chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal blistering, Oropharyngeal pain, Pain, Pyrexia, Streptococcal identification test negative
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 62 year old male who on 19-FEB-2009 was vaccinated subcutaneously in his left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot#662997/1619X).  "As of yesterday (on 09-APR-2009) the patient was complaining of blisters on his tongue and a very sore throat to the point where his teeth hurt.  He had one small blister outside of his mouth.  He went to his doctor and strep test he did proved negative.  He was put on antibiotics.  He has a low grade fever.  He didn't tell the doctor about the shot until today.  The patient called the health department today and the nurse told him to go back to his doctor and have them culture the rash."  Follow up information was received from a Registered Nurse (R.N.) concerning the patient with Penicillin allergy and a history of chickenpox when he was a young child who on 19-FEB-2009 was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot number 662997/1619X).  The patient did not experience a rash post vaccination.  On 09-APR-2009 the patient went to see a physician because he developed multiple blisters both inside and outside of his mouth, on tongue, and in his throat.  He also reported that he was "in extreme pain", had pain when he swallowed and stated that his "teeth hurt".  The patient had a fever of 100 degrees Fahrenheit.  The patient's pain rated as 10 out of 10.  The patient was encouraged to see if the doctor could culture for varicella zoster.  Culture for strep was negative.  On 16-APR-2009, the patient was seen by his primary care physician who started him on anti-viral medications.  The physician stated the signs/symptoms were similar to zoster by did not feel it was zoster.  As of 17-APR-2009, the patient had not recovered.  On 20-APR-2009 the patient feeling better but still in pain.  It was reported that the patient was not recently exposed to chicken pox or shingles.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Tongue blistering, Toothache
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 62 year old male who on 19-FEB-2009 was vaccinated subcutaneously in his left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot#662997/1619X).  "As of yesterday (on 09-APR-2009) the patient was complaining of blisters on his tongue and a very sore throat to the point where his teeth hurt.  He had one small blister outside of his mouth.  He went to his doctor and strep test he did proved negative.  He was put on antibiotics.  He has a low grade fever.  He didn't tell the doctor about the shot until today.  The patient called the health department today and the nurse told him to go back to his doctor and have them culture the rash."  Follow up information was received from a Registered Nurse (R.N.) concerning the patient with Penicillin allergy and a history of chickenpox when he was a young child who on 19-FEB-2009 was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot number 662997/1619X).  The patient did not experience a rash post vaccination.  On 09-APR-2009 the patient went to see a physician because he developed multiple blisters both inside and outside of his mouth, on tongue, and in his throat.  He also reported that he was "in extreme pain", had pain when he swallowed and stated that his "teeth hurt".  The patient had a fever of 100 degrees Fahrenheit.  The patient's pain rated as 10 out of 10.  The patient was encouraged to see if the doctor could culture for varicella zoster.  Culture for strep was negative.  On 16-APR-2009, the patient was seen by his primary care physician who started him on anti-viral medications.  The physician stated the signs/symptoms were similar to zoster by did not feel it was zoster.  As of 17-APR-2009, the patient had not recovered.  On 20-APR-2009 the patient feeling better but still in pain.  It was reported that the patient was not recently exposed to chicken pox or shingles.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Oral pain, Oropharyngeal blistering, Pyrexia, Streptococcal identification test negative
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 62 year old male who on 19-FEB-2009 was vaccinated subcutaneously in his left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot#662997/1619X).  "As of yesterday (on 09-APR-2009) the patient was complaining of blisters on his tongue and a very sore throat to the point where his teeth hurt.  He had one small blister outside of his mouth.  He went to his doctor and strep test he did proved negative.  He was put on antibiotics.  He has a low grade fever.  He didn't tell the doctor about the shot until today.  The patient called the health department today and the nurse told him to go back to his doctor and have them culture the rash."  Follow up information was received from a Registered Nurse (R.N.) concerning the patient with Penicillin allergy and a history of chickenpox when he was a young child who on 19-FEB-2009 was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot number 662997/1619X).  The patient did not experience a rash post vaccination.  On 09-APR-2009 the patient went to see a physician because he developed multiple blisters both inside and outside of his mouth, on tongue, and in his throat.  He also reported that he was "in extreme pain", had pain when he swallowed and stated that his "teeth hurt".  The patient had a fever of 100 degrees Fahrenheit.  The patient's pain rated as 10 out of 10.  The patient was encouraged to see if the doctor could culture for varicella zoster.  Culture for strep was negative.  On 16-APR-2009, the patient was seen by his primary care physician who started him on anti-viral medications.  The physician stated the signs/symptoms were similar to zoster by did not feel it was zoster.  As of 17-APR-2009, the patient had not recovered.  On 20-APR-2009 the patient feeling better but still in pain.  It was reported that the patient was not recently exposed to chicken pox or shingles.  Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Viral infection
Clinical narrative: Information has been received from a Registered Nurse (R.N.) concerning a 62 year old male who on 19-FEB-2009 was vaccinated subcutaneously in his left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot#662997/1619X).  "As of yesterday (on 09-APR-2009) the patient was complaining of blisters on his tongue and a very sore throat to the point where his teeth hurt.  He had one small blister outside of his mouth.  He went to his doctor and strep test he did proved negative.  He was put on antibiotics.  He has a low grade fever.  He didn't tell the doctor about the shot until today.  The patient called the health department today and the nurse told him to go back to his doctor and have them culture the rash."  Follow up information was received from a Registered Nurse (R.N.) concerning the patient with Penicillin allergy and a history of chickenpox when he was a young child who on 19-FEB-2009 was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (Merck) (lot number 662997/1619X).  The patient did not experience a rash post vaccination.  On 09-APR-2009 the patient went to see a physician because he developed multiple blisters both inside and outside of his mouth, on tongue, and in his throat.  He also reported that he was "in extreme pain", had pain when he swallowed and stated that his "teeth hurt".  The patient had a fever of 100 degrees Fahrenheit.  The patient's pain rated as 10 out of 10.  The patient was encouraged to see if the doctor could culture for varicella zoster.  Culture for strep was negative.  On 16-APR-2009, the patient was seen by his primary care physician who started him on anti-viral medications.  The physician stated the signs/symptoms were similar to zoster by did not feel it was zoster.  As of 17-APR-2009, the patient had not recovered.  On 20-APR-2009 the patient feeling better but still in pain.  It was reported that the patient was not recently exposed to chicken pox or shingles.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, X-ray
Clinical narrative: Information has been received from a physician concerning a 63 year old female patient who on 25-MAR-2009 was vaccinated with ZOSTAVAX (Merck) (Lot # 0197T). On 23-MAR-2009 the patient experienced pain, tenderness to touch, swelling and warmth at the site of injection and surrounding area on her left arm after administration of ZOSTAVAX (Merck). The patient stated that her left shoulder hurt the night prior to receiving ZOSTAVAX (Merck). On an unspecified date the patient had visited physician's office for medical attention. On 13-APR-2009 X ray of her left arm was performed. At the time of reporting the patient's pain, tenderness to touch, swelling and warmth at the site of injection and surrounding area on her left arm persisted. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Herpes zoster, Pruritus, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a nurse concerning a patient with unknown history of shingles prior to receiving ZOSTAVAX (Merck) who was vaccinated with a dose of ZOSTAVAX (Merck) (lot# was not available). The patient developed shingles "2 weeks after receiving the vaccine". Follow up information was received from a Licensed Practical Nurse (L.P.N.) concerning the 75 year old female patient with histories of breast cancer and chickenpox when she was less than 7 year old of age as well as no drug allergies who on 02-APR-2009 (at 11:00 am) was vaccinated subcutaneously in the right arm with the first dose of ZOSTAVAX (Merck) (lot number 662998/1620X). Concomitant therapy included chondroitin sulfate sodium (+) glucosamine sulfate, calcium, multivitamins, ENAPRIL, calcium ascorbate, B12, atenolol, aspirin and alendronate sodium (MSD). The patient did not experience a rash post vaccination. The patient had gallbladder removed on 12-JAN-2009 and rehospitalized on 25-JAN-2009 with complications. The patient stated that she was still recovering at the time of injection. On 09-APR-2009 the patient noticed itchy vesicle at the base of right neck. The area was itchy all day. It works upon on 10-APR-2009 with 4 grouped vesicles and more pruritus. There was no pain or aching. The patient felt fatigue and pruritus. There was vesicles never blister. The patient was seen in physician's office on 11-APR-2009. Tzanck test was done on 11-APR-2009 and the result was positive for zoster. HZV culture was done on 11-APR-2009. Final report on 12-APR-2009 indicated that no varicella-zoster virus was detected. The patient was given VALTREX, 1 g, three times a day for 7 days. The patient didn't keep 10 day follow up appointment. She stated she felt fine. As of 04-MAY-2009, the patient stated that vesicles still visible but fading. It was reported that the patient was not recently exposed to chicken pox or shingles. No further information is available.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a  Nurse Practitioner (N.P.) concerning a 68 year old patient who on 03-APR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#663779/1791X). On 13-APR-2009 the patient experienced redness, tenderness and swelling where the vaccine was given. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Secondary transmission
Clinical narrative: Information has been received from a health care professional concerning a 63 year old male patient who on an unspecified date experienced a possible secondary transmission from his wife who around the second week of December 2008 was vaccinated with a dose of ZOSTAVAX vaccine (Merck). It was reported that the patient experienced and itchy rash on his trunk. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: Information has been received from a physician concerning a patient who on 18-MAR-2009 was vaccinated with ZOSTAVAX (Merck). The physician reported that on 20-MAR-2009, the patient developed bullous pemphigoid. The patient sought medical attention and was seen by the physician. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash, Rash erythematous
Clinical narrative: Information has been received from a consumer and a Registered Pharmacist (R.Ph) concerning a 77 year old male patient with a history of "Dental implantation" on 05-JAN-2009 and penicillin allergy, who on 26-JAN-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # 663175/1553X) subcutaneously. Concomitant therapy included simvastatin (manufacturer unknown), lisinopril (manufacturer unknown) and vitamins (unspecified). It was reported that on "middle of February 2009" approximately 15-FEB-2009 the patient developed a case of shingles. It was reported that they looked like they were "red spots" on his forehead and on his lower arm between his elbow and his hand. It seemed as if they were getting better however they never cleared up. It was reported that the "red spots" got worse especially with the itching. It was reported that the patient was experiencing a rash on both arms. The patient saw a dermatologist on 14-APR-2009 and was diagnosed with shingles. There were no laboratory diagnostic tests performed. It was reported that the patient had not recovered at the time of the report. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a 67 year old female patient allergic to aspirin and sulfa drugs, and with thyroid disorder who on 16-DEC-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Merck) (lot# not provided) 0.65ml. Concomitant therapy included thyroid medication. On approximately 08-APR-2009 ("a little less than a week ago") the patient received a PAP test and results came back that she had HPV. She has been with her husband for 35 years and believe this may have been caused by the ZOSTAVAX vaccine (Merck). Patient sought unspecified medical attention. At the time of this report patient had not yet recovered. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 65 year old female with no known drug reactions/allergies, who on 05-JAN-2009 was vaccinated with ZOSTAVAX (Merck) (Lot # 663177/1413X). Concomitant therapy included NEXIUM, TARKA and CELEXA. On approximately 19-JAN-2009, 2 weeks after getting the vaccine, the patient experienced shingles on her hand (she noticed 2 spots on her hand). At the time of the report, the patient had recovered (unspecified date). The patient did not seek medical attention. Additional information has been requested.
Age: 16.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning a 16 year old patient who "last week" was accidentally vaccinated with ZOSTAVAX (Merck). Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a medical assistant concerning a 60 year old male patient who about 2 weeks ago was vaccinated with ZOSTAVAX (Merck) and had a "rash on the left side and left shoulder". The physician had not seen the patient yet but from the description given by the patient believed it may possibly be shingles. The patient had called the physician's office for medical attention. The outcome of the patient's rash on the left side and left shoulder was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a medical assistant concerning a female who on 31-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included REMICADE treatment when the ZOSTAVAX (Merck) was given. On 10-APR-2009 the patient experienced an injection site reaction where vaccine was given. It was reported that the area of the reaction was swollen, warm and red. The patient sought medical attention by visiting the physician's office. At the time of reporting (15-APR-2009) the patient was not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture, Herpes zoster
Clinical narrative: Information has been received from a 73 year old female patient who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot# was not provided). On 09-APR-2009 the patient developed shingles after getting the vaccine. The patient sought unspecified medical attention. At the time of reporting the patient was not recovered. Lab diagnostic included culture test. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dry skin, Erythema, Skin exfoliation
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 65 year old female with blood pressure high and a previous small pox vaccination, the patient had a scar where the small pox vaccine was given, who in February 2009, was vaccinated with a dose of ZOSTAVAX (Merck) on the left side, left arm. The patient was likely taking blood pressure medication. About a month and a half later the patient came back and stated that the scar was red, dry and scaly. The patient also stated that previously there had been blisters inside the scar. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse (at the physician's office) concerning a patient who was vaccinated with ZOSTAVAX (Merck). The patient experienced a case of shingles after vaccination. The outcome of the patient's shingles was not reported. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning a 25 year old patient who on 16-APR-2009 was vaccinated with ZOSTAVAX vaccine (Merck) for chickenpox instead of varicella virus vaccine live (Merck) due to human error. No adverse effect was reported. Follow-up information has been received from the administrative staff who administered the vaccines to the patients. The administrative staff confirmed that the 25 year old female patient received ZOSTAVAX vaccine (Merck) (lot # 662755/1621X) on 01-APR-2009 (not 16-APR-2009 as previously reported) instead of chickenpox. Follow-up information has been received from a healthcare worker that on 01-APR-2009 the female patient with no illness at the time of vaccination was vaccinated with a dose of ZOSTAVAX vaccine (Merck) instead of varicella virus vaccine live (Merck) in error. The patient's arm was red and swollen at the vaccination site. At the time of reporting the outcome for the patient's arm being red and swollen at the vaccination site was reported as recovered. 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 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) two weeks ago (on 31-MAR-2009). Subsequently, the patient developed shingles after having received ZOSTAVAX (Merck) on an unspecified date. The patient sought unspecified medical attention. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Anorexia, Blister, Fatigue, Herpes zoster, Malaise
Clinical narrative: Information has been received from a physician concerning a 66 year old male with no pertinent medical history and no known drug allergies/drug reactions who on 02-APR-2009 was vaccinated with ZOSTAVAX (Merck) (Dose and route not reported). There was no concomitant medication. On 10-APR-2009 the patient experienced mild case of shingles on his leg after receiving a dose of ZOSTAVAX (Merck). It was reported that the patient felt "ill" and had fatigue. The patient saw a dermatologist. It was reported that the patient was recovering at the time of the report. Follow up information was received from a physician who reported that the patient was having recurring bouts of shingles every 4-6 days since vaccination with ZOSTAVAX (Merck). It was reported that they were in relation to L1, L4, L5 and started to occurred at C7 and C8. It was reported that he was fatigued and had loss of appetite. Telephone follow-up information was received which reported that the patient's wife explained that her husband was vaccinated with ZOSTAVAX (Merck) and developed vesicles. The patient was seen by a dermatologist and was diagnosed with shingles. The patient's wife stated that he was not treated with antiviral medication because he was not seen within 48 hours of developing shingles. Since the initial episode, her husband had been developing recurring bouts of zoster lesions every 4-6 days which were traveling to different dermatomes (L1, L4 and L5 and C7 and C8) with separate crops over separate time periods. The patient's wife explained that her husband's recurring shingles were not classic shingles and she was concerned. Her worry was transmission because his lesions were traveling to different dermatomes and were not typical shingles. The patient's wife stated that her husband had been trying to get another appointment with his physician. Telephone follow-up information was received from the patient's wife who reported that her continued to concern regarding the "atypical" nature of her husband's and her signs/symptoms and was seeking additional information. The patient's wife reported they were alright, but that "some days, they just do not feel well". She reported that her husband's last new lesions were on Sunday May 3rd with no more since. His lesions continued to be in the C7 & C8, and L4 & L5 dermatomes. The patient's wife also stated that she and her husband were seeing an infectious disease physician the following day on May 6th. Follow-up information was received from via email from the physician who reported that the patient's rash came out 6 days after vaccination, so the rash was likely due to wild type VZV, not Oka. The patient's wife was convinced that she and her husband have herpes zoster. The patient's wife did not want to see another dermatologist. The physician said her that she could submit samples for PCR from her and her husband's recurrent rash to test. This is one of several cases from the same source. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Lip pain
Clinical narrative: Information has been received from a 61 year old female consumer with no pertinent medical history and no known drug allergies, who on 15-APR-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot not reported). There was no concomitant medication. On 16-APR-2009 the patient experienced "blisters" on the left side of her face above her lip and "it is just a little sore". She had not spoken or seen her physician yet to determine a diagnosis. At the time of reporting, 17-APR-2009, the patient's symptoms persisted. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest X-ray, Dyspnoea, Palpitations
Clinical narrative: Information has been received from a registered nurse concerning a 63 year old male who on 05-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Merck). On 29-JAN-2009 the patient called the office and reported that as he was leaving the office on 05-JAN-2009 after he received ZOSTAVAX (Merck) he started to have shortness of breath, heart palpitations but no chest pain. The nurse reported that on 18-FEB-2009 the patient called back and stated that he still was having two to three episodes a day but not enough to wake him up while he was sleeping. The patient had gone for a follow up chest X-ray but the result was not provided. The patient called the office for medical attention. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Lethargy, Pain, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner concerning a 70 year old female who on 13-APR-2009 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck). On 15-APR-2009, a day and a half after the vaccination, the patient experienced flu like symptoms. She had achy, fever and lethargic. At time of reporting, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a 65 year old female registered nurse with no pertinent medical history or drug reactions or allergies reporting herself who on 17-APR-2009 was vaccinated IM instead of SC with the first dose of ZOSTAVAX (Merck) into the left deltoid. Concomitant therapy included vitamins (unspecified). On 18-APR-2009 her left arm became a little sore. On the same day, the patient recovered. No lab tests were done. The patient did not seek medical attention. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has with allergies to PENICILLIN, CEPHALOSPORIN, non-steroidal anti-inflammatory drugs and silver containing compounds who on 07-AUG-2007 was vaccinated with one dose of ZOSTAVAX (Merck). Concomitant therapy included estrogens, PREMARIN, ACTONEL, SEREVENT DISKUS, DILAUDID, DOXYCYCLINE and HYDROCHLOROTHIAZIDE (manufacturer unknown). On approximately 12-APR-2009, "within the last week", the patient developed a rash on her right calf. At the time of this report, the patient had not recovered. No lab tests were done. Unspecified medical attention was sought. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a greater than 70 year old female who on 11-JUN-2008, "last summer", was vaccinated with the first dose of ZOSTER vaccine live (Merck) (lot # 658844/0204X).  On approximately 10-APR=2009, "within the last 10 days", the patient developed shingles.  No details about the shingles were known except the rash was still present.  The patient had not recovered at this time.  The patient saw the physician and sought unspecified medical attention.  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 (Merck). On approximately 06-APR-2009 ("two weeks ago") the patient experienced shingles outbreak. On unknown date, the patient recovered. This patient had been enrolled in a study on ZOSTAVAX (Merck) which has been closed. The protocol # was V211009 and the allocation # was 12341. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pruritus
Clinical narrative: Information has been received from a 76 year old female, with no known drug reactions/allergies and no pertinent medical history, who in approximately June 2008, "he last summer" was vaccinated with ZOSTAVAX (Merck). There was no concomitant medication. The patient reported that on 01-APR-2009, she developed shingles after receiving ZOSTAVAX (Merck). She had little blisters on her lower left back. She had no pain but the blisters were itchy. She had to take antiviral medications for 5 days. At the time of the report, the patient was recovering. The patient saw the physician. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Dizziness, Fatigue, Hyperhidrosis, Muscular weakness
Clinical narrative: Information has been received from a consumer concerning himself who on 20-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Two days later the patient developed "weak muscles, sweating and dizziness." The consumer stated he felt tired and his legs were also sweating. The consumer stated he went to the emergency room but was not admitted. He reported he still felt "burning on his face, neck, arms and back" and believed this may be from the vaccine. He stated that he had never had shingles in the past but had read about shingles and stated that his symptoms resemble "what it feels like before and after someone has shingles". The consumer stated he was given the vaccine at a military base but was seeing a different physician at the time. At the time of reporting the patient was not recovered. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Condition aggravated, Diarrhoea, Full blood count abnormal, Platelet count decreased
Clinical narrative: Information has been received from a medical technologist concerning her 65 year old husband with idiopathic thrombocytopenic purpura and no drug allergies who on 13-APR-2009 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapy included prednisone, levothyroxine and cholesterol medication. The patient developed some symptoms 48 hours after the vaccine (approximately 15-APR-2009). He had been experiencing stomach cramps and diarrhea. Also his platelet count had decreased significantly after the vaccine. Prior to vaccination, the complete blood count had been between 100000 to 120000. After the vaccination, the count decreased to 66000. The patient sought medical attention and was seen by a physician. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a 77 year old female patient with no medical history or allergies who had 2 previous outbreaks of shingles. the patient was vaccinated with ZOSTAVAX vaccine (Merck) (lot # 6649091/0140Y) SC on 16-APR-2009. The patient developed shingles for the third time after receiving ZOSTAVAX vaccine (Merck) on 17-APR-2009. This shingles outbreak was on the left side of the patient's face, jaw and mouth. The patient reported to the registered pharmacist that this was a milder outbreak than she had had in the past. The patient had made a phone call fro medical attention. At the time of reporting the patient was recovering from the shingles on the left side of the patient's face, jaw and mouth. Additional information has been requested.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 72 year old patient with diabetes who on 28-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 658361/1090U). It was reported that the patient developed an outbreak of shingles. The rash was on the right side of her back and leg. The patient was seen in the office on 22-APR-2009. It was reported that the patient was given MEDROL dose pack and VALTREX. The patient was not hospitalized and it was not life threatening. The outcome of the patient was not reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye disorder, Eyelid ptosis, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 85 year old female who was vaccinated with a dose of ZOSTAVAX vaccine (Merck) 0.65 ml. About 5 months after receiving ZOSTAVAX vaccine (Merck), the patient experienced a "severe" case of shingles. At the time of reporting, the patient was having "trouble with her right eye" and was still in a lot of pain. At the time of reporting the patient had not recovered. The patient sought unspecified medical attention. Follow-up information has been received from a physician. There was no collection of lesions for PCR. No direct fluorescent antibody test was performed. The physician reported that the patient is an 81 year old female (previously reported as 85 year old) with a history of chickenpox as youngster and allergy to sulfa, rofecoxib (MSD), statins and AVELOX. On 03-APR-2008, the patient was vaccinated with a "standard" dose of ZOSTAVAX vaccine (Merck) (lot# 659268/1430U) into her left upper arm. Concomitant medication included diltiazem-HCL, NEXIUM, aspirin, CENTRUM, calcium (unspecified) (+) vitamin D (unspecified), and an unspecified vitamins therapy. The physician reported that the patient developed a severe case of shingles "8 months after vaccination" on 23-DEC-2008. It was reported that the rash did not occur at the site of injection within 42 days of the vaccination. The patient developed a shingles type rash with several lesions on her right side face, eye, ear, neck and forehead. The patient assessed pain as 10, the most painful in a scale from 1 to 10. It was reported that the patient had very severe prolonged symptoms and now with partial right ptosis. There was no recent exposure to chickenpox. The physician reported that at the time of reporting, the patient was still recovering. The patient had a history of allergy while on prior therapy with statin (manufacturer unspecified) (WAES: 0905USA02615) and VIOXX (MSD, WAES 0905USA02616). No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy, Herpes zoster, Pain in extremity, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a physician concerning her 65 year old mother who was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (no lot number was provided) about 6 months ago (approximately October 2008) and soon after broke out in what looked like a chicken pox rash all over her body. Last Thursday (16-APR-2009), she was complaining of her arm hurting really bad. She went to the emergency room and was diagnosed with Shingles. It was unknown if the patient was admitted into hospital. Lab diagnostics included biopsy. At the time of reporting (23-APR-2009) the patient was not recovered. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Herpes zoster, Pain, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 63 year old male who on 16-APR-2009 was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (route not reported, lot number 663672/1709X). Concomitant therapy included simvastatin (MSD). On 21-APR-2009, the patient came back to the office to show that he developed a red rash on his trunk area on his right side around the rib cage all around the back. The physician added that the patient said that he had minimal pain and he did not want to take any medication for it. The patient was prescribed VALTREX by the physician. The reporter noted that this was a "classic shingles". It was not specified if the patient had shingles prior receiving ZOSTAVAX (Merck). Follow up information has been received from a physician concerning a 62 year old male with no pertinent medical history reported and no known drug allergies and no illness at the time of vaccination who on 16-APR-2009 was vaccinated in the right deltoid with first 0.65mL dose of ZOSTAVAX (Merck) (route not reported, lot number 663672/1709X). The physician reported that on 21-APR-2009, the patient presented to the doctor with a three day rash with pain. The patient was vaccinated on 16-APR-2009 with a 0.65mL dose of ZOSTAVAX (Merck) (Lot # 663672/1709X) in the right deltoid. The patient's rash occurred in the left lower quadrant of abdomen. Date of herpes zoster reported as 23-APR-2009. Distribution and dermatome involved was L1 dermatome on left. Patient's maximum temperature was 99.4F and his pain was rated a 3 on a scale of 1 to 10 (10 being most). The patient had no other systemic symptoms. There was no history of chickenpox, no recent exposure to chickenpox or herpes zoster. There was no direct fluorescent antibody and no specimen collected. Subsequently, the patient recovered from herpes zoster. The patient recovered on an unspecified date. No further information is available.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 68 year old female with sulfonamide allergy and a history of uterine cancer, cervical cancer and appendicectomy who on 21-APR-2009 was vaccinated with ZOSTAVAX (Merck) (0.65ml, SQ, lot number: 664029/0196Y). Concomitant therapy included aspirin, VITA C, omega-3 marine triglycerides, vitamins (unspecified), SYNTHROID, alendronate sodium (MSD), chondroitin sulfate sodium (+) glucosamine sulfate and levoglutamide. The pharmacist reported a patient developed a raised, red pruritic and warm area at the site of injection on 23-APR-2009. The size of the area was 1 inch by 3 inch. The patient sought medical attention via pharmacist. No additional information was provided. Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Discomfort, Erythema, Headache, Rash maculo-papular
Clinical narrative: Information has been received from a physician and a Licensed Visiting Nurse concerning an 83 year old male patient who on 20-APR-2009 was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included NEXIUM.  On 20-APR-2009 night the patient's face got a little red.  As the week went on the patient's face started swelling little by little.  ZOSTAVAX (Merck) was given at another facility.  The patient visited the physician's office for medical attention.  The physician examined the patient "today" and described the patient having a macularpapular rash on both cheeks, some on the forehead, there was burning and the patient was uncomfortable.  There was swelling of the face especially the cheeks.  The patient was afebrile and had severe headache on the right frontal area.  The rash was not affecting the eyes.  At the time of reporting the patient's adverse events persisted.  Additional information has been requested.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Information has been received from a physician and a Licensed Visiting Nurse concerning an 83 year old male patient who on 20-APR-2009 was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included NEXIUM.  On 20-APR-2009 night the patient's face got a little red.  As the week went on the patient's face started swelling little by little.  ZOSTAVAX (Merck) was given at another facility.  The patient visited the physician's office for medical attention.  The physician examined the patient "today" and described the patient having a macularpapular rash on both cheeks, some on the forehead, there was burning and the patient was uncomfortable.  There was swelling of the face especially the cheeks.  The patient was afebrile and had severe headache on the right frontal area.  The rash was not affecting the eyes.  At the time of reporting the patient's adverse events persisted.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a registered pharmacist concerning a 67 year old female patient who on 19-APR-2009 was vaccinated with ZOSTAVAX (Merck) (lot # 663333/1555X) SQ. At time of reporting the patient had tingling, itching and a small blister that is trying to form. The patient had a case of shingles on an unspecified date of the buttocks. The shingles had all cleared up and pain subsided for one month prior to the patient receiving ZOSTAVAX (Merck). The patient called the registered pharmacist on 24-APR-2009 to inquire if the shingles could reoccur on the same location as the previous shingles episode. The patient was not experiencing pain. The patient had a visit to physician for medical attention. The physician prescribed Acyclovir (manufacturer unspecified) 400mg 3 times daily for 5 days. The patient's tingling and itching and a small blister that is trying to form persisted. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Information has been received from a consumer concerning herself (a 61 year old female) with no medical history and drug allergies who on 21-APR-2009 was vaccinated with a dose of ZOSTER vaccine live (Merck).  Concomitant therapy included HYDROCHLOROTHIAZIDE.  On 22-APR-2009 the patient developed an injection site reaction after receiving ZOSTER vaccine live (Merck).  Initially redness was about 2 and 1/2 inches across.  On 24-Apr-2009 the redness has increased from her shoulder to her elbow.  The area was "hard" and very painful like a "bee sting".  The patient sought medical attention and was seen by nurse and pharmacist.  At the time of reporting the patient was not recovered.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Laboratory test normal, Pruritus, Rash pustular
Clinical narrative: Information has been received from a 67 year old female with arthritis, osteopenia, high cholesterol, high blood pressure as well as allergy reaction to blood transfusion and IPV dye and drug reaction to antibiotic concerning herself who in October 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # is not available). Concomitant therapy included simvastatin, TOPROL XL TABLETS, CELEBREX, ramipril, BENTYL, alendronate sodium (MSD) and NASACORT. It was reported that after a few days (around 20-APR-2009 or 21-APR-2009) the patient developed a pimple like bumps on her right arm, 2 bumps and 1 was bigger than the other and they looked like pustules and they were red and very itchy. The patient spoke to her niece who was a nurse and described the bumps to her and she mentioned that it might be a chicken pox. The patient occasionally get hives because she was just sensitive to a lot of things, but these bumps looked different from her usual hives." At the tie of reporting the patient was not recovered. Follow up information was received on 04-MAY-2009 from the patient by phone stated that her physician did a scraping of the bumps on her arm and it came back negative. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a "74 year old" female who in April 2007, was vaccinated with a single dose of ZOSTAVAX (Merck) (dose, route and lot number unspecified). There was no concomitant therapy. A "couple of weeks ago" (approximately 10-APR-2009), the patient came down with shingles. The patient sought unspecified medical attention. The outcome of the patient was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Infection
Clinical narrative: Information has been received from a pharmacist (from a drug information center) concerning a male patient who received approximately on 19-APR-2009 a dose of ZOSTAVAX (Merck) (dose, route and lot number not specified). It was reported that the patient was prescribed AUGMENTIN after vaccination. The pharmacist reported it was not known why the patient was taking AUGMENTIN but the pharmacist did not believe it was directly related to the injection. The outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain in extremity, Pruritus, Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 64 year old male patient with type 2 diabetes mellitus, hyperlipidaemia, hepatitis C antibodies with undetectable viral levels, hypertension and erectile dysfunction who on 22-APR-2009 was vaccinated with ZOSTAVAX (Merck) (Lot # 664028/0137Y) subcutaneously into the left arm.  On 27-APR-2009 the patient developed pain in his right leg as well as itching.  He had been diagnosed with shingles.  There were no laboratories diagnostic studies performed.  The patient sought medical attention office visit.  Follow up information has been received from a physician concerning the patient, a veterinarian, with no drug reaction or allergies and an unknown history of chickenpox, with no recent exposure to chickenpox or shingles, who on 24-APR-2009 (previously reported as 22-APR-2009) was vaccinated with a dose of ZOSTAVAX (Merck) (lot #664028/0137Y) SC in the left arm.  24 hours after vaccination on 25-APR-2009 the patient developed a vesicular rash with 25 lesions distributed on right front and lateral thigh, along dermatomes L3 and L4 on right thigh.  The patient was still getting new lesions.  Patient had a pain (4 in scale 0-10) at site of lesions.  There was no temperature and no other systemic symptoms.  The patient had not recovered.  The patient was enrolled in a Identification Program to identify if VZV is present and if it is present to identify if it is associated wit the wild type (WT) strain or with the Merck vaccine VZV strain.  The sample of the vesicular lesion on the right this was collected on 04-MAY-2009.  Follow-up information was received which reported that the PCR results for the specimen from the vesicular lesion identified the presence of wild-type VZV.  Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Licensed Practical Nurse (LPN), a 69 year old female concerning herself, she was vaccinated in the arm with one dose of ZOSTAVAX (Merck) (LOT# 663196/1417X) on 28-NOV-2008. Concomitant therapy included an "unspecified blood pressure medication". On 20-APR-2009, the patient developed shingles on the right side of her trunk. The patient was seen by a physician, no laboratory or diagnostic tests were performed. At the time of the report the patient had not recovered. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 63 year old female who on 17-APR-2009 was vaccinated with ZOSTAVAX (Merck) (lot#663673/1710X, route and site of administration not reported). The patient experienced rash on the inside of her left arm after the vaccination was given. The physician informed that the rash did not look like a shingles like rash and there were no vesicles present. The patient called the physician's office on 27-APR-2009 for unspecified medical attention, and reported that she had a rash in her rib cage area now. At the time of reporting the patient was not recovered. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Swelling
Clinical narrative: Information has been received from a registered nurse concerning a 70 year old male with a history of herpes simplex treated with VALTREX and acyclovir in December 2007 who on 22-APR-2009 was vaccinated with ZOSTAVAX (Merck) (Lot#663883/0132Y) (dose and route not reported) in his upper right arm. Concomitant therapy included albuterol. On 24-APR-2009 the patient had a rash on medial side of his right arm. And the rash was bubbly and raised, it is the size of baseball in diameter. The patient has gone to office to seek medical attention. At the time of reporting, the outcome of rash was not recovered. Additional information has been requested.