chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin normal, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Information has been received from a nurse practitioner concerning a 66 year old female with blood pressure high and cholesterol high who in July 2008, was vaccinated with ZOSTAVAX (Merck) (lot # not provided).  Concomitant therapy included MAXIDE, ATENOLOL (manufacturer unknown), BENICAR and other unspecified medicines.  Shortly after the vaccination, the patient broke out in a rash that covered a majority of her body.  It was not vescicular but was described as involving upper and lower layers of skin.  It was like hives/welts on the upper skin and red blotches underneath.  It was very itchy.  She was stopped on her cholesterol medications with no improvement.  Her blood pressure medication was changed to one less likely to cause rash but she has very high blood pressure  readings and must be medicated.  No improvement.  It was thought to be sun related but did not respond to that therapy.  The patient went to her primary physician's office and also saw specialists.  She had a skin biopsy which was negative.  Numerous unspecified tests by dermatologists were also performed (results unknown).  At the time of the report, on 14-NOV-2008, the rash persisted.  The patient was not interested in PCR analysis.  Follow-up information has been received which indicated that the biopsy of rash are came.  The result was that the rash was reaction to scarce water and had nothing to do with ZOSTAVAX.  This one of two reports from the same  source.  Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a nurse concerning a male who in July 2008, was vaccinated with ZOSTER (Oka/Merck) (lot # not provided).  In the week of 10-NOV-2008, the patient experienced itchy rash.  It was unspecified if the patient sought medical attention.  At the time of the report, on 14-NOV-2008, the outcome of the patient was unknown.  This is one of two reports received from the same source.   Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Neuralgia
Clinical narrative: Information has been received from a nurse practitioner concerning a 65 year old female with a history of breast cancer in 1998 and an allergy to sulfa who on 06-NOV-2008 was vaccinated with ZOSTAVAX (Merck) (route and site not reported).  Concomitant therapy included estrogens, PREMARIN, ZYRTEC and therapy unspecified CERAX.  On approximately 10-NOV-2008, "a week ago" the patient developed neuraliga and blisters on her left buttock and left thigh. The patient's neuraliga and blisters on her buttock and left thigh persisted.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Pruritus
Clinical narrative: Information has been received from a 77 year old female patient with high cholesterol, high blood pressure, allergic to sulfa and a history of shingles who in the spring of 2008, was vaccinated with ZOSTER (Oka/Merck).  Concomitant therapy included NATURES MADE CHOLEST OFF.  A couple of month after the patient experienced little red pimples on her left side that would itch around her hip, her buttocks, her shoulder.  And at one time she had some on her right elbow.  The patient also reported that she put some anti-itching cream on and eventually the little red pimples would dry up and go away, but then eventually they would come back.  The pimples did not blister up, and the patient stated that the pimples she got were nothing like she had when she actually had the shingles.  The patient also reported that while taking NATURES MADE CHOLEST OFF, she experienced heart burn.  At the time of reporting, the adverse events were ongoing.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Facial pain, Hot flush, Pain
Clinical narrative: Information has been received from a physician concerning a male patient who was a physician as well, vaccinated sometime in august 2008 with a 0.65ml dose of ZOSTERVAX. Subsequently the patient experienced hot flashes and aches and pains on face 2 weeks after vaccination. The patient sought medical attention. Outcome was unknown additional information has been requested.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Pyrexia, Tenderness
Clinical narrative: Information has been received from a consumer who on 14-NOV-2008 was vaccinated with a dose of ZOSTER (Oka/Merck).  She reported that "3 days ago", on 14-NOV-2008, her 52-year-old son who lives with her started to experience fever, chills and soreness on the right side of his head and he was in bed for 3 days.  Per mother, when her son went to a physician, he was advised that he had shingles because of his symptoms.  "Visual examination" was performed.  At the time of the report, on 17-NOV-2008, the patient had not recovered from the event.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a consumer concerning her husband, a 62 year old male with no pertinent medical history and no known drug reactions/allergies who on 13-NOV-2008 was vaccinated with a 0.65 ml dose of ZOSTER (Oka/Merck).  There was no concomitant medication.  The patient experienced injection site reaction liked redness and rash.  The patient's injection site redness and injection site rash persisted.  The patient did not seek medical attention.  No further information is available.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pruritus, Feeling hot, Flushing, Laboratory test, Paraesthesia
Clinical narrative: Information has been received from an administrative assistant and physician concerning himself, a 78 year old male with hypertension and high cholesterol and no known drug reactions/allergies who on 25-AUG-2008 was vaccinated subcutaneously with a dose of ZOSTER (Oka/Merck) (Lot # 659268/0158X).  Concomitant therapy included losartan postssium-HCTZ (MSD) and LIPITOR.  On approximately 08-SEP-2008, 2 - 3 weeks later the patient developed itchy eyes, flushing of the face and a warmth sensation in his face.  The facial symptoms had not resolved but the intensity of the symptoms changed.  Following the development of the facial symptoms, the patient also developed pins and needles in the rest of his body that came and went.  The patient's adverse events persisted.  Blood work was completed and the results were normal.  It was unspecified if the patient sought medical attention.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 13-NOV-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTER (Oka/Merck) (Lot # 663194/1415X).  The patient experienced a rash on her arm after receiving ZOSTER (Oka/Merck).  The rash was described as a red line extending down her arm.  The patient's symptom was recovering.  The patient spoke to the pharmacist.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Paraesthesia, Pruritus, Rash, Tenderness
Clinical narrative: Information has been received from a 77 year old female registered nurse (R.N.) with codeine allergy who in April 2007, was vaccinated with a dose of ZOSTER (Oka/Merck).  Concomitant therapy included LIPITOR and MSD.  On 07-NOV-2008 the patient began experiencing soreness and tingling/itching under skin at her ribcage.  She then started to break out with a larger rash surrounded by what "looks like 3 spider bites"
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: Information has been received from a 77 year old female registered nurse (R.N.) with codeine allergy who in April 2007, was vaccinated with a dose of ZOSTER (Oka/Merck).  Concomitant therapy included LIPITOR and MSD.  On 07-NOV-2008 the patient began experiencing soreness and tingling/itching under skin at her ribcage.  She then started to break out with a larger rash surrounded by what "looks like 3 spider bites"
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning her 63 year old female mother with no drug reactions/allergies, who on 13-NOV-2008 was vaccinated intramuscularly with a dose of ZOSTER (Oka/Merck) at another office.  There was no concomitant medication.  On 13-NOV-2008, the patient developed red, swollen and painful area at the injection site.  It is unknown if the patient
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injected limb mobility decreased, Pain, Tenderness
Clinical narrative: Information has been received from a 73 year old female patient with allergies to "apernepherin" and codeine, who on 28-OCT-2008 was vaccinated with ZOSTER (Oka-Merck).  The patient reported that on 29-OCT-2008 experienced soreness in her right arm where received the vaccine.  She stated that as the days went on the pain and soreness were a little more to the point where she had to adjust the weight she lifts on her right arm.  She also reported that the pain and soreness was not bad enough to have to take something for it, but about 2 days ago (approximately 17-NOV-2008) she was up through the night because of the pain.  The patient stated that on 19-NOV-2008 the pain was not really there is a more of a weakness in her arm and she felt it was going away.  Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Epistaxis, Epistaxis, Foot and mouth disease, Gingival pain
Clinical narrative: Information has been received from a physician and 65 year old female patient allergic to PERCODAN, MORPHINE; and AVELOX and with stress situation, hypertension and osteoporosis, who on 24-OCT-2008 at 11:30  was vaccinated with a dose of ZOSTER vaccine (lot number 662971/1214X) SC in the upper arm. Concomitant therapy included DIOVAN, NORVASC and estradiol. Two weeks later, approximately in 7-NOV-2008, the patient experienced blisters like lesions around her ankles, her forearms and both her mouth and nose. Inside her mouth she had white spots and her gums are very sore. Her nose starts bleeding when she tries to blow it because of lesions. The lesions are red with bubble in the middle. She stated that she had foot and mouth disease. In follow up the physician reported that on 17-NOV-2008 she had oral and hand vesicles which were painful and diffuse. No laboratory tests were performed. Subsequently, the patient recovered form vesicles and painful. The patient sought unspecified medical attention. Additional information is not available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin lesion
Clinical narrative: Information has been received from a physician and 65 year old female patient allergic to PERCODAN, MORPHINE; and AVELOX and with stress situation, hypertension and osteoporosis, who on 24-OCT-2008 at 11:30  was vaccinated with a dose of ZOSTER vaccine (lot number 662971/1214X) SC in the upper arm. Concomitant therapy included DIOVAN, NORVASC and estradiol. Two weeks later, approximately in 7-NOV-2008, the patient experienced blisters like lesions around her ankles, her forearms and both her mouth and nose. Inside her mouth she had white spots and her gums are very sore. Her nose starts bleeding when she tries to blow it because of lesions. The lesions are red with bubble in the middle. She stated that she had foot and mouth disease. In follow up the physician reported that on 17-NOV-2008 she had oral and hand vesicles which were painful and diffuse. No laboratory tests were performed. Subsequently, the patient recovered form vesicles and painful. The patient sought unspecified medical attention. Additional information is not available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with 0.65 ml dose of ZOSTER vaccine and after receiving the vaccine developed a case of shingles. Eventually the patient experienced herpetic neuralgia. The patient sought medical attention. At the time of reporting. the patient had not recovered. This is one case of two cases received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist and a nurse concerning a 61 year old female with allergies to "Ilosine" and CODEINE who on 17-NOV-2008 was vaccinated with ZOSTER vaccine (lot # 663194/1415X). Concomitant therapy included tramadol HCl. On 20-NOV-2008 the patient developed a quarter size red area at the site of injection with a red ring around it. The area between the quarter size red area and ring was clear. It was unspecified if the patient sought medical attention. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. Follow-up information received on 23-DEC-2008. Vaccination with ZOSTAVAX was given subcutaneously on the left upper arm. Patient developed a lump at the injection site on 19-NOV-2008, two days after given. It became itchy and patient then developed a halo like rash around site on 21-NOV-2008, four days after injection. At the time of the report the rash had subsided but areas was still discolored. No further information is available.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Laboratory test
Clinical narrative: Information has been received from a 68 year old male with allergy to quinolone products who on 18-NOV-2008 was vaccinated with ZOSTER vaccine, 0.65ml (lot # not provided). Concomitant therapy included ezetimibe (+) simvastatin, montelukast sodium and prostate medication (manufacturer unknown). On 19-NOV-2008 the patient experienced warmth, redness and a lump at the injection site. "Routine labs" were performed (results unknown). The patient's warmth, redness and a lump at the injection site persisted. Unspecified medical attention was sought. This is in follow-up to report(s) previously submitted on 12/21/2008.  Follow-up information received from a health professional concerning a patient with colonic polyp, cholelithiasis, diverticulitis and drug reaction to LEVAQUIN who received the first dose of ZOSTAVAX (Merck) (lot# 659673/0557X) into the left upper arm on 18-NOV-2008, the patient sought medical attention and was instructed to use BENADRYL if the symptoms persisted.  Subsequently, the patient recovered.  Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: This is in follow-up to report(s) previously submitted on 12/23/2008. Initial and follow-up information have been received from a registered pharmacist and an 84 year old retired female with gastric side effects to salicylate and NSAIDS, osteoporosis, diagnosed with unspecified cancer in 1985 and received "flu shot" on 14-OCT-2008 and a history of a history of scarlet fever when she was 11 years old, pneumonia as a child, who on 15-NOV-2008 was vaccinated with the first dose of ZOSTAVAX (Merck) SC 0.65 ml (lot # not reported) at 11:00. Concomitant therapy included PROTONIX, FORTICAL, enteric coated aspirin and loperamide HCl. On 21-NOV-2008 (also reported as "approximately 1-2 weeks after vaccination) the patient started to experience being "ice cold" and chilly that lasted for 2 days. The patient recovered from cold and chilly on 23-NOV-2008. The patient sought medical attention and spoke to the registered pharmacist. Follow-up information was received. The patient's feeling of being extremely cold lasted for approximately 2 days. No other symptoms were noted. The patient recovered on 23-NOV-2008. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old male with no pertinent medical history and no drug reactions/allergies, who on 19-NOV-2008 was vaccinated with one dose ZOSTER vaccine via subcutaneous (lot # 662969/1206X). Concomitant therapy included therapy unspecified "FLOXAMINE", OXYBUTIN, theophylline cr and carbidopa (+) levodopa (MSD). Subsequently the patient experienced injection site reaction. The injection site was red, swollen a warm to touch. The patient sought unspecified medical attention via telephone call. No lab diagnostics studies were performed. The patient's injection site reaction was not recovered.  This is in follow-up to report(s) previously submitted on 12/23/2008.  Follow-up information was received from the Register Pharmacist on 19-DEC-2008.  The patient with no illness at the time of vaccination on 19-NOV-2008 was vaccinated the first dose of ZOSTAVAX (Merck).  On 19-NOV-2008, the patient developed redness, warmth, swelling at injection site.  On 20-NOV-2008 the patient contacted us and his MD advised to take diphenhydramine.  On 21-NOV-2008, the patient's redness, warmth and swelling at injection site were resolved.  Additional information has been registered.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 81 year old female with penicillin and sulfa allergies and hypothyroidism, hypertension, gastroesophageal reflux disease and sleep apnoea who on 7-NOV-2008 was vaccinated with ZOSTER vaccine (lot # 663196/1417X) (dose not reported). There was no concomitant medication. On 17-NOV-2008, ten days after the vaccination the patient developed shingles after receiving ZOSTER vaccine. The patient developed non painful vesicular rash behind her right ear. The physician saw the patient. No lab diagnostics studies was performed. As of 24-NOV-2008 the patient was recovering from shingles. No further information is available. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 67 year old patient who was vaccinated on unspecified date  instead of VARICELLA virus vaccine (MSD). No adverse effect was reported. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a 70-year-old male patient who in March 2008 was vaccinated SQ with a dose of 0.65 ml ZOSTER vaccine (lot number and injection site unknown). Subsequently, "within about 5 days of getting ZOSTER vaccine, the patient developed shingles. The patient was treated and sent to a dermatologist. The patient's outcome was not reported. The reporter also stated that the ZOSTER vaccine caused the shingles. 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 pharmacist concerning a female patient in her 60s who on an unknown date was vaccinated SQ with a dose of ZOSTER vaccine (lot number and injection site unknown). Seven days after vaccination, the patient returned to the pharmacy with redness at the injection site. The area was 4 to 5 inches in diameter. It was not a hematoma. The pharmacist stated that the patient is fine now. No further information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has bee received  from a registered nurse concerning a 70 year old male patient who in approximately March 2008, was vaccinated with a dose of ZOSTER vaccine (lot # not provided). In approximately March 2008, within 5 days of getting vaccinated with ZOSTER vaccine, the patient developed shingles. The patient sought medical attention, he was "treated and sent to dermatologist" The registered nurse felt that shingles was related to therapy with ZOSTER vaccine. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Influenza like illness, Nausea, Pyrexia
Clinical narrative: Information has been received from a registered nurse and a female patient who on 24-NOV-2008 was vaccinated with ZOSTER vaccine (Lot # not provided) subcutaneously. On 24-NOV-2008 after the patient received ZOSTER vaccine, she developed a fever of 101F later that evening. The same day the patient contacted the office and was suggested to take ADVIL. On 25-NOV-2008 the patient called the office and complained of nausea, weakness and arthralgia. The patient has been scheduled for an office visit later that day. On 26-NOV-3008 the patient called to report that she experienced a flu like symptoms and her heart were raising?? after she received ZOSTER vaccine. There were no laboratory diagnostic studies performed/ At the time of this report on 25-NOV-2008, the patient"not recovered". Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Laboratory test
Clinical narrative: Information has been received from a 73 year old female patient with CODEINE allergy, who on 09-OCT-2008 was vaccinated with 0.65 ml dose of ZOSTER vaccine. Concomitant therapy included blood pressure medication. On approximately 13-NOV-2008, "about 5 weeks after receiving" the vaccine, the patient had experienced severe pain on the upper right side of her hip however no rash had developed at that time. She had gone to the Emergency Room where she had prescribed acyclovir and PREDNISONE only if rash occurred. On an unspecified date, the patient had routine labs. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, Herpes zoster
Clinical narrative: Information has been received from a health professional concerning an 80- year old male patient who sometime in late April or early May 2008 was vaccinated with a dose of ZOSTAVAX vaccine at another site. On 21-NOV-2008, the patient developed the shingles. The patient sought unspecified medical attention. At time of reporting, it is unknown if the patient recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 12/23/2008. Follow-up information has been received from a  completed questionaire on 10-FEB-2009, from a nurse practitioner. It was reported that the 80 year old male patient with rheumatoid arthritis, gastroesophageal reflex disease, coronary artery disease, chronic obstructive pulmonary disease, osteopenia, protate cancer, vitamin B12 deficiency and chronic renal insufficiency and a history of chickenpox in childhood, in April 2008, was vaccinated with a dose of ZOSTAVAX vaccine at a local pharmacy. Concomitant therapy included methotrexate,REMICADE, PRILOSEC, metoprolol, ACTONEL, TYLENOL, and cyanocobalamin. On 31-NOV-2008 the patient developed 3 small clusters of vesicles in the right side of back and lateral chest. Systemic symptoms included mild skin eruptions and neuralgia. A rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient had a maximum body temperature measurement of 98.6. There was no a direct fluorescence antibody done and the specimen was not collected for Polymerase Chain reaction. There was no  a photo taken. As of 08-JAN-2009 the patient recovered. Additional information is not expected.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician and a nurse concerning an 83 year old male patient with diabetes and on dialysis who in 2007 was vaccinated with 0.65ml dose of ZOSTER vaccine. The physician stated that the patient developed shingles this year after receiving ZOSTAVAX last year. At the time of this report it is unknown if the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 74 year old female concerning himself, with a history of chickenpox (when was little) and sulfonamide allergy, who on 08-JAN-2008 was vaccinated with ZOSTER vaccine (Lot # 658396/0967U), 0.65 ml, subcutaneously. Concomitant therapy included SIMVASTSTIN (MSD). The caller stated that in November 2008, the patient developed shingles in the left side of her scalp after having been vaccinated with the vaccine. Her physician prescribed VALTREX. The patient sought unspecified medical attention. At the time of the report, the patient was recovering. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Initial information has been received from a physician and follow up information from a health professional concerning a 66 year old female patient who with no known allergies who on 21-Oct-2008 was vaccinated intramuscularly in her right deltoid with 0.65ml dose of ZOSTER vaccine (lot# 659406/0298X). Concomitant therapy included vitamins (unspecified). On 25-Oct-2008 the patient developed an eruption on the left side of her neck with approximately 5 lesions, along a dermatome consistent with shingles (also reported as mild shingles) and no pain (0 on a scale of 0 to 10 with 10 being the highest). A direst fluorescent antibody was not performed. A photo was not taken. At the time of this report the patient had recovered. The patient was enrolled in the VARICELLA  ZOSTER virus identification program to identify if VZV is present and if it is present to identify if it is associated with the wild- type VZV strain. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pain in extremity
Clinical narrative: Information has been received from a consumer and a physician  concerning his 63 year old wife with no pertinent medical history and no drug reactions or allergies who on 03-OCT-2008, was vaccinated with a 0.5 ml dose of ZOSTAVAX (Oka-Merck) (lot number not provided).  Concomitant therapy included vitamins (unspecified).  On approximately 07-OCT-2008 ("October 7th or 8th") the patient experienced an outbreak of shingles on her legs and has been in severe pain since.  The patient still had blisters on her legs.  No lab diagnostics studies were performed.  Therapy with ZOSTAVAX was discontinued on 03-OCT-2008.  At the time of reporting, the adverse events were ongoing.  The patient has been to the dermatologist twice.  Additional information has been requested. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. Follow up information was received from a physician who reported that the patient had typical zoster of the right lower leg with pain. The patient stated that she received ZOSTAVAX (Oka/Merck) approximately 5 days prior by her family physician. The patient was placed on VALTREX 1 gm TID for 7 days and resolved except for some granulation at one persistent lesion. Additional information is not expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male patient with no pertinent medical history who on approximately 22-OCT-2008 ("approximately 2 weeks ago") was vaccinated with ZOSTAVAX (Oka/Merck) (lot number not available) SC into the arm. There was no concomitant medication. On approximately 01-NOV-2008 ("10-14 days after vaccination") the patient experienced chickenpox. The patient could not remember if he had ever had chickenpox. After stopping therapy the patient recovered from chickenpox. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ZOSTER (Oka/Merck) (lot # not provided).  Secondary suspect therapy included influenza virus vaccine (unspecified).  Subsequently the patient experienced unspecified adverse event.  At the time of the report, on 05-NOV-2008, the outcome of the patient was unknown.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain
Clinical narrative: Information has been received from a physician concerning his mother in her 70's who was vaccinated with a dose of ZOSTAVAX intramuscularly by his sister who is a registered nurse by mistake. Subsequently the patient experienced lightheaded and pain at site. It was uknown if the patient sought any medical attention. The outcome of the patient's experience was unknown. The physician felt that pain with the injection was caused by the needle and not the vaccine. This is a consolidation of two reports concerning the same patient. No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Pain, Pruritus, Rash, Skin tightness
Clinical narrative: Information has been received from a 71 year old male "allergic to shellfish)", with thyroid problems and a history of shingles (the patient "had shingles about 5 years ago"), who on 10-OCT-2008 was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included PROTONIX and thyroid medication.  The caller reported that he received ZOSTAVAX (Merck) and about a week ago, on approximately 27-OCT-2008, he started experiencing itching on his chest.  The physician told the patient it was caused by dry skin, however about 3 or 4 days ago, on approximately 30-OCT-2008, he started experiencing itching, tightness of the skin (sometimes painful) and a rash (small red dots) on his chest and thigh going down to his groin area.  At the time of the report, the patient had not recovered.  The patient sought medical attention.   No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Eyelid pain, Oral pain, Photophobia, Rash pruritic
Clinical narrative: Information has been received from a female who in May 2008 originally had shingles of the left buttock. Since then, she has had nausea and headache. On 22-JUL-2008, the patient was vaccinated with ZOSTAVAX. It was reported that on 05-SEP-2008, the headache became persistent. She was seen by her primary car physician and treated for a possible sinus infection. The patient then noticed light-sensitivity. The ophthalmologist found a normal eye exam so he referred the patient to neurologist who prescribed her Topamax and Verapamil for the headache. On 24-OCT-2008 the patient developed shingles of the left buttock area and was prescribed Acyclovir. On 30-OCT-2008 the patient developed a widespread, itchy rash with soreness inside her mouth and under her eyelids. The patient had an appointment scheduled with neurologist on 04-NOV-2008. At the time of the report the patient had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Sinusitis
Clinical narrative: Information has been received from a female who in May 2008 originally had shingles of the left buttock. Since then, she has had nausea and headache. On 22-JUL-2008, the patient was vaccinated with ZOSTAVAX. It was reported that on 05-SEP-2008, the headache became persistent. She was seen by her primary car physician and treated for a possible sinus infection. The patient then noticed light-sensitivity. The ophthalmologist found a normal eye exam so he referred the patient to neurologist who prescribed her Topamax and Verapamil for the headache. On 24-OCT-2008 the patient developed shingles of the left buttock area and was prescribed Acyclovir. On 30-OCT-2008 the patient developed a widespread, itchy rash with soreness inside her mouth and under her eyelids. The patient had an appointment scheduled with neurologist on 04-NOV-2008. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lymphadenopathy, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female who on 31-OCT-2008 was vaccinated with one dose of ZOSTAVAX, Lot number 663195/1416X. On 01-OCT-2008, the patient was vaccinated with influenza virus vaccine (unspecified) and it was unspecified if the patient was on other medications. It was reported that "over the weekend" on approximately 01-NOV-2008 the patient developed swelling at the injection site and rash on her left breast. Also, her lymph nodes were swollen. The pharmacist had not seen the patient. At the time of the report the patient had not contacted her physician yet. At the time of the report the patient was recovering. The patient sought medical attention, called pharmacist. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a patient who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) at the lower arm. On an unspecified date, the patient developed mild shingles. The patient's shingles persisted. No lab tests were performed. The patient was seen in the office and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated SC with a 0.65ml dose of ZOSTAVAX at the lower arm. On an unspecified date, the patient developed mild shingles. Subsequently, the patient recovered from shingles. No lab tests were performed. The patient was seen in the office and sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site vesicles, Injection site warmth
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 64 year old female who on 09-OCT-2008 was vaccinated with a dose of ZOSTAVAX, 0.65 ML, SC into the left arm. On 10-OCT-2008, the patient developed vesicles (4 inch x 8 inch) around the injection site. It was described as a red, hot itchy rash. No blisters. The patient called her physician and was treated with Benadryl for 2 days. On 14-OCT-2008, the patient recovered. No further information is available. This is one of several reports from the same source.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 64 year old female who on 10-OCT-2008 was vaccinated with her first dose of ZOSTAVAX (Oka/Merck) (lot #662971/1213X) SC into the left arm. On the morning of 11-OCT-2008 the patient developed redness (area at 4 inch x 8 inch) around the injection site and down the arm, red and itchy, with no blisters. The patient was treated with BENADRYL. Subsequently, the patient recovered. The patient had no adverse event following prior vaccination of FLUZONE on 29-NOV-2006 and 04-OCT-2007. No further information is available. This is one of several reports from the same source.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a "mid to late seventies" female patient, who on an unspecified date, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The pharmacist reported that the patient developed a case of shingles after receiving the ZOSTAVAX vaccine. The patient sought unspecified medical attention. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse concerning a 95 year old female who in August 2007, was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). On 16-OCT-2008 the patient developed shingles. The patient was recovering from shingles. The patient was seen by the physician and sought unspecified medical attention. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood cholesterol increased, Erythema, Hypertension, Induration, Local reaction
Clinical narrative: Information has been received from a physician concerning a 70 year old male with hypertension and cholesterol levels raised both controlled with medication who on 06-OCT-2008 was vaccinated with influenza vaccine (manufacturer unknown) in the left arm. On 07-OCT-2008 was vaccinated with a dose of ZOSTAVAX (lot # 659408/0300X) (Oka/Merck). The vaccine was administered with a physician prescription at a local clinic. On 07-OCT-2008, the patient experienced localized reaction red, hard painful spreading down the arm to the elbow on the right chest area then breaking up into knots. The patient had a fever of 100 that lasted one day with malaise lasting one week. The patient was not in bed and did not have a headache. At the time of this report, the patient was not actually seen by a provider during the course of the reaction. The patient's wife questioned whether the vaccine was kept adequately frozen since the patient and her husband heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they were told that the vaccine was being prepared till the actual receipt of the injection. The clinic clarified that the vaccine was stored transported from another pharmacist off site in a cooler with ice packs. The clinic also mention that the Company was contacted and mentioned that a lot check was done on the vaccine lot and found no problems in their data. This is one of several reports received from the same source. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 70 year old male with hypertension and cholesterol levels raised both controlled with medication who on 06-OCT-2008 was vaccinated with influenza vaccine (manufacturer unknown) in the left arm. On 07-OCT-2008 was vaccinated with a dose of ZOSTAVAX (lot # 659408/0300X) (Oka/Merck). The vaccine was administered with a physician prescription at a local clinic. On 07-OCT-2008, the patient experienced localized reaction red, hard painful spreading down the arm to the elbow on the right chest area then breaking up into knots. The patient had a fever of 100 that lasted one day with malaise lasting one week. The patient was not in bed and did not have a headache. At the time of this report, the patient was not actually seen by a provider during the course of the reaction. The patient's wife questioned whether the vaccine was kept adequately frozen since the patient and her husband heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they were told that the vaccine was being prepared till the actual receipt of the injection. The clinic clarified that the vaccine was stored transported from another pharmacist off site in a cooler with ice packs. The clinic also mention that the Company was contacted and mentioned that a lot check was done on the vaccine lot and found no problems in their data. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Activities of daily living impaired, Headache, Injection site erythema, Injection site induration, Injection site inflammation
Clinical narrative: Information has been received from a physician concerning a 67 year old female with a history of sjogren syndrome who on 06-Oct-2008 was vaccinated with influenza vaccine in the left arm. On 07-Oct-2008 was vaccinated with a dose of ZOSTERVAX (lot#659408/0300X) "under the right arm 1 finger away from the arm pit". Within hours after of the vaccination, the patient experienced a large injection site reaction consisting of warmth, in duration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever, malaise and severe headache. The vaccine had been administered at a clinic from a single vial with a physician's prescription. The patient experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest. No rash but involved area was very swollen, red warm to touch, painful and was also described "hard as a rock". The area on the arm and chest then "broke up" after about a week into smaller knots. The patient also described a sore knot developed across her right shoulder blade approximately quarter size which lasted about a week. Patient was in bed one week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation. The patient called physician because she thought she had the flu and was not seen by physician but prescribed Z-PAC on 22-Oct-2008. The patient felt better by 25-Oct-2008. On 30-Oct-2008, the patient had blood work but the patient was not sure why or what type of blood work was being collected and would be contacted by a physician next week. Currently injection site was red, pinkish blue 2 inches by one inch in size with no pain. The patient questioned whether the vaccine was kept adequately frozen since the patient and her husband heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they where told that the vaccine was being prepared till the actual receipt of the injection. The clinic clarified that the vaccine was stored transported from another pharmacy off site in a cooler with ice packs. The clinic also mention that the company was contacted and mentioned that a lot check was done on the vaccine lot and found no problems in their data. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Malaise, Musculoskeletal pain
Clinical narrative: Information has been received from a physician concerning a 67 year old female with a history of sjogren syndrome who on 06-Oct-2008 was vaccinated with influenza vaccine in the left arm. On 07-Oct-2008 was vaccinated with a dose of ZOSTERVAX (lot#659408/0300X) "under the right arm 1 finger away from the arm pit". Within hours after of the vaccination, the patient experienced a large injection site reaction consisting of warmth, in duration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever, malaise and severe headache. The vaccine had been administered at a clinic from a single vial with a physician's prescription. The patient experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest. No rash but involved area was very swollen, red warm to touch, painful and was also described "hard as a rock". The area on the arm and chest then "broke up" after about a week into smaller knots. The patient also described a sore knot developed across her right shoulder blade approximately quarter size which lasted about a week. Patient was in bed one week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation. The patient called physician because she thought she had the flu and was not seen by physician but prescribed Z-PAC on 22-Oct-2008. The patient felt better by 25-Oct-2008. On 30-Oct-2008, the patient had blood work but the patient was not sure why or what type of blood work was being collected and would be contacted by a physician next week. Currently injection site was red, pinkish blue 2 inches by one inch in size with no pain. The patient questioned whether the vaccine was kept adequately frozen since the patient and her husband heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they where told that the vaccine was being prepared till the actual receipt of the injection. The clinic clarified that the vaccine was stored transported from another pharmacy off site in a cooler with ice packs. The clinic also mention that the company was contacted and mentioned that a lot check was done on the vaccine lot and found no problems in their data. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pyrexia, Swelling
Clinical narrative: Information has been received from a physician concerning a 67 year old female with a history of sjogren syndrome who on 06-Oct-2008 was vaccinated with influenza vaccine in the left arm. On 07-Oct-2008 was vaccinated with a dose of ZOSTERVAX (lot#659408/0300X) "under the right arm 1 finger away from the arm pit". Within hours after of the vaccination, the patient experienced a large injection site reaction consisting of warmth, in duration, pain, extending from the elbow to the breast and chest, along with systemic symptoms including fever, malaise and severe headache. The vaccine had been administered at a clinic from a single vial with a physician's prescription. The patient experienced 1/2 dollar size pink spot within 30 minutes of receiving vaccine which over the next several days continued to spread down the arm to the elbow and across the chest. No rash but involved area was very swollen, red warm to touch, painful and was also described "hard as a rock". The area on the arm and chest then "broke up" after about a week into smaller knots. The patient also described a sore knot developed across her right shoulder blade approximately quarter size which lasted about a week. Patient was in bed one week with extreme headache, fever of 100.5, malaise with the injection site, arm and chest inflammation. The patient called physician because she thought she had the flu and was not seen by physician but prescribed Z-PAC on 22-Oct-2008. The patient felt better by 25-Oct-2008. On 30-Oct-2008, the patient had blood work but the patient was not sure why or what type of blood work was being collected and would be contacted by a physician next week. Currently injection site was red, pinkish blue 2 inches by one inch in size with no pain. The patient questioned whether the vaccine was kept adequately frozen since the patient and her husband heard it had been transported from another pharmacy 40 minutes away and also there was a delay of about a half hour from the time they where told that the vaccine was being prepared till the actual receipt of the injection. The clinic clarified that the vaccine was stored transported from another pharmacy off site in a cooler with ice packs. The clinic also mention that the company was contacted and mentioned that a lot check was done on the vaccine lot and found no problems in their data. This is one of several reports received from the same source. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a 73 year old female who in approximately September 2008, "about a month ago", was vaccinated with ZOSTAVAX (Lot# was not available, therapy route, site unknown). Subsequently the patient developed rash on injection site on her right arm. The patient sought medical attention. The patient's outcome was unknown. Additional information has been requested.