chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 4 year old male who on an unspecified date was vaccinated with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 659428/1589U). Concomitant vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), poliovirus vaccine and measles-mumps-rubella vaccine (manufacturer unspecified). After receiving the dose of varicella virus vaccine live (Oka/Merck) on 14-FEB-2008, the patient developed redness, itching and a slight rash around the injection site. There were no laboratory or diagnostic studies performed. On an unspecified date, the patient had recovered. A product complaint was not reported. Additional information has been requested.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning two patients both "older children" who received on an unspecified date a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date, it was indicated that the two patients developed breakthrough varicella. No intervention was reported. On an unspecified date, both patients had recovered. A product quality complaint was not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow up information from the nurse, identified a 4 year old male child, who on 11-AUG-2004 was vaccinated with the first dose of varicella virus vaccine (lot # not reported), and on 31-AUG-2007, was vaccinated in follow up with the first dose of live measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot #658187/0790U). On 09-FEB-2008, the child was diagnosed with varicella. No additional details were provided. Follow-up information received from the nurse indicating that the patient recovered from varicella on an unknown date. This is one of several reports from the same source.
Age: 3.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a 36 month old patient who at the age of 12 months (date unspecified) was vaccinated with varicella virus vaccine live (Oka/Merck). Two years later (36 months of age, unspecified date), it was reported that the patient developed shingles. 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.  Follow-up information received from a registered nurse indicated that she was called for the original reporter to report that the case was received from a nurse at another physician's office and concerns a patient who was vaccinated with the vaccine at 12 months and developed shingles 2 years later.  The patient's care facility's information was provided.  Please contact for further information.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Underdose
Clinical narrative: Information has been received from a health professional concerning a patient who on 12-DEC-2007, while receiving varicella virus vaccine live (Oka/Merck), did not receive the whole dose as a result of the vaccine administrator receiving a splash in the eye from the vaccine. Current patient status was not reported. A product quality complaint was not reported. This is one of two reports from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning an "8" year old male with asthma who on an unspecified date was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). It was indicated that "about 8 days after receiving the varicella virus vaccine live (Oka/Merck)" (date not specified), the patient developed a rash on his lower extremities, which moved up his body. It was reported that the rash did not look like chicken pox, but it was not ruled out. At the time of this report, the patient had not recovered. A product quality complaint was not reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a male child with no pertinent medical history, and no known drug reaction/allergies, who on 21-FEB-2008 was vaccinated with a 0.5 ml subcutaneous dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 21-FEB-2008, the patient developed redness at the injection site. It was indicated that no other symptoms were noted. No laboratory or diagnostic studies were performed. At the time of this report, it was indicated that the patient was recovering. A product quality complaint was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning an approximately 8 year old male who in May 2000, was vaccinated with varicella virus vaccine live (Oka/Merck). In 2007, the patient developed a case of chicken pox. A product quality complaint was not reported. Follow up information from the health professional indicated that there was no additional information to provide.
Age: 65.0
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an "about" 65 year old patient who in September 2007, was inadvertently vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). Medical attention was sought in the office. It was reported that this was not product confusion. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature, Herpes zoster, Irritability, Pain in extremity, Rash
Clinical narrative: Information has been received from a physician concerning a 19 month old male with no known drug allergies and no pertinent medical history, who on 13-JUN-2007 was vaccinated with a 0.5 ml subcutaneous dose in the right arm of varicella virus vaccine live (Oka/Merck) (lot# 657002/0337U). There was concomitant medication. On 01-FEB-2008 the patient developed pain in the right arm. The patient's parents informed the physician that he had become fussy and was shaking his right arm. On 02-FEB-2008 (also reported as "3 days ago", 03-FEB-2008), the patient developed a shingles rash down the right arm. The physician indicated there were about 30 to 40 lesions, and that it was a C-5 (cervical) distribution from the right shoulder down the entire arm. The physician reported that the patient had not had any natural exposure to the virus. Laboratory and diagnostic studies were not performed. At the time of this report, it was reported that on am unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Tremor
Clinical narrative: Information has been received from a physician concerning a 19 month old male with no known drug allergies and no pertinent medical history, who on 13-JUN-2007 was vaccinated with a 0.5 ml subcutaneous dose in the right arm of varicella virus vaccine live (Oka/Merck) (lot# 657002/0337U). There was concomitant medication. On 01-FEB-2008 the patient developed pain in the right arm. The patient's parents informed the physician that he had become fussy and was shaking his right arm. On 02-FEB-2008 (also reported as "3 days ago", 03-FEB-2008), the patient developed a shingles rash down the right arm. The physician indicated there were about 30 to 40 lesions, and that it was a C-5 (cervical) distribution from the right shoulder down the entire arm. The physician reported that the patient had not had any natural exposure to the virus. Laboratory and diagnostic studies were not performed. At the time of this report, it was reported that on am unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Full blood count, Immediate post-injection reaction, Liver function test, Metabolic function test
Clinical narrative: Information has been received from a physician concerning a 15 year old 245 lb. approximately 67 in. (last measured 2006) immuno-compromised male with chronic neutropenia who on 11-JAN-2008, was vaccinated with a first dose in the right arm of varicella virus vaccine live (Oka/Merck) (lot#/ "1339V"). Concomitant therapy included unspecified medication. Illness at the time of vaccination was reported as sinusitis. It was indicated that he immediately broke out in a rash after he had received the vaccine. On 04-FEB-2008, the physician indicated that the rash was papular rash; he was covered head to toe; had 5 to 6 millimeter sized welts, also described as blanchy raised patches. The patient itched badly and developed fevers to 103 degrees Fahrenheit. With regard to the patient's history, the patient was sent to an emergency department. It was indicated that the emergency department initiated therapy with acyclovir. Diagnostic studies performed included complete blood count, liver function studies, and basic metabolic panel. Results of the diagnostic studies were not reported. It was indicated that he was released the same day from the emergency department. It was mentioned that on an unspecified date the acyclovir significantly improved the rash, and stopped the fever. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Pallor, Pruritus, Pyrexia, Rash papular, Urticaria
Clinical narrative: Information has been received from a physician concerning a 15 year old 245 lb. approximately 67 in. (last measured 2006) immuno-compromised male with chronic neutropenia who on 11-JAN-2008, was vaccinated with a first dose in the right arm of varicella virus vaccine live (Oka/Merck) (lot#/ "1339V"). Concomitant therapy included unspecified medication. Illness at the time of vaccination was reported as sinusitis. It was indicated that he immediately broke out in a rash after he had received the vaccine. On 04-FEB-2008, the physician indicated that the rash was papular rash; he was covered head to toe; had 5 to 6 millimeter sized welts, also described as blanchy raised patches. The patient itched badly and developed fevers to 103 degrees Fahrenheit. With regard to the patient's history, the patient was sent to an emergency department. It was indicated that the emergency department initiated therapy with acyclovir. Diagnostic studies performed included complete blood count, liver function studies, and basic metabolic panel. Results of the diagnostic studies were not reported. It was indicated that he was released the same day from the emergency department. It was mentioned that on an unspecified date the acyclovir significantly improved the rash, and stopped the fever. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated intramuscular, on an unspecified date, with a dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient experienced a breakthrough of varicella (less than 50 lesions). At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 31-JAN-2008 was vaccinated with a second subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (lot# 658964/1466U). On 03-FEB-2008, the patient developed itching, silver dollar sized redness and raised-like rash. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a coordinator of health services concerning a second grader who may have been vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In February 2008,("over the last several weeks"), the patient developed chickenpox. The reporter did not know if the patient had been vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck); could not verify administration route and did not know if it had ever been introduced. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/16/2008.  Follow-up information received 21-APR-2008:  The coordinator of health services does not have specific patient information on any of the children.  Additional information is not expected.
Age: 60.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 60 year old patient who "about 9 months ago" (approximately May 2007), was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) rather than zoster vaccine live (Oka/Merck). There was no reported adverse experience related to this event. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female who on 22-JAN-2008, who was supposed to have received zoster vaccine live (Oka/Merck), was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck). The patient was not experiencing any known symptoms. It was indicated that the incident was due to human error. A product quality complaint was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a male with irritable bowel who was vaccinated on 11-FEB-2008 with varicella virus vaccine live (Oka/Merck) second dose. The doctor reported that a child received a second dose of varicella virus vaccine and immediately experienced a large raised area, like a white bubble at the injection site. The physician feels that it was administered intradermally rather than subcutaneously. The patient was treated with ice as needed and will be seen in the office on 13-FEB-2008. The patient was vaccinated with the first dose at one year of age. It was reported that the patient had not improved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella zoster serology negative
Clinical narrative: Information has been received from a health professional concerning a female who on 26-JAN-2007, received her first 0.5 ml subcutaneous dose of varicella virus vaccine live (Oka/Merck). On 26-FEB-2007, she received her second 0.5 ml subcutaneous dose of varicella virus vaccine live (Oka/Merck). It was indicated that on 08-FEB-2008, her antibody titer for varicella was negative. The patient sought medical attention at the physician's office. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female who on 05-OCT-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck), and a second dose on 08 FEB 2007. There was no concomitant medication. Approximately one year after the second dose of varicella virus vaccine live (Oka/Merck), on 06-FEB-2008, the patient developed 8-10 chickenpox lesions, on her chest and 3-4 on her back. The lesions were described as small and raised with yellow fluid. It was also reported that the patient developed 8-10 watery pimples on her back and a couple on her chest on 05 FEB 2008. The patient had some itching, and was afebrile, with a normal appetite and activity. The patient was seen at the doctors office at 11:45 (date unspecified), and chickenpox was confirmed. Unspecified medical attention was sought. The lot number was not available. There was no product quality complaint. At the time of reporting the patient was recovered.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: FLUX, PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 12 month old male with no pertinent medical history, drug reactions or allergies who on 27-OCT-2007 was vaccinated subcutaneously with 0.5 mL of varicella virus vaccine live (Oka/Merck) (lot # 658374/1117U). Concomitant therapy included influenza virus vaccine (unspecified) and Prevnar. On 12-NOV-2007, the patient developed redness, local heat and swelling at injection site. The patient recovered from the redness, local heat and swelling at the injection site on an unspecified date. Unspecified medical attention was sought. There was no product quality complaint. There was no lab diagnostic studies performed. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information  has been received from a nurse practitioner concerning a 1 year old female with no medical history and no drug allergies, who on 04-FEB-2008 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 659693/1766U). Concomitant vaccination included PREVNAR vaccine(CRM197), administered in a different injection site from the varicella virus vaccine live (Oka/Merck). On 13-FEB-2008 the patient developed an injection site reaction where the varicella virus vaccine live (Oka/Merck) was administered. The symptoms included redness, local heat, and swelling. The patient was treated with an antibiotic. No laboratory diagnostics were performed. At the time of the report the patient was recovering. This is one of two reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect dose administered, Wrong technique in drug usage process
Clinical narrative: Information has been received from a health professional concerning patients (number of patients not specified) who were vaccinated with varicella virus vaccine live (Oka/Merck) and may have received doses that were "other than indicated dosing", and/or doses that were prepared with "sterile water" instead of the diluent in the vaccine administration. It was indicated that the administering physician's office and number of population involved was not specified. There were no adverse events reported. A product quality complaint was not reported. Follow up information indicated that information reported had been part of a conversation, and she has no further information available. She indicated she wanted to say that there are physicians out there that think they can use sterile water. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Drug ineffective
Clinical narrative: Information has been received from a physician regarding a 22 year old female who on 07-JUL-2006 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). A second dose of varicella virus vaccine live (Oka/Merck) was administered on 04-AUG-2006. Concomitant therapy included Ortho Tri-Cyclen. The physician reported that the patient experienced a lack of efficacy. On 03-OCT-2007, the patient had a negative antibody test. The patient's VZV antibody level was found to be seronegative. The patient has no pertinent medical history, and no drug allergies. The patient did seek unspecified medical treatment, however, she did not have to be hospitalized, it was not life threatening nor a significant disability. The physician did not have the lot numbers because the patient was vaccinated a a hospital. At the time of the report, the patient still had not recovered. Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 53-year-old female who on 18-OCT-2007 was vaccinated subcutaneous with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # /1335U) instead of zoster vaccine live (Oka/Merck). The NP stated this occurred due to medical error not product confusion. No adverse experience occurred due to the event. A product quality complaint was not involved. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Limb discomfort, Oedema peripheral, Pruritus
Clinical narrative: Information has been received from a physician concerning an 11 year old female who on 11-OCT-2007, received a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included human papillomavirus vaccine (MSD), meningococcal ACYW conjugated vaccine (diphtheria toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 13-OCT-2007, she developed itchiness, soreness, as well as being red and swollen down back of right arm to the elbow. The patient sought unspecified medical attention. It was reported that the physician recommended hydrocortisone cream and diphenhydramine (BENADRYL). Current patient status was not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated subcutaneous with a 0.65 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No adverse reaction. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning an approximately 7-year-old female with no pertinent medical history pr allergies who on 10-JUL-2001 was vaccinated subcutaneous with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) was seen in the office on 17-OCT-2007 and was diagnosed with chickenpox of the face, ears, head, trunk, buttocks and both legs. No therapy was prescribed. No concomitant medications and no diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a physician concerning a healthy 23 year old female health care worker with no pertinent medical history who in approximately 2006, was vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck). In approximately 2007, the patient's IgG varicella titers were still negative. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning an 8-year-old female with no pre-existing allergies, birth defects, or medical conditions who on 23-MAR-2000 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot #: "1682N" and "1588J"). There was no illness at the time of vaccination. On 17-JUL-2007, the patient was seen in the office and diagnosed with post varicella. Unspecified medical attention was sought. There were no adverse events following prior vaccination. It was noted that the patient's mother developed shingles in July 2007. There was no product quality complaint. This is one report of several from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 3 year old white male with no pre-existing allergies, birth defects, or medical conditions, who on 05-APR-2005 was vaccinated IM in the right leg with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 649446/0651P). On 10-JUL-2007 the patient was diagnosed with varicella. There were no diagnostic studies performed. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. The outcome was reported as recovered as of 26-JUL-2007. There was no product quality complaint. This is one report of several from the same source. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician's assistant concerning a patient who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). No symptoms were reported. The incident was reported as a medication error not a product confusion. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 16-OCT-2007 was vaccinated SC with a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported that it was a medical error and not due to product confusion. No adverse experience was reported. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Seroconversion test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with 2 doses of varicella virus vaccine live (Oka/Merck) and failed to seroconvert. The patient was tested for seropositivity after exposure to the varicella-zoster virus and had a negative titer. No additional information is expected.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning a patient who on 07-JUN-2007, was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (MSD). Reportedly he had no ill effects. Product quality complaint was not reported. Further information was not available.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Initial and follow-up information has been received from a registered nurse concerning an 11 year old male with no known allergies or pertinent medical history who on 08-APR-1997 was vaccinated SQ with a first dose of varicella virus vaccine live (Oka/Merck) (Lot #621073/0083E). Concomitant vaccination included a first SC dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot #618887/1244D). On 19-OCT-2007, the patient experienced breakthrough chicken pox. The patient had 25-30 scabbed lesions on the neck, trunk and face. The patient also had seven new lesions on the right plantar area. The patient was seen in the office (also reported as medical attention was not sought). There were no lab studies performed. On an unspecified date the patient recovered. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white female with medical history or allergies who on 18-MAR-1997 was vaccinated SC on right arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 620624/1538D). There was no illness at the time of vaccination. On 29-APR-2004, the patient come home from school with medical case of few spots that eventually crusted and went away. No medical attention was sought. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 12-year-old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, on 01-FEB-2007, the patient experienced chickenpox. It was also noted that the patient's brother developed chickenpox after vaccination with varicella virus vaccine live (Oka/Merck) (Lot # 0702USA03440). Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a 7 year old male with chronic renal insufficiency, asthma and allergic rhinitis reaction airways who on 13-SEP-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 657944/1003U). The patient was on certain medication for chronic renal insufficiency and asthma. It was reported that after vaccination the patient had an anaphylactic reaction and went to the ER and it was resolved within one day. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Face injury, Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a 10 year old female who "sometime last week" on approximately 15-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) and hepatitis A vaccine (inactive) (VAQTA). The patient was sitting on the exam table when vaccinated. Post vaccination she "passed out, fell on her face, and hit her lip". The patient was monitored at the office and recovered. There was no product quality complaint. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 13 month old female with no known pre-existing allergies, birth defects, or medical conditions, who on 13-MAY-2003 received a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot# 643586/0802M). There was no reported illness at the time of vaccination and no adverse events following prior vaccination. On 05-JUN-2003 at 09:05, the patient's dad phoned the physician's office to report that blisters were cropping up on the patient's trunk, legs and arms. The blisters reportedly were breaking, and crusting. It was indicted that calamine lotion was applied to the "crusts", and Benadryl was administered for itching. There were no relevant diagnostic tests and laboratory values. On 18-JUN-2003, the patient recovered. A product quality complaint was not reported. At the time of this report, the patient was now a 5 year old 57lb. 44 3/4 in. female.
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, Herpes zoster, Pain, Pruritus
Clinical narrative: Information has been received from a physician concerning her husband, approximately a 40 year old male who in 2000 was vaccinated with a dose of varicella virus live (Oka/Merck) and received the second dose in the same year. The physician reported that her husband who came to the US was tested for varicella titer which was negative. In 2003 or 2004 the patient experienced mild case of shingles. "It was itchy and not a lot of pain". Unknown if medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 12-month-old male with no medical history or allergies, who on 08-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658297/1106U). There was no concomitant medication. On 18-OCT-2007, 10 days after vaccination, the patient experienced "full blow chickenpox (more than 50 lesions)". Unspecified medical attention was sought, no laboratory or diagnostic studies were performed. No outcome information was reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 7-year-old white female student  with cefprozil (CEFZIL) allergy who on 13-JAN-1998 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 624248/1102E). There was no illness at the time of vaccination. On 29-MAR-2004 the patient broke out in chickenpox. No medical attention was sought. The patient was treated with calamine (+) camphor (+) pramoxine hydrochloride (AVEENO), calamine and diphenhydramine hydrochloride (BENEDRYL). Subsequently, the patient recovered from chickenpox.
Age: 0.9
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 9-year-old Caucasian female with no known allergies who in August 1995, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) in another office. On 27-FEB-2004 the patient broke out with a mild case of chickenpox. No medical attention was sought. It was reported that the patient's mother treated her with oat (AVEENO BATHS) and diphenhydramine hydrochloride (BENADRYL). Subsequently, the patient recovered from mild case of chickenpox on an unknown date. Additional information is requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse concerning an 8-year-old male with no known drug allergies who on 31-JUL-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 25-FEB-2004 at 09:15 am, the patient experienced an outbreak of blisters on his face, head, chest , legs and arms; some are crusted. No medical attention was sought. The patient's mom treated with calamine lotion and Benadryl. Subsequently, the patient recovered from the outbreak. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12-year-old female who "11 years ago" in approximately 1996, was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On 22-OCT-2007, the patient sought medical attention and was diagnosed with wild-type chickenpox. The number of lesions is not known but the physician stated that she was "covered from head to feet". At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a company representative concerning a 1 year old twin patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient broke out in a mild case of chickenpox. This was one of several reports from the same source. No further information is available.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Loss of consciousness
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who "some time last week" on approximately 15-OCT-2007, was vaccinated with varicella virus vaccine live (Oka/Merck) and Menactra. Post vaccination the patient "passed out". The patient was monitored in the office and recovered. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on 24-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The nurse reports the products were stored in the wrong spot in the office and varicella virus vaccine live (Oka/Merck) was given inadvertently. She does not feel that this was product confusion, it was a case of human error. No adverse events reported. A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Age: 0.8
Sex: U
Vaccine: VARCEL
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a company representative concerning a 10 month old patient who was the sibling of a set of 2 1/2 year old twins. The twins actually received doses of varicella virus vaccine live (Oka/Merck) and the 10 month old sibling experienced a full blown case of chickenpox via secondary transmission. This was one of several reports from the same source. No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Laboratory test, Rash papular
Clinical narrative: Information has been received from a consumer concerning his 11 year old daughter with no past medical history who in September 1998, may have been vaccinated with varicella virus vaccine live (Oka/Merck). On 21-OCT-2007, she developed shingles. On 24-OCT-2007, therapy was initiated with acyclovir. A product quality complaint was not reported. Follow up information by the patient's physician reported that she could not confirm which vaccine was administered since it was administered by a prior physician. The physician confirmed that on 21-OCT-2007, the patient developed vesicle/papule lesions over to dermatomes on the lower thoracic area on the back. A specimen sent for varicella virus identification was reported as "inadequate". The physician reported that at the time of this report the patient was recovering. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Culture positive, Staphylococcal infection, Varicella post vaccine
Clinical narrative: Information has been received from a certified medical assistant concerning a healthy 9-year-old female with no pertinent allergies, who on 23-FEB-2000 was vaccinated subcutaneously with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck) (lot# 632276/1454J). There was no concomitant medication. On 23-OCT-2007, the patient developed chicken pox and was seen in the doctor's office on 25-OCT-2007 with about 50 scattered papular, crusted lesions. No laboratory or diagnostic tests were performed. The outcome was reported as recovering. No product quality complaint was involved. Follow-up information received indicates that the patient was vaccinated in the right arm with varicella virus vaccine live (Oka/Merck) (lot# "1126J"). On 23-Oct-2007, the patient developed 75-100 lesions all over. Culture of a lesion revealed a staph infection. The patient was given clindamycin and Bactroban was used on the lesions. On an unspecified date the patient recovered. Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Swelling
Clinical narrative: Information has been received from a registered nurse concerning an 18-year-old 200 lb. 69 in. female with a history of benign neoplasm of the pituitary gland and craniopharyngeal duct with no known drug reactions/allergies who on 19-OCT-2007 was vaccinated SC with a 0.5mL second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included Gardasil and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified). Concomitant medications included replacement hormones (therapy unspecified) and numerous medications (therapy unspecified). There was no reported illness at the time of the vaccinations. On 19-OCT-2007 at 20:00 hours, (also reported as "two days later"), the reporter indicated that the patient's worse day was 20-OCT-2007. She presented to the physician on 22-OCT-2007, who indicated the area was the "size of 2 inches all around "(also reported as about 3" in diameter). The patient was treated with cold compresses, OTC Benadryl cream and ice. There were no laboratory or diagnostic studies performed. The patient's vaccination history included: 26-JUN-1989, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and OPV (manufacture unspecified); 25-AUG-1989, a second dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified), and a second dose of OPV (manufacture unspecified); 27-OCT-1989, a third dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified) and a third dose of OPV (manufacture unspecified); 13-JAN-1990, a fourth dose of diphtheria toxoid (+) pertussis acellular vaccine  (unspecified) (+) tetanus toxoid (manufacturer unspecified); 09-FEB-1990, rubella virus vaccine (therapy unspecified); 11-AUG-1990, a first dose of measles virus vaccine live(Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), and Hib conj vaccine (OMPC) (manufacturer unspecified) 13-NOV-1990, a fourth dose of OPV; 02-JUN-1993, a first dose of hepatitis B vaccine (recombinant) (manufacturer unspecified); 21-JUL-1993, a second dose of hepatitis B vaccine (recombinant) (manufacturer unspecified); 27-DEC-1993, a third dose of hepatitis B vaccine (recombinant) (manufacturer unspecified); 18-May-1994, a fifth dose of OPV and a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3), 06-MAY-1995, a first dose of varicella virus live vaccine; 29-APR-1999, hepatitis A vaccine (manufacturer unspecified, an influenza vaccine (manufacturer unspecified) on 15-NOV-2001, 16-NOV-2002, 08-NOV-2003, 13-NOV-2004, and 15-NOV-2005. A product quality complaint was not reported. Additional information is not expected.  Follow up infromation from the patient's mother provided no addditional information. Current patient status was not reported.  Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Antibody test, Varicella
Clinical narrative: Information has been received from a consumer concerning her 7-year-old daughter with no pertinent medical history and no drug reactions/allergies who on 11-SEP-2007 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included hepatitis A vaccine (inactive) (MSD). On 25-SEP-2007, two weeks later, the patient broke out in a rash. The rash was diagnosed as the chickenpox. A "test for chickenpox" was obtained. The outcome was recovering. Medical attention was sought. There was no product quality complaint. Follow up information from the physician indicated that there was no additional information available. Current patient status was no reported. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Bacterial culture negative, Blister, Ear pain, Erythema, Otorrhoea
Clinical narrative: Information has been received from a consumer concerning her 7-year-old daughter with no pertinent medical history and no drug reactions/allergies who on 11-SEP-2007 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy that day included hepatitis A vaccine (inactive) (MSD). On 25-SEP-2007, two weeks later, the patient broke out in a rash. The rash was diagnosed as the chickenpox. A "test for chickenpox" was obtained. The outcome was recovering. Medical attention was sought. There was no product quality complaint. Follow up information from the physician indicated that there was no additional information available. Current patient status was no reported. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Antibody test, Varicella
Clinical narrative: Information has been received from a physician concerning an approximate 7-year-old female with no pertinent medical history or allergies who on 11-DEC-2001 and 11-SEP-2007 was vaccinated with her first and second dose of varicella virus vaccine live (Oka/Merck) (lot # 658194/1095U 1st dose). Concomitant vaccine included Havrix. On approximately 11-SEP-2007 the patient experienced relapsing painful, red blisters of the ears following the second vaccination. "The progression is the ear turns red and swells with blisters, the blisters rupture and the swelling goes down and the pain goes away." The patient's reaction occurs predominantly on the left ear, but both ears have been involved. The patient seems to spontaneously resolve after 2 to 3 days of painful red blisters and the reaction comes back about one week later. It was reported the patient complained of a painful left ear and discharge on 25-SEP-2007. On 05-OCT-2007, it was also reported the patient left school early because her right ear was painful, turned purple and had a blister that popped. The physician reports the blisters have occurred and resolved three times since the vaccination on 11-SEP-2007. On an unspecified date the patient had an evaluation by an ear, nose and throat specialist and had a culture of a blister and the results showed no growth of bacteria anaerobic or aerobic. At the time of the report the patient's status was relapsing-not recovered. A product quality complaint was not involved. Additional information has been requested.