chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer concerning her 11 year old daughter with no drug reations/allergies or pertinent medical history who was vaccinated with varicella virus vaccine live (Oka/Merck) at age 14 months. There was no concomitant medication reported. The patient experienced a mild case of chickenpox which the patient's mother felt might have been due to receiving an unspecified anti-viral. The patient's outcome was not reported. No additional information was available.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning an 8 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 657001/0338U). Subsequently, the patient experienced local injection site reaction about 5-6 centimeters in diameter, raised and very hard to touch. Medical attention was sought. The patient was treated with Benadryl (manufacturer unspecified). Subsequently, the patient recovered from local injection site reaction, raised and very hard to touch. No product quality complaint was involved. Nurse also reported that another 5 patients who are of at least 4 years of age also experienced a similar reaction to their second dose of varicella virus vaccine live (Oka/Merck). Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning an 8 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On 27-JUN-2007 the patient experienced rash at the injection site (patient's thigh). The rash was originally the size of a quarter but eventually spread to the whole thigh. Medical attention was sought. The patient was given benadryl which did not help then steroids (manufacturer unspecified) then the rash went away in couple of days. The patient was recovered. No product quality complaint was involved. Additional information has been requested.
Age: 35.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 35 year old male with no medical history or allergies who on approximately 26-JUN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On approximately 29-JUN-2007, three days after vaccination the patient experienced varicella like rash. The patient was treated with Benadryl. At the time of report the patient was recovering with some lesions remaining. A product quality complaint was not involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: DTAPH, OPV, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning an 11-year-old female with no allergies and a history of eczema who in 1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included TriHIBit and poliovirus vaccine live oral (manufacturer unknown). Three years later, in 2000, the patient developed "a mild case of" chickenpox. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The outcome was reported as recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white female with no pre-existing allergies, or pertinent medical history who on 09-JUL-2001 was vaccinated with a first dose of subcutaneously into the left thigh with varicella virus vaccine live (Oka/Merck) (Lot # 638248/0496L). Concomitant therapy that same day included a first dose, administered subcutaneously into the right thigh, of measles-mumps-rubella vaccine (M-M-R II) (Lot # 638599/0598L). There was no illness at the time of vaccination. On 30-JUN-2007 the patient developed less than 20 lesions on her face and trunk. The lesions did not itch. The patient was without fever, or any signs or symptoms of infection. There were no lab diagnostic studies performed. The patient recovered from less than 20 lesions on face and trunk on 02 JUL 2007. Additional information is not expected.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Information has been received from a physician concerning an 18 month old male with no medical history or allergies who on 06-JUL-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 654525/1041F). Concomitant therapy included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). On 06-JUL-2007, after vaccination the patient developed redness and a welt like area at injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Decreased appetite, Erythema, Pain, Skin reaction, Skin warm
Clinical narrative: Information has been received from a physician concerning a 11 year old male who on 08-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck lot# 656819/0172U). On 09-JUN-2007 the patient's mom had indicated that her son experienced a localized skin reaction, 2 1/2 inch area of skin red and warm. On 10-JUN-2007 the patient was achy and had decreased appetite and no fever. The patient was taken to urgent care and started on Keflex. The patient's mom was to call back for further concerns but never called back. As of 11-JUN-2007, the patient was reported as recovering. No product quality complaint was involved. Additional information is not expected.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Body temperature, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical student concerning one 10 year old patient who was vaccinated with a second 0.5mL subcutaneous dose varicella virus vaccine live (Oka/Merck) (Lot #656923/0451U). The patient developed injection site reaction with redness, swelling, warm and tender to touch that lasted 3-4 days. The patient was afebrile. This patient had a sibling who received the same lot number and did not have a reaction to the second dose. Unspecified medical attention was sought. This is one of three reports received from the same source. The physician is requesting a lot check. A review of the release testing lots revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the center for Biologics Evaluation and Research and was released. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a female who on 25-MAY-2006 was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) 0.5 mL SQ instead of zoster vaccine live (Oka/Merck). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Dermatitis contact, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a nurse concerning an 11 year old 75 lb male with a sulfa allergy who on 06-JUL-2007 was vaccinated with his second dose of varicella virus vaccine live (Oka/Merck) (lot.no 657650/0716U) and Menactra in the R arm and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid in the L deltoid. At the time of the vaccination, the patient had contact dermatitis described as an itchy rash on his trunk and extremities. He was treated with fluocinolone, cool compress, Benadryl, bacitracin and Calamine. On 09-JUL-2007, the patient was seen in follow up of the poison ivy on his face, ear, left finger and arm, R hand, back and under R arm. He also had a 1 1/2 inch circle of induration, redness and some slight tenderness 1 1/2 inches below the varicella injection site of his R arm, which occurred on 08-JUL-2007. The patient's poison ivy and injection site induration, redness and tenderness persisted (in follow up, the outcome was reported as unknown). He was prescribed oral prednisone for the contact dermatitis but it was discontinued on 12-JUL-2007 due to behavioral side effects. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old male who on 30-Jan-1996, was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot# unspecified). A booster dose of varicella virus vaccine live (Oka/Merck) was administered on 22-May-2007 (lot# 656692/04572U). There was no concomitant medication. The nurse reported that the patient experienced bump on the upper right arm which was diagnosed as cellulitis after booster dose. Injection site warm, red, tender, no pus and inflamed. After having used cold compresses and Motrin to relieve the symptoms, the patient was ordered on Keflex. The patient's status was reported as unspecified. No product quality complaint was involved.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old white female who on 06-JUN-2000 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot#). There was no concomitant medication. On 08-JUN-2007 the patient was diagnosed with varicella. No further sequel symptoms were reported. Subsequently, on 15-JUN-2007 the patient recovered from varicella. No further information is available.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 10 year old patient who at 15 months of age, in approximately 1998, was vaccinated with varicella virus vaccine live (Oka/Merck). Two months post vaccination, in approximately 1998, the patient developed chickenpox.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 7 year old patient who at one year of age, in approximately 2001, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). At six years of age, in approximately 2006, the patient developed shingles. The patient subsequently recovered on an unspecified date. At the time the patient was scheduled to received a "booster dose," the patient's parent informed the physician of the prior event. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Dermatitis diaper, Erythema, Rash papular, Scab, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 15 month old female who on 18-JUN-2007 was vaccinated subcutaneously in the left quadricep 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 pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR). On 27-JUN-2007 (as reported by her mother) the patient developed a pimple like diaper rash. The physician reported the AE as "multiple red lesions in diaper area in different stages. Some scabbed over and other appeared to have fluids." The patient recovered. Follow-up information from a health professional indicated that on 29-JUN-2007 the patient developed red papules with fluid and crusting lesions on her diaper area. It was reported 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: 1.3
Sex: F
Vaccine: DTAP, PNC, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 15 month old female who on 18-JUN-2007 was vaccinated subcutaneously in the left quadricep 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 pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR). On 27-JUN-2007 (as reported by her mother) the patient developed a pimple like diaper rash. The physician reported the AE as "multiple red lesions in diaper area in different stages. Some scabbed over and other appeared to have fluids." The patient recovered. Follow-up information from a health professional indicated that on 29-JUN-2007 the patient developed red papules with fluid and crusting lesions on her diaper area. It was reported 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: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7-year-old female with no pre-existing allergies, birth defects, or medical conditions, who on 27-SEP-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There were no illnesses at the time of vaccination. On 01-JUL-2007, the patient went to the doctor's office with chickenpox lesions all over that were itchy. No laboratory or diagnostic tests were performed. On 09-JUL-2007, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Headache, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 10-year-old female with drug allergies to sulfa, Zithromax and amoxicillin, who on 23-SEP-1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There were no illnesses at the time of vaccination. On 26-JUN-2007, the patient come to the office with her mom and presented with headache and a rash on her trunk and face which had about 20 papules, some clustered, on an erythematous base. No laboratory or diagnostic tests were performed. On 09-Jul-2007, the patient recovered. This is one of several reports from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pruritic, Skin lesion
Clinical narrative: Information has been received from a registered nurse (RN) concerning an 11-year-old white female student, with no pre-existing birth defects, medical conditions, or adverse events following prior vaccinations, who on 29-JUN-1998 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). At the time of vaccination the patient presented with a sore throat and mild lymphadenopathy. On 01-JUL-2007 the patient experienced a rash from the scalp to the trunk that was very itchy and had a duration of one day. It is reported that there were 20 lesions in various stages. The patient was afebrile. It was reported in WAES# 0707USA01595 that all other "sibs" had chickenpox. It was unknown if medical attention was sought. No laboratory or diagnostic tests were performed. It is reported that the patient recovered on 09-Jul-2007. The RN also reported that four of the patient's siblings developed chicken pox following varicella virus vaccine live (Oka/Merck) administration (WAES:, 0706USA04088, 0707USA01593, 0707USA01594, 0707USA01595). This is of several reports from the same reporter. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an 8-year-old female with no pre-existing allergies, birth defects or medical conditions who on 22-JUL-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 29-JUN-2007, the patient developed various lesions on her back and legs that had a 4 day duration. There were approximately 15 lesions in various stages. The patient was afebrile. There were no other symptoms. It was reported on WAES# 0707USA01595 that all other "sibs" have had chickenpox. It is unspecified if medical attention was sought. No laboratory or diagnostic tests were performed. The patient recovered on 09-JUL-2007. The patient had no adverse events following prior vaccinations. The R.N. also reported four of the patient's siblings developed chickenpox following varicella virus vaccine live (Oka/Merck) WAES numbers: 0706USA04088, 0707USA01591, 0707USA0194, 0707USA1595). This report is one of several reports from the same source. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 6-year-old female with no pre-existing allergies, birth defects or medical conditions, who on 08-JUL-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 02-JUL-2007, the patient developed over 50 lesions and had a temperature of 99-100 degrees. The mom was treating with Tylenol. The mother called the office and stated that the "brother had chickenpox 2 weeks ago." No laboratory or diagnostic tests were performed. No medical attention was sought. On 09-JUL-2007 the patient recovered. The R.N. also reported that four of the patient's siblings developed chickenpox following varicella virus vaccine live (Oka/Merck) administration (WAES numbers: 0706USA04088, WAES0707USA01591, 0707USA01593, 0707USA01595). This is one of several reports from the same reporter.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 6-year-old white female with no pre-existing allergies, birth defects, or medical conditions who on 08-JUL-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 04-JUL-2007 the patient's mother called and stated that all of the patient's siblings had chickenpox, and now the patient has a few lesions. The patient was afebrile. No medical attention was sought. No laboratory or diagnostic tests were performed. On 09-Jul-2007 the patient recovered. This is one of several reports from the same reporter. The RN also reported that four of the patient's siblings developed chicken pox following varicella virus vaccine live (Oka/Merck) administration (WAES numbers: 0706USA04088, 0707USA01591, 0707USA01593, 0707USA01594). Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old retired female with no drug allergies who had an initial outbreak of herpes zoster about 6 months ago who on 10-JUL-2007 was vaccinated with a 0.5mL SC dose of varicella virus vaccine live (Oka/Merck) (lot # 656078/0169U) in the deltoid instead of zoster vaccine live (MSD). There was no illness at the time of vaccination. The wrong vaccination was given because of a "staff error." No adverse event was reported. Unspecified medical attention was sought. No lab diagnostic studies were performed. The patient's recovery status was unknown. Additional information has been requested. Follow-up information received from a registered nurse stated that this was a medication error. She stated that it had nothing to do with the packaging or storage conditions or indications. She stated it was caused by the healthcare professional doing insufficient checks. She reported that the patient did not have any concurrent conditions such as being immunocompromised or receiving chemotherapy or corticosteroids.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date in 2007 the patient developed chickenpox after being exposed to another child who was vaccinated with varicella virus vaccine live (Oka/Merck) on 21-APR-1999, developed shingles. 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: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient with no medical history who on 29-MAY-2007 was vaccinated with one 0.5ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot #657195/0366U). Concomitant vaccines administered included routine vaccinations for a one year visit. The patient developed a breakthrough case of chicken pox. Additional information has been requested.
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: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a male patient who on 11-JUL-2007 was vaccinated with .68cc of varicella virus vaccine live (Oka/Merck) (654754/1333F) instead of zoster vaccine live (Oka/Merck). No adverse experience and no symptoms were reported. The nurse mentioned that the event was not a case of product confusion and instead was a result of human error. No further information was available. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a healthcare professional stated that when he went to grab the male patient's vaccine, he was rushing and didn't pay as much attention to it as he should have. The office kept both vaccines in the same freezer and he saw the varicella wording on the vaccine and grabbed the wrong one. The patient did not have an adverse event. The patient was in the office yesterday, on 23-AUG-2007 and received the zoster vaccine live (Oka/Merck).
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Rash
Clinical narrative: Information has been received from a medical assistant concerning a male who on approximately 25-JUN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a rash and headache. Details about the rash and the timing of the onset of symptoms is unknown. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a female who on an unspecified date, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 02-JUL-2007, the patient experienced a rash with less than 50 lesions. On 07-Jul-2007, the rash and lesions were all scabbed over and the event was considered to be mild-per a telephone conversation with the mother and the doctor's office. It was unspecified if medical attention was sought. Follow-up information indicates that no laboratory or diagnostic tests were performed. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 34 month old white female with no pertinent medical history or allergies, who on 30-AUG-2004 in the afternoon was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck) (Lot# 647763/0191P) in the left lower arm. There was no concomitant medication. On 11-JUL-2007 the patient developed shingles involving the left arm. Unspecified medical attention was sought. No labs were performed. Subsequently the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 7 year old male who on 17-JUL-2007 at 14:15 PM was vaccinated SC on right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657109/0444U). It was reported that on 19-JUL-2007, the patient developed injection site reactions involving redness, swelling and induration. Additional information has been received from the licensed visiting nurse who stated patient had injection site pain and swelling on 19-JUL-2007. Additional information has been received from licensed visiting nurse who stated the patient experienced redness and swelling at injection site and had some pain. At the time of report the patient had recovered. No further information is expected. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with varicella virus vaccine live (Oka/Merck) and developed a severe local injection site reaction after receiving the vaccine. No further information was provided. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with the first SC dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed outbreak of chickenpox. Unknown medical attention was sought. Unknown patient outcome status reported. No product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
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 developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days." There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #656262/1497F). Two weeks after vaccination the patient developed redness and a papule at the injection site. The papule was confirmed to be chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, 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 21-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.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a Nurse concerning a female who on 22-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot # 656923/0451U). On 22-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.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a female who on 21-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" 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.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test abnormal, Immunology test normal, Injection site erythema, Lethargy, Pyrexia
Clinical narrative: Information has been received from a physician concerning her son (age not reported) who is allergic to Motrin and has a history of asthma, gastritis, pyloric stenosis and failure to thrive as an infant, who approximately "two years ago" was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). The physician and mother reported that on approximately 10-JUL-2007 at 15:30, her son was vaccinated in the left upper arm with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# not reported) and within 24 hours the child vomited. On approximately 11-JUL-2007 at night the child had fever, 103F, and generalized rash all over the body, especially trunk and upper extremities, small red papules. In addition, the child had a 2 or 3 centimeter red patch at the injection site. It was reported that the child is lethargic and was being treated with Tylenol and hydrocortisone cream on the skin. It was also noted that when the child received the first dose of varicella virus vaccine live (Oka/Merck), he had broken out with vesicles on his leg. The physician and mother reported that her son is extremely allergic to ibuprofen and she thinks the rash is due to hypersensitivity. The patient sought unspecified medical attention. The patient's status was reported as not recovered. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular, Vomiting
Clinical narrative: Information has been received from a physician concerning her son (age not reported) who is allergic to Motrin and has a history of asthma, gastritis, pyloric stenosis and failure to thrive as an infant, who approximately "two years ago" was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). The physician and mother reported that on approximately 10-JUL-2007 at 15:30, her son was vaccinated in the left upper arm with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# not reported) and within 24 hours the child vomited. On approximately 11-JUL-2007 at night the child had fever, 103F, and generalized rash all over the body, especially trunk and upper extremities, small red papules. In addition, the child had a 2 or 3 centimeter red patch at the injection site. It was reported that the child is lethargic and was being treated with Tylenol and hydrocortisone cream on the skin. It was also noted that when the child received the first dose of varicella virus vaccine live (Oka/Merck), he had broken out with vesicles on his leg. The physician and mother reported that her son is extremely allergic to ibuprofen and she thinks the rash is due to hypersensitivity. The patient sought unspecified medical attention. The patient's status was reported as not recovered. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old white female with no drug allergies or pertinent medical history, who on 30-SEP-1996 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (Lot # 617219/0250D) into the left thigh. There was no illness at the time of vaccination. On 03-JUL-2007 in the morning, the patient developed 10 to 12 skin lesions on the face, neck, trunk, and arms. Medical attention was sought via doctor visit. No diagnostic studies or lab tests were performed. The patient was treated with oatmeal (AVEENO) and diphenhydramine HCL (BENADRYL). Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Blood human chorionic gonadotropin, Culture urine positive, Drug exposure during pregnancy, HIV test negative, Syphilis test
Clinical narrative: Information has been received through the Merck pregnancy registry from a nurse practitioner concerning a 20 weeks pregnant 14-year-old female whose last menstrual period was 19-Jun-2007 (she had a full period throughout) with a concurrent condition of asthma and has no known allergies. On 10-JUL-2007 she was vaccinated at an unknown site with a subcutaneous injection of 0.5 milliliters varicella virus vaccine live (Oka/Merck). Suspected vaccinations included Gardasil (MDS), (duration and dose not reported), hepatitis A virus vaccine inactivated (manufactured unspecified), (duration and dose not reported) and Menactra. On 14-JUL-2007, the patient found out she was 20 weeks pregnant. Medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow up information was recived. Patient did well with her pregnancy.She delivered between 19-NOV-2007 and 6-DEC-2007. The baby was healthy and fine with no congunital defects.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Body temperature increased, Herpes zoster, Pain, Pruritus
Clinical narrative: Information has been received from a physician concerning a 12 year old female with no drug allergies or history of chicken pox, who was vaccinated on 25-JUN-2007 with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot# 656825/0307U) in the right arm. There was no concomitant medication. On 01-JUL-2007, the patient developed shingles around the left eye described as itchy and slightly painful. The physician described the shingles lesions with approximately 8 wet vesicles in a linear pattern below the left eye. There was no recent exposure to chicken pox or shingles. Unspecified medical attention was sought. Lab diagnostic studies included a maximum body temperature of 98.4 F. No specimen was obtained for PCR. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Incorrect route of drug administration, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 6 year old male with developmental delay and seizures, who on 11-SEP-2001 was vaccinated with the first dose of Varicella virus vaccine live (Oka/Merck) (Lot #638242/0563L) into the right deltoid. Concomitant therapy included dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and a dose of poliovirus vaccine inactivated (unspecified). On 28-JUN-2007, the patient developed a moderate varicella infection with 50 to 500 blisters. No medical attention was sought. No diagnostic studies or lab tests were performed. On 05-JUL-2007, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 3-year-old male with no pre-existing allergies, birth defects or medical conditions who on 06-JUL-2005 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 647960/0070R). There was no concomitant medication. There was no illness at the time of vaccination. On 25-MAY-2007, the patient was seen in the physician's office with 11-12 lesions on his neck and hairline. He was treated with Benadryl, Motrin and Aveeno Bath. There were no diagnostic or laboratory testes performed. The patient recovered. Additional information is not available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Mass
Clinical narrative: Information has been received from a nurse concerning a female who on an unknown date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657449/0597U). Subsequently, the patient experienced "cellulitis" after getting second dose. The physician was concerned that there might be a problem with the lot number. The patient sought unspecified medical attention. A lot check has been requested. The patient recovered on an unspecified date. Follow-up information was received via telephone call from a licensed practical nurse who reported that the female patient was between the age of 7-11 years old. She developed "softball sized bumps on her arms" following varicella virus vaccine live (Oka/Merck) (Lot # 657449/0597U). The physicians office had since switched to using another lot of vaccine and have had no problems. The records of testing prior to release of lot # 657449/0597U have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. No additional information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a registered nurse concerning 4 children, 5 to 6 years of age and both males and females, who in 2007 were vaccinated subcutaneously with the second dose of varicella virus vaccine live (Oka/Merck). Within 24 hours of the vaccination, the patients developed cellulitis reactions near the injection site. There was no report of rash or vesicles. All of the patients were treated with antibiotics. Subsequently, they recovered from cellulitis. Additional information has bee requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health care worker concerning a 10 year old patient who on 02-JUL-2007 was vaccinated with an unspecified vaccine, possibly varicella virus vaccine live (Oka/Merck). On 13-JUL-2007, patient sought medical attention due to spots all over. Subsequently, the patient experienced vaccine-related case of chickenpox. No titers have been drawn. Patient's recovery status was unknown. No product quality complaint reported. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning an adult patient who was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) due to human error. It is unknown if medical attention was sought. The patient's recovery status is unknown. No product quality complaint reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 39-month-old male with no pre-existing allergies, birth defects, or medical conditions who on 05-APR-2005 was vaccinated IM in the right leg with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 626689/0651H). There was no illness at the time of vaccination. On 10-JUL-2007, the patient was diagnosed with varicella. There were no adverse events following prior vaccinations. There were no relevant diagnostic tests or laboratory data. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella
Clinical narrative: Information has been received from a consumer concerning an 8 year old male with attention deficit/hyperactivity disorder who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy was an unspecified ADHD medication. Three days after vaccination, the patient subsequently came into contact with shingles and developed chickenpox on the trunk, about 30 pox. There was no fever. It is unknown whether medical attention was sought. Patients outcome status was unknown. No product quality complaint reported.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a male patient age 7 to 10 years old who was vaccinated SC in the arm with first and second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot number 657457/0601U). It was reported that 24 hours post the booster dose of varicella virus vaccine live (Oka/Merck) he developed a large, red, hard and swollen area at the injection site. Unspecified medical attention was sought.  No treatment was provided. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning an adult patient who on 16-JUL-2007 was inadvertently vaccinated intramuscularly with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced no adverse experience. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from the pharmacist indicates that he was informed of the experience from the personnel health department. His understanding of what occurred was that the physician wrote that the patient should receive "varicella zoster" or "herpes zoster," which ever the correct vaccine was, and the other person grabbed the wrong product. The date of birth, age and lot number were unknown. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 15-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot Number 657446/0518U). On 16-JUN-2007, the patient developed a reaction after receiving her second dose of varicella virus vaccine live (Oka/Merck). The patient developed redness of her arm within 24 hours of vaccination, accompanied by a fever. On 17-JUN-2007, the red area on her arm worsened and spread which required a visit to the emergency room where she was given clindamycin and Benadryl. The patient was not hospitalized. On 19-JUN-2007, the patient was considered to be fully recovered post vaccination. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Delirium, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 10 year old male who on 12-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). After receiving his second dose of varicella virus vaccine live (Oka/Merck), on 14-JUL-2007, the patient developed redness and swelling of his arm from the deltoid (where the vaccination was given) down to his elbow. This reaction prompted a visit to the emergency room. The patient was not admitted to the hospital. The patient went back to the emergency room on  15-JUL-2007 for a second visit. The patient also experienced a low grade fever and was said to be "delirious." The patient was not admitted to the hospital. The patient was prescribed Augmentin during one of the emergency room visits. As of 16-JUL-2007, the patient was said to be recovering. 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 7 year old female who in 2001, at one year of age was vaccinated with a 0.5ml SC dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a case of chicken pox. No labs tests were performed. The patient was ordered acyclovir. It was reported that the patient has no serious complications. The patient's present status is not recovered. No products quality complaint reported. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 13 month old female who on 12-JUN-2007 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). She was vaccinated with measles-mumps-rubella vaccine (M-M-R II) at the same time at a different injection site. On 28-JUN-2007 the patient experienced localized rash at the injection site of varicella virus vaccine live (Oka/Merck). On 29-JUN-2007 the patient developed a rash all over her body. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 7 year old female with no pertinent medical history or drug allergies who on 11-JUL-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 0592U). There was no concomitant medication. On 12-JUL-2007 the patient developed injection site redness and injection site swelling 3 inches in diameter size. Office was contacted on 12-JUL-2007 and 13-JUL-2007. No labs were performed. The patient's present status was unknown. No product quality complaint reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: HEPA, PNC, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a physician concerning a 12 month old patient on 16-JUL-2007 was vaccinated with varicella virus vaccine live (Lot # 657718/0778U). Concomitant therapy included hepatitis A virus vaccine (unspecified) and pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR). On 16-JUL-2007 the patient experienced an injection site reaction from varicella virus vaccine and MMR (655420/0279U) (WAES0709USA03971. The patient developed raised "ring" like wheal on right thigh where the patient received varicella virus vaccine. Diphenhydramine hydrochloride (BENADRYL) was prescribed and on 17-JUL-2007 the patient recovered. Additional information has been requested.