chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 08-OCT-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an approximate 5-year-old patient who on 11-Feb-2003 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 11-year-old female who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 24-SEP-2007, the patient developed chickenpox. The patient's mother sought medical attention via phone call with the school nurse who contacted the health department. No diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. This is one of several reports received from the same source. Follow-up information indicated the patient was not vaccinated at the health department. Her "condition resolved" on an unspecified date. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed visiting nurse concerning a patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a non-serous localized injection site reaction. It was unspecified if medical attention was sought. The injection site reaction resolved on an unspecified day by 06-APR-2007. No further information was provided. Additional information is not expected. This is on of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a licensed visiting nurse concerning a patient who on an unspecified date was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed a non-serious localized injection site reaction. It was unspecified if medical attention was sought. The injection site reaction resolved on an unspecified day by 06-APR-2007. No further information was provided. Additional information is not expected. This is one of several reports from the same source.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no known drug allergies and sickle cell trait, who on 05-AUG-1998, received her initial 0.5 mL subcutaneous dose, and on 21-SEP-2007, she received her second 0.5 mL subcutaneous dose in the right arm of varicella virus vaccine live (Oka/Merck). There was no reported illness at the time of vaccination. On 24-SEP-2007, she was evaluated in the physicians office after she experienced a 3 inch X 3.5 inch area of erythema at injection site. Treatment included the "recommendation of Benadryl". On 26-SEP-2007, she was re-evaluated in follow up and "the symptoms had improved". There were no laboratory or diagnostic tests performed. No product quality complaint was reported. No further information was available. Follow up information from the physicians office reported that the patient was treated with clindamycin 300 mg every eight hours and Benadryl 25 mg every eight hours as needed (duration not reported). At the time of this report it was reported that the patient had recovered. Upon follow up, a caller (unidentified) stated there was no additional adverse event information and does not wish to receive any further letters. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 67 year old female patient who on 26-SEP-2007, was vaccinated with mL dose in the right deltoid of varicella virus vaccine live (Oka/Merck) (lot # 654696/1056F) instead of zoster vaccine live (Oka/Merck). No adverse events or current patient status were reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 20 month old male with no known pre-existing allergies, birth defects or medical conditions, who on 29-JAN-2007, was vaccinated with a subcutaneous dose of varicella virus vaccine live (Oka/Merck) ("lot # 08047"). The patient also received on an unreported date a subcutaneous dose in the right of measles virus vaccine live (Enders-Edmonston) (lot # "08047"). There was no reported illness at the time of the vaccination. It was reported that there was no adverse events from previous vaccinations. On 22-SEP-2007, the patient developed shingles (herpes zoster). "It manifested in a typical manner at the upper extremity to the arm with little vesicles." The patient was seen by the physician and therapy was initiated with acyclovir. Current patient status was not reported. No product quality complaint was reported. No further information was available. Additional information received from the physician's office reported that the treatment also included calamine lotion. No diagnostic test or laboratory studies were reported. It was reported that around 01-OCT-2007, the patient had recovered. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 7 year old male, with no pertinent medical history, drug reactions or allergies who on 22-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #643086/0474M). There was no concomitant medication. On 26-SEP-2007, the patient developed a fever and the classic chickenpox vesicles. At the time of reporting the patient was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female junior high school student who about six months ago, in approximately March 2007, was vaccinated with 0.5 mL, booster shot, of varicella virus vaccine live (Oka/Merck). On an undisclosed date the patient developed shingles. At the time of reporting the patient was recovered. Unspecified medical attention was sought. There was no product quality complaint.
Sex: U
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). The patient developed a varicella outbreak shortly after vaccination characterized by a generalized vesicular rash. It was unknown if medical attention was sought. Subsequently, the patient recovered and the rashes have since resolved. There was no product quality complaint. This is one of several reports from the same source.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health registered nurse concerning a 7 year old male who on 25-OCT-2000 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a county health nurse concerning a 9 year old female who on 11-JUN-1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-FEB-2007 the patient developed varicella, between 50 and 249 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male junior high school student who about six months ago, in approximately March 2007, was vaccinated with 0.5 ml, booster shot, of varicella virus vaccine live (Oka/Merck). On an undisclosed date the patient developed shingles. At the time of reporting the patient was recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 2.9
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 35 month old female who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date in 2007, the patient developed chickenpox after being exposed to another child who had shingles. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health professional concerning a 10 year old male who on 06-FEB-1998 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-FEB-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 0.6
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning an 8 month old male who on an unspecified date in 2007 developed chickenpox after being exposed to another child who was vaccinated with varicella virus vaccine live (Oka/Merck), on 21-APR-1999 and subsequently developed shingles. It was noted that the patient had not been vaccinated with varicella virus vaccine live (Oka/Merck). 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: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 7 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658432/1246U). Subsequently, the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008.  Follow up information has been received on 24-MAR-2008 from a medical assistant concerning a 7 year old male patient with no pre-existing allergies, birth defects, or medical condition who, on 11-DEC-2007, was vaccinated with a second dose of VARIVAX (Merck) (Lot #658412/1246U) subcutaneously in the left thigh at 9:30 AM.  It was also reported that the patient did not have any illnesses at the time of vaccination.  Other vaccinations received the same day included VAQTA (lot number 659186/1258U) intramuscularly in right thigh.  On 13-DEC-2007 (also reported as 13-DEC-2008), the patient developed redness, pain, 2 mm red indurated area around VARIVAX (Merck) (lot 658432/1246U) injection site on left thigh.  On an unspecified date, the patient recovered.  No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning an 8 year old patient who was vaccinated with a varicella virus vaccine live (Oka/Merck) (Lot #659533/1594U). Subsequently the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #659533/1594U). Subsequently the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Follow up information has been received from a medical assistant concerning a 5 year old male patient with no pre-existing allergies, birth defects, or medical conditions, who on 21-JAN-2008, was vaccinated with a second dose of varicella vaccine live (Oka/Merck) (LOT #659533/1594U, dose not reported) subcutaneously in the left thigh. It was also reported that the patient had no illnesses at the time of vaccination. Other vaccination received on 21-JAN-2008 included hepatitis A virus vaccine inactivated (MSD) (lot number 654514/0304U) intramuscularly in right thigh. On 23-JAN-2008, the patient developed a red, hot swollen area at injection site on left thigh. On an unspecified date, the patient recovered. No further information is available.
Age: 6.0
Sex: F
Vaccine: HEP, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 6 year old female patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #659155/1366U). Subsequently, the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested. Follow up information has been received from a medical assistant on 24-MAR-2008 concerning a 6 year old female patient with an allergy (hives) to amoxicillin who on 29-JAN-2008, was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot #659155/1366U) (dose unknown), subcutaneously in the left thigh. It was also reported that the patient had no illnesses at the time of vaccination. Other vaccinations received on the same day included hepatitis A virus vaccine inactivated (MSD) (lot number 657307/0442U), intramuscularly in the right thigh and hepatitis B virus vaccine rHBsAG (yeast) (MSD) (lot number 652882/0106F), intramuscularly in the right thigh. On an unspecified date, the patient experienced redness/swelling with pain over varicella virus vaccine live (Oka/Merck) site. No itching was noted. On an unknown date, the patient recovered. It was also reported that the patient's siblings experience an adverse event on varicella virus vaccine live (Oka/Merck) (MDS) WAES 0803USA00596). No further information is available.
Age: 1.13
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 13 month old female patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #659155/1366U). Subsequently, the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Follow up information has been received on 24-MAR-2008 from a medical assistant concerning a white 13 month old female patient who on 23-JAN-2008 was vaccinated with a second dose of VARIVAX (lot # 659155/1366U), dose unknown. Subcutaneously in the right thigh. Other vaccination received on 23-JAN-2008 included hepatitis A virus vaccine inactivated (MSD) ( lot number 657307/0440U) intramuscularly, left thigh and MMR II (lot number 656544/0700F) subcutaneously, left thigh. On an unspecified date, the patient experienced a red raised are on right thigh around VARIVAX site. It was also reported that in an unspecified date, the patient experienced swelling and itching afte receiving VARIVAX. On an unknown date, the patient recovered. No further information is available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Abdominal pain upper, Anorexia, Herpes zoster, Vomiting, Weight decreased
Clinical narrative: Information has been received from a consumer concerning her 6 year old niece with no pertinent medical history and an allergy to milk products, who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 03-MAR-2008, the patient was diagnosed with shingles on her right arm. "She was given an antiviral and Motrin for the pain."On 04-MAR-2008, the patient's mother reported that "her daughter had developed a few new blisters on her right hand. She had also been experiencing severe stomach pain, vomiting, and loss of appetite and weight. It was noted that the patient's father noticed two blisters on his arm but was not sure if it was related to his daughter's case of shingles. No further information was given. Unspecified medical attention was sought by the pediatrician. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.24
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Pyrexia, Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who on 02-OCT-1997 was vaccinated SC with a first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) ( lot number: 622625/0085E). Concomitant therapy included Pediarix, measles-mumps-rubella vaccine (MDS) and Hib conj vaccine (unspecified carrier). On 26-FEB-2008, the patient developed a general rash of 50-500 lesions and a temperature of 103.3. The patient was diagnosed with chickenpox. No other information was available at the time. There were no lab diagnostic studies performed. Unspecified medical attention was sought through a phone call. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information from the registered nurse provided no additional information. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 50 year old female who in approximately 1996 or 1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In approximately 1996 or 1998 the patient experienced a chickenpox rash. The caller was not certain of the date of administration but stated that the patient received the vaccination in either 1996 or 1998. The patient experienced a mild case of chickenpox during that time period in which she received the vaccine. The patient was not being seen at the practice at the time of experiencing the chickenpox. There was no further information. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old male who on 05-MAR-2008, inadvertently was vaccinated with a 0.5 mL subcutaneous dose of in the left arm of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). It was indicated by the registered nurse that it was staff error only. The patient had no reported adverse complaints post vaccination. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008.  Initial and follow up information has been received from a registered nurse concerning a 65 year old male who on 05-MAR-2008, inadvertently was vaccinated with a 0.5 ml, subcutaneous dose in the left arm of varicella virus vaccine live (Merck) (Lot # 658052/1008U) instead of zoster vaccine live (Merck) (MSD).  It was indicated by the registered nurse that it was staff error only.  The patient had no reported adverse complaints post vaccination.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Culture, Rash vesicular, Varicella
Clinical narrative: Information has been received from a health professional concerning a 7 year old male with peanut allergy and a history of mild asthma who was vaccinated with 0.5 ml subcutaneous doses of varicella virus vaccine live (Oka/Merck) on 07-FEB-2001 and 18-SEP-2007 (Lot# 658184/1094U). There was no concomitant medication. "About 3 weeks ago", on approximately 30-JAN-2008, symptoms of a rash began and two days ago, on 03-MAR-2008, a second rash developed. The rash was determined to be chickenpox. Rashes were described as vesicular and pustular lesions. At the time of the report the patient was seen in the office. No product quality complaint was involved. No other information was provided. This is  one of several reports from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/16/2008. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 7 year old female, with no medical history and no allergies, who was vaccinated with 0.5 mL doses of varicella virus vaccine live (Oka/Merck) on 11-OCT-2007 and 09-OCT-2007 (Lot# 658423/1180U). There was not concomitant medication. "About six days ago", on approximately 28-FEB-2008, symptoms began. Symptoms were described as bumps on the body itching, less than 50 pocks areas and no vesicles. It was reported that it appeared that the patient was no longer contagious. Subsequently the patient recovered. The patient was seen in the office on 05-MAR-2008. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. No other information was provided. This is one of several reports from the same source. This is in follow-up to report (s) previously submitted on 5-16-2008. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site urticaria, Pain, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 11 year old male who on 26-FEB-2008 was vaccinated with a second dose subcutaneously in the left arm of varicella virus vaccine live (Oka/Merck) (lot# 659696/1762U). On 28-FEB-2008, the patient developed a large welt at the site of the varicella virus vaccine live (Oka/Merck) injection. It was indicated that he also developed itchiness (site unspecified), pain (site unspecified), and low grade temp. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male with no known allergies and no pertinent medical history who on 29-MAR-2001 was vaccinated with VARIVAX (Merck). On 04-MAR-2008, the patient developed chicken pox. The patient was seen in the physician's office on 05-MAR-2008 and the chicken pox was described as less than 50 lesions and generalized over whole body. The chicken pox was itchy, but no fever was noted. Laboratory diagnostic studies were not performed. As of 06-MAR-2008, the patient had not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008.  Initial and follow up information has been received from a health professional concerning a 7 year old male with no known allergies and no pertinent medical history who on 29-MAR-2001 was vaccinated with VARIVAX (Merck).  The patient was seen in the physician's office on 05-MAR-2008 for an itchy rash that was present for one day prior to evaluation in the office.  Upon examination it was noted that the patient had 10 to 12 papular vesicular lesions with some scabing lesions scattered on the trunk and legs, also described as less than 50 lesions and generalized over whole body and was itchy.  The patient was afebrile.  A clinical diagnosis of varicella was made.  Laboratory diagnostic studies were not performed.  At the time of reporting the patient had recovered on an unspecified date.  Additional information is not expected.
Age: 1.2
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature, Rash vesicular
Clinical narrative: Information has been received from a county health nurse as confirmed by a school nurse and patient's mother concerning a 9 year old male patient with unknown medical history, drug reactions or allergies who on 25-FEB-2000 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot number 632369/1461J) subcutaneously in the right arm. No concomitant medications were reported. On 27-FEB-2008, the patient had a generalized varicella like rash with 44 lesions, but no fever. All lesions were crusted over. The patient experienced no problems and had recovered on an unknown date. It was reported that patient sought medical attention "in the office." There was no product quality complaint. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a county health nurse concerning a 6 year old male who on 18-JAN-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 10-MAR-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had take place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Skin test negative
Clinical narrative: Information has been received from a health professional concerning an 8 year old female with no medical history and no known allergies who on 05-SEP-2007, received her second dose of varicella virus vaccine live (Oka/Merck) (lot # 658018/1007U) 0.5 mL subcutaneously in the outer aspect of the left upper arm. Concomitant vaccine included Havrix. On 07-SEP-2007, she returned to the office for evaluation of the outer aspect of the upper left arm (site of varicella virus vaccine live (Oka/Merck) administration) that was red, swollen and blistered. Diagnostics included a culture of the blister that revealed no significant findings. Treatment included: a prescription for Keflex of 5 days duration and a "dry dressing". On 10-SEP-2007, the patient's mother called the physician's office to report a new blister. Patient's current status was not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Local swelling
Clinical narrative: Information has been received from a physician concerning a 4 year old female who on 20-SEP-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (no lot number provided). Almost immediately after vaccination, the patient developed an area 6 to 70 cm in size with localized swelling and redness. The area was gray-looking in the center where there was swelling. The patient was treated with Benadryl and monitored for 30 minutes. The swelling went down and the patient was released. The patient was noted to be recovering. There was no product quality complaint. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male who on 25-JUL-2007 and 12-SEP-2007 was vaccinated with his first and second (lot# 654813/1088F) 0.5ml doses of varicella virus vaccine live (Oka/Merck). There was no other concomitant medication. On 12-SEP-2007, the patient developed a rash on his face which was mainly on his nose. On that same day medical attention was sought through the health department. At the time of this report the patient was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Tenderness, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 6-year-old male who on 13-Sep-2007 was vaccinated subcutaneously with a second dose of 0.5 milliliters of varicella virus vaccine live (Oka/Merck). The first subcutaneous dose of 0.5 milliliters of varicella virus vaccine live (Oka/Merck) was received on 31-May-2002. Subsequently, on an unspecified date after the second dose, the patient developed hives. The condition progressed to a 3x3 inch rash on the upper arm. It was raised and tender to the feel. Unspecified medical attention was sought. The outcome was reported as recovering. No product quality complaint was involved. Follow-up information has been received from the nurse who states that she was not able to identify the patient and was not able to provide any further information. No further adverse events were provided. Follow-up information has been received from the L.P.N. who indicated that no further information was available. This is one of several reports from the same source. No further information is available.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a 16 year old female with a penicillin allergy and no pertinent medical history who on 22-APR-1996 was vaccinated SC in the left triceps with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck). On 18-SEP-2007 the patient received SC in the left arm a second booster dose of varicella virus vaccine live (Oka/Merck) (Lot#658197/0853U). Concomitant vaccines included a second dose of MSD vaccine (yeast) (Lot#658560/1062U) given in the right arm, and a dose of MENACTRA vaccine (dip toxoid) (Lot#U2402AAA) also given in the left arm. On 19-SEP-2007 the patient developed a swollen and red arm. The nurse told the mother to apply a warm compress, look for any red lines, or fever, and to let the office know if the patient's arm did not improve. No lab studies were performed. On 20-SEP-2007 the mother called and said the arm was worse. The nurse instructed her to continue with the warm compresses. The nurse made a follow up call to the mother on 21-SEP-2007 and the arm continued to be reddened, but the swelling was less. On an unspecified date the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 658176/1011U). It was reported that a series of parents have been calling since the administration of the second dose of varicella virus vaccine live (Oka/Merck) to report that the children are experiencing local non-systemic reactions. The patient's parent sought medical attention via a phone call to the child's physician. Subsequently, the patient recovered at an unspecified date per the nurse "because no parents called back after initial call'. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 9 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced injection site reaction of swelling and itching that lasted for more than three days. Medical attention was sought. The patient has been recovering. No product quality complaint was involved. This one of two reports from the same source (WAES0708USA05334). Further information has been requested.
Age: 17.0
Sex: F
Vaccine: FLU3, HPV4, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 17-year-old female with no pertinent medical history or allergies who on 27-APR-1998 was vaccinated subcutaneous with her first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 658406/1175U) and her second dose on 17-SEP-2007. Concomitant therapies included amitriptyline hydrochloride (MSD), ethinyl estradiol/norgestimate (TRI-SPRINTEC) and another vaccine administered on 17-SEP-2007. On 20-SEP-2007 the patient experienced redness, pain, swelling and itching at the injection site of the left upper arm. The patient was examined in the office later the same day and the exam revealed 8x7 cm area of redness with a central 1.5x1.5 cm induration. The physician recommended cool compress and BENADRYL. No diagnostic labs were performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Follow-up information received on 07-DEC-2007 indicated the patient was vaccinated at 15:00 subcutaneous in the left arm on 17-SEP-2007 with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658406/1175U) (lot # 658406/1175U was previously reported as the first dose). There were no illnesses at the time of vaccination. Concomitant vaccines administered on 17-SEP-2007 at 15:00 included a first intramuscular dose of BOOSTRIX (lot # AC528015AA), a first intramuscular dose of MSD vaccine (yeast) (lot # 658560/1062U) and a fifth intramuscular dose of FLUZONE vaccine inactivated (lot # U2436AA). On 19-SEP-2007 (previously reported as 20-SEP-2007) the patient experienced 8x7 cm area of redness with a 1.5x1.5 cm induration on the left post arm at the site of the varicella virus vaccine live (Oka/Merck) injection. The patient was seen in the office of the 20-SEP-2007 for red, swollen itch. On 01-OCT-2007 the patient was seen at a "visit" and was "okay". Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days", There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old female who in approximately the year 1997, when he was 12 months old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In May 2007 5 to 10 days after her brother the patient experienced breakthrough chicken pox with 2 dozen lesions on this torso and 3 dozen lesions on his head. Unspecified medical attention was sought. Unspecified medical attention was sought. He was treated with calamine (+) camphor (+) diphenhydramine hydrochloride (CALADRYL) and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) baths. It was reported that his lesions healed. No diagnostic laboratory tests were undertaken. No product quality complaint was involved. This is one of several reports received from the same source. It was reported that the patient's brother WAES0706USA01505 experienced a similar event following vaccination with varicella virus live (Oka/Merck). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested
Age: 12.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Some time after receiving the vaccine the patient developed chicken pox. It was unknown whether medical attention was sought, the patient's outcome was unknown. No product quality complaint was involved. This is one of two patients of same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Some time after receiving the vaccine the patient developed chicken pox. It was unknown whether medical attention was sought, the patient's outcome was unknown. No product quality complaint was involved. This is one of two patients of same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella, Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 year old male with Attention deficit/hyperactivity disorder, who on 25-JUL-2007 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 657195/0366U). Concomitant therapy included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). Three weeks after the vaccination the patient developed chicken pox. Medical attention was sought. Subsequently, the patient recovered from chicken pox. No product quality complaint was involved. This is one of two patients of same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a certified medical assistant concerning a 12 year old male with Attention deficit/hyperactivity disorder, who on 25-JUL-2007 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 657195/0366U). Concomitant therapy included diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). Three weeks after the vaccination the patient developed chicken pox. Medical attention was sought. Subsequently, the patient recovered from chicken pox. No product quality complaint was involved. This is one of two patients of same source. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Abasia, Arthralgia, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse concerning a 2-year-old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed joint pain and was unable to walk. The patient sought unspecified medical attention. At the time of the report the patient's status was recovering. A product quality complaint was not involved. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed an injection site reaction. The patient sought unspecified medical attention. The patient's status was reported as "improved after a couple of days". There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been been requested.
Age: 15.0
Sex: F
Vaccine: MEN, VARCEL
Symptoms: Blood glucose, Blood human chorionic gonadotropin positive, Blood test, Drug exposure during pregnancy, Rash
Clinical narrative: Information has been received through the Merck pregnancy registry from a consumer concerning her 15 year old daughter, with no medical history and no allergies, who on 20-FEB-2008 was vaccinated with a single dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccine included a dose of meningococcal vaccine (unspecified). On 28-FEB-2008 the reporter learned that her daughter was pregnant. The patient was at approximately 2 months gestation. It was reported that the patient also developed a rash on her back. At the time of the report the patient had not been seen by a physician. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning an 11 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #657715/0609U). Subsequently the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested. Follow-up: Concomitant vaccines administered on 30-AUG-2007. Concomitant vaccines administered on 30-AUG-2007 included a first intrmuscular dose of hepatitis A virus vaccine inactivated (lot # 652293/0249U) adminsitered in the left arm and a first intramuscular dose ADACEL (lot # C2825AA) administered in the left arm. On 31-AUG-2007 the patient developed as injection site reaction described as injection site swelling and injection site itching. It was also noted on 31-AUG-2007 the patient experienced a 4 cm red, swollen area over VARIVAX site that was painful to touch. The patient sought unspecified medical attention.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 5 year old male, who was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658430/1183U) in his thigh. He experienced "profuse swelling the size of a golf ball" at the injection site. Medical attention (unspecified) was sought. Current patient status was not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a medical assistant concerning a 12 year old male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658432/1246U). Subsequently the patient developed an injection site reaction described as in. There was no product quality complaint. Follow-up information was received which reported that on 09-OCT-2007 the 12 year old whThis report is one of several fite male patient with no pre-existing allergies, birth defects, medical conditions was vaccinated subsquently in in the left arm with the second dose of Varivax (lot #658432/1246U). On the same day the patient was also vaccinated with the first dose of FLUZONE (lot #U2443AA) intramuscularly in the right arm. On 12-OCT-2007 the patient rom the same sourc experienced injection site itch. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 03-AUG-2007, was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The pharmacist stated that it was "staff error and not product confusion". The patient experienced no adverse experiences. A product quality complaint was not reported. No other information was available. Additional information is not expected.