chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster, Pain, Vaccination failure, Varicella virus test
Clinical narrative: Information has been received from a physician concerning an 83 year old female patient with osteoarthritis, elevated cholesterol, degenerative joint disease, hypertension, and no allergies who on 22-APR-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not reported), 0.65 ml subcutaneous. The physician reported that on 14-FEB-2009 the patient developed shingles. The patient was seen in the physician's office again on 23-FEB-2009 because she still had the shingles and was experiencing pain. The shingles were located under right breast radiating under arm to her back. the physician interested in PCR analysis. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information has been received from the physician concerning the female patient with hypertension, osteoporosis, degenerative joint disease, generalised anxiety disorder, osteoarthritis, elevated cholesterol, and no known drug allergies and a status post pulmonary embolism (x2) who on 22-APR-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported), 0.65 mL subcutaneous.  Concomitant therapy included lovastatin (manufacturer unknown), TOPROL, warfarin, BONIVA, citalopram and levothyroxine sodium.  Rash did not occur at the site of injection or elsewhere within 42 days of the vaccination.  Shingles developed on 14-FEB-2009 in the right T5 dermatome.  Pain described as 6-7.  The patient has a history of chickenpox in her childhood.  There was a recent exposure to shingles, not to chickenpox.  A sample of the lesion was collected on 25-FEB-2009.  The sample was taken from a vesicular lesion and a scab on the chest under her right breast (results not reported).  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 25-FEB-2009.  The PCR results from a vesicular lesion and a scab on the chest under her right breast identified the presence of WT VZV.  Follow up information from her physician revealed that the white female patient (weight: 184 pounds, height: 64 inches) who on 22-APR-2008 was vaccinated with a dose of ZOSTAVAX (lot # not reported), 0.65 mL subcutaneous.  On 10-FEB-2009 developed zoster.  The physician stated that there was no adverse events, but it was considered a vaccine failure.  The patient recovered on an unspecified date.  Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Injection site vesicles, Paraesthesia, Scab
Clinical narrative: Information has been received from a nurse practitioner concerning a 72 year old female homemaker with no history of HSV I or II and allergy to aspirin, osteoporosis, irritable bowel syndrome and gastrooesophageal reflux disease who on 01-FEB-2008 at 15:30, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 658210/1079U) 0.5 mL, subcutaneously into her left upper arm.  Concomitant therapy included ACTONEL, HYOSCYAMINE and OMEPRAZOLE (MSD).  The nurse reported that within 48 hours of vaccine, on 03-FEB-2008, the patient described a few small blister like lesions on her left arm at the injection site and had 4x4 inch patches of these blisters on each buttocks.  The nurse reported that the patient described as burning and tingling, then scab over and go away.  Had had frequently since injection.  The patient had 3 noted on right buttock.  The nurse stated that there were "3 blister like herpetic like lesions" at visit on 12-FEB-2009.  At time of reporting, the patient had not recovered.  There were no lab and diagnostic tests.  There was no illness at time of vaccination.  Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a registered nurse concerning an 79 year old male with type 2 diabetes mellitus, coronary artery disease and prostate cancer who on 08-NOV-2007 was vaccinated with 0.65 ml of ZOSTAVAX (Oka/Merck) subcutaneously.  Concomitant therapy included LANTUS, GLUCOPHAGE, GLUCOTROL XL, LIPITOR, PREVACID, VASOTEC, ATENOLOL, aspirin, CYANOCOBALAMIN, PROCARDIA, FLOMAX and AVODART.  On 05-FEB-2009 the patient experienced shingles.  The patient was experiencing a painful shingles rash on the right side of his body.  As of 11-FEB-2009 the patient's shingles persisted.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Information has been received from a 71 year old female with allergic reaction to FLAGYL who on 20-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included TEKTURNA, LOSARTAN POTASSIUM MSD, AMLODIPINE, NEXIUM, TRICOR, baby aspirin, and METOPROLOL.  In the night on 20-FEB-2009 the patient started to experience fever and chills and had been experiencing it since.  The fever only starts in the evening and she felt fine during the day.  The patient sought unspecified medical attention.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes simplex serology positive, Herpes zoster, Immunology test, Laboratory test abnormal
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). It was reported that "about a year later" the patient developed a severe case of shingles on the leg. The patient sought unspecified medical attention. In the follow-up the physician reported that the 65 year old retired female patient, with HASHIMOTO's thyroiditis and autoimmune thyroid disease who was vaccinated one year ago, recently developed classic zoster confirmed by immunofluorescence of smears from a vesicle, the patient's symptoms were grouped blisters on 12-JAN-2009 and blisters down legs on 15-jan-2009. Labs diagnostics studies performed included direct positive to immunofluorescence assay to determinate varicella zoster virus and negative to immunofluorescence assay to determinate herpes zoster virus. On 16-JAN-2009 patient was recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received from the physician concerning the patient with no illness at the time of vaccination who on 12-FEB-2008 in the morning was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot number 658867/1413U) subcutaneous in the left upper arm.  The patient did not have a rash at the site of injection or elsewhere within 42 days of the vaccination.  The distribution of the dermatones involved was at 5-2.  The patient had a history of chickenpox (date unknown) and there is not a recent exposure to chickenpox or herpes zoster.  There was no a specimen collected from PCR and was no a photo taken.  Additional information has been requsted.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). It was reported that "about a year later" the patient developed a severe case of shingles on the leg. The patient sought unspecified medical attention. In the follow-up the physician reported that the 65 year old retired female patient, with HASHIMOTO's thyroiditis and autoimmune thyroid disease who was vaccinated one year ago, recently developed classic zoster confirmed by immunofluorescence of smears from a vesicle, the patient's symptoms were grouped blisters on 12-JAN-2009 and blisters down legs on 15-jan-2009. Labs diagnostics studies performed included direct positive to immunofluorescence assay to determinate varicella zoster virus and negative to immunofluorescence assay to determinate herpes zoster virus. On 16-JAN-2009 patient was recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received from the physician concerning the patient with no illness at the time of vaccination who on 12-FEB-2008 in the morning was vaccinated with the first dose of ZOSTAVAX (Merck) (Lot number 658867/1413U) subcutaneous in the left upper arm.  The patient did not have a rash at the site of injection or elsewhere within 42 days of the vaccination.  The distribution of the dermatones involved was at 5-2.  The patient had a history of chickenpox (date unknown) and there is not a recent exposure to chickenpox or herpes zoster.  There was no a specimen collected from PCR and was no a photo taken.  Additional information has been requsted.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Eyelids pruritus, Skin lesion
Clinical narrative: Information has been received from a physician concerning a female in her 70s who "about a year ago" was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not provided).  After receiving ZOSTAVAX (Oka/Merck), the patient experienced "lesions and itching on her eyelid".  The patient had sought medical attention.  At the time of reporting the patient had recovered from the adverse effect.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 29-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 29-JAN-2009 the patient experienced pain. tenderness and redness at the injection site. The patient was advised to take BENADRYL and follow up with the doctor or with the pharmacist if the adverse event did not go away. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse practitioner concerning a male patient who at the "beginning of December 2008" was vaccinated with ZOSTAVAX (Oka/Merck). 11-15 days after receiving ZOSTAVAX (Oka/Merck) "between December 2008 and January 2009" the patient developed a rash. The nurse noted that it was not a Varicella rash and was more like hives or urticaria and all over the whole body. The patient had sought unspecified medical attention. At the time of reporting the patient had recovered from adverse effect. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 72 year old female with diabetes, sulfonamide and a history of tetanus who about one and a half to two years ago, was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included Metformin and LANTUS. On 08-Feb-2009 the patient experienced shingles. The patient was prescribed acyclovir as treatment. The patient sought medical attention through an office visit. At the time of this report the patient had not recovered. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister
Clinical narrative: Information has been received from a 71 year old female patient with a history of shingles before receiving the vaccine and blisters around her lips since she was a child and no known drug allergies or reactions who on 2-OCT-2008, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # not provided). There was no concomitant medication. On approximately 9-OCT-2008 ("about 1-2 weeks after vaccination") the patient experienced outbreaks of blisters around her lips have been more common. Therapy with ZOSTAVAX (Oka/Merck) was discontinued. Routine labs were performed (no results provided). The patient's blisters around her lips persisted. The patient did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes simplex serology positive
Clinical narrative: Information has been received from physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) on an unspecified date. Subsequently the patient experienced testing positive for Herpes Simplex Virus 2 Antibodies. At the time of this patient sought medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test negative, Biopsy skin normal, Blood test normal, Laboratory test normal, Pruritus
Clinical narrative: Information has been received from a physician concerning a 61 year old female with diabetes who in February 2008, was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not specified). In May 2008, a couple months after the patient received the ZOSTAVAX, she started experiencing hives. The patient went to an allergist who performed multiple tests that all came back negative and she was prescribed prednisone (manufacturer unspecified). The patient has been experiencing itchy hives every day since May 2008. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received from the female patient who stated that she still experienced the hives.  Follow up information has been received from the patient who stated that she had been experienceing hives since May 2008.  She had all the blood work and skin biopsy done and everything came back negative.  The patient believed the hives were caused by the vaccine.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a physician concerning a 61 year old female with diabetes who in February 2008, was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not specified). In May 2008, a couple months after the patient received the ZOSTAVAX, she started experiencing hives. The patient went to an allergist who performed multiple tests that all came back negative and she was prescribed prednisone (manufacturer unspecified). The patient has been experiencing itchy hives every day since May 2008. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received from the female patient who stated that she still experienced the hives.  Follow up information has been received from the patient who stated that she had been experienceing hives since May 2008.  She had all the blood work and skin biopsy done and everything came back negative.  The patient believed the hives were caused by the vaccine.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 21-FEB-2009 was vaccinated with one dose of ZOSTAVAX (Oka/Merck) (Lot# not reported). Two days later, on 23-FEB-2009 the patient had a case of anaphylaxis. Now the patient recovered from anaphylaxis. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: Information has been received from a female consumer who was vaccinated with ZOSTAVAX (Oka/Merck). The consumer reported my physician did not believe that my symptoms were a result of the ZOSTAVAX (Oka/Merck). There was a "nasty stomach bug" going around at the time of my vaccination, so it was concluded that my symptoms were related to that. The consumer was fine at the report time. This is one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea
Clinical narrative: Information has been received from a female consumer who was vaccinated with ZOSTAVAX (Oka/Merck). The consumer reported my physician did not believe that my symptoms were a result of the ZOSTAVAX (Oka/Merck). There was a "nasty stomach bug" going around at the time of my vaccination, so it was concluded that my symptoms were related to that. The consumer was fine at the report time. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: Information has been received from a 61 year old female with spastic colon, high cholesterol, "thyroid problems" and reactions to NEOSPORIN, "BASATRASIN" and "COLOSPORIN", who on 11-DEC-2008 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SIMVASTATIN (manufacturer unknown), ESTROGENS, PREMARIN, SYNTHROID and AMITRIPTYLINE HYDROCHLORIDE (manufacturer unknown) reported as "AMOTRIPOLINE". The patient reported that about four hours after receiving ZOSTAVAX (Oka/Merck), she was sitting in a chair and then all of sudden she had a stomach cramps and then she had to use the bathroom and her stools were very soft. The patient reported that her stomach was still a little unsettled but had not had any stomach cramps. At time of reporting, The patient was recovering. There were no lab diagnostic studies performed. The patient did not seek medical attention. No further information is available.   This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a female consumer who was vaccinated with ZOSTAVAX.  The consumer reported my physician did not believe that my symptoms were a result of the ZOSTAVAX.  There was a "nasty stomach bug" going around at the time of my vaccination, so it was concluded that my symptoms were related to that.  The consumer was fine at the report time.  This is one of several reports from the same source.  Follow-up information was received from the consumer.  She reported she did not have a reaction to the ZOSTAVAX.  There was a stomach virus going around at the same time she received the vaccine and that was what effected her.  Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea
Clinical narrative: Information has been received from a 61 year old female with spastic colon, high cholesterol, "thyroid problems" and reactions to NEOSPORIN, "BASATRASIN" and "COLOSPORIN", who on 11-DEC-2008 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SIMVASTATIN (manufacturer unknown), ESTROGENS, PREMARIN, SYNTHROID and AMITRIPTYLINE HYDROCHLORIDE (manufacturer unknown) reported as "AMOTRIPOLINE". The patient reported that about four hours after receiving ZOSTAVAX (Oka/Merck), she was sitting in a chair and then all of sudden she had a stomach cramps and then she had to use the bathroom and her stools were very soft. The patient reported that her stomach was still a little unsettled but had not had any stomach cramps. At time of reporting, The patient was recovering. There were no lab diagnostic studies performed. The patient did not seek medical attention. No further information is available.   This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a female consumer who was vaccinated with ZOSTAVAX.  The consumer reported my physician did not believe that my symptoms were a result of the ZOSTAVAX.  There was a "nasty stomach bug" going around at the time of my vaccination, so it was concluded that my symptoms were related to that.  The consumer was fine at the report time.  This is one of several reports from the same source.  Follow-up information was received from the consumer.  She reported she did not have a reaction to the ZOSTAVAX.  There was a stomach virus going around at the same time she received the vaccine and that was what effected her.  Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Skin warm
Clinical narrative: Information has been received from a medical assistant and a nurse practitioner (N.P.) concerning an 81 year old female patient with hyperlipidaemia, osteoporosis, hypertension, osteoarthritis as well as aspirin and CODEINE allergies who on 09-FEB-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included CELEXA, SIMVASTATIN (MSD), DYAZIDE, SULINDAC and alendronate sodium (+) cholecalciferol (MSD).  On 11-FEB-2009 the patient may possibly have developed shingles.  The patient noticed that one arm (unknown which arm) developed erythema and was warm to the touch.  The area was not pruritic.  The patient came to the office and the nurse practitioner initially thought it was cellulitis.  The affected area was 3 inches in diameter and there were a few areas that were of a different texture.  The patient was prescribed KEFLEX but the patient has not had any improvement.  The nurse practitioner suspected that it may be shingles.  At the time of reporting (12-FEB-2009) the patient had not recovered.  The patient sought medical attention by visiting the physician's office.  Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician's assistant concerning a girl who on an unspecified date was vaccinated with a first dose of VARIVAX (Oka/Merck). On 12-FEB-2009, the 9 year old patient should have received her second dose, however she was vaccinated with ZOSTAVAX (Oka/Merck) due to human error. No adverse effects reported. Follow up information was received from a Practice Manager concerning the patient who on 13-MR-2009 received the first dose of VARIVAX (Oka/Merck). The patient was inadvertently given ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) for second dose. It was a case of human error and not product confusion. The nurse pulled the VARIVAX (Oka/Merck) box out of the freezer and there was a loose vial of ZOSTAVAX (Oka/Merck) in the VARIVAX (Oka/Merck) box. The ZOSTAVAX (Oka/Merck) was given by mistake. The office has now initiated a process whereby the two vaccines will be stored in different sections of the freezer. And the nurse will ask another person to verify the bottle before withdrawing the vaccine. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Neuralgia, Rash pustular
Clinical narrative: Information has been received from a 65 year old female with blood pressure and thyroid problem who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) about 1 year ago. Concomitant therapy included blood pressure and thyroid medications (unspecified). The patient also had reaction to the Flu shot year ago and that caused her arm to puff up. In December 2008, the patient developed shingles after receiving ZOSTAVAX (Oka/Merck). She considered it a milder case and it was on her right breast up and underneath her arm. There about 14-15 pustules and the nerve pain was not at all severe. She stated it started first as the nerve pain then the rash developed. The patient also had a reaction at the injection site at the time the vaccine was given. She developed a big, round, red mark on her arm. Subsequently, the patient recovered about 2 weeks after the reaction started. The patient sought unspecified medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes, Herpes zoster, Injection site erythema, Injection site haematoma, Injection site pruritus
Clinical narrative: Information has been received from a 60 year old female with sulfonamide, morphine, DEMEROL and CELEBREX allergy who on 02-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck), lot number unknown. Concomitant therapy included VALTREX, simvastatin (manufacturer not reported), PLAVIX, DIAZIDE, fluconazole and omeprazole (manufacturer not reported). On 03-JAN-2009 the patient experienced warmth, redness, swelling, and itching at the injection site. Patient then developed bruising. Patient stated that she received vaginal herpes after the vaccine and as of 14-JAN-2009 has developed shingles. It was reported that she usually develops a case of the shingles at 3-4 times a year. "Routine labs" were performed (results not provided). Patient not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Laboratory test
Clinical narrative: Information has been received from a 60 year old female with sulfonamide, morphine, DEMEROL and CELEBREX allergy who on 02-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck), lot number unknown. Concomitant therapy included VALTREX, simvastatin (manufacturer not reported), PLAVIX, DIAZIDE, fluconazole and omeprazole (manufacturer not reported). On 03-JAN-2009 the patient experienced warmth, redness, swelling, and itching at the injection site. Patient then developed bruising. Patient stated that she received vaginal herpes after the vaccine and as of 14-JAN-2009 has developed shingles. It was reported that she usually develops a case of the shingles at 3-4 times a year. "Routine labs" were performed (results not provided). Patient not recovered. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Hyperaesthesia, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old male who on 05-Jan-2009 was vaccinated with ZOSTAVAX, subcutaneously, lot number was not specified. On 10-Jan-2009 the patient experienced red, raised rash on his left chest and it extended to the neck and left upper arm. It was reported that the patient experienced an aching discomfort involving the neck both shoulders and left wrist. His scalp and area of the left forearm were sensitive to touch. Patient not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haematoma, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a 60 year old female receptionist who in December 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (no lot# provided). About 48 hours after receiving the vaccine she had a red oval shape at the injection site that was itchy and swollen and then about two days after the red oval shape appeared it turned into a bruise that lasted about 8 days. The patient reported that she did not see a physician about this; she just put Benadryl cream on the bruise. No lab diagnostics studies performed. Then on the tenth day the bruise went away. Patient recovered about ten days after the red oval shape appeared. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient with no known drug allergies, who on 12-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not provided) 0.65ml subcutaneously. On 14-JAN-2009 the patient developed a local injection site reaction. The area was swollen, red, itchy and slightly raised. The area was 2 to 3 inches in diameter at the injection site. Patient sought medical attention via the pharmacy. No lab diagnostic studies were performed. At the time of this report, patient had not recovered yet. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacy tech concerning a female patient in her late 60's who on approximately 01-Jan-2009, "approximately two weeks ago" was vaccinated with ZOSTAVAX (Oka/Mereck) (Lot# not provided). After vaccination, patient experienced excessive pain at injection site. Ibuprofen and ice were suggested as treatment. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 60 year old male patient with a history of Human immunodeficiency virus exposure 20 years ago and no drug reactions or allergies who on 02-Jan-2009 was vaccinated SC with one dose of ZOSTAVAX (Oka/Merck) (Lot#662859 / 1561X) . Concomitant therapy included acyclovir. Subsequently the patient had developed shingles. The Nurse practitioner was notified on 13-Jan-2009 that the patient had developed a rash and had gone to see the Dermatologist who diagnosed him. There were no Laboratory Diagnostic Studies performed. At the time on the report on 14-Jan-2008 the patient was not recovered. The patient sought medical attention with an office visit to a dermatologist. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a Nurse Practitoner concerning a 60 year old male patient with a history of Human immunodeficiency virus exposure 20 years ago and no drug reactions or allergies who on 02-JAN-2009 was vaccinated SC with one dose of ZOSTAVAX (Merck) (Lot # 662859/1561X).  Concomitant therapy included ACYCLOVIR.  Subsequently the patient had developed shingles.  The Nurse Practitioner was notified on 13-JAN-2009 that the patient had developed a rash and had gone to see the Dermatologist who diagnosed him.  There were no Laboratory Diagnostics Studies performed.  At the time of the report on 14-JAN-2008 the patient was not recovered.  The patient sought medical attention with an office visit to a Dermatologist.  Additional information is not expected.  Attempts to obtain follow-up information have been unsuccessful.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Virus culture negative
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) in 2008. Subsequently, two to three weeks after vaccination (2008), the patient experienced generalized vesicular rash and big spot on his right forehead. Follow up information was received from the physician reporting that the 80 years old male patient received a dose of ZOSTAVAX (Oka/Merck) on 30-JUN-2008. On 18-NOV-2008 the patient developed zoster on the left fifth chest wall with diffuse vesicular rash. Cultures of vesicular fluid were negative for virus and bacteria. The patient recovered in December 2008. Additional information is not expected.
Age: 22.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a 22 year old female employee who handles the intact ZOSTAVAX vaccine (Oka/Merck) vials storage purposes only (does not administer the vaccine), and on 13-JAN-2009 was diagnosed with shingles. Vesicular rash distributed on the left abdomen. The patient was seen by her unspecified physician and was prescribed VALTREX. The pharmacist stated that she felt that handling the vaccine vials may be related to the development of shingles. Patient not recovered. Follow up information was received from the registered pharmacist reported that the patient was a pharmacy technician who developed shingles in January 2009. The patient was enrolled in the Program to identify VZV is present and if it is present identify if it is associated with the wild- type (WT) VZV strain or with the OKA/Merck vaccine VZV strain. Subsequently the patient recovered. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Insomnia, Rash erythematous, Rash macular
Clinical narrative: Information has been received from a 65 year old female registered nurse, who is the consumer, with hypersensitivity and allergic reaction to antibiotics and a history of flu which she had on October 2008, who on 26-NOV-2008, "a day before thanksgiving" was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not provided). Concomitant therapy included influenza virus vaccine (unspecified) and glucosamine sulfate (unspecified). On 26-NOV-2008 the patient experienced rash above the belt buckle. On approximately 27-NOV-2008 the patient's rash appeared across her abdomen up her left side and across the back of her rib cage. The consumer is unsure if the rash was caused from ZOSTAVAX (Oka/Merck). The consumer saw her physician who gave her prednisone and BENADRYL to help with the rash, which she described as "blotchy red dots like measles", since she could not sleep. No lab diagnostics studies performed. After two doses of prednisone her rash went away. The consumer reported that she also had a cold that she developed on 24-DEC-2008, "Christmas eve", and she had an itchy throat, breathing difficulties and chest tightness. At the time of this report the patient had recovered. No further information is available.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Throat irritation
Clinical narrative: Information has been received from a 65 year old female registered nurse, who is the consumer, with hypersensitivity and allergic reaction to antibiotics and a history of flu which she had on October 2008, who on 26-NOV-2008, "a day before thanksgiving" was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not provided). Concomitant therapy included influenza virus vaccine (unspecified) and glucosamine sulfate (unspecified). On 26-NOV-2008 the patient experienced rash above the belt buckle. On approximately 27-NOV-2008 the patient's rash appeared across her abdomen up her left side and across the back of her rib cage. The consumer is unsure if the rash was caused from ZOSTAVAX (Oka/Merck). The consumer saw her physician who gave her prednisone and BENADRYL to help with the rash, which she described as "blotchy red dots like measles", since she could not sleep. No lab diagnostics studies performed. After two doses of prednisone her rash went away. The consumer reported that she also had a cold that she developed on 24-DEC-2008, "Christmas eve", and she had an itchy throat, breathing difficulties and chest tightness. At the time of this report the patient had recovered. No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Musculoskeletal stiffness
Clinical narrative: Information has been received from a registered pharmacist concerning an 80 year old female with arthritis and sulfa allergy who on 02-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number 663174/1552X), subcutaneously (site not reported). The patient experienced stiff neck and developed a large red spot at the site of injection after receiving the vaccine. Patient not recovered. Additional information was received from a licensed practical nurse who reported that the 80 year old female patient was vaccinated with a first dose of ZOSTAVAX (Oka/Merck) (lot number also reported as 663672/1709X, route not reported) into her right deltoid arm. The patient was vaccinated at the local pharmacy. There was no illness at time of vaccination. The patient developed 7-8cm redness area at injection site the day post vaccination. The nurse also reported that the patient developed stiff neck but has a history of arthritis. The patient was not sure if the pain in neck was related to injection. The patient recovered within 2 weeks. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a nurse concerning a 76 or 77 year old female patient who in Mary 2008, was vaccinated with ZOSTAVAX (Oka/Merck), lot number was not reported. Concomitant therapy included lovastatin (manufacturer unknown), vitamins (unspecified) and "PANOLA". In December 2008, the patient experienced shingles. The patient sought unspecified medical attention. Her outcome is unknown. Follow up call information received on 12-FEB-2009. The physician reported that as of 12-FEB-2009 the patient's skin lesions completely healed and he wouldn't be able to send a sample. The patient was seen in the office the same day for follow-up and she was having pain in the left thoracic area, where she had the skin lesions. The patient reported that about 2 weeks ago she also developed another little crop of blisters under her left arm on the same side as the initial outbreak, but in a different dermatome. This area also healed and the patient had no remaining scabs. The physician indicated that he would report again if the patient develops another episode of herpes zoster in order to process a sample through the Varicella Zoster Virus Identification Program. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacy student concerning a patient who about 1 month ago, was vaccinated with a dose of ZOSTAVAX (Oka/Merck), subcutaneously, site of administration unknown. The patient experienced soreness at the injection site since receiving the vaccine. Patient. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 72 year old male who on 06-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 662996/1618X). On approximately 06-JAN-2009, the patient experienced a large, red and inflamed/raised area at the injection site and also had bumps at the injection site. The patient was seen on 09-JAN-2009 for the reactions. No treatment was given. The patient was told to monitor the reaction and call the office if symptoms got worse or did not improve. In January 2009, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Oropharyngeal pain, Pain in extremity, Toothache
Clinical narrative: Information has been received from a registered pharmacist concerning a 72 year old female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot : 663195/1416X). On an unspecified date the patient's teeth hurt, had fever sores on mouth, throat pain and left arm pain. On an unspecified date the patient recovered from all her symptoms and was "feeling better". This is one of several reports from the same source. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster disseminated
Clinical narrative: Information has been received from a nurse practitioner concerning a male patient who in December 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not provided). Concomitant therapy included MEDROL DOSEPAK. On approximately 05-JAN-2009, "one week ago", the patient experienced dissemination of the herpes virus. "It is not known if he is speaking about herpes zoster or a different strain of the herpes virus". Patient sought unspecified medical assistance. At the time of the report the patient had not recovered. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Back pain, Chest pain, Influenza, Pain
Clinical narrative: Initial information has been received from a pharmacist concerning a 77 year old male who on 30-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck). It was reported that on 11-JAN-2009 the patient started having back pain which spread to the chest and stomach. On 12-JAN-2009, the date of the report, the pain was "all over" when he touched skin. The patient believed this might be from ZOSTAVAX (Oka/Merck). Additional information received from the patient reported that he started to experience the pain all over his body on the evening of 09-JAN-2009. It hurt to even lay down because the pain sensation took over. The patient did not have any other "flu symptoms" which was why he believed it might be because of the ZOSTAVAX (Oka/Merck). At the time of this report, the patient was not recovered. Follow-up information was received from the pharmacist concerning the 77 year old male with no illness at time of vaccination or pre-exisiting allergies who on 30-DEC-2008 at 15:00 was vaccinated SC with the first dose of ZOSTAVAX (lot # 662996/1618X). concomitant therapy included LOTEL, FLONASE and DYAZIDE. ON 13-JAN-2009, at 14:00 the patient experienced pain upon touching skin around torso area which recovered after approximately 1 days without any medication. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neck pain, Skin lesion
Clinical narrative: Information has been received from a 68 year old female patient with sulfonamide allergy and a history of blood pressure high who in approximately 2008 "about a year ago", was vaccinated with ZOSTAVAX (Oka/Merck). Then on approximately 15-DEC-2008 "about four weeks ago" the patient started to have a pain on the left side of her neck and then the lesions came out behind her ear across the front of the left side of her neck and chin. The patient reported that she saw her physician and dermatologist who told her she had developed the shingles. The patient reported that she was now on PREDNISONE and antiviral medication, name and manufacturer unspecified, and was also given PERCOCET to help the pain she was having due to the shingles. The patient reported that now the lesions were starting to go away and the pain was still there but it was not as bad as before. No further adverse effect information was reported. The patient had seen physician for medical attention. The patient was recovering from the adverse effect. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 62 year old female who on 08-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 662996/1618X). On approximately 08-JAN-2009, the patient experienced a large, red and inflamed/raised area at the injection site. The patient was seen on 09-JAN-2009 for the reactions. No treatment were given. The patient was told to monitor the reaction and call the office if symptoms got worse or did not improve. In January 2009 the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: Information has been received from an office manager concerning a 66 year old female who on 08-Jan-2009 was vaccinated with a dose of ZOSTAVAX (lot#662996/1618X). On approximately 08-Jan-2009, the patient experienced a large, red and inflamed / raised area at the injection site. The patient was seen on 09-Jan-2009 for the reactions. No treatments were given. The patient was told to monitor the reaction and call the office if symptoms got worse or did not improve. In January 2009 the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis, Echocardiogram
Clinical narrative: Information has been received from a 68 year old female patient with breast cancer, atrial fibrillation, cardiac valve leak, neuropathy peripheral, sulfonamide allergy, penicillin allergy and allergy to other unspecified medications and a history of shingles who in November 2007, was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # not provided). Concomitant medication include unspecified heart medications. After she received vaccine she experienced an area of her skin became inflamed but shingles never broke through the skin. She reported that she had a history of peripheral neuropathy in her fingers and toes but it went away in June 2008 and she felt that vaccine caused it to get better. She also reported that ZOSTAVAX (Oka/Merck) helped her "to get over atrial fibrillation". "Echo test" was performed, but the result was not reported. At the time of the report on 12-JAN-2008 the patient was not recovered. The patient sought medical attention with physician. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site rash, Rash erythematous
Clinical narrative: Information has been received from a medical assistant concerning a 69 year old female who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) and a dose of PNEUMOVAX 23. Subsequently, the patient experienced a fine red rash around the torso. The reaction started at the area where the patient was vaccinated (area unspecified). The patient had not been seen by the physician at the time of the report. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning a 91 year old female who on 12-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot #: 663178/1414X). On 25-DEC-2008 the patient developed a painful zoster-like rash on her left shoulder to upper breast. The patient has been treated with VICODIN for pain. The patient sought medical attention via office visit. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Insomnia, Pain in extremity
Clinical narrative: Information has been received from a 74 year old female with Crohn's disease, penicillin and Keflex allergy who on 08-Jan-2009 was vaccinated with a dose of ZOSTAVAX. Concomitant therapy included PLAVIX, ZOLOFT, generic pramipexole dihydrochloride and AMBIEN. On 08-Jan-2009, the patient had difficulty sleeping the night after vaccination. She took AMBIEN and was still unable to sleep. She also had pain in her left leg going from her thigh to ankle. The muscles contracted and her veins felt like they were burning. She had calf soreness in her left leg on 09-Jan-2009. At the time of this report, the patient was recovering. The patient spoke to pharmacist for medical attention. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a 62 year old female nurse with penicillin and PREDNISONE allergy, hypercholesterolaemia and osteopenia and a history of shingles twice in the past who on 07-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included LIPITOR, EZETIMIBE (MSD), LEXAPRO and BONIVA.  On 08-JAN-2009 the patient developed a slight itch, redness and a lump on her arm at the injection site after receiving ZOSTAVAX (Oka/Merck).  The nurse also reported a headache after receiving ZOSTAVAX  (Oka/Merck).  The nurse had sought medical attention in the office.  Follow-up information has been received from the physician that the nurse was vaccinated with ZOSTAVAX (Oka/Merck) (lot number 663194/1415X) at 1:00 PM on 07-JAN-2009 and no reaction happened.  At 22:00 PM on 08-JAN-2009 the patient developed 1 inch X 1 inch red area at the injection site.  No rash happened.  On 10-JAN-2009 the red area had gone.  No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Dyspnoea, Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who on approximately 1-JAN-2009 "last week" was vaccinated with ZOSTAVAX (Oka/Merck) SQ and had an anaphylactic reaction. The patient had a rash and shortness of breath and was taken to the hospital (unspecified hospital and if it was an extended stay). The patient was at the pharmacy for medical attention. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Blood blister, Lip blister
Clinical narrative: Information has been received from a healthcare student concerning a male patient who on 07-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck).  The patient developed a "blood blister" on the lip after receiving ZOSTAVAX (Oka/Merck).  The patient spoke with pharmacist for medical attention.  No further information is available.