chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 33 year old male with no known allergies who on 27-MAR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) SC in the upper right arm towards the back. Concomitant vaccination included Engerix-B in the left deltoid. On 28-MAR-2007, the patient developed a swollen redness at the injection site. It was not warm to the touch and the patient was non febrile. The patient received no treatment. Over the counter Tylenol and Advil was recommended if needed. No product quality complaint involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Tic
Clinical narrative: Information has been received from a physician concerning an 8 year old male who "three weeks ago," on approximately 09-MAR-2007, was vaccinated with 0.5 mL of varicella virus vaccine live (Oka/Merck). Three days post vaccination, on approximately 12-MAR-2007, the patient developed tics. It is unknown what body parts were affected by the tics. At the time of reporting, the patient was not recovered. No lab diagnostics studies were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain, Tendonitis
Clinical narrative: Information has been received from a physician concerning an 80 year old male who, about one week ago, on 23-MAR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). The physician reported, about one week post vaccination, that the patient has severe tendonitis, and is in a lot of pain, and needed a steroid injection. No other details provided. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a health professional concerning a 13 year old male student with an allergy to ampicillin who on 12-MAR-1996 (year to be clarified) was vaccinated with varicella virus vaccine live (Oka/Merck) (lot # 608578/0389B) in the left arm at 10:50 am. There were no previous doses given and no concomitant therapy reported. It was reported that the patient developed more than 50 lesions which did not require treatment. The patient recovered on 24-MAR-2007. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female with no pertinent medical history, drug reactions or allergies, who had an upper respiratory tract infection and viral pharyngitis at the time of vaccination, on 25-JAN-2001, with her first dose of varicella virus vaccine live (Oka/Merck) (Lot # 635461/1246K). Concomitant therapy, that same day, included Prevnar (lot # 472546). On 30-MAR-2007, the patient developed a rash over her entire body. On 31 MAR 2007, the patient was seen in the doctor's office and diagnosed with post Varivax varicella. Supportive care was recommended. At the time of reporting the outcome was unknown. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: DTAP, PPV, VARCEL
Symptoms: Inappropriate schedule of drug administration, Varicella post vaccine
Clinical narrative: Information was received from a registered nurse, concerning a 4 year old male with no medical history or allergies who on 28-MAR-2003 was vaccinated into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 649263/0589P). Concomitant therapy, that same day, included a third dose, into the left thigh of Tripedia (lot # V1343CA) and a third dose, into the left thigh, of Pneumovax (Lot # A74404B). The patient had no illness at the time of vaccination. On 22 MAR 2007, the patient developed bumps on the face, arms, legs and back. The patient was examined and diagnosed with chickenpox. The patient presented with about 35-40 lesions on his face, upper and lower extremities. The patient was treated with acyclovir, 200mg, QID X five days. On 02 APR 2007, the patient was considered recovered. There was no laboratory test performed. There was no product quality complaint involved. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old white male weighing 108 kg and height of 59.8 inches with no illness at time of vaccination and no pre-existing medical history who on 29-JUL-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 08-MAR-2007 the patient developed 30-40 pox all over. The patient sought unspecified medical attention. On 15-MAY-2007, the patient recovered. 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 physician concerning a 9 year old male, with a prior history of vaccination for "chickenpox," who on 17-DEC-1998 was vaccinated with varicella virus vaccine live (Oka/Merck). On Thursday night, 01-MAR-2007, the patient developed a rash that blossomed over the next day and a half. On 03 MAR 2007, the patient was alert and cooperative, when he was seen for an office visit. He presented with "what definitely looked like chicken pox lesion" on his chest, back and extending up into his hairline. There were about 20 lesions in total. The patient was diagnosed with chickenpox at that time, and supportive care as well as signs and symptoms requiring a call back were discussed. At the time of reporting the patient was recovered. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. The subject's medical history included febrile seizure. Concurrent medical conditions included drug allergy to Zithromax. On 26 July 2007 at 16:20, the subject received 5th dose of Infanrix (unknown). On 26 July 2007, immediately after vaccination with Infanrix, the subject experienced mild fever, warm to touch, injection site redness and swelling. Approximately two to three days after the vaccination, the subject also experienced discoloration of skin that was described as looking like the end of a bruise site, or a birth mark but almost black. The discoloration was approximately four inches long and covered the entire deltoid region from the acromion process to the auxiliary crease. An injection site induration with a bulls eye reddened area (injection site) where the injection occurred was also noted. The subject's range of motion was not restricted and his arm and shoulder did not hurt. At the time of reporting the events were unresolved. The nurse reported that she was not aware of any adverse events following previous vaccinations. Follow-up received on 16 October 2007 via the nurse. The subject received Infanrix intramuscularly in the left deltoid. She indicated that the subject was diagnosed with a local reaction post immunization. The onset of earliest signs and symptoms was reported as 25 August 2007. She noted that the events were unresolved as of 09 October 2007, the subject's skin was still discolored. She considered that the events were not serious and possibly related to Infanrix. The subject had not experienced any adverse events following previous vaccinations.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Skin discolouration, Skin warm
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 4-year-old male subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. The subject's medical history included febrile seizure. Concurrent medical conditions included drug allergy to Zithromax. On 26 July 2007 at 16:20, the subject received 5th dose of Infanrix (unknown). On 26 July 2007, immediately after vaccination with Infanrix, the subject experienced mild fever, warm to touch, injection site redness and swelling. Approximately two to three days after the vaccination, the subject also experienced discoloration of skin that was described as looking like the end of a bruise site, or a birth mark but almost black. The discoloration was approximately four inches long and covered the entire deltoid region from the acromion process to the auxiliary crease. An injection site induration with a bulls eye reddened area (injection site) where the injection occurred was also noted. The subject's range of motion was not restricted and his arm and shoulder did not hurt. At the time of reporting the events were unresolved. The nurse reported that she was not aware of any adverse events following previous vaccinations. Follow-up received on 16 October 2007 via the nurse. The subject received Infanrix intramuscularly in the left deltoid. She indicated that the subject was diagnosed with a local reaction post immunization. The onset of earliest signs and symptoms was reported as 25 August 2007. She noted that the events were unresolved as of 09 October 2007, the subject's skin was still discolored. She considered that the events were not serious and possibly related to Infanrix. The subject had not experienced any adverse events following previous vaccinations.
Sex: F
Vaccine: DTAP
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of allergic reaction in a female subject of unspecified age who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Diphtheria tetanus acellular pertussis, manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of Diphtheria tetanus acellular pertussis (unknown). At an unspecified time after vaccination with Diphtheria tetanus acellular pertussis, the subject experienced an allergic reaction. At the time of reporting the outcome of the event was unspecified.
Age: 0.2
Sex: F
Vaccine: DTAP
Symptoms: Skin haemorrhage
Clinical narrative: This case was reported by the mother of a consumer and described the occurrence of a bleeding skin disorder in a 2 month old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, Hepatitis B (Recombinant) and inactivated poliovirus vaccine combined (manufacturer unspecified) for prophylaxis. On an unspecified date the subject received unspecified dose of diphtheria and tetanus toxoids and acellular pertussis adsorbed, Hepatitis B (Recombinant) and inactivated poliovirus vaccine combined (unknown). At an unspecified time after vaccination with diphtheria and tetanus toxoids and acellular pertussis adsorbed, Hepatitis B (Recombinant) and inactivated poliovirus vaccine combined, the subject developed a bleeding skin disorder. It was a level three immune system allergy. The subject was also diagnosed with a peanut allergy. At the time of reporting the outcome of the events was unspecified.
Age: 1.5
Sex: F
Vaccine: DTAP, PNC
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of swelling at the injection site in an 18-month-old subject of unspecified gender who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site and injection site discomfort. At the time of reporting the outcome of the events was unspecified. These events occurred in three different subjects. It was reported that one of the subject's arms looked like it could have been drained due to the swelling. The swelling area was also described as similar to the palm of the hand. Follow-up was received on 27 November 2007 from the healthcare professional. The subject was an 18-month-old female. The subject had no adverse events following receipt of prior immunizations. On an unspecified date, the subject received a 4th dose of Infanrix (intramuscular, right thigh). Concurrent vaccination included Prevnar (Wyeth Labs; intramuscular; left thigh). On 5 November 2007, at an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site, injection site discomfort and cellulitis. The events improved on 7 November 2007. The healthcare professional considered the events were possibly related to vaccination with Infanrix. Comment: Cellulitis was assessed as medically serious by GSK.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a healthcare professional to a sales representative and described the occurrence of swelling at the injection site in a subject between 4-6 years of age (gender unspecified) who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine (Infanrix, GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Infanrix (unknown). At an unspecified time after vaccination with Infanrix, the subject experienced swelling injection site and injection site discomfort. At the time of reporting the outcome of the events was unspecified. These events occurred in three different subjects. It was reported that one of the subject's arms looked like it could have been drained due to the swelling. The swelling area was also described as similar to the pain of the hand. Follow-up was received on 27 November 2007 from the healthcare professional. The subject was a 2 year old female. The subject had no adverse events following receipt of prior immunizations. On an unspecified date, the subject received the 4th dose of Infanrix at an unspecified site of administration. On 5 November 2007, the subject experienced swelling injection site, injection site discomfort and cellulitis. The subject was treated with Co-trimoxazole (BACTRIM) and the events improved on 7 November 2007. The healthcare professional considered the events to possibly be related to vaccination with Infanrix. Comment: Cellulitis was assessed as medically serious by GSK.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a 25-year-old female subject who was vaccinated with Infanrix (GlaxoSmithKline) for prophylaxis. On 26 November 2007 at 09:30, the subject inadvertently received 1st dose of Infanrix (.5 mL, left arm). No other vaccinations were received on 26 November 2007. On 26 November 2007, 12 hours after the vaccination with Infanrix, the subject experience fever, injection site pain, injection site redness, a little swelling injection site and wrong vaccine administered. The events were considered to be systemic due to the fever. The subject consulted a healthcare professional and required medical attention in the doctor's office. The subject was treated with an unspecified antipyretic. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Infanrix.
Age: 73.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old male who on 09-APR-2007 was mistakenly vaccinated with varicella virus vaccine live (Oka/Merck) in place of zoster vaccine live (Oka/Merck). The pharmacist reports that confusion was made between the zoster vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) was dispensed instead of zoster vaccine live (Oka/Merck). The nurse did not notice the difference and administered the varicella virus vaccine live (Oka/Merck) rather than the zoster vaccine live (Oka/Merck). There were no problems reported. Unspecified medical attention was sought. The product was properly ordered by the physician. There was no product quality complaint. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 05-SEP-2002 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On Friday, 09-MAR-2007, the patient started breaking out in a rash, which the mother thought to be chickenpox. On 12 MAR 2007 the patient presented for an office visit with "definite chickenpox" over her trunk, groin and in her hairline. Supportive measures were disused, and instructions for returning to school. Given that the patient was afebrile, she was vaccinated, at the same visit, subcutaneously, into the left arm, with a "booster" dose of varicella virus vaccine live (Oka/Merck) (Lot # 653971/0796F). At the time of reporting the patient was considered recovered. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 08-JAN-2004 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 12-MAR-2007, the patient's mother called the physician's office to report the patient had developed "chickenpox disease." Subsequently, the patient recovered. There was no product quality complaint. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with varicella virus vaccine live (Oka/Merck). The patient experienced a varicella-like rash with approximately 35 lesions after receiving the varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Rash, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a patient who, 45 days ago, on approximately 21-FEB-2007, was vaccinated with varicella virus vaccine live (Oka/Merck). The patient subsequently developed a rash of greater than 50 lesions. At the time of reporting the patient had not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female who, about three weeks ago, on approximately 15-MAR-2007, was vaccinated subcutaneously with her first dose of 0.5 mL varicella virus vaccine live (Oka/Merck). On approximately 28-MAR-2007, two weeks after receiving the vaccination, the patient developed a rash that was vesicular on her cheek, back, stomach, legs and on the arm that she did not get the injection. There were "large areas of induration." The rash was not at the injection site. The number of lesions was not reported. Unspecified medical attention was sought. At the time of reporting, the patient was considered recovering. There was no product quality complaint. Follow up information was received from the physician, who reports that "it turned out not to be vaccine related."
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male with egg and peanut allergies and no other medical history who on 19-MAR-2007 was vaccinated intramuscularly in the thigh with a 0.5 mL dose of with varicella virus vaccine live (Oka/Merck) (lot# 656566/1511F). The patient later developed a rash around the injection site. On the same day, the patient was also vaccinated intramuscularly in the thigh with a dose of measles-mumps-rubella vaccine (MSD). The patient sought unspecified medical attention. No diagnostic laboratory tests were performed. The patient was reported as recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 5-year-old patient who on 19-MAR-2002 was vaccinated with a 0.5 milliliter dose of varicella virus vaccine live (Oka/Merck) (lot# 638495/1904X). On 11-FEB-2007 the patient experienced a break through case of chicken pox. On an unspecified date, the patient was seen at an urgent care facility and was diagnosed with chickenpox. No further action was to be taken. The patient provided date-stamped photographic evidence of chickenpox. The patient was not sent for ser-testing. No further action was to be taken. Subsequently, it is reported that the patient recovered from chicken pox. No product quality complaint was involved. No further information is expected.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning second and third graders who were vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently, there was chickenpox "outbreak" in an elementary school. The physician was unsure how many children had previous been vaccinated. Further information has been received from the office manager in the physicians office. It was reported that there was only one patient who had chickenpox and that was a 13 year old male. It was reported she had no idea how many patients were involved in the outbreak. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 7 year old female no pertinent medical history and no known drug reactions/allergies who in 2001 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 27-DEC-2006, the patient was vaccinated with the second dose of varicella virus vaccine live 0.5 ml (Oka/Merck) (Lot # 654806/1065P) SQ. On 02-APR-2007 the patient experienced mild case (6-7 lesions) of chicken pox. The patient's mild case (6-7 lesions) of chicken pox persisted. No diagnostic laboratory studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a healthcare worker concerning a patient (age and gender not reported) who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). The healthcare worker reported that the patient had breakthrough chickenpox. There was no product quality complaint. Follow-up information from a healthcare worker indicated that no further information about the case was available. "It was something mentioned about someone who had been vaccinated and then gotten chickenpox, no names were mentioned, no dates, just the one fact." Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning an 8 year old male who in 1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 05-APR-2007 the patient experienced a mild breakthrough case of the chicken pox. The patient had less than 50 lesions and had no fever. The patient's chicken pox persisted. Medical attention was sought. Follow up information has been received from the physician concerning an eight year old boy who on 13-SEP-1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 02-APR-2007 the patient developed varicella exanthens status post immunization. The patient was instructed to use AVEENO and CLARITIN for the itch. It was reported the patient recovered. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Speech disorder
Clinical narrative: Information has been received through the Merck Pregnancy Registry from a 41 year old consumer concerning her 9 year old daughter, with a history of drug exposure in utero in NOV-1996 with varicella virus vaccine live (Oka/Merck). The mother, at 31 years of age, reported receiving varicella virus vaccine live (Oka/Merck) early in her pregnancy. The number of weeks gestation at the time of the vaccination was not known. (Original Case# 638799). The mother reports that her daughter has been healthy, but does have a speech impediment at the present time. It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Antibody test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a health professional concerning a 21 year old male with developmental delay, sulfonamide allergy, and allergies to Tegretol, Dilantin, Rocephin, a history of spastic retro ganglion who on 04-SEP-1997 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 623129/0550E) and a second dose of M-M-R II (lot #619236/006E). On 10 OCT-1997, the patient was vaccinated subcutaneously into the right arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 622968/0686E) and a "Flu Vaccine" in the left arm, (Lot # 7t81898). Concomitant therapy included Singulair, Levoxyl, dietary supplement (unspecified), and unspecified anti-seizure medication. On 8 FEB 2007, a varicella titer was obtained. The results, show "antibody not detected. No adverse experience is related to this event. Medical attention was sought. The plan is to have the patient "return for a Varivax."
Age: 1.4
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash, Skin lesion, Varicella
Clinical narrative: Information has been received from a public county health nurse concerning a 26 month old male who on 02-JUN-2006 was vaccinated SQ in the left arm with the first dose of varicella virus vaccine live (Oka/Merck). On 29-MAR-2007 the patient presented with chicken pox rash on his arms, leg and trunk. The patient had less than 50 lesions and had a slight fever. Treatment with Tylenol and oral Benadryl PRN was given. Medical attention was sought. The patient recovered from the fever and chicken pox rash. No additional information is expected.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a male who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). It was reported that the two vaccines were stored in the same freezer and the pharmacist "just pulled out" the wrong vaccine. The nurse then gave the vaccine though she "knew something wasn't right." The patient had no adverse event. There was no product quality complaint involved. On an unspecified date since this event the patient was correctly vaccinated with zoster vaccine live (Oka/Merck) (MSD). No further information was provided. Additional information has been requested. The patient's wife had the same experience with vaccination (WAES # 0706USA03508).
Age: 74.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old female who on 09-APR-2007 was mistakenly vaccinated with varicella virus vaccine live (Oka/Merck) in place of zoster vaccine live (Oka/Merck). The pharmacist reports that confusion was made between the zoster vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck) was dispensed instead of zoster vaccine live (Oka/Merck). The nurse did not notice the difference and administered the varicella virus vaccine live (Oka/Merck) rather than the zoster vaccine live (Oka/Merck). There were no problems reported. Unspecified medical attention was sought. The product was properly ordered by the physician. There was no product quality complaint. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning his 8 year old granddaughter, with no pertinent medical history, who three weeks ago, on approximately 20-MAR-2007, was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On approximately 27-MAR-2007, one week post vaccination, the patient was diagnosed with shingles. The shingles appeared on her face. Unspecified medical attention was sought. At the time of reporting the patient was considered to be recovering. There was no product quality complaint. No further information is available.
Age: 3.9
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 47 month old female who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck), and subsequently developed a mild case of chickenpox. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 18-OCT-2001 was vaccinated subcutaneously into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 638245/0779L). The patient had no illness at the time of vaccination. On 06-APR-2007, the patient developed a rash on her "belly and chest." On 07 APR 2007, the patient recovered from the "rash on belly and chest." No lab diagnostic tests were performed. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician concerning a 9 year old male who on 13-JAN-1999 was vaccinated subcutaneously into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 628246/1655H). The patient did not have any illness at the time of vaccination. On 07-APR-2007, the patient's mother reported that the patient had developed a pimple like rash on face and maxillary area. On 09-APR-2007, the mother reported that the patient developed "probably 24 lesions." There were no lab diagnostic studies performed. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a licensed practical nurse concerning an 8 year old male with no known allergies or pertinent medical history who on 02-OCT-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On approximately 05-APR-2007, the patient experienced chickenpox. Unspecified medical attention was sought, there were no lab tests performed. The patient was treated with oatmeal baths and Caladryl. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a 5 year old patient with no allergies or pertinent medical history who on 22-MAR-2007 was vaccinated SC with a 0.5 mL second dose of varicella virus vaccine live (Oka/Merck) (lot# "1497S"). There was no concomitant medication. On 24-Mar-2007, the patient developed 8 to 9 cm red hot and tender area at the injection site. The patient sought unspecified medical attention. No labs were performed. Subsequently, the patient recovered. No further information was provided. No product quality complaint was involved. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning an 11 year child, with a history of natural varicella at 13 months of age, who developed a mild form of chickenpox. The break out occurred subsequent to his sibling breaking out, on approximately 05-APR-2007, in a chickenpox rash of approximately 100 vesicles, papular and very pruritic lesions, after being vaccinated on 22-MAR-2007, with a second dose of varicella virus vaccine live (Oka/Merck) (Waes # 0704USA01455). Unspecified medical attention was sought. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a child who developed a chickenpox break through of 50-70 lesions after being vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Pruritus, Rash macular
Clinical narrative: Information has been received from a physician concerning a 7 year old patient, with no pertinent medical history, or pre existing allergies, who on 24-JUL-2000 was vaccinated subcutaneously into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 634478/0091K). Suspect therapy, that same day, included a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 635283/0406K), administered subcutaneously into the left thigh. There was no known illness at the time of vaccination. On 01-APR-2007, the patient developed itchy spots on the body and arms. Some spots on body and arms had watery centers. One was present on the outer eyelid, but there was no swelling of the eyes. On 03 APR 2007, the patient recovered. No relevant diagnostic tests were performed. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning a patient with no known allergies or pertinent medical history, who on 19-MAR-2007 was vaccinated SC with a second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 656079/1306F). Concomitant therapy included amoxicillin. On 22-MAR-2007, the patient had an injection site that was red and tender to touch after vaccination. Unspecified medical attention was sought. No labs were performed. Subsequently, the patient recovered. There was no product quality complaint. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Initial and follow-up information has been received from a certified medical assistant concerning a 9 year old female with no known allergies or pertinent medical history who on 02-OCT-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 638244/0466L). There was no illness at the time of vaccination. On 16-APR-2007 the patient experienced chickenpox with 10 to 15 vesicular lesions on her trunk, arms, neck and back. Unspecified medical attention was sought. There was no product quality complaint involved. Subsequently, on an unspecified date the patient recovered. No further information was provided. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 27-FEB-2007 was vaccinated subcutaneously with a 0.5 mL of varicella virus vaccine live (Oka/Merck) (Lot# 656079/1306F). Concomitant therapy included Nasonex and Flonase. On 01-MAR-2007, the patient experienced bump about 2 inches, swollen and red hot raised to touch at the injection site. Medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. It was reported that the patient's twin brother experienced an adverse event following vaccination (WAES # 0704USA04534). Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning an 11-year-old male who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced minor varicella-like rash. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information from the nurse practitioner indicated that she could not remember the patient's name. No further information was available.
Age: 1.6
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white male who on 13-AUG-1999 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 02-APR-2007 the patient's mother noticed spots on his waist band. The patient then presented to the physician's office on 03-APR-2007 and was diagnosed with chickenpox. The patient had no fever. There were no lab tests performed. The patient and his sibling(s) had no adverse following prior vaccination. The patient recovered on 09-APR-2007. No further information was provided. No further information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a health professional concerning a 6 year old male who on 13-AUG-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 28-MAR-2007 the patient experienced fever and varicella rash of less than 50 lesions. The patient was treated with TYLENOL, rest and fluids. Subsequently, the patient recovered from fever and varicella rash. Medical attention was sought. No product complaint was involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female who was vaccinated SC with a dose of varicella virus vaccine live (Oka/Merck). The patient developed a localized reaction at the injection site. The nurse described the reaction as lesion like rash with swelling and erythema. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising, Injection site mass, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 20 year old female "member of the staff" who, on 05-APR-2007, was vaccinated with varicella virus vaccine live (Oka/Merck) from her family physician. On 06-APR-2007 the patient developed a very severe bruise with significant swelling at the injection site. A large lump also developed at that site, and she experienced a fever. She was treated by her family physician. At the time of the report, the patient was recovering from the very severe bruise, swelling at the injection site, injection site lump, and fever. The product quality complaint was not involved. No further information is available.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Seroconversion test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a health professional concerning a 5 year old male with haemodialysis, end stage renal disease (ESRD), reactive airways disease, hyperplasia, potter's syndrome and allergic reaction to Biaxin and Tetracycline who on 21-AUG-2003 and 28-APR-2006 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included fluticesone propionate (FLOVENT), somatropin, ranitidine HCl (ZANTAC) and vitamins (unspecified). The patient was shown to have seroconverted after the first vaccination, but after yearly antibody tests were performed, it showed no seroconversion after the second vaccination. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from a physician concerning a 40 year old female acquaintance who in approximately 1996 was vaccinated with varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced antibody levels that were either seronegative or low seropositive. Medical attention was sought. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old male who on 12-APR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). The patient was given a prescription for the "shingles vaccine" and VARIVAX was dispensed and was administered instead of zoster vaccine live (Oka/Merck) (ZOSTAVAX). The pharmacist dispensed the VARIVAX vaccination in error due to both vaccinations containing varicella zoster vaccine. The patient took VARIVAX vaccination to the physician and it was administered. The patient sought unspecified medical attention. It was unclear how or when the error was discovered. No problems reported. No further information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature, Rash papular, Scab, Skin lesion
Clinical narrative: Information has been received from a pediatric center concerning a 7 year old male child with no medical history or allergies who on 14-AUG-2000 was vaccinated with varicella virus vaccine live (Oka/Merck). The patient was vaccinated elsewhere. On 09-APR-2007, the patient developed very small papules, 10-20 lesions, some lesions crusted. The patient did not have a fever. The patient is still recovering however, an outcome of recovered on 11-APR-2007 was provided. Medical attention was not sought. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash papular, Rash pustular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old white male with no known allergies who on 01-OCT-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 17-MAR-2007 the patient experienced rash. On 19-MAR-2007, the patient was seen in the office with 50 small papules/pustules on trunk, face, and limbs. It was reported that the patient's grandfather has shingles 2 weeks prior while taking care of the patient. The patient recovered on 24-MAR-2007. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a consumer concerning his 8 year old son who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On approximately 25-APR-2007 "three weeks ago" the patient developed a breakthrough of chicken pox. The reported referred to it as "mild". The patient sought unspecified medical attention. The patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 mL, injection (Oka/Merck) (Lot # and route not provided). Subsequently, the patient developed chicken pox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. 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. Further information has been received from a school nurse who reported a female was vaccinated with varicella virus vaccine live on 24-JUL-1995. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). 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 registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 ml, injection (Oka/Merck) (lot # and route not provided). Subsequently the patients developed chicken pox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. 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. Further information has been received from a school nurse who reported that a male patient was vaccinated with varicella virus vaccine live, on 12-OCT-1995. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). No further information is available. This is one of several reports from the same source.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 ml, injection (Oka/Merck) (lot # and route not provided). Subsequently the patients developed chicken pox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. 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. Further information has been received from a school nurse who reported that a male patient was vaccinated with varicella virus vaccine live, on 20-FEB-1996. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). Additional information has been requested. This is one of several reports from the same source. Follow up information was received from a registered nurse who reports no further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning six patients who were vaccinated with varicella virus vaccine live, 0.5 mL, injection (Oka/Merck) (lot # and route not provided). Subsequently, the patients developed chicken pox and had been previously vaccinated. Unspecified medical attention was sought. The patient outcomes were not reported. There was no product quality complaint. 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. Further information has been received from a school nurse who reported that a male patient was vaccinated with varicella virus vaccine live, on 15-JUN-1995. The nurse reported that the patient developed chickenpox. All of the parents and pediatrician felt the cases were mild with minimal missed time at school (approx 2-3 days out sick). No further information is available.