chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 77 year old male who on 14, Mar 2007 was vaccinated with a 0.65 ml dose of zoster vaccine live (Oka/Merck). On 14, Mar 2007 the patient experienced a severe red swollen arm at the injection site. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No additional information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a 0.65 mL dose of Zostavax. Subsequently the patient experienced an outbreak of shingles. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. This is in follow-up to report(s) previously submitted on 4/13/2007.  Additional information from the physician indicated that no further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Medication error, No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 69 year old female who on 16, Mar 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) rather that varicella virus vaccine live (Oka/Merck) (MSD). It was reported that there was confusion with which vaccine the patient was supposed to get after she lost her prescription and both vaccines were on back order. Unspecified medical attention was sought. At the time of the report the patient had not had any adverse reactions. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a 77 year old female who on 24-FEB-2007 was vaccinated with a dose of Zostavax. On 16-Mar-2007 the patient developed a rash on her face. The pharmacist referred the patient to a physician for an assessment. It was not reported if additional medical attention was sought. No further information available. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: VARZOS
Symptoms: Medication error, No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a physician assistant concerning a 26 year old male who on 19, Mar 2007 was vaccinated with a 0.65 ml dose of zoster vaccine  live (Oak/Merck) instead of varicella virus vaccine live (Oak/Merck) (MSD). No adverse experience was reported. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered nurse concerning a male over 60 years old who on 16, Mar 2007 was vaccinated in the forearm with a 0.65 ml dose if zoster vaccine live (Oka/Merck). Subsequently, the patient developed a rash. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with no known history or allergies who on 16-MAR-2007 was vaccinated SC in the left deltoid with a dose of Zostavax (lot# 656607/0163U). On 17-MAR-2007 the patient experienced redness, swelling, itching, warm to touch and tenderness at the injection site. The skin area is raised a little bit and the size of the area is the diameter of an apple. The patient has no pain. When pressure is applied to the injection site there is a lump that is felt. Unspecified medical attention was sought. No laboratory test were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is expected.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with no known history or allergies who on 16-MAR-2007 was vaccinated SC in the left deltoid with a dose of Zostavax (lot# 656607/0163U). On 17-MAR-2007 the patient experienced redness, swelling, itching, warm to touch and tenderness at the injection site. The skin area is raised a little bit and the size of the area is the diameter of an apple. The patient has no pain. When pressure is applied to the injection site there is a lump that is felt. Unspecified medical attention was sought. No laboratory test were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture positive, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning an 80 year old female who was vaccinated with a dose of zoster vaccine live (Oka/Merck). The patient has a severe case of chicken pox". There was an unknown number of lesions. The patient sought unspecified medical attention. The patient's outcome was not reported. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin lesion
Clinical narrative: Information has been received from a registered nurse who on 23-FEB- 2007 was vaccinated SC with a 0.5 ml dose of Zostavax (lot# 656413/1477F). There was no concomitant medication. About two weeks post vaccination, on approximately 09-MAR-2007 she experienced 4 itchy, non-vesicular bumps on her forehead and on the side of her nose. Medical attention was sought. The nurse reported that she was treated with valacyclovir hydrochloride (VALTREX), and the bumps resolved. A product quality complaint was not involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Medication error, Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 12 to 15 month old patient who was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of a dose of varicella virus vaccine live (Oka/Merck) (MSD). It was to have been the patient's first dose of varicella virus vaccine live (MSD). A product quality complaint was not involved. Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a certified medical assistant concerning a 52 year old female with no known allergies, breast cancer and hypothyroidism who on 26, Feb 2007 was vaccinated IM in the right deltoid with one single dose of zoster vaccine live (Oka/Merck) (lot# 656412/1476F). Concomitant therapy included divalproex sodium (DEPAKOTE), tiagabine hydrochloride (GABATRIL), escitalopram oxalate (LEXAPRO), tamoxifen citrate. levothyrcxine Na (SYNTHROID) and cimetidine (TAGAMET). A few days after vaccination, on approximately 01, Mar 2007, the patient developed swelling, redness, pain and warmth at the injection site. The patient had decreased range of motion of her right arm. The patient was examined on 02, Mar 2007 and was prescribed a course of cephalexin (KEFLEX), prednisone and acetaminophen (+) oxycodone hydrochloride (PERCOCET). There were no lab studies performed. Follow-up exams on 05, Mar 2007 and 09, Mar 2007 revealed that the injection site was still swollen and painful but the redness and warmth had resolved. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a patient who on 23-MAR-2007 was vaccinated with a dose of Zostavax when varicella (MSD) was ordered. No adverse experience was related to this event. The physician reported that this was not product confusion, but related to staff misinformation. A product quality complaint was not involved.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a 64 year old female registered dental hygienist with osteopenia and an allergy to an unspecified antibiotic that " started with a C" who on 13-MAR-2007 was vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included risedronate sodium (ACTONEL). On 17-MAR-2007 four days after vaccination, the patient developed red itchy patches on her arm. A few days later her stomach started itching but she did not have any visible rash on her stomach. She stated that she did not have any break through varicella-like lesions. No medical attention was sought and no diagnostic laboratory tests were performed. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female who in December 2006, was vaccinated with a "normal dose" of zoster vaccine live (Oka/Merck). In December 2006, after vaccination the patient experienced redness, swelling in an approximately 3 inch by 3 inch area around the injection site. This lasted for two weeks before it subsided. Subsequently, the patient recovered on unspecified therapy. Medical attention was not sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Follow-up information has been received from a registered nurse.  It was noted that the patient had a history of postherpetic neuralgia, hemifacial spasm, hypothyroidism and Saltmann's nodular dystrophy in November 1990.  She was vaccinated SC in the right upper armwith a first dose of ZOSTAVAX (Merck) (lot # 652966/0623F) on 14-DEC-2006 at 09:35.  Concomitant therapy included ASPIRIN 43 mg daily, SYNTHROID 50 mcg daily, mulitivitamin, folic acid and chondroitin sulfate sodium (+) glucosamine sulfate.  There was no illness at the time of vaccination.  When the patient was in the office on 22-MAR-2007 she mentioned a reaction she had "back in December" to the vaccine.  At that time she stated that she got a 3 inch diameter welt with erythema after shot.  After 2 weeks it went away and the patient recovered.  The patient had no other problems or concerns since.  No further information was provided.  Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 81 year old female consumer with no known history or allergies who on 06, Mar 2007 was vaccinated SC with a 0.65 ml dose of zoster vaccine live (Oka/Merck). Concomitant therapy included atorvastation calcium (LIPITOR), and alendronate sodium (MSD). On 15, Mar 2007 the patient developed shingles. Unspecified medical attention was sought. No laboratory test were performed. At the time of the report the patient was recovering. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Anorexia, Decreased appetite, Fatigue
Clinical narrative: Information has been received from a 64 year old female with no allergies and hypertension who on 22-MAR-2007 was vaccinated SC with a dose of Zostavax . Concomitant therapy included atenolol (manufacturer unknown), Klor-con. On 22-MAR-2007, the patient experienced fatigue, shortly after receiving the vaccine. On 23-MAR-2007, she also experienced a loss of appetite which still continued at the time of the report. Her energy level had improved. Unspecified medical attention was sought.  No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Additional inforamtion has been received from a physician who reported that on 23-Mar-2007 at 1:00 AM (previously reported as 22-Mar-2007), the patient experienced anorexia and fatigue. The patient recovered on 25-Mar-2007. The patient had no adverse events following prior vaccination. No further information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Aspartate aminotransferase increased, Blister, Blood glucose increased, Blood test
Clinical narrative: Information has been received from a 60 year old female licensed practical nurse with allergies to unspecified narcotics and Compazine and no medical history who on 19-MAR-2007 was vaccinated with a dose of Zostavax (lot # 656609/0015U). There was no concomitant medication. On approximately 21-MAR-2007, 24 to 36 hours after vaccination, the patient developed a "light" case of shingles on her back and waist. She went to the emergency room and was prescribed prednisone and Famvir. Unspecified blood work and urology work were performed (results not provided). At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a 60 year old female with allergies to unspecified narcotics and COMPAZINE and no medical history who on 19-MAR-2007 at 16:00 was vaccinated SC in the left upper arm with a first dose of ZOSTAVAX (Oka/Merck) (lot # 656609/0015U). There was no concomitant medication. There was no illness at the time of vaccination. On 19-MAR-2007 at "14:00" the patient developed pain in her right "mid quadrant" and she went to the ER for treatment. On 24-MAR-2007 (previously reported as 24 to 36 hours after vaccination), shingles blisters appeared (reported to be a "light" case of shingles) on her back and waist. She went to the emergency room, labs were performed and the patient was prescribed prednisone 30 mg po bid for 7 days, then 15 mg bid for 7 days, then 15 mg daily for 7 days and FAMVIR 1 capsule po daily. At the time of the report, the patient's recovery status was unknown. A product quality complaint was not involved. The patient had no AE's following prior vaccination. It was noted that the patient works in a hospital environment with patient contact with immunocompromised patients. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the Oka/Merck vaccine VZV strain. Specimens were obtained from large swabs from the patient's throat and back. It was reported that these specimens were inadequate. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture throat, Globulins increased, Herpes zoster, Herpes zoster, Laboratory test
Clinical narrative: Information has been received from a 60 year old female licensed practical nurse with allergies to unspecified narcotics and Compazine and no medical history who on 19-MAR-2007 was vaccinated with a dose of Zostavax (lot # 656609/0015U). There was no concomitant medication. On approximately 21-MAR-2007, 24 to 36 hours after vaccination, the patient developed a "light" case of shingles on her back and waist. She went to the emergency room and was prescribed prednisone and Famvir. Unspecified blood work and urology work were performed (results not provided). At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a 60 year old female with allergies to unspecified narcotics and COMPAZINE and no medical history who on 19-MAR-2007 at 16:00 was vaccinated SC in the left upper arm with a first dose of ZOSTAVAX (Oka/Merck) (lot # 656609/0015U). There was no concomitant medication. There was no illness at the time of vaccination. On 19-MAR-2007 at "14:00" the patient developed pain in her right "mid quadrant" and she went to the ER for treatment. On 24-MAR-2007 (previously reported as 24 to 36 hours after vaccination), shingles blisters appeared (reported to be a "light" case of shingles) on her back and waist. She went to the emergency room, labs were performed and the patient was prescribed prednisone 30 mg po bid for 7 days, then 15 mg bid for 7 days, then 15 mg daily for 7 days and FAMVIR 1 capsule po daily. At the time of the report, the patient's recovery status was unknown. A product quality complaint was not involved. The patient had no AE's following prior vaccination. It was noted that the patient works in a hospital environment with patient contact with immunocompromised patients. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the Oka/Merck vaccine VZV strain. Specimens were obtained from large swabs from the patient's throat and back. It was reported that these specimens were inadequate. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neutrophil count increased, Polymerase chain reaction
Clinical narrative: Information has been received from a 60 year old female licensed practical nurse with allergies to unspecified narcotics and Compazine and no medical history who on 19-MAR-2007 was vaccinated with a dose of Zostavax (lot # 656609/0015U). There was no concomitant medication. On approximately 21-MAR-2007, 24 to 36 hours after vaccination, the patient developed a "light" case of shingles on her back and waist. She went to the emergency room and was prescribed prednisone and Famvir. Unspecified blood work and urology work were performed (results not provided). At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow-up information has been received from a 60 year old female with allergies to unspecified narcotics and COMPAZINE and no medical history who on 19-MAR-2007 at 16:00 was vaccinated SC in the left upper arm with a first dose of ZOSTAVAX (Oka/Merck) (lot # 656609/0015U). There was no concomitant medication. There was no illness at the time of vaccination. On 19-MAR-2007 at "14:00" the patient developed pain in her right "mid quadrant" and she went to the ER for treatment. On 24-MAR-2007 (previously reported as 24 to 36 hours after vaccination), shingles blisters appeared (reported to be a "light" case of shingles) on her back and waist. She went to the emergency room, labs were performed and the patient was prescribed prednisone 30 mg po bid for 7 days, then 15 mg bid for 7 days, then 15 mg daily for 7 days and FAMVIR 1 capsule po daily. At the time of the report, the patient's recovery status was unknown. A product quality complaint was not involved. The patient had no AE's following prior vaccination. It was noted that the patient works in a hospital environment with patient contact with immunocompromised patients. The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type strain or with the Oka/Merck vaccine VZV strain. Specimens were obtained from large swabs from the patient's throat and back. It was reported that these specimens were inadequate. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immune system disorder, Injection site pustule, Listless, Pruritus
Clinical narrative: Information has been received from a 67 year old retired female registered nurse with allergies to penicillin, cephalexin (KEFLEX) and a history of hysterectomy on 13-JUN-2003, who on Thursday, 22-MAR-2007 was vaccinated SC below the right deltoid with a dose of Zostavax. Concomitant therapy included lisinopril-HCTZ (MSD), estradiol (ESTRACE) 1 mg, atorvastatin calcium (LIPITOR) 10 mg and venlafaxine HCl (EFFEXOR XR) 150. On approximately 23-MAR-2007 (reported to be by Friday night or Saturday morning) the patient noticed about 3 pustules under the injection site, was feeling listless and some itching. The reporter stated that she was under a lot of stress at the time of vaccination due to the loss of her sister in December. The patient stated that this may have made her immune system low. At the time of the report medical attention had been sought though the patient confirmed that she would follow up with her physician. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Varicella
Clinical narrative: Information has been received from a physician concerning a 65 year old female who on an unspecified date was vaccinated SC with a dose of Zostavax (lot # 652936/0981F). It was noted that the patient was on other unspecified medications. One of two weeks after vaccination, the patient experienced a breakout of chickenpox. The physician reported that he swabbed the pocs. sent the cultures to a laboratory, and referred the patient to a dermatologist. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. Dose/frequency and therapy route were not reported. Subsequently the patient experienced rash. Medical attention was sought. The patient's outcome was unknown. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated subcutaneously with a "single dose vial" of Zostavax (lot# 654604/1405F) on an unspecified date. It was reported that the patient was taking concomitant therapy, however, the specific medications are unspecified. Subsequently, two weeks post vaccination (on an unspecified date) the patient developed some chickenpox. The physician reported that the patient developed a full-blown break out of chickenpox 3 months post vaccination. Medical attention was sought and it was reported that the physician swabbed the pox and sent culture to a lab. The patient was referred to a dermatologist. The outcome was unspecified. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female patient who on 22-MAR-2007 was vaccinated with a 0.5 mL dose of Zostavax. On 25-MAR-2007 the patient experienced swelling and redness at the injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of Zostavax. Subsequently he experienced injection site rash which was characterized by the physician as "not zoster like rash". Medical attention was sought. Subsequently, he received from injection site rash. The product quality complaint was not involved. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic
Clinical narrative: Information has been received from a physician concerning an "around 85 year old" male with an allergy to egg, who "recently" was vaccinated with "single dose vial" of Zostavax. Subsequently about a week later the patient developed an allergic dermatitis rash. The physician did not think that the rash was vaccine related. Medical attention was sought. Subsequently, the patient recovered from an allergic dermatitis rash. The product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Rash papular
Clinical narrative: Information has been received from a physician concerning a 65-year-old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently, four days after the vaccination, the patient developed a soreness and had a red papule on the patient's upper shoulder opposite to where the vaccine was administered. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular, Skin lesion
Clinical narrative: Information has been received from a physician concerning one of her female nurses who was 60 years of age with high blood pressure, who on 15-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included losartan potassium (MSD), 50 mg daily; and atenolol, 25 mg daily. On 29-MAR-2007, while in the shower, the patient noticed she had developed 7 red spots along the thorax that are unilateral. The lesions are papular, none appeared to be vesicular, which the physician believes is shingles. It was reported that she had no other signs or symptoms, no pain and "does not feel sick". There was no recent varicella exposure. The patient was scheduled to be seen by the physician on 31-MAR-2007. At the time of this report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered nurse concerning a 74 year old male who on 21-Mar-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). On 26-Mar-2007 the patient presented with shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information received from the registered nurse indicated that the patient recovered on an unspecified date. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash, Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a registered nurse concerning a 71 year old male with no known allergies, hypertension, benign prostatic hyperplasia and hyperlipidaemia and a history of appendicectomy and prostate surgery who on 22-MAR-2007 was vaccinated SC in the left deltoid with a 0.65 ml (also reported as a 0.5 ml) dose of Zostavax (lot # 656413/1477F). Concomitant therapy included simvastatic (manufacturer unknown), NORVASC, minerals (unspecified) (+) vitamins (unspecified) (CENTRUM SILVER) and finasteride (manufacture unknown). The patient called the office on 29-MAR-2007 and reported that "sometime during the past 2 days" on approximately 27-MAR-2007 he developed a red rash with fluid filled blisters on his abdomen. The patient was going to go to the office for evaluation. At the time of the report no lab tests had been reported. There was no product quality complaint involved. Additional information from the physician indicated that the patient was seen in the office on 29-MAR-2007. The physician obtained several swab samples from vesicular lesions. The physician planned to enroll the patient 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 or with the manufacturer vaccine VZV strain. No further information was provided. Additional information received from the physician indicated that on 23-MAR-2009 the patient developed 4 herpes zoster lesions olong the T8 dermatome on the left. It was reported tht the patient had no recent exposure to chickenpox or shingles. On 29-MAR-2007 swabs were obtained form vesicular lesions, these specimens were sent to the lab on 17-APR-2007. The specimen was an adequate specimen and was determined to be wild type strain. At the time of the report the patient had not yet recovered. Additional information received from the physician indicated that patient's current status was recovered (no recovery date provided). No additional information is expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Information has been received from a 70 year old female consumer with a history of a swelling reaction when administered a tetanus shot, who on 27-MAR-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On 28-MAR-2007 the patient experienced a red spot at the injection site. The patient also mentioned that the area was hard and painful when touched. Medical attention was not sought, there were no labs performed. At the time of the report the patient had not recovered. There was no product quality involved. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash
Clinical narrative: Information has been received from a registered nurse concerning a male who on 15-MAR-2007 was vaccinated with a dose of Zostavax (lot # 656413/1477F). Eight hours after vaccination, the patient broke out with a blistering rash on her neck. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a female with a history of herpes zoster who on 23-FEB-2007 was vaccinated with a dose of Zostavax. On 29-MAR-2007 the patient experienced zoster like rash. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a healthcare worker concerning a female who on 27-MAR-2007 was vaccinated with a dose of Zostavax. On 28-MAR-2007 the patient experienced inflammation and redness at the injection site. The patient's inflammation and redness at the injection site persisted. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Anorexia, Back pain, Chills, Computerised tomogram, Computerised tomogram
Clinical narrative: Information has been received from a 61 year old male with no known history of allergies who on 16-MAR-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On approximately 23-MAR-2007 (reported as a week after getting the vaccine) the patient experienced pain on his right side around the kidney area, chills and loss of appetite. A CT Scan and blood work were performed (results no reported). The patient's pain on his right side around the kidney area and chills and loss of appetite persisted. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/13/2007.  Additional information was received.  On 23-MAR-2007 the physician reported that the patient experienced low back pain/chills.  The patient was evaluated further by his orthopedist.  It was also reported that symptoms felt to be due to back strain.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a 61 year old male with no known history of allergies who on 16-MAR-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On approximately 23-MAR-2007 (reported as a week after getting the vaccine) the patient experienced pain on his right side around the kidney area, chills and loss of appetite. A CT Scan and blood work were performed (results no reported). The patient's pain on his right side around the kidney area and chills and loss of appetite persisted. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/13/2007.  Additional information was received.  On 23-MAR-2007 the physician reported that the patient experienced low back pain/chills.  The patient was evaluated further by his orthopedist.  It was also reported that symptoms felt to be due to back strain.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a medical assistant concerning a male who was vaccinated with a dose of Zostavax. Subsequently, the patient developed a non-painful rash on the neck, that the physician identified as shingles. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity
Clinical narrative: Information has been received from a 61 year old male with allergy to "NEOSPAN" who in approximately December 2006 (reported as "2 or 3 months ago"), was vaccinated with a dose of Zostavax. Concomitant vaccination included influenza (unspecified). On approximately 24-MAR-2007 the patient"came down with shingles". The patient experienced pain in legs, "calfs", and above left kidney. Outcome was reported as recovering. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Information has been received from a 66 year old female consumer with no known allergies with a thyroid disorder who on 28-MAR- 2007 was vaccinated with a dose of Zostavax. Concomitant therapy included levothyroxine Na (SYNTHROID) and esomeprazole magnesium (NEXIUM). On 28-MAR-2007 the patient experienced muscle pain throughout her body. At the time of the report, the patient had not recovered. Unspecified medial attention was sought. No product quality complaint involved. No further information is available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Information has been received from a nurse practitioner concerning a 72 year old male with no known medical history who on 05-FEB-2007 was vaccinated with a .065 ml dose of Zostavax vaccine live. On 12-FEB-2007 the patient developed a rash at the injection site of 4x5 cm red, warmth and tenderness. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow up information has been received from a nurse practitioner concerning a 72 year old retired male with no known allergies or pertinent medical history who on 06-FEB-2007 was vaccinated SC in the left deltoid with a 0.65 ml first dose of ZOSTAVAX (lot # 654604/1406F). There was no illness at the time of vaccination. On 12-FEB-2007 the patient developed a rash at the injection site of 4x5 cm red, warmth, tenderness and itching. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Headache, Pyrexia
Clinical narrative: Information has been received from a health professional concerning an approximately 63 year old female with a history of sinus infection in February who on approximately 23-MAR-2007 was vaccinated with a 0.65 ml dose of Zostavax. Within twenty four hours of vaccination the patient experienced a mild fever which went as high as 103 degrees farenheit on the third day. After having the fever for three days, she developed a mild headache. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient experienced an outbreak of shingles. Unspecified medical attention was sought. 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 rash
Clinical narrative: Information has been received from a physician concerning a male Patient who was vaccinated with a dose of Zostavax. Subsequently, he experienced injection site rash which was characterized by the physician as "not zoster like rash". Medical attention was sought. Subsequently, he recovered from injection site rash. The product quality complaint was not involved. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Sensation of heaviness
Clinical narrative: Information has been received from a nurse practitioner concerning a 17 year old female patient who was vaccinated with Gardasil (lot# 655619/1427F) (0.5 ml), intramuscularly in the deltoid. Concomitant therapy included birth control pills. Subsequently the patient complained of heaviness and pain in left arm. The patient outcome was reported as recovered. No product quality complaint was involved.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Insomnia, Mental disorder
Clinical narrative: Information has been received from a dentist concerning his daughter a 16 year old female who on an unspecified date in approximately February 2007, was vaccinated with the first dose of Gardasil (Yeast) (lot# not provided). Subsequently, "within one week of vaccination" the patient developed extreme anxiety, sleeplessness and was in a "bad psychological state". The patient was seen by a counselor for unspecified treatment. The patient was said to be recovering on an unspecified therapy. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Anxiety, Injection site discomfort, Injection site pain, Limb discomfort, Pain
Clinical narrative: Initial and follow up information ahs been received from a Registered Nurse concerning a 26 year old female patient who on 06-NOV-2006 was vaccinated IM in the left deltoid with her first dose of Gardasil, lot #653735-0688F. Concomitant therapy included FLOVENT, albuterol, omeprazole, clindamycin, and DIFFERIN. The patient experienced severe pain and significant discomfort from her neck to her fingers on her left arm after the vaccination. Her symptoms lasted approximately two weeks. medical attention was sought. The patient stated "I ... cut back a little on what I did", however she was able to maintain her normal activities of daily living. She did not take any treatment medications even though it was painful to lift her arm. Due to the severity of her symptoms, the patient was apprehensive in receiving her second dose of Gardasil. She has not yet received her second dose. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a Registered Nurse concerning a 26 year old female patient who on 06-NOV-2006, at 8:15 AM, was vaccinated IM in left deltoid with her first dose of GARDASIL, (lot #653735/0688F). Concomitant therapy included FLOVENT, albuterol, omeprazole (MSD), clindamycin, and DIFFERIN. The patient experienced severe pain and significant discomfort from her neck to her fingers on her left arm after the vaccination. Medical attention was sought. The patient stated "I ... cut back a little on what I did"; however she was able to maintain her normal activities of daily living. She did not take any treatment medications even though it was painful to lift her arm. As of 20-NOV-2006 her symptoms resolved. Due to the severity of her symptoms, the patient was apprehensive in receiving her second dose of GARDASIL. At the time of this report, she has not yet received her second dose. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: Initial and follow up information ahs been received from a Registered Nurse concerning a 26 year old female patient who on 06-NOV-2006 was vaccinated IM in the left deltoid with her first dose of Gardasil, lot #653735-0688F. Concomitant therapy included FLOVENT, albuterol, omeprazole, clindamycin, and DIFFERIN. The patient experienced severe pain and significant discomfort from her neck to her fingers on her left arm after the vaccination. Her symptoms lasted approximately two weeks. medical attention was sought. The patient stated "I ... cut back a little on what I did", however she was able to maintain her normal activities of daily living. She did not take any treatment medications even though it was painful to lift her arm. Due to the severity of her symptoms, the patient was apprehensive in receiving her second dose of Gardasil. She has not yet received her second dose. Additional information has been requested. 07/06/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a Registered Nurse concerning a 26 year old female patient who on 06-NOV-2006, at 8:15 AM, was vaccinated IM in left deltoid with her first dose of GARDASIL, (lot #653735/0688F). Concomitant therapy included FLOVENT, albuterol, omeprazole (MSD), clindamycin, and DIFFERIN. The patient experienced severe pain and significant discomfort from her neck to her fingers on her left arm after the vaccination. Medical attention was sought. The patient stated "I ... cut back a little on what I did"; however she was able to maintain her normal activities of daily living. She did not take any treatment medications even though it was painful to lift her arm. As of 20-NOV-2006 her symptoms resolved. Due to the severity of her symptoms, the patient was apprehensive in receiving her second dose of GARDASIL. At the time of this report, she has not yet received her second dose. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fatigue, Nausea
Clinical narrative: Information has been received from a physician concerning a 13 year old female who in February 2007 "within the last month", was vaccinated IM with a first 0.5 ml dose of Gardasil (yeast). There was no concomitant medication. "Within 24 hours post vaccination" the patient experienced nausea, dizziness, and fatigue, which lasted until the next day. Unspecified medical attention was sought. No treatment was given. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a registered nurse who reported that "most patients" (95%) who were vaccinated with Gardasil (dosage and date not reported). They experienced pain at the injection site. Their symptoms lasted for 1/2 to a couple of days, the average being 1-2 days. No further information was available.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Pain in extremity, Underdose
Clinical narrative: Information has been received from a certified medical assistant concerning a 21 year old female with a history of menstrual migraine who on 08-JAN-2007 was vaccinated with her first dose of Gardasil (lot # 655165/1425F). Concomitant therapy included duloxetine hydrochloride (CYMBALTA). On 08-JAN-2007 the patient experienced redness of the arm and itching at the site of injection, which spread to itching around the injection site. The patient also had pain radiating down the right arm for a few weeks. Unspecified medical attention was sought. Subsequently, the patient recovered after 3 weeks. The medical assistant also mentioned that the patient had been vaccinated on 09-Mar-2007 with her 2nd dose of Gardasil (lot# 656372/0243U) and received less than 1/2 the normal dose for reason unknown. It was reported that the injection site was immediately itchy. No product quality complaint was involved. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Inappropriate schedule of drug administration, Injection site mass, Pruritus
Clinical narrative: Information has been received from a 21 year old female with no pertinent medical history and no history of drug reactions/allergies who on 09-FEB-2007 was vaccinated with first dose of Gardasil (yeast ) (lot # not reported) injection. Concomitant therapy included cefdinir (OMNICEF), cetirizine hydrochloride (ZYRTEC), dexamethasone/tobramycin (TOBRADEX), cough, cold, and flu therapies ("VIGRAMOX") and antihistamine (unspecified). On 09-MAR-2007, the patient was vaccinated with second dose of Gardasil (yeast) (lot # not reported) injection. No concomitant therapy at the time of receiving the second dose of the vaccine. On approximately 09-FEB-2007, following the first injection, the patient experienced slight redness and itching which were gone by the next day (approximately 10-FEB-2007). Medical attention was sought. Also she had a "hard bump" at the injection site which lasted for approximately two weeks (approximately 23-FEB-2007) before going away. The hard bump felt like a knot in her skin. On 09-MAR-2007, the patient received second injection of Gardasil vaccine only one month after the first dose. At the time of reporting, she has not had any adverse experience following the second injection of vaccine. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site nodule, Injection site pain, Paraesthesia
Clinical narrative: Information has been received from a certified medical assistant (CMA) concerning a 25 year old female who on 06-DEC-2006 was vaccinated with first dose of Gardasil (lot # 653736/0868F). On 06-FEB-2007, the patient was vaccinated with second dose of Gardasil (lot # 655165/1425F) IM in the right arm. There was no concomitant medication. On approximately 02-MAR-2007, about one month after the vaccination, the patient experienced tingling and pain at the injection site (unspecified duration), and a lump of undetermined size at the injection site. The patient sought medical attention. at the time of reporting, the tingling and pain at the injection site and lump of undetermined size at the injection site persisted. No other information was available at the time of reporting. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site induration, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 26 year old female who on 15-FEB-2007 was vaccinated with the first dose of Gardasil (yeast) (lot# 655503/0012U). On approximately 22-February-2007, "approximately one week after vaccination", the patient developed a 10 cm. firm, red area at the injection site, and a low grade fever. The patient was scheduled to be seen by a health care provider on 12-MAR-2007. At the time of this report, the outcome of the events was unknown. Additional information has been requested.