chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a 75 year old female who on 04-APR-2008 was vaccinated with the first dose of ZOSTAVAX (Oka/Merk), in her arm, intramuscularly. Concomitant therapy included CALTRATE, SYNTHROID and atenolol. The pharmacist reported that a week after vaccination, on approximately 11-APR-2008,  the patient experienced a rash with red bumps all over her left and right arms, no blisters or itching; also described it as small dots. The patient was seen by a dermatologist who was unsure what the rash was but "burned them off". The pharmacist reported she was not sure if it was drug interaction with another drug. At the time of the report the patient had recovered. No further information is available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration, Paraesthesia, Rash
Clinical narrative: Information has been received from a physician concerning a 60 year old male patient who on 23MAY-2008 was vaccinated with first dose of ZOSTAVAX (LOT # 659763/1875U), intramuscularly at 10:00 hours. There was no concomitant medication. The physician reported that on 04-JUN-2008, the patient developed paresthesian patch like, at the left anterior cervical region with skin eruption. it appeared patient developed zoster 15 days post vaccination. The patient's symptoms (unspecified symptoms) started 3 days before, in approximately 04-JUN-2008. The patient was given VALTREX. At the time of the report the patient was recovering. The patient sought medical attention. Diagnostic test was clinical exam only. No further information in available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 62 year old female nurse who on 06-JUN-2008 was vaccinated subcutaneously with ZOSTAVAX vaccine (Oka/Merck). There was no concomitant medication. A nurse is reporting that after she had received ZOSTAVAX vaccine (Oka/Merck), on 07-JUN-2008, the injection site became red and swollen. The patient did not seek for medical attention. At the time of the report, the patient was recovering. There was no product quality complain. Follow up information was received from a 62 year old nurse with no known drug allergies who reported that on 06-JUN-2008 at 3:30 pm she was vaccinated subcutaneously on the right arm with ZOSTAVAX vaccine (Oka/Merck) (Lot number 659407/0295X). There was no concomitant medication reported. On 06-JUN-2008 in pm she developed a local reaction, red, warm, slightly swollen which lasted 10 days. The patient recovered. There was no illness at the time of vaccination. No further information is available.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Decreased appetite, Inappropriate schedule of drug administration, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 51 year old female with depression, diabetes, neuropathy peripheral, an allergy to BEXTRA and hyperlipidemia and a history of urinary tract infection treated with MACROBID, who on 05-JUN-2008 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Oka/Merck) (Lot # 659760/0159X). Concomitant therapy included simvastatin, NASACORT, metformin, fexofenadine hydrochloride (+) ALLEGRA-D, LANTUS, aspirin, FLEXERIL, LYRICA, RHINOCORT, oxycodone, KLONOPIN, glipizide, NEURONTIN, CYMBALTA, VIAGRA and ZYRTEC. The physician reported that a patient who received ZOSTAVAX (Oka/Merck), experienced redness and swelling at the site of injection a few hours after being vaccinated on 05-JUN-2008. On 06-JUN-2008, patient developed severe migraines and took two IMITREX 100 mg tablets and the migraine went away. Patient also experienced a decreased in appetite. On 07-JUN-2008, the patient developed blisters with puss periorally. Patient visited the physician on 09-JUN-2008 and upon examination the physician stated the blisters looked yellow, were shrinking, and were slightly raised. Patient also experienced tongue swelling and developed a cold sore on her gum in the back. Patient was treated with prednisone and cetrizine HCl. Unspecified medial attention was sought. At the time of the report, the patient had not recovered from the AEs. There was no product quality complaint. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Migraine, Oral herpes, Swollen tongue
Clinical narrative: Information has been received from a physician concerning a 51 year old female with depression, diabetes, neuropathy peripheral, an allergy to BEXTRA and hyperlipidemia and a history of urinary tract infection treated with MACROBID, who on 05-JUN-2008 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Oka/Merck) (Lot # 659760/0159X). Concomitant therapy included simvastatin, NASACORT, metformin, fexofenadine hydrochloride (+) ALLEGRA-D, LANTUS, aspirin, FLEXERIL, LYRICA, RHINOCORT, oxycodone, KLONOPIN, glipizide, NEURONTIN, CYMBALTA, VIAGRA and ZYRTEC. The physician reported that a patient who received ZOSTAVAX (Oka/Merck), experienced redness and swelling at the site of injection a few hours after being vaccinated on 05-JUN-2008. On 06-JUN-2008, patient developed severe migraines and took two IMITREX 100 mg tablets and the migraine went away. Patient also experienced a decreased in appetite. On 07-JUN-2008, the patient developed blisters with puss periorally. Patient visited the physician on 09-JUN-2008 and upon examination the physician stated the blisters looked yellow, were shrinking, and were slightly raised. Patient also experienced tongue swelling and developed a cold sore on her gum in the back. Patient was treated with prednisone and cetrizine HCl. Unspecified medial attention was sought. At the time of the report, the patient had not recovered from the AEs. There was no product quality complaint. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a nurse concerning a 79 year old male who on 16-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Merck). The nurse reported that on 19-MAY-2008 the patient experienced dermatomal distribution of shingles. The patient sought medical attention "yes nurse". The patient was given VALTREX and unspecified pain medication. Lot # was not available. It was reported "our patient that got ZOSTAVAX did not really have a adverse effect, he simply got shingles after having the vaccine" " Date of ZOSTAVAX 11/07, Shingles dx 5/08" It was reported that the physician said "no follow-up is required. Patient recovered without incident" No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 66 year old female with not known allergies or pertinent medical history who on 07-APR-2008 was vaccinated SQ with a dose of ZOSTAVAX (Merck) 0.65 ml (Lot # 659761/0157X). Concomitant therapy included ALLEGRA and Prevacor. The pharmacist reported that the patient who received ZOSTAVAX (Merck) developed welts at the panty line, bra line, and near the neck that manifest after taking an evening shower and subside by the morning. The patient noticed the welts first appearing about two weeks on approximately 21-APR-2008 after receiving the ZOSTAVAX (Merck) injection. The welts persists although less intense. No other symptoms or treatment reported. The patient's physician did not attribute the welts to ZOSTAVAX (Merck). The patient sought medical attention, he was seen in the office visit. There was no product quality complaint. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: Information has been received from a registered nurse concerning a 65 year old female, weight 147 pounds height 61 inches, with a history of oral cold sores who on 29-MAY-2008 at 13:30 was vaccinated with the first dose of ZOSTAVAX (Oka/Merck) subcutaneously (lot#: 659614/0161X). There was no concomitant medication. Within an hour after vaccination, the patient stated she had a "cold sore" on her lip. The patient had a history of cold sore on lips, but she stated it had not occurred in awhile. The patient felt strongly it was related to the vaccine. She was unable to take her anti-viral medication due to the vaccine. After 2-3 days, the patient recovered from cold sore on lip. It was unspecified if the patient sought medical attention. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a 13 year old female who on 28-MAY-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) instead of her second dose of VARIVAX (Merck). This was related to staff error and not product confusion. No adverse effect reported. The healthcare worker also reported the same events for patient's brother (refer to WAES# 0805USA06014). Additional information has been requested.
Age: 95.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a 95 year old male who on August 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck), subcutaneously, 0.65ml. The nurse practitioner reported that on 09-JUN-2008, the patient developed a case of shingles. The rash was on his trunk. He was treated with VALTREX. At the time of the report the patient was recovering. Medical attention was sought. Follow-up information indicated no new information. No further information is available.
Age: 11.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 11 year old male patient who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The nurse reported that the patient received ZOSTAVAX instead of VARIVAX (Oka/Merck). There was no product confusion discovered, just a nurse error. No adverse event reported. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Loss of consciousness, Speech disorder
Clinical narrative: Information has been received from a pharmacist concerning a 75 year old patient who on 05-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 659410/0412X) 0.65ml SQ. On 09-JUN-2008 the patient blacked out for a short period of time and then had difficulty speaking. The patient was recovering. The patient sought medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site vasculitis
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with ZOSTAVAX (Oka/Merck). The physician reported that the patient received ZOSTAVAX (Oka/Merck) and had a little bump at the injection site for about 2 weeks then it turned into vasculitis. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient who on 04-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (route and site of administration not reported) at the pharmacy. On 04-JUN-2008 the patient broke out "rash all over her trunk", the patient's rash all over her trunk persisted. The patient has a follow up scheduled with her physician. The patient sought medical attention and called the pharmacy. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a medical assistant and a nurse practitioner concerning a 74 year old female who on 27-FEB-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot number, route and site of administration not reported) one vial, once. On 05-JUN-2008, 2 months after receiving ZOSTAVAX vaccine the patient developed shingles which was located in T7-T9 dermatome on the left side. It was noted that the patient's case was "pretty severe" covering almost the entire dermatome. The patient's shingles persisted. The patient sought medical attention in the physician office. A sample was collected for testing. The patient was enrolled in the VZVIP program. The vaccine zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Oka/Merck vaccine strain. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning a patient who was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). Subsequently the patient experienced shingles. The patient went to the doctor's office and sought unspecified medical attention. No product quality complain was involved.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who on approximately 11-APR-2008 (also reported as two months ago) was vaccinated with ZOSTAVAX (Oka/Merck) by subcutaneous injection (lot number and injection site not reported). Right after the administration of vaccine the patient developed a rash at the injection site. Rash was elongated, and the reporter regarded it as an allergic reaction. Unspecified medical attention was sought. Subsequently, the patient recovered from the event. No complain of product quality was involved. Follow-up information was received on 07-JUL-2008 from the pharmacist concerning a 72 year old female with penicillin and sulfa allergies who on 26-MAR-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot #659762/1874U). On 26-MAR-2008 upon administration, the patient complained of minor burning sensation which subsided within a few minutes. Policy required the patient to site down in front end of pharmacy for at least 15 minutes. Subsequently the patient developed red rash around injection site. The redness was oval about 2 inches long and 1 inch wide with some itching. The rash was not raised. The patient also had tenderness. The patient stayed in pharmacy for about 30 minutes after vaccination. After 30 minutes,the patient felt fine. The itchiness was subsiding and the rash was slightly less red. The next day the pharmacist called the patient. The patient reported that the rash was completely gone. Some tenderness still existed, but probably due to the soreness of receiving an injection. The pharmacist thought that no medical follow up required. The reaction was minor and resolved itself within a few hours. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Information has been received from a pharmacist concerning a patient who on approximately 11-APR-2008 (also reported as two months ago) was vaccinated with ZOSTAVAX (Oka/Merck) by subcutaneous injection (lot number and injection site not reported). Right after the administration of vaccine the patient developed a rash at the injection site. Rash was elongated, and the reporter regarded it as an allergic reaction. Unspecified medical attention was sought. Subsequently, the patient recovered from the event. No complain of product quality was involved. Follow-up information was received on 07-JUL-2008 from the pharmacist concerning a 72 year old female with penicillin and sulfa allergies who on 26-MAR-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (Lot #659762/1874U). On 26-MAR-2008 upon administration, the patient complained of minor burning sensation which subsided within a few minutes. Policy required the patient to site down in front end of pharmacy for at least 15 minutes. Subsequently the patient developed red rash around injection site. The redness was oval about 2 inches long and 1 inch wide with some itching. The rash was not raised. The patient also had tenderness. The patient stayed in pharmacy for about 30 minutes after vaccination. After 30 minutes,the patient felt fine. The itchiness was subsiding and the rash was slightly less red. The next day the pharmacist called the patient. The patient reported that the rash was completely gone. Some tenderness still existed, but probably due to the soreness of receiving an injection. The pharmacist thought that no medical follow up required. The reaction was minor and resolved itself within a few hours. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a female who on approximately 10-JUN-2008, "yesterday", was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The pharmacist reported in follow up that immediately after the vaccine was given by the patient's physician, the patient began experiencing a reaction that looked like "flat red circle at the injection site that was 3 inches in diameter", which was also reported as " a red circular raised area". The patient spoke to pharmacist to pharmacist to sought unspecified medical attention. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Information has been received from a 62 year old female with no known allergies who on 08-JUN-2008 was vaccinated with ZOSTAVAX (lot no. not reported) via injection. Route and site of injection were not reported. Concomitant therapy included lisinopril (manufacturer unknown), SYNTROID, metformin and "Nadalol". On 10-JUN-2008 the patient developed oval shaped red bump at the injection site which felt hard to touch after vaccination. The patient's oval shaped red bump at the injection site persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: Information has been received from a 64 year old female who on 10-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 11-JUN-2008 the patient experienced rapid heart beat (120) and missed heart beats. At the time of the report, it was unknown if the patient had recovered from the events. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Pain, Palpitations
Clinical narrative: Initial information has been received from an 85 year old female with spine and neck problems and a history of shingles (4 times in the past) who on 10-JUN-2008was vaccinated with a dose of ZOSTAVAX (Merck). The patient was also given tetanus toxoid at the same time. On 10-JUN-2008 post vaccination the patient experienced pain at the injection site, soreness all over her body and flu like symptoms. Follow-up information has been received form the patient concerning the patient had a "weakness in the head" prior to vaccination but never headache. After receiving a tetanus vaccine (unspecified manufacturer) and ZOSTAVAX (Merck) on the same arm at the same visit, the patient said that it became sore. The patient also experienced heart palpitations at times and headaches that came and went. the patient felt as if she had gotten weaker since vaccination. Concomitant therapy included LEVOXYL, LIPITOR, metoprolol, ALTACE, NORVASC and baby aspirin. At the time of this report the outcome were unknown. The patient spoke to pharmacist. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate normal, Injection site discolouration, Injection site mass, Injection site pruritus, Lymphoedema
Clinical narrative: Information has been received from a 75 year old female with hyperlipidemia, osteoporosis, insomnia, chronic sinusitis, anxiety and depression and a history of hysterectomy, lumpectomy, lymphadenectomy, breast cancer with some lymph nodes removed from that left arm, radiotherapy and breast lump and no allergies who on 06-JUN-2008 at 11:00 AM was vaccinated subcutaneously in her right arm with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ZOLOFT, RESTORIL, and alprazolam. The patient reported that about 21 years ago she had a lumpectomy done on her left breast where they had removed all of her lymph nodes. On 11-JUN-2008 the patient's left hand, finger and palm was swollen to the point where she can not tighten her hand. The patient had a sort of stiff feeling in the left arm. The patient also reported that at the injection site it was black and blue with a red ring around it, itchy and there was a lump underneath the skin, and underneath her right arm the patient was having a weird sensation feeling that the patient had not had before. The patient reported that as of 12-JUN-2008 her hand was still swollen, she still had the injection site reactions and the sensation under her arm, but she had spoken to her physician and would be seeing him at the office on 13-JUN-2008. Review of system indicated that the patient's weight was stable and her appetite was good, no chest pain or palpitations and no dyspnea, cough or sputum. Physical examination indicated: Blood pressure 116/80; Pulse 78; Respirations 14 and Temperature 98.6 degrees Fahrenheit. The patient was well developed, well nourished and in no acute distress. The patient's left arm did have lymphedema, from the elbow down it was obvious. Palpation of the axilla did not reveal any lymphadenopathy. There was no edema in the right arm. The left arm had full rang of motion. No product quality complaint was involved. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Oedema peripheral, Respiratory rate decreased
Clinical narrative: Information has been received from a 75 year old female with hyperlipidemia, osteoporosis, insomnia, chronic sinusitis, anxiety and depression and a history of hysterectomy, lumpectomy, lymphadenectomy, breast cancer with some lymph nodes removed from that left arm, radiotherapy and breast lump and no allergies who on 06-JUN-2008 at 11:00 AM was vaccinated subcutaneously in her right arm with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ZOLOFT, RESTORIL, and alprazolam. The patient reported that about 21 years ago she had a lumpectomy done on her left breast where they had removed all of her lymph nodes. On 11-JUN-2008 the patient's left hand, finger and palm was swollen to the point where she can not tighten her hand. The patient had a sort of stiff feeling in the left arm. The patient also reported that at the injection site it was black and blue with a red ring around it, itchy and there was a lump underneath the skin, and underneath her right arm the patient was having a weird sensation feeling that the patient had not had before. The patient reported that as of 12-JUN-2008 her hand was still swollen, she still had the injection site reactions and the sensation under her arm, but she had spoken to her physician and would be seeing him at the office on 13-JUN-2008. Review of system indicated that the patient's weight was stable and her appetite was good, no chest pain or palpitations and no dyspnea, cough or sputum. Physical examination indicated: Blood pressure 116/80; Pulse 78; Respirations 14 and Temperature 98.6 degrees Fahrenheit. The patient was well developed, well nourished and in no acute distress. The patient's left arm did have lymphedema, from the elbow down it was obvious. Palpation of the axilla did not reveal any lymphadenopathy. There was no edema in the right arm. The left arm had full rang of motion. No product quality complaint was involved. Additional information is not expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Inappropriate schedule of drug administration, Swelling, Tenderness
Clinical narrative: Initial information has been received from a physician concerning a 56 year old female who on 09-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number not provided). Concomitant therapy included ALLEGRA, LIPITOR, CELEBREX, aspirin, WELLBUTRIN, DIFLUCAN, and PROTONIX. On 10-JUN-2008 the patient developed redness, swelling, tenderness and warmth. It was unspecified where on the body patient had this . No further information was provided. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Neurological examination
Clinical narrative: Information has been received from a registered nurse (R.N.) concerning the nurse with a history of chickenpox who vaccinated approximately 300 people with ZOSTAVAX (Merck) in the last 7 months. Subsequently, the patient experienced constant headaches in the back of his neck. The patient was seeing a neurologist. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning an elderly female who on 06-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck). Subsequently, the patient recovered from rash and felt generally poor. Unspecified medical attention was sought. No product quality complaint involved. Additional information is not expected. The N.P. could not identify the patient that experienced these adverse events.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 65 year old female with no pertinent medical history, drug reactions or allergies who on 04-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ZETIAL, calcium (unspecified) and vitamin D (unspecified). On 06-JUN-2008 the patient experienced Shingles. At the time of the report the patient was recovering from Shingles. The patient sought medical attention by coming to physician. No product quality complaint involved. Follow-up information was received on 01-JUL-2008 from a practice manager concerning a patient who on 04-JUN-2008 was vaccinated in the left side with a 0.5 ml dose of ZOSTAVAX (Oka/Merck) (Lot #659406/0298X, expiration date 25-JUL-2009). On 06-JUN-2008 the patient developed rash in the left groin. Then blisters appeared in the left groin. The patient also had pain rated a 5 out of 10. She was treated with acyclovir cream. At the time of the report, the patient had recovered from the event. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a female patient from another pharmacy who developed rash after receiving ZOSTAVAX vaccine (Oka/Merck) (Dose, Frequency, Therapy route, Lot # unspecified). It was unspecified if medical attention was sought. VZVID information provided. Caller was not interested at this time. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female with no pertinent medical history who on 11:00 am on 06-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot# 659614/0161X) at left arm, SQ, single dose, once. There was no concomitant medication. On 07-JUN-2008 at 1:00 PM the patient developed an injection site reaction. The injection site area was warmth and the size of a lemon. The patient took BENADRYL (manufacturer unknown) for the treatment. The patient called the office and the office told the patient to contact the health department.This is in follow-upto report (s) previously submitted on 9/24/2008. Follow-up information was reported that the patient also got cold sores on her mouth, which occurred on 15-Jun-2008 or 16-Jun-2008 (previous reported as about a week after being vaccinated). The patient reported that she has never had cold sores before. The patient had been treated with ZOVIRAX ointment. The patient had seen a dermatologist since "It's not quite right on her lip." The patietn called the physician to seek medical attention. The patient was recovered. Additional information is not expected. The patient is recovering for the events. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: Information has been received from a receptionist at the physician's office concerning a patient who in approximately April 2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (dose and administrating site not reported). The patient experienced a "break out" (unspecified as to what this exactly means) a few days after the shot. Subsequently, the patient recovered from break out (unspecified as to what this exactly means). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Viral infection
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Subsequently the patient experienced viral like symptoms. At the time of report, no outcome was reported. Additional information has been requested.
Sex: M
Vaccine: TTOX, VARZOS
Symptoms: Injection site pain
Clinical narrative: Initial information has been received from a consumer concerning her husband who on 10-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). The patient was also given TETANUS TOXOID at the same time. On 10-JUN-2008 post vaccination the patient experienced pain at the injection site with no other symptoms. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Neuralgia, Rash macular
Clinical narrative: Information has been received from a physician concerning a 76 year old female with stress (recently) who on 09-JUN-2008 was subcutaneously vaccinated with a 0.64 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included alendronate sodium (MSD). On 12-JUN-2008 the patient developed several red blotches on her right chest area and neuralgia pain behind her right ear and face. Approximately 6 days after vaccination, on 14-JUN-2008 the event broke out in shingles and the patient had a large amount of vesicles on her chest (a rather extensive distribution of shingles). Medical attention was sought, the patient was seen by a physician. The patient was given VALTREX. The patient's neuralgia recovered and her shingles persisted. On 16-JUN-2008 the VZV sample was obtained and on 26-JUN-2008 VZV identification program resulted indicated that it was a wild type strain. Follow up information was received which reported the patient had a history of chickenpox but no recent exposure to chickenpox or shingles and there were many lesions distributed in patient's left anterior wall and left upper extremity "posterior cervical", the patient was afebrile. The sample was collected from left axillary field. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a 76 year old female with stress (recently) who on 09-JUN-2008 was subcutaneously vaccinated with a 0.64 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included alendronate sodium (MSD). On 12-JUN-2008 the patient developed several red blotches on her right chest area and neuralgia pain behind her right ear and face. Approximately 6 days after vaccination, on 14-JUN-2008 the event broke out in shingles and the patient had a large amount of vesicles on her chest (a rather extensive distribution of shingles). Medical attention was sought, the patient was seen by a physician. The patient was given VALTREX. The patient's neuralgia recovered and her shingles persisted. On 16-JUN-2008 the VZV sample was obtained and on 26-JUN-2008 VZV identification program resulted indicated that it was a wild type strain. Follow up information was received which reported the patient had a history of chickenpox but no recent exposure to chickenpox or shingles and there were many lesions distributed in patient's left anterior wall and left upper extremity "posterior cervical", the patient was afebrile. The sample was collected from left axillary field. Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received form a 75 year old female patient with no pertinent medical history and drug reactions/allergies reported who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) 0.65ml injection (route and administrating site not reported). There was no concomitant medication. On 14-JUN-2008 the patient developed shingles. The patient's shingles persisted. The patient did not seek medical attention.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site rash, Injection site vesicles
Clinical narrative: Information has been received from a nurse concerning a 65 year old White female with a history of left breast cancer and hypertension and with no known drug allergy who on 16-JUN-2008 was vaccinate with a first dose of ZOSTAVAX (Oka/Merck) (lot# 659408/0300X) 0.65ml intradermally in her right forearm. The area of the forearm had a circle of fluid at the injection site and the 50 cent size rash caused pain. The patient felt achy and not well for the first week post vaccination. The arm finally was back to normal on approximately 21-JUL-2008 (also reported as approximately 21-JUL-2008). The patient will be getting re-immunized on 04-AUG-2008. The patient sought medical attention in office. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain
Clinical narrative: Information has been received from a nurse concerning a 65 year old White female with a history of left breast cancer and hypertension and with no known drug allergy who on 16-JUN-2008 was vaccinate with a first dose of ZOSTAVAX (Oka/Merck) (lot# 659408/0300X) 0.65ml intradermally in her right forearm. The area of the forearm had a circle of fluid at the injection site and the 50 cent size rash caused pain. The patient felt achy and not well for the first week post vaccination. The arm finally was back to normal on approximately 21-JUL-2008 (also reported as approximately 21-JUL-2008). The patient will be getting re-immunized on 04-AUG-2008. The patient sought medical attention in office. Additional information is not expected.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes virus infection
Clinical narrative: Information has been received from a 55 year old male patient with a history of herpes virus infection 5 years ago. The patient had been having outbreaks since the fall of 2001. Some doctors had said he had shingles and a dermatologist said it was herpes (not genital). The patient, in 2007 was vaccinated with a dose of ZOSTAVAX (Merck) (rout and administrating site not reported). Subsequently the patient experienced herpes again. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from an 85 year old female with penicillin allergy and aspirin and inhibitors drug hypersensitivity who on 13-JUN-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (route and administrating site not reported). Concomitant therapy included LIPITOR. One hour after getting the vaccine the patient experienced a bad headache. The patient took some TYLENOL and the headache stopped a couple hours later. The patient did not seek medical attention. No further information is available.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Herpes zoster, Pain, Pruritus, Pyrexia
Clinical narrative: Information has been received from physician concerning an 87 year old female with Polymyalgia rheumatics, hypertension, hypothyroidism, osteoporosis and a history of chickenpox and no drug reactions/allergies history reported who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot #659407/0295X) 0.65ml SQ in the right deltoid. Concomitant therapy included PREDNISONE (manufacturer unknown), FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. On 14-JUN-2008 the patient experienced shingles. The patient sought medical attention in the office. On the morning of 14-JUN-2008, the patient noted the rash below the left breast which spread to her left trunk at night time. Lesions distribution was noted to be on the T1-T2 dermatome. The patient rated her pain an eight on a scale of zero (least) to ten (most). The patient had itching and a temperature of 99 degrees F. The patient had no recent exposure to shingles of chicken pox. A specimen was collected on 16-JUN-2008 from a crusted vesicle/papule. The patient was recovering. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present to identifyif it is associated with the wild type strain or with Oka/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was wild type strain. On 02-JUL-2008 the physician reported that the patient's rash was better, but she was still having pain which he was treating with medication. Additional information has been requested. This is one of several reports from the same source.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella zoster virus serology positive
Clinical narrative: Information has been received from physician concerning an 87 year old female with Polymyalgia rheumatics, hypertension, hypothyroidism, osteoporosis and a history of chickenpox and no drug reactions/allergies history reported who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot #659407/0295X) 0.65ml SQ in the right deltoid. Concomitant therapy included PREDNISONE (manufacturer unknown), FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. On 14-JUN-2008 the patient experienced shingles. The patient sought medical attention in the office. On the morning of 14-JUN-2008, the patient noted the rash below the left breast which spread to her left trunk at night time. Lesions distribution was noted to be on the T1-T2 dermatome. The patient rated her pain an eight on a scale of zero (least) to ten (most). The patient had itching and a temperature of 99 degrees F. The patient had no recent exposure to shingles of chicken pox. A specimen was collected on 16-JUN-2008 from a crusted vesicle/papule. The patient was recovering. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present to identifyif it is associated with the wild type strain or with Oka/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was wild type strain. On 02-JUL-2008 the physician reported that the patient's rash was better, but she was still having pain which he was treating with medication. Additional information has been requested. This is one of several reports from the same source.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from physician concerning an 87 year old female with Polymyalgia rheumatics, hypertension, hypothyroidism, osteoporosis and a history of chickenpox and no drug reactions/allergies history reported who on 11-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot #659407/0295X) 0.65ml SQ in the right deltoid. Concomitant therapy included PREDNISONE (manufacturer unknown), FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. On 14-JUN-2008 the patient experienced shingles. The patient sought medical attention in the office. On the morning of 14-JUN-2008, the patient noted the rash below the left breast which spread to her left trunk at night time. Lesions distribution was noted to be on the T1-T2 dermatome. The patient rated her pain an eight on a scale of zero (least) to ten (most). The patient had itching and a temperature of 99 degrees F. The patient had no recent exposure to shingles of chicken pox. A specimen was collected on 16-JUN-2008 from a crusted vesicle/papule. The patient was recovering. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present to identifyif it is associated with the wild type strain or with Oka/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was wild type strain. On 02-JUL-2008 the physician reported that the patient's rash was better, but she was still having pain which he was treating with medication. Additional information has been requested. This is one of several reports from the same source.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Herpes zoster, Pain, Pruritus, Pyrexia
Clinical narrative: Information has been received from a physician concerning an 87 year old female with hypertension, Polymyalgia rheumatica, hypothyroidism and osteoporosis who on 11-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included PREDNISONE, FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. on 14-JUN-2008 the patient developed shingles. The patient went to see the physician. No lab diagnostics studies were performed. At the time of report, the patient's shingles persisted. The physician is interested in the VZV identification program. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning an 87 year old female with hypertension, Polymyalgia rheumatica, hypothyroidism and osteoporosis who on 11-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included PREDNISONE, FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. on 14-JUN-2008 the patient developed shingles. The patient went to see the physician. No lab diagnostics studies were performed. At the time of report, the patient's shingles persisted. The physician is interested in the VZV identification program. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 87 year old female with hypertension, Polymyalgia rheumatica, hypothyroidism and osteoporosis who on 11-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included PREDNISONE, FOSAMAX, LIPITOR, DIOVAN and SYNTHROID. on 14-JUN-2008 the patient developed shingles. The patient went to see the physician. No lab diagnostics studies were performed. At the time of report, the patient's shingles persisted. The physician is interested in the VZV identification program. Additional information has been requested.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician who reported that her mother was talking with her friend, a at least 75 year old patient who was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently the patient experienced a rash. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician who reported that her mother was talking with her friend, a 70 year old patient who was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently the patient experienced a rash. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash, Injection site urticaria, Rash pruritic, Urticaria
Clinical narrative: Information has been received from two physicians concerning a 64 year old female with a history of adverse drug reaction to TAGAMET (dizziness) and (ZANTAC)(dizziness), estrogen intolerance, and (PRILOSEC)(diarrhea) and hives when she was a child, who on 11-JUN-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck) (LOT # 659406/0298X) 0.5 ml subcutaneously for the prevention of shingles. Concomitant therapy included multivitamins, (CANTRATE) and (ACIPHEX). The initial physician reported that on 11-JUN-2008, the patient experienced an itchy rash with hives at the zoster vaccine live injection site. The second physician reported that on 16-JUN-2008 the patient experienced hives on her legs, arms and back. At the time of the report the patient was recovering from itchy rash with hives at the zoster vaccine live injection site. The outcome of hives in her arms, legs and back is unknown. No additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Information has been received from a registered nurse concerning a female who on 12-JUN-2008 was vaccinate with ZOSTAVAX vaccine (Oka/Merck) (lot#: 659409/0409X).  13-JUN-2008 the patient developed redness and a blister at  the injection site. The patient was treated wit ROCEPHIN and as of 19-JUN-2008 she was recovering. The patient was seen at the physicians office. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Burning sensation, Hot flush, Injection site discolouration, Injection site nodule
Clinical narrative: Information has been received from a pharmacist and an 80 year old female with sulfonamide and codeine allergy who on 07-JUN-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Merck)(LOT #659326/1824U). Concomitant therapy included hydroxyzine hydrochloride. The pharmacist reported that on 14-JUN-2008, he phoned the patient for a follow up check and the patient said she was fine after the vaccination. On 17-JUN-2008, the patient called the pharmacy stating her rib cage was on fire and she had a burning sensation on both sides of her trunk, no difficulty breathing, no rash, afebrile. The patient reported that she had a horrible burning sensation all over her body, and that she had to cover herself in wash cloths for 9 days. The patient stated she currently had a "brown stain" at the injection site and a "big knot" where the injection was given. On 11-JUN-2008, the patient's physician stated that she was allergic to the vaccine prescribed. The patient took CLARITIN, 2 in 48 hours and TYLENOL 500mg, every other day. The patient reported that as of 12-JUL-2008, there had not been a day, in which she didn't have hot flashes, and a very sore aching arm where the vaccine was injected. On 06-AUG-2008, the patient called to state that "she is still experiencing the same conditions after receiving ZOSTAVAX vaccine (Merck) and that she experienced pain and suffering. At the time of the report the patient had not recovered. The patient sought medical attention visiting her physician two times. Additional information has been requested as the consumer requested to contact her physician.  This is in follow-up to report (s) previously submitted on 9/24/2008; 12/23/2008. On 25-FEB-2009 the patient called and reported that she was still experiencing pain in her arm. Additional information is not expected.