chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blister, Discomfort, Herpes zoster, Pain
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning an 82 year old male patient with codeine allergy, DEMEROL allergy, morphine allergy, SEPTRA allergy, FLOXIN allergy and THORAZINE allergy, hypertension, diabetes, neuropathy peripheral and reactive airways disease and a history of chickenpox in his 50's who on 09-APR-2010 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# 664636/0874Y) into his right arm. Concomitant therapy included DYAZIDE, NEURONTIN, finasteride (manufacturer unknown), DUONEB and cyanocobalamin. On 22-JUN-2010 the patient developed shingles. The patient had lesions presented on right 12th dermatome region. The patient reported his pain to be 9 to 10 on a scale of 1 to 10. The patient also had back pain and discomfort. It was reported that the patient had no exposure to chickenpox or shingles. No rash occurred at the injection site or elsewhere within 42 days of the vaccination. No direct fluorescent antibody was done and no photos had been taken. The patient visited the office. On 24-JUN-2010, the patient was started on antiviral medications. Urine test was performed with normal result. At the time of this report, the patient's shingles persisted. 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 Merck vaccine strain. A lesion sample was collected on 28-JUN-2010. The sample was taken from vesicle. On 28-JUN-2010 the sample was sent to the laboratory. Follow up information has been received from the nurse who reported that the patient had an appointment with the physician because he still had lesions. Follow up information has been received which reported the VZV final result was wild type strain. Follow up information has been received from the registered nurse concerning the 82 year old retired male patient who on 09-APR-2010 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (lot# 664636/0874Y) into his right arm. On 22-JUN-2010, the patient developed shingles post receiving vaccine. On 06-JUL-2010, the patient recovered from shingles. Additional follow up information has been received which reported that on 28-JUN-2010, three vesicle lesion samples were collected and on the same day the samples were sent to the laboratory. On 29-JUN-2010 the sample arrived in laboratory. VZV DNA and B globin were amplified and the VZV strain identification showed adequate specimen which identified the presence of wild type strain. Follow up information has been received from the registered nurse concerning the 82 year old retired male patient who on 09-APR-2010 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (lot# 664636/0874Y) into his right arm. There was no illness at time of vaccination. On 24-JUN-2010, the patient developed shingles post receiving vaccine. On 06-JUL-2010, the patient recovered from shingles. Additional information is not expected.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion, Urine analysis normal, Varicella virus test positive
Clinical narrative: Initial and follow up information has been received from a registered nurse concerning an 82 year old male patient with codeine allergy, DEMEROL allergy, morphine allergy, SEPTRA allergy, FLOXIN allergy and THORAZINE allergy, hypertension, diabetes, neuropathy peripheral and reactive airways disease and a history of chickenpox in his 50's who on 09-APR-2010 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# 664636/0874Y) into his right arm. Concomitant therapy included DYAZIDE, NEURONTIN, finasteride (manufacturer unknown), DUONEB and cyanocobalamin. On 22-JUN-2010 the patient developed shingles. The patient had lesions presented on right 12th dermatome region. The patient reported his pain to be 9 to 10 on a scale of 1 to 10. The patient also had back pain and discomfort. It was reported that the patient had no exposure to chickenpox or shingles. No rash occurred at the injection site or elsewhere within 42 days of the vaccination. No direct fluorescent antibody was done and no photos had been taken. The patient visited the office. On 24-JUN-2010, the patient was started on antiviral medications. Urine test was performed with normal result. At the time of this report, the patient's shingles persisted. 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 Merck vaccine strain. A lesion sample was collected on 28-JUN-2010. The sample was taken from vesicle. On 28-JUN-2010 the sample was sent to the laboratory. Follow up information has been received from the nurse who reported that the patient had an appointment with the physician because he still had lesions. Follow up information has been received which reported the VZV final result was wild type strain. Follow up information has been received from the registered nurse concerning the 82 year old retired male patient who on 09-APR-2010 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (lot# 664636/0874Y) into his right arm. On 22-JUN-2010, the patient developed shingles post receiving vaccine. On 06-JUL-2010, the patient recovered from shingles. Additional follow up information has been received which reported that on 28-JUN-2010, three vesicle lesion samples were collected and on the same day the samples were sent to the laboratory. On 29-JUN-2010 the sample arrived in laboratory. VZV DNA and B globin were amplified and the VZV strain identification showed adequate specimen which identified the presence of wild type strain. Follow up information has been received from the registered nurse concerning the 82 year old retired male patient who on 09-APR-2010 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (lot# 664636/0874Y) into his right arm. There was no illness at time of vaccination. On 24-JUN-2010, the patient developed shingles post receiving vaccine. On 06-JUL-2010, the patient recovered from shingles. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 61 year old male patient who in January 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The physician stated that in June 2010, the patient experienced a bilateral rash on his thigh but the physician did not think it was shingles. The physician stated that "the rash seems to be controlled by 400 mg of acyclovir (manufacturer unspecified)". At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 75 year old female consumer with heart disease, cholesterol, blood pressure and breast cancer and with no drug reactions or allergies who on 30-SEP-2010 was vaccinated with ZOSTAVAX (Merck) (lot # unknown). Concomitant therapy included CRESTOR, BENICAR, anastrozole, baby aspirin and GABAPEN. The patient had a history of pain and increased high blood pressure while on prior therapy with rofecoxib (MSD, WAES 1010USA02491). The consumer mentioned that on 04-OCT-2010 she had a mild case of shingles. The consumer went to their health care professionals and they diagnosed it as shingles. No laboratory diagnostics studies were performed. At the time of report, the patient's outcome was unknown. No laboratory tests were performed. It was reported that an unspecified treatment was given. No further information is available.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old male with a history of shingles at 21 years old and no drug reactions/allergies who on 09-MAR-2010 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (LOT# 665520/1196Y, expiration 21-FEB-2011). There was no concomitant medication. The patient had bumps on the upper left chest area with no pain 3 weeks after getting ZOSTAVAX (Merck). Physician gave the patient something for shingles but specific name of medication unknown. A couple of days ago ("today" was 30-JUN-2010), the patient recovered from shingles. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient in her early 60's who on an unspecified date was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on an unspecified date, the patient was diagnosed with shingles by her physician. At the time of the report, the patient's outcome was unknown. This is one of two reports from the same source. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Dyspnoea, Heart rate increased, Muscular weakness
Clinical narrative: Information has been received from an 85 year old female patient with asthma, blood pressure abnormal, heart problems and allergy to VISIPAQUE who on 05-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included BYSTOLIC, PLAVIX, ADVAIR, ACTONEL, CRESTOR and KEPPRA and "Renidine". On 07-OCT-2010 the patient had joint pain and weakened legs, difficulty breathing, felt very weak, a little pain, and noticed her resting heart rate went up 40 points. No laboratory diagnostics studies were performed. The patient mentioned that she was feeling better at the time of reporting. She mentioned she would contact her doctor. No further information is available.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from an 85 year old female patient with asthma, blood pressure abnormal, heart problems and allergy to VISIPAQUE who on 05-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included BYSTOLIC, PLAVIX, ADVAIR, ACTONEL, CRESTOR and KEPPRA and "Renidine". On 07-OCT-2010 the patient had joint pain and weakened legs, difficulty breathing, felt very weak, a little pain, and noticed her resting heart rate went up 40 points. No laboratory diagnostics studies were performed. The patient mentioned that she was feeling better at the time of reporting. She mentioned she would contact her doctor. No further information is available.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a registered pharmacist (R.Ph) concerning 69 years old female patient who on 29-SEP-2010 was vaccinated subcutaneously with a 0.65mL dose of ZOSTAVAX (Merck) (lot number unknown). The pharmacist reported that the patient developed a zoster-like rash on her trunk after receiving ZOSTAVAX (Merck). The patient stated that was too painful to wear a bra. The patient sought unspecified medical attention. At the time of report, the patient had not recovered from zoster-like rash on her trunk. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased, Condition aggravated
Clinical narrative: Information has been received from a registered pharmacist concerning a 72 year old female patient with diabetes, penicillin and "quinolones" allergy and a history of shingles who on 08-OCT-2010, was vaccinated SQ with 0.65 ml dose of ZOSTAVAX (Merck) (Lot# not reported). It was reported that approximately on 09-OCT-2010 "over the weekend" the patient had elevated blood sugar. The patient did tell the pharmacist that she needed a new machine because she was having high readings previous to ZOSTAVAX (Merck). The patient after receiving ZOSTAVAX (Merck) was having even higher readings. The patient also stated that she did not want to get shingles again. At the time of the report, the patient had not recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site irritation, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female patient with a history of hyperthyroidism and no drug reactions or allergies who on 10-SEP-2009 was vaccinated via the IM route with a dose of ZOSTAVAX (Merck) (lot# 664319/0562Y). This medication was given accidentally. The intended medication was to be MENACTRA. The patient experienced a localized irritation at the site of injection about the size of a quarter. The injection site was the left deltoid. The patient did not seek any medical attention. On an unspecified date, the patient recovered. Follow up information has been received which reported that the patient received a dose of ZOSTAVAX (Merck) instead of MENACTRA by mistake. The patient developed redness at the site with discomfort. At the time of this report, the patient had recovered without treatment. This is an amended report. Redness at injection site and discomfort at injection site were added as adverse events. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female who on 11-OCT-2010 (also reported as 14OCT2010) was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 664671/0149Z, expiration date 01-APR-2011) in the left arm. The pharmacist reported that one week after the customer received the vaccine she still had a "hardness" at the injection site, but no rash. The patient reported that she went to see her physician on 18-OCT-2010. The injection site reaction was 3 inches by 1 inch, red, warm and itchy. It began on 16-OCT-2010 (also reported as 17-OCT-2010). These events persisted. The healthcare professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Paraesthesia, Throat irritation
Clinical narrative: Information has been received from a 34 year old female medical assistant with no drug reactions or allergies and no medical history who has been giving ZOSTAVAX  (Merkc) injections for 1 year. There was no concomitant medication. On approximately 27-SEP-2010 (reported as "3 weeks ago"), she began to experience "itchy throat" when she reconstituted the ZOSTAVAX (Merck). The "itch throat" took approximately 20 minutes to resolve. The patient reported that she was wearing latex gloves when she administered ZOSTAVAX (Merck). Whenever she would administer the ZOSTAVAX (Merck), she would get red and develop an "itchy throat". The other medical assistant had had to take over giving this vaccination to patient. The patient also reported that she got a tingling sensation in her throat that usually cleared up about 20 minutes after she administered the vaccine to a patient. This had happened the past couple of times. No lab diagnostics studies were performed. At the time of the report, the patient had recovered from "tingling sensation in her throat" on 18-OCT-2010 and recovered from "itchy throat" on an unspecified date. the patient did not seek medical attention. This is one of the reports from the same source. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Headache, Pain
Clinical narrative: Information has been received from a 61 year old female with no medical history and no drug reaction or allergies who on 22-JUL-2010 was vaccinated injection with ZOSTAVAX (Merck). Concomitant therapy included LIPITOR. The patient was experiencing pain, warmth and headaches after receiving the ZOSTAVAX (Merck) and had persisted for 10 to 20 weeks. At the time of reporting, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 71 year old female patient with no pertinent medical history, drug reactions or allergies who on 23-AUG-2010 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # unknown). There was no concomitant medication. The patient reported that about a week after receiving the ZOSTAVAX (Merck) on 28-AUG-2010, she was experiencing a severe rash. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been received.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a Doctor of pharmacy concerning a 69 year old female patient with a history of swelling to an unspecified tetanus vaccine ten years earlier, who on 05-OCT-2010 was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (Merck) (Lot # not reported). There was no concomitant medication. The pharmacist reported that on 08-OCT-2010 the patient experienced 2 inch diameter, red, possible slightly swollen area centered on the injection site. Pharmacist reported that the patient stated that the area turned red within 1-2 days of following administration of ZOSTAVAX (Merck). At the time of the report, the patient was recovering. There were no laboratories performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with no pertinent medical history and no drug reactions/allergies, who on 28-JUN-2010 was vaccinated subcutaneously with a single dose of ZOSTAVAX (Merck) (LOT# 664636/0874Y, expiration 20-DEC-2010). There was no concomitant medication. On 29-JUN-2010 the patient experienced a rash consisting of red lesions on the left side of her torso. There were no lab diagnostics studies performed. The patient sought medical attention through  telephone call to pharmacist. At this time of reporting, the patient was not recovered. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV, TTOX, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning her 76 year old husband with a history of thyroid cancer three years ago and had no known drug allergies who on 23-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number and expiry dates unknown) intramuscularly in his right deltoid. Secondary suspect vaccination administered during the same visit included PNEUMOVAX 23 in his right deltoid. Other concomitant vaccination included tetanus toxoid (manufacturer unknown) in his left deltoid during the same visit. Other concomitant therapy included SYNTHROID, lisinopril-HCTZ and FLOMAX. On 24-JUN-2010, the patient developed a red, warm to touch and painful area of 2 inches in diameter at the site of injection. The patient sought unspecified medical attention. No laboratory tests were performed. the patient was taking naproxen. At the time of the report, the patient had not recovered. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a male Pharm. D. concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). The pharmacist reported that the patient experienced upper body rash. At the time of the report the patient's outcome was not reported. No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site pruritus
Clinical narrative: Information has been received from a 73 year old female consumer with no medical history and no known drug allergies who on 23-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included aspirin and chondroitin sulfate sodium (+) glucosamine sulfate. The day after, on 24-JUN-2010 the patient noticed redness and irritation around the injection site. The patient said it has been itching her pretty badly as well. The patient did not seek any medical attention. No laboratory tests were performed. At the time of the report, the patient had not recovered. No further information is available.
Age: 30.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 30 year old patient who on 16-JUN-2010 was inadvertently vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) SQ in the left arm instead of VARIVAX (Merck). No adverse event was reported. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 84 year old female patient with hypertension, diverticulitis, acid reflux, celiac disease, "ceomalformations", allergies to generic medications: amoxicillin, acetaminophen and DARVOCET, LASIX, VALIUM and sulfonamide allergy (generic medication) and a history of shingles who on 28-OCT-2009 was vaccinated with a single dose of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included prednisone (manufacturer unknown), VALTREX, MICARDIS, amlodipine, SYNTHROID, COUMADIN, PLAVIX and simvastatin (manufacturer unknown). The patient reported that after receiving the vaccine on 21-JUN-2010 she developed shingles. At the time of the report the patient had not recovered. Follow-up information has been received from a physician who reported that the patient did not have adverse reaction. The patient was upset because of developing shingles outbreak 6 months post vaccination. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 69 year old female who on 03-FEB-2009 was vaccinated SC with 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). Around 20-OCT-2010 the patient came down with shingles. It was reported that therapy with ZOSTAVAX (Merck) was discontinued. At the time of reporting, the outcome of shingles was unknown. The patient had sought unspecified medical attention. Follow-up information has been received from the physician concerning the patient. The patient received the ZOSTAVAX (Merck) (lot # 662997/1619X) at 9:00 AM on 03-FEB-2009. On 20-OCT-2010 the patient developed shingles. Outcome of the event was not reported. No further information is available.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old male patient with lymphoma in October 2004 (reported as "six years ago") and no drug reactions or allergies, who on 18-OCT-2010 was vaccinated SQ in the left arm with a dose of ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. On 19-OCT-2010 the patient developed redness, induration, warmth and itching at the injection site of the left upper arm. The patient stopped by the pharmacy and the pharmacy reported the size of the reaction area to be 2 inches by 3 inches. No therapy was prescribed. No lab diagnostics studies were performed. At the time of reporting, the patient's outcome was unknown. Follow-up information was received from a pharmacist who stated that the patient had truly recovered. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who "about one month ago" in approximately September 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (No lot # provided). "A week ago" on 13-OCT-2010 the patient experienced outbreak of shingles after being administered ZOSTAVAX (Merck). Unspecified medical attention had been sought. The status of the patient was unknown. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Periarthritis, Rash
Clinical narrative: Information has been received from a consumer concerning an 87 year old wife with no drug reactions/allergies, who on 22-JUL-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported). Consumer reported that on 15-SEP-2010 in "mid September" his wife had developed a rash on her right arm, the rash was from her wrist to her shoulder. Consumer also reported that she also developed a "frozen shoulder". Consumer stated that they had gone to dermatologist since he administered the ZOSTAVAX (Merck) (Lot # not reported). Dermatologist prescribed her a "cream" to apply to the rash and he also gave her a "pill". Consumer reported that the physician called the rash "Herpes something" and then he said "shingles" Consumer reported that his wife also had seen their primary care physician , who had prescribed a "patch" for his wife to wear. Consumer reported that the rash had resolved although there were marks on her arm where you could still tell where the rash was. Consumer stated that the "frozen shoulder" was better but still present and his wife continued physical therapy. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Information has been received from an approximately 78 year old female patient with allergy to Anesthesia and a history of mastectomy who on 22-OCT-2009, was vaccinated with a dose of 0.65 ml of ZOSTAVAX (Merck) (Lot#Unknown), SQ. Concomitant therapy included gabapentin and capsaicin. It was reported that on approximately 17-SEP-2010, she had symptoms of "back itching, and had welts on the right side of her body, front and back after receiving ZOSTAVAX (Merck)". The patient also experienced "brief burning" (onset unknown); while on therapy with capsaicin. At the time of the report the patient was recovering. The patient sought unspecified medical attention. Follow-up information was received from a physician who stated that they did not have documentation were indicates that the patient received ZOSTAVAX (Merck) and it was not listed in her allergies. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female patient who on 03-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). It was reported that on 13-OCT-2010, the patient called to the pharmacist and said that she got a shingle's like rash on her neck. At the time of the report, the patient's outcome was unknown. It was reported that an unspecified treatment was given for the adverse event. This is one of several reports from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Information has been received from a Registered Pharmacist concerning a 64 year old female patient who "about a week ago" on approximately 06-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on an unspecified date, the patient experienced redness and warmth in her arm. The pharmacist stated that the patient still had redness and a little warmth in her arm. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a male patient who "about 6 months ago" in approximately April 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown) and "a few weeks after" developed a rash on the left buttocks dermatone. The physician stated that had not tested the rash to identify the origin of the rash. At the time of the report, the patient had recovered. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin irritation
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female patient who on 12-OCT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that on approximately 12-OCT-2010, the patient experienced redness and irritation on her arm. The pharmacist stated that the patient's symptoms from her ZOSTAVAX (Merck) lasted a month (conflicted information). At the time of the report, the patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Musculoskeletal pain, Pain, Pruritus, Rash
Clinical narrative: Information has been received from a 61 year old female consumer concerning herself who on 25-SEPT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported) in the back of her left arm for shingles prevention. Her relevant medical history and concomitant medications include neuropathy for which she took NEURONTIN and diabetes for which she took glimepiride; irregular heartbeat for which she took atenolol; high triglycerides for which she took an unknown medication; high cholesterol for which she took simvastatin. Her relevant past drug history was unknown. On 26-SEPT-2010, she woke up in the morning with a rash on the right side of her chest. In 2010, sometime after developing the rash, she developed sores which turned to hives, itching, and stinging pain on her buttocks and she had been awake most of the night. She had had no laboratory testing performed. As of 09-OCT-2010, the rash had resolved, but continued to have hives, itching, sores, and stinging pain on her buttocks and she was still awake most of the night due to the pain. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin ulcer, Urticaria
Clinical narrative: Information has been received from a 61 year old female consumer concerning herself who on 25-SEPT-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported) in the back of her left arm for shingles prevention. Her relevant medical history and concomitant medications include neuropathy for which she took NEURONTIN and diabetes for which she took glimepiride; irregular heartbeat for which she took atenolol; high triglycerides for which she took an unknown medication; high cholesterol for which she took simvastatin. Her relevant past drug history was unknown. On 26-SEPT-2010, she woke up in the morning with a rash on the right side of her chest. In 2010, sometime after developing the rash, she developed sores which turned to hives, itching, and stinging pain on her buttocks and she had been awake most of the night. She had had no laboratory testing performed. As of 09-OCT-2010, the rash had resolved, but continued to have hives, itching, sores, and stinging pain on her buttocks and she was still awake most of the night due to the pain. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a female consumer who was vaccinated with ZOSTAVAX (Merck). On an unspecified date, the patient had a reaction to the vaccine. It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia
Clinical narrative: Information has been received from a female patient with allergic reaction to monosodium L-glutamate who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). After receiving the vaccine she had been unable to sleep. It was unknown if the patient sought medical attention. At the time of the report the outcome of unable to sleep was unknown. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an unknown age and gender patient who in June 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# 665524/1374Y). In June 2010, the patient reported a reaction which included redness, swelling and inflammation. It was noted that the patient's relevant history, concomitant medications and past drug history were unknown. It was unspecified if lab tests were performed. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning an unknown age and gender patient who in June 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# 665524/1374Y). In June 2010, the patient reported a reaction which included redness, swelling and inflammation. It was noted that the patient's relevant history, concomitant medications and past drug history were unknown. It was unspecified if lab tests were performed. At the time of the report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who in June 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 665524/1374Y). The patient's relevant medical history, concomitant medications and past drug history were unknown. On an unknown date, in June 2010, the consumer reported a reaction, more than the normal localized reaction which include redness, swelling, and inflammation. It was unknown if there was any relevant laboratory data. As of 19-JUN-2010 it was unknown if the consumer still had redness, swelling and inflammation. It was unspecified if the patient sought medical attention. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who in June 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 665524/1374Y). The patient's relevant medical history, concomitant medications and past drug history were unknown. On an unknown date, in June 2010, the consumer reported a reaction, more than the normal localized reaction which include redness, swelling, and inflammation. It was unknown if there was any relevant laboratory data. As of 19-JUN-2010 it was unknown if the consumer still had redness, swelling and inflammation. It was unspecified if the patient sought medical attention. Follow-up information has been received from the pharmacist who reported that the patient experienced reactions that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist did not think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: Information has been received from a pharmacist concerning 5 patients who were vaccinated with a dose of ZOSTAVAX (Merck) (lot # 665524/1374Y). All the patients experienced a rash 24 hours after the ZOSTAVAX (Merck) was given. The patients sought medical attention by calling pharmacist. At the time of report, the patient's outcome was unknown. Follow-up information has been received from the pharmacist who reported that one of the patients experienced a reaction that occurred about 24 hours post-vaccination and involved a silver dollar size rash with redness and swelling at the injection site. The patient did not receive medical attention. At the time of report, the patient's outcome was unknown. The pharmacist commented that they vaccinated 300 patients with ZOSTAVAX (Merck) without any issues and then they had 5 patients who all had the same delayed injection site reactions which occurred the same week and from the same lot. The pharmacist didn't think this was a coincidence since they had no problems with the other patients, plus each of these 5 patients were vaccinated from the same ZOSTAVAX (Merck) lot number 665524/1374Y. This is one of several reports received from the same source. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female with an allergy to penicillin who on 18-JUN-2010 was vaccinated SQ with a single dose of ZOSTAVAX (Merck) (lot # 665514/0145Z) at the pharmacy. On 19-JUN-2010 the patient developed itchy, fluid-filled blisters on the backs of both thighs and on one arm. The patient self-treated with BENADRYL cream topically with slight improvement in symptoms. There were no laboratory studies performed. the patient sought medical attention by calling pharmacist. At the time of report, the patient had not recovered. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a family member concerning an 84 year old female with asthma chronic who in June 2007, was a dose of vaccinated with ZOSTAVAX (Merck) in a pharmacy, without getting advice from her primary physician. Concomitant therapy included corticosteroids (unspecified). She had been on corticosteroids (unspecified) for 50 years to treat her asthma. In June 2007, the patient got shingles. The blisters had gone away but the pain never ceased. The patient was currently on LYRICA for pain. The patient did not receive medical attention. At the time of the reporting, the patient had not recovered. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast pain, Fatigue, Herpes zoster
Clinical narrative: Information has been received from an approximately 63 year old female patient with penicillin allergy and shingles about six years who in approximately March 2010 ( about two or three months ago"), was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). There was no concomitant medication. In approximately March 2010 ("about two or three months ago"), the patient experienced shingles for about three days, and the rash was in the same spot the original rash had been. The patient also experienced intense breast pain. After a few days of these symptoms, the patient had been about 90 percent pain free. Shingles had made her very tired and now she had her energy back. No lab diagnostics studies were performed. In approximately April 2010 ("about two months ago"), the patient recovered. The patient did not seek medical attention. No further information is available.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Pruritus, Rash
Clinical narrative: Information has been received from an unknown reporter concerning a 65 year old male patient who was vaccinated on an unspecified date with a intramuscularly dose of ZOSTAVAX (Merck) (Lot #: not reported). On 30-APR-2010, after receiving the ZOSTAVAX (Merck), the patient began breaking out in different areas of his body. The patient's caller stated that "is not sure if it is actual shingles or just a rash. It was extremely itchy, but goes away in 10 minutes after it appears". At the time of the report the patient was not recovered from shingles or rash, but recovering from itching. The patient also was vaccinated by intramuscular route instead of subcutaneous route. No adverse event were reported. Patient sought unspecified medical attention. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Pain, Rash, X-ray limb normal
Clinical narrative: Information has been received from a consumer concerning his 72 year old wife with diabetes and a history of several strokes, no drug reactions/allergies who was vaccinated on 15-JUN-2010, with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot#: not reported) on her right arm. Concomitant therapy included ascorbic acid and "vitamin C", pyridoxine "B6", "3 blood pressure medicines", "fluid pills" and "heart rhythm pill". On 17-JUN-2010, the patient started feeling pain (specific area not provided), noticed a rash on both of her arms, and swelled knees. On 19-JUN-2010, the patient's husband took her to the emergency room where an x-ray was taken on the knees and there were no broken bones. Consumer took patient to her doctor on 22-JUN-2010, who prescribed "pain medication and a cream" (names and manufacturers were unspecified for either medication). Consumer also reported that the knee swelling worsened on 23-JUN-2010. At the time of the report, the rash was "not as bad as it was before" after using the "cream" that the doctor prescribed. Pain a swelled knees persisted. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pruritus, Injection site swelling, Tenderness
Clinical narrative: Information has been received from a pharmacist concerning an 86 year old female with no medical history or allergies who on 21-JUN-2010 was vaccinated SQ with a dose of ZOSTAVAX (Merck) (lot # 664673/0150Z). There was no concomitant medication. On 22-JUN-2010 the patient developed headache, and also redness, swelling (the size of the palm of the hand) and itchiness at the injection site. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of report, the patient had not recovered. Follow-up information has been received which reported on 21-JUN-2010, the female patient was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664673/0150Z). The patient experienced redness, tenderness and itchiness which were intense for 1 week, and these symptoms slowly subsided during the second to third week. On 21-JUL-2010, approximately 1 month later, the patient recovered and no longer bothered by adverse effects. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: Information has been received from a 71 year old male with type 2 diabetes mellitus, and allergies to erythromycin, tetracycline, LIPITOR, penicillin and epinephrine who on 18-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) injection. On 19-JUN-2010 the patient experienced a spike in his blood pressure of 70 point after getting the vaccine. At the time of report, the patient was recovering. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old male with high blood pressure and no allergies who on 20-FEB-2010 was vaccinated SQ with a dose of ZOSTAVAX (Merck) (lot # 665309/1173Y). Concomitant therapy included lisinopril, atenolol and hydrochlorothiazide. "About 3 weeks ago" on approximately 02-JUN-2010 the patient had an outbreak of shingles. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of report, the patient's outcome was unknown. Additional information has been requested.