chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Respiratory rate
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-year-old male with an allergy to CECLOR and a questionable allergy to amoxicillin with no pertinent medical history, who on 28-JUN-2007 was vaccinated with a subcutaneous 0.5 milliliter booster dose in the left arm of VARIVAX (Oka/Merck) (lot# 657787/0718U).  There was no illness at the time of vaccination.  There were no concomitant medications given.  On 30-JUN-2007 the patient developed a red hard lump on his left arm at the injection site and an upper extremity rash.  He went to the emergency room on 30-Jun-2007 where he was administered one dose of ROCEPHIN and an unspecified steroid.  On 01-Jul-2007 he went back to the emergency room with a temperature of 100.8 degrees Fahrenheit, increased redness and he was diagnosed with cellulitis.  He received another dose of ROCEPHIN and was sent home with AUGMENTIN and ibuprofen for discomfort.  On 02-Jul-2007 his fever was gone and his rash was barely dusty pink.  Laboratory studies performed showed a normal complete blood count and a normal blood chemistry test.  The outcome is reported as recovering.  No product quality complaint was involved.  This is one of two reports from the same reporter.  Follow-up information received on 02-Aug-2007 states that the patient is a 9th grade student who has no past medical history.  On 01-Jul-2007 at 2010 hours the patient went to the emergency room with an oral body temperature of 98.5, blood pressure was 143/98, pulse 98, respiratory rate 20, SaO2 99% on room air and a pain level of 0-1 out of 10.  His initial assessment was normal.  CBC blood results on 30-Jun-2007 and 01-Jul-2007 were normal.  He was discharged at 2245 hours.  The outcome is reported as recovered.  There were no adverse events following prior vaccinations.  No more information is expected.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 14-year-old female with no pertinent medical history or allergies, who on 29-JUN-2007 was vaccinated in the left deltoid with a subcutaneous booster dose of 0.5 milliliters of VARIVAX (lot# 657787/0718U).  There was no concomitant medication.  On 01-JUL-2007 the patient developed an oval red area in left forearm (8x5 centimeters) and itching.  The patient took CLARITIN, and then went to the emergency room.  KEFLEX was prescribed but the mother held it off until she was to be evaluated again.  No laboratory or diagnostic tests were performed.  The nurse has not seen or heard from them and the outcome is unknown.  No product quality complaint was involved.  Follow-up information has been received which concerns a 13-year-old female, (previously reported as a 14-year-old) with no pre-existing allergies, birth defects or medical conditions who was vaccinated with a second dose of 0.5 milliliters of VARIVAX (lot# 657787/0718U).  There was no illness at the time of vaccination.  On 01-Jul-2007, the site of the injection became red, raised, and hot to touch that was large.  Per the mom, there was no measurement done in the emergency room.  The patient was prescribed KEFLEX but was never taken because the site improved.  The patient recovered on 03-Jul-2007.  This is one of several reports from the same reporter.  Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site pain
Clinical narrative: Information has been received from a health professional concerning a 16 year old male, with no medical history and no allergies, who on 12-JUL-2007 was vaccinated with a second subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (Lot# 657786/0717U). Concomitant therapy included benzoyl peroxide (PROACTIVE SOLUTION CLEANSER). There was no illness at the time of vaccination and no adverse events following prior vaccination. Subsequently the patient experienced cellulitis with pain at the sight of injection. It was reported that the patient was started on cephalexin (KEFLEX). Follow-up information from a health professional indicated that the patient recovered on 20-JUL-2007. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning an 6 year-old female with no pre-existing allergies, birth defects, or medical conditions who on 10-JUL-2007 was vaccinated SC in the upper arm with a second dose of VARIVAX (Oka/Merck) (Lot"06024/30184").  There was no illness at the time of vaccination.  On 11-JUL-2007 the patient woke up with red, swollen tender to touch arm.  She was seen in the office and diagnosed with local reaction vs cellulitis 2 degrees to VARIVAX (Oka/Merck) and treated with KEFLEX.  Unspecified medical attention was sought.  There were no adverse events following prior vaccination.  The outcome was reported as recovered.  There was no product quality complaint.  This is one report of several from the same source.  No additional information is expected.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Information has been received from a pediatric office concerning a 6 year old white female who on 16-JUL-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot# 65783/0644U) into the right arm. At the time of vaccination the patient was in remission from leukemia. Concomitant vaccinations included a second dose of hepatitis A virus vaccine inactivated (MDS) (Lot # 657307/0442U). Other concomitant drug therapy included Synthroid and growth hormone. On 17-JUL-2007 the patient developed swelling 1 & 1/2 in diameter, redness, and tenderness at an unspecified site. No medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint. No further information is available.
Age: 1.1
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning her 3 year old 37 lb. 5 oz. son with allergies to peanuts, penicillin, and milk, who at the age of 13 months (August 2005) received his fourth dose of PEDVAX HIB (OMPC) (manufacturer unspecified).  Concomitant vaccination included a fourth dose of PREVNAR.  It was indicated that the patient developed hives following the vaccinations (date not specified).  Medical treatment and current patient status was not reported.  A product quality complaint was not reported.  The patient experienced hives following vaccination with VARIVAX (WAES# 0711USA02516).  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: HIBV, PNC, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a health professional concerning her 3 year old 37 lb. 5 oz. son with allergies to peanuts, penicillin, and milk, who on 17-JUL-2007, was vaccinated with a first subcutaneous dose in the left arm of VARIVAX (lot# 657795/0772U).  There was no reported illness at the time of vaccination.  His mother had reported that an hour after receiving the vaccine, the patient developed hives.  Follow up information from a nurse in the children's clinic indicated that his parents had reported an area of urticaria over his right trunk.  There was no reported cough, wheeze, or angioedema.  An examination later in the day revealed no rash or allergic signs or symptoms.  Who examined the patient was not reported.  There were no relevant diagnostic tests or laboratory data.  It was indicated that on 17-JUL-2007, the patient had recovered.  A product quality complaint was not reported.  The patient experienced hives following vaccination with HIB conj (manufacturer unknown) (WAES# 0802USA00235).  Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a licensed practical nurse concerning a male patient 11 years of age, with no pertinent medical history, drug reactions or allergies, who two weeks ago, on 17-JULY 2007, was vaccinated subcutaneously with a second dose, 0.5mL , of varicella virus vaccine live (Oka/Merck) (Lot # 657787/0718U). There was no concomitant medication. Within 24 hours of the vaccination, on 19 JUL 2007, the patient developed a golf ball size area with a 6 X 9 cm area of erythema and swelling at the injection site. The patient had no reaction with their first vaccination with varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. There were no lab diagnostic studies performed. There was no product quality complaint. The patient subsequently recovered three days after having been vaccinated. The office requested a lot check on Lot # 657787/0718U. This is one of several reports from the same source. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected. This report is a consolidated report.
Age: 12.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who on 19-JUL-2007 was vaccinated with her second dose of VARIVAX (Oka/Merck) (Lot# 657783/0644U) in the left thigh.  Concomitant vaccinations included the second dose of Tdap (Aventis Pasteur) (Lot# C2734A4) in the right thigh.  On 20-JUL-2007 the patient developed a 2" area that was red, itchy, and slightly tender.  No medical attention was sought.  The patient was treated with BENADRYL and the area was noted to be improving.  The patient's recovery status was unknown.  Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site warmth, No reaction on previous exposure to drug
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old male patient, with no pertinent medical history, drug reactions or allergies, who on 16 July 2007, was vaccinated subcutaneously into the right arm with a second dose, 0.5mL, of varicella virus vaccine live (Oka/Merck) (Lot # 657787/0718U). There was no concomitant medication. Within 24 hours of the vaccination, the patient developed a 2 inch erythema and heat at injection site. The patient had no reaction with their first vaccination with varicella virus vaccine live (Oka/Merck). There were no lab diagnostic studies performed. There was no product quality complaint. The patient subsequently recovered three days after having been vaccinated. The office requested a lot check on Lot # 657787/0718U. This is one of several reports received from the same source. A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Information has been received from a licensed practical nurse concerning a 10.5 year old male patient with no pertinent medical history, drug reactions or allergies, who on 12 JUL 2007, was vaccinated subcutaneously into the left arm with a second dose, 0.5ml, of VARIVAX (Oka/Merck) (Lot # 657787/0718U). There was no concomitant medication.  Within 24 hours of the vaccination, the patient developed two "one inch" erythema.  The patient had no reaction with their first vaccination with VARIVAX (Oka/Merck).  There were no lab diagnostic studies performed.  There was no product quality complaint.  The patient subsequently recovered three days after having been vaccinated.  The office requested a lot check on Lot # 657787/0718U.  This is one of several reports received from the same source.  A review of the release testing data revealed that the lot in question conformed to all required testing at the time of product release.  The lot complies with the standards of the center and was released.  No further information is expected.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pruritus, Swelling, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 17-JUL-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck) lot# 654747/1062F) in the right thigh. On 18-JUL-2007, the patient developed a 2'X3" solid, red and raised, itchy area with blistery skin, that was tender to the touch. No medical attention was sought. The patient's recovery status was unknown. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration, Pruritus, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 7 year old female who on 16-JUL-2007 was vaccinated with her second dose of VARIVAX (Oka/Merck) (Lot# 657783/0644U).  Concomitant vaccination included the first dose of VAQTA  (MSD) (Lot# 657307/0442U) in the left thigh.  On 18-JUL-2007 the patient developed a 3" diameter area, that was solid, red, tender, with itchy skin.  No medical attention was sought.  The patient was treated with BENADRYL.  The patient's recovery status was unknown.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a health professional concerning an 11 year old female, who on 26-FEB-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 656081/1308F) in the right thigh. Concomitant vaccinations administered that day included the first dose of Gardasil vaccine(MSD) (lot # 656049/0187U) in the left thigh and the first dose of hepatitis A virus vaccine inactivated (MSD) (lot#656071/1280F) in the left thigh. On 27-FEB-2007, the patient experienced 2' X 2' spot that was solid, red, swollen and tender. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. No further information is available.
Age: 11.0
Sex: F
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received concerning a 11 year old female who on 08-MAY-2007 was vaccinated in the right leg with a second dose of VARIVAX (Oka/Merck) (Lot# 656572/0115U).  Concomitant therapy included a first dose of MENACTRA (Lot # CU2232AA) in the left leg and a fifth dose of TRIPEDIA (Lot# C2720AA) in the right leg.  On 09-MAY-2007 the patient developed a red swollen, and painful injection site.  The two immunizations in the right leg measured (1)-4cm x 10 cm and (2)-8cm x 10 cm.  The patient was treated with AUGMENTIN.  Subsequently, the patient recovered.  No other information was provided.  Additional information is not expected.  This is one of several reports from the same source.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Lymphadenopathy, Rash macular
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on 10-APR-2007 was vaccinated with VARIVAX (Oka/Merck) (lot # "1509E").  On 12-APR-2007 the patient experienced 3 cm x 3 cm macular erythema on thigh + 1a x 0.5 cm right inguinal node reactive secondary to VARIVAX.  Subsequently, the patient recovered from 3 cm x 3 cm macular erythema on thigh + 1a x 0.5 cm right inguinal node reactive secondary to VARIVAX.  Additional information is expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Information has been received concerning a 14 year old white female who on 18-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot number 657715/0609U). On 19-JUN-2007, the patient experienced itchiness and 2/1/2" X 1 1/2" area of solid red, swollen and itchy. Resolved with Benadryl. Additional information is expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 10 year old white female with no pertinent medical history or allergies who on 31-MAY-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot#657406/0516U). There was no concomitant medication. On 01-JUN-2007, the patient experienced 2" X 2" injection site redness and swelling. No diagnostic labs were performed and no treatment was needed. Subsequently, the patient recovered. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a 6 year old male who on 10-MAY-2007 was vaccinated with a dose of VARIVAX (lot#656572/0115U). On 11-MAY-2007 the patient experienced swollen red area on thigh 6cm x 4cm. Medical attention was sought. Treated with KEFLEX for 7 days. The patient recovered from swollen red area on thigh. No product quality complaint was involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a 9 year old male who on 26-APR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (lot number 656572/0115U). Concomitant therapy included hepatitis A vaccine (inactive, for the treatment of Prophylaxis (duration and dose not reported). On 27-APR-2007, the patient experienced 4cm X 6cm area red-swollen & tender. Resolved on its own in approximately 24 hours. Additional information is expected.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a 10 year old male who on 18-JUN-2007 was vaccinated with a dose of varicella virus live (Oka/Merck) (lot# 65746/0516U). On 19-JUN-2007, the patient experienced swollen area from the shoulder to elbow 8 cm X 11 cm. Treated with Allegra 30 mg BID. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Local swelling, Pain, Skin discolouration
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 657842/0494U). Concomitant vaccination included the second dose of hepatitis A virus vaccine inactivated (MSD). On 12-July-2007, the patient experienced a 3" X 3" area that was red, swollen and painful, and 4.5 X 4.5 pink color. She went to the ER for urgent care. Subsequently, the patient recovered from red, swollen, painful 3" X 3" area and 4.5 X 4.5 pink color. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Information has been received from a physician concerning a 17 year old female who on 04-JUN-2007 was vaccinated with a second dose of VARIVAX (lot# 03694). Subsequently the patient experienced an area size of a half dollar red, swollen and tender. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 7 year old male (52 lbs., 48") who on 22-JAN-2007 was vaccinated with the second dose of VARIVAX (Lot #654697/1057F). Concomitant therapy included VAQTA (Lot #656495/1209F). On 23-JAN-2007 the patient experienced injection site redness, swelling and itching. Subsequently, the patient recovered. Medical attention was sought. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Information has been received from a health professional concerning a 9 year old male with hypersensitivity who on 15-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) ( lot # "0298U"). On 16-MAY-2007, the patient experienced a 2" X 2" area of red, raised itchiness. Additional information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Information has been received concerning a 5 year old male who on 27-MAR-2007 was vaccinated with a second dose of VARIVAX (lot# 656081/1308F). There was no concomitant medication. On 28-MAR-2007 the patient developed an area the size of a baseball that was itchy and red. There was no other information provided.  Additional information has been requested. This is one of several reports from the same source.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 21-JUL-2007 was vaccinated in the left thigh with the second dose of varicella virus vaccine live (Oka/Merck) (Lot #657456/0600U). Concomitant therapy included the first dose of Gardasil (Lot #658094/0524U) in the right thigh. Subsequently, the patient experienced injection site redness, injection site tenderness in the left thigh that was hard, blistery and itchy. The area was swollen in a 6" X 8" area. Subsequently, the patient recovered in 6 days. Zyrtec was given. No further information is available.
Age: 12.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 12 year old female who on 21-JUL-2007 was vaccinated in the left thigh with the second dose of varicella virus vaccine live (Oka/Merck) (Lot #657456/0600U). Concomitant therapy included the first dose of Gardasil (Lot #658094/0524U) in the right thigh. Subsequently, the patient experienced injection site redness, injection site tenderness in the left thigh that was hard, blistery and itchy. The area was swollen in a 6" X 8" area. Subsequently, the patient recovered in 6 days. Zyrtec was given. No further information is available.
Age: 12.0
Sex: F
Vaccine: DTAP, HEPA, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a health professional concerning a 12 year old female who on 27-JUL-2007 was vaccinated in the left arm with a second dose of VARIVAX (lot# 658023/08240). Concomitant vaccinations included the first dose of VAQTA (lot# 657842/04940) in the right arm, and the fifth dose of TRIPEDIA (lot# 275844) in the right arm. Subsequently the patient experienced left arm swelling, and an area of redness the size of an orange, with no pus. Follow up information reported that the swelling and redness resolved with BENADRYL. A product quality complaint was not reported. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Tenderness, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 12 year old male who on 27-JUL-2007 was vaccinated with his second dose of varicella virus vaccine live (Oka/Merck) in the left thigh. On 28-JUL-2007, the patient developed a 2" X 3" area of red, welted skin, that was tender, not itchy. No medical attention was sought. The patient was treated with Benadryl and was better. Subsequently, the patient recovered. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 17 year old female who on 01-AUG-2007 was vaccinated with her second dose of varicella virus vaccine live (Oka/Merck) (lot# 658023/0824U) in the right arm. On 02-AUG-2007, her right deltoid area became swollen, red, tender and her entire upper arm was also affected. No medical attention was sought. The patient was advised to be treated with Benadryl. The patient's recovery status was unknown. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Erythema, Local reaction, Local swelling, Pruritus
Clinical narrative: Information has been received from a health care professional concerning a 12 year old female who on02-AUG-2007was vaccinated into the right arm with a second dose of VARIVAX (Lot # 658023/0824U). Concomitant therapy included vaccination into the right arm with DAPTACEL (Lot #C2609AA). On 03-AUG-2007, the patient developed a localized reaction at the "VARIVAX" site, an egg sized red, itchy area, that resolved with BENADRYL. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema
Clinical narrative: Information has been received concerning a 9 year old male who on 06-AUG-2007 was vaccinated into the left thigh with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 658064/0831U). On 07-AUG-2007, the patient developed a 4X2 inch area of redness surrounded by a light pink 1 cm border. No "itchiness" was present. The patient was "better with Benadryl". Additional information is not expected.
Age: 13.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Antibody test positive, Blister, Herpes zoster, Immunology test
Clinical narrative: Information has been received from a health professional concerning a 13 year old male with a history of chickenpox (less than 10 lesions) who on 19-JUL-2007 was vaccinated on the left arm with a second 0.5mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 657783/0644U). Concomitant therapy on the same day included a second dose on left arm of hepatitis A virus vaccine inactivated (MDS) (Lot # 657842/0494U), a first dose on right arm of Menactra (Lot # U2326AA) and a first dose on right arm of Adacel (Lot # C2734AA). It was reported that on 27-JUL-2007, the patient developed grouped vesicles on right upper chest and on right anterior shoulder. The patient was diagnosed with shingles. Unspecified medical attention was sought. Additional information has been received from a health professional who stated that the patient's rash started on 27-JUL-2007 and was described as grouped vesicles on right upper chest, right interior shoulder and top of shoulder. Also scapula with few up to neck with less that 50 lesions. The patient had undertaken an immunofluoresent Monoclonal antibody test which came out to be positive for varicella zoster. No further information is expected.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Pruritus, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 12 year old white female who on 09-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 658064/0831U) (Lot # invalid) in the left arm. There was no illness at the time of vaccination. Concomitant vaccinations included a dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Lot# UZ330AA) in the right arm and a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (Lot# CZ771AA) in the left arm. There was no illness at the time of vaccination. On 09-AUG-2007 the patient developed an area 4" in diameter that was red, itchy and tender. No medical attention was sought. No labs or diagnostic tests were performed. There was no signs of infection. The patient was advised to be treated with diphenhydramine (HCL) (BENADRYL). The recovery status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from the nurse in the physicians office. The nurse noted that the first 3-4 patients who received lot # 657404/0592U had an injection site reaction which were not as severe as the one another patient had. This occurred within a 2 week period of when they first opened the lot of vaccine. The nurse reported that she filed reports on "all of them." Further information has been received from the nurse. The nurse reported that the office does not keep a list of patients who have experienced injections site reactions. Therefore she was unable to provide patient identifiers. Attempts to obtain patient identifiers are being made. Additional information is not expected.
Sex: U
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from the nurse in the physicians office. The nurse noted that the first 3-4 patients who received lot # 657404/0592U had an injection site reaction which were not as severe as the one another patient had. This occurred within a 2 week period of when they first opened the lot of vaccine. The nurse reported that she filed reports on "all of them." Further information has been received from the nurse. The nurse reported that the office does not keep a list of patients who have experienced injections site reactions. Therefore she was unable to provide patient identifiers. Attempts to obtain patient identifiers are being made. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a consumer concerning her 8 year old son with hypersensitivity and a history of Wolff-Perkinson-White syndrome (no evidence of this at this time) who on 13-AUG-2007 was vaccinated with VARIVAX in the left arm as a booster dose. Concomitant therapy included FLONASE and CLARITIN. The consumer reported that her son received his booster dose on 13-AUG-2007 and he developed an injection site reaction. On the morning of 15-AUG-2007 her son stretched and she noticed the back of his left arm. There were tiny red dots around the injection site. The area was surrounded by an irregular dark red patch and around that area was a three inch patch of inflammation. The consumer described the area like a fried egg with the yolk as the tiny red dots surrounded by the swelling. The physician prescribed cephalexin and Mupirocin 2% ointment. The consumer reported that with the use of these medication there has been improvement, but not resolution in her son's reaction. The consumer also reported another patient had a similar reaction. Further information has been received from the nurse in the physicians office. The nurse reported that the patient was vaccinated on 13-AUG-2007 with VARIVAX Lot # 657404/0592U. On the evening of 14-AUG-2007 the patient developed redness and induration at the injections site which measured 2 cm x3 cm. The patient had no pain. The patient recovered one week after injections. The nurse also noted that the first 3-4 patients who received lot # 657404/0592U had an injection site reaction which were not as severe as the one this patient had. This occurred within a 2 week period of when they first opened the lot of vaccine. The nurse reported that she filed reports on "all of them." Further information received from the nurse. The nurse reported that the office does not have any further information regarding the other patients. Additional information not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 8 year old son with hypersensitivity and a history of Wolff-Perkinson-White syndrome (no evidence of this at this time) who on 13-AUG-2007 was vaccinated with VARIVAX in the left arm as a booster dose. Concomitant therapy included FLONASE and CLARITIN. The consumer reported that her son received his booster dose on 13-AUG-2007 and he developed an injection site reaction. On the morning of 15-AUG-2007 her son stretched and she noticed the back of his left arm. There were tiny red dots around the injection site. The area was surrounded by an irregular dark red patch and around that area was a three inch patch of inflammation. The consumer described the area like a fried egg with the yolk as the tiny red dots surrounded by the swelling. The physician prescribed cephalexin and Mupirocin 2% ointment. The consumer reported that with the use of these medication there has been improvement, but not resolution in her son's reaction. The consumer also reported another patient had a similar reaction. Further information has been received from the nurse in the physicians office. The nurse reported that the patient was vaccinated on 13-AUG-2007 with VARIVAX Lot # 657404/0592U. On the evening of 14-AUG-2007 the patient developed redness and induration at the injections site which measured 2 cm x3 cm. The patient had no pain. The patient recovered one week after injections. The nurse also noted that the first 3-4 patients who received lot # 657404/0592U had an injection site reaction which were not as severe as the one this patient had. This occurred within a 2 week period of when they first opened the lot of vaccine. The nurse reported that she filed reports on "all of them." Further information received from the nurse. The nurse reported that the office does not have any further information regarding the other patients. Additional information not expected.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a physician concerning his 16 month old daughter with no known allergies or pertinent medical history who on 02-JUL-2007 was vaccinated with a dose of VARIVAX (Lot #657099/0453U). There was no concomitant medication. On approximately 23-JUL-2007 (approximately three weeks later) the patient developed some spots on her back, and then more spots on her legs which were then confirmed as chicken pox. Unspecified medical attention was sought. No lab studies were reported. At the time of this report the patient was recovering. There was no further information provided. There were no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Contusion, Local swelling, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 5 year old male who on 01-AUG-2007 was vaccinated with his second dose of VARIVAX (Lot# 658023/0824U). On 02-AUG-2007 the patient developed a fist-sized orange/red bruised area, which was swollen and tender. There was no signs of infection noted. No medical attention was sought. Subsequently the patient's status was noted to be resolving but the bruised area remained. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: Information has been received concerning an 11 year old male who on 20-AUG-2007 was vaccinated in the left arm with a second dose of VARIVAX (Lot#657783/0644U). On 21-AUG-2007 the patient developed a 2"x2" red, raised, tender area which was not infected. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 13-AUG-2007 was vaccinated with VARIVAX (654824/0724F). On 14-AUG-2007 the patient developed redness and swelling at the injection site. The redness was approximately 5x5 inches plus a 3/4 inch induration. The patient was placed an antibiotics. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 14 year old female with no allergies and no medical history who on 02-OCT-1997 was vaccinated with a second 0.5ml subcutaneous dose of VARIVAX (Lot # 657944/1003U) in the right arm. There was no illness at the time of vaccination. ON 15-AUG-2007 the patient developed a 4 x 4.5 cm injection site reaction with erythema, tenderness, redness and swelling. There were no laboratory or diagnostic tests performed. No medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: DTAP, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a health professional concerning a 15 year old male with allergic rhinitis who on 22-AUG-2007 at 15:30 was vaccinated SC with his second dose of varicella virus vaccine live (Oka/Merck) (lot# 658059/0838U) in the right arm. There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 15:30 included the first IM dose of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (lot# U2378BA) in the right deltoid and an IM booster (fourth) dose of diphtheria toxoid (+) pertussis acellular 3-component vaccine (+) tetanus toxoid (INFANRIX) (lot# AC52B016BA) in the left deltoid. On 23-AUG-2007 at 13:50 per mother's report, at the back of right arm, presumed site of varicella virus vaccine live (Oka/Merck) injection the patient developed a red and hard area that was approximately 8 x 10 cm round. The patient did not seek medical attention. The outcome was unknown. Follow-up information received from the reporting health professional indicated that to further treatment was necessary for the patient. No further information is available.
Age: 11.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a medical assistant and physician concerning an 11 year old male with no pre-existing medical conditions or drug allergies who on 22-AUG-2007 at 15:45 (previously reported as 23-AUG2007) was vaccinated with the second SC dose VARIVAX (lot# 658059/0838U) in the left arm. Illness at the time of vaccination was an ear infection. Suspect vaccination administered on that same day at 15:45 included the first dose (also reported as second dose) of MENACTRA (lot# U2388BA) in the left deltoid. Concomitant drug therapy included ZITHROMAX. On 23-AUG-2007 in the evening, the patient developed an 14 cm by 7 cm area that was red, indurated, and hot at the injection site for varicella virus vaccine live (lot# 658059/0838U) (previously reported as injection site swelling and redness around the thigh). A subjective fever was reported. The patient was treated with KEFLEX twice a day for 10 days. Medical attention was sought through a doctor visit. On 26-AUG-2007 the patient recovered. There was not product quality complaint. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old female patient with a history of reactive airways disease who on 20-AUG-2007 at 11:30 AM was vaccinated with the second dose of VARIVAX, SQ, in right arm (lot number 658059/0838U). Concomitant therapy included albuterol MDI. No illnesses reported at the time of vaccination. On 21-AUG-2007 the patient experienced 7x8 cm area of induration and 4x4 cm area of erythema. It was reported that the patient's outcome was unknown. No further information is available.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP, VARCEL
Symptoms: Drug administered at inappropriate site, Erythema, Immediate post-injection reaction, Incorrect route of drug administration, Pruritus
Clinical narrative: Initial and follow up information has been received from a health professional concerning a 13 year old female who on 27-SEP-2007, at 10:07, was vaccinated with a first dose of 0.2 mL of varicella virus vaccine live (Oka/Merck) (Lot # 65843/1184U) intradermally into the left forearm, followed later by the remaining dose of 0.3 mL subcutaneously into the left arm (Lot # 658431/1184U). Concomitant vaccine therapy that same day, at 10:07, included , a first dose of Gardasil intramuscularly into the right arm (Lot # 654535/0960F), a first dose of Adacel, intramuscularly into the left arm (Lot # C2491AA), and a first does of Menactra intramuscularly into the right arm (Lot # U2062AA). The patient was initially given 0.2 mL into the left forearm as an intradermal shot. The patient was later given the remaining 0.3 mL subcutaneously into the left upper arm. There was an immediate localized skin erythema and itching at the left forearm. This event was reported as a nursing error, and not product confusion. Unspecified medical attention was sought at the office. There was no product quality complaint. At the time of reporting the patient had recovered on an undisclosed date. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a physician concerning a 9 year old male who was vaccinated on left thigh with a second dose of VARIVAX. Subsequently the patient developed injection site erythema 13x11 cm and injection site induration 7x7 cm. It was reported that the patient was seen in office but no treatment was undertaken. The patient's reaction improved by 50% next day and it resolved rapidly. Follow-up information has been received from the reporting physician indication that on 23-OCT-2007 the patient was vaccinated SC with his second dose of VARIVAX (lot# 658589/1274U) in the thigh. On 24-OCT-2007 the patient developed a large local reaction with 13 x 11 cm erythema, 7 x 7 cm induration and swelling and a temperature of 100.2. On 27-OCT-2007 the patient was recovered. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: FLUN3, VARCEL
Symptoms: Cough, Dyspnoea, Face oedema, Urticaria
Clinical narrative: Information has been received from a Registered Nurse concerning a 9 year old male with a penicillin allergy who on 30-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #658597/1336U). Concomitant therapy included FluMist. On 30-OCT-2007, the patient experienced difficulty breathing, hives, cough and facial edema. The patient was treated with Benadryl, epinephrine, albuterol and Decardon. The patient recovered on the same day. Additional information has been requested. 3/25/2010 Follow up informtion received from the nurse. She didn't have any further information to provide regarding the case. Further information is not expected.
Age: 12.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Cellulitis, Erythema, Induration, Pain in extremity
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 12-year-old female with penicillin allergy and Azithromycin allergy who on 30-OCT-2007 was vaccinated SC on one arm with a 0.5 ml dose of VARIVAX (Lot # 658932/1343U). Concomitant therapy on the same day on another arm included a dose of MENACTRA. On 31-Oct-2007 the patient presented with cellulitis. The patient had a red arm that was painful. The patient was brought to the emergency room and was treated with cephalexin. At the time of report the patient was recovering. A product quality complaint was not involved. Follow-up information has been received from the R.N. which indicates that the patient is a female with an allergy to PEDIAZOLE. The patient was vaccinated in the AM, subcutaneously in the right arm, with a first dose of VARIVAX. Additional concomitant vaccination included on 15-NOV-2007, a first intramuscular dose in the left arm with FLUZONE (lot# U2513AA). On 31-Oct-2007, the patient had a 5x5 cm reddened, indurated area on the back of the right upper arm. There was no pus. There was no blistering. She was seen in the ER and given BACTRIM. No laboratory or diagnostic studies were performed. On 15-NOV-2007 the patient was seen in the clinic and recovered. Additional information has been requested. This is one of several reports received from the same source.
Age: 5.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 5 year old female who on 08-NOV-2007 was vaccinated SC with her second dose of VARIVAX (lot# 658932/1343U) in the left arm. There was no illness at the time of vaccination. Suspect vaccination administered on that same day included the sixth IM dose of FLUZONE (lot# U2490AA) in the left deltoid. On 09-NOV-2007 that patient presented to the clinic with a 2 x 2.5cm size that was indurated and warm at injection site. The outcome was unknown. Follow-up information indicated that no further treatment was necessary for the patient. No further information is available.
Age: 3.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 45 month old female who on 13-NOV-2007 at 18:00 hours, received her second subcutaneous dose in the left of varicella virus vaccine live (Oka/Merck) (lot#658932/1343). Concomitant vaccinations included a third dose of influenza virus whole virion 3v vaccine inactivated (FLUZONE) (lot # U24490AA). It was reported that in the morning of 14-NOV-2007, she developed erythema and warmth around the injection area, and was treated for cellulitis with cephalexin (KEFLEX) for 10 days. There was no relevant diagnostic tests or laboratory data. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLUN3, IPV, VARCEL
Symptoms: Rash papular, Urticaria
Clinical narrative: Information has been received from a physician concerning a 5 year old female with no pre-existing medical conditions or allergies who on 05-NOV-2007 at 13:30 was vaccinated SC with her second dose of VARIVAX (lot# 658932/1343U) in the left thigh. There was no illness at the time of vaccination. Concomitant vaccinations administered on that same day at 13:30 included the fourth SC dose of IPOL (lot# Z10692) in the left thigh and the first intranasal dose of FLUMIST (lot# 500489P). On the morning of 11-NOV-2007 the patient developed a hive-like rash all over face, neck, trunk and lower extremities with papules 0.5 cm to 10 cm in diameter. It was noted that no vesicles were present. The patient did not seek medical attention. The patient was treated with anti-itch therapy only. The outcome was unknown. Follow-up information from the reporting physician indicated that there were no further problems with this patient.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female with no known medical history, drug reactions or allergies who on 15-AUG-2006 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot # 649998/0909R). Concomitant vaccine therapy that same day included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # "649274/0896P"), a fifth dose of Daptacel (lot # U1615BA) and a fourth dose of poliovirus vaccine inactivated (Vero) (IPOL) (Lot # 40576). On 28-OCT-2007, the patient developed "varicella disease" with between 50 to 500 lesions. On an undisclosed date the patient recovered. There was no illness at the time of vaccination. No relevant diagnostic testing was performed. The patient had no known adverse events following prior vaccinations. No further information is expected.