chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Subsequently the patient "developed a 4 cm by 4 cm bolus lesion on the tricep area of injection site". Physician would like to know if this was due to "shingles". The status of the patient was unknown. The patient sought unspecified medical attention. Follow up information has been received from a physician indicating that the patient had a rash at the injection site. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Pain in extremity
Clinical narrative: Information has been received from a 63 year old female patient with sinus infection, allergy to insect bites, tetracycline, penicillin and ampicillin, and a history of "bad poison ivy" 2 years ago who on 09-FEB-2011 was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). Concomitant therapy included Z-PAK, aspirin and vitamin D (unspecified). Patient stated that on 11-FEB-2011 2 days after receiving ZOSTAVAX (Merck), the patient experienced an injection site reaction with redness and slight itching. Patient stated that ZOSTAVAX (Merck) was not given deep into the muscle. On 12-FEB-2011, the patient experienced red rash at injection site and inner arm pain. On 15-FEB-2011, the area of her arm was dark red with slight itch, slightly raised and 1 inch wide by 5 inches long going down the arm. There were no blisters or open areas, no drainage or crusting. On 21-FEB-2011, the area had gradually faded and was very light. Patient had not contacted a health care professional. There was no prior history of herpes zoster. No treatment was given to the patient. There were no laboratory diagnostics studies performed. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired drug administered, Injection site pain, Pain, Pyrexia
Clinical narrative: Information has been received from a male concerning himself who on an unspecified date was vaccinated with an expired dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). No adverse event (AE) was reported. At the time of reporting, the patient's status was not provided. Follow-up information was received from the male patient who reported that on 21-FEB-2011, he was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route not reported, lot # 664444/0722Y, expired date 21-NOV-2010). On 22-FEB-2011, he developed a fever of 99.5F and body aches. The patient consulted by phone with doctor who advised him to take TYLENOL. The patient had recovered. Follow-up information was received from the male patient who reported that it was in the evening of 21-FEB-2011 (previously reported as 22-FEB-2011) he experienced fever and body aches. Follow-up information was received from the physician who reported that a 75 year old male pharmacy associate with no known allergies on 21-FEB-2011 at 15:30 was vaccinated subcutaneously on the arm with an expired first dose of ZOSTAVAX (Merck) (lot # 664444/0722Y). On 22-FEB-2011 (previously reported as 21-FEB-2011) the patient experienced soreness at site of injection and mild fever. The reporter mentioned that he did not know if the patient had siblings. There was no illness at time of vaccination. No lab diagnostics studies were performed. On 23-FEB-2011 patient recovered. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Immune system disorder, Influenza
Clinical narrative: Information has been received from a 62 year old female patient with blood pressure high and codeine allergy who on 23-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route, and Lot# not reported) DIOVAN. The consumer stated that she thought the vaccine weakened her immune system because she came down with the flu on 02-FEB-2011 although she got influenza virus vaccine (unspecified) (manufacturer unknown) about 4 months ago. Antibiotics (unspecified) were given as a treatment for the events. There were no laboratories diagnostics performed. At the time of the report the patient had recovered. The patient reported that she may have transmitted shingles to her sister WAES# (1102USA03545). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site abscess sterile, Injection site mass, Injection site reaction
Clinical narrative: Information has been received from a 60 year old male consumer with high blood pressure, glaucoma and high cholesterol and no allergies who on 16-FEB-2011 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included LIPITOR, DIVON-50, NORVASC and COSOPT. The consumer stated that on 18-FEB-2011 the patient experienced a red spot and lump at the injection site. The consumer reported that it was a "sterlic abscess". The patient would go to follow-up with his physician. There were no laboratories diagnostics performed. There was no treatment given for the events. The patient's red spot at the injection site and lump at the injection site and sterile abscess persisted. The patient did not seek medical attention. Follow up information has been received from a physician and medical records concerning a 60 year old retired male patient with glaucoma, high blood pressure (also reported as hypertension), high lipids, arthritis and a history of zoster vaccination (06-Oct-2009) who on 16-Feb-2011 was vaccinated in the left posterior upper arm with ZOSTAVAX (Merck) (lot # 669191/1456Z, expiration date 28-JAN-2012). On 18-Feb-2011 at 12:45, the patient went to the emergency room with an allergic reaction including a 3 cm (also reported as .3 cm) x 3.5 cm red raised edematous and erythematous area with a 1.5 cm x 2 cm darker edematous and erythematous area on the patient's left posterior upper arm at the injection site, "no abscess" was noted. The patient reported no pain or pruritus. The patient's allergic reaction was also noted as a red blanching rash area on the patient's left posterior upper arm where he had the injection. The patient was treated with KEFLEX. On 21-Feb-2011, the patient was seen in the office. The physician reported the patient had recovered. All available medical records will be provided upon request. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pallor, Rash erythematous
Clinical narrative: Information has been received from a 60 year old male consumer with high blood pressure, glaucoma and high cholesterol and no allergies who on 16-FEB-2011 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included LIPITOR, DIVON-50, NORVASC and COSOPT. The consumer stated that on 18-FEB-2011 the patient experienced a red spot and lump at the injection site. The consumer reported that it was a "sterlic abscess". The patient would go to follow-up with his physician. There were no laboratories diagnostics performed. There was no treatment given for the events. The patient's red spot at the injection site and lump at the injection site and sterile abscess persisted. The patient did not seek medical attention. Follow up information has been received from a physician and medical records concerning a 60 year old retired male patient with glaucoma, high blood pressure (also reported as hypertension), high lipids, arthritis and a history of zoster vaccination (06-Oct-2009) who on 16-Feb-2011 was vaccinated in the left posterior upper arm with ZOSTAVAX (Merck) (lot # 669191/1456Z, expiration date 28-JAN-2012). On 18-Feb-2011 at 12:45, the patient went to the emergency room with an allergic reaction including a 3 cm (also reported as .3 cm) x 3.5 cm red raised edematous and erythematous area with a 1.5 cm x 2 cm darker edematous and erythematous area on the patient's left posterior upper arm at the injection site, "no abscess" was noted. The patient reported no pain or pruritus. The patient's allergic reaction was also noted as a red blanching rash area on the patient's left posterior upper arm where he had the injection. The patient was treated with KEFLEX. On 21-Feb-2011, the patient was seen in the office. The physician reported the patient had recovered. All available medical records will be provided upon request. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site vesicles, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 63 year old female with penicillin and codeine allergy who on 11-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669405/1416Z, expiration date 21-JAN-2012). Concomitant therapy included hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), estrogens (unspecified) and calcium (unspecified). On 11-FEB-2011 the patient had cluster-like blisters around injection site and having a fever along with flu-like symptoms. TYLENOL (unspecified dose, frequency and manufacturer) was given for the symptoms. The patient visited on 15-FEB-2011 and reported that her symptoms were starting to get better, however the blisters were still visible. At the time of reporting, the patient was recovering. No further information is available.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning an approximately 5 year old child who on an unspecified date was vaccinated with a 0.5ml dose of ZOSTAVAX (Merck) (lot # 669538/1390Z) (only 0.5ml was given not the 0.65ml) instead of VARIVAX (Merck) in error. The pharmacist stated that this was suppose to be child's second dose of VARIVAX (Merck). Pharmacist stated that the child received the first dose of VARIVAX (Merck) on 23-MAR-2007. No adverse event reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Flatulence, Insomnia, Irritable bowel syndrome
Clinical narrative: Information has been received from an 86 year old female patient who on 11-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 12-FEB-2011 the patient experienced weakness, severe vomiting, and diarrhea after administration. She was no longer vomiting but currently had a spastic colon, diarrhea, gas, trouble sleeping and weakness. She stated, her "whole body was in turmoil". She had been examined by a nurse on 12-FEB-2011. She would follow up with her physician on 15-FEB-2011. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from an 86 year old female patient who on 11-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 12-FEB-2011 the patient experienced weakness, severe vomiting, and diarrhea after administration. She was no longer vomiting but currently had a spastic colon, diarrhea, gas, trouble sleeping and weakness. She stated, her "whole body was in turmoil". She had been examined by a nurse on 12-FEB-2011. She would follow up with her physician on 15-FEB-2011. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Information has been received from a healthcare worker concerning a 65 year old female who on 11-SEP-2009 was vaccinated with "just one time shot" of ZOSTAVAX (Merck) (Lot # 664091/0140Y). It was reported that it was a vaccine failure with ZOSTAVAX (Merck). On 26-MAY-2010 the patient got shingles. It was a rash on her back and it was diagnosed as shingles. She was prescribed NEURONTIN and VALTREX which was given to treated it. "It was a mild case." It was reported that the patient was fine and recovered from shingles. The patient sought unspecified medical attention. Additional information has been requested.
Age: 1.02
Sex: U
Vaccine: VARZOS
Symptoms: Drug name confusion, No adverse event, Product label issue, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 12 month old patient who on 05-NOV-2010 was vaccinated with 1/2 dose of ZOSTAVAX (Merck) injection instead of VARIVAX (Merck) accidentally by a student nurse on the left arm. The patient was not experiencing any known symptoms. Follow up information has been received from the physician. The physician stated that the child had not experienced any problems since ZOSTAVAX (Merck) (lot# 665521/1226Y) was administered. The physician stated that he felt the mix up was due to the labels being too small and the names of the vaccines were too easy to confuse with one another. No additional information is expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Activated partial thromboplastin time prolonged, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood glucose increased, Blood urea increased
Clinical narrative: Information has been received from a 63 year old female patient with penicillin allergy, CIPRO allergy, HYCODAN allergy, SUPRAX allergy, hypertension, asthma and allergy who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included losartan potassium (manufacturer unknown), NASALIDE, AEROBID, albuterol, CARAFATE, famotidine and CITRACAL + D. On 10-FEB-2011 the patient developed pain at the injection site of left upper arm. On 11-FEB-2011 the patient was evaluated by her unspecified pulmonologist and was found to have a 4 inch by 5 inch area of redness, warmth, and swelling at the injection site. She was diagnosed with cellulitis and prescribed oral CECLOR. On 12-FEB-2011 the patient developed a fever of 101.8F. She was evaluated in the emergency room of hospital. Chest X-ray, X-ray and ultrasound of the left upper arm, and complete blood count were ordered. The X-rays and ultrasound were normal but the neutrophil count was elevated. The patient treated with intravenous clindamycin. The patient was release from the emergency room on oral clindamycin and she was currently recovering. Follow up information has been received from medical records and a physician concerning a 63 year old female patient who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 12-FEB-2011, the patient was evaluated in the emergency room for cellulitis of her left upper extremity. The patient was given acetaminophen oral, 1000 mg, once by mouth and clindamycin HCL injection, 600 mg intravenous piggyback in dextrose 5 percent water over thirty minutes for a total of four doses. On 13-FEB-2011, the patient had the following diagnostic tests performed: left humerus X-ray that showed no acute osseous abnormality, no abnormal periosteal reaction or erosive changes; chest X-ray that showed no acute cardiopulmonary disease; sonogram of her left upper extremity that showed left upper extremity edema without focal fluid collection; and laboratory test that showed high neutrophil percent auto (87.7%), low mean platelet volume (7.1 fL), high neutrophil absolute (6.0 uL), high urea nitrogen (22 mg/dL), high random glucose (126mg/dL), high aspartate (66 IU/L), high alanine aminotransferase (85 IU/L), high activated partial thromboplastin time (52.2 seconds), moderate blood in urine, and trace levels of leukocyte esterase U in urine. On 13-FEB-2011, the patient was discharged from the emergency room with the following instructions: stop taking cefactor and clindamycin. Patient was instructed to return to the emergency room for persistent, worsening, or new symptoms, including: fever, worsening pain or swelling and to follow up with her primary physician. All available medical records will be provided upon request. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood urine present, Cellulitis, Chest X-ray normal, Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 63 year old female patient with penicillin allergy, CIPRO allergy, HYCODAN allergy, SUPRAX allergy, hypertension, asthma and allergy who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included losartan potassium (manufacturer unknown), NASALIDE, AEROBID, albuterol, CARAFATE, famotidine and CITRACAL + D. On 10-FEB-2011 the patient developed pain at the injection site of left upper arm. On 11-FEB-2011 the patient was evaluated by her unspecified pulmonologist and was found to have a 4 inch by 5 inch area of redness, warmth, and swelling at the injection site. She was diagnosed with cellulitis and prescribed oral CECLOR. On 12-FEB-2011 the patient developed a fever of 101.8F. She was evaluated in the emergency room of hospital. Chest X-ray, X-ray and ultrasound of the left upper arm, and complete blood count were ordered. The X-rays and ultrasound were normal but the neutrophil count was elevated. The patient treated with intravenous clindamycin. The patient was release from the emergency room on oral clindamycin and she was currently recovering. Follow up information has been received from medical records and a physician concerning a 63 year old female patient who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 12-FEB-2011, the patient was evaluated in the emergency room for cellulitis of her left upper extremity. The patient was given acetaminophen oral, 1000 mg, once by mouth and clindamycin HCL injection, 600 mg intravenous piggyback in dextrose 5 percent water over thirty minutes for a total of four doses. On 13-FEB-2011, the patient had the following diagnostic tests performed: left humerus X-ray that showed no acute osseous abnormality, no abnormal periosteal reaction or erosive changes; chest X-ray that showed no acute cardiopulmonary disease; sonogram of her left upper extremity that showed left upper extremity edema without focal fluid collection; and laboratory test that showed high neutrophil percent auto (87.7%), low mean platelet volume (7.1 fL), high neutrophil absolute (6.0 uL), high urea nitrogen (22 mg/dL), high random glucose (126mg/dL), high aspartate (66 IU/L), high alanine aminotransferase (85 IU/L), high activated partial thromboplastin time (52.2 seconds), moderate blood in urine, and trace levels of leukocyte esterase U in urine. On 13-FEB-2011, the patient was discharged from the emergency room with the following instructions: stop taking cefactor and clindamycin. Patient was instructed to return to the emergency room for persistent, worsening, or new symptoms, including: fever, worsening pain or swelling and to follow up with her primary physician. All available medical records will be provided upon request. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Mean platelet volume decreased, Neutrophil count increased, Pyrexia
Clinical narrative: Information has been received from a 63 year old female patient with penicillin allergy, CIPRO allergy, HYCODAN allergy, SUPRAX allergy, hypertension, asthma and allergy who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included losartan potassium (manufacturer unknown), NASALIDE, AEROBID, albuterol, CARAFATE, famotidine and CITRACAL + D. On 10-FEB-2011 the patient developed pain at the injection site of left upper arm. On 11-FEB-2011 the patient was evaluated by her unspecified pulmonologist and was found to have a 4 inch by 5 inch area of redness, warmth, and swelling at the injection site. She was diagnosed with cellulitis and prescribed oral CECLOR. On 12-FEB-2011 the patient developed a fever of 101.8F. She was evaluated in the emergency room of hospital. Chest X-ray, X-ray and ultrasound of the left upper arm, and complete blood count were ordered. The X-rays and ultrasound were normal but the neutrophil count was elevated. The patient treated with intravenous clindamycin. The patient was release from the emergency room on oral clindamycin and she was currently recovering. Follow up information has been received from medical records and a physician concerning a 63 year old female patient who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 12-FEB-2011, the patient was evaluated in the emergency room for cellulitis of her left upper extremity. The patient was given acetaminophen oral, 1000 mg, once by mouth and clindamycin HCL injection, 600 mg intravenous piggyback in dextrose 5 percent water over thirty minutes for a total of four doses. On 13-FEB-2011, the patient had the following diagnostic tests performed: left humerus X-ray that showed no acute osseous abnormality, no abnormal periosteal reaction or erosive changes; chest X-ray that showed no acute cardiopulmonary disease; sonogram of her left upper extremity that showed left upper extremity edema without focal fluid collection; and laboratory test that showed high neutrophil percent auto (87.7%), low mean platelet volume (7.1 fL), high neutrophil absolute (6.0 uL), high urea nitrogen (22 mg/dL), high random glucose (126mg/dL), high aspartate (66 IU/L), high alanine aminotransferase (85 IU/L), high activated partial thromboplastin time (52.2 seconds), moderate blood in urine, and trace levels of leukocyte esterase U in urine. On 13-FEB-2011, the patient was discharged from the emergency room with the following instructions: stop taking cefactor and clindamycin. Patient was instructed to return to the emergency room for persistent, worsening, or new symptoms, including: fever, worsening pain or swelling and to follow up with her primary physician. All available medical records will be provided upon request. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound scan abnormal, Urine analysis abnormal, Urine leukocyte esterase positive
Clinical narrative: Information has been received from a 63 year old female patient with penicillin allergy, CIPRO allergy, HYCODAN allergy, SUPRAX allergy, hypertension, asthma and allergy who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included losartan potassium (manufacturer unknown), NASALIDE, AEROBID, albuterol, CARAFATE, famotidine and CITRACAL + D. On 10-FEB-2011 the patient developed pain at the injection site of left upper arm. On 11-FEB-2011 the patient was evaluated by her unspecified pulmonologist and was found to have a 4 inch by 5 inch area of redness, warmth, and swelling at the injection site. She was diagnosed with cellulitis and prescribed oral CECLOR. On 12-FEB-2011 the patient developed a fever of 101.8F. She was evaluated in the emergency room of hospital. Chest X-ray, X-ray and ultrasound of the left upper arm, and complete blood count were ordered. The X-rays and ultrasound were normal but the neutrophil count was elevated. The patient treated with intravenous clindamycin. The patient was release from the emergency room on oral clindamycin and she was currently recovering. Follow up information has been received from medical records and a physician concerning a 63 year old female patient who on 09-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 12-FEB-2011, the patient was evaluated in the emergency room for cellulitis of her left upper extremity. The patient was given acetaminophen oral, 1000 mg, once by mouth and clindamycin HCL injection, 600 mg intravenous piggyback in dextrose 5 percent water over thirty minutes for a total of four doses. On 13-FEB-2011, the patient had the following diagnostic tests performed: left humerus X-ray that showed no acute osseous abnormality, no abnormal periosteal reaction or erosive changes; chest X-ray that showed no acute cardiopulmonary disease; sonogram of her left upper extremity that showed left upper extremity edema without focal fluid collection; and laboratory test that showed high neutrophil percent auto (87.7%), low mean platelet volume (7.1 fL), high neutrophil absolute (6.0 uL), high urea nitrogen (22 mg/dL), high random glucose (126mg/dL), high aspartate (66 IU/L), high alanine aminotransferase (85 IU/L), high activated partial thromboplastin time (52.2 seconds), moderate blood in urine, and trace levels of leukocyte esterase U in urine. On 13-FEB-2011, the patient was discharged from the emergency room with the following instructions: stop taking cefactor and clindamycin. Patient was instructed to return to the emergency room for persistent, worsening, or new symptoms, including: fever, worsening pain or swelling and to follow up with her primary physician. All available medical records will be provided upon request. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Bronchitis, Condition aggravated, Herpes zoster, Inflammation
Clinical narrative: Information has been received from a 64 year old female consumer with penicillin and variety of unspecified seizure medications allergies, seizure disorder and history of shingles who on 01-AUG-2010 was vaccinated with 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported), SQ. Concomitant therapy included DILANTIN, phenobarbital, ATIVAN and FOSAMAX. The consumer stated that on 31-JAN-2011 her herpes flared up and started to blister on 02-FEB-2011. The patient mentioned that on 07-FEB-2011 started AVELOX for bronchitis and on 09-FEB-2011 at afternoon all trace of herpes had gone. The patient reported that on unspecified date a (early 70's) old scar in her face got inflamed and clear. The patient also reported that in 2010 the patient had one flared up, but nothing since 70's. She claimed that her doctor did not know what kind of herpes it was, and AVELOX should not had effect on virus, but she thought that maybe it did. "AVELOX seemed to clear up the outbreak of herpes on her face. It should not have any effect on it". On 09-FEB-2011 the patient had recovered from herpes. The patient did not seek medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Local swelling
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 69 year old male patient who on 03-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669538/1390Z). The doctor of pharmacy stated that in February 2011, the patient developed localized redness and swelling which resolved on its own in February 2011. There was no treatment given for the events. It was unspecified if the patient sought unspecified medical attention. Follow-up information has been received from the doctor of pharmacy, who reported that the female patient (previously reported as a male) with unknown illness and unknown pre-existing allergies birth defects, at the time of vaccination was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 669538/1390Z), SQ, 13:00 on 03-FEB-2011. The doctor of pharmacy stated that the patient experienced Localized reaction, including redness and swelling. There were no laboratories diagnostics performed. The doctor of pharmacy stated that the patient did not want to be contacted. At the time of the report the patient had recovered. It was also reported that the patient had no adverse event follow prior vaccination. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female patient who on 07-FEB-2011 was vaccinated with a first 0.65ml dose of ZOSTAVAX (Merck) (Lot#669192/1457Z, Exp Date 29-JAN-2012). Concomitant mediation included "sleeping pills". The pharmacist stated that on approximately 07-FEB-2011 after receiving ZOSTAVAX (Merck) the patient experienced redness in the arm where the injection was administered. At the time of the report the patient outcome was unknown. The patient sought unspecified medical attention. Follow-up information has been received from a registered pharmacist who reported that the 70 year old female patient with no illness at the time of vaccination received a first dose of ZOSTAVAX (Merck) (Lot#669192/1457Z), unknown time in afternoon on 07-FEB-2011. The registered pharmacist stated that on 17-FEB-2011 (previously reported as 07-FEB-2011) in afternoon the patient complained of redness around area, 10 days past injection the patient called on 02-MAR-2011, and stated that the redness went away a couple of days after vaccination. On approximately 19-FEB-2011 and 20-FEB-2011 the patient had recovered. The patient did not seek medical attention. There was no laboratory diagnostic studies performed. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a female consumer, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The consumer stated that she noticed a small rash at the injection site of where she received the ZOSTAVAX (Merck). The consumer stated that the pharmacist thought she had had the band-aid too long and just told her to wait a few days to see what happened. At the time of the report, the patient's outcome was unknown. No further information is available.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a certified medical assistant concerning an 81 year old male patient with hypertension, high cholesterol, gastrooesophageal reflux disease (GERD) and no drug reactions or allergies who on 10-FEB-2011 was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot # 665530/0697Z, expire date 28-APR-2011), 0.65 ml, subcutaneously. Concomitant therapy included CELEBREX, NEXIUM, VIREAD, LOPID, COLACE, loratadine (MSD) and AZOR. Certified medical assistant stated that on 16-FEB-2011, the patient developed herpes on his left flank and was seen in the office in 17-FEB-2011. The patient was given acyclovir 800 mg 5 times a day for 5 days and hydrocortisone cream 0.1%. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female who on an unknown date, was vaccinated with ZOSTAVAX (Merck) (dose, route and lot# not reported). Subsequently the patient experienced rashes. It was unknown if the patient sought medical attention. At the time of reporting, the outcome was unknown. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female with a history of chronic myeloid leukaemia who on an unspecified date was vaccinated with ZOSTAVAX (Merck). Subsequently the patient experienced a zoster rash at injection site after administration. At the time of the report the outcome was not reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered pharmacist concerning a 65 year old female patient, who on 25-FEB-2011 was vaccinated with a standard dose of ZOSTAVAX (Merck) (Lot # 669535/1506Z EXP 02-FEB-2012) SQ. The pharmacist reported that the patient developed redness at the injection site after receiving ZOSTAVAX (Merck). The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Information has been received from a 78 year old male consumer with type 2 diabetes, blood pressure, penicillin and BIAXIN allergies who on 24-FEB-2011 "Last Thursday" around 15:30 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included insulin, JANUVIA, MICARDIS and metformin. The consumer stated that on 24-FEB-2011 he took his blood sugar around 7:30 and the next morning on 25-FEB-2011 it was in the 200 range. The consumer also stated that normally his sugar levels are between 108-112. The consumer mentioned that "everyday" after the shot was administered his levels had remained elevated. His numbers had been 203, 205, 208, and on 28-FEB-2011 were 269. The consumer stated that he was thinking that since it was a live vaccine that it elevated his levels a bit just like a cold would. The consumer stated that normally when he gets a cold or something his levels get elevated, but he stated that his no 100% sure if this is the case or not. The consumer spoke to the pharmacist and they did no have information about sugar levels raised after a vaccine administration. There was no treatment given for the events. At the time of the report the patient had not recovered from the symptoms. This is one of two reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning a female patient in her 70's who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) at a local pharmacy (unspecified pharmacy). The reporter stated that a shot while after receiving the ZOSTAVAX (Merck) (unspecified length of time), she had contracted shingles. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Polymerase chain reaction, Rash vesicular, Skin lesion
Clinical narrative: Information has been received via telephone call from a medical assistant concerning an 86 year old female retired patient who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 659614/0161X, expire date not reported), subcutaneously in the right arm. Concomitant therapy included TRIAVIL, ATACAND, NORVASC, thyroid, hydrochlorothiazide, calcium (unspecified) (+) vitamin D (unspecified), flax seed, hydrocodone, vitamin E, Flora Source, fish oil, vitamin C and vitamin D3. Medical assistant stated that on 24-FEB-2011, the patient was seen in the office with a case of shingles. Medical assistant explained that it was the "worse case ever seen" and the patient had lesions everywhere. Physician's diagnosis was acute onset diffuse herpes zoster vesicular eruption dorsal 6&7 and also at L2&3 on the right side posterior. Medical assistant explained that the physician punctured one of the lesions on thoracic area mid clavic line T-6,7 to collect vesicular fluid for the sample for PCR studies. The patient was treated with famciclovir 500 mg three times a day for 7 days. At the time of the report, patient's outcome was unknown. Follow-up information received via telephone call from the medical assistant indicated that on 03-MAR-2011 the patient was seen in the office and was improving, but in a lot of pain. In the office discussed the option of treating her with hydrocodone for pain, however pain meds were not started at that point. 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 Merck vaccine strain. On 04-MAR-2011, the PCR results from the vesicular specimen (collected on 24-FEB-2011) showed that Varicella Zoster Virus DNA was not amplified as well as , B-globin DNA was not either. The specimen was inadequate, negative for B-globin and no strain was identified. A lesion sample was collected on 24-FEB-2011. The sample was taken from a swab. VZV DNA was amplified. On 18-MAR-2011, the PCR result from the swab specimen identified the presence of wild type strain. Follow-up information was received from a physician concerning a patient who in the morning of 07-MAY-2008 was vaccinated with the first dose of ZOSTAVAX (Merck) in the right deltoid. The physician stated that on 22-FEB-2011 at 11:00 (previously reported as 24-FEB-2011 by the medical assistant), the patient developed herpes zoster with left thoracic D-6-7 eruption that diffusely involved 2 levels. The physician mentioned that they attempted to send it for identification but it was apparently not enough or dry. The patient did not seek medical attention. At the time of the report, the patient recovered. Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: Information has been received via telephone call from a medical assistant concerning an 86 year old female retired patient who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 659614/0161X, expire date not reported), subcutaneously in the right arm. Concomitant therapy included TRIAVIL, ATACAND, NORVASC, thyroid, hydrochlorothiazide, calcium (unspecified) (+) vitamin D (unspecified), flax seed, hydrocodone, vitamin E, Flora Source, fish oil, vitamin C and vitamin D3. Medical assistant stated that on 24-FEB-2011, the patient was seen in the office with a case of shingles. Medical assistant explained that it was the "worse case ever seen" and the patient had lesions everywhere. Physician's diagnosis was acute onset diffuse herpes zoster vesicular eruption dorsal 6&7 and also at L2&3 on the right side posterior. Medical assistant explained that the physician punctured one of the lesions on thoracic area mid clavic line T-6,7 to collect vesicular fluid for the sample for PCR studies. The patient was treated with famciclovir 500 mg three times a day for 7 days. At the time of the report, patient's outcome was unknown. Follow-up information received via telephone call from the medical assistant indicated that on 03-MAR-2011 the patient was seen in the office and was improving, but in a lot of pain. In the office discussed the option of treating her with hydrocodone for pain, however pain meds were not started at that point. 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 Merck vaccine strain. On 04-MAR-2011, the PCR results from the vesicular specimen (collected on 24-FEB-2011) showed that Varicella Zoster Virus DNA was not amplified as well as , B-globin DNA was not either. The specimen was inadequate, negative for B-globin and no strain was identified. A lesion sample was collected on 24-FEB-2011. The sample was taken from a swab. VZV DNA was amplified. On 18-MAR-2011, the PCR result from the swab specimen identified the presence of wild type strain. Follow-up information was received from a physician concerning a patient who in the morning of 07-MAY-2008 was vaccinated with the first dose of ZOSTAVAX (Merck) in the right deltoid. The physician stated that on 22-FEB-2011 at 11:00 (previously reported as 24-FEB-2011 by the medical assistant), the patient developed herpes zoster with left thoracic D-6-7 eruption that diffusely involved 2 levels. The physician mentioned that they attempted to send it for identification but it was apparently not enough or dry. The patient did not seek medical attention. At the time of the report, the patient recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Influenza, Injection site erythema, Injection site haematoma
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 60 year old female patient with fibromyalgia who on 17-FEB-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). In February 2011, the patient experienced redness, bruising and hard bump 6 inches in length at the injection site. The patient also got a cold sore, headache and "flu like symptoms". No laboratories were performed. The patient sought medical attention by contacting the physician's office. The certified medical assistant reported that on an unspecified date symptoms were resolved and the patient was fine. Follow up information has been received from the Certified Medical Assistant informing that the patient with no illness at time of vaccination, who on 17-FEB-2011 at AM, was vaccinated with the first dose of ZOSTAVAX (Merck) subcutaneously (lot number 669589/1453Z). On 17-FEB-2011, the patient felt achy with flu symptoms. The injection site became red, bruised and swollen "6 inches in diameter" and herpes outbreak in upper lip. Onset of symptoms came in the afternoon lasting for a few days. No laboratories were performed. The patient did not seek medical attention. At the time of the report the patient was recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Oral herpes, Pain
Clinical narrative: Information has been received from a Certified Medical Assistant concerning a 60 year old female patient with fibromyalgia who on 17-FEB-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not reported). In February 2011, the patient experienced redness, bruising and hard bump 6 inches in length at the injection site. The patient also got a cold sore, headache and "flu like symptoms". No laboratories were performed. The patient sought medical attention by contacting the physician's office. The certified medical assistant reported that on an unspecified date symptoms were resolved and the patient was fine. Follow up information has been received from the Certified Medical Assistant informing that the patient with no illness at time of vaccination, who on 17-FEB-2011 at AM, was vaccinated with the first dose of ZOSTAVAX (Merck) subcutaneously (lot number 669589/1453Z). On 17-FEB-2011, the patient felt achy with flu symptoms. The injection site became red, bruised and swollen "6 inches in diameter" and herpes outbreak in upper lip. Onset of symptoms came in the afternoon lasting for a few days. No laboratories were performed. The patient did not seek medical attention. At the time of the report the patient was recovered. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Information has been received from a 67 year old consumer reporting herself with no pertinent medical history and no drug allergies or reactions who on 01-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included metformin. The patient stated that on 01-MAR-2011 after received the ZOSTAVAX (Merck), the injection site swelled up and a hive developed. The patient was not given treatment. The patient did not seek medical attention. There was no labs or diagnostic tests performed. Upon the reported time, the patient was not recovered. No further information is available.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Neuralgia, Rash pustular
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 51 year old male patient with a history of a previous outbreak in March 2001 at a different location and "not known" drug allergies or reactions, who on 03-DEC-2010, was vaccinated subcutaneously in the left deltoid with a 0.65 ml dose of ZOSTAVAX (Merck) (lot #669408/1384Z, expiration date: 12-JAN-2012). Concomitant therapy included simvastatin (manufacturer unknown). Pharmacist reported that on 15-FEB-2011 the patient developed a single lesion in the center of his back and nerve pain in the area after administration of a dose of ZOSTAVAX (Merck). It was reported that the patient was diagnosed with shingles. Patient was treated with VALTREX and VICODIN. At the time of the report patient was recovering. Patient sought unspecified medical attention. Follow up information has been received from a Doctor of Pharmacy. It was reported that the patient, who "10 years ago" (in March 2001), experienced shingles outbreak on shoulder area. It was reported that on, 03-DEC-2010 morning, the patient was vaccinated with a first dose of ZOSTAVAX (Merck). The pharmacist reported that on 15-FEB-2011 the patient had a single "pustule" in the middle of the back and pain (nerve), similar to the shingles outbreak he experienced 10 years ago. No laboratory diagnostic tests were performed to the patient. The patient was seen by the primary care physician who prescribed him valacyclovir 1gr three times a day (TID) for 7 days and hydrocodone (+) acetaminophen 5-500 mg as required/necessary (PRN) for pain. At the time of the report patient had recovered (date unspecified). No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from an office manager concerning a male patient who on 31-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) subcutaneously (expiration date and lot number not reported). On 01-APR-2011, the patient developed rash on the neck. The patient had been seeking medical attention with a physician. The patient did not improve. At the time of the report the patient was not recovered. Follow up information has been received from a healthcare worker from the physician's office informing that they did not know who the patient was on this case. The office did not wish to receive any further follow-up in this case because they did not believe there was a true adverse effect. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a female patient with allergy to BENADRYL who on unknown dates was vaccinated subcutaneously with 0.65 mL of ZOSTAVAX (Merck) (Lot# and expiration date not reported) and with a dose of PNEUMOVAX 23 (Lot# and expiration date not reported). It was reported that the patient received ZOSTAVAX and PNEUMOVAX 23 on separate occasions and a couple of years ago she experienced shortness of breath. The nurse seemed to think that it was on patient's head that she experienced the same reaction on two different occasions. The patient sought unspecified medical attention (Just called the office). As treatment for the adverse event the patient received albuterol. At the time of reporting the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a female of unknown age who "2 days ago" in March 2011, was vaccinated with ZOSTAVAX (Merck) (dose and frequency unknown for an unknown indication). Relevant medical history, relevant past drug history and relevant concomitant medications were unknown. The pharmacist reported that the consumer came in with a very bad red rash. She wondered if it could be shingles given the fact that ZOSTAVAX (Merck) is a live vaccine. It was unknown if there was any relevant laboratory data. As of 25-MAR-2011, it was unknown if the consumer will continue on ZOSTAVAX (Merck) and the status of her rash was unknown. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 62 year old female patient who on 29-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported), intramuscularly. No adverse symptoms were noted. Follow up information was received from the physician concerning the 62 year old female patient with osteopenia, macular degeneration and no known drug allergies, who on 29-MAR-2011 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot number 669191/1456Z), possibly intramuscularly into the left deltoid and who on "29 or 30-MAR-2011" experienced some local arm pain. At the time of the report, the patient had recovered (date unspecified). No further information is available.