chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Hypersensitivity, Rash
Clinical narrative: Information has been received from a registered nurse concerning a 14 month old male who, on 4 OCT 2007, was vaccinated with varicella virus vaccine live (Oka/Merck). On 02-DEC-2007 the patient developed a shingles rash after receiving varicella virus vaccine live (Oka/Merck), which it was noted was documented as an allergic reaction. At the time of reporting it was documented as an allergic reaction. At the time of reporting it was noted that the patient "was fine" and not hospitalized.  Unspecified medical attention was sought. There was no product quality complaint. Follow up information was received in which the nurse reported that there is no further information available.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Erythema, Induration, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 13-DEC-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck0 (Lot# 659360/1577U). On 14-DEC-2007 the patient experienced cellulitis, fever, induration and erythema of the right arm. The patient was sent to the emergency room. Subsequently, the patient recovered. No product quality complaint was involved. No other information was provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow-up has been received from a nurse concerning a 10 year old female with no known allergies or pertinent medical history who on 13-DEC-2007 at 16:30 was vaccinated SQ in the right arm with VARIVAX (Merck) (Lot# 659360/1577U). On 14-DEC-2007 the patient experienced right arm with 3 cm indurated, erythema of arm, 7 cellulitis from vaccine. The patient treated with KEFLEX 500 mg and SEPTRA DS. There was no illness at the time of vaccination. The patient required emergency room/Doctor visit. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, VARZOS
Symptoms: Varicella, Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning his 1 year old son who on 24-AUG-2007 was vaccinated with ZOSTAVAX. Concomitant therapy included MMR II. Initial report indicated that on 24-AUG-2007 the patient was vaccinated with a dose of VARIVAX, and by 31-AUG-2007 the patient started to breakout with the chicken pox. Consumer also reported that they received a phone call from the physician's office, stating that they had accidentally given the patient the adult dose of the vaccine. Consumer reported that the patient currently had about 20 chicken pox lesions all over his body (left leg, face, and under his arm). Follow up information received on 04-SEP-2007 indicated that the patient received ZOSTAVAX in error instead of VARIVAX. Medical attention was sought. The patient's outcome was unknown. Additional information had been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Incorrect dose administered, Irritability, Teething
Clinical narrative: Information has been received from a health professional and a certified medical assistant concerning a 12 month old Caucasian female patient who on 10-SEP-2007 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (Lot # 658291/1100U) and the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) with two separate syringes on the same day in the leg. There was no illness at the time of vaccination. Medical attention was sought. It was reported that the patient was "more fussy than normal, but is as well teething at the time". Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Irritability, Teething
Clinical narrative: Information has been received from a health professional and a certified medical assistant concerning a 12 month old Caucasian female patient who on 10-SEP-2007 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (Lot # 658291/1100U) and the first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) with two separate syringes on the same day in the leg. There was no illness at the time of vaccination. Medical attention was sought. It was reported that the patient was "more fussy than normal, but is as well teething at the time". Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, VARCEL
Symptoms: Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 12-AUG-1999 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 659072/1469U). There was no concomitant medication. On 12-JAN-2008 the patient developed a 5 inch area at the injection site that was red, swollen, hard and painful. On 15-JAN-2008 the patient was seen "in the office" at which time the redness had gone down, but the patient had a golf ball size knot at the injection site and complained of paresthesia below the injection site extending into the hand. "Sensation testing" of the hand was performed. The patient was able to distinguish sharp from soft, but was unable to distinguish warm from cold. No treatment was prescribed. The patient was first vaccinated with varicella virus vaccine live (Oka/Merck) on 12 AUG 1999 and had no reported reaction. At the time of reporting the patient had not recovered. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information has been received from a health professional concerning a 13 year old female, with no pertinent medical history, drug reactions or allergies who on 11 JAN 2008, at 11:05, was vaccinated subcutaneously, into the left arm, with a second dose of VARIVAX (Merck) (lot # 659072/1469U). There was no illness at the time of vaccination. It was reported that on 17 JAN 2008 the patient was recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, VARCEL
Symptoms: Sensory disturbance
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 12-AUG-1999 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 659072/1469U). There was no concomitant medication. On 12-JAN-2008 the patient developed a 5 inch area at the injection site that was red, swollen, hard and painful. On 15-JAN-2008 the patient was seen "in the office" at which time the redness had gone down, but the patient had a golf ball size knot at the injection site and complained of paresthesia below the injection site extending into the hand. "Sensation testing" of the hand was performed. The patient was able to distinguish sharp from soft, but was unable to distinguish warm from cold. No treatment was prescribed. The patient was first vaccinated with varicella virus vaccine live (Oka/Merck) on 12 AUG 1999 and had no reported reaction. At the time of reporting the patient had not recovered. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information has been received from a health professional concerning a 13 year old female, with no pertinent medical history, drug reactions or allergies who on 11 JAN 2008, at 11:05, was vaccinated subcutaneously, into the left arm, with a second dose of VARIVAX (Merck) (lot # 659072/1469U). There was no illness at the time of vaccination. It was reported that on 17 JAN 2008 the patient was recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Nerve stimulation test abnormal
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 12-AUG-1999 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 659072/1469U). There was no concomitant medication. On 12-JAN-2008 the patient developed a 5 inch area at the injection site that was red, swollen, hard and painful. On 15-JAN-2008 the patient was seen "in the office" at which time the redness had gone down, but the patient had a golf ball size knot at the injection site and complained of paresthesia below the injection site extending into the hand. "Sensation testing" of the hand was performed. The patient was able to distinguish sharp from soft, but was unable to distinguish warm from cold. No treatment was prescribed. The patient was first vaccinated with varicella virus vaccine live (Oka/Merck) on 12 AUG 1999 and had no reported reaction. At the time of reporting the patient had not recovered. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information has been received from a health professional concerning a 13 year old female, with no pertinent medical history, drug reactions or allergies who on 11 JAN 2008, at 11:05, was vaccinated subcutaneously, into the left arm, with a second dose of VARIVAX (Merck) (lot # 659072/1469U). There was no illness at the time of vaccination. It was reported that on 17 JAN 2008 the patient was recovered. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL, VARCEL
Symptoms: No reaction on previous exposure to drug, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female who on 12-AUG-1999 was vaccinated subcutaneously with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 659072/1469U). There was no concomitant medication. On 12-JAN-2008 the patient developed a 5 inch area at the injection site that was red, swollen, hard and painful. On 15-JAN-2008 the patient was seen "in the office" at which time the redness had gone down, but the patient had a golf ball size knot at the injection site and complained of paresthesia below the injection site extending into the hand. "Sensation testing" of the hand was performed. The patient was able to distinguish sharp from soft, but was unable to distinguish warm from cold. No treatment was prescribed. The patient was first vaccinated with varicella virus vaccine live (Oka/Merck) on 12 AUG 1999 and had no reported reaction. At the time of reporting the patient had not recovered. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information has been received from a health professional concerning a 13 year old female, with no pertinent medical history, drug reactions or allergies who on 11 JAN 2008, at 11:05, was vaccinated subcutaneously, into the left arm, with a second dose of VARIVAX (Merck) (lot # 659072/1469U). There was no illness at the time of vaccination. It was reported that on 17 JAN 2008 the patient was recovered. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female with seasonal allergies, headaches and a history of Lyme disease in June 2006, who on 05-NOV-1998 and 10-JAN-2008 was vaccinated SC with the first and second (lot# 659166'1499U) 0.5 ml doses of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 11-JAN-2008 the patient developed an injection site rash and the patient was checked in the office on 12-JAN-2008. The patient's injection site reaction was described as an 11 by 12 cm area of hard, warm, red skin, tender to touch with no streaking. No labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. Follow-up information from the reporting registered nurse indicated that the 10 year old white female who on 10-JAN-2008 at 14:00 was vaccinated SC with her second dose of varicella virus vaccine live (Oka/Merck) (lot# 659166/1499U). There was no illness at the time of vaccination. On 11-JAN-2008 in the morning the patient developed a 11 x 12 cm area that was hard, warm, with red skin and tender to the touch. It was noted that the patient had no streaking. Subsequently the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female with seasonal allergies, headaches and a history of Lyme disease in June 2006, who on 05-NOV-1998 and 10-JAN-2008 was vaccinated SC with the first and second (lot# 659166'1499U) 0.5 ml doses of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 11-JAN-2008 the patient developed an injection site rash and the patient was checked in the office on 12-JAN-2008. The patient's injection site reaction was described as an 11 by 12 cm area of hard, warm, red skin, tender to touch with no streaking. No labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. Follow-up information from the reporting registered nurse indicated that the 10 year old white female who on 10-JAN-2008 at 14:00 was vaccinated SC with her second dose of varicella virus vaccine live (Oka/Merck) (lot# 659166/1499U). There was no illness at the time of vaccination. On 11-JAN-2008 in the morning the patient developed a 11 x 12 cm area that was hard, warm, with red skin and tender to the touch. It was noted that the patient had no streaking. Subsequently the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 9 year old female with asthma and no history of drug reaction or allergies who on 06-DEC-1999 was vaccinated with a second dose (the first dose was 06-DEC-1999) of varicella virus vaccine live (Oka/Merck) (lot#659166/1499U), subcutaneously. No concomitant medication was reported. On 11-JAN-2008, the patient experienced injection site reaction. The patient was checked in the office on 12-Jan-2008, the injection site was described as 11 cm red, warm, mildly tender and itchy skin with no streaking. It was reported that the patient was recovering from the site reaction. No product quality complaint. Lot Check Results: The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center of Biologics Evaluation and Research and was released by the regulatory agency. This is one of several reports received from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 9 year old female with asthma and no history of drug reaction or allergies who on 06-DEC-1999 was vaccinated with a second dose (the first dose was 06-DEC-1999) of varicella virus vaccine live (Oka/Merck) (lot#659166/1499U), subcutaneously. No concomitant medication was reported. On 11-JAN-2008, the patient experienced injection site reaction. The patient was checked in the office on 12-Jan-2008, the injection site was described as 11 cm red, warm, mildly tender and itchy skin with no streaking. It was reported that the patient was recovering from the site reaction. No product quality complaint. Lot Check Results: The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met requirements of the Center of Biologics Evaluation and Research and was released by the regulatory agency. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Dizziness, Erythema, Headache, Hypersensitivity, Injection site cellulitis
Clinical narrative: Information has been received from a health professional concerning a 11 year old 164 1/2 lb  61 in male with an allergy to nickel, who on 25-JAN-2008, was vaccinated with a second subcutaneous dose in the upper deltoid of the left arm of varicella virus vaccine live (Oka/Merck) (lot# 656906/1759U). Concomitant vaccination included a second intramuscular dose in the left deltoid of hepatitis A vaccine (inactive) (HAVRIX) (lot# AHAVB211AA). It was indicated that both vaccines were administered in the left arm at the patient's request. There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. It was indicated that on 25-JAN-2008, he noticed redness. On 26-JAN-2008, he developed a headache and dizziness. On 26-JAN-2008, he developed a red and swollen injection site reaction at the varicella virus vaccine live (Oka/Merck) site. On 28-JAN-2008, at 13:45 hours upon physical examination, he denied headache or dizziness, and there was a 19 1/2 cm by 16 cm red indurated area on his left shoulder and arm. The physicians diagnosis was left arm cellulitis versus possible allergic reaction. On 28-JAN-2008, antibiotic therapy was initiated with cephalexin (KEFLEX), 500 mg twice a day, for 10 days. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Skin warm
Clinical narrative: Information has been received from a health professional concerning a 11 year old 164 1/2 lb  61 in male with an allergy to nickel, who on 25-JAN-2008, was vaccinated with a second subcutaneous dose in the upper deltoid of the left arm of varicella virus vaccine live (Oka/Merck) (lot# 656906/1759U). Concomitant vaccination included a second intramuscular dose in the left deltoid of hepatitis A vaccine (inactive) (HAVRIX) (lot# AHAVB211AA). It was indicated that both vaccines were administered in the left arm at the patient's request. There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. It was indicated that on 25-JAN-2008, he noticed redness. On 26-JAN-2008, he developed a headache and dizziness. On 26-JAN-2008, he developed a red and swollen injection site reaction at the varicella virus vaccine live (Oka/Merck) site. On 28-JAN-2008, at 13:45 hours upon physical examination, he denied headache or dizziness, and there was a 19 1/2 cm by 16 cm red indurated area on his left shoulder and arm. The physicians diagnosis was left arm cellulitis versus possible allergic reaction. On 28-JAN-2008, antibiotic therapy was initiated with cephalexin (KEFLEX), 500 mg twice a day, for 10 days. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Cellulitis, Dizziness, Erythema, Headache, Hypersensitivity
Clinical narrative: Information has been received from a health professional concerning a 11 year old 164 1/2 lb  61 in male with an allergy to nickel, who on 25-JAN-2008, was vaccinated with a second subcutaneous dose in the upper deltoid of the left arm of varicella virus vaccine live (Oka/Merck) (lot# 656906/1759U). Concomitant vaccination included a second intramuscular dose in the left deltoid of hepatitis A vaccine (inactive) (HAVRIX) (lot# AHAVB211AA). It was indicated that both vaccines were administered in the left arm at the patient's request. There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. It was indicated that on 25-JAN-2008, he noticed redness. On 26-JAN-2008, he developed a headache and dizziness. On 26-JAN-2008, he developed a red and swollen injection site reaction at the varicella virus vaccine live (Oka/Merck) site. On 28-JAN-2008, at 13:45 hours upon physical examination, he denied headache or dizziness, and there was a 19 1/2 cm by 16 cm red indurated area on his left shoulder and arm. The physicians diagnosis was left arm cellulitis versus possible allergic reaction. On 28-JAN-2008, antibiotic therapy was initiated with cephalexin (KEFLEX), 500 mg twice a day, for 10 days. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: HEPA, VARCEL, HEPA, VARCEL
Symptoms: Induration
Clinical narrative: Information has been received from a health professional concerning a 11 year old 164 1/2 lb  61 in male with an allergy to nickel, who on 25-JAN-2008, was vaccinated with a second subcutaneous dose in the upper deltoid of the left arm of varicella virus vaccine live (Oka/Merck) (lot# 656906/1759U). Concomitant vaccination included a second intramuscular dose in the left deltoid of hepatitis A vaccine (inactive) (HAVRIX) (lot# AHAVB211AA). It was indicated that both vaccines were administered in the left arm at the patient's request. There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. It was indicated that on 25-JAN-2008, he noticed redness. On 26-JAN-2008, he developed a headache and dizziness. On 26-JAN-2008, he developed a red and swollen injection site reaction at the varicella virus vaccine live (Oka/Merck) site. On 28-JAN-2008, at 13:45 hours upon physical examination, he denied headache or dizziness, and there was a 19 1/2 cm by 16 cm red indurated area on his left shoulder and arm. The physicians diagnosis was left arm cellulitis versus possible allergic reaction. On 28-JAN-2008, antibiotic therapy was initiated with cephalexin (KEFLEX), 500 mg twice a day, for 10 days. On an unspecified date, the patient recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL, VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a health professional concerning a 13 year old female with no known allergies or pertinent medical history who on 14-JAN-2008, was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 659359/1576U). Concomitant vaccinations included hepatitis A vaccine, Menactra and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unspecified). There was no concomitant medication. On 14-JAN-2008, after she received the vaccine, she fainted. It was indicated that she was seen by the physician in the office. There were no laboratory or diagnostic tests performed. It was reported that on 14-JAN-2008, she had recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPAB, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Injection site reaction, Varicella virus test positive, Virus culture
Clinical narrative: Information has been received from a physician concerning a 15 month old white female with no pre-existing allergies, birth defects, or medical conditions, who on 06-NOV-2007 at 12:32 hours, was vaccinated with a first subcutaneous dose in the left deltoid of varicella virus vaccine live (Oka/Merck) (lot# 658431/1184U). Concomitant vaccination on 06-NOV-2008 included: at 12:32 hours, a first subcutaneous dose in the left deltoid of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 656034/0182U0, at 12:30 hours a first intramuscular dose in the right deltoid of hepatitis A vaccine (inactive) (HAVRIX) (lot# ahavb200aa), and at 12:33 hours, a fourth subcutaneous dose in the right deltoid of PREVNAR (lot# 870143U). There was no reported illness at the time of the vaccinations. On 08-FEB-2008, the patient developed zoster in the same arm as her vaccination with varicella virus vaccine live (Oka/Merck). It was indicated that the patient was seen in the physician's office and was being treated with acyclovir. VZV Analysis by PCR was offered but the physician had already sent vesicles for culture. The sample of the lesion was collected on 09-FEB-2008. Samples were obtained from unspecified site as a swab and media at a local hospital. They were resulted on 20-FEB-2008, by the Centers for Disease Control and Prevention National VZV Labatory as POSITIVE for VZV DNA Detection, VZV Genotype was reported as VACCINE, Actin Control DNA was POSITIVE and reported specimen was adequate. It was reported that as of 21-FEB-2008, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL, HEPAB, MMR, PNC, VARCEL
Symptoms: Herpes zoster, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a 15 month old white female with no pre-existing allergies, birth defects, or medical conditions, who on 06-NOV-2007 at 12:32 hours, was vaccinated with a first subcutaneous dose in the left deltoid of varicella virus vaccine live (Oka/Merck) (lot# 658431/1184U). Concomitant vaccination on 06-NOV-2008 included: at 12:32 hours, a first subcutaneous dose in the left deltoid of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 656034/0182U0, at 12:30 hours a first intramuscular dose in the right deltoid of hepatitis A vaccine (inactive) (HAVRIX) (lot# ahavb200aa), and at 12:33 hours, a fourth subcutaneous dose in the right deltoid of PREVNAR (lot# 870143U). There was no reported illness at the time of the vaccinations. On 08-FEB-2008, the patient developed zoster in the same arm as her vaccination with varicella virus vaccine live (Oka/Merck). It was indicated that the patient was seen in the physician's office and was being treated with acyclovir. VZV Analysis by PCR was offered but the physician had already sent vesicles for culture. The sample of the lesion was collected on 09-FEB-2008. Samples were obtained from unspecified site as a swab and media at a local hospital. They were resulted on 20-FEB-2008, by the Centers for Disease Control and Prevention National VZV Labatory as POSITIVE for VZV DNA Detection, VZV Genotype was reported as VACCINE, Actin Control DNA was POSITIVE and reported specimen was adequate. It was reported that as of 21-FEB-2008, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Abscess, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 1 year old male with no medical history and no drug allergies, who on 04-FEB-2008 was vaccinate SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 659693/1766U). Concomitant vaccination included Prevnar, administered in a different injection site from the varicella virus vaccine live (Oka/Merck). On 13-FEB-2008 the patient developed an injection site reaction where the varicella virus vaccine live (Oka/Merck was administered. The symptoms included redness, local heat, and swelling. The patient was treated with an unspecified antibiotic. No laboratory diagnostics were performed. At the time of the report the patient was recovering. No product quality complaint was involved. This is one of two reports from the the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information was received from a nurse practitioner who reported that the patient had presented with complaints of swelling, warmth and a red lump on the left thigh at the injection site, of the VARIVAX (Merck, which was diagnosed as a sterile abscess. The patient was treated with BACTRIM suspension PO for ten days. At the time of reporting the patient was recovered (date unspecified). This is one of two reports from the same source. Additional information is not expected.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL, PNC, VARCEL
Symptoms: Abscess sterile, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 1 year old male with no medical history and no drug allergies, who on 04-FEB-2008 was vaccinate SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 659693/1766U). Concomitant vaccination included Prevnar, administered in a different injection site from the varicella virus vaccine live (Oka/Merck). On 13-FEB-2008 the patient developed an injection site reaction where the varicella virus vaccine live (Oka/Merck was administered. The symptoms included redness, local heat, and swelling. The patient was treated with an unspecified antibiotic. No laboratory diagnostics were performed. At the time of the report the patient was recovering. No product quality complaint was involved. This is one of two reports from the the same source. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2008. Follow up information was received from a nurse practitioner who reported that the patient had presented with complaints of swelling, warmth and a red lump on the left thigh at the injection site, of the VARIVAX (Merck, which was diagnosed as a sterile abscess. The patient was treated with BACTRIM suspension PO for ten days. At the time of reporting the patient was recovered (date unspecified). This is one of two reports from the same source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Feeling hot, Inflammation, Injection site erythema, Rash erythematous
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, and from a physician's assistant, concerning an 11 year old female patient with acne noted on her left arm and reaction to OMINCEF (caused clostridium difficile-pseudomonas colitis), and a history of urinary tract infection (diagnostics on bladder were normal), bronchial infection and ear tube insertion, who on 25-NOV-1997 was vaccinated with the first dose and on 22-FEB-2008 was vaccinated SC in the left arm, with the second dose of VARIVAX (Oka/Merck) (lot #659737/1783U). Immediately after receiving the booster dose on 22-FEB-2008, the patient experienced a sore arm. On 23-FEB-2008, her arm felt warm and uncomfortable. On 24-FEB-2008, she noticed her arm was warm down to the elbow and there was a rash. On 25-FEb-2008, the patient was seen by the PA, who noticed cellulitis encompassing the entire posterior and lateral aspect of the left upper arm. The NP indicated there was a "huge patch across the top of her arm around the injection site and it was cellulitis underneath." The border of the cellulitis was marked, and the patient was instructed to call if it enlarged. Treatment included cold packs, and KEFLEX; ZANTAC and ALLEGRA D were prescribed as needed. At the time of this report, the outcome of the events was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted ob 5/16/2008. Treatment icluded cold packs, and KEFLEX 500 mg TID x7 days;ZANTAC and ALLEGRA D were prescribed as needed. On 27-FEB-2008, the patient recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Cystogram, Discomfort, Injection site cellulitis, Pain in extremity, Rash
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, and from a physician's assistant, concerning an 11 year old female patient with acne noted on her left arm and reaction to OMINCEF (caused clostridium difficile-pseudomonas colitis), and a history of urinary tract infection (diagnostics on bladder were normal), bronchial infection and ear tube insertion, who on 25-NOV-1997 was vaccinated with the first dose and on 22-FEB-2008 was vaccinated SC in the left arm, with the second dose of VARIVAX (Oka/Merck) (lot #659737/1783U). Immediately after receiving the booster dose on 22-FEB-2008, the patient experienced a sore arm. On 23-FEB-2008, her arm felt warm and uncomfortable. On 24-FEB-2008, she noticed her arm was warm down to the elbow and there was a rash. On 25-FEb-2008, the patient was seen by the PA, who noticed cellulitis encompassing the entire posterior and lateral aspect of the left upper arm. The NP indicated there was a "huge patch across the top of her arm around the injection site and it was cellulitis underneath." The border of the cellulitis was marked, and the patient was instructed to call if it enlarged. Treatment included cold packs, and KEFLEX; ZANTAC and ALLEGRA D were prescribed as needed. At the time of this report, the outcome of the events was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted ob 5/16/2008. Treatment icluded cold packs, and KEFLEX 500 mg TID x7 days;ZANTAC and ALLEGRA D were prescribed as needed. On 27-FEB-2008, the patient recovered. No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Skin warm
Clinical narrative: Information has been received from a nurse practitioner, via a company representative, and from a physician's assistant, concerning an 11 year old female patient with acne noted on her left arm and reaction to OMINCEF (caused clostridium difficile-pseudomonas colitis), and a history of urinary tract infection (diagnostics on bladder were normal), bronchial infection and ear tube insertion, who on 25-NOV-1997 was vaccinated with the first dose and on 22-FEB-2008 was vaccinated SC in the left arm, with the second dose of VARIVAX (Oka/Merck) (lot #659737/1783U). Immediately after receiving the booster dose on 22-FEB-2008, the patient experienced a sore arm. On 23-FEB-2008, her arm felt warm and uncomfortable. On 24-FEB-2008, she noticed her arm was warm down to the elbow and there was a rash. On 25-FEb-2008, the patient was seen by the PA, who noticed cellulitis encompassing the entire posterior and lateral aspect of the left upper arm. The NP indicated there was a "huge patch across the top of her arm around the injection site and it was cellulitis underneath." The border of the cellulitis was marked, and the patient was instructed to call if it enlarged. Treatment included cold packs, and KEFLEX; ZANTAC and ALLEGRA D were prescribed as needed. At the time of this report, the outcome of the events was unknown. Additional information has been requested. This is in follow-up to report(s) previously submitted ob 5/16/2008. Treatment icluded cold packs, and KEFLEX 500 mg TID x7 days;ZANTAC and ALLEGRA D were prescribed as needed. On 27-FEB-2008, the patient recovered. No further information is available.
Age: 23.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Abnormal labour, Alpha 1 foetoprotein amniotic fluid normal, Caesarean section, Drug exposure during pregnancy, Ultrasound scan abnormal
Clinical narrative: Information has been received through the Merck pregnancy registry from a 23 year old pregnant (31 weeks) female consumer with seasonal allergies and no other pertinent medical history who on 05-DEC-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included antimicrobial (unspecified). Illness at the time of vaccination included a cold. On 05-DEC-2007 the patient had a red bump on her arm at the injection site which lasted fro about one week. Medical attention was not sought. There was no product quality complaint involved. No further information was provided. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Upper respiratory tract infection
Clinical narrative: Information has been received through the Merck pregnancy registry from a 23 year old pregnant (31 weeks) female consumer with seasonal allergies and no other pertinent medical history who on 05-DEC-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included antimicrobial (unspecified). Illness at the time of vaccination included a cold. On 05-DEC-2007 the patient had a red bump on her arm at the injection site which lasted fro about one week. Medical attention was not sought. There was no product quality complaint involved. No further information was provided. No further information is expected.
Age: 23.0
Sex: F
Vaccine: HEP, VARCEL, VARCEL
Symptoms: Drug exposure during pregnancy, Injection site erythema, Injection site mass
Clinical narrative: Information has been received through the Merck pregnancy registry from a 23 year old pregnant (31 weeks) female consumer with seasonal allergies and no other pertinent medical history who on 05-DEC-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included antimicrobial (unspecified). Illness at the time of vaccination included a cold. On 05-DEC-2007 the patient had a red bump on her arm at the injection site which lasted fro about one week. Medical attention was not sought. There was no product quality complaint involved. No further information was provided. No further information is expected.
Age: 1.2
Sex: M
Vaccine: DTAP, HEPA, VARCEL, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a veterinarian concerning her 15 month old son who on 28-FEB-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) Lot# 659693/1766U.  There was no concomitant medication.  On 09-MAR-2008 the patient developed a generalized varicella like rash.  It was indicated that were approximately nine varicella like lesions on the child's buttocks, back, and legs.  The patient has been treated with oatmeal baths.  At the time of this report the patient is recovering.  A product quality complaint has not been reported.
Age: 1.2
Sex: M
Vaccine: DTAP, HEPA, VARCEL, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a veterinarian concerning her 15 month old son who on 28-FEB-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) Lot# 659693/1766U.  There was no concomitant medication.  On 09-MAR-2008 the patient developed a generalized varicella like rash.  It was indicated that were approximately nine varicella like lesions on the child's buttocks, back, and legs.  The patient has been treated with oatmeal baths.  At the time of this report the patient is recovering.  A product quality complaint has not been reported.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Ataxia, Ganglioneuroblastoma, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 26-NOV-2007 was vaccinated SC with a 0.5 mL dose of VARIVAX. There was no concomitant medication. The physician mentioned that about a month after the patient received the vaccine, the patient was diagnosed with ataxia. The patient was hospitalized for one day so that a "work up" could be performed prior to the diagnosis. Lab diagnostic studies performed included a MRI that was negative and a spinal tap that showed a count of 10 white blood cells. Other unspecified lab studies were performed. No additional information was available. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Tremor
Clinical narrative: Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 26-NOV-2007 was vaccinated SC with a 0.5 mL dose of VARIVAX. There was no concomitant medication. The physician mentioned that about a month after the patient received the vaccine, the patient was diagnosed with ataxia. The patient was hospitalized for one day so that a "work up" could be performed prior to the diagnosis. Lab diagnostic studies performed included a MRI that was negative and a spinal tap that showed a count of 10 white blood cells. Other unspecified lab studies were performed. No additional information was available. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL, VARCEL
Symptoms: Ataxia, CSF white blood cell count, Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 16 month old female with no pertinent medical history and no drug reactions/allergies, who on 26-NOV-2007 was vaccinated SC with a 0.5 mL dose of VARIVAX. There was no concomitant medication. The physician mentioned that about a month after the patient received the vaccine, the patient was diagnosed with ataxia. The patient was hospitalized for one day so that a "work up" could be performed prior to the diagnosis. Lab diagnostic studies performed included a MRI that was negative and a spinal tap that showed a count of 10 white blood cells. Other unspecified lab studies were performed. No additional information was available. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Induration, Pruritus, Rash, Rash erythematous
Clinical narrative: Information has been received from a pharmacy student concerning a 7 year old female who on an unspecified date was vaccinated with VARIVAX (Oka/Merck) (lot# 659358/1568U).  On an unspecified date the patient developed and injection site reaction after the vaccination.  The injection site reaction was a large half dollar size inflamed area.  At the time of reporting it was unknown if the patient had recovered.  No other information was available.  Additional information has been requested.  This is one of two reports from the same source.
Age: 7.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a pharmacy student concerning a 7 year old female who on an unspecified date was vaccinated with VARIVAX (Oka/Merck) (lot# 659358/1568U).  On an unspecified date the patient developed and injection site reaction after the vaccination.  The injection site reaction was a large half dollar size inflamed area.  At the time of reporting it was unknown if the patient had recovered.  No other information was available.  Additional information has been requested.  This is one of two reports from the same source.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Information has been received from a pharmacy student concerning an 8 year old female who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 659358/1568U). On an unspecified date the patient developed an injection site reaction after the vaccination. The injection site reaction was a large half dollar size inflamed area. At the time of reporting it was unknown if the patient had recovered. No other information was available. Additional information has been requested. This is one of two reports from the same source.
Age: 8.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Injection site inflammation
Clinical narrative: Information has been received from a pharmacy student concerning an 8 year old female who on an unspecified date was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 659358/1568U). On an unspecified date the patient developed an injection site reaction after the vaccination. The injection site reaction was a large half dollar size inflamed area. At the time of reporting it was unknown if the patient had recovered. No other information was available. Additional information has been requested. This is one of two reports from the same source.
Age: 14.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Abdominal pain upper, Biopsy skin abnormal, Blister, Blood pressure, Body temperature increased
Clinical narrative: Information has been received from a physician concerning a 14-year-old female with a history of a bone marrow transplant in 2004 who on an unknown date was vaccinated with a third dose of VARIVAX. On an unspecified date it was reported that patient had "transmission from varicella virus vaccine live". It was noted the patient was sitting next to a child with a rash. The patient is now hospitalized with a varicella rash. The physician also reports that he does not know if there was an adverse experience, he wants to "know if it is a vaccine strain or infection". At the time of the report the patient's status was unknown. A product quality complaint was not involved. The physician indicated that he received the VZVIP questionnaire and he would be sending in a sample collected from a scraping of a "varicella rash". This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Carotid artery occlusion, Chest X-ray normal, Erythema, Herpes zoster, Influenza like illness
Clinical narrative: Information has been received from a physician concerning a 14-year-old female with a history of a bone marrow transplant in 2004 who on an unknown date was vaccinated with a third dose of VARIVAX. On an unspecified date it was reported that patient had "transmission from varicella virus vaccine live". It was noted the patient was sitting next to a child with a rash. The patient is now hospitalized with a varicella rash. The physician also reports that he does not know if there was an adverse experience, he wants to "know if it is a vaccine strain or infection". At the time of the report the patient's status was unknown. A product quality complaint was not involved. The physician indicated that he received the VZVIP questionnaire and he would be sending in a sample collected from a scraping of a "varicella rash". This is one of several reports received from the same source. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Myalgia, Oxygen saturation, Pharyngolaryngeal pain, Pyrexia, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 14-year-old female with a history of a bone marrow transplant in 2004 who on an unknown date was vaccinated with a third dose of VARIVAX. On an unspecified date it was reported that patient had "transmission from varicella virus vaccine live". It was noted the patient was sitting next to a child with a rash. The patient is now hospitalized with a varicella rash. The physician also reports that he does not know if there was an adverse experience, he wants to "know if it is a vaccine strain or infection". At the time of the report the patient's status was unknown. A product quality complaint was not involved. The physician indicated that he received the VZVIP questionnaire and he would be sending in a sample collected from a scraping of a "varicella rash". This is one of several reports received from the same source. Additional information has been requested.