chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female patient "in her sixties" in 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot# not reported). The physician stated that the patient experienced "within the last couple a months" also reported "4 months after vaccination" a zoster like rash down her left lower extremity that occurred in the L3 and L4 dermatomes. It was reported that the patient on an unspecified date recovered from zoster like rash down her left lower extremity in the L3 and L4 dermatomes. The patient sought unspecified medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 60 year old female office manager who on 12-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669263/1361Z). Later on 12-JAN-2011 the patient experienced redness, soreness, warmth and a knot at the site of injection site that lasted 2 weeks. She did not receive treatment. She did not develop a rash. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 67 year old male with no pertinent medical history or drug allergies/reactions, who on 22-JAN-2011 was vaccinated subcutaneously with "a single vial" dose of ZOSTAVAX (Merck) (Lot #669191/14656Z, exp 01/28/2012). There was no concomitant medication. Pharmacist reported that the patient experienced adverse reactions after receiving a dose of ZOSTAVAX (Merck). The patient experienced swelling, about "size of a silver dollar" and itching around injection site (approximately on 22-JAN-2011). No lab diagnostic studies were performed. The patient was treated with ALLEGRA for the adverse events. The patient's outcome was unspecified at the time of the report. Follow up information has been received from a Registered Pharmacist concerning a 67 year old retired male patient with no pertinent medical history, no drug allergies or reactions and no illness at the time of vaccination, who on 22-JAN-2011, was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (Lot #669191/14656Z, exp 01/28/2012). The pharmacist reported that on 23-JAN-2011, the patient had itching around injection site and swelling about "size of a silver dollar", which lasted "1 week". Patient recovered from adverse events on 30-JAN-2011. It was reported that patient did not seek medical attention. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema multiforme
Clinical narrative: Information has been received from a registered pharmacist concerning a patient, who an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The pharmacist reported that the patient developed erythema multiforme. At the time of the report, the patient's outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Information has been received from a 62 year old female patient with no pertinent medical history and no drug reactions or allergies who in September 2010 had received a tuberculosis skin test. On last Friday afternoon on 21-JAN-2011, the patient was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and expire date not reported), subcutaneously. There was no concomitant medication. Patient stated that on 22-JAN-2011 within 24 hours from receiving ZOSTAVAX (Merck), she developed an itchy rash on her arm and her back and then she realized there were a few poxes on her back and one on her arm. Patient mentioned that her back pox had gone away but the one on her arm was dime sized, raised and very itchy. There were no laboratory diagnostics studies performed. The patient sought unspecified medical attention. No treatment was given to the patient. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Medical assistant concerning a 75 year old male patient who in May 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). On 07-FEB-2011, the patient reported to the practice with shingles. Treatment included VALTREX 1 gram BID x7 days, LYRICA 75 mg TID and VICODIN prn for pain. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular, Skin discomfort
Clinical narrative: Information has been received from a physician concerning a male patient who on 31-JAN-2011 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck). On 03-FEB-2011 the patient developed 3 zoster-like lesions on his right flank. The patient was experiencing some discomfort at site of rash. No treatment was given. At the time of the report, the patient had not recovered from his adverse events. It was unknown if the patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Ocular hyperaemia
Clinical narrative: Information has been received from a doctor of pharmacy concerning a female patient, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). The pharmacist reported that the patient's eye area was red. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Flank pain, Headache, Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her husband, a 71 year old male patient with dementia and no allergies, with a pertinent medical history of open heart surgery and knee replacement who on 29-DEC-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot# 669187/1543Z, Exp date 06-FEB-2012), "in the arm". Concomitant therapy included albuterol sulfate, PREVACID, lisinopril-HCTZ, cyproheptadine hydrochloride (MSD), NIASPAN, TOPROL XL TABLETS, LIPITOR, aspirin, NAMENDA, ARICEPT, VENTOLIN HFA, albuterol sulfate inhaler, SYMBICORT and oxygen. The consumer stated that her husband "three weeks ago" on approximately 13-JAN-2011 experienced headaches "a dull pain in his head" and vision problems. The nurse that administered ZOSTAVAX (Merck) mentioned that the consumer's husband could experience certain side-effects 45 days after receiving the vaccines. It was no treatment given for the events. The patient was checked for vision problems (No results reported). At the time of the report the patient had not recovered. Follow up information has been received from the consumer who reported that on 17-APR-2011 her husband developed a case of shingles. The patient had blisters, burning, itching and pain on his right side. They had not yet contacted their physician but would do so. At the time of reporting the patient's status was unknown. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Visual impairment
Clinical narrative: Information has been received from a consumer concerning her husband, a 71 year old male patient with dementia and no allergies, with a pertinent medical history of open heart surgery and knee replacement who on 29-DEC-2010 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot# 669187/1543Z, Exp date 06-FEB-2012), "in the arm". Concomitant therapy included albuterol sulfate, PREVACID, lisinopril-HCTZ, cyproheptadine hydrochloride (MSD), NIASPAN, TOPROL XL TABLETS, LIPITOR, aspirin, NAMENDA, ARICEPT, VENTOLIN HFA, albuterol sulfate inhaler, SYMBICORT and oxygen. The consumer stated that her husband "three weeks ago" on approximately 13-JAN-2011 experienced headaches "a dull pain in his head" and vision problems. The nurse that administered ZOSTAVAX (Merck) mentioned that the consumer's husband could experience certain side-effects 45 days after receiving the vaccines. It was no treatment given for the events. The patient was checked for vision problems (No results reported). At the time of the report the patient had not recovered. Follow up information has been received from the consumer who reported that on 17-APR-2011 her husband developed a case of shingles. The patient had blisters, burning, itching and pain on his right side. They had not yet contacted their physician but would do so. At the time of reporting the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, expire date and route not reported). Physician stated that on an unspecified date after getting ZOSTAVAX (Merck), the patient experienced a neuropathy in her face. The patient sought unspecified medical attention. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a Licensed Practical Nurse concerning a patient who on 31-JAN-2011 was vaccinated with a dose of ZOSTAVAX (dose, route and lot # unspecified). The Nurse reported that on 03-FEB-2011 the patient experienced blisters around the injection site. The Nurse reported they were not shingles like in appearance. It was also reported that "Packet offered. Nurse adamant about not receiving. Packet not faxed.". At the time of the report patient's outcome was not reported. It was not specified if patient sought medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a 60 year old female consumer with a history of cold sores who in early April (on approximately 01-APR-2010) was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). The consumer reported that ever since she was a child, cold sores appeared on her mouth 3-6 times a year. The consumer reported that since she had ZOSTAVAX (Merck) she had not had any sores appear. Sometimes there was a tingling as though one wanted to appear but none had erupted since April. The consumer reported that she was very happy with this outcome as the sores had progressively gotten worse over the years, sometimes erupting down her chin. At the time for the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an approximately 69 year old male consumer, who on an unspecified dates was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported). The consumer reported that in approximately 2010, he experienced shingles after receiving a dose of ZOSTAVAX (Merck). The consumer said he had previous cases of shingles before. Follow up information has been received from the consumer indicating that he received the vaccine at a pharmacy and that he understood he should had waited 6 weeks after an episode, he was not told or did not ask. The consumer reported that he was vaccinated days after the outbreak-shortly thereafter he experienced 2 short outbreaks. Then he was symptoms free for 1 year since he had had 3-4 episodes not as profound as original. The consumer would like to know for a possibility of a booster. No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Herpes zoster, Rash papular
Clinical narrative: Information has been received from a licensed visiting nurse concerning an 86 year old female patient who on 04-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 659407/0295X, expiry date 24-JUL-2009, route not reported). Licensed visiting nurse stated that on 23-JAN-2011, the patient presented with shingles to their office. At the time of the report, the patient had not recovered. Follow-up information has been received from a completed questionnaire. A licensed visiting nurse reported that the patient with hypertension, hypothyroidism, hyperlipidaemia, coronary artery disease (CAD native coronary artery), type 2 diabetes mellitus (uncomplicated), impaired renal function, renal artery stenosis, cecal AVMs (arteriovenous malformation), allergy to erythromycin and sulfonamide antibiotics and a history of anemia and lumbar stenosis on 04-JUN-2008 at 3:13 p.m. was vaccinated SC with a first 0.65 ml dose of ZOSTAVAX (Merck) in her left deltoid. Concomitant therapy included PRAVACHOL, omeprazole, SYNTHROID, SULAR, TOPROL XL, DIOVAN, CITRUCEL, iron (unspecified), "Colon-help", calcium (unspecified) (+) vitamin D (unspecified), vitamins (unspecified) and aspirin. On 27-JAN-2011 the patient presented to the physician's office with burning sensation at waistline and rash since Sunday. The patient developed classic pink papular eruptions in clusters along right beltline, consistent with zoster (date of herpes zoster was previously reported as 23-JAN-2011). Rash did not occur within 42 days of vaccination. The specimen was not collected for PCR. It was mentioned that perhaps the patient was tolerating the herpes zoster better as she had the vaccine. It was too late for treatment with antivirals. That same day the patient's pulse was 68, systolic 160, diastolic 64 and temperature 97.60. It was also reported that the patient had a 24 hr Holter and no significant arrhythmias were noted that would be causing dizziness. For hypothyroidism, borderline TSH (thyroid-stimulating hormone) earlier in the month, would re-check. Physical examination was normal. The patient would visit the office in 3 months. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received form a female patient who on 28-JAN-2011 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (lot number not reported). On 28-JAN-2011 the patient experienced "injection-site-redness", itchiness and she said it hurt to touch. The patient's injection site redness and itchiness and she said it hurt to touch persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a registered nurse (R.N.) concerning a 65 year old female with no drug allergies/reactions who on 16-MAR-2009 was vaccinated with a dose of ZOSTAVAX (lot # 663775/1789X). On approximately 24-JAN-2011 the patient experienced shingles under the breastbone and around to the back on one side of the body. At the time of reporting, the patient had not recovered from shingles under the breastbone and around to the back on one side of the body. The patient sought unspecified medical attention. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a 69 year old female patient who in November 2009, was vaccinated with a dose of ZOSTAVAX (dose, route and Lot# unspecified). Patient reported that she "contracted shingles less than 2 years (in January 2011) after receiving the ZOSTAVAX". At the time of the report patient's outcome was not reported. Patient sought unspecified medical attention. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Rash papular
Clinical narrative: Information has been received from a Medical assistant concerning an approximately 65 year old patient who on 16-DEC-2010 was vaccinated with a dose of ZOSTAVAX (lot number not provided). On 18-JAN-2011 the patient reported to the practice with shingles (onset day not specified). It was reported a treatment with LIDODERM, famciclovir and MEDROL dose pack. At the time of the report the patient had not recovered. Follow up information was received from a nurse practitioner concerning the 65 year old male patient with hypertension, hyperlipidaemia, benign prostatic hyperplasia, chronic kidney disease, hypothyroidism, psoriasis, diverticulitis, kidney stone, rhinitis allergic and no acute illness at time of vaccination who on 16-DEC-2010 was vaccinated at 12:15p.m, IM, at the right upper arm, with the first dose of ZOSTAVAX. The nurse stated that on 19-JAN-2011 the patient reported 3 day rash at the left upper chest axilla, complained of pruritis and 2 papular vesicular lesions consisted with herpes zoster identified. It was given LIDODERM and famciclovir 500mg for 7 days as a treatment for the adverse events. On 23-JAN-2011 the patient recovered. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rash erythematous
Clinical narrative: Information has been received form a pharmacist concerning a 64 year old female with a history of "previous outbreaks of small red dots" who on 13-SEP-2010 was vaccinated with the first dose of ZOSTAVAX (lot number 665518/1311Y, expiration date 03-OCT-2011). Concomitant therapy included an unspecified anti-depressant. On an unspecified date the patient "had experiences of recurrent outbreaks of small red dots at various body sites" while on ZOSTAVAX. The patient was given ZOVIRAX cream for treatment. At time of the report, the patient's out come was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a 65 year old female registered nurse reported herself with no pertinent medical history and drug reactions/allergies who on 04-FEB-2011 was vaccinated with ZOSTAVAX, subcutaneous in upper right arm. On the same day she was also vaccinated PNEUMOVAX in the same arm. Other concomitant therapy included SYNTHROID and simvastatin (MSD). On an unspecified date, the nurse experienced a lot of pain and swelling around injection site of ZOSTAVAX in upper right arm, and she also reported her entire arm was very painful and she believe it is from the ZOSTAVAX injection site. No lab diagnostics studies were performed. It was unknown if she sought medical attention. Ibuprofen was given to treat AEs. At the time of report, the nurse present status was unknown. No further information is available.
Age: 5.0
Sex: U
Vaccine: DTAP, IPV, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received form a Medical assistant (reported as M.D. in contact details) concerning a 5 year old patient with no Pertinent Medical History and Drug Reactions/Allergies who on 08-FEB-2011 was inadvertently received ZOSTAVAX (subcutaneously right thigh, lot no. 669190/1455Z, exp date 29-JAN-2012) instead of VARIVAX. Concomitant therapy included DAPTACEL and poliovirus vaccine (manufacture unknown). No adverse effects have been reported of observe. The patient sought unspecified medical attention. No treatment was given for AE. Follow up information received from the same medical assistant reported that it was not a case of product confusion. The office manger stated that the two bottles were next to each other in the freezer and that the person giving the shot did not verify the bottle clearly enough. Follow-up information was received from the office. It was reported that no adverse reactions were identified. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Rheumatoid arthritis
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 68 year old female patient with rheumatoid arthritis and no drug reactions or allergies, who on 28-JAN-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 667610/1355Z EXP 26-OCT-2011) SQ in the left upper arm. There was no concomitant medication. The pharmacist reported that the patient experienced a flare up of rheumatoid arthritis after administration of ZOSTAVAX. There were no lab diagnosis/studies performed. The patient sought unspecified medical attention. It was reported that the patient had not received treatment for the adverse event. At the time of the report, the patient had not recovered. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Lot #, expire date and route not reported) (Merck). Physician stated that on an unspecified date, the patient experienced a severe case of shingles. At the time of the report, patient's outcome was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Information has been received from a 60 year old female with insulin resistance, asthma and codeine allergy (reported as "could not take codeine") who on 08-FEB-2011 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX and a dose of PNEUMOVAX the same day. Concomitant therapy included LEVEROXINE, metformin, montelukast sodium (MSD), CRESTOR and ZOLOFT. On 09-FEB-2011 (the next day) the patient's arm became swollen, red and itchy. The patient was not sure which product might have caused the AE. No treatment was given. No lab diagnostics studies were performed. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow-up information was received from a physician indicating a 60 year old female who on 08-FEB-2011 (previously reported by the consumer as 09-FEB-2011) at 11:07 am was vaccinated subcutaneously in her left arm with the first 0.65 ml dose of ZOSTAVAX (Lot # 669537/1386Z). There was no illness at time of vaccination. On 08-FEB-2011 the patient experienced redness, swelling, itching and welt. There were no relevant diagnostic tests. On 18-FEB-2011, the patient recovered from redness swelling, itching and welt. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a Registered Nurse concerning a 63 year old female patient with hypertension and no relevant medical history and past drug history who on 08-FEB-2011 was vaccinated in her right arm with a 0.5 ml dose of ZOSTAVAX (Merck) (lot # 669537/1386Z; Expiration date: January 2012). Concomitant therapy included citalopram, bisoprolol (reported as "bisopol") and isradipine (reported as "isratapine") (also reported as no concomitant medications). On 08-FEB-2011, hours after getting the injection, the patient called the nurse with symptoms of a blister like rash on her waist in the front and on the sides, and no other symptoms. There was no relevant laboratory data. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the nurse concerning the patient with penicillin allergy, who on 08-FEB-2011 at 12:00 was vaccinated with a dose of ZOSTAVAX (Merck) SQ in her left arm (also reported as right arm). The nurse reported that on 08-FEB-2011 at 16:45 the patient called to complain of a blistery rash around her abdomen in front and sides. On 09-FEB-2011 in the afternoon, the patient was worse; blisters had gone but rash spread. The patient's husband was having a surgery on 10-FEB-2011 so patient wanted to know if contagious referred to CDC (Centers for Disease Control) or country health. At the time of the report, the patient had recovered. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female patient, who on 06-FEB-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 669192/145Z) SQ. The pharmacist reported that on 06-FEB-2011 the patient developed a rash, redness and swelling. The patient's physician prescribed acyclovir because of the reaction to ZOSTAVAX. The patient was also treated with TYLENOL. It was reported that the patient contacted pharmacist stated that it was just a local redness and swelling and not appeared to be shingles. At the time of the report, the patient had not recovered. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain of skin
Clinical narrative: Information has been received form a 65 year old female consumer with osteoporosis and cholesterol and no drug reactions or allergies, who "in October or November 2010", was vaccinated with a dose of ZOSTAVAX (Lot # not reported). Concomitant therapy included alendronate sodium (MSD), simvastatin (manufacturer unknown) and trazodone HCl. The consumer reported that she was administered ZOSTAVAX on Monday and by Wednesday she developed a rash which her physician said was shingles. The consumer noted that the rash was on her back, sides and chest and was extremely painful for about a month and a half. The consumer noted she still had a rash in those places but it was not painful, it just looked bad. There were no longer any open lesions. It was reported that the consumer had received an unspecified treatment for the adverse events. The consumer sought unspecified medical attention. At the time of the report, the consumer was recovering. Follow up information has been received from a physician concerning the retired patient with no illness at time of vaccination and a history of chicken pox and herpes zoster several years ago, who on 13-OCT-2010 was vaccinated with the first dose of PNEUMOVAX (Lot # 667912/0933Z) IM in the left arm and on 25-OCT-2010 was vaccinated with the first dose of ZOSTAVAX (Lot # 665430/17649Y). The physician reported that on 02-NOV-2010 the patient developed a rash from the right nipple line to the thoracic spine with several congregation of vesicles on an erythematous base. The patient had not recent exposure to chickenpox or herpes zoster. There was not a direct fluorescent antibody done. There was not specimen collected for PCR. There was not photo taken. At the time of the report, the patient had recovered. No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Pain
Clinical narrative: Information has been received from a 71 year old male consumer who in December 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot # not reported). The consumer stated that in December 2010 was diagnosed with a case of shingles. The consumer did not remember ever having chicken-pox. The patient has been given steroid injections for the pain and discomfort. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information was received from the consumer who stated that in February 2009 (previously reported as December 2010) with a dose of ZOSTAVAX (Merck) at the age of 71. The patient stated that he cannot remember ever having chicken pox, but it was possible. Whether from fatigue, mental anxiety or a weakening of the immune system, in December 2010, the patient was diagnosed with shingles with its symptoms, especially the pain. He stated that only after a series of steroids injections, he was relieved of almost all the pain and "discomfort". The patient stated that if ZOSTAVAX (Merck) only lessens the symptoms and/or duration for the shingles, he was as thankful to have had the vaccination as he was for the steroid treatment. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Antibody test negative, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received form a 62 year old female physician with osteoporosis who on 08-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Lot # and expire date not reported), intramuscularly. Physician stated that immediately after ZOSTAVAX administration on 08-JAN-2011, she experienced pain and itching in her upper arm near the injection site specially the dorsal side. The next day on 09-JAN-2011, her entire arm was involved. During the next 3-4 weeks she had lessening of the injection site pain and more triceps pain with swelling and tenderness. Physician stated that at the time of the report, some pain and swelling continued. On 08-FEB-2011, physician developed a non-traditional shingles-like rash across her abdomen. Physician was treated with acyclovir and mentioned that a private physician ordered "testing" of the rash immediately after it developed, but she had not received the results. Physician sought unspecified medical attention. At the time of the report, physician was recovering. Follow-up information was received form a questionnaire and the female physician and informatics with allergy to sulfa, osteoarthritis, no illness at the time of vaccination, no recent exposure to chickenpox or herpes zoster and a history of chickenpox at the age 5 year who on 08-JAN-2011 at 9:30 a.m was vaccinated with the first dose of ZOSTAVAX (Lot # 669406/13572 and expire date not reported), 0.65 ml, intramuscularly in the lower border of the left deltoid. Physician stated that on 08-JAN-2011, shortly after ZOSTAVAX administration at 9:30 a.m, she experienced severe left arm, dorsal and ventral pain (deep ache) that lasted 4 weeks, unremitting. The pain gradually became more focal over the triceps and at the first week on approximately 15-JAN-2011, she was unable to lift her arm with the 2 degree pain. By 6 weeks on approximately 18-FEB-2011, the pain was completely resolved. On 08-FEB-2011, a typical zoster rash appeared (vesicles on an erythematous base) on the abdomen, the dermatome had a T10 distribution of 4 patches but there was no pain and no systemic symptoms. At the time of this report, the rash was primarily macular, the vesicles had always been more papular, there was no fluid and patient was a 90% recovered since her skin remains hyperpigmented in the 4 areas but papulas had resolved. There was no a recent exposure to chickenpox or herpes zoster. The maximum temperature was 97F degree. No fluid for culture was collected but a swab of maculopapular area was taken, negative for Polymerase chain reaction (PCR), direct fluorescent antibody (DFA) was none. No photo was taken. The physician sought medical attention by a doctor visit. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Laboratory test normal, Muscle swelling, Myalgia, Pain in extremity
Clinical narrative: Information has been received form a 62 year old female physician with osteoporosis who on 08-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Lot # and expire date not reported), intramuscularly. Physician stated that immediately after ZOSTAVAX administration on 08-JAN-2011, she experienced pain and itching in her upper arm near the injection site specially the dorsal side. The next day on 09-JAN-2011, her entire arm was involved. During the next 3-4 weeks she had lessening of the injection site pain and more triceps pain with swelling and tenderness. Physician stated that at the time of the report, some pain and swelling continued. On 08-FEB-2011, physician developed a non-traditional shingles-like rash across her abdomen. Physician was treated with acyclovir and mentioned that a private physician ordered "testing" of the rash immediately after it developed, but she had not received the results. Physician sought unspecified medical attention. At the time of the report, physician was recovering. Follow-up information was received form a questionnaire and the female physician and informatics with allergy to sulfa, osteoarthritis, no illness at the time of vaccination, no recent exposure to chickenpox or herpes zoster and a history of chickenpox at the age 5 year who on 08-JAN-2011 at 9:30 a.m was vaccinated with the first dose of ZOSTAVAX (Lot # 669406/13572 and expire date not reported), 0.65 ml, intramuscularly in the lower border of the left deltoid. Physician stated that on 08-JAN-2011, shortly after ZOSTAVAX administration at 9:30 a.m, she experienced severe left arm, dorsal and ventral pain (deep ache) that lasted 4 weeks, unremitting. The pain gradually became more focal over the triceps and at the first week on approximately 15-JAN-2011, she was unable to lift her arm with the 2 degree pain. By 6 weeks on approximately 18-FEB-2011, the pain was completely resolved. On 08-FEB-2011, a typical zoster rash appeared (vesicles on an erythematous base) on the abdomen, the dermatome had a T10 distribution of 4 patches but there was no pain and no systemic symptoms. At the time of this report, the rash was primarily macular, the vesicles had always been more papular, there was no fluid and patient was a 90% recovered since her skin remains hyperpigmented in the 4 areas but papulas had resolved. There was no a recent exposure to chickenpox or herpes zoster. The maximum temperature was 97F degree. No fluid for culture was collected but a swab of maculopapular area was taken, negative for Polymerase chain reaction (PCR), direct fluorescent antibody (DFA) was none. No photo was taken. The physician sought medical attention by a doctor visit. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymerase chain reaction, Pruritus, Rash, Rash macular, Rash papular
Clinical narrative: Information has been received form a 62 year old female physician with osteoporosis who on 08-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Lot # and expire date not reported), intramuscularly. Physician stated that immediately after ZOSTAVAX administration on 08-JAN-2011, she experienced pain and itching in her upper arm near the injection site specially the dorsal side. The next day on 09-JAN-2011, her entire arm was involved. During the next 3-4 weeks she had lessening of the injection site pain and more triceps pain with swelling and tenderness. Physician stated that at the time of the report, some pain and swelling continued. On 08-FEB-2011, physician developed a non-traditional shingles-like rash across her abdomen. Physician was treated with acyclovir and mentioned that a private physician ordered "testing" of the rash immediately after it developed, but she had not received the results. Physician sought unspecified medical attention. At the time of the report, physician was recovering. Follow-up information was received form a questionnaire and the female physician and informatics with allergy to sulfa, osteoarthritis, no illness at the time of vaccination, no recent exposure to chickenpox or herpes zoster and a history of chickenpox at the age 5 year who on 08-JAN-2011 at 9:30 a.m was vaccinated with the first dose of ZOSTAVAX (Lot # 669406/13572 and expire date not reported), 0.65 ml, intramuscularly in the lower border of the left deltoid. Physician stated that on 08-JAN-2011, shortly after ZOSTAVAX administration at 9:30 a.m, she experienced severe left arm, dorsal and ventral pain (deep ache) that lasted 4 weeks, unremitting. The pain gradually became more focal over the triceps and at the first week on approximately 15-JAN-2011, she was unable to lift her arm with the 2 degree pain. By 6 weeks on approximately 18-FEB-2011, the pain was completely resolved. On 08-FEB-2011, a typical zoster rash appeared (vesicles on an erythematous base) on the abdomen, the dermatome had a T10 distribution of 4 patches but there was no pain and no systemic symptoms. At the time of this report, the rash was primarily macular, the vesicles had always been more papular, there was no fluid and patient was a 90% recovered since her skin remains hyperpigmented in the 4 areas but papulas had resolved. There was no a recent exposure to chickenpox or herpes zoster. The maximum temperature was 97F degree. No fluid for culture was collected but a swab of maculopapular area was taken, negative for Polymerase chain reaction (PCR), direct fluorescent antibody (DFA) was none. No photo was taken. The physician sought medical attention by a doctor visit. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin hyperpigmentation
Clinical narrative: Information has been received form a 62 year old female physician with osteoporosis who on 08-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Lot # and expire date not reported), intramuscularly. Physician stated that immediately after ZOSTAVAX administration on 08-JAN-2011, she experienced pain and itching in her upper arm near the injection site specially the dorsal side. The next day on 09-JAN-2011, her entire arm was involved. During the next 3-4 weeks she had lessening of the injection site pain and more triceps pain with swelling and tenderness. Physician stated that at the time of the report, some pain and swelling continued. On 08-FEB-2011, physician developed a non-traditional shingles-like rash across her abdomen. Physician was treated with acyclovir and mentioned that a private physician ordered "testing" of the rash immediately after it developed, but she had not received the results. Physician sought unspecified medical attention. At the time of the report, physician was recovering. Follow-up information was received form a questionnaire and the female physician and informatics with allergy to sulfa, osteoarthritis, no illness at the time of vaccination, no recent exposure to chickenpox or herpes zoster and a history of chickenpox at the age 5 year who on 08-JAN-2011 at 9:30 a.m was vaccinated with the first dose of ZOSTAVAX (Lot # 669406/13572 and expire date not reported), 0.65 ml, intramuscularly in the lower border of the left deltoid. Physician stated that on 08-JAN-2011, shortly after ZOSTAVAX administration at 9:30 a.m, she experienced severe left arm, dorsal and ventral pain (deep ache) that lasted 4 weeks, unremitting. The pain gradually became more focal over the triceps and at the first week on approximately 15-JAN-2011, she was unable to lift her arm with the 2 degree pain. By 6 weeks on approximately 18-FEB-2011, the pain was completely resolved. On 08-FEB-2011, a typical zoster rash appeared (vesicles on an erythematous base) on the abdomen, the dermatome had a T10 distribution of 4 patches but there was no pain and no systemic symptoms. At the time of this report, the rash was primarily macular, the vesicles had always been more papular, there was no fluid and patient was a 90% recovered since her skin remains hyperpigmented in the 4 areas but papulas had resolved. There was no a recent exposure to chickenpox or herpes zoster. The maximum temperature was 97F degree. No fluid for culture was collected but a swab of maculopapular area was taken, negative for Polymerase chain reaction (PCR), direct fluorescent antibody (DFA) was none. No photo was taken. The physician sought medical attention by a doctor visit. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear infection, Injection site erythema, Injection site haematoma, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 69 year old female patient with allergy to aspirin who on 15-FEB-2011 was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot # and expire date not reported), subcutaneously in the right upper arm. Registered pharmacist stated that on 16-FEB-2011, the patient experienced redness, soreness and warmth at the injection site of the right upper arm. The patient called the physician's office and was advised to use BENADRYL, TYLENOL, and ice compresses. The patient called the pharmacist on 18-FEB-2011 to report that the area of the reaction "looked like a big bruise" and measured "about 4 inches by 7 inches". The patient also mentioned to the pharmacist that the patient experienced the area of reaction "looked like a big bruise". The patient also mentioned to the pharmacist that "her ear was infected" and she was self-treating with unspecified ear drops. There were no laboratory diagnostics studies performed. At the time of the report, the patient had not recovered. Follow up information has been received from a registered pharmacist (R. Ph) concerning a patient with no known allergies, birth defects and medical conditions (also reported as aspirin allergy) with no illness at the time of vaccination who on 15-FEB-2011 at 12:15 pm, was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number and dose not reported). On 16-FEB-2011, "day after vaccination", the patient reported red and sore hot spot. Also it was noticed that it became worse after couple days and subsided after 1-1 1/2 week. The patient did not seek medical attention. At the time of the report, the patient recovered. No further information is available.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a registered pharmacist concerning a 64 year old male patient with allergy to aspirin, who on 05-JAN-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # 665307/1171Y) SQ. The pharmacist stated that the patient came into her pharmacy "a couple of months ago" and told the pharmacist that he had broken out in shingles in September 2010. It was reported that an unspecified treatment was given for the adverse event. The patient was fully recovered at that time. Follow up information has been received from the pharmacist concerning the patient with no noted illness at time of vaccination who on 05-JAN-2010 was vaccinated with a first dose of ZOSTAVAX (Lot # 665307/1171Y) in the left triceps, at the pharmacy. In October 2010 the patient had symptoms of outbreak and went to primary care for follow up with his physician. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site reaction, Myalgia
Clinical narrative: Information has been received form a 60 year old registered nurse with no pertinent medical history and no drug reactions or allergies, who on 17-FEB-2011 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) intramuscularly instead of subcutaneously. There was no concomitant medication. The nurse reported that within 2 hours the patient experienced muscle soreness at the injection site. The soreness worsened during the night but was subsiding on 18-FEB-2011. There were no lab diagnosis/studies performed. The patient did not seek medical attention. Follow up information has been received from the nurse indicating that on 17-FEB-2011 at 15:00 she was vaccinated with ZOSTAVAX in the right deltoid. On 17-FEB-2011 at 19:00 the patient experienced muscle soreness. At the time of the report, the patient had recovered. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a registered pharmacist that reported hearing second hand of a patient with undiagnosed leukemia who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Lot #, expire date and route not reported). Registered pharmacist stated that on unspecified date after being administered ZOSTAVAX, the patient developed shingles. Registered pharmacist mentioned that it was subsequently discovered that "this patient had diagnosed leukemia". It was unknown if the patient sought medical attention. At the time of the report, patient's outcome was unknown. Attempts are being made to verify the existence of an identifiable patient and reporter. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 73 year old husband with allergies to azithromycin and no medical histories, who on 13-JAN-2011 was vaccinated with a dose of ZOSTAVAX (therapy route and lot # not provided). Concomitant therapy included baby aspirin and lisinopril-HCTZ. On 10-FEB-2011 the patient broke out in hives across her back and chest. They had been treating the hives with CALAMINE LOTION and "CALADRYL" but they did not seem to be subsiding. The reporter stated that they initially thought that he broke out in shingles but she stated that their healthcare professional (HC) ruled shingles out based on a description of the rash. The HCP stated that he thought it was an allergic reaction to the vaccine. No lab diagnostics studies were performed. At the time of reporting, the patient's status was not provided. Patient sought unspecified medical attention and contacted the pharmacy to inquire. Follow-up information was expected received from the patient who reported that his doctor only suggested that ZOSTAVAX and did not instruct him to get it. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a patient who 6 months ago, on approximately 22-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route and lot # not provided). On an unspecified date the patient developed shingles after administration of ZOSTAVAX (Merck). Unspecified medical attention had been sought. At the time of reporting, the patient had not recovered. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old female patient who on 22-APR-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported), SQ. Pharmacist stated that "after a week" on 29-APR-2010 of ZOSTAVAX (Merck) was administered the patient had noticed a rash all over her body. An unknown treatment was given for the event. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 70 year old female patient with hypertension who on 21-FEB-2011 was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included aspirin, hydrochlorothiazide (manufacturer unknown), multi-vitamins (unspecified), calcium (unspecified) and omega-3. The physician stated that on 22-FEB-2011 the patient experienced some redness at the injection site after receiving ZOSTAVAX (Merck). There was no treatment given for the events. There were no laboratories diagnostics performed. At the time of the report the patient's redness at the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Tachycardia
Clinical narrative: Information has been received from a Registered Nurse concerning an 87 year old male patient with no pertinent medical history or drug reactions/allergies, who "last week" (on approximately 01-FEB-2011) at "around 9:30 am", was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # unspecified). Concomitant therapy included "an antibiotic". The nurse reported that "last week" (on approximately 01-FEB-2011), the same day he received ZOSTAVAX (Merck) by 5:00 pm, the patient reported "feeling weak and light on his feet" and that also had tachycardia. No lab diagnostic studies were performed. Subsequently, "the following day" (approximately on 02-Feb-2011), the patient recovered from "feeling weak and light on his feet" and from tachycardia. The patient sought unspecified medical attention. Additional information has been requested.