chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male with no pertinent medical history or drug allergies who in approximately 2000 and on 08-APR-2008 was vaccinated SC with his first and second 0.5 ml doses of VARIVAX (Oka/Merck).  Concomitant vaccination administered with the first dose of VARIVAX (Oka/Merck) included a dose of DTAP.  On 10-APR-2008 was seen by the physician and presented with cellulitis on the injection site characterized by an 8 by 11 cm raised border area which was tender and warm to the touch.  No labs or diagnostic studies were performed.  The patient was treated with AMOXIL.  The outcome was unknown.  It was also noted that the patient had no reactions when he received his first dose of VARIVAX (Oka/Merck).  There was no product quality complaint.  Follow-up information from the reporting registered nurse indicated that the 12 year old (238 lb.) black male who on 08-APR-2008 at 17:15 was vaccinated SC with his second dose of VARIVAX (Oka/Merck) (lot # 659343/1777U).  No further information is available.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Information has been received from a medical assistant concerning a 11 year old female with no pertinent medical history and no allergies who on 22-Dec-1997 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (lot#659698/1770U). There was no concomitant medication. A couple of days later the patient developed swelling redness, warmth, tightness and induration at the injection site on the left arm. At the time of the report it was known it patient had recovered from swelling, redness, warmth tightness and induration at the injection site. Medical attention was sought. This is one of several reports received from the same source. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Skin tightness
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old female who on 01-APR-2004 was vaccinated subcutaneously with the first 0.5 ml dose of VARIVAX. The patient received the 0.5 ml booster of VARIVAX (lot# 659730/1781U) subcutaneously on 28-MAR-2008. There was no concomitant medication. On possibly the next day (approximately 29-MAR-2008) the patient developed swelling, redness, warmth, tightness and induration at the injection site. Subsequently, the patient recovered from swelling, redness, warmth, tightness and induration at the injection site. The patient contacted the office. This is one of the three reports from the same source. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Skin warm, Tenderness
Clinical narrative: Information has been received from a health professional concerning a 14 year old male with no illness at the time of vaccination and amoxicillin allergy who on 10-APR-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) Lot number 660057/1806U) subcutaneously in right arm. On 11-APR-2008 the patient's right arm had a 3.5 *3.5 area of redness, warmth and a center with 1*0.5 of firmness and tenderness. At the time of reporting, the patient had not recovered. Additional information had been requested.
Sex: M
Vaccine: VARCEL, VARZOS, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: On 02-MAY-2008, information was received from a phone call placed in regards to another patient (WAES 0803USA01418).  The physician also indicated a male patient who was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not provided).  One month after the patient had received VARIVAX (Merck) in error, he went back to the physician's office to receive a dose of ZOSTAVAX (Merck).  The patient's outcome was unknown.  Additional information has been requested.
Sex: M
Vaccine: VARCEL, VARZOS, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: On 02-MAY-2008, information was received from a phone call placed in regards to another patient (WAES 0803USA01418).  The physician also indicated a male patient who was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not provided).  One month after the patient had received VARIVAX (Merck) in error, he went back to the physician's office to receive a dose of ZOSTAVAX (Merck).  The patient's outcome was unknown.  Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARCEL, VARZOS, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 72 year old male with no medical history, who on 04-MAR-2008 was vaccinated with VARIVAX (Oka/Merck) (lot # 659204/1470U) in the right deltoid. The physician notified that on 04-MAR-2008 VARIVAX (Oka/Merck) was administered instead of ZOSTAVAX. No adverse events were reported. There was no illness at the time of vaccination. It was reported that the patient recovered. Follow up information has been received from a nurse which reported that this was a medication error, a mistake and she took the wrong vial from the freezer, and was not as careful as she should have been. The patient was then given the correct vaccine ZOSTAVAX (Oka/Merck) (date unspecified). Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARCEL, VARZOS, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 72 year old male with no medical history, who on 04-MAR-2008 was vaccinated with VARIVAX (Oka/Merck) (lot # 659204/1470U) in the right deltoid. The physician notified that on 04-MAR-2008 VARIVAX (Oka/Merck) was administered instead of ZOSTAVAX. No adverse events were reported. There was no illness at the time of vaccination. It was reported that the patient recovered. Follow up information has been received from a nurse which reported that this was a medication error, a mistake and she took the wrong vial from the freezer, and was not as careful as she should have been. The patient was then given the correct vaccine ZOSTAVAX (Oka/Merck) (date unspecified). Additional information is not expected.
Age: 14.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 14 year old female with no pertinent medical history, drug reactions or allergies who on 08-APR-2008 was vaccinated with VARIVAX (Merck) (Lot # 660057/1806U).  There was no concomitant medication.  "This week" on approximately 14 APR 2008 the patient developed, redness, swelling and warmth to touch around the injection site after the second dose of vaccinated with VARIVAX (Merck).  The patient received the first dose in 1999.  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnosis studies performed.  The medical assistant noted that a total of four patients, have had injection site reaction after vaccination with VARIVAX (Merck), two of which have had the same reaction from VARIVAX (Merck) (Lot # 660057/1806U) as this patient.  Attempts to obtain additional identifying information to distinguish the individual patients mentioned in this report have been unsuccessful.  Additional information will be provided if available.  This is one of four reports received from the same source.  Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 6 year old female with no pertinent medical history or allergies who on 14-APR-2008 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 660057/1806U). The patient developed swelling, redness and warmth to touch at the area around the injection site after her first dose with VARIVAX (Merck). Medical attention was sought via phone call to the office. At the time of reporting it was unknown if the patient had recovered from the events. This is one of several reports from the same source. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Dyspnoea, Generalised erythema, Livedo reticularis
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old boy with dilated cardiomyopathy, hypoxic ischemic encephalopathy and spastic quadriparesis and a history of cardiac arrest who on 09-APR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 659941/1791U) and a dose of MMR II (lot # 658164/1672U) (doses not reported). Concomitant therapy included HIBOR and a dose of PEDIARIX. Subsequently the patient experienced mottling of his skin following by generalized erythema. The patient was treated in the physician's office with Benadryl and Tylenol. Then the patient was allowed to go home. Subsequently, the patient experienced difficulty breathing. His mother took him to a hospital where he received oxygen and was then discharged. Subsequently, the patient recovered form mottling of his skin, generalized erythema and difficulty breathing. Additional information has been requested.
Age: 1.03
Sex: M
Vaccine: DTAPHEPBIP, MMR, VARCEL, DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Generalised erythema, Immediate post-injection reaction, Livedo reticularis
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old boy with dilated cardiomyopathy, hypoxic ischemic encephalopathy and spastic quadriparesis and a history of cardiac arrest who on 09-APR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 659941/1791U) and a dose of MMR II (lot # 658164/1672U) (doses not reported). Concomitant therapy included HIBOR and a dose of PEDIARIX. Subsequently the patient experienced mottling of his skin following by generalized erythema. The patient was treated in the physician's office with Benadryl and Tylenol. Then the patient was allowed to go home. Subsequently, the patient experienced difficulty breathing. His mother took him to a hospital where he received oxygen and was then discharged. Subsequently, the patient recovered form mottling of his skin, generalized erythema and difficulty breathing. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthropod bite, Rash erythematous, Rash papular
Clinical narrative: Information has been received from a nurse practitioner concerning a 15 month old girl with bilateral otitis media who on 15-APR-2008 was vaccinated with the first dose of VARIVAX (lot#: 660082/1977U) 0.5 ml subcutaneously into the left thigh and the first dose of MMR II (lot#: 656914/0809U) into the left thigh. Concomitant therapy included Omnicef for the treatment of a recent case of otitis media. On 28-APR-2008 (previously reported as 15-APR-2008) the patient had a larger number of ant bites. On 29-APR-2008 the patient developed a generalized papular erythematous rash over her trunk and extremities that did not look like Chickenpox. Subsequently the patient recovered. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood glucose increased, Culture throat negative, Herpes zoster, Pruritus generalised, Urine analysis abnormal
Clinical narrative: Information has been received from a physician concerning an 8 year old girl with no pertinent medical history and no history of drug reactions or allergies who at 10AM of 23-APR-2008 was vaccinated subcutaneously in her left arm with the second dose of VARIVAX (lot#: 659154/1495U). There was no concomitant medication. The patient's mother reported to the physician on 30-APR-2008 that her daughter felt like she had a "fur feeling" all over her or an itchiness feeling. The physician reported that the patient had a sensation of a "furry animal in bed with her-tingling all over, and said the fur was poisonous." The patient sought medical attention with a physician office visit. The physician considered the symptoms consistent with shingles. On 30-APR-2008, the following lab tests were obtained: Throat culture-negative for Group A, C and G strept; urinalysis (clean catch) revealed trace leukocytes and hemoglobin, small ketones and 6 WBCs; and electrolytes-within normal limits except for glucose 151 mg/dl (nl range 65-99). The patient was treated with Naproxen and fever "control". On 05-MAY-2008 the patient recovered. Additional information is not expected.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Urine ketone body present, Urine leukocyte esterase positive
Clinical narrative: Information has been received from a physician concerning an 8 year old girl with no pertinent medical history and no history of drug reactions or allergies who at 10AM of 23-APR-2008 was vaccinated subcutaneously in her left arm with the second dose of VARIVAX (lot#: 659154/1495U). There was no concomitant medication. The patient's mother reported to the physician on 30-APR-2008 that her daughter felt like she had a "fur feeling" all over her or an itchiness feeling. The physician reported that the patient had a sensation of a "furry animal in bed with her-tingling all over, and said the fur was poisonous." The patient sought medical attention with a physician office visit. The physician considered the symptoms consistent with shingles. On 30-APR-2008, the following lab tests were obtained: Throat culture-negative for Group A, C and G strept; urinalysis (clean catch) revealed trace leukocytes and hemoglobin, small ketones and 6 WBCs; and electrolytes-within normal limits except for glucose 151 mg/dl (nl range 65-99). The patient was treated with Naproxen and fever "control". On 05-MAY-2008 the patient recovered. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: DTAP, HEPA, MNQ, VARCEL
Symptoms: Body temperature increased, Crohn's disease, Heart rate increased, Immunosuppression, Oxygen saturation
Clinical narrative: Information has been received from a registered nurse and medical records concerning a 16 year old male child with no known allergies, chronic Crohn's disease and history of immunosuppression who on 11-APR-2008 was vaccinated SQ in the left gluteal with a second dose of VARIVAX (lot # 659230/1513U). Concomitant vaccinations included HAVRIX (lot # AHAVB225) IM in the right gluteal, MENACTRA (lot # U7553AA) IM in the left gluteal, and TRIPEDIA) (lot # C2889AA) IM in the right gluteal. Concomitant therapy include Prednisone, Methotrexate, folic acid, Flagyl. It was noted that the patient had a recent exacerbation of his Crohn's disease last month. Subsequently, on 03-MAY-2008 the patient developed a rash on his left ear and a temperature of 101.3. Medical attention was sought. At which time the patient's temperature was 102, and his rash was felt to be a varicella infection. The patient was admitted to the hospital for monitoring and IV therapy due to his immunosuppression secondary to his Crohn's disease and recent flare up. PCR test results from a skin lesion were positive for varicella. There were no imaging studies performed. The patient was treated with IV Zovirax and a 1 Liter bolus of IV fluids. The patient's open sores were treated with Bactroban. On an unspecified date the patient recovered. The patient's vaccination history included: doses TRIPEDIA (+) Pertussis vaccine (unspecified) (+) Tetanus toxoid (manufacturer unknown) on 21-NOV-1991, 25-FEB-1992, 10-NOV-1992, 03-OCT-1993, and 04-MAR-1996, doses of HIB conj vaccine (unspecified carrier) (manufacturer unknown) on 03-OCT-1991, 21-NOV-1991, 25-FEB-1992 and 10-NOV-1992, doses of Poliovirus vaccine inactivated (unspecified) (manufacturer unknown) on 03-OCT-1991, 21-NOV-1991, 10-NOV-1993, and 04-MAR-1996, doses of MMR II on 30-NOV-1992 and 04-MAR-1996 and doses Hepatitis B virus vaccine (manufacturer unknown) on 09-AUG-1995, 02-OCT-1995 and 04-MAR-1996. Additional information is not expected.
Age: 16.0
Sex: M
Vaccine: DTAP, HEPA, MNQ, VARCEL
Symptoms: Rash, Respiratory rate increased, Skin lesion, Varicella post vaccine, Viral DNA test positive
Clinical narrative: Information has been received from a registered nurse and medical records concerning a 16 year old male child with no known allergies, chronic Crohn's disease and history of immunosuppression who on 11-APR-2008 was vaccinated SQ in the left gluteal with a second dose of VARIVAX (lot # 659230/1513U). Concomitant vaccinations included HAVRIX (lot # AHAVB225) IM in the right gluteal, MENACTRA (lot # U7553AA) IM in the left gluteal, and TRIPEDIA) (lot # C2889AA) IM in the right gluteal. Concomitant therapy include Prednisone, Methotrexate, folic acid, Flagyl. It was noted that the patient had a recent exacerbation of his Crohn's disease last month. Subsequently, on 03-MAY-2008 the patient developed a rash on his left ear and a temperature of 101.3. Medical attention was sought. At which time the patient's temperature was 102, and his rash was felt to be a varicella infection. The patient was admitted to the hospital for monitoring and IV therapy due to his immunosuppression secondary to his Crohn's disease and recent flare up. PCR test results from a skin lesion were positive for varicella. There were no imaging studies performed. The patient was treated with IV Zovirax and a 1 Liter bolus of IV fluids. The patient's open sores were treated with Bactroban. On an unspecified date the patient recovered. The patient's vaccination history included: doses TRIPEDIA (+) Pertussis vaccine (unspecified) (+) Tetanus toxoid (manufacturer unknown) on 21-NOV-1991, 25-FEB-1992, 10-NOV-1992, 03-OCT-1993, and 04-MAR-1996, doses of HIB conj vaccine (unspecified carrier) (manufacturer unknown) on 03-OCT-1991, 21-NOV-1991, 25-FEB-1992 and 10-NOV-1992, doses of Poliovirus vaccine inactivated (unspecified) (manufacturer unknown) on 03-OCT-1991, 21-NOV-1991, 10-NOV-1993, and 04-MAR-1996, doses of MMR II on 30-NOV-1992 and 04-MAR-1996 and doses Hepatitis B virus vaccine (manufacturer unknown) on 09-AUG-1995, 02-OCT-1995 and 04-MAR-1996. Additional information is not expected.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 6 year old male who on 01-MAY-2008 was vaccinated with a second dose of VARIVAX 0.5 ml subcutaneous (Oka/Merck) (LOT# 660283/1971U). About 5 minutes post vaccination, the patient developed redness and hives at the injection site. The area was not itchy. The patient was watched for about 30 minutes and the symptoms began to resolve. The patient sought medical attention in office. There was no product quality complaint. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 7 year old white female with no related medical history and drug allergies who was vaccinated her first dose of VARIVAX (Merck) (Lot # was not available) on 12-MAR-2002.  On 12-MAY-2008 the patient was subcutaneously vaccinated with the second dose of VARIVAX (Merck) (Lot # 660335/0097X) as her booster.  On 13-MAY-2008 the patient developed cellulitis of injection site and had redness, swelling, tenderness of the site.  On 14-MAY-2008 the physician saw the patient.  And the patient started on KEFLEX.  The symptoms lasted for 7-10 days.  Subsequently the patient recovered from the cellulitis.  No additional information is available.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pain in extremity, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 35 year old female who on 18-APR-2008 was vaccinated into the left arm subcutaneously with a first dose of VARIVAX (Merck) (Lot #). On 19-MAY-2008 the patient was vaccinated into the left arm subcutaneously with a second dose of VARIVAX (Merck) (Lot # 656172/1498F). The nurse reported that on 20-MAY-2008 the patient developed a swollen, reddened and sore left arm. The patient was examined on 22-MAY-2008 and there was an unspecified varicella like rash. The patient was instructed to take TYLENOL and to apply ice as needed for pain. At the time of the report the patient was recovering. The patient sought medical attention; she was seen in the physician office. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Back pain, Pruritus generalised
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 9 year old male with no pertinent medical history and no allergies who on 05-OCT-1999 was vaccinated subcutaneously with 0.5 ml first dose of VARIVAX. No adverse reaction was noted. On 22-MAY-2008 the patient was vaccinated subcutaneously with a 0.5 ml second dose of VARIVAX (lot #660042/1899U). There was no concomitant therapy. On 25-MAY-2008 the patient experienced severe systemic itching and stabbing low back pain on both sides of the back, no rash, neck pain or fever. On 28-MAY-2008 the patient was seen in the physician's office, there was no redness or rash but itching and pain continued, the patient was treated with Hydroxyzine hydrochloride 10 mg 1-2 tablets every 6 hours for the itch. No laboratory or diagnostic studies were performed. At the time of this report the patient had not recovered. Additional information is not expected.
Age: 14.0
Sex: M
Vaccine: MNQ, VARCEL
Symptoms: Flushing, Lip swelling, Rash, Urticaria
Clinical narrative: Information has been received from a physician concerning a 14 year old male who on 30-MAY-2008 was vaccinated with the second dose of VARIVAX (Merck) (lot#659932/1790U).  Concomitant therapy included MENACTRA.  On 30-MAY-2008 within 45 minutes of the vaccination with VARIVAX (Merck) the patient developed flushing and his lips swelled.  On 31-MAY-2008 the patient had a rash and hives all over his face.  On an unspecified date the patient recovered from the events.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a consumer concerning her 9 year old son with allergy to nuts and wasp sting and a history of anaphylactic reaction to wasp stings. He has had anaphylactic reactions in the past to FLUZONE (Sanofi Pasteur) and DTAP (Aventis Pasteur) who on 09-JUN-2008 was vaccinated with a dose of VARIVAX 0.5 ml booster shot (Oka/Merck) (Lot #660278/1894U). There was no concomitant medication. Mother reported an adverse experience on her son. On 09-JUN-2008 the patient received a booster shot of VARIVAX (Oka/Merck) and within seconds had an anaphylactic reaction. He went to the hospital for one day. The patient recovered "a couple days after receiving shot". There was no product quality complaint. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Body temperature increased, Incorrect route of drug administration, Intensive care, Local swelling
Clinical narrative: Information has been received from a pharmacist and a physician concerning a 15 year old female with no known drug reactions/allergies and with systemic lupus erythematosus and lupus nephritis and no history of chicken pox and who had negative varicella titers who on 24-MAY-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) IM in her left arm (lot # 659232/1514U). Concomitant therapy included CELLCEPT, calcium carbonate, losartan potassium, enalapril maleate (manufacturer unknown), LIPITOR, PLAQUENIL and ferrousSO4. A few days after the vaccination, the patient had a runny nose and swelling on the right side of the neck. On 10-JUN-2008 the patient had a pimple like lesion on her face. On 11-JUN-2008 the patient found 3 vesicles on her left arm and went to see her primary care provider. The primary care provider gave her ibuprofen and AUGMENTIN. On 15-JUN-2008 there were more generalized lesions spreading to the legs, trunk (back, chest and abdomen) and face. On 17-JUN-2008 the patient developed a fever of 102 F and went to the emergency room. CELLCEPT was stopped. The patient was given as treatment, low dose ACYCLOVIR 400 mg every 6 hours IV and BENADRYL, vancomycin, ARTIFICIAL TEARS, TYLENOL for the symptoms. On 19-JUN-2008 the patient's symptoms were still progressing and getting worse so the patient went back to the emergency room and was admitted to the hospital for IV ACYCLOVIR. As of 23-JUN-2008, the patient was in isolation in the intensive care unit in the hospital as a precaution. The reporting physician stated that the primary care physician did not feel that the vaccine caused the chickenpox, however, the reporting physician felt that it was related to the vaccine based on the incubation time for the disease and the timing to the vaccination. The physician further explained that the patient has lupus and lupus nephritis and was taking CELLCEPT. As of 23-JUN-2008, the patient was recovering. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Oka/Merck vaccine strain. The sample of the lesion was collected on 24-JUN-2008. The samples were taken from a crusted anterior scalp lesion and a posterior neck crusted lesion. The PCR results for the specimen from the crusted lesions were VZV positive, not typable. As of 18-AUG-2008, the patient recovered from the chicken pox. Additional information is not expected. This is one of several reports from the same source.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Polymerase chain reaction, Pyrexia, Rash, Rhinorrhoea, Scab
Clinical narrative: Information has been received from a pharmacist and a physician concerning a 15 year old female with no known drug reactions/allergies and with systemic lupus erythematosus and lupus nephritis and no history of chicken pox and who had negative varicella titers who on 24-MAY-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) IM in her left arm (lot # 659232/1514U). Concomitant therapy included CELLCEPT, calcium carbonate, losartan potassium, enalapril maleate (manufacturer unknown), LIPITOR, PLAQUENIL and ferrousSO4. A few days after the vaccination, the patient had a runny nose and swelling on the right side of the neck. On 10-JUN-2008 the patient had a pimple like lesion on her face. On 11-JUN-2008 the patient found 3 vesicles on her left arm and went to see her primary care provider. The primary care provider gave her ibuprofen and AUGMENTIN. On 15-JUN-2008 there were more generalized lesions spreading to the legs, trunk (back, chest and abdomen) and face. On 17-JUN-2008 the patient developed a fever of 102 F and went to the emergency room. CELLCEPT was stopped. The patient was given as treatment, low dose ACYCLOVIR 400 mg every 6 hours IV and BENADRYL, vancomycin, ARTIFICIAL TEARS, TYLENOL for the symptoms. On 19-JUN-2008 the patient's symptoms were still progressing and getting worse so the patient went back to the emergency room and was admitted to the hospital for IV ACYCLOVIR. As of 23-JUN-2008, the patient was in isolation in the intensive care unit in the hospital as a precaution. The reporting physician stated that the primary care physician did not feel that the vaccine caused the chickenpox, however, the reporting physician felt that it was related to the vaccine based on the incubation time for the disease and the timing to the vaccination. The physician further explained that the patient has lupus and lupus nephritis and was taking CELLCEPT. As of 23-JUN-2008, the patient was recovering. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Oka/Merck vaccine strain. The sample of the lesion was collected on 24-JUN-2008. The samples were taken from a crusted anterior scalp lesion and a posterior neck crusted lesion. The PCR results for the specimen from the crusted lesions were VZV positive, not typable. As of 18-AUG-2008, the patient recovered from the chicken pox. Additional information is not expected. This is one of several reports from the same source.
Age: 15.0
Sex: F
Vaccine: VARCEL
Symptoms: Skin lesion, Varicella, Varicella post vaccine, Viral DNA test positive
Clinical narrative: Information has been received from a pharmacist and a physician concerning a 15 year old female with no known drug reactions/allergies and with systemic lupus erythematosus and lupus nephritis and no history of chicken pox and who had negative varicella titers who on 24-MAY-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) IM in her left arm (lot # 659232/1514U). Concomitant therapy included CELLCEPT, calcium carbonate, losartan potassium, enalapril maleate (manufacturer unknown), LIPITOR, PLAQUENIL and ferrousSO4. A few days after the vaccination, the patient had a runny nose and swelling on the right side of the neck. On 10-JUN-2008 the patient had a pimple like lesion on her face. On 11-JUN-2008 the patient found 3 vesicles on her left arm and went to see her primary care provider. The primary care provider gave her ibuprofen and AUGMENTIN. On 15-JUN-2008 there were more generalized lesions spreading to the legs, trunk (back, chest and abdomen) and face. On 17-JUN-2008 the patient developed a fever of 102 F and went to the emergency room. CELLCEPT was stopped. The patient was given as treatment, low dose ACYCLOVIR 400 mg every 6 hours IV and BENADRYL, vancomycin, ARTIFICIAL TEARS, TYLENOL for the symptoms. On 19-JUN-2008 the patient's symptoms were still progressing and getting worse so the patient went back to the emergency room and was admitted to the hospital for IV ACYCLOVIR. As of 23-JUN-2008, the patient was in isolation in the intensive care unit in the hospital as a precaution. The reporting physician stated that the primary care physician did not feel that the vaccine caused the chickenpox, however, the reporting physician felt that it was related to the vaccine based on the incubation time for the disease and the timing to the vaccination. The physician further explained that the patient has lupus and lupus nephritis and was taking CELLCEPT. As of 23-JUN-2008, the patient was recovering. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Oka/Merck vaccine strain. The sample of the lesion was collected on 24-JUN-2008. The samples were taken from a crusted anterior scalp lesion and a posterior neck crusted lesion. The PCR results for the specimen from the crusted lesions were VZV positive, not typable. As of 18-AUG-2008, the patient recovered from the chicken pox. Additional information is not expected. This is one of several reports from the same source.
Age: 17.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Body temperature increased, Pyrexia, Rash, Rash vesicular, Scab
Clinical narrative: Information has been received from a pharmacist concerning a 17 year old female with no known drug reactions/allergies, no recent exposure to chickenpox or shingles and with systemic lupus erythematosus which was diagnosed at 14 year old and on therapy with CELLCEPT who was vaccinated on 03-JUN-2008 with a dose of VARIVAX (Oka/Merck) (route and administrating site not reported) (lot# 659740/0165X) and VAQTA (lot# 659186/1258U). Concomitant therapy included ADACEL, CELLCEPT and PLAQUENIL. On 16-JUN-2008 (also reported as 15-JUN-2008) the patient developed a rash, then fever, and was hospitalized on 21-JUN-2008 with disseminated varicella. She was treated with ACYCLOVIR IV. The patient had 50-100 vesicular lesions which distributed on her face, back, extremities and abdomen. The patient's maximum temperature was 103.1 F. On 27-JUN-2008, the physician reported that the patient was recovering from the varicella. The patient did not appear to have any vesicular lesions remaining, and the majority of her lesions were scabbed and/or healed. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Oka/Merck vaccine strain. The sample of the lesions was collected on 27-JUN-2008. The sample was taken from a crusted vesicle. The sample taken was inadequate, no strain was identified. On 15-JUL-2008 it was reported the patient had recovered from the varicella. Additional information has been requested. This is one of several reports from the same source.
Age: 17.0
Sex: F
Vaccine: HEPA, TDAP, VARCEL
Symptoms: Varicella post vaccine, Viral test
Clinical narrative: Information has been received from a pharmacist concerning a 17 year old female with no known drug reactions/allergies, no recent exposure to chickenpox or shingles and with systemic lupus erythematosus which was diagnosed at 14 year old and on therapy with CELLCEPT who was vaccinated on 03-JUN-2008 with a dose of VARIVAX (Oka/Merck) (route and administrating site not reported) (lot# 659740/0165X) and VAQTA (lot# 659186/1258U). Concomitant therapy included ADACEL, CELLCEPT and PLAQUENIL. On 16-JUN-2008 (also reported as 15-JUN-2008) the patient developed a rash, then fever, and was hospitalized on 21-JUN-2008 with disseminated varicella. She was treated with ACYCLOVIR IV. The patient had 50-100 vesicular lesions which distributed on her face, back, extremities and abdomen. The patient's maximum temperature was 103.1 F. On 27-JUN-2008, the physician reported that the patient was recovering from the varicella. The patient did not appear to have any vesicular lesions remaining, and the majority of her lesions were scabbed and/or healed. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Oka/Merck vaccine strain. The sample of the lesions was collected on 27-JUN-2008. The sample was taken from a crusted vesicle. The sample taken was inadequate, no strain was identified. On 15-JUL-2008 it was reported the patient had recovered from the varicella. Additional information has been requested. This is one of several reports from the same source.
Age: 16.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site pain, Skin warm
Clinical narrative: Information has been received from a registered nurse concerning a 16 year old female who on 18-JUN-2008 at 8:45 am was vaccinated subcutaneously on the left arm with a second dose of VARIVAX (Merck) (Lot #660278/1894U). Concomitant vaccination included a first dose of MENACTRA (Lot #U2622AA) intramuscularly in the right arm. On 19-JUN-2008 the patient experienced an injection site approximately 4 cm area of redness and tenderness, hot to touch. Signs symptoms occurred approximately in 24 hours of vaccine. The reaction was due to VARIVAX. At the time of the report, the patient recovered. There was no illness at the time of vaccination. No further information is available.
Age: 13.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 13 year old male with no allergies or pertinent medical history who on 18-JUN-2008 was vaccinated with the second dose of VARIVAX (Merck) (lot # 660278/1894U) subcutaneously in the left arm at 8:45 am. There were no illness at the time of the vaccination. There was no concomitant medication. On 19-JUN-2008 the patient experienced injection site redness and tenderness 2.5cms diameter within 24 hours post-vaccination. The injection site was also hot to touch. At the time of the report, the patient had recovered. It is unknown if the patient sought medical attention. No further information is available.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a health professional concerning a 14 year old female with no pre-existing drug allergies and medical conditions who on 24-JUN-2008 was vaccinated in the left arm with the second dose of VARIVAX (Merck) (LOT# 659935/1900U) and was also vaccinated in the left arm with the sixth dose of TRIPEDIA (LOT# C2995BA). There was no illness at time of vaccination. On 25-JUN-2008 the patient started with a local reaction. The injection site was bumpy, had a rash and was itchy. There was a 6 inches in diameter red area. The local reaction was improving with BENADRYL. On 30-JUN-2008, the patient recovered from the symptoms. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 4 year old female who on 23-JUN-2008 was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot no. 660278/1894U) into the right arm. On the same day the patient was also vaccinated MMR II (MSD) (lot no. 659416/1944U) via subcutaneous route into the left arm, TRIPEDIA (lot no. C2933AB) via intramuscular route into the left arm and IPOL (lot no. A0474) via intramuscular route into the right arm. Within 24 hours of vaccination, the patients developed an injection site reaction involving redness and swelling. There was warmth and tenderness great than 2 centimeter. Parents of the patients were told to treat with ice, BENADRYL and MOTRIN. No cellulitis had been involved. At the time of this report, the patient was fully recovered. The reporter considered these reactions seemed to be with the booster VARIVAX (Merck). This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: U
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning an 11 year old patient who on 01-JUL-2008 was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot # 659845/0270X). The patient developed injection site reactions after being vaccinated with the second dose. The reactions included redness, swelling and local heat. The outcome was unknown. The patient sought medical attention and was treated with antibiotics. This is one of several reports received from the same source. Additional information is not expected.
Age: 11.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Oedema peripheral, Skin lesion
Clinical narrative: Initial and follow-up information has been received from a nurse concerning a 11 year old male who on 24-JUN-2008 at 9:30 AM was vaccinated subcutaneously with the second 0.5 ml dose of VARIVAX (Merck) (lot no. 660278/1894U) into the right thigh. At the same time the patient was vaccinated intramuscularly with the first dose of ADACEL (lot no. C2824AA) into the left thigh. Within 24 hours of vaccination, the patient developed an injection site reaction involving redness and swelling. The patient had swelling from his elbow to his shoulder. The nurse reported in the follow up that the patient had tender, erythematous lesion at the right thigh. The inner aspect of the lesion was bright red and had a size of 5cmX4cm. The outer circle of the lesion was 7.5cmX10cm. Parents of the patient were told to treat with ice, BENADRYL and MOTRIN. No cellulitis had been involved. At the time of this report, the patient was fully recovered. The reporter considered these events were reactions to VARIVAX (Merck). This is one of several reports received from the same source. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug exposure during pregnancy, Muscle spasms
Clinical narrative: Information has been received from a registered nurse (R.N.) through the Merck pregnancy registry concerning a 22 year old female with no medical history or drug allergies who on 19-JUN-2008 was vaccinated with a dose of VARIVAX (Merck). There was no concomitant medication. The patient was pregnant while receiving VARIVAX (Merck). The pregnancy was normal to date although the patient had mild cramping. The patient was seen in office. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Hand-foot-and-mouth disease, Vomiting
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 12 month old female with no relevant medical history or allergies who on 21-JUL-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number 659204/1470U), subcutaneously (injection site not reported) and a dose of MMR II (lot number 658169/1926U) by subcutaneous injection. Concomitant therapy included a dose of HAVRIX. On 23-JUL-2008 10 pm, the patient experienced one episode of vomiting, two hours later, the patient experienced febrile seizure. On the next day, the patient was diagnosed with hand, foot, and mouth disease. Unspecified medical attention was sought. Subsequently the patient recovered from all the events. Upon internal review febrile seizure was determined to be serious as an other important medical event. Additional information is not expected.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a 4 year old female with otitis media recurrent who on 21-JUL-2008 was vaccinated subcutaneously with her second 0.5 ml dose of VARIVAX (Merck) (Lot #661122/0539X). There was no concomitant medication. On 23-JUL-2008 the patient developed redness and swelling at the injection site. On the same day the patient was seen by the nurse. The patient was treated with BENADRYL chewables for the erythema. On 25-JUL-2008 the patient recovered from redness and swelling at the injection site. A lot check was initialized. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. This is one of the several reports from the same source. Additional information has been requested.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old female with no known pertinent medical history or drug reactions/allergies who on 11-JAN-2002 was vaccinated with a first dose of VARIVAX (Merck) 0.5 ml SQ. On 30-JUL-2008 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot #661122/0539X) 0.5 ml SQ. There was no concomitant medication. On 01-AUG-2008 the patient experienced redness and swelling at the injection site and was seen on 01-AUG-2008. The patient was given CLARITIN for the erythema and recovered on 04-AUG-2008. This is one of several reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the center and was released. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Blood test abnormal, Dyspnoea, Incorrect route of drug administration, No reaction on previous exposure to drug
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 4 year old male with a pet allergy, syndactyly on toes and speech delay, who on 04-AUG-2008, was vaccinated IM into right thigh with the second dose of VARIVAX (Merck) (Lot # 660340/0315X). Concomitant vaccination included HAVRIX. Approximately 10-20 minutes after vaccination, the patient experienced an anaphylactic reaction (shortness of breath and trouble breathing), urticaria and decrease in saturation detected via pulse oximetry (90% during on set of event). The patient was given EPI subcutaneously and CLARITIN PO to treat the symptoms of the experience. Over 1-2 hour, the patient recovered. "The patient was fine now." The reporting physician considered the patient's anaphylactic reaction to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the center and was released. No further information is available.  This is in follow-up to report(s) previously submitted on 5/15/2009. Initial and follow-up information has been received from a physician concerning a 4 year old male with a pet allergy, syndactyly on toes and speech delay, who on 04-AUG-2008, was vaccinated IM into the right thigh with the second dose of VARIVAX (Merck) (Lot # 660340/0315X). Concomitant vaccination included HAVRIX. Approximately 10-20 minutes after vaccination, the patient experienced an anaphylactic reaction (shortness of breath and trouble breathing), urticaria and decrease in saturation detected via pulse oximetry (90% during on set of event). The patient was given EPI subcutaneously and CLARITIN PO to treat the symptoms of the experience. Over 1-2 hour, the patient recovered. "The patient was fine now." The reporting physician considered the patient's anaphylactic reaction to be life threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investiagation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from a physician. The physician reported that bloodwork showed that this was a reaction to a gelatin in the vaccine. The physician also noted that the patient had no reaction with the first dose. No further information is available.