chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse, concerning a 12 year old male with a history of cardiac murmur as an infant, who was vaccinated with a first 0.5ml, SC, dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed a mild breakthrough case of chicken pox. Unspecified medical attention was sought. The patients status is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 12 month old female, with no medical conditions or pre existing allergies, who on 30-APR-2007, at 14:30, was vaccinated subcutaneously into the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 656279/1503F). Concomitant therapy, that same day, included a first dose of Vaqta administered intramuscularly into the left thigh (Lot# 655320/1009F) and a first dose of M-M-R II administered subcutaneously into the right arm. There was no illness at the time of vaccination. On 01-MAY-2007, at 19:00, the patient developed a breakthrough of chickenpox, consisting of approximately 14-16 lesions, including one in the oral cavity. Unknown medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting the patient's status was unknown. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Erythema, Rash papular, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 12 month old female, with no medical conditions or pre existing allergies, who on 30-APR-2007, at 14:30, was vaccinated subcutaneously into the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 656279/1503F). Concomitant therapy, that same day, included a first dose of Vaqta administered intramuscularly into the left thigh (Lot# 655320/1009F) and a first dose of M-M-R II administered subcutaneously into the right arm. There was no illness at the time of vaccination. On 01-MAY-2007, at 19:00, the patient developed a breakthrough of chickenpox, consisting of approximately 14-16 lesions, including one in the oral cavity. Unknown medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting the patient's status was unknown. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old Caucasian/Hispanic female with no medical history and no allergies who on 30-Apr-2007 was vaccinated with a first 0.5ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 656279/1503F) in the left arm. Concomitant vaccines administered on the same day included a first intramuscular dose of hepatitis A virus vaccine inactivated (MSD) (Lot # 655320/1009F) in the left thigh and a first subcutaneous dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) (MSD) (Lot # 654691/1026F) in the right arm. Concomitant therapy included carbinoxamine maleate/pseudoephedrine HC (RONDEC) and azithromycin (ZITHROMAX). There was no illness at the time of vaccination. On 01-MAY-2007 the patient experienced break through chickenpox. The patient broke out in red bumps on the evening after receiving varicella virus vaccine live (Oka/Merck). The patient was seen on 02May2007 in the office and the physician's exam revealed papular papules and lesions, different stages compatible with chicken pox. There were at least 6 to 12 lesions on the face and chest area. There were no laboratory or diagnostic tests performed. At the time of this report, the patient was recovering. No further information was available. No product quality complaint was sought. Follow-up information stated breakthrough chicken pox, approximately 14-16 lesions, with one lesion in the oral cavity. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Erythema, Rash papular, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old Caucasian/Hispanic female with no medical history and no allergies who on 30-Apr-2007 was vaccinated with a first 0.5ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 656279/1503F) in the left arm. Concomitant vaccines administered on the same day included a first intramuscular dose of hepatitis A virus vaccine inactivated (MSD) (Lot # 655320/1009F) in the left thigh and a first subcutaneous dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) (MSD) (Lot # 654691/1026F) in the right arm. Concomitant therapy included carbinoxamine maleate/pseudoephedrine HC (RONDEC) and azithromycin (ZITHROMAX). There was no illness at the time of vaccination. On 01-MAY-2007 the patient experienced break through chickenpox. The patient broke out in red bumps on the evening after receiving varicella virus vaccine live (Oka/Merck). The patient was seen on 02May2007 in the office and the physician's exam revealed papular papules and lesions, different stages compatible with chicken pox. There were at least 6 to 12 lesions on the face and chest area. There were no laboratory or diagnostic tests performed. At the time of this report, the patient was recovering. No further information was available. No product quality complaint was sought. Follow-up information stated breakthrough chicken pox, approximately 14-16 lesions, with one lesion in the oral cavity. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with 0.5 ml dose of varicella virus vaccine live (Oka/Merck). It was reported that patient developed "significant amount of erythema" 3 days after vaccination. At the time of report, the patient was fine and was recovered. Unspecified medical attention was sought. A product quality complaint was not involved.
Age: 1.4
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 17 month old female who on 13-NOV-2006 was vaccinated SC with first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 653973/0798F). On 02-MAY-2007, the physician diagnosed the patient was a breakthrough case of chickenpox and reported that the patient had chickenpox all over her body, including in the ear canal. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 70 year old female who, "today", on 04May2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 651280/0803R). The patient came into the office stating she needed the varicella virus vaccine live (Oka/Merck) however, the nurse stated that the patient was mistaken and she needed the zoster vaccine live (MSD). It was reported that the event was a staff error. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 3 year old patient (gender unknown) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient experienced a mild case of chicken pox. Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful. This is one of several reports received from the same source. The patient's sibling (WAES# 0705USA001188) had a similar experience following vaccination with varicella virus vaccine live (Oka/Merck). No additional information is expected.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 2 year old patient (gender unknown) who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient experienced a mild case of chickenpox. Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in this report were unsuccessful. This is one of several reports received from the same source. The patient's sibling (WAES# 0705USA001187) had a similar experience following vaccination with varicella virus vaccine live (Oka/Merck). No additional information is expected.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Body temperature, Rash, Vaccination failure, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year old female who "sometime in January," in January 2007, was vaccinated with a second dose of 0.5mL injection of varicella virus vaccine live (Oka/Merck). In 2007, the patient developed a breakthrough case of chickenpox with less than 20 lesions after receiving the second dose. No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow-up information was received from a registered nurse who reports that the patient, a female, was vaccinated subcutaneously into the right arm on 08 JAN 2007 at 11:00 with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 654132/1151F). Concomitant vaccines administered at 11:00, on the same day included a second intramuscular dose of hepatitis A virus vaccine inactivated (Lot # 656495/1209F) in the right arm. The patient came to the office on 04-MAY-2007 and was diagnosed with varicella, vaccine failure, and a rash appeared on the abdomen that morning. There was no fever. Chickenpox was going around school a few weeks prior to the onset. There were no complications. The patient was treat symptomatically. The outcome was unknown at the time of reporting. No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male with no known medical history or allergies, who received a first and second dose of varicella virus vaccine live (Oka/Merck), on 12-FEB-1997 (0.5 mL, SC) and on 22-NOV-2005 (lot number "U19355AA), respectively. There was no concomitant medication. It was reported that on 03-MAY-2007 the patient experienced itchiness with a varicella like rash, 34-35 lesions on his face, chest, back and legs. Unspecified medical attention was sought. It was reported that the patient's status is not recovered. No laboratory tests were done. No product quality complaint was involved. In follow-up it was reported that on 04-MAY-2007 the patient developed 34-35 papular lesions on his face, chest, back and legs. The patient recovered on 17-MAY-2007. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a clinic worker, concerning a patient with an unknown medical history, who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck), instead of zoster vaccine live (MSD). It was unknown if medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). The patient received the first dose of vaccine 11 years ago. It was reported that two days after vaccination, the the patient developed "significant induration and redness in about 3 inch diameter around injection site." Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old male who on 10-FEB-1999 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). It was reported that "now", on approximately 04-MAY-2007, the patient has a full blown case of chickenpox with more than 250 lesions. The case was reported to the health department. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not 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 physician concerning a 6 year old white female with food allergy to corn products, amoxicillin and zithromax allergy who on 10-DEC-2001 was vaccinated with first dose of varicella virus vaccine live (Oka/Merck) (Lot #640119/0965L). Concomitant vaccines included measles-mumps-rubella vaccine (MMR) (Lot #639138/0738L). On 02-MAY-2007, the child developed 3 lesions (site unspecified). On 03-MAY-2007, the child developed 15-20 lesions. There was no itching or any other problems. The child's mother had called and stated child was exposed at school. In May 2007, the patient recovered from lesions. There was no diagnostic labs done. There was no illness at time of vaccination. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a health professional concerning an 11 year old male with no medical history and no allergies who on 04-APR-2007 was vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck). There were no concomitant medications. On 09-APR-2007 the patient developed a cropped vesicular rash less than 50 lesions on his abdomen and back. He was seen in the office on 16-Apr-2007 where it was determined he was recovering and cleared to go back to school. On 07-May-2007, he was seen in the office with the same symptoms as on 09-Apr-2007, "varicella like lesions" on his back and abdomen. These lesions were new lesions on the same location as the initial "outbreak". No varicella zoster virus (VZV) analysis was done with the initial rash nor with the later recurrence. A teacher is in her first trimester and shows no symptoms but is concerned about exposure because of the "relapse". At the time of this report, the patient had not recovered. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning a 3-year-old male whose brother was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) on 24-APR-2007. On 04-MAY-2007, this patient contracted full blown chickenpox. The sibling who received the vaccination did not experience an adverse event following vaccination with varicella virus vaccine live (Oka/Merck0. No additional information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information received from a Family Nurse Practitioner indicates that the physician who reported the event originally does not work at the clinic anymore and no other staff member is aware of the incident. Additional information is not available.
Age: 19.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an age approximately 19-20 year old male who "a couple of years ago" at approximately 17-18 years of age was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). It was reported that "a couple weeks ago" on approximately April-2007, the patient developed shingles. The patient's status is recovering. No product quality complaint was involved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a 10 year old female with no medical history or allergies who on 10-FEB-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. It was reported that on 03-MAY-2007 the patient developed chickenpox with 20 scattered papules and vesicles all over her body. The patient was not experiencing fever. It was unknown if the patient received a second dose of the vaccine because the patient was switched to another practice and her records were not all received. Unspecified medical attention was sought. No laboratory tests were performed. The patient's status was reported as recovering. No product quality complaint was involved. Follow-up information indicated that the patient was given a dose of varicella virus vaccine live (Oka/Merck) at another doctor's office. There was no illness at time of vaccination. The outcome was reported as recovered. No other information reported. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Axillary pain, Body temperature, Body temperature increased, Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old male with no medical history or allergies who on 05-MAY-2007 at 9:30 AM was vaccinated SC in the left arm with a 0.5mL dose of varicella virus vaccine live (Oka/Merck) (lot number 657002/0337U). There was no illness at the time of vaccination. On 05-MAY-1997 within 24 hours of the vaccination, the patient developed an injection site reaction. The patient was seen in the office on 07-May-2007 and the reaction was described as a sore and painful injection site with a 9X7 inches pustule in left arm with a central pustule at the injection site and a low grade fever. The patient was given a prescription for Augmentin 400 mg/5ml two teaspoons twice daily for 10 days. The patient was to be rechecked in the office 7-MAY-2007. The patient's status is recovering. No product quality complaint was involved. Additional information has been received from medical assistant who stated that on 06-MAY-2007 the patient vomited in the morning. On the day of vaccination 05-MAY-2007, the patient developed redness and soreness at vaccine site. The symptoms worsened and the patient was seen in office on 07-MAY-2007 with approximately 9X7 inch redness and induration and central pustule at injection site. There was no fever (99.5). The patient was experiencing some pain on left axilla. The patient was treated with Augmentin. At the time of report the patient had recovered.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site pustule, Pyrexia, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old male with no medical history or allergies who on 05-MAY-2007 at 9:30 AM was vaccinated SC in the left arm with a 0.5mL dose of varicella virus vaccine live (Oka/Merck) (lot number 657002/0337U). There was no illness at the time of vaccination. On 05-MAY-1997 within 24 hours of the vaccination, the patient developed an injection site reaction. The patient was seen in the office on 07-May-2007 and the reaction was described as a sore and painful injection site with a 9X7 inches pustule in left arm with a central pustule at the injection site and a low grade fever. The patient was given a prescription for Augmentin 400 mg/5ml two teaspoons twice daily for 10 days. The patient was to be rechecked in the office 7-MAY-2007. The patient's status is recovering. No product quality complaint was involved. Additional information has been received from medical assistant who stated that on 06-MAY-2007 the patient vomited in the morning. On the day of vaccination 05-MAY-2007, the patient developed redness and soreness at vaccine site. The symptoms worsened and the patient was seen in office on 07-MAY-2007 with approximately 9X7 inch redness and induration and central pustule at injection site. There was no fever (99.5). The patient was experiencing some pain on left axilla. The patient was treated with Augmentin. At the time of report the patient had recovered.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 7-year-old female with a history of impetigo and no known drug allergies, who on 13-DEC-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccines administered that day included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and a dose of poliovirus vaccine inactivated (Vero) (IPOL). It was reported that on 20-JUL-2000 the patient developed shingles rash of the face. Unspecified medical attention was sought and not treatment was required. Subsequently, on an unspecified date, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning her 14 year old daughter who "8 years ago, " in approximately 1999, was vaccinated with varicella virus vaccine live (Oka/Merck). On 05-MAY-2007, the patient developed a severe case of chickenpox, with lesions in her mouth, axilla and upper trunk. She had a fever as high as 102 degrees Fahrenheit and tremors. She was treated with Valtrex. It was reported that she  also had migraines with the influenza vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HEP, VARCEL
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Information has been received from a physician assistant concerning a patient who on approximately 05-MAY-2007 was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine administered on the same day included a 0.5mL intramuscular dose of hepatitis B virus vaccine rHBsAg (yeast). Three days post vaccination, on 08-MAY-2007, the patient developed a fever. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 9 year old female patient who in approximately 1999 was vaccinated SC with first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On 08-MAY-2007, the patient was supposed to receive the second dose of varicella virus vaccine live (Oka/Merck), but the physician found out that the patient's dermatologist had diagnosed the patient with shingles. The patient's mother stated that the patient recovered "a while ago." Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male, with no medical history or allergies who on 07-MAY-2007 at 14:30 PM was vaccinated with a second SC dose of varicella virus vaccine live (Oka/Merck) (lot number 656259/1509F). There was no illness at the time of vaccination. It was report that a few hours after receiving the vaccine injection the patient developed redness, warmth, and swelling at the injection site. No treatment was recommended. The symptoms had persisted and were not resolved as of 9-May-2007. No laboratory studies were performed. Unspecified medical attention was sought. No product quality complaint was involved. Additional information was received from the nurse who reported that in the AM of 08-MAY-07, the patient had a red, swollen, painful arm that was hot to the touch. The patient was afebrile. It was reported that the patient recovered on 10-MAY-07. The patient had no adverse events following prior vaccination. Follow up information was received from the nurse who reported that the reactions were self limiting and went away 72 hours later. No other visits or labs were required. No further information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: Vaccine positive rechallenge, Varicella
Clinical narrative: Information has been received from a physician concerning a male patient who on 20-Jun-2003 and 15-Mar-2007 was vaccinated with a first and second 0.5 mL dose of varicella virus vaccine live (Oka/Merck). It was reported that approximately one year after the first vaccine, in 2004, the patient developed a mild case of chickenpox. The patient received the second vaccine and on 07-May-2007 the patient again experienced a mild case of chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. The patient's brother had a similar experience after therapy with varicella virus vaccine live (Oka/Merck) (WAES number 0705USA05299). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
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 a breakthrough case of varicella. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male weighing 59 lbs and height of 49 1/2 inches, with no pre-existing medical history and no known illness at time of vaccination, who on 15-FEB-2007 was vaccinated subcutaneously in the right thigh with a dose of varicella virus vaccine live (Oka/Merck) (lot# 632368/1460J) and subcutaneously in the left thigh with a dose of measles-mumps-rubella vaccine (lot # 633705/1660J). The registered nurse reported that on 01-MAY-2007, the patient developed lesions. He was seen in the office on 02-MAY-2007 with less than 50 lesions in various stages. The patient recovered on 04-MAY-2007. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash macular
Clinical narrative: Information has been received from a registered nurse concerning a 37 month old male with no known drug allergies who on 30-MAR-2005 was vaccinated with a first subcutaneous dose of varicella vaccine live (Oka/Merck) (Lot# 64855B/0443P) in the left thigh. Concomitant vaccines administered on 30-Mar-2005 included a first subcutaneous dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (HPV-77) (MSD) (Lot# 647647/0991P) in the right thigh. There was no illness at the time of vaccination. On 01-MAY-2007, the patient started breaking out in spots on the left lateral thigh. On 03-May-2007, his mother noticed more spots. There were no laboratory or diagnostic tests performed. Subsequently, the patient recovered. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling injection site in a 5-year-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. Previous and/or concurrent vaccination included influenza virus vaccine given on 21 November 2007. On 21 November 2007 at 14:00 the subject received 1st dose of Infanrix (unknown, right arm). On 21 November 2007, 1 hour after vaccination with Infanrix, the subject experienced swelling injection site, injection site pruritus and mark at injection site approximately 2 inches by 1.5  inches. The immunization series was discontinued. The events of swelling injection site and injection site pruritus resolved after three days. The reporter was not certain the vaccine administered was Infanrix. At the time of reporting the mark at injection site was unresolved.
Age: 1.3
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Rash papular, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white female, with no known allergies, who on 10-APR-2002 was vaccinated SQ, in the left thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot number 638816/1236L). There was no illness at the time of vaccination. On 01-MAY-2007 the patient started with lesions. On 02-MAY-2007 the patient was seen in the office with less than 25 red papules, in various stages. The patient recovered on 04-MAY-2007. Patient was not hospitalized, and no laboratory tests were performed. No further information is expected.
Age: 1.3
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white female, with no known allergies, who on 10-APR-2002 was vaccinated SQ, in the left thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot number 638816/1236L). There was no illness at the time of vaccination. On 01-MAY-2007 the patient started with lesions. On 02-MAY-2007 the patient was seen in the office with less than 25 red papules, in various stages. The patient recovered on 04-MAY-2007. Patient was not hospitalized, and no laboratory tests were performed. No further information is expected.
Age: 1.3
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Erythema, Rash papular, Skin lesion
Clinical narrative: Information has been received from a healthcare professional concerning a 6 year old white female who on 10-APR-2002 was vaccinated subcutaneously in the left thigh with a dose of varicella virus vaccine live (Oka/Merck) (lot# 638816/1236L). On 01-MAY-2007 the patient developed less than 25 lesions. On 04-MAY-2007, the patient recovered. Follow up information was received on 16-MAY-2007 from the nurse who reported that the patient recovered on 04-MAY-2007. This report is related to 0705USA02127 (sibling). Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a healthcare professional concerning a 6 year old white female who on 10-APR-2002 was vaccinated subcutaneously in the left thigh with a dose of varicella virus vaccine live (Oka/Merck) (lot# 638816/1236L). On 01-MAY-2007 the patient developed less than 25 lesions. On 04-MAY-2007, the patient recovered. Follow up information was received on 16-MAY-2007 from the nurse who reported that the patient recovered on 04-MAY-2007. This report is related to 0705USA02127 (sibling). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white male weighing 54 lbs and height of 48 3/4 inches with no pre-existing medical history or illness at time of vaccination who on 08-NOV-2001 was vaccinated subcutaneously in the left thigh with a dose of varicella virus vaccine live (Oka/Merck) (lot# 638429/0426L) and subcutaneously in the left thigh with a dose of measles-mumps-rubella vaccine (lot # 640962/1095L). The nurse reported that on 03-MAY-2007 the patient developed lesions on the face, trunk, buttocks and legs in various stages. On 03-MAY-2007, the patient recovered. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a nurse concerning a 9 year old male with no medical history who on 08-MAY-2007, was vaccinated with a 0.5ml dose in the thigh of varicella virus vaccine live (Oka/Merck) (Lot #"0326U"). Concomitant vaccine administered on the same day in the same thigh included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 09-MAY-2007, the patient experienced a golf ball sized knot on his thigh at the injection site with a 3 inch radius of redness that ached was painful. No additional information was provided at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 12 month old female who in January or February 2007, was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccines included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) and a dose of poliovirus vaccine inactivated (Vero). After receiving varicella virus vaccine live (Oka/Merck), the patient developed a varicella type rash with quite a few spots. No additional information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a physician stated that this Caucasian patient received a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 656281/1504F) on 27-MAR-2007 in the right arm. There was no illness at the time of vaccination and no allergies or medical history. There were no adverse events following prior vaccinations. The patient developed a significant rash and fever within 21 days of vaccine administration. No medical attention was sought. Subsequently the patient recovered.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an approximately 11 year old male who "10 years ago", in approximately 1997, was vaccinated with varicella virus vaccine live (Oka/Merck). "This week", in May 2007, the patient experienced normal breakthrough. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male who on 03-OCT-2005 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included cefdinir (OMNICEF). The patient developed a breakthrough case of chickenpox after receiving varicella virus vaccine live (Oka/Merck). The number of lesions is not known. It is not known if the patient recovered. There was no additional information to report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who within the week of 07-MAY-2007 thru 11-MAY-2007 was vaccinated with  varicella virus vaccine live (Oka/Merck) 0.5 ml SQ rather than zoster vaccine live (Oka/Merck). The pharmacist reported this was not due to product confusion. No adverse experience related to this event. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who in May 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination on that same day included an unknown vaccine. In May 2007, the patient's arm swelled up. Pediatric office follow-up scheduled. Unknown present status for patient reported. No product quality complaint reported. No further information is available.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male child with a penicillin allergy and seasonal allergies who on 08-MAY-2007 was vaccinated SC in the back of the left arm with the second 0.5ml dose of varicella virus vaccine live (Oka/Merck) (657192/0362U). It was reported that the patient did not have a reaction with his first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine given the same day included in the right deltoid a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) and in the left deltoid a dose of diphtheria toxoid (+) pertussis acellular 1-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus toxoid (DTAP-IPV). Concomitant medications include fexofenadine hydrochloride (ALLEGRA), montelukast sodium (MSD) and albuterol. On 09-MAY-2007 the patient experienced redness and swelling at the injection site. On 10-MAY-2007 it was reported via a phone call that the patient's arm was more swollen and the red spot was larger. On 11-MAY-2007 the child was seen in the office at 15:15 pm and the child's arm was tender at the injection site and swollen about 5 inches in diameter with an irregular circle noted. The inner circle was red with a darker red on the outer circle. The child was treated with cephalexin (KEFLEX). The patient's status at the time of the report was not recovered. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a registered nurse stated that the patient received a concomitant intramuscular dose of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) (Lot # "C2644AA") in the left arm. The lot # for MENACTRA was "U2227AA". On 10-MAY-2007, the patient's left arm (back of arm) became swollen, red, and tender to touch. The patient called the office on 10-MAY-2007 and was advised to come in. The patient was seen on 11-MAY-2007 and diagnosed with cellulitis and place on cephalexin (KEFLEX) 250mg, 1 tablet, three times a day. On 21-MAY-2007, a follow-up call was made to the parent and it was noted that the patient's symptoms had resolved. The patient recovered. There were no diagnostic tests or labs performed. There were no adverse events following prior vaccinations. There was no illness at the time of vaccination.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 9 year old male who in approximately 1999 was vaccinated with a 0.5 mL SC dose of varicella virus vaccine live (Oka/Merck) (Lot number not provided) a 1 year of age. Subsequently, the patient developed breakthrough chickenpox with 50 to 100 lesions. Unspecified medical attention was sought. The patient was noted as "doing better." No product quality complaint reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Rash papular, Rash pustular
Clinical narrative: Information has been received concerning an 8 year old white male allergic to amoxicillin and cefprozil (CEFZIL) who on 14-JUN-1999 was vaccinated with a subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot #629259/0307J) in the right arm. Concomitant vaccines administered on the same day included a subcutaneous dose of measles-mumps-rubella vaccine (M-M-R II) (630261/0133J) administered in the left arm. The patient had no illness at the time of vaccination. On 10-MAY-2007 the patient developed a fine papular rash, some with papular centers and pustules, approximately 4-5 on the abdomen. Subsequently, the patient recovered. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male with no know medical history or allergies who on 20-MAY-1998 was vaccinated with a subcutaneous dose of varicella virus vaccine live (Oka/Merck) in the right thigh (Lot # "1567G"). Concomitant vaccines administered on the same day included subcutaneous dose of M-M-R II (Lot #625833/0033H) in the left thigh. The patient had no illness at the time of vaccination. On 06-MAY-2007, the patient started itching and on 09-MAY-2007 the patient broke out in lesions with less than or equal to 50 lesions. Subsequently, the patient recovered. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash maculo-papular, Rash pustular
Clinical narrative: Information has bee received from a nurse practitioner concerning a 36 year old female who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #656077/1491F). Subsequently, the patient experienced 2 small pustules and a raised macular papular rash 4 cm X 5 mm 24 hours after receiving the vaccine. As of 15-MAY-2007, the patient had not recovered. Medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information received indicated that the nurse practitioner was unable to locate the patient's chart, no name was provided. No further information is available. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a nurse practitioner concerning a 10 year old female with no known allergies or pertinent medical history who on 02-JUN-1998 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #623652/0805D). There was no concomitant medication. On 12-MAY-2007, the patient experienced a varicella like rash of over 50 lesions. The rash developed over her neck and chest and has spread to the face and all extremities. The patient was told to take Benadryl. As of 15-MAY-2007, the patient had not recovered. Medical attention was sought. No labs were performed. Follow up information received from the physician indicated that the patient was seen in the office with varicella. No additional adverse experiences were reported. No further information was provided. No further information is expected.
Age: 1.1
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 9 year old female (55lbs., 47 inches) who on 05-AUG-1998 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #626400/0663H). Concomitant therapy included measles-mumps-rubella vaccine (MSD) (Lot #627842/0798H), for the treatment of prophylaxis (duration and dose not reported). On 10-MAY-2007, the patient experienced chickenpox. Subsequently, the patient recovered from chickenpox. No further information is available.
Age: 7.0
Sex: U
Vaccine: VARCEL
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Information has been received from a physician concerning a 7 year old patient with "no unusual medical history" who on 12-NOV-2003 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On 11-MAY-2007, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 656173/1499F). On 13-MAY-2007 (two days after receiving second dose of vaccine), the patient experienced wheezing and shortness of breath. The patient was treat with epinephrine and nebulizer. It was reported that the patient "responded well," but the outcome was not reported. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Pharyngolaryngeal pain, Pruritus, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a physician concerning a male who on 05-NOV-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) and did not experience any symptoms following this dose. The patient was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) on 16-APR-2007. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and ibuprofen (MOTRIN). The physician reported that the patient came in to the office on 16-MAY-2007 with a fever, headache, and sore throat. There were also 4 lesions on the patient's left forearm with an itch. The physician believed it was breakthrough chicken pox. The onset of the adverse events was reported as unknown. No further information was provided. No laboratory or diagnostic tests were provided. No laboratory or diagnostic tests were performed. No product quality complaint was involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a male who on 05-NOV-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) and did not experience any symptoms following this dose. The patient was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) on 16-APR-2007. Concomitant therapy included cetirizine hydrochloride (ZYRTEC) and ibuprofen (MOTRIN). The physician reported that the patient came in to the office on 16-MAY-2007 with a fever, headache, and sore throat. There were also 4 lesions on the patient's left forearm with an itch. The physician believed it was breakthrough chicken pox. The onset of the adverse events was reported as unknown. No further information was provided. No laboratory or diagnostic tests were provided. No laboratory or diagnostic tests were performed. No product quality complaint was involved. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a health professional concerning an 8 year old female whose twin sister was vaccinated with a 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot#626409/0666H) on 21-Oct-1998. It was reported, that "currently," in 2007, the patient had one questionable lesion with no other symptoms. No other information was provided. The patient's twin sister experienced a varicella rash and a fever following vaccination with varicella virus vaccine live (Oka/Merck) (WAES# 0705USA00066). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a student either a sophomore or junior in high school, who was vaccinated with varicella virus vaccine live (Oka/Merck) on an unknown date, from another physician (information unknown). The patient developed breakthrough chickenpox. The chickenpox was severe with more than 50 lesions, and was a "full blown case." Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed "significant amount of erythema" 3 days after vaccination. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.