chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Fatigue, Nausea, Pain
Clinical narrative: Information has been received from a consumer concerning a female who on 06-SEP-2007 was vaccinated with Zostavax (Oka/Merck) (lot #"01940U").  On 06-SEP-2007 the patient experienced extreme pain from neck to toe, nausea, stomach pain and fatigue.  As of 10-SEP-2007 the patient's extreme pain from neck to toe, nausea, stomach pain and fatigue persisted.  Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Information has been received from a nurse concerning a 79 year old white female with hypothyroidism, drug hypersensitivities to codeine, neomycin sulfate, polymyxin B sulfate and bacitracin zinc (Neosporin), and fluticasone nasal (Flonase) and no other medical history, who on 30-Aug-2007 at 10:00 was vaccinated with the first SC dose of Zostavax (lot #658081/0743U) in the left arm.  On approximately 03-Sep-2007 the patient developed localized erythema > 50 cm in size.  No medical attention was sought.  On 07-Sep-2007 the patient recovered.  Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 75 year old female who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient developed a rash resembling chicken pox on one arm and diffused over other parts of her body, which was not unilateral like zoster.  The physician did not see the patient and only spoke to her on the phone.  She was prescribed an anti-viral and within two weeks the vesicles were gone. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Blister, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an approximately 50 years old female registered nurse with history of chickenpox as a child and allergies and takes diphenhydramine hydrochloride (Benadryl) as and when needed who administered a dose of Zostavax.  It was reported that on 25-Aug-2007 the patient experienced lower abdominal pain for 2 days.  On the third day the patient developed blisters on her lower abdomen.  The patient was seen at office and was diagnosed with shingles.  The patient was treated with acyclovir tablets and cream for 10 days and pregabalin (Lyrica) for pain.  It was reported that the patient's lesions had healed but they were still discovered and she still had pain in the lower abdominal area.  At the time of report the patient had recovered from shingles but not from lower abdominal pain.  A product quality complaint was not involved.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Information has been received from a consumer concerning her 85 year old husband with seborrhoeic dermatitis on scalp, uses pacemaker for an irregular hear beat and history of right knee replacement who on approximately 12-Aug-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy included warfarin sodium (Coumadin), potassium chloride (K-Lor), furosemide, metoprolol succinate (Toprol XL Tablets), omeprazole (MSD) and candesartan cilexetil (Atacand).  On approximately 05-Sep-2007 the patient developed a rash on his lower back.  The patient also developed a bunch of individual rashes which were raised a bit and red in color.  The rashes were causing quite a bit of itching.  The patient had not seen the physicians and the reporter was not sure if the patient had shingles.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a female consumer in her 60's, who is an administrator for her physician's medical group but at a different office.  On an unspecified date she was vaccinated in the arm (laterality not specified) with a dose of Zostavax.  There was no concomitant medication.  Subsequently, 2 days post vaccination, the patient developed a fist sized large, swollen, red area at the injection site which lasted one 1 week.  A nurse at the office reported that she thinks the patient had an allergic type reaction.  Unspecified medical attention was sought.  On an unspecified date the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning her mother with no pertinent medical history or known drug allergies who was vaccinated subcutaneously with a 0.65 milliliter dose of Zostavax.  There was no concomitant medication.  On an unspecified date, the patient developed a blister the size of a band aid at the injection site.  Unspecified medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome is unknown.  No product quality complaint was involved.  Follow-up information was received concerning a 60-year-old white, retired female with no pre-existing allergies, birth defects or medical conditions who was vaccinated in her left arm on 11-Sep-2007 at 4:30 PM with her first dose of Zostavax (lot #658207/0883U).  There was no illness at the time of vaccination.  On 13-Sep-2007 at 10:30 AM the patient developed raised blisters at the injection site that was 15mm x 40mm (previously reported as a blister the size of a band aid).  There was no drainage, fever, soreness or complications.  The patient was completely recovered by 15-Sep-2007.  Additional information is not expected. This is in follow-up to report (s) previously submitted on 12/21/2007. Additional follow-up information was received from the R.N. which stated that the patient received 0.5ml (previously reported as 0.55 ml) of ZOSTAVAX vaccine (Merck). There were "blisters at the injection site, only under the band-aid area. It did not crust over or drain. There was no pain, fever or malaise". Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain
Clinical narrative: Information has been received from a certified medical assistant concerning a 72-year-old female who on 26-Jul-2007 was vaccinated with a 0.6 ml dose of Zostavax (lot #657558/0461U).  Concomitant therapy included levothyroxine Na (Synthroid), estrogens, conjugated (Premarin), hydrochlorothiazide (manufacturer unknown) and amlodipine besylate (Norvasc).  On approximately 22-Aug-2007, (the exact date was unknown, but was documented as occurring several weeks before the patient notified the physician's office which was on 05-Sep-2007) the patient experienced pain and a "knot" at the injection site.  There were no other symptoms or complaints.  Medical treatment was sought by a phone call to the office on 05-Sep-2007.  No laboratory tests or diagnostic procedures were performed.  As of 12-Sep-2007 the injection site pain persisted.  It was unknown if the "knot" persisted.  No product quality complaint was involved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 65-year-old female who about "one month and one week ago," approximately on 05-Aug-2007, was vaccinated subcutaneously with a 0.65 milliliter dose of Zostavax.  On approximately 29-Aug-2007, ("it is unknown when symptoms began, however for at least 2 weeks") the patient experienced pain in the arm (unspecified site) of the injection site.  The pain is experienced when the patient "reaches out".  Symptoms do not include swelling, redness, or rash.  No laboratory or diagnostic studies were performed.  The patient sought medical attention by speaking with the pharmacist.  The outcome was reported as not recovered.  No product quality complaint was involved.  No further information is available.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician via a registered nurse (RN) from the poison control center concerning a 12-month-old male who on 12-SEP-2007 was vaccinated with a dose of Zostavax  (Oka/Merck) instead of Varivax (Oka/Merck).  The reporter stated that the vials looked similar.  Subsequently, the patient experienced no symptoms.  Unspecified medical attention was sought.  No product quality complaint was involved.  Follow-up information states that a relative called the poison control center to report the mix up of vaccinations and that the infant did receive a dose of Varivax (Oka/Merck) after receiving a dose of Zostavax (Oka/Merck).  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry eye, Injection site swelling, Nasopharyngitis
Clinical narrative: Information has been received from a 64-year-old female consumer with penicillin and nitrofurantoin (Macrobid) allergy and a history of surgery in June of 2007, who on 11-Sep-2007 was vaccinated with a dose of Zostavax.  Concomitant therapy included "vaginal cream".  At the end of the day on 11-Sep-2007 the patient experienced "dry eyes, colds and swelling at the injection site".  No medical attention was sought.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning 9 patients between the ages of 4 months and 15 years who were vaccinated with Zostavax (Oka/Merck) rather than Varivax (Oka/Merck) (MSD) during the time period of 01-AUG-2007 and 17-AUG-2007.  None of the patients experienced a reaction, local or systemic.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: Information has been received from a 69 year old female with hypertension who on 10-SEP-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included loratadine (Claritin), vitamins (unspecified), aspirin, amlodipine besylate (Norvasc) and lisinopril.  On 11-SEP-2007 the patient had an increase in her blood pressure from the 120's to the 160's.  The patient's increase in her blood pressure persisted.  The patient did not seek medical attention.  No further information is available.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Dizziness, Vomiting
Clinical narrative: Information has been received from a female who, on an unspecified date, was vaccinated with Zostavax and an influenza virus vaccine (unspecified).  No information was provided with regard to the patient's medical history and concomitant therapy.  Subsequently the patient experienced dizzy spells and vomiting.  The patient did not seek medical attention.  The patient noted she got the vaccines administered at the same time so she did not know which vaccine made her feel that way.  The patient outcome was not provided.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered nurse concerning a female over the age of 60 with no pertinent medical history who on approximately 13-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  On approximately 15-JUL-2007 the patient experienced a varicella-like rash.  The patient sought medical attention and no labs/diagnostics were performed.  Subsequently, the patient recovered from the varicella-like rash.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 66 year old female who on 10-SEP-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included Pneumovax (MSD).  On 10-SEP-2007, the patient developed shingles type injection site rash.  The patient sough medical attention.  As of 13-SEP-2007, the patient was recovering.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Laboratory test, Pruritus, Rash erythematous
Clinical narrative: Initial and follow up information has been received from a nurse concerning a 74 year old female with a history of chicken pox who on 31-AUG-2007 was vaccinated SC in the left arm with a dose of Zostavax (Oka/Merck) (Lot #657765/0585U).  Concomitant therapy included estrogens, conjugated (+) medroxyprogesterone acetate (Prempro).  On 07-SEP-2007 the patient complained of a backache.  On 13-SEP-2007, (previously reported as 11-SEP-2007), the patient developed pain on the right side of her upper back and itching.  This was also described as a shingles like rash.  She subsequently developed a raised red rash on her back and under her right arm.  The patient saw the doctor and a sample of blister was sent to a lab for testing.  The patient was treated with valacyclovir (Valtrex) and prednisone.  The patient was seen in the office on 24-SEP-2007 and the rash was improving, her pain was gone.  The patient is recovering.  The nurse indicated that they sent a scraping of the rash to an outside lab and it was negative for VZV.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash vesicular, Viral test negative
Clinical narrative: Initial and follow up information has been received from a nurse concerning a 74 year old female with a history of chicken pox who on 31-AUG-2007 was vaccinated SC in the left arm with a dose of Zostavax (Oka/Merck) (Lot #657765/0585U).  Concomitant therapy included estrogens, conjugated (+) medroxyprogesterone acetate (Prempro).  On 07-SEP-2007 the patient complained of a backache.  On 13-SEP-2007, (previously reported as 11-SEP-2007), the patient developed pain on the right side of her upper back and itching.  This was also described as a shingles like rash.  She subsequently developed a raised red rash on her back and under her right arm.  The patient saw the doctor and a sample of blister was sent to a lab for testing.  The patient was treated with valacyclovir (Valtrex) and prednisone.  The patient was seen in the office on 24-SEP-2007 and the rash was improving, her pain was gone.  The patient is recovering.  The nurse indicated that they sent a scraping of the rash to an outside lab and it was negative for VZV.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Neuralgia, Pain
Clinical narrative: Information has been received from a physician concerning a 77 year old male with diabetes, hypertension, arthritis and coronary artery disease who on 20-Aug-2007 was vaccinated SC with a single dose of Zostavax (lot #656858/0356U).  "One week after vaccination", on approximately 27-Aug-2007 the patient developed pain and a rash which followed the "radial and medial" nerve path down from the injection site on his arm to his hand.  Unspecified medical attention was sought, and the patient was diagnosed with shingles.  The patient was treated with valacyclovir (Valtrex) and over the counter medications for the pain.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 77 year old male with diabetes, hypertension, arthritis and coronary artery disease who on 20-Aug-2007 was vaccinated SC with a single dose of Zostavax (lot #656858/0356U).  "One week after vaccination", on approximately 27-Aug-2007 the patient developed pain and a rash which followed the "radial and medial" nerve path down from the injection site on his arm to his hand.  Unspecified medical attention was sought, and the patient was diagnosed with shingles.  The patient was treated with valacyclovir (Valtrex) and over the counter medications for the pain.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a female consumer who on 11-SEP-2007 was vaccinated SC with a 0.5 ml single dose of Zostavax (Oka/Merck) (Lot#658211/0884U). On 12-SEP-2007 the patient developed injection site redness. The pharmacist told the patient to take diphenhydramine HCl (Benadryl) 25 mg every 6 hours for the symptom, and to ice the site. At the time of this report the redness was improving, but it seemed to be "spreading" more outward from the original injection site. The patient was seen by her physician. At the time of this report the patient was recovering. No further information was provided. There was no product quality complaint involved. Follow up information from the pharmacist indicated that the patient recovered on 15-SEP-2007. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site vesicles, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 65 year old female with no known allergies and no pertinent medical history who on 26-JUL-2007 was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included amlodipine besylate (+) atorovastatin calcium (Caduet).  The physician reported that the patient developed four small vesicular lesions at the injection site, and on her left leg.  No symptoms were noted.  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 was vaccinated on an unspecified date with Zostavax.  On an unknown date, the patient developed shingles post vaccination.  It was reported that "it was not that bad of a case".  Unspecified medical attention was sought.  The outcome is reported as unknown.  No product quality complaint was involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a female who was vaccinated with Zostavax (Oka/Merck).  The patient developed a rash on her body a week after receiving Zostavax.  As of 14-SEP-2007, the patient had not recovered.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received concerning a female with a history of malignant neoplasms who was vaccinated with Zostavax (Oka/Merck).  Subsequently the patient experienced a rash.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site cyst, Injection site mass
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 14-AUG-2007 was vaccinated with Zostavax (Oka/Merck). Subsequently, the patient developed a lump at the site of the injection. On 14-SEP-2007, the patient was examined and had a 3 x 4 x 0.9 cm cystic mass. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacy technician concerning a 74 year old female who was vaccinated with Zostavax (Oka/Merck).  The technician reported that the patient experienced rash after receiving Zostavax.  Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cyst, Injection site erythema, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 66 year old female who was approximately 10-AUG-2007, was vaccinated with Zostavax (Oka/Merck). The physician reported that after vaccination with Zostavax (specific date unspecified), the patient had a local reaction at the injection site. The injection site reaction was painful, red and swollen. The reaction never completely resolved and now had become a complex mass 3.4 x 3.9 by 3.6 cm in diameter at the injection site. The mass was diagnosed as a soft tissue complex cystic mass on 14-SEP-2007 by ultrasound. The physician indicated that as of 14-SEP-2007 it was about 5 weeks from the vaccination with the Zostavax. The patient's soft tissue complex cystic mass persisted. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Ultrasound scan abnormal
Clinical narrative: Information has been received from a physician concerning a 66 year old female who was approximately 10-AUG-2007, was vaccinated with Zostavax (Oka/Merck). The physician reported that after vaccination with Zostavax (specific date unspecified), the patient had a local reaction at the injection site. The injection site reaction was painful, red and swollen. The reaction never completely resolved and now had become a complex mass 3.4 x 3.9 by 3.6 cm in diameter at the injection site. The mass was diagnosed as a soft tissue complex cystic mass on 14-SEP-2007 by ultrasound. The physician indicated that as of 14-SEP-2007 it was about 5 weeks from the vaccination with the Zostavax. The patient's soft tissue complex cystic mass persisted. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Zostavax.  Subsequently the patient received both Zostavax vaccine and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) at the same office visit.  No symptoms or adverse reactions were reported.  This is one of several reports received from the same source.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Paraesthesia, Rash pustular
Clinical narrative: Information has been received from a female who was vaccinated with Zostavax (Oka/Merck). A few week later the patient experienced "electrical shock" in her right eye and she had pustules on her right eyebrow down to her eyelids. The patient went to a specialist and was prescribed valacyclovir (Valtrex) for 7 days. The patient's electrical shock in her right eye and pustules on her right eyebrow persisted. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Urine analysis
Clinical narrative: Information has been received from a 74 year old female with no drug allergies or pertinent medical history who on 08-Apr-2007 was vaccinated with a single dose of Zostavax.  Concomitant therapy included estrogens (unspecified).  On 02-Aug-2007 (a few months after vaccination) the patient developed shingles on her left side around her ear, neck, and shoulder.  Unspecified medical attention was sought.  Shingles was diagnosed.  Unspecified blood and urine tests were performed with no results reported.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a 57 year old female with no pertinent medical history, drug reactions or allergies who on 14-SEP-2007, in the PM, was vaccinated subcutaneously with a first dose into the left arm with Zostavax (Oka/Merck) (Lot 3 658211/0884U). On 15 SEP 2007, at approximately 10:00, the patient developed a localized reaction at the site of injection, left arm, which was warm and painful, with redness, swelling, and itchy. The red area was approximately 2.5 inches in diameter. The swelling was approximately a 1/2 inch from normal. The reported events persisted for 6 days. (Initially the reported area involved was 1 1/2 inches in diameter with swelling of 4 centimeters). The patient was reported to have recovered on approximately 21 SEP 2007. The patient had no adverse events following prior vaccinations. No relevant diagnostic tests were performed. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 57 year old female with no pertinent medical history, drug reactions or allergies who on 14-SEP-2007, in the PM, was vaccinated subcutaneously with a first dose into the left arm with Zostavax (Oka/Merck) (Lot 3 658211/0884U). On 15 SEP 2007, at approximately 10:00, the patient developed a localized reaction at the site of injection, left arm, which was warm and painful, with redness, swelling, and itchy. The red area was approximately 2.5 inches in diameter. The swelling was approximately a 1/2 inch from normal. The reported events persisted for 6 days. (Initially the reported area involved was 1 1/2 inches in diameter with swelling of 4 centimeters). The patient was reported to have recovered on approximately 21 SEP 2007. The patient had no adverse events following prior vaccinations. No relevant diagnostic tests were performed. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a certified medical assistant concerning a white male with diabetes and hyperlipidemia who on 06-SEP-2007 was vaccinated SC on right arm with a dose of Zostavax (Oka/Merck) (Lot #656858/0356U).  On 13-SEP-2007 the patient experienced shingles on face.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been received from the certified medical assistant who stated that patient developed significant herpes zoster on left side of his face.  On an unspecified date the patient had recovered.  No further information is expected.
Age: 5.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse (LPN) concerning a 5 and 3/4-year-old male who on 17-SEP-2007 was vaccinated with a subcutaneous dose of 0.65 milliliters of Zostavax (Oka/Merck) instead of Varivax.  Subsequently, the patient did not experience any known symptoms.  It was unspecified if medical attention was sought.  It was reported that this was not product confusion but a medical error.  No product quality complaint was involved.  Follow-up information from the LPN indicates that the patient's mother reported that the patient was doing fine and had not experienced any problems with the vaccine.  The lot number for the Zostavax (Oka/Merck) administered was 656412/1476F.  The LPN reported that the clinic does not routinely have Zostavax (Oka/Merck) in stock but will order it when a patient requests it.  Both vaccines were maintained in the same freezer on the same shelf.  The Zostavax (Oka/Merck) vaccine was for a patient in a satellite office and the nurse thought it had already been sent to the other office.  The nurse grabbed the Zostavax (Oka/Merck) vaccine by mistake since it was in a single-dose baggie on top of the note card that said Varivax.  There was also a note in the freezer in the same area to save 2 Varivax doses for 2 specific patients.  The LPN indicated that it was a medical mistake.  The clinic is now going to separate the Varivax from the Zostavax (Oka/Merck) vaccine in the freezer by putting them in 2 different containers on two different shelves.  They are also going to clearly label them.  Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a medical assistant concerning a 63 year old female with chronic obstructive pulmonary disease and amoxicillin allergy and a history of lung cancer who on 04-Sep-2007 was vaccinated SC with a dose of Zostavax (Lot #656858/0356U).  Concomitant therapy included atorvastatin calcium (Lipitor), gabapentin (Neurontin), oxaprozin (Daypro), venlafaxine HC1 (Effexor XR), aluminum hydroxide/magnesiumhydroxide (Maalox), flaxseed, vitamins (unspecified), ascorbic acid (+) chondroitin sulfate sodium (+) glucosamine sulfate (+) manganese (unspecified) (Osteo-Bi-Flex), fexofenadine hydrochloride (Allegra) and acetaminophen (+) propoxyphene napsylate (Darvocet-N).  On approximately 11-Sep-2007, 7 days after vaccination the patient developed an itchy rash and red spots on her legs, inner thighs and torso.  Unspecified medical attention was sought.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had not recovered.  No diagnostic laboratory tests were undertaken.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Further information has been received from a physician concerning this 63 years old female who 7 days after being vaccinated with ZOSTAVAX developed an itchy rash. The patient was seen on 17Sep-2007 with multiple papular lesions to the arms legs and buttocks. The patient recovered on 29-SEP-2007. Additional information is not expected.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Pain of skin
Clinical narrative: Information has been received from a 75 male with high cholesterol and high blood pressure who on 18-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck). Concomitant therapy included telmisartan (Micardis), Simvastatin (MSD), vardenafil dihydrochloride (Levitra) and mometasone furoate (Nasonex). On approximately 27-AUG-2007 the patient developed sensitivity reactions near the injection site (upper left arm). The area was not visibly different from other areas but the patient felt pain at the surface of his skin. It was reported that the pain was not as bad on 19-SEP-2007 as compared to few days ago. The patient also stated that he had cough that started around the time of vaccination. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Cough, Dyspnoea, Malaise, Pharyngolaryngeal pain
Clinical narrative: Information has been received from a male consumer, a pharmacist, with no pertinent medical history and a sulfonamide allergy, who on 14-SEP-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  It was reported that the patient had a sore throat and some malaise prior to being vaccinated with Zostavax (Oka/Merck).  On 17-SEP-2007 the patient stated that "the symptoms have become worse over the last few days, and now include a runny nose and cough", and he reported "having difficulty breathing with the cold".  No medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rhinorrhoea
Clinical narrative: Information has been received from a male consumer, a pharmacist, with no pertinent medical history and a sulfonamide allergy, who on 14-SEP-2007 was vaccinated subcutaneously with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  It was reported that the patient had a sore throat and some malaise prior to being vaccinated with Zostavax (Oka/Merck).  On 17-SEP-2007 the patient stated that "the symptoms have become worse over the last few days, and now include a runny nose and cough", and he reported "having difficulty breathing with the cold".  No medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes simplex serology negative, Herpes zoster, Myalgia, Oral disorder
Clinical narrative: Information has been received from a physician concerning a 72-year-old male with no known drug allergies, who has diabetes, high blood pressure, anemia, asthma, osteoarthritis, hyperlipidemia and cervical neuropathy, and a history of herpes zoster in July of 2005 (it was also reported that the patient had no prior history of shingles). On 09-JUL-2007 he was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 657767/0740U). Concomitant therapy included Glyburide, Gabapentin, montelukast sodium (MSD), hydrochlorothiazide (+) valsartan (Diovan HCT), niacin (Niaspan), fluticasone propionate (+) salmeterol xinafoate (Advair) and albuterol. On 06-Sep-2007 the patient received a dose of influenza virus vaccine (unspecified) (manufacturer unknown). On 10-SEP-2007 the patient came to see the doctor with shingles. The patient had a painful mouth lesions, burning of right face, vesicular lesions of right hand, pain in prepuce. The patient told the doctor that the symptoms appeared 3 days before the office visit. The patient was treated with acetaminophen (+) codeine phosphate (Tylenol with Codeine), acyclovir and tetracycline. On 14-Sep-2007 the patient saw a dentist who prescribed valacyclovir hydrochloride (Valtrex). It was unknown if valacyclovir hydrochloride (Valtrex) was taken along with acetaminophen (+) codeine phosphate (Tylenol with Codeine), acyclovir and tetracycline. On 15-Sep-2007 the patient was seen by a cardiologist, (which may have been for a regular follow up), it was unknown if it was shingles related. The cardiologist notified the primary physician that the shingles were spreading. The patient's lesions were located on the left nare, left upper lip, left mid chest, right inside of mouth, and genitalia. No laboratory or diagnostic tests were performed. The outcome was not reported. No product quality complaint was involved. The physician was not interested in the VZV ID program because the lesions had scabbed over and it had been 10 days. Follow-up information received concerning a 73-year-old (previously reported as a 72-year-old), retired male who on 09-Jul-2007 was vaccinated in the left deltoid with a 0.5 milliliter dose of Zostavax (Oka/Merck). At the time of vaccination the patient had muscle aches. It was reported that 60 days post vaccination, on 07-Sep-2007, the patient developed shingles with lesions on the mouth, right face, right hand, prepuce, nose, left upper lip, lower gum and upper chest. The lesions lasted 27 days and were not on a specific dermatome. The patient rated his pain as a 10 (0 being least and 10 being the most painful). There were no other systemic symptoms. The patient did not have a history of chickenpox, however he was seen in the emergency room on 27-Jun-2005 for herpes zoster. The patient's maximum temperature was 97.9 and had a HSV culture done which was negative, no isolated on 17-Sep-2007. There was no photo taken and a direct fluorescent antibody was not done. The patient recovered on 04-Oct-2007. Additional information is not expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Penis disorder, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 72-year-old male with no known drug allergies, who has diabetes, high blood pressure, anemia, asthma, osteoarthritis, hyperlipidemia and cervical neuropathy, and a history of herpes zoster in July of 2005 (it was also reported that the patient had no prior history of shingles). On 09-JUL-2007 he was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 657767/0740U). Concomitant therapy included Glyburide, Gabapentin, montelukast sodium (MSD), hydrochlorothiazide (+) valsartan (Diovan HCT), niacin (Niaspan), fluticasone propionate (+) salmeterol xinafoate (Advair) and albuterol. On 06-Sep-2007 the patient received a dose of influenza virus vaccine (unspecified) (manufacturer unknown). On 10-SEP-2007 the patient came to see the doctor with shingles. The patient had a painful mouth lesions, burning of right face, vesicular lesions of right hand, pain in prepuce. The patient told the doctor that the symptoms appeared 3 days before the office visit. The patient was treated with acetaminophen (+) codeine phosphate (Tylenol with Codeine), acyclovir and tetracycline. On 14-Sep-2007 the patient saw a dentist who prescribed valacyclovir hydrochloride (Valtrex). It was unknown if valacyclovir hydrochloride (Valtrex) was taken along with acetaminophen (+) codeine phosphate (Tylenol with Codeine), acyclovir and tetracycline. On 15-Sep-2007 the patient was seen by a cardiologist, (which may have been for a regular follow up), it was unknown if it was shingles related. The cardiologist notified the primary physician that the shingles were spreading. The patient's lesions were located on the left nare, left upper lip, left mid chest, right inside of mouth, and genitalia. No laboratory or diagnostic tests were performed. The outcome was not reported. No product quality complaint was involved. The physician was not interested in the VZV ID program because the lesions had scabbed over and it had been 10 days. Follow-up information received concerning a 73-year-old (previously reported as a 72-year-old), retired male who on 09-Jul-2007 was vaccinated in the left deltoid with a 0.5 milliliter dose of Zostavax (Oka/Merck). At the time of vaccination the patient had muscle aches. It was reported that 60 days post vaccination, on 07-Sep-2007, the patient developed shingles with lesions on the mouth, right face, right hand, prepuce, nose, left upper lip, lower gum and upper chest. The lesions lasted 27 days and were not on a specific dermatome. The patient rated his pain as a 10 (0 being least and 10 being the most painful). There were no other systemic symptoms. The patient did not have a history of chickenpox, however he was seen in the emergency room on 27-Jun-2005 for herpes zoster. The patient's maximum temperature was 97.9 and had a HSV culture done which was negative, no isolated on 17-Sep-2007. There was no photo taken and a direct fluorescent antibody was not done. The patient recovered on 04-Oct-2007. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a 72 year old female consumer with no known allergies and a history of shingles for 45 years who on 05-SEP-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck).  Since 06-SEP-2007, the day after vaccination, the patient had 3 outbreaks of shingles on her right leg.  Patient advised that the rash had cleared but she was having pain that was radiating from her big toe to the base of her spine.  Unspecified medical attention was sought.  No lab studies were performed.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information has been received from the consumer who stated that she had developed two additional outbreaks of shingles on 02-NOV-2007 and another on 07-NOV-2007.  The patient had 2 lesions on her gluteusmaximus.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site bruising, Myalgia, Swelling
Clinical narrative: Information has been received from a physician's assistant concerning a 65 year old female with no medical history or allergies who on 13-Sep-2007 was vaccinated SC with a single dose of Zostavax (Lot #658208/0886U).  Concomitant therapy included estrogens, conjugated (+) medroxyprogesterone acetate (Prempro) and levothyroxine Na (Synthroid).  On approximately 14-Sep-2007, within 24 to 48 hours of vaccination the patient experienced joint pain, muscle achiness and muscle pain.  It was reported that the injection site area was pretty bruised and there was spreading of erythema and swelling.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Herpes zoster, Inappropriate schedule of drug administration, Stomatitis
Clinical narrative: Information has been received from a physician concerning a 57-year-old female with no pertinent medical history or allergies who on 11-JUN-2007 was vaccinated intramuscularly with (1 vial once) dose of Zostavax. Concomitant therapy included "FIORCET" and AMBIEN. On 06-AUG-2007 the patient developed "shingles like" symptoms after vaccination. The patient presented with sores in her mouth and pain on her right eye brow. She saw a nurse practitioner and then an ophthalmologist. The ophthalmologist prescribed VALTREX for the symptoms. 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: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Local reaction, Rash
Clinical narrative: Information has been received from a physician concerning a male in his 70's who was vaccinated with Zostavax (Oka/Merck).  Concomitant therapy included methotrexate.  Subsequently the patient experienced a minimal localized shingles rash.  As of 17-SEP-2007 the patient had recovered.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Information has been received from a pharmacist concerning afemale with itchy scalp and itchy head who on 15-SEP-2007 was vaccinated with Zostavax (Lot # 657559/0462U) 0.65 ml dose. No information was provided with regard to the patient's medical history and concomitant therapy. On 16-SEP-2007 the patient developed an unspecified rash on her scalp and neck. The patient noted that the areas were itchy prior to the administration of the vaccine. The patient contacted the physician. The patient outcome was not reported. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion, Varicella
Clinical narrative: Information has been received from a physician concerning a 68 year old female who on 06-AUG-2007 was vaccinated SC with a dose of Zostavax. On 17-SEP-2007 the patient was seen at the physician's office. The patient developed a rash with two lesions at a non-injection site which the physician suspected to be varicella. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a Nurse Practitioner concerning a female who in approximately August 2007, was vaccinated with Zostavax (Oka/Merck). The Nurse Practitioner reported that in approximately August 2007, the patient experienced an aching pain at the injection site. There was no redness at the site. The patient's aching pain at the injection site persisted. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphthous stomatitis, Condition aggravated, Culture wound
Clinical narrative: Information has been received from a physician concerning a 71 year old female with a history of canker sores who on 07-Sep-2007 was vaccinated with Zostavax.  There was no concomitant medication.  On 08-Sep-2007 the patient experienced canker sore.  She sought medical attention.  A culture was taken (results not reported).  She was recovering as of 18-Sep-2007.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site erythema, Injection site inflammation, Injection site mass, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a 66 year old female who on 13-Sep-2007 was vaccinated with Zostavax (Lot #658207/0883U).  Concomitant therapy included "TDAP".  On 15-Sep-2007 the patient experienced an 11 x 14 cm red, inflamed area at the injection site after receiving zoster vaccine.  Within that area was a 3 x 5 raised blister.  The patient also experienced flu symptoms, achiness, and a fever just less than 102 degrees.  Follow-up information has been received from a registered nurse indicating that the 66 year old retired white female with hypertension and no allergies who on 13-Sep-2007 was vaccinated with an SC dose of Zostavax (lot #658207/0883U) in the right arm.  There was no illness at the time of vaccination.  On 15-Sep-2007 (also reported as 01-Oct-2007) the patient developed a large erythematous welt with a central blister at the injection site.  The patient sought medical attention through a doctor visit.  No labs or diagnostic studies were performed.  The patient was "recovered after 1 week."  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Urticaria
Clinical narrative: Information has been received from a physician concerning a 66 year old female who on 13-Sep-2007 was vaccinated with Zostavax (Lot #658207/0883U).  Concomitant therapy included "TDAP".  On 15-Sep-2007 the patient experienced an 11 x 14 cm red, inflamed area at the injection site after receiving zoster vaccine.  Within that area was a 3 x 5 raised blister.  The patient also experienced flu symptoms, achiness, and a fever just less than 102 degrees.  Follow-up information has been received from a registered nurse indicating that the 66 year old retired white female with hypertension and no allergies who on 13-Sep-2007 was vaccinated with an SC dose of Zostavax (lot #658207/0883U) in the right arm.  There was no illness at the time of vaccination.  On 15-Sep-2007 (also reported as 01-Oct-2007) the patient developed a large erythematous welt with a central blister at the injection site.  The patient sought medical attention through a doctor visit.  No labs or diagnostic studies were performed.  The patient was "recovered after 1 week."  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning his mother-in-law who in approximately 2006 was vaccinated with Zostavax.  In approximately 2006, post vaccination, the patient developed a rash at the injection site, an elevated fever and body aches and pains.  The patient did not seek treatment at the time.  Subsequently, the patient recovered from the events.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a physician concerning his mother-in-law with no pertinent medical history who in approximately 2006 was vaccinated with ZOSTAVAX vaccine (Merck). There was no concomitant therapy. On an unspecified date in 2006, post vaccination, the patient developed a rash at the injection site an elevated fever and body aches and pains. It was reported that "the arm" was red and swollen at the site of the injection for one week. Subsequently, the patient recovered, on an unspecified date. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.