chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
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, 0.5 mL, injection (Oka/Merck) (lot # and route not provided). Subsequently, the patients developed chickenpox 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 female was vaccinated with varicella virus vaccine live, on 21-MAY-1997. 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. No further information is available.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis contact, Eczema, Exposure to communicable disease, Pruritus, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with asthma and no allergies who on 16-OCT-2003 was vaccinated SC with a first 0.5mL dose of varicella virus vaccine live (Oka/Merck) (lot# 644796/0336N). Concomitant therapy included fluticesone propionate (FLOVENT). On 13-Apr-2007 the patient was seen with a rash on the right side of the face, neck, shoulder and back. The patient had 30 to 40 itchy lesions that developed initially on her neck and face. It eventually spread to her right neck and upper back with none on her trunk. They are described as being scattered papules with some scabbing and no clear vesicles or pustules. The patient had known exposure to chickenpox. On 20-APR-2007 the rash was unchanged. The lesions were determined to be a contact dermatitis coupled with eczema. Unspecified medical attention was sought. No lab diagnostic testing was done. The patient is being treated symptomatically with acetaminophen (TYLENOL) and calamine + camphor + pramoxine hydrochloride (AVEENO) bath. The patient is recovering. No further information is available. No product complaint was involved. No further information available. Follow-up information has been received from a registered nurse concerning a now 5 year female on 23-APR-2007 stating that the patient was diagnosed with contact dermatitis coupled with eczema (formally reported as follicular eczema flare as rash noted to start shortly after metal hair beads had been put in hair rather than chicken pox). No further information. Additional follow-up information has been received on 05-NOV-2007 from a registered nurse stating that the above reaction was determined to be eczema and not breakthrough chickenpox. The child had known exposure to chickenpox. The nurse stated that she did not have any other information to report.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Rash papular, Scab, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with asthma and no allergies who on 16-OCT-2003 was vaccinated SC with a first 0.5mL dose of varicella virus vaccine live (Oka/Merck) (lot# 644796/0336N). Concomitant therapy included fluticesone propionate (FLOVENT). On 13-Apr-2007 the patient was seen with a rash on the right side of the face, neck, shoulder and back. The patient had 30 to 40 itchy lesions that developed initially on her neck and face. It eventually spread to her right neck and upper back with none on her trunk. They are described as being scattered papules with some scabbing and no clear vesicles or pustules. The patient had known exposure to chickenpox. On 20-APR-2007 the rash was unchanged. The lesions were determined to be a contact dermatitis coupled with eczema. Unspecified medical attention was sought. No lab diagnostic testing was done. The patient is being treated symptomatically with acetaminophen (TYLENOL) and calamine + camphor + pramoxine hydrochloride (AVEENO) bath. The patient is recovering. No further information is available. No product complaint was involved. No further information available. Follow-up information has been received from a registered nurse concerning a now 5 year female on 23-APR-2007 stating that the patient was diagnosed with contact dermatitis coupled with eczema (formally reported as follicular eczema flare as rash noted to start shortly after metal hair beads had been put in hair rather than chicken pox). No further information. Additional follow-up information has been received on 05-NOV-2007 from a registered nurse stating that the above reaction was determined to be eczema and not breakthrough chickenpox. The child had known exposure to chickenpox. The nurse stated that she did not have any other information to report.
Age: 1.3
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old male who on 30-DEC-1999, when he was 15 months old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Recently," in April 2007 the patient developed a breakthrough of chickenpox with approximately 25 lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from a physician who reported that on 15-APR-2007 the patient was seen in the physician's office and had developed a breakthrough of chickenpox. The patient had recovered from chickenpox after 1 week. No further information is expected.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Pyrexia, Varicella
Clinical narrative: Information has been received from a school nurse concerning a 35 year old female who on 30-MAR-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed chickenpox. The patient experienced soreness around the injection site shortly before the fever which started on 14-Apr-2007. On 15-Apr-2007, the rash with fluid filled vesicles developed. The Nurse counted about 10-15 lesions through out the patient's body and noted that new ones are still coming. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a registered radiologic technologist concerning a 5-year-old male relative with no pertinent medical history and no allergies, who was vaccinated on 17-JUN-2002 in the right thigh with a single dose of varicella virus vaccine live (Oka/Merck) (lot # 638244/0466L). There was no concomitant medication given. On 14-MAR-2007, the patient experienced unspecified pain rated 8-9 out of 10. On 17-MAR-2007, the patient experienced a blister like rash on the inside of his right leg from the groin area to the foot. The rash was made up of vesicles and papules in the L1-L4 dermatome. He had a fever of 100.8. The child was take to the emergency department of a local hospital and was instructed to apply hydrocortisone cream and to take Advil. After doing so the rash became worse. On 19-Mar-2007, the doctor saw the patient and diagnosed him as having shingles. The outcome was reported as recovered. No product quality complaint was involved. Additional information has been requested.
Age: 62.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 62 year old patient who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (MSD). No symptoms have been reported. It was noted that this was due to human error and not product confusion. There was no product quality complaint involved. No further information was provided. Follow-up information received on 04-OCT-2007 via telephone: Medical assistant indicated no adverse effect occurred from administering varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). She stated this event was the result of human error and was essentially a lack of communication. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 9 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient come down with chickenpox. Medical attention was sought. The patient's outcome was not known. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with no allergies and medical history who on 08-OCT-2001 was vaccinated SQ with 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 638252/0225L). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD). On 15-APR-2007, the patient developed chickenpox with 30 to 40 lesions. It was described as multiple papular vesicular lesions on the trunk, extremities, and scalp. There were also several lesions on patient's palate. The patient also experienced fever. Unspecified medical attention was sought and no lab diagnostic tests were performed. At the time of the report the patient still had chickenpox lesions. A product quality complaint was not involved. Additional information has been requested.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Varicella zoster serology negative
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 32 year old female registered nurse who on 30-JUN-2004 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # "VA304A42B") in another country. The patient has a vaccination record that reports that a varicella vaccine was administered on 30-JUN-2004. The name on the vaccination record was "Varilrix," but the record is a copy of a photocopy and not clear. The patient on 26-MAR-2007 had negative antibody titer for varicella. The patient reported that a second dose of varicella vaccine was done, but no record was documented. No symptoms or problems were reported. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the licensed visiting nurse who reported that the patient had received a second dose of varicella virus vaccine live (Varilrix) (lot # VA304A42B") on 23-AUG-2006 and was said to have negative antibody titer for varicella. It was reported that the patient recovered. No other information is expected.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Allergy test, Injection site discolouration, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no medical history or allergies who on 23-MAR-2007 at 11:00 AM was vaccinated SC in left arm with first dose of varicella virus vaccine live (Oka/Merck) (Lot# 654812/1087F). Concomitant therapy on the same day included an IM first dose of hepatitis A vaccine (inactive) (MSD) (Lot # 656497/1213F) in left arm and an IM first dose on right arm of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) (Lot # AC52B0093A). There was no illness at the time of vaccination. In April 2007, 2 weeks after vaccination, the patient developed a 6-8 inch red swollen area at the injection site. The area was hot and itchy. It was reported that "there was an explosion at the injection site". There was a white ring around the site and it "looked like a giant chickenpox". The patient was taken to the emergency room and no treatment but compresses were suggested. The patient subsequently recovered in 7 days. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that on 05-APR-2007, 2 weeks after vaccination the patient developed at the injection site 6-8" raised red area, hot, itchy, white ring around red area with white center raised. The patient recovered in 7 days. The patient had undertaken allergy test for varicella virus vaccine live (MSD). No further information is expected.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no medical history or allergies who on 23-MAR-2007 at 11:00 AM was vaccinated SC in left arm with first dose of varicella virus vaccine live (Oka/Merck) (Lot# 654812/1087F). Concomitant therapy on the same day included an IM first dose of hepatitis A vaccine (inactive) (MSD) (Lot # 656497/1213F) in left arm and an IM first dose on right arm of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) (Lot # AC52B0093A). There was no illness at the time of vaccination. In April 2007, 2 weeks after vaccination, the patient developed a 6-8 inch red swollen area at the injection site. The area was hot and itchy. It was reported that "there was an explosion at the injection site". There was a white ring around the site and it "looked like a giant chickenpox". The patient was taken to the emergency room and no treatment but compresses were suggested. The patient subsequently recovered in 7 days. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that on 05-APR-2007, 2 weeks after vaccination the patient developed at the injection site 6-8" raised red area, hot, itchy, white ring around red area with white center raised. The patient recovered in 7 days. The patient had undertaken allergy test for varicella virus vaccine live (MSD). No further information is expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health care worker concerning a 11 year old female with latex allergy, allergic reaction to amoxicillin (+) clavulanate potassium and diphenhydramine hydrochloride, and no pertinent medical history, who on 17-APR-2007 was vaccinated intramuscularly with varicella virus vaccine live (Oka/Merck) (lot # 656290/0113U). There was no concomitant medication. On 17-APR-2007 the patient experienced increased swelling of the upper right arm with warmth and tenderness noted at the injection site. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male patient under the age of 10 years who was vaccinated with 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On 18-APR-2007, the patient experienced small breakthrough of rash after vaccination. Unspecified medical attention was sought. At the time of report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Skin lesion
Clinical narrative: Information has been received concerning a 12 year old male with no allergies who was vaccinated with varicella virus vaccine (Oka/Merck). There was no illness at the time of vaccine. The patient developed five-six lesions on the chest, with vesicles, and one lesion on the arm and abdomen for 24 hours. At the time of this report, the outcome was unknown. Additional information has been requested.
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 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot#656079/1306F). Concomitant therapy included mometasone furoate (NASONEX) and flaticasone proplonate (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 (WAES3 0704USA02160). Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: DTAP, HIBV, MMR, OPV, PPV, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 6 year old female with asthma and seasonal allergies who on 18-MAY-2001 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccines included a first, second, third and fourth doses of diphtheria toxoid (+) tetanus toxoid pertussis vaccine (unspecified) on 29-JUN-2000, 08-SEP-2000, 03-NOV-2000 and 18-MAY-2001; a first, second and third dose of poliovirus vaccine live oral on 29-JUN-2000, 08-SEP-2000, 18-MAY-2001; a first dose of II measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 18-MAY-2001; a first, second, third and fourth doses of Hib conj vaccine (unspecified carrier) on 29-JUN-2000, 08-SEP-2000, 03-NOV-2000, 18-MAY-2001; a first, second, and third doses of hepatitis B virus vaccine (unspecified) on 02-MAY-2000, 29-JUN-2000, 03-NOV-2000; a first dose of varicella virus vaccine live (unspecified) on 18-MAY-2001; a first and second doses of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) on 08-SEP-2000, 03-NOV-2000; a first and second doses of pneumococcal conj vaccine (unspecified) on 06-FEB-2001, 18-MAY-2001. The physician reported that the 6 year old patient was due for her second dose of varicella virus vaccine live (Oka/Merck) next week but on 20-APR-2007 the patient experienced "breakthrough with over 200 lesions all over her body" after receiving the first dose on 18-MAY-2001. There is no plan to re-vaccinate the patient with the second dose due to the breakthrough. The patient was being treated with a topical cream such as calamine lotion and she was being hydrated. No lot number was provided. Unspecified medical attention was sought. No lab diagnostic studies were performed. There was no illness at time of vaccination. Adverse event(s) following prior vaccination included: chicken pox (none reported for the patient's sibling). No further information was provided. Outcome reported as recovered with 27-APR-2007 as recovery date. There was no product quality complaint. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 7 year old Hispanic male who on 15-FEB-2007, was vaccinated left anterior thigh with a second dose of varicella virus vaccine live (Oka/Merck) (lot number: 656122/1309F). There was no illness at the time of vaccination. On 16-FEB-2007 at 8:34 the patient developed a 3 inch round swollen erythematous area at site of injection. No lab diagnostics studies were performed. Unspecified medical attention was sought. The outcome was reported as recovered within a week. There were no adverse events following prior vaccination. There was no product quality complaint. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Axillary pain, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 7 year old white male who on 20-APR-2007 was vaccinated subcutaneously into the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 656279/1503F). On 22-APR-2007 the patient developed swelling and redness at injection site and pain underarm. On 25 APR 2007 the patient was considered recovered. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 34 month old female, who on 07-JUL-2005 was vaccinated with 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot number "0610P"). On 14-MAR-2007 the patient developed breakthrough of 20-25-lesions with a temperature of 101 degrees. Medical attention was sought. Subsequently, the patient recovered 02-APR-2007. No laboratory tests were performed. No product quality complaint was involved. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 16-OCT-1998 was vaccinated with a 0.05 ml dose of varicella virus vaccine live (Oka/Merck). On 12-MAR-2007 she developed "a breakthrough of scattered vesicular lesions". Unspecified medical attention was sought. The patients recovery status is unknown. No product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Impetigo, Rash, Rash papular
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old caucasian male with a hypersensitivity to seltzer and no known medical history was vaccinated SC in the left arm on 06-MAY-1998 with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot number, 625051/1578E). There was no illness at the time of vaccination. There were no concomitant medications. It was reported that the patient was seen in the physician's office 23-APR-2007 with a two day history of rash on his abdomen. The symptoms were described as 40 red papules (central papules on red base) which were scattered over his trunk, extremities and face. No laboratory tests were reported. No product quality complaint was involved. Information was received from the registered nurse reporting that the patient was seen in the office on 23-APR-2007 with a two day history of rash noted as 40 red papules. The patient was rechecked on 25-APR-2007 and it was felt that this was not chicken pox. The diagnosis was impetigo. On 28-APR-2007, the patient recovered. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 61 year old female who on 20-APR-2007 was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 654750/1256F) instead of zoster vaccine live (Oka/Merck) (MSD). The patient had no averse events. No other information was provided. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 9 year old female who on 20-APR-2007 was vaccinated with 0.5mL varicella virus vaccine live (Oka/Merck) (Lot# 656287/1508F). On 21-APR-2007, the patient developed swelling, heat and redness in the arm which she was vaccinated. The area affected was 2 to 3 inches in diameter. At the time of this report the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports received from the same source. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 10 year old male who on 18-APR-2007 was vaccinated with 0.5ml of varicella virus vaccine live (Oka/Merck) (lot# 656287/1508F). On 19-APR-2007 the patient developed swelling, heat, and redness in the arm in which he was vaccinated. The area affected was 2 to 3 inches in diameter. At the time of this report, the patient had not recovered. The reporter requested a lot check. Unspecified medical attention was sought. No other details were provided. No product quality complaint was involved. This is one of several reports received from the same source. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who on 19-APR-2007 was vaccinated with 0.5mL varicella virus vaccine live (Oka/Merck) (Lot# 656287/1508F). On 20-APR-2007, the patient developed swelling, heat and redness in the arm in which she was vaccinated. The area affected was 2 to 3 inches in diameter. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No other details were provided. No product quality complaint was involved. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with varicella virus vaccine live (Oka/Merck). The patient was inadvertently administered varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (MSD). There was no adverse event. No other details. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a female patient who was intended to received a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) 26-MAR-2007 inadvertently was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that improper vaccination was not due to product confusion. The patient received second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) on 02-APR-2007. No problems were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 26-FEB-2007 was possibly vaccinated with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot# 647538/0784R) instead of a dose of zoster vaccine live (MSD). The patient's chart stated that the patient received a dose of zoster vaccine live (MSD) but the lot number listed was for varicella virus vaccine live (MSD). The nurse could not verify which of the two vaccines that the patient actually received. The patient did not experience any problems or difficulties. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a male who in 2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). No second dose of varicella virus vaccine live (Oka/Merck) was administered. The mother of the patient told the nurse that in September 2006 the patient developed a bad case of shingles on the face (duration unspecified). In March 2007, the patient also developed a breakthrough of chickenpox over the whole body that was described as moderate to severe. At the time of this report, the present status of the patient was unclear. No other information was reported at this time. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 9 year old male with no medical history and no allergies who on 29-APR-1999 was vaccinated with a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot # 628695/1671H) in the left thigh. The father of the patient stated that the patient developed chickenpox and did not have a fever, per the father. No other information was available at the time of this report. No product quality complaint was involved. Medical attention was not sought. There were no laboratory or diagnostic tests performed. The outcome is unknown. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site rash, Rash papular
Clinical narrative: Information has been received from a licensed practical nurse concerning a 14 month old caucasian male patient with no known medical history or allergies who on 30-MAR-2007 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot number 653966/0906F). There was not illness at the time of vaccination. Subsequently the patient developed a rash at the injection site. Unspecified medical attention was sought. No product quality complaint was involved. Information was received from licensed practical nurse reporting that on 09-APR-2007 the patient developed a reaction to varicella virus vaccine live (Oka/Merck) that was administered in the left thigh. It was reported that the left thigh had a small papule surrounded by mild redness. The patient was seen for this reaction on an unspecified date. No treatment was reported. At the time of the report the patient's recovery status was unknown. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 17 year old female with no allergies who on 23-APR-2007 was vaccinated with a second dose of 0.5mL subcutaneous varicella virus vaccine live (Oka/Merck) (Lot# 653305/0438F). On 24-APR-2007, the patient experienced pain, swelling and induration at the injection site. The patient was instructed to mark the area of swelling and induration and it was found that the area increased in size the following day. At the time of this report, the patient had not recovered and no further information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who on 09-APR-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). The patient developed a low grade rash of 10-12 small lesions over the patient's arms, neck, face, and trunk that were firm to touch. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) and developed a case of chickenpox a couple of years later. The patient recovered from the chickenpox on an unknown date. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 56 year old female who had chickenpox as a child, who on 27-MAR-2007 was vaccinated with 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 656078/0169U) instead  of zoster vaccine live (MSD). The patient came in without a written order by her physician and the patient may have incorrectly told another nurse on the day of vaccination which vaccine she was to receive. The nurse believed that since the patient had chickenpox as a child, the patient was supposed to get zoster vaccine live (MSD). The nurse is waiting for a call back from the patient's physician to confirm whether varicella vaccine live (Oka/Merck) or zoster vaccine was supposed to be given. The nurse will call back with additional information. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is expected.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 9 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient developed breakthrough chickenpox in December 2006. At the time of this report, the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 11 or 12 year old male who in August 1995, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included montelukast sodium (MSD). In 2006 the patient developed shingles under arm and lasted for approximately 2 weeks. At the time of report, the patient had full recovery from shingles. Unspecified medical attention was sought. a product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Antibody test abnormal
Clinical narrative: Information has been received from a physician assistant concerning a female patient who in 1998, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient may have failed to seroconvert. In 2000, antibody lab work was performed. "It was reported that the antibody test they used was not effective to test for varicella immunity." No product quality complaint was involved. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old female, who on 15-NOV-2000 was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed a full blown case of chickenpox. The family of three children received the vaccine and two of the older children developed a full blown case of chickenpox. Unspecified medical attention was sought. The patient's status at the time of the report was recovered. No product quality was involved. It was reported that the patient's brother WAES# 0704USA06527 experienced a similar adverse event following vaccination with varicella virus vaccine live. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 6 year old male who on 09-MAY-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 641264/1180L). In October or November 2006 the patient experienced a full blown case of chickenpox. The number of lesions on patient's body was unknown. Unspecified medical attention was sought. At the time of the report the patient had recovered. A product quality complaint was not involved. No further information is available. It was also reported that the patient's sister had a similar experience after therapy with varicella virus vaccine live (Oka/Merck) (WAES # 0704USA06478).
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced an allergic reaction (rash) at injection site. It was unknown whether medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced an allergic reaction (rash) at injection site. It was unknown whether medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Information has been received from a physician concerning a 15 month old female who on 11-APR-2007 was vaccinated with 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included "all vaccines required at 15 months." On 25-APR-2007, the patient developed "asystematic bumps." The bumps were described as pink superficial papules with no pustules. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the physician who stated that approximately 2 weeks after vaccination, the patient developed 5-6 erythematous papules at the injection site. The patient's experience was reported as "no adverse reaction" but a "normal reaction." The papules went away in 1 week. No further information is expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 36 month old male who was vaccinated with a 0.5mL of varicella virus vaccine live (Oka/Merck). The patient developed a rash of a few lesions while taking varicella virus vaccine live (Oka/Merck). No other information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck) (MSD). No additional information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from physician, concerning a patient who was vaccinated with second dose of varicella virus vaccine live (Oka/Merck) and developed zoster. The physician noted that this was reported to him by a colleague at another practice. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 27-APR-2007 it was reported that the patient developed a localized reaction that was bad enough to have the patient back to see the pediatrician. There was no additional information to report. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Skin lesion, Varicella
Clinical narrative: Information has been received from a health professional concerning an 8 year old female with no medical history and no allergies who on 21-OCT-1998 was vaccinated with 0.5ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 626409/0666H). Concomitant therapy included a multivitamin. On 29-APR-2007 the patient developed a varicella rash. The patient had about 40 lesions and had a fever of 101 degrees Fahrenheit. At the time of this report. The patient had not recovered. No further information was available at the time of this report. Unspecified medical attention was sought. No product quality complaint was involved. The patient's twin sister experienced one questionable lesion following this vaccination with varicella virus vaccine live (Oka/Merck) (WAES#0705USA03172). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a patient who on 30-APR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). There was no adverse event. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 year old male who on 27-FEB-1996 was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 610247/0445B) in the right arm. "4 days ago," on 27-APR-2007, the patient developed "breakthrough greater than 250 lesions and fever after receiving varicella virus vaccine live (Oka/Merck)." The patient sought medical attention at the doctor's office. The outcome is unknown. No further information was provided. No product quality complaint was involved. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a registered nurse concerning a 20 month old white male 23 lbs., 32 inches, who on 04-DEC-2006 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #654528/1044F). Concomitant therapy included influenza virus split virion 3v vaccine inactivated (FLUZONE (influenza virus split virion 3v vaccine inactivated)) and measles-mumps-rubella vaccine (M-M-R II). On 24-APR-2007 the patient experienced maculo-papular lesions on the abdomen and groin. Subsequently, the patient recovered from maculo-papular lesions on the abdomen and groin. The patient was seen by a physician and treated with Calamine and Benadryl. The patient was 6 lbs. 12 oz. at birth and has no siblings. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARCEL
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Information has been received from a physician concerning a 60 year old female who was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck). After receiving the varicella virus vaccine live (Oka/Merck), the patient developed polymyalgia rheumatica and an elevated sedimentation rate. At the time of this report, the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a female pharmacist who developed shingles on 11 FEB 2007, two weeks after her daughter was vaccinated, on 30 JAN 2007, with varicella virus vaccine live (Oka/Merck). On 14 FEB 2007, the patient was seen medically for a mild episode. On an unspecified date the event resolved without complications. The patient sought unspecified medical attention from her physician. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a physician concerning a 5 year old male who was vaccinated with a 0.5mL, second dose of varicella virus vaccine live (Oka/Merck). It was reported that a few weeks after receiving the vaccine he developed a few lesions on his back. The patient did not have any adverse events after the initial dose which was on year prior to the second dose. Subsequently, the patient recovered. No laboratory tests were reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old hispanic child with no medical history or allergies who on 23-APR-2007 at 10:45 AM was vaccinated SC on left arm with 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 656076/1490F). At the time of vaccination the patient did not have any illness. On 24-APR-2007 the patient developed a "baseball sized" red, hot, swollen and painful area at the injection site. Unspecified medical attention was sought, no treatment was required. It was reported that the child had also received a dose of varicella virus vaccine live (Oka/Merck) at a year old without adverse symptoms. At the time of report, the patient had recovered. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that the patient developed a painful, red swollen warm to touch arm in morning of 24-APR-2007. The patient recovered on 28-APR-2007. No further information is expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 14 year old female with no medical history and no allergies who on 30-APR-2007 was vaccinated with a second 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 657193/0363U)in the left arm. There were no concomitant medications. There was no illness at the time of vaccination. On 01-MAY-2007, in the morning, the patient experienced a baseball sized red, hot, swollen and painful area of the arm at the injection site that was warm to touch. No treatment was required. There were no laboratory or diagnostic tests performed. The patient recovered on 03-MAY-2007. No additional information was available. No product quality complaint was involved. This is one of several reports received from the same source. Follow-up information received from a registered nurse stated that the patient's symptoms were self-limiting and went away in approximately 72 hours. There was no treatment necessary. There were no other visits nor was any follow-up needed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who in 1996 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included Zovirax and Healtheries Arthrex. In 1999 the patient experienced "mild breakthrough." In 2007 the patient experienced "severe breakthrough." The patient had a significant fever for one day but did not require hospitalization. Follow-up information from the nurse indicated that she did not have any further information. No additional information is expected.