chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Information has been received from a physician concerning himself, a 70 year old male patient, with no pertinent medical history and no known drug allergies, who in "Spring of 2008" was vaccinated with a dose of ZOSTAVAX (Oka/Merck) subcutaneously.  Concomitant therapy included EZETIMIBE (+) SIMVASTATIN (MSD) and ASPIRINE.  Subsequently, "a few weeks ago" (in approximately January 2009), he developed a vesicular rash and mild pain in his right forehead that spread to his scalp.  The pain, "on a scale of 1 to 10, was a 1".  The pain lasted only for 12 to 18 hours, and the rash gradually went away after a week.  Patient did not seek medical attention and no lab diagnostic studies were performed.  This is one of several reports received from the same source.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a healthcare student concerning a female who on 3-APR-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 658325/1429U). On 14-DEC-2008 the patient developed shingles. The patient sought medical attention by office visit. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Lymphadenopathy
Clinical narrative: Information has been received from a physician concerning his father who on an unknown date, was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not reported).  Subsequently the patient experienced swollen lymph nodes all over his body.  The fluid was removed from biopsy (result not reported).  Unspecified medical attention was sought.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, route and site not reported).  The physician reported "a patient developed a rash after receiving ZOSTAVAX (Oka/Merck).  It is unknown if the rash was a VARICELLA rash".  No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on an unknown date, was vaccinated with ZOSTAVAX (Oka/Merck) SQ (lot # not reported).  Subsequently the patient developed a shingles-type rash multiple times after receiving the vaccine.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission, Viral DNA test positive
Clinical narrative: Information has been received from a physician and a nurse.  It was reported that a 62 year old female with type II diabetes, hypertension, congenital heart disease, dyslipidemia, hypothyroidism and penicillin allergy (AMOXIL caused gastrointestinal upset), and a history of chickenpox who on 05-FEB-2009 was vaccinated SQ into left arm with a 0.65ml ZOSTAVAX (Oka/Merck) (lot # 662997/1619X).  Concomitant medication included AVALIDE, TOPROL XL, PRAVACHOL, METFORMIN, LEVOTHYROXINE SODIUM, aspirin and CHOLECALCIFEROL.  The female did not experience any symptoms.  Subsequently, the female's husband developed shingles.  On 08-FEB-2009 symptoms began in his mouth as a sensation of cold sores.  The patient called an unspecified dentist who did some X-rays.  The patient had blisters on the left side of the tongue and left side of the lips and outside on the chin on the left side.  There was a pain that shot up to the left ear to the tip of the forehead on the left side.  The patient was in a lot of pain and also had a headache.  The patient was given VALTREX.  As of 10-FEB-2009 the patient's outcome was unknown.  Follow-up information was received from the licensed nurse (L.N.) on 12-FEB-2009 which reported that the 61 year old male experienced 7 vesicles on the mandibular branch of 5th cranial nerve then to the mouth.  His maximum temperature was unknown.  Other systemic symptoms included headache, difficulty swallowing and itching pain.  He was in the office twice for his shingles.  As of 12-FEB-2009, the patient still symptomatic pending, he was not recovered.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion was collected on 12-FEB-2009.  The sample was taken from 2 vesicular lesions one in patient's mouth and the other on his chin.  The PCR results for the specimen from 2 vesicular lesions one in patient's mouth and the other on his chin identified the presence of WT VZV.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml subcutaneously. Subsequently the patient developed shingles. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: Information has been received from a physician concerning a 62 year old female with several autoimmune diseases, who about a month ago approximately January 2009 was vaccinated SC with a 0.65ml dose of ZOSTAVAX (Oka/Merck) approximately in January 2009, the patient "had an outbreak of herpes" on her buttocks. The physician said it was not shingles. According to the physician, the herpes "seems to be recurrent" and it "crosses over and then it comes back". The outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician concerning a 62 year old female with several autoimmune diseases, who about a month ago approximately January 2009 was vaccinated SC with a 0.65mL dose of ZOSTAVAX.  The physician reported that within 48 hours of getting ZOSTAVAX (Merck) approximately in January 2009, the patient "had an outbreak of herpes" on her buttocks.  The physician said that it was not shingles.  According to the physician, the herpes "seems to be recurrent" and it "crosses over and then it comes back".  The outcome of the patient was unknown.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Reaction to previous exposure to any vaccine
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.65mL dose of ZOSTAVAX (Oka/Merck).  The physician reported that one month after vaccination the patient developed shingles.  The outcome of the patient was unknown.  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck).  The physician reported that one month after vaccination the patient developed shingles.  The patient sought unspecified medical attention.  Follow up information has been received from the physician.  She reported that she was not the patient's primary healthcare provider.  The physician stated that the patient had the ZOSTAVAX (Merck) a while back and had an outbreak "long after" getting the vaccination.  She stated that she did not have much of the information requested.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning a patient who on 10-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The physician reported that the patient on 12-FEB-2009 experienced shingles 2 days after receiving ZOSTAVAX (Oka/Merck). The patient sought unspecified medical attention. Additional information has been requested. Follow up information was received from a Medical Assistant from the reporting physician's office that a lesion culture taken on 16-FEB-2009 came back positive for VZV (Varicella Zoster Virus). Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: Information has been received from a licensed practical nurse concerning a 79 year old female who on 29-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number, site not reported) 0.65ml SQ. Concomitant therapy included simvastatin (MSD), ALTACE, alendronate sodium (manufacturer unknown) and sotalol hydrochloride. On 8-JAN-2009 the patient developed polymyalgia rheumatica after administration of ZOSTAVAX (Oka/Merck). The patient discontinued taking simvastatin (MSD) after the symptoms developed. Sedimentation rate was performed with no result reported. The patient's polymyalgia rheumatica persisted. Additional information has been requested.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an 89 year old male with allergies to GUAIFENESIN, PENICILLIN and SUDAFED, and "no pertinent medical history", who on 14-APR-2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 659267/1836U) for prevention of shingles.  Concomitant therapy included "all kinds of medications".  3 days ago, on 13-FEB-2009 the patient experienced shingles.  The shingles was along the dorsal root ganglia.  The patient sought medical attention at dermatologist's office.  The patient was given a prescription of VALTREX.  As of 16-FEB-2009.  The patient has not recovered.  Additional information has been requested. Follow-up information was received from the pharmacist which reported that an 89 year old retired male at 2:00 PM 14-APR-2008 was vaccinated SQ into the left arm with a first dose of ZOSTER vaccine live (MERCK) (lot # 659267/1836U).  It was reported that the AE onset date was 14-FEB-2009.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Nodule, Rash, Skin lesion
Clinical narrative: Information has been received from a medical assistant concerning an 80 year old female with diastolic dysfunction, hypertension, systolic murmur, cholesterol high and hypothyroidism, and no drug allergies who on 10-FEB-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 663199/1551X).  Concomitant therapy included (MICARDIS HCT), PROVERA, SYNTHROID, LIPITOR, ADVAIR, aspirin, K-TAB, OPTIVAR OPHTHALMIC SOLUTION, NASONEX, ALBUTEROL and CLONIDINE.  Subsequently the patient experienced shingles like rash on the right side of her body.  The patient sought medical attention at physician's office.  No lab tests were performed.  As of 16-FEB-2009, the patient has not recovered.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information was received from a registered nurse (R.N.) which reported that an 80 year old female at 10:00 am 10-FEB-2009 was vaccinated IM into arm with a first dose of ZOSTAVAX.  There is no illness at the time of the vaccination.  It was reported that the patient came back to office on 16-FEB-2009 at 09:30.  The patient developed rash on head, vesicular lesion and a couple of nodules on back of scalp which "appeared like shingles but unsure".  No lab tests were performed.  Three weeks after the vaccination, the patient recovered.  No further information is available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a 59 year old female with allergic PENICILLIN, SULFONAMIDE and ERYTHROMYCIN, and no pertinent medical history, who on 07-JAN-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported).  Concomitant therapy included unspecified thyroid medication.  On 07-JAN-2009 the patient experienced swelling, redness and feeling "getting poked with 10,000 needles" at the injection site.  She also stated that she doesn't "feel good" and has diarrhea.  The patient sought unspecified medical attention.  None lab tests were performed.  As of 16-FEB-2009, the patient was recovering.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 77 year old female who on 12-FEB-2009 was vaccinated SQ with ZOSTAVAX (Oka/Merck) in the left arm (Lot # not reported). After receiving the ZOSTAVAX (Oka/Merck), on 13-FEB-2009, the patient had an injection site reaction. The patient had soft tissue swelling, allergic reaction, fever and pruritis. The patient was being treated with a steroid dose pack, heat and elevation. The patient was not recovered from adverse events. It was reported that the patient sought medical attention: seen in office. Additional information has been requested. 06/24/09 This is in follow-up to report(s) previously submitted on 3/27/2009. Additional information has been received from the physician who reported that the patient with no illness at time of vaccination experienced allergic reaction-erythema, soft tissue swelling, and pruritis. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 77 year old female who on 12-FEB-2009 was vaccinated SQ with ZOSTAVAX (Oka/Merck) in the left arm (Lot # not reported). After receiving the ZOSTAVAX (Oka/Merck), on 13-FEB-2009, the patient had an injection site reaction. The patient had soft tissue swelling, allergic reaction, fever and pruritis. The patient was being treated with a steroid dose pack, heat and elevation. The patient was not recovered from adverse events. It was reported that the patient sought medical attention: seen in office. Additional information has been requested. 06/24/09 This is in follow-up to report(s) previously submitted on 3/27/2009. Additional information has been received from the physician who reported that the patient with no illness at time of vaccination experienced allergic reaction-erythema, soft tissue swelling, and pruritis. No further information is available.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Secondary transmission, Skin lesion
Clinical narrative: Information has been received from a physician assistant concerning a male with hypertension, osteoarthritis and no drug allergies whose wife in December 2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck).  Concomitant therapy included PRILOSEC, DIOVAN, TIMOPTIC, vitamin D (unspecified), omega-3 vitamin and vitamin B complex.  On 02-FEB-2009 the male patient developed shingles.  He was seen in the office with blisters and post herpetic neuralgia pain on the right groin, right thigh and low back on the right side.  The area affected was dermatome L1.  The female who received the vaccine was not experiencing any symptoms or problems.  Follow-up information was received from the physician assistant concerning the 76 year old male with a history of chickenpox during childhood whose 74 year old wife on 29-DEC-2008 was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck) (lot #:  663198/1419X) into the right deltoid.  It was reported that the patient and his wife lived together.  On 09-Feb-2009, the male patient developed shingles.  He developed vesicular rash with extensive lesions on the right hip, groin and low back.  The area affected was dermatome L2.  The patient had grade 9 pain.  The maximum temperature was 99.  At the time of this report, the patient was recovered.  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a physician assistant concerning a male with hypertension, osteoarthritis and no drug allergies whose wife in December 2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck).  Concomitant therapy included PRILOSEC, DIOVAN, TIMOPTIC, vitamin D (unspecified), omega 3 vitamin) and vitamin B complex.  On 02-FEB-2009 the male patient developed shingles.  He was seen in the office with blisters and post herpetic neuralgia pain on the right groin, right thigh and low back on the right side.  The area affected was dermatome L1.  The female who received the vaccine was not experiencing any symptoms or problems.  Follow-up information was received from the physician assistant concerning the 76 year old male with a history of chickenpox during childhood whose 74 year old wife on 29-DEC-2008 was vaccinated with a 0.5 ml dose of ZOSTAVAX (Merck) (lot #: 663198/1419X) into the right deltoid.  It was reported that the patient and his wife lived together.  On 09-FEB-2009, the male patient developed shingles.  He developed vesicular rash with extensive lesions on the right hip, groin and low back.  The area affected was dermatome L2.  The patient had grade 9 pain.  The maximum temperature was 99.  At the time of this report, the patient was recovered.  Follow up information reported that the physician assistant was unable to provide further adverse event information.  No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dyspnoea, Malaise, Nasopharyngitis, Pain
Clinical narrative: Information has been received from a 61 year old female with iodine (IVP dye) allergy and a history of headaches while on therapy with DEMEROL and respiratory problems while on therapy with LISINOPRIL (manufacturer unknown;  WAES 0902USA03524), LIPITOR, NEURONTIN and GLUCOPHAGE who on 19-JAN-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck).  Concomitant therapy included BYETTA, MSD, GLUCOTROL, ASPIRIN, minerals (unspecified) + vitamins (unspecified) CENTRUM, AMBIEN, DIOVAN HCT, BUMEX, calcium (unspecified), OMEGA-3, vitamin E, vitamin D (unspecified), LEXAPRO and NEXIUM.  On 20-JAN-2009, after getting ZOSTAVAX, the patient experienced fever, cold, pain and did not feel good at all.  The patient was prescribed ZYRTEC for the adverse events that she got after vaccination, but her symptoms got worse.  The patient sought unspecified medical attention.  The patient was not recovered at the time of the report.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information was received from a physician concerning a 61 year old female who on 19-JAN-2009 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 662858/1558X).  On 20-JAN-2009 the patient experienced shortness of breath (SOB), cough and wheezing.  Chest X-ray was performed with negative result.  The patient was prescribed with MEDROL dose pack and albtuterol MD1.  At the time of this report, the patient was not recovered.  No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Wheezing
Clinical narrative: Information has been received from a 61 year old female with iodine (IVP dye) allergy and a history of headaches while on therapy with DEMEROL and respiratory problems while on therapy with LISINOPRIL (manufacturer unknown;  WAES 0902USA03524), LIPITOR, NEURONTIN and GLUCOPHAGE who on 19-JAN-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck).  Concomitant therapy included BYETTA, MSD, GLUCOTROL, ASPIRIN, minerals (unspecified) + vitamins (unspecified) CENTRUM, AMBIEN, DIOVAN HCT, BUMEX, calcium (unspecified), OMEGA-3, vitamin E, vitamin D (unspecified), LEXAPRO and NEXIUM.  On 20-JAN-2009, after getting ZOSTAVAX, the patient experienced fever, cold, pain and did not feel good at all.  The patient was prescribed ZYRTEC for the adverse events that she got after vaccination, but her symptoms got worse.  The patient sought unspecified medical attention.  The patient was not recovered at the time of the report.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information was received from a physician concerning a 61 year old female who on 19-JAN-2009 was vaccinated SC with a dose of ZOSTAVAX (Merck) (lot # 662858/1558X).  On 20-JAN-2009 the patient experienced shortness of breath (SOB), cough and wheezing.  Chest X-ray was performed with negative result.  The patient was prescribed with MEDROL dose pack and albtuterol MD1.  At the time of this report, the patient was not recovered.  No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Oral herpes, Pruritus, Rash macular, Urticaria
Clinical narrative: Information has been received from a 67 year old female with allergic reaction to ERYTHROMYCIN, KEFLEX, sulfa, FLAGYL, BUTALBITAL, aspirin and TOLCIN and a history of shingles and "stomach issues" who on 12-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number, route and site not reported).  There was no concomitant medication.  On 13-DEC-2008 the patient developed cold sores all over her lips, blotches on her face (cheeks and forehead) and welts on her back.  The patient saw her physician and a nurse practitioner.  The nurse practitioner prescribed ACYCLOVIR.  However, within one day of taking ACYCLOVIR the patient had stomach pains so she had to stop.  The nurse practitioner then switched her to VALTREX.  The patient recently saw her chiropractor and as he was doing a treatment to her back he told her the welts on her back were chickenpox.  The patient had also been having severe itching.  The patient had been using BENADRYL and CLARITIN.  The patient had used some ZOVIRAX cream that seemed to help clear up welts.  The patient took VALTREX for 2 weeks and stopped.  The patient was currently taking lysine once a day.  The patient said each day the welts seemed to "morph" and changed but the patient was getting better.  The patient said, "They look like giant measles under the skin."  This is one of several reports received the same source.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a 67 year old female with allergic reaction to ERYTHROMYCIN, KEFLEX, sulfa, FLAGYL, BUTALBITAL, aspirin and TOLCIN and a history of shingles and "stomach issues" who on 12-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot number, route and site not reported).  There was no concomitant medication.  On 13-DEC-2008 the patient developed cold sores all over her lips, blotches on her face (cheeks and forehead) and welts on her back.  The patient saw her physician and a nurse practitioner.  The nurse practitioner prescribed ACYCLOVIR.  However, within one day of taking ACYCLOVIR the patient had stomach pains so she had to stop.  The nurse practitioner then switched her to VALTREX.  The patient recently saw her chiropractor and as he was doing a treatment to her back he told her the welts on her back were chickenpox.  The patient had also been having severe itching.  The patient had been using BENADRYL and CLARITIN.  The patient had used some ZOVIRAX cream that seemed to help clear up welts.  The patient took VALTREX for 2 weeks and stopped.  The patient was currently taking lysine once a day.  The patient said each day the welts seemed to "morph" and changed but the patient was getting better.  The patient said, "They look like giant measles under the skin."  This is one of several reports received the same source.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) from another doctor's office.  Then shortly after, the patient had developed shingles.  It is unknown if the patient sought medical attention.  The physician reported that the patient had recovered.  This is one of two cases from the same source.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: Information has been received from a pharmacy technician concerning a 60 year old female patient who on 17-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # 662856-1559X). At the evening of 17-FEB-2009 after receiving the vaccine the patient developed an injection site reaction. The area was slightly raised, red and "hard under the skin". The patient sought unspecified medical attention. At the time of reporting the patient had not recovered. Additional information has been requested.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 78 year old male patient with a previous cause of shingles in October 2008, who on 16-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 662998/1620X) 0.65ml.  On 18-FEB-2009 the patient experienced a blister above his left eye and itching.  The patient sought advice from his physician who believed that it was a case of shingles. Follow-up information was received on 13-MAY-2009 from the pharmacist via telephone call indicating the patient's name. The pharmacist also reported that he found out later that the patietn had shingles approximately 2 weeks prior to his vaccination, therefore, after the vaccination the shingles re-appeared. The patient was advised to contact a physician. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Rash
Clinical narrative: Information has been received from a pharmacist concerning an adult female patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.56 ml.  On approximately 18-JAN-2009 the patient experienced nauseous and minor rash.  On an unspecified date the patient recovered.  The patient sought unspecified medical attention.  No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female with allergies to alendronate sodium (MSD) WAES # 0902USA04457 and penicillin allergy who on 16-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number 663638/1706X). On 18-FEB-2009 the patient experienced redness, swelling and increasing pain at the injection site (location of injection site unknown). The patient's redness and swelling and increasing pain at the injection site persisted. The patient sought unspecified medical attention. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an 81 year old female patient with a history of shingles on her trunk and no known drug allergies, who on 08-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 66333/1555X) subcutaneously.  Concomitant therapy included CYMBALTA.  On 08-FEB-2009, one month later, the patient developed shingles with lesions in her ears and throat.  Patient sought medical attention by speaking with the pharmacists.  At the time of this report the patient had not recovered.  Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an over 65 year old patient who on approximately 20-DEC-2008, two months ago, was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On approximately 20-FEB-2009, "2 months later", the patient came down with shingles.  The patient sought unspecified medical attention.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml (lot # not reported). After getting ZOSTAVAX (Oka/Merck), on 18-FEB-2009 the patient developed Varicella like rash. The outcome of the patient's adverse events was not reported. It was reported that the patient sought unspecified medical attention. Additional information has been requested.
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning an approximately 70 year old patient with cardiac failure who was vaccinated SQ with ZOSTAVAX (Oka/Merck) 0.65 ml (Lot # not reported). After getting ZOSTAVAX (Oka/Merck), the patient developed shingles six months to a year. The outcome of the patient's adverse events was not reported. It was reported that the patient's sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction
Clinical narrative: Information has been received from a pharmacist concerning a female patient with sulfa allergy who on 18-FEB-2009 was vaccinated with ZOSTAVAX (Oka/Merck) S.Q.. On 19-FEB-2009 the patient experienced injection site reaction.  The area is red, itchy and had a "knot".  The patient went to see the pharmacist for medical attention.  The patient's adverse effect persisted.  No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Electronystagmogram abnormal, Eyelid ptosis, Nuclear magnetic resonance imaging normal, Nystagmus
Clinical narrative: Information has been received from a registered nurse concerning herself with a history of osteoporosis and borderline elevated LDL who on 04-AUG-2008 was vaccinated with ZOSTAVAX (Oka/Merck) S.Q. into her left arm.  Concomitant therapy included ALENDRONATE SODIUM (dose, duration and indication not reported) and LIPITOR.  On 01-SEP-2008 the patient had been experiencing tinnitus of her left ear.  The nurse had seen 2 family physicians and 2 specialists regarding her symptoms.  She had a constant hissing in her ear 24 hours a day.  There was a change in pitch from time to time and she had "clicking" in her ear from time to time.  The nurse had also experienced dizziness that had subsided.  The nurse continued to have hissing in her ear.  The nurse had been treated with decongestants, antihistamines and DRAMAMINE.  The nurse reported that it was not life threatening but it was "life spoiling".  A magnetic resonance imaging (MRI) of her ear did not reveal any abnormality of the ear but she saw that the report listed "ptosis" but she had no other information about that result.  The patient underwent an ENG (results not provided).  The nurse had visited physician's office for medical attention. Follow up was received from the retired registered nurse with a frontal maningioma that on 01-AUG-2000 (not 04-AUG-2000 as previously reported) she was vaccinated with her first dose of ZOSTAVAX S.Q: into her left arm. There was no illness at the time of vaccination. On 01-SEP-2000 at 08:00 AM the patient experienced sudden onset of tinnitus and hearing loss. Th ehearing loss of the patient's last ear was ongoing. The patient's ENG report on 19-FEB-2009 showed essentially normal ENG with evidence of very slight positional nystagmus, able to rule out vestibular nerve and/or end organ lesion, positional finding not significant at this time. On 16-JAN-2005 MRI images of the brain and internal auditorycanals were performed. THe results were benign left frontal dural-based extraaxial homogeneoualy enhancing mass, consistent with a coningioma, no evidence of a vestibular schwanoma seen, bilateral internal carotid arteries were normal as viewed, mild bilateral proptosis (previously reported as ptosis) seen and thyroid disease should be excluded. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Sudden hearing loss, Tinnitus, Tinnitus
Clinical narrative: Information has been received from a registered nurse concerning herself with a history of osteoporosis and borderline elevated LDL who on 04-AUG-2008 was vaccinated with ZOSTAVAX (Oka/Merck) S.Q. into her left arm.  Concomitant therapy included ALENDRONATE SODIUM (dose, duration and indication not reported) and LIPITOR.  On 01-SEP-2008 the patient had been experiencing tinnitus of her left ear.  The nurse had seen 2 family physicians and 2 specialists regarding her symptoms.  She had a constant hissing in her ear 24 hours a day.  There was a change in pitch from time to time and she had "clicking" in her ear from time to time.  The nurse had also experienced dizziness that had subsided.  The nurse continued to have hissing in her ear.  The nurse had been treated with decongestants, antihistamines and DRAMAMINE.  The nurse reported that it was not life threatening but it was "life spoiling".  A magnetic resonance imaging (MRI) of her ear did not reveal any abnormality of the ear but she saw that the report listed "ptosis" but she had no other information about that result.  The patient underwent an ENG (results not provided).  The nurse had visited physician's office for medical attention. Follow up was received from the retired registered nurse with a frontal maningioma that on 01-AUG-2000 (not 04-AUG-2000 as previously reported) she was vaccinated with her first dose of ZOSTAVAX S.Q: into her left arm. There was no illness at the time of vaccination. On 01-SEP-2000 at 08:00 AM the patient experienced sudden onset of tinnitus and hearing loss. Th ehearing loss of the patient's last ear was ongoing. The patient's ENG report on 19-FEB-2009 showed essentially normal ENG with evidence of very slight positional nystagmus, able to rule out vestibular nerve and/or end organ lesion, positional finding not significant at this time. On 16-JAN-2005 MRI images of the brain and internal auditorycanals were performed. THe results were benign left frontal dural-based extraaxial homogeneoualy enhancing mass, consistent with a coningioma, no evidence of a vestibular schwanoma seen, bilateral internal carotid arteries were normal as viewed, mild bilateral proptosis (previously reported as ptosis) seen and thyroid disease should be excluded. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial neuralgia
Clinical narrative: Information has been received from an office staff in physician office concerning a 63 year old female patient with a history of Fibro Myalgia who was vaccinated with ZOSTAVAX. A couple days later after receiving ZOSTAVAX the patient experienced neuralgia on the right side of her head and face. The patient saw the physician for medical attention. At the time of reporting, the patient recovered from the adverse effect. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning a 73 year old female with osteoporosis and hypertension and no known drug allergies who on 17-FEB-2009 was vaccinated with ZOSTAVAX (Oka/Merck) 0.65 ml, subcutaneously (lot # 663175/1553X). Concomitant therapy included alendronate sodium (MSD), EVISTA, triamterene (manufacturer unknown), calcium (unspecified), vitamins (unspecified) and aspirin (manufacturer unknown). On 19-FEB-2009 the patient experienced erythema at the injection site 14 cm by 7 cm with central induration. Patient was also experiencing pruritis. At the time of the report, on 20-FEB-2009, the patient has not recovered from the symptoms. The patient sought medical attention by office visit and no lab diagnostics studies were performed. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a 67 year old female with penicillin allergy and high blood pressure who on 1-JUN-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot not reported). Concomitant therapy included RAMIPRIL and hydrochlorothiazide. On 14-FEB-2009 or 15-FEB-2009 the patient developed shingles despite receiving ZOSTAVAX (Oka/Merck). The rash began on her upper left chest and spread to her back and shoulder. The pain had been mild to moderate. Her physician described it a a severe case. She had been taking VALTREX and ibuprofen. At the time of reporting, 23-FEB-2009, the patient was recovering. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Information has been received from a 67 year old female with penicillin allergy and blood pressure high who on 01-JUN-2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported).  Concomitant therapy included ramipril and hydrochlorothlazide.  On 14-FEB-2009 or 15-FEB-2009 the patient developed shingles despite receiving ZOSTAVAX (Merck).  The rash began on her upper left chest and spread to her back and shoulder.  The pain had been mild to moderate.  Her physician described it as a severe case.  She had been taking VALTREX and ibuprophen.  At the time of reporting, 23-FEB-2009, the patient was recovering.  Additional information has been received from the physician who reported that no testing had been done in their office, and suggested contacting the patient's primary care provider.  Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema, Injection site rash, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a consumer of 77 year old female with a history of high blood pressure and drug reaction to niacin and stent put in 6-7 years ago, in approximately 2002, who on 20-FEB-2009 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included SIMVASTATIN (MSD), vitamins (unspecified), aspirin and METOPROLOL.  When the patient woke up on 21-FEB-2009, at the injection site, which was on the back on her right arm there was red mark the size of a half dollar, then later on in the day there was swelling, itching and pain below the injection site.  The patient also reported that on the red mark were little bumps and it was also warm.  The patient stated that she called her physician on 22-FEB-2009 who came to look at the injection site and he thought it was some type of allergic reaction and gave her a prescription of HYDROCORTIZONE (Manufacturer unspecified) and she had been using it, since the then her reaction has been gradually getting better.  Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Information has been received from a consumer of 77 year old female with a history of high blood pressure and drug reaction to niacin and stent put in 6-7 years ago, in approximately 2002, who on 20-FEB-2009 was vaccinated with ZOSTAVAX (Oka/Merck).  Concomitant therapy included SIMVASTATIN (MSD), vitamins (unspecified), aspirin and METOPROLOL.  When the patient woke up on 21-FEB-2009, at the injection site, which was on the back on her right arm there was red mark the size of a half dollar, then later on in the day there was swelling, itching and pain below the injection site.  The patient also reported that on the red mark were little bumps and it was also warm.  The patient stated that she called her physician on 22-FEB-2009 who came to look at the injection site and he thought it was some type of allergic reaction and gave her a prescription of HYDROCORTIZONE (Manufacturer unspecified) and she had been using it, since the then her reaction has been gradually getting better.  Additional information is not expected.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arrhythmia, Herpes simplex
Clinical narrative: Information has been received from a physician concerning a 73 year old female who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) approximately on 23-JAN-2009 (3 to 4 weeks ago).  The physician stated in approximately January 2009 a patient experienced a more intense than usual and longer duration of an episode of Herpes Simplex 2 weeks after administration of the vaccine.  The patient also experienced a change in her rhythm.  The physician did not know if the administration of ZOSTAVAX (Oka/Merck) was related to her patient's symptoms.  As of 23-FEB-2009 the patient was not recovered.  The patient sought unspecified medical attention via telephone.  Additional information is not expected.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of drug administration, Skin swelling
Clinical narrative: Information has been received from a pharmacist concerning a patient who on 23-FEB-2009 was vaccinated intradermally with a dose of ZOSTAVAX (Oka/Merck). The reporter stated that after she gave the ZOSTAVAX (Oka/Merck) there was a "bubble" under the skin which then "diffused to the size of a nickel". The pharmacist stated that the patient went to see her physician after she was given the ZOSTAVAX (Oka/Merck). At the time of reporting, the patient had not recovered. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow up information has been received from a health professional on 17-MAR-2009.  It was reported that on 23-FEB-2009, the 78 year old female patient was vaccinated subcutaneously in the left arm (previously reported as intradermally) with one dose of ZOSTAVAX (Merck) (Lot # 663881/1787X) at 11:00 a.m.   At 11:15 a.m., the patient had visible "bubble" under skin and some redness.  No discomfort was involved.  The patient went to PCP and was told to use cold compressess.  The patient stated that redness and bubble went away the following day.  Additional information is not expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a physician and a licensed practical nurse concerning an 86 year old female patient with hypertension, coronary artery disease, hyperlipidemia and is allergic to DAPSONE, PLAQUENIL, MONCYCLINE and ROFECOXIB (MSD) and three other undecipherable medications, who on 16-NOV-2006 was vaccinated with a dose of ZOSTAVAX (lot # 652965/0622F) 0.65 ml on the left deltoid.  Concomitant therapy included NORVASC, METOPROLOL, LIPITOR and amitriptyline hydrochloride.  Patient has not had any recent exposure to chickenpox or herpes zoster.  On 03-FEB-2009 the patient developed shingles and experienced pain.  Patient had 7 vesicular lesions, "quarter size vesicular rash", on the right buttock zone.  Patient sought unspecified medical attention.  Patient's maximum temperature was 96.9  Subsequently, the patient recovered from shingles but her pain persisted.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Back pain, Hypersensitivity, Injection site pain, Laboratory test
Clinical narrative: Information has been received from a physician concerning himself, a 61 year old male patient with a history of pain and vaccine reaction and no known drug allergies who "about 10-12 years ago" received the INFLUENZA vaccine (unspecified), and within a few hours he felt soreness on his left side, where the injection was given. It spread to the whole left side of his body and lasted for about a day. On 16-FEB-2009 patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not provided) 0.65 ml. Concomitant therapy included FLOMAX and SIMVASTATIN. On 18-FEB-2009, "2 days after receiving ZOSTER (Oka/Merck), the patient experienced soreness and hypersensitivity around his lower back and lower stomach. Patient sought unspecified medical attention. Routine labs were performed. Therapy with ZOSTER (Oka/Merck) was discontinued. The patient's soreness hypersensitivity around his lower back and lower stomach persisted. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from a physician concerning himself, a 61 year old male patient with a history of pain and vaccine reaction and no known drug allergies who "about 10-12 years ago" received the INFLUENZA vaccine (unspecified), and within a few hours he felt soreness on his left side, where the injection was given. It spread to the whole left side of his body and lasted for about a day. On 16-FEB-2009 patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not provided) 0.65 ml. Concomitant therapy included FLOMAX and SIMVASTATIN. On 18-FEB-2009, "2 days after receiving ZOSTER (Oka/Merck), the patient experienced soreness and hypersensitivity around his lower back and lower stomach. Patient sought unspecified medical attention. Routine labs were performed. Therapy with ZOSTER (Oka/Merck) was discontinued. The patient's soreness hypersensitivity around his lower back and lower stomach persisted. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 61 year old male patient who on 5-FEB-2009 at 13:25 was vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (Lot number 663637/1705X) SQ in the left arm. On 5-FEB-2009 in the evening post vaccination, the patient experienced redness, rash and pain at injection site, later noted in the upper left arm. On 16-FEB-2009, the patient went to an urgent care center and they told him that he had shingles and the only treatment was to prescribe something for the pain. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been provided from a physician concerning a female patient who on 13-FEB-2009 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/MercK) (lot # 663333/1555X). The physician stated that the patient developed a case of shingles in the buttocks and groin area after receiving the vaccine. The patient sought unspecified medical attention. At the time of reporting the patient had not recovered. Follow up information has been received concerning and 81 year old female patient with no medical history, allergies and no recent exposure to chickenpox or shingles who on 13-FEB-2009 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot # 663333/1555X), 0.65 mL in her right hip, Concomitant therapy included NEXIUM, felodipine, and SYNTHROID. On 23-FEB-2009 the patient developed a case of shingles. The patient enrolled in the Varicella Zoster Identification Program to identify if VZV is present, and if present, to identify whether it is associated with the wild type VZV strain or whether it is identified with the Oka/Merck vaccine VZV strain. The patient developed rash described as a case of herpes zoster at gluteus mid-thigh dermatome. On an unspecified date the patient recovered. Additional  information is not expected.