chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Dermatitis allergic, Injection site erythema, Injection site rash, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a physician concerning an adult male patient with no pertinent medical history and none sensitive skin band-aid cause redness who in early January 2011, was vaccinated with an adult dose of VARIVAX (Merck) (668296/0858Z). There was no concomitant medication. On approximately 21-JAN-2011 ("1-2 weeks ago"), the patient developed a red, non vesicular, non itchy rash at the injection site and at the area below the injection site. The physician mentioned that the patient complained that the area below the injection site felt hot and itchy for the past few days. The physician stated that on 04-FEB-2011, the patient came to receive the second dose of VARIVAX (Merck), and the area below the injection site was red, and it looked like a localized skin allergic reaction. The second dose of VARIVAX (Merck) was not given to the patient. There was no lab diagnostics studies performed. At the time of the report, the outcomes were unknown. The patient via saw physician to seek medical attention. Follow up information has been received from a health professional reported that on 04-JAN-2011, the patient received subcutaneously the first dose of VARIVAX (Merck) (668296/0858Z). On 11-JAN-2011, the patient developed itch hive about one week with the initial injection. At the time of the report, the patient had recovered from his adverse events. The patient did not seek medical attention. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: VARCEL
Symptoms: Skin reaction, Skin warm, Urticaria
Clinical narrative: Information has been received from a physician concerning an adult male patient with no pertinent medical history and none sensitive skin band-aid cause redness who in early January 2011, was vaccinated with an adult dose of VARIVAX (Merck) (668296/0858Z). There was no concomitant medication. On approximately 21-JAN-2011 ("1-2 weeks ago"), the patient developed a red, non vesicular, non itchy rash at the injection site and at the area below the injection site. The physician mentioned that the patient complained that the area below the injection site felt hot and itchy for the past few days. The physician stated that on 04-FEB-2011, the patient came to receive the second dose of VARIVAX (Merck), and the area below the injection site was red, and it looked like a localized skin allergic reaction. The second dose of VARIVAX (Merck) was not given to the patient. There was no lab diagnostics studies performed. At the time of the report, the outcomes were unknown. The patient via saw physician to seek medical attention. Follow up information has been received from a health professional reported that on 04-JAN-2011, the patient received subcutaneously the first dose of VARIVAX (Merck) (668296/0858Z). On 11-JAN-2011, the patient developed itch hive about one week with the initial injection. At the time of the report, the patient had recovered from his adverse events. The patient did not seek medical attention. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female patient who on 07-JUN-2010 was vaccinated with a dose of VARIVAX (Merck) (lot number 665392/1080Y) (it was unknown if it was the first or second dose). Concomitant therapy included MMR II and KINRIX. The nurse reported that between 07-JUN-2010 and 08-JUN-2010 the patient had a fever of 101 and vomited four times in one day after receiving VARIVAX (Merck). At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Information has been received from a medical assistant concerning a 12 month old male with no pertinent medical history and no drug reaction/allergies who on 18-JAN-2011 was vaccinated subcutaneously with a 0.5 mL dose of VARIVAX (Merck) (lot# 668597/1181Z; exp date unknown). There was no concomitant medication. On approximately 24-JAN-2011 ("last week"), the patient had been diagnosed with chickenpox. The patient had 2 lesions on the back, 3 lesions on the head, and 2 lesions in the diaper area. The patient had 1-2 lesions of the 7 lesions that had scabbed over. There was no treatment given for chickenpox. There was no lab diagnostics studies performed. At the time of the report, the patient was recovering from chickenpox. The patient visit the physician's office to seek medical attention. Additional information has been requested.
Age: 1.09
Sex: M
Vaccine: VARCEL
Symptoms: Lethargy, Rash vesicular
Clinical narrative: Information has been received from a physician concerning her 44 month old son with no pertinent medical history, no known drug reactions who in December 2007 (also reported as when he was 15 month old), was vaccinated SQ with a 0.5 ml first and only dose of VARIVAX (Merck) (Lot#: not reported). Concomitant therapy included vitamins (unspecified). The physician reported that her son developed 10 to 12 vesicular lesions on his legs and some could be on his neck after receiving VARIVAX (Merck). The physician also stated that her son had about 10 vesicles below both knees mostly around the ankle and a few on the calf. The physician's son was also lethargic. The physician requested a VZV Analysis by PCR (Polymerase Chain Reaction) and wanted to send viral isolates. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old male patient who on 19-JUL-2010 was vaccinated with a first dose or second dose of VARIVAX (Merck) (route unspecified and lot number:665967/0224Z). Concomitant vaccines included a dose of HAVRIX, a dose of KINRIX and dose of MMR II. The nurse advised that "between the dates of 19-JUL-2010 and 21-JUL-2010, the patient had a localized reaction after receiving the first or second dose (unknown whether dose the patient received) of VARIVAX (Merck). The physician believed could have been cellulitis". At the time of the report the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blister, Culture throat negative, Exposure to communicable disease, Eye pruritus, Lymphadenopathy
Clinical narrative: Information has been received from a Registered Nurse concerning a 14 year old male child with sore throat at the time of vaccination, who on 23-JAN-1997 was vaccinated with the first dose of VARIVAX (Merck) (lot# 619272/1339D) subcutaneously into his left arm. It was reported that the patient's mother and father were diagnosed with shingles. A few days later on 02-JAN-2011, the patient developed chickenpox - over thirty blisters, some were draining and some had crusted, and he also experienced eyes itchy and red but no blisters or requiring eye medications. On 18-JAN-2011, the patient recovered from the events. Follow-up information has been received from a physician concerning the 14 year old (also reported as "15 year old") male child with no medical history or illness at the time of vaccination, who on 23-JAN-1997 was vaccinated with the first dose of VARIVAX (Merck) (lot# 619272/1339D) subcutaneously into his left arm. Other suspect therapy included the first dose of MMR II (lot# 618617/0734D) subcutaneously into his right arm on the same day. The physician reported that on 08-JAN-2011 about 30 lesions (previously reported as "blisters") that went thru weepy and crusted stage itchy. The patient had enlarged lymph node (LN) with fever 101-102. It also reported that both parents were diagnosed shingles for few days before this patient's reaction (RXN). The patient had throat culture test for strep which was negative; "quick and plate". On 20-JAN-2011 (previously reported as "18-JAN-2011"), the patient recovered from the events. The patient sought medical attention via doctor visit. This is one of several reports received from the same source. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Ocular hyperaemia, Pruritus, Pyrexia, Scab, Varicella post vaccine
Clinical narrative: Information has been received from a Registered Nurse concerning a 14 year old male child with sore throat at the time of vaccination, who on 23-JAN-1997 was vaccinated with the first dose of VARIVAX (Merck) (lot# 619272/1339D) subcutaneously into his left arm. It was reported that the patient's mother and father were diagnosed with shingles. A few days later on 02-JAN-2011, the patient developed chickenpox - over thirty blisters, some were draining and some had crusted, and he also experienced eyes itchy and red but no blisters or requiring eye medications. On 18-JAN-2011, the patient recovered from the events. Follow-up information has been received from a physician concerning the 14 year old (also reported as "15 year old") male child with no medical history or illness at the time of vaccination, who on 23-JAN-1997 was vaccinated with the first dose of VARIVAX (Merck) (lot# 619272/1339D) subcutaneously into his left arm. Other suspect therapy included the first dose of MMR II (lot# 618617/0734D) subcutaneously into his right arm on the same day. The physician reported that on 08-JAN-2011 about 30 lesions (previously reported as "blisters") that went thru weepy and crusted stage itchy. The patient had enlarged lymph node (LN) with fever 101-102. It also reported that both parents were diagnosed shingles for few days before this patient's reaction (RXN). The patient had throat culture test for strep which was negative; "quick and plate". On 20-JAN-2011 (previously reported as "18-JAN-2011"), the patient recovered from the events. The patient sought medical attention via doctor visit. This is one of several reports received from the same source. No further information is available.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Wound secretion
Clinical narrative: Information has been received from a Registered Nurse concerning a 14 year old male child with sore throat at the time of vaccination, who on 23-JAN-1997 was vaccinated with the first dose of VARIVAX (Merck) (lot# 619272/1339D) subcutaneously into his left arm. It was reported that the patient's mother and father were diagnosed with shingles. A few days later on 02-JAN-2011, the patient developed chickenpox - over thirty blisters, some were draining and some had crusted, and he also experienced eyes itchy and red but no blisters or requiring eye medications. On 18-JAN-2011, the patient recovered from the events. Follow-up information has been received from a physician concerning the 14 year old (also reported as "15 year old") male child with no medical history or illness at the time of vaccination, who on 23-JAN-1997 was vaccinated with the first dose of VARIVAX (Merck) (lot# 619272/1339D) subcutaneously into his left arm. Other suspect therapy included the first dose of MMR II (lot# 618617/0734D) subcutaneously into his right arm on the same day. The physician reported that on 08-JAN-2011 about 30 lesions (previously reported as "blisters") that went thru weepy and crusted stage itchy. The patient had enlarged lymph node (LN) with fever 101-102. It also reported that both parents were diagnosed shingles for few days before this patient's reaction (RXN). The patient had throat culture test for strep which was negative; "quick and plate". On 20-JAN-2011 (previously reported as "18-JAN-2011"), the patient recovered from the events. The patient sought medical attention via doctor visit. This is one of several reports received from the same source. No further information is available.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Information has been received from a physician concerning a 30 month old male patient who was vaccinated with one dose of VARIVAX (Merck) when he was 1 year old in approximately August 2009. Sometime in past two weeks in approximately January 2011 the patient developed shingles. Patient developed the rash on right thigh where the VARIVAX (Merck) was administered. The patient sought unspecified medical attention. No treatment was given. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 1.58
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Diarrhoea, Injection site erythema, Injection site infection, Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a consumer concerning her 19 month old son no pertinent medical history and with milk allergy and possibly egg whites uncooked allergy, who in the past received a dose of DTaP with no adverse symptoms noted. On 15-APR-2010 was vaccinated with a dose of VARIVAX (Merck) in his left arm (dose, lot number and route not reported). Concomitant vaccine included DTaP (manufacturer unknown) on the same day (15-APR-2010) in his right arm. On 22-APR-2010 the patient experienced a large, red swollen area on his left arm, fever and diarrhea. Over the next day or two the area on his arm became larger with a swirl like "hurricane like" pattern to it. On 26-APR-2010, the patient was seen by a physician. The area of his arm looked like it was "pus filled". The patient was treated with an unnamed antibiotic and "it completely stripped his digestive system" with diarrhea and loose stools. Stool cultures 3 times were negative, no parasites found, the patient remained without formed stools which were continuing to 26-JUL-2010 and he still had a red mark on his left arm. He would see his pediatrician on 27-JUL-2010 and possibly an allergist. Follow-up information has been received from a physician concerning a male patient with allergies to cats, dogs and amoxicillin who on 15-APR-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot n. 666486/1647Y), subcutaneously in his left arm. Concomitant therapy included a fourth dose of INFANRIX (lot n. C3380AA), IM in the right arm. Reporter stated that mother called from out of state on 16-APR-2010. Patient had rash on left arm, warm to touch. It was recommended to see a local doctor. Patient was seen at the reporting physician's office on 10-MAY-2010 and the patient was healing from a skin lesion on left arm. This date, the patient recovered from rash on left arm and warm to touch. Additional information is not expected.
Age: 1.58
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Injection site swelling, Injection site warmth, Parasite stool test negative, Pyrexia, Skin lesion
Clinical narrative: Information has been received from a consumer concerning her 19 month old son no pertinent medical history and with milk allergy and possibly egg whites uncooked allergy, who in the past received a dose of DTaP with no adverse symptoms noted. On 15-APR-2010 was vaccinated with a dose of VARIVAX (Merck) in his left arm (dose, lot number and route not reported). Concomitant vaccine included DTaP (manufacturer unknown) on the same day (15-APR-2010) in his right arm. On 22-APR-2010 the patient experienced a large, red swollen area on his left arm, fever and diarrhea. Over the next day or two the area on his arm became larger with a swirl like "hurricane like" pattern to it. On 26-APR-2010, the patient was seen by a physician. The area of his arm looked like it was "pus filled". The patient was treated with an unnamed antibiotic and "it completely stripped his digestive system" with diarrhea and loose stools. Stool cultures 3 times were negative, no parasites found, the patient remained without formed stools which were continuing to 26-JUL-2010 and he still had a red mark on his left arm. He would see his pediatrician on 27-JUL-2010 and possibly an allergist. Follow-up information has been received from a physician concerning a male patient with allergies to cats, dogs and amoxicillin who on 15-APR-2010 was vaccinated with the first dose of VARIVAX (Merck) (lot n. 666486/1647Y), subcutaneously in his left arm. Concomitant therapy included a fourth dose of INFANRIX (lot n. C3380AA), IM in the right arm. Reporter stated that mother called from out of state on 16-APR-2010. Patient had rash on left arm, warm to touch. It was recommended to see a local doctor. Patient was seen at the reporting physician's office on 10-MAY-2010 and the patient was healing from a skin lesion on left arm. This date, the patient recovered from rash on left arm and warm to touch. Additional information is not expected.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Laboratory test abnormal, Pain in extremity, Pyrexia, Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 4.5 year old male with no history of chicken pox who in approximately 2003, reported as "at 13 months of age", was vaccinated with a dose of VARIVAX (Merck) and was healthy with no medical condition. "4 years ago", in February 2007 when the patient was 4.5 years old, he experienced 102 fever with left arm pain of unknown etiology and subsequently developed shingles on the left side of his body from neck to left wrist. The physician sent in the vesicle to CDC and it was confirmed as Merck strain. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Axillary mass, Blister, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old female patient who on 19-JUL-2010 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot number 666344/1657Y, expiring on 25-NOV-2011) SC, a 0.5 ml dose of ADACEL (Lot number C3382AA, expiring on 25-FEB-2010) IM at a separate injection site in the right arm, and a 0.5 ml dose of MMR II (HAS, Lot number 666248/1567Y, expiring on 06-NOV-2011) SC to her left arm. Concomitant medications included blood pressure medication (unspecified). On 20-JUL-2010 within 24 hours the patient reported developing a large, swollen, hot, pink to red area centered on the VARIVAX (Merck) injection site, that was growing in size. The nurse advised her to use cool compresses. On Friday, 23-JUL-2010 the patient reported a blisterlike rash on both of her legs, as well as fever and swollen lymph nodes in the right armpit. Nurse saw patient on Monday, 26-JUL-2010 and reported that the rash on the legs seemed to have cleared up to series of bright red dots, and that the fever had resolved, and that the swollen lymph node had returned to a normal size. Follow up information has been received from an other health professional indicated that the patient had never been seen at their clinic nor their hospital from what the health professional could tell. The health professional asked if we were sure it was one of their providers. Follow up information has been received from a physician reported that the patient was not their patient. Follow up information has been received from the registered nurse concerning the 46 year old female (also reported as 47 year old) patient who on 19-JUL-2010 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (Lot number 666344/1657Y, expiring on 25-NOV-2011) subcutaneously in the right arm around noon, the sixth booster 0.5 ml dose of ADACEL (Lot number C3382AA, expiring on 25-FEB-2010) intramuscularly at a separate injection site in the right deltoid at noon, and the third 0.5 ml dose of MMR II (HAS, Lot number 666248/1567Y, expiring on 06-NOV-2011) subcutaneously to her left arm at noon. On 20-JUL-2010 the patient complained of pain and fever at VARIVAX (Merck) injection site (right arm) - large area red, hot and swollen. On 21-JUL-2010 redness increased in length 8 to 10 inches in length. On 23-JUL-2010 lump was noted in right armpit and was very tender. Patient still complained of low fever and blistered like rash at lower legs. The patient was recommended to have BENADRYL as directed and CALADRYL lotion to legs. If the symptoms were worse the patient was advised to consult with emergency room physician. There were no lab diagnostic tests performed. The patient recovered on 03-AUG-2010 after approximately 2 weeks. Additional information is not expected.
Age: 46.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Injection site warmth, Lymph node pain, Lymphadenopathy, Pyrexia, Rash erythematous
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old female patient who on 19-JUL-2010 was vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot number 666344/1657Y, expiring on 25-NOV-2011) SC, a 0.5 ml dose of ADACEL (Lot number C3382AA, expiring on 25-FEB-2010) IM at a separate injection site in the right arm, and a 0.5 ml dose of MMR II (HAS, Lot number 666248/1567Y, expiring on 06-NOV-2011) SC to her left arm. Concomitant medications included blood pressure medication (unspecified). On 20-JUL-2010 within 24 hours the patient reported developing a large, swollen, hot, pink to red area centered on the VARIVAX (Merck) injection site, that was growing in size. The nurse advised her to use cool compresses. On Friday, 23-JUL-2010 the patient reported a blisterlike rash on both of her legs, as well as fever and swollen lymph nodes in the right armpit. Nurse saw patient on Monday, 26-JUL-2010 and reported that the rash on the legs seemed to have cleared up to series of bright red dots, and that the fever had resolved, and that the swollen lymph node had returned to a normal size. Follow up information has been received from an other health professional indicated that the patient had never been seen at their clinic nor their hospital from what the health professional could tell. The health professional asked if we were sure it was one of their providers. Follow up information has been received from a physician reported that the patient was not their patient. Follow up information has been received from the registered nurse concerning the 46 year old female (also reported as 47 year old) patient who on 19-JUL-2010 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) (Lot number 666344/1657Y, expiring on 25-NOV-2011) subcutaneously in the right arm around noon, the sixth booster 0.5 ml dose of ADACEL (Lot number C3382AA, expiring on 25-FEB-2010) intramuscularly at a separate injection site in the right deltoid at noon, and the third 0.5 ml dose of MMR II (HAS, Lot number 666248/1567Y, expiring on 06-NOV-2011) subcutaneously to her left arm at noon. On 20-JUL-2010 the patient complained of pain and fever at VARIVAX (Merck) injection site (right arm) - large area red, hot and swollen. On 21-JUL-2010 redness increased in length 8 to 10 inches in length. On 23-JUL-2010 lump was noted in right armpit and was very tender. Patient still complained of low fever and blistered like rash at lower legs. The patient was recommended to have BENADRYL as directed and CALADRYL lotion to legs. If the symptoms were worse the patient was advised to consult with emergency room physician. There were no lab diagnostic tests performed. The patient recovered on 03-AUG-2010 after approximately 2 weeks. Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site urticaria
Clinical narrative: Information has been received from a Registered Nurse concerning a 9 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-FEB-2011 was vaccinated with second dose of VARIVAX (Merck) (lot no. 668454/1043Z, exp date 11-APR-2012) 0.5 mL subcutaneously in the left arm. The patient received the first dose of VARIVAX (Merck) on 14-OCT-2002. On an unspecified date, the patient developed a 3 inch in diameter, red, swollen, hive like (rather than cellulitis) injection site reaction that was painful and itchy (no rash noted) following the second vaccination with VARIVAX (Merck). The patient was seen in the office on 10-FEB-2011 and was told to ice the area. No laboratory diagnostics studies were performed. No improvement to the injection site reaction was noted on 11-FEB-2011. At the time of this report, the patient's outcome was not recovered. Additional information has been requested.
Age: 1.81
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Local reaction, Pruritus, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 21 month old female patient who on 10-FEB-2011 was vaccinated SC into right arm with the first dose of VARIVAX (Merck) (lot # 667814/1307Z) at 16:00. Concomitant therapy included the first dose of MMR II (MSD) (lot # 668987/1249Z) given SC into left arm at 16:00. On 10-FEB-2011 the patient experienced local reaction immediate to subcutaneous (subQ) injection to deltoid, large, hive-like swelling-seemingly itchy. No systemic symptoms. The patient was given BENADRYL, and observed for 30-40 minutes. Redness and swelling had gone by discharge from office. The patient experienced identical reaction to MMR II (MSD, WAES # 1102USA01867) given opposite deltoid subcutaneous (subQ). Additional information has been requested.
Age: 1.81
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 21 month old female patient who on 10-FEB-2011 was vaccinated SC into right arm with the first dose of VARIVAX (Merck) (lot # 667814/1307Z) at 16:00. Concomitant therapy included the first dose of MMR II (MSD) (lot # 668987/1249Z) given SC into left arm at 16:00. On 10-FEB-2011 the patient experienced local reaction immediate to subcutaneous (subQ) injection to deltoid, large, hive-like swelling-seemingly itchy. No systemic symptoms. The patient was given BENADRYL, and observed for 30-40 minutes. Redness and swelling had gone by discharge from office. The patient experienced identical reaction to MMR II (MSD, WAES # 1102USA01867) given opposite deltoid subcutaneous (subQ). Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a consumer concerning her 23 month old niece who a few years ago was vaccinated with a 0.5 ml dose of VARIVAX (Merck). The consumer reported that her niece was diagnosed with shingles lesion on forehead on 26-JUL-2010. At the time of the report the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a Medical Assistant concerning a patient who on 28-JUL-2010, was inadvertently vaccinated SQ with a dose of VARIVAX (Merck) (Lot#: not reported) instead of ZOSTAVAX (Merck). No adverse effect was reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a registered nurse concerning 4 patients who on 28-JUL-2010 were vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) instead ZOSTAVAX (Merck). No adverse events were reported. It was unknown if the patients sought medical attention. Follow-up information was received from the registered nurse on a phone call. She was unable to provide any patient information: patient name, date of birth and neither lot number. All patients will be revaccinated with ZOSTAVAX (Merck) on 28-AUG-2010. The vaccine mix up occurred due to human error and the VARIVAX (Merck) and ZOSTAVAX (Merck) were now clearly separated. Follow-up information was received from the registered nurse which reported that on 21-JUL-2010 at 4 p.m, the patients were vaccinated subcutaneously into the left arm with a dose of VARIVAX (Merck) (Lot # 665907/1605Y). No adverse reactions reported by the patients. No further information is available.
Sex: M
Vaccine: IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction
Clinical narrative: Information has been received from a medical assistant concerning a male who was vaccinated with a dose of VARIVAX (Merck) and a dose of  MMR II (MSD). Concomitant therapy included a dose of poliovirus vaccine (manufacturer unknown). Subsequently the patient developed severe local site reaction 2 days after vaccination. The site was red and swollen, but the patient had no fever. It was not a cellulitis. The patient received unspecified medical attention. The patient had not recovered at time of reporting. No further information is available.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Oral herpes
Clinical narrative: Information has been received from a school nurse concerning her 12 year old daughter who on 22-JUL-2010 was vaccinated with a dose of VARIVAX (Merck) (lot # 666733/0066Z). On 22-JUL-2010 the patient experienced redness and swelling at the injection site. On 26-JUL-2010 the patient came down with bad fever blister and her physician put her on ABREVA. The patient went to the doctor's office. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Dermatitis diaper, Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient who on 19-JUL-2010 was vaccinated SQ with a first dose of VARIVAX (Merck) (Lot# 666821/0223Z). Concomitant therapy included MMR II (Lot# unknown) and HIB (Lot# unknown). The physician reported that the patient received VARIVAX and was brought back in on 28-JUL-2010 because the baby had a fever and a really bad diaper rash. When the physician examined the patient he noticed a knot on the patient's leg from where he gave VARIVAX and asked the mother about it. The mother informed the physician that the knot was much worse, it was huge and red and swollen with blisters (onset reported as "shortly after getting the vaccine", approximately 19-JUL-2010). At the time of the report, the patient was recovering. The physician was concerned with the lot. The patient sought medical attention by a doctor visit. This is one of several reports from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up was received from a physician who reported that the patient with no pre-existing allergies, no birth defects and no medical conditions who on 19-JUL-2010, was vaccinated SQ in the right deltoid with the first dose of VARIVAX (Merck) (666821/0223Z) at 15:30. On the same day, the patient was vaccinated SQ in the left deltoid with the first dose of MMR II (Lot# 1740V) at 15:30. There was no illness at the time of vaccination. The physician stated that the patient had 3cm of erythema, swollen, hot and tender in thigh. It last for more than one week. At the time of the report, the patient recovered. No further information is available.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site vesicles, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 12 month old female patient who on 19-JUL-2010 was vaccinated SQ with a first dose of VARIVAX (Merck) (Lot# 666821/0223Z). Concomitant therapy included MMR II (Lot# unknown) and HIB (Lot# unknown). The physician reported that the patient received VARIVAX and was brought back in on 28-JUL-2010 because the baby had a fever and a really bad diaper rash. When the physician examined the patient he noticed a knot on the patient's leg from where he gave VARIVAX and asked the mother about it. The mother informed the physician that the knot was much worse, it was huge and red and swollen with blisters (onset reported as "shortly after getting the vaccine", approximately 19-JUL-2010). At the time of the report, the patient was recovering. The physician was concerned with the lot. The patient sought medical attention by a doctor visit. This is one of several reports from the same source. A preliminary lot check investigation was performed. To date our investigation has found that this lot conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX (Merck). Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up was received from a physician who reported that the patient with no pre-existing allergies, no birth defects and no medical conditions who on 19-JUL-2010, was vaccinated SQ in the right deltoid with the first dose of VARIVAX (Merck) (666821/0223Z) at 15:30. On the same day, the patient was vaccinated SQ in the left deltoid with the first dose of MMR II (Lot# 1740V) at 15:30. There was no illness at the time of vaccination. The physician stated that the patient had 3cm of erythema, swollen, hot and tender in thigh. It last for more than one week. At the time of the report, the patient recovered. No further information is available.
Age: 37.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash generalised, Rash papular
Clinical narrative: Information has been received from a physician's assistant concerning a 37 year old female patient who on 16-JUL-2010 was vaccinated with a 0.5mL dose of VARIVAX (Merck) (Lot number 665582/1232Y) (Expiration date: 27-AUG-2011). The physician's assistant reported that on 18-JUL-2010 the patient experienced rash all over his body. On 31-JUL-2010, the patient was seen in the office by physician's assistant and he noted a red rash with one mm papules covering the entire body. Patient had pruritus. Physician's assistant provided betamethasone cream and had not heard back from patient since. At the time of the report, the patient's outcome was unknown. The patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Anaemia, Drug exposure during pregnancy, Foetal growth restriction, Ultrasound scan, Urinary tract infection
Clinical narrative: Information has been received from a registered nurse, for VARIVAX (Merck) and GARDASIL, Pregnancy Registry products, concerning a female who on 21-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported) and a dose of GARDASIL (lot#, route and site of administration not reported) while pregnant. Concomitant therapy included MENACTRA. No adverse effect was reported. Unspecified medical attention was sought. It was unspecified if laboratory diagnostics studies were performed. Follow up information has been received from a registered nurse concerning the 14 year old patient who on 21-AUG-2009 was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). Other medications used during pregnancy included prenatal vitamins, ferrous sulfate for anemia, and MACROBID for urinary tract infection (UTI) (02-NOV-2009 to 09-NOV-2009 and 17-FEB-2010 to 24-FEB-2010). Ultrasound was performed respectively on 02-DEC-2009, 09-MAR-2010, 26-MAR-2010, 06-APR-2010 and 13-APR-2010 to analyzing size, Intrauterine growth restriction (IUGR). On 03-MAY-2010, 41 weeks from LMP (18-JUL-2009) the patient delivered a normal male infant. The patient had no complication during pregnancy or labor/delivery. There was no diagnostic test performed during pregnancy. There were no infections or illness during pregnancy. Follow up information has been received from the consumer who stated that her baby "is fine and he's healthy and he's very strong". Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARCEL
Symptoms: Accidental exposure, No adverse event
Clinical narrative: Information has been received from a physician assistant concerning a 74 year old female patient who on 04-FEB-2010 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). Physician assistant stated that no adverse effect. Additional information has been requested. This is one of several reports from the same source.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Activities of daily living impaired, Drug exposure during pregnancy, Thrombosis, Ultrasound scan normal, Vaginal haemorrhage
Clinical narrative: Information has been received from a healthcare worker, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 39 year old female patient with no medical and no allergies who on 22-FEB-2010 was vaccinated with a single 0.5 ml dose of VARIVAX (Merck) (lot # 665587/1203Y). There was no concomitant medication. On 22-FEB-2010 the consumer received VARIVAX (Merck) inadvertently while being pregnant. The patient's LMP was "about 5 months" in approximately September 2009, and expected date of delivery date was in approximately July 2010. The patient sought medical attention by "office called her". Follow-up information has been received from the healthcare worker concerning the 39 year old female with a history of 8 pregnancies, 3 live births, stillbirth or miscarriage occurrence (<12 weeks), no birth defect occurrence in previous pregnancy and no illness at time of vaccination who on 22-FEB-2010 at 12:00 was vaccinated SQ with a dose of VARIVAX (Merck) (lot # 665587/1203Y) in her left arm. The patient was 5 month pregnant and was given VARIVAX (Merck). The patient was seen by a doctor on 24-FEB-2010. It was unknown if the patient was tested for varicella antibodies before vaccination with VZV containing vaccine. On 09-MAR-2010, ultrasound was performed due to vaginal bleeding and the result was normal with some clot, off work for 1 week then reevaluated next week. Maternal serum-alpha-fetoprotein (MSAFP) was declined. It was unknown if the patient had local reaction at vaccination site. It was unknown if the patient had varicella (chickenpox) symptoms or herpes zoster (shingles) symptoms post vaccination. Follow-up information has been received from a registered nurse in the obstetrician/gynecologist (OB/GYN) office. The patient was an established patient (last office visit in August 2010). The patient had been "fired" from the practice due to a very large financial matter. The consumer's chart had been frozen with no access. No additional information was available. Additional information was received from a receptionist in the patient's primary care physician's office who reported the patient's last office visit was in November 2008. The patient was not given the VARIVAX (Merck) at this physician's office. The patient was now considered lost of follow-up (LTF). Additional information is not expected.
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Pyrexia, Scab, Urticaria, Varicella
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old female patient with no pertinent medical history or allergies who on 07-NOV-2000 was vaccinated with the first 0.5ml dose of VARIVAX (Merck) (lot# not reported). On 08-NOV-2008 the patient was vaccinated with the second 0.5ml dose of VARIVAX (Merck) (lot# 660823/0421X). There was no concomitant medication. On 22-MAR-2010 the patient developed chickenpox. The patient presented with approximately 30 "dots" on her abdomen, arm and left upper thigh along with some fever. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. At the time of this report, the patient's chickenpox had not recovered. Follow up information has been received from the Registered Nurse who reported that the patient was re-examined last week (approximately on 15-APR-2010) and was recovering. All of her blisters were scabbed over most and most were gone. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a 78 year old female patient who on 04-FEB-2010 was inadvertently vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck). Physician assistant stated that no adverse effect. Additional information has been requested. This is one of several reports from the same source.
Age: 50.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test, Herpes zoster, Wrong drug administered
Clinical narrative: Information has been received from a licensed registered nurse concerning a 50 year old female with sulfonamide allergy and a history of shingles multiple times in the past, who on 16-SEP-2009 was inadvertently vaccinated with a dose of VARIVAX (Merck) (lot # 664327/0778Y). ZOSTAVAX (Merck) was the intended vaccine. On 12-MAR-2010 the patient had another outbreak of shingles. The reporter stated that this was not a product confusion, but staff error. Relevant test included varicella titer, result not reported. The patient had visited office. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a 72 year old male consumer who intended to have ZOSTAVAX (Merck) for prevention of shingles but on 23-FEB-2010 was vaccinated with a dose VARIVAX (Merck) accidently at his physician's office. It was reported that the product field was incorrectly populated by original case owner and should state "VARIVAX" No additional adverse information given. It was unknown if the patient sought medical attention. No further information is available.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Fatigue, Headache, Nausea, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 39 year old female patient with hypertension and depression, no known drug allergies and a history of gastric disorder who on 02-MAR-2010 was vaccinated subcutaneously with VARIVAX (Merck) (lot# 665992/1402Y). Concomitant therapy included lisinopril, omeprazole (MSD) and "DREN". On 13-MAR-2010 the patient experienced a mild varicella-like rash on her trunk area, body aches, fatigue, headache and a loss of appetite after receiving her first dose of VARIVAX (Merck). The patient sought unspecified medical attention. The results of the VZV titer was negative which were performed prior to receiving VARIVAX (Merck). On 22-MAR-2010, the patient recovered from these events. Follow-up information has been received from the registered nurse concerning a Records Clerk who on 02-MAR-2010 was vaccinated subcutaneously with a first dose of VARIVAX (Merck). On 13-MAR-2010, the patient developed generalized body rash, body aches, nausea, and itching. On an unspecified date, the patient recovered from these events. No further information is available.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a 39 year old female patient with hypertension and depression, no known drug allergies and a history of gastric disorder who on 02-MAR-2010 was vaccinated subcutaneously with VARIVAX (Merck) (lot# 665992/1402Y). Concomitant therapy included lisinopril, omeprazole (MSD) and "DREN". On 13-MAR-2010 the patient experienced a mild varicella-like rash on her trunk area, body aches, fatigue, headache and a loss of appetite after receiving her first dose of VARIVAX (Merck). The patient sought unspecified medical attention. The results of the VZV titer was negative which were performed prior to receiving VARIVAX (Merck). On 22-MAR-2010, the patient recovered from these events. Follow-up information has been received from the registered nurse concerning a Records Clerk who on 02-MAR-2010 was vaccinated subcutaneously with a first dose of VARIVAX (Merck). On 13-MAR-2010, the patient developed generalized body rash, body aches, nausea, and itching. On an unspecified date, the patient recovered from these events. No further information is available.
Age: 13.0
Sex: U
Vaccine: VARCEL
Symptoms: Erythema, Skin warm, Swelling, Vasculitis
Clinical narrative: Information has been received from a physician concerning a 13 year old patient with obesity and had no known allergies who on 15-MAR-2010 was vaccinated subcutaneously in left arm with the second 0.5 mL dose of VARIVAX (Merck) (LOT# 665692/1297Y). The office was contacted on 16-MAR-2010 regarding patient and examined the patient in office on 17-MAR-2010 and 19-MAR-2010. The patient was diagnosed with localized vasculitis with topical infection. The area was 12cm of dark pink and 5cm of deep red in the center. The area was swollen and warm. Patient was treated with BACTRIM DS one tablet daily for 10 days. Patient did seem to be improving. No serious intervention needed. This is one of the two reports from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Information has been received from an office nurse concerning her now 11 year old daughter with significant allergies and allergic to antibiotics (names were unspecified) who was vaccinated with the second dose of VARIVAX (Merck) when she was 9 years old. After receiving the second dose of VARIVAX (Merck) the patient had a large local reaction at the injection site that went from the shoulder to the elbow. The nurse did not mention what arm the vaccine was given in. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 26-MAR-2010 was vaccinated SC with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). There were no adverse events reported. All telephone attempts to contact the reporter have been unsuccessful. Additional information has been received from a nurse indicated she had the form and would fax it to our company after she filled it out. Follow-up information has been received from a registered nurse concerning the 60 year old female patient with no illness at time of vaccination and LIPITOR allergy caused muscle ache and left breast mass, depression, colonic polyp and skin rash who on 26-MAR-2010 at 09:30 was vaccinated SC into the left deltoid with the first dose of VARIVAX (Merck) (Lot# 665583/1207Y) and vaccinated SC in the right arm with the first dose of ZOSTAVAX (Merck) (Lot# 664444/0722Y) at a community Health Center. The patient had no adverse event. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Nausea, Pain in extremity
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old male with no pertinent medical history and no drug allergies, who on 12-JUL-2010 was vaccinated with VARIVAX (Merck) (lot # 658936/1350U), MMR II (MSD), and DTaP. The patient's mother reported to the office that on 12-JUL-2010 the patient experienced nausea and leg pains and was given MOTRIN and was feeling better. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. Additional information has been requested.