chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered
Clinical narrative: Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with two doses of zoster vaccine live (Oka/Merck). The physician reported the patient received her two doses of zoster vaccine live (Oka/Merck). Subsequently, after receiving two doses of zoster vaccine live (Oka/Merck) she was diagnosed with shingles on 10-MAR-2008. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Headache, Hypoaesthesia, Influenza like illness, Pyrexia
Clinical narrative: Information has been received from a physician assistant concerning a 73 year old male consumer with a history of prostate cancer who on 14-MAR-2008 was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck). Subsequently, on 15-MAR-2008 the patient developed flu like symptoms and numb finger tips. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information from the physician assistant indicated that this 72 year old whit male consumer with rhinitis allergic, atrial flutter, atrial fibrillation, and mitral valve prolapse and a history of prostate cancer who on 14-MAR-2008 was vaccinated SQ in the left deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). There was no illness at the time of vaccination. Subsequently, on 15-MAR-2008 the patient complained of feeling shaky and feverish the day after vaccine administration. It was also reported that the tips of his fingers started feeling numb. The right side of his head was sore to touch and the skin on his right temple was slightly red. There was no site reaction. The patient was told to treat his symptoms with acetaminophen (TYLENOL). The patient recovered approximately 7 days after vaccination. Follow-up information indicated no new information. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Information has been received from a physician assistant concerning a 73 year old male consumer with a history of prostate cancer who on 14-MAR-2008 was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck). Subsequently, on 15-MAR-2008 the patient developed flu like symptoms and numb finger tips. Unspecified medical attention was sought. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information from the physician assistant indicated that this 72 year old whit male consumer with rhinitis allergic, atrial flutter, atrial fibrillation, and mitral valve prolapse and a history of prostate cancer who on 14-MAR-2008 was vaccinated SQ in the left deltoid with a first dose of zoster vaccine live (Oka/Merck) (lot # 659325/1823U). There was no illness at the time of vaccination. Subsequently, on 15-MAR-2008 the patient complained of feeling shaky and feverish the day after vaccine administration. It was also reported that the tips of his fingers started feeling numb. The right side of his head was sore to touch and the skin on his right temple was slightly red. There was no site reaction. The patient was told to treat his symptoms with acetaminophen (TYLENOL). The patient recovered approximately 7 days after vaccination. Follow-up information indicated no new information. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Neuralgia
Clinical narrative: Information has been received from a consumer concerning his 74 year old wife with no known allergies and high blood pressure who on an unspecified date in October 2007, was vaccinated with 0.65ml of zoster vaccine live (Oka/Merck). Subsequently, within 10 days after getting zoster vaccine live (Oka/Merck), the patient developed nerve pain. Unspecified medical attention was sought and the patient had "tests" performed (results not provided). At the time of the report the patient was not recovered. There was no product quality complaint involved. No further information is available,
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a male who on 14-MAR-2008 was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck) and was monitored for 30 minute post vaccination. On 17-MAR-2008 the patient developed 5 inch swelling at the injection site. The patient called the clinic and had follow-up with his primary care physician for medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a 68 year old female with penicillin and meperidine hydrochloride (DEMEROL) allergies and a history of shingles and embolus leg who "five-six months ago" in approximately October 2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included esomeprazole magnesium (NEXIUM), simvastatin (MSD) and ezetimibe (MSD). On 07-FEB-2008 the patient was diagnosed with shingles. It was noted that the patient had the rash and the pain but the blisters never appeared. Unspecified medical attention was sought, there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Additional information received from someone in the physician's office indicated that this 68 year old female was vaccinated in the left deltoid with a 0.5 ml first dose of ZOSTAVAX (Oka/Merck) (lot # 657766/0620U) on 22-SEP-2007. Subsequently the patient presented to the ER for flank pain. The patient thought that she was coming down with shingles but that diagnosis was never made. On an unspecified date the patient recovered. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with zoster vaccine live (Oka/Merck) on approximately 15-FEB-2008. On approximately 07-MAR-2008, the patient developed shingles. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Injection site bruising, Injection site haematoma, Injection site swelling, Injection site ulcer
Clinical narrative: Information has been received from a physician concerning a 78 year old female with rheumatoid arthritis and no known allergies who on 18-OCT-2007 was vaccinated once with 0.65 mL zoster vaccine live (Oka/Merck) (lot # 658209/1085U). Concomitant therapy included methotrexate. Initially, on 18-OCT-2007 the patient had bruising and swelling which turned into a hematoma over the injection site. Medical attention was sought, there were no lab studies performed. The physician saw the patient on 17-MAR-2008, the patient developed ulceration on the injection site. She had a 1 centimeter by 1 centimeter ulcer on the arm. However, she had no systemic symptoms including fever. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a 68 year old female consumer with penicillin, and sulfonamide allergies, and an allergic reaction to antibiotics and anti-depressants who on 10-MAR-2008 was vaccinated SQ with 0.65 once with zoster vaccine live (Oka/Merck). Concomitant therapy included venlafaxine HCL (EFFEXOR), amlodipine besylate (NORVASC), acetaminophen/hydrocodone bitartrate (LORTAB) and zolpidem tartrate (AMBIEN). Subsequently, "a day or 2 after  the shot" on
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy
Clinical narrative: Information has been received from a female who on 12-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot number reported as 658397/1820U). On 15-MAR-2008, the patient went to the Emergency Room and was diagnosed with BELL'S PALSY. It was unclear what prompted the ER visit and it was not further specified if the patient was admitted to the hospital. No other information was reported. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 35 year old patient who on 03-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). The patient was then administered a dose of varicella virus vaccine live (Oka/Merck) (MSD) on the same day. No symptoms were reported. It was unspecified if medical attention was sought. This was noted to be a case of human error and not product confusion. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial palsy, Facial paresis, Incorrect route of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 68 year old female who "about three weeks ago" on approximately 13-MAR-2008 was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Subsequently, the patient developed BELL'S PALSY, paralysis of the facial nerve. The patient sought medical attention in the office. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Follow-up information from a physician's assistant indicated that the 68 year old retired female with penicillin allergy, diabetes mellitus, hypertension and scleroderma and a history of myocardial infarction who on 13-MAR-2008 at 13:15 was vaccinated IM with her first dose of zoster vaccine live (Oka/Merck) (lot# 659762/1874U) in the left deltoid. There was no illness at the time of vaccination. On 01-APR-2008, the patient developed right side BELL'S PALSY. The patient was not recovered at the time of this report. Follow-up information from the physician assistant indicated the patient was seen on 10-APR-2008 and had mild persistent weakness on the right side of her face. At the time of the report it was noted that the patient was improving (recovering). Additional information is not expected. 7/18/08-records received-DOS 4/3/08-C/O right sided facial weakness and droop since yesterday. Started with pain behind right ear. Right eye tearing , unable to close eye at night. 4/10/08-visit-Bell's palsy improving with increased strength in face.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 62 year old female consumer with no known allergies or pertinent medical history who on 31-MAR-2008 was vaccinated SQ with a 0.65ml dose of zoster vaccine live (Oka/Merck) (lot # 659404/1826U). There was no concomitant medication. Subsequently, on 01-APR-2008 the patient experienced an injection site rash after receiving the vaccination. The rash was described as a red raised area at the injection site that was warm to touch, circular and approximately two inches wide. The patient was seen in the office. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from a licensed practical nurse concerning this 62 year old white female retired consumer with no known allergies or pertinent medical history who on 31-MAR-2008 was vaccinated SQ in the left upper arm with a 0.65ml dose of zoster vaccine live (Oka/Merck) (lot # 659404/1826U) at 10:00 am. There was no illness at the time of vaccination or concomitant medication. Subsequently, on 01-APR-2008 the patient reported her upper arm started itching and when she noticed it, it was swollen approximately 2 inches in diameter with small blisters. It was reported that this lasted approximately 3-4 days (reported as recovered on 05-APR-2008). It was also reported that it completely resolved on 10-APR-2008. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 62 year old female consumer with no known allergies or pertinent medical history who on 31-MAR-2008 was vaccinated SQ with a 0.65ml dose of zoster vaccine live (Oka/Merck) (lot # 659404/1826U). There was no concomitant medication. Subsequently, on 01-APR-2008 the patient experienced an injection site rash after receiving the vaccination. The rash was described as a red raised area at the injection site that was warm to touch, circular and approximately two inches wide. The patient was seen in the office. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information has been received from a licensed practical nurse concerning this 62 year old white female retired consumer with no known allergies or pertinent medical history who on 31-MAR-2008 was vaccinated SQ in the left upper arm with a 0.65ml dose of zoster vaccine live (Oka/Merck) (lot # 659404/1826U) at 10:00 am. There was no illness at the time of vaccination or concomitant medication. Subsequently, on 01-APR-2008 the patient reported her upper arm started itching and when she noticed it, it was swollen approximately 2 inches in diameter with small blisters. It was reported that this lasted approximately 3-4 days (reported as recovered on 05-APR-2008). It was also reported that it completely resolved on 10-APR-2008. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Lymphadenopathy, Pain in extremity, Skin warm
Clinical narrative: Information has been received from a physician who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, "2 weeks after the injection" she developed an inflammatory mass on her tricep that had warmth, redness and pain. Her axillary lymph nodes were also swollen, which lasted for about 2 weeks. Unspecified medical attention was sought. It was unspecified if lab studies were performed. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Upper extremity mass
Clinical narrative: Information has been received from a physician who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, "2 weeks after the injection" she developed an inflammatory mass on her tricep that had warmth, redness and pain. Her axillary lymph nodes were also swollen, which lasted for about 2 weeks. Unspecified medical attention was sought. It was unspecified if lab studies were performed. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hyperaesthesia, Injected limb mobility decreased, Injection site erythema, Injection site reaction
Clinical narrative: Information has been received from a registered nurse and physician concerning a 62 year old female consumer who on 04-DEC-2007 (reported by the physician as 08-FEB-2008) was vaccinated once SQ with 0.65 mL of zoster vaccine live (Oka/Merck) (lot# 658084/0888U) in the upper arm. Concomitant therapy included EXFORGE, DYAZIDE and PREMARIN. Subsequently, the patient experienced an injection site reaction after vaccination. The patient's entire arm developed excessive redness, swelling, and warmth from her shoulder to her wrist. One week after the vaccination the patient was treated with LEVAQUIN. Medical attention was sought, the patient was seen by the nurse. It was unspecified if lab studies were performed. The patient's arm returned to normal 3 weeks after vaccination on approximately 25-DEC-2007. There was no product quality complaint involved. The physician reported that, on 09-FEB-2008 in the AM, the patient began with a slightly red area which progressed to a large area below the elbow about halfway to the wrist. The area was extremely swollen, hot and very sensitive to touch. Her arm and shoulder were difficult to raise. On 11-FEB-2008, the physician looked at her arm and felt that the patient needed to be on LEVAQUIN for 7 days. This was about 2 weeks after the vaccine injection. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a registered nurse and physician concerning a 62 year old female consumer who on 04-DEC-2007 (reported by the physician as 08-FEB-2008) was vaccinated once SQ with 0.65 mL of zoster vaccine live (Oka/Merck) (lot# 658084/0888U) in the upper arm. Concomitant therapy included EXFORGE, DYAZIDE and PREMARIN. Subsequently, the patient experienced an injection site reaction after vaccination. The patient's entire arm developed excessive redness, swelling, and warmth from her shoulder to her wrist. One week after the vaccination the patient was treated with LEVAQUIN. Medical attention was sought, the patient was seen by the nurse. It was unspecified if lab studies were performed. The patient's arm returned to normal 3 weeks after vaccination on approximately 25-DEC-2007. There was no product quality complaint involved. The physician reported that, on 09-FEB-2008 in the AM, the patient began with a slightly red area which progressed to a large area below the elbow about halfway to the wrist. The area was extremely swollen, hot and very sensitive to touch. Her arm and shoulder were difficult to raise. On 11-FEB-2008, the physician looked at her arm and felt that the patient needed to be on LEVAQUIN for 7 days. This was about 2 weeks after the vaccine injection. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck) (lot # 658861/1822U). Subsequently, the patient developed an erythematous injection site rash. It was unspecified if medical attention was sought. The patient recovered on an unspecified date. There was no product quality complaint involved. Follow-up information from the pharmacist indicated she did not have the names of the patients involved in the event. Additional information requested. This is one of several reports from the same source.
Age: 6.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Erythema, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 year old female consumer who on 01-APR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck). The patient received unspecified concomitant vaccinations. Subsequently, the patient was take to the emergency room for localized redness of both the left arm and the right arm. It was unspecified if lab studies were performed. The child was not hospitalized. The CMA reported they did not give the vaccination at that office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a patient who 3 weeks ago on approximately 12-MAR-2008 was vaccinated SQ with 0.65mL of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced a local injection site reaction after the vaccination was given. The reaction was 2 inches in diameter. Medical attention was sought, the patient spoke to the nurse. It was unspecified if lab studies were performed. The reaction lasted for 2 days. The patient recovered on approximately the 14-MAR-2008. There was no product quality complaint involved. Follo up information was received which reported that the physician had no additional infomation. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a 73-year-old female consumer with hypertension, sulfonamide, codeine and morphine allergies and a history of breast cancer who on 02-APR-2007 was vaccinated with a first dose series of 0.65ml of zoster vaccine live (Oka/Merck). Concomitant therapy included "several medications that the patient could not name at the time of the call." Subsequently, 10 days after vaccination on 12-APR-2007 the patient developed a rash over her entire body. Medical attention was not sought. There were no lab studies performed. It was reported that the patient had not contacted her physician thus far. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. Follow-u8p information was received from a physician, concerning a 72 year old retired female with many medications allergies who on 02-Apr-2008 was vaccinated with the first dose 0.5 ml of ZOSTER (Merck) in the left deltoid. The onset date of the rash in 12-Apr-2008 on approximatel 25-Apr-2008, the patient recovered. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Local reaction
Clinical narrative: Initial and follow up information has been received from a physician concerning a 65 year old female, enrolled in the VZV Identification program, with allergic reaction to tetracycline, iodine allergy and hypersensitivity to AVELOX, hyperthyroidism, hyperlipidemia, and hypertension who on 14-APR-2008 was vaccinated subcutaneously into the left arm with 0.65 mL if zoster vaccine live (Oka/Merck) (Lot # 659762/1874U). Concomitant therapy included atenolol, ZETIA, TRICOR, MICARDIS HCT and ATACAND. On 16-APR-2008, at 3:00, the patient developed a superficial local reaction/ rash 3 cm in diameter at the injection site, that was also described as a red area around the site 1" by 2" and bright red. It was noted that there were no recent exposures to chickenpox or shingles. Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. At the time of reporting the patient had recovered (date unspecified). Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning female over 60 years old who on 11-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (no lot# provided). On that same day the patient developed pain and redness at the injection site. Therapy with zoster vaccine live (Oka/Merck) was discontinued. The outcome was unknown. There was no product quality complaint. Additional information has n=been requested. This is one of several reports from the same source.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male consumer who on an unspecified date was vaccinated with a dose of 0.65 mL of zoster vaccine live (Oka/Merck). Subsequently, the patient developed a mild outbreak of shingles. The patient was seen by the physician, it was unspecified if lab studies were performed. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Age: 6.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 6 year old female consumer who on 31-MAR-2008 was inadvertently vaccinated IM with a first dose of zoster vaccine live (Oka/Merck) (lot # 658397/1820U) instead of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that this was not a case of product confusion. Medical attention was sought in the office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the nurse indicated that the confusion was in regards to not understanding the difference between the two vaccines. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who in approximately August 2007, about 8 months ago was vaccinated with her first dose of zoster vaccine live (Oka/Merck). On approximately 02-MAR-2008 about 4 weeks ago, the patient was diagnosed with shingles. The patient sought unspecified medical attention. The outcome was unknown. No further information was provided. There was no product quality complaint. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 32 year old female consumer who on 16-APR-2008 was inadvertently vaccinated with zoster vaccine live (Oka/Merck) (lot # 659762/1874U) instead of with varicella virus live (Oka/Merck) (MSD). Concomitant vaccination included measles-mumps-rubella vaccine (Oka/Merck) (MSD). It was reported this was not product confusion, but human error. It was unspecified if medical attention was sought or if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from the registered nurse indicated that the vaccine was administered to the patient at the end of the day and the nurse was tried. It was noted that the nurse was distracted because the patient had many questions. It was also noted that the nurse did not perform the triple verification of the label that is required by the facility. The registered nurse reported that she has spoken to the patient and the patient was "doing fine." Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a 63 year old female consumer with no known allergies or pertinent medical history who on "last Friday" (28-MAR-2008) was vaccinated with a first 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658325/1429U) "in her lower arm between her wrist and elbow." There was no concomitant medication. Subsequently, right after receiving the vaccination she developed a red and inflamed injection site. Medical attention was not sought and there were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Follow-up information from the patient indicated that the vaccination was ordered by her regular physician and administered by a physician friend after she picked it up from the pharmacy. It was noted that the vaccination was administered into her lower forearm. At the time of the report the patient's status was unknown. The patient also reported that she had no adverse reaction. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a 73 year old male consumer with no known allergies, "optic nerve damage, loss of his left eye, bumps on the top of his hair line and very painful bumps on the left side of his face and forehead," and a history of optic nerve surgery who on 11-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included morphine, duloxetine hydrochloride (CYMBALTA), temazepam and esomeprazole magnesium (NEXIUM). The patient reported that about 15 to 20 minutes after receiving the vaccination his nerves relaxed and he did not have any pain. The patient said he usually had very bad pain at night time, but on Sunday and Monday (13-APR-2008 and the 14-APR-2008) he did not have any pain sleeping and was very relaxed. The patient also reported that the pain has started to come back little by little but it was not as bad as it has been in the past. There was no medical attention sought, or lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning his male cousin who on 31-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, on 07-APR-2008 the patient developed a rash. The rash was described as a maculopapular rash on the patient's arms forearms, and chest. Medical attention was sought, the patient spoke to the physician. It was unspecified if lab studies were performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old male consumer who in November 2007, was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, sometime after receiving the vaccination the patient developed shingles on an unspecified date. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an approximately 60 year old female consumer with no known allergies or pertinent medical history who on 10-APR-2008 was vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On approximately 11-APR-2008, the patient developed pain and swelling at the injection site. On 16-APR-2008, the patient called and reported the symptoms to the pharmacist. There were no lab studies performed. The patient reported that the pain and swelling seemed to get better during the day but got worse at night. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, sometime last week on approximately 08-APR-2008 he experienced swelling, pain, and redness at the injection site after receiving the vaccination. It was unspecified if medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 72 year old consumer with a history of having chickenpox twice, who on an unspecified date was vaccinated SQ with 0.65ml of zoster vaccine live (Oka/Merck). Subsequently a year after receiving the vaccination the patient developed a mild case of shingles. Medical attention was sought in the office. It was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product complaint involved. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 62 year old female consumer with no known allergies or pertinent medical history who on 31-MAR-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, on 02-APR-2008 the patient developed shingles. The patient had approximately ten lesions on her right forehead. The patient was seen by the the physician. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. The patient's sister also had an adverse experience after vaccination with zoster vaccine live (Oka/Merck) (WAES # 0804USA05038).
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician concerning a 54 year old female consumer with diabetes and rheumatoid arthritis who on 07-FEB-2008 was vaccinated IM with 0.65 mL  of zoster vaccine live (Oka/Merck). On 10-APR-2008, the patient was seen in the physician's office with a rash on T3 dermatome. It was unspecified if lab studies were performed. The patient was diagnosed with shingles. The patient was treated with VALTREX 1000 mg three times a day for 10 days. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information from the physician indicated that the patient also had neuritis. At the time the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning his wife who on an unspecified date was vaccinated with a first dose of zoster vaccine live (Oka/Merck). Subsequently, sometime last week on approximately 08-APR-2008 the patient experienced pain, redness and swelling at the injection site after receiving the vaccination. It was unspecified if medical attention was sought. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning a female who on 19-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck), 0.65 mL, subcutaneously (LOT # 659268/0158X). On 21-APR-2008 the patient developed two vesicular lesions over on her ribs. No other symptoms were noted. The patient contacted the pharmacist. No further information was available.
Age: 1.1
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 14 month old male who on 22-APR-08 was vaccinated SC with a 0.5 mL dose of zoster vaccine live (Oka/Merck) (lot number 658605/1089U) instead of varicella virus vaccine live (Oka/Merck). The physician indicated that this was a human error because both vaccines were stored in the freezer and the vial was placed turned backwards. Moving forward, they will store the two vaccines in separate places. The physician's suggestions for Merck were: writing in large fonts and different colors on the cap as well as all around the vial; Z and For Adult only and V and For Child only for zoster vaccine live (Oka/Merck) and varicella virus vaccine live (Oka/Merck), respectively. No product quality control issue was reported. No adverse effects were reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 68 year old female patient who on 03-OCT-2007 was vaccinated subcutaneous into the upper left arm with a .65 ml dose of zoster vaccine live (Oka/Merck) (lot # 658212/0887U). On 11-APR-2008 the patient broke out in shingles. The patient went to an instant care clinic on 14-APR-2008 and then to physician's office on 15-APR-2008 and both healthcare professionals confirmed diagnosis of shingles. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning his wife who on 16-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On an unspecified date the patient developed shingles. The patient's diagnosis was confirmed by a physician and the patient was treated with anti-viral medication. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Age: 45.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 45-year-old patient who on 21-APR-2008 was inadvertently vaccinated subcutaneously with 0.65 mL dose of zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (MSD). This was not a case of product confusion, but related to an order written as "varicella vaccine." No adverse effect reported. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 21-MAR-2008 was vaccinated with the first dose of varicella virus vaccine Live (Oka/Merck). On 21-APR-2008 the patient returned to the office and received zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live (Oka/Merck) (human error). No product quality complaint involved. The patient did not seek medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site vesicles, Pruritus generalised, Skin lesion
Clinical narrative: Information has been received from a 63 year old white female consumer with hypertension and penicillin allergy and history of shingles 40 years ago who on 18-APR-2008 was vaccinated subcutaneously with 0.65 ml of zoster vaccine live (Oka/Merck). Concomitant therapy included "a diuretic"(therapy unspecified) and "blood pressure medication" (therapy unspecified). One day post vaccination, on 19-APR-2008, the patient developed blister like eruptions at the injection site and a blinding headache. The consumer also noted that she had started to feel itchy all over her body. At the time of reporting the patient had not yet recovered. Medical attention was not sought. There were no lab diagnostic studies performed. There was no product quality complaint. Follow up information was received from a physician who reported on 18 APR 2008 at 10:00 that patient was vaccinated subcutaneously into the right arm with a first dose of zoster vaccine live (Oka/Merck), (lot # 659326/1824U). It was noted that on 21 APR 2008 the patient called the physician stating that she had sores all over and was very itchy, (previously reported by the consumer as "developed blister like eruptions at the injection site and started to feel itchy all over"). An office visit was scheduled, but the patient did not keep the appointment. There was no illness at the time of vaccination. The patient's status was unknown at the time of reporting. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Neuralgia
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old white female consumer with no known allergies who on 14-FEB-2008 was vaccinated SQ in the left arm with 0.5mL of zoster vaccine live (Oka/Merck) (lot # 659324/1835U). There was no illness at time of vaccination. On 15-FEB-2008, the patient had "nerve irritation running down her left arm". On 19-APR-2008, medical attention was sought, the patient spoke with the pharmacist and stated that she had "nerve pain" at the injection site. There were no lab studies performed. The patient's sister is a physician (not sure what kind) and told the patient to take (BENADRYL). Subsquently, the patient recovered from the symptoms. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash
Clinical narrative: Information has been received from a 62 year old female who "3 weeks ago" on approximately 31-MAR-2008, was vaccinated with zoster vaccine live (Oka/Merck). There was no illness reported at the time of vaccination. "Three days after" she was given the zoster vaccine live (Oka/Merck), on approximately 03-APR-2008, the patient had a rash on both collar bones and spoke to a nurse for medical attention. "Two weeks later'" on approximately 17-APR-2008, she had a rash on her thighs. The patient reported she put a band-aid on the rash and had a reaction to the band-aid she always used. She stated she never had rashes from the band-aid and never had rashes in general before. Subsequently, the patient recovered from the rash on both collar bones and rash on her thighs. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received from the patient. She reported that the physician "did not see the rash", she only reported it over the phone. Additional information is not expected.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a physician concerning an approximately 60 year old patient who on 11-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On that same day, the patient developed pain and redness at the injection site. The patient sought unspecified medical attention. The outcome was unknown. Therapy with zoster vaccine live (Oka/Merck) was discontinued. There was no product quality complaint. Additional information has been requested. This is one of several reports from the same source.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site nodule, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 71-year-old female consumer with no known allergies who on 10-SEP-2007 was vaccinated SQ in the left upper arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658083/0885U). Subsequently, the patient developed a firm, itchy nodule at the injection site of the left upper arm. The nodule was "flesh-colored" and "about the size of a pencil eraser." Medical attention was sought, the patient spoke to the pharmacist. There were no lab studies performed. At the time of the report the patient had not recovered. The patient was planning to consult her physician next week. There was no product quality complaint involved. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was received which reported that the patient did not see the doctor when her spouse came for vaccination and she thought the firm, itchy nodule was where injection was given, but the physician thought it was to center of arm "to" much. No further information is expected.
Age: 32.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 32-year-old patient who on 18-APR-2008 was inadvertently vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck) instead of with varicella virus vaccine live (MSD) at a public health department. It was reported this was not product confusion. There were no adverse events reported. Medical attention was sought, The patient contacted the office. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 61 year old female consumer with penicillin, codeine allergies and no pertinent medical history who on 11-APR-2008 was vaccinated in the right arm with zoster vaccine live (Oka/Merck). Subsequently, on 12-APR-2008 the patient developed erythema at the site of injection about the size of a half dollar after administration of the vaccine. The patient also reported that the area is sore to touch. Medical attention was sought, the patient had an office visit. There were no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Myalgia
Clinical narrative: Information has been received from a consumer concerning a female patient who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). It was reported that the patient woke up with severe lower back pain the morning after vaccination. At the time of the report the pain had migrated to her right calf muscle and had not resolved. There was no product quality complaint involved. The reporter indicated that she read this letter written by the patient to a medical advice column in the newspaper. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who on an unknown date was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). On an unspecified date, one day post vaccination, the patient developed shingles. The patient was seen by physician. At the time of the report the patient's status was recovering. A product quality complaint was not involved. No further information is available.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 54-year-old male with an allergy to VICODIN, hypertension and a history of shingles who on 24-APR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included PREVACID, LIPITOR, WELLBURTIN, lisinopril (manufacturer unknown), atenolol (manufacturer unknown) and "clonosopine." On 25-APR-2008, the patient developed shingles markings in his pubic hair area 1 1/2 inches in length and about 1/2 inches wide. The consumer was convinced he had shingles because he has experienced shingles several times prior to receiving the vaccine. The patient did not seek medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Age: 71.0
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 pharmacist concerning a 71 year old female consumer with no known drug allergies who on 17-APR-2008 was vaccinated SQ with 0.65 mL of zoster vaccine live (Oka/Merck) (lot # 658325/1429U). Subsequently, on an unspecified date the patient developed redness, swelling, and tenderness at the injection site after immunization with the vaccine. It was also reported that on 24-APR-2008 the patient also developed itching at the injection site. Medical attention was sought, the patient called the pharmacist. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.