chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old female with a history of being highly allergic who "about five years ago", in approximately 2002, was vaccinated with varicella virus vaccine live (Oka/Merck). The site stated "lot available" however, lot number was not provided. The patient developed shingles after receiving the vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Fatigue, Headache, Rash pruritic
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old white female, with no pertinent medical history, birth defects, or allergies, who on 13-SEP-2001 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 05-APR-2007 the patient presented with a two day history, approximate onset 03 APR 2007, of an itchy rash on her back, chest and the back of her neck, which now was spreading to her arms and legs, along with a headache and fatigue. On 15 APR 2007 the patient had recovered. Additional information is not expected.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative, No adverse event
Clinical narrative: Information has been received from a pharmacist concerning a male who in approximately 1997, about ten years ago was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). In approximately May 2007, the patient's titer level was done, showing no antibodies and is scheduled for second dose of varicella virus vaccine live (Oka/Merck) soon. Unspecified medical attention was sought. No product quality complaint reported. No further information is available.
Age: 8.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Rash generalised, Varicella
Clinical narrative: Information has been received from a health professional concerning an 8 year old Hispanic male student who in 2000 (previously reported as approximately May 2004) was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On 30-APR-2007 (previously reported as May 2007), the patient developed a mild case of chicken pox characterized by blisters, fever, and rash all over the body. Medical attention was sought on that same day when the patient went to the physician's office. In May 2007 the patient recovered. No product quality complaint reported. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning an 11-year-old female with no pertinent medical history or allergies, who on 21-May-2007 was vaccinated subcutaneously with a second 0.5 milliliters dose of varicella virus vaccine live (Oka/Merck) (lot# 656576/0446U). There was no concomitant medication. The nurse practitioner reported that on 23-May-2007 the patient experienced pain and swelling at the injection site. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. Subsequently, the patient recovered from the swelling and pain at injection site. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a physician concerning a patient who on 30-MAY-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). On 30-MAY-2007 the patient developed an injection site rash with redness, pain and inflammation at the injection site. The physician treated the patient with an antibiotic (unspecified). At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was sought. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who was vaccinated with second dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient developed a welt at the injection site. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Cellulitis, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male, who on an unknown date, was vaccinated in the thigh with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced pain, cellulitis and swelling in the thigh of the leg that received the vaccine. The patient's status was unknown. No product quality complaint was involved. This information is one of several reports from the same source. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Inflammation, Oedema peripheral
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old female with amoxicillin allergy and medical history of aseptic meningitis who on 17-MAY-2007 at 10:30 AM was vaccinated SC on left arm with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 656690/0126U). It was reported that patient had received 1st dose of varicella virus vaccine live (MSD) on 26-MAY-1998. There was no concomitant medication. There was no illness at the time of vaccination. It was reported that on 18-MAY-2007 the patient developed inflamed, swollen arm 24 hours after vaccination that lasted for 2 to 3 days. No fever was reported. Unspecified medical attention was sought. At the time of report, the patient had recovered. A product quality complaint was not involved. Additional information has been received from registered nurse who stated that parents of the patient called the physician on 18-MAY-2007 and 19-MAY-2007 to report that child had developed large area of redness and swelling from shoulder to elbow. The patient was afebrile. No other symptoms were noted. The patient was not seen in the office. The patient was advised cold compresses. On 20-MAY-2007 the patient recovered. No diagnostic laboratory tests were undertaken. There was no adverse event following prior vaccination. No further information is expected.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Drug exposure during pregnancy, Laboratory test, Rash
Clinical narrative: Information has been received through the Merck pregnancy registry from a physician (MD) concerning a 2 month pregnant hospitalized 35-year-old-female who approximately 2 months ago, about the time she became pregnant, had her 17-month-old child vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, on an unspecified date, the patient experienced an atypical rash on her abdomen that was atypical for varicella and was hospitalized. It is reported that the patient has no known history of chicken pox and is considered not immune for varicella. Diagnostic laboratory tests included titers to be drawn on an unspecified date. The patient was also seen by a dermatologist and said if the patient were felt to have varicella, they would call the MNSC to obtain information regarding testing to determine the type of varicella. The M.D. placed a call to infectious disease for consultation. The M.D. was not aware of the child who was vaccinated having a rash. It is unspecified if a product quality complaint was involved. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G increased, Pyrexia, Rash
Clinical narrative: Information has been received from a physician concerning a 24 month old female who in 2006 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In 2007 the patient developed rash and fever. The physician stated that the rash was not varicella-like. The patient also had elevated IgG level. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 31-MAY-2007 was vaccinated subcutaneously in the right deltoid with 0.5 mL (appropriate dose is 0.65 mL) instead of zoster vaccine live (Oka/Merck) (Lot # 652455/1018R) instead of zoster vaccine live (Oka/Merck). Physician reported that there were 2 boxes behind one another and the physician didn't see the zoster vaccine live (Oka/Merck) box. This is not product confusion. Patient sought unspecified medical attention. No further information was available. Follow-up information received from the physician's office stated that the patient did not experience an adverse event as a result of the product confusion. The physician simply grabbed the wrong vial out of the freezer as the varicella virus vaccine live (Oka/Merck) and zoster vaccine live (Oka/Merck) were next to one another. The patient was not on chemotherapy, corticosteroids and did not have a history of HIV/AIDS, cancer or any other immune deficiencies. Additional information is not expected.
Age: 0.2
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a pharmacy technician concerning her white 27 month old son with no pertinent medical history or drug allergies who on 29-NOV-1995 was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot number not provided). There was no illness at the time of vaccination. On approximately 15-DEC-1995 the patient developed chickenpox, less than 20 spots found. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient thought to have been vaccinated with varicella virus vaccine live (Oka/Merck), on unspecified date. Four to six weeks  post vaccination the patient developed chickenpox. No further information was available. Additional information is not expected.
Age: 2.3
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Rash papular, Skin exfoliation, Skin ulcer, Varicella
Clinical narrative: Information has been received from a physician concerning his daughter, a 27-month-old female who in July 2006, was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck). It was unknown if the vaccination was given with a single dose vial or pre-filled syringe. On 01-AUG-2007 the patient developed "papular lesions all over her body" which progressed to "exfoliating bullae and punched out ulcers," that could best be described as "full blown chicken pox." The patient was treated with antibiotics in case of secondary infections. On an unspecified date the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a certified medical assistant concerning a female patient who was vaccinated with a second 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 0851U). There was no concomitant medication.  The patient developed an injection site reaction after vaccination with the second dose of varicella virus vaccine live (Oka/Merck). Symptoms were described as a big red rash at the site of injection. The rash was described as being "puffy" and a "big circle". The physician prescribed an unspecified medication for the symptoms. No further information was available. Unspecified medical attention was sought. No product quality complaint was involved. This is the first of three cases for this reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. The patient developed chicken pox 4 to 6 hours after vaccination. The outcome was unknown. There was no product quality complaint. This is one of several reports from the same source.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a female "a little over 1 year old" who on 20-JUL-2007 was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck). On 10-AUG-2007 the patient was seen for chickenpox. Unspecified medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 12 year old female who was vaccinated with one 0.5ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 658000/0845U). The patient developed redness, warmth and swelling at the injection site. The dimension of the swelling was 2 and 1/4 inch by 1 and 1/2 inches. The patient contacted the physician. The outcome is recovering. No product quality complaint was involved. No further information was available. This is three cases reported by the same source. Additional information has been requested.
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 06-AUG-2007 was vaccinated with a second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 658056/0835U) in the left arm. On 06-AUG-2007 the patient's arm became red and swollen to an area of 2"x3". No medical attention was sought. The patient's recovery status was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a patient who on 14-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and experienced anaphylaxis after vaccination. It was unknown whether medical attention was sought. The recovery status was unknown. This is one of several reports from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a health professional concerning a 6 year old female who on 07-AUG-2007 was vaccinated with her second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 0657941/0851U) in the left arm. On 09-AUG-2007 28 hours after administration, the patient developed a low grade temperature and pain at the injection site which was also very red, swollen, and warm to touch. No medical attention was sought. The patient's recovery status was unknown. 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 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 was sought through the reporting physician. No labs or diagnostic studies were performed. A cold compress was recommended as treatment for the patient. 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.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Tuberculin test
Clinical narrative: Information has been received from a medical assistant concerning a female who was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot # 657941/0851U) 0.5 mL second dose. The medical assistant is reporting the patient developed an injection site reaction after the second dose. The symptoms were described as a "big red rash" at the site. The rash is described as puffy and big circle. The physician has prescribed a medication for the symptoms. It was reported that the patient was recovering and sought unspecified advice. The patient also had a PPD done on 13-AUG-2007 which was read on 15-AUG-2007 (results not provided). This is one of five reports from the same source. The physician reported that these patients had similar reactions after their second doses of varicella virus vaccine. The physician has decided not to vaccinate patient's with the second dose due to these experiences. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a medical assistant concerning a male patient who was vaccinated with varicella virus vaccine live (Oka/Merck) (LOT # 657941/0851U) second dose. The medical assistant reported that the patient developed an injection site reaction after the second dose. The symptoms were described as a "big red rash" at the site, the rash is described as puffy and big circle. The physician has prescribed an unspecified medication for the symptoms. It was reported that the patient was recovering and sought unspecified medical advice. This is one of five reports from the same source. The physician reported that these patients had similar reactions after their second dose due to these experiences. Further information has been received regarding this 6 year old male patient who was vaccinated on 15-AUG-2007 with varicella virus vaccine live (Oka/Merck) (LOT # 657941/0851U) second dose subcutaneously at approximately 10:00 AM. The physician reported that there were no pre-existing conditions not any illness at the time of vaccination. The physician reported that the patient had localized erythema. This is one of five reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a patient who on 11-OCT-2007, was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). Initially it was reported that this was a case of product confusion, but the health care provider on telephone follow up reported that it was just human error and did not have anything to do with an actual product confusion. No adverse experiences were related to this event. No further information was available. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a physician concerning a 14 year old male with no pertinent medical history, drug reactions or allergies who on 11-JUL-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). On 15 AUG 2007, the patient was vaccinated subcutaneously into the left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot #"0822U"). There was no concomitant medication. On 16-AUG-2007, the patient developed an injection site reaction described as a 14 X 16 erythematous induration. The patient was started on Augmentin as a precaution for infection (local cellulitis vs reaction to varicella virus vaccine live (Oka/Merck). At the time of reporting the patient was recovering. Unspecified medical attention was sought. There was no product quality complaint. Follow up information was received from an office manager, who indicated under HIPPA she was not permitted to release any patient information without patient authorization. Follow up information from a physician indicated that on 15 AUG 2007 the patient, who had no pertinent medical history, or pre existing allergies was also vaccinated with a second dose of hepatitis A virus vaccine inactivated (Havrix), into the right arm, (Lot # AHAVB184BA). There were no illnesses at the time of vaccination. No further information is expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Dyspnoea, Ocular hyperaemia, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 9 year old male who on 16-AUG-2007 in the AM, was vaccinated with a second SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 658056/0835U). At one hour after administration, the patient developed shortness of breath, hives, and red eyes. Medical attention was sought when the patient returned to the office. The patient was treated with diphenhydramine (HCL) (BENADRYL), albuterol nebulizer, solumeterol, and oxygen. As of 27-AUG-2007 follow up information via telephone cell indicated that the patient was taken directly from the office via ambulance to the emergency room for evaluation and observation because of the treatments he was administered post vaccination. Hospital admission was unknown. The patient's recovery status was unknown. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARCEL
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning his 77 year old father who on 14-AUG-2007 was vaccinated with a 0.5 mL SC dose of varicella virus vaccine live (Oka/Merck). On 19-AUG-2007, the patient developed tingling to the eye and skin around the eye. Unspecified medical attention was sought. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site induration, Injection site oedema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male with no medical history or allergies who on 07-AUG-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On approximately 07-AUG-2007, (within 24 hours of vaccination, the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information received on 11-OCT-2007 from a registered nurse concerning a 10-year old male with an allergy to penicillin who on 08-AUG-2007 was vaccinated subcutaneous in the left arm with his second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 657192/0362U). There were no illnesses at the time of vaccination. Concomitant vaccine administered intramuscularly on 08-AUG-2007 in the right arm included Havrix A (lot# AHAVB186AA). On 09-AUG-2007, the patient developed a hard raised edematous area at the injection site approximately about the size of a half dollar with overall reaction approximately 6-8 inches in diameter. The patient sought unspecified medical attention. No diagnostic labs were performed. On an unspecified date the patient recovered from all adverse events. This is one of several reports received from the same source. Additional information is not expected.
Age: 1.9
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a heath professional concerning a 9 year old male with a history of chickenpox at three months of age who on 01-DEC-1998 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced shingles. Unspecified medical attention was sought.. The patient recovered from shingles. Follow-up information was received on 11-SEP-2007. Information has been received from a health professional concerning a 9-year-old white male with a history of chickenpox at three months of age and no allergies who on 22-OCT-1999 was vaccinated subcutaneous, left arm, with his first dose of varicella virus vaccine live (Oka/Merck) (Lot # 626780/0672H). There were no illnesses at the time of vaccination. On 14-JUN-2007 the patient developed shingles on his left forearm and elbow area. There was no pain or secondly infection. At an unspecified date the patient recovered from shingles. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a health professional concerning a 13 year old female who on 14-AUG-2007 was vaccinated SC with a dose of varicella virus vaccine live (Oka/Merck) (Lot 657941/0851U). It was reported that on 15-AUG-2007, the patient developed an injection site redness that was "size of dollar bill". Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 13-AUG-2007 was vaccinated SC (left) with a second dose of varicella virus vaccine live (Oka/Merck) (657944/0851U). On 15-AUG-2007, the patient developed injection site redness; injection site swelling 3 inches in diameter; injection site warmth to the touch; and a mildly painful injection site reaction. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site induration, Injection site oedema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old female with a sulfa and erythromycin allergy with no additional pertinent medical history who on 16-AUG-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On approximately 16-AUG-2007, (within 24 hours of vaccination), the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information has been received from a registered nurse concerning a 13-year-old white female with Biaxin, sulfa and erythromycin allergy who on 16-AUG-2007 was vaccinated subcutaneous with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 657784/0645U). There were no illnesses at the time of vaccination. Concomitant vaccines administered on 16-AUG-2007 included a first intramuscular dose of Menactra administered intramuscular in the right thigh, a first dose of Havrix administered intramuscular in the right thigh, a dose of Boostrix and a dose of Gardasil (MSD). On 20-AUG-2007, the patient experienced an "injection site reaction; hard, raised edematous area the size of a quarter with outside area 6 to 8 inches in diameter". No diagnostic labs were performed. On an unspecified date the patient recovered from all adverse events. This is one of several reports received from the same source. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with no pertinent medical history or allergies who on 16-AUG-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 657784/0645U). No concomitant medication use was reported. On approximately 16-AUG-2007, (within 24 hours of vaccination) the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information was received on 11-OCT-2007 from a registered nurse concerning an 8-year-old female with amoxicillin and Cefzil allergy who on 16-AUG-2007 was vaccinated subcutaneous in the right thigh with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 657107/03368U) (previously reported as lot # 657784/0645U). There were no illnesses at the time of vaccination. Concomitant vaccines administered on 16-AUG-2007 included a first intramuscular dose of Havrix administered in the left thigh (lot AHAVB186AA). On 17-AUG-2007, the patient developed a hard, raised swollen area the size of a half dollar; overall site reaction with edema and redness was approximately 6-8 inches in diameter. On an unspecified date the patient recovered. This is one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Erythema, Fatigue, Groin pain, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Within 24 hours of the vaccination the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information was received on 13-SEP-2007. Follow-up information has been received from a registered nurse concerning a 12-year-old female with no pertinent medical history or allergies who on 24-AUG-2007 was vaccinated subcutaneous with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 657192/0362U). Concomitant vaccines administered on 24-AUG-2007 included a first dose of Gardasil (MSD) (Lot # 6469U), sixth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GlaxoSmithKline) (Lot # AC52B02AA), first dose of Menactra (Sanofi Pasteur) (Lot # U2391BA), and first dose of hepatitis A virus vaccine (unspecified) GlaxoSmithKline) (lot # AHAVB186AA). On 24-AUG-2007, the patient developed severe increased left thigh left groin pain; 2 inch edematous; reddened area noted on left thigh; lymph node in groin area enlarged and fatigue. The patient returned to the clinic for medical attention on 27-AUG-2007 and had a mean platelet volume of 10.0 fluid (normal range 0.0-9.9 fl). Subsequently, the patient recovered from all adverse experiences on 29-AUG-2007. This one of several reports received from the same source. Additional information is not expected.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site swelling, Lymphadenopathy, Mean platelet volume increased, Oedema
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Within 24 hours of the vaccination the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information was received on 13-SEP-2007. Follow-up information has been received from a registered nurse concerning a 12-year-old female with no pertinent medical history or allergies who on 24-AUG-2007 was vaccinated subcutaneous with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # 657192/0362U). Concomitant vaccines administered on 24-AUG-2007 included a first dose of Gardasil (MSD) (Lot # 6469U), sixth dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GlaxoSmithKline) (Lot # AC52B02AA), first dose of Menactra (Sanofi Pasteur) (Lot # U2391BA), and first dose of hepatitis A virus vaccine (unspecified) GlaxoSmithKline) (lot # AHAVB186AA). On 24-AUG-2007, the patient developed severe increased left thigh left groin pain; 2 inch edematous; reddened area noted on left thigh; lymph node in groin area enlarged and fatigue. The patient returned to the clinic for medical attention on 27-AUG-2007 and had a mean platelet volume of 10.0 fluid (normal range 0.0-9.9 fl). Subsequently, the patient recovered from all adverse experiences on 29-AUG-2007. This one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old male with no medical history, a penicillin and CECLOR allergy (causes hives) who on 07-AUG-2007 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). On approximately 07-AUG-2007 (within 24 hours of vaccination) the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information was received on 13-SEP-2007. Follow-up information has been received from a registered nurse concerning an 11-year-old white male with a penicillin and cefaclor (CECLOR) allergy who on 07-AUG-2007 was vaccinated subcutaneous in the right thigh with his second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657192/0362U). Concomitant vaccines administered on 07-AUG-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GlaxoSmithKline) (Lot # AC52B011CA), hepatitis A virus vaccine (unspecified) (GlaxoSmithKline) (Lot # AHAVB186AA) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Sanofi Pasteur) (lot # U2379BA). On 07-AUG-2007 (at approximately 20:00 hour) the patient experienced "severe pain at sight", temperature of 104.4, redness and swelling at injection site, small knot at injection site about the size of one half dollar with redness surrounding the site. The patient required an emergency room visit due to extreme pain, fatigue, and fever. No diagnostic labs were performed. The patient recovered from all adverse experiences on approximately 13-AUG-2007. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 11 year old male with no medical history, a penicillin and CECLOR allergy (causes hives) who on 07-AUG-2007 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). On approximately 07-AUG-2007 (within 24 hours of vaccination) the patient experienced an injection site reaction. The patient had a hard raised swelling area the size of a "half dollar" following the varicella virus vaccine live (Oka/Merck) vaccination. The overall size of the swelling was about 6 to 8 inches in diameter on the arm. It was reported the patient contacted their physician. No diagnostic laboratory tests were performed. At the time of the report the patient was recovering. A product quality complaint was not involved. Follow-up information was received on 13-SEP-2007. Follow-up information has been received from a registered nurse concerning an 11-year-old white male with a penicillin and cefaclor (CECLOR) allergy who on 07-AUG-2007 was vaccinated subcutaneous in the right thigh with his second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657192/0362U). Concomitant vaccines administered on 07-AUG-2007 included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (GlaxoSmithKline) (Lot # AC52B011CA), hepatitis A virus vaccine (unspecified) (GlaxoSmithKline) (Lot # AHAVB186AA) and meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Sanofi Pasteur) (lot # U2379BA). On 07-AUG-2007 (at approximately 20:00 hour) the patient experienced "severe pain at sight", temperature of 104.4, redness and swelling at injection site, small knot at injection site about the size of one half dollar with redness surrounding the site. The patient required an emergency room visit due to extreme pain, fatigue, and fever. No diagnostic labs were performed. The patient recovered from all adverse experiences on approximately 13-AUG-2007. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Allergy to vaccine, Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck). After receiving the second dose of varicella virus vaccine live (Oka/Merck) the patient had a large rash on their thigh. The patient previously had an allergic reaction to the first shot of varicella virus vaccine live (Oka/Merck), but the physician was not aware of this until after the second dose was given. No diagnostic labs were performed. It was reported the patient sought medical attention at their doctor's office. The patient recovered from the allergic reaction to varicella virus vaccine live (Oka/Merck) and the large rash on their thigh. A product complaint was not involved. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: UNK, VARCEL
Symptoms: Lymphocyte count abnormal
Clinical narrative: Information has been received concerning a 10 year old male with no medical history or allergies who on 25-JUL-2007 were vaccinated with a booster dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a hepatitis virus vaccine (unspecified) that was administered on 25-JUL-2007. On 14-AUG-2007 routine blood tests revealed the patient experienced an abnormal lymphocyte count. It was reported the patient called their physician and was advised that a repeat blood test would be performed to confirm the abnormal lymphocyte count. A product quality complaint was not involved. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a physician concerning a patient who on 14-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and experienced anaphylaxis after vaccination. It was unknown whether medical attention was sough. The recovery status was unknown. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Ear pain, Pharyngitis streptococcal, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with no known drug reactions/allergies who on 03-MAY-2002 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 20-AUG-2007, the patient developed a chickenpox type rash that started with several spots. On 21-AUG-2007, the rash was all over the patient's body in different stages. The rash was very itchy. The patient sought unspecified medical attention. The patient was treated with Benadryl and Calamine Lotion. The patient's chickenpox type rash persisted. There was no product quality complaint involved. Follow-up information was received on 21-SEP-2007 from a registered nurse concerning an 8-year-old female with no pre-existing medical conditions or allergies, who on 03-MAY-2002 was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 20-AUG-2007, the patient developed a chickenpox type rash that was described as many small papula/pustules on trunk, itchy (varicella). The patient was prescribed to take subs in the shower twice daily with soapy water along with Benadryl, Tylenol and Calamine Lotion. At the time of the report the patient's status was reported as "significantly better". Vaccination records indicated that the patient was vaccinated with 3 intramuscular does of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown), 5 intramuscular doses of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), 4 intramuscular doses of Hib conj vaccine (unspecified carrier), 5 doses of poliovirus vaccine inactivated (unspecified), 2 subcutaneous doses of measles virus vaccine  live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD), one dose of hepatitis a virus vaccine (unspecified), one dose of therapy unspecified "PV', one dose of therapy unspecified "BCG" and one does of therapy unspecified "montre". Information received on 21-SEP-2007 contained the following adverse events: massive ear pain (25-MAY-2007) and strep (Aug 2007). This is one of several reports from the same source. Additional information is not expected.
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a nurse concerning her daughter (age not reported) who was vaccinated with a second dose of 0.5 mL of varicella virus vaccine live (Oka/Merck) (lot # 617355/0567D). Subsequently the patient experienced rash around injection site after being vaccinated with varicella virus vaccine live (Oka/Merck). The patient sought unspecified medical attention. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Mass
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 10-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot #658024/0833U). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot#655414/1470F). On 10-AUG-2007 the patient developed a red bump on her right arm after vaccination. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This patient also had adverse experiences after therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (WAES0708USA03318).
Age: 5.0
Sex: F
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician concerning a 5 year old female who on 10-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot #658024/0833U). Concomitant therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot#655414/1470F). On 10-AUG-2007 the patient developed a red bump on her right arm after vaccination. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This patient also had adverse experiences after therapy with measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (WAES0708USA03318).
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site mass, Injection site pain
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.