chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 10-year-old male student with an allergy and no known drug allergies who on 28-AUG-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. Concomitant therapy included Sudafed. The physician reported that on the evening of 28-AUG-2007, the patient developed pruritus around the legs, a red macular area over the right ankle as well as papules and a vesicle. The physician also reported that, at the time of the follow up appointment, the patient also had papules on the back and shoulder which were itchy, but non were scabbed. A dermatologist examined the patient and indicated that it was probably a varicella-like rash. The patient had no fever with this reaction. No laboratory/diagnostic tests were performed. The patient subsequently recovered. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Body temperature, Erythema, Pharyngolaryngeal pain, Pruritus
Clinical narrative: Information has been received from a physician concerning a 9-year old (previously reported as 8) female with no known allergies who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) when she was approximately 12 months old. On an unspecified date the patient experienced 250 lesions all over her body that was described as a papular rash with some red, some blistered, some crusted after receiving varicella virus vaccine live (Oka/Merck). It was reported that patient has new lesions daily since last evaluation with an increased itch "most itchy on head" (no relief with oatmeal baths). On 31-JUL-2007, the patient had an oral temperature of 98.5. The patient sought unspecified medical attention. The patient was previously treated with Benadryl at increased doses, calamine, oatmeal baths and ibuprofen which was alternated with Tylenol. On 31-JUL-2007, the patient's physician stopped the Benadryl and prescribed hydroxyzine 12.5-25 mg by mouth six times a day, as well as Tylenol/ibuprofen for "temps". A product quality complaint  was not involved. On 31-JUL-2007, she also experienced a "throat painful". Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 9-year old (previously reported as 8) female with no known allergies who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) when she was approximately 12 months old. On an unspecified date the patient experienced 250 lesions all over her body that was described as a papular rash with some red, some blistered, some crusted after receiving varicella virus vaccine live (Oka/Merck). It was reported that patient has new lesions daily since last evaluation with an increased itch "most itchy on head" (no relief with oatmeal baths). On 31-JUL-2007, the patient had an oral temperature of 98.5. The patient sought unspecified medical attention. The patient was previously treated with Benadryl at increased doses, calamine, oatmeal baths and ibuprofen which was alternated with Tylenol. On 31-JUL-2007, the patient's physician stopped the Benadryl and prescribed hydroxyzine 12.5-25 mg by mouth six times a day, as well as Tylenol/ibuprofen for "temps". A product quality complaint  was not involved. On 31-JUL-2007, she also experienced a "throat painful". Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 11 year old female with drug hypersensitivity who on 24-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot number "10294"). On 25-AUG-2007, the patient experience significant swelling, warmth and redness at the injection site. Subsequently, the patient recovered from significant swelling, warmth and redness at the injection site. No further information is available.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a health professional concerning an 11 year old male who on 05-SEP-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) ("Lot # 05976"). On 05-SEP-2007, the patient developed a nickel size red mark at injection site, that was painful to touch. At the time of reporting the patient was not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test abnormal
Clinical narrative: Information has been received from a physician concerning her daughter with a history of childhood eczema and a normal delivery 3 and 1/2 months ago who on two unspecified dates in 1998 was vaccinated with first and second doses of varicella virus vaccine live (Oka/Merck) 3 to 4 weeks apart. The patient was an adult in 1998 at the time of vaccination. Recently the patient had titers that were either very low or negative. Unspecified medical attention was sought. Lab studies were performed for varicella titer which was low or negative. No further information was provided. There was no product quality complaint involved. No further information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 10 year old white male who on 13-JUL-2007 at 9:30 AM was vaccinated SC on right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657647/0535U). It was reported that on 14-JUL-2007 the patient developed 2 inch non-vesicular whelp that was red and warm to touch. No medical attention was sought. No further information is expected. This is one of several reports from the same source.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Post herpetic neuralgia, Skin lesion
Clinical narrative: Information has been received from a physician concerning a healthy 5-year-old female with no pertinent medical history who on 03-JUN-2003 was vaccinated with a subcutaneous dose of 0.5 milliliters of varicella virus vaccine live (Oka/Merck) (Lot# 642640/0308M). There was no concomitant medication. On 07-SEP-2007 the patient developed shingles. On 10-SEP-2007, the patient was seen at the doctor's office with about 15 lesions on the right leg. No laboratory or diagnostic tests were performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up information received on 26-Sep-2007 states that "the patient developed post herpetic neuralgia in the last few days". No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a doctor of pharmacy concerning 3 patients' (60 + years old) who were vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse reactions were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 8.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pharyngolaryngeal pain, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 8 year old white male status post submucuscleft palate (no pain) with an allergy to amoxicillin (+) clavulanate potassium (augmentin) who on 16-MAY-2007 in the AM was vaccinated IM in the right deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot# 656608/0032U). there was no illness at the time of vaccination. On 23-MAY-2007 the patient experienced acute febrile illness, with sore throat and headache. Subsequently, the patient recovered from acute febrile illness, sore throat and headache. The reported indicated its unlikely vaccine related as sister had been sick earlier in week with the same. No product complaint was involved. Follow up information indicated that no adverse events took place. There were no relevant diagnostic tests or laboratory data. The patient's brother also experienced as adverse event (WAES #0706USA04457). No additional information has been requested.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a physician concerning a 37 year old female who in September 2001, was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant medication. Subsequently the patient failed to seroconvert after receiving first injection in September 2001 and the second injection in November 2004. As of 11-SEP-2007, the patient experienced no adverse symptoms. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning his son who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed a break through case of chickenpox. Unspecified medical attention was sought. 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: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 20 year old female patient who on an unspecified date was vaccinated with a 0.5 mL second dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed injection site swelling and pain. Unspecified medical attention was sought. 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: 1.1
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning 5-year-old male with no reported medical history who, on 19-AUG-2002, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) and a third dose of poliovirus vaccine inactivated (unspecified). On 10-MAY-2007 at 11:25 am, the patient developed break through chickenpox. It was unspecified if medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 13 year old female with asthma and no known allergies who in approximately September 2007, was vaccinated SC with a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck) (Lot# 658291/1100U). There was no concomitant medication. It was noted that the patient received the first dose on 02-SEP-1999. On 11-SEP-2007 the patient experienced an injection site reaction which was described as an area of redness approximately four inches in diameter with a cluster of blisters in the center of the circle. The patient was seen at the office. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 13-year-old female who on 17-AUG-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657941/0851U). There was no concomitant medication. On 21-AUG-2007, the patient experienced a red, itchy rash at the injection site four days after vaccination. It was reported one chickenpox lesion was located directly over the injection site. The patient sought unspecified medical attention. No diagnostic labs were performed. No more lesions developed and at an unknown date the patient recovered from all adverse events. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a one year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 06-MAR-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Further information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 4 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 02-Apr-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Additional information is expected.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 12 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 10-APR-2007, the patient was diagnosed with chickenpox. Medical attention was sought, The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Further information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a one year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 04-Apr-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Additional information is expected.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning an eight year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 29-MAY-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Further information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 12 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 30-Mar-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Additional information is expected.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 9 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 30-MAR-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Further information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 10 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 27-Apr-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Additional information is expected.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning an 11 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 26-APR-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Further information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning an 8 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 26-Apr-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Additional information is expected.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 5 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 26-APR-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Further information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning an 8 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 30-MAR-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from the same source. Further information has been requested.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 9-year-old patient who "within last week", approximately on 12-Jun-2007, was vaccinated in the arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot number unknown). "Over the course of last week", starting approximately 12-Jun-2007, the patient experienced an induration in the arm, redness and itching at the injection site. It is unspecified if medical attention was sought. No outcome was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Contusion, Erythema, Myalgia, Swelling
Clinical narrative: Information has been received from ah health professional concerning a 14 year old female who on 22-AUG-2007 was vaccinated with her second SC dose of varicella virus vaccine live (Oka/Merck) (lot # 658052/1008U) in the left arm. On 24-AUG-2007, the patient developed muscle aching, redness, bruising and mild swelling. No medical attention was sought. The patient's recovery status was unknown. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, Rash papular
Clinical narrative: Information has been received from a physician concerning a 9-year-old female with no pertinent medical history or allergies who on 07-APR-2003 was vaccinated subcutaneous in the left arm with varicella virus vaccine live (Oka/Merck) (Lot # 641148/0791M). Concomitant vaccine included a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 644644/1080M) administered on 07-APR-2003. On 04-SEP-2007, the patient developed 5 vesicles/15 papules on her arms, legs, scalp and axilla that was treated with Benadryl and calamine lotion per physician. The patient sought medical attention via a doctor visit. No diagnostic labs were performed. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with a penicillin allergy, and no pertinent medical history, who on 07-JUN-2007 (also reported as 11-JUN-2007) was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included an IM dose of Menactra which was given at the same site. Within 24 hours, the patient developed redness, swelling and itching at the injection site. Unspecified medical attention was sought. There were no lab studies performed. At the time of this report the patient was recovering. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin papilloma
Clinical narrative: Information has been received from a pharmacist concerning her 7 year old daughter with eczema, asthma, sulfonamide allergy, egg allergy, hypersensitivity to soy and a peanut allergy, who in approximately 2004 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included Cutivate, Pulmicort and albuterol as needed. In October 2006, "about three years after receiving varicella virus vaccine live (Oka/Merck)", the patient developed warts on her hands and arms. Medical attention was sought and she has had over 100 laser therapy treatments for the warts. No lab studies were performed. At the time of the report the patient had not recovered. No other information has been provided. There was no product quality complaint involved. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: Information has been received from a physician concerning a 26 month old female with no pertinent medical history who in approximately 2005 (about two years ago) was vaccinated with varicella virus vaccine live (Oka/Merck) 0.5 mL. There was no concomitant medication. On 11-JUN-2007, the patient experienced multiple spots on thigh and abdomen ("more than 20 spots"). The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. The patient's multiple spots on thigh and abdomen ('more than 20 spots") persisted at the time of the report. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 9 to 10 year old male who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed "swelling the size of a grapefruit on his thigh". Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 14 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) when "he was one or two". It was reported that after vaccination the patient broke out with a shingles type rash at the age of 14. The rash was on one side of his back. Subsequently, the patient recovered. There were no laboratory tests performed. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning her 13 year daughter who on an unreported date was vaccinated with varicella virus vaccine live (Oka/Merck). The patient, at 13 years of age recently (2007) developed a severe case of chickenpox. The patient, along with her older (16) and younger sisters (11), had all been previously immunized. The 11 year old had a breakthrough at the same time as her 13 year old sister. The patient did not develop chickenpox following past exposures to the virus years ago when her oldest sister (16) exhibited a breakthrough case of chickenpox. This is one of several reports from the same. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: MMR, UNK, VARCEL
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse who received a call from the patient's mother who reported that her 1 year old was vaccinated with varicella virus vaccine live (Oka/Merck) and measles-mumps-rubella vaccine, and an unknown vaccination. Subsequently, after receiving the above vaccinations, the patient experienced rash all over the body especially the head. The patient's rash all over the body especially the head persisted. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 28 year old female with an allergy to aspirin who in approximately May 2007 (about a month ago), was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). In approximately May 2007 (about a month ago), the patient experienced itching, redness, swelling and hardness around the area of injection on her right arm after her first dose of varicella virus vaccine live (Oka/Merck). The symptoms returned yesterday after the patient received the second dose of varicella virus vaccine live (Oka/Merck). At the time of the report the patient had not recovered from the itching, redness, swelling and hardness around the area of injection on her right arm. The patient sought unspecified medical attention. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 9 year old male who on 09-JUL-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 10-JUN-2007, the patient developed a severe case of chickenpox with about 500 lesions. Unspecified medical attention was sought. No lab diagnostic studies were performed. As of 13-JUN-2007, the patient's severe case of chickenpox persisted. There was no product quality complaint. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (MSD). No adverse side effects were reported. The nurse reported that episode as a mistake. A product quality complaint was not involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 11-JUN-2007 was vaccinated with a second dose of 0.5 mL varicella virus vaccine live (Oka/Merck) (lot # 656999/0334U). On 12-JUN-2007, the patient developed swelling and redness, approximately 14 X 18.5 centimeters at the injection site. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 5 year old male with no known allergies or pertinent medical history who on 05-JUN-2007 was vaccinated SC with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 657195/0366U). Concomitant therapy included the "regular vaccines for a kindergarten visit". On 07-JUN-2007, the patient developed chickenpox on his neck, abdomen and chest. There were only a few (less than 50) lesions. Unspecified medical attention was sought, there were no labs performed. The patient's status at the time of the report was unknown. There was no product quality complaint involved. No further information was provided. 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 12 month old female 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 routine vaccinations for a one year visit. On 31-MAY-2007, the patient developed a full body case of chickenpox. No laboratory or diagnostic tests were done. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a male child who in August of 2005 was vaccinated with a subcutaneous injection of 0.5 milliliters of varicella virus vaccine live (Oka/Merck) (lot# 647719/0194P). On approximately 10-JUN-2007, the patient developed a varicella rash. It is unknown how may lesions the patient developed or if the patient had any other symptoms. It is also unknown if the patient received 1 or 2 doses in the past. Unspecified medical treatment was sought. No outcome was reported. The facility is requesting a lot check be performed. No product quality complaint was involved. The records of testing prior to release of the lot in question 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. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It is reported that when the patient got the varicella virus vaccine live (Oka/Merck) she had a "shingles outbreak on top of her head". No lot number was provided. Unspecified medical attention was sought. On an unspecified date, the patient recovered from the shingles outbreak on top of her head. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 25 month old female who on 08-NOV-2006 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). One month later the patient received a second dose of varicella virus vaccine live (Oka/Merck). The doses were not given at the clinic where the reporting nurse was located. On an unspecified date in May 2007, the patient developed a varicella rash. Unspecified medical attention was sought. At the time of this report the patient was recovered. No further information was provided. There was no product quality complaint involved. No further information is expected.
Age: 11.0
Sex: F
Vaccine: TTOX, VARCEL
Symptoms: Injection site pain
Clinical narrative: Information has been received from a licensed practical nurse concerning her 11 year old daughter who on 14-JUN-2007 was vaccinated with a varicella virus vaccine live (Oka/Merck) via intramuscular route. Concomitant vaccination included tetanus toxoid. The patient experienced injection site pain which was being treated with acetaminophen and cold compresses. The patient's injection site pain persisted. No product complaint was reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a company representative concerning a 17 year old male who at the age of five, in approximately 1995, was vaccinated with varicella virus vaccine live (Oka/Merck). On 09-JUN-2007 the patient developed chickenpox. The doctor performed a culture of the rash and sent it off to the lab where it was confirmed that the rash was chickenpox. The patient was treated with valacyclovir tablets (VALTREX). Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 12 year old male who on 10-JUN-1998 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 625047/1574E). On 13-JUN-2007 the patient developed chickenpox rash. Number of lesions was unknown. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a 7 year old female who was vaccinated with a dose varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed a case of the chicken pox after receiving a dose of varicella virus vaccine live (Oka/Merck). The patient's status was not reported. There was no product quality complaint involved. No further information is available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
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). On 15-JUN-2007 the patient experienced injection site reaction. The patient's injection site reaction persisted. No further information is available.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a physician concerning an approximately 33 year old female speech pathologist with hypothyroidism and asthma and a history of hypertension who in 1993 and 200 was vaccinated with the first dose and second dose of varicella virus vaccine live (Oka/Merck), respectively. Concomitant therapy included levothyroxine Na (SYNTHROID). In June 2007 (last week), the patient had an antibody test drawn at the hospital and she failed to seroconvert. The patient sought unspecified medical attention. No product quality complaint was involved. Follow-up information was received from the physician who reported "I did not immunize the patient, but she gave a history of receiving immunization x 2 without becoming immune." No additional information is expected.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a nurse concerning a 9 year old patient who in 1997 was vaccinated with varicella virus vaccine live (Oka/Merck). In May 2007 through 18-JUN-2007, the patient experienced a mild case of chicken pox. The symptoms were mild, a rash on the torso. No VZV titers were taken. No specific treatment was required. Unspecified medical attention was sought. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of male pediatric patients of various ages who were vaccinated with a second subcutaneous 0.5ml dose of varicella virus vaccine live (Oka/Merck). The patients developed an injection site reaction the following day and the area was red and hot to touch. All patients have recovered. Unspecified medical attention was sought. No other details were available. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: Initial and follow up information has been received from a physician concerning a 6 year old female who on 13-JUN-2007 was vaccinated subcutaneously in the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 656576/0446U). Concomitant therapy included a first dose in the left arm of hepatitis A virus vaccine (HAVRIX) (Lot#AHAVR172AB). The patient also received a dose of loratidine 1-2 hours prior to vaccination. There was no illness at the time of vaccination. On 13-JUN-2007 within one hour after the vaccination the patient experienced hives, swelling of her lips and itchy hands and feet. The patient was evaluated at a local emergency room and treated with diphenhydramine hydrochloride (BENADRYL). The patient did not require hospitalization. The symptoms resolved within 2 hours and the patient completely recovered. The physician also added that the patient developed hives and lip swelling after vaccination with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 18-MAY-2005. (WAES# 0710USA00801). No product quality complaint was involved. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Skin infection
Clinical narrative: Information has been received from a physician concerning a 6-year-old female who on an unspecified date was vaccinated with an injection of varicella virus vaccine live (Oka/Merck) (lot number not provided). Subsequently, on an unspecified date, the patient developed cellulitis (location unspecified) which became infected and the child had to go to the emergency room. On an unspecified date, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 12-month-old male with a penicillin allergy, a history of reactive airway disorder and sinusitis, who on 16-NOV-1999 was vaccinated intramuscularly, instead of subcutaneously, with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On the morning of 19-JUN-2007, at the age of 8, the patient experienced 50-75 chicken pox lesions. He was treated with diphenhydramine hydrochloride (BENADRYL) as needed. There were no laboratory or diagnostic tests performed. The outcome for the chicken pox is reported as not recovered. No product complaint was involved. Follow-up information received indicated that the vaccination did not occur at the current physician's office. The patient developed 50-75 lesions on the abdomen, chest and back. The patient weighed 73 pounds. Treatment also included sarna lotion. On 30-Jun-2007 the patient recovered. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a 7-year-old female who was vaccinated on 06-Jun-2007 in her leg (laterality unspecified) with a dose of varicella virus vaccine live (Oka/Merck) (lot# 657408/0517U). Concomitant therapy included a dose of hepatitis A vaccine (inactive) (HAVRIX). Subsequently, on an unspecified date, the patient developed swelling and itching at injection site which lasted 3-4 days. Unspecified medical attention was sought. The outcome is reported as recovered. No product quality complaint was issued. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 24-month-old male who on an unspecified date was vaccinated with a dose of varicella virus vaccine (Oka/Merck). Subsequently, approximately one year after being vaccinated with varicella virus vaccine live (Oka/Merck) the patient developed varicella-like lesions on his chest. It is not known how many lesions were present. The lot number was unavailable. The patient sought unspecified medical treatment. The outcome is reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). It was reported that the two vaccines were stored in the same freezer and the pharmacist "just pulled out" the wrong vaccine. The nurse then gave the vaccine though she "knew something wasn't right." The patient had no adverse event. There was no product quality complaint involved. On an unspecified date since this event the patient was correctly vaccinated with zoster vaccine live (Oka/Merck) (MSD). No further information has been requested. The patient's husband had the same experience with vaccination (WAES # 0704USA01344).
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck).Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had vaccinated subcutaneously with a first dose of 0.5 ml of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chicken in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine live (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.