chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chicken in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grad, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports from the same source.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pharyngolaryngeal pain, Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12-year-old male who on 12-JUN-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 08-OCT-2007, the patient was diagnosed with a "mild case of chickenpox". There were less than fifty pox and the child was experiencing a headache, sore throat, and fever. The patient sought medical attention via an office visit. On 12-OCT-2007, the patient recovered.  A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated with a first and second (on 04-APR-2007) does of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated with a first and second (on 04-APR-2007) doses of 0.5 ml of varicella virus vaccine live (Oka-Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated with a first and second (on 04-ARP-2007) doses of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a school nurse concerning a middle school student who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed chickenpox. Patient's outcome was unknown. No other information was available.
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). Subsequently the patient came down with chicken pox. Medical attention was sought. The patient's outcome was not known. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 13 year old daughter with no pertinent medical history and no drug reactions/allergies who was vaccinated with varicella virus vaccine live (Oka/Merck) at age 21 months. There was no concomitant medication reported. On approximately 06-JUN-2007, the patient developed a severe case of chickenpox with over 300 lesions. She did not seek medical attention. As of 20-JUN-2007, she was recovering. No additional information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella
Clinical narrative: Information has been received from a consumer concerning a potential varicella outbreak in a female who was vaccinated with varicella virus vaccine live (Oka/Merck). A woman in her sister's neighborhood had a bad case of shingles and did not restrict her contact with others. The woman's daughter, who was vaccinated with varicella virus vaccine live, then came down with a case of varicella (150 blisters). The pediatrician of the child asked that the child not be brought into the office, since they felt that she was contagious. At the time of the report, the outcome of the patient's varicella (150 blisters) was unknown. The product quality complaint was not involved. Additional information has been requested. The consumer also provided information regarding other patients' experience while on treatment with varicella virus vaccine live (WAES #'s 0706USA04140 and 0706USA04141).
Sex: F
Vaccine: VARCEL
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Headache
Clinical narrative: Information has been received from a pharmacy student concerning a female patient who on 11-JUN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 18-JUN-2007, the patient experienced dizziness, rapid heart rate, weakness, shortness of breath, headache and diarrhea. It was reported that the symptoms resolved in 2 days with no medical treatment. Unspecified medical attention was sought. On 20-JUN-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Heart rate increased
Clinical narrative: Information has been received from a pharmacy student concerning a female patient who on 11-JUN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 18-JUN-2007, the patient experienced dizziness, rapid heart rate, weakness, shortness of breath, headache and diarrhea. It was reported that the symptoms resolved in 2 days with no medical treatment. Unspecified medical attention was sought. On 20-JUN-2007, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning her 7 year old child, a male with Wolff-Parkinson-White Syndrome, asthma, bicuspid aortic valve, hypersensitivity to Miralax and non steroidal anti-inflammatory drugs, who on 12-APR-2007, in the AM, was vaccinated subcutaneously with a booster dose of varicella virus vaccine live (Oka/Merck) and hepatitis A virus vaccine inactivated (manufacturer not specified). There was no illness at the time of vaccination. Other concomitant therapy included Singulair, an unspecified allergy eye drops, Flovent and flecainide acetate. On 18-JUN-2007, in the PM, the patient developed an itchy rash with red bumps on the chest and back, approximately 40. The patient was seen for "more bumps" on legs and arms. At this time the physician diagnosed the rash as "most likely chicken-pox". A family member, who is a dermatologist, also thought the rash resembled chicken-pox. The patient recovered on 25 JUN 2007. The nurse reported that the physician stated "it was not due to the vaccine". No product quality complaint was involved. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on 15-JUN-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck). On 18-JUN-2007 the physician was contacted because "over a 48 hour period after receiving the vaccine", the patient's arm where the injection was received was red, swollen, hard bump, and the size of an orange. It was noted the patient received her first vaccination of varicella virus vaccine live (Oka/Merck) around 12 months of age. The physician was concerned that this was cellulitis, but deemed this was not the case. Follow up information by the physician reported that the patient has recovered. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white female who on 21-JAN-1999 was vaccinated subcutaneously into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 628694/1663H). Concomitant therapy that same day included a first dose of measles-mumps-rubella vaccine (Lot # 628706/1540H) administered subcutaneously into the left thigh. There was no illness at the time of vaccination. There are no known pre-existing allergies or medical conditions. There was no concomitant medication. On 07-MAY-2007 the patient's mother called to report that her daughter developed 60 lesions all over her body, including her vaginal area. At the time of reporting the patient had recovered from 60 lesions all over her body. There were no lab diagnostic studies performed. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a patient who on approximately 30-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot 656576/0446U). On 01-JUN-2007, the patient experienced hard swollen area at the injection site, accompanied with redness and the area was hot to the touch. This is one of several reports from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a 6 year old male with no pertinent medical history or allergies who on 07 Aug 2006 was vaccinated subcutaneously into the right arm with a second dose of 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 649998/0909R). There was no illness at the time of vaccination. The patient developed a mild case of breakthrough with a typical rash. On 04- JUN 2007, the patient was "brought in" for an itchy rash. Subsequently, the patient recovered. There were no lab diagnostic tests performed. No further information was reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 5 year old male who in approximately 2004 at the age of 18 months was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a mild case of chicken pox. Unspecified medical attention was sought. At the time of this report the patient's status was not reported. There were no lab studies performed. No further information was provided. There was no product complaint involved. No further information is expected.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a health professional concerning a female who on 30-MAY-2007 was vaccinated subcutaneously in the left quadrant, with varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced local reaction around the injection site. "Symptoms included a low grade fever, "large round circle" of swelling, redness and a little heat around the injection site." Subsequently, the patient recovered from local reaction around the
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a healthcare worker concerning an approximately 13 year old male who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a fever, and large swelling at the injection site, with redness and heat at the injection site. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Skin discolouration
Clinical narrative: Information has been received from a health professional concerning a female who on 29-MAY-2007 was vaccinated, subcutaneously in the right arm, with varicella virus vaccine live (Oka/Merck) (lot# 656821/0174U). Subsequently the patient experienced local reaction around the injection site. "Symptoms included swelling, redness, and "slightly raised" around the injection site. Also, medical chart lists "+/- pink and purple" with the symptoms. BENADRYL and ice packs were instructed for treatment." The patient sought unspecified medical attention. Subsequently, the patient recovered from local reaction around the injection site. This is one of two cases for this physician. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Nurse concerning a female who on 29-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot # 656923/0451U). On 29-MAY-2007, the patient received a second dose of varicella virus vaccine live (Oka/Merck) and experienced an injection site rash that measured 2" X 3" to 3" X 3" in diameter which was red, hot to the touch and swollen. Subsequently, the patient recovered from the injection site rash 2 days later after treatment with an antihistamine (therapy unspecified) and cold compresses. This is one of several reports received from the same source. Additional information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 34 month old male who on 26-JUL-2008 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On 02-JUN-2007, the patient developed a break through case of chickenpox. Unspecified medical attention was sought. The patient had 7 lesions and received no treatment. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old white female with no medical history or allergies who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 27-MAY-2007 the patient developed rash and was seen in office on 31-MAY-2007. The patient had multiple lesions on her back and torso that were to numerous to count. It was reported that the patient was administered vaccine at other office and no records of vaccination were available. On 31-MAY-2007 the patient recovered. No medical attention was sought and no diagnostic laboratory tests were undertaken. No further information is expected. This is one of several reports received from the same source.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male with no medical history or allergies who on 19-JUN-2000 was vaccinated SC on right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 635205/0073K). Concomitant therapy on same day included a SQ first dose on left thigh of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 632456/0173K). At the time of vaccination, the patient was suffering from bronchitis. On 23-MAY-2007, the patient developed rash and increased body temperature. No medical attention was sought and no diagnostic laboratory tests were undertaken. No further information is available. This is one of several reports received from the same source.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 6 year old male with no illness at time of vaccination, who on 22-MAR-2007 was vaccinated SC in the left leg with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 639899/0977L). There were no concomitant medications. On 19-JUN-2007, the patient experienced varicella. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a female who "about 3 years ago", in approximately 2004, was vaccinated with a subcutaneous single dose of varicella virus vaccine live (Oka/Merck). On 17-JUN-2007, the patient developed breakthrough chickenpox rash of about 40 lesions on the trunk and neck. The patient also developed a low grade fever of 99 degrees fahrenheit for a day. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a nurse concerning a 43 year old female who 10 years ago was vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced negative equivocal antibody titers. Medical attention was sought. No problems reported. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Culture throat negative, Pyrexia, Streptococcal identification test negative, Varicella post vaccine
Clinical narrative: Information has been received concerning a 9 year old white male with no medical history and no drug allergies who on 29-JUN-2003 was vaccinated with a single subcutaneous dose of varicella virus vaccine live (Oka/Merck) ("Lot #1423F") in the left arm. Illness at the time of vaccination included a fever and sore throat. On 19-JUN-2007, the patient developed breakthrough chicken pox rash with 75 lesions (pox) on the face, trunk and back. The patient also had a low grade fever. On 18-JUN-2007 a quick test streptococcus was done with negative results. Subsequently, the patient recovered on 26-JUN-2007. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information received from the physician regarding laboratory results: Throat culture plate performed on 20-Jun-2007 - negative, Rapid Strep performed on 18-Jun-2007 - negative. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Nausea, Pharyngolaryngeal pain, Pruritus, Pyrexia, Rash papular
Clinical narrative: Information has been received from a consumer concerning a potential varicella outbreak in her 8 year old niece who, on an undisclosed date was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). The patient had a total of 37 itchy pimples that turned to blisters, starting on her face and spreading to her trunk and arms. The patient also developed a fever of 102, nausea and a sore throat. The illness was considered mild and treated with Advil and Tylenol for mild fever. The events all resolved in 7 days. The pediatrician of the child asked that the child not be brought into the office, since they felt that she was contagious. The original source of illness was thought to be a woman in her nieces neighborhood who had a bad case of shingles and did not restrict her contact with others, but the physician informed her that several cases were seen in the school system prior to summer break. The product quality complaint unit was not involved. Additional information has been requested. The consumer also provided information regarding other patients' experiences while on treatment with varicella virus vaccine live (WAES #0706USA03851, 0706USA04141, 0709USA00017).
Sex: M
Vaccine: VARCEL
Symptoms: Acne, Skin discolouration
Clinical narrative: Information has been received from a consumer concerning a potential varicella outbreak in a male child who was vaccinated with varicella virus vaccine live (Oka/Merck). A woman in her sister's neighborhood had a bad case of shingles and did not restrict her contact with others. A child became ill with spots/pimples on his legs. The pediatrician of the child asked that the child not be brought into the office, since they felt that he was contagious. At the time of the report, the outcome of the patient's varicella was unknown. The product quality complaint unit was not involved. Additional information has been requested. The consumer also provided information regarding other patients' experiences while on treatment with varicella virus vaccine live (WAES #0706USA03851, 0706USA04140).
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site vesicles
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 5 year old male patient with no known medical history or allergies, who on 16-JUN-2003 and 18-JUN-2007 at 16:30 PM was vaccinated SC in the left arm with a first and second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (lot number 657109/0444U). On 20-JUN-2007, the patient developed water filled blisters and cellulitis 2 days after the vaccination near the injection site. The patient was seen 20-JUN-2007 and prescribed an antibiotic. No laboratory tests were performed. At the time of the report the patient's status was recovering. No product quality complaint was involved. Additional information has been received from the licensed visiting nurse who stated that the patient was 5 years old and had injection site reaction. It was reported that the office did not track the episode as they were told it was "normal". It was also reported that the incidence was with the varicella virus vaccine live (Oka/Merck) (MSD) and not with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+)  rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (MSD). Additional information has been received from the licensed visiting nurse who stated that on 20-JUN-2007 patient developed red, hot induration area at injection site and developed vesicles that were tender and measured 9.5 cm. The patient was treat with Keflex for developing cellulitis at sites. At the time of report the patient had recovered. No further information is expected. This is one of several reports from the same source.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 11-JUN-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Ten days later, on approximately 21-JUN-2007, the patient developed a diffuse rash. No further information is available.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 month old female who on 19-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 657404/0592U). The patient developed an immediate injection site rash (left arm). The patient was treated with Benadryl and ice. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male with an allergy to Augmentin who on 06-MAY-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 00326). On 23-MAY-2007, the patient experienced acute febrile illness with sore throat and headache. Subsequently, the patient recovered from acute febrile illness, sore throat and headache. The reporter indicated it's unlikely vaccine related as sister had been sick earlier in week with the same. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 9 year old son who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed chickenpox. The patient developed flu-like symptoms on 15-JUN-2007 and a rash appeared on 17-JUN-2007. The patient was pulled out of his swim meet because of his symptoms. He was to stay away from other children for seven days. It was also noted that his sister seemed to be coming down with chickenpox as well and developed a high fever and upset stomach, "the first two signs of chickenpox," according to the reporter. No further information is available.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Herpes zoster, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old male with a history of asthma, and no drug reactions or allergies, who on 09-DEC-2003 was vaccinated subcutaneously with 0.5mL of varicella virus vaccine live (Oka/Merck) (Lot # 643032/0593M). Concomitant therapy included Ventolin and inhaled corticosteroid (unspecified) (+) montelukast. The patient was initially examined on 21-JUN-2007 for a cough, and instructed to use his inhaler. He was examined again on 22-JUN-2007 because his arm hurt. The patient had a 1.5cm by 2 cm macular lesion on left shoulder. On 25-JUN-2007 the patient was examined and presented with a vesicular rash from shoulder to wrist. The patient did not have any other symptoms than pain. The patient was started on Zovirax for treatment of shingles. The patient was not recovered at the time of reporting. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 6 year old patient who on 18-JUN-2007 (also reported as 19-JUN-2007) was vaccinated with a second subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot #656692/0457U). Secondary suspect vaccine administered on the same day included Havrix administered in the same arm. On 19-JUN-2007, the patient developed a rash that was red and hard around the injection site and had hives. The patient was treated with cold compresses and Benadryl (unspecified manufacturer). No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 4 year old male who on 12-JUN-2007 with no medical history or allergies was vaccinated on left leg with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 657456/0600U). Concomitant therapy included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (MSD) on left leg. Other concomitant therapy on right leg included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of hepatitis A virus vaccine (unspecified), a dose of hepatitis B virus vaccine (unspecified) and "fluoride". On 13-JUN-2007 it was reported that patient developed cellulitis after receiving several vaccines. The affected area was large and around the injection site the skin was sore, warm to touch and red. The patient was started on Augmentin on 14-JUN-2007. He was then changed to clindamycin on 15-JUN-2007 when the area did not improve. The cellulitis had resolved. On 23-JUN-2007, the patient developed a fever. On 24-JUN-2007, the patient developed a papulovesicular rash on the back of his neck, legs and chest. At the time of report the patient had not recovered. A product quality complaint was not involved. Further information has been received from the physician regarding this male with four siblings who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Lot # ) IM on left leg, a dose of diphtheria toxoid (+) pertussis vaccine unspecified (+) tetanus toxoid GSK (lot # AU21b115bb) IM third dose and a first dose of hepatitis A virus vaccine (unspecified) GSK) (LOT # AHAVB14BAA) and "fluoride". The physician reported that on 12-JUN-2007 the patient's injection site was red swollen and warm. The physician reported that the possible cellulitis was treated with Augmentin then clindamycin. The physician reported that the patient improved. The physician reported that there was questionable MRSA at the site. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a health professional concerning a 4 year old male who on 12-JUN-2007 with no medical history or allergies was vaccinated on left leg with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 657456/0600U). Concomitant therapy included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (MSD) on left leg. Other concomitant therapy on right leg included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, a dose of hepatitis A virus vaccine (unspecified), a dose of hepatitis B virus vaccine (unspecified) and "fluoride". On 13-JUN-2007 it was reported that patient developed cellulitis after receiving several vaccines. The affected area was large and around the injection site the skin was sore, warm to touch and red. The patient was started on Augmentin on 14-JUN-2007. He was then changed to clindamycin on 15-JUN-2007 when the area did not improve. The cellulitis had resolved. On 23-JUN-2007, the patient developed a fever. On 24-JUN-2007, the patient developed a papulovesicular rash on the back of his neck, legs and chest. At the time of report the patient had not recovered. A product quality complaint was not involved. Further information has been received from the physician regarding this male with four siblings who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Lot # ) IM on left leg, a dose of diphtheria toxoid (+) pertussis vaccine unspecified (+) tetanus toxoid GSK (lot # AU21b115bb) IM third dose and a first dose of hepatitis A virus vaccine (unspecified) GSK) (LOT # AHAVB14BAA) and "fluoride". The physician reported that on 12-JUN-2007 the patient's injection site was red swollen and warm. The physician reported that the possible cellulitis was treated with Augmentin then clindamycin. The physician reported that the patient improved. The physician reported that there was questionable MRSA at the site. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 19-JUN-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). The date of the first vaccine as not reported. Concomitant therapy included Havrix. It was further noted that the patient received the Havrix on the same day, in the same arm. On approximately 19-JUN-2007 the patient experienced a rash that was red and hard around the injection site was well as hives. The patient was treated with Benadryl. The patient's outcome was not reported. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 2 year old male who in approximately 2006 "about a year ago" was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced chickenpox (broke into lesions). Medical attention was not sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 10 year old female with an allergy to Vantin who on 11-MAY-1999 was vaccinated with a dose varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a rash 2 weeks after vaccination, on approximately 24 MAY 1999. The nurse did not see the rash but the patient's mother said the rash was like chicken pox like sores and itchy. Medical attention was sought. The patient recovered on an unspecified date. No product quality complaint was involved. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 9 year old female who on 21-APR-1999 was vaccinated SC with a first dose of varicella virus vaccine live (Oka/Merck). On 13-May-2007, the patient experienced a bad breakthrough case of herpes zoster around C2-C4. The patient was treated with a dose of Bactroban in combination therapy with a dose of Zovirax. At the time of the report the patient's status was recovered. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning two female children 4 to 6 years of age who were vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced redness, pain and swelling at the injection site. Additional information has been requested. This is one of several reports from the same source.
Age: 15.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a nurse concerning several patients who were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot #s 657403/0715U and 657404/0592U). The nurse reported that several patients came back to the office complaining of fever and red "knot" at the injection site. The patients outcome was not reported. There was no product quality complaint involved. Additional information has been requested. Follow-up information received stated that this Caucasian 15 year old male patient with an allergy to cefixime (SUPRAX) received a second subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot # 657403/0715U) in the right arm on 22-JUN-2007. Concomitant vaccine administered on the same day included an intramuscular first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Lot # U2331AA) in the in the left arm. there was no illness at the time of vaccination. The patient developed a silver dollar sized knot, warm to touch with a swollen arm. No medical attention was sought. Subsequently, the patient recovered.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 4 year old white male weighing 43 lbs and 41 inches in height who on 06-FEB-2007 was vaccinated subcutaneously with the second dose of varicella virus vaccine live (Oka/Merck) (lot# 654030/0913F). There was no concomitant medication. On 25-JUN-2007 the patient developed moderate to severe case of chicken pox. The patient sought unspecified medical attention. The patient was treated with acyclovir. The patient was recovering. There was no product quality complaint. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a medical assistant concerning a 30 year old female who received two injections of varicella virus vaccine live (Oka/Merck). Subsequently the patient did not develop an immunity as evidenced by failed serological testing. No adverse symptoms were reported. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: FLUX, VARCEL
Symptoms: Influenza, Varicella post vaccine
Clinical narrative: Information has been received from a female patient with a history of cervical cancer who was vaccinated with varicella virus vaccine live (Oka/Merck) at a free clinic several years ago and had a breakthrough of varicella. Concomitant vaccine included influenza virus vaccine (unspecified). The patient also developed the flu after receiving the flu vaccine. Unspecified medical attention was sought. The caller could not provide any additional information at this time. No product quality complaint was involved. No further information is available.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a company representative concerning a 6 year old male relative who was vaccinated with varicella virus vaccine live (Oka/Merck) and subsequently the patient "broke out with chickenpox after getting varicella virus vaccine live (Oka/Merck)". The number of lesions was unknown. The lot number was not provided. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAP, HBHEPB, MMR, PNC, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site vesicles, Rash morbilliform
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning a 12 month old white female, with no pertinent medical history, drug reactions or allergies, who on 14-JUN-2007 at 10:50 was vaccinated subcutaneously in the left thigh with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck) ( lot # 656823/0305U). Concomitant therapy included a fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (TRIPEDIA) (lot # C2569AA) given in left thigh, a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) given in the left thigh. Additional suspect vaccinations include a third dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (MSD) (Lot#654537/0500F) given in the right thigh and a first dose of measles virus vaccine live (Enders-Edmonston) (-) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot#655270/1409F) given in the right thigh. Illness at the time of vaccination included bilateral serous otitis. On the morning of 28-JUN-2007 the patient's mother discovered "rashes" on the patient. The patient developed a red area, that was approximately 1.5 cm in diameter (previously reported as bigger than a nickel but smaller than a quarter) on her left thigh (at or near the injection site). There were 3 fluid filled vesicles within this red area. The patient also had morbilliform (previously reported as billiform) rash over the upper trunk extending into the diaper area (sparing the rest of the body). Medical attention was sought. There were no lab studies performed. At the time of the initial report the patient had not recovered. In follow up it was noted that the patient's status was unknown. Additional information is not expected
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician's assistant concerning a 12 month old patient who in June 2007, was vaccinated with varicella virus vaccine live (Oka/Merck). In June 2007, the patient developed a severe case of varicella, at which time there was also an outbreak of varicella in the patient's community. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Serology negative
Clinical narrative: Information has been received from a physician assistant concerning a 46 year old female who was vaccinated twice with varicella virus vaccine live (Oka/Merck) and subsequently has a negative varicella titer. Subsequent to the vaccinations the patient has had exposure to chickenpox and shingles, but did not develop chickenpox. No adverse symptoms were reported. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 15 month old male who on 18-JUN-2007 was vaccinated subcutaneously in the left thigh with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 657412/0594U). Other vaccinations given on the same day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and Prevnar. On 25-JUN-2007, the patient developed a "rash on the face and hand". On 29-JUN-2007, the patient developed a "rash on the left cheek and dorsal aspect of left hand". The physician reported that "the rash was 6 to 8 red papules on left check and left hand. No vesicles present." The patient recovered. There was no product quality complaint involved. Follow-up information from a health professional indicated that on 25-JUN-2007 the patient developed lesions. He was seen at the office on 29-JUN-2007 and he had 6 to 8 red papule lesions on his left hand and cheek. It was to be atypical chickenpox. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 24-MAR-2003 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot number 641161/0796M). On 30-MAY-2007 the patient experienced chickenpox. No further information is available.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 14-SEP-2000 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot # 657787/0718U). On 30-JUN-2007 the patient experienced local reaction at injection site. No additional information is available.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 9 year old patient who on 29-JUN-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On 29-JUN-2007, the patient developed redness and swelling at the injection site. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 13 year old female, with an allergy to penicillin (Unspecified, who at 12 months of age, in approximately 1995, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck), and subsequently developed a varicella like rash. The patient was vaccinated at a practice unrelated to the reporter; therefore a further description of the rash and lot number is unavailable. The patient recovered on an unspecified date. There was no product quality complaint. Additional information has been requested.