chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Oral herpes, Rash, Skin lesion, Upper respiratory tract infection
Clinical narrative: Information has been received form a pharmacist concerning a 63 year old female patient with no reported drug allergies and no reported medical history who on 20-DEC-2010 was administered ZOSTAVAX (Merck) (lot # 665525/0695Z). The patient did not receive any concomitant vaccinations. On 06-JAN-2011 the patient reported to the pharmacist that she had a cold sore on her lip. On 08-JAN-2011, the patient reported that she had a rash on the left side of her abdomen. On 08-JAN-2011, the patient went to a "walk-in clinic and was seen by a doctor. The patient was diagnosed with shingles and was treated with an antiviral medication (unspecified). The outcome was unknown. Follow-up information has been received from a licensed practical nurse concerning the patient. The patient had allergies to SEPTRA DS and penicillin, diabetes, hypertension and hypercholesterolemia. The patient received ZOSTAVAX (Merck) on 20-DEC-2010 (injection was given at another facility). Three weeks after the shingles vaccine, on 10-JAN-2011, the patient developed upper respiratory infection, then broke out in lesions on lip, left lower rib and back area. The patient was seen at doctor's office on 14-JAN-2011. No lab test was performed. At the time of reporting, outcome of the events was unknown. This is one of several reports received form the same source. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Burning sensation, Erythema, Urticaria
Clinical narrative: Information has been received from an 82 year old female patient with allergy to tetracycline and a history of breast cancer who on 23JUL2010 received a dose of ZOSTAVAX (Merck). Concomitant therapy was reported as prednisone, cephalexin, triamcinolone, hydroxyzine hydrocholoride, acyclovir, methylprednisolone, betamethasone valerate, doxepin HCl and EPICERAM. She reported that she obtained the shingles vaccine and the next day she experienced burning in her leg and hip (also reported as 23JUL2010). The second day the patient broke out in hives. Since then, she has experienced burning and itching of the scalp. She had seen several specialists and had been prescribed several medications and none of the treatments took away her symptoms. She stated that a few of her doctors had stated it was because of the ZOSTAVAX (Merck). She also mentioned that a doctor stated possibly she had been administered a bad batch of ZOSTAVAX (Merck). Pt reported blood work and biopsy were performed (results not provided). Follow up information from the consumer on 10JAN11 reported that she is still experiencing symptoms. She stated she "knows it is because of the shot" and that she "was fine before she got it". The patient had not recovered at time of report. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Biopsy, Blood test, Burning sensation, Immunisation reaction, Pruritus
Clinical narrative: Information has been received from an 82 year old female patient with allergy to tetracycline and a history of breast cancer who on 23JUL2010 received a dose of ZOSTAVAX (Merck). Concomitant therapy was reported as prednisone, cephalexin, triamcinolone, hydroxyzine hydrocholoride, acyclovir, methylprednisolone, betamethasone valerate, doxepin HCl and EPICERAM. She reported that she obtained the shingles vaccine and the next day she experienced burning in her leg and hip (also reported as 23JUL2010). The second day the patient broke out in hives. Since then, she has experienced burning and itching of the scalp. She had seen several specialists and had been prescribed several medications and none of the treatments took away her symptoms. She stated that a few of her doctors had stated it was because of the ZOSTAVAX (Merck). She also mentioned that a doctor stated possibly she had been administered a bad batch of ZOSTAVAX (Merck). Pt reported blood work and biopsy were performed (results not provided). Follow up information from the consumer on 10JAN11 reported that she is still experiencing symptoms. She stated she "knows it is because of the shot" and that she "was fine before she got it". The patient had not recovered at time of report. Additional information has been requested.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from an 82 year old female patient with allergy to tetracycline and a history of breast cancer who on 23JUL2010 received a dose of ZOSTAVAX (Merck). Concomitant therapy was reported as prednisone, cephalexin, triamcinolone, hydroxyzine hydrocholoride, acyclovir, methylprednisolone, betamethasone valerate, doxepin HCl and EPICERAM. She reported that she obtained the shingles vaccine and the next day she experienced burning in her leg and hip (also reported as 23JUL2010). The second day the patient broke out in hives. Since then, she has experienced burning and itching of the scalp. She had seen several specialists and had been prescribed several medications and none of the treatments took away her symptoms. She stated that a few of her doctors had stated it was because of the ZOSTAVAX (Merck). She also mentioned that a doctor stated possibly she had been administered a bad batch of ZOSTAVAX (Merck). Pt reported blood work and biopsy were performed (results not provided). Follow up information from the consumer on 10JAN11 reported that she is still experiencing symptoms. She stated she "knows it is because of the shot" and that she "was fine before she got it". The patient had not recovered at time of report. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 56 year old female with no pertinent medical history or drug allergies, who on 27-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#669187/1543Z, expiration date: 06-FEB-2012). Patient's daughter came into the pharmacy on 30-DEC-2010 to report that her mother, experienced swollen right arm after receiving a dose of ZOSTAVAX (Merck) (approximately on 27-DEC-2010). On an unspecified date, the patient sought medical attention at the Emergency Room and was diagnosed with cellulitis and treated with KEFLEX 500 mg and prednisone. At the time of the report the patient's cellulitis outcome was not provided. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 56 year old female with no pertinent medical history or drug allergies, who on 27-DEC-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot#669187/1543Z, expiration date: 06-FEB-2012). Patient's daughter came into the pharmacy on 30-DEC-2010 to report that her mother, experienced swollen right arm after receiving a dose of ZOSTAVAX (Merck) (approximately on 27-DEC-2010). On an unspecified date, the patient sought medical attention at the Emergency Room and was diagnosed with cellulitis and treated with KEFLEX 500 mg and prednisone. At the time of the report the patient's cellulitis outcome was not provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dysphonia, Injection site nodule, Laryngitis, Malaise, Rash
Clinical narrative: Information has been received from a 65 year old female patient with diabetes, thyroid condition and triglycerides and no drug reactions/allergies who on 22-DEC-2010 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck). Concomitant therapies included:LIPITOR, LOPID, ISOSORBIDE SL, NEURONTIN, SYNTHROID, REQUIP, CAPTIN, VICKS NYQUIL MULTISYMPTOM COLD AND FLU RELIEF (NEW FORMULA), insulin (manufacturer unknown) and eye drops (manufacturer unknown). One day after vaccination, she developed a 2 inch wide red mark on her left arm at the site of the vaccine injection. She also reported that developing a ball inside the arm. A few days later she developed laryngitis, had difficulty breathing, and had green sputum that was turning yellow. She reported that being on oxygen that was helping. Also she reported having no appetite. The patient did not seek medical attention. Lab data: blood work for triglycerides. At the time of report the patient's status was recovering. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood triglycerides, Decreased appetite, Dyspnoea, Injection site erythema, Laryngitis
Clinical narrative: Information has been received from a 65 year old female patient with diabetes, thyroid condition and triglycerides and no drug reactions/allergies who on 22-DEC-2010 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck). Concomitant therapies included:LIPITOR, LOPID, ISOSORBIDE SL, NEURONTIN, SYNTHROID, REQUIP, CAPTIN, VICKS NYQUIL MULTISYMPTOM COLD AND FLU RELIEF (NEW FORMULA), insulin (manufacturer unknown) and eye drops (manufacturer unknown). One day after vaccination, she developed a 2 inch wide red mark on her left arm at the site of the vaccine injection. She also reported that developing a ball inside the arm. A few days later she developed laryngitis, had difficulty breathing, and had green sputum that was turning yellow. She reported that being on oxygen that was helping. Also she reported having no appetite. The patient did not seek medical attention. Lab data: blood work for triglycerides. At the time of report the patient's status was recovering. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Sputum discoloured, Upper extremity mass
Clinical narrative: Information has been received from a 65 year old female patient with diabetes, thyroid condition and triglycerides and no drug reactions/allergies who on 22-DEC-2010 was vaccinated intramuscularly with a dose of ZOSTAVAX (Merck). Concomitant therapies included:LIPITOR, LOPID, ISOSORBIDE SL, NEURONTIN, SYNTHROID, REQUIP, CAPTIN, VICKS NYQUIL MULTISYMPTOM COLD AND FLU RELIEF (NEW FORMULA), insulin (manufacturer unknown) and eye drops (manufacturer unknown). One day after vaccination, she developed a 2 inch wide red mark on her left arm at the site of the vaccine injection. She also reported that developing a ball inside the arm. A few days later she developed laryngitis, had difficulty breathing, and had green sputum that was turning yellow. She reported that being on oxygen that was helping. Also she reported having no appetite. The patient did not seek medical attention. Lab data: blood work for triglycerides. At the time of report the patient's status was recovering. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness, Headache, Heart rate increased, Pallor
Clinical narrative: Information has been received from a 70 year old female Registered Nurse with no pertinent medical history and sulfa allergies, who on 20-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 665515/1373Y), on the back of right arm. There was no other concomitant medication reported. Post vaccination the nurse stated she developed swelling and redness at the injection site. The next day, on 21-JAN-2011, she experienced headache. On 24-JAN-2011 the nurse said that she was sitting at home in the evening and felt like "she was dying or going to pass out, her heart was bounding". She called the paramedics and was taken to emergency room. Her blood pressure was 220/120 and her heart rate was 132. She was treated with metoprolol 25 mg once a day and released, was not hospitalized. The nurse reported that the same thing occurred on 26-JAN-2011, the nurse called paramedics and was rushed to the same emergency room with high blood pressure and released, was not hospitalized. The nurse stated she felt better for a little while but then got the feeling "she was dying or going to pass out, her heart was bounding". Lab tests performed included: blood work, lumbar puncture, chest X-ray, echocardiogram, ultrasound of carotid artery, all tests were normal. The nurse stated her cardiologist could not figure what was wrong. At the time of the report the nurse's outcome was not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Palpitations, Tremor
Clinical narrative: Information has been received from a 70 year old female Registered Nurse with no pertinent medical history and sulfa allergies, who on 20-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 665515/1373Y), on the back of right arm. There was no other concomitant medication reported. Post vaccination the nurse stated she developed swelling and redness at the injection site. The next day, on 21-JAN-2011, she experienced headache. On 24-JAN-2011 the nurse said that she was sitting at home in the evening and felt like "she was dying or going to pass out, her heart was bounding". She called the paramedics and was taken to emergency room. Her blood pressure was 220/120 and her heart rate was 132. She was treated with metoprolol 25 mg once a day and released, was not hospitalized. The nurse reported that the same thing occurred on 26-JAN-2011, the nurse called paramedics and was rushed to the same emergency room with high blood pressure and released, was not hospitalized. The nurse stated she felt better for a little while but then got the feeling "she was dying or going to pass out, her heart was bounding". Lab tests performed included: blood work, lumbar puncture, chest X-ray, echocardiogram, ultrasound of carotid artery, all tests were normal. The nurse stated her cardiologist could not figure what was wrong. At the time of the report the nurse's outcome was not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test normal, Chest X-ray normal, Dizziness, Echocardiogram normal, Feeling abnormal
Clinical narrative: Information has been received from a 70 year old female Registered Nurse with no pertinent medical history and sulfa allergies, who on 20-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 665515/1373Y), on the back of right arm. There was no other concomitant medication reported. Post vaccination the nurse stated she developed swelling and redness at the injection site. The next day, on 21-JAN-2011, she experienced headache. On 24-JAN-2011 the nurse said that she was sitting at home in the evening and felt like "she was dying or going to pass out, her heart was bounding". She called the paramedics and was taken to emergency room. Her blood pressure was 220/120 and her heart rate was 132. She was treated with metoprolol 25 mg once a day and released, was not hospitalized. The nurse reported that the same thing occurred on 26-JAN-2011, the nurse called paramedics and was rushed to the same emergency room with high blood pressure and released, was not hospitalized. The nurse stated she felt better for a little while but then got the feeling "she was dying or going to pass out, her heart was bounding". Lab tests performed included: blood work, lumbar puncture, chest X-ray, echocardiogram, ultrasound of carotid artery, all tests were normal. The nurse stated her cardiologist could not figure what was wrong. At the time of the report the nurse's outcome was not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haematology test normal, Headache, Hypertension, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a 70 year old female Registered Nurse with no pertinent medical history and sulfa allergies, who on 20-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 665515/1373Y), on the back of right arm. There was no other concomitant medication reported. Post vaccination the nurse stated she developed swelling and redness at the injection site. The next day, on 21-JAN-2011, she experienced headache. On 24-JAN-2011 the nurse said that she was sitting at home in the evening and felt like "she was dying or going to pass out, her heart was bounding". She called the paramedics and was taken to emergency room. Her blood pressure was 220/120 and her heart rate was 132. She was treated with metoprolol 25 mg once a day and released, was not hospitalized. The nurse reported that the same thing occurred on 26-JAN-2011, the nurse called paramedics and was rushed to the same emergency room with high blood pressure and released, was not hospitalized. The nurse stated she felt better for a little while but then got the feeling "she was dying or going to pass out, her heart was bounding". Lab tests performed included: blood work, lumbar puncture, chest X-ray, echocardiogram, ultrasound of carotid artery, all tests were normal. The nurse stated her cardiologist could not figure what was wrong. At the time of the report the nurse's outcome was not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lumbar puncture normal, Palpitations, Ultrasound Doppler, Ultrasound scan normal
Clinical narrative: Information has been received from a 70 year old female Registered Nurse with no pertinent medical history and sulfa allergies, who on 20-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 665515/1373Y), on the back of right arm. There was no other concomitant medication reported. Post vaccination the nurse stated she developed swelling and redness at the injection site. The next day, on 21-JAN-2011, she experienced headache. On 24-JAN-2011 the nurse said that she was sitting at home in the evening and felt like "she was dying or going to pass out, her heart was bounding". She called the paramedics and was taken to emergency room. Her blood pressure was 220/120 and her heart rate was 132. She was treated with metoprolol 25 mg once a day and released, was not hospitalized. The nurse reported that the same thing occurred on 26-JAN-2011, the nurse called paramedics and was rushed to the same emergency room with high blood pressure and released, was not hospitalized. The nurse stated she felt better for a little while but then got the feeling "she was dying or going to pass out, her heart was bounding". Lab tests performed included: blood work, lumbar puncture, chest X-ray, echocardiogram, ultrasound of carotid artery, all tests were normal. The nurse stated her cardiologist could not figure what was wrong. At the time of the report the nurse's outcome was not recovered. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Skin lesion
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 68 year old female with "acid stomach", bone density decreased and reaction/allergy to penicillin (PCN) who on 31-JAN-2011, was vaccinated subcutaneously in the left upper arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 669188/1454Z, expiration date 28-JAN-2012). Concomitant therapy included ACTONEL and NEXIUM. The pharmacist reported that the patient received the ZOSTAVAX (Merck) and experienced erythema at the injection site and area was warm to the touch (date unspecified). No lab diagnostic studies were performed. At the time of the report, the outcome of the patient was not recovered. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a Doctor of Pharmacy concerning a 68 year old female with "acid stomach", bone density decreased and reaction/allergy to penicillin (PCN) who on 31-JAN-2011, was vaccinated subcutaneously in the left upper arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 669188/1454Z, expiration date 28-JAN-2012). Concomitant therapy included ACTONEL and NEXIUM. The pharmacist reported that the patient received the ZOSTAVAX (Merck) and experienced erythema at the injection site and area was warm to the touch (date unspecified). No lab diagnostic studies were performed. At the time of the report, the outcome of the patient was not recovered. The patient sought medical attention by contacting the pharmacist. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Pyrexia, Rash generalised, Varicella
Clinical narrative: Information has been received from a 60 year old male consumer with a history of heart attack and no drug reactions or allergies, who on 18-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) IM. Concomitant therapy included lisinopril (manufacturer unknown), atenolol, simvastatin (manufacturer unknown), LUMIGAN, COSOPT and ALPHAGAN. On 01-FEB-2011, "two weeks" after the consumer received ZOSTAVAX (Merck), the consumer developed chicken pox. There were no Lab diagnosis/studies performed. The consumer sought unspecified medical attention. The consumer received antiviral medication. At the time of the report, the consumer was recovering. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a 60 year old male consumer with a history of heart attack and no drug reactions or allergies, who on 18-JAN-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not reported) IM. Concomitant therapy included lisinopril (manufacturer unknown), atenolol, simvastatin (manufacturer unknown), LUMIGAN, COSOPT and ALPHAGAN. On 01-FEB-2011, "two weeks" after the consumer received ZOSTAVAX (Merck), the consumer developed chicken pox. There were no Lab diagnosis/studies performed. The consumer sought unspecified medical attention. The consumer received antiviral medication. At the time of the report, the consumer was recovering. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Oral herpes
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 76 year old male patient with cold sores on his lips (on his face), no known allergies, who on 20-DEC-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number 6667611/1356Z, Exp. Date 26-OCT-2011) subcutaneously in his left arm. Concomitant therapy included acyclovir. It was reported that on 20-DEC-2010, later that evening after the patient was vaccinated, the cold sores on his lips got worse. It was reported that the patient went to see pharmacist. At the time of the report, the patient had not recovered. Follow up information has been received from the consumer reporting on himself who stated that "a quickening of his herpes simplex response came right" after receiving ZOSTAVAX (Merck). His nose was twitching. Concomitant therapy included acyclovir, warfarin, LIPITOR, divalproex sodium and nasal spray. In February 2011, after he went to see the doctor, he started to break out with pimples under his nose and above and below his lip. He went to see his pharmacist and got upset and then broke out with pimples on his chest that did bleed. The consumer reported that if he would had been told from the beginning to get off of the acyclovir, he would have. That information was sent to the pharmacist about stopping the medication one day before and not taking it again until several days after vaccination with ZOSTAVAX (Merck). Doxycycline and fluocinonide cream, which did not work, were given as a treatment for the experience. At the time of the report, the consumer was recovering after taking antibiotic doxycycline, which has gotten rid of the pimples and helped with his rosacea but his nose was still a slightly twitching. The consumer stated that he was going to see his dermatologist soon for lab diagnostics results and that his physicians wanted him to get a second shot but the consumer did not know if he would since he did not want to get shingles. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Condition aggravated, Muscle twitching, Oral herpes, Rosacea
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 76 year old male patient with cold sores on his lips (on his face), no known allergies, who on 20-DEC-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number 6667611/1356Z, Exp. Date 26-OCT-2011) subcutaneously in his left arm. Concomitant therapy included acyclovir. It was reported that on 20-DEC-2010, later that evening after the patient was vaccinated, the cold sores on his lips got worse. It was reported that the patient went to see pharmacist. At the time of the report, the patient had not recovered. Follow up information has been received from the consumer reporting on himself who stated that "a quickening of his herpes simplex response came right" after receiving ZOSTAVAX (Merck). His nose was twitching. Concomitant therapy included acyclovir, warfarin, LIPITOR, divalproex sodium and nasal spray. In February 2011, after he went to see the doctor, he started to break out with pimples under his nose and above and below his lip. He went to see his pharmacist and got upset and then broke out with pimples on his chest that did bleed. The consumer reported that if he would had been told from the beginning to get off of the acyclovir, he would have. That information was sent to the pharmacist about stopping the medication one day before and not taking it again until several days after vaccination with ZOSTAVAX (Merck). Doxycycline and fluocinonide cream, which did not work, were given as a treatment for the experience. At the time of the report, the consumer was recovering after taking antibiotic doxycycline, which has gotten rid of the pimples and helped with his rosacea but his nose was still a slightly twitching. The consumer stated that he was going to see his dermatologist soon for lab diagnostics results and that his physicians wanted him to get a second shot but the consumer did not know if he would since he did not want to get shingles. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Skin haemorrhage
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 76 year old male patient with cold sores on his lips (on his face), no known allergies, who on 20-DEC-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot number 6667611/1356Z, Exp. Date 26-OCT-2011) subcutaneously in his left arm. Concomitant therapy included acyclovir. It was reported that on 20-DEC-2010, later that evening after the patient was vaccinated, the cold sores on his lips got worse. It was reported that the patient went to see pharmacist. At the time of the report, the patient had not recovered. Follow up information has been received from the consumer reporting on himself who stated that "a quickening of his herpes simplex response came right" after receiving ZOSTAVAX (Merck). His nose was twitching. Concomitant therapy included acyclovir, warfarin, LIPITOR, divalproex sodium and nasal spray. In February 2011, after he went to see the doctor, he started to break out with pimples under his nose and above and below his lip. He went to see his pharmacist and got upset and then broke out with pimples on his chest that did bleed. The consumer reported that if he would had been told from the beginning to get off of the acyclovir, he would have. That information was sent to the pharmacist about stopping the medication one day before and not taking it again until several days after vaccination with ZOSTAVAX (Merck). Doxycycline and fluocinonide cream, which did not work, were given as a treatment for the experience. At the time of the report, the consumer was recovering after taking antibiotic doxycycline, which has gotten rid of the pimples and helped with his rosacea but his nose was still a slightly twitching. The consumer stated that he was going to see his dermatologist soon for lab diagnostics results and that his physicians wanted him to get a second shot but the consumer did not know if he would since he did not want to get shingles. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Information has been received from a doctor of pharmacy and a 64 year old female consumer, with morphine and sulfa allergy, and no other pertinent medical history, who on 06-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included aspirin. Pharmacist reported that on 06-FEB-2011 the patient developed rash at the site that was "twice size of a cell phone". On 09-FEB-2011 pharmacist and patient both called to report that patient had a low grade fever, aching, coughing and flu like symptoms. Patient called pharmacy. It was unspecified if the patient was given any treatment or if lab diagnostics studies were performed. At the time of the report the patient's outcome was unknown. Follow up information was received from a doctor of pharmacy who reported that the patient was still experiencing injection site pain and redness. Follow up information was received from the doctor of pharmacy reported that on 06-FEB-2011 the patient was vaccinated SQ on the left arm with a dose of GARDASIL (lot number 669192/1457Z). It was reported that the patient had immediate redness at injection site, increased to "egg size" over next few days. The patient reported headache and flu-like symptoms. After 10 days, the patient continued to report symptoms. The patient sited initial low-grade fever and after 10 days a temperature of 98.7 degrees F. The patient insisted this was a fever because her normal body temperature was low (did not state how low). It was reported that the patient required doctor visit. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a doctor of pharmacy and a 64 year old female consumer, with morphine and sulfa allergy, and no other pertinent medical history, who on 06-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included aspirin. Pharmacist reported that on 06-FEB-2011 the patient developed rash at the site that was "twice size of a cell phone". On 09-FEB-2011 pharmacist and patient both called to report that patient had a low grade fever, aching, coughing and flu like symptoms. Patient called pharmacy. It was unspecified if the patient was given any treatment or if lab diagnostics studies were performed. At the time of the report the patient's outcome was unknown. Follow up information was received from a doctor of pharmacy who reported that the patient was still experiencing injection site pain and redness. Follow up information was received from the doctor of pharmacy reported that on 06-FEB-2011 the patient was vaccinated SQ on the left arm with a dose of GARDASIL (lot number 669192/1457Z). It was reported that the patient had immediate redness at injection site, increased to "egg size" over next few days. The patient reported headache and flu-like symptoms. After 10 days, the patient continued to report symptoms. The patient sited initial low-grade fever and after 10 days a temperature of 98.7 degrees F. The patient insisted this was a fever because her normal body temperature was low (did not state how low). It was reported that the patient required doctor visit. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cough, Headache, Immediate post-injection reaction, Influenza like illness, Injection site erythema
Clinical narrative: Information has been received from a doctor of pharmacy and a 64 year old female consumer, with morphine and sulfa allergy, and no other pertinent medical history, who on 06-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included aspirin. Pharmacist reported that on 06-FEB-2011 the patient developed rash at the site that was "twice size of a cell phone". On 09-FEB-2011 pharmacist and patient both called to report that patient had a low grade fever, aching, coughing and flu like symptoms. Patient called pharmacy. It was unspecified if the patient was given any treatment or if lab diagnostics studies were performed. At the time of the report the patient's outcome was unknown. Follow up information was received from a doctor of pharmacy who reported that the patient was still experiencing injection site pain and redness. Follow up information was received from the doctor of pharmacy reported that on 06-FEB-2011 the patient was vaccinated SQ on the left arm with a dose of GARDASIL (lot number 669192/1457Z). It was reported that the patient had immediate redness at injection site, increased to "egg size" over next few days. The patient reported headache and flu-like symptoms. After 10 days, the patient continued to report symptoms. The patient sited initial low-grade fever and after 10 days a temperature of 98.7 degrees F. The patient insisted this was a fever because her normal body temperature was low (did not state how low). It was reported that the patient required doctor visit. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Pain, Pyrexia
Clinical narrative: Information has been received from a doctor of pharmacy and a 64 year old female consumer, with morphine and sulfa allergy, and no other pertinent medical history, who on 06-FEB-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number not provided). Concomitant therapy included aspirin. Pharmacist reported that on 06-FEB-2011 the patient developed rash at the site that was "twice size of a cell phone". On 09-FEB-2011 pharmacist and patient both called to report that patient had a low grade fever, aching, coughing and flu like symptoms. Patient called pharmacy. It was unspecified if the patient was given any treatment or if lab diagnostics studies were performed. At the time of the report the patient's outcome was unknown. Follow up information was received from a doctor of pharmacy who reported that the patient was still experiencing injection site pain and redness. Follow up information was received from the doctor of pharmacy reported that on 06-FEB-2011 the patient was vaccinated SQ on the left arm with a dose of GARDASIL (lot number 669192/1457Z). It was reported that the patient had immediate redness at injection site, increased to "egg size" over next few days. The patient reported headache and flu-like symptoms. After 10 days, the patient continued to report symptoms. The patient sited initial low-grade fever and after 10 days a temperature of 98.7 degrees F. The patient insisted this was a fever because her normal body temperature was low (did not state how low). It was reported that the patient required doctor visit. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Genital herpes, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from an approximately 63 year old male consumer with no allergies and no pertinent medical history who in June 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot# not reported). Concomitant therapy included LIPITOR. The consumer stated that "three weeks later" on approximately June 2010, the patient experienced herpes outbreak, than a month later on approximately July 2010, another herpes outbreak, and once more he had shingles rash and the pain that follows. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes virus infection, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from an approximately 63 year old male consumer with no allergies and no pertinent medical history who in June 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and Lot# not reported). Concomitant therapy included LIPITOR. The consumer stated that "three weeks later" on approximately June 2010, the patient experienced herpes outbreak, than a month later on approximately July 2010, another herpes outbreak, and once more he had shingles rash and the pain that follows. At the time of the report the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Vision blurred
Clinical narrative: Information has been received from a pharmacist concerning an 83 year old female with Brain Surgery 26 years ago walks with cane history of Equilibrium problem, Hypertension, Glaucoma and Penicillin, cephalosporins, DILANTIN allergies who on 27-JAN-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669189/1389Z, 0.65ml, SC). Concomitant therapy included potassium (unspecified), verapamil, LUMIGAN. On an unspecified date, the patient experienced dizziness. The Pharmacist stated that the patient called the pharmacy stating she was experiencing dizziness. Pharmacist suggested Meclizine and offered to call the doctor but the patient did not want her doctor contacted. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. The patient's dizziness persisted. No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness
Clinical narrative: Information has been received from a pharmacist concerning an 83 year old female with Brain Surgery 26 years ago walks with cane history of Equilibrium problem, Hypertension, Glaucoma and Penicillin, cephalosporins, DILANTIN allergies who on 27-JAN-2011 was vaccinated with ZOSTAVAX (Merck) (lot # 669189/1389Z, 0.65ml, SC). Concomitant therapy included potassium (unspecified), verapamil, LUMIGAN. On an unspecified date, the patient experienced dizziness. The Pharmacist stated that the patient called the pharmacy stating she was experiencing dizziness. Pharmacist suggested Meclizine and offered to call the doctor but the patient did not want her doctor contacted. There were no labs or diagnostic tests performed. The patient received unspecified medical attention. The patient's dizziness persisted. No further information is available.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from two pharmacists concerning a 64 year old female who on 12-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 667609/1354Z Exp: 26-OCT-2011). The patient reported on 14-MAR-2011 that she had a silver-dollar-size swelling around the injection site. It was not known how soon after the injection the swelling occurred. The patient did not complain of pain, tenderness of warmth, but the pharmacist, had not asked if these conditions existed and the patient was not available to consult. The reporter was only of aware of the swelling. It was also reported that the patient called on pharmacy on 15-MAR-2011, and reported that the swelling around the injection site was getting bigger and was painful. The patient sought unspecified medical attention. No treatment was given for the adverse events. At the time of the report, the patient's outcome regarding painful injection site was unknown. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Acupuncture, Arthralgia, Immediate post-injection reaction, Insomnia, Nervous system disorder
Clinical narrative: Information has been received from a 72 year old female with arthritis, neuropathy peripheral and house dust allergy and a history of chickenpox and shingles who on 01-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 669538/1390Z, dose, route not reported). On 01-MAR-2011, after she got the ZOSTAVAX (Merck), her arthritis flared up by 3 times the pain. Every bone in her body was aching and the nerves in the back of her legs felt like they were on fire and if she was sitting down for a while they became numb. She called the clinic back. At the time of reporting, the patient had not recovered. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Condition aggravated, Dyskinesia, Insomnia
Clinical narrative: Information has been received from a 72 year old female with arthritis, neuropathy peripheral and house dust allergy and a history of chickenpox and shingles who on 01-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 669538/1390Z, dose, route not reported). On 01-MAR-2011, after she got the ZOSTAVAX (Merck), her arthritis flared up by 3 times the pain. Every bone in her body was aching and the nerves in the back of her legs felt like they were on fire and if she was sitting down for a while they became numb. She called the clinic back. At the time of reporting, the patient had not recovered. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthritis, Bone pain, Burning sensation, Condition aggravated, Hypoaesthesia
Clinical narrative: Information has been received from a 72 year old female with arthritis, neuropathy peripheral and house dust allergy and a history of chickenpox and shingles who on 01-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# 669538/1390Z, dose, route not reported). On 01-MAR-2011, after she got the ZOSTAVAX (Merck), her arthritis flared up by 3 times the pain. Every bone in her body was aching and the nerves in the back of her legs felt like they were on fire and if she was sitting down for a while they became numb. She called the clinic back. At the time of reporting, the patient had not recovered. No further information is available.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 77 year old female patient who on 21-MAR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 669191/1456Z, expire date 28-JAN-2012), 0.65 ml, subcutaneously in the left arm. Concomitant therapy included diltiazem HCL, lisinopril (manufacturer unknown) and zolpidem tartrate. The doctor of pharmacy stated that on 22-MAR-2011 around 17:00, the patient started to itch at the injection site and there was a "red area" that developed. The doctor of pharmacy added that on 23-MAR-2011, the patient went back to the pharmacy. The doctor of pharmacy reported the injection site as raised, red, about 2 inches in diameter and itchy. No rashes or other areas were reported as abnormal. The patient reported no fever and no pain. The patient was treated with BENADRYL orally and hydrocortisone cream topically. The patient sought unspecified medical attention. At the time of this report, patient's outcome was unknown. Follow-up information was received from a registered pharmacist (previously reported as Doctor of Pharmacy) concerning a retired patient with no illness at the time of vaccination and no preexisting allergies, birth defects or medical conditions who on 21-MAR-2011 at 14:30 was vaccinated with the first dose of ZOSTAVAX (Merck). The registered pharmacist stated that on 23-MAR-2011 at 17:00 (previously reported as 22-MAR-2011 around 17:00), the patient developed erythema, redness, swelling and itching at the injection site. The size was "2x a silver dollar and length was greater than width". No relevant diagnostics tests were performed. It was unknown if the patient sought medical attention. On an unspecified date, the patient recovered. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Erythema, Injection site erythema, Injection site swelling, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female patient with drug reaction to betadine, amitriptyline, hydrocodone, ATIVAN, KLONOPIN, mirtazapine, tetracycline and blue dye allergy who on 11-MAR-2011 was vaccinated with a single dose of ZOSTAVAX (Merck), 0.65ml, subcutaneous. (Lot number not reported). The pharmacist reported that on 11-MAR-2011 the patient developed an injection site reaction described as a red, swollen, itchy rash in the evening following administration of the vaccine. The rash spread down the rest of the arm, down the hand and into the fingers during the next day, and it continued unabated to the present day. The pharmacist reported that the patient had a pre-planned hospital admission to an unspecified facility, for an unspecified surgical procedure, at an unspecified time during the week following the vaccination; she also reported that the hospital admission was not related to the vaccination. The patient sought medical attention by visiting unspecified physician. The pharmacist reported that patient's physician had sent off samples for unspecified lab work to determine if the patient had developed a case of shingles. BENADRYL and BENADRYL cream were given as a treatment for the experience. At the time of the report, the patient had not recovered. Follow up information has been received from the pharmacist reporting that the 61 year old female patient was still having active break outs with swelling and itching. Her physician (name unspecified) confirmed that she had shingles by doing an unspecified test (previously reported). At the time of the report, the patient had not recovered. Follow up information has been received from the doctor of pharmacy reporting that the 61 year old female patient with drug allergy to DARVOCET, amitriptyline, KLONOPIN, hydrocodone, blue dye, ATIVAN, REMERON, BETADINE and tetracycline, who on 11-MAR-2011 was vaccinated in her right arm, with the first dose of ZOSTAVAX (Merck) (Lot number 669533/1383Z) at 18:30 p.m. in a pharmacy with private funds. On 11-MAR-2011 at 19:00 the patient experienced swelling/redness at injection site. It was reported that later, the patient experienced swelling, redness and itching on entire arm lasted over a month with continued side effects-confirmed active shingles. At the time of the report, the patient had not recovered from active shingles. Additional information has been requested.