chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: F
Vaccine: HEPA, VARCEL, VARCEL
Symptoms: Bacterial culture negative, Blister, Ear pain, Erythema, Otorrhoea
Clinical narrative: Information has been received from a physician concerning an approximate 7-year-old female with no pertinent medical history or allergies who on 11-DEC-2001 and 11-SEP-2007 was vaccinated with her first and second dose of varicella virus vaccine live (Oka/Merck) (lot # 658194/1095U 1st dose). Concomitant vaccine included Havrix. On approximately 11-SEP-2007 the patient experienced relapsing painful, red blisters of the ears following the second vaccination. "The progression is the ear turns red and swells with blisters, the blisters rupture and the swelling goes down and the pain goes away." The patient's reaction occurs predominantly on the left ear, but both ears have been involved. The patient seems to spontaneously resolve after 2 to 3 days of painful red blisters and the reaction comes back about one week later. It was reported the patient complained of a painful left ear and discharge on 25-SEP-2007. On 05-OCT-2007, it was also reported the patient left school early because her right ear was painful, turned purple and had a blister that popped. The physician reports the blisters have occurred and resolved three times since the vaccination on 11-SEP-2007. On an unspecified date the patient had an evaluation by an ear, nose and throat specialist and had a culture of a blister and the results showed no growth of bacteria anaerobic or aerobic. At the time of the report the patient's status was relapsing-not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 76 year old white male with no pertinent medical history, and an allergy to aspirin who on 10 OCT 2006, was vaccinated intramuscularly into the left arm with a first dose of varicella virus vaccine live (Oka/Merck) rather than zoster vaccine live (Oka/Merck) (646536/0550R), instead of zoster vaccine live (Oka/Merck), "which is what the patient wanted". There was no illness at the time of vaccination. No adverse symptoms were reported. There was no product quality complaint. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 66-year-old female who on 26-OCT-2007 at 12:08 pm was vaccinated subcutaneously in the right deltoid with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot# 652722/1127R). No previous dose had been given. There was no illness at the time of vaccination. On 26-OCT-2007, the patient was inadvertently administered a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was unspecified if medical attention was sought and the nurse practitioner confirmed that this was not a case of product confusion, but rather human error. Subsequently, no problems were reported. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). On an unspecified date (after vaccination) the patient developed chickenpox. The patient sought unspecified medical attention. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin disorder
Clinical narrative: Information has been received from a medical assistant concerning a 37 year old male with hypercholesterolaemia and no drug allergies who on 12-OCT-2007 was vaccinated SC with is first 0.5 mL dose of varicella virus vaccine live (Oka/Merck).Concomitant drug therapy included Pravachol. On 19-OCT-2007, the patient developed "a few scattered red bumps." The patient contacted the physician's office by phone and no treatment was recommended. No labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality compliant. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a health professional concerning a 7 year old 58 1/2 lb. 44 in. female who on 25-JUN-2001 received a first dose subcutaneous in the right deltoid of varicella virus vaccine live (Oka/Merck) (lot# 638490/1900K). It was reported that at the time of vaccinated the patient presented with a fever (102) and a tummy ache. On 19-SEP-2007, it was reported that she developed one blister on the back of her thigh. It was reported that medical attention or treatment was not sought. At the time of this report it was reported that the patient had recovered. A product quality complaint was not reported. Additional information was not available. Additional information is not expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 28-month-old female with no pre-existing birth defects, medical conditions or known allergies who on 24-JAN-2003 was vaccinated subcutaneous in the left deltoid with her first dose of varicella virus vaccine (Oka/Merck) (lot # 640725/0788M). There were no illnesses at the time of vaccination. On 07-JUN-2004, the patient experienced a small outbreak (3-4) on chest, 4-5 more the next day with a fever. The patient was treated with Aveeno bath, calamine and Benadryl. No diagnostic labs were performed. On an unspecified date the patient recovered. Additional information is not expected.
Age: 1.2
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning an 8-year-old female with no pre-existing allergies, birth defects, or medical conditions, who on 18-DEC-1997 was vaccine with a second dose of varicella virus vaccine live (Oka/Merck). There was no illness at the time of vaccination. On 07-NOV-2007, the patient broke-out with a mild case of chickenpox. The patient used calamine lotion, Aveeno and Benadryl. Subsequently, the patient recovered. There were no relevant diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 29-OCT-2007 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported as a medical error, another nurse grabbed the wrong vaccine. No adverse experience was reported. A product quality was not involved. Follow-up information has been received concerning a 76-year-old male patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 658061/1092U). The reason for the product confusion was that one nurse pulled the vaccine out of the refrigerator and drew it up. That nurse was called away and another nurse just took it and administered it. Additional information is not expected. This is one of several reports received from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who, "about a week ago", on approximately 22-OCT-2007, was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient was inadvertently vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). It was unspecified if medical attention was sought. Subsequently, no adverse events were reported. No product quality complaint was involved. Follow-up information has been received from the office manager who confirmed that one female patient was given varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). No other details were available at the time of this report. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 32 month old male with no medical history or allergies who on 08-SEP-1998 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In September 1998, within days of vaccination the patient developed a severe case of chickenpox. It was reported that the patient was vaccinated by another physician. No diagnostic laboratory tests were undertaken. 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.
Age: 63.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a 63 year old male who on 29-OCT-2007 was vaccinated with a dose varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). The pharmacist stated that the patient was not vaccinated at the pharmacy. No other information. There was no product quality complaint. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 65 year old female who was vaccinated with pneumococcal 23 polysaccharide vaccine (manufacturer unknown). Concomitant therapy included Effexor XR and vitamins (unspecified). The consumer reported that afterwards both of her arms were sore. Current patient status and medical attention was not reported. A product quality complaint was not reported. No further information was available. The patient experienced psoriasis of the scalp, swollen glands, and skin lesion following vaccination with zoster vaccine live (Oka/Merck) (WAES#0710USA04043). Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a health professional concerning a 9 year old male with a history of asthma and rhinitis allergies who on 22-JAN-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 12-OCT-2007, the patient developed a varicella rash. There was not illness at the time of vaccination. There was no relevant diagnostic tests and laboratory data. Unspecified medical attention was sought. On 19-OCT-2007, the outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Dermatitis contact, Pruritus, Rash
Clinical narrative: Information has been received from a health professional concerning a 9 year old male with hypersensitivity to amoxicillin and no pertinent medical history who on 25-MAY-1999 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657449/0597U). There was no concomitant medication. There was no illness at the time of vaccination. On 25-OCT-2007, the patient developed a rash on his face and torso for "one day". The patient was afebrile. On an undisclosed date the patient also developed itchy vesicles and was reportedly asymptomatic. The patient recovered from the rash on his face and torso in one day, and the itchy vesicles on an undisclosed date. Additional information was received from a nurse who reports that the rash was originally thought to be chickenpox on 25 OCT 2007, but when the child was seen on 30 OCT 2007 for an unrelated condition, the rash on the face and torso was diagnosed as poison ivy. No further information is expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning an approximately 4 to 5 year old patient who was vaccinated with the second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (no lot number available). The patient had no fever. The patient developed 15 lesions. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with the first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (no lot number available). The patient developed breakthrough after the first dose. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a 16 year old 96 lb. 61 1/4 in. female who on 31-JUL-2007, was vaccinated with a second subcutaneous dose in the left arm of varicella virus vaccine live (Oka/Merck) (Lot # 657649/0815U). There was no reported illness at the time of vaccination. Follow up information form the nurse indicated that on 01-AUG-2007, the patient developed in the arm at the injection site, "baseball size", warm to touch, and tender for 3 days. Medical attention sought was not reported. There were no relevant diagnostic tests or laboratory data. As of 03-AUG-2007, the patient had recovered. The patient's vaccination history included on 20-OCT-1992, varicella virus vaccine live (Oka/Merck). A product quality complaint was not reported. Follow up information indicated that the office "did not feel the event met the criteria of an adverse event". Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who on 30-OCT-2007 was vaccinated SC with a 0.65 mL dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck). The varicella virus vaccine live (Oka/Merck) was reconstituted with 0.65 mL of diluent and administered. The patient was seen at the office. There was no product quality complaint. Follow-up information from the nurse stated that the patient was inadvertently given varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) because the two products were at the same location side by side and the nurse was new. The site has since then stored the two products in separate and labeled locations. The patient did not experience any adverse experience. No other information given. Follow-up information has been received concerning an 82-year old retired female with osteoporosis and degenerative arthritis, who has no no known allergies. On 30-OCT-2007 at 15:50, the patient was vaccinated in the left arm with a first intramuscular dose (previously reported as subcutaneous) of varicella virus vaccine live (Oka/Merck) (lot# 658287/1173U). On 27-Nov-2007, the patient was vaccinated intramuscularly in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot# 658212/0887U). Concomitant medications included aspirin, vitamin D and Evista. There was no illness at the time of vaccinations. No adverse events were noted. Follow up information has been received which indicates that there is no further information to report. Follow-up information has been received which stated "no adverse reaction was noted. No further information at this time." No further information is available.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a nurse concerning a 12 year old female who on 22-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 658287/1173U). Concomitant therapy that day included Gardasil, Hepatitis A vaccine (inactive) (MSD), Fluzone (manufacturer unknown) Menactra (manufacturer unknown). On 24-OCT-2007, the "patient reported redness surrounding the injection site approximately 48 hours after receiving the vaccination." No further information was given. The outcome was reported as recovered on 26-OCT-2007. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 13-year-old female who on 05-SEP-2007 was vaccinated subcutaneous in the left arm with her second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657941/0851U). On 07-SEP-2007, the patient developed 1/2 dollar redness and tenderness, as well as warmth to touch and slight pruritic (site unspecified). At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Cellulitis, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a certified nurse practitioner concerning an 8 year old female who on 28-AUG-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (LOT# 658196/1018U) in left arm, subcutaneously. On 29-AUG-2007, the patient experienced a small raised area at the site of injection then redness spread. On 30-AUG-2007, the red area was spreading (8X8 cm), swelling with yellow drainage, and fever up to 101. She was diagnosed with cellulitis. The outcome of the patient's events were not reported. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a nurse concerning a 7 year old female who on 22-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 657719/1001U). Concomitant therapy that day included hepatitis A vaccine (inactive) (MSD) and Fluzone (manufacturer unknown). On 22-OCT-2007, " the patient experienced redness and itchiness on her right thigh near the injection site" after receiving the vaccination. No further information was given. The outcome was reported as recovered. There was no product quality complaint. Follow-up information has been received which indicated that the patient had no pre-existing allergies, birth defects or medical conditions. On 26-Oct-2007 (previously reported as 22-Oct-2007) at 3:15 PM the patient was vaccinated in the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 657719/1001U) There was no illness at the time of vaccination. On 27-Oct-2008 (previously reported as 22-Oct-2007) at 12 PM the patient developed a 1 cm red, pruritic area several centimeters around the varicella virus vaccine live (Oka/Merck) injection site. Around 31-Oct-2007, the patient recovered. It was reported that the patient has never had an adverse event following prior vaccinations. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning an 8 year old female patient who on 20-AUG-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (LOT# 658056/0835U). On 22-AUG-2007, the patient experienced redness and swelling at the site. The patient's outcome was not reported. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, VARCEL
Symptoms: Erythema
Clinical narrative: Information has been received from a nurse concerning a 9 year old female who on 22-OCT-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot number: 658287/1173U). Concomitant therapy that day included Fluzone (manufacturer unknown), Gardasil and hepatitis A vaccine (inactive) (MSD). "The patient experienced 2 centimeters of irregular erythema on her left arm after receiving the vaccination." No further information was given. The outcome was reported as recovered on 26-OCT-2007. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an adult patient who in August 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient inadvertently received varicella virus live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD) due to human error. A product quality complaint was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received a physician an adult patient who in August 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). The patient inadvertently received varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD) due to human error. A product quality complaint was not involved. Follow-up information was received on 20-SEP-2007 via a telephone call. The physician reported the patient did not experience an adverse event and "is doing fine". This is one of several reports from the same source.
Age: 1.3
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Varicella
Clinical narrative: Information has been received from a licensed practical nurse concerning a 16 month old 27 lb. 31 in. female with no pertinent medical history and no drug reactions/allergies, who on 18-OCT-2007 at 11:00 hrs. was vaccinated intramuscularly in the right thigh with a first 0.5 mL dose of varicella virus live (Oka/Merck) (lot# 654523/1155F). There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. There was no concomitant medication. On 30-OCT-2007, the patient developed a widespread vesicular rash described as a red colored raised skin lesions. On 31-OCT-2007, the patient was examined in the office and diagnosed with chickenpox. There were no lab diagnostic studies performed. Treatment included acyclovir, 150 mg orally, three times a day for 10 days. At the time of this report, on an unspecified date the patient had recovered. The reporter felt that the chicken pox was vaccine induced. There was no product quality complaint. Additional information is not expected.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 3 year old male who was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). The patient had a breakthrough of varicella all over the body "the next day" after receiving the vaccination. The physician also noticed pock marks inside the throat area. No additional adverse event information was reported. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 9-year-old female with no pertinent medical history or allergies who on 11-SEP-2007 was vaccinated subcutaneous with her second dose of varicella virus vaccine live (Oka/Merck) (Lot # /1094U). There was no concomitant medication. On 13-SEP-2007, the patient developed a red swollen area on her arm the size of a silver dollar after receiving her second vaccination of varicella virus vaccine live (Oka/Merck). The patient's parent sought medical attention via a phone call and no treatment was required. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister
Clinical narrative: Information has been received from a physician concerning a 10-year-old male with asthma and no history of varicella who on 12-OCT-1998 was vaccinated subcutaneous in the right thigh with his first dose of varicella virus vaccine live (Oka/Merck) (lot # 625477/0653H). There were no illnesses at the time of vaccination. In June 2007, the patient developed "10-12 vesicles on his left anterior thigh". The physician states that she did not see the above vesicles, therefore, she does not know if they were varicella-like (the patient was not examined by the physician). There were no diagnostic labs performed. On 12-DEC-2007 at 15:00 the patient was vaccinated subcutaneous in the left thigh with a second dose of varicella virus vaccine live (Oka/Merck) (lot # 658411/1023U) without any reaction. The physician also states that the patient is immunocompetent. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a patient (age and gender reported as unspecified) who on an unspecified date was vaccinated subcutaneous with 0.5 mL dose of varicella virus vaccine live (Oka/Merck). It was reported the patient had an adverse experience after vaccination. The patient's status at the time of the report is unknown A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a male with no drug reactions/allergies who on 07-NOV-2002 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). ON 03-OCT-2007, the patient was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot 658403/1121U). There was no concomitant medication. On 05-OCT-2007, the patient experienced red, irritated, tennis ball size reaction at the site of the injection and chickenpox rashes down the entire left arm. Subsequently, it was reported that the patient recovered from red, irritated, tennis ball size reaction at the site of the injection and chickenpox rashes down the entire left arm. The office assumed the patient had recovered because the patient hasn't followed up with office. No laboratory diagnostic studies were performed. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a male who on 13-SEP-2007 was vaccinated subcutaneous with "1 vial" of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) (MSD). The patient sought medial attention via an office visit. No diagnostic labs were performed. No adverse reaction observed. A product quality complaint was not involved. Additional information has been requested.
Age: 0.4
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female with asthma and penicillin allergy who on 28-SEP-2007 was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 658375/1118U). On 29-SEP-2007 the patient developed redness, swelling and tenderness to the left deltoid. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been received from the registered nurse stated that the patient had recovered on 05-OCT-2007. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 7-year-old female with no pertinent medical history or allergies who on 10-SEP-2007 was vaccinated intramuscularly with 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 658194/1095U). There was no concomitant medication. On approximately 11-SEP-2007, the patient developed erythema at the injection site within 24 hours of receiving her second dose of varicella virus vaccine live (Oka/Merck). The patient sought medical attention via a phone call. No diagnostic labs were performed. At the time of the report the patient's status was unknown. A product quality complaint was not involved. This is one of several 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 pharmacist concerning 4 adult patients who were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) instead of a dose of zoster vaccine live (Oka/Merck). It was reported to be product confusion. No adverse experiences were reported. A product quality was not involved. 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: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a physician concerning a 10 year old female with no pertinent medical history, drug reactions or allergies who on 07-SEP-2007 was vaccinated intramuscularly with a second dose , 0.5 mL, of varicella virus vaccine live (Oka/Merck) (lot # 658194/1095U). There was no concomitant medication. On approximately 08-SEP-2007, within 24 hours of receiving the vaccine, the patient developed erythema, soreness, pruritus and a rash at the injection site. The patient was diagnosed with cellulitis and treatment with cephalexin (Keflex). No lab diagnostic tests were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 10 year old female with no pertinent medical history, drug reactions or allergies who on 07-SEP-2007 was vaccinated intramuscularly with a second dose , 0.5 mL, of varicella virus vaccine live (Oka/Merck) (lot # 658194/1095U). There was no concomitant medication. On approximately 08-SEP-2007, within 24 hours of receiving the vaccine, the patient developed erythema, soreness, pruritus and a rash at the injection site. The patient was diagnosed with cellulitis and treatment with cephalexin (Keflex). No lab diagnostic tests were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 10 year old female with no pertinent medical history, drug reactions or allergies who on 10-SEP-2007 was vaccinated intramuscularly with a second dose , 0.5 mL , of varicella virus vaccine live (Oka/Merck) (Lot # "10954U). There was no concomitant medication. On approximately 11-SEP-2007, within 24 hours of receiving the vaccine, the patient developed erythema, soreness, pruritus, and a rash at the injection site. No lab diagnostic tests were performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 4 year old male with no pertinent medial history or drug allergies, who was vaccinated with his second 0.5ml IM dose of varicella virus vaccine live (Oka/Merck) (658194/1095U). There was no concomitant medication. Within 24 hours of receiving the dose, the patient developed erythema and swelling at the injection site. Medical attention was sought by telephone contact. No labs or diagnostic studies were performed. The patient's recovery status was unknown. There was no product quality complaint. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who in approximately August 2007, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot#658000/0845U). On 15-AUG-2007 the patient developed injection site pain and swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Sex: U
Vaccine: VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who in approximately August 2007, was vaccinated with doses of varicella virus vaccine live (Oka/Merck) (Lot#657944/1003U). On 21-AUG-2007 the patient developed injection site pain and swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Roseola
Clinical narrative: Information has been received from a pharmacist concerning his 12 month old son with no pertinent medical history or drug allergies who on 28-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 17-SEP-2007 the patient developed a rash. Medical attention was sought via contact to the physician's office. No lab diagnostic studies were performed. It was noted that the patient was not recovered. There was no product quality complaint. Follow-up information has been received from a pharmacist indicating that the rash that developed on approximately 18-SEP-2007 3 weeks after vaccination, was a reaction not associated with varicella virus vaccine live (Oka/Merck), but caused by another viral infection (ROSEOLA). No further information is available.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 2-year-old female who was vaccinated when she was 12 months old with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient developed shingles. The patient sought medical attention via an office visit with her physician. The patient recovered at an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old female with no pertinent medical history or drug allergies who on 13-SEP-2007 was vaccinated with her second 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (lot# 658373/1116U). There was no concomitant medication. On 14-SEP-2007 the patient developed a red, warm, raised and swollen area at the injection site. Medical attention was sought through contacting the physician's office. No lab diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 2-year-old patient with no pertinent medical history or allergies who at one year of age was vaccinated with her first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (Lot # unknown). There was no concomitant medication. On an unspecified date the patient experienced "a shingles rash". Medical attention was sought via an office visit. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: Information has been received from a corpsman concerning a 9-year-old female with no pertinent medical history or allergies who on 14-SEP-2007 was vaccinated subcutaneous with her second dose of varicella virus vaccine live (Oka/Merck) (Lot # 656576/0446U). There was no concomitant medication. On 14-SEP-2007 the patient passed out for 6-10 seconds after vaccination. The patient sought unspecified medical follow-up. Subsequently, on 14-SEP-2007 the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male with no pertinent medical history or drug allergies who on 14-SEP-2007 was vaccinated with his second 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (lot# 658373/1116U). There was no concomitant medication. On that same day while the patient was in the physician's office, the patient developed a red, warm, raised, swollen area at the injection site. No lab diagnostic studies were performed. The symptoms improved before the patient left the office and the patient was noted to be recovering. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 17 year old white female who on 13-SEP-2007 at 16:00 (previously reported as 14-SEP-2007) was inadvertently vaccinated with the second SC dose of varicella virus vaccine live (Oka/Merck) (lot# 657105/1000U) in the right arm 6 days after first dose (lot# 657105/1000U) on 07-SEP-2007 (previously reported as 8 days after dose). No adverse symptoms were reported. It was noted that the patient was scheduled to receive a dose of Gardasil (MSD). No medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old female who was vaccinated subcutaneously with the second dose of varicella virus vaccine live (Oka/Merck) (lot#658373/1116U). Concomitant therapy included measles-mumps-rubella vaccine (MSD) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. Subsequently the patient developed a red, warm, raised and swollen area at the injection site. The patient's mother had contacted the physician's office to report this event. This is one of several reports from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Erythema, Pruritus, Rash papular, Varicella
Clinical narrative: Information has been received from a physician concerning a 12-month-old  male who on 15-OCT-2007 was vaccinated intramuscular with his first dose of varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U) and a first intramuscular dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot # 657244/0527U). On 27-OCT-2007 (previously reported as 25-OCT-2007) the patient broke out on small papular lesions with red base itchy varicella but all equal size and shape spread all over the face, neck, arm, body and leg. It was reported the patient had "no fever and the child was otherwise fine". The patient sought medical attention through their physician and was treated with diphenhydramine oral (BENADRYL). No diagnostic labs were performed. On 29-OCT-2007 the patient recovered. A product quality complaint was no involved. Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Rash morbilliform
Clinical narrative: Information has been received from a physician concerning a 12-month-old  male who on 15-OCT-2007 was vaccinated intramuscular with his first dose of varicella virus vaccine live (Oka/Merck) (lot# 658586/1272U) and a first intramuscular dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot # 657244/0527U). On 27-OCT-2007 (previously reported as 25-OCT-2007) the patient broke out on small papular lesions with red base itchy varicella but all equal size and shape spread all over the face, neck, arm, body and leg. It was reported the patient had "no fever and the child was otherwise fine". The patient sought medical attention through their physician and was treated with diphenhydramine oral (BENADRYL). No diagnostic labs were performed. On 29-OCT-2007 the patient recovered. A product quality complaint was no involved. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician assistant concerning a 65 year old male with aspirin allergy and glaucoma and a history of skin cancer and kidney stones who on 15-AUG-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included Lipitor, Flomax and Xalatan. On 11-SEP-2007, the patient developed chicken pox. The patient first noticed a rash on his ankles. The chicken pox lesions have been progressively moving up the patient's body and are no on his legs and trunk. Unspecified medical attention was sought. No lab studies were preformed. At the time of this report the patient had not recovered. There was no further information provided. There was no product quality complaint involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 9 year old female with an allergy to penicillin who on 10-Mar-2000 was vaccinated with a first does and 14-Sep-2007 was vaccinated SQ with a 0.5 mL second dose of varicella virus vaccine live (Oka/Merck) (lot# 658373/1116U). The patient was seen in the office on 17-Sep-2007 and had a 3 inch raised red area at the injection site. The reaction was noticed on 15-Sep-2007. The patient was recovered from the red area on 19-Sep-2007 but the area the injection was given was still visible. No product complaint was involved. This is one of the multiple reports of the same source. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: FLU3, VARCEL
Symptoms: Dyspnoea, Face oedema, Livedo reticularis, Wheezing
Clinical narrative: Information has been received from a physician concerning an approximately 9-year-old child who was vaccinated on an unspecified date with a dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccination included a dose of influenza virus split virion 3v vaccine inactivated (FLUZONE (influenza virus split virion 3v vaccine inactivated) (Sanofi Pasteur). Subsequently the patient experienced a possible anaphylactic reaction which included wheezing, shortness of breath, facial edema and facial mottling. The patient was stabilized and transported to the nearest hospital. No other information was available. This event not occur at the reporting physicians office. This is one of several reports from the same reporter. Additional information has been requested,
Sex: U
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 658177/1012U). It was reported that a series of parents have been calling since the administration of the second dose of varicella virus vaccine live (Oka/Merck) to report that the children are experiencing local non-systemic reactions. The parent of the child sought medical attention via a phone call to the child's physician. Subsequently, the patient recovered at an unspecified date per the nurse "because no parents called back after initial call". A product quality complaint was not involved. This is one of several reports from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye pain
Clinical narrative: Information has been received from a health professional concerning a 6 year old male's father who on approximately 05-SEP-2007 was squirted with varicella virus vaccine live (Oka/Merck) into his eyes when his son who was being vaccinated, moved. The father experienced stinging to his eyes. His eyes were flushed at the office. The outcome is reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. This is one report of several from the same source. Additional information has been requested. 3/25/2010 Follow up from a registered nurse indicated that no additional information was available. Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a advance registered nurse practitioner concerning a 78-year-old female who on 17-Sep-2007 was vaccinated at 13:15 subcutaneous in the left arm with her first 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 658194/1095U) for the prevention of shingles instead of zoster vaccine live (Oka/Merck) (MSD). There were no illnesses at the time of vaccination. The nurse practitioner stated that this was not product confusion it was a medication error due to wrong vaccine given. There was no adverse experience related to this event. No diagnostic labs were performed. On 31-OCT-2007 at 13:15, the patient was re-immunized with her first dose of zoster vaccine live (Oka/Merck) (MSD) (lot # 658085/0882U). There was no product quality complaint. Additional information is not expected.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a 13-month-old female who on 28-SEP-2007 at 9:30 am was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot# 658525/1255U). Subsequently, on an unspecified date, the patient developed mild chickenpox. No outcome was reported. Follow-up information indicated that the patient had a mild case of varicella and experienced no sequelae. It was reported that she appeared well as of 30-NOV-2007. No additional information is expected.