chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Nasopharyngitis, Pruritus generalised, Rash generalised, Vaccination failure
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 year old female with no pertinent medical history and no drug reactions/allergies, who on 05-OCT-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 637957/1882K). Concomitant therapy included measles-mumps-rubella vaccine (MSD) and "hemin". On 15-NOV-2007, the patient developed chickenpox after receiving the vaccination. The patient presented with itchy red rash all over the body. She has no fever, but had mild cold symptoms. The patient had been eating and drinking well. No further information was available. There was no lab diagnostic studies performed. Unspecified medical attention was sought. The patient had been by the physician. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 7 year old female with no pertinent medical history and no drug reactions/allergies, who on 05-OCT-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 637957/1882K). Concomitant therapy included measles-mumps-rubella vaccine (MSD) and "hemin". On 15-NOV-2007, the patient developed chickenpox after receiving the vaccination. The patient presented with itchy red rash all over the body. She has no fever, but had mild cold symptoms. The patient had been eating and drinking well. No further information was available. There was no lab diagnostic studies performed. Unspecified medical attention was sought. The patient had been by the physician. There was no product quality complaint. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old male with a history of convulsion, mental and motor retardation and an allergy to Biaxin who on 04-OCT-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot number: 0912F). Concomitant therapy included Lamictal, Keppra, Prevacid and Tranxene. The patient developed chickenpox rash all over the body along with a low grade fever after receiving the vaccination. The patient felt uncomfortable and itchy. There were no lab diagnostics studies performed. Unspecified medical attention was sought. The patient saw the nurse. The outcome was reported as recovered. No further information was available. There was no product quality complaint. Additional information has requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Oedema peripheral, Urticaria
Clinical narrative: Information had been received from a physician concerning a 14 year old female who on 26-NOV-2007 was vaccinated SC with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On 27-NOV-2007, the patient experienced swelling of hands and feet as well as widespread hives. On 28-NOV-2007, the patient was examined in the office. There were no lab diagnostics studies performed. Unspecified medical attention was sought. The outcome was reported as recovering. No further information was available. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a recent increase in chicken pox outbreaks with some of her patients that have received the first dose of varicella virus vaccine live (Oka/Merck). Representative had no additional information. There was no product quality complaint. This is one report of several from the same source. Additional information is expected.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 10-year-old male with a history of "NKAM", tracheo-oesophageal fistula, multiple congenital abnormalities, macrosomia and hydrocephalus who on 28-AUG-2007 was vaccinated subcutaneous in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 658177/1012U). Concomitant vaccine administered on 28-AUG-2007 included a second intramuscular dose of Havrix (lot # AHAVB18ZAA) administered in the left arm. On 30-AUG-2007, the patient developed a red, swollen painful local at injection site (duration 24-48 hours) that was treat with a cool compress and ibuprofen (manufacturer unknown). On an unspecified date the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 11-year-old female who on 12-JAN-1998 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 623654/0806E). On 27-NOV-2007, the patient developed more than 50 chicken pox lesions on her body even after being vaccinated. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. At the time of the report the patients status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a 10 year old male who on 31-OCT-2007 was vaccinated subcutaneously into the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot #659064/1357U). On 02-NOV-2007, the patient developed a red area near the injection site the size of a quarter, a low grade fever and a headache. The patient recovered on an undisclosed date. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 29-OCT-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported as a medical error, another nurse grabbed the wrong vaccine. No adverse experience was reported. A product quality complaint was not involved. Follow-up information has been received concerning a 72-year-old female who was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). The reason for the confusion was that  one nurse pulled the vaccine out of the refrigerator and drew it up. That nurse was called away and another nurse took it and administered it. Additional information is not expected. This is one of several reports received from the same source.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 10-year-old immunocompromised female with Crohn's Disease and no allergies to food or medication who on 03-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # "0424"). Concomitant therapy included Remicade and Imuran (both for Crohn's Disease). The patient had demonstrated the appropriate immune response after vaccination. Subsequently, the patient experienced disseminated varicella. The reaction was noted to be a rash of greater than 200 lesions on her face, trunk, groin and extremities. A specimen was obtained on 20-NOV-2007, and sent to the laboratory on 04-DEC-2007. The specimen was a vesicle. The PCR analysis was positive for wild type. It was noted that the patient had no recent immunization. The patient did not have a recent exposure to chickenpox or shingles. The patient recovered. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Pain of skin
Clinical narrative: Information has been received from a consumer concerning a 17 year old female with asthma and no allergies who in the mid-1990s was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Two weeks ago", on approximately 20-NOV-2007, the patient experienced headache and general fatigue. She had skin soreness on the left side of her face and left side of her trunk. Also her right calf had skin soreness. The patient's mother was calling the symptoms shingles. The patient had no lesions and had been treated with Advil for pain. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Laboratory test
Clinical narrative: Information has been received from a physician's assistant concerning a 7 year old female with reactive airway disease who on 08-FEB-2001, received a one time 0.5 cc dose subcutaneously in the left upper arm of varicella virus vaccine live (Oka/Merck /Lot# 631467/1682J). It was initially reported that at the time of vaccination she had an upper respiratory infection with no fever. Follow up information from the physician assistant reported no illness at the time of vaccination. There was no concomitant medication. On 01-DEC-2007, the patient developed a rash and small vesicles on the left arm and shoulder. On 03-DEC-2007, she presented to the physician's office with vesicles and no scab formation noted to be of dermatomal distribution. She was diagnosed with shingles. Treatment included acyclovir. At the time of this report the patient was recovering. The physician's assistant indicated that they had planned to send a specimen for zoster varicella identification, but the specimen was sent to a conventional laboratory facility that was unable to perform the identification test and would not forward the specimen. Therefore, no specimen would be sent for zoster varicella identification. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male with no medical history or allergies who on 08-MAY-2002 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 635455/1145K). There was no concomitant medication. On 27-NOV-2007, the patient developed a mild chickenpox rash. No treatment was needed. No diagnostic laboratory tests were undertaken. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been requested. This is on of several reports received from the same source.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 17 month old male with no medical history or allergies who on 02-JUL-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 657787/0718U). There was no concomitant medication. On 04-OCT-2007, the patient developed a mild chickenpox rash. No treatment was needed. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male who in the morning of 21-DEC-2001 was vaccinated with a first subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (Lot # 638245/0779L). On 20-OCT-2007, the patient developed rash all over body with 50 to 500 lesions. At the time of report the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 10 year old male with no medical history or allergies who in March 1998, was vaccinated SC with a first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 02-DEC-2007, the patient developed a zoster rash involving dermatomes 2, 3 and 4 located on his right leg. The patient experience some pain due to the rash but had no fever. The patient was treated with acyclovir but the patient had to discontinue it's use because it caused him to have stomach upset. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who on 23-APR-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 627337/1057H). On 26-NOV-2007, the patient developed rash on back, arms and stomach. The patient had less than 50 lesions. A product quality complaint was not involved. Additional information has been requested. This is one of several reports from the same source.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male who on 08-JAN-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot number: 627337/1057H). On 13-NOV-2007, the patient developed breakthrough, described as a rash on his neck, face, back torso and a fever. Rash was between 50 to 500 lesions. Patient was diagnosed by physician. No additional information was available. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. This is one of several cases from the same source. Additional information is not expected.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 16-JUN-1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 619271/1338D). On 05-NOV-2007, the patient developed a breakthrough of chickenpox. The patient had rash on shoulders, chest, head, abdomen and legs. The patient also had fever and had less than 50 lesions. On an unspecified date the patient had recovered. Additional information is not expected. This is one of several reports received from the same source.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male who on 02-NOV-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 637957/1882K). On 24-NOV-2007, the patient developed a breakthrough of varicella. The patient developed rash on his stomach, back and legs. The patient had fever and less than 40 lesions. At the time of report the patient was recovering. Additional information has been requested. It was reported that the patient's brother WAES # 0712USA01364 experienced a similar adverse event following vaccination with varicella virus vaccine live (Oka/Merck). This is one of several reports received from the same source.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximately 3 or 4 year old male who (at 12-15 months of age) in approximately 1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In approximately 1998 (2-3 years later) the patient was diagnosed with chickenpox. No other information was available. Unspecified medical attention was sought in the physician's office. The outcome was reported as recovered. There was no product quality complaint. Additional information is expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 10-year-old female who on 05-FEB-1999 was vaccinated with a first subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (Lot # 627337/1057H). On 27-NOV-2007, the patient developed a case of breakthrough, described as a rash located on her trunk, back, face, legs and head. The patient had a fever and lesions from 50 to 500 in number. The school nurse diagnosed it. Follow up information provided no additional information regarding current patient status. A product quality complaint was not reported. Follow up information from the registered nurse provided no additional information. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 8-year-old male who on 29-SEP-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 632616/1688J). On 14-NOV-2007, the patient developed breakthrough chickenpox. The patient had a rash on his legs, feet and trunk. No fever was noted. It was also reported the patient had 50 to 500 lesions and was diagnosed by his parents. The patient sought unspecified medical attention. On an unspecified 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.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, DTAP, MNQ, VARCEL
Symptoms: Angioedema, Dyspnoea, Lip pain, Swelling face
Clinical narrative: Information has been received from a physician concerning a 16-year-old female with asthma and an allergy to mepivacaine who on 20-NOV-2007 at 14:30 was vaccinated subcutaneous in the left arm with a booster dose (also reported as first dose) of varicella virus vaccine live (Oka/Merck) (lot # 658958/1351U). There were no illness at the time of vaccination. Concomitant vaccines administered on 20-NOV-2007 at 14:30 included an intramuscular dose of Menactra (U2421AA) administered in the right arm and intramuscular dose of Adacel (lot # C2863AA) administered in the left arm. Concomitant therapies included hormonal contraceptives (manufacturer unspecified) and Claritin. On 20-NOV-2007, the patient experienced difficulty breathing and facial swelling. On 25-NOV-2007, 5 days after the vaccine was given, the patient visited the office and had angioedema of the lips. The patient's mother reported to the physician on 27-NOV-2007 that the patient's lips had been sore for 4 days and her face is now swollen. The patient went to see the doctor the same day and was treated with steroids and improved. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, DTAP, MNQ, VARCEL
Symptoms: Gingival pain, Lip swelling, Swelling face
Clinical narrative: Information has been received from a physician concerning a 16-year-old female with asthma and an allergy to mepivacaine who on 20-NOV-2007 at 14:30 was vaccinated subcutaneous in the left arm with a booster dose (also reported as first dose) of varicella virus vaccine live (Oka/Merck) (lot # 658958/1351U). There were no illness at the time of vaccination. Concomitant vaccines administered on 20-NOV-2007 at 14:30 included an intramuscular dose of Menactra (U2421AA) administered in the right arm and intramuscular dose of Adacel (lot # C2863AA) administered in the left arm. Concomitant therapies included hormonal contraceptives (manufacturer unspecified) and Claritin. On 20-NOV-2007, the patient experienced difficulty breathing and facial swelling. On 25-NOV-2007, 5 days after the vaccine was given, the patient visited the office and had angioedema of the lips. The patient's mother reported to the physician on 27-NOV-2007 that the patient's lips had been sore for 4 days and her face is now swollen. The patient went to see the doctor the same day and was treated with steroids and improved. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, DTAP, MNQ, VARCEL
Symptoms: Angioedema, Dyspnoea, Lip pain, Swelling face
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female student with a drug allergy to mepivacaine HCL who on 20-NOV-2007 at 14:30 was vaccinated SC with his first dose of varicella virus vaccine live (Oka/Merck) (lot# 658958/1351U) in the left arm. There was no illness at the time of vaccination. Suspect vaccinations administered on that same day at 14:30 included the first IM dose of Daptacel (lot# C2863AA) in the left arm and the first IM dose of Menactra (lot# U2421AA) in the right arm. After vaccination, the patient developed upper lip swelling, sore gums and facial swelling and the patient sought medical attention through the physician's office on 27-NOV-2007. The outcome was unknown at the time of this report. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL, DTAP, MNQ, VARCEL
Symptoms: Gingival pain, Lip swelling, Swelling face
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 year old female student with a drug allergy to mepivacaine HCL who on 20-NOV-2007 at 14:30 was vaccinated SC with his first dose of varicella virus vaccine live (Oka/Merck) (lot# 658958/1351U) in the left arm. There was no illness at the time of vaccination. Suspect vaccinations administered on that same day at 14:30 included the first IM dose of Daptacel (lot# C2863AA) in the left arm and the first IM dose of Menactra (lot# U2421AA) in the right arm. After vaccination, the patient developed upper lip swelling, sore gums and facial swelling and the patient sought medical attention through the physician's office on 27-NOV-2007. The outcome was unknown at the time of this report. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a male who on 06-AUG-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed varicella. At the time of reporting the patient's status was unknown. It was also reported the patient's sibling had an adverse experience WAES # 0710USA02657. Follow-up information received on 26-FEB-2008 indicated the reporter could not not identify the patient in their records from the information that was provided. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HEP, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 12-year-old white male with a history of osteochondrosis and "ADND" who was vaccinated subcutaneous in the left arm at 11:58 with a dose of varicella virus vaccine live (Oka/Merck) (lot # 658594/1330U). Concomitant vaccines administered on 26-NOV-2007 included a first intramuscular dose of MENACTRA (dip toxoid) administered at 11:58 in the left arm as well as an intramuscular dose of hepatitis B virus vaccine rHBsAg (yeast) (ENGERIX-B) administered at 11:58 in the right arm. On 28-NOV-2008 at 13:54 the patient experienced redness and swelling at the injection site (previously reported as a large injection site reaction). The area was also reported as firm and tender. The patient did not receive any treatment and was advised to take ibuprofen. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck), staff error. At the time of the report the patient's status was unknown. A product quality complaint was not involved. No further information is available.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse (RN) concerning a kindergarten entry aged patient of approximately 5-years of age patient who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Subsequently, "two weeks after vaccination" the patient developed a chickenpox like rash. It was unspecified if medical attention was sought. No further information was available at the time of this report. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who on 05-DEC-2007 was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). The nurse reports that this was related to staff error and not product confusion. No adverse experience was related to this event. No product quality complaint was involved. Additional information has been received from a registered nurse and nursing supervisor. It was confirmed that the patient did receive a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck) (MSD). She explained that this was a case of human error and misunderstanding. The order was written correctly but the medical assistant administered the wrong vaccine. There were no issues with regards to labeling, storage location, etc. It was reported to be "purely human error". Since then, a rep has come out and given an educational talk regarding zoster vaccine live (Oka/Merck). The patient is fine and will be re-vaccinated. Additional information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site scab, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 10-year-old male who in approximately November 2007 (within the last month), was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 659204/1470U). In approximately November 2007 (within the last month), the patient experienced injection site redness, fever, and crusting around the injection site area. The patient was taken to the emergency room twice. The office suspected the diluent and disposed of all diluent of that lot number (lot number unavailable). On an unspecified date the patient recovered. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who on 02-JUN-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 07-Jun-1999 (5 days later) the patient had a rash all over her body. The outcome was reported as recovered. No other information. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (school nurse) concerning a child between the ages of 6 and 11 years old who in September 1998, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 03-DEC-2007 the patient was experiencing chickenpox. It was not specified how many doses of varicella virus vaccine live (Oka/Merck) the patient received. Medical attention was sought via an office visit with the physician. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacy intern concerning a patient who on 10-DEC-2007 was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) "due to human error." The intern reported that the patient had no symptoms. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Rash papular, Scab
Clinical narrative: Information has been received from a health professional concerning a 13 year old 69 1/2 lb. 57 1/4 in. white male with no pre-existing allergies, birth defects, or medical conditions who on 09-MAR-2001, received his first dose subcutaneous in the left arm of varicella virus vaccine live (Oka/Merck) (lot# 635948/1333K). No illness at time of vaccination, and no adverse events following previous vaccinations were reported. It was reported that on 03-DEC-2007 at 14:00 hours, the patient developed crusted vesicles and papules scattered on his abdomen and forehead. He sought medical attention at the physician's office. There were no relevant diagnostic tests or laboratory data. At the time of this report, it was reported that the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 8-year-old female who on 11-AUG-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 13-year-old female who on 20-JUL-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 10-year-old female who on 06-OCT-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality compliant was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 75-month-old female who on 13-SEP-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 648554/0584P). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 7-year-old female who on 30-APR-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 83-month-old female who on 31-JAN-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 649446/0651P). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 5-year-old female who on 13-JUN-2003 and 05-JUL-2007 was vaccinated with her first and second dose of varicella virus vaccine live (Oka/Merck) (lot # 657099/0453U 2nd dose). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 77-month-old female who on 17-JUN-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 78-month-old female who on 10-JUN-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # "0890P"). On approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 5-year-old female who on 18-JUL-2005 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 644252/1155M). ON approximately 06-NOV-2007 ("within the last two weeks") the patient developed breakthrough chickenpox. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a health professional concerning a 43 year old female with a history of varicella who on 12-DEC-2007, while administering a dose of varicella virus vaccine live (Oka/Merck), was splashed in the eye with the vaccine. It was reported that she removed her contact lens and flushed the eye with sterile saline. It was reported that she developed "irritation" on the day of the event. At the time of this report, she was no longer experiencing any complaints. It was indicated that the patient who was receiving the vaccine, did not receive the full dose. A product quality complaint was not reported. This case is closed. This is one of tow reports from the same source.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Blood test, Eye irritation
Clinical narrative: Information has been received from a physician concerning a 43 year old female nurse with hypertension and a history of chickenpox when younger and no history of immunodeficiency or immunosuppressive therapy, who on 10-DEC-2007 was splashed in her one eye upon administration for a child with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658022/0823U). Concomitant drug therapy included metoprolol succinate (TOPROL XL). On that same day moments after the event, the patient felt a burning sensation. The patient removed her contact lens and flushed eye with normal saline. The patient sought medical attention through a physician who reported no abnormalities. The burning sensation disappeared but the patient went to an emergency room for an evaluation. A blood test was performed and the patient was released. On that same day the patient was recovered. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician who stated that on approximately 20-NOV-2007 he accidentally administered himself with a dose of varicella virus vaccine live (Oka/Merck) (MSD). He indicated that it was no product confusion, he did not read the label. No symptoms were reported. No other details. There was no product quality complaint. Follow-up information indicated no adverse reaction. No new information. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Cough, Pyrexia, Varicella post vaccine, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning her 6-year-old daughter with no pertinent medical history and no known drug allergies, who on 06-JUL-2006 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included poliovirus vaccine, measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. The first dose of varicella virus vaccine live (Oka/Merck) was given on 17-SEP-2007 with concomitant vaccinations Prevnar and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). On15-Nov-2007, the patient broke out in chickenpox all over her body, (head, neck, hair, in one ear and trunk). The child had a fever for 4 days of 102F, vomited for 3 days and a cough. No medical attention was sought, the mother monitored the child's condition at home and administered Tylenol and ibuprofen. The child is recovering but the cough persisted. No product quality complaint was involved. Additional information is not expected.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 15-month-old male who on 02-NOV-2007 was vaccinated subcutaneously in the right leg with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 658300/1022U). On 06-NOV-2007, the patient experienced papules, vesicles on the legs and back and was diagnosed with possible varicella from the vaccine. The outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Underdose
Clinical narrative: Information has been received from a registered nurse concerning a patient. It was reported that on 10-DEC-2007, while the healthcare worker was administering varicella virus vaccine live (Oka/Merck) to the patient, she was splashed in the eye. It was reported that the patient who was receiving the vaccine did not get the full dose. Medical attention sought was not reported. A product quality complaint was not reported. This is one of two reports from the same source.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Varicella, Viral DNA test positive
Clinical narrative: Information has been received from a lab specialist and nurse practitioner concerning a 2 year old patient who on 16-AUG-2006 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 650232/0911R). Subsequently, the patient developed "a flaming case of the chickenpox." The patient was seen for unspecified medical attention. The outcome was unknown. There was no product quality complaint. Follow-up information from a questionnaire indicated that the 27 month old male with no past history of chickenpox or no other medical history or drug allergies who on 16-AUG-2006 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 650232/0911R). There was no concomitant medication. On 05-DEC-2007, the patient developed herpes zoster dermatome at the 5th position of the lumbar region. The vesicular rash hand scab/skin lesions distributed to 4 areas: the lumbar area, right leg, thigh and calf. There was no recent exposure to chickenpox or shingles noted and the time interval since exposure was the date of vaccination. On approximately 14-DEC-2007 the patient had a maximum temperature of 98.8 and no other systemic symptoms. The patient was enrolled in VZIP: Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. The sample of the lesion was collected on approximately 14-DEC-2007. The sample was taken from a vesicular lesion on the right leg. Additional follow-up information indicated that the on 02-JAN-2008 PCR results for the specimen from a vesicular lesion on the right leg revealed that VZV OKA/MERCK Vaccine Strain. Additional follow-up information indicated that the specimen was obtained on 14-DEC-2007 by a lesion from a scab on the patient's skin (also reported as vesicular lesion: as the source, sent on 17-DEC-2007 and received by the laboratory on 18-DEC-2007. The results revealed an adequate specimen with amplified VZV DNA, vaccine-type strain. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pain in extremity, Physical examination
Clinical narrative: Information has been received from a physician concerning an 11 year old male who on 30-NOV-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658965/1355U). Suspect vaccination administered on that same day included a dose of Menactra in the left leg. Other concomitant drug therapy included Zyrtec and Flonase. On 01-DEC-2007 the patient was diagnosed with cellulitis characterized by pain in his leg (limped the entire day), a rash on the knee and into the groin and swelling in the interior thigh of his right leg. The patient sought unspecified medical attention. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting physician and medical records indicated that an 11 year old male with seasonal allergic rhinitis since 02-OCT-2006, a history of closed fracture of distal forearm (not specified) 09-NOV-2006 and no other medical conditions or allergies who on 30-NOV-2007 at 15:30 was vaccinated SC with his second dose of varicella virus vaccine live (Oka/Merck) (lot# 658965/1355U) in the right leg. There was no illness at the time of vaccination. Concomitant vaccination administered on that day at 15:30 included a dose of Menactra in the left leg. Other concomitant drug therapy initiated on 16-OCT-2007 included Zyrtec 10 mg chewables 1 tablet PO once daily and Flonase 50 mcg 2 sprays each nostril BID. PM 26-OCT-2007 the patient was started on acetaminophen (+) codeine 120-12 mg/5 mL solution 10 mL PO every 3 to 4 times per day. On 01-DEC-2007, at 9:00 the patient experienced pain, tenderness, and redness of the right leg. The patient was given Tylenol by his (a nurse in a pediatric outpatient department) for some relief from pain and swelling. The patient sought medical attention through a pediatric office visit on 03-DEC-2007. Remarkable exam findings included an alert, non-ill appearance with large erythema of right leg at the anterior thigh with swelling. There was no induration, drainage or purulence, but 2 small pimples with itchiness were noted. Visible lymph observed at the right side. The distal neurovascular (NV) status was normal and the left thigh was also normal. The patient's right thigh pain was rated as moderate (5/10). There were no other relevant diagnostic tests and laboratory data. The assessment was cellulitis of the right leg status post vaccination. The patient was treated with warm compresses and Motrin for 3 to 4 days. Subsequently, the patient recovered. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning an 11 year old male who on 30-NOV-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658965/1355U). Suspect vaccination administered on that same day included a dose of Menactra in the left leg. Other concomitant drug therapy included Zyrtec and Flonase. On 01-DEC-2007 the patient was diagnosed with cellulitis characterized by pain in his leg (limped the entire day), a rash on the knee and into the groin and swelling in the interior thigh of his right leg. The patient sought unspecified medical attention. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting physician and medical records indicated that an 11 year old male with seasonal allergic rhinitis since 02-OCT-2006, a history of closed fracture of distal forearm (not specified) 09-NOV-2006 and no other medical conditions or allergies who on 30-NOV-2007 at 15:30 was vaccinated SC with his second dose of varicella virus vaccine live (Oka/Merck) (lot# 658965/1355U) in the right leg. There was no illness at the time of vaccination. Concomitant vaccination administered on that day at 15:30 included a dose of Menactra in the left leg. Other concomitant drug therapy initiated on 16-OCT-2007 included Zyrtec 10 mg chewables 1 tablet PO once daily and Flonase 50 mcg 2 sprays each nostril BID. PM 26-OCT-2007 the patient was started on acetaminophen (+) codeine 120-12 mg/5 mL solution 10 mL PO every 3 to 4 times per day. On 01-DEC-2007, at 9:00 the patient experienced pain, tenderness, and redness of the right leg. The patient was given Tylenol by his (a nurse in a pediatric outpatient department) for some relief from pain and swelling. The patient sought medical attention through a pediatric office visit on 03-DEC-2007. Remarkable exam findings included an alert, non-ill appearance with large erythema of right leg at the anterior thigh with swelling. There was no induration, drainage or purulence, but 2 small pimples with itchiness were noted. Visible lymph observed at the right side. The distal neurovascular (NV) status was normal and the left thigh was also normal. The patient's right thigh pain was rated as moderate (5/10). There were no other relevant diagnostic tests and laboratory data. The assessment was cellulitis of the right leg status post vaccination. The patient was treated with warm compresses and Motrin for 3 to 4 days. Subsequently, the patient recovered. Additional information has been requested.