chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old female who was vaccinated with VARIVAX (Oka/Merck). The patient reported that the "patient was diagnosed with breakthrough chicken pox after receiving VARIVAX when she was one year old". It was not reported if the patient sought medical attention or not  this is one of several reports from the same source. No further information is available.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Convulsion
Clinical narrative: Information has been received from a physician concerning a 12-month-old patient who was vaccinated with a dose of VARIVAX (Oka/Merck) and eight days later was vaccinated with a dose of MMR II. It was reported that the child has been experiencing seizures. It was unknown if the child had any seizures prior to the vaccines. It was also reported that the child had developmental problems prior to the vaccination. Medical attention was sought via a phone call. The outcome was not reported. No product quality complaint was involved. Upon internal review seizures was considered to be other important medical event. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 12 year old 104 lb. 55 in. female who on 03-Oct-1996 at the age of 12 months, was vaccinated with the VARIVAX (Oka/Merck). On 29-Feb-2008, the patient developed breakthrough chicken pox after vaccination of approximately 50 lesions. There were no revenlant diagnostic and or laboratory studies performed. In March 2008 (day unspecified), the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Clinical narrative: Information has been received from a physician concerning a 12 month old male who on 26-Feb-2008 was vaccinated subcutaneously with 0.5ml of VARIVAX (Oka/Merck). On 14-March-2008 the patient developed chickenpox. The patient had less than fifty lesions and they were mostly on his scalp and trunk. At the time of reporting the patient had recovered, date unspecified. Unspecified medical attention was sought, which included an office visit. There was no product quality complaint. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a nurse concerning a 45 year old, non-pregnant female physician with probable recurrent exposures to wild type disease (patient is pediatrician), no significant past medical history, denied immunocompromise, cancer, and history of chickenpox at approximately 4 years of age, who on 26-MAR-2008 had a small amount of VARIVAX (dose and lot number not provided) splashed in her right eye. There was no concomitant medication. The eye was flushed with sterile saline solution, and the physician complained of burning a little bit. No other symptoms were reported. It was unknown if the physician sought medical attention. There was no product quality complaint. Additional information has been requested.
Age: 1.1
Sex: M
Vaccine: VARCEL
Clinical narrative: Information has been received from a health department registered nurse who received information from the patient's mother concerning a 7 year old male with no pertinent medical history and no drug reactions/ allergies who on 16-NOV-2001 was vaccinated subcutaneous in right arm with a first dose of VARIVAX (lot# 638245/0779L). There was no concomitant medication. On 17-MAR-2008 the patient developed chickenpox. The patient was evaluated by an unspecified physician and no treatment was prescribed. No specific symptoms or treatment was reported. Unspecified medical attention was sought with an office visit. The product quality complaint unit was not involved. This is one of several reports that was received from the same source. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: HEPA, IPV, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an approximately 5 year old female patient with no medical history who was vaccinated with a dose of VARIVAX (Merck), injection (lot number 659698/1770U, dose not provided). Concomitant therapy included DTaP, HAVRIX and poliovirus vaccine. The patient received VARIVAX (Merck) and later her left upper arm became red and warm to the touch. The patient also complained of itching at the site. The site of injection was 4 centimeters round and swollen. No complaint of fever or pain was reported. There was no quality complaint. Additional information was requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old male child with no known allergies or pertinent medical history who on 18-NOV-1999 was vaccinated with a first dose of VARIVAX (Oka/Merck).  There was no concomitant medication.  Subsequently, on 20-MAR-2008 the patient developed chickenpox.  Medical attention was sought, the patient was seen by the physician.  There were no lab studies performed.  At the time of the report the patient was recovering.  It was noted that it was not known if the patient received a second dose of VARIVAX (Oka/Merck) because the vaccine was administered at a different practice.  The was no product quality complaint involved.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Similar reaction on previous exposure to drug, Skin lesion
Clinical narrative: Information has been received from a nurse concerning a 3 year old boy with no pertinent medical history and no history of drug reactions or allergies who 2 years ago (in approximately March 2006), was vaccinated with one dose of VARIVAX (Oka/Merck) at another facility than the reporter's facility. There was no concomitant medication. On 20-MAR-2008 the patient developed widespread red lesions. The nurse stated the diagnosis may be possible chickenpox. No treatment has been recommended. As of 26-MAR-2008 the patient's chickenpox persisted. The patient's mother also mentioned her daughter received one dose of VARIVAX (Oka/Merck) in 2002 and developed "a few red bumps on her buttocks". (Refer to WAES# 0805USA01256.) No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Haemorrhage, Injection site rash, Injection site scar, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her daughter with no known drug allergies or pertinent medical history who "sometime during the week of 17-FEB-2008" was vaccinated with VARIVAX (Oka/Merck). There was no concomitant medication. Subsequently, 2 days after vaccination on approximately 21-FEB-2008 the patient developed a rash and swelling around the injection site. A week after, on approximately 28-FEB-2008 bloody blisters appeared. At the end of the week, the child had about 10-12 chickenpox vesicles and "puck marks." She developed a Scar on or around the injection site. Medical attention was sought, the was seen at the office. There were no labs studies performed. It was reported that the patient recovered 3 weeks after vaccination, on approximately 09-MAR-2008. There was no product quality complaint involved. Additional information has been requested.
Age: 1.1
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 13 month old patient who on 17-MAR-2008 was vaccinated with VARIVAX (Merck). The patient was given VARIVAX (Merck) in the thigh (right side). Eight days after vaccination the patient presented red & swollen thigh (right side). The patient sought medical attention and came to see physician. As the time of repot the patient was improving. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Clinical narrative: Information has been received from a consumer concerning a 12 year old male with Penicillin allergy and a history of chickenpox who on 11-March-2008 was vaccinated with VARIVAX (Oka/Merck). Concomitant therapy included MENACTRA and diphtheria toxoid + pertussis vaccine + tetanus toxoid (unspecified) tetanus toxoid. The patient was previously vaccinated on 06-Mar-1997 with VARIVAX (Oka/Merck). The patient met his grandmother who is immunocompromised and has lymphoma on 14-Mar-2008 and she developed nerve pain and shingles on 18-March-2008. The experiences of the 12 year old male are documented in WAES#0803USA05043. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a nurse concerning a female who in 2002 was vaccinated with one dose of VARIVAX (Merck). The patient's mother reported to the nurse that subsequently her daughter developed "a few red bumps on her buttocks". The nurse did not examine the patient. The patient's outcome was not reported. The nurse also reported that the patient's brother developed widespread red lesions after receiving one dose of VARIVAX (Merck) in 2006. (Refer to WAES # 0803USA04509.) No further information is available.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a licensed vocational nurse concerning a 39 month old female who on 25-FEB-2008 was vaccinated with the first dose of VARIVAX (Merck) (lot #659351/1775U) 0.5 ml via subcutaneous administration. The patient was experiencing ear infection when vaccine was given. On 11-MAR-2008 the patient experienced an injection site reaction, had a red indurated area. The patient sought medical attention by speaking with the nurse. Subsequently, the patient recovered. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from an advanced practice registered nurse concerning a 78 year old postmenopausal female, weight 142lb, height 59.5 inches, with osteoarthritis, hearing deficit (left), hypertension, incontinence and cholesterolaemia who on 29-JAN-2008 was vaccinated in the arm with the second dose of VARIVAX (Merck) (lot# 659154/1495U) instead of zoster vaccine live (Merck) by mistake.  Concomitant therapy included LIPITOR, OXYBUTYNIN, ASPIRIN, "OCCIVIT", multi-vitamins and LISINOPRIL-HCTZ (MSD).  The reporter stated the error may have due to a storage issue because the products were stored in the same bag in the freezer.  This was not a product confusion.  As of 19-JUN-2008, no adverse events were noted.  Additional information is not expected.
Age: 1.0
Sex: M
Vaccine: FLUX, VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 18 month old male who on 08-OCT-2007 was vaccinated in right arm subcutaneously with a dose of VARIVAX (Merck, lot #658378/1122U). Concomitant therapy included an unspecified influenza shot received at the same time of VARIVAX. The physician said that VARIVAX was a vaccine failure: Physician states that the patient's parents mentioned that the child had a rash since 23-APR-2008. The rash was getting better as of the report date. Upon inspection, the physician thought it looked like simple dermatitis; however, it was unilateral but in unilateral dermatome across the chest which lead the physician to believe that the patient experienced shingles. The patient had not been clinically exposed to chicken pox that the physician knew of but he felt that the patient must had been exposed unknowingly and had a subclinical case. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 15 month old patient who was vaccinated IM with a first dose of VARIVAX. Concomitant therapy within the same visit included MMR vaccine. Within 24 hours post vaccination, the patient developed a fever of 103 and experienced redness swelling at site of injection. Unspecified medical attention was sought. Subsequently, the patient recovered from the events; it was noted "cleared on its own". Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old female patient who on 24-MAR-2008 was vaccinated SQ with a fourth dose of 0.5 of VARIVAX (Merck) (lot # 659351/1775U) at 10:26 AM. Subsequently, on 26-MAR-2008 the patient developed vesicles and also a red, warm, swollen injection site from the vaccination. Medical attention was sought, the family spoke to the nurse. It was unspecified if lab studies were performed. The patient was treated with BENADRYL. At the time of the report the patient was recovering. There was no product quality complaint involved. This is one of several reports from the same source. Follow up information has been received from the pediatrician's office. The onset date of the adverse events were reported as 25-MAR-2008 at 11:40 AM. The reporter provided the following information: itching, pain, swelling and warmth at injection site. The initial area of reaction measured 8 cm X 8 cm and was reduced to 4.25 cm of erythema and mild induration on "24-MAR-2008". There were no vesicles. There were no illnesses at time of vaccination and there were no lab tests performed. The adverse events were recovered on 30-MAR-2008. There was no mention of outcome of pruritis. No further information is available.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old female patient who on 24-MAR-2008 was vaccinated SQ with a fourth dose of 0.5 of VARIVAX (Merck) (lot # 659351/1775U) at 10:26 AM. Subsequently, on 26-MAR-2008 the patient developed vesicles and also a red, warm, swollen injection site from the vaccination. Medical attention was sought, the family spoke to the nurse. It was unspecified if lab studies were performed. The patient was treated with BENADRYL. At the time of the report the patient was recovering. There was no product quality complaint involved. This is one of several reports from the same source. Follow up information has been received from the pediatrician's office. The onset date of the adverse events were reported as 25-MAR-2008 at 11:40 AM. The reporter provided the following information: itching, pain, swelling and warmth at injection site. The initial area of reaction measured 8 cm X 8 cm and was reduced to 4.25 cm of erythema and mild induration on "24-MAR-2008". There were no vesicles. There were no illnesses at time of vaccination and there were no lab tests performed. The adverse events were recovered on 30-MAR-2008. There was no mention of outcome of pruritis. No further information is available.
Age: 1.5
Sex: F
Vaccine: VARCEL
Clinical narrative: Information has been received from a physician concerning a 17 month old female who two months ago, in March 2008, was vaccinated with VARIVAX (Oka/Merck). Subsequently the patient experienced a rash on the upper arm which extended to the neck. The rash presented on the same arm used to administer the vaccine. Shingles had not been ruled out as the cause of the rash. Subsequently, the patient had recovered from the rash. The patient sought medical attention by physician office visit. There was no product quality complaint. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a nurse concerning a 13 year old female who on 21-FEB-2008 was vaccinated with the second dose of VARIVAX, 0.5 ml subcutaneously (SC) (Lot #659351/1775U). On 26-FEB-2008, the patient presented with a red indurated reaction at the injection site and also the upper area of the arm. There were no vesicles present. The patient recovered on an unspecified date. The consumer contacted the physician. Follow up information was from a registered pharmacist reported that the patient with seasonal allergies who was vaccinated with a booster dose of VARIVAX, 0.5 "mg" subcutaneously (SC) (Lot #659351/1775U, expire date 06-NOV-2009). "7 days later", on 28-FEB-2008 (previously reported at 26-FEB-2008) the patient experienced swelling and redness at injection site. No therapy was given. On 02-MAR-2008, the patient recovered. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a patient who on unspecified dates was vaccinated with two doses of VARIVAX (Merck). About eight months after the second dose, the patient developed chicken pox. Subsequently, the patient recovered from chicken pox. The patient sought medical attention (unspecified). Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Dermatitis diaper, Dry skin, Skin discolouration
Clinical narrative: Information has been received from a physician concerning a 12 month old female with no pertinent medical history and no drug reactions/allergies, who on 16-MAR-2008 was vaccinated SC with a 0.5 mL dose of VARIVAX  (Oka/Merck) (lot number: /1493U). There was no concomitant medication. On 26-MAR-2008 the patient had 3 "dots" that were located on the thigh, lower abdomen and in the head. The "dots" are dry. The physician mentioned the patient also had a diaper rash. No further information was available. There was no laboratory diagnostic studies performed. Unspecified medical attention was sought; the patient was seen in office on 27-MAR-2008. The outcome was reported as not recovered. There was no product quality complaint. follow-up information received on 13-MAY-2008 The physician did not remember the name of the patient; he was covering for another physician. The physician did not believe it was chicken pox rash This is one report of several from the same source. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Pharyngitis streptococcal, Rash erythematous, Rash vesicular, Viral infection
Clinical narrative: Information has been received from a consumer concerning her daughter, a 9 year old girl with no known  allergies or pertinent medical history who was vaccinated in the arm with the first dose VARIVAX (Merck) (Lot # not provided) when she was 12 month old.  On 25-APR-2008 the patient was vaccinated in the arm with second dose of VARIVAX (Merck) (Lot # not provided).  There was no concomitant medication.  The very next day the patient was diagnosed with strep throat and was put on therapy with AUGMENTIN which was completed on 04-MAY-2008.  That is when the patient's spots began.  The reporter stated "the spots looked like mosquito bit bumps, with raised read heads that are now turning a yellowish color.  These bumps were very red, painful, and stung.  On the 4th day the bumps or rash were spreading to the child's sides around to her back."  The patient sought medical attention.  She was seen at the doctor office on 07-MAY-2008 for follow up.  Diagnosis was "virus" and one nurse told the reporter it "looks like chicken pox".  The patien'ts treatment was "HYPOXYX" which the reporter said "is not working".  As the time of report, the patient didn't recover from the spots.  The reporter questioned if the patient should be seen by a dermatologist and stated she would call the doctor office again.  No further information is available.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a male who's son on 16-MAR-2008 was vaccinated with a dose of VARIVAX (Merck). The patient's father had shingles. No further information was available. There was no product quality complaint. This is one report of several from the same source. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning a male patient who developed varicella and secondary transmission from his son, who had been vaccinated with VARIVAX (Oka/Merck) and developed shingles (WAES# 0805USA00862). The physician noted "the child's father has now developed chickenpox and that samples from him are also being tested".
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Malaise, Pruritus, Urticaria
Clinical narrative: Information has been received from a consumer concerning a 12 year old male with penicillin allergy and a history of chickenpox who on 11-MAR-2008 was vaccinated with VARIVAX. Concomitant therapy included MENACTRA and DTAP (+) Tetanus toxiod. The patient was previously vaccinated on 06-Mar-1997 with VARIVAX. On 24-MAR-2008, the patient did "not feel well", and on 26-MAR-2008, the patient developed white oblong shape very itchy hives that went away with Benadryl. At the time of this report, the patient was recovering from hives. The consumer talked with the physician. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash macular
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 5 year old male with a soy allergy and no pertinent medical history who on 08-May-2008, was vaccinated SQ with a second dose of VARIVAX (Merck) (lot #659937/1789U). On 09-MAY-2008 the patient developed red blotches on his face after vaccination with VARIVAX (Merck). Medical attention was sought, the patient was seen by the nurse practitioner. No lab diagnostics were performed. The patient is recovering of blotches on his face. Follow-up information has been received on 12-JUN-2008 from a registered nurse (R.N.). She reported that the event was not related to VARIVAX (Merck). Additional information is not expected.
Age: 1.8
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Varicella
Clinical narrative: Information has been received from a grandmother concerning her 21 month old grandson with eczema who was vaccinated with a second dose of VARIVAX (Merck). The grandmother reported that on 10-MAY-2008, her grandson had developed a fever and a few red spots and the child's mother thought it was rosiola. The grandmother reported that on 11-MAY-2008 the patient had developed big red spots. The child was taken to his physician's office on 12-MAY-2008 and was diagnosed with chicken pox, which had not scabbed over. At the time of the report the patient had not recovered. No further information is available.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a 7 year old female who on approximately 14-MAR-2008 was vaccinated with a second dose of VARIVAX (Merck).  Subsequently the patient fainted in the office about 10-15 minutes after receiving her second dose of the vaccine.  No other information was available at the time.  Unspecified medical attention was sought, in the physician's office.  The outcome was reported as recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Neonatal disorder, Pregnancy test positive
Clinical narrative: Information has been received from a registered nurse (R.N.) through a Merck pregnancy registry concerning a 31 year old female with no pertinent medical history or drug reactions/allergies who on 17-MAR-2008 and 05-MAY-2008 was vaccinated with a first and second dose of VARIVAX (Merck) (lot #659725/1661U and #659938/1787U, respectively). There was no concomitant medication. On 11-MAY-2008 the patient had a urine pregnancy test at home and found that she was pregnant. There were no adverse symptoms. Follow up information was received from the physician via questionnaire reported that the patient had 2 previous pregnancies and 2 full-term deliveries. She was given prenatal vitamins during this pregnancy. On 10-DEC-2008 (36 weeks from the last menstrual period) the patient delivered a normal female baby without any congenital anomalies. It was reported that the baby had pre-term respiratory distress syndrome. The physician felt that there was no features related to varicella. Additional information is not expected.
Age: 16.0
Sex: F
Vaccine: VARCEL
Clinical narrative: Information has been received from a health professional concerning a 16 year old female with asthma who on 12-MAR-2008 was vaccinated subcutaneously in the left arm with a second dose of VARIVAX (Merck) (Lot # 659730/1781). There was no illness at the time of vaccination. The date of the first dose was not reported. On 14-MAR-2008 the patient presented with an induration which was approximately 8 cm diameter on her left upper lateral arm, which was warm to the touch, erythema, and tenderness. The patient was treated with Duricef 500 mg PO BID for 10 days for possible cellulitis. The outcome was reported as unknown. No further information is available.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a 34 year old female who was accidentally exposed to VARIVAX (Oka/Merck).   Concomitant therapy included allergy medication as needed.  The patient reported that while her 6 year old daughter was receiving the booster dose of VARIVAX some of the liquid splashed in both of her eyes.  She sought medical attention in the physician's office.  When she returned home and about 1 hour and 45 minutes after the splash into her eyes she was able to remove her contact lenses and flushed her eyes with water.  He eyes had mild burning before and after flushing.  At the time of the report her eyes felt a little irritated, and she was considered to be recovering.  Additional information has been requested.  Associated WAES#0805USA02974.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a first dose of VARIVAX (Merck). The nurse reported that the patient developed a fever and a red swollen arm that lasted for 7 days on the injection site arm following the first vaccination. The nurse practitioner did not have any further information at the time. No other information was reported. Unspecified medical attention was sought, patient returned to the office for second vaccination. There was no product quality complaint. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning an approximately 5 year old female who was vaccinated with a dose a VARIVAX (Oka/Merck). The physician reported that the patient experienced an unknown type of injection site reaction. The patient was treated with antibiotic. At the time of the report the patient was assumed to be recovered because she had not been in contact with the office since. Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male with no pertinent medical history or allergies who on 08-MAY-2008 was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (LOT# 659724/1660U). Secondary suspect vaccination included a dose of MMRII. The nurse reported that on 12-MAY-2008 the patient was experiencing chickenpox. The patient had twenty "red watery" blisters on his back and three blisters on his chest. No diagnostic studies were performed. At the time of the report, the patient had not recovered, and had no blisters on the arms or legs. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old female who in the morning of 17-FEB-2006 was vaccinated with the first dose of VARIVAX (Merck) (lot number:  650223/0426R) 0.5 ml subcutaneously on right arm.  On 22-MAR-2008 the patient developed chickenpox.  The patient had less than 50 lesions in total, and the lesions were limited to the patient's truck and face.  No other symptoms were noted.  Medical attention was sought by phone call to the office.  The outcome was reported as recovered on 27-MAR-2008.  Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: VARCEL
Clinical narrative: Information has been received from a public health nurse concerning a 15 year old female child who in 1999 was vaccinated with her first dose of VARIVAX (Oka/Merck). The child received her second dose of VARIVAX (Oka/Merck) in October 2008. The child developed chickenpox in the first week of January of 2009. The child was seen by a nurse for medical attention. This is one of the 4 children from the same source. One of the 4 children developed 50 to 200 lesions and was prescribed VALTREX. No further information is available.
Age: 7.0
Sex: M
Vaccine: VARCEL
Clinical narrative: Information has been received from a public health nurse concerning a 7 year old male child who in 2002 was vaccinated with her first dose of VARIVAX (Merck). The child received her second dose of VARIVAX (Merck) in October 2008. The child developed chickenpox in the first week of January of 2009. The child was seen by a nurse for medical attention. This is one of the 4 children from the same source. One of the 4 children developed 50 to 200 lesions and was prescribed VALTREX. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a public health nurse concerning a 5 year old female child who in 2004 was vaccinated with her first dose of VARIVAX (Merck). The child received her second dose of VARIVAX (Merck) in November 2008. The child developed chickenpox in the first week of January 2009. The child was seen by a nurse for medical attention. This is one of the 4 children from the same source. One of the 4 children developed 50 to 200 lesions and was prescribed Valtrex. No further information is available.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Registered Nurse concerning a patient who was vaccinated with VARIVAX (Merck) (Lot # not reported) instead of ZOSTAVAX (Merck). Registered Nurse reported this was not a product confusion and that it was an office error. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a patient who on 30-JAN-2009 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). No symptoms reported. This is one of several reports received from the same source. Further information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Reaction to previous exposure to any vaccine, Vomiting
Clinical narrative: Information has been received from a consumer concerning her son with reaction to all vaccines and medications he has received that contain gelatin who in 2001, was vaccinated with VARIVAX (Oka/Merck). The patient experienced vomiting after vaccination. The consumer stated that in 2007 her son had a reaction after he was given "a varicella vaccine". The reporter did not know if it was VARIVAX (Oka/Merck) or not. She said after he received the vaccine, he vomited "a slimy material and air. "This lasted for "a few hour". The patient also experienced an adverse event on MMR II (WAES#0901USA04120). Additional information has been requested.
Age: 1.2
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning a 10 year old male with no medical history who on 14-APR-2000 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 632370/1462J). Secondary suspect therapy included a first dose of MMR II on 14-APR-2000. The two vaccinations were given in different arms. On 28-JAN-2009 the patient experienced chickenpox. The patient came into the physician's office to be diagnosed. No relevant lab tests were performed. It was reported that they are unsure if the patient will be getting the booster of VARIVAX (Oka/Merck). As of 05-FEB-2009, the patient's outcome was unknown. This is one of several reports received from the same source. The patient's sibling also experienced an adverse event following vaccination (WAES # 0902USA00865). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a doctor's front desk employee concerning a friend who had a reaction to VARIVAX (Merck) (lot# not reported). It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Skin lesion, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female with no known medical history and drugs allergies, who on 08-SEP-2005 was vaccinated with a dose of VARIVAX (Merck), subcutaneous. There was no concomitant medication. The patient was exposed to a person who had shingles two weeks ago. On 04-FEB-2009 the patient developed chicken pox. The patient had a fever from 04-FEB-2009 to 05-FEB-2009. The patient was seen on 05-FEB-2009 and it was reported that the patient had about 30 chicken pox lesions scattered on her face and upper torso. The patient was seen again on 06-FEB-2009 for follow up and the nurse mentioned that the patient had more lesions. No laboratories studies performed. The patient sought medical attention through an office visit. At the time of this report that patient had not recovered. Additional information has been requested. Follow up information received on 26-MAR-2009 from the registered nurse stated that it was a student patient with no known medical history and illness at the time of vaccination. The patient received a second dose of VARIVAX (lot # 647958/0068R), subcutaneoulsy into the left arm on 08-SEP-2005. On 04-FEB-2009 at 09:00 the patient developed more than 30 viscles and fever but the reporter stated that this was not an adverse event since the patient was exposed to shingles 2 weeks priot the vaccination. No laboratorties studies performed. The patient required emergency room visit/doctor visit. The patient recovered on 09-FEB-2009. No further information is available.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old female patient, with no known drug reactions/allergies and no pertinent medical history, who on 28-JAN-2009 was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 662374/1405X), 0.5ml, subcutaneously. There was no concomitant medication. The nurse practitioner reported that on 31-JAN-2009, the patient developed a fever followed by a red, painful, itchy rash on her arms and legs that started at the injection site and spread all over her entire body and swelling of her cheeks after receiving her second dose of the vaccine. The rash was decreased as pustules some with a white center. The nurse practitioner reported that the patient was treated with BENADRYL for the symptoms, but the BENADRYL was not helping. She also reported that the rash appeared to be getting worse and did not appear to be the chickenpox. At the time of the report, the patient had not recovered. The patient sought medical attention at the nurse's practitioner office. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Rash pustular, Swelling face
Clinical narrative: Information has been received from a nurse practitioner concerning a 5 year old female patient, with no known drug reactions/allergies and no pertinent medical history, who on 28-JAN-2009 was vaccinated with the second dose of VARIVAX (Oka/Merck) (Lot # 662374/1405X), 0.5ml, subcutaneously. There was no concomitant medication. The nurse practitioner reported that on 31-JAN-2009, the patient developed a fever followed by a red, painful, itchy rash on her arms and legs that started at the injection site and spread all over her entire body and swelling of her cheeks after receiving her second dose of the vaccine. The rash was decreased as pustules some with a white center. The nurse practitioner reported that the patient was treated with BENADRYL for the symptoms, but the BENADRYL was not helping. She also reported that the rash appeared to be getting worse and did not appear to be the chickenpox. At the time of the report, the patient had not recovered. The patient sought medical attention at the nurse's practitioner office. Additional information is not expected.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test, Drug exposure during pregnancy, Vaginal haemorrhage
Clinical narrative: Information has been received from a 17 year old female, for the Pregnancy Registry for VARIVAX (Merck), with asthma and no drug reaction who on 23-JAN-2009, "2 weeks ago Friday", was vaccinated SQ with a 0.5 ml dose of VARIVAX (Merck) when she was pregnant.  The patient did not know if she had gotten VARIVAX in the past, so she did not know if this shot was reintroduction or not.  There was no concomitant medication.  On 01-FEB-2009, at 4:00 AM, the patient noticed "a little bleeding in her underwear".  Unspecified "blood work" was performed, result not reported.  The patient did not have a physician she was seeing.  The patient was 9 weeks pregnant at the time of this report.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/15/2009. Follow-up information has been received from another nurse-midwife in the office. It was reported that the patient has an uncomplicated pregnancy course and was induced at 41 weeks gestation for being post dates. She had a 12 hours labor and a spontaneous vaginal birth of a viable female, weighing 71 lbs. 1oz. Neither the baby nor the mother had any complications at the birth or afterwards, that she was aware of. The nurse-midwife looked at through the patient's chart prenatally and at the 6 weeks postpartum visit notes and concluded that she did not see anything to indicated there was anything abnormal for this baby or that the mother had any difficulty either. Everything seemed fine. No further information is available.
Age: 72.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 72 year old patient who was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck) due to nursing error. No adverse effect reported. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Abnormal sensation in eye, Accidental exposure
Clinical narrative: Information has been received from a female registered nurse (R.N.). It was reported that a drop of VARIVAX (Oka/Merck) (lot # not reported) splashed into the nurse's eye when she was vaccinating a patient. The nurse stated that she had contacts on but she removed the contacts and rinsed her eye with contact lens saline solution. The nurse stated that she "feels funny because she is wearing glasses but does not believe this was from the vaccine splashing in her eye". Her eye was normal except "for feeling like there is a little something in it". Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash papular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 11 year old female patient who on 27-AUG-2007 was vaccinated with her first dose of VARIVAX (Oka/Merck) (lot # 638250/0467L).  The patient was vaccinated with her second dose of VARIVAX (Oka/Merck) (lot # 660658/0173X) on 02-JUN-2008.  On 19-JAN-2009 the patient developed chicken pox on trunk after getting her second dose of VARIVAX (Oka/Merck).  The patient had sought medical attention.  The outcome of the patient's chicken pox on truck was not reported.  Additional information has been requested. Follow-up information hab s been received from healthcare professional that on 27-AUG-2001 (not 27-2007) the 11 year old female patient with no allergies and no illness at time of vaccination was vaccinated with her first dose of VARIVAX (lot # 638250/0467L) SQ into her arm. On 02-JUN-2008 the patient was vaccinated with her second dose of VARIVAX (lot # 660658/0173X) SQ in her left arm. On 3:00 PM 19-JAN-2009 the patient experienced red papular lesions on trunk. There were approximately 20-30 lesions mainly on the trunk with moderate pruritis. The rash lasted for approximately 7-10 days. The patient was seen in office to visit physician 22-JAN-2009 with 3 days history of red papular lesions on trunk. No laboratory or diagnostic test was performed. At the time of reporting the patient had recoverd from these adverse events. No further information is available.
Age: 1.11
Sex: U
Vaccine: VARCEL
Symptoms: Exposure to communicable disease, Rash erythematous
Clinical narrative: Information has been received from a physician concerning an 8 year old patient who on 11-AUG-2001 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 22-JAN-2009, the patient developed chicken pox on face, lips and arms. The patient sought unspecified medical attention. Additional information has been requested. Follow-up information was received from a physician. It was reported that the 8 year old female (birth weight 4 lbs 1 oz, now 54 lbs 8 oz) with no illness at time of vaccination or pre-existing allergies, birth defects or medical conditions was vaccinated SQ with the first dose of VARIVAX (Merck) (lot #: 638250/0467L) into left thigh on 11-AUG-2001. On 20-JAN-2009, at 10:20, the patient developed several red regular lesions after exposure to varicella at school. ON 22-JAN-2009, the patient was seen in office. At the time of this report, the patient was recovered. No further information is available.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: Information has been received from a registered nurse concerning a female junior volunteer who on 19-OCT-1995 was vaccinated with a first dose of VARIVAX (Merck). The volunteer was given another dose of VARIVAX (Merck) "a couple of days ago". Her titers drawn that showed no immunity to varicella. No adverse effects reported. The patient did not seek medical attention. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Pyrexia, Respiratory disorder
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning her 9 year old daughter with no pertinent medical history and drug allergies who on 11-JUL-2000 and 03-FEB-2009 was vaccinated SQ with a first dose and second 0.5ml dose of VARIVAX (Merck) (lot # 635441/0122K for dose 1, lot # 662148/1528X for dose 2). There was no concomitant medication. On 07-FEB-2009 the patient experienced headache, body aches and a fever. On 08-FEB-2009 the patient experienced rash on chest, back, arm and legs. The nurse practitioner reported that the patient had chickenpox. There are 12 lesions noted. No lab tests were performed. As of 09-FEB-2009, the patient was not recovered. Follow-up information was received from the nurse practitioner on 11-FEB-2009 which reported that currently the patient had 25 little poxes. Follow-up information was received from the NP who is the patient's mother. It was reported that the 9 year old female patient with no relevant medical history who on 11-JUL-2000 and at 3:00 pm 03-FEB-2009 was vaccinated SQ with a first dose and second 0.5ml dose of VARIVAX (Merck) (lot # 635441/0122K for dose 1, lot # 662148/1528X for dose 2). The second dose was vaccinated into the left arm. There was no illness at the time of vaccination. Subsequently the patient started with headache and fever 4 days after the vaccination, on 07-FEB-2009. On the 5th day, 08-FEB-2009, the patient developed a vesicular rash. It was reported that "no school or work for 4 days". The patient also had mild respiratory symptoms started around the 7th day, on approximately 10-FEB-2009. On 13-FEB-2009 the patient recovered. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HBHEPB, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a physician concerning an 8 year old female who on 31-MAY-2001 was vaccinated with her first dose of VARIVAX (Oka/Merck) (lot number 637672/1610K, route and site not reported). Concomitant therapy included her first dose of MMR II and the third dose of COMVAX. On 30-JAN-2009 the patient developed chickenpox. The physician reported that they were unsure if the patient will be getting the booster of VARIVAX (Oka/Merck). No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Keratitis interstitial, Photophobia, Pyrexia, Rhinitis, Vision blurred
Clinical narrative: Information has been received from a physician via in a published article, concerning a 11 year old patient with a seizure disorder and a history of mild eczema, and results of an ocular examination one year prior which were normal, who was vaccinated with a dose of VARIVAX 0.5 mL into the left deltoid without any resulted skin reaction. Concomitant therapy included daily oral Levetiracetam to treat the seizure disorder. One week following administration of the vaccine, the patient developed rhinitis and a mild fever that lasted 2 days. Two weeks following the vaccination, the patient noted blurry vision and photophobia in the right eye and her mother noted 3 whites spots on the cornea and was referred to the physician for new-onset blurry vision. On examination, visual acuity measured 20/30 OD and 20/20 OS. Corneal sensation was normal in both eyes. Intraocular pressure measured 14 mm Hg OD and 18 mm Hg OS. There was no conjunctival injection or anterior chamber inflammation. In the right cornea, there were several well circumscribed avascular opacities that appeared to be white blood cells at varying stromal depths. The left eye was unaffected. The posterior segment examination results were normal in both eyes. Epstein-Barr virus DNA was not detected by polymerase chain reaction. The patient was treated with a 1 month course of Prednisolone acetate, 1 %, starting at 4 times per day, with resolution of the interstitial keratitis at 2 weeks and return of visual acuity to 20/20. At the 6 month follow up visit, there was no sign of reoccurrence. Comment: Complications of VARIVAX have included disease caused by both wild type and Oka strain varicella zoster virus. There are few reports of ocular manifestations after varicella vacinnation in the literature, and they found no previous reports describing avascular interstitial keratitis. In the case that they had reported, the close temporal association of the vaccination and the development of a corticosteroid responsive keratitis lead them to suggest that this complication represented an immune mediated response to the vaccine strain. One possible explanation for the unilaterality is that the patient rubbed one eye with a hand that had previously touched her site of inoculation, leading to unilateral antigen presentation to the cornea and unilateral disease. Unilateral disease had frequently been described following smallpox vaccination, presumably from this type of touch. In addition, systemic disease may also manifest unilaterally. Immune medicated interstitial keratitis should be recognized as a possible adverse effect of the VARIVAX vaccine. No further information is available.