chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck). Subsequently the patient experienced adverse event. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female who on an unspecified date was vaccinated with ZOSTAVAX.  Subsequently the patient broke out in "shingles like pox" on her forehead and stomach post vaccination.  The reporter is not interested in VZV Analysis by PCR.  The patient's "symptoms" resolved.  At the time of reporting the patient was "okay".  No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female "in her later 70's" who in January 2008, was vaccinated with 0.65 ml "one dose" of ZOSTAVAX.  Two weeks post vaccination, in approximately January 2008, the patient developed a "mild case of shingles" on opposite arm and not on the arm of the injection.  The physician noted that the patient did not have any pain, nor did they have a history of shingles.  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient was recovered (date unspecified).  Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 77 year old male who on 16-JAN-2008 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included VASOTEC, nadolol and NORVASC. The physician reported that "the patient had shingles after he was given Zostavax (Oka/Merck)". Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure, Condition aggravated, Hypotension, Neuralgia, Speech disorder
Clinical narrative: Information has been received from a consumer concerning her 73 year old husband with iodine allergy "discovered 26 years ago" and neuropathic pain.  It was reported that the patient had injuries because of a car accident in 1981 and developed neuropathy pain 5 years ago "but it is light pain".  On 15-JAN-2008, the patient was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included LYRICA, lovastatin (manufacturer unknown), "trismeterene", amlodipine besylate, "denazetril", and clonazepam.  The reporter stated that the patient experienced neuropathy pain triple times the usual pain "one hour after receiving Zostavax vaccine".  The patient was brought to the hospital.  A lot number was not provided.  The reporter also stated that the patient did not have a history of shingles.  The patient also had "extreme low blood pressure" and there were changes in his speech after receiving Zostavax (Oka/Merck).  It was reported that there was "test to check blood pressure".  The patient was recovering from the pain.  Outcome was reported as recovering.  The patient sought medical attention: "see the physician".  There was no product quality complaint.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Flank pain, Skin discomfort
Clinical narrative: Information has been received from a physician concerning his 72 year old mother with a history of diverticulitis who "three weeks ago" on approximately 01-JAN-2008 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). "Five days ago" on approximately 18-JAN-2008 the patient developed flank pain and skin sensitivity on the right side in her ribcage area that he estimated (from a description over the phone) to be at the T7-8 dermatome level. This was also reported as a "shingles like reaction" however, there was no rash at that time. The patient was taking ibuprofen. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Information has been received from a nurse practitioner concerning a male who was vaccinated with a dose of ZOSTAVAX, .65 ml.  Subsequently the patient developed a 4 inch round, red, raised, swollen spot at the injection site.  No lot number was provided.  On an unspecified date, the patient recovered.  The patient sought unspecified medical attention.  There was no product quality complaint.  In follow-up information, an office staff member reported that the patient's experience was already reported to VAERS on 28-NOV-2007.  It was reported that the patient had a 2 inch round, red, swollen area, not a 4 inch.  No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site pruritus, Swelling
Clinical narrative: Information has been received from a pharmacist concerning an about 67 year old female who on 19-JAN-2008 was vaccinated SC in the right upper arm with a single dose of Zostavax (Oka/Merck).  On approximately 19-JAN-2008 the patient developed an "itchy irritation" at the injection site.  The patient sought medical attention by calling the pharmacist.  There were no lab studies performed.  On 23-JAN-2008 the patient recovered from itching nad swelling. There was no product quality complaint involved.  No further information was provided.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Culture, Herpes zoster, Medication error
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who was vaccinated with a dose of ZOSTAVAX that was stored at a freezer range above the recommended range.  The RN reported that the patient subsequently developed a shingles-like rash.  The patient was seen in a physician's office and the rash was cultured (results not provided).  No other symptoms or treatment was reported.  At the time of this report, the outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse (RN) concerning a female patient with no history of chickenpox who was vaccinated with a dose of ZOSTAVAX.  The RN reported that the patient developed shingles on her face.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  The RN noted that the vaccine was stored properly.  This is one of several reports from the same source.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 70 year old female with hypercholesterolemia who on 11-JAN-2008, was vaccinated with a subcutaneous single dose in the left forearm of ZOSTAVAX (Oka/Merck). Concomitant therapy included simvastatin (MSD), aspirin, and calcium. One day after receiving the vaccine, on 12-JAN-2008, the patient developed a 4 by 3 cm. area of redness with a central blister at the injection site of the left forearm. On 15-JAN-2008, the patient was examined by the physician in the office. No diagnostic or laboratory studies were performed. The physician indicated that the symptoms resolved without treatment. As of an unspecified date, the patient is fully recovered. A product quality complaint was not reported. This is one of 2 cases from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Hyperaesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female with no medical history of allergies who on 08-JAN-2008 was vaccinated SC with a dose of ZOSTAVAX (Lot # 658397/1820U).  Concomitant therapy included unspecified therapy.  On approximately 22-JAN-2008, 2 weeks after vaccination the patient experienced shooting pain in back and side and also felt that the skin in those areas was very sensitive.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a nurse concerning an immunocompromised female with a history of spleen removal who was vaccinated with a 0.65 mL dose of Zostavax (Oka/Merck).  The nurse reported that the patient had a "bad reaction".  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Culture, Medication error, Rash vesicular
Clinical narrative: Information has been received from a registered nurse (RN) concerning a patient who was vaccinated on an unspecified date with a dose of ZOSTAVAX (Merck) that was stored at a freezer range above the recommended range.  The RN reported that the patient subsequently developed a shingles-like rash.  The patient was seen in a physician's office and the rash was cultured (results not provided).  No other symptoms or treatment was reported.  At the time of this report, the outcome was unknown.  This is one of several reports from the same source.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning his 70 year old wife who on 21-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 23-JAN-2008 the patient developed a red area at injection site that was itchy.  At the time of report the patient had not recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: Information has been received from a female nurse practitioner who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX.  It was reported that within a few hours of vaccination the patient developed a size of a tennis ball red spot in her arm and had a small amount of swelling in it.  The patient stated that the red spot resolved in itself.  A product quality complaint was not involved.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Faeces discoloured
Clinical narrative: Information has been received from a 61 year old male with no medical history or allergies who on 15-JAN-2008 was vaccinated with a 0.5 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included CHANTIX.  On 16-JAN-2008 the patient had black stools.  No diagnostic laboratory tests were undertaken.  No medical attention was sought.  At the time of report the patient had not recovered.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female consumer with a history of shingles twice, who on 24-JUL-2007 was vaccinated with a dose of ZOSTAVAX.  On approximately 24-OCT-2007, the patient developed shingles.  The consumer reported that "I had the disease twice, so I contacted two doctors to get their advise as to whether I should or should not get the vaccine.  The answers from both were a definite yes, no question.  Just three months later, I developed the disease, and now 11 weeks later, I am still suffering".  It was unspecified if medical attention was sought.  Follow-up information has been received in which the consumer provided the address of her physician.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female with asthma, elevated cholesterol and an aspirin allergy who on approximately 03-DEC-2007 ("6 weeks ago") was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant drug therapy included ezetimibe (+) simvastatin (MSD), PREMARIN, TOPAMAX and an unspecified tranquilizer.  On 10-JAN-2008 the patient was diagnosed with shingles, located on the left side of her face in the temple area.  The patient sought medical attention through a physician's office visit.  No labs or diagnostic studies were performed.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a healthcare professional concerning a 71-year-old male, with a history of chickenpox, who on 04-JAN-2008 was vaccinated subcutaneous in the right deltoid with his first 0.65 ml dose of ZOSTAVAX (Merck) (lot # 658867/1413U).  There was no recent exposure to chickenpox or herpes zoster.  On approximately 10-JAN-2008, 6 days post vaccination, the patient developed shingles on the left side (ribs).  The patient sought unspecified medical attention.  On 25-JAN-2008 the patient recovered.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. The event was considered non serious. Further information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Rash erythematous
Clinical narrative: Information has been received from a 72-year-old male with no pertinent medical history or allergies who on 11-JAN-2007 was vaccinated "orally with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included hydrochlorothiazide (manufacturer not specified), lisinopril (manufacturer not specified), metoprolol (manufacturer not specified), NIASPAN and LIPITOR. On 14-JAN-2007 the patient "developed a red rash on his left hand with bumps that are under the skin after receiving ZOSTAVAX". The patient did not seek medical attention. No diagnostic labs were performed. 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: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Scab
Clinical narrative: Information has been received from a physician concerning a 64 year old female with blood pressure high cholesterol high who on 12-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included LIPITOR, AVAPRO, CARDIZEM CD and aspirin. On approximately 11-JAN-2008 ("3-4 days ago") the patient developed shingles rash that was mild that was mild confined to one finger of one hand. The shingles was painless and did not bring any discomfort. The patient described Valtrex 1 gr twice daily for 7 days. The patient is recovering and the rash is scabbing. Follow-up information received from the Herpes Zoster Questionnaire on 16-Jan-2008 indicating that the patient was vaccinated with ZOSTAVAX (Oka/Merck) (lot#658361/1090U). A rash did occur with an onset of approximately 09-Jan-2008 isolated to the one finger with 4 or 5 zoster like lesions. The patient had no fever and was experiencing pain rated as a "3" on a scale of 1 to 10. No other systemic symptoms reported. The patient had not yet recovered, still has lesions. Patient has a history of chickenpox in her childhood. No recent exposure to chicken pox or herpes zoster. Follow-up information was received from the VZV identification program indicating that the sample of the lesion was collected on 16-Jan-2008 and sent to the laboratory on 21-Jan-2008 and the source of the specimen was a "scab", did not mention the site. The specimens arrived at the laboratory on 24-Jan-2008. Results: Was VZV DNA amplified - No. Was B-globin DNA amplified - No. Interpretation: Inadequate specimen - No strain ID. Results reported on 04-Feb-2008. Follow-up information was received from the VZV identification program indicating that the sample was ran twice and the result was still "inadequate". No further information is expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 74 year old female with no pertinent medical history, drug reactions or allergies who "11 months ago" in approximately February 2007, was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX.  Concomitant therapy included alendronate sodium.  In approximately October 2007, the patient developed shingles.  The patient reports being seen by her doctor for the "breakthrough" and was given antibiotics.  At the time of reporting the patient was recovering.  There was no product quality complaint.  There were no lab diagnostic studies performed.  At the time of reporting the patient's status was recovering.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  On an unspecified, following vaccination, the patient was seen by her rheumatologist and the patient's rheumatologist stated the vaccine caused the patient to develop arthritis.  The physician reported that she had been in contact with the rheumatologist and it was noted the patient's arthritis is improving.  A product quality complaint was not involved.  The reporter felt that arthritis was related to therapy with Zostavax (Oka/Merck).  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Swelling, Urticaria
Clinical narrative: Information has been received from a health professional concerning a 76 year old female with no pertinent medical history, drug reactions or allergies who on 13-DEC-2007, at 15:20, was vaccinated into the left upper arm with a first dose of Zostavax (Oka/Merck) (Lot# 658863/1414U).  There was no illness at the time of vaccination.  On 15-DEC-2007 the patient developed a local reaction described as a red area approx a 3 cm. circle that had also been reported as swollen, which was not found at the time of examination on 20 DEC 2007.  Upon examination only "local redness to the superficial skin" was observed.  The patient complained of mild urticaria at the site.  The patient was treated with "antihistamine".  The patient was recovered on 20 DEC 2007.  No further information is expected.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Lip exfoliation
Clinical narrative: Information has been received from a female who on 03-DEC-2007 was vaccinated with 0.65 ml ZOSTAVAX injection.  Concomitant therapy included olmesartan medoxomil (BENICAR).  Subsequently, the patient experienced lip burning and peeling.  Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Abscess, Pain, Rash, Surgery
Clinical narrative: Information has been received from a pharmacist concerning a retired male physician who on an unspecified date, was vaccinated with a single dose of Zostavax (Oka/Merck).  On an unspecified date, the patient developed a small localized rash on his torso which was very painful.  It was reported that it developed into a large growth or abscess at the base of his spine which required surgery to have it removed.  It was not specified if the patient was hospitalized as an in-patient for the surgery.  Current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dysgeusia
Clinical narrative: Information has been received from a female patient who on an unspecified date received an "oral" dose of ZOSTAVAX and developed a metallic taste in her mouth after receiving the vaccine.  Medical attention sought and current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory disorder
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old male who on 14-JAN-2008 was vaccinated with Zostavax (Oka/Merck).  Two days later (16-JAN-2008), he developed a respiratory illness (unspecified).  It was reported that the patient's physician wanted to place the patient on corticosteroids but because of the recent vaccination, that therapy was held off.  The patient was taking an unspecified antibiotic (dose, and duration not reported).  Medical attention was not specified.  At the time of this report, the patient was recovering.  A product quality complaint was not reported.  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 pharmacist concerning an 80 year old male consumer who on 14-JAN-2008 at 4:05 pm was vaccinated SC with ZOSTAVAX (Merck) (lot # 659325/1833U).  There were no illnesses at the time of vaccination.  Subsequently, 2-3 days after vaccine administration (approximately 16-JAN-2008) the patient came down with respiratory illness (unspecified).  It was reported that the patient's physician wanted to give the patient a course of cortisosteroids "but it was contraindicated in live vaccine administration."  The patient was taking an unspecified antibiotic (dose, and duration not reported).  Medical attention was not specified.  At the time of this report, the patient's status was unknown.  A product quality complaint was not reported.  Further information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a consumer concerning his wife, who on 28-SEP-2007 was vaccinated with ZOSTAVAX.  That evening (28-SEP-2007), she developed itching.  Medical treatment sought by the patient was not specified.  By the next day (29-SEP-2007), the itching had resolved.  A product quality complaint was not reported.  This is one of two cases from the same source.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Blister, Burning sensation, Dermatitis, Headache
Clinical narrative: Information has been received from a 60 year old female consumer with multiple sclerosis, leukemia, allergies to iodine, and AVONEX, with a history of chemotherapy who on 13-DEC-2007 was vaccinated in the right arm with a dose of Zostavax (Oka/Merck) (lot # 658396/0967U).  Concomitant therapy included ALTACE, PAXIL and PROVIGIL.  She reported that after she received the vaccine (December 2007) she developed a headache.  Medical attention sought and outcome in regard to the headache was not reported.  She also reported that 2 days after the vaccination (December 2007), her arms swelled up, and she had blisters that started to itch.  She reported that she would scratch them open but they would not get infected, and were not filled with pus.  On an unspecified date, she developed a rash on her face, scalp, shoulders, and the tops of her legs.  She described the rash as bumps that looked like they were underneath the skin everyday and every 4 to 5 days they would "break out and scab".  She was evaluated by a dermatologist and underwent diagnostics that included: a "swab" of the blisters "(ruled out chicken pox"); and an unspecified "biopsy for shingles".  The patient indicated that since "having leukemia and chemo, she has had no immune system" and had not recovered.  A product quality complaint was not reported.  Follow up information from a physicians assistant indicated that the skin biopsy obtained by the dermatologist revealed non-specific dermatitis and did not confirm herpes zoster or any varicella related rash.  At the time of this report, current patient status was not reported by the physician assistant.  Follow-up information from the consumer indicated she was still covered in "these blisters" and neither her physician or dermatologist could tell her what they are.  This is one of three reports received from the same source.  Additional information has been requested. 06/24/08 This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information from the physician assistant indicated that the patient has an odd rash: It was a fine papular rash when she saw the patient. The rash is more diffuse now, but was still present. The physician assistant reported the patient indicated the rash is vesicular at times. She asked the patient to come in during a vesicular time to obtain a specimen. The patient also stated her arms swell and get tiny blisters on them. The symptoms come and go with no apparent cause or reason and her back "feels like it is on fire". This is one of several reports received from the same source. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pruritus, Rash, Rash vesicular, Scab
Clinical narrative: Information has been received from a 60 year old female consumer with multiple sclerosis, leukemia, allergies to iodine, and AVONEX, with a history of chemotherapy who on 13-DEC-2007 was vaccinated in the right arm with a dose of Zostavax (Oka/Merck) (lot # 658396/0967U).  Concomitant therapy included ALTACE, PAXIL and PROVIGIL.  She reported that after she received the vaccine (December 2007) she developed a headache.  Medical attention sought and outcome in regard to the headache was not reported.  She also reported that 2 days after the vaccination (December 2007), her arms swelled up, and she had blisters that started to itch.  She reported that she would scratch them open but they would not get infected, and were not filled with pus.  On an unspecified date, she developed a rash on her face, scalp, shoulders, and the tops of her legs.  She described the rash as bumps that looked like they were underneath the skin everyday and every 4 to 5 days they would "break out and scab".  She was evaluated by a dermatologist and underwent diagnostics that included: a "swab" of the blisters "(ruled out chicken pox"); and an unspecified "biopsy for shingles".  The patient indicated that since "having leukemia and chemo, she has had no immune system" and had not recovered.  A product quality complaint was not reported.  Follow up information from a physicians assistant indicated that the skin biopsy obtained by the dermatologist revealed non-specific dermatitis and did not confirm herpes zoster or any varicella related rash.  At the time of this report, current patient status was not reported by the physician assistant.  Follow-up information from the consumer indicated she was still covered in "these blisters" and neither her physician or dermatologist could tell her what they are.  This is one of three reports received from the same source.  Additional information has been requested. 06/24/08 This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information from the physician assistant indicated that the patient has an odd rash: It was a fine papular rash when she saw the patient. The rash is more diffuse now, but was still present. The physician assistant reported the patient indicated the rash is vesicular at times. She asked the patient to come in during a vesicular time to obtain a specimen. The patient also stated her arms swell and get tiny blisters on them. The symptoms come and go with no apparent cause or reason and her back "feels like it is on fire". This is one of several reports received from the same source. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin test
Clinical narrative: Information has been received from a 60 year old female consumer with multiple sclerosis, leukemia, allergies to iodine, and AVONEX, with a history of chemotherapy who on 13-DEC-2007 was vaccinated in the right arm with a dose of Zostavax (Oka/Merck) (lot # 658396/0967U).  Concomitant therapy included ALTACE, PAXIL and PROVIGIL.  She reported that after she received the vaccine (December 2007) she developed a headache.  Medical attention sought and outcome in regard to the headache was not reported.  She also reported that 2 days after the vaccination (December 2007), her arms swelled up, and she had blisters that started to itch.  She reported that she would scratch them open but they would not get infected, and were not filled with pus.  On an unspecified date, she developed a rash on her face, scalp, shoulders, and the tops of her legs.  She described the rash as bumps that looked like they were underneath the skin everyday and every 4 to 5 days they would "break out and scab".  She was evaluated by a dermatologist and underwent diagnostics that included: a "swab" of the blisters "(ruled out chicken pox"); and an unspecified "biopsy for shingles".  The patient indicated that since "having leukemia and chemo, she has had no immune system" and had not recovered.  A product quality complaint was not reported.  Follow up information from a physicians assistant indicated that the skin biopsy obtained by the dermatologist revealed non-specific dermatitis and did not confirm herpes zoster or any varicella related rash.  At the time of this report, current patient status was not reported by the physician assistant.  Follow-up information from the consumer indicated she was still covered in "these blisters" and neither her physician or dermatologist could tell her what they are.  This is one of three reports received from the same source.  Additional information has been requested. 06/24/08 This is in follow-up to report(s) previously submitted on 3/26/2008. Follow-up information from the physician assistant indicated that the patient has an odd rash: It was a fine papular rash when she saw the patient. The rash is more diffuse now, but was still present. The physician assistant reported the patient indicated the rash is vesicular at times. She asked the patient to come in during a vesicular time to obtain a specimen. The patient also stated her arms swell and get tiny blisters on them. The symptoms come and go with no apparent cause or reason and her back "feels like it is on fire". This is one of several reports received from the same source. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 74 year old female with hypertension and hypercholesterolemia, with a history of thyroid cancer and basal cell carcinoma who on 18-JAN-2008, was vaccinated with a subcutaneous single dose of ZOSTAVAX.  Concomitant therapy included hydrochlorothiazide, aspirin and "cholesterol medicine" (therapy unspecified).  One day after receiving the vaccine (19-JAN-2008), the patient developed a 4 cm by 5 1/2 cm area of redness with a single blister at the injection site.  On 21-JAN-2008, she was examined by the physician in the office.  No diagnostic or laboratory studies were performed.  The physician indicated that the patient's symptoms were resolving without requiring treatment.  A product quality complaint was not reported.  This is one of two cases from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Musculoskeletal discomfort, Paraesthesia, Rash macular
Clinical narrative: Information has been received from a physician and pharmacist concerning a female who on 28-DEC-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  Subsequently "the patient developed a shingles-like reaction."  The pharmacist stated that the patient had a tingling uncomfortable feeling in her upper back and also tiny red blotches in that area.  The pharmacist stated that the patient sought medical attention through a physician who stated that the patient "could have developed a mild case of shingles."  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Information has been received from a pharmacy technician concerning a female who in approximately June 2007, was vaccinated with a dose of Zostavax (Oka/Merck).  In approximately July 2007, the patient developed a widespread rash that was red, itchy and bumpy.  The rash had been persistent, with newly developed lesions in a widespread distribution.  The patient was examined by her unspecified physician and was treated with an antihistamine.  The symptoms have not improved thus far.  It was noted that the patient was scheduled for a dermatologic consult in the near future.  There was no product quality complaint.  Additional information has been received from a pharmacy technician indicated that the patient was sent to a dermatologist and was given antihistamine.  The rash cleared two weeks after the original adverse event was filed.  No additional information was provided.  Follow-up information received indicated that there was no additional information in regards to this case.  No additional information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a male consumer who on 06-JAN-2008 was vaccinated with 0.65 ml of Zostavax (Oka/Merck).  On 06-JAN-2008 the patient developed redness and swelling at the injection site.  At the time of reporting the patient had not yet recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with Zostavax (Oka/Merck) and one week later developed chickenpox.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Information has been received from a nurse concerning her 63 year old mother with allergies to penicillin and codeine, who on 04-JAN-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included vitamins (unspecified). On an unspecified date, the patient developed a 1 and 1/2 inch by 1 inch induration and the site was pretty red. The patient sought medical attention by calling her daughter who is a nurse. No diagnostic or laboratory studies were performed. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Blister, Burning sensation, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Information has been received from a 64 year old male consumer with hiatal hernia cancer of the leg, lower back problems, allergies to sulfa and CIPRO, with a history of prostatitis who on 28-SEP-2007 was vaccinated with 0.5 ml subcutaneous in the left arm of Zostavax (Oka/Merck) (lot# "108484").  Concomitant vaccination included influenza in the opposite arm (right).  Concomitant medications included CLARITIN, FLONASE, NEXIUM, ADVAIR, baby aspirin, and FLOMAX.  There was no reported history of chicken pox, and no reported recent exposure to chicken pox or herpes zoster.  He reported that later that evening (28-SEP-2007), he developed a blister-like rash on the middle of his back.  He also experienced a burning and itching sensation all over his body.  The next day (29-SEP-2007), he developed red, itchy, non-fluid bumps on his chest area.  Since then the red itchy bumps developed in any area that was exposed to heat or became warm.  He has had the rash on the back of his neck, crotch area, legs, palms of his hands, and feet.  The rash usually cleared if he self administered BENADRYL and applied cool compresses.  On an unspecified date, he was examined by his physician and was prescribed a tapered dose of prednisone for 6 days.  He developed hives and redness over his entire body after the first day of starting the prednisone (date not reported).  By the end of the sixth day of prednisone, the hives had resolved and he was back to the state he was prior to starting the prednisone.  The blisters on his back have scabbed and healed.  The patient's physician reported that on day # 4 post vaccination (02-OCT-2007), he developed a red itchy rash at the injection site.  Medical attention sought for the site events was not reported.  There was no reported collection of a specimen for "PCR" or a direct fluorescent antibody.  The physician reported that on an unspecified date, the patient had recovered.  It was noted that the patient started radiation therapy three weeks after the administration of Zostavax (Oka/Merck).  A product quality complaint was not reported.  This is one of two reports from the same source.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Scab
Clinical narrative: Information has been received from a 64 year old male consumer with hiatal hernia cancer of the leg, lower back problems, allergies to sulfa and CIPRO, with a history of prostatitis who on 28-SEP-2007 was vaccinated with 0.5 ml subcutaneous in the left arm of Zostavax (Oka/Merck) (lot# "108484").  Concomitant vaccination included influenza in the opposite arm (right).  Concomitant medications included CLARITIN, FLONASE, NEXIUM, ADVAIR, baby aspirin, and FLOMAX.  There was no reported history of chicken pox, and no reported recent exposure to chicken pox or herpes zoster.  He reported that later that evening (28-SEP-2007), he developed a blister-like rash on the middle of his back.  He also experienced a burning and itching sensation all over his body.  The next day (29-SEP-2007), he developed red, itchy, non-fluid bumps on his chest area.  Since then the red itchy bumps developed in any area that was exposed to heat or became warm.  He has had the rash on the back of his neck, crotch area, legs, palms of his hands, and feet.  The rash usually cleared if he self administered BENADRYL and applied cool compresses.  On an unspecified date, he was examined by his physician and was prescribed a tapered dose of prednisone for 6 days.  He developed hives and redness over his entire body after the first day of starting the prednisone (date not reported).  By the end of the sixth day of prednisone, the hives had resolved and he was back to the state he was prior to starting the prednisone.  The blisters on his back have scabbed and healed.  The patient's physician reported that on day # 4 post vaccination (02-OCT-2007), he developed a red itchy rash at the injection site.  Medical attention sought for the site events was not reported.  There was no reported collection of a specimen for "PCR" or a direct fluorescent antibody.  The physician reported that on an unspecified date, the patient had recovered.  It was noted that the patient started radiation therapy three weeks after the administration of Zostavax (Oka/Merck).  A product quality complaint was not reported.  This is one of two reports from the same source.  Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a 64 year old male consumer with hiatal hernia cancer of the leg, lower back problems, allergies to sulfa and CIPRO, with a history of prostatitis who on 28-SEP-2007 was vaccinated with 0.5 ml subcutaneous in the left arm of Zostavax (Oka/Merck) (lot# "108484").  Concomitant vaccination included influenza in the opposite arm (right).  Concomitant medications included CLARITIN, FLONASE, NEXIUM, ADVAIR, baby aspirin, and FLOMAX.  There was no reported history of chicken pox, and no reported recent exposure to chicken pox or herpes zoster.  He reported that later that evening (28-SEP-2007), he developed a blister-like rash on the middle of his back.  He also experienced a burning and itching sensation all over his body.  The next day (29-SEP-2007), he developed red, itchy, non-fluid bumps on his chest area.  Since then the red itchy bumps developed in any area that was exposed to heat or became warm.  He has had the rash on the back of his neck, crotch area, legs, palms of his hands, and feet.  The rash usually cleared if he self administered BENADRYL and applied cool compresses.  On an unspecified date, he was examined by his physician and was prescribed a tapered dose of prednisone for 6 days.  He developed hives and redness over his entire body after the first day of starting the prednisone (date not reported).  By the end of the sixth day of prednisone, the hives had resolved and he was back to the state he was prior to starting the prednisone.  The blisters on his back have scabbed and healed.  The patient's physician reported that on day # 4 post vaccination (02-OCT-2007), he developed a red itchy rash at the injection site.  Medical attention sought for the site events was not reported.  There was no reported collection of a specimen for "PCR" or a direct fluorescent antibody.  The physician reported that on an unspecified date, the patient had recovered.  It was noted that the patient started radiation therapy three weeks after the administration of Zostavax (Oka/Merck).  A product quality complaint was not reported.  This is one of two reports from the same source.  Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Hemicephalalgia, Nuclear magnetic resonance imaging normal, Red blood cell sedimentation rate normal
Clinical narrative: Information has been received from an 83 year old male female with asthma, hypothyroidism, hypercholesterolemia, osteoporosis, hypertension and drug allergies to PRONESTYL, THEODUR, quinidine, ACTONEAL, EVISTA, FELDENE, and VICODIN, who on 08-AUG-2007 was vaccinated with Zostavax (Oka/Merck). Concomitant therapy included SYNTHROID, ZESTRIL, ezetimibe (MSD), FLOVENT, albuterol (inhaler), calcium (unspecified) and vitamins (unspecified). About six weeks (19-SEP-2007) after she received the vaccine, she developed a left sided headache. She described the pain as being located behind her left ear and radiated to the back of her head. She was examined in the office by her primary care physician who referred her for a neurological evaluation. She underwent diagnostic studies that included: sedimentation rate (normal) and an MRI of the brain (normal). The patient was referred to a pain management clinic, but the headache resolved on 01-JAN-2008, without requiring the pain management evaluation. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from an 82 year old male with an unspecified blood pressure disorder and a history of sulfonamide and statin allergy who on 01-FEB-2007 was vaccinated subcutaneously with 0.65 ml of Zostavax (Oka/Merck) ( Lot # 656413/1477F).  Concomitant therapy included "beta blockers" and "blood pressure medication".  In DEC 2007, approximately one month prior to reporting, the patient developed a rash on his arms and the center of his back after receiving the Zostavax (Oka/Merck) vaccine.  The consumer reported that the rash lasted approximately three weeks.  At the time of reporting the consumer noted he was recovering.  There were no lab diagnostic studies performed.  There was no product quality complaint.  Additional information is not expected.
Age: 92.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 92 year old female who in "October 2007", was vaccinated with Zostavax (Oka/Merck). Within the "past week" in approximately Jan 2008, and approximately three months after receiving Zostavax (Oka/Merck), the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patient's status was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who in "early" December 2007, was vaccinated with Zostavax (Oka/Merck).  Five to six days post vaccination the patient developed a rash on her face.  The rash remitted, and the patient developed another rash on the opposite side of the face (date unspecified).  The physician prescribed an antibiotic to treat the rash.  The rash resolved.  There were no other symptoms or treatment.  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Oedema peripheral, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old male with allergic reaction to bee sting who on 07-DEC-2007 was vaccinated with Zostavax (Oka/Merck) ( lot # 658604/1088U).  On 09-DEC-2007, two days after vaccination the patient developed injection site rash.  The rash was on the injection site arm and the whole lower arm was swollen, warm and red.  The pharmacist reported that on 10-DEC-2007 the patient was treated with a steroid dose pack.  The patient sought medical attention.  No product quality complaint was involved.  The physician reported that the patient recovered.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with Zostavax (Oka/Merck) .65mL sub cutaneous.  Subsequently the patient developed cellulitis.  Subsequently, the patient recovered from cellulitis.  The patient sought unspecified medical attention.  There was no product quality complaint involved.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Contusion, Electrocardiogram, Fatigue, Feeling abnormal
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.