chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Eschar, Incorrect route of drug administration, Malaise, Nausea
Clinical narrative: Information has been received from a 66 year old male registered pharmacist with gluten resistant enteropathy and with no drug reaction/allergies who on 01-JUL-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) possibly IM. Concomitant therapies included: unnamed medication for gluten. After receiving ZOSTAVAX (Merck) injection, on 04-JUL-2010 he experienced a fever blistered on his lip with open lesion and the following day he experienced malaise and nausea. The patient did not seek medical attention. No treatment required. There was no lab diagnostic test performed. He stated the injection was given with a 5/8 inch needle but it might have been administered intramuscularly. He was interested in the VZVID program. At the time of report the patient's status was recovering. Follow up information has been received from the 65 year old (previously reported as 66 year old) male patient with childhood chickenpox and no known allergies who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 664444/0722Y) at the deltoid area. On 05-JUL-2010 the patient experienced a fever blistered on his lip with open lesion. Other systemic symptom included: malaise. The patient had no recent exposure to chickenpox or shingles. On 06-JUL-2010 the specimen was collected for PCR. The source of specimen was vesicle from upper lip. At the time of report the patient's status was recovered. Follow up information has been received indicated that lesion sample was an adequate specimen but no VZV identified. Final results are VZV negative. 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. A lesion sample was collected on 06-JUL-2010. The sample was taken from a upper lip eschar scab. The PCR result from the scab specimen was negative for VZV. The B-globin DNA was amplified. The PCR date was 09-JUL-2010. Final result was: adequate specimen, no VZV identified negative. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes, Polymerase chain reaction, Scab, Skin lesion, Varicella virus test negative
Clinical narrative: Information has been received from a 66 year old male registered pharmacist with gluten resistant enteropathy and with no drug reaction/allergies who on 01-JUL-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) possibly IM. Concomitant therapies included: unnamed medication for gluten. After receiving ZOSTAVAX (Merck) injection, on 04-JUL-2010 he experienced a fever blistered on his lip with open lesion and the following day he experienced malaise and nausea. The patient did not seek medical attention. No treatment required. There was no lab diagnostic test performed. He stated the injection was given with a 5/8 inch needle but it might have been administered intramuscularly. He was interested in the VZVID program. At the time of report the patient's status was recovering. Follow up information has been received from the 65 year old (previously reported as 66 year old) male patient with childhood chickenpox and no known allergies who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 664444/0722Y) at the deltoid area. On 05-JUL-2010 the patient experienced a fever blistered on his lip with open lesion. Other systemic symptom included: malaise. The patient had no recent exposure to chickenpox or shingles. On 06-JUL-2010 the specimen was collected for PCR. The source of specimen was vesicle from upper lip. At the time of report the patient's status was recovered. Follow up information has been received indicated that lesion sample was an adequate specimen but no VZV identified. Final results are VZV negative. 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. A lesion sample was collected on 06-JUL-2010. The sample was taken from a upper lip eschar scab. The PCR result from the scab specimen was negative for VZV. The B-globin DNA was amplified. The PCR date was 09-JUL-2010. Final result was: adequate specimen, no VZV identified negative. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with drug reactions/allergies to CIPRO and sulfa. There was no pertinent medical history. On 09-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z). The registered nurse reported that on 09-JUL-2010, the patient experienced swelling, itching, warmth, redness and pain at the injection site. On an unspecified date "on the weekend", the patient went to Urgent Care and the physician at the Urgent care recommended cortisone topically and BENADRYL by mouth. The registered nurse stated that on 12-JUL-2010, the patient came to the office and was prescribed ZYRTEC because patient indicated that the BENADRYL they recommended at the Urgent care made her sleepy. The physician also recommended she ice the area. Patient was instructed to contact the office in two days if the reaction did not clear up and nurse stated that the patient had not contacted the office. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the registered nurse who reported that on 09-JUL-2010 at 13:48, the patient was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z) SC into her right arm. On 11-JUL-2010 (previously reported as 09-JUL-2010), the patient experienced circular induration below injection site, tender, edema, milder erythema which extended beyond original outline, and itching. The diagnosis of lab tests was other serum reaction not elsewhere classified. The outcome was unknown. The patient did not seek medical attention. Supplemental information was received from the registered nurse who reported that on 09-JUL-2010 at 12:00 (previously reported as 13:48), the patient was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z) SC into her right arm. On 11-JUL-2010 the patient experienced redness, swelling, pain and itching. The outcome was not reported. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Laboratory test abnormal, Oedema, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with drug reactions/allergies to CIPRO and sulfa. There was no pertinent medical history. On 09-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z). The registered nurse reported that on 09-JUL-2010, the patient experienced swelling, itching, warmth, redness and pain at the injection site. On an unspecified date "on the weekend", the patient went to Urgent Care and the physician at the Urgent care recommended cortisone topically and BENADRYL by mouth. The registered nurse stated that on 12-JUL-2010, the patient came to the office and was prescribed ZYRTEC because patient indicated that the BENADRYL they recommended at the Urgent care made her sleepy. The physician also recommended she ice the area. Patient was instructed to contact the office in two days if the reaction did not clear up and nurse stated that the patient had not contacted the office. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the registered nurse who reported that on 09-JUL-2010 at 13:48, the patient was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z) SC into her right arm. On 11-JUL-2010 (previously reported as 09-JUL-2010), the patient experienced circular induration below injection site, tender, edema, milder erythema which extended beyond original outline, and itching. The diagnosis of lab tests was other serum reaction not elsewhere classified. The outcome was unknown. The patient did not seek medical attention. Supplemental information was received from the registered nurse who reported that on 09-JUL-2010 at 12:00 (previously reported as 13:48), the patient was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z) SC into her right arm. On 11-JUL-2010 the patient experienced redness, swelling, pain and itching. The outcome was not reported. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Serum sickness, Tenderness
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female patient with drug reactions/allergies to CIPRO and sulfa. There was no pertinent medical history. On 09-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z). The registered nurse reported that on 09-JUL-2010, the patient experienced swelling, itching, warmth, redness and pain at the injection site. On an unspecified date "on the weekend", the patient went to Urgent Care and the physician at the Urgent care recommended cortisone topically and BENADRYL by mouth. The registered nurse stated that on 12-JUL-2010, the patient came to the office and was prescribed ZYRTEC because patient indicated that the BENADRYL they recommended at the Urgent care made her sleepy. The physician also recommended she ice the area. Patient was instructed to contact the office in two days if the reaction did not clear up and nurse stated that the patient had not contacted the office. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow up information was received from the registered nurse who reported that on 09-JUL-2010 at 13:48, the patient was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z) SC into her right arm. On 11-JUL-2010 (previously reported as 09-JUL-2010), the patient experienced circular induration below injection site, tender, edema, milder erythema which extended beyond original outline, and itching. The diagnosis of lab tests was other serum reaction not elsewhere classified. The outcome was unknown. The patient did not seek medical attention. Supplemental information was received from the registered nurse who reported that on 09-JUL-2010 at 12:00 (previously reported as 13:48), the patient was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot#: 665532/0711Z) SC into her right arm. On 11-JUL-2010 the patient experienced redness, swelling, pain and itching. The outcome was not reported. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Induration, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 12-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number 665532/0711Z). The nurse reported that the patient experienced pain, redness, itching and warmth at the injection site. The patient went for an office visit on 15-JUL-2010 and the doctor recommended take CLARITIN during the day and BENADRYL at night. Patient had not contacted the office since her visit on 15-JUL-2010. At the time of the report, the patient's outcome was unknown. This is one of two reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665532/0711Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from a registered nurse who indicated that the 60 year old patient with no illness at the time of vaccination on 12-JUL-2010 at 1:00 p.m. was vaccinated SC with a first dose of ZOSTAVAX (Merck) into her left arm. On 14-JUL-2010 after midday (p.m.) the patient developed pain, redness, slight warmth and slight induration, non-tender. Allergic reaction was diagnosed. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female patient with no pertinent medical history and no drug reactions or allergies, who on 12-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number 665532/0711Z). The nurse reported that the patient experienced pain, redness, itching and warmth at the injection site. The patient went for an office visit on 15-JUL-2010 and the doctor recommended take CLARITIN during the day and BENADRYL at night. Patient had not contacted the office since her visit on 15-JUL-2010. At the time of the report, the patient's outcome was unknown. This is one of two reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 665532/0711Z were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information has been received from a registered nurse who indicated that the 60 year old patient with no illness at the time of vaccination on 12-JUL-2010 at 1:00 p.m. was vaccinated SC with a first dose of ZOSTAVAX (Merck) into her left arm. On 14-JUL-2010 after midday (p.m.) the patient developed pain, redness, slight warmth and slight induration, non-tender. Allergic reaction was diagnosed. At the time of the report, the outcome of the patient was unknown. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Oral herpes, Paraesthesia, Rash
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 52 year old female patient who on 15-JUL-2010, was vaccinated with 0.65 ml SC dose of ZOSTAVAX (Merck) (Lot#: not reported) vaccination. Concomitant therapy included prednisone. The doctor of pharmacy advised that on 15-JUL-2010, the patient had a tingling in her cheek after receiving the ZOSTAVAX (Merck). The patient was also starting to develop a fever blister after the vaccination. At the time of the report, the patient was recovering from tingling in her cheek and fever blister. The patient did not seek medical attention. Follow-up information was received from an other health professional who reported that a 52 year old female patient with arthritis inflammation of wrist (mild to moderate doses), on 15-JUL-2010, was vaccination SQ in the left arm with 0.65 ml dose of ZOSTAVAX (Merck) (Lot#: reported as 1265Y which is valid for VARIVAX (Merck) at 16:00. It was also reported that from 2 to 3 hours after vaccination, the patient experienced flush and rash on her face (the flushing cleared up overnight). There was not rash at injection site. Fever blister on lip appeared 24 hours after vaccination. At the time of the report, the patient recovered. No further information is expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site rash, Rash
Clinical narrative: Information has been received from a 62 year old female patient with codeine and penicillin allergies who on 21-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck). No lot number provided. Concomitant therapy included acyclovir and CELEXA. On 22-JUL-2010 the patient developed a severe case of shingles within 24 hours. She reported blisters from her "jawline to butt." She also reported that her left arm, the arm she received the injection in, had 40 spots from there down to her hand. There were no labs or diagnostic tests performed. Caller also reported that new rash stopped producing around 24-JUL-2010. The patient had not recovered at time of reporting. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash pustular, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female patient with allergy to penicillin and sulfa who on 14-JUL-2010, was vaccinated with a 0.65 ml SC dose of ZOSTAVAX (Merck) (lot # 665525/0695Z). On 24-JUL-2010, the patient was presented to pharmacy with lesions, blisters and pustules, up her back, and wrapped around her right side, and continuing onto her abdomen. At the time of reporting, the patient was not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient who on 19-JUL-2010 was vaccinated with ZOSTAVAX (Merck) (Lot # 665530/0697Z), 0.65 mL, SQ. Two days later, on 21-JUL-2010 the patient developed a case of herpes zoster. It was reported that the patient recovered "within a week" on approximately 28-JUL-2010. The patient sought unspecified medical attention. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Injection site pain, Rash, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female who on 13-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664669/0152Z). On about 05-AUG-2010 the patient experienced shingles. The patient first developed injection site pain and then 2 dots near the injection site. Then redness and swelling spread near the site. The patient saw an unknown physician who diagnosed shingles and prescribed an unknown antiviral and TRAMADOLOR. At the time of the report, the outcome was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Rash vesicular
Clinical narrative: Information has been received from a 60 year old female with blood pressure high, cholesterol high and AUGMENTIN allergy who on 11-AUG-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (SC). Concomitant therapy included aspirin, pravastatin Na, cardiozen 240 mg, NEXIUM, WELLBUTRIN XL, vitamin A and omega-3 marine triglycerides. On 12-AUG-2010 the patient experienced body aches, chills, a low grade temperature and a rash-like reaction, which she believed was chicken pox. The patient also stated that she was not informed that she would need to stay away from susceptible patients and was concerned that her pregnant daughter who had had a previous case of chicken pox and her immunocompromised husband were at risk of getting the virus. The patient did not seek medical attention. There were no diagnostics studies performed. At the time of the report, the patient had not recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction, Rash maculo-papular, Rash papular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 60 year old female with blood pressure high, chronic obstructive pulmonary disease, gastrooesophageal reflux and psychiatric disorder and no drug allergy and a history of chickenpox who on 11-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (SC, lot# 665531/0698Z, EXP. 28-APR-2011) into her left arm. Concomitant therapy included TENORMIN, simvastatin, ADVAIR, SPIRIVA, PROAIR, omeprazole, PAXIL, SEROQUEL, clonidine and donetal. The patient did not recent exposure to chickenpox or shingles. A rash did not occur at the site of the injection post vaccination. On or about 14-AUG-2010, the patient developed fluid filled vesicles rash several in crepis on her right flank along a thoracic dermatome. On 14-AUG-2010, the patient also experienced herpes zoster at dermatome T8. On 16-AUG-2010, the physician saw the patient and confirmed this appearance. There were no lab diagnostic studies performed. 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. A lesion sample was obtained and sent to the laboratory on 18-AUG-2010. The sample was taken from a papule lesion. The PCR result from the papule lesion indicated that it was wild type strain. Follow up information was received and reported that specimen was obtained and sent to the laboratory on 17-AUG-2010 (previously reported as 18-AUG-2010). The specimen was from the lesion and maculopapular. The specimen arrived in laboratory on 19-AUG-2010. VZV DNA was amplified and then VZV strain identification showed wild type, B-globin was not amplified. The result was adequate specimen, wild type strain. Follow up information was received from the physician concerning the 60 year old female with no illness at time of vaccination, no known drug allergy and a history of chickenpox when she was a child who on 11-AUG-2010 was vaccinated with the first 0.5 ml dose of ZOSTAVAX (Merck) (SC, lot# 665531/0698Z) into her left arm. Concomitant therapy included TENORMIN, simvastatin, ADVAIR, SPIRIVA, PROAIR, omeprazole, PAXIL, SEROQUEL, KLONOPIN (previously reported as clonidine) and DONNATAL (previously reported as donetal). On 14-AUG-2010 (also reported as 16-AUG-2010) herpes zoster occurred and right flank thoracic dermatome had red cluster papular. There were no other symptoms. There was no photo taken. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella virus test positive
Clinical narrative: Information has been received from a physician concerning a 60 year old female with blood pressure high, chronic obstructive pulmonary disease, gastrooesophageal reflux and psychiatric disorder and no drug allergy and a history of chickenpox who on 11-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (SC, lot# 665531/0698Z, EXP. 28-APR-2011) into her left arm. Concomitant therapy included TENORMIN, simvastatin, ADVAIR, SPIRIVA, PROAIR, omeprazole, PAXIL, SEROQUEL, clonidine and donetal. The patient did not recent exposure to chickenpox or shingles. A rash did not occur at the site of the injection post vaccination. On or about 14-AUG-2010, the patient developed fluid filled vesicles rash several in crepis on her right flank along a thoracic dermatome. On 14-AUG-2010, the patient also experienced herpes zoster at dermatome T8. On 16-AUG-2010, the physician saw the patient and confirmed this appearance. There were no lab diagnostic studies performed. 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. A lesion sample was obtained and sent to the laboratory on 18-AUG-2010. The sample was taken from a papule lesion. The PCR result from the papule lesion indicated that it was wild type strain. Follow up information was received and reported that specimen was obtained and sent to the laboratory on 17-AUG-2010 (previously reported as 18-AUG-2010). The specimen was from the lesion and maculopapular. The specimen arrived in laboratory on 19-AUG-2010. VZV DNA was amplified and then VZV strain identification showed wild type, B-globin was not amplified. The result was adequate specimen, wild type strain. Follow up information was received from the physician concerning the 60 year old female with no illness at time of vaccination, no known drug allergy and a history of chickenpox when she was a child who on 11-AUG-2010 was vaccinated with the first 0.5 ml dose of ZOSTAVAX (Merck) (SC, lot# 665531/0698Z) into her left arm. Concomitant therapy included TENORMIN, simvastatin, ADVAIR, SPIRIVA, PROAIR, omeprazole, PAXIL, SEROQUEL, KLONOPIN (previously reported as clonidine) and DONNATAL (previously reported as donetal). On 14-AUG-2010 (also reported as 16-AUG-2010) herpes zoster occurred and right flank thoracic dermatome had red cluster papular. There were no other symptoms. There was no photo taken. No further information is available.
Age: 13.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from an office manager concerning a 12 year old male patient who on 17-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 665308/1177Y) instead of VARIVAX (Merck). No adverse experience was reported. Follow up information has been received from the office manager who stated that it was just a mistake. She said that it was not someone new to the process but that they had since remedied any potential for confusion of products stored in the freezer by placing them in separate trays with labeling. Additional information is not expected.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an 89 year old female with no pertinent medical history and no drug allergies, who on 20-AUG-2010 was vaccinated with a standard dose of ZOSTAVAX (Merck) (SC, lot # 664668/0153Z). There was no concomitant medication. The patient developed an injection site reaction after vaccination. The injection site had been red and swollen. There were no labs or diagnostic tests performed. The patient called the pharmacist for medical attention, and not recovered at time of report. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Information has been received regarding a female patient who was given ZOSTAVAX (Merck), 0.65mL injection (lot #0876Y, exp 20DEC10) on 17AUG2010 and developed swelling and blisters around the injection site. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 53 year old female with no medical history or drug reactions/allergies reported who on 23-AUG-2010 was vaccinated with ZOSTAVAX (Merck) (lot# 665531/0698Z) SQ (dose and frequency was reported as "standard route"). Concomitant therapy included allopurinol. A pharmacist was reporting that a patient developed an injection site reaction after receiving ZOSTAVAX (Merck). The patient's injection site appeared to be red and swollen. It's about 6 inches long and 3 inches wide. The patient was not recovered at the time of reporting. The patient sought medical attention. Follow up information has been received from a Registered of Pharmacist who reported hat the patient was vaccinated with ZOSTAVAX (Merck) (lot# 665531/0698Z) SQ single dose at 12:30 pm on 23-AUG-2010. On the same date on 23-AUG-2010 the patient developed a rash and itching at the site of injection. The reaction lasted for about 7 days. The patient required doctor visit. The doctor determined it was an adverse reaction to the vaccine. The patient was recovered from rash and itching at the site of injection on 31-AUG-2010. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a 79 year old female registered nurse who on 16-AUG-2010 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) at a pharmacy. Concomitant therapy included pain medication. On 18-AUG-2010 the patient developed shingles 2.5 day after receiving ZOSTAVAX (Merck). She said that a registered nurse (name not provided) administered the vaccination. She was examined by a dermatologist four days later. At the time of reporting, the patient was recovering. Follow-up information was received from the 79 year old female with hypertension and rash who on 16-AUG-2010 was vaccinated SC in the left deltoid with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 664274/0959Y). Concomitant therapy included hydrochlorothiazide (manufacture unknown) and "altage". On 18-AUG-2010 the patient experienced herpes zoster which distributed on left chest, back and hand. There was no specimen collected for PCR. On 01-OCT-2010 the patient recovered, but he still had persistent pain. The patient also reported that on unspecified date he was vaccinated with 0.2 ml FLUMIST intranasal. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 62 year old female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The patient reported that she received ZOSTAVAX (Merck) and got shingles 6 weeks later. At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. No further information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blister, Herpes zoster, Laboratory test, Pain of skin
Clinical narrative: Information has been received from a 70 year old male consumer with a "lung issue" and no drug reactions/allergies, who on 20-SEP-2010 was vaccinated with a "one time" dose of ZOSTAVAX (Merck) SQ. Concomitant therapy included ADVAIR, SPIRIVA and lisinopril (manufacturer unknown). Consumer reported that a month and a half later, on 07-NOV-2010 he had experienced stomach ache, his skin hurt on his back and right arm and he developed blisters. Usual lab work was performed in April. The consumer sought unspecified medical attention At the time of the report the consumer was recovering. Follow up information was received from a health care professional, who reported that the patient (height 70 inches) with seasonal allergies and no illness at time of vaccination, who on 20-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot #664673/0150Z) (route not reported), into his left deltoid. On 07-NOV-2010 the patient experienced herpes zoster. No laboratory tests were reported. At the time of this report the patient was not recovered from herpes zoster. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pustular
Clinical narrative: Information has been received from a registered pharmacist concerning a 64 year old female with a history of depression and no drug reaction/allergies who on 13-DEC-2010 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (dose not reported, lot # 669261/1362Z). On 18-DEC-2010 "five days later" the patient noted pustules and a rash. She saw her nurse practitioner on 22-DEC-2010 who noted the rash was consistent with herpes zoster. The patient had not recovered. She would be treated with VALTREX, TYLENOL and CALAMINE LOTION. No diagnostic laboratory tests were performed. The patient sought medical attention by office visit. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Headache, Herpes zoster, Lymphadenopathy
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female patient with acute asthma, osteoporosis, depression, and drug reactions/allergies to lots of medications and antibiotics, who on 22-DEC-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 667609/1354Z, expiration date of 26-OCT-2011) subcutaneously into her left arm. The patient also took unspecified concomitant therapy. The pharmacist reported the patient developed shingles post vaccination. The pharmacist stated that it took the patient one month to recover. The patient sought unspecified medical attention and she was given unspecified antibiotics treatment for the event. Follow-up information has been received from the pharmacist reporting that the patient had received ZOSTAVAX (Merck) and was diagnosed with the shingels (date not reported). It took the patient one month to recover. Follow-up information was received from medical records regarding a 63 year old female who on 22DEC10 at 6 P.M. (18:00 hours) was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 667609/1354Z, expiration date 26OCT11) in her left upper arm. Other medications taken by the patient at the time of vaccination were listed as VENTOLIN  HFA, bupropion, and alendronate. It is unknown if the patient has a history of chickenpox or recent exposure to chickenpox or herpes zoster, however, the patient reported that her brother developed shingles (unknown date). The patient had no outbreaks of shingles before the vaccination. The administering pharmacist reported that the patient called the pharmacy to report that she felt warmth in the arm and palm of left hand following the vaccination on 22DEC10 at 11 PM (21:00 hours). She then noticed itch/rash on skin area below her left thumb/left palm area near thumb on 23DEC10 and some fever with burning sensation in her arm (left). She also developed dull headaches (also reported as "severe" headache) x3 with raised bump along with blistering rash on her left upper scapula area and below neckline (L C6-7). There was no rash at the site of the injection. On 24DEC10 the patient developed wheezing. It was also reported the patient developed swollen lymph node and small patches of blistering rash on L forearm. Pain along her left arm. The patient was seen by her primary physician on 29DEC10. The physician stated that the patient had been recovering from a viral syndrome that included bronchospasm, over the last few weeks. He stated "One cannot exclude the possibility that the patient was incubating shingles at the time the vaccine was given, but that coincidence is hardly credible." The patient was diagnosed with singles and was treated with VALTREX, CLARITIN, ibuprofen, VENTOLIN, and CALADRYL. It was reported that the patient recovered on approximately 30JAN11. This is one of several reports received from the same source. Additional information has been requested. All available medical records will be provided upon request.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash pruritic, Skin warm, Urticaria, Wheezing
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female patient with acute asthma, osteoporosis, depression, and drug reactions/allergies to lots of medications and antibiotics, who on 22-DEC-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 667609/1354Z, expiration date of 26-OCT-2011) subcutaneously into her left arm. The patient also took unspecified concomitant therapy. The pharmacist reported the patient developed shingles post vaccination. The pharmacist stated that it took the patient one month to recover. The patient sought unspecified medical attention and she was given unspecified antibiotics treatment for the event. Follow-up information has been received from the pharmacist reporting that the patient had received ZOSTAVAX (Merck) and was diagnosed with the shingels (date not reported). It took the patient one month to recover. Follow-up information was received from medical records regarding a 63 year old female who on 22DEC10 at 6 P.M. (18:00 hours) was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 667609/1354Z, expiration date 26OCT11) in her left upper arm. Other medications taken by the patient at the time of vaccination were listed as VENTOLIN  HFA, bupropion, and alendronate. It is unknown if the patient has a history of chickenpox or recent exposure to chickenpox or herpes zoster, however, the patient reported that her brother developed shingles (unknown date). The patient had no outbreaks of shingles before the vaccination. The administering pharmacist reported that the patient called the pharmacy to report that she felt warmth in the arm and palm of left hand following the vaccination on 22DEC10 at 11 PM (21:00 hours). She then noticed itch/rash on skin area below her left thumb/left palm area near thumb on 23DEC10 and some fever with burning sensation in her arm (left). She also developed dull headaches (also reported as "severe" headache) x3 with raised bump along with blistering rash on her left upper scapula area and below neckline (L C6-7). There was no rash at the site of the injection. On 24DEC10 the patient developed wheezing. It was also reported the patient developed swollen lymph node and small patches of blistering rash on L forearm. Pain along her left arm. The patient was seen by her primary physician on 29DEC10. The physician stated that the patient had been recovering from a viral syndrome that included bronchospasm, over the last few weeks. He stated "One cannot exclude the possibility that the patient was incubating shingles at the time the vaccine was given, but that coincidence is hardly credible." The patient was diagnosed with singles and was treated with VALTREX, CLARITIN, ibuprofen, VENTOLIN, and CALADRYL. It was reported that the patient recovered on approximately 30JAN11. This is one of several reports received from the same source. Additional information has been requested. All available medical records will be provided upon request.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Feeling hot, Headache, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female patient with acute asthma, osteoporosis, depression, and drug reactions/allergies to lots of medications and antibiotics, who on 22-DEC-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 667609/1354Z, expiration date of 26-OCT-2011) subcutaneously into her left arm. The patient also took unspecified concomitant therapy. The pharmacist reported the patient developed shingles post vaccination. The pharmacist stated that it took the patient one month to recover. The patient sought unspecified medical attention and she was given unspecified antibiotics treatment for the event. Follow-up information has been received from the pharmacist reporting that the patient had received ZOSTAVAX (Merck) and was diagnosed with the shingels (date not reported). It took the patient one month to recover. Follow-up information was received from medical records regarding a 63 year old female who on 22DEC10 at 6 P.M. (18:00 hours) was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 667609/1354Z, expiration date 26OCT11) in her left upper arm. Other medications taken by the patient at the time of vaccination were listed as VENTOLIN  HFA, bupropion, and alendronate. It is unknown if the patient has a history of chickenpox or recent exposure to chickenpox or herpes zoster, however, the patient reported that her brother developed shingles (unknown date). The patient had no outbreaks of shingles before the vaccination. The administering pharmacist reported that the patient called the pharmacy to report that she felt warmth in the arm and palm of left hand following the vaccination on 22DEC10 at 11 PM (21:00 hours). She then noticed itch/rash on skin area below her left thumb/left palm area near thumb on 23DEC10 and some fever with burning sensation in her arm (left). She also developed dull headaches (also reported as "severe" headache) x3 with raised bump along with blistering rash on her left upper scapula area and below neckline (L C6-7). There was no rash at the site of the injection. On 24DEC10 the patient developed wheezing. It was also reported the patient developed swollen lymph node and small patches of blistering rash on L forearm. Pain along her left arm. The patient was seen by her primary physician on 29DEC10. The physician stated that the patient had been recovering from a viral syndrome that included bronchospasm, over the last few weeks. He stated "One cannot exclude the possibility that the patient was incubating shingles at the time the vaccine was given, but that coincidence is hardly credible." The patient was diagnosed with singles and was treated with VALTREX, CLARITIN, ibuprofen, VENTOLIN, and CALADRYL. It was reported that the patient recovered on approximately 30JAN11. This is one of several reports received from the same source. Additional information has been requested. All available medical records will be provided upon request.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Mass, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female patient with acute asthma, osteoporosis, depression, and drug reactions/allergies to lots of medications and antibiotics, who on 22-DEC-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 667609/1354Z, expiration date of 26-OCT-2011) subcutaneously into her left arm. The patient also took unspecified concomitant therapy. The pharmacist reported the patient developed shingles post vaccination. The pharmacist stated that it took the patient one month to recover. The patient sought unspecified medical attention and she was given unspecified antibiotics treatment for the event. Follow-up information has been received from the pharmacist reporting that the patient had received ZOSTAVAX (Merck) and was diagnosed with the shingels (date not reported). It took the patient one month to recover. Follow-up information was received from medical records regarding a 63 year old female who on 22DEC10 at 6 P.M. (18:00 hours) was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 667609/1354Z, expiration date 26OCT11) in her left upper arm. Other medications taken by the patient at the time of vaccination were listed as VENTOLIN  HFA, bupropion, and alendronate. It is unknown if the patient has a history of chickenpox or recent exposure to chickenpox or herpes zoster, however, the patient reported that her brother developed shingles (unknown date). The patient had no outbreaks of shingles before the vaccination. The administering pharmacist reported that the patient called the pharmacy to report that she felt warmth in the arm and palm of left hand following the vaccination on 22DEC10 at 11 PM (21:00 hours). She then noticed itch/rash on skin area below her left thumb/left palm area near thumb on 23DEC10 and some fever with burning sensation in her arm (left). She also developed dull headaches (also reported as "severe" headache) x3 with raised bump along with blistering rash on her left upper scapula area and below neckline (L C6-7). There was no rash at the site of the injection. On 24DEC10 the patient developed wheezing. It was also reported the patient developed swollen lymph node and small patches of blistering rash on L forearm. Pain along her left arm. The patient was seen by her primary physician on 29DEC10. The physician stated that the patient had been recovering from a viral syndrome that included bronchospasm, over the last few weeks. He stated "One cannot exclude the possibility that the patient was incubating shingles at the time the vaccine was given, but that coincidence is hardly credible." The patient was diagnosed with singles and was treated with VALTREX, CLARITIN, ibuprofen, VENTOLIN, and CALADRYL. It was reported that the patient recovered on approximately 30JAN11. This is one of several reports received from the same source. Additional information has been requested. All available medical records will be provided upon request.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Wheezing
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female patient with acute asthma, osteoporosis, depression, and drug reactions/allergies to lots of medications and antibiotics, who on 22-DEC-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 667609/1354Z, expiration date of 26-OCT-2011) subcutaneously into her left arm. The patient also took unspecified concomitant therapy. The pharmacist reported the patient developed shingles post vaccination. The pharmacist stated that it took the patient one month to recover. The patient sought unspecified medical attention and she was given unspecified antibiotics treatment for the event. Follow-up information has been received from the pharmacist reporting that the patient had received ZOSTAVAX (Merck) and was diagnosed with the shingels (date not reported). It took the patient one month to recover. Follow-up information was received from medical records regarding a 63 year old female who on 22DEC10 at 6 P.M. (18:00 hours) was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# 667609/1354Z, expiration date 26OCT11) in her left upper arm. Other medications taken by the patient at the time of vaccination were listed as VENTOLIN  HFA, bupropion, and alendronate. It is unknown if the patient has a history of chickenpox or recent exposure to chickenpox or herpes zoster, however, the patient reported that her brother developed shingles (unknown date). The patient had no outbreaks of shingles before the vaccination. The administering pharmacist reported that the patient called the pharmacy to report that she felt warmth in the arm and palm of left hand following the vaccination on 22DEC10 at 11 PM (21:00 hours). She then noticed itch/rash on skin area below her left thumb/left palm area near thumb on 23DEC10 and some fever with burning sensation in her arm (left). She also developed dull headaches (also reported as "severe" headache) x3 with raised bump along with blistering rash on her left upper scapula area and below neckline (L C6-7). There was no rash at the site of the injection. On 24DEC10 the patient developed wheezing. It was also reported the patient developed swollen lymph node and small patches of blistering rash on L forearm. Pain along her left arm. The patient was seen by her primary physician on 29DEC10. The physician stated that the patient had been recovering from a viral syndrome that included bronchospasm, over the last few weeks. He stated "One cannot exclude the possibility that the patient was incubating shingles at the time the vaccine was given, but that coincidence is hardly credible." The patient was diagnosed with singles and was treated with VALTREX, CLARITIN, ibuprofen, VENTOLIN, and CALADRYL. It was reported that the patient recovered on approximately 30JAN11. This is one of several reports received from the same source. Additional information has been requested. All available medical records will be provided upon request.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received form a pharmacist concerning a 63 year old female patient with no reported drug allergies and no reported medical history who on 20-DEC-2010 was administered ZOSTAVAX (Merck) (lot # 665525/0695Z). The patient did not receive any concomitant vaccinations. On 06-JAN-2011 the patient reported to the pharmacist that she had a cold sore on her lip. On 08-JAN-2011, the patient reported that she had a rash on the left side of her abdomen. On 08-JAN-2011, the patient went to a "walk-in clinic and was seen by a doctor. The patient was diagnosed with shingles and was treated with an antiviral medication (unspecified). The outcome was unknown. Follow-up information has been received from a licensed practical nurse concerning the patient. The patient had allergies to SEPTRA DS and penicillin, diabetes, hypertension and hypercholesterolemia. The patient received ZOSTAVAX (Merck) on 20-DEC-2010 (injection was given at another facility). Three weeks after the shingles vaccine, on 10-JAN-2011, the patient developed upper respiratory infection, then broke out in lesions on lip, left lower rib and back area. The patient was seen at doctor's office on 14-JAN-2011. No lab test was performed. At the time of reporting, outcome of the events was unknown. This is one of several reports received form the same source. Additional information has been requested.