chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Pruritus, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning an over 65 year old female who "within the last two weeks" (on approximately 07-OCT-2007) was vaccinated SC with a first dose of ZOSTAVAX Oka/Merck). Subsequently "about a week or two ago", on approximately 11-OCT-2007 the patient developed 8 postural-type independent lesions resembling chickenpox on different areas of her body (on her hand, leg, face, etc.). The patient sought medical attention from the pharmacist who treated the patient with BENADRYL. The lesions on the patient's extremities disappeared but a new lesion formed on her face. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning a 57 year old female who on 25-SEP-2007 at approximately 11:45 and was vaccinated SQ with a first dose fo ROTATEQ (Oka/Merck) (lot # 658083/08850) in her left arm. On 09/30/2007 the patient noticed on her right arm and right leg she had something that looked like blister puff but it itched and burned. She thought it might have been mosquito bites. The next day one wsa on the inside of her left arm in the elbow area. On 07-OCT-2007 she had one on the left side of her face under her eye and also one on her neck. Medical attention was sought on 08-OCT-2007 in the pharmacy. The patient spoke to the pharmacist about the problem and said she had taken BENADRYL by mouth and it did help. The one underneath her eye was still visible. The patient was told she could see the physician if she liked, but she did not want to. The patient was given a box of BENADRYL 25mg and told it didn't appear to be shingles. AIt was explained to the patient that she was probably just building an immune response to the vaccine. The pharmacist spoke with the patient on 12-OCT-2007 and she was doing fine and had no more bumps or blisters. At the time of the report the patient had recovered. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received concerning an 85 year old female with sulfonamide allergy and procaine allergy and a history of lung cancer, hypothyroidism and osteoporosis who on 13-OCT-2007 was vaccinated with a single dose of ZOSTAVAX. Concomitant therapy included ACTONEL, SYNTHROID, ATARAX and BENICAR. On 14-OCT-2007 the patient developed herpes zoster on the left flank and back. The patient was examined in the office on 15-OCT-2007 and was prescribed acyclovir and TYLENOL#3. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 76 year old female with allergies to TYLENOL, ibuprofen and gluten and a history of car accident and an accident at her apartment (door fell on her) who in August 2007, was vaccinated with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included codeine and aspirin. On approximately 02-OCT-2007 the patient developed rash on her hands. No 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 available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 70 year old female with no known allergies, rheumatoid arthritis and a history of hyperthyroidism and irritable bowel syndrome, who on 11-OCT-2007 was vaccinated SC with a dose of zoster vaccine live (Oka/Merck) (Lot#657766/0620U). There was no concomitant medication. On 13-OCT-2007, the patient developed an injection site reaction that was a red, raised and warm area that was about 4 inches. The patient called the doctor's office. No further information was provided. There was no product quality complaint involved. Additional information has been requested. 03/26/2008 Follow-up information from the reporting licensed practical nurse indicated that a 70 year old female who on 11-OCT-2007 at 13:30 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck) (lot#657764/0620U) in the right upper arm. On 12-OCT-2007 (also reported as 13-OCT-2007) the patient developed a warm, red, raised area at the injection site. It was noted that the patient did not seek medical attention but reported the events by phone and did not receive treatment. On 15-OCT-2007 the patient was recovered. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Blister, Dermatitis bullous, Pruritus
Clinical narrative: Information has been received from a physician concerning a 69 year old male who on 26-JUL-2007 was vaccinated with a single first dose on left arm of ZOSTAVAX (lot # 656858/0356U). Concomitant therapy included simvastatin, VERAPAMIL ER, WELLBUTRIN, hydrochlorothiazide, VICODEN, DEMEROL, ezetimibe and unspecified therapy. On 01-SEP-2007, the patient developed a bullous rash. The patient was seen at physician's office on 10-SEP-2007 to inform him of the issue and the physician treated the patient with ATARAX and a series of steroidal cream for the itching. The patient underwent biopsy. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the health professional who works in the lab who stated that the patient currently had vesicles on his hand. Additional information has been received from the physician who stated that the patient on 01-SEP-2007 developed vesicles that was described as vesicular rash with countless lesions on extremities. Follow up information was received from a nurse who reported that the patient had numerous fluid filled vesicles on all of his extremities and his trunk. The nurse reported that the patient had a biopsy done (date and location unspecified) of which the results were still pending. The nurse noted that the patient had not yet been assigned a diagnosis, due to the pending results. At the time of reporting the patient was "not totally better". Additional information requested. This is in follow-up to report(s) previously submitted on 12/21/07. Additional information was received from the physician. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The physician reported that on 25-OCT-2007, the sample was collected and arrived in the laboratory on 26-OCT-2007. Interpretation of the sample revealed inadequate specimen, negative for betaglobin no strain ID. No further information is expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 67 year old female (also reported as 57), with a history of nausea on DEMEROL and gastrointestinal bleeding on MOTRIN, and an unspecified hypersensitivity to PROCARDIA, who on 02-OCT-2007 was vaccinated with a first dose of ZOSTAVAX  (Oka/Merck) (Lot # 658208/0886U) 0.65 mL administered subcutaneously into the right upper outer arm. There was no illness at the time of vaccination. Concomitant therapy included PREVACID, ALLERGRA, "allergy shots" (unspecified), FEMHRT, and estradiol. On 03-OCT-2007, "early", the patient reported developing a reaction at the injection site abut 2.5" in diameter, that was red, warm, which at 22:30 became "painful". The patient sought medical attention. The physician reported that on 04 OCT 2007 there was local, painful, erythematous swelling noted over deltoid area. The patient was treated with elevation, ice, acetaminophen and cephalexin (for cellulitis). Symptoms gradually resolved. On approximately 14 OCT 2007 the patient was considered recovered. No labs or diagnostic studies were performed. This is one of several reports from the same source. No further information is expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 79 year old male who on 01-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (lot # 658083/0885U). There was no concomitant medication. On approximately 10-OCT-2007, 10 days after the vaccination the patient experienced shingles like rash on his torso. Unspecified medical attention was sought. at the time of report the patient had recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 65-year-old female who on 25-SEP-2007 was vaccinated with a "single dose" of ZOSTAVAX (lot # 658083/0885U). On 05-OCT-2007 (ten days post vaccination) the patient developed a shingles like rash on her back. The patient sought medical attention via an office visit with her physician. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning 10 children who were vaccinated with a 0.65 ml dose of ZOSTAVAC thinking it as a dose of VARIVAX. No adverse experience were reported. A product quality complaint was not involved. No further information is available.
Age: 76.0
Sex: M
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient was vaccinated for prevention of shingles. A product quality complaint was not involved. Additional information has been requested. 05/16/2008 Information has been received from a patient with no pre-existing allergies, birth defects or medical conditions, who on 17-OCT-2007 was vaccinated with a dose of VARIVAX (Oka/Merck). It was reported that the patient was vaccinated for prevention of shingles. There was no relevant diagnostic tests and laboratory data. There were no adverse events following prior vaccination. There was no illness at time of vaccination. There was no adverse experience. A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from a physician indicating that the patient called his office greatly concerned about the varicella injection he had received. He stated the shot he received was called ZOSTAVAX (Oka/Merck). He expressed his frustration about the error and wanted answers. The physician explained that the varicella vaccine he received was actually ordered for another patient who was scheduled for an appointment that day. When this patient walked in on their busiest day of the week without an appointment, wanting the shot right then, he was inadvertently confused with the other patient. The office did their best to accomodate the patient. The physician told the patient that it was not usual and customary to drop in a medical office without an appointment, for routine medical care. The patient was overly concerned that it would cause harm to him. The physician explained that "shingles" is cause by the varicella virus, the same virus that causes chickenpox. The vaccine ZOSTAVAX (Oka/Merck) is actually a boosted dose of the chickenpox vaccine currently given to children. The physician told the patient that since he had the chickenpox and the vaccines in the past, it should not cause an adverse effect on him. The physician informed the patient that he would call the manufacturer to confirm that information. He patient indicated that he already called but would do more research to find out himself. The physician indicated to the patient that he did not carry ZOSTAVAX (Oka/Merck) and that he would have to obtain it elsewhere. The patient indicated that he already scheduled an appointment with his wife's physician. The patient indicated that he was "sorry that he had to turn him into the insurance company". The patient expressed gratitude for all the previous medical care the physician rendered and requested that the physician forward the patient's medical record to the other physician. No other information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a consumer regarding a female patient who on 17-OCT-2007 was vaccinated with a 0.65 ml dose of ZOSTAVAX. On approximately 17-OCT-2007 the patient developed chicken pox. The consumer could not tell how may lesions there were. It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. No further information is available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed visiting nurse concerning a 60 year old male with hyperlipidemia and hypertension and no drug allergies who on 11-SEP-2007 was vaccinated SC with a 0.5 ml one time dose ZOSTAVAX (lot# 657765/0585U) in the right deltoid. Concomitant drug therapy included atenolol 50 mg once daily, naproxen 500 mg twice daily and simvastatin 80mg at bedtime. On 04-OCT-2007 the patient developed a mild case of shingles. The patient sought medical attention via physician's office. No labs or diagnostic studies were performed. The outcome was unknown. The patient was treated with VALTREX 1 g 3 times daily for 7 days. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female consumer with a history of shingles who received a 0.65 ml dose of zoster vaccine live (Oka/Merck) and after administration she reported that she got shingles. She sought unspecified medical attention. A product quality complaint was not reported. No further information was available. This in follow-up to report (s) previously submitted on 12/21/2007. Follow up information from a physician indicated that the patient received the ZOSTAVAX vaccine (Merck) vaccination in April (year not specified), and claimed that she developed shingles one month later, though she was never examined at the medical care provider's office to confirm the diagnosis. The reporter was unaware that an adverse reaction has been reported. Current patient status was not reported. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female with penicillin allergy and a history of fibromyalgia who on 11-OCT-2007 was vaccinated SC with a dose of ZOSTAVAX (Oka/Merck) (lot # 657766/0620U). There was no concomitant medication. On 12-OCT-2007, the patient developed an extremely red, raised, firm and swollen injection site reaction. The patient was treated with antibiotics and warm compress. No diagnostic laboratory tests were under taken. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pruritus
Clinical narrative: Information has been received from a 76 year old female with no pertinent medical history or drug allergies, who on 15-OCT-2007 was vaccinated with a single dose of zoster vaccine live (Oka/Merck) (lot number unknown). Concomitant drug therapy included Advair, Zyrtec and Levothroid. On that same night the patient developed extreme inflammation covering a large portion on her left arm and left arm also itched. No medical attention was sought. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased
Clinical narrative: Information has been received from a female consumer who was vaccinated on an unspecified date with a "single dose" of zoster vaccine live (Oka/Merck). On 17-OCT-2007, the patient experienced a temperature of 100 degrees after receiving zoster vaccine live (Oka/Merck). It was unspecified if medical attention was sought. The outcome was not reported. No product quality complaint was involved. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer, who reported that "his friend, a male, was diagnosed with shingles not long after receiving ZOSTAVAX", in August 2007. He had a very mild case of shingles on his lips and he recovered from it quickly. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Anorexia, Asthenia, Chills, Headache, Hyperhidrosis
Clinical narrative: Information has been received from a female consumer with no pertinent medical history or drug allergies, who on 11-OCT-2007 was vaccinated with one dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On 12-OCT-2007, the patient woke up during the night with chills, sweating and a slight headache. On 13-OCT-2007, the patient also experienced loss of appetite and no energy. No medical attention was sought. No labs or diagnostic studies were performed. On that same day the patient recovered. There was no product quality complaint. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician's staff member concerning a male patient (age not reported) who on an unspecified date was vaccinated with ZOSTAVAX. Subsequently, after vaccination, the patient developed a rash. The patient's outcome was not reported. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a physician's staff member and a physician concerning a 96 year old female patient (previously reported as a male) who on an 05-DEC-2006 was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot # 052965/0622F) in right deltoid. On 24-JAN-2007, the patient developed shingles had diffuse varicella like pruritic rash two-three weeks prior. Subsequently, the patient recovered. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a male with no drug allergies who on 16-OCT-2007 was vaccinated SC with a dose of ZOSTAVAX (lot number unknown). On 18-OCT-2007 the patient developed erythema at the injection site area. The patient contacted the pharmacist for medical attention. The patient was not recovered. There was no product quality complaint. Follow-up information has been received from a pharmacist indicating on 18-OCT-2007 the patient also developed soreness on the same arm that was vaccinated at an area opposite of the injection (on the posterior side) for ZOSTAVAX (lot# 658084/0888U). Follow-up information has been received from a pharmacist indicating that the 68 year old white male attorney was vaccinated with one SC dose of ZOSTAVAX (lot# 658084/0888U) at 14:00 on 16-OCT-227. Subsequently, the patient recovered from erythema the injection site area and soreness on arm. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old female with no pertinent medical history or drug allergies, who on 16-OCT-2007 was vaccinated with a one time SC 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot# 657766/0620U) in the left arm. Concomitant drug therapy included Synthroid and vitamins (unspecified). On 17-OCT-2007, the patient experienced injection site pain, redness, itching, warmth on an inflamed 2 X 2 inch patch area. The patient called the physician's office and came into the office for a visit. The physician stated that it looked like a cellulitis reaction. No labs or diagnostic studies were performed. The patient was treated with anti-itch cream. The patient's outcome was not recovered at the time of reporting. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Musculoskeletal stiffness
Clinical narrative: Information has been received from an adult female who on approximately 01-OCT-2006 was vaccinated with a dose of zoster vaccine live (Oka/Merck). The patient was "a little stiff that same day." As of 19-OCT-2007 the patient "still had a black and blue mark at the injection site but no rash." The patient did not seek medical attention. The outcome was unknown. There was no product quality complaint. No further information is available.
Age: 79.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a male with diabetes, history of heart disease, chronic lung disease (not related to smoking), sleep apnoea, hypertension, chronic insomnia, benign prostatic hyperplasia, osteoarthritis, history of pulmonary embolism and cerebrovascular accident and no known allergies who on 09-OCT-2007 was vaccinated subcutaneously with "one dose" of ZOSTAVAX (lot # 658212/0887U). There were no illnesses at the time of vaccination. Concomitant therapy included LIPITOR, AMARYL, LUNESTA, LYRICA, RODEX, ACTOS, ALEXAN, atenolol (MSD), FLOMAX, DIOVAN HCT, ENABLEX, PERCOCET and influenza virus vaccine (unspecified) that was administered in the left deltoid on 09-OCT-2007 in the morning(lot # U2446AA). On 11-OCT-2007 the patient developed shingles within 49 hours post vaccination. On 13-OCT-2007 the patient was seen again via an office visit and was treated with ZOVIRAX and steroids. On 16-OCT-2007 the patient was seen again via an office visit with the NP and there was no improvement in his symptoms. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. This is one two reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a single dose of ZOSTAVAX. It was reported that two days after vaccination the patient developed rash. The physician stated that she was unsure if the rash was due to the vaccine. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Laboratory test, Rash, Skin lesion, Virus culture
Clinical narrative: Information has been received from a physician and a 72 year old female with osteopenia, hypothyroidism, urge incontinence and hyperlipidemia and a penicillin allergy who on 16-OCT-2007 was vaccinated SC a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 658084/0888U). Concomitant drug therapy included DITROPAN, CRESTOR, ZOLOFT and  SYNTHROID. On 18-OCT-2007 the patient developed 10 lesions that were not in the dermatome. On 19-OCT-2007 the patient was seen by the physician for her "rash that was diagnosed as the shingles." No diagnosis was noted by the physician. A viral culture sample was performed with an expected response in 2-4 weeks and a "swab test" was also performed. The outcome was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning an 84 year old female with hypertension, gastroesophageal reflux disease, hypothyroidism and drug allergies to penicillin, cephalosporin, sulfa drugs, morphine, codeine, iodine, phenobarbital and latex, who on 29-AUG-2007 was vaccinated SC with a 0.65 mL dose of ZOSTAVAX(Oka/Merck) (lot# 657675/06180). Concomitant drug therapy included BENICAR HCT, NEXIUM, SYNTHROID, SULAR and DYAZIDE. On 01-SEP-2007, the patient experienced hives. The patient was treated with BENADRYL. Subsequently the patient recovered. There was no product quality complaint. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Allergy test, Postnasal drip, Sneezing
Clinical narrative: Information has been received from a consumer concerning her 70 year old husband with no pertinent medical history who on 11-JUN-2007 was vaccinated SC with one 0.65 ml dose of ZOSTAVAX (no lot number available). There was no concomitant medication. On approximately 11-JUN-2007 "shortly after vaccination," the patient experienced sneezing and post nasal drip. Unspecified medical attention was sought. An "A test for allergies" was performed. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a registered nurse concerning a 77 year old female who on 17-OCT-2007 was vaccinated with one 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot# 658082/0744U). On 18-OCT-2007 the patient experienced 3 blisters, one close to the injection site, one on both her left and right arm. The right ring finger blister was described as a scaly patch. The patient called the physician's office for medical attention. "The spots have all since cleared up therefore no sample will not be sent." The patient was recovered. There was no product quality complaint. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Incorrect dose administered, Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a 60 year old nurse with "controlled blood pressure", gastrooesophageal reflux disease (reported as "GERD or NUD"), "bad knees", "bungions", dry eyes, cough variant asthma and sulfonamide allergy who on 10-OCT-2007 was vaccinated with a dose of ZOSTAVAX 0.5 ml, IM "for shingles recurrence prevention". Vaccines received the same day included influenza virus vaccine (unspecified) (manufacturer unknown). Concomitant therapy included PREVACID, RESTASIS, RESTORIL, SONATAm NORVASC, "Solutab". The nurse reported that she was given ZOSTAVAX in one arm and influenza virus vaccine (unspecified) in the other arm. She reported that they both hurt but that the ZOSTAVAX hurt more than the flu shot. The pain lasted about 5 days to one week (date of recovery reported as 10-OCT-2007). The patient did not seek medical attention. There was no product quality complaint. No further information is available.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Inappropriate schedule of drug administration, Injection site erythema
Clinical narrative: Information has been received from a medical assistant concerning an approximately 40 year old female with a history of recurring shingles who on 17-OCT-2007 was vaccinated with a dose of ZOSTAVAX. It was noted that the patient did not have an active case of shingles at the time of vaccination. On 18-OCT-2007 the patient experienced redness at the injection site and some dizziness. Subsequently, the patient recovered. Unspecified medial attention was ought. No product quality complaint was involved. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia, Rash
Clinical narrative: Information has been received from a 78-year-old male who on 21-SEP-2007 was vaccinated subcutaneous with a 0.65 mL dose of zoster vaccine live (Oka/Merck). On 05-OCT-2007, the patient broke out in a rash around his waist that was causing nerve pain which was scattered in various areas of his body. The patient stated that his physician said  "that this is not an outbreak of shingles". 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: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Psoriasis, Skin lesion
Clinical narrative: Information has been received from a 65 year old female with no medical history or allergies, who on 17-SEP-2007, was vaccinated with a 0.65 mL dose of zoster vaccine live (Oka/Merck). Concomitant therapy included Effexor XR and vitamins (unspecified). "About a week after receiving zoster vaccine", on approximately 24-SEP-2007, the patient developed psoriasis in her scalp. Subsequently, she reported that she developed sores under her collar bone and swollen glands "several days" after receiving the vaccine. It was reported that she sought unspecified medical attention from her physician. The patient reported that at the time of the report she was recovering. A product quality complaint was not reported. No further information was available. The patient experienced pain in her arms following vaccination with "pneumococcal 23V polysaccharide vaccine" (manufacturer unknown) (WAES0170USA06172).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration
Clinical narrative: Information has been received from a female licensed practical nurse who on an unspecified date was vaccinated SC with a dose of ZOSTAVAX. Subsequently the patient noticed that the injection site felt hard for several days. Medical attention was not sought. No other symptoms were noted. Subsequently, the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old female who on 19-OCT-2007 was vaccinated IM with a zoster vaccine live (Oka/Merck). It was reported that the patient could not sleep and was concerned. The patient had no symptoms at the time of vaccination. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning a 69 year old female who on 19-OCT-2007 was vaccinated with a first dose of ZOSTAVAX vaccine (Merck) (Lot # 658604/1088U). It was reported that the patient could not sleep and was concerned. The patient had no symptoms at the time of vaccination. Additional information from the pharmacist indicated that no adverse event occurred. Additional information is not expected.
Age: 15.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Initial and follow-up information has been received from a medical assistant concerning a 15 year old female who on 02-APR-2007 was inadvertently vaccinated with a dose of zoster vaccine life (Oka/Merck) (lot # 656607/0163U) instead of varicella virus vaccine live (Oka/Merck) (MSD). It was reported that this was due to human error. It was unspecified if medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a 63 year old female consumer with a penicillin allergy and no other pertinent medical history who on 17-OCT-2007 was vaccinated in the left arm with a dose of  ZOSTAVAX. Concomitant therapy included SYNTHROID, meloxicam, an unspecified medication for "when your arteries get clogged up" and vitamins (unspecified). Subsequently the injection site became reddish, the area was the size of a quarter. Medical attention was not 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. This is in follow-up to report(s) preciously submitted 12/21/2007. Information has been received from a 63 year old female consumer with a PENICILLIN allergy and no other partinent medical history who on 17-OCT-2007 was vaccinated in the left arm with a dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID, MELOXICAM, an unspecified medication for "when your arteries get clogged up" and vitamins (unspecified). Subsequently the injection site became reddish, the area was the size of a quarter. Medical attention was not 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. Follow-up information was received from someone in the physician's office. The patient was vaccination IM in the left deltoid with a first dose of ZOSTAVAX (Merk) (lot #657766/0920U) on 17-OCT-2007. Subsequently the patient developed a red reaction the size of a 50 cent piece. The patient's outcome was not reported. No further information was provided. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from an approximately 83 year old female consumer with "no reported pertinent medical history", drug reactions or an allergy who on 07-APR-2007 was vaccinated with a "single dose of the series" of ZOSTAVAX. Concomitant therapy included LEVOXYL, atenolol, PAXIL, HYZAAR, PROTONIX, COUMADIN and oxygen. The patient reported that in the "middle of September" she had a small outbreak of shingles. She noted she had "red pimple like dots", that were red, itchy and gave her a "twinge of a headache that lasted for a second". They started on the hairline down to her forehead. The patient was seen by her physician and diagnosed with a mild case of shingles. At the time of reporting the consumer was not yet recovered. She noted that "this has lasted for about six weeks and she still has the rash". There were no lab diagnostics studies performed. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is follow-up to report (s) previously submitted on 12/21/2007. Follow up information was received from a physician's assistant who reported "I am unaware of any patient of mine who had an adverse reaction to ZOSTAVAX". No further information is expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 61-year-old female with a pertinent medical history "many" unnamed" and no known allergies who on 16-OCT-2007 was vaccinated subcutaneous with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658208/0886U). The patient was taking "many unnamed" concomitant medications. On 18-OCT-2007, the patient developed a "red swollen area 5 inches long from middle of upper arm to elbow, afebrile". The patient sought unspecified medical attention on 18-OCT-2007. No diagnostic labs were performed. On an unspecified date the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a pharmacist concerning a 58 year old female with no pertinent medical history or drug allergies who on 19-OCT-2007 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot# 658603/1081U0. Concomitant drug therapy included IMITREX, montelukast sodium, verapamil and ZYRTEC. On 20-OCT-2007 the patient developed shingles. The patient contacted the pharmacist for medical attention. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site irritation, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a 73 year old female with no pertinent medical history or drug allergies who on 19-OCT-2007 was vaccinated with a dose of ZOSTAVAX. Concomitant drug therapy included SYNTHROID and TOPROL XL TABLETS. On 20-OCT-2007 the patient "developed a red rash where the shot was given. The site was hard as a rock, burning, itching and the redness crawled up her arm." The patient did not seek medical attention. The patient was not recovered. There was no product quality complaint. Additional information is not expected. Follow-up information has been received from a 73 year old female indicating that the adverse experiences took several weeks to clear up. Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Oral herpes, Pain of skin, Pruritus, Rash, Skin discolouration
Clinical narrative: Information has been received from a 78 year old male with high blood pressure, rheumatoid arthritis and a bad case of chickenpox at age 13 and a penicillin allergy who on approximately "12-OCT-2007" was vaccinated with a single dose of ZOSTAVAX. Concomitant vaccination administered on that day included a dose of influenza virus vaccine (unspecified). Concomitant drug therapy included allopurinol; aspirin, VYTORIN, folic acid, hydrochlorothiazide, PLAQUENIL, methotrexate, LOPRESSOR, ACCUPRIL, ZOCOR, terazosin hydrochloride and other blood pressure and rheumatoid arthritis therapy. On 16-OCT-2007 the patient felt like he was getting a cold sore on his upper lip. Then he began experiencing itching on the buttock and his wife looked at and said it looked like a bunch of spider bites. The patient then developed small liquid filled lesions all over his body. The lesions have turned black and the liquid inside had dried up and started to crust. Medical attention was attempted by the patient contacting the physician without a call back. No labs or diagnostic studies were performed. The patient was noted to be recovering. There was no product quality complaint. Follow-up information has been received from a registered nurse indicating that the patient with a history of prostate cancer, coronary artery disease, hypertension, benign prostatic hyperplasia, hyperlipidemia and rheumatoid arthritis was vaccinated on 12-OCT-2007 with a SC dose of ZOSTAVAX (658839/1411U) in the left deltoid/arm. Concomitant vaccination administered on that same day included an IM dose of influenza virus split virion 3v vaccine inactivated (lot# U2528AA) in the right deltoid. Other concomitant drug therapy included allopurinol, ACCUPRIL 10 mg, HCTZ 25 mg, LOPRESSOR 125 mg, ezetimibe (+) simvastatin 10 mg/40mg, PLAQUENIL 200 mg BID and methotrexate 2.5 mg. On 16-OCT-2007 the patient developed a painful rash on his buttocks. No medical attention was sought. The outcome was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old female with a codeine allergy who on 20-OCT-2007 was vaccinated with a dose of ZOSTAVAX in the left arm. On approximately 29-SEP-2007 the patient was vaccinated with a dose of Influenza virus vaccine (unspecified) also in the left arm. On 22-OCT-2007, during a doctor office visit, the patient's left arm was hard, red and hot to the touch at the injection site. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a 74-year-old female consumer with a history of shingles and no known allergies, who in the "summer of 2007" developed shingles after being exposed to people who had just received zoster vaccine live (Oka/Merck). The patient did not receive zoster vaccine herself. The patient believes that her immune system was weakened due to a previous history of Hydrocortone injections (manufacturer unknown) (WAES # 0710USA03751), and therefore developed shingles because she had been exposed to people who had been given zoster vaccine live (Oka/Merck) that same day. Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The outcome was reported as recovering. No product quality complaint was involved. Follow-up information received from the physician's office reports that the patient believes she was exposed to zoster vaccine live (Oka/Merck) in the waiting room when sat near another woman who was there for the shingles vaccine. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood creatinine, Laboratory test, Red blood cell count increased
Clinical narrative: Information has been received from a physician's office manager concerning a 60 year old female with high blood pressure, migraines, high cholesterol, diverticulitis, and a metacarpophalange joint deformity with drug allergies to penicillin, novacaine and IMITREX who on 14-AUG-2007 was vaccinated SC with a dose of ZOSTAVAX (lot# 658085/0822U) in the left deltoid. There was no illness at the time of vaccination. There was no concomitant medication. On 21-AUG-2007 the patient developed bilateral pain in her wrists especially at night. It was noted that the patient has no history of lupus or rheumatoid arthritis. The patient was seen by the physician. A creatinine test was performed. Other lab diagnostic tests included sedimentation rate approximately 10. AMA was negative. RF was less than 20. The patient was not recovered. There was no product quality complaint. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a patient (age and gender not reported) who on 08-OCT-2007 was vaccinated with ZOSTAVAX. On 10-OCT-2007 the patient experienced reddened area 2" X 1" on upper arm at injection site. At the time of reporting, the area was starting to go away, but he patient had not fully recovered. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning a 66 year old female who on 08-OCT-2007 was vaccinated with ZOSTAVAX (Lot # 658084/0888U). On 10-OCT-2007, the patient experienced reddened area 2" x 1" on upper arm at injection site. In follow-up, it was reported that red, itchy, localized to site 2" x 1". On 23-OCT-2007, the physician reported that it was "still red." On 27-OCT-2007, the physician reported "gone." The physician reported that as of 27-OCT-2007, the patient was recovered. The patient was treated with BENADRYL/ice. The patient sought unspecified medical attention. No further information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Information has been received from a pharmacist as relayed by a physician concerning a patient (age and gender not reported) who on approximately 02-OCT-2007 "3 weeks ago" was vaccinated with ZOSTAVAX. On approximately 23-OCT-2007 ("3 weeks after administration of vaccine") the patient experienced "mild shingles appearance at the injection site". The physician examined patient on 23-OCT-2007 and prescribed an unspecified treatment. The patient's outcome was reported as not recovered. Additional has been requested.
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Anorexia, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a female who on 17-OCT-2007 was vaccinated with ZOSTAVAX 0.65 mL. Other concomitant vaccines included influenza virus vaccine (unspecified) and PNEUMOVAX. On 17-OCT-2007 the patient experienced pain and a lot of swelling at injections site, fever and loss of appetite. Therapy with ZOSTAVAX was discontinued. The patient's pain injection site and swelling at injection site and fever and loss of appetite persisted. The patient sought unspecified medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a male twin with no other medical history who was vaccinated SC with a single dose of zoster vaccine live (Oka/Merck). The physician reported that the patient subsequently developed a rash. Medical attention was sought via telephone call. No laboratory/diagnostic tests were performed. At the time of this report, the patient's rash persisted. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Skin lesion
Clinical narrative: Information has been received from a Nurse Practitioner concerning a 64 year old male who on 12-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). The nurse Practitioner reported that on 13-OCT-2007 the patient came back to the office with a full outbreak of shingles. It was also reported that the patient had lesions and itchiness but it was not painful to the patient. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: Information has been received from a health professional concerning a male physician who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient developed erythematous bump at injection site. The patient recovered on an unspecified date without any medical treatment. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician's office receptionist concerning a female who was vaccinated with a dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently the patient experienced varicella like rash. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Paraesthesia, Pruritus
Clinical narrative: Information has been received from an 81 year old male who on 16-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included cyanacobalamin injection and other unspecified medication. On 19-OCT-2007 night the patient experienced headache, sweating itching and tingling on top of his chest and arms that went away after 2 to 3 hrs. The patient stated that he did not have any rashes. No diagnostic laboratory tests were undertaken. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a registered pharmacist concerning a 71 year old female with no pertinent medical history and a drug reaction/allergy to Codeine, who on 11-OCT-2007 was vaccinated SC in the back of the left arm with a 0.65ml zoster vaccine live (Oka/Merck) (lot number: 657766/0620U). On 14-OCT-2007 or 15-OCT-2007 (approximately 3 or 4 days later) the patient developed a 6 inch red mark above and below the injection site. The red mark was not raised and was not hot to the touch. The red mark had become dull but the discoloration was still visible. The outcome was reported as recovering. Unspecified medical attention was sought at the pharmacy. There was no product quality complaint. Additional information has been requested.