chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate normal, Oedema peripheral, Pain in extremity, Palpitations, Pruritus
Clinical narrative: Information has been received from a physician concerning a 60 year old female with depression, benign tumor, osteoporosis, hyperlipidemia and adverse drug reactions to allergies to AMBIEN, VICODIN, PROZAC and sulfonamide who on 08-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant drug therapy included LIPITOR, BONIVA, aspirin 81 mg and fluoxetine HCl.  On 08-JAN-2008 the patient "felt out of it, dumb, absent, sedated and fatigue."  She felt better the next day.  On 10-JAN-2008, the patient "felt weird."  The patient's arm was swollen and sore."  The affected area was about the size of a silver dollar, and was raised and bruised.  The patient also experienced itching, anxiety and as if her heart was racing.  The patient was seen in the physician's office for medical attention.  Lab diagnostic studies performed included an EKG and a heart rate of 73.  The patient was treated with BENADRYL for the itching but she only took one dose.  The patient's symptoms have not resolved at the time of this report.  There was no product quality complaint.  Follow-up information received from the reporting physician indicated that the patient had a history of adverse drug reactions to AMBIEN (paradoxical reaction), PROZAC ("shaky") and hypersensitivity to sulfonamide (hives) who on 08-JAN-2008 at 10:50 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658324/1821U) in the lateralis area.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Sedation, Swelling
Clinical narrative: Information has been received from a physician concerning a 60 year old female with depression, benign tumor, osteoporosis, hyperlipidemia and adverse drug reactions to allergies to AMBIEN, VICODIN, PROZAC and sulfonamide who on 08-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant drug therapy included LIPITOR, BONIVA, aspirin 81 mg and fluoxetine HCl.  On 08-JAN-2008 the patient "felt out of it, dumb, absent, sedated and fatigue."  She felt better the next day.  On 10-JAN-2008, the patient "felt weird."  The patient's arm was swollen and sore."  The affected area was about the size of a silver dollar, and was raised and bruised.  The patient also experienced itching, anxiety and as if her heart was racing.  The patient was seen in the physician's office for medical attention.  Lab diagnostic studies performed included an EKG and a heart rate of 73.  The patient was treated with BENADRYL for the itching but she only took one dose.  The patient's symptoms have not resolved at the time of this report.  There was no product quality complaint.  Follow-up information received from the reporting physician indicated that the patient had a history of adverse drug reactions to AMBIEN (paradoxical reaction), PROZAC ("shaky") and hypersensitivity to sulfonamide (hives) who on 08-JAN-2008 at 10:50 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658324/1821U) in the lateralis area.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: Information has been received from a nurse concerning a 72 year old female who on 14-AUG-2007 was vaccinated with a single dose of ZOSTAVAX. Later that same day the patient experienced a fever and felt tired for a couple of days.  The patient did not contact the office about the events until her next doctor's appointment. The patient reported the she "felt better a few days later" There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 64 year old male patient with hyperlipidaemia, hypertension, asthma, eczema and coronary artery disease who on 10-DEC-2007 was vaccinated with a dose of ZOSTAVAX (dose and frequency unknown). On 14-DEC-2007, the patient experienced a shingles like rash on the upper right hand quadrant of his torso and was seen by his physician. The patient's outcome was unknown. There was no quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning a female in her 60's who in December 2007, was vaccinated with Zostavax (Oka/Merck) 0.65 mL.  Three days later, the patient developed shingles.  The patient sought unspecified medical attention.  The patient's shingles persisted.  There was no product quality complaint.  No further information is available.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an 87 year old female who on 07-DEC-2007 was vaccinated with ZOSTAVAX. On 18-DEC-2007 the patient developed shingles. The patient's shingles persisted. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Lacrimation increased, Lip swelling, Oral pain, Rash pustular
Clinical narrative: Information has been received from a registered nurse concerning a 67-year-old female with hypothyroidism and an allergy to penicillin allergy and DEMEROL who on 10-DEC-2007 was vaccinated subcutaneous with a dose of Zostavax (Oka/Merck) (lot # 658212/0887U).  Concomitant therapy included SYNTHROID.  On 16-DEC-2007 the patient developed a right upper lip pustule with swelling.  The patient also developed soreness of the right upper cheek and the roof of her mouth.  A pustule developed near her right eye.  The patient was examined in the office on 17-DEC-2007 and a culture of a pustule was taken.  The culture results were negative for virus.  On 21-DEC-2007, the patient was examined in the office again.  The exam revealed tearing of the right eye.  The patient was started on VALTREX and referred to an ophthalmologist for consultation.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Virus culture negative
Clinical narrative: Information has been received from a registered nurse concerning a 67-year-old female with hypothyroidism and an allergy to penicillin allergy and DEMEROL who on 10-DEC-2007 was vaccinated subcutaneous with a dose of Zostavax (Oka/Merck) (lot # 658212/0887U).  Concomitant therapy included SYNTHROID.  On 16-DEC-2007 the patient developed a right upper lip pustule with swelling.  The patient also developed soreness of the right upper cheek and the roof of her mouth.  A pustule developed near her right eye.  The patient was examined in the office on 17-DEC-2007 and a culture of a pustule was taken.  The culture results were negative for virus.  On 21-DEC-2007, the patient was examined in the office again.  The exam revealed tearing of the right eye.  The patient was started on VALTREX and referred to an ophthalmologist for consultation.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a health professional concerning a 76 year old female who on 14-DEC-2007 was vaccinated with Zostavax (Oka/Merck) (Lot # 658863/1414U), and subsequently developed localized rash. No treatment was required. There was no concomitant medication. At the time of reporting the patient was recovered. It was noted by the reporter that on 20 DEC 2007 "the patient was seen again today". This is one of several reports received from the same source. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 84-year-old female who on 17-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 19-DEC-2007 (1-2 days post vaccination) the patient developed a shingles-like rash.  At the time of the report the patient's status was unknown.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning an 84-year-old female (60 in) who on 18-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 658395/0966U). The patient indicated that there was one previously dose. On 19-DEC-2007 (1-2 days post vaccination) the patient developed a skin rash on back, torso and neck (formerly reported as shingles-like rash). The patient sought unspecified medical attention. The physician consulted with a dermatologist. The patient recovered as of 19-JAN-2008. Additional information is not expected.
Age: 2.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 2 year old male who on 22-DEC-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658086/0761U) instead of Varivax (Oka/Merck). The nurse stated this was an administration error; there was no product confusion. Subsequently the patient experienced no problems. The reporter felt that child having received Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) with no problems reported was not related to therapy with Zostavax (Oka/Merck). There was no product quality complaint. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old male who on 27-NOV-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658839/1411U) 0.65 mL SC in the left arm.  There was no concomitant medication.  On approximately 11-DEC-2007 the patient developed a raised, itchy, red rash on his left arm, which covered the entire upper arm from the shoulder to the elbow.  The patient's raised, itchy red rash persisted.  The patient sought medical attention.  Additional information has been requested.  Follow-up information has been received from the responsible physician concerning a 72 year old male with arteriosclerotic heart disease, benign prostatic hypertrophy and glaucoma who on 27-NOV-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658839/1411U) 0.65 mL SC in the left arm.  Concomitant therapy included INFLUENZA VIRUS VACCINE USP administered the "prior month."  In December 2007, one week after the vaccination, the patient developed a sore, swollen and red left arm at site of the injection.  Then (date not provided) the patient developed a papular rash on the left and right biceps and thighs.  The patient sought medical attention.  There was no product quality complaint.  Outcome of the sore, swollen, red left arm was not provided; however, the papular rash persists and "is now slowly clearing."  Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old male who on 27-NOV-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658839/1411U) 0.65 mL SC in the left arm.  There was no concomitant medication.  On approximately 11-DEC-2007 the patient developed a raised, itchy, red rash on his left arm, which covered the entire upper arm from the shoulder to the elbow.  The patient's raised, itchy red rash persisted.  The patient sought medical attention.  Additional information has been requested.  Follow-up information has been received from the responsible physician concerning a 72 year old male with arteriosclerotic heart disease, benign prostatic hypertrophy and glaucoma who on 27-NOV-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658839/1411U) 0.65 mL SC in the left arm.  Concomitant therapy included INFLUENZA VIRUS VACCINE USP administered the "prior month."  In December 2007, one week after the vaccination, the patient developed a sore, swollen and red left arm at site of the injection.  Then (date not provided) the patient developed a papular rash on the left and right biceps and thighs.  The patient sought medical attention.  There was no product quality complaint.  Outcome of the sore, swollen, red left arm was not provided; however, the papular rash persists and "is now slowly clearing."  Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 65 year old female with hypertension who on approximately 14-NOV-2007 six weeks ago was vaccinated with a dose of ZOSTAVAX. Concomitant drug therapy included ZYRTEC, BENICAR and PROZAC. On approximately 26-DEC-2007 the patient developed a rash across both sides of her left arm. The rash had no blisters and no pain, but was itchy. It was unknown whether medical attention was sought. The outcome was unknown. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Hypersensitivity, Pruritus generalised, Skin lesion
Clinical narrative: Information has been received from a consumer concerning a 61 year old male patient (250 pounds, 72 inches) with diabetes, high blood pressure, high cholesterol, psoriasis and no drug allergies, who on 15-OCT-2007 was vaccinated with Zostavax (Oka/Merck) "single dose series." Concomitant therapy included influenza virus vaccine (unspecified), GLUCOPHAGE, BYETTA and unspecified medications for high cholesterol and high blood pressure. The reporter, who is the patient's wife, stated that five days after receiving the vaccination (20-OCt-2007) the patient started to itch all over his body from head to toe. The patient sought medical attention at the physician's office. According to the wife, the physician said the patient had an allergic reaction and gave him ZYRTEC. The wife also reported that "a couple of weeks later, the patient started to get sores all over his body" and went to the emergency room. According to the wife, the physician stated that "it was not shingles but some type of reaction," and put the patient on prednisone (manufacturer not specified). The patient stopped taking prednisone because it made him vomit. The patient's itching, sores and allergic reaction persisted. No diagnostic lab studies were performed. Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Information from medical records indicated that on 28-DEC-2007 the patient was diagnosed with subacute spongiotic dermatitis with eosinophilic spongiosis of the left abdomen. On 21-JAN-2008 the patient presented for re-evaluation of his rash. Three weeks prior a biopsy demonstrated eosinophilic spongiosis. Differential diagnosis clinically and histopathologically was allergic contact dermatitis versus drug eruptions versus urticarial bullous pemphigoid. Since his last appointment the patient used triamcinolone wet dressing to the affected areas and did well. He had almost complete resolution of the rash when he applied them, but if he stopped using them the rash recurred. He was tolerating the doxepin well. Current medications included amlodipine, atenolol, ATACAND, furosemide, lovastatin (manufacturer unknown), metformin, aspirin and recently BYETTA, all of which he had been on for several years, the most recent addition was lovastatin. He had no allergies. The physician's impression and plan was to continue triamcinolone and wet dressings and decreased the frequency. He was instructed to contact the physician of there was an exacerbation or flare when trying to titrate down. Doxepin was continued for symptomatic relief. To rule out urticarial bullous pemphigoid, a biopsy was performed on the perilesional area on the right flank. Bullous pemphigoid was ruled out. The impression of the biopsy was a negative study. Additional infromation is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Culture stool, Diarrhoea, Full blood count, Pain
Clinical narrative: Information has been received from a 73 year old female patient with hypertension and no allergies who on 24-DEC-2007 was vaccinated with Zostavax (Oka/Merck) 0.65 mL (single dose series).  Concomitant therapy included ZETIA, MIRAPEX, nortriptyline, sulindac, NORVASC and vitamins (unspecified).  On 25-DEC-2007 the patient became drowsy and experienced diarrhea.  The patient sought medical attention via telephone.  Subsequently, the patient recovered from the drowsiness and diarrhea.  There was no product quality complaint. Followup information has been received the physician concerning the patient with hypertension and neuropathy peripheral, vitamin b12 deficiency and gastric ulcer and with no illness at time of vaccination who on 24-DEC-2007 (also reported as "24-DEC-2008) was vaccinated with a first dose of ZOSTAVAX (lot # 658306/0967U). The CBC (complete blood cell count). Stool culture were performed but the results was not reported. on 25-DEC-2007 the patient experienced body aches, diarrhea, chilling without rigorn and no fever, abdominal pain, emesis or rash. The on 03-JAN-2008 the patient recovered.No further information was available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: Information has been received from a 73 year old female patient with hypertension and no allergies who on 24-DEC-2007 was vaccinated with Zostavax (Oka/Merck) 0.65 mL (single dose series).  Concomitant therapy included ZETIA, MIRAPEX, nortriptyline, sulindac, NORVASC and vitamins (unspecified).  On 25-DEC-2007 the patient became drowsy and experienced diarrhea.  The patient sought medical attention via telephone.  Subsequently, the patient recovered from the drowsiness and diarrhea.  There was no product quality complaint. Followup information has been received the physician concerning the patient with hypertension and neuropathy peripheral, vitamin b12 deficiency and gastric ulcer and with no illness at time of vaccination who on 24-DEC-2007 (also reported as "24-DEC-2008) was vaccinated with a first dose of ZOSTAVAX (lot # 658306/0967U). The CBC (complete blood cell count). Stool culture were performed but the results was not reported. on 25-DEC-2007 the patient experienced body aches, diarrhea, chilling without rigorn and no fever, abdominal pain, emesis or rash. The on 03-JAN-2008 the patient recovered.No further information was available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 70 year old male with a history of psoriasis who on 26-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On 27-DEC-2007 the patient went into the office and was diagnosed with abdominal zoster. No further adverse event information. Unspecified medical attention was sought through the physician. There was no product quality complaint. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Rash
Clinical narrative: Initial and follow-up information has been received from a licensed practical nurse and physician concerning an 84 year old male with hypercholesterolaemia and penicillin allergy who on 02-NOV-2007 was vaccinated SC with a single dose of ZOSTAVAX. Concomitant drug therapy included simvastatin tablets. On 21-DEC-2007 the patient developed a red, raised rash on his right cheek of face as confirmed by nurse. On 28-DEC-2007 the physician examined the patient and diagnosed possible herpes zoster. No labs or diagnostic studies were performed. Details of the treatment plan were unknown. The patient was not recovered at the time of this report. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning a female friend who was vaccinated with a dose of Zostavax (Oka/Merck). On an unspecified date the patient had injection site redness, swelling and pain. At the time of the report the patient's status was unknown. It was noted the patient's friend had a similar reaction to Zostavax (Oka/Merck) (WAES # 0712USA01226). This is one of two reports received from the same source. No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Asthenia, Full blood count normal, Metabolic function test normal, Muscle spasms, Nervousness
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning an 83-year-old female with penicillin and aspirin allergy who on 08-JUN-2007 was subcutaneously vaccinated into left arm with the first  dose of Zostavax (Oka/Merck) (Lot number 656395/0290U). There was no illness at the time of the vaccination. Concomitant medication included BONIVA, NEXIUM and ATIVAN. On 13-JUN-2007 the patient experienced diffuse pain and weakness throughout her body. The patient was seen by her physician. The Complete Blood Cell count (CBC), Comprehensive Metabolic Profile (CMP) and thyroid function test were performed and the results were normal. The patient felt that her body aches were much worse since the vaccination. She first thought that it was due to the therapy with BONIVA. The patient stopped the therapy with BONIVA. The pain was the same. At the time of the report, the patient's events persisted. Follow-up information was received on 13-AUG-2008 the patient was still hurting all over. She had burning pain and drawing, cramping of hand, leg and toes. The patient felt the skin blotched all over the body. She was weak and nervous too. The patient thought that the shot had messed up her immune system. No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Pain, Pain, Rash macular, Thyroid function test normal
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning an 83-year-old female with penicillin and aspirin allergy who on 08-JUN-2007 was subcutaneously vaccinated into left arm with the first  dose of Zostavax (Oka/Merck) (Lot number 656395/0290U). There was no illness at the time of the vaccination. Concomitant medication included BONIVA, NEXIUM and ATIVAN. On 13-JUN-2007 the patient experienced diffuse pain and weakness throughout her body. The patient was seen by her physician. The Complete Blood Cell count (CBC), Comprehensive Metabolic Profile (CMP) and thyroid function test were performed and the results were normal. The patient felt that her body aches were much worse since the vaccination. She first thought that it was due to the therapy with BONIVA. The patient stopped the therapy with BONIVA. The pain was the same. At the time of the report, the patient's events persisted. Follow-up information was received on 13-AUG-2008 the patient was still hurting all over. She had burning pain and drawing, cramping of hand, leg and toes. The patient felt the skin blotched all over the body. She was weak and nervous too. The patient thought that the shot had messed up her immune system. No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARCEL
Symptoms: Adverse event
Clinical narrative: This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning an 83-year-old female with penicillin and aspirin allergy who on 08-JUN-2007 was subcutaneously vaccinated into left arm with the first  dose of Zostavax (Oka/Merck) (Lot number 656395/0290U). There was no illness at the time of the vaccination. Concomitant medication included BONIVA, NEXIUM and ATIVAN. On 13-JUN-2007 the patient experienced diffuse pain and weakness throughout her body. The patient was seen by her physician. The Complete Blood Cell count (CBC), Comprehensive Metabolic Profile (CMP) and thyroid function test were performed and the results were normal. The patient felt that her body aches were much worse since the vaccination. She first thought that it was due to the therapy with BONIVA. The patient stopped the therapy with BONIVA. The pain was the same. At the time of the report, the patient's events persisted. Follow-up information was received on 13-AUG-2008 the patient was still hurting all over. She had burning pain and drawing, cramping of hand, leg and toes. The patient felt the skin blotched all over the body. She was weak and nervous too. The patient thought that the shot had messed up her immune system. No further information is available.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site swelling
Clinical narrative: Information has been received from a 51-year-old female consumer with attention deficit disorder and a "drug reaction to almost every vaccination" who on 07-DEC-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included RITALIN. The patient experienced swelling at the injection site right after receiving the vaccination. Unspecified medical attention was sought. There were no laboratory or diagnostic studies performed. The patient reported that the swelling was gone within a week. No product quality complaint was involved. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a health professional concerning a 77-year-old male with a history of atrial fibrillation and chronic lymphocytic leukaemia who on 06-DEC-2007 was vaccinated subcutaneously with a 0.65 ml dose of Zostavax (Oka/Merck). No list of medications or allergies were available. On approximately 13-DEC-2007 the patient developed a large area of redness and swelling at the injection site. The patient was seen in the office on 13-DEC-2007, no treatment was required and no lab or diagnostic studies were required. Subsequently, the patient recovered from the redness and swelling at the injection site. No product quality complaint was involved. Additional information has been received. The patient received an injection of Zostavax (Oka/Merck) and approximately 24 hours later (on approximately 07-DEC-2007) he noticed a redness, tenderness and swelling at the injection site that peaked in 2 days and gradually subsided over a 3 week period of time. The patient was reported recovered as of the end of December 2007. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 75 year old male with no pertinent medical history, drug reactions or allergies who on 12-NOV-2007, at 12:15, was vaccinated subcutaneously into the left arm with a first dose of Zostavax (Oka/Merck) (Lot #658398/1087U).  There was no concomitant medication.  On 15-DEC-2007 the patient "may have developed shingles".  He started with one spot, then a rash around the spot.  The patient experienced pain when laying down at night.  The pain radiated around to the abdominal side.  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient had not yet recovered.  Follow up information was received from a nurse who reports that a 75 year old male verbalized that on 15 DEC 2007 "he started to get a rash, which was painful at times and took ADVIL.  The rash started at the tailbone area and radiated to the lower right quadrant of HBD and hip".  The final outcome was not reported at this time.  Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Information has been received from a consumer concerning her husband, a 76 year old male with no pertinent medical history, drug reaction or allergies who "about three months ago" approximately NOV 2007 was vaccinated with Zostavax (Oka/Merck). There was no concomitant medication. In approximately 2007, "shortly after receiving the vaccine", the patient developed a rash on his face; and blister like lesions on his neck and back. At the time of reporting the patient had not yet recovered from the rash on his face and the blister like lesions on his neck and back. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 64 year old female with no pre-existing allergies or medical conditions who on 02-OCT-2007 in the A.M., received a single dose series subcutaneous in the right arm of Zostavax (Oka/Merck) (lot#658082/1744U). There was no reported illness at the time of vaccination, and no adverse events following prior vaccination. On 03-OCT-2007, the patient developed reddness, swollen, hot, and itchiness at the injection site. The patient sought medical attention by a physician. No lab or diagnostics studies were performed. On an unspecified date the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from an office manager concerning a 65-year-old female with allergic reaction to tetracycline, codeine, morphine, naprosyn and fentanyl, who on 02-MAY-2007 was vaccinated subcutaneously with a "single dose vial" of ZOSTAVAX (lot # 656395/0290U). Concomitant therapy included CRESTOR, estrogens (unspecified) and "lipid medication" (therapy unspecified). On an unspecified date the patient developed "shingles pain" at her abdomen. The patient sought medical attention via an office visit with a physician. No diagnostic labs were performed. At the time of the report the patient's status was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abasia, Blood test, Borrelia burgdorferi serology negative, Bronchitis, Burning sensation
Clinical narrative: Information has been received from a 68-year-old female with a sulfonamide allergy and no pertinent medical history, who in October 2007 ("towards the end of October"), was vaccinated subcutaneous once with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included HCTZ and DILTIAZEM XR. In October 2007 ("towards the end of October"), the patient stated "she is still sore at the injection site". The patient also stated that she developed bronchitis "shortly after receiving the shot". She has also developed muscle pain, "can't event walk", and "can't even bend my fingers". She also has pain in her feet and "even my fingernails hurt". The patient did not seek medical attention. No diagnostic labs were performed. The patient started taking LYRICA 6 days ago and it "seems to help the pain". At the time of the report the patient's status was recovering. A product quality complaint was not involved. Follow-up information received 04-FEB-2008 via a phone call with a physician. The physician reported that the patient did not call the office to report these adverse events. He stated he would follow-up with the patient on the reported adverse events. Follow-up received 25-FEB-2008 from the consumer: The patient stated "I have been feeling like I have pins and needles in my hands and feet". "I Have a hard time getting up and walking after sitting, and I Have had two major falls where I had to go to get x-rays. I have gained 13 pounds". She also stated that her physician did "bloodwork" but she "didn't know what he was looking for". Her physician referred her to a neurologist because of "severe pain" who performed an MRI and checked her for lupus, lyme disease, and B-12 deficiencies. All the tests came back negative. The patient is currently taking CELEBREX and NAPROXEN and switched from LYRICA to GABARONE. The patient also stated  about two weeks post vaccination, her finger nails got paper thin and started "feeling". Her hands and feet got numb and her tongue is numb too. She said it "feels like the end of my tongue is burned". The patient was also vaccinated with influenza virus vaccine (unspecified) the same day she received ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Dysstasia, Fall, Gait disturbance, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Information has been received from a 68-year-old female with a sulfonamide allergy and no pertinent medical history, who in October 2007 ("towards the end of October"), was vaccinated subcutaneous once with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included HCTZ and DILTIAZEM XR. In October 2007 ("towards the end of October"), the patient stated "she is still sore at the injection site". The patient also stated that she developed bronchitis "shortly after receiving the shot". She has also developed muscle pain, "can't event walk", and "can't even bend my fingers". She also has pain in her feet and "even my fingernails hurt". The patient did not seek medical attention. No diagnostic labs were performed. The patient started taking LYRICA 6 days ago and it "seems to help the pain". At the time of the report the patient's status was recovering. A product quality complaint was not involved. Follow-up information received 04-FEB-2008 via a phone call with a physician. The physician reported that the patient did not call the office to report these adverse events. He stated he would follow-up with the patient on the reported adverse events. Follow-up received 25-FEB-2008 from the consumer: The patient stated "I have been feeling like I have pins and needles in my hands and feet". "I Have a hard time getting up and walking after sitting, and I Have had two major falls where I had to go to get x-rays. I have gained 13 pounds". She also stated that her physician did "bloodwork" but she "didn't know what he was looking for". Her physician referred her to a neurologist because of "severe pain" who performed an MRI and checked her for lupus, lyme disease, and B-12 deficiencies. All the tests came back negative. The patient is currently taking CELEBREX and NAPROXEN and switched from LYRICA to GABARONE. The patient also stated  about two weeks post vaccination, her finger nails got paper thin and started "feeling". Her hands and feet got numb and her tongue is numb too. She said it "feels like the end of my tongue is burned". The patient was also vaccinated with influenza virus vaccine (unspecified) the same day she received ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Myalgia, Nuclear magnetic resonance imaging, Pain in extremity, Paraesthesia
Clinical narrative: Information has been received from a 68-year-old female with a sulfonamide allergy and no pertinent medical history, who in October 2007 ("towards the end of October"), was vaccinated subcutaneous once with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included HCTZ and DILTIAZEM XR. In October 2007 ("towards the end of October"), the patient stated "she is still sore at the injection site". The patient also stated that she developed bronchitis "shortly after receiving the shot". She has also developed muscle pain, "can't event walk", and "can't even bend my fingers". She also has pain in her feet and "even my fingernails hurt". The patient did not seek medical attention. No diagnostic labs were performed. The patient started taking LYRICA 6 days ago and it "seems to help the pain". At the time of the report the patient's status was recovering. A product quality complaint was not involved. Follow-up information received 04-FEB-2008 via a phone call with a physician. The physician reported that the patient did not call the office to report these adverse events. He stated he would follow-up with the patient on the reported adverse events. Follow-up received 25-FEB-2008 from the consumer: The patient stated "I have been feeling like I have pins and needles in my hands and feet". "I Have a hard time getting up and walking after sitting, and I Have had two major falls where I had to go to get x-rays. I have gained 13 pounds". She also stated that her physician did "bloodwork" but she "didn't know what he was looking for". Her physician referred her to a neurologist because of "severe pain" who performed an MRI and checked her for lupus, lyme disease, and B-12 deficiencies. All the tests came back negative. The patient is currently taking CELEBREX and NAPROXEN and switched from LYRICA to GABARONE. The patient also stated  about two weeks post vaccination, her finger nails got paper thin and started "feeling". Her hands and feet got numb and her tongue is numb too. She said it "feels like the end of my tongue is burned". The patient was also vaccinated with influenza virus vaccine (unspecified) the same day she received ZOSTAVAX. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Paraesthesia oral, Vitamin B12 normal, Weight increased, X-ray
Clinical narrative: Information has been received from a 68-year-old female with a sulfonamide allergy and no pertinent medical history, who in October 2007 ("towards the end of October"), was vaccinated subcutaneous once with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included HCTZ and DILTIAZEM XR. In October 2007 ("towards the end of October"), the patient stated "she is still sore at the injection site". The patient also stated that she developed bronchitis "shortly after receiving the shot". She has also developed muscle pain, "can't event walk", and "can't even bend my fingers". She also has pain in her feet and "even my fingernails hurt". The patient did not seek medical attention. No diagnostic labs were performed. The patient started taking LYRICA 6 days ago and it "seems to help the pain". At the time of the report the patient's status was recovering. A product quality complaint was not involved. Follow-up information received 04-FEB-2008 via a phone call with a physician. The physician reported that the patient did not call the office to report these adverse events. He stated he would follow-up with the patient on the reported adverse events. Follow-up received 25-FEB-2008 from the consumer: The patient stated "I have been feeling like I have pins and needles in my hands and feet". "I Have a hard time getting up and walking after sitting, and I Have had two major falls where I had to go to get x-rays. I have gained 13 pounds". She also stated that her physician did "bloodwork" but she "didn't know what he was looking for". Her physician referred her to a neurologist because of "severe pain" who performed an MRI and checked her for lupus, lyme disease, and B-12 deficiencies. All the tests came back negative. The patient is currently taking CELEBREX and NAPROXEN and switched from LYRICA to GABARONE. The patient also stated  about two weeks post vaccination, her finger nails got paper thin and started "feeling". Her hands and feet got numb and her tongue is numb too. She said it "feels like the end of my tongue is burned". The patient was also vaccinated with influenza virus vaccine (unspecified) the same day she received ZOSTAVAX. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a 62 year old female consumer with no medical history, drug reactions or allergies who on 31-DEC-2007 was vaccinated with 0.65 ml of ZOSTAVAX. There was no concomitant medication. On 31-DEC-2007 the patient developed redness and swelling at the injection site, and ran low grade fever after receiving the vaccine. There were no lab diagnostic studies performed. The caller also reported that her mother developed a headache after receiving ZOSTAVAX on 31-DEC-2007. The reporter declined to offer any additional information. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Injection site mass
Clinical narrative: Information has been received from a 72 year old female with hypertension, a history of dry cough and codeine allergy who in approximately November 2007 "about two months ago," was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant drug therapy included atenolol and LOTREL. In approximately November 2007, the patient developed a lump at injection site that had not resolved after 2 months. The patient also mentioned that he experienced "dry, unproductive cough while taking LOTREL and that NORVASC caused the same reaction." The patient did not seek medical attention. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. Follow-up information from a physician indicated that the 72 year old female who on 01-NOV-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658395/0966U) in the left deltoid. The patient did not report any adverse event to the physician when contacted regarding this notice. The patient told the physician she had a small "lump at the injection site which resolved spontaneously. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Scar
Clinical narrative: Information has been received from an administering licensed practical nurse concerning a 61 year old retired female with a cardiac pacemaker who on the morning of 18-DEC-2007 was vaccinated SC with the first dose of Zostavax (Oka/Merck) (lot# 658867/1413U) in the left thigh.  Concomitant drug therapy included simvastatin (MSD), SYNTHROID, blood pressure pill (unspecified), vitamins (unspecified), and fish oil.  On 02-JAN-2008 at 19:00 the patient developed little tiny bumps that were reddened and looked like heat.  The patient did not seek medical attention.  No lab diagnostic studies were performed.  The patient was not recovered at the time of this report.  Follow-up information from the reporting licensed practical nurse indicated that there was no illness at the time of vaccination.  The patient's rash was "gone and never hurt and went away about a couple of days ago."  The patient noted that there were "still some signs of rash, faint spots, scar-looking things."  The patient was noted to be recovered on 10-JAN-2008.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Local reaction
Clinical narrative: Initial and follow-up information has been received from a physician and nurse concerning a patient who in November 2007, was vaccinated SC with a dose of Zostavax (Oka/Merck) (lot# 658395/0966U).  In November 2007 "within the last month," the patient developed a localized injection site reaction.  It was unknown whether medical attention was sought.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Induration, Local reaction
Clinical narrative: Information has been received from a registered nurse concerning a female with no drug reactions or allergies who on 28-DEC-2007 was vaccinated subcutaneously into the thigh with 0.65ml of Zostavax (Oka/Merck) ( Lot #656394/0162U).  Concomitant therapy included NORVASC, omeprazole, prednisone, PRINIVIL, VYTORIN, TOBRADEX, hydrochlorothiazide, nitroglycerin, xanthophyll, TOPROL XL TABLETS, acetaminophen, calcium (unspecified) and aspirin.  Post vaccination the patient developed localized redness, firmness and discomfort. At the time of reporting the patient had recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female with no pertinent medical history or drug allergies who on 04-JAN-2008 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (lot# 658839/1411U). There was no concomitant medication. On that same day the patient experienced dizziness. The patient did not seek medical attention. No labs or diagnostic studies were performed. The patient was not recovered at the time of this report. There was no product quality complaint. Follow-up information from a physician indicated that the patient was not administered Zostavax (Oka/Merck) (lot# 658839/1411U) in the office. No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Antinuclear antibody negative, Arthralgia, Body temperature increased, C-reactive protein normal, Fatigue
Clinical narrative: Information has been received from an approximately 69 year old female with high blood pressure and a history of an unspecified "reaction to the smallpox vaccine", who on approximately 19-NOV-2007, was vaccinated with 0.5 ml of Zostavax (Oka/Merck).  Concomitant therapy included two unspecified high blood pressure medications, and vitamins.  On approximately 19-NOV-2007 3 to 4 hours post vaccination with Zostavax (Oka/Merck); the patient developed an elevated temperature and headache.  A couple days later, on approximately 21-NOV-2007 the patient developed a rash on her torso and legs, along with pain in her hands and feet, and swelling in her ankles.  It was also reported that the patient developed a low grade fever which lasted about four weeks.  The patient went to the emergency room (ER), but was not admitted.  Unspecified blood work was obtained, of which the results were not reported.  At the time of reporting the patient was recovering.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information has been received from a physician concerning a 71 year old female with blood pressure high and no pre-existing allergies or drug reactions who on approximately 26-NOV-2007 was vaccinated intramuscularly with a first dose of Zostavax (Oka/Merck) (Lot # 658361/1090U).  There was no illness at the time of vaccination.  Concomitant therapy included aspirin, calcium (unspecified) (+) vitamin D (unspecified), UNIRETIC and "MUR".  On 27-NOV-2007 the patient developed a rash, fever, myalgia, fatigue and arthralgia.  The patient had also reported that she had developed a headache and temperature 3 to 4 hours after vaccination, and that a low grade temperature remained for about 4 weeks.  The patient had also reported developing swelling in her ankles, of which the outcome was not reported.  The physician reported that the patient had no prior adverse events following prior vaccinations (also reported by the patient as having had an unspecified "reaction to the smallpox vaccine").  The physician reported the patient was recovered (on approximately 18 DEC 2007), and that her rash, fever, myalgia, fatigue and arthralgia lasted for three weeks.  No further information is expected.