chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old patient of unknown gender with allergic reaction to ROCEPHIN and BIAXIN who on 03-MAR-2011 was vaccinated with 0.65ml ZOSTAVAX (Merck) in the right arm. The patient's relevant concomitant medications were unknown. On 03-MAR-2011, 10-15 minutes after receiving ZOSTAVAX (Merck), the patient experienced soreness, swelling and itching at the injection site. The affected area was about 4 inches by 2 inches. The patient had had no laboratory testing performed. As of 05-MAR-2011, it was unknown if the patient would continue ZOSTAVAX (Merck) and the events continued. This pharmacist advised that the patient use cold compresses, an antihistamine, and a pain reliever for events. Follow-up information has been received from the pharmacist concerning with female patient with no illness at the time of vaccination who on 03-MAR-2011 PM 5:15, was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 669192/1457Z) in left arm (previously reported as "in right arm"). The pharmacist reported that on 03-MAR-2011 at 17:15 the patient experienced 5x2 inches redness raised and rash immediately after getting vaccination. On 21-MAR-2011, the patient had recovered. Follow-up information has been received from the pharmacist indicating that the patient experienced approximately 4x1 inches red area raised immediately. The patient had no shingles prevention. There were no diagnostic and laboratory tests performed. The adverse event lasted for 3 weeks. On 24-MAR-2011 (previously reported as "21-MAR-2011"), the patient had recovered. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old patient of unknown gender with allergic reaction to ROCEPHIN and BIAXIN who on 03-MAR-2011 was vaccinated with 0.65ml ZOSTAVAX (Merck) in the right arm. The patient's relevant concomitant medications were unknown. On 03-MAR-2011, 10-15 minutes after receiving ZOSTAVAX (Merck), the patient experienced soreness, swelling and itching at the injection site. The affected area was about 4 inches by 2 inches. The patient had had no laboratory testing performed. As of 05-MAR-2011, it was unknown if the patient would continue ZOSTAVAX (Merck) and the events continued. This pharmacist advised that the patient use cold compresses, an antihistamine, and a pain reliever for events. Follow-up information has been received from the pharmacist concerning with female patient with no illness at the time of vaccination who on 03-MAR-2011 PM 5:15, was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 669192/1457Z) in left arm (previously reported as "in right arm"). The pharmacist reported that on 03-MAR-2011 at 17:15 the patient experienced 5x2 inches redness raised and rash immediately after getting vaccination. On 21-MAR-2011, the patient had recovered. Follow-up information has been received from the pharmacist indicating that the patient experienced approximately 4x1 inches red area raised immediately. The patient had no shingles prevention. There were no diagnostic and laboratory tests performed. The adverse event lasted for 3 weeks. On 24-MAR-2011 (previously reported as "21-MAR-2011"), the patient had recovered. No further information is available.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Information has been received from a registered nurse concerning an 85 year old male patient with a history of cataract surgery 3 weeks ago (approximately 11-FEB-2011), who on an unspecified date was vaccinated SQ with a dose of 0.65 ml of ZOSTAVAX (Merck) (lot number not provided). On an unknown date, the patient who received ZOSTAVAX (Merck) developed shingles in the same eye that he had cataract surgery 3 weeks ago. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Information has been received from a male consumer who reported that a woman who he had spoken remembered a case of a patient who was vaccinated with a dose of ZOSTAVAX (Merck) (Dose, route and Lot# not reported). The consumer stated that the patient's blood sugar raised after ZOSTAVAX (Merck) was administered. At the time of the report the patient's outcome was unknown. This is one of two reports received from the same source. Attempts are being made to verify the existence of an identifiable patient. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a 68 year old female patient with no allergies and no pertinent medical history who in July-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Dose, route and Lot# not reported). Concomitant therapy included EFFEXOR, CELEBREX, HCTZ/triamterene, omega-3 marine triglycerides and baby aspirin. The consumer stated that in August 2010, a month after having ZOSTAVAX (Merck) experienced cold sores on one side of her face and cold sores all over her body. There were no laboratories diagnostics performed. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a Doctor of pharmacy concerning a female patient with no allergies who on 02-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Dose and Lot# not reported), SQ. The doctor of pharmacy stated that on 04-MAR-2011 the patient experienced redness and rash (without pustules) at injection site. There were no laboratories diagnostics performed. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a consumer concerning an "about 70 year old" female friend who on an unknown date, was vaccinated with only one dose of 0.65ml ZOSTAVAX (Merck) (route and lot# not reported). The patient had pain throughout the arm of the injection after receiving ZOSTAVAX (Merck). The patient did not seek medical attention. At the time of reporting, the outcome was unknown. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). The patient had come to office for a dose of VARIVAX (Merck). No adverse event reported. The patient did not seek medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Rash erythematous
Clinical narrative: Information has been received from a registered pharmacist (R.Ph) concerning a 60 year old female with a history of cancer who on unspecified date, was vaccinated a dose of ZOSTAVAX (Merck) subcutaneously (lot # not reported). It was reported that the patient experienced a raised, red rash at the site injection site which went away soon after. No treatment was given for the adverse event. The patient received an unspecified medical attention. At the time of the report, the patient had recovered. Follow up information has been received from a registered pharmacist concerning a 60 year old retired female who had cancer 4-1/2 to 5 years ago (approximately in May 2006). On 23-MAR-2011, the patient was vaccinated with the first dose of ZOSTAVAX (Merck) at 17:00 subcutaneously and outer aspect of left upper arm (lot number: 669187/1543Z) (dose not reported). No illness at the time of vaccination. On 24-MAR-2011, "next day", the patient presented redness around injection site. Also it was noticed that the patient did not seem concerned and injection site was visually checked twice. No relevant diagnostics test and laboratory data were performed. At the time of the report, the patient had recovered on unspecified date. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 64 year old female with arthritis and no drug reactions or allergies, who on 22-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck), subcutaneously (Lot # 669263/1361Z, expiration date: 15-JAN-2012). Concomitant therapy included REQUIP (manufacturer unknown), calcium (manufacturer unknown), TRICOR (manufacturer unknown), aspirin (manufacturer unknown), vitamin D (manufacturer unknown) and lovastatin (manufacturer unknown). On 23-MAR-2011, the physician reported that the patient developed shingles and the shingles did not develop at the site of the injection. Also, it was reported that the shingles appeared at the right flank and anterior abdominal wall. The patient received unspecified medical attention. No lab diagnostics studies were performed. FAMVIR was the treatment given for the adverse event. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 61 year old male patient who on 14-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# and expiration date not reported) and then on 10-MAR-2011 developed shingles. It was reported that the patient's rash was bilateral and confined to the buttock area. The patient had no pain associated with the rash. The patient visited the office on 29-MAR-2011 for an unrelated issue and physician reported that he is fully recovered. Follow up information has been received from a physician concerning a 61 year old male patient who on 14-JAN-2011 was vaccinated intramuscularly in the left upper extremity with a first dose of ZOSTAVAX (Merck) (Lot# 665310/1195Y and expiration: 24-FEB-2011). Physician stated that the patient had shingles out break (on left buttock, also progress over on right, seen by dermatologist also). It was reported that the patient was evaluated by a dermatologist. At the time of reporting the patient had recovered. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning an 80 year old female with hypertension, coronary artery disease, chronic anxiety and codeine, statins allergies who on 20-MAR-2007 was vaccinated SC with a dose of ZOSTAVAX (Merck). Concomitant therapy included COUMADIN and "quite a few medications". The patient presented to the physician's office on 02-MAR-2011 and was "diagnosed with shingles." No lab diagnostics study was performed. The patient was being treated with VALTREX, PERCOCET and NEURONTIN. There were no lab diagnostic studies performed. At the time of the report, the patient had not recovered. Follow-up information was received from a physician indicating that the patient got shingles in March 2011, although she received the vaccination in 2007 or 2008. The physician felt that shingles was not related to therapy with ZOSTAVAX (Merck). No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Information has been received from a registered pharmacist (R. Ph) concerning a 65 year old female patient with a history of breast cancer who on 28-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck), 0.65 ml, subcutaneously in right arm (Lot # 670381/0171AA, expiration date: 07-MAY-2012). On 30-MAR-2011, the patient called to R. Ph to report a red, round swollen, warm to touch area at the injection site. Also, it was reported that the rash seemed to be worse than it was on previous day (29-MAR-2011). The patient did not seek medical attention. Not treatment was given for the adverse event. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient with a history of shingles and no drug reactions or allergies reported, who in March 2009 (2 years ago), was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). The patient recently acquired a mild case of shingles. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who in April 2010 was vaccinated subcutaneously, with a dose of 0.65 ml ZOSTAVAX (Merck) (Lot # not reported). The physician reported that on approximately 25-MAR-2011, the patient was seen at his office with a case of shingles. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a pharmacist concerning a male patient who was vaccinated with a dose of ZOSTAVAX (Merck) (dose, expiration date and lot number not reported). On an unknown date the patient developed rash or possibly "shingles" after he received ZOSTAVAX (Merck). The patient called the pharmacy where he received the ZOSTAVAX (Merck) to report the incidence of rash. The patient did not complain of much pain associated with the rash. The pharmacist stated that the patient was not assessed by physician for definitive diagnosis of shingles. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dry skin
Clinical narrative: Information has been received from a consumer reporting on herself who on approximately 01-MAR-2011, "a month ago", was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot number not reported). On 30-MAR-2011, "2 days ago", the patient experienced an overall dry patch on her right hip. It was unknown if the patient sought medical attention. The patient did not improve. At the time of the report the patient was not recovered. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a female with no drug allergies or medical histories, who on 04-MAR-2011 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not provided). There was no concomitant medication. On 07-MAR-2011 the patient noticed that the area around the injection site was red, hard and hot to touch. The area was 1 inch wide extending 7 inches down the patient's arm from the injection site. It was also reported that the patient denied that the area was painful or itchy. No treatment was give to this adverse event. Patient sought medical attention via calling the pharmacist. No lab diagnostics studies were performed. At the time of reporting, the patient had not recovered. Follow up information has been received from a registered pharmacist (R.Ph) concerning a 60 year old female who on 04-MAR-2011 was subcutaneously vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 669263/1361Z. Exp: 15-JAN-2012). The reporter stated that am on 06-MAR-2011 the patient noticed a large "red" area extending from injection site almost down to elbow-hot to touch, hard raised at injection site. On 12-MAR-2011 it resolved itself by day eight. It was unknown if the patient sought medical attention. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with Sulfa and Erythromycin allergy and no pertinent medical history who on 04-MAR-2011 was vaccinated Subcutaneously in the right arm with a 0.65ml dose of ZOSTAVAX (Merck) (Lot # 669408/1384Z, expiration date 19-JAN-2012). There was no other concomitant medication. On 04-MAR-2011 the patient developed swelling at the injection site following vaccination with ZOSTAVAX (Merck) (Lot # 669408/1384Z). The swelling was reported to be red and warm to the touch. The swelling started to develop immediately after the patient received the vaccination. The swelling had traveled down the arm from the injection site to the elbow. The patient sought unspecified medical attention. No treatment was given for the events. No lab diagnostics studies were performed. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Myalgia, Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old male patient with diabetes, hyperlipidaemia, hypertension and no drug allergies who on 04-MAR-2011 was vaccinated SC with 0.65 ml ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included DIOVAN, CLARITIN and aspirin. On 04-MAR-2011, 4 to 5 hours post administration, the patient experienced nausea, chills and his body was violently shaking. The shaking lasted all night and on 05-MAR-2011 ("the next day") his muscles were sore. No treatment was given to the patient. Lab diagnostics studies were not performed. At the time of reporting, the patient was recovering but the symptoms had not subsided. The patient did not seek medical attention. Follow up information has been received from a certified medical assistant concerning the patient who on 04-MAR-2011 at 12:16 PM was vaccinated SC with his first dose of ZOSTAVAX (Merck) (lot # 669191/1456Z) in the left arm. On 04-MAR-2011 around 4:00 PM the patient started feeling not himself and tired. Around 5:00 PM he felt sleepy with severe shivering and chills. By the morning of 05-MAR-2011, the patient recovered from the adverse events. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Somnolence, Tremor
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old male patient with diabetes, hyperlipidaemia, hypertension and no drug allergies who on 04-MAR-2011 was vaccinated SC with 0.65 ml ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included DIOVAN, CLARITIN and aspirin. On 04-MAR-2011, 4 to 5 hours post administration, the patient experienced nausea, chills and his body was violently shaking. The shaking lasted all night and on 05-MAR-2011 ("the next day") his muscles were sore. No treatment was given to the patient. Lab diagnostics studies were not performed. At the time of reporting, the patient was recovering but the symptoms had not subsided. The patient did not seek medical attention. Follow up information has been received from a certified medical assistant concerning the patient who on 04-MAR-2011 at 12:16 PM was vaccinated SC with his first dose of ZOSTAVAX (Merck) (lot # 669191/1456Z) in the left arm. On 04-MAR-2011 around 4:00 PM the patient started feeling not himself and tired. Around 5:00 PM he felt sleepy with severe shivering and chills. By the morning of 05-MAR-2011, the patient recovered from the adverse events. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain, Paraesthesia
Clinical narrative: Information has been received from an approximately 69 year old female with no concomitant medication or drug allergies who, in approximately 2009, about two years ago, was vaccinated with a dose of ZOSTAVAX (Merck). There was not concomitant therapy. The patient reported that "well over a year ago", in approximately 2010, she had weird, tingly feeling and pain. The pain began on the right side and then travelled over the middle near the belly button and it seemed like shingles was trying to come out. The pain came and went. The patient sought unspecified medical attention. The patient was treated with acyclovir 400 mg, 5 tablets a day for 10 days, and tramadol. The patient stated that she was no longer taking tramadol but she was still taking acyclovir. None of lab diagnostics studies performed. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Laboratory test, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old male patient with no drug allergies and no medical history who on 03-MAR-2011 was vaccinated subcutaneously in the left arm with 0.65 ml (cc) ZOSTAVAX (Merck) (lot # 669536/1387Z). In the morning of 07-MAR-2011 the patient felt itchy on his back near his shoulder blade. His wife looked at his back and he had a circular patch of small blisters on one side of his back near his shoulder (which side of the back was not identified). The circular patch of small blisters was not painful, there was no burning and it was just described as itchy. No treatment was given to the patient. Lab diagnostics studies were performed. The patient was referred to his family physician. At the time of reporting, the patient did not recover from the adverse events. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Information has been received from a 76 year old female with chronic obstructive pulmonary disease (COPD), atrial flutter, blood pressure and thyroid disorder and no drug allergies who on 03-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot# not reported). Concomitant therapy included bisoprolol, levothyroxine Na, PRADAXA, omeprazole, pravastatin Na and ipratropium bromide. On 04-MAR-2011 the patient noticed her arm was red and swollen at the injection site. It had been almost a week since she had ZOSTAVAX (Merck) administered. She also had itchy hands. No lab diagnostics studies were performed. The patient did not seek medical attention. At the time of reporting, the outcomes were unknown. Follow up information has been received from a physician concerning the patient with shellfish allergy who on 03-MAR-2011 at 11:00 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 669259/1360Z, dose not reported) into her left deltoid. Patient experienced redness at inject site, swelling and itchy hands on 04-MAR-2011. It was not sure if S/E (side effect) from vaccine per MD. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female patient who on an unknown date, was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (route and lot# not reported). Ten days after she was vaccinated, the patient came back with a blister like rash around the injection site. The patient sought unspecified medical attention. The patient was treated with VALTREX. At the time of reporting, the outcome was unknown. Follow-up information has been received from the registered nurse concerning a 64 year old female with type 2 diabetes mellitus and hypertension who on 21-FEB-2011 at 8:40 am vaccination subcutaneously with a dose of ZOSTAVAX (Merck) (lot# 669259/1360Z). On 03-MAR-2011 the patient developed extensive blistery rash itchy and painful at site of injection. Patient was given VALTREX, PO, 1 g three times a day, for 7 days. On 07-MAR-2011 the patient began to complain of itch/pain on trunk of same side of injection (blisters and redness). On an unspecified date, the patient recovered. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash vesicular
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning a female patient who on an unknown date, was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (route and lot# not reported). Ten days after she was vaccinated, the patient came back with a blister like rash around the injection site. The patient sought unspecified medical attention. The patient was treated with VALTREX. At the time of reporting, the outcome was unknown. Follow-up information has been received from the registered nurse concerning a 64 year old female with type 2 diabetes mellitus and hypertension who on 21-FEB-2011 at 8:40 am vaccination subcutaneously with a dose of ZOSTAVAX (Merck) (lot# 669259/1360Z). On 03-MAR-2011 the patient developed extensive blistery rash itchy and painful at site of injection. Patient was given VALTREX, PO, 1 g three times a day, for 7 days. On 07-MAR-2011 the patient began to complain of itch/pain on trunk of same side of injection (blisters and redness). On an unspecified date, the patient recovered. Additional information is not expected.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician (D.O.) concerning a 34 year old female who on 08-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 669533/1383Z, dose and route not reported). The patient was supposed to receive VARIVAX (Merck). No adverse events were reported. The patient did not seek medical attention. Follow up information has been received from the physician concerning a female patient who on 08-MAR-2011 at 8:30 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot# 669533/1383Z). Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 72 year old male patient with no drug allergies and no medical history who on 10-JAN-2008 was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included unspecified medications because the patient did not recall what he took. On 04-MAR-2011 the patient broke out with shingles. The patient had sought unspecified medical attention. Unspecified treatment was given to the patient. Lab diagnostics studies were not performed. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: Information has been received from a pharmacist concerning a male patient who "About four months ago" in approximately November 2010, was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck) (lot number not reported), SQ. Pharmacist stated that the patient "About four months ago" in approximately November 2010, experienced musculoskeletal pain. At the time of the report the patient's musculoskeletal pain persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, Injection site pain
Clinical narrative: Information has been received from a doctor of pharmacy concerning a patient, who on 04-MAR-2011 was vaccinated with an expired 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 664637/0748Y Exp 23-NOV-2011) SQ. No adverse reactions were reported. Follow up information has been received from the doctor of pharmacy concerning the 65 year old female patient with no known drug reactions or allergies, who was vaccinated with ZOSTAVAX (Merck) subcutaneously in the left arm. The patient experienced just normal soreness at the site of injection. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). It was reported that the patient got the ZOSTAVAX (Merck) shot and then got shingles, but much less severe outbreak. It was unknown if the patient had shingles before or if the severity was based on shingles in general. At the time of reporting, the patient's status was not provided. Patient sought unspecified medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with high blood pressure, depression, hypothyroidism and no drug reactions/allergies who on 07-MAR-2011 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot # 667610/1355Z; exp date: 26-OCT-2011). Concomitant therapy included atenolol, citalopram, meloxicam, metformin, and levothyroxine. On 08-MAR-2011, the patient developed redness at the injection site. On 08-MAR-2011, the patient developed redness at the injection site. The treatment of cold compress and BENADRYL were given to the adverse event. There was no lab diagnostics studies performed. At the time of the report, the patient was recovering from her adverse event. The patient sought an unspecified medical attention. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 60 year old male with depression and allergy to codeine who on 07-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included citalopram. It was reported that the patient realized "yesterday morning", 09-MAR-2011, (previously reported as 09-SEP-2011), the injection site is extremely itchy, swollen, warm, red and it looks like a boil. The consumer mentioned he would call his HCP. He was given unspecified treatment. And no lab diagnostics studies performed. The patient did not seek medical attention. The patient present status was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 66 year old female with PHENERGAN allergy who on 02-JAN-2009 was vaccinated SC with 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included atenolol and aspirin. On around 28-FEB-2010 the patient developed shingles diagnosed by her doctor. The patient was treated with valacyclovir hydrochloride. The patient's shingles persisted. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a female patient who on 15-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). The patient reported that she experienced swelling and pain at the injection site. It was unspecified if the patient sought medical attention, received any treatment of if any lab diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a female consumer reporting on herself, who on 18-MAR-2011 was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck), 0.5 ml, subcutaneously, (Lot number not reported). The consumer reported that she experienced injection site redness on 20-MAR-2011. It was unknown if the patient sought unspecified medical attention. At the time of the report the consumer had not recovered. No further information is available.
Age: 17.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 17 year old patient who on 14-MAR-2011 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot # not reported) instead of VARIVAX (Merck). No adverse effects reported. It was unspecified that if the patient sought medical attention. All telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the physician concerning the 17 year old male patient with no illness at the time of vaccination and with no pertinent medical history who at 2:00 pm on 15-MAR-2011 (previously reported as 14-MAR-2011) was given ZOSTAVAX (Merck) (lot # not reported) instead of VARIVAX (Merck). The patient did not seek medical attention. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Nasal disorder
Clinical narrative: Information has been received from an 86 year old female consumer with no pertinent medical history and no drug allergies who on 16-MAR-2011 was vaccinated with booster dose of ZOSTAVAX (Merck) (lot # and expiration date not reported). Concomitant therapy included SYNTHROID. On 21-MAR-2011 she experienced a line on the center of her nose. Patient did not seek medical attention. At the time of reporting the patient had not recovered. A blood work was performed on 14-MAR-2011 (results were not provided). Follow up information has been received from the 76 year old retired consumer with hyperlipidemia, hypercholesterolemia and hypothyroidism and a lesion sore on left breast at time of vaccination, indicating that the adverse event occurred on 19-MAR-2011 (previously reported as 21-MAR-2011) and that she was never seen regarding this adverse reaction. There were no lab diagnosis/studies performed. On approximately 24-MAR-2011, the patient had recovered. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 75 year old female patient with drug reactions or allergies to sulfanilamide, PLAQUENIL and pertinent medical history of high blood pressure, arthritis who "sometime in 2007" was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 658603/1081U (dose and route not reported). Concomitant therapy included prednisone, TOPROL XL TABLETS, LIPITOR and vitamin D. The physician reported that on an unspecified date the patient had 16 cases of shingles since that time. The patient was given VALTREX for the shingles. At the time of the report the patient had recovered. The patient sought unspecified medical attention. Follow up information has been received from a nurse who stated that the vaccine of ZOSTAVAX (Merck) was not administered by this physician. Follow up information has been received from a licensed practical nurse who indicated that they have no information. No further information is available.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Musculoskeletal stiffness
Clinical narrative: Information has been received from a 74 year old male consumer reporting on himself, with high blood pressure and penicillin allergy, who on 10-MAR-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck), subcutaneously. (Lot number not reported). Concomitant therapy included ZESTRIL. The consumer reported that on 11-MAR-2011, one day after received the ZOSTAVAX, he experienced lightheaded, dizziness, and a stiff neck. No treatment was given for the experience and no lab diagnostics studies were performed. At the time of the report patient had not recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse reaction, Musculoskeletal pain, Myalgia, Paraesthesia, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 65 year old male with hypertension, cholesterol high and arthritis who on 13-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) in his deltoid region of right arm. On 17-DEC-2010 (AE onset day was reported as "13-DEC-2010"), four days after receiving ZOSTAVAX (Merck), the patient was seen by the physician and complained of a "reaction" after the vaccine. The patient was seen for a low grade fever, muscle aches, right shoulder pain, and lastly, a tingling, slight rash and paresthesias over the next couple of days after receiving the vaccine. Physician provided photos of the patient's rash. On 17-DEC-2010, doctor gave the patient VALTREX, an antiviral medication for the treatment of the adverse events. At the time of the report, the patient had recovered from his adverse events ("date not specified, unknown how long symptoms lasted"). Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 65 year old male with hypertension, cholesterol high and arthritis who on 13-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) in his deltoid region of right arm. On 17-DEC-2010 (AE onset day was reported as "13-DEC-2010"), four days after receiving ZOSTAVAX (Merck), the patient was seen by the physician and complained of a "reaction" after the vaccine. The patient was seen for a low grade fever, muscle aches, right shoulder pain, and lastly, a tingling, slight rash and paresthesias over the next couple of days after receiving the vaccine. Physician provided photos of the patient's rash. On 17-DEC-2010, doctor gave the patient VALTREX, an antiviral medication for the treatment of the adverse events. At the time of the report, the patient had recovered from his adverse events ("date not specified, unknown how long symptoms lasted"). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a 62 year old female patient with medical history of breast surgery and sulfonamide and codeine allergy who on 25-MAR-2011 was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: LEXAPRO, simvastatin (manufacturer unknown) and EVISTA. On 27-MAR-2011 the patient experienced a rash two days after vaccination. She said the swelling had progressively gotten worse since the day of the injection on 25-MAR-2011. The patient had lab tests as "annual check-ups" without result reported. The patient did not seek medical attention. At the time of report the patient's status was not recovered. Follow up information was received from the registered pharmacist concerning the 62 year old female patient who on 25-MAR-2011 was vaccinated suncutaneously with a 0.5 ml dose of ZOSTAVAX (Merck) in the pharmacy where the pharmacist worked. The pharmacist was requesting information regarding the VZVIP program. He was made aware of our program when reporting the case to the agency. She reported that she experienced a red, itchy hot rash after being vaccinated with vaccinated ZOSTAVAX (Merck). On 01-APR-2011 the pharmacist reported that the patient came back into the pharmacy and he was able to look at her rash. The rash was red, warm and there was a firm mass at the injection site. She was treated with BENADRYL and "declomethasone" and was experiencing relief. Additional information is not expected. This is one of several reports from the same source.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: Information has been received from a 62 year old female patient with medical history of breast surgery and sulfonamide and codeine allergy who on 25-MAR-2011 was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (Merck). Concomitant therapies included: LEXAPRO, simvastatin (manufacturer unknown) and EVISTA. On 27-MAR-2011 the patient experienced a rash two days after vaccination. She said the swelling had progressively gotten worse since the day of the injection on 25-MAR-2011. The patient had lab tests as "annual check-ups" without result reported. The patient did not seek medical attention. At the time of report the patient's status was not recovered. Follow up information was received from the registered pharmacist concerning the 62 year old female patient who on 25-MAR-2011 was vaccinated suncutaneously with a 0.5 ml dose of ZOSTAVAX (Merck) in the pharmacy where the pharmacist worked. The pharmacist was requesting information regarding the VZVIP program. He was made aware of our program when reporting the case to the agency. She reported that she experienced a red, itchy hot rash after being vaccinated with vaccinated ZOSTAVAX (Merck). On 01-APR-2011 the pharmacist reported that the patient came back into the pharmacy and he was able to look at her rash. The rash was red, warm and there was a firm mass at the injection site. She was treated with BENADRYL and "declomethasone" and was experiencing relief. Additional information is not expected. This is one of several reports from the same source.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 69 year old male patient who in approximately 2009, 1.5 years ago, was vaccinated with a dose of ZOSTAVAX (Merck). Now, two to three days ago, on approximately 25-MAR-2011, the patient had shingles. Physician was not in group and did not want to provide his address. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Information has been received from a healthcare worker concerning a 77 year old female patient who on 05-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On 22-MAR-2011 the patient developed a rash. No treatment was given for this adverse event. At the time of reporting, the outcome of the patient was unknown. The patient sought unspecified medical attention. Follow up information has been received from physician concerning a 77 year old female with diabetes, atrial fibrillation, hypertension and a history of cerebrovascular accident, transient ischaemic attack, basal cell carcinoma and chickenpox and no drug allergies who on 05-MAR-2011 was vaccinated with ZOSTAVAX (Merck) (lot # not reported). The reporter stated that 18 days after vaccination ("on 22-MAR-2011"), the patient developed erythematous wheals on right buttock. They were linear without vesiculation. At the time of reporting, the outcome of the patient was unknown. The patient had sought medical attention by doctor visit. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Polymerase chain reaction, Varicella, Varicella virus test
Clinical narrative: Information has been received from a registered pharmacist (R. Ph) concerning a 62 year old male with no medical history and no drug reaction/allergies and no recent exposure to chickenpox who on 08-MAR-2011 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669408/1384Z) in left deltoid. On 25-MAR-2011 the patient noted "three pox marks that were red and raised, 1/4 inch apart in a row (line formation) and each about 1/8 inch high, there was no pain or itching", it included chickenpox . There was no shingles. No treatment was given for the event. No lab diagnostics studies performed. At the time of reporting, the patient had not recovered. The patient sought unspecified medical attention. 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." According to the VZVIP guide on 30-MAR-2011 the lesion sample was collected from skin. Follow-up information was received from the lab. The specimen was collected from lesion of left upper arm. The specimen arrived in lab on 01-APR-2011. The final PCR (polymerase chain reaction) result was inadequate specimen. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Information has been received from an 75 year old female consumer reporting herself with drug reaction to tetanus shot and "nastain" and allergies (unspecified), who on 15-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and site not reported). On 21-MAR-2011, the patient experienced sharp nerve pain along her leg. The consumer believed it may be due to the ZOSTAVAX (Merck). It was given a steroid shot for the adverse event. Lab diagnostics studies were not performed. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 68 year old male who on 28-OCT-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 22-JUN-2010 the patient developed shingles one time within four years of receiving ZOSTAVAX (Merck). The patient was given VALTREX for treatment. The patient sought unspecified medical attention. Upon the time of the report, the patient's present status was unknown. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 85 year old male who on 08-APR-2008 was subcutaneously vaccinated with ZOSTAVAX (Merck) (dose and lot# not reported). On 26-MAR-2009 and on 21-DEC-2010 the patient experienced shingles two times within four years of receiving ZOSTAVAX (Merck). It was unspecified if the patient sought medical attention. The patient was treated with VALTREX. At the time of reporting, the outcomes were unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site rash, Myalgia
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 62 year old female with migraine, fibromyalgia and allergy to PAXIL, NORVASC, ELAVIL who on 01-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 670386/0236AA; expiry on 17-MAY-2012). Concomitant therapy included KLONOPIN, atenolol, lisinopril-HCTZ (manufacturer unknown), PHENERGAN, multivitamin with calcium. On 02-APR-2011, the patient woke up with a headache that was still severe, joint and muscle pain especially on the left side of her body where ZOSTAVAX was administered, including pain in her left toe joints as well as her left elbow. In addition, she had a 6-inch by 2-inch red, raised rash at the injection site. No treatment was given for the adverse events. The re was no lab diagnostics performed. At the time of the report, the patient had not recovered from her adverse events. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning to a retired physician who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). The reporting physician mentioned that on an unspecified date he believed the patient had developed a case of shingles after receiving ZOSTAVAX (Merck). At the time of the report, the patient's outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.