chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Secondary transmission, Vaccination failure, Varicella
Clinical narrative: Information has been received from a physician concerning a child who developed chickenpox subsequent to his sibling developing a chicken pox break through of 50-70 lesions after being vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (WAES#0704USA01871). Unspecified medical attention was sought. There was no product quality complaint. This one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a child who developed chickenpox subsequent to his sibling developing a chicken pox break through of 50-70 lesions after being vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (WAES#0704USA01871). Unspecified medical attention was sought. There was no product quality complaint. This one of several reports received from the same source. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Blister, Rash papular, Rash pruritic, Vaccination failure, Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old male patient with a medical history of asthma, obesity and seasonal allergies who on 22-MAR-2007 was vaccinated with a second subcutaneous dose of VARIVAX. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 04-APR-2007, the patient developed a diffuse vesicular rash on the face, chest and back, 50-60 lesions, pruritic. Medical attention was not sought. The event resolved after 10 days, on 13-APR-2007. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Secondary transmission, Vaccination failure, Varicella
Clinical narrative: Information has been received from a physician concerning an 8 year old male patient with a medical history of asthma, obesity and seasonal allergies who on 22-MAR-2007 was vaccinated with a second subcutaneous dose of VARIVAX. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 04-APR-2007, the patient developed a diffuse vesicular rash on the face, chest and back, 50-60 lesions, pruritic. Medical attention was not sought. The event resolved after 10 days, on 13-APR-2007. Additional information is not expected.
Age: 8.0
Sex: M
Vaccine: VARCEL, VARCEL, VARCEL
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 8 year old male patient with a medical history of asthma, obesity and seasonal allergies who on 22-MAR-2007 was vaccinated with a second subcutaneous dose of VARIVAX. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 04-APR-2007, the patient developed a diffuse vesicular rash on the face, chest and back, 50-60 lesions, pruritic. Medical attention was not sought. The event resolved after 10 days, on 13-APR-2007. Additional information is not expected.
Age: 12.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Injection site irritation, Injection site pruritus, Injection site urticaria
Clinical narrative: Information has been received from a health professional concerning a 12 year old male who on 13-APR-2007, was vaccinated with a second dose of 0.5 mL varicella virus vaccine life (Oka/Merck). On 13-APR-2007, the patient experienced hives all around the injection site and was itching and burning 15 minutes after getting the vaccine. The patient is considered recovered from the event. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested. Follow-up information received from a register nurse stated that on 13-APR-2007, this patient received a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) in the left arm (Lot# 654812/1087F). Concomitant vaccines administered on the same day included an intramuscular dose of Boostrix (Lot # "804") in the left arm and an intramuscular dose of Havrix (lot #855") in the right arm. On 13-APR-2007, the patient developed hives and itching at the sight of the injection. The patient denied difficulty breathing or agitation. The patient was observed for a period of time. After observing the patient, the reaction seemed to subside. The patient was advised to take some Benadryl and notify the site of any other problems. The site followed up with the patient 3 hours later and the father stated that the patient was fine and that the hives had subsided. The patient did not seek medical care. The patient was considered recovered.
Age: 9.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Mass
Clinical narrative: Information has been received from a physician concerning a 9-year-old female who on 18-APR-2007 at 2:00 in the afternoon, was vaccinated in the left arm with a second single dose of varicella virus vaccine live(Oka/Merck) (lot# 656688/0124U), having had a first dose "years ago". Concomitant vaccination included a third single dose in the left arm of hepatitis A virus vaccine inactivated (HAVRIX). On 18-APR-2007, at approximately 4:00 in the afternoon, the patient experienced a mildly raised red knot approximately 4 cm in diameter in her left arm. Unspecified medical attention was sought. No laboratory or diagnostic testing was performed. The physician reported that the red knot had become progressively worse. On an unspecified date the patient recovered. No product quality complaint was involved. Additional information is not expected.
Age: 9.0
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 nurse concerning a 9 year old female with no medical history or allergies who on 23-APR-2007 at 11:17 AM was vaccinated SC in left arm with a 0.5 ml second dose of VARIVAX (Lot # 656688/0124U).  There was no concomitant medications.  There was no illness at the time of vaccination.  On 24-APR-2007 the patient developed slight swelling and redness around injection site on left arm.  On 25-APR-2007 the patient's symptoms worsened with increased redness, swelling and a fever of 100.9 F.  The patient was ordered to apply ice to the injection site for 10 minutes three times a day.  The patient was also ordered to take MOTRIN 400 mg by mouth three times a day for 2-4 days as needed for fever and pain.  No diagnostic laboratory tests were performed.  A product quality complaint was not involved.  The swelling and redness at injection site and fever were considered to be other important medical events by the reporter.  Additional information has been received from the nurse who stated that on 24-APR-2007 the patient developed slight swelling and redness.  On 25-APR-2007 the patient was seen in office with increasing swelling and fever with body temperature of 100.9 F.  The physician noted a large well demarcated warm, red, tender area on left deltoid of 3 x 3 inches.  The physician assessed as local reaction to vaccine.  The patient was prescribed to use ice 3 times a day for 10 minutes along with MOTRIN 400 mg by mouth 3 times a day for 2-4 days.  The patient was asked to return to office in 24-36 hours if she was not feeling better.  There were no adverse events following prior vaccination for patient and her sibling.  At the time of report the patient had recovered.  No further information is expected.  This is one of several reports received from the same source.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Local reaction, No reaction on previous exposure to drug, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 9 year old female with no medical history or allergies who on 23-APR-2007 at 11:17 AM was vaccinated SC in left arm with a 0.5 ml second dose of VARIVAX (Lot # 656688/0124U).  There was no concomitant medications.  There was no illness at the time of vaccination.  On 24-APR-2007 the patient developed slight swelling and redness around injection site on left arm.  On 25-APR-2007 the patient's symptoms worsened with increased redness, swelling and a fever of 100.9 F.  The patient was ordered to apply ice to the injection site for 10 minutes three times a day.  The patient was also ordered to take MOTRIN 400 mg by mouth three times a day for 2-4 days as needed for fever and pain.  No diagnostic laboratory tests were performed.  A product quality complaint was not involved.  The swelling and redness at injection site and fever were considered to be other important medical events by the reporter.  Additional information has been received from the nurse who stated that on 24-APR-2007 the patient developed slight swelling and redness.  On 25-APR-2007 the patient was seen in office with increasing swelling and fever with body temperature of 100.9 F.  The physician noted a large well demarcated warm, red, tender area on left deltoid of 3 x 3 inches.  The physician assessed as local reaction to vaccine.  The patient was prescribed to use ice 3 times a day for 10 minutes along with MOTRIN 400 mg by mouth 3 times a day for 2-4 days.  The patient was asked to return to office in 24-36 hours if she was not feeling better.  There were no adverse events following prior vaccination for patient and her sibling.  At the time of report the patient had recovered.  No further information is expected.  This is one of several reports received from the same source.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Oedema peripheral, Pain, Pyrexia, Vomiting
Clinical narrative: Information has been received from a healthcare professional concerning a 5-year-old (previously reported as a 6-year-old) white female who on 01-MAY-2007 was vaccinated subcutaneous in the right arm with a second dose of VARIVAX (lot # 654522/1154F). there were no illnesses at the time of vaccination. Concomitant vaccines administered on 01-MAY-2007 included: a first intramuscular dose of VAQTA (lot # 656017/1280F) administered in the left arm, a second subcutaneous dose of MMR II administered in the left arm, a fourth intramuscular dose of IPOL (lot # 20324) administered in the right arm and a fifth intramuscular dose of DAPTACEL (lot # 02552AA) administered in the right arm. On 01-MAY-2007 (previously reported as four days after getting the second dose of vaccine) the patient developed a large area of redness and swelling (red swollen arm) - "achyness, 'Lumpy pain', 'vomited'" and a fever of 103.2 per the patient's mom. Unspecified medical attention was sought. At the time of reporting the patient's status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a health professional concerning a 7 year old male who on 14-FEB-2002 was vaccinated with varicella virus vaccine live (Oka/Merck). On 18-APR-2007 the patient developed varicella with less than 50 lesions. Subsequently, the patient recovered. No product quality complaint was involved. This is one of several reports received from the same source. Further information has been requested. Follow-up information received from a registered nurse states no further information is available about this case.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male who on 01-MAY-2000 was vaccinated with varicella virus vaccine live (Oka/Merck). On 07-APR-2007 the patient experienced varicella, 50-500 lesions. At the time of reporting, the patient had recovered, on an unspecified date, from varicella 50-500 lesions. No further information is available.
Age: 1.9
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old male who on 09-NOV-1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 08-APR-2007, the patient developed varicella (50-500 lesions). At the time of reporting, the patient recovered, on an unspecified date, from varicella (50-500 lesions). No further information is available.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 6 year old who on 13-JUN-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). On 24-FEB-2007 the patient developed varicella, 50-500 lesions. At the time of reporting, the patient had recovered, on an unspecified date, from varicella 50-500 lesions. No further information is available.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 7-year-old female who on 12-FEB-2007 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 24-FEB-2007, the patient experienced 50-500 varicella lesions. No medical attention was sought. On an unspecified date, the patient recovered. This is on of several reports from the same source. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 6-year-old male who on 28-JAN-2002 was vaccinated with a dose of VARIVAX. On 07-FEB-2007 the patient experienced less than 50 varicella lesions. On 07-FEB-2007 the patient experienced less than 50 varicella lesions. No medical attention was sought. On an unspecified date, the patient recovered. This is one of several reports from the same source. Additional information is not expected.
Age: 1.1
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 7-year-old male, in which it was unknown if there were any preexisting allergies, birth defects or medical conditions, who on 21-JAN-2001 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It is unknown if there were any illnesses at the time of vaccination. On 19-APR-2007, the patient experienced less than 50 varicella lesions. No medical attention was sought. On an unspecified date, the patient recovered. This is one of several reports from the same source. No more information is expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old male who on 07-AUG-2003 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 07-JAN-2007, the patient developed varicella with less than 50 lesions. On an unspecified date the patient recovered. This is one of several reports from the same source. Follow up information was received from the registered nurse who reported that no further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Eye swelling, Face oedema, Rash, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 9 year old male, with no medical history and no allergies, who on 15-JAN-1999 was vaccinated subcutaneously with a first dose of varicella virus vaccine live (Oka/Merck) in the left arm. On Monday, 21-MAY-2007, at 14:30, the patient received a second subcutaneous dose into the left arm of varicella virus vaccine live (Oka/Merck) (Lot # 656821/0174U). The patient had headaches and contact dermatitis at the time of vaccination. There was no concomitant medication. On 21 MAY 07, the patient had a rash on his arm, neck and face for which Benadryl was prescribed. The development was unknown since there was a contact dermatitis prior to the vaccination with varicella virus vaccine live (Oka/Merck). On 23 May 07, the parent contacted the office, and indicated the patient's face and eyes ere swollen, and neck was red. Previously prescribed Benadryl hand not been given. The patient was seen in the emergency room for marked edema about the face, particularly the periorbital area, mild erythematous rash to the forehead, and an extensive macular papular erythematous rash over the anterior and lateral neck. Some linear excoriation and linear vesicular-type lesions were also present over the left side of the neck, and right upper extremity. The patient was treated with an oral dose of Orapred as well as a dose of Benadryl. The patient was discharged in stable condition with a provisional diagnosis of contact dermatitis, probable poison ivy exposure. A tapered dose of steroids and Benadryl elixir were prescribed. At the time of reporting the outcome was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Bacterial culture negative, Body temperature increased, Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received from a health professional concerning a 10 or 11 year old child who was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot 657192/0362U# or 656821/0174U). Two days post vaccination, the patient presented to the clinic with an erythematous, very large (size of a baseball) swelling at the injection site (site unknown). A culture test was performed which was negative for bacteria. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality was involved. This is report 2 of 3. Additional information has been requested. Follow-up information received from nurse indicating that the patient received a vaccination of varicella virus vaccine live (Oka/Merck) (656823/0305U) also reported as (lot 657192/0362U# or 656821/0174U) on 27-Apr-2007 sub cutaneous in the right arm and also received a PPD (lot# LC2246AA) intradermal in the left forearm at physical on 24-Apr-2007 and returned to the clinic on 26-Apr-2007 with a red-large blister at the injection site. 12 cm x 12 cm - red raised, warm 3 1/2 x 2 cm blister in the center. The patient was started on K-flex 500 mg capsule twice daily for 10 days, motrin 1 PRN and tylenol 1 PRN. The patient complained of stomach pain at the time of vaccination and has a history of GERD and "NRMA". Patient had a temperature of 100.9 F. after the vaccination on 25-Apr-2007.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Information has been received from a health professional concerning a 10 or 11 year old child who was vaccinated with a 0.5ml dose of varicella virus vaccine live (Oka/Merck) (lot 657192/0362U# or 656821/0174U). Two days post vaccination, the patient presented to the clinic with an erythematous, very large (size of a baseball) swelling at the injection site (site unknown). A culture test was performed which was negative for bacteria. Subsequently, the patient recovered. Unspecified medical attention was sought. No product quality was involved. This is report 2 of 3. Additional information has been requested. Follow-up information received from nurse indicating that the patient received a vaccination of varicella virus vaccine live (Oka/Merck) (656823/0305U) also reported as (lot 657192/0362U# or 656821/0174U) on 27-Apr-2007 sub cutaneous in the right arm and also received a PPD (lot# LC2246AA) intradermal in the left forearm at physical on 24-Apr-2007 and returned to the clinic on 26-Apr-2007 with a red-large blister at the injection site. 12 cm x 12 cm - red raised, warm 3 1/2 x 2 cm blister in the center. The patient was started on K-flex 500 mg capsule twice daily for 10 days, motrin 1 PRN and tylenol 1 PRN. The patient complained of stomach pain at the time of vaccination and has a history of GERD and "NRMA". Patient had a temperature of 100.9 F. after the vaccination on 25-Apr-2007.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Injection site discomfort, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old female (previously reported as male) who on 03-MAY-2007 was vaccinated SC with a second dose of varicella virus vaccine live (Oka/Merck) (Lot#656122/1309F). Additional suspect vaccination included an IM first dose of Gardasil (Lot# 657622/0388U). Subsequently the patient developed a raised welt, swelling and discomfort at the injection site which was the size of a softball. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information is not expected. This is one of several reports from the same source.
Age: 11.0
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Facial palsy, Hypoaesthesia facial, Paraesthesia
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male who on 31-MAY-2007 was vaccinated SC on left arm subcutaneously, with first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (Lot # 656259/1509F). Concomitant therapy included IM first dose on left deltoid of diphtheria toxoid (+) pertussis acellular vaccine (Sanofi Pasteur) (+) tetanus toxoid (Lot # C2688AA). On 31-MAY-2007 the patient experienced tingling along left jaw line, droopiness of face and transient numbness of left jaw line. Symptoms occurred 15 minutes after administration of his first dose. Forty minutes after administration, the numbness had resolved but there was residual tingling. The patient sought unspecified medical attention. A product quality complaint was not involved. Current status of the patient is unknown. Additional information has been received from the registered nurse who stated that on 31-MAY-2007 at 14:00 PM the patient experienced numbness and tingling along the left side of jawline within 15 minutes of receiving vaccines. The patient also described a feeling of "droopiness" on left side of face. All symptoms resolved within hours. The patient recovered on the same date. No further information is expected.
Sex: F
Vaccine: VARCEL
Symptoms: Genital rash, Laboratory test, Rash, Vaccination failure, Varicella
Clinical narrative: Information has been received from a consumer concerning his daughter, who was one of seven children in grades 1 and 2 (combined) who reportedly had a chickenpox, including her daughter. The reporter noted that her daughter had been previously vaccinated with VARIVAX on an unspecified date. In December 2006, the daughter developed a papular rash on her face, trunk, back and genitalia, which was confusingly not vesicular, but in different stages. The rash first appeared on her daughter around Christmas. At the time of this report the rash had not shown any scabs. His daughter was afebrile, active, and felt perfectly fine otherwise. The reporter communicated she felt that clearly there seems to be some failure of the vaccine suggesting the need for a booster or another wild variant strain not covered by the vaccine. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Information has been received from a reporter concerning an 8 year old female who on 05-JUN-2007 was vaccinated with a subcutaneous dose of varicella virus vaccine live (Oka/Merck) in the left arm (Lot # 656569/0114U). In the morning of 07-JUN-2007, 48 hours post vaccination, the patient developed left arm light induration and redness. No medical attention was sought. At the time of this report, the outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Erythema, Pruritus, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 5-year-old male with no pertinent medical history and no previous drug reactions/allergies who on 14-JUN-2002 was vaccinated subcutaneously with his first dose of 0.5 ml of VARIVAX (Oka/Merck) "(Lot # 639373/1206L)".  Concomitant therapy included acyclovir, 200 mg daily for five days.  On 24-JAN-2007, eighteen hours post vaccination, the patient was seen in the doctor's office with a rash on his face and complaints of itching.  The varicella rash was described as having less than 50 lesions on his neck face, trunk and legs.  The lesions on his neck, face, and trunk were erythematous papules; the lesions on his legs are tiny clear vesicles.  The patient was afebrile.  Unspecified medical attention was sought.  No laboratory or diagnostic testing was performed.  There was no product complaint involved.  The patient reportedly recovered on 26 JAN 2007.  Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Erythema, Pruritus, Rash generalised, Rash papular
Clinical narrative: Information has been received from a health professional concerning a 6-year-old female with reactive airway disease, with no history of drug reactions or allergies, who on 17-JUL-2001 (Lot # 635451/1143K) and 23-AUG-2003 was vaccinated intramuscularly with the first and second doses of varicella virus vaccine live (Oka/Merck). Concomitant therapy included albuterol inhaler. ON 28-JAN-2007, the patient experienced approximately 50 lesions on her body. It was noted that the patient's father recently had chickenpox. On 29-JAN-2007, the patient was seen in the doctor's office for an itchy rash she developed the previous day. The rash started on her chest and progressed to her face and back. The parent reported that she had a low grade temperature, which when measured was 99.9, while in the office. The patient had 60-70 red papules on her face, chest, back arms and legs. Several scabbed areas over some vesicular. The patient was sent home to isolation. The patient was prescribed symptomatic relief with baths and Tylenol. No laboratory or diagnostic studies were performed. The outcome was unknown at the time of this report. there was no product quality complaint involved. Additional information is not expected.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Vaccination failure
Clinical narrative: Information has been received from a health professional concerning a 6-year-old female with reactive airway disease, with no history of drug reactions or allergies, who on 17-JUL-2001 (Lot # 635451/1143K) and 23-AUG-2003 was vaccinated intramuscularly with the first and second doses of varicella virus vaccine live (Oka/Merck). Concomitant therapy included albuterol inhaler. ON 28-JAN-2007, the patient experienced approximately 50 lesions on her body. It was noted that the patient's father recently had chickenpox. On 29-JAN-2007, the patient was seen in the doctor's office for an itchy rash she developed the previous day. The rash started on her chest and progressed to her face and back. The parent reported that she had a low grade temperature, which when measured was 99.9, while in the office. The patient had 60-70 red papules on her face, chest, back arms and legs. Several scabbed areas over some vesicular. The patient was sent home to isolation. The patient was prescribed symptomatic relief with baths and Tylenol. No laboratory or diagnostic studies were performed. The outcome was unknown at the time of this report. there was no product quality complaint involved. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Skin lesion, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 55 year old female who on 26-JAN-2007 was vaccinated with a dose (0.5 ml) of varicella virus vaccine live (lot # 654083/0917F) (Oka/Merck). There was no concomitant medication. On approximately 30-JAN-2007, "about four days after receiving injection" the patient experienced redness and swelling. On 16-FEB-2007 the patient experienced broke out with 50 or less lesions after receiving varicella virus vaccine live. The patient's redness and swelling and lesions persisted. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information received from the registered nurse indicating that the patient's age is actually 55 years old. No further information is available.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Erythema, Incorrect route of drug administration, Pruritus, Pyrexia
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white male with a concurrent condition of attention Deficit Hyperactivity Disorder (ADHD), with no reported drug reaction or allergies, who on 24-November-1998 was vaccinated with a first 0.5 ml dose intramuscularly with VARIVAX (Lot Number 626959/0846H). Concomitant therapy that day included a first MMR II, which was also administered on 24-November-1998, and FOCALIN and STRATTERA. on 21-February-2007, the patient developed chickenpox, including red lesions on the chest and back, along with a temperature of 101 F. The patient's was not recovered at the time of this report. Unspecified medical attention was sought. Follow up information indicated that on 21-FEB-2007 the patient developed red lesions on his chest and back for one week. There were scabbing over and his skin was sensitive and itching. He was treated with acyclovir 400mg TID. The outcome was recovered. The reporter considered the event to be an other important medical event. There was no product quality complaint. No additional information is expected.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Scab, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 9 year old white male with a concurrent condition of attention Deficit Hyperactivity Disorder (ADHD), with no reported drug reaction or allergies, who on 24-November-1998 was vaccinated with a first 0.5 ml dose intramuscularly with VARIVAX (Lot Number 626959/0846H). Concomitant therapy that day included a first MMR II, which was also administered on 24-November-1998, and FOCALIN and STRATTERA. on 21-February-2007, the patient developed chickenpox, including red lesions on the chest and back, along with a temperature of 101 F. The patient's was not recovered at the time of this report. Unspecified medical attention was sought. Follow up information indicated that on 21-FEB-2007 the patient developed red lesions on his chest and back for one week. There were scabbing over and his skin was sensitive and itching. He was treated with acyclovir 400mg TID. The outcome was recovered. The reporter considered the event to be an other important medical event. There was no product quality complaint. No additional information is expected.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Rubella antibody negative, Scab, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a 13 year old male, with no prior history of chicken pox nor been vaccinated.  A titer was done on 28-January-2007 which showed no immunity.  On 05-February-2007 the child was vaccinated subcutaneously at 16:30; with a first dose of VARIVAX (Lot # 654750/1256F).  The child had no prior medical history or allergies and no illness at the time of vaccination.  The patient developed what was considered to be a mild case of breakthrough (less than 50 lesions), varicella type rash on 20-FEB-2007 at 17:00.  On 21-February-2007 child was seen by the physician, and was said to have new lesions appearing and some crusted over.  Unspecified medical attention was sought.  There was no product quality complaint.  The patient recovered on 01-Mar-2007.  No further information is expected.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Lethargy, Otitis media, Otorrhoea, Pyrexia
Clinical narrative: Information has been received from a registered nurse (RN) concerning, who breast fed her daughter, a 14 month old female with no pertinent medical history, drug reaction or allergies who on 16-JAN-2007 was vaccinated subcutaneously with 0.5 ml of varicella virus vaccine live (Oka/Merck) (Lot # 652871/0430F). On approximately 01-FEB-2007, 29 days after being vaccinated, the patient developed a low temperature of 97.1 F rectally, with lethargy and clear fluid discharge from the right ear canal. On 10-FEB-2007, nine days later, the patient became febrile with an axillary temperature of 102.2 F and was subsequently diagnosed with otitis media. The patient was first treated with amoxicillin, followed by augementin. At the time of the report, the otitis media was considered to be resolving. There was no concomitant therapy. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. The nurse also noted that she is currently breastfeeding her daughter, and developed a widespread red, itchy rash on 25 FEB 2007. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination failure, Viral skin infection
Clinical narrative: Information has been received from a registered nurse concerning a child who was vaccinated with varicella virus vaccine live (Oka/Merk).Subsequently the patient developed lesions starting in the hairline, face, chest and abdomen. The child was diagnosed with a viral rash, but the nurse believed that it was chickenpox. As of 05-DEC-2006, the patient had not recovered. The registered nurse also reported on other childrens' experiences with varicella virus vaccine live (Oka/Merck) (WAES#6012USA00711). No additional information is expected.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site vesicles, Pruritus, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 25-MAY-2007 was vaccinated subcutaneously into the left deltoid with a "single vial", second dose of varicella virus vaccine live (Oka/Merck) (Lot #656071/0110U). Concomitant therapy included hepatitis A vaccine (inactive) (HAVRIX). On 19-JUN-2007 the patient was seen in the physician office due to the development of approximately 20-30 red itchy spots both legs, which were reported to be maculopapular. It was noted at that visit that the patient also had 6 lesions, which appeared vesicular, at injection site. The patient was treated with acyclovir 200mg over 5 ml (1 tsp twice daily for seven days). At the time of reporting the patient's outcome was not reported. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 7 year old female with an allergy to penicillin and CEFZIL and no medical history who on 11-JUN-2007 was vaccinated with a second 0.5ml subcutaneous dose of VARIVAX (Lot# 656692/0457U).  The date of the initial dose was unspecified and there was no documented reaction to the first dose.  There were no concomitant medications.  On 11-JUN-2007, 30 minutes post vaccination, the patient developed an injection area reaction that was 2 by 1 centimeters with scattered flat redness.  The patient was given BENADRYL and ORAPRED while in the office.  The patient's mother reported that the patient was doing better on 14-JUN-2007.  At the time of this report, the patient was recovering.  No further information was available.  No product quality complaint was involved.  This is patient 2 of 3.  A lot check has been requested.  The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory.  The lot met the requirements of the Center for Biologics Evaluation and Research and was released.  Additional information has been requested.  Follow-up information received from a registered nurse stated that the patient was vaccinated with VARIVAX in the left deltoid.  The patient was discharged from the office, alert and without signs of shortness of breath.  The patient is considered recovered.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male patient with an allergy to penicillin and no medical history who on 11-JUN-2007 was vaccinated with a second 0.5 mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 656692/0457U). There were no concomitant medications. The date of the initial dose was unspecified and there was no documented reaction to the first dose. The patient developed a 4X4 area that was red and swollen 30 minutes post vaccination at the injection site. The patient was treat with Benadryl and Orapred. The patient did not respond to the treatment and was seen by the physician on 14-JUN-2007 because the area remained red and swollen and was also now hot. The patient was prescribed a five day course of an unspecified antibiotic on 14-JUN-2007. No further information was available. No product quality complaint was involved. This is patient 1 of 3. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. Follow-up information received from a registered nurse stated that the patient was vaccinated with varicella virus vaccine live in the left deltoid. The outcome is unknown.
Age: 10.0
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 female patient with no medical history and no allergies,  who on 11-JUN-2007 was vaccinated with a second 0.5mL subcutaneous dose of varicella virus vaccine live (Oka/Merck) (lot #656692/0457U). There were no concomitant medications. There was no documented reaction to the first dose and the date of this dose was unspecified. The patient developed a reaction after receiving varicella virus vaccine live (Oka/Merck) with a 2 X 1/2 by 4 centimeter area at the injection site that was swollen, red, hot and hard. The patient was treated with warm compresses on 13-JUN-2007 and will be seen by the physician today, 14-JUN-2007. There were no laboratory or diagnostic tests performed. No further information was available. No product quality complaint was involved. This is patient 3 of 3. A lot check has been requested. The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information received from a registered nurse stated that the patient was vaccinated with varicella virus vaccine live (Oka/Merck) in the left deltoid. The patient had a 2/1/2 X 4 swollen area that was red, swollen, hot, hard at the injection site starting 13-JUN-2007. The patient was seen in the office on 14-JUN-2007 and the area was 9 X 5 1/2. The outcome is unknown.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Pruritus
Clinical narrative: Information has been received from a physician concerning a healthy 16-year-old male who on 14-JUN-2007 was vaccinated subcutaneously in the left arm with his second dose of 0.5 milliliters of VARIVAX (lot# "04574").  His first dose was on 08-Feb-1996.  On 17-JUN-2007 the patient developed shingles on the left side of his neck with mild itching.  He did not have a fever or any pain.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: Information has been received from a health professional concerning a 4 year old female who on 21-MAR-2005 was vaccinated with varicella virus vaccine live (Oka/Merck). On 19-JUL-2007, the patient experienced a breakthrough disease varicella, severity 1-less than 50 spots counted in 30 seconds. Medical attention was sought. The patient recovered from varicella. No product quality complaint was involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4, MEN, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a healthcare employee concerning an 18 year old female who on 08-MAY-2007 was vaccinated with VARIVAX (Lot # 656078/0169U).  Concomitant vaccine therapy administered at the same time included a first dose of GARDASIL.  On 08-MAY-2007 the patient developed a local injection site reaction in the arm with swelling and redness.  Symptoms resolved without any treatment.  No other information was available at the time of this report.  Unspecified medical attention was sought.  No product quality complaint was sought.  Additional information has been requested.  Follow-up information received from a certified medical assistant stated that on 08-MAY-2007, the patient was vaccinated with a second subcutaneous dose of VARIVAX in the upper left arm.  A first intramuscular dose of GARDASIL (Lot # 657006/0188U) was given in the left deltoid.  A first subcutaneous dose of MENOMUNE (Lot # U2278AA) was given in the upper right arm on 08-MAY-2007.  The patient stated that her arms hurt the day of injection, 08-MAY-2007 and then redness and swelling appeared on 09-MAY-2007 which lasted until 13-MAY-2007.  The patient was seen on 11-MAY-2007 and the redness was approximately a quarter size.  Subsequently, the patient recovered.
Age: 14.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Induration, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 14 year old female student with no medical history or allergies, who on 25-JUN-2007 at 13:12, was vaccinated with her second SC dose of varicella virus vaccine live (Oka/Merck) (lot# 657783/0644U) in the right arm. Concomitant vaccination administered that day at 13:12 included a first IM dose of Gardasil vaccine (MDS) (lot# 658094/0524U) in the left arm. There was no illness at the time of vaccination. On 28-JUN-2007, at 14:59 the patient developed a 4-5 cm diameter area of the right arm that was red, hard, and slightly tender for 2 days, with induration 2 cm within, over the right tricep. No medical attention was sought. No labs or diagnostic studies were performed. The patient was reassured and advised to apply an ice pack and take Motrin. Subsequently the patient recovered. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Rash generalised
Clinical narrative: Information has been received from a physician concerning a 10 year old female who on 06-JUL-2007 was vaccinated with VARIVAX (Oka/Merck) (lot no. 657446/0518U).  On 08-JUL-2007 the patient developed a rash all over her body but was mainly concentrated at the injection site.  Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, TDAP, VARCEL
Symptoms: Contusion, Erythema, Nodule, Tenderness
Clinical narrative: Information has been received from a health professional concerning an 11 year old female with no medical history or allergies who on 02-JUL-2007 was vaccinated on left arm with a dose of varicella virus vaccine live (Oka/Merck) (lot # 657715/0609U). The concomitant therapy on the same day included Gardasil (MSD) (Lot # 657737/0522U), and dose of Adacel (lot # C2734AA) and a first dose of hepatitis A virus vaccine inactivated (MSD) (Lot # 657307/0442U). There was no illness at the time of vaccination. On 03-JUL-2007, the patient developed a 2X4 cm nodule that was red and tender. It was reported that the nodule looked like a bruise. On 5-JUL-2007, the patient was recovering. No diagnostic laboratory tests were undertaken. There were no adverse events following prior vaccination. Additional information has been received from the health professional stating the patient developed a 2X4 cm nodule which was red and tender. There was no infection. The patient had recovered on 09-JUL-2007. No further information is expected.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood pressure, Body temperature increased, Cellulitis, Full blood count normal, Heart rate normal
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-year-old male with an allergy to CECLOR and a questionable allergy to amoxicillin with no pertinent medical history, who on 28-JUN-2007 was vaccinated with a subcutaneous 0.5 milliliter booster dose in the left arm of VARIVAX (Oka/Merck) (lot# 657787/0718U).  There was no illness at the time of vaccination.  There were no concomitant medications given.  On 30-JUN-2007 the patient developed a red hard lump on his left arm at the injection site and an upper extremity rash.  He went to the emergency room on 30-Jun-2007 where he was administered one dose of ROCEPHIN and an unspecified steroid.  On 01-Jul-2007 he went back to the emergency room with a temperature of 100.8 degrees Fahrenheit, increased redness and he was diagnosed with cellulitis.  He received another dose of ROCEPHIN and was sent home with AUGMENTIN and ibuprofen for discomfort.  On 02-Jul-2007 his fever was gone and his rash was barely dusty pink.  Laboratory studies performed showed a normal complete blood count and a normal blood chemistry test.  The outcome is reported as recovering.  No product quality complaint was involved.  This is one of two reports from the same reporter.  Follow-up information received on 02-Aug-2007 states that the patient is a 9th grade student who has no past medical history.  On 01-Jul-2007 at 2010 hours the patient went to the emergency room with an oral body temperature of 98.5, blood pressure was 143/98, pulse 98, respiratory rate 20, SaO2 99% on room air and a pain level of 0-1 out of 10.  His initial assessment was normal.  CBC blood results on 30-Jun-2007 and 01-Jul-2007 were normal.  He was discharged at 2245 hours.  The outcome is reported as recovered.  There were no adverse events following prior vaccinations.  No more information is expected.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Laboratory test normal, Oxygen saturation normal
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 14-year-old male with an allergy to CECLOR and a questionable allergy to amoxicillin with no pertinent medical history, who on 28-JUN-2007 was vaccinated with a subcutaneous 0.5 milliliter booster dose in the left arm of VARIVAX (Oka/Merck) (lot# 657787/0718U).  There was no illness at the time of vaccination.  There were no concomitant medications given.  On 30-JUN-2007 the patient developed a red hard lump on his left arm at the injection site and an upper extremity rash.  He went to the emergency room on 30-Jun-2007 where he was administered one dose of ROCEPHIN and an unspecified steroid.  On 01-Jul-2007 he went back to the emergency room with a temperature of 100.8 degrees Fahrenheit, increased redness and he was diagnosed with cellulitis.  He received another dose of ROCEPHIN and was sent home with AUGMENTIN and ibuprofen for discomfort.  On 02-Jul-2007 his fever was gone and his rash was barely dusty pink.  Laboratory studies performed showed a normal complete blood count and a normal blood chemistry test.  The outcome is reported as recovering.  No product quality complaint was involved.  This is one of two reports from the same reporter.  Follow-up information received on 02-Aug-2007 states that the patient is a 9th grade student who has no past medical history.  On 01-Jul-2007 at 2010 hours the patient went to the emergency room with an oral body temperature of 98.5, blood pressure was 143/98, pulse 98, respiratory rate 20, SaO2 99% on room air and a pain level of 0-1 out of 10.  His initial assessment was normal.  CBC blood results on 30-Jun-2007 and 01-Jul-2007 were normal.  He was discharged at 2245 hours.  The outcome is reported as recovered.  There were no adverse events following prior vaccinations.  No more information is expected.