chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain in extremity, Sleep disorder
Clinical narrative: Information has been received from a medical assistant concerning a 72 year old female with allergies to PENICILLIN, SERTRALINE, ZOLOFT, LOVASTATIN and SENTANUL and no pertinent medical history who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot# 659615/0162X). Concomitant therapy included CRESTOR. The patient developed local injection site reaction after receiving ZOSTAVAX vaccine. The injection site was red and swollen. The redness spread into linear streaks above and below the injection point. The patient had terrible pain on her arm and wasn't able  to sleep. The patient eventually developed a 2 by 5 cm oval erythematous patch on the left posterior upper arm around the injection point. The entire area was tender and had an appearance of severe inflammation, but it didn't appear to be cellulitis. The patient was prescribed BETAMETHASONE CREAM, CLARITIN, and BENADRYL. The patient saw the physician. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 60 year old male who on an unspecified date was vaccinated with a single dose of ZOSTAVAX. On approximately 20-JUN-2008 the patient developed zoster. Zoster was improved after stopping therapy  with ZOSTAVAX. No product quality complaint was involved. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Flushing, Palpitations, Weight decreased
Clinical narrative: Information has been received from a physician concerning a female with a history of breast cancer who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently the patient experienced palpitation, flushing, weakness and over the course of several months the patient had lost 30 lbs. On an unspecified date, the patient was sent to emergency room but specified reason was unknown. At the time of report, the patient was recovering. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a physician and a 62 year old female patient with penicillin and erythromycin allergy who on 24-MAY-2007, was vaccinated with a dose of ZOSTAVAX (lot # 657675/0618U), subcutaneous in her left arm. Concomitant therapy included TENORMIN, ALLEGRA and ESTRACE. The patient reported experiencing itchiness all over her body 5 months after receiving ZOSTAVAX, in October 2007; also reported by the physician in February 2008. A rash sometimes accompanied the itchiness and on unspecified date, after biopsy was done, it was diagnosed as hives. The physician reported that he thought they were not related to ZOSTAVAX. At the time of the report the patient has not recovered from hives but the physician reported that rash and itching were under control. The patient sought medical attention by her physician and dermatologist. This is one of two reports provided by the same source. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex serology negative, Herpes zoster, Pain, Viral DNA test positive
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning a 72 year old female patient with no pertinent medical history or allergies who on 22-JUN-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot #652947/1411F). Concomitant therapy included vitamins (unspecified), LIPITOR, aspirin, METROGEL and triamcinolone topical. The nurse reported that on 23-JUN-2008, the patient developed herpes zoster on left knee to left buttock, L 4-5 distribution. The patient stated she had "unbearable pain". The same day, a viral culture was done; varicella zoster virus DNA detected and it was negative for herpes simplex type 1 and 2 DNA. The nurse was not interested in VZV Analysis by PCR. At the time of the report the patient was recovering. The patient sought medical attention at the physician's office. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: Information has been received from a female patient who in November 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). The patient stated that about one week after receiving ZOSTAVAX vaccine, in November 2007, she had itching at injection site. The physician prescribed various creams, that did not resolve latter event. The physician also prescribed LIDOCAINE, which also did not help. On 30-JUN-2008, the patient was schedule to see a dermatologist. At the time of the report the patient had not recovered. The patient sought medical attention. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Pain
Clinical narrative: Information has been received from a registered nurse concerning a 72 year old female with mitral valve prolapse, hypertension, arthritis, hypercholesterolaemia and ACCUPRIL allergy and a history of subthyroidectomy who on 27-JUN-2008 was vaccinated with a dose of ZOSTAVAX (lot #659615/0162X). Concomitant therapy included ezetimibe (MSD), propanolol HCl, LOPID, digoxin, PREMARIN, ACCUPRIL, diazepam, SULAR. The nurse reported that the patient developed a 5.5 by 5.5 inch erythemous pruritic rash at the injection site after administration of ZOSTAVAX. The patient stated the area was sore. The patient's vital signs were normal. In follow-up information the nurse reported that the patient had itchy body aches. The nurse reported that on 13-JUL-2008, spoke with the patient and she stated that the reaction had completely subsided within 5 days and had a further problems. The nurse reported that the patient's husband had had shingles for weeks prior the patient's vaccination. At the time of the report the patient has recovered. The patient sought medical attention. No further information is available.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a registered nurse concerning her 77 year old husband with allergic reaction to amoxicillin (+) AUGMENTIN who on 17-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR. The nurse reported that on 21-JUN-2008, her husband developed an oral herpes infection. On 21-JUN-2008, patient took FAMVIR 1500 mg to halt the progression of the oral herpes infection. The oral infection subsided. On 22-JUN-2008, the patient recovered. The patient did not seek medical attention. This is one of two reports provided by the same source. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a medical assistant concerning a 77 year old male, with no known allergies and no medical history reported, who on approximately 18-MAY-2008 was vaccinated with ZOSTAVAX (Oka/Merck). There was no concomitant medication. The patient experienced intermittent fever after receiving ZOSTAVAX (Oka/Merck). He was given a prescription for ZOSTAVAX (Oka/Merck) on 12-MAY-2008 to be filled and given at another facility. He was seen on 21-MAY-2008 in the physician office because of the fever. There were no laboratory diagnostic studies performed. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Melanocytic naevus, Oedema peripheral
Clinical narrative: This is follow-up to report(s) previously submitted on 5/24/2008. Information has been received from a 68 year old registered nurse with an unspecified thyroid disorder, mitral valve prolapse, haemangioma of liver, acute fibromyalgia, nodules and scar tissue on the lungs from bouts of pneumonia, DEMEROL and VICODIN drug allergies, unspecified environmental allergies and a history of pertussis, who on 17-JUN-2008 was vaccinated subcutaneously in the deltoid with 0.65 ml of ZOSTAVAX (Merck). Concomitant therapy included LIPITOR, amitriptyline hydrochloride, lorazepam, AMBIEN and diltiazem HCL. The nurse reported that she developed a swollen arm a day after receiving ZOSTAVAX (Merck) on 18-JUN-2008. The nurse stated the swelling resolved without treatment in about one week; however, the nurse stated there appears now to be "a small mole" that developed at the injection site. Follow up information was received from the physician on 03-DEC-2010 indicated that there was no actual adverse event. The patient did not seek treatment for the symptoms, and did not seek for medical attention. At the time of reporting the patient is recovering from the AE. There was no product quality complaint. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic
Clinical narrative: Information has been received from a physician concerning a female patient in her 70s with no pertinent medical history and no allergy who was vaccinated with ZOSTAVAX SC. There was no concomitant medication. The patient experienced ophthalmic zoster three times after vaccination. The patient sought medical attention and saw the physician. This is one of two reports from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Rash vesicular
Clinical narrative: Information has been received from a 65 year old male consumer with no known drug allergies who on 14-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). On 16-JUN-2008  the patient experienced flu like symptoms and developed "chicken pox like rash" on legs below the knee. At the time of this report, the patient was recovering from the symptoms. The patient sought unspecified medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her friend, a 72 year old female who in approximately June 2006 (about two years ago) was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). "Recently", the patient developed shingles. The patient's outcome was unknown. It was unspecified if any medical attention was sought. Additonal information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Headache, Hypoaesthesia, Inappropriate schedule of drug administration, Nasopharyngitis
Clinical narrative: Information has been received from a medical assistant concerning a 48 year old female with depression, anxiety and chronic back pain and allergic to LEVAQUIN and unspecified narcotic who on 27-JUN-2008 was vaccinated with ZOSTAVAX by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included XANAX, ATIVAN, and LORTAB. On 28-JUN-2008 the patient developed a cough, cold like symptoms, numbness from the left arm to the hand, ache and pain, and headache. On 30-JUN-2008, it was reported that the patient was "being seen at the office today with a chief complaint of overall aches. Other symptoms have not resolved." Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Information has been received from a medical assistant concerning a 48 year old female with depression, anxiety and chronic back pain and allergic to LEVAQUIN and unspecified narcotic who on 27-JUN-2008 was vaccinated with ZOSTAVAX by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included XANAX, ATIVAN, and LORTAB. On 28-JUN-2008 the patient developed a cough, cold like symptoms, numbness from the left arm to the hand, ache and pain, and headache. On 30-JUN-2008, it was reported that the patient was "being seen at the office today with a chief complaint of overall aches. Other symptoms have not resolved." Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Hepatitis A antibody positive, Hepatitis B antibody, Hepatitis C antibody positive, Hepatitis C positive, Rash
Clinical narrative: Information has been received from a physician concerning a 62 year old male with penicillin and ramipril allergy, hypertension, hyperlipid, hepatitis A, hepatitis B and hepatitis C who on 14-AUG-2007 at 9:56AM was vaccinated with the first dose of ZOSTAVAX (lot#: 658207/0883U) 0.65ml subcutaneously in the left arm. Concomitant therapy included simvastatin (MSD), TOPROL XL TABLETS and aspirin. On 06-JUN-2008 the patient noticed a rash on the left side of his waist (at the T10 area). No fever was noted. The patient did not see a doctor. Subsequently, scabs developed and the patient recovered. The patient was Hepatitis A, B, C antibody positive and Hepatitis B antigen negative. No further information is available.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Information has been received from a physician concerning a 62 year old male with penicillin and ramipril allergy, hypertension, hyperlipid, hepatitis A, hepatitis B and hepatitis C who on 14-AUG-2007 at 9:56AM was vaccinated with the first dose of ZOSTAVAX (lot#: 658207/0883U) 0.65ml subcutaneously in the left arm. Concomitant therapy included simvastatin (MSD), TOPROL XL TABLETS and aspirin. On 06-JUN-2008 the patient noticed a rash on the left side of his waist (at the T10 area). No fever was noted. The patient did not see a doctor. Subsequently, scabs developed and the patient recovered. The patient was Hepatitis A, B, C antibody positive and Hepatitis B antigen negative. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient in her 70s with no pertinent medical history and no allergy who was vaccinated with ZOSTAVAX vaccine (Oka/Merck) SC. There was no concomitant medication. The patient developed shingles on her arm. The patient sought medical attention and saw the physician. This is one of two reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Erythema, Herpes virus infection, Swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a female in her 60's who on 24-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number was not provided). On 26-JUN-2008 the patient developed cellulitis and herpetic outbreak. The patient went to hospital for an oral antibiotic, but was not admitted. The patient had swelling, redness, and blistering and it was said it was a herpetic outbreak. The patient was noted to be recovering. No product quality complaint was involved. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old female with hypertension and hypercholesterolaemia and no drug allergies who on 18-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (659411/0293X). There was no concomitant medication. On 23-JUN-2008 the patient developed unspecified itching and hives. The patient sought treatment with an unspecified provider who prescribed BENADRYL and a follow up appointment on 01-JUL-2008. No other symptoms or treatment reported. At the time of this report, the patient's unspecified itching and hives persisted. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a doctor of pharmacy concerning her mother a 60 year old female who on 18-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently the patient had redness at the injection site. At the time of this report, the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning an approximately 65 year old female who on 24-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently, on an unspecified date the patient developed 2 inch by 2 inch area of redness with a few red lesions at the injection site of the right arm. The pharmacist stated there were no vesicles. At the time of this report, the patient's symptoms persisted. The patient came to the pharmacy to seek unspecified medical attention. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Ocular hyperaemia, Vision blurred
Clinical narrative: Information has been received from a physician concerning a 33 year old female employee with no pertinent medical history and no allergies who received a splash of solution in her eye when she was administering ZOSTAVAX vaccine (Oka/Merck) to a patient. There was no concomitant medication. Eye was immediately flushed with running water. There was slight redness around the eye with some blurring. Her a slight redness around the eye and the eye with some blurring were recovering. She sought medical attention in office. Follow up information has been received. The employee was fine and at work, and had no symptoms. She stated that she was preparing the vaccine and was removing air from the syringe when a "minute amount" splashed in her eye. She was able to give the full dose to patient. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Paraesthesia, Skin irritation
Clinical narrative: Information has been received from a physician concerning a 63 year old female who on 02-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX. On 17-JUN-2008 the patient experienced pins and needles on her skin, neuropathic pain on her thoracic dermatome and sever skin irritation. At the time of this report, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: Information has been received from a 74 year old female who in 2008, "a few months ago" was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On an unknown date, the patient developed gout after receiving ZOSTAVAX (Oka/Merck). The patient was not sure if the symptom was caused by ZOSTAVAX (Oka/Merck). The patient's outcome was unknown. It was unspecified if the patient sought medical attention. No further information is available.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Herpes zoster, Incorrect dose administered, Injection site pruritus
Clinical narrative: Information has been received from two nurses and a consumer concerning the 67 year old male with type 2 diabetes mellitus, osteoarthritis, hypertension, obesity and a history of chickenpox in childhood and no allergies who on 19-JUn-2008 was vaccinated with ZOSTAVAX 0.5ml SC (lot # 658862/1415U). Concomitant therapy included LANTUS, metformin,
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes virus infection, Injection site vesicles, Scab
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 65 year old male with no relevant medical history or allergies who on 18-JUN-2008 was vaccinated with a 0.5 ml dose of ZOSTAVAX (lot number 659408/300X) by subcutaneous injection in the left deltoid. There was no concomitant medication. On 01-JUL-2008, also reported as "a couple of days", the patient developed a herpes form blister at the injection site, which scabbed over after blister broke. After accidental arm contacted, the blister was painless. The patient applied NEOSPORIN to the rash. The patient's outcome was unknown. Additional information is not expected.
Age: 6.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist and a patient safety manager concerning a 6 year old female who at 10:45 a.m., on 26-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). The patient had been seen since then by her primary care physician on 27-JUN-2008 and 01-JUL-2008. She was fine with no adverse experiences. She was scheduled for VARIVAX vaccine (Oka/Merck) in 6 months. The patient safety manager felt this was a case of human error. Both vaccines are stored in the same freezer, though on separate shelves. They do a large volume of vaccinations and can be quite busy. The patient safety manager's senior management has issued an alert to other military bases to be careful to avoid such incidences. They have since placed "high alert" tags on the vaccines to remind the staff to be careful not to confuse ZOSTAVAX vaccine (Oka/Merck) and VARIVAX vaccine (Oka/Merck). This is one of several reports form the same source. The patient's sibling was also vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) instead of VARIVAX vaccine (Oka/Merck) (WAES0806USA08964). Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a female patient who on 01-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient reported that on 03-JUN-2008, 2 days after receiving the vaccine, she developed a rash 2x4 inches in the area where she received her ZOSTAVAX injection. At the time of the report the patient had not recovered. The patient did not seek medical attention. No further information is available.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 62 year old male with blood pressure high and no allergies who on 30-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included NEXIUM. On 01-JUL-2008, 24 hours after vaccination, the patient experienced injection site reactions. The patient had slight erythema, tenderness and fullness at injection site. The fullness was further defined as soft and feels like it was fluid filled. The patient's injection site reactions, slight erythema, tenderness and fullness at injection site persisted. The patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female patient with no pertinent medical history and no allergies who on 30-JUN-2008 was vaccinated with ZOSTAVAX (lot# 659410/0412X) SC. Concomitant therapy included XANAX. The patient developed a left arm injection site reaction after vaccination. The pharmacist stated that the patient had a red area about 4-5 inches in diameter surrounding the injection site. The patient's injection site erythema persisted. The patient sought medical attention by phone call. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 63 year old female patient with sulfonamide allergy and a history of shingles 15 years ago who on 06-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included PRAVACHOL, NASONEX, and vitamins (unspecified). On 25-JUN-2008 the patient experienced Shingles rash. On 02-JUL-2008, the patient recovered from Shingles rash. The patient sought medical attention and visited doctors. This is one of several reports from the same source. Additional information has been requested. 12/23/2008 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician and a 63 year old female patient with sulfonamide allergy and a history of shingles 15 years ago who on 06-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) in the left arm. Concomitant therapy included PRAVACHOL, NASONEX and vitamins (unspecified). On 25-JUN-2008 the patient experienced shingles rash at the right T4 dermatome. On 02-JUL-2008, the patient recovered from shingles rash. The patient sought medical attention and visited doctors. This is one of several reports from the same source. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash macular
Clinical narrative: Information has been received from a nurse practitioner concerning a 69 year old female with diabetes, hypertension, unspecified allergies and penicillin allergy who on 30-JUN-2008 was vaccinated subcutaeously with the single dose of ZOSTAVAX (lot no. 659408/0300X) into the left upper arm. Concomitant therapy included glyburide, ACTOS, quinapril HCl, propranolol HCl, simvastatin (manufacturer unknown) and ZYRTEC. On 03-JUL-2008 the patient developed a red, itchy, macular "hand-sized" rash at the injection site of the left upper arm. On the same day, the patient was seen in the clinic and was prescribed BENADRYL. At the time of this report, the patient's red, itchy, macular rash at the injection site persisted. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning himself, who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Two weeks later, the patient developed Shingles. The patient's outcome was unknown. Unspecified medical attention was sought. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site streaking
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female with no pertinent medical history and no known drug reactions/allergies who on 12-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (LOT# 649404/1826U). There was no concomitant medication. On 07-JUl-2008 the patient returned to the pharmacy with a red streak 2.5 inches x 1 inch on the back of her right arm near the injection site. It was itchy but not raised. No treatment was required at this time. The patient's symptoms persisted. Unspecified medical attention was sought. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation
Clinical narrative: Information has been received from a licensed practical nurse concerning a female who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (route and administering site not reported). Subsequently the patient experienced atrial fibrillation. The patient believed this happened because of this immunization. The patient sought unspecified medical attention. It was noted that this was a new patient to the office and she had not been to the doctor in approximately 10 years. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a 67 year old female with cholesterol high, cardiac murmur and sulfonamide allergy and a history of Shingles in her 30's who on 29-NOV-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 658398/1087U). Concomitant therapy included atenolol, SYNTHROID, therapy unspecified (water pill), aspirin, calcium (unspecified) and ginkgo. On 19-DEC-2007 the patient experienced Shingles attack. The patient reported that she had history of Shingles since in her 30's and every time she's exposed to somebody with chickenpox or if she was on a stressful condition, she would always get Shingles attack. The patient reported that from the time she received ZOSTAVAX (Oka/Merck), she already had 5 Shingles attacks in 7 months. The patient's Shingles persisted. The patient sought medical attention. Follow up information was received from the physician. The patient reported rash that was never seen in the physician's office for it. It can not state that the patient actually has Shingles. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported). Subsequently the patient developed herpes zoster. The patient sought unspecified medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 66 year old female who was vaccinated with a dose of ZOSTAVAX (lot number, injection site and route not reported). Subsequently, the patient experienced shingles. The patient sought unspecified medical attention. At the time of reporting, the patient was recovering from the event. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008. Follow-up information was received from the physician which reported that the physician did not have all of the details other than the patient developed shingles and had previously received the vaccine. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a male concerning his 79 year old wife with osteoporosis and allergies (unspecified) and a history of transient ischemic attack ministroke who in August 2007, was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included PLAVIX and alendronate sodium. Subsequently, just the other day, the patient developed a rash or hives. It began on one side and spread to the other side. It appeared and disappeared, from one side to the other, then spread to the belly, then the small part of her back, under her breast, and now it was under her armpits. The doctor gave the patient steroids and ointment (unspecified), but she still has the rash or hives. The reporter stated that the patient's allergies have nothing related to this occurrence. The caller didn't think it was Shingles but he was unsure what it was. At the time of the report, the patient's rash or hives persisted. The patient sought medical attention with a physician office visit. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a 74 year old female with high cholesterol, allergic  to sulfur medication, penicillin and erythromycin who on 04-JUL-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included SYNTHROID, DETROL LA, NEURONTIN, PLAVIX, baby aspirin, simvastatin (manufacturer unknown), metoprolol, calcium (unspecified) and vitamins (unspecified). Two days after getting the vaccine, on 06-JUL-2008, the patient developed redness, soreness and warmth (the size of a coffee cup) at the injection site. As of the day of reporting, the patient was recovering. The patient sought unspecified medical attention. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 67 year old female who on 19-SEP-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#: 658085/0882U) subcutaneously. Subsequently the patient developed Shingles. The shingles are located on her upper arm, shoulder and her breast. The lesions were draining "last week" (beginning of July, 2008) and were starting to scab. On 03-JUL-2008, the patient was placed on antivirals. The patient sought unspecified medical attention and was seen by a dermatologist. A sample of the herpes zoster was not obtained since there was "nothing to send". The patient's final outcome was not known. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Nail discolouration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 69 year old male with no pertinent medical history and no history of drug reactions or allergies who on 31-JAN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). There was no concomitant medication. Three weeks after vaccination (on approximately 21-FEB-2008) the patient developed purple toenails. His wife told the nurse that it looked like he was hit on the toes with a hammer. The patient's purple toenails persisted. The patient did not seek medical attention and has not been seen by the doctor. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse concerning a 69 year old male with hypothyroidism and no known allergies who on 31-JAN-2008 was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) (lot#: 658838/1412U) SQ into the right upper arm. The patient had herpes simplex at the time of the vaccination. The patient stated he had not any fever blister since. There was no concomitant medication. Three weeks after vaccination (on approximately 21-FEB-2008) the patient developed purple toenails, 2 on one foot, and 3 on the other foot. His wife told the nurse that it looked like he was hit on the toes with a hammer. Subsequently, the patient recovered. The toenails grew out in 2 months. The patient did not seek medical attention and has not been seen by the doctor. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a 63 year old female patient concerning her grandson, who on 13-JUN-2008 was exposed to his grandmother who was vaccinated with ZOSTAVAX on 06-JUN-2008. On 23-JUN-2008, he developed atypical chicken pox. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature normal, Burning sensation, Dehydration, Fatigue, Feeling cold
Clinical narrative: Information has been received from an over 60 year old female, a practice manager at a physician's office, who "within the last 2 months" (in approximately May 2008), was vaccinated with ZOSTAVAX (Oka/Merck). Four days after vaccination, the patient developed a varicella like rash on her arms and legs. The varicella like rash lasted for 14 days. On 03-JUL-2008 the patient woke up in the middle of the night and had a tingling sensation and parts of her skin were painful to touch. The patient felt like she was experiencing a muscle ache that you would get with the flu. She vomited 3 times over the course of 4 hours and she had a low grade fever of 100F. The following day she was fine except for feeling dehydrated and tired. She had 2 glasses of water. The patient said she had "symptoms similar to food poisoning". The patient was seen by the physician where she works but not the physician who gave the vaccine. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the 65 year old patient with hypothyroidism who on 06-JUN-2008 at 11:40 am was vaccinated subcutaneously with her first dose of ZOSTAVAX (Oka/Merck) (lot #659410/0412X) in her arm. On 09-JUN-2008 the patient developed Poxs on extremities which lasted approximately 3 weeks. No relevant laboratory or diagnostic tests were performed. Subsequently, the patient recovered. On 03-JUL-2008 at approximately 2 am, the patient awoke with a freezing cold sensation with pains in her arms and legs. On touch, her skin hurt. It felt like it was burned. This persisted for approximately 3 hours. Suddenly the patient had a spasm or twitching in her spine at the waist area. This lasted for approximately 30 minutes. The patient's next realization was that it was morning and got out of bed. The feeling of the skin had disappeared and she had no pain in the spine or any of her extremities. The only symptoms she had was an elevated temperature of 102 which responded to TYLENOL and an overall feeling of being tired. Later in the day the patient felt totally normal and her energy level returned. The patient did not report this to her physician as all symptoms disappeared. The patient had never experienced anything even remotely similar to these symptoms and had been exercising daily for many months with no side effects. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Muscle twitching, Myalgia, Pain in extremity, Pain of skin
Clinical narrative: Information has been received from an over 60 year old female, a practice manager at a physician's office, who "within the last 2 months" (in approximately May 2008), was vaccinated with ZOSTAVAX (Oka/Merck). Four days after vaccination, the patient developed a varicella like rash on her arms and legs. The varicella like rash lasted for 14 days. On 03-JUL-2008 the patient woke up in the middle of the night and had a tingling sensation and parts of her skin were painful to touch. The patient felt like she was experiencing a muscle ache that you would get with the flu. She vomited 3 times over the course of 4 hours and she had a low grade fever of 100F. The following day she was fine except for feeling dehydrated and tired. She had 2 glasses of water. The patient said she had "symptoms similar to food poisoning". The patient was seen by the physician where she works but not the physician who gave the vaccine. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the 65 year old patient with hypothyroidism who on 06-JUN-2008 at 11:40 am was vaccinated subcutaneously with her first dose of ZOSTAVAX (Oka/Merck) (lot #659410/0412X) in her arm. On 09-JUN-2008 the patient developed Poxs on extremities which lasted approximately 3 weeks. No relevant laboratory or diagnostic tests were performed. Subsequently, the patient recovered. On 03-JUL-2008 at approximately 2 am, the patient awoke with a freezing cold sensation with pains in her arms and legs. On touch, her skin hurt. It felt like it was burned. This persisted for approximately 3 hours. Suddenly the patient had a spasm or twitching in her spine at the waist area. This lasted for approximately 30 minutes. The patient's next realization was that it was morning and got out of bed. The feeling of the skin had disappeared and she had no pain in the spine or any of her extremities. The only symptoms she had was an elevated temperature of 102 which responded to TYLENOL and an overall feeling of being tired. Later in the day the patient felt totally normal and her energy level returned. The patient did not report this to her physician as all symptoms disappeared. The patient had never experienced anything even remotely similar to these symptoms and had been exercising daily for many months with no side effects. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia, Rash vesicular, Vomiting
Clinical narrative: Information has been received from an over 60 year old female, a practice manager at a physician's office, who "within the last 2 months" (in approximately May 2008), was vaccinated with ZOSTAVAX (Oka/Merck). Four days after vaccination, the patient developed a varicella like rash on her arms and legs. The varicella like rash lasted for 14 days. On 03-JUL-2008 the patient woke up in the middle of the night and had a tingling sensation and parts of her skin were painful to touch. The patient felt like she was experiencing a muscle ache that you would get with the flu. She vomited 3 times over the course of 4 hours and she had a low grade fever of 100F. The following day she was fine except for feeling dehydrated and tired. She had 2 glasses of water. The patient said she had "symptoms similar to food poisoning". The patient was seen by the physician where she works but not the physician who gave the vaccine. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Follow up information was received from the 65 year old patient with hypothyroidism who on 06-JUN-2008 at 11:40 am was vaccinated subcutaneously with her first dose of ZOSTAVAX (Oka/Merck) (lot #659410/0412X) in her arm. On 09-JUN-2008 the patient developed Poxs on extremities which lasted approximately 3 weeks. No relevant laboratory or diagnostic tests were performed. Subsequently, the patient recovered. On 03-JUL-2008 at approximately 2 am, the patient awoke with a freezing cold sensation with pains in her arms and legs. On touch, her skin hurt. It felt like it was burned. This persisted for approximately 3 hours. Suddenly the patient had a spasm or twitching in her spine at the waist area. This lasted for approximately 30 minutes. The patient's next realization was that it was morning and got out of bed. The feeling of the skin had disappeared and she had no pain in the spine or any of her extremities. The only symptoms she had was an elevated temperature of 102 which responded to TYLENOL and an overall feeling of being tired. Later in the day the patient felt totally normal and her energy level returned. The patient did not report this to her physician as all symptoms disappeared. The patient had never experienced anything even remotely similar to these symptoms and had been exercising daily for many months with no side effects. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an over 60 year old male who "a couple of months ago" (in approximately May 2008), was vaccinated with the first dose of ZOSTAVAX subcutaneously. Subsequently, in approximately May 2008, the patient developed shingles. The shingles cleared on its own, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 63 female who on 27-DEC-2007 was vaccinated with a single dose of ZOSTAVAX (lot#: 656609/0015U). On 10-JAN-2008, the patient developed a mild case of shingles. There were blisters underneath one breast. The outcome of the shingles was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Secondary transmission
Clinical narrative: Information has been received from a physician concerning a female who was exposed to her mother who on 07-MAY-2008 was vaccinated with a dose of ZOSTAVAX. On 31-MAY-2008, the patient developed a disseminated vesicular rash. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Initial and follow-up information has been received regarding a case in litigation from a 78 year old male with osteoporosis and no allergies who on 08-JUL-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included alendronate sodium (MSD). On approximately 11-JUL-2008, also reported as three or four days after receiving the vaccine, the patient developed fever, headache, dizziness, nausea, pain in the ankles and blood spots on his left arm. The patient's events persisted. The patient did not seek any medical attention. Follow-up information was received from the patient which reported that he continued to have headaches and he developed blood spots on his left arm. The patient did not seek any medical attention. Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin haemorrhage
Clinical narrative: Initial and follow-up information has been received regarding a case in litigation from a 78 year old male with osteoporosis and no allergies who on 08-JUL-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX by subcutaneous injection (lot number and injection site not reported). Concomitant therapy included alendronate sodium (MSD). On approximately 11-JUL-2008, also reported as three or four days after receiving the vaccine, the patient developed fever, headache, dizziness, nausea, pain in the ankles and blood spots on his left arm. The patient's events persisted. The patient did not seek any medical attention. Follow-up information was received from the patient which reported that he continued to have headaches and he developed blood spots on his left arm. The patient did not seek any medical attention. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a 52 year old female registered nurse with a history of shingles in April 2006 and family history of bells palsy concerning herself, who on 08-JUL-2008 was vaccinated with a dose of ZOSTAVAX (lot no. 659409/0409X). Concomitant therapy included atenolol. On 09-JUL-2008, "the next day", the nurse began experiencing a red, itchy rash. The nurse was not sure if it was a shingles rash. At the time of this report, the nurse's red rash and itchy rash persisted. She did not seek medical attention. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 61 year old female with a history of chickenpox as a child who on 31-JUL-2007 was vaccinated with a single 0.65 ml dose of ZOSTAVAX (lot no. 658086/0761U) into the right arm. Concomitant therapy included METFORM, lorazepam, LIPITOR and lisinopril (manufacturer unknown). On 07-JUL-2008, the patient developed "shingles with pain." It was reported in follow-up that the patient had classic erythematous, vesicular rash in the right trunk around the right side the right breast (Dermatome: right thorax). The number was too numerous to count. The outcome was unknown. The patient sought unspecified medical attention. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female with allergy to QUINOLONE and no pertinent medical history who on 07-JUL-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (lot no. 659404/1826U at the pharmacy in her right arm. On 09-JUL-2008 the patient called the pharmacy stating she had local redness with itching at the injection site. On 10-JUL-2008 the patient was seen in the pharmacy and the area was three inches in diameter with itching. At the time of this report, the patient's symptoms persisted. The patient sought unspecified medical attention in the pharmacy. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008.  Initial and follow-up information has been received from a pharmacist concerning a 77 year old female with drug reaction to LEVAQUIN and clonidine who on 07-JUL-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot no. 659404/18260) in her right arm at the pharmacy.  On 09-JUL-2008 the patient called the pharmacy stating she had local redness with itching at the injection site.  On 10-JUL-2008 the patient was seen in the pharmacy and the area was three inches in diameter with itching.  It was reported in follow up that the patient contacted the pharmacy a few days after vaccination and called the physician.  Both of them told her it would go away.  The pharmacist reported that on 04-SEP-2008 the patient stated that the redness traveled to elbow and around circumference of arm and lasted about 3 weeks.  The patient was fully recovered.  Additional information is not expected.