chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a female consumer who on an unspecified date was vaccinated with a dose of zoster vaccine live (Oka/Merck). Subsequently, 1 week after the vaccine was administered the patient developed redness, itching, and swelling at the injection site. Medical attention was sought, the patient called the physician. It was unspecified if lab studies were performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: Information has been received from a 75 year old female consumer with an allergic reaction to some medication in the past, but she doesn't remember the name of the medication and no pertinent medical history who on 06-MAR-2008 was vaccinated with a 0.65mL dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, on 08-MAR-2008 the patient experienced headache and pain all over her body after getting zoster vaccine live (Oka/Merck). Unspecified medical attention was sought, there were no lab studies involved. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information has been received from a physician concern this 75 year old female consumer with polymyalgia rheumatica, neuropathy peripheral, hypothyroidism, hyperlipidemia and osteoporosis who on 06-MAR-2008 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658839/1411U) at 11:00 am. There was no illness at the time of vaccination. Concomitant therapy included levothyroxine Na, alendronate sodium (+) cholecalciferol (MSD), ibuprofen, calcium (unspecified) and vitamins (unspecified). Subsequently, on 06-MAR-2008 the patient complained of aches, nausea, headache and "I burn all over." At the time of the report the patient's status was unknown. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information from the physician indicated that the patient complained of one and a half week of chills, fever, sweats, headache and all over body ache. At the time of the report the patient recovered on or about 17-MAR-2008. It was reported that the patient stated "she is doing well". Additional information is not expected.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Information has been received from a 75 year old female consumer with an allergic reaction to some medication in the past, but she doesn't remember the name of the medication and no pertinent medical history who on 06-MAR-2008 was vaccinated with a 0.65mL dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, on 08-MAR-2008 the patient experienced headache and pain all over her body after getting zoster vaccine live (Oka/Merck). Unspecified medical attention was sought, there were no lab studies involved. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information has been received from a physician concern this 75 year old female consumer with polymyalgia rheumatica, neuropathy peripheral, hypothyroidism, hyperlipidemia and osteoporosis who on 06-MAR-2008 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (lot # 658839/1411U) at 11:00 am. There was no illness at the time of vaccination. Concomitant therapy included levothyroxine Na, alendronate sodium (+) cholecalciferol (MSD), ibuprofen, calcium (unspecified) and vitamins (unspecified). Subsequently, on 06-MAR-2008 the patient complained of aches, nausea, headache and "I burn all over." At the time of the report the patient's status was unknown. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Follow-up information from the physician indicated that the patient complained of one and a half week of chills, fever, sweats, headache and all over body ache. At the time of the report the patient recovered on or about 17-MAR-2008. It was reported that the patient stated "she is doing well". Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a 68 year old female consumer with no known allergies or pertinent medical history who on 04-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included alendronate sodium (MSD), calcium (unspecified) (+) vitamin D (unspecified), vitamins (unspecified), biotin and PROZAC. On 05-APR-2008, the patient experienced tenderness, erythema, pruritus, and warmth at the site of injection after vaccination. The patient reported that the erythema at the injection site "spread to about the size of a top of a can of vegetables." Unspecified medical attention was sought with the pharmacist. There were no lab studies performed. On 08-APR-2008, the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a 1 year old consumer who on 17-JAN-2008 was vaccinated with zoster vaccine live (Oka/Merck), instead of varicella virus vaccine live (Oka/Merck) (MSD). The reporter stated it was not due to product confusion. No adverse experience related to this event. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information from a practice manager indicated the incident was human error as the office personnel inadvertently grabbed the wrong vial. Both the zoster vaccine live (Oka/Merck) and the varicella virus vaccine live (Oka/Merck) (MSD were stored in the same freezer on the same self. Since the incident, the vaccines are no stored in separate bins in the freezer. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer concerning a male consumer who on an unspecified date was vaccinated IM with zoster vaccine live (Oka/Merck). Subsequently, the patient experienced injection site pain. At the time of the report the patient's status was unknown. Additional information has been requested. This is one of several reports from the same source.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial and follow up information has been received from a pharmacist concerning a 68 year old female consumer who on 29-MAR-2008 at 10:00 was vaccinated SQ in the right arm with a dose of zoster vaccine live (Oka/Merck) (lot # 659763/1875U). Subsequently, on 29-MAR-2008 the patient developed redness, soreness and swelling at the injection site. (Previously reported as a general reaction at the injection site). The patient was treated with cold compresses and BENADRYL. The redness, soreness and swelling at the injection site had resolved as of 04-APR-2008 and the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning her 67 year old husband who on 01-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck). On 02-APR-2008 he developed redness and swelling at the injection site. Medical attention was not sought and there were no lab studies performed. At the time of the report the patient's symptoms were resolving without requiring treatment. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning an 85 year old female consumer who's husband was diagnosed with shingles on 11-JAN-2008, who on 15-JAN2008 was vaccinated with zoster vaccine live (Oka/Merck). On 29-JAN-2008, the patient developed a few spots on her body, location not provided. On 30-JAN-2008, she had more spots. Medical attention was sought in the office, there were no lab studies performed. The patient was diagnosed with varicella. The patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 67 year old female who on 06-NOV-2007 was vaccinated in the right upper arm with a 0.65 mL dose of zoster vaccine live (Oka/Merck) (lot # 658398/1087U). ON 29-FEB-2008 (also reported as 03-MAR-2008 or 04-MAR-2008) the patient developed a shingles rash from her neck to the top of head on the left side only. It was reported that a rash did not occur at the injection site or elsewhere within 42 days of vaccination. Unspecified medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Depression, Discomfort, Drug hypersensitivity, Eye pain, Eyelid margin crusting
Clinical narrative: Information has been received from a health professional concerning a 64-year-old female who on 25-MAR-2008 at 10:15 AM was vaccinated SC in the right arm with a dose of zoster vaccine live (Oka/Merck) (lot # 659323/1613U). On 29-MAR-2008, the patient had a new exacerbation on the right arm of herpes zoster which she had in that area previous in December. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial and follow up information has been received from a health professional concerning a 64 year old female with sulfonamide allergy, gastrooesophageal reflux disease, drug hyperemotivity, depression, hypothyroidism and tremor and a history of hives, herpes zoster, goitre, thyroidectomy total (1959) and total hysterectomy (1995), who on 25-MAR-2009 at 10:15 AM was vaccinated with ZOSTAVAX (Merck) (lot no. 659323/1613U) via the subcutaneous injection route into her right arm. Current medication included aspirin, ATARAX, CHANTIX, FAMVIR, LEVAQUIN, metoprolol, NEXIUM, NIASPAN ER, nitroglycerin, OSCAL D, PREVACID, RESPA-DM, montelukast sodium, SYNTHROID, VALTREX, ezetimibe (+) simvastatin, WELLBUTRIN SR. On 29-MAR-2008, the patient experienced a new exacerbation of herpes zoster on the right arm which she had in that area previously in December. It was relieved by ATARAX. In the morning of 01-APR-2008, the patient presented to physician with slight discomfort, pain to right eye and some crusting. The patient denied fever or chills. The patient's right forearm and the right arm. The patient characterized the quality as pruritic, burning and itching. Severity was described as worsening. Duration is 6 days. The patient's outcome was not reported. The physician prescribed ATARAX 25mg, 25-50mg every six hours as required. No further information is expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastrooesophageal reflux disease, Hypothyroidism, Mammogram, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 64-year-old female who on 25-MAR-2008 at 10:15 AM was vaccinated SC in the right arm with a dose of zoster vaccine live (Oka/Merck) (lot # 659323/1613U). On 29-MAR-2008, the patient had a new exacerbation on the right arm of herpes zoster which she had in that area previous in December. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial and follow up information has been received from a health professional concerning a 64 year old female with sulfonamide allergy, gastrooesophageal reflux disease, drug hyperemotivity, depression, hypothyroidism and tremor and a history of hives, herpes zoster, goitre, thyroidectomy total (1959) and total hysterectomy (1995), who on 25-MAR-2009 at 10:15 AM was vaccinated with ZOSTAVAX (Merck) (lot no. 659323/1613U) via the subcutaneous injection route into her right arm. Current medication included aspirin, ATARAX, CHANTIX, FAMVIR, LEVAQUIN, metoprolol, NEXIUM, NIASPAN ER, nitroglycerin, OSCAL D, PREVACID, RESPA-DM, montelukast sodium, SYNTHROID, VALTREX, ezetimibe (+) simvastatin, WELLBUTRIN SR. On 29-MAR-2008, the patient experienced a new exacerbation of herpes zoster on the right arm which she had in that area previously in December. It was relieved by ATARAX. In the morning of 01-APR-2008, the patient presented to physician with slight discomfort, pain to right eye and some crusting. The patient denied fever or chills. The patient's right forearm and the right arm. The patient characterized the quality as pruritic, burning and itching. Severity was described as worsening. Duration is 6 days. The patient's outcome was not reported. The physician prescribed ATARAX 25mg, 25-50mg every six hours as required. No further information is expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation, Tremor
Clinical narrative: Information has been received from a health professional concerning a 64-year-old female who on 25-MAR-2008 at 10:15 AM was vaccinated SC in the right arm with a dose of zoster vaccine live (Oka/Merck) (lot # 659323/1613U). On 29-MAR-2008, the patient had a new exacerbation on the right arm of herpes zoster which she had in that area previous in December. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Initial and follow up information has been received from a health professional concerning a 64 year old female with sulfonamide allergy, gastrooesophageal reflux disease, drug hyperemotivity, depression, hypothyroidism and tremor and a history of hives, herpes zoster, goitre, thyroidectomy total (1959) and total hysterectomy (1995), who on 25-MAR-2009 at 10:15 AM was vaccinated with ZOSTAVAX (Merck) (lot no. 659323/1613U) via the subcutaneous injection route into her right arm. Current medication included aspirin, ATARAX, CHANTIX, FAMVIR, LEVAQUIN, metoprolol, NEXIUM, NIASPAN ER, nitroglycerin, OSCAL D, PREVACID, RESPA-DM, montelukast sodium, SYNTHROID, VALTREX, ezetimibe (+) simvastatin, WELLBUTRIN SR. On 29-MAR-2008, the patient experienced a new exacerbation of herpes zoster on the right arm which she had in that area previously in December. It was relieved by ATARAX. In the morning of 01-APR-2008, the patient presented to physician with slight discomfort, pain to right eye and some crusting. The patient denied fever or chills. The patient's right forearm and the right arm. The patient characterized the quality as pruritic, burning and itching. Severity was described as worsening. Duration is 6 days. The patient's outcome was not reported. The physician prescribed ATARAX 25mg, 25-50mg every six hours as required. No further information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: Information has been received from a Registered Nurse concerning a female between the ages of 60-70 who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient had a sore arm and discomfort after receiving zoster vaccine live (Oka/Merck). Additional information has bee requested. This is one of several reports from the same source.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a male patient who in July 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). In September 2007, the patient developed a body rash of red spots from his chest to his feet. His family doctor sent him to a dermatologist. The dermatologist was very concerned and gave him a cream to try to cure the rash. The dermatologist was unable to determine the type because he did not itch. After a month of different creams, he was referred to a dermatology clinic. The clinic doctor determined that it was due to the shingles vaccine. He is using strong steroid cream now. It is six months since the rash started and he is only a little better. He noted that he could not recommend the vaccine to his friends and he wished he had never taken the shot. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Hyperaesthesia
Clinical narrative: Initial and follow-up information has been received from a 66 year old retired registered nurse with no known drug allergies or pertinent medical history who on 29-FEB-2008 (previously reported as 28-FEB-2008) was vaccinated SC in the left arm with a first dose of zoster vaccine live (Oka/Merck) at 11:30 (lot# 658325/1429U). There was no illness at the time of vaccination. Concomitant therapy included simvastatin (manufacturer unknown) , quinapril HCl, unspecified thyroid medicine, and verapamil. Subsequently, on 09-MAR-2008 she developed "sensitive skin" below the injection site to about 2-3 inches above the elbow. She stated she did not experience any pain, redness, fever, swelling or rash to the area. She stated she only had discomfort if the area was touched, even fabric irritated the area. The patient stated this lasted approximately ten days. She also mentioned that later some sensitivity of skin to her left flank area was developed. This sensitivity was not as severe as the sensitivity on her arm. Medical attention was not sought. At the time of the report the patient recovered on approximately 19-MAR-2008. There was no product quality complaint involved. No additional information is expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Body temperature, Herpes zoster, Rash, Skin lesion
Clinical narrative: Initial information has been received from a consumer concerning her 80 year old mother with diabetes (type unspecified) and a history of shingles in 2006 who on 23-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included insulin and VICODIN. On 09-MAR-2008, medical attention was sought in the hospital emergency room where the patient was diagnosed with shingles, there were no lab studies performed. The patient's daughter stated her mother was treated with VALTREX and discharged. The patient's daughter also stated that her mother had a severe case of shingles in 2006, that was located on the other side of her body from this current outbreak of shingles. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information was received from the physician's office concerning an 80 year old consumer with diabetes (type unspecified), penicillin and BACTRIM allergies. On 23-AUG-2007, the patient was vaccinated SQ in the right deltoid with a single dose of zoster vaccine live (Oka/Merck) (lot # 656858/0356U). Additional concomitant therapy included PREVACID, aspirin, metformin, folic acid, losartan potassium (MSD), AMBIEN, and PLAVIX. Approximately seven months after vaccination, on 12-MAR-2008 (also reported as 09-Mar-2008 and 13-MAR-2008) the patient's left arm had an extensive red inflamed rash, with intermittent white blisters and numerous lesions, also reported as recurrent shingles on her left arm. It was unknown if the patient had a history of chickenpox or herpes zoster. The patient's pain was rated 6-7 on a scale of 0 (least) to 10 (most). The patient's maximum temperature was reported as 98.4. On 21-MAR-2008 the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) strain or with The OKA/Merck vaccine strain. The sample of a lesion was collected on 13-MAR-2008 and sent to the laboratory on 13-MAR-2008. The sample was taken from a unknown source. The PCR sample was an Inadequate Specimen, Negative for B-GLOBIN, No Strain I.D. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Viral DNA test negative
Clinical narrative: Initial information has been received from a consumer concerning her 80 year old mother with diabetes (type unspecified) and a history of shingles in 2006 who on 23-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included insulin and VICODIN. On 09-MAR-2008, medical attention was sought in the hospital emergency room where the patient was diagnosed with shingles, there were no lab studies performed. The patient's daughter stated her mother was treated with VALTREX and discharged. The patient's daughter also stated that her mother had a severe case of shingles in 2006, that was located on the other side of her body from this current outbreak of shingles. At the time of the report the patient had not recovered. There was no product quality complaint involved. Follow-up information was received from the physician's office concerning an 80 year old consumer with diabetes (type unspecified), penicillin and BACTRIM allergies. On 23-AUG-2007, the patient was vaccinated SQ in the right deltoid with a single dose of zoster vaccine live (Oka/Merck) (lot # 656858/0356U). Additional concomitant therapy included PREVACID, aspirin, metformin, folic acid, losartan potassium (MSD), AMBIEN, and PLAVIX. Approximately seven months after vaccination, on 12-MAR-2008 (also reported as 09-Mar-2008 and 13-MAR-2008) the patient's left arm had an extensive red inflamed rash, with intermittent white blisters and numerous lesions, also reported as recurrent shingles on her left arm. It was unknown if the patient had a history of chickenpox or herpes zoster. The patient's pain was rated 6-7 on a scale of 0 (least) to 10 (most). The patient's maximum temperature was reported as 98.4. On 21-MAR-2008 the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) strain or with The OKA/Merck vaccine strain. The sample of a lesion was collected on 13-MAR-2008 and sent to the laboratory on 13-MAR-2008. The sample was taken from a unknown source. The PCR sample was an Inadequate Specimen, Negative for B-GLOBIN, No Strain I.D. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: FLU3, TTOX, VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: Information has been received from an office manager concerning a 65 year old female consumer with no known allergies or pertinent medical history who on 19-DEC-2007 was vaccinated with zoster vaccine live (Oka/Merck). Concomitant vaccination and therapy included influenza virus vaccine (unspecified) and tetanus toxoid. Subsequently, 2 weeks after vaccination on 02-JAN-2008 the patient developed shingles. The lesions were on her left buttocks. Medical attention was sought, the patient called the physician. There were no lab studies performed. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 6/24/2008. Medical attention was sought, the patient called the physician on 02-APR-2008. There was no product quality complaint involved. Additional information is not expected.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy, Rash
Clinical narrative: Information has been received from an 82-year-old male consumer with no known allergies and a history of an "existing auto immune disease" who in February 2007, was vaccinate SQ with a first dose of 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included PROTONIX. Subsequently, in July 2007, the patient was advised that the vaccination caused the reactivation of his pemphigus. Unspecified medical attention was sought and the patient had a biopsy performed. The results were not reported. At the time of the report the patient recovered on an unspecified date. There was no product quality complaint involved. Follow-up information from the physician indicated that the patient thought his pemphigus flared after receiving the vaccine. As per the physician "he was wrong." The skin eruption was unrelated to both his pemphigus or the vaccine. It was noted that the patient did not have a AE from the vaccine. On an unspecified date the patient recovered. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Pain, Skin warm
Clinical narrative: Information has been received from an 80 year old female consumer who "may be allergic to nickel" and has a history of a hip replacement who on 11-APR-2008 was vaccinated with a first dose of zoster vaccine live (Oka/Merck) on her upper right thigh. There was no concomitant medication. Subsequently, on 12-APR-2008 the patient had a dot, which was the size of an egg, that was hot, red and painful. The patient reported she put an ice pack on her thigh to help with the warmth, but she still had the red, warm egg shaped spot. The patient also reported the spot had spread a little bit and was pink on the edges. Medical attention was sought, the patient called the physician. There were no lab studies performed. At the time of the report the patient had not recovered. Additional information has been requested.  09/24/2008 This is in follow-up to report(s) previously submitted on 6/24/2008. Initial information has been received from an 80 year old female concerning herself and follow up information was received from the registered nurse. The patient "may be allergic to nickel" and had a history of a hip replacement, who on the morning of 11-APR-2008 was vaccinated subcutaneously in upper right thigh with a first dose of ZOSTAVAX (Oka/Merck) (LOT# 658604/1088U). There was no concomitant medication. Then patient reported that on 12-APR-2008 she had a dot, which was the size of an egg, that was hot, red and painful. The patient reported that she put an ice pack on her thigh to help with the warmth, but she still had the red, warm egg shaped spot. The patient also reported that the spot had spread a little bit and was pink on the edges. The nurse reported, in conflict, that on the morning of 11-APR-2008, the patient noticed that the injection site was very red and warm, which lasted one week (and recovered). The nurse also reported that there was no pain "so far" and that no other complaints were verbalized by the patient. The final outcome of the pain reported by the patient was not reported. Medical atttention was sought, the patient called the physician. There was no lab studies performed. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/26/2008. Information has been received from a 68 year old female consumer with "severe digestive tract problems," high cholesterol, allergic reaction to antibiotics and "other different types of medications," and a history of shingles in 1965, pancreatitis and removal of melanoma who on Saturday 12-APR-2008 was vaccinated in the arm with "one shot" of 0.65mL of ZOSTERVAX (Oka/Merck). Concomitant therapy included PREVACID, LIPITOR, and PLAVIX. Subsequently, after receiving the vaccine on 12-APR-2008 the patient experienced headache, and the injection site became red, swollen like the size of a baseball and it was hot to touch. The patient stated she still had symptoms and the pain she experienced on the injection arm was the same pain she had when she had shingles before. There was no medical attention sought and there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. Information has been received from a 68 year old female with severe digestive tract problems, high cholesterol, allergic reaction to cephalexin, erythermycin, prednisone, MOBIC, ACTENOL and CELEBREX and a history of shingles in 1965, pancreatitis and removal of melanoma who on 12-APR-2008 was vaccinated with a 0.65ml dose of ZOSTAVAX. cocomitant therapy included PREVACID, LIPITOR and PLAVIX. On 15-APR-2008 the patient experienced headache, and the injection site became red, swollen like the size of a baseball and it was hot to touch. The patient stated she still had symptoms and the pain she experienced on the injection arm was the same pain she has when she had shingles before. There was no medical attention sought and there were no lab studies performed. Additional information from the physician indicated that the patient recovered from the events. There was not product quality complaint involved. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Information has been received from an 84 year old male consumer concerning his female friend who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). The consumer stated his friend was given zoster vaccine live (Oka/Merck) and she "itched all over her body" the day she received it. The AE "cleared up" the following day. Follow-up information from the reporter indicated "it has been some time" since he reported the ill effect of someone and does not remember the event. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Drug hypersensitivity, Food allergy, Herpes zoster, Infection via vaccinee
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female consumer with type 2 diabetes mellitus, sulfonamide and shellfish allergies who developed shingles in a cervical dermatome distribution on 08-APR-2008 after being exposed to her mother who was vaccinated with zoster vaccine live (Oka/Merck) on 05-APR-2008. Concomitant therapy included LEXAPRO, quinapril HCl, GLUCOPHAGE, sitagliptin phosphate (MSD) and potassium acetate. It was noted that the first lesion erupted on 08-APR-2008. On 12-APR-2008 the patient sought medical attention at an immediate care facility because of neck pain and a second vesicular lesion. There were no lab studies performed. The patient was treated with VALTREX, and given a prescription of hydrocodone bitartrate for pain. The patient was referred by the immediate care physician to her primary care provider for follow-up. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was from the physcian who thought shingles was a reactivation of a latent disease and there was no relationship between patient's symptoms and relative's vaccination and she also thought that it was not significant. No further information is expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Type 2 diabetes mellitus
Clinical narrative: Information has been received from a registered nurse concerning a 61 year old female consumer with type 2 diabetes mellitus, sulfonamide and shellfish allergies who developed shingles in a cervical dermatome distribution on 08-APR-2008 after being exposed to her mother who was vaccinated with zoster vaccine live (Oka/Merck) on 05-APR-2008. Concomitant therapy included LEXAPRO, quinapril HCl, GLUCOPHAGE, sitagliptin phosphate (MSD) and potassium acetate. It was noted that the first lesion erupted on 08-APR-2008. On 12-APR-2008 the patient sought medical attention at an immediate care facility because of neck pain and a second vesicular lesion. There were no lab studies performed. The patient was treated with VALTREX, and given a prescription of hydrocodone bitartrate for pain. The patient was referred by the immediate care physician to her primary care provider for follow-up. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008. Follow up information was from the physcian who thought shingles was a reactivation of a latent disease and there was no relationship between patient's symptoms and relative's vaccination and she also thought that it was not significant. No further information is expected.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgic amyotrophy
Clinical narrative: Information has been received from a consumer concerning her father who is in his "early sixties" who was diagnosed with PARSONAGE-TURNER syndrome by a physician several years ago after receiving the influenza virus (unspecified) (manufacturer unspecified), who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, several weeks after receiving the zoster vaccine live (Oka/Merck) vaccination his symptoms of PARSONAGE-TURNER
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female consumer with no known allergies, bipolar disorder and insomnia who in March 2007, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included lithium, WEROQUEL, AMBIEN, PREMARIN, and CELEBREX. Two days ago, on 05-MAR-2008 the patient developed a cold sore in the mouth. Medical attention was sought, the patient spoke to the pharmacist. There were no lab studies performed. At the time of the report the patient was not recovered. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source. Follow-up information from the pharmacist indicated that the patient was vaccinated a year ago at another facility, and that she did not think the patient's cold sore was related to the vaccination. No additional information was reported for this case.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Herpes zoster, Herpes zoster ophthalmic, Injection site bruising, Injection site erythema
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning a female patient who is absolutely certain that she had chickenpox as child and has never previously had shingles who exactly 3 weeks ago on 21-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On 11-APR-2008 the patient was seen by the physician and appeared to have shingles in the left ophthalmic nerve distribution. Her symptoms included burning on the skin, with rash onset 5-6 hours later, low grade fever, and myalgias. It was noted that this seemed classic, as well as the rash and distribution. It was also noted that the patient had a severe injection site reaction with swelling, erythema, warmth, and bruising for 3 days. At the time of the report the patient's status concerning the shingles was unknown. Additional information has been requested. Follow up information was received from a health professional concerning the patient's reaction was not due to ZOSTAVAX (Oka/Merck), but it was dur to a dermatological treatment the patient was receiving at that time. Follow up information was received from a physician concerning the patient had facial celulitis, not zoster outbreak. The facial celulitis was not related to shingles vaccine, turned out to be coincidental timing was unfortunate.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pyrexia, Rash
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning a female patient who is absolutely certain that she had chickenpox as child and has never previously had shingles who exactly 3 weeks ago on 21-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On 11-APR-2008 the patient was seen by the physician and appeared to have shingles in the left ophthalmic nerve distribution. Her symptoms included burning on the skin, with rash onset 5-6 hours later, low grade fever, and myalgias. It was noted that this seemed classic, as well as the rash and distribution. It was also noted that the patient had a severe injection site reaction with swelling, erythema, warmth, and bruising for 3 days. At the time of the report the patient's status concerning the shingles was unknown. Additional information has been requested. Follow up information was received from a health professional concerning the patient's reaction was not due to ZOSTAVAX (Oka/Merck), but it was dur to a dermatological treatment the patient was receiving at that time. Follow up information was received from a physician concerning the patient had facial celulitis, not zoster outbreak. The facial celulitis was not related to shingles vaccine, turned out to be coincidental timing was unfortunate.
Sex: F
Vaccine: VARZOS
Symptoms: Skin burning sensation
Clinical narrative: This is in follow-up to report (s) previously submitted on 6/24/2008. Information has been received from a physician concerning a female patient who is absolutely certain that she had chickenpox as child and has never previously had shingles who exactly 3 weeks ago on 21-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On 11-APR-2008 the patient was seen by the physician and appeared to have shingles in the left ophthalmic nerve distribution. Her symptoms included burning on the skin, with rash onset 5-6 hours later, low grade fever, and myalgias. It was noted that this seemed classic, as well as the rash and distribution. It was also noted that the patient had a severe injection site reaction with swelling, erythema, warmth, and bruising for 3 days. At the time of the report the patient's status concerning the shingles was unknown. Additional information has been requested. Follow up information was received from a health professional concerning the patient's reaction was not due to ZOSTAVAX (Oka/Merck), but it was dur to a dermatological treatment the patient was receiving at that time. Follow up information was received from a physician concerning the patient had facial celulitis, not zoster outbreak. The facial celulitis was not related to shingles vaccine, turned out to be coincidental timing was unfortunate.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 62 female consumer with no known allergies and a history of shingles who in November 2007, was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included AGGRENOX, NEURONTIN, hydroxyzine hydrochloride, CRESTOR and ALTACE. Subsequently, in "late November 2007" on approximately 26-NOV-2007, the patient developed shingles after receiving the vaccine. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Pain
Clinical narrative: Information has been received from a pharmacist concerning a female consumer with insomnia, quinolones and clavunate acid allergies and a history of shingles who on 20-FEB-2008 was vaccinated SQ with zoster vaccine live (Oka/Merck). There was no concomitant medication. Subsequently, a couple days after receiving zoster vaccine live (Oka/Merck) the patient experienced shingles pain. It was unknown whether the patient had any rashes. Medical attention was sought, the patient spoke to the pharmacy manager. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source. Follow-up information from the pharmacist indicated that the patient was vaccinated in the pharmacy and on an unspecified date developed cold sores in her mouth and outside her lip. The patient has since recovered, and was recently in the pharmacy and "looked fine." The pharmacist did not provide additional information concerning the patient's shingles pain that was initially reported.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site papule
Clinical narrative: Information has been received from a female consumer who on "last Tuesday" approximately 01-APR-2008 was vaccinated once with 0.65mL of zoster vaccine live (Oka/Merck). Subsequently, the patient developed a raised, red, "quarter sized hard lump" at the injection site. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Follow-up information has been received from a physician concerning this 60 year old female consumer with sulfonamide and seasonal allergies, depression, reactive airways disease and irritable bowel syndrome who on 08-APR-2008 was vaccinated SQ in the left arm with a first dose of zoster vaccine live (Oka/Merck) (659763/1875U). There was no illness at the time of vaccination. Subsequently, the patient developed a local reaction of bumps at the injection site (per the patient's report). It was noted that the patient was not seen in the office and there were no lab studies performed. The patient recovered on an unspecified date. Additional information is not expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a 76 year old female consumer with unspecified drug allergies and high blood pressure who on 04-MAR-2008 was vaccinated with single dose of series of zoster vaccine live (Oka/Merck). Concomitant therapy included "SPIRONLACT" and lorazepam. Subsequently, on 05-MAR-2008, the day after receiving zoster vaccine live (Oka/Merck) the patient reported that at the injection site she had a little bit of itching and redness that went beyond where the band-aid was on her arm. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Facial pain, Injection site erythema, Injection site swelling
Clinical narrative: Initial and follow-up information has been received from a 64 year old retired pharmacist with penicillin and sulfonamide allergies who on 01-APR-2008 was vaccinated at 10:30 am in the upper left arm with zoster vaccine live (Oka/Merck). Concomitant therapy included LIPITOR, losartan potassium (MSD), NORVASC, hydrochlorothiazide, "tucor," atenolol, vitamin D and CENTRUM SILVER. Subsequently, on 02-APR-2008 the patient developed redness and swelling at the injection site for a period of 5 days. The patient also developed a blister type rash on her upper right facial cheek. The outbreaks were linear across her cheek and under her eye. The outbreaks persisted for 12 days. The patient also reported she had slight transient pain in that area. Medical attention was not sought and there were no lab studies performed. The report the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information is not expected. This is one of several reports from the same source.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a 74 year old female consumer with no pertinent medical history and an allergic reaction to LEVAQUIN and AUGMENTIN and a history of shingles about 50 years ago, who on 26-FEB-2008 was vaccinated with zoster vaccine live (Oka/Merck). There was no concomitant medication. On 01-MAR-2008, the patient developed two cold sores, 4 days after receiving a dose of zoster vaccine live (Oka/Merck). Medical attention was sought via a phone call. There was no lab studies performed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information is not expected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Blister, Blood pressure, Body temperature, Herpes zoster
Clinical narrative: Initial and follow up information has been received from a physician and an 81 year old male consumer with no known allergies and with a history of atrial fibrillation and severe balance issues (for 2 years and most recent episode approximately 21-FEB-2008) who on 27-FEB-2008 (also reported as 28-FEB-2008) was vaccinated with 0.65mL of zoster vaccine live (Oka/Merck). Concomitant therapy included COUMADIN and simvastatin (manufacturer unknown). Subsequently, on 13-MAR-2008 the patient developed a blister rash on his anterior left thigh. On 14-MAR-2008 he presented to the physician's office. Upon exam the patient had shingles on left leg. He was treated with VALTREX 1 gram every 8 hours X 7 days. Patient reported that on 12-MAR-2008 he "was walking and it was hard to straighten out, he drifted backward." EMS was called, vital signs were ok and there were no speech problems. "Carotids-no bruits, ROMBERG-negative, movement within normal limits and tandem walking was ok." Impression was imbalance. An MRI and MRA of the head were planned. As of 18-APR-2008 the patient was recovered from the shingles. There was no product quality complaint involved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: Information has been received from a physician concerning a consumer who on unspecified dates was vaccinated with first and second doses of zoster vaccine live (Oka/Merck). The time of the doses were not specified, but it was reported they were not given on the same day. It was also reported that the patient had increased side effects at the injection site. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a physician concerning a consumer who on unspecified dates was vaccinated with first  and second doses of ZOSTAVAX (Merck).  The time of the doses were not specified, but it was reported they were not given on the same day.  It was also reported that the patient had increased side effects at the injection site.  At the time of the report the patient's status was unknown.  There was no product quality complaint involved.  Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Information has been received from a physician's assistant concerning an approximately 66 year old female consumer with "sensitivity to vaccines" and no pertinent medical history who in approximately March 2008, was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included lovastatin. It was reported that the patient received the vaccine and later felt fatigue.