chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster
Clinical narrative: Information has been received from an 80 year old female with a history of shingles, and a "very bad reaction to pneumonia vaccine and to a tetanus shot" who on 09-AUG-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included unspecified "cholesterol medication" and "blood pressure medicine".  On approximately 10-AUG-2007 ("the next day or so") the patient broke out in shingles on the right side of her head.  The patient went to the ER because of the headache from the shingles, but she was not admitted.  No lab studies were performed.  At the time of the report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with a single dose of Zostavax.  Subsequently, 2 days after vaccination, the patient developed redness and blisters at the injection site.  The patient called the office.  No treatment was recommended by the physician.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who, on an unspecified date, was vaccinated with Zostavax.  No information was provided with regard to the patient's medical history and concomitant therapy.  Subsequently, three days after the patient was vaccinated, he developed shingles.  The patient was examined in the physician's office, but no details were available.  No further information is available.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: Information has been received from a physician concerning a 76 year old white female who was vaccinated SC in the right deltoid on 10-Aug-2007 with a first dose of Zostavax (Lot #656858/0356U).  The day after being vaccinated with Zostavax, the patient developed an elevated blood pressure of 175/90.  The patient's blood pressure returned to normal the next day and the patient recovered.  The patient sought medical attention.  Follow up information from the physician indicated that the patient experienced a severe elevation of blood pressure up to 178/104, 24 hours after vaccination.  This was confirmed with multiple blood pressure readings.  There was no prior history of blood pressures this high.  There was no illness at the time of vaccination.  The blood pressure resolved on its own.  The patient was asymptomatic the whole time.  On 13-Aug-2007 the patient recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a physician concerning a 76 year old female with "blood pressure" who was vaccinated SC in the right deltoid on 10-AUG-2007 with a first dose of ZOSTAVAX vaccine (Merck) (Lot#656858/0356U). Concomitant medication included a blood pressure pill (therapy unspecified), one pill a day. The day after being vaccinated with ZOSTAVAX vaccine (Merck), the patient developed an elevated blood pressure of 175/90. The patient's blood pressure returned to normal the next day and the patient recovered. The patient sought medical attention. Follow up information from the physician indicated that the patient experienced a severe elevation of blood pressure up tp 178/104, 24 hours after vaccination. This was confirmed with multiple blood pressure readings. There was no prior history of blood pressure this high. There was no illness at the time of vaccination. The bood pressure resolved on its own. The patient was asymptomatic the whole time. On 13-AUG-2007 the patient recovered. No further information was provided. There was no product quality complaint involved. Follow up information from the consumer indicated that her blood pressure the day after the vaccination was 203/100. It was not indicated who obtained that reading. He reported that she has "not felt good since" she took the vaccine. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a 76 year old male with no known drug reactions/allergies who on 15-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck) by injection. No information was provided with regard to the patient's concomitant therapy. On 12-SEP-2007 the patient had a rash on his breast going around to his back. The patient sought unspecicifed medical attention and on 13-SEP-2007 he was diagnosed with shingles. As of 19-SEP-2007, the patient's shingles persisted. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash generalised, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with zoster vaccine live (Oka/Merck). The physician reported that the patient experienced a itchy rash all over their back that looked like shingles. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal pain, Pain, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a 62 year old female registered nurse who in February 2007, was vaccinated SC on left arm with a 0.65 ml zoster vaccine live (Oka/Merck). In February 2007, same day after vaccination the patient experienced pain on left arm. The next day she developed itching and pain which lasted for 2 weeks. It was reported that the itching had gone away but the pain had not resolved and extended from her shoulder to elbow, especially if she lays on it the wrong way. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 12 month old male who on 19-SEP-2007 was inadvertently vaccinated with Zostavax (Oka/Merck) (Lot #654604/1406F) instead of Varivax (Oka/Merck) (MSD).  The reporter noted that it was not product confusion but human error.  No adverse reaction was noted.  Follow-up information was received on 28-SEP-2007 via a phone call.  The LPN stated that Zostavax (Oka/Merck) and Varivax (Oka/Merck) (MSD) vaccines had been side by side in the refrigerator.  Since the incident, they have been separated and placed in different colored bags.  The patient was last seen on 26-SEP-2007 and was fine.  Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site rash, Skin lesion, Smallpox
Clinical narrative: Information has been received from a 71 year old male physician who on 06-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that after vaccination the patient developed 2 large red lesions.  One lesion was on the stomach area and the other was at the injection site.  The lesions then developed into smallpox.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Oedema peripheral
Clinical narrative: Information has been received from an approximately 69 year old male physician who in approximately January 2007, was vaccinated with zoster vaccine live (Oka/Merck). In September 2007 the patient developed shingles in more than one dermatome. The patient had shingles on half of his body, on his right foreman and arm, which became swollen and red including his right hand. He also had shingles on his left hand and forearm, up to his elbow, on his right flank and right chest to his waist, hip and thigh. The patient started therapy with VALTREX and NEUROTIN. As of 20-SEP-2007 the patient's symptoms were improving and the lesions were crusting over. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with 0.65 ml dose of Zostavax. Subsequently the patient developed shingles on her face. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a head nurse concerning a 32 year old female who has never had chicken pox and received her first vaccination with Varivax (Oka/Merck) in August 2007.  On 20-SEP-2007 patient presented to the physician's office for her second dose of Varivax (Oka/Merck) and was inadvertently vaccinated with Zostavax (Oka/Merck) (Lot #657765/0585U).  The patient was notified of the mixup and had no side effects from receiving Zostavax (Oka/Merck).  It was reported the patient will not be vaccinated again with Varivax (Oka/Merck).  Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 10 year old male who on 20-SEP-200 was vaccinated subcutaneously in his right arm with Zostavax (Lot #657559/0462U) instead of Varivax. The medical assistant confirmed this was staff error. In follow-up, the medical assistant reported the patient did not have any side effects from receiving Zostavax and he will not be vaccinated again with Varivax. Additional information has been requested. This is in follow-up to reports previously submitted on 12/21/2007.  Follow-up information from the medical assistant indicated that the patient, a 10 year old male did go onto develop erythema, induration, warmth and pain >4 inches wide in diameter at the injection site on an unspecified date. Medical attention was not sought. The patient recovered on an unspecified date. No further information was provided. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site haematoma, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a consumer, a female physician, who was vaccinated with on an unspecified date with a dose of Zostavax (Oka/Merck) by another physician. Subsequently, one day after the vaccination the patient developed a hematoma and swelling at the injection site. The second day after the vaccination, she had a high fever and chills. Unspecified medical attention was sought. She took an unspecified medicine for the fever. After a couple of days, the patient recovered. This is one of several reports received from the physician. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Abdominal pain upper, Anxiety, Colonoscopy, Nervousness
Clinical narrative: Information has been received from the husband of an 86-year-old female with many unspecified drug allergies, who on 18-JUL-2007 was vaccinated with a dose zoster vaccine (Oka/Merck). Concomitant therapy included lorazepam (ATIVAN), bisoprolol, fexofenadine hydrochloride (ALLEGRA) and levothyroxine Na (SYNTHROID). On an unspecicifed date the patient began experiencing severe anxiety, nervousness, blurry vision, abdominal pain and trouble going to the bathroom. On 27-Sep-2007 the husband called and said that his wife was experiencing pain in her stomach. On an unknown date, the patient had a colonoscopy and MRI with results pending and a stool test. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up information received from the consumer indicates that there was no additional information. Follow-up information was received from a health care professional in the physicians office concerning a retired, white female who was vaccinated in the right arm with a first dose of zoster vaccine live (Oka/Merck) (lot# 658081/0743U). The health care professional reported that there were no objective findings. The patient called the office to say "she did not feel well" and the patient blamed it on the vaccine. The outcome was reported as recovered. Additional information is not expected.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging, Stool analysis, Vision blurred
Clinical narrative: Information has been received from the husband of an 86-year-old female with many unspecified drug allergies, who on 18-JUL-2007 was vaccinated with a dose zoster vaccine (Oka/Merck). Concomitant therapy included lorazepam (ATIVAN), bisoprolol, fexofenadine hydrochloride (ALLEGRA) and levothyroxine Na (SYNTHROID). On an unspecicifed date the patient began experiencing severe anxiety, nervousness, blurry vision, abdominal pain and trouble going to the bathroom. On 27-Sep-2007 the husband called and said that his wife was experiencing pain in her stomach. On an unknown date, the patient had a colonoscopy and MRI with results pending and a stool test. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up information received from the consumer indicates that there was no additional information. Follow-up information was received from a health care professional in the physicians office concerning a retired, white female who was vaccinated in the right arm with a first dose of zoster vaccine live (Oka/Merck) (lot# 658081/0743U). The health care professional reported that there were no objective findings. The patient called the office to say "she did not feel well" and the patient blamed it on the vaccine. The outcome was reported as recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a mid 60 year old female who on approximately 10-SEP-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck). On 20-SEP-2007 the patient experienced rash on her mid arm. The patient's rash on her mid arm persisted. Unspecified medical attention was sought. No product quality complaint. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Initial and follow up information has been received from a 76 year old female with no known pre existing allergies, or medical conditions, who has been under stress due to her husband's death a few weeks prior to reporting. On 18-SEP-2007 the patient was vaccinated into the left deltoid with a first dose of Zostavax (Lot # 658083/0885U). Concomitant therapy included LEXAPRO which she takes for stress. The patient reported that two days after receiving Zostavax, on 20-SEP-2007, she developed a rash in the center of her chest. The patient reported it was not vesicular and not unilateral. The patient called the pharmacy where she picked up the vaccine. The rash resolved without incident. Medical attention was not sought. No labs were performed. There was no product quality complaint involved. At the time of reporting the patient had recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blood test, Erythema, Gait disturbance, Herpes zoster
Clinical narrative: Information has been received from a 60 year old female consumer with a history of an arm operation and severe vomiting caused by AUGMENTIN who on 12-JUN-2007 was vaccinated with a single dose of Zostavax. Concomitant therapy included BENICAR, NORVASC and ACTONEL. "Two days later" on 14-JUN-2007 the arm in which she was vaccinated "blew up like a balloon" and turned red-pink "the color of a raspberry". Within one week the arm returned to normal. Approximately 1 1/2 weeks later the patient developed five small crusty blisters on the back of her left thigh. There was no pain in the leg from these blisters and they subsequently went away. After this, the patient developed pain in the left thigh. Gradually, the pain progressively became worse. She had difficulty walking and had to limp on her left leg. The pain continued to progress "to the worst pain she has ever experienced." She was diagnosed with shingles. She was initially prescribed ZOVIRAX and subsequently she also took LYRICA and TRILEPTAL. As a result of taking these medicines, she experienced diminished memory. At the time of the report she continued to have pain, but it was not as severe as before. No further information was provided. There was no product quality complaint involved. Additional information ahs been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Memory impairment, Nuclear magnetic resonance imaging, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a 60 year old female consumer with a history of an arm operation and severe vomiting caused by AUGMENTIN who on 12-JUN-2007 was vaccinated with a single dose of Zostavax. Concomitant therapy included BENICAR, NORVASC and ACTONEL. "Two days later" on 14-JUN-2007 the arm in which she was vaccinated "blew up like a balloon" and turned red-pink "the color of a raspberry". Within one week the arm returned to normal. Approximately 1 1/2 weeks later the patient developed five small crusty blisters on the back of her left thigh. There was no pain in the leg from these blisters and they subsequently went away. After this, the patient developed pain in the left thigh. Gradually, the pain progressively became worse. She had difficulty walking and had to limp on her left leg. The pain continued to progress "to the worst pain she has ever experienced." She was diagnosed with shingles. She was initially prescribed ZOVIRAX and subsequently she also took LYRICA and TRILEPTAL. As a result of taking these medicines, she experienced diminished memory. At the time of the report she continued to have pain, but it was not as severe as before. No further information was provided. There was no product quality complaint involved. Additional information ahs been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immune system disorder
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient was not immunocompromized but did have a somewhat suppressed immune system.  The patient picked up the vaccine at the pharmacy which is next door to the doctor's office and immediately went back to the doctor's office and got vaccinated.  The patient after vaccination came back to the office with herpes zoster.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Rash macular
Clinical narrative: Information has been received from a physician concerning a 64 year old female with no known allergies and no recent exposures to chickenpox or shingles, who on 07-SEP-2007 was vaccinated with zoster vaccine live (Oka/Merck) (lot no. "3073U"). Concomitant therapy included included atorvastatin calcium (LIPITOR). In September 2007, the patient developed erythema at the injection site of th L arm. On 14-SEP-2007 the patient developed a herpes zoster macular rash on the R leg. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 60 year old female who on 21-SEP-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  On 23-SEP-2007 the patient developed injection site redness and vesicular lesions at the injection site.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Initial information has been received from a physician concerning a 4 year old patient who on 24-SEP-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Follow up information has been received from a medical assistant who indicated that the patient was inadvertently vaccinated with Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  She indicated that this was due to "stupidity and human error".  No reaction with the patient was noted.  Additional information is not expected. This is in follow-up to report (s) previously submitted on 12/21/2007. Follow-up information was received concerning a female with no pre-existing allergies, birth defects of medical conditions whowas vaccinated subcutaneously in the left arm at approximately 11:00 AM with a first dose of ZOSTAVAX (Merck (lot#656859/0357U). There was no illness at the time of vaccination. Additional information is not expected.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a female who on 23-JUL-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). On 22-SEP-2007 or 23-SEP-2007 the patient developed a "very mild case of shingles". Medical attention was sought and the nurse practitioner visually confirmed and diagnosed the patient with shingles. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Follow up information on 25-SEP-2007 indicated that the office was not able to provide a specimen for VZV analysis. Follow-up information concerning an 83-year-old retired, registered nurse with no know allergies and a childhood history of chickenpox, who on 23-JUL-2007 was vaccinated intramuscularly with her first dose of 0.7 milliliters in the right deltoid with Zostavax vaccine (Oka/Merck) (lot# 658081/0743U). Concomitant medications included calcium with vitamin D and "non-contributing" medications. 61 days post vaccination, the patient developed a vesicular rash with seven lesions on her left posterior thigh (dermatome S-1). Treatment included "famvair" 500 milligrams #21, PO TID, for 7 days with resolution noted. There was no fever (maximum temperature of 98.4 degrees PO) and mild pain symptoms (rated a 3-4 on a scale of 0 to 10 with 0 being the least) were noted. It was also reported that there was no recent exposure to chickenpox or herpes zoster, a direct fluorescent antibody was not done, no specimen was collected for PCR and no photos were taken. Additional information is not expected.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Culture wound positive, Herpes zoster, Inappropriate schedule of drug administration, Pain
Clinical narrative: Information has been received from an approximately 55 year old female physician who in the end of August 2007, was vaccinated with a single dose of Zostavax (Oka/Merck).  Two weeks after vaccination, the physician developed a "minor case of shingles in the perineum" which were small and painful vesicles.  The patient treated herself and the vesicles were cultured to confirm that her condition was shingles.  At the time of this report the physician had recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning an over 60 year old patient who on 22-SEP-2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 24-SEP-2007 the patient developed shingles in a small area low on the right side of the patient's back. The shingles were not painful. Unspecified medical attention was sought. At the time of this report the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning a 68 year old female who on 29-JUN-2007 was vaccinated with a dose of Zostavax (Lot# 657676/0619U). "Approximately three months later" the patient developed shingles. The patient called the pharmacy to report the issue. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse concerning a 68 year old female with a penicillin allergy who on 29-JUN-2007 at 09:40 was vaccinated SC in the left arm with a dose of zoster vaccine live (Oka/Merck) (Lot#657676/0619U). There was no illness at the time of vaccination. On 21-SEP-2007 the patient was told by her family physician that she had shingles. No further information was provided. There was no product complaint involved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on approximately 14-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck) instead of Varivax.  It was reported that this was not product confusion but a medical error.  Subsequently, the patient did not experience any symptoms.  It was unspecified if medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 81 year old female with no medical history or allergies who was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck). It was reported that 2 months after vaccination the patient developed shingles. Unspecicifed medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. No further information is expected.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Hyperaesthesia, Pain, Rash
Clinical narrative: Information has been received from a 77 year old male attorney with no known allergies and a heart condition who on "probably June 2007", was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included unspecified medications for his heart condition.  Two weeks after receiving the vaccination the patient developed rashes and pain.  The rashes went away and only lasted for a very short period of time, but the pain continued at the time of the report.  The pain in the back was less than the pain in the front especially the left side which was very painful and sensitive to any clothing.  Unspecified medical attention was sought.  It was noted that routine "blood work once a month for his heart condition" was performed, no results were reported.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysaesthesia, Fatigue, Osteoporosis, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a female consumer who on an unspecified date in February 2007, was vaccinated SC with a dose of Zostavax (Oka/Merck). Subsequently, after a long drive the patient developed fatigue. She was so fatigued that she was in bed for three days. After the return drive she had to stay in bed for a week, due to fatigue. The patient also reported small areas on different parts of her body where red rashes have devleoped, most recently on her wrist. At the time of the report the fatigue had resolved but the rashes persisted. Unspecified medical attention was sought. No further information has been requested. This is a consolidation of two reports concerning the same patient. Follow-up information from the physician indicated that the 65 year old white female retired accountant with osteoporosis who on 15-MAR-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) in the left deltoid. There was no illness at the time of vacination. In September 2007, the patient experienced profound fatigue and was in bed for 3 days. Generalized dysnethesia followed by a rash like "chickenpox" on the arms, legs, forehead and nose were also noted. No labs or diagnostic studies were performed. It was initially reported to the physician via phone that the patient was "still breaking out." In September 2007, VALTREX was requested. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Accidental exposure, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a patient who on an unspecified date developed a zoster rash. The patient administered doses of zoster vaccine live (Oka/Merck) at a clinic. No information was provided. Follow up information received from the pharmacist confirmed that a health care worker who administers the vaccine came down with a confirmed case of zoster. The worker was not previously vaccinated. Additional information is not expected. This is one of several reports from the same source.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vesicles, No reaction on previous exposure to drug, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old male with hypertension and hypercholesterolemia and no allergies who on 20-SEP-2007 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck) (Lot #658212/0887U).  Concomitant therapy included meloxicam (Mobic), omega-3 marine triglycerides, chondroitin sulfate sodium (+) glucosamine sulfate, atorvastatin calcium (Lipitor), finasteride (MSD) and nifedipine (Nifedical XL).  There was no illness at the time of vaccination.  On 23-SEP-2007 the patient developed a clear fluid filled blister at the injection site.  The lesion was the size of a nail head.  Unspecified medical attention was sought.  At the time of the report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been received from registered nurse who stated that the patient had small blister (nail head sized) noted on 23-SEP-2007 and was flatter day of report on 24-SEP-2007.  The patient had recovered on an unspecified day.  No diagnostic laboratory tests were undertaken.  There was no adverse event following prior vaccination for the patient or patient's sibling.  No further information is expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 68 year old female who on 21-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot#658208/0886U). On 22-SEP-2007 the patient developed injection site itching, tenderness, redness and swelling the size of a golf ball. Unspecified medical attention was sought. Subsequently, on 25-SEP-2007, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning an 89 year old retired white female, who was unsure if she had chickenpox, who on 29-AUG-2007 was vaccinated with a 0.65 ml subcutaneous dose in the left arm of zoster vaccine live (Oka/Merck) (Lot# 658083/0885U). Concomitant therapy included nitroglycerin, sertraline HCl, atorvastatin calcium (LIPITOR), levothyroxine Na and ranitidine. On 29-AUG-2007 the patient experienced rash around injection site. The patient stated to the reporter that the rah was not bothering her. She was counseled to keep an eye on it and to inform the reporter if it worsened. On the evening of 31-AUG-2007 the reporter inspected her arm and said it was clear of the rash. The patient was considered to be recovered on 31- AUG-2007. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse concerning a female patient (age not reported) with a history of flu vaccination site reaction who on 18-SEP-2007 was vaccinated with Zostavax (Oka/Merck) (Lot#658208/0886U). On 21-SEP-2007, the patient experienced redness, swelling, and warm to touch at injection site. No rash was noted. The size of the area was 3 inches by 3 inches. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Stomach discomfort
Clinical narrative: Information has been received from a nurse concerning a 61 year old female who on 20-SEP-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658208/0886U).  On 21-SEP-2007, the patient experienced redness, swelling, and warm to touch at injection site.  The swelling size was 1 inch by 3 inches.  The patient also complained of "knots in stomach" but no vomiting.  The patient sought unspecified medical attention.  On 25-SEP-2007, the patient recovered.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Injection site bruising, Injection site erythema, Injection site reaction, No reaction on previous exposure to drug
Clinical narrative: Information has been received from the vaccine nurse concerning a 66 year old female patient who on an unspecified date was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed a welt at injection site and injection site became bruised.  The patient did visit the doctor's office.  The patient's outcome was reported as recovering.  Additional information has been requested. Follow up information was received from licensed practical nurse concerning a 66 year old female, with an allergy to sulfa drugs, who on 12-SEP-2007, at 10:00, was vaccinated subcutaneously into the deltoid with a first dose of ZOSTAVAX (Lot # 657765/0585U). On 13-SEP-2007, at 02:00, the patient developed a softball size wheal and redness at the deltoid. There was no illness at the time of vaccination. The patient's sibling had shingles. The patient had no prior history of adverse events with previous vaccinations. No lab diagnostic testing was performed. The patient recovered on an undisclosed date. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from the vaccine nurse concerning a 66 year old female patient who on an unspecified date was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed a welt at injection site and injection site became bruised.  The patient did visit the doctor's office.  The patient's outcome was reported as recovering.  Additional information has been requested. Follow up information was received from licensed practical nurse concerning a 66 year old female, with an allergy to sulfa drugs, who on 12-SEP-2007, at 10:00, was vaccinated subcutaneously into the deltoid with a first dose of ZOSTAVAX (Lot # 657765/0585U). On 13-SEP-2007, at 02:00, the patient developed a softball size wheal and redness at the deltoid. There was no illness at the time of vaccination. The patient's sibling had shingles. The patient had no prior history of adverse events with previous vaccinations. No lab diagnostic testing was performed. The patient recovered on an undisclosed date. Additional information is not expected.
Age: 44.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 44 year old patient who on an unspecified date was vaccinated with Zostavax (Oka/Merck), 0.5 ml, subcutaneously, instead of Varivax (Oka/Merck).  No adverse experience was related to this event.  It was reported that it was not due to product confusion but to a medical error.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction
Clinical narrative: Information has been received from a woman concerning her friend who was vaccinated on an unknown date with a dose of Zostavax (Oka/Merck). Subsequently, the patient experienced a headache which lasted for 2 days and an injection site reaction. It was unknown if medical attention was sought. The patient recovered from the headache, but the outcome of the injection site reaction was unknown. No product quality complaint was involved. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pain, Eye pain, Full blood count normal, Headache, Neck pain
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old white male with hypertension, seasonal allergies and headaches who on the AM of 27-AUG-2007 was vaccinated subcutaneously with zoster vaccine live (Oka/Merck) (Lot # 656606/0033U). On 06-SEP-2007 the patient developed pain in his head, scalp, and temporal area, along with pain in the right eye, eyelid, ear pain, and right sided neck pain. The patient had no lesions. On 06 SEP 2007 a CBC with auto diff and Westergren Sed rate were obtained, of which the results were all within normal limits. There was no illness at the time of vaccination. The patient recovered on an undisclosed date. There was no product quality complaint. No further information is available.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from a registered nurse concerning a 66 year old white male with hypertension, seasonal allergies and headaches who on the AM of 27-AUG-2007 was vaccinated subcutaneously with zoster vaccine live (Oka/Merck) (Lot # 656606/0033U). On 06-SEP-2007 the patient developed pain in his head, scalp, and temporal area, along with pain in the right eye, eyelid, ear pain, and right sided neck pain. The patient had no lesions. On 06 SEP 2007 a CBC with auto diff and Westergren Sed rate were obtained, of which the results were all within normal limits. There was no illness at the time of vaccination. The patient recovered on an undisclosed date. There was no product quality complaint. No further information is available.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a consumer concerning a 74 year old male who on 18-SEP-2007 was vaccinated with a 0.65 ml dose of Zostavax. On 24-SEP-2007 the patient experienced extreme pain all over body. At the time of report the patient had not recovered. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of drug administration, Laboratory test normal
Clinical narrative: Information has been received from a 48 year old female with sulfonamide allergy and penicillin allergy and a history of shingles, 2 caesarean section, appendicitis, hepatitis b, hysterectomy due to fibroids and "mono about 8 years ago" who on 10-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included occasional alprazolam (XANAX) and "CLARITON D". On 19-SEP-2007 the patient developed "yet another" case of shingles. The patient reported that she had blisters that started inside of the upper right eye lid on the cornea, a spot on her face on the upper left cheek bone, a spot under her right eye, a spot on and in her ear and in her throat, an area acrossed her breast, and a spot on her left leg. It was reported that she conducted few laboratory tests in March 2007 and the physician noted "everything was normal". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  01/14/2008 Lot # obtained 0618U. /pc 03/21/2008 MR received for ER visit 9/26/2007 with DX: Herpes Zoster.  Nausea. Pt presented to ER with c/o pain r/t Shingles. Lesions began 1 wk prior. Seen by PMD 3/25/07 but no improvement noted with meds.  Pt also c/o nausea, vomiting and dizziness. Vision and hearing OK.  Lesions noted around R eye.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Information has been received from a physician concerning a female who on 16-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On 26-SEP-2007 the patient developed a large welt around the injection site.  The patient sought medical attention via a phone call with the physician.  On an unspecified date the patient recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Rash generalised, Rash papular
Clinical narrative: Information has been received from a physician concerning a 65 year old male with no medical history or allergies won 04-AUG-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included LIPITOR and FLOMAX. On approximately 10-SEP-2007 the patient developed a papular rash all over the body that was mostly on both legs. it was reported that patient was vaccinated at another physician's office. Unspecified medical attention was sought. A biopsy showed that it was not suggestive of Herpes Zoster rash. At the time of report the patient had not recovered. A quality complaint was not involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Laboratory test, Rash generalised
Clinical narrative: Information has been received from a 63 year old female with history of shingles (two times) and hypertension, hyperlipidemia and codeine allergy who on 04-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included atenolol, simvastatin (MSD) and estrogens, conjugated (+) medroxyprogesterone acetate (Prempro).  In July 2007, the patient developed rash over entire body.  The patient had undergone biopsy which was inconclusive of shingles.  The patient was prescribed skin creams and ointments by her physician which were ineffective.  The patient had undergone blood test (results pending).  At the time of report the patient had not recovered.  A product quality complaint was not involved.  No further information is expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Body temperature increased, Herpes zoster, Pain, Rash papular
Clinical narrative: Initial and follow up information has been received from a physician concerning a 72 year old female with an unknown history of chicken pox who on 07-SEP-2007 was vaccinated IM in the left deltoid with a 0.65 ml dose of Zostavax (Oka/Merck) (Lot#658083/0885U). On 21-SEP-2007 (also reported as 24-SEP-2007) the patient developed a papular rash with small vesicles on the right side of her chest with dermatone distribution, the patient was diagnosed with shingles. Unspecified medical attention was sought. No lab studies were performed. No further information was provided. There was no product quality complaint involved. Follow up information from the physician indicated that the patient had concomitant medications of amlodipine besylate (+) atorvastatin calcium (Caduet), zolpidem tartrate (Ambien), metoprolol succinate (Toprol XL), olmesartan medoxomil (Benicar), and venlafaxine hydrochloride (Effexor XR). The patient had a maximum temperature of 99.4 degrees F. Her pain was a 6 on a scale of 0 (least) to 10 (most). There were no other systemic symptoms. There was no recent exposure to chicken pox or herpes zoster. There was no DFA or PCR done. A photo was not taken. On an unspecified dose the patient recovered. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant concerning a 67 year old female who on 13-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (Lot #657766/0620U).  On 15-SEP-2007 (2 days after vaccination) the patient developed shingles on her back.  The patient's shingles on her back persisted.  Unspecified medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information was received from a female consumer who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck) in the back of her arm.  Subsequently the patient developed injection site pain, redness and a lump.  No further information was provided.  There was no product quality complaint involved.  No further information is available.
Age: 11.0
Sex: F
Vaccine: HPV4, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning an 11 year old female with azithromycin (Zithromax PAC) allergy (abdominal pain) who on 27-SEP-2007 was vaccinated on left arm with a dose of Zostavax (Oka/Merck) (lot #658212/0887U) instead of a dose of Menactra.  Concomitant therapy on same day included a dose on right arm of Gardasil (MSD).  It was reported as a staff error and not product quality complaint.  The patient was monitored post-vaccination with no apparent side effects during the time of observation.  A product quality complaint was not involved.  Additional information has been received from the certified medical assistant who stated that it was human error.  The staff member just grabbed the wrong package.  The patient was administered a dose of Menactra and no adverse events were noted.  No further information is expected.
Age: 63.0
Sex: F
Vaccine: DTP, VARZOS
Symptoms: Incorrect dose administered, Injection site urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 63-year-old female with a penicillin, aspirin and NSAIDS allergy as well as an allergy to insect/bee stings who on 06-SEP-2007 at 10:00 hours was vaccinated subcutaneous in the right arm with a 0.5 ml dose of Zostavax(Lot # 657764/0584U). There were no illnesses at the time of vaccination. Concomitant vaccines included DTaP administered on 06-SEP-2007 in the right arm and influenza virus vaccine (unspecified) administered on 27-SEP-2007. It was reported the patient developed a "welt" at the injection site after vaccination. The patient reported the event during a doctors appointment on 27-SEP-2007. The nurse stated that there was no welt seen on that appointment. She also reported that it was not clear whether the patient has a history of chicken pox. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information is not expected.