chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Lip pain
Clinical narrative: Information has been received from a 68 year old female on 13-NOV-2007 was vaccinated with ZOSTAVAX (Merck). On 14-NOV-2007 the patient experienced a sore on her lower lip that looked white and painful. At the time of report the patient said "the sore on her lip has improved a little bit but its still there." The patient is recovering from the sore on her lower lip. The patient sought medical attention by calling the physician. Additional information has been requested. Follow-up information has been received from the patient with no known drug reactions/allergies reported. The sore on her lip went way after one week (approximately 21-NOCV-2008). No additional information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female with no allergies who on 13-NOV-2007 received a 0.65 ml subcutaneous dose of ZOSTAVAX (lot# 658361/1090U). There was no concomitant medication. On 15-NOV-2007 she developed reddness at injection site and the area was hot to touch. The patient contacted the pharmacist. Further medical attention and/or treatment was not reported. A product quality complaint was not reported. Additional information was not available. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Injection site erythema, Injection site pain, Pain
Clinical narrative: Information has been received from an 84 year old female consumer with no pertinent medical history and no drug reactions/allergies, who on 09-NOV-2007 was vaccinated SC with a .65 mL dose of ZOSTAVAX (Merck). Concomitant medication included "blood pressure medication" (manufacturer unknown). On 11-NOV-207 the patient developed "red spots" on her arm at injection site. At first it was a "stabbing pain" and then a "burning pain" and later progressed to " a lot of pain". The patient stated that the adverse event did not improve. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/23/2007; 3/26/2008. Information has been received from an 84-year-old female consumer with no pertinent medical history and no drug reactions/allergies, who on 09-NOV-2007 was vaccinated subcutaneously with 0.65 mL dose of ZOSTAVAX (Merck). Concomitant medication included "blood pressure medication" (manufacturer unknown). On 11-NOV-2007 the patient developed "red spots" on her arm at the injection site. At first it was "stabbing pain" and then it was "burning pain" and later progressed to "a lot of pain". The patient stated that the adverse event did not improve. There were no lab diagnostics studies performed. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information has been received from the physician concerning a patient with allergies to penicillin and sulfa who was vaccinated in the AM on 09-NOV-2007 in the left arm with a first dose of ZOSTAVAX (Merck) (lot# 65862/1415U). Concomitant medications included DIOVAR, Verapamil, "hyorclatine" and "spirivc". On 12-NOV-2007 the patient presented with shingles along the right chest wall. It was unspecified if the patient sought medical attention via the emergency room or a doctor visit. On an unspecified date the patient recovered.
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information  has been received from a pharmacist concerning a patient who on 12-NOV-2007 was vaccinated with a .65 mL dose of ZOSTAVAX. On 12-NOV-2007 the patient developed a slight rash all over. No further information was reported. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Stomatitis
Clinical narrative: Information has been received from a physician concerning a 60 year old male with a history of  mouth sores who was vaccinated with a dose of ZOSTAVAX and developed "prolonged mouth sores". No further information was provided regarding this adverse experience. Unspecified medical attention was sought. The outcome was reported as recovered. There was no product quality complaint. Additional information is expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning an 81 year old female who on approximately 12-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (lot# 658208/0886U). On approximately 30-OCT-2007 about two weeks later, the patient broke out in shingles. On 31-OCT-2007 the patient came to the physician's office and was diagnosed with ophthalmic zoster. "The patient was prescribed FAMVIR and was referred to an eye doctor." The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a consumer who was vaccinated with a dose of ZOSTAVAX. Subsequently the patient developed injection site warmth, swelling and bruising. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture positive, Herpes simplex, Herpes zoster, Laboratory test, Pain
Clinical narrative: Information has been received from a physician concerning a 62 year old female with no pertinent medical history or drug allergies who vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. Subsequently the patient developed shingles "7-8 days after immunization with ZOSTAVAX." Medical attention was sought in the physician's office. Lab diagnostic studies performed included lesions that were cultured which revealed a positive result for HSV-type 1. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.  Follow-up information has been received from the reporting physician indicating that the 62 year old retired female with a history of chickenpox during childhood who on 15-OCT-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 656859/0357U) in the right arm. There was no illness at the time of vaccination. On 27-OCT-2007 the patient developed a rash of 24 to 36 lesions over her left breast/flank consistent with herpes zoster for a 2 week duration. It was noted that there was no recent exposure to chickenpox or herpes zoster. The patient had a moderate pain intensity level of 4. No treatment was given. On 15-NOV-2007 the patient was recovered. The sample of the lesion was collected on 08-NOV-2007. The sample was taken from a vesicular lesion on the flank. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 62 year old female with no pertinent medical history or drug allergies who vaccinated with a dose of ZOSTAVAX. There was no concomitant medication. Subsequently the patient developed shingles "7-8 days after immunization with ZOSTAVAX." Medical attention was sought in the physician's office. Lab diagnostic studies performed included lesions that were cultured which revealed a positive result for HSV-type 1. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.  Follow-up information has been received from the reporting physician indicating that the 62 year old retired female with a history of chickenpox during childhood who on 15-OCT-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 656859/0357U) in the right arm. There was no illness at the time of vaccination. On 27-OCT-2007 the patient developed a rash of 24 to 36 lesions over her left breast/flank consistent with herpes zoster for a 2 week duration. It was noted that there was no recent exposure to chickenpox or herpes zoster. The patient had a moderate pain intensity level of 4. No treatment was given. On 15-NOV-2007 the patient was recovered. The sample of the lesion was collected on 08-NOV-2007. The sample was taken from a vesicular lesion on the flank. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye irritation, Eye pain, Eye pruritus, Eyelid irritation
Clinical narrative: Initial and follow up information has been received from a physician concerning a 65 year old female, with a history of childhood chickenpox, lipids, hypothyroidism and osteoporosis and no known drug allergies who was vaccinated into the left arm on 12 NOV 2007 at 11:15 with a first dose of ZOSTAVAX (Merck) (Lot # 658361/1090U). Concomitant therapy included ZOCOR, SYNTHROID, alendronate sodium (MSD), ezetimibe (+) simvastatin (MSD) and PREVACID, PROMETRIUM, VIVELLE-DOT. On 15-NOV-2007 the patient stated that the outer edge of her right eye was red, itchy and sensitive and her eyelids bothered her. The patient developed a single vesicle at the lateral margin of her eye. The patient also developed numbness of the cheek below the effected eye. No treatment was initiated. On 16-NOV-2007 the patient reported that the pain around her eye had worsened and she has a blister on the outer edge. The consumer stated that the pain moved from her eye to her mouth. Unspecified medical attention was sought. The consumer reported that on 16-NOV-2007 her eye was starting to get better and the pain was starting to subside. The consumer also reported that in approximately September 2007 she went to another country and was vaccinated with hepatitis A virus vaccine inactivitated (manufacturer unknown) (which she took before and after the trip). The physician stated that "the patient was diagnosed with shingles since the vesicle was located in the dermatomal distribution of the trigeminal nerve (maxillary)". The physician reported that the patient had no recent exposure to chickenpox or shingles. There was no reported illness at the time of vaccination. VZV1P program information was provided, though at the time of reporting the physician was unable to obtain a specimen. No lab diagnostic studies were performed. There was no product quality complaint. At the time of reporting the patient was considered recovered on 21 NOV 2007. This is one several reports received from the same source. Additional information is not expected. This is a consolidation of two reports concerning the same patient. Follow up information has been received on 15-JAN-2008 from a consumer who reported that she developed a mild case of shingles in her right eye and numbness in her right cheek. No further information provided. This is a consolidation of two reports concerning the same patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia facial, Hypothyroidism, Lipids, Ocular hyperaemia
Clinical narrative: Initial and follow up information has been received from a physician concerning a 65 year old female, with a history of childhood chickenpox, lipids, hypothyroidism and osteoporosis and no known drug allergies who was vaccinated into the left arm on 12 NOV 2007 at 11:15 with a first dose of ZOSTAVAX (Merck) (Lot # 658361/1090U). Concomitant therapy included ZOCOR, SYNTHROID, alendronate sodium (MSD), ezetimibe (+) simvastatin (MSD) and PREVACID, PROMETRIUM, VIVELLE-DOT. On 15-NOV-2007 the patient stated that the outer edge of her right eye was red, itchy and sensitive and her eyelids bothered her. The patient developed a single vesicle at the lateral margin of her eye. The patient also developed numbness of the cheek below the effected eye. No treatment was initiated. On 16-NOV-2007 the patient reported that the pain around her eye had worsened and she has a blister on the outer edge. The consumer stated that the pain moved from her eye to her mouth. Unspecified medical attention was sought. The consumer reported that on 16-NOV-2007 her eye was starting to get better and the pain was starting to subside. The consumer also reported that in approximately September 2007 she went to another country and was vaccinated with hepatitis A virus vaccine inactivitated (manufacturer unknown) (which she took before and after the trip). The physician stated that "the patient was diagnosed with shingles since the vesicle was located in the dermatomal distribution of the trigeminal nerve (maxillary)". The physician reported that the patient had no recent exposure to chickenpox or shingles. There was no reported illness at the time of vaccination. VZV1P program information was provided, though at the time of reporting the physician was unable to obtain a specimen. No lab diagnostic studies were performed. There was no product quality complaint. At the time of reporting the patient was considered recovered on 21 NOV 2007. This is one several reports received from the same source. Additional information is not expected. This is a consolidation of two reports concerning the same patient. Follow up information has been received on 15-JAN-2008 from a consumer who reported that she developed a mild case of shingles in her right eye and numbness in her right cheek. No further information provided. This is a consolidation of two reports concerning the same patient.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral pain, Osteoporosis
Clinical narrative: Initial and follow up information has been received from a physician concerning a 65 year old female, with a history of childhood chickenpox, lipids, hypothyroidism and osteoporosis and no known drug allergies who was vaccinated into the left arm on 12 NOV 2007 at 11:15 with a first dose of ZOSTAVAX (Merck) (Lot # 658361/1090U). Concomitant therapy included ZOCOR, SYNTHROID, alendronate sodium (MSD), ezetimibe (+) simvastatin (MSD) and PREVACID, PROMETRIUM, VIVELLE-DOT. On 15-NOV-2007 the patient stated that the outer edge of her right eye was red, itchy and sensitive and her eyelids bothered her. The patient developed a single vesicle at the lateral margin of her eye. The patient also developed numbness of the cheek below the effected eye. No treatment was initiated. On 16-NOV-2007 the patient reported that the pain around her eye had worsened and she has a blister on the outer edge. The consumer stated that the pain moved from her eye to her mouth. Unspecified medical attention was sought. The consumer reported that on 16-NOV-2007 her eye was starting to get better and the pain was starting to subside. The consumer also reported that in approximately September 2007 she went to another country and was vaccinated with hepatitis A virus vaccine inactivitated (manufacturer unknown) (which she took before and after the trip). The physician stated that "the patient was diagnosed with shingles since the vesicle was located in the dermatomal distribution of the trigeminal nerve (maxillary)". The physician reported that the patient had no recent exposure to chickenpox or shingles. There was no reported illness at the time of vaccination. VZV1P program information was provided, though at the time of reporting the physician was unable to obtain a specimen. No lab diagnostic studies were performed. There was no product quality complaint. At the time of reporting the patient was considered recovered on 21 NOV 2007. This is one several reports received from the same source. Additional information is not expected. This is a consolidation of two reports concerning the same patient. Follow up information has been received on 15-JAN-2008 from a consumer who reported that she developed a mild case of shingles in her right eye and numbness in her right cheek. No further information provided. This is a consolidation of two reports concerning the same patient.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 74 year old female  with asthma who on 17-NOV-2007 received a subcutaneous dose in her arm of ZOSTAVAX. Concomitant therapy included ADVAIR and montelukast sodium (MSD), the patient developed an injection reaction reported as swelling and an erythema at the injection site with a fever in the evening of 17-NOV-2007. The swelling was described as around four inches in diameter with the erythema around two inches in diameter both at the injection site. It was reported that she had a fever of 100.2 degrees Fahrenheit through 18-NOV-2007. As of 19-NOV-2007. As of 19-NOV-2007, it was reported that the swelling and erythema was unchanged. Further information was not available. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old female with allergy to "everything" and a history of lupus who on 16-NOV-2007 was vaccinated SC with a single dose of ZOSTAVAX (lot # 658602/1080U). There was no concomitant medication. On 16-NOV-2007, after vaccination the patient developed injection site reaction. It was reported that the redness at the injection site was initially the size of "teacup saucer", but it subsided to the size of baseball. At the time of report the patient was recovering. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information has been received from a 79 year old female with celecoxib allergy, "CIPERAL" allergy, latex tape allergy and sulfonamide allergy and a history of cardiac pacemaker insertion, neuropathy, hip replacement, knee arthroplasty, colostomy and hernia operations who in November 2006, was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included famciclovir and "HYDROCODIENE". In November 2007, the patient experienced outbreak of shingles. It was reported that the patient's physician was almost certain to be shingles. The patient was being screened for shingles and was waiting for results. Unspecified medical was sought. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested. Additional information received from the consumer states that on 12-Nov-2007 the patient broke out with blisters on the buttocks and down the right thigh. The patient immediately called her doctor. She was examined and diagnosed with shingles. The patient stated that it was very painful. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning a male with a "weakened immune system" who was vaccinated with a dose of ZOSTAVAX. On an unspecified date the patient developed shingles. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site macule, Injection site rash
Clinical narrative: Information has been received from a physician concerning a female patient over the age of 60 who on approximately 05-NOV-2007 (2 weeks ago) was vaccinated with a 0.65 ml dose of ZOSTAVAX. On approximately 05-NOV-2007 (2 weeks ago but within 48 hours of being vaccinated) the patient returned to the doctors office with a rash around the injection site. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested. Follow-up information has been received from a physician concerning a 60-year-old female with no known drug allergies who on 02-NOV-2007 was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck) (lot # 658084/0888U). Concomitant therapy included losartan potassium-HCTZ, SYNTHROID and "therapy unspecified" (therapy illegible). On 05-NOV-2007 the patient developed an erythema rash 16 x 7 cm on left deltoid with no vesicles or bulla with an appearance of episode like erythematous macule. The patient did not have any recent exposure to chickenpox or shingles. On an unspecified date the patient recovered. The patient was enrolled in the varicella zoster virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck VZV strain. Additional information has been requested.
Age: 1.05
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12-month-old patient who on 19-NOV-2007 at 11:10 was inadvertently vaccinated subcutaneously in the right thigh with a first 0.5 ml dose of ZOSTAVAX (Merck) (lot # 658209/1085U) instead of varicella virus live (Oka/Merck). On 19-NOV-2007 at 11:10 the patient developed swelling and erythema at the injection site. The patient sought medical attention via an office visit. On 26-NOV-2007 the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 20-NOV-2007 was vaccinated subcutaneously in the left arm with ZOSTAVAX (lot# 658605/1089U) instead of varicella virus vaccine live (Oka/Merck). The office indicated they have a refrigerator for the pediatric vaccines and a refrigerator for the adult vaccines. On 20-NOV-2007 someone in the office moved the pediatric vaccines to the adult refrigerator. The medical assistant (MA) did not realize this and did not look clearly at the vial to see it was ZOSTAVAX and not varicella virus vaccine (Oka/Merck). The MA states this was clearly a staff error only. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Formication
Clinical narrative: Information has been received from an approximately 71 year old male consumer with no pertinent medical history of drug allergies who in September 2007, "about two months," was vaccinated with one dose of ZOSTAVAX. Concomitant drug therapy included LIPITOR. In October 2007 "about a month and a half ago," the patient experienced "a crawling sensation around eyes, mostly near eyebrow of the right eye" and " a burning on arm similar to sunburn." It was noted that the patient "told the doctor" of the events. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested. Follow-up information has been received from a medical assistant indicating that a 76 year old (also reported as approximately 71 year old) retired male who on 05-SEP-2007 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 658081/0743U) in the left arm. On 27-AUG-2007 the patient was seen by the physician for a burning sensation on forehead. On 17-OCT-2007 the patient complained of a crawling sensation under skin. It was noted that the patient never reported connecting the symptoms with the vaccine. The patient also did not contact the physician's office about a reaction or any problems. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a 62 year old female with no pertinent medical history and an adverse drug reaction history with statin drugs who on 13-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (no lot number was provided). Suspect drug therapy included ezetimibe (+) simvastatin (MSD), tablet every other day (dose and indication not reported). Other concomitant drug therapy included raloxifene hydrochloride (EVISTA). In November 2007 "a couple of days ago," the patient experienced a headache. The patient did not seek medical attention. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 1 year old patient who was vaccinated with ZOSTAVAX instead of varicella vaccine live (Oka/Merck). Staff error only. The patient's outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Laboratory test, Lip swelling, Rash, Swelling face
Clinical narrative: Information has been received from a 48 years old female consumer with a history of shingles, (patient stated that she had shingles twice in the past 2 years) and a drug reactions/allergies which included: a drug reaction to food preservatives and seasonal allergies who on 16-NOV-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included SYNTHROID. On 17-NOV-2007 ("at around 7:00pm") the patient experienced a "severe allergic reaction" after receiving the vaccine. The patient reported that her lips and face were swollen. The patient also noted that she was brought to the emergency room on Saturday and Sunday nights. She was given IV and steroids in the emergency room. No further information was provided. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested. Follow-up received 04/16/2008 from a physician concerning a 48 year old female with a history of "hypersensitivity to MOBIC (which causes angioedema"), who on 16-NOV-2007 was vaccinated subcutaneously into the left arm with a first dose of zoster vaccine live (Oka/Merck) ("Lot # 00883U"). The patient had a rash at the time of vaccination. On 19-NOV-2007 the patient presented to the emergency room with a "significant rash" and was given BENADRYL and prednisone. The physician reported adding ZYRTEC. The patient's symptoms of itchy rash improved and steroids were stopped by 30 NOV 2007. The patient was considered recovered as of 10 NOV 2007. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female customer who came in and stated that she had been vaccinated with a dose of ZOSTAVAX and three weeks later broke out in shingles. It was unspecified if medical attention was sought. No outcome was reported. No further information is available. Follow-up information has been received from the pharmacy that stated "I did not administer the shot-patient told me about adverse drug reaction (ADR)". No more information was available. No further information is expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information has been received from a 67-year-old female with no pertinent medical history or allergies who in May 2007, was vaccinated with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included acyclovir 800 mg 5 times a day for 10 days. On 03-NOV-2007 the patient reported having "pain and blisters on stomach, waist, and right side of back". On 08-NOV-2007 the patient reported she was diagnosed with shingles. No diagnostic labs were reported. At the time of reporting the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a pharmacist concerning a 77-year-old male who on approximately 20-OCT-2007 was vaccinated with a "single dose" of ZOSTAVAX. Concomitant therapy included blood pressure medication. On approximately 20-OCT-2007 the patient developed a rash all over his body. Unspecified medical attention was sought. Subsequently, on an unspecified date the patient recovered. No product quality complaint was involved. Additional information has been requested. 03/26/2008 No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with no pertinent medical history or drug allergies who on 13-NOV-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 14-NOV-2007 the patient developed an itchy spot that was about 2.5 x 2.5 inches. The patient sought medical attention by contacting the pharmacist. No labs or diagnostic studies were performed. The patient was treated with diphenhydramine HCl (BENADRYL) capsules and hydrocortisone (CORTISONE) ointment to help relieve the symptom. The itching was a little less but did not go away. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 45.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 45 year old female medical assistant with no pertinent medical history who on 18-OCT-2007 was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On that same day, the patient developed injection site redness, warmth and swelling. The patient sought unspecified medical attention. No labs or diagnostic studies were performed. In November 2007, "about 1 month later" the patient recovered. There was no product quality complaint. Additional information has been requested. 03/26/2008 Follow-up information indicated that a 45 year old female certified medical assistant with a history of shingles who on 18-OCT-2007 at 16:00 was vaccinated IM with the first dose of ZOSTAVAX (Oka/Merck) (lot# 658209/1085U) in the right arm. On 18-Oct-2007 (also reported as 21-OCT-2007) the patient developed injection site redness, warmth and swelling lasting five weeks. The patient did not seek medical attention but was noted to have had a yearly physical. It was also noted that on approximately 21-OCT-2007 the patient broke out in shingles lasting 2 & 1/2 months. Additional follow-up information indicated that the 45 year old female certified medical assitant with several GI problems and a history of shingles, zollinger-ellison syndrome followed by an unspecified surgery who on 18-OCT-2007 was vaccinated with the first dose of ZOSTAVAX (lot# 658209/1085U). There was no illness at the time of vaccination. Concomitant drug therapy included TOPROL XL tablets and nonsteroidal anti-inflammatory drug (unspecified). On 18-OCT-2007 the patient experienced injection site redness that lasted 6 weeks (also reported as 5 weeks) and broke out in shingles 3 days after vaccination. Subsequently, the patient recovered. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: DTAP, MNQ, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 14 year old male who on 01-AUG-2007 was accidentally administered a single dose of ZOSTAVAX (Oka/Merck) (lot# 654504/1406F) instead of VARIVAX. It was reported that no adverse side effects resulted from the vaccination. Further information was not available. additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 6 year old female who on 20-NOV-2007 was vaccinated subcutaneously in the left arm with zoster vaccine live (Oka/Merck) ( lot# 658605/1089U) instead of varicella virus vaccine live (Oka/Merck). The office indicated they have a refrigerator for the pediatric vaccines and a refrigerator for the adult vaccines. On 20-NOV-2007 someone in the office moved the pediatric vaccines to the adult refrigerator. The medical assistant (MA) did not realize this and did not look clearly at the vial to see it was zoster vaccine live (OKA/Merck) and not varicella virus vaccine live (Oka/Merck). The MA states this was clearly a staff error only. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy site unspecified normal, Immunosuppression, Medication error, Pruritus, Rash
Clinical narrative: Information has been received from a pharmacist concerning her 79 year old father with a history of chemotherapy, surgery and splenic marginal zone lymphoma and splenectomy who in May 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). In June 2007, (one month after vaccination) the patient developed a bilateral leg rash from the thigh to the ankle. The patient was seen by dermatologist who prescribed an unspecified steroid cream for the rash. The physician also performed a biopsy (type unspecified) that was reported to be negative. The rash was concentrated in the right lower leg. At the time of the report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been received from the pharmacist who stated that the patient had splenic marginal zone lymphoma treated in the past with chemotx and a subsequent splenectomy. The pharmacist reported that prior to the splenectomy the patient's WBC count ran consistently above 200,000 and he was anemic and thrombocytopenic. Post splenectomy the patient is no longer anemic or thrombocytopenic and his WBC count ran generally in 20-30,000 range. The pharmacist reported that her father was immunocompromised. It was also reported that the patient developed a rash on both legs within 1 month post-vaccination. The rash on both legs from the thighs to ankles, and front to back of each leg. It was reported that at present the rash persisted on a small area of the right leg only. The patient continued to experience significant itching both in places where the rash as well as other areas of the body in which there was no rash. The patient never had any past skin issues.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Information has been received from a pharmacist concerning her 79 year old father with a history of chemotherapy, surgery and splenic marginal zone lymphoma and splenectomy who in May 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). In June 2007, (one month after vaccination) the patient developed a bilateral leg rash from the thigh to the ankle. The patient was seen by dermatologist who prescribed an unspecified steroid cream for the rash. The physician also performed a biopsy (type unspecified) that was reported to be negative. The rash was concentrated in the right lower leg. At the time of the report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been received from the pharmacist who stated that the patient had splenic marginal zone lymphoma treated in the past with chemotx and a subsequent splenectomy. The pharmacist reported that prior to the splenectomy the patient's WBC count ran consistently above 200,000 and he was anemic and thrombocytopenic. Post splenectomy the patient is no longer anemic or thrombocytopenic and his WBC count ran generally in 20-30,000 range. The pharmacist reported that her father was immunocompromised. It was also reported that the patient developed a rash on both legs within 1 month post-vaccination. The rash on both legs from the thighs to ankles, and front to back of each leg. It was reported that at present the rash persisted on a small area of the right leg only. The patient continued to experience significant itching both in places where the rash as well as other areas of the body in which there was no rash. The patient never had any past skin issues.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who in June 2007, was vaccinated SC with a dose of zoster vaccine live (Oka/Merck). In September 2007, the patient developed shingles. It was reported that the patient's husband also developed shingles after vaccination with zoster vaccine live (Oka/Merck) (WAES # 0710USA00954). Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning an 87 year old female with no drug allergies who on 12-OCT-2007 was vaccinated SC with a single dose of zoster vaccine live (Oka/Merck) (lot # 658083/0885U). Secondary suspect therapy on 13-OCT-2007 included an IM dose of influenza virus vaccine  (unspecified) (lot # U2510A). There was no illness at the time of vaccination. The patient developed redness, swelling and warmth at injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been received from a registered nurse who stated that the patient on 13-OCT-2007 had his left arm swollen, hot and painful. It was described it as "a size of baseball". The patient was reassured with heat of 2 hours. At the time of reporting the patient's condition was unknown. No further information is expected.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia, Erythema, Headache, Pruritus
Clinical narrative: I was administered the shingles vaccine on 12/27/2007 approx. 5PM AK time.  I checked my arm the following morning and it seemed fine.  About midday I noticed an itch and slight headache.  I checked my arm and noticed a red area about 3 inches in diameter.  It is now 8:30PM AK Time 12/28/2007 and the headache persists, the redness and itchiness is about the same.  I also have heartburn for some reason.  I had a severe reaction to vancomycin (antibiotic) and I'm wondering if I should not have had this injection.
Age: 1.07
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Biopsy lung abnormal, Blood culture, Breath sounds abnormal, Bronchoscopy, Chronic sinusitis
Clinical narrative: EVERY TIME HE GOT VACCINATED HE WOULD IMMEDIATELY HAS RESPIRATORY DISTRESS, ABNORMALLY HIGH FEVER'S up to 104 THE HIGHEST., TROUBLES BREATHING ABOUT ONE HOUR POST,TRACHAELMALACIA, lethargy, moving slowly as if joints hurt/ SWOLLEN LYMPHNODES AROUND THE NECK/ CONSTANT DIAREAH COLOR PUTTY GREY/ RED SORE THROAT WOULDN'T EAT,WHEEZING SILENT CRY And ear infections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received for multiple ER visits, consults, and admissions for respiratory issues (cyanosis, increased WOB, stridor, noisy breathing, pneumonia) throughout 2007. DX include: Croup with Bronchospasm, RSV Bronchiolitis 2/24/07, Respiratory Distress. Laryngeal tracheomalacia. Bronchospasm, Cyanosis of unknown etiology. Cough. Fever. Frequent OVs with PCP throughout 2007. 01/22/2008 MR received for DOS 9/13-15/07 with DX:  Observation for spells including oxygen desaturation, bradycardia, and hypopnea. Pt has had long standing hx of cyanotic spells, changes in breathing, hypoxemia, and bradycardia. Pt had and Adenoidectomy, bilateral myringotomy and typmanostomy tube placement, Direct microlaryngoscopy with bronch and tracheal study, Echo, pulse oximetry.  Child became hypoxic post-procedure in PACU. Pulmonary consult states no clear etiology of multiple respiratory problems but likely a combo of prematurity, laryngomalacia, and viral respiratory illnesses. Vaccine data updated in VAERS. Follow-up: Immune system challenged at times. ? developmental - Behavior delay. But doing so much better! ? developmental / behavioral / immune system challenged hearing - speech delay.
Age: 1.07
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Crying, Cyanosis, Diarrhoea, Diet refusal, Dyspnoea
Clinical narrative: EVERY TIME HE GOT VACCINATED HE WOULD IMMEDIATELY HAS RESPIRATORY DISTRESS, ABNORMALLY HIGH FEVER'S up to 104 THE HIGHEST., TROUBLES BREATHING ABOUT ONE HOUR POST,TRACHAELMALACIA, lethargy, moving slowly as if joints hurt/ SWOLLEN LYMPHNODES AROUND THE NECK/ CONSTANT DIAREAH COLOR PUTTY GREY/ RED SORE THROAT WOULDN'T EAT,WHEEZING SILENT CRY And ear infections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received for multiple ER visits, consults, and admissions for respiratory issues (cyanosis, increased WOB, stridor, noisy breathing, pneumonia) throughout 2007. DX include: Croup with Bronchospasm, RSV Bronchiolitis 2/24/07, Respiratory Distress. Laryngeal tracheomalacia. Bronchospasm, Cyanosis of unknown etiology. Cough. Fever. Frequent OVs with PCP throughout 2007. 01/22/2008 MR received for DOS 9/13-15/07 with DX:  Observation for spells including oxygen desaturation, bradycardia, and hypopnea. Pt has had long standing hx of cyanotic spells, changes in breathing, hypoxemia, and bradycardia. Pt had and Adenoidectomy, bilateral myringotomy and typmanostomy tube placement, Direct microlaryngoscopy with bronch and tracheal study, Echo, pulse oximetry.  Child became hypoxic post-procedure in PACU. Pulmonary consult states no clear etiology of multiple respiratory problems but likely a combo of prematurity, laryngomalacia, and viral respiratory illnesses. Vaccine data updated in VAERS. Follow-up: Immune system challenged at times. ? developmental - Behavior delay. But doing so much better! ? developmental / behavioral / immune system challenged hearing - speech delay.
Age: 1.07
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Ear infection, Faeces discoloured, Haemophilus infection, Hypokinesia, Insomnia
Clinical narrative: EVERY TIME HE GOT VACCINATED HE WOULD IMMEDIATELY HAS RESPIRATORY DISTRESS, ABNORMALLY HIGH FEVER'S up to 104 THE HIGHEST., TROUBLES BREATHING ABOUT ONE HOUR POST,TRACHAELMALACIA, lethargy, moving slowly as if joints hurt/ SWOLLEN LYMPHNODES AROUND THE NECK/ CONSTANT DIAREAH COLOR PUTTY GREY/ RED SORE THROAT WOULDN'T EAT,WHEEZING SILENT CRY And ear infections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received for multiple ER visits, consults, and admissions for respiratory issues (cyanosis, increased WOB, stridor, noisy breathing, pneumonia) throughout 2007. DX include: Croup with Bronchospasm, RSV Bronchiolitis 2/24/07, Respiratory Distress. Laryngeal tracheomalacia. Bronchospasm, Cyanosis of unknown etiology. Cough. Fever. Frequent OVs with PCP throughout 2007. 01/22/2008 MR received for DOS 9/13-15/07 with DX:  Observation for spells including oxygen desaturation, bradycardia, and hypopnea. Pt has had long standing hx of cyanotic spells, changes in breathing, hypoxemia, and bradycardia. Pt had and Adenoidectomy, bilateral myringotomy and typmanostomy tube placement, Direct microlaryngoscopy with bronch and tracheal study, Echo, pulse oximetry.  Child became hypoxic post-procedure in PACU. Pulmonary consult states no clear etiology of multiple respiratory problems but likely a combo of prematurity, laryngomalacia, and viral respiratory illnesses. Vaccine data updated in VAERS. Follow-up: Immune system challenged at times. ? developmental - Behavior delay. But doing so much better! ? developmental / behavioral / immune system challenged hearing - speech delay.
Age: 1.07
Sex: M
Vaccine: HIBV, MMRV, PNC
Symptoms: Lethargy, Lymphadenopathy, Pharyngeal erythema, Pharyngolaryngeal pain, Pneumonia pneumococcal
Clinical narrative: EVERY TIME HE GOT VACCINATED HE WOULD IMMEDIATELY HAS RESPIRATORY DISTRESS, ABNORMALLY HIGH FEVER'S up to 104 THE HIGHEST., TROUBLES BREATHING ABOUT ONE HOUR POST,TRACHAELMALACIA, lethargy, moving slowly as if joints hurt/ SWOLLEN LYMPHNODES AROUND THE NECK/ CONSTANT DIAREAH COLOR PUTTY GREY/ RED SORE THROAT WOULDN'T EAT,WHEEZING SILENT CRY And ear infections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received for multiple ER visits, consults, and admissions for respiratory issues (cyanosis, increased WOB, stridor, noisy breathing, pneumonia) throughout 2007. DX include: Croup with Bronchospasm, RSV Bronchiolitis 2/24/07, Respiratory Distress. Laryngeal tracheomalacia. Bronchospasm, Cyanosis of unknown etiology. Cough. Fever. Frequent OVs with PCP throughout 2007. 01/22/2008 MR received for DOS 9/13-15/07 with DX:  Observation for spells including oxygen desaturation, bradycardia, and hypopnea. Pt has had long standing hx of cyanotic spells, changes in breathing, hypoxemia, and bradycardia. Pt had and Adenoidectomy, bilateral myringotomy and typmanostomy tube placement, Direct microlaryngoscopy with bronch and tracheal study, Echo, pulse oximetry.  Child became hypoxic post-procedure in PACU. Pulmonary consult states no clear etiology of multiple respiratory problems but likely a combo of prematurity, laryngomalacia, and viral respiratory illnesses. Vaccine data updated in VAERS. Follow-up: Immune system challenged at times. ? developmental - Behavior delay. But doing so much better! ? developmental / behavioral / immune system challenged hearing - speech delay.