chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Pyrexia, Skin lesion
Clinical narrative: Information has been received from a certified medical assistant concerning her 12 month old son with no known allergies and asthma who on 17-JUN-2003 was vaccinated with a dose of Varivax (lot # "0018M"). Concomitant therapy included a dose of HIBTITER. One week after vaccination, on 27-JUN-2003 the patient developed 5 lesions which cleared in a week. During this time period the patient also had a fever of 101.7F. The patient then developed three more lesions that also cleared in a week. Unspecified medical attention was sought. It was reported that all of the lesions were on the patient's legs or trunk. The patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted 05/16/2007. Information has been received from a certified medical assistant concerning her 12 month old son with no known allergies and asthma who on 17-JUN-2003 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot # "0018M"). Concomitant therapy included a dose of (HIBTITER) (CRM197). One week after vaccination, on 27-JUN-2003 the patient developed 5 lesions which cleared in a week. During this time period the patient also had a fever of 10.7F. The patient then developed three more lesions that also cleared in a week. Unspecified medical attention was sought. It was reported that all of the lesions were on the patient's legs or trunk. The patient recovered. Therer was no product quality complaint involved. No further information was provided. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: Information has been received from a nurse practitioner through the Merck pregnancy registry concerning a female who was vaccinated with Varivax. Subsequently the patient experienced an unspecified "pregnancy adverse event." Unspecified medical attention was sought. It was reported that the nurse practitioner would call with additional information. At the time of this report, no additional details were available. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Rash, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white female with no known drug allergies, no hospitalizations or surgeries and no significant past medical history, who on 16-MAY-2001 was vaccinated with a dose of Varivax. It was unknown if there was illness at the time of vaccination. On 06-FEB-2007 the patient was noted to be itching her back and her mom saw several red very pruritic lesions with vesicles appearing in the center. When bathing the patient, her mother noted that the rash had spread across her chest and abdomen and was spreading to her extremities and face. Most of the lesions were scratched open with only a few lesions with vesicles noted. On the same day the patient presented to the emergency department. The physician noted that there were multiple scattered round red lesions on her back, chest and abdomen with the central area appearing to be vesicles or scratched open with previous vesicles present. The physician reported that the the lesions had a pox lesion appearance. It was reported that there were no lesions in the patient's ears or mouth. There was no secondary cellulitis noted. The patient was diagnosed with a pruritic viral exanthema: probable chickenpox/varicella rash. The patient was treated with a 25 mg po dose of BENADRYL and instructed to continue with BENADRYL 25 mg q6 hours for itching. The patient was also instructed to use CALAMINE LOTION and AVEENO bath for comfort. There was a reported outbreak of chickenpox at the patient's school "several weeks" prior to the patient's presentation to the ED. It was reported that the patient recovered on 06-FEB-2007. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female who on 27-JAN-1999 was vaccinated in the left thigh with a first dose of Varivax (lot # 626767/0668H). On 05-FEB-2007 the patient developed chickenpox. It was reported that the patient had less than 50 lesions with blisters on the chest, under her arms and on her legs. No further information was provided. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 75 year old patient (gender not reported) who was vaccinated with one dose of Varivax instead of Zostavax. Product confusion was ruled out, nursing error. Patient did not report any adverse events. There was no product quality complaint. Follow up information obtained from the physician indicated that there were no product confusion. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature normal, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female with asthma who on 10-APR-21002 was vaccinated SC with a 0.5 ml dose of Varivax (638931/1144L). Concomitant therapy included ADVAIR and montelukast sodium. On 01-FEB-2007 the patient experienced 20 lesions on her back and 2 lesions on her face with a temperature of 100F. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 02/11/2010 Follow up information has been received from the physical who reported that the patient presentd to the office on 01-FEB-2007 with a low grade temp of 100 degrees and varicella rash. The physician reported that patient received symptomatic treatment icluding calamine and baking soda. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 12 month old female who in 1999, at 12 months of age, was vaccinated with Varivax. On 12-FEB-2007 the patient developed 'breakthrough". The final outcome was unknown at the time of this report. It is unknown if medical attention was sought. There was no product quality complaint. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a pediatric office concerning a 7-year-old male who on 10-AUG-2001 was vaccinated with a dose of Varivax. Subsequently, on 01-FEB-2007 the office received a call that the patient had a rash with 3 small, red spots that were not itchy. It was noted at that time that the patient was prone to dermatitis, experienced chickenpox. Subsequently, the patient recovered from chickenpox. On 02-FEB-2007, the office received another all; the patient was complaining of pink papules over her arms, legs and trunk though they were not itchy. He was seen in the office and was diagnosed with chickenpox. It was noted that some of the papules were crusted over on his stomach, arms and legs. There were approximately 50 lesions. It was reported that the patient recovered on an unspecified date. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 10 year old white female who on 19-DEC-1997 was vaccinated SC in the right arm with a first dose of Varivax (lot # 624064/0810E). Nine years after vaccination, on 09-JAN-2007 the patient developed varicella. No further information was provided. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with no known allergies or medical history who on 02-DEC-1999 was vaccinated SC with a first dose of Varivax (lot # 630683/0439J). There was no illness at the time of vaccination. There was no concomitant medication. On 12-FEB-2007, the patient presented to the office with chickenpox. There were 50 to 75 scattered papules with pimple-like centers, and right posterior auricular lymph node. Symptomatic treatment was provided. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that on 12-FEB-2007, the patient was seen in the office with a one day history of 50 to 75 scattered red papules. There were no clear blisters or vesicles. The right posterior lymph node was over riding the mastoid bone and was palpable and tender but not red, warm or swollen. The patient recovered on 15-FEB-2007. No further information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health care worker concerning a 10-12 year old male who in approximately 1996 was vaccinated with Varivax. Recently, the patient experienced chicken pox breakthrough. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with no known allergies or pertinent medical history who on 19-JAN-2007 was vaccinated SC with a "standard" second dose of Varivax. There was no concomitant medication. About a week after vaccination, on approximately 26-JAN-2007 the patient had a local reaction at the site of injection. The patient's symptoms included a golf ball sized welt which was warm and tender to the touch. Medical attention was not sought, lab studies were not performed. On an unspecified date the patient's symptoms subsided and she recovered. There was no product quality complaint involved. No additional information was provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Pyrexia, Varicella
Clinical narrative: Information has been received from a consumer concerning her 11 year old grandson who in approximately 2001, "sometime around the age of five years old" was vaccinated with a dose of Varivax (Merck) for the prevention of chicken pox. The consumer reported she was told by her daughter that her grandson developed a mild form of chicken pox after receiving the vaccine, "three weeks ago." The grandmother reported that the patient developed a fever of 103 degrees at first before developing the chicken pox. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The reporter noted that the patient was "over it two weeks ago" (on an unspecified date in February 2007). A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from the grandmother indicating that "her grandson got a light case of chicken pox. He had got vaccine when he was younger. He had low fever and some sores, not adverse. He missed school for 5 days due to fever and scabs. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 10 year old patient who was vaccinated with a 0.5ml dose of Varivax. Subsequently, a couple of years after receiving the vaccine, the patient experienced breakthrough chickenpox. It was unknown how many lesions the patient developed. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.19
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a male with no prior drug reactions and with asthma who on 22-FEB-1998, was vaccinated with a 0.5 mL Varivax (Lot #626399/0654H). Concomitant therapy included FLONASE, ADVAIR, CLARITIN. Subsequently, after receiving Varivax, the patient developed chickenpox lesions. Unspecified medical attention was sought. As of 15-FEB-2007, the lesions were less than 30 and the patient was not recovered. The patient's chickenpox lesions persisted. Additional information has been requested. 02/11/2010 Follow up information indicated that on 15-FEB-2007 the patient developed chickenpox. The patient recoverd. There were no relevant diagnositic tests or laboratory data. It was noted that the patient's sibling developed chickenpox on 01-FEB-207 at 12 years of age (WAES # 071USA043411). No additional information is expected.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Rash, Rash papular, Skin nodule
Clinical narrative: Information has been received from a physician concerning a 6 year old female, with no pertinent medical history, drug reactions or allergies, who on 20-MAR-2002 was vaccinated subcutaneously with Varivax (lot number 641268/1295L). On 19-February-2007 the patient presented with a rash which began 13-February-2007. The rash, which was papular, extended from the right elbow to her fingers. The rash was not vesicular in nature, but had three areas of distinct indurated nodules, with three to five nodules in each area. The rash was reportedly painful. The patient was treated with prednisone and hydroxyzine hydrochloride. There was no concomitant therapy. The patient was recovering at the time of this report. Lab diagnostics were not performed. There was no product quality complaint. Additional information has been requested.
Age: 1.16
Sex: M
Vaccine: VARCEL
Symptoms: Attention deficit/hyperactivity disorder, Pityriasis rosea, Pyrexia, Rash papular, Varicella
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 9-year-old male with attention deficit disorder, who on 25-MAR-1999 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (Oka/Merck). There was no concomitant medication. On 13-FEB-2007 the patient developed 75-100 scattered raised red papules on his back, chest, upper legs and groin area. It was reported that he did not have a fever or any other symptoms. The patient was seen by a physician. No laboratory or diagnostic test were performed and the physician diagnosed the patient with atypical varicella or pityriasis. The patient recovered on 20-FEB-2007. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male who was vaccinated with the second dose of Varivax (Oka/Merck). Subsequently within days after being give the second dose the patient experienced injection site irritation including swelling, redness and warmth in a six inch area surrounding the injection site. Also, he had raised bumps at the injection site. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Rash vesicular
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 5-year-old female who on 27-AUG-2002 was vaccinated subcutaneously with a 0.5 ml Varivax (Oka/Merck) (lot number reported as "1294C"). No concomitant medications were given. On 02-FEB-2007 the patient developed vesicles on her neck and back. It was reported that the child had been exposed to varicella at school. The patient recovered within a week, on 09-FEB-2007. The incident was described as "uneventful illness". Additional information is not expected.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female who on 12-JUN-2001 was vaccinated with the first SQ dose of Varivax (Oka/Merck) (Lot #634498/0089L). There was no concomitant medication. On 02-FEB-2007, the patient was seen in the doctor's office. The mother stated the child had a fever 2 weeks ago. On 02-FEB-2007, the patient experienced vesicles on back, trunk, face and thighs. On an unspecified date, the patient recovered from vesicles on back, trunk, face and thighs and fever. No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Nasopharyngitis, Pyrexia, White blood cell count
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who was vaccinated with his second dose of Varivax (Oka/Merck). Subsequently, two days post vaccination, the patient developed a fever and cold symptoms. The patient was taken to an emergency room and blood was drawn. The patient's white blood cell count was "low, but was still within normal limits." The patient was not hospitalized. The registered nurse indicated that the patient had never experienced an adverse event post vaccination with any vaccines prior to this vaccination. The product quality complaint unit was not involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Full blood count, Lyme disease, Pyrexia
Clinical narrative: Information has been received from a mother of triplets who reported that two of her triplets have received the second dose of Varivax (Oka/Merck) and have experienced low grade and persistent fevers that spike at night. The following is regarding one of the triplets, a 7 year old female, who on 26-JAN-2007 was vaccinated with Varivax (Oka/Merck) in her arm (unknown which arm or specific route). There was no concomitant medication or medical history. On 01-FEB-2007, six days after receiving Varivax (Oka/Merck), the patient experienced low grade fever and persistent fevers that spike at night. The highest the fever had been was 103 degrees F. The fevers have been ongoing for 22 days. The child has been on (cefdinir) OMNICEF since 18-FEB-20007, but is still experiencing fevers. On 22-FEB-2007, the patient underwent laboratory evaluation which included a CBC and Lyme disease test (results not provided). The patient's sister also experienced an adverse event (WAES # 0702USA04021). Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Chills, Full blood count, Laboratory test, Pyrexia
Clinical narrative: Information has been received from a mother of triplets who reported that two of her triplets have received the second dose of varicella virus vaccine live and have experienced low grade and persistent fevers that spike at night. This report is concerning one of the triplets, a 7 year old female with no known medical history or allergies who on 26-Jan-2007 was vaccinated with varicella virus vaccine live  (Oka/Merck) in her arm. (unknown which arm or specific route). There was no concomitant medication. On 02-FEB-2007 or 03-FEB-2007 the patient experienced a low grade fever. The highest the fever has been was 101-102 degrees F. the child had also experienced chills and can't get warm. The fevers have been going on for 18 to 19 days now. On 22-FEB-2007, the patient underwent laboratory evaluation which included a CBC and Lyme disease test (results not provided). Additional information has been requested. The sister's experience following vaccination is discussed in WAES #0702USA04015.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin lesion, Swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 55 year old female who on 26-JAN-2007 was vaccinated with a dose (0.5 ml) of varicella virus vaccine live (lot # 654083/0917F) (Oka/Merck). There was no concomitant medication. On Approximately 30-JAN-2007, "about four days after receiving injection" the patient experienced redness and swelling. On 16-FEB-2007 the patient experienced broke out with 50 or less lesions after receiving varicella virus vaccine live. the patient's redness and swelling and lesions persisted. unspecified medical attention was sought. there was no product quality complaint. Follow-up information received from the registered nurse indicating that the patient's age is actually 55 years old. No further information available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Herpes zoster, Rash macular, Skin lesion
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 year old female with no allergies or medical history who on 04-SEP-2001 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus live (Wister RA 27/3) (Oka/Merck) (MSD). Over five years later, on 20-FEB-2007 the patient developed shingles on the left arm. She initially presented with one lesion and the lesions have progressed to multiple macular clustered vesicles from her shoulder to the hand. Unspecified medical attention was sought. The patient was being treated with acyclovir (Zovirax). No diagnostic laboratory tests were performed. The patient's shingles persisted. A product quality complaint was not involved.  Additional information has been requested. This is an follow-up to report(s) previously submitted on 5/16/2007. Information has been received from a certified medical assistant concerning a 6 year old female with no allergies or medical history who on 04-SEP-2001 was vaccinated SC with a 0.5 mL dose of VARIVAX (Merck) (lot #639128/0567L). Concomitant vaccination included a dose of MMR II (lot # 639570/0698L). Over five years later on 20-FEB-2007 the patient developed shingles on the left arm. She initially presented with one lesion and the lesions have progressed to multiple macular clustered vesicles from her shoulder to the hand. Unspecified medical attention was sought. The patient was being treated with ZOVIRAX. No diagnostic laboratory tests were performed. Subsequently the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a male, who was vaccinated with varicella vaccine, live (Oka/Merck). Subsequently the patient developed breakthrough chickenpox, approximately 50 lesions. Unspecified medical attention was sought. No other information was provided at the time of this report. There was no product complaint. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse reaction
Clinical narrative: Information has been received from a physician concerning an unidentified patient who was vaccinated with varicella vaccine live (Oka/Merck); instead of varicella-zoster vaccine (Oka/Merck) Varivax. There was no adverse event. It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Incorrect route of drug administration, Pruritus, Scab, Skin lesion
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 9 year old male with a concurrent condition of attention Deficit Hyperactivity Disorder (ADHD), with no reported drug reaction or allergies, who on 24-November-1998 was vaccinated with a first 0.5 ml dose intramuscularly with Varivax (Lot Number 626959/0846H). Concomitant therapy that day included a first MMR II, which was also administered on 24-November-1998, and dexmethylphenidate hydrochloride (FOCALIN) and atomoxetine hydrochloride (STRATTERA). On 21-February-2007, the patient developed chickenpox, including red lesions on the chest and back, along with a temperature of 101 F. The patient's was not recovered at the time of this report. Unspecified medical attention was sought. Follow up information indicated that on 21-FEB-2007 the patient developed red lesions on his chest and back for one week. There were scabbing over and his skin was sensitive and itching. He was treated with acyclovir 400mg TID. The outcome was recovered. The reporter considered the event to be an other important medical event. There was no product quality complaint. No additional information is expected.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 9 year old male with a concurrent condition of attention Deficit Hyperactivity Disorder (ADHD), with no reported drug reaction or allergies, who on 24-November-1998 was vaccinated with a first 0.5 ml dose intramuscularly with Varivax (Lot Number 626959/0846H). Concomitant therapy that day included a first MMR II, which was also administered on 24-November-1998, and dexmethylphenidate hydrochloride (FOCALIN) and atomoxetine hydrochloride (STRATTERA). On 21-February-2007, the patient developed chickenpox, including red lesions on the chest and back, along with a temperature of 101 F. The patient's was not recovered at the time of this report. Unspecified medical attention was sought. Follow up information indicated that on 21-FEB-2007 the patient developed red lesions on his chest and back for one week. There were scabbing over and his skin was sensitive and itching. He was treated with acyclovir 400mg TID. The outcome was recovered. The reporter considered the event to be an other important medical event. There was no product quality complaint. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse reaction
Clinical narrative: Information has been received from a medical assistant concerning a patient who on 29-JAN-2007 was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot number 655066/1143F), instead of a dose of zoster virus vaccine live (Oka/Merck). The error was reportedly not due to product confusion. There was no adverse experience related to this event. It is unknown if medical attention was sought. The patient's present status was unknown at the time of the report. There was no product quality complaint.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning her 6 year old daughter, who in 2002 at the age of one, was vaccinated with varicella virus vaccine live (Oka/Merck). In September 2006, her daughter developed a mild breakthrough of chickenpox. Her lesions were located on her shoulder and genital area, .accompanied by a low grade fever. Unspecified medical attention was sought. The nurse reported that chicken pox was going around at the local school. There was no product quality complaint. It was also noted that the patient's two sisters developed after vaccination with varicella virus live (Oka/Merck) (WAES#0703USA00658 and WAES#0703USA00659)
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Lethargy, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 2 year old female who on 22-FEB-2007 was vaccinated intramuscularly with 0.5 mL varicella virus live (Oka/Merck) (Lot # 653307/0439F). The patient received the first dose of varicella virus vaccine live (Oka/Merck) IM instead of subcutaneously. The patient's mother reported that the patient developed redness on the belly, back and arms the afternoon after the vaccination with varicella virus live (Oka/Merck). The patient was lethargic that night and had a fever of 100 degrees Fahrenheit.  The mother was advised to give the patient therapy with diphenhydramine hydrochloride (BENADRYL). No lab diagnostic studies were performed. On 23-FEB-2007 the patient was reported to be "much better," but the condition of the redness was unknown (also reported patient had not recovered). Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a liscensed practical nurse concerning a 5 year old female who on 23-JAN-2004 was vaccinated with varicella virus vaccine live (Oka/Merck). within the last week (February 2007), the patient experienced a breakthrough with the varicella virus vaccine live. The patient developed more than 50 lesions three years after getting the varicella virus vaccine live administered to her. The outcome of the breakthrough was not provided. There was no product quality complaint. unspecified medical attention was sought. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information was received from a physician concerning his son with no pertinent medical history, who previously, at 15 months of age was vaccinated with his first dose of varicella virus vaccine, live (oka/Merck0. Subsequently the child experienced a 1 centimeter ring of vesicles around the injection site. the physician did not consider the event to be serious because the child did not experience fever or other symptoms. The child was recovered at the time of the report. No further information was provided. There was no product quality complaint
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a teenage patient who was vaccinated with a second dose of varicella virus live (Oka/Merck). On approximately 16-FEB-2007, the patient experienced a reaction at the injection site". The nurse reported that the area felt hot and had redness and swelling. There was no product quality complaint. The patient's status was not reported. Additional information will be provided if available.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information was received from a nurse practioner concerning a patient, who was vaccinated with varicella virus live (Oka/Merck). Subsequently the patient developed chicken pox five days after being administered the vaccine. The status of the patient was unknown at the time of this report. it is unknown if medical attention was sought. There was no product quality complaint.
Sex: F
Vaccine: VARCEL
Symptoms: Diabetes mellitus
Clinical narrative: Information has been received from a physician concerning his daughter, with no unusual medical history, who has vaccinated many years ago with varicella virus vaccine live (Oka/Merck). Four weeks subsequent to the vaccination the patient developed diabetes. The patient's mother thought that the diabetes might have been caused by therapy with varicella virus vaccine live (Oka/Merck). The patient has been treated for the diabetes. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 13 year old male, with no prior history of chicken pox nor been vaccinated. A titer was done on 28-January-2007 which showed no immunity. On 05-February-2007 the child was vaccinated subcutaneously at 16:30; with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#654750/1256F). The child had no prior medical history or allergies and no illness at the time of vaccination. The patient developed what was considered to be a mild case of breakthrough ( less than 50 lesions), varicella type rash on 20-FEB-2007 at 17:00. On 21-Februaury-2007 child was seen by the physician, and was said to have new lesions appearing and some crusted over. Unspecified medical attention was sought. There was no product quality complaint. The patient recovered on 01- MAR-2007. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a break through of varicella of less that 50 lesions. Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from the physician who reported that he was not aware of any recent adverse reaction to VARIVAX (Merck). No further information is expected.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a female, "in her 30-40's ", with renal failure and possible lupus, who on 10-JAN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) for a workup for a kidney transplant. On 25-JAN-2007 the patient experienced developed a mild case of chicken pox, about 16 lesions. Subsequently, the patient recovered on an unknown date. Unspecified medical attention was sought. No product Quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from an allergist physician who reported that he was asked to see a female patient who recently received her first dose of varicella virus vaccine live (Oka/Merck) and developed an injection site reaction. There was no rash. the patient sought unspecified medical attention. The physician did not see the patient as of this report and did not know anything else at this time. The patient's family physician administered the vaccine. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a consumer concerning her daughter who was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced site irritation. The consumer did not specify if the patient sought medical attention. As of 28-FEB-2007, the patient's outcome was not reported. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: HEP, HIBV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 12 month old daughter who on 28 DEC 2006 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy that same day included a dose of Hib conj vaccine (OMPC) (manufacturer unknown), hepatitis B virus vaccine rHBsAG (Yeast) (manufacturer unknown), and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) (manufacturer unknown). Approximately two weeks after receiving the vaccines, approximately 11 JAN 2007 the child developed a very swollen lump on her upper left thigh. The child was seen by the pediatrician, it was noted that she developed a cyst, and it was assumed that it was from the vaccines, possibly due to the chicken pox vaccine. The child had received two shots in each leg, and this occurred where the varicella virus vaccine live (Oka/Merck) had been given. The mother was instructed to put compresses on the leg and watch and see if it got bigger. The spot was a 2 X 2 inch area. It did not enlarge, and it did disappear. Additional information has been requested.
Age: 1.53
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a male patient (age not reported) with delayed motor function and a history of gastrooesophageal reflux disease and premature birth at 32 weeks, who on 02-SEPT-2005 was vaccinated subcutaneously on his thigh with the first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck) (Lot#646548/0393R). The nurse reported that after the patient received the first dose of the vaccine on approximately 02-SEP-2005, he developed swelling at the injection site, which was on his thigh (unspecified if left thigh or right thigh). On 22-FEB-2007, the patient was vaccinated subcutaneously in his left arm with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#654610/1049F). There was no concomitant medications. On approximately 22-FEB-2007, the patient experienced swelling and warmth at the injection site. He developed cellulitis to the same arm that was approximately 6 cm x 7 cm. On 27-FEB-2007, the patient's arm was still swollen. The patient sought unspecified medical attention. The patient has been treated with sulfamethoxazole (+) trimethoprim (BACTRIM) and he is recovering. No laboratory diagnostic tests were performed. There was no product quality complaint. Additional information has been requested.2/11/10 Additional information was received from the registered nurse stating that "the patient never came into the office for evaluation description of the adverse event was given to her over the phone by the patient's parent."
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female pediatric patient who was vaccinated subcutaneously with a 0.5 mL dose of varicella virus live (Oka/Merck). On a unspecified date, the patient developed a rash of less that 50 flat lesions, after vaccination. The patient sought unspecified medical attention. The patient's outcome was not reported. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning her 13 year old daughter who in approximately 1999, at 5 years of age, was vaccinated with varicella virus live (Oka/Merck). On 18-February-2007, the patient developed a mild case of chickenpox, with less than 50 lesions and a low grade fever. Unspecified medical attention was sought. the nurse reported that chickenpox was going around at the local school. There was no product quality  complaint. It was also noted that the patient's two sisters developed an adverse event after vaccination with varicella virus live (Oka/Merck) (WAES#0703USA00658 and WAES#0703USA06659). Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning her 10 year old daughter who in approximately 2000, at three years of age, was vaccinated with varicella virus live (Oka/Merck). On 20-February-2007, the patient developed a mild case of chickenpox, with less than 50 lesions and no fever at that time. Unspecified medical attention was sought. The nurse reported that chicken pox was going around at the local school. There was no product quality complaint. It was also noted that the patient's two sisters developed an adverse event after vaccination with varicella virus vaccine live (Oka/Merck) (WAES#0702USA04089 and WAES#0703USA06659). Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male, who was vaccinated with varicella virus vaccine, live (Oka/Merck). Subsequently the patient developed breakthrough chickenpox. It is unknown if medical attention was sought. No other information was provided at the time of this report. There was no product complaint. No further information is available.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female with no drug reactions/allergies who on 07-JUL-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 02-MAR-2007 the patient developed chicken pox on her face and upper body. The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. The patient was reported to be recovering. There was no product quality complaint. Additional information has been requested. Follow-up received 05/23/2008. Follow-up information received from the physician indicating that on 07-Jul-1999, concomitant therapy included measles-mumps-rubella vaccine (MSD), diphtheria toxoid (-) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. On 03-Mar-2007. Previously reported on 02-Mar-2007) there was a pruritic rash on the face and upper body, afebrile, 1 day duration. Patient recovered from the events on 05-Mar-2007. No further information is expected. Information has been received from a physician concerinng a 11 year old female who on 07-July-1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 03-Mar-2007 the patient recovered experienced chicken pox on her face and upper body. Subsequently, the patient recovered from chickenpox on her face and upper body.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Scab, Skin lesion, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no drug reactions/allergies or medical history who on 30-JUL-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 23-FEB-2007 the patient developed breakthrough chickenpox rash after receiving the vaccine. The lesions were multiple tiny vesicles on the base of the trunk and scabs on lower lip and lower abdomen. The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. The patient was recovering. There was no product quality complaint. Additional information has been requested. Follow up information. The registered nurse reported that the patient visited the physician on 27-FEB-2007 and that she had "hives" over body. On exam, the patient presented with multiple vesicles on erythema base of trunk, scab on lower lip and scabbed lesions on lower abdomen. On an unknown date the patient recovered. Follow up information received on 16-MAY-2007 reported that the patient was vaccinated with VARIVAX (Merck) and that she recovered on an unknown date. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no drug reactions/allergies or medical history who on 30-JUL-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 23-FEB-2007 the patient developed breakthrough chickenpox rash after receiving the vaccine. The lesions were multiple tiny vesicles on the base of the trunk and scabs on lower lip and lower abdomen. The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. The patient was recovering. There was no product quality complaint. Additional information has been requested. Follow up information. The registered nurse reported that the patient visited the physician on 27-FEB-2007 and that she had "hives" over body. On exam, the patient presented with multiple vesicles on erythema base of trunk, scab on lower lip and scabbed lesions on lower abdomen. On an unknown date the patient recovered. Follow up information received on 16-MAY-2007 reported that the patient was vaccinated with VARIVAX (Merck) and that she recovered on an unknown date. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female patient in her 60's who on 06-MAR-2007 was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot#652551/1112R) instead of a dose of zoster vaccine live (Oka/Merck). The physician reported that product confusion occurred. The physician also reported that she will most likely wait 1 month and revaccinate patient with zoster vaccine live (Oka/Merck) A product quality complaint was involved. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a registered nurse concerning a 35 year old female who while attending college, in approximately 2001 (5 to 6 years ago) was vaccinated with the first 0.5 mL dose of varicella vaccine live (Oka/Merck). The patient never received a second dose. Titers were recently drawn but results showed that the patient was not seropositive. No adverse event reported. The patient was vaccinated by different provider in a different state. There was no product quality complaint. Additional information has been received frrom registered nursthat the negative titer was an adverse event, therefore WAES # 0703USA00951 is being deleted from our files on varicella virus vaccine live.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a patient who was vaccinated with a dose of varicella virus live (Oka/Merck). The patient was given a prescription to receive zoster vaccine live (Oka/Merck) (MSD) and the pharmacy administered varicella virus vaccine live (Oka/Merck). It was unclear exactly how the error was made and if there was any product confusion. The error was discovered and the patient then received zoster vaccine live (Oka/Merck) (MSD). No problems were reported. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Varivax (Merck). Subsequently, the patient developed 20 to 30 pox. Unspecified medical attention was sought. The outcome was reported as recovered. No additional information to report. There was no product quality complaint involved. Additional information has been requested. No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 9 year old male who on an unknown date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot#654523/1155F). Concomitant therapy was not reported. On an unknown date, the patient received varicella virus vaccine live in the right arm and the skin raised 7" x 8" around the injection site. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 4 year old male with a history of sinus infection who in approximately 2004 was vaccinated with varicella virus live (Oka/Merck) at approximately 1 year of age. On 14-FEB-2007, the patient developed shingles in the mandibular area with 3 separate crops of vesicles on inflamed bases. Unspecified medical attention was sought. The patient was treated with acyclovir (Zovirax). No lab tests were performed. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male pediatric patient who has been vaccinated subcutaneously with 0.5 ml of varicella virus vaccine (Oka/Merck), and subsequently developed a rash. Unspecified medical attention was sought. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning one male pediatric patient who was vaccinated subcutaneously with 0.5 ml of varicella virus vaccine live (Oka/Merck), and subsequently developed shingles. Unspecified medical attention was sought. There was no product quality complaint. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available. Additional information has been requested.