient is no longer a member of their practice (since 01-JUL-2004). She confirmed her date of birth to be 14-JUN-1994. A response was received by a physician indicating that she was never notified of this by any patient. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a public health registered nurse who was told by the local school system, concerning a 10-year-old female who on 29-MAY-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 622850/0537E). On 31-OCT-2007, the patient developed a rash with 50-500 chicken pox like lesions. It was unspecified if medical attention was sought. On an unspecified date, the patient recovered. No product quality complaint was involved. Follow-up information has been received which indicates that the patient was vaccinated in the right arm with a subcutaneous first dose of varicella virus vaccine live (Oka/Merck) in the AM. This is one of several reports from the same reporter. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Ear disorder, Haemoptysis, Nasopharyngitis, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a medical assistant concerning an 18 month old male with no drug allergies who on 08-DEC-2007 was vaccinated IM with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 657793/0713U). Suspect vaccination administered during the same visit included a dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). On 17-DEC-2007, the patient developed a rash on his back described as a "clear, blister-looking, slightly red and raised area." The child also had "cold-like symptoms" including a fever, runny nose and congestion. The patient sought unspecified medical attention. The patient was not recovered at the time of this report. It was also noted that the patient's mother was pregnant and the office was concerned about risk of transmission but no symptoms with the mother were noted. There was no product quality complaint. Follow-up information has been received from the reporting medical assistant concerning a 15 month old (also reported male) who on 08-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 657793/0713U) in the left thigh. There was no illness at the time of vaccination. Suspect vaccination administered on that day at 10:00 included the first IM dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MDS) (lot # 653626/0426F) in the right thigh. Concomitant vaccinations administered on that same day at 10:00 included the fourth IM dose of Prevnar (lot # B54013H) in the right thigh and the first IM dose of Fluzone (U2502AA) in the right thigh. On 17-DEC-2007 at 07:00 the patient experienced a low grade fever and a chicken pox-like rash. At that same time the patient was pulling at his ear and spit up bloody phlegm. The patient sought medical attention at the clinic. The outcome was unknown. It was noted that the patient's mother was less than 3 months pregnant and did not know how serious the event would be for her. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: FLU3, MMR, PNC, VARCEL
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Information has been received from a medical assistant concerning an 18 month old male with no drug allergies who on 08-DEC-2007 was vaccinated IM with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 657793/0713U). Suspect vaccination administered during the same visit included a dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manufacturer unknown). On 17-DEC-2007, the patient developed a rash on his back described as a "clear, blister-looking, slightly red and raised area." The child also had "cold-like symptoms" including a fever, runny nose and congestion. The patient sought unspecified medical attention. The patient was not recovered at the time of this report. It was also noted that the patient's mother was pregnant and the office was concerned about risk of transmission but no symptoms with the mother were noted. There was no product quality complaint. Follow-up information has been received from the reporting medical assistant concerning a 15 month old (also reported male) who on 08-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 657793/0713U) in the left thigh. There was no illness at the time of vaccination. Suspect vaccination administered on that day at 10:00 included the first IM dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MDS) (lot # 653626/0426F) in the right thigh. Concomitant vaccinations administered on that same day at 10:00 included the fourth IM dose of Prevnar (lot # B54013H) in the right thigh and the first IM dose of Fluzone (U2502AA) in the right thigh. On 17-DEC-2007 at 07:00 the patient experienced a low grade fever and a chicken pox-like rash. At that same time the patient was pulling at his ear and spit up bloody phlegm. The patient sought medical attention at the clinic. The outcome was unknown. It was noted that the patient's mother was less than 3 months pregnant and did not know how serious the event would be for her. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old white female with no pre-existing allergies or pertinent medical history who on 15-JAN-1998 was vaccinated into the right arm with a first dose varicella virus vaccine live (Oka/Merck) ("Lot # 1102"). There was no concomitant medication. There was no illness at the time of vaccination. On 05-DEC-2007, at 9:00, the patient developed 20-30 pox on her body. On 12 DEC 2007 that patient recovered. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rash pustular, Scab, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 10.5 year old male who on 01-DEC-2007 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck) (Lot # not provided). On 05-DEC-2007 the patient developed a varicella rash, consisting of 10-15 itchy lesions on the trunk, neck, shoulder and two crusted pustules. The patient sought unspecified medical attention. At the time of reporting, the patient was recovering. There was no product quality complaint involved. Follow-up information indicated no new information. This is one report of two received from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 10.5 year old male who on 01-DEC-2007 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck) (Lot # not provided). On 05-DEC-2007 the patient developed a varicella rash, consisting of 10-15 itchy lesions on the trunk, neck, shoulder and two crusted pustules. The patient sought unspecified medical attention. At the time of reporting, the patient was recovering. There was no product quality complaint involved. Follow-up information indicated no new information. This is one report of two received from the same source. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 7 year old 49 lb. 49 inch female with no pre-existing allergies, birth defects, or medical conditions, who on 07-DEC-2007 was vaccinated with a second 0.5 ml subcutaneous dose in the right anterior thigh of varicella virus vaccine live (Oka/Merck) (Lot #659355/1518U)> Concomitant vaccination included a first dose in the left anterior thigh of hepatitis A virus vaccine inactivated (HAVRIX) (lot#AHAB225AA). There was no reported illness at the time of vaccination, and no concomitant medication. On 08-DEC-2007, within 24 hours of the vaccination, the patient developed a 103F fever, "a reddened area as large as a softball, slight swelling, and small bumps at the injection site". The reddened area was not tender to the touch. The patient's mother sought medical attention by phone and was instructed to apply a compress to the patient's right thigh and give the patient ibuprofen (ADVIL). On 09-DEC-2007, the patient was seen in follow-up. The area was improved, slightly reddened and warm. Follow up information from the nurse indicated that "immunization reaction protocols" were used, and on an unspecified date, the patient had recovered. There were no other symptoms and no other treatment was given. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin reaction
Clinical narrative: Information has been received concerning a 14 month old male who on 12-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) 0.5 ml SC. Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) for prophylaxis (duration and dose not reported). On 18-DEC-2007 the patient developed "two non-fluid filled spots". One spot was on the patient's ankle, and the other spot was on his buttocks. The patient's mother sought medical attention via telephone. The patient's two non-fluid filled spots persisted. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received concerning an 8 year old female who on 12-DEC-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) 0.5 mL subcutaneous in the right arm (lot#659355/1518U). There was no illness at the time of vaccination and no concomitant medication. On 13-DEC-2007, the patient developed a 3-inch in diameter injection site reddened area. The patient had no fever. The patient's mother sought medical attention by phone and was instructed to apply a compress to the patient's right arm and give the patient Advil. Follow up information from the nurse indicated that their "Immunization Reaction Protocol" was used. There were no other symptoms and no other treatment was given. Follow up information from the nurse provided no additional information. Current patient status was not reported. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Information has been received from an employee in a physicians' office concerning a 15 year old female student with a penicillin allergy who on 04-DEC-2007 at 15:30 was vaccinated SC with her second dose of varicella virus vaccine live (Oka/Merck) (lot# 658999/1490U) in the right tricep. There was no illness at the time of vaccination. On 04-DEC-2007 at approximately 20:00, the patient contacted a physician to report that she developed redness and pain with a 4 inch circular, firm rash that was tender to touch at the injection site of varicella virus vaccine live (Oka/Merck) given 7 hours ago. The patient was afebrile with no streaking up the arm. On 06-DEC-2007, the patient was seen by the physician who noted the painful rash was worsening at the vaccination site. The rash was approximately 11 X 12.5cm and erythematous, warm and tender with no streaking. On that same day the patient was treated with Keflex. On 12-DEC-2007 was recovered. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Biopsy skin, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 10 year old female with Crohn's Disease who on 03-SEP-1999 was vaccinated with varicella virus vaccine live (Oka/Merck) ("Lot # 0424"). Concomitant therapy included Remicade and Imuran. On an unreported date, approximately NOV 2007, the patient developed a disseminated rash with > 200 lesions of face, trunk, groin and extremities. It was noted that the patient had no recent immunization at the time. On 30 November 2007, a specimen was obtained from a vesicular lesion as part of the VZV identification program. The specimen was submitted to "differentiate vaccine reactivation". The laboratory findings indicated the specimen was of a wild type strain. The patient had not had any recent exposure to chickenpox or shingles. At the time of reporting the patient had recovered (date unspecified). Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning an 11 year old male who on 03-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 1352U). Concomitant therapy included DTaP-IPV and meningococcal vaccine (unspecified). Subsequently, the patient fainted after the vaccination. Prior to the vaccination the patient appeared to be nervous. Unknown medical attention was sought. The patient's outcome is unknown. No product quality complaint was involved. This is one of the multiple reports from the same source. Further information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 16-year-old male who was vaccinated (in infancy) with his first dose of varicella virus vaccine live (Oka/Merck) and not a second booster. On an unknown date (when he was 16-years-old) the patient developed a rash pleomorphic on torso and neck classic of chicken pox (previously reported as varicella), as well as a fever, headache, and sore throat. The patient was seen in the emergency room (previously reported as "hospitalized"). The patient was discharged from the ER on symptomatic treatment. The physician reports that "this is a case of a 2nd booster". On an unknown date the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 66 years old female who on 19-DEC-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) rather than zoster vaccine live (Oka/Merck). No product confusion, just administration error. No problems reported. No other information was reported. There was no product quality complaint. Follow-up information received from a registered nurse indicated that there was no adverse event reported. Product confusion was reported because the nurse administered the wrong varicella virus vaccine. The vaccines are now kept in separate freezers. The nurse stated that there was no other information to report. No additional information is expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 27-SEP-2007 was vaccinated with a second 0.5mL dose of varicella virus vaccine live (Oka/Merck), (lot number not reported). On 27-SEP-2007, the patient developed a chicken pox rash that started on the patient's scalp and then moved to her face, chest, arms and legs. The patient also developed a fever of 101 degrees F. No further information was available. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. Follow up information has been received from a physician concerning an 11 year old female with no pre-existing allergies, or medical conditions who on 23-MAR-1998 was vaccinated subcutaneously into the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (658293/1102U). Concomitant vaccine therapy administered within four weeks of varicella virus live included a first dose of Gardasil administered intramuscularly (IM) (Lot #656372/0243U), a sixth dose of Tripedia (Lot # C2770AA) administered IM into the left arm and a first dose of Menactra (Lot # N2339AA), administered IM. On 27-SEP-2007, at 10:00, the patient developed a rash on her scalp, and moved to her face, chest, arms and legs. The patient complained of severe itching. the patient was seen at the doctor's office for a history of a fever up to 101 F. Observations at that time included a vesicular papular rash all over her face, arms, legs, chest and abdomen. The patient was advised to remain off from school at home, and isolated from siblings. No follow up was required unless problems should arise. No diagnostics labs studies obtained. There was no concomitant therapy. Medical attention was sought. There was not illness at the time of vaccination. There were no adverse events following previous vaccinations. At the time of reporting the patient's status was unknown (previously reported as recovered). Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male with no pertinent medical history and who has drug reactions/allergies to amoxicillin, who on 01-AUG-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck), (lot number not reported). There was no concomitant medication. On 30-SEP-2007, the patient presented with a rash and on 02-OCT-2007 was diagnosed with chickenpox. No lab diagnostics studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Rash papular, Scab, Skin lesion, Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 month old male patient with no pre-existing allergies, birth defects, medical conditions, who 0n 08-FEB-2005 was vaccinated in the right leg at 3:10 with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 648940/0657P). On 30-OCT-2007 at 9:50 AM the patient experienced chickenpox that including papular lesions, fluid-filled vesical and scabbed over lesions. There were no relevant diagnostic tests and laboratory data. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. No further information was provided. There was no product quality complaint. Follow-up information indicated that the outcome was reported as recovered. No additional information is expected.
Age: 1.3
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Rash papular, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 month old male patient with no pre-existing allergies, birth defects, medical conditions, who 0n 08-FEB-2005 was vaccinated in the right leg at 3:10 with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 648940/0657P). On 30-OCT-2007 at 9:50 AM the patient experienced chickenpox that including papular lesions, fluid-filled vesical and scabbed over lesions. There were no relevant diagnostic tests and laboratory data. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. No further information was provided. There was no product quality complaint. Follow-up information indicated that the outcome was reported as recovered. No additional information is expected.
Age: 1.3
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Rash papular, Scab, Skin lesion, Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 month old male patient with no pre-existing allergies, birth defects, medical conditions, who on 08-FEB-2005 was vaccinated in the right leg at 3:10 with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 648940/06579). On 30-OCT-2007 at 9:50 AM the patient experienced a chicken-pox breakthrough including papular lesions, fluid-filled vesical and scabbed over lesions. There were no relevant diagnostic tests and laboratory data. The outcome was reported as recovered. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. No further information was provided. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Blister, Rash papular, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 month old male patient with no pre-existing allergies, birth defects, medical conditions, who on 08-FEB-2005 was vaccinated in the right leg at 3:10 with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 648940/06579). On 30-OCT-2007 at 9:50 AM the patient experienced a chicken-pox breakthrough including papular lesions, fluid-filled vesical and scabbed over lesions. There were no relevant diagnostic tests and laboratory data. The outcome was reported as recovered. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. No further information was provided. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning his 10 year old daughter with no pertinent medical history and an allergy to penicillin and hay fever who at approximately one to one and a half years of age, in approximately 1997, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). The physician reported that his daughter received "a booster dose" of varicella virus vaccine live (Oka/Merck) (date unspecified) and the "next day" her arm was itchy at the injection site. On that same day, later at night, it was reported that the area was indurated with a red half dollar size area. The physician reported "that is morning (20 DEC 2007) the area is twice the size of yesterday. It was reported that the patient had already been seen by her pediatrician, and there are plans for her to be seen by an allergist that day. There were no symptoms after her first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant therapy. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting the patient had not yet recovered. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Drug exposure during pregnancy, Urinary tract infection
Clinical narrative: Information has been received from a nurse practitioner, for the Pregnancy Registry for varicella virus vaccine live (Oka/Merck), concerning a 24 year old pregnant female (LMP: 23-OCT-2007) who on 29-NOV-2007 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck) (Lot # 659113/1360U) 0.5 mL IM. Concomitant therapy included prenatal vitamins (unspecified). On 11-DEC-2007 the patient had a prenatal screen blood test. The patient sought unspecified medical attention. On 14-DEC-2007 the patient was treated with nitrofurantoin (MACROBID) for a urinary tract infection. Additional information has been requested. 6/18/10 Follow up informatin was received from the nurse practitioner. It was reported that the estimated date of delivery was 04-AUG-2008 and on 03-AUG-2008 the patient had a normal spontaneous vaginal delivery of a normal infant female with no congenital anomalies weighing 7 pounds and 8 ounces. The apgar was 9/9. No further information is available.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 16 year old female with unknown pertinent medical history and unknown drug reactions/allergies, who was vaccinated with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck), (lot number: 658197/0853U).  On 21-SEP-2007 the patient developed "exaggerated swelling and erythema at injection site". The date of the first vaccination is unknown. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Mass
Clinical narrative: Information has been received from a physician concerning a 12 year old female with unknown pertinent history and unknown drug reactions/allergies, who was vaccinated SC with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck), (lot number not reported). The patient "came in 2 days after the vaccination" with erythema and swelling at injection site. The patient also had eight "spots" on her abdomen, one of which was vesicular. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Drug exposure during pregnancy, Pregnancy test, Smear test, Ultrasound scan
Clinical narrative: Information has been received through Merck pregnancy registry from a pharm D. concerning a 33-year-old pregnant female (LMP 20-MAY-2007) with no pertinent medical history or allergies who on 04-OCT-2007 (also reported as 05-OCT-2007) was vaccinated intramuscularly with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included prenatal vitamins (unspecified). On 04-OCT-2007 the patient came to the emergency room for vaginal bleeding and the physician noticed that her children had chickenpox. The physician was thinking of administering immunoglobulin to the patient but realized that she was "outside the criteria" and decided against it. A nurse who was not aware of this decision administered varicella virus vaccine live (Oka/Merck) intramuscularly thinking that it was immunoglobulin. Pharmacist stated this was not a situation of product confusion. The patient had a pregnancy test, genital wet mount (negative for trichomonas), chem panel and ultrasound performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow-up information received on 27-MAY-2009 indicated the patient was homeless and the reporter was unable to obtain additional information at this time. Additional information is not expected.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaginal haemorrhage, Wrong drug administered
Clinical narrative: Information has been received through Merck pregnancy registry from a pharm D. concerning a 33-year-old pregnant female (LMP 20-MAY-2007) with no pertinent medical history or allergies who on 04-OCT-2007 (also reported as 05-OCT-2007) was vaccinated intramuscularly with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included prenatal vitamins (unspecified). On 04-OCT-2007 the patient came to the emergency room for vaginal bleeding and the physician noticed that her children had chickenpox. The physician was thinking of administering immunoglobulin to the patient but realized that she was "outside the criteria" and decided against it. A nurse who was not aware of this decision administered varicella virus vaccine live (Oka/Merck) intramuscularly thinking that it was immunoglobulin. Pharmacist stated this was not a situation of product confusion. The patient had a pregnancy test, genital wet mount (negative for trichomonas), chem panel and ultrasound performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow-up information received on 27-MAY-2009 indicated the patient was homeless and the reporter was unable to obtain additional information at this time. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Culture positive, Culture wound positive, Erythema, Methicillin-resistant staphylococcal aureus test positive, Pruritus
Clinical narrative: Information has been received from a physician concerning a 6 year old female with no pertinent medical history or drug reactions/allergies, who on 21-SEP-2007 was vaccinated with a first 0.5mL dose of varicella virus vaccine live (Oka/Merck), (lot number 658018/1007U). On 23-SEP-2007, two days post vaccination, the patient developed a rash on her legs and then on her arms, and complained of itching. The physician reports the patient was without fever, cough, or cold. Observations included erythematous, papule lesion over the legs. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. No treatment was required. No follow up was required. No relevant diagnostic testing was performed. At the time of vaccination the patient had a scalp infection, for which fungal and pus cultures of the scalp were sent. Results were positive for MRSA. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Information has been received from a physician concerning a 6 year old female with no pertinent medical history or drug reactions/allergies, who on 21-SEP-2007 was vaccinated with a first 0.5mL dose of varicella virus vaccine live (Oka/Merck), (lot number 658018/1007U). On 23-SEP-2007, two days post vaccination, the patient developed a rash on her legs and then on her arms, and complained of itching. The physician reports the patient was without fever, cough, or cold. Observations included erythematous, papule lesion over the legs. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. No treatment was required. No follow up was required. No relevant diagnostic testing was performed. At the time of vaccination the patient had a scalp infection, for which fungal and pus cultures of the scalp were sent. Results were positive for MRSA. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 3 and a half year old male with unknown pertinent medical history and unknown drug reactions/allergies, who on 14-APR-2004 was vaccinated with a first 0.5mL dose of varicella virus vaccine live (Oka/Merck), (lot number not provided). The physician stated that the patient came with shingles on approximately 20-SEP-2007. No history of chicken pox was noted. No further information is provided. No lab diagnostics studies were performed. The outcome was reported as recovering. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer reporting on her 10-year-old female daughter with no pertinent medical history or allergies who on 13-MAY-1998 (when she was 14 months old) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 625378/0066H). There was no concomitant medication. On 04-OCT-2007 the patient was diagnosed with shingle. The patient sought unspecified medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Follow-up information received on a barely legible medical record indicated there are no childhood records on the patient. On 04-OCT-2007 the patient had an office visit and her chief complaint were blisters on the left upper back (herpes zoster on left upper back). The patient was treated with acyclovir 500 mg for 21 days and ibuprofen 600 mg (frequency and duration illegible). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning a 7 year old male who was vaccinated on 01-MAR-2001 with varicella virus vaccine live (Oka/Merck) (Lot #635449/1141K) 0.5 mL SQ in the left arm. Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and hepatitis B virus vaccine (manufacturer unspecified). On 04-DEC-2007 the patient developed a chicken pox rash with more than 50 lesions all over his body and a fever of 104 F after receiving varicella virus vaccine live. The nurse reported that she spoke to the mother on 17-DEC-2007 and was told the patient had fully recovered from all symptoms. Additional information is not expected.
Age: 0.4
Sex: F
Vaccine: DTAP, HEP, PPV, RV5, VARCEL
Symptoms: Bronchiolitis, Inappropriate schedule of drug administration, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a 5 month old 14 lb white/hispanic female with no pre-existing allergies, birth defects, or medical conditions who on 22-DEC-2007 at approx. 1700 hrs. Received a first subcutaneous 0.5 ml dose in the left leg of varicella virus vaccine live (Oka/Merck) (lot#658020/0826U). Concomitant vaccinations included a second dose in the right deltoid of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (C2760AA, specific vaccine not specified), a second dose in the right thigh of hepatitis B virus vaccine rHBsAg (yeast) (lot# 654746/1245F), a second dose in the right deltoid of pneumococcal 23v polysaccharide vaccine (manufacturer unknown), and a second oral dose of ROTATEQ vaccine live (human-bovine) (655483/111F). Illness at the time of the vaccinations was reported as mild upper respiratory infection (URI) symptoms, rhinorrhea, and cough. There were no adverse events following prior vaccination. It was indicated that on 09-JAN-2008, the patient developed bronchiolitis that did not require hospitalization. It was noted that the symptoms seemed to have been developing prior to vaccination. There were no relevant diagnostic tests or laboratory studies performed. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 2.5
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 30 month old female who was vaccinated with varicella virus vaccine live (Oka/Merck). On 02-OCT-2007 the patient experienced chicken pox. The chicken pox was described as mild, only 20 lesions. It was unknown if medical attention was sought. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse in a physician's office concerning an 8 year old white male, with no known medical history or allergies, who on 18-DEC-2007 was vaccinated with a second SC/LA dose of varicella virus vaccine live (Oka/Merck) (Lot #659533/15994U). Concomitant vaccine administered on the same day included a first IM/RA dose of hepatitis A vaccine (inactive) (MSD) (Lot# 657307/0442U). There was no illness at the time of vaccination and no adverse events following prior vaccination. On 19-DEC-2007 the patient returned to the physician's office and presented with an inflamed injection site, injection site swelling, and injection site itching. It was reported that the patient experienced pain with rings of erythema around the varicella virus vaccine live (Oka/Merck) injection site. The patient recovered on 22-DEC-2007. There was no product quality complaint. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 9 year old female patient who on 12-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #657108/0369U). On 14-DEC-2007 the patient experienced an injection site reaction, described as inflamed injection site, injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source. Follow-up information was received which reported that on 12-DEC-2007 the patient with no pre-existing allergies, birth defects or medical conditions was vaccinated subcutaneously in the right thigh with a second dose of VARIAVAX (Oka/Merck) (Lot #657108/0369U). On the same day the patient also received the first dose of HAVRIX (Lot #AHAVB1B2A) and FLUZONE (lot #U2438AA) both given IM in the left thigh. There was no illness at the time of vaccination. On 14-DEC-2007 the patient experienced an injection site reaction in the right thigh, described as inflamed injection site, injection site swelling, itching, redness and hotness. On an unspecified date the patient recovered from the events. Additional information is not expected. This is one of several reports from the same source.
Age: 9.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 9 year old female patient who on 12-DEC-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #657108/0369U). On 14-DEC-2007 the patient experienced an injection site reaction, described as inflamed injection site, injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source. Follow-up information was received which reported that on 12-DEC-2007 the patient with no pre-existing allergies, birth defects or medical conditions was vaccinated subcutaneously in the right thigh with a second dose of VARIAVAX (Oka/Merck) (Lot #657108/0369U). On the same day the patient also received the first dose of HAVRIX (Lot #AHAVB1B2A) and FLUZONE (lot #U2438AA) both given IM in the left thigh. There was no illness at the time of vaccination. On 14-DEC-2007 the patient experienced an injection site reaction in the right thigh, described as inflamed injection site, injection site swelling, itching, redness and hotness. On an unspecified date the patient recovered from the events. Additional information is not expected. This is one of several reports from the same source.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with no medical history who on 05-AUG-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There were no concomitant medications. The child never received second dose of vaccine. It was reported that the patient's grandmother (his caretaker in the afternoons) was vaccinated with a dose of zoster vaccine live (MSD) on approximately 27-SEP-2007. The child developed lesions on 03-OCT-2007, 6 days after his grandmother was vaccinated. The child was seen in office on 04-OCT-2007 with over 100 lesions on his face, trunk, arms, and mouth. The doctor diagnosed the child with chickenpox. The child was recommended to have diphenhydramine hydrochloride (BENADRYL) and baths. There were no laboratory or diagnostic tests performed. It was not known if the child had any other recent exposure to chickenpox. At the time of report the patient was not recovered. A product quality complaint was not involved. No further information is available.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician's assistant concerning a 7 year old patient with no pertinent medical history, drug reactions or allergies who on 16-MAR-2001 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 635459/0759K). There was no concomitant medication. On 12-SEP-2007 the patient experienced varicella like rash covering entire body. Subsequently, the patient recovered. Medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who in December 2007 "about 2 weeks ago", was vaccinated inadvertently with varicella virus vaccine live (Oka/Merck). The pharmacist reported that the pharmacy might have dispensed varicella virus vaccine live (Oka/Merck) in error; this was not product confusion. The patient sought medical attention at the physician's office. There was no adverse event reported. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a second dose of 0.5 ml of varicella virus vaccine live (Oka/Merck). The patient developed a shingles type rash on the arm of administration a few days after receiving the first dose of varicella virus vaccine live (Oka/Merck). A few days after receiving the second dose of varicella virus vaccine live (Oka/Merck), the patient developed a shingles type rash on the arm of administration. The patient recovered from both episodes on an unspecified dates. Medical attention was sought. The patient was seen by a physician. There was no product quality complaint. Additional information has been requested.