chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old female with peanut allergy who on 27-SEP-1996 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 658178/1013U). On 21-AUG-2007, the patient was vaccinated subcutaneously in the left thigh with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck), a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA, lot # 62391BA, mfr. Sanofi Pasteur) "in the same thigh but many inches apart", a dose of GARDASIL vaccine (yeast) (lot # 0469U), diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (lot# AC52B024AA, mfr. GSK) and hepatitis A virus vaccine (unspecified) (lot# AHAVB186AA, mfr. GSK). The registered nurse reported that within 20 minutes post vaccination the patient experienced an injection site reaction with redness 1 to 1.5 inches in diameter. The patient sought unspecified medical attention. No treatment required. There was no product quality complaint involved. Follow-up information was received on 05-SEP-2007. Follow-up information was received via a telephone call with a registered nurse who stated she did not know if the patient had recovered. Follow-up information was received on 13-SEP-2007. Follow-up information was received via a telephone call with a registered nurse who updated the varicella virus vaccine live (Oka/Merck) lot number (658178/1013U). Follow-up information was received on 25-SEP-2007 from a registered nurse concerning a 11-year-old (also reported as 12 years old) white female with a peanut allergy who on 27-SEP-1996 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck) and her second subcutaneous 0.5 ml dose administered in her left thigh on 21-AUG-2007 (lot # 658178/1013U). There were no illnesses at the time of the report. Concomitant vaccines administered on 21-AUG-2007 (lot # 658178/1013U). There were no illnesses at the time of the report. Concomitant vaccines administered on 21-AUG-2007 included a first intramuscular dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) administered in her left thigh (lot # U2391BA), a first intramuscular dose of GARDASIL vaccine (yeast) (MSD) administered in her right thigh (lot # 0469U), a fifth intramuscular dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (BOOSTRIX) administered in her right thigh (lot # AC52B024AA) and a first intramuscular dose of hepatitis A vaccine (inactive) (HAVRIX) administered in her right thigh (lot # AHAVB186AA). On 21-AUG-2007 (immediately following injection) the patient experienced an injection site reaction with redness 1 to 1.5 inches in diameter, knot in center of site, extreme pain at injection site, hard raised swollen area the size of a half dollar with total induration 6-8 inches in circumference. On 26-AUG-2007 the patient recovered from all adverse experiences. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning the granddaughter, a 15 month old female, of a middle aged woman who was vaccinated with varicella virus vaccine live (Oka/Merck) and then developed shingles. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old male who in 2001 (12 months of age) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In June 2007 (2 months ago), the patient experienced shingles. Unspecified medical attention was sought. Subsequently, the patient recovered from shingles. A product quality complaint was not involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Dysphagia, Dyspnoea, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 5 year old male who on 04-AUG-2003 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On 20-AUG-2007, the patient received a second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 658054/10100). On 20-Aug-2007, the patient developed difficulty breathing and swallowing, and was itchy all over his body. The physician advised the nurse to take the patient to the local emergency room. The patient was advised to take Benadryl and was given an epinephrine pen. The physician suggested that the patient see an allergist. No laboratory or diagnostic tests were performed. No additional information was provided. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of female pediatric patients of various ages who were vaccinated with a second subcutaneous 0.5mL dose of varicella virus vaccine live (Oka/Merck). The patients developed an injection site reaction the following day and the area was red and hot to touch. All patients have recovered. Unspecified medical attention was sought. No other details were available. No product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash papular, Rash pustular
Clinical narrative: Information has been received concerning a 5 year old white male who on 23-SEP-2002 was vaccinated in the right leg with a first dose of varicella virus vaccine live (Oka/Merck) (Lot#642632/0324M). On 06-AUG-2007, the patient developed a generalized rash with about 30 papules and a few pustules concentrated on the lower trunk and upper legs. On 09-AUG-2007 the patient was seen in the office. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected. This is one of several reports from the same source regarding a sibling.
Age: 1.5
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash papular, Rash pustular
Clinical narrative: Information has been received concerning a 7 year old male who on 27-JUN-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 06-AUG-2007, the patient developed a generalized itchy rash. On 09-AUG-2007, the patient was seen in the office. At that time there were about 30 papules and a few pustules concentrated on the lower trunk and upper legs. Subsequently, the patient recovered after about 10 days on 16-AUG-2007. No further information was provided. There was no product quality complaint involved. Additional information is not expected. The patient's brother also had an adverse event after vaccination with varicella virus vaccine live (Oka/Merck) (WAES#0708USA04378).
Age: 13.0
Sex: M
Vaccine: HEPA, MEN, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 13 year old male with a history of chickenpox who on 20-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Additional suspect vaccination given in the same arm included a dose of hepatitis A vaccine (inactive) (manufacturer unknown). Other concomitant therapy given in the other arm included meningococcal vaccine (unspecified) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 21-AUG-2007 the patient's mother called the office and reported that the patient developed injection site swelling. Ice was applied to the site and acetaminophen (TYLENOL) and ibuprofen (MOTRIN) were prescribed. The patient was seen in the office on 22-AUG-2007, the swelling had resolved and there was minimal redness at the injection site. At the time of the report the patient was recovering. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Nodule
Clinical narrative: Information has been received from a physician concerning a 11 year old male who on 14-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (656922/0450U). In approximately August 2007, the patient experienced a nodule, local injection site pain and local injection site swelling. He sought unspecified medical attention. Subsequently, the patient recovered from a nodule, local injection site pain and local injection site swelling. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Nodule, Tuberculin test
Clinical narrative: Information has been received from a physician concerning a 14 year old male who on 26-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot # 656922/0450U). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). It was noted a TB skin test was performed. In approximately July 2007, the patient experienced a nodule, local injection site pain and local injection site swelling. He sought unspecified medical attention. Subsequently, the patient recovered from a nodule, local injection site pain and local injection site swelling. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Nodule
Clinical narrative: Information has been received from a physician and a nurse concerning a 10 year old female who on 02-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck), lot# 657796/0842U), second dose, single dose vial. Concomitant therapy included hepatitis A vaccine (inactive) (HAVRIX) and human papillomavirus vaccine (MSD). In 2007, the patient developed a nodule and experienced injection site pain and swelling. As of 23-AUG-2007, the patient recovered. An initial dose was administered however not reported. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Nodule, Tuberculin test
Clinical narrative: Information has been received from a physician and a nurse concerning a male who on 26-JUN-2007 was vaccinated with his second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 656177/0675U). Subsequently the patient developed a nodule and experienced local injection site pain and swelling after vaccination. Medical attention was sought via physician office visit on 10-JUL-2007. Lab diagnostic studies included a TB skin test. The patient was treated with sulfamethoxazole and trimethoprim (SEPTRA) 2 teaspoonfuls BID for 10 days. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 13 year old female who was vaccinated with her second 0.5ml dose of varicella virus vaccine live (Oka/Merck) (No lot number was provided). Subsequently 10 days after vaccination, the patient broke out with chicken pox of 80-100 lesions. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Nodule
Clinical narrative: Information has been received from a physician and a nurse concerning a female who on 17-JUL-2007 was vaccinated with her second SC dose of varicella virus vaccine life (Oka/Merck) (Lot# 656177/0675U). Subsequently the patient developed a nodule and experienced local injection site pain and swelling after vaccination. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella zoster serology negative
Clinical narrative: Information has been received from a registered nurse concerning a female with a history of leukaemia in 1995 and no drug allergies, who on 29-JUN-1998 and 23-AUG-2007 was vaccinated with her first and second 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot number unknown for both doses). Concomitant therapy included fexofenadine hydrochloride (ALLEGRA). The patient failed to seroconvert following the administration of her first dose of varicella virus vaccine live (Oka/Merck). Unspecified medical attention was sought. Lab diagnostic studies included a seronegative VZV antibody titer. The patient's recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 10 year old male with no pertinent medical history or drug allergies who on 13-AUG-2007 were vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot# 658021/0827U). There was no concomitant medication. On 15-AUG-2007 the patient developed injection site redness and swelling. Medical attention was sought through the reporting physician. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. This is one of three reports from the same source.  Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 13 year old male with no pertinent medical history or drug allergies, who on 13-AUG-2007 was vaccinated with a 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot# 658021/0827U). There was no concomitant medication. On 15-AUG-2007, the patient developed injection site redness and swelling. Medical attention sought through the reporting physician. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. This is one of three reports from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female who on 23-AUG-2007 was vaccinated with 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 658018/1007U) in the upper right arm instead of zoster vaccine live (MSD) due to staff error. On that same day, medical attention was sought in office after vaccination. Recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Nodule
Clinical narrative: Information has been received from a physician and a nurse concerning a female who on 14-AUG-2007 was vaccinated with her second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 656992/0450U). Subsequently, the patient developed a nodule and experienced local injection site pain and swelling after vaccination. Unspecified medical attention was sought. The patient was treated with Septra twice a day for 7 days. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 3 year old male, the son of an employee at her clinic, who at the age of 1 was vaccinated with a single first dose of varicella virus vaccine live (Oka/Merck). Within 24 hours of vaccination, the patient developed chickenpox. The child went to the pediatrician's office. No lab studies were performed. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with no pertinent medical history and no known allergies who on 24-AUG-2007 was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot#658419/1027U). There was no concomitant medication. On 24-AUG-2007, the nurse was uncertain of the route in which the vaccine was given, she was not sure if she aspirated prior to administration. After administering the dose she noticed that there was blood in the syringe. The patient developed some bruising at the injection site. Unspecified medical attention was sought. The patient was instructed to place ice on the site. No lab studies were performed. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old patient who on an unspecified date was vaccinated with a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed injection site swelling and pain. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 10 year old male with no pertinent medical history or drug allergies, who on 23-AUG-2007 was vaccinated with a SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 658058/0837U) in the left arm. There was no concomitant medication. ON 24-AUG-2007, the patient experienced 1.5' X 1' area of injection site swelling, redness and itching. The patient sought medical attention through a telephone call to the physician's office. No lab diagnostic studies were performed. The patient was treated with Motrin, Benadryl, and warm compresses. The patient was not recovered. There was no product quality complaint. Follow-up information has been received from a licensed visiting nurse indicating that the 10 year old male with a history of seizures who on 23-AUG-2007 was vaccinated SC with his second dose of varicella virus vaccine live (Oka/Merck) (lot# 658058/0837U). There was no illness at the time of vaccination. The patient recovered from redness, itching and swelling. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Rash, Varicella
Clinical narrative: Information has been received from a newspaper article titled "Varicella Breaks Out Despite Double Vaccine Doses" from July 15, 2007, concerning a child who received two doses of varicella virus vaccine live (Oka/Merck) on unspecified dates. It is reported that in the fall of 2006, sometime after the second vaccination, the child had a mild outbreak of varicella, with less than 250 lesions. The rash lasted about 4 days. The case was confirmed and positive by using polymearse chain reaction test. It is unspecified if medical attention was sought. The outcome is recovered. Additional information is expected.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician and a nurse concerning an 8 year old patient who was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot# 658059/0838U). Subsequently, the day after administration, the patient experienced injection site cellulitis characterized by injection swelling and redness. Unspecified medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 9 year old male with no pertinent medical history or drug allergies, who on 23-AUG-2007 was vaccinated with a 0.5 ml SC dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On that same day the patient developed a fever of 101.5 F a short time after the vaccination. Medical attention was sought through an ER visit. The patient was treated with OTC acetaminophen (TYLENOL) and had not responded. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 07-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658197/0853U). On 09-AUG-2007, the patient developed localized rash at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site cellulitis, Injection site erythema, Injection site induration, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 14 year old male who on 23-AUG-2007 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck). On 24-Aug-2007, the patient developed a localized cellulitis rash at injection site. The patient sought unspecified medical attention. Subsequently, after therapy was stopped, the patient recovered. Therapy was not reintroduced. Additional information has been requested. The same physician also reported on the experience of the patient's brother WAES# 0709USA04222. Follow-up information received from the physician indicating that the patient was a 14 year old male who on 23-Aug-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot#658197/0853U) in the left deltoid (IM). No concomitant medication was reported. The patient received 1 previous dose on an unknown date. ON 24-Aug-2007, the patient experienced erythema/warmth and induration at the vaccine site measuring approximately 8 X 5 cm. No tenderness or pruritus was reported. It was a local reaction at the vaccine site, treated with Benadryl every 8 hours X 1 to 2 days cold compresses. The event resolved on 26-Aug-2007. No further information expected.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 14 year old male who on 23-AUG-2007 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck). On 24-Aug-2007, the patient developed a localized cellulitis rash at injection site. The patient sought unspecified medical attention. Subsequently, after therapy was stopped, the patient recovered. Therapy was not reintroduced. Additional information has been requested. The same physician also reported on the experience of the patient's brother WAES# 0709USA04222. Follow-up information received from the physician indicating that the patient was a 14 year old male who on 23-Aug-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot#658197/0853U) in the left deltoid (IM). No concomitant medication was reported. The patient received 1 previous dose on an unknown date. ON 24-Aug-2007, the patient experienced erythema/warmth and induration at the vaccine site measuring approximately 8 X 5 cm. No tenderness or pruritus was reported. It was a local reaction at the vaccine site, treated with Benadryl every 8 hours X 1 to 2 days cold compresses. The event resolved on 26-Aug-2007. No further information expected.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning a 19 year old female who on 20-MAR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot no. 655994/1302F). On 22-MAR-2007, the patient developed a localized reaction at the injection which was cellulitis. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 30-JUL-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). On 01-AUG-2007, the patient developed cellulitis at the injection site which traveled down below the elbow and was 3 1/2 by 2 inches. The patient went to the ER but was not admitted. She was treated with Keflex. Subsequently, the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 28-FEB-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 654804/1258F). On 02-MAR-2007, the patient experienced injection site reaction which was cellulitis. Medical attention was sought. Subsequently, the patient recovered from injection site reaction which was cellulitis. No product quality complaint was involved. Additional information has been requested.
Age: 8.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 8 year old patient who was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot #658059/0838U). Subsequently, the patient experienced cellulitis, abnormal swelling and redness at the injection site. The patient's outcome was not reported. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician and a nurse concerning a 14 year old patient who was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (lot# 0838U). Subsequently the day after administration, the patient developed abnormal swelling and redness at the injection site. It was unknown whether medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source. Attempts are being made to obtain the identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available.
Age: 16.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 16 year old patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658059/0838U). Subsequently the day after administration, the patient developed abnormal swelling and redness at the injection site. It was unknown if medical attention was sought. The patient's recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report. Additional information will be provided if available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on an unspecified date in May 2002, was vaccinated with a single first dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed a C4, 5, 6 shingles rash on her left arm. She had no documented case of breakthrough. Medical attention was sought by the patient who had the rash for 5 days. The physician prescribed acyclovir and Tylenol with Codeine. She is on no other medications. No further information was provided. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Nurse concerning a 4 year old female who on 30-AUG-2004 at the age of 1 year was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 648080/0079P). In the interim between ages of 1 and 4 years, the patient experienced shingles. Medical attention was sought. The 4 year old was a new patient at this doctors office. The patient was recovered. No product quality complaint was involved. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning an 11 year old male who's mother called 24 hours after the patient was vaccinated with his second dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced a 2 inch circle of bumpy redness around the injection site area and skin was hot to the touch. The patient's 2 inch circle of bumpy redness around the injection site area and skin was hot to the touch persisted. Unspecified medical attention was sought. Additional information is expected.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a company representative concerning her 12 month old son who on 03-MAR-2007 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot number not provided). On 05-APR-2007, the patient developed oval shaped blisters on his leg, trunk and arms (30 in total). The blisters cleared off after 24 hours. Prescribing physician's information was not provided. Unspecified medical attention was sought. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) at one year old and a couple of years later developed shingles. Patient had not received the second dose yet. No additional information was provided. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV, VARCEL
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old female with no pre-existing allergies, birth defects, medical conditions, who on 12-OCT-2007 at 9:30 AM was vaccinated IM in the left arm with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot number: 658965/1355U) instead of zoster vaccine live (Oka/Merck) (MSD). Concomitant therapy included: pneumococcal 14v polysaccharide vaccine (lot number:651357/0391F) (MSD) SC in the right arm; Fluzone (lot number U244288) IM in the left deltoid. It was not considered to be a product confusion by the office. The nurse that gave the varicella virus vaccine live (Oka/Merck) was new and made a nursing error. No symptoms or problems note. No further information available. Unspecified medical attention was sought. There were no relevant diagnostic tests and laboratory data. There was no illness at the time of vaccination. There were no adverse events following prior vaccinations. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Herpes zoster, Nasal congestion, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse concerning a 2 year old male with no pertinent medical history and a drug reaction/allergies to amoxicillin who on 16-OCT-2003 was vaccinated SC in the right thigh with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. The rash developed 3 days (on approximately 17-DEC-2004) after an influenza vaccination (manufacturer unknown) on 14-DEC-2004. The patient was seen in the office on 28-DEC-2004 with a rash that was present for 2 weeks. The rash was described as having a dermatomal distribution initially in the right axillary area that spread toward the sternum and did not cross the mid-line. The rash had multiple lesions numbering 4 dozen and was concentrated in the axillary area. The rash was accompanied by cough and congestion with mild stridor, with a mild fever for 3 days. The rash was described as a zoster rash. On 04-JAN-2005 the patient was seen in the office for a rash that developed a few days prior. This rash was described as a blotchy, burgundy colored rash in the lower extremities, non-raised and non-papular. It was unclear if this rash was related to a recent viral illness. The patient's father had a similar "type illness" while in another country due to exposure to several family members in another country that were ill. No other information was reported. There were no lab diagnostics studies performed. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Stridor
Clinical narrative: Information has been received from a nurse concerning a 2 year old male with no pertinent medical history and a drug reaction/allergies to amoxicillin who on 16-OCT-2003 was vaccinated SC in the right thigh with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. The rash developed 3 days (on approximately 17-DEC-2004) after an influenza vaccination (manufacturer unknown) on 14-DEC-2004. The patient was seen in the office on 28-DEC-2004 with a rash that was present for 2 weeks. The rash was described as having a dermatomal distribution initially in the right axillary area that spread toward the sternum and did not cross the mid-line. The rash had multiple lesions numbering 4 dozen and was concentrated in the axillary area. The rash was accompanied by cough and congestion with mild stridor, with a mild fever for 3 days. The rash was described as a zoster rash. On 04-JAN-2005 the patient was seen in the office for a rash that developed a few days prior. This rash was described as a blotchy, burgundy colored rash in the lower extremities, non-raised and non-papular. It was unclear if this rash was related to a recent viral illness. The patient's father had a similar "type illness" while in another country due to exposure to several family members in another country that were ill. No other information was reported. There were no lab diagnostics studies performed. The outcome is reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 17 year old female with no known drug allergies, cholelithiasis, gastroesophageal reflux disease and Raynaud's with a family history of systemic lupus erythematosus who on 26-SEP-2007, received 0.5 ccs subcutaneous of varicella virus vaccine live (Oka/Merck) (lot# "3069U"). Concomitant therapy included Menactra vaccine (lot# C834U). On 27-SEP-2007, the physician received a phone call reporting that her arm got red, warm and was tender. Treatment included ice and Benadryl. On 29-SEP-2007, she was seen by the physician who reported that the majority of th symptoms were at the site of the varicella vaccine live (Oka/Merck) (MSD) and not at the Menactra site, and the symptoms had mostly resolved. No product quality complaint was reported. No further information was available. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning a patient who on 07-JUN-2007, was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (MSD). Reportedly she had no ill affects. Product quality complaint was not reported. Further information was not available. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a 77-year-old male who on 02-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The patient sought medical attention via a phone call with the pharmacist. The pharmacist stated it was product confusion. It was reported the vials looked similar and both vaccines were stored in the freezer. It was also reported the names sound similar. A product quality complaint was noted. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Nausea, Pruritus, Rash, Rash vesicular
Clinical narrative: Information has been received from a certified medical assistant concerning a 12-year-old white male with no pertinent medical history or allergies who on 18-SEP-2007 was vaccinated subcutaneous with a second 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 658374/1117U). The patient received his first dose years ago at another practice. There were no illnesses at the time of vaccination. Concomitant vaccines included hepatitis A vaccine (inactive) (HAVRIX) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 27-SEP-2007 (previously reported as 26-SEP-2007) the patient experienced nausea and vomiting. On 27-SEP-2007 the patient developed a rash on his chest and itching. It was also reported the patient had a "temperature" and vomiting the day after the shot was given. The patient's mother phoned the office and the child was seen the next day (28-SEP-2007). On 28-SEP-2007 the patient had a varicella like rash on his chest with 10-12 lesions. No diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: Information has been received from a certified medical assistant concerning a 12-year-old white male with no pertinent medical history or allergies who on 18-SEP-2007 was vaccinated subcutaneous with a second 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot # 658374/1117U). The patient received his first dose years ago at another practice. There were no illnesses at the time of vaccination. Concomitant vaccines included hepatitis A vaccine (inactive) (HAVRIX) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). On 27-SEP-2007 (previously reported as 26-SEP-2007) the patient experienced nausea and vomiting. On 27-SEP-2007 the patient developed a rash on his chest and itching. It was also reported the patient had a "temperature" and vomiting the day after the shot was given. The patient's mother phoned the office and the child was seen the next day (28-SEP-2007). On 28-SEP-2007 the patient had a varicella like rash on his chest with 10-12 lesions. No diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 9-year-old female who was vaccinated subcutaneous with a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date the patient developed a rash under both of her arms starting at her armpits and ending at the middle of her forearms. The patient sought medical attention via an office visit. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 12-year-old female (previously reported as a male) with no pertinent medical history or allergies who on 27-AUG-2007 at 10:30 am was vaccinated subcutaneous in the left arm with her second dose of varicella virus vaccine live (Oka/Merck) (lot # 657944/1003U). Concomitant vaccine administered on 27-AUG-2007 at 10:30 am intramuscularly, in the left arm, included a first dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot # U2370AA). There were no illnesses at the time of vaccination. On 04-SEP-2007 (also reported as 5 days after vaccination) the patient developed a "full outbreak varicella with over 100 lesions on her body". The patient was sent to the hospital with no other adverse experiences. On an unspecified date the patient recovered. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 3-year-old male with coeliac disease who in 2005 (2 years ago) was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included montelukast sodium (MSD) and Nasonex. On an unspecified date the patient developed chickenpox. The patient sought medical attention via an office visit with a physician. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Follow-up information indicated "we can not remember which patient it was ". Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning his daughter who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced breakthrough varicella characterized by a few papular vesicles. The physician suspected non-wild type varicella. Medical attention was sought. The patient's outcome was recovered. There was no product quality complaint. This is one of several reports from the same source. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 7 year old female with no allergies or pertinent medical history who on 22-DEC-2000 was vaccinated with a first 0.5 ml dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 03-AUG-2007 the patient developed shingles. Unspecified medical attention was sought. No lab studies were performed. The patient was recovering. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 36 month old male with no medical history or allergies who on 20-JUN-2007 was vaccinated on the left arm with a first dose of varicella virus vaccine live (Oka/Merck (Lot # 649738/0120R). There was no illness at the time of vaccination. It was reported that on 13-AUG-2007 the patient broke out with lesions inspite of having been vaccinated. The patient developed more than 50 lesions. On 21-AUG-2007, the patient was recovering. No medical attention was sought. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a nurse concerning a 9 year old male who on 23-AUG-2007 was vaccinated subcutaneously with varicella virus vaccine live (Oka/Merck) (Lot #657996/0843U). The patient developed a 2X4 centimeter red rash with a 2 centimeter ring around it (total diameter of about 10 centimeters) after receiving the 2nd dose of varicella virus vaccine live. The patient sought medical attention. The patient was seen in the office for a visit on 28 AUG 2007. The outcome was not reported. No further information available.
Age: 17.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 17 year old female who was vaccinated with varicella virus vaccine live (Oka/Merck) (657718/0778U). Concomitant therapy included human papillomavirus vaccine (MSD). Subsequently, the patient developed a rash after receiving her second dose of varicella. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Information has been received from a nurse concerning a male between the ages of 11 and 12 years of age who on 27-AUG-2007 was vaccinated with one dose of varicella virus vaccine live (Oka/Merck). In the evening of 27-AUG-2007, the patient experienced a rash. The nurse reported that she thought the patient was "already exposed to chicken pox". The patient was seen in the office for the event and was noted to be recovering. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site pruritus, Injection site swelling, Rash
Clinical narrative: Information has been received from a nurse concerning a 16 year old male who in approximately 1994, "around age 3 or 4" was vaccinated with the first 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On an unspecified date, the patient was vaccinated with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations that same day included on dose of Menactra, one dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid and one dose of hepatitis A vaccine (inactive) (MSD). Subsequently, the patient experienced swelling and itching around the injection site after his second dose of varicella virus vaccine live (Oka/Merck). The reporter noted the patient also experienced a rash about the size of his palm. It was noted the injection was "given on a Tuesday and the rash was still there by Saturday". The outcome of events was unknown. The patient sought medical attention from his mother who was a nurse at the office. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been receive from a nurse concerning four patients who were vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced breakthrough chickenpox. They have about 4 to 5 lesions on their body. All four kids live in the same house. Medical attention was sought. The patients were recovering. No product quality complaint was involved. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 3 year old patient who was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). The patient received the vaccination at 13 months old and on 14-Aug-2007, at 3 years and 9 months old, the patient had developed chickenpox lesions. Lesions dried after one week (21-AUG-2007). Medical attention was sought. The patient recovered. No product quality complaint was involved. Additional information has been requested.