chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Polymerase chain reaction, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female who on 16-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 06-APR-2011, the patient returned to the pharmacy reported that she was seen by her physician because she developed a rash on her back on unspecified date. The patient reported that the rash was triangular in shape and it itched and "had little bumps," but no burning or pain. She stated that her physician said, "That looks like shingles." On the same day, the patient called to clarify that she had not seen her doctor and was asking the pharmacist if she should contact her doctor. The rash was at the base of her spine, triangular shaped, itchy with little blisters, felt rough to touch. Used generic NEOSPORIN first aid ointment on area (manufacturer unknown). She had not called the doctor yet but stated she would contact him in the AM. At the time of the report, the patient's status was unknown. Follow up information has been received from a physician and the registered pharmacist respectively concerning the 73 year old female patient with hypertension, high cholesterol, osteoporosis, allergies to LEVAQUIN, MACRODANTIN, cefdinir and antihistamines and a history of chickenpox who on 16-MAR-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (expiry on 15-JAN-2012) into the left deltoid. Concomitant therapy included carvedilol, lisinopril (manufacturer unknown), LEVOXYL, and LIPITOR. On 23-MAR-2011 (onset date also reported as approximately 01-APR-2011), the patient experienced rough raised, red rash. Number of lesions were reported as 3 cm cluster. Distribution of lesions was midline. On 08-APR-2011, doctor's office evaluated the adverse experience. On an unspecified date, the patient's rash was recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 08-APR-2011, a lesion sample was collected. The sample was taken from swab of dry erythematous patch on midline lower back. No results provided. Follow-up information was received from a health professional who reported that on 13-APR-2011, the specimen arrived to the laboratory. There was no VZV DNA amplified and no B-globin DNA was amplified. The final PCR analysis result from the vesicular specimen indicated that the specimen was inadequate. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin lesion, Varicella virus test
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female who on 16-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck). On 06-APR-2011, the patient returned to the pharmacy reported that she was seen by her physician because she developed a rash on her back on unspecified date. The patient reported that the rash was triangular in shape and it itched and "had little bumps," but no burning or pain. She stated that her physician said, "That looks like shingles." On the same day, the patient called to clarify that she had not seen her doctor and was asking the pharmacist if she should contact her doctor. The rash was at the base of her spine, triangular shaped, itchy with little blisters, felt rough to touch. Used generic NEOSPORIN first aid ointment on area (manufacturer unknown). She had not called the doctor yet but stated she would contact him in the AM. At the time of the report, the patient's status was unknown. Follow up information has been received from a physician and the registered pharmacist respectively concerning the 73 year old female patient with hypertension, high cholesterol, osteoporosis, allergies to LEVAQUIN, MACRODANTIN, cefdinir and antihistamines and a history of chickenpox who on 16-MAR-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (expiry on 15-JAN-2012) into the left deltoid. Concomitant therapy included carvedilol, lisinopril (manufacturer unknown), LEVOXYL, and LIPITOR. On 23-MAR-2011 (onset date also reported as approximately 01-APR-2011), the patient experienced rough raised, red rash. Number of lesions were reported as 3 cm cluster. Distribution of lesions was midline. On 08-APR-2011, doctor's office evaluated the adverse experience. On an unspecified date, the patient's rash was recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. On 08-APR-2011, a lesion sample was collected. The sample was taken from swab of dry erythematous patch on midline lower back. No results provided. Follow-up information was received from a health professional who reported that on 13-APR-2011, the specimen arrived to the laboratory. There was no VZV DNA amplified and no B-globin DNA was amplified. The final PCR analysis result from the vesicular specimen indicated that the specimen was inadequate. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 4 year old female who on 05-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669187/1543Z, expiration date 06-FEB-2012) instead of VARIVAX (Merck) (lot # not reported) mistakenly. No adverse event was seen. It was unspecified if the patient sought 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: Antibody test positive, Blood test normal, Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: Information has been received from a 61 year old female with "thyroid condition", a previous case of shingles years ago when on chemotherapy for cancer (before ZOSTAVAX (Merck) became available) and no drug reactions/allergies who about a year and a half ago (in approximately October 2009) was vaccinated with ZOSTAVAX (Merck) (lot # not reported) at a local pharmacy. Concomitant therapy included unspecified thyroid medication. Approximately ten days ago (approximately on 27-MAR-2011), the patient developed a "case of shingles". The patient's shingles persisted. No lab diagnostics studies were performed. No treatment was given for the event. The patient sought unspecified medical attention. The patient noted she spoke with her pharmacist on 06-APR-2011 and the pharmacist told her "she was not the only one this has happened to." Follow up information has been received from the patient reporting that she had symptoms of pain and sensitivity. After numerous blood tests, it was found that she was immune to the disease. The patient spoke to her pharmacist and the pharmacist told her that she wasn't the only customer that had complain about getting symptoms. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms
Clinical narrative: Information has been received from a physician concerning a 64 year old female who on approximately 01-FEB-2011 (early February 2011) was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Merck) (lot# not reported). Second suspect therapy included LIPITOR. On approximately 01-FEB-2011 (early February 2011), the patient experienced "muscle spasms in her chest on the right side after receiving ZOSTAVAX (Merck). The doctor did say her dosage of LIPITOR was increased the same day but it was not clear whether this had anything to do with the adverse event. The patient sought unspecified medical attention. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Induration, Inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female patient with no medical history who on 12-MAR-2011 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not reported). There was no concomitant medication. On 12-MAR-2011, "the adverse events began on the day the vaccine was given", the patient experienced a very significant swelling that was very hot to the touch at the injection site. Approximately on 16-MAR-2011, "within 3-4 days of the adverse events starting", the patient recovered from a very significant swelling that was very hot to the touch at the injection site. No diagnostic laboratory tests performed. No treatment was given for the adverse events. The patient sought medical attention by calling the pharmacy the day after having received ZOSTAVAX (Merck). Follow-up information has been received from a registered pharmacist concerning the 67 year old patient who on 11-MAR-2011 at 18:15 pm (previously reported as 12-MAR-2011) was vaccinated subcutaneously into back of arm with ZOSTAVAX (Merck) (Lot number 669590/1507Z). Subsequently back of patient's arm became inflamed and hard. About the size, it looked like baseball on ""grape fruit" for 4-5 days. Patient was told to go to doctor. Patient called doctor and was told to wait a few days. Patient did wait and area returned to normal. The patient had recovered from the events within 4 to 5 days. No laboratory test was done. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered pharmacist (R.PH.) concerning a patient who on 01-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# and expiration not reported). On 03-APR-2011, two days later, the patient experienced redness at the injection site. The patient sought unspecified medical attention. No treatment was given for this adverse event. At the time of reporting the outcome of the patient was unknown. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered pharmacist (R. Ph) concerning a 67 year old female patient who on 06-APR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number and site of administration not reported). On 06-APR-2011, the patient experienced redness at the injection site. No treatment was given for the adverse event. The patient did not seek medical attention. At the time of the report, the patient had recovered from redness at the injection site on an unspecified date. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a doctor of pharmacy concerning an approximately 63 year old female with a history of shingles 6 weeks before vaccination (approximately on 06-DEC-2010, who on 17-JAN-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number not reported). The doctor of pharmacy reported that on 17-JAN-2011 after the vaccine was given the patient's entire arm from the shoulder down to the elbow became red and swollen. Time frame to start of the swelling after the vaccine was administered was not specified. No treatment was given for the experience. At the time of the report, the patient's outcome was unknown. The patient did not seek medical attention. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old female patient with dermatitis and oxycodone allergy, who on 23-MAR-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously, (Lot number 669191/1456Z). Concomitant therapy included MAXZIDE, SYNTHROID, omega-3 marine triglycerides and FLEXERIL. The nurse reported that the patient developed shingle like rash after receiving the vaccine. The rash appeared bilateral on scalp, neck and face along with nerve pain. Prednisone and dexamethasone IM were given as a treatment for the experience. No labs diagnostics studies were performed. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female patient who on 30-MAR-2011, was vaccinated with a dose of ZOSTAVAX (Merck) (route not reported) (lot number 669260/0152AA, Exp. 01-MAY-2012). On 30-MAR-2011, the patient developed "on and off tingling in the arm from the elbow to the fingers" soon after. The patient called pharmacy to seek medical attention. There was no treatment given for the event. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a physician concerning about his 60 year old wife who on 08-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported). The wife reported no relevant medical history or past drug history. Concomitant medication also included cinnamon. In April 2011 after receiving the ZOSTAVAX (Merck) the physician stated that his wife experienced burning, itching and pain bilaterally around the waist line which was accompanied by a red rash no vesicles. On 09-APR-2011 and 10-APR-2011, the rash was treated with an unknown topical steroid. There was no relevant laboratory data. As of 10-APR-2011, the physician's wife continued to experience burning, itching and pain bilaterally around the waist line which was accompanied by a red rash no vesicles. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered pharmacist concerning a male patient who on 21-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck), subcutaneously (dose and lot number not provided). The pharmacist informed that on 21-MAR-2011, the patient experienced pain at the injection site that had lasted since the injection was given on 21-MAR-2011. The patient did not seek medical attention. At the time of the report, the adverse event did no improve. The patient's outcome was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site warmth, Swelling
Clinical narrative: Information has been received from a physician concerning an "around" 60 year old female patient who on 15-MAR-2011 was vaccinated SC with a 0.65ml dose of ZOSTAVAX (Merck). On 15-MAR-2011 shortly after administration, the patient experienced redness and swelling of the body that lasted a week and a hot feeling around injection site for a few days. On approximately 03-APR-2011 ("this week"), the patient recovered. It was reported that the adverse events improved while on therapy (it was also reported that no treatment was given for the adverse events). The patient did not seek medical attention. No further information is available.
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 the patient believed he 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.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 year old female with thyroid nodule, osteopenia, hyperlipidaemia, arthritis, keratosis, ibuprofen and latex allergy and a history of coronary artery bypass who on 04-JUN-2010 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 665431/1744Y), subcutaneously into her left arm. Concomitant therapy included SYNTHROID, aspirin, PLAVIX, metoprolol, LIPITOR, doxycycline and  NITROSTAT. On 05-JUN-2010 the patient experienced headache, fever of 99 degrees F and body aches after administration of ZOSTAVAX (Merck). Her left upper arm was swollen, red, warm, itchy and painful. She was examined in the office on 08-JUN-2010. She had a swollen lymph node and a firm red area about 7 cm in size at the site of injection. The redness was spreading up her arm about 15 cm. She was diagnosed with a local reaction and instructed to apply ice and monitor the area. No laboratories studies performed. At the time of the report the patient was recovering. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Oedema peripheral, Pain, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 year old female with thyroid nodule, osteopenia, hyperlipidaemia, arthritis, keratosis, ibuprofen and latex allergy and a history of coronary artery bypass who on 04-JUN-2010 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 665431/1744Y), subcutaneously into her left arm. Concomitant therapy included SYNTHROID, aspirin, PLAVIX, metoprolol, LIPITOR, doxycycline and  NITROSTAT. On 05-JUN-2010 the patient experienced headache, fever of 99 degrees F and body aches after administration of ZOSTAVAX (Merck). Her left upper arm was swollen, red, warm, itchy and painful. She was examined in the office on 08-JUN-2010. She had a swollen lymph node and a firm red area about 7 cm in size at the site of injection. The redness was spreading up her arm about 15 cm. She was diagnosed with a local reaction and instructed to apply ice and monitor the area. No laboratories studies performed. At the time of the report the patient was recovering. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: Information has been received from a licensed practical nurse concerning a 60 year old female with thyroid nodule, osteopenia, hyperlipidaemia, arthritis, keratosis, ibuprofen and latex allergy and a history of coronary artery bypass who on 04-JUN-2010 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 665431/1744Y), subcutaneously into her left arm. Concomitant therapy included SYNTHROID, aspirin, PLAVIX, metoprolol, LIPITOR, doxycycline and  NITROSTAT. On 05-JUN-2010 the patient experienced headache, fever of 99 degrees F and body aches after administration of ZOSTAVAX (Merck). Her left upper arm was swollen, red, warm, itchy and painful. She was examined in the office on 08-JUN-2010. She had a swollen lymph node and a firm red area about 7 cm in size at the site of injection. The redness was spreading up her arm about 15 cm. She was diagnosed with a local reaction and instructed to apply ice and monitor the area. No laboratories studies performed. At the time of the report the patient was recovering. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a 66 year old female patient with a history of shingles and no known drug allergies, who in December 2006, was vaccinated in the left arm with a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). Concomitant therapy included OTC vitamins (unspecified) and BIOFLEX. In January 2007, the patient experienced injection site pain. The patient stated that some days are better than others but the pain had never subsided. The patient sought unspecified medical attention. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Acne, Erythema
Clinical narrative: Information has been received from a 74 year old male patient with a history of herpes simplex and no drug reactions or allergies, who "the first week on June, 2009" (on approximately 01-JUN-2009) was vaccinated with a 0.65 ml single dose of ZOSTAVAX (Merck). Concomitant therapy included pravastatin Na, DICLOMINE, "isolbide", metoprolol and FLOMAX.  The consumer reported that "within a week of receiving ZOSTAVAX (Merck)" (on approximately 08-JUN-2009) he started to develop little white pimples that had a red mark around the pimple all across the forehead. The consumer reported that he had seen a couple physicians and no one can figure out what it was. Laboratory diagnostic studies were not performed. Then, recently, he asked his family and found out that he never had the chickenpox as a child. The consumer stated that he still had these little white pimples that have a red mark around the pimple. Follow-up information has been received from a physician who reported that vaccine was not given by him. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a 62 year old female consumer with no pertinent medical history and no known drug reactions/allergies who in June 2008, "2 years ago", was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. After a week to 10 days of receiving ZOSTAVAX (Merck), the consumer began to experience tingling and prickling on her scalp, as well as frequent itching to the point of loss of sleep. The consumer sought unspecified medical attention. At the time of the report, the consumer had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Blister
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with ZOSTAVAX (Merck) (lot # not reported). The physician stated that on an unspecified date, the patient received the vaccine on a Wednesday and by that Friday the patient developed pimples and blisters on her pubic area. The following week, the patient was given steroids (unspecified) as well as antibiotics (unspecified). At the time of the report, the patient's outcome was unknown. The patient sought medical attention at the physician's office. Follow up information has been received from the physician who reported that he had tried to contact the patient for additional information but the physician believed that the patient could have left the area and was unable to get any additional information. No further information is available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 59 year old female patient with asthma and heart disease, allergy to sulfa, quinolones and tetracycline who on 01-JUN-2010 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 665524/1374Y, exp 25-MAR-2011). Concomitant therapies included: digoxin (manufacturer unknown) and LAMICTAL. On an unspecified date the patient had an injection site reaction that initially was the size of a dime but was not the size of a quarter. The area was swollen and red but not painful. Pharmacist could not remember if the patient described it as being a rash. The patient sought medical attention by calling the pharmacist. There was no lab diagnostic test. The patient was taking BENADRYL to treat her symptoms. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 5 year old male who was inadvertently vaccinated with a dose of ZOSTAVAX (Merck) (SC, lot # 665520/1196Y) instead of PROQUAD (Merck) (human error not PQC). No adverse effects were reported. Follow up information received from a medical assistant concerning a 5 year old male who on 09-MAY-2010 at 1:30 pm was vaccinated with a first dose of ZOSTAVAX (Merck) (SC, lot # 66529Z/1224Y, previously reported as 665520/1196Y) in the right leg. No adverse effects were reported. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist on 11-JUN-2010 concerning a 63 year old female with no pertinent medical history and no drug reaction/allergy who on 09-JUN-2010 was vaccinated subcutaneously with a "standard dose" of ZOSTAVAX (Merck) (LOT# 665516/1271Y, expire March 2011). There was no concomitant medication. After receiving the vaccine, (approximately 09-JUN-2010) the patient experienced some redness at the injection site. There was no lab diagnostic study performed. Unspecified medical attention was sought. At this time of reporting, the patient was recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a pharmacy student concerning a 66 year old female with herpes simplex on her back who on 08-JUN-2010 was vaccinated subcutaneously with a 0.6 ml ZOSTAVAX (Merck) (lot# 665522/1765Y). Concomitant therapy included acyclovir. On 09-JUN-2010 the patient called the pharmacy and stated that her "lesions on her back showed up today". At the time of the report, the patient had not recovered. There was no laboratory test performed. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 12 year old male who on 10-JUN-2010 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Merck) (LOT# not reported) with no adverse symptoms reported. The nurse reported that the patient was intended to receive his second dose of VARIVAX (Merck); was inadvertently administered the ZOSTAVAX (Merck). Follow-up information has been received from the licensed practical nurse concerning the 12 year old male with no illness at time of vaccination (school physical) and no drug allergies and no medical history who on 10-JUN-2010 at 16:34 was vaccinated subcutaneously in left deltoid with a single dose of ZOSTAVAX (Merck) (LOT# 664671/0149Z). Concomitant therapy/vaccination received at the same time at 16:34 included the fifth dose of ADACEL (LOT# C3446AA, IM, at right deltoid) and a dose of APLISOL (lot number 94775, left forearm, intraderm). The patient didn't experience any adverse event. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, X-ray
Clinical narrative: Information has been received from a consumer concerning her 75 year old mother with cholesterol disease and no drug allergies who on 13-SEP-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# "0741Y"). There was no concomitant medication. Over the weekend (on approximately 06-JUN-2010) the patient experienced shingles. She thought initially that it was indigestion or heart problems. X-ray and blood work were done without result provided. Unspecified medical attention was sought. At this time of reporting, the patient has not recovered. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling drunk, Mental status changes, Speech disorder
Clinical narrative: Information has been received from a 77 year old female consumer with hypertension, depression and drug hypersensitivity to a lot of medications who on approximately 11-MAY-2010, "one month ago" was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included NARDIL and losartan-potassium-HCTZ. On approximately 11-MAY-2010, 2 hours after receiving ZOSTAVAX (Merck), the patient experienced a change in mental status. The reporting consumer stated that she "felt drunk and said inappropriate things". The patient sought unspecified medical attention. No laboratory tests were performed. The adverse symptoms resolved after one hour. The patient had a history of "flu-like" symptoms while on prior therapy with PNEUMOVAX 23 (WAES#1006USA02019). No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female with no medical history or no known drug allergies who on 14-JUN-2010 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot #664637/0748Y, expiration date 23-NOV-2010) into the left arm which was the same site that the patient received "small pox vaccine" as a child. Concomitant therapy included COMIPATCH and alendronate sodium. Subsequently, in June 2010, the patient experienced redness and slight swelling at the injection site about the diameter of a golf ball with white induration after administration of ZOSTAVAX (Merck). The patient sought unspecified medical attention via pharmacist. There was no lab diagnostics studies performed. At the time of this report, the patient did not recover. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Induration
Clinical narrative: Information has been received from a physician concerning a 65 year old male patient with a sensitivity to tetanus shot, who on approximately 07-JUN-2010 was vaccinated with a 0.65ml single dose of ZOSTAVAX (Merck) (Lot#: not reported) subcutaneously. The physician advised that the patient had a red circle on their arm the size of a half dollar which was hard a few hours after the administration of the ZOSTAVAX (Merck). The physician believed it was an allergic reaction. The patient sought unspecified medical attention. There were no labs performed. At the time of the report the patient was recovering. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a physician concerning a male patient in his 80's who "in the last couple of months" (approximately in 2010) was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not provided). The physician reported that "3 months after getting the vaccine" (approximately in 2010) the patient experienced a case of zoster. The physician reported that the patient was still experiencing some nerve pain. At the time of the report the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who in June 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 665524/1374Y, expiration date 25-MAR-2011). The patient's relevant medical history, concomitant medications and past drug history are unknown. On an unknown date in June 2010 the consumer reported a reaction, more than the normal localized reaction which included redness, swelling and inflammation. It was unknown if there was any relevant laboratory data. As of 19-JUN-2010 it was unknown if the consumer still had redness, swelling and inflammation. It was unspecified if the patient sought medical attention. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient 's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. This is one of several reports received from the same source. A lot check has been initiated. 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. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who in June 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 665524/1374Y, expiration date 25-MAR-2011). The patient's relevant medical history, concomitant medications and past drug history are unknown. On an unknown date in June 2010 the consumer reported a reaction, more than the normal localized reaction which included redness, swelling and inflammation. It was unknown if there was any relevant laboratory data. As of 19-JUN-2010 it was unknown if the consumer still had redness, swelling and inflammation. It was unspecified if the patient sought medical attention. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient 's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. This is one of several reports received from the same source. A lot check has been initiated. 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. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from a registered pharmacist concerning a 65 year old female who on 15-JUN-2010 was vaccinated with ZOSTAVAX (Merck). On approximately 17-JUN-2010 (also reported as 1.5 to 2 days after the vaccination) the patient developed a 1.5 inch area of inflammation and swelling around the injection site. The patient contacted the pharmacist to seek medical attention. At the time of the report, the patient had not recovered. This report was amended. The onset date was changed from 18-JUN-2010, day approximately to 17-JUN-2010. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Scab, Skin lesion
Clinical narrative: Information has been received from a physician, allergist, concerning a 68 year old male patient who never had chicken pox nor the chicken pox vaccine prior to being vaccinated with ZOSTAVAX (Merck) and was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#: not reported) at his primary healthcare professional office 2 years ago, in JUN 2008. The physician reported that the patient presented with shingles rash on 03-JUN-2010, on right side of abdomen extending on the flank and lower back. Lesions were crusted and neurologic pain persisted. The patient was on VALTREX and his outcome was not recovered. The patient sought unspecified medical attention. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 71 year old female patient with a history of high blood pressure and penicillin allergy, who on 10-JUN-2010, was vaccinated with a 0.65ml SQ dose of ZOSTAVAX (Merck) (Lot#: 665515/1373Y). The pharmacist mentioned that the patient had redness at the injection site for 1 week; the redness area itched at times and felt hot. It was confirmed there was no rash. The patient visited the pharmacist. At the time of the report the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test, Paraesthesia, Rash generalised, Urine analysis
Clinical narrative: Information has been received from an 81 year old female patient with a history of thyroid problem who on 18-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID. On 18-MAY-2010 (also reported as a day or so after receiving the vaccine), the patient began experiencing weakness which had progressively become worse over time. As of this morning, she woke up with the feeling of "pins and needles all over my body" and she stated that she could feel rashes "popping up" everywhere, with the most troublesome rashes being in both her left and right eye. The patient went to a doctor on Friday due to the extreme weakness and he took bloodwork and a urinalysis to look into it. The patient said that she would be going again today as soon as they open due to the rashes that had begun. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old male patient who on 10-JUN-2010, was vaccinated with a 0.60ml SQ dose of ZOSTAVAX (Merck) (lot#: 665311/1310Y), pharmacist mentioned he withdrew the entire amount of the reconstituted ZOSTAVAX (Merck) and it was 0.60ml. On 11-JUN-2010, the patient had redness at the injection site for a couple of days. At the time of the report, the patient recovered from redness at injection site. The patient visited the pharmacist. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient got a rash in the torso area from the neck to the pelvis. The patient was very itchy with a really bad rash. The patient sought unspecified medical attention. At the time of the report, the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Pain in extremity
Clinical narrative: Information has been received from a female patient who on 09-JUN-2010, was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient experienced "her arm somewhat soar", and had a bright red mark the size of a golf ball on the injection site and it was hard. At the time of reporting, the adverse events persisted. It is unknown if the patient sought medical attention. No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female patient who about 3 months ago (approximately March 2010), was vaccinated with a dose of ZOSTAVAX (Merck). Now the patient had an itchy rash on both her arms. The patient sought medical attention and stopped in the pharmacy. The pharmacist thought the patient had shingles. But the patient had not been to a physician. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 81 year old male patient with high blood pressure, who in September 2009 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included ibuprofen, ENAPRIL and "nurton". In October 2009, the patient experience shingles. The patient reported he had broken out with shingles twice. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Unspecified labs diagnostics studies were performed. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Information has been received from a 61 year old female with asthma bronchial and no drug reaction/allergies who on approximately 18-JUL-2010, ("6 months and 3 weeks ago" as reported) was vaccinated with the first 0.65 ml dose of ZOSTAVAX (Merck) subcutaneously, lot # not reported. There was no concomitant medication. On approximately 18-JUL-2010 (about "6 months and 3 weeks ago as reported") the patient experienced joint pain while on ZOSTAVAX (Merck). The patient sought an unspecified medical attention, no treatment was given for this adverse event, and the adverse event did not improve, the patient had not recovered at the time of reporting. No lab diagnostics study was performed. Follow up information was received from the physician, who stated "have not used it" and "NA". No further information is available.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Pruritus
Clinical narrative: Information has been received from a consumer concerning his 65 year old wife who on an unspecified date was vaccinated with ZOSTAVAX (Merck) (lot# not reported). Subsequently the patient experienced intense redness, itching and blisters. At the time of the report, the outcome of the events was unknown. No further information is available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 72 year old male with a history of prostate cancer, skin cancer and drug reactions/allergies to FLOMAX and morphine who on 11-JUN-2010 was vaccinated with a 0.65 ml ZOSTAVAX (Merck). Concomitant therapy included doxazosin mesylate. On 16-JUN-2010 (also reported as five days later) the patient experienced a rash on one of his legs above the "sockline" and then the other leg. The patient did not seek any medical attention. The patient's rash on one of his legs above the "sockline" and then the other leg persisted. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient experienced shingles. At the time of report, the patient's outcome was unknown. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Merck) (no lot number provided). On an unspecified date, the patient experienced shingles. At the time of the report, the patient had not recovered. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female consumer who on 16-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck). On 16-JUN-2010, after getting ZOSTAVAX (Merck), the patient experienced shingles. At this time of reporting, the patient's shingles persisted. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Mass, Rash
Clinical narrative: Information has been received from a 60 year old female patient with hypertension and hyperlipidaemia and a history of open heart surgery in past, ulcerative colitis (but was currently in remission) and shingles in 2007 who on 22-JUN-2010 was vaccinated IM with ZOSTAVAX (Merck) into her left deltoid. Concomitant therapy included high blood pressure medicine and high cholesterol medicine. On 24-JUN-2010 the patient developed sensitivity and a bump in location of previous zoster outbreak on, which had progressed to light rash, and more bumps. The patient had not seen her physician yet. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria, Myalgia
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female with an allergy to opioid analgesics and nitrofuran analogs who on approximately 24-JUN-2010 (reported as on 24-JUN-2010 or 25-JUN-2010) was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included antiinflammatories, esterase cream, topical steroid solution, diuretic (unspecified) and DIAZIDE (pharmacist stated that patient also utilized unknown mail order pharmacy, medication list was likely incomplete due to pharmacist's lack of knowledge). On 26-JUN-2010, Saturday, the patient came into the pharmacy complaining of muscle soreness and a big welt at the injection site. Pharmacist could not specify which arm or route of administration; and mentioned that patient was very slight of stature. Pharmacist reported that the patient stated that the welt had been bigger the day before, and also reported that she recommended over the counter BENADRYL for the patient. At this time of reporting, the patient was recovering. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: Information has been received from a 69 year old male with a history of prostate cancer and with no drug reactions/allergies who in approximately January 2010 (also reported as 4 or 5 months ago), was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included "omeeraelle", glycopyrrolate, ZOLOFT, AZILECT and FLOMAX. On 27-JUN-2010 the patient experienced a case of shingles which produced blisters on his left side. The patient did not seek any medical attention and there was no laboratory test performed. At the time of the report, the patient had not recovered. Additional information has been requested.