chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female who on 17-NOV-2007 was vaccinated subcutaneously with ZOSTAVAX.  On 20-NOV-2007 the patient developed a large red raised bump at the injection site, with a "little pain" associated with it.  It was reported that the patient did not seek medical attention, but the patient was told to "take two diphenhydramine hydrochloride (BENADRYL) and come back in two days if the bump did not go away".  The patient did not return to the pharmacy.  There was no product quality complaint.  Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Culture, Eye pain, Herpes zoster, Surgery
Clinical narrative: Information has been received from a 47-year-old female with a history of screws and rods in her back and spinal fusion surgery who on 14-JAN-2008 was vaccinated with her first dose of ZOSTAVAX (lot # 658210/1079U).  On 11-FEB-2008 the patient broke out with a case of shingles.  She reported that she had at least 25 cases of shingles or more previously which all started after her third back/spine fusion surgery.  The patient reported that her shingles are on the left side of her face, exterior of her lips, inside her mouth, throat, glands, in her sinus cavity and they look like clusters of blisters.  She also stated she has pain in her eyes.  The patient did not seek medical attention.  On an unspecified date the patient had a "sculpt done of her sinus cavity and a culture".  At the time of the report the patient's status was not recovered.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from a PharmD concerning a 61-year-old female who on approximately 02-FEB-2008 ("last week") was vaccinated subcutaneous in the arm with a dose of ZOSTAVAX (Oka/Merck). On approximately 02-FEB-2008 "last week" the patient experienced warm, red circle approximately 2 inches in diameter with a paler circle around it at the injection site. The pharmacist mentioned that it resembled a bull's eye. 'It has been a week since it appeared and it is just starting to subside". The patient sought unspecified medical attention. A product quality complaint was not involved. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 59-year-old male who on 04-MAY-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 11-FEB-2008 the patient developed shingles.  Unspecified medical attention was sought.  The outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Information has been received from a consumer.  The consumer reported that she saw on the internet that a patient "had shingles, then he got the shingles vaccine, and then he got nerve pain."  The consumer could not recall where on the internet she read this.  She had no further information.  There was no product quality complaint.  No further information is available.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from a 62 year old male consumer with no known allergies or pertinent medical history who on 28-JAN-2008 was vaccinated IM with a 0.65 ml first dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 31-JAN-2008 the patient developed a case of shingles.  Medical attention was not sought, there were no lab studies performed.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Information has been received from a 62 year old female consumer with fibromyalgia and "a whole list of drug allergies"who on 02-FEB-2008 was vaccinated in the left arm with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID. On the evening of 02-FEB-2008 the patient experienced really bad pain in her left arm where the vaccine was given. It was very sore and tender around the injection site. There was also redness. It was noted to be worse on 04-FEB-2008. Medical attention was sought. There were no lab studies performed. There was no product quality complaint involved. No further information was provided. No further information is available.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her husband, a 78-year-old male with hypertension and no known allergies, who on 29-JAN-2008 was vaccinated subcutaneously with a 0.65 ml dose of Zostavax (Oka/Merck) (product circular# 9815604).  Concomitant therapy included blood pressure medication (name not provided).  On 04-FEB-2008 the patient was diagnosed with shingles in the physicians office.  There were no laboratory studies or diagnostic tests performed.  The patient's shingles persisted.  No product quality complaint was involved.  Additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning a female who on approximately 23-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that after vaccination the patient experienced significant itching and redness on arms and legs.  It was reported that the nurse had not seen the patient nor had the patient seen by any healthcare provider.  At the time of report the patient had not recovered.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Medication error
Clinical narrative: Information has been received from a female who was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck).  It was reported that the vaccine was stored above 5 degrees F for 25-27 minutes before reconstitution.  The patient experienced itching at injection site, "but it was not anything that I wouldn't expect".  A product quality complaint was not involved.  No further information is available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular, Secondary transmission
Clinical narrative: Information has been received from a physician regarding a 59 year old female whose husband was vaccinated on 19 JAN 2008 with a 0.65 ml of ZOSTAVAX (Lot # "0179U"), and about one week later, on approximately 26 JAN 2008, she developed painful, dermatomal vesicular eruptions of the right buttock and right inguinal area.  The patient was evaluated in the office and determined to have varicella zoster.  The patient was on the following medications at the time of the event: thyroid (ARMOUR THYROID TABLETS), exetimibe (ZETIA) and HCTZ/triamterene (MAXIDE).  The patient denied any drug reactions, allergies and stated "she does not have a problem with her immune system".  No lab diagnostic studies were performed.  There was no product quality complaint.  At the time of reporting it was not noted if the patient had recovered, but it was reported that "the patient was no longer being treated for this experience".  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information is not expected.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Rash erythematous, Skin warm
Clinical narrative: Information has been received from a physician concerning a 69-year-old male with a history of lymphoma that is in remission and no known drug allergies, who on 29-JAN-2008 was vaccinated in the left arm with a dose of Zostavax (Oka/Merck).  There was no concomitant medication.  It was reported that the patient's siblings had experienced shingles so the patient's primary physician recommended the vaccination.  "A few days later," on approximately 01-Feb-2008, the patient had a circular, red rash on his right lower abdomen.  The affected area grew in size.  There were no vesicles, but the area was sensitive and hot "as if there are nerves coming to the surface".  The patient sought medical attention in the office.  There were no laboratory or diagnostic tests performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Anti-thyroid antibody, Urticaria
Clinical narrative: Information has been received from a physician concerning a 62 year old female with hypertension, arthritis, thyroid nodules and drug hypersensitivity to codeine and ULTRAM who on an undisclosed date in November 2007, was vaccinated, by her primary health care provider, with ZOSTAVAX (Oka/Merck). There was no concomitant medication. In November 2007, two days post vaccination, the patient developed hives and was treated with BENADRYL. At the time of reporting the patient still had 'a form of hives, called derma griffism. It was reported that this was hives at pressure points". At the time of reporting the patient was not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a consumer, with an allergy to "phenergan" and no pertinent medical history, who was recently exposed to her husband who was vaccinated on 27-Jan-2008 with a dose of ZOSTAVAX (Oka/Merck). The consumer is currently taking alendronate sodium (MSD). In the "middle of January", also reported as "a couple of weeks" after her husband was vaccinated, the patient recognized symptoms of shingles. She sought medical attention at the dermatologist who told her that she had a mild case of shingles on her left buttock. The patient reported that "it feels like a cactus thorn in my left buttock when I lean back and sit." There were no laboratory or diagnostic studies performed. The outcome was reported as recovering. No product quality complaint was involved. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a doctor of pharmacy student concerning a 69 year old female with no history of drug reactions or allergies who on 28-JAN-2008 was vaccinated subcutaneously into the right arm with ZOSTAVAX (Oka/Merck) (Lot #658862/1415U). On 29-JAN-2008 the patient developed a rash "on the right side only and only on her bottom". The patient was treated with acyclovir. The patient's rash hs stayed "about the same" since it started and remained present at the time of reporting. It is unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 64-year-old female who on 05-FEB-2008 was vaccinated subcutaneously with "1 vial" of ZOSTAVAX. In the evening of 06-Feb-2008 the patient developed a "burning feeling" in her hands and feet with some mild swelling of the hands and feet. Medical attention was sought via a phone call on the morning of 07-Feb-2008. There was no laboratory or diagnostic studies. The outcome was reported as recovering. No product quality complaint was involved. Additional information has been requested. Follow-up information has been received on 04-Apr-2008 from her physician who indicated that he "does not remember which patient it was or the specifics of the reactions". Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Local reaction
Clinical narrative: Information has been received from a physician concerning a 62-year-old female who on 31-JAN-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX. The lot number was not provided. Concomitant therapy included an "antibiotic". On 01-FEB-2008 the patient experienced local irritation at the injection site. Unspecified medical attention was sought. The outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blood chloride decreased, Blood creatinine normal, Cold sweat
Clinical narrative: Information has been received from a physician concerning a 65 year old female with rheumatoid arthritis and drug hypersensitivity to iodine, "Prevacid" and "Prilose" who on 29-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck) (lot#658862/1415U).  Concomitant therapy included ZANTAC 75, MIACALCIN, CARAFATE, VALIUM, INDERAL, SOMA, vitamin D (unspecified), TUMS and VIVELLE.  On 29-JAN-2008 the patient developed diffuse joint pain within four hours of vaccination with Zostavax (Oka/Merck).  The joint pain was located at multiple sites and symptoms felt similar to an arthritis attack.  Currently, the patient was feeling 50% better from her initial symptoms.  It was reported that the patient received a 0.5ml dose of Zostavax (Oka/Merck) intramuscularly.  The physician stated that he will confirm the dosing and route of administration with the nurse.  Regarding medical attention the patient was seen 5-6 days after vaccination.  No product quality complaint.  Additional information has been requested. 02/17/2010 Follow up information was received by the physician indicating that the patient received the dose of dose ZOSTAVAX  subcutaneously (previously reported IM) on 29-JAN-2008 an 11:12am. The patient also experineced back pain and cold/clammy on an unknown date. The patient cam in for a MD visit and had the labs drawn. All labs were normal except chloride 100.9 MEQ/L (range 101-112) and creatinine 0.52 mg/dL (range 0.7-1.3). All o ther labs were WNL. No further information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Incorrect dose administered, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician concerning a 65 year old female with rheumatoid arthritis and drug hypersensitivity to iodine, "Prevacid" and "Prilose" who on 29-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck) (lot#658862/1415U).  Concomitant therapy included ZANTAC 75, MIACALCIN, CARAFATE, VALIUM, INDERAL, SOMA, vitamin D (unspecified), TUMS and VIVELLE.  On 29-JAN-2008 the patient developed diffuse joint pain within four hours of vaccination with Zostavax (Oka/Merck).  The joint pain was located at multiple sites and symptoms felt similar to an arthritis attack.  Currently, the patient was feeling 50% better from her initial symptoms.  It was reported that the patient received a 0.5ml dose of Zostavax (Oka/Merck) intramuscularly.  The physician stated that he will confirm the dosing and route of administration with the nurse.  Regarding medical attention the patient was seen 5-6 days after vaccination.  No product quality complaint.  Additional information has been requested. 02/17/2010 Follow up information was received by the physician indicating that the patient received the dose of dose ZOSTAVAX  subcutaneously (previously reported IM) on 29-JAN-2008 an 11:12am. The patient also experineced back pain and cold/clammy on an unknown date. The patient cam in for a MD visit and had the labs drawn. All labs were normal except chloride 100.9 MEQ/L (range 101-112) and creatinine 0.52 mg/dL (range 0.7-1.3). All o ther labs were WNL. No further information is expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer who knew of a 77-year-old female who was vaccinated on an unspecified date with a dose of ZOSTAVAX (product circular# 9815604). Subsequently, on an unknown date, the patient developed shingles. No additional information about the patient was available. No product quality complaint was involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a physician with unspecified drug allergies and pertinent medical history who on an unspecified date was vaccinated with a single dose of Zostavax (Oka/Merck).  Subsequently, he experienced electrical pulsating feeling every "once," for about a week in the arm that he received the injection.  At the time of this report the patient's outcome status is unknown.  No product quality complaint involved.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist and physician's office concerning a 70 year old male with no history of cancer, leukemia or HIV and a history of chickenpox, and unknown shingles history who on 14-JAN-2008 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck) (lot# 658397/1820U) in the right arm.  The patient had no prednisone or immunosuppressive products noted.  On 21-JAN-2008 the patient developed shingles.  On 29-JAN-2008 the patient contacted the pharmacist to inform him that he was diagnosed with shingles located on his arm.  The pharmacist contacted the physician's office to confirm the shingles diagnosis, which was located on the patient's abdomen, not the arm.  The outcome was unknown.  There was no product quality complaint.  Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site swelling
Clinical narrative: Information has been received from a pharmacy technician concerning a 77-year-old male with no previous medical history, who on 28-JAN-2008 was vaccinated with an intramuscular dose of Zostavax (Oka/Merck) (lot# 658839/1411U) (circular # 9815604).  There was no concomitant medication.  On an unspecified date, the patient experienced swelling in his upper arm to the elbow.  The patient called the pharmacy.  No laboratory or diagnostic studies were performed.  The outcome was reported as not recovered.  No product quality complaint was involved.  This is one of several reports from the same reporter.  Additional information has been requested. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a pharmacy technician concerning a 77-year-old male consumer with no previous medical history and no known allergies, who on 28-JAN-2008 was vaccinated SQ (also reported IM) in the left arm with a first dose of ZOSTAVAX (Oka/Merck) (lot# 658839/1411U) (circular # 9815604). There was no concomitant medication. On 29-JAN-2008, the patient experienced swelling in his upper arm to the elbow. The patient called the pharmacy. No laboratory or diagnostic studies were performed. The outcome was reported as not recovered. No product quality complaint was involved. This is one of several reports fromthe same reporter. Further information has been requested. Follow-up information from the pharmacy indicated that the patient had swelling down his left arm from the injection site to the elbow, it was a red streak of swelling. Not painful, a little itchy. It was suggested to put ice to the injection site and BENADRYL for the itch. The patient called on 30-JAN-2008 and reported "all cleared up".
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 82 year old male with hepatitis c, no drug reactions or allergies and a history of 3 prior cases of shingles, a broken back twice, a rash on and off in the groin area, constipation while on therapy with codeine and DARVOCET and winter itch who on 16-NOV-2007 was vaccinated with ZOSTAVAX (Oka/Merck). Concomitant therapy included VALTREX and amlodipine besylate. The patient reported that approximately two months after he received ZOSTAVAX (Oka/Merck), on approximately 28-JAN-2008, he was diagnosed with shingles. At the time of reporting the patient had not yet recovered. There were no lab diagnostic studies performed. unspecified attention was sought. There was no product quality complaint. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 61 year old female with no pertinent medical history, drug reactions or allergies who on 27-JAN-2008 was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX (Lot # 659325/1823U).  There was no concomitant medication.  On 29-JAN-2008, approximately 48 hours post vaccination, the patient developed redness and swelling at the injection site, about 2.5 inches in diameter.  At the time of reporting the patient had not yet recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture positive, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female "in her mid to late 60's" who on an unspecified date was vaccinated with a "single dose" of zoster vaccine live (Oka/Merk). "Within the last few weeks" prior to reporting, in approximately January 2008, the patient developed a severe varicella rash which was cultured and positively identified as shingles. At the time of reporting the patient was recovering. Unspecified medical attention was sought.  There was no product quality complaint.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Neurological examination, Paraesthesia
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female with no known allergies who on 12-DEC-2007 was vaccinated SC in the upper arm with a 0.65 ml dose of Zostavax (Oka/Merck) (lot # 658605/1089U).  "About 2 weeks after vaccination" on approximately 26-DEC-2007 the patient developed paresthesia in her feet, shins and one of her lower thighs (side not specified).  The patient saw a neurologist and had a motor/neurologic evaluation.  There was no product quality complaint involved.  No further information was provided.  Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising
Clinical narrative: Information has been received from a pharmacist concerning an 84 year old female who on 22-JAN-2008 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 658603/1081U). Concomitant therapy included PLAVIX. On 22-JAN-2008 the patient experienced bruising at the injection site that became progressively worse over the days following vaccination. The patient sought medical attention via speaking to the pharmacist. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an 81 year old female who on 21-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  On 21-JAN-2008 the patient experienced an injection site reaction with swelling and redness at the injection site.  The patient's injection site reaction persisted.  Unspecified medical attention was sought through the pharmacist.  No product quality complaint.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Information has been received from a licensed practical nurse concerning a 65 year old female who on 28-JAN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On an unspecified date the patient developed a rash at the injection site where she was vaccinated with vaccinated with ZOSTAVAX (Oka/Merck). It was also noted that the patient had shingles on her arm. Unspecified medical attention was sought. At the time of reporting the patient had not yet recovered. There was no product quality complaint. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site erythema, Injection site scab, Injection site scar
Clinical narrative: Information has been received from a female consumer with no pertinent medical history, drug reactions or allergies who "about 6 months ago", in approximately June 2007, was vaccinated with ZOSTAVAX.  Concomitant therapy included rosuvastatin calcium (CRESTOR), alendronate sodium (FOSAMAX) and atenolol.  In June 2007, the patient developed warmth and redness at injection site "right after" receiving ZOSTAVAX.  On an unspecified date "the area scabbed over and was about the size of a fingernail".  On an undisclosed date the scab fell off and "the area left was scarred and rough".  On 30 JUN 2008 the patient reported that "the area" was discolored, "white".  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested. Follow up information has been received from a health professional concerning a 81 year old female with hyperlipidemia, anemia, and osteoporosis who on 28 AUG 2007, was vaccinated subcutaneously into the left arm with a first dose of ZOSTAVAX (Merck) (Lot # 657765/0585U). There was no illness at the time of vaccination. It was reported that "within one week of injection" the patient developed a hard white lump with red around it". The patient was seen by a dermatologist who "scraped tissue and froze it with nitrogen". The patient reported that she was left with a scar. At the time of reporting the patient had not yet recovered. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a female consumer with no pertinent medical history, drug reactions or allergies who "about 6 months ago", in approximately June 2007, was vaccinated with ZOSTAVAX.  Concomitant therapy included rosuvastatin calcium (CRESTOR), alendronate sodium (FOSAMAX) and atenolol.  In June 2007, the patient developed warmth and redness at injection site "right after" receiving ZOSTAVAX.  On an unspecified date "the area scabbed over and was about the size of a fingernail".  On an undisclosed date the scab fell off and "the area left was scarred and rough".  On 30 JUN 2008 the patient reported that "the area" was discolored, "white".  There were no lab diagnostic studies performed.  Unspecified medical attention was sought.  There was no product quality complaint.  Additional information has been requested. Follow up information has been received from a health professional concerning a 81 year old female with hyperlipidemia, anemia, and osteoporosis who on 28 AUG 2007, was vaccinated subcutaneously into the left arm with a first dose of ZOSTAVAX (Merck) (Lot # 657765/0585U). There was no illness at the time of vaccination. It was reported that "within one week of injection" the patient developed a hard white lump with red around it". The patient was seen by a dermatologist who "scraped tissue and froze it with nitrogen". The patient reported that she was left with a scar. At the time of reporting the patient had not yet recovered. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Burning sensation, Rash maculo-papular
Clinical narrative: Information has been received from a physician concerning a 61 year old male with asthma, eczema, benign prostatic hyperplasia and pollen allergy who on 28-DEC-2007 was vaccinated subcutaneously into the left upper arm with "a single dose" of Zostavax (Oka/Merck) and influenza virus vaccine (unspecified), which was administered in the right upper arm.  Concomitant therapy included saw palmetto.  On 01-JAN-2008, four days after being administered the vaccines; the patient developed a macular-papular rash on his back.  The rash was reported to have started on the right mid-thorax and spread to the left mid-thorax with a localized area under the left breast.  The patient complained of a "sunburn-like burning" in the area of the rash.  The patient self treated the rash "DESONIDE" Cream and the rash resolved.  The rash returned after the "DESONIDE" Cream was discontinued.  The patient was examined in the office on 29 JAN 2008 at which time the exam revealed a 6 cm rash.  The burning sensation was improved at that time.  The physician recommended that patient continue to apply the "DESONIDE" Cream as needed.  At the time of reporting the patient had not yet recovered.  There was no product quality complaint.  There were no lab diagnostic studies performed.  Additional information has been requested. In follow up the physician indicated that the patient received both ZOSTAVAX (Merck) (lot# 14144) and FLULAVAL (lot# AFLLAAUWAAVN708) the same day. Four days after the patient received the injections he developed irritation, sunburn and chill-like feeling, no fever. The patient used hydrocortisone 1% cream with relief. The patient was seen on 29-JAN-2008 and had a maculopapular rash below his shoulder blades he recovered on 29-Feb-2008. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a physician concerning a male, who "8 months ago", in approximately May 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck) in the thigh.  It was reported that the patient experienced pain in his thigh where he got the vaccination with zoster vaccine live (Oka/Merck)for the last 8 months. Subsequently, the patient recovered. No product quality complaint was involved. No other information provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a registered nurse (RN) concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included prednisone.  The RN reported that the patient subsequently had reaction to Zostavax (Oka/Merck) because she was also given prednisone on the same day.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  The RN noted that the vaccine was stored properly.  This is one of several reports from the same source.  Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female who on 17-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# not available). On "25-JAN-2008 the patient experienced diagnosed with shingles. "The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Follow-up information from the reporting pharmacist concerning a 72 year old female who on 17-JAN-2008 at 11:18 was vaccinated with her first dose of ZOSTAVAX (Oka/Merck) (lot# 658838/1412U) in the left deltoid. On 19-JAN-2008 the developed a reaction that worsened on 20-JAN-2008. The patient went to the physician and was diagnosed with shingles on 21-JAN-2008. The patient was treated with VALREX. The outcome was unknown. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Information has been received from a 69 year old male with no medical history or allergies who on 16-DEC-2007 was vaccinated with a 0.5 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included IMITREX and PREVACID. On 17-DEC-2007 the patient experienced pain at injection in his arm. The pain eventually moved to the patient's other arm. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an elderly female who was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient developed 2 bouts of shingles.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/26/2008. Additional information has been received which indicated that neither the patient nor the doctor wish to follow up. No further information is expected.
Age: 7.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse practitioner concerning a 7 year old female who was vaccinated with a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck).  The nurse stated the error as not a product confusion.  No adverse event was reported.  No medical attention was sought.  A product quality complaint was not involved.  Additional information has been received from a health professional who stated that the patient was vaccinated with Zostavax (MSD) because that was written on the billing sheet.  The person who gave the patient vaccination did what they were told.  The patient had no problems after vaccination.  The office had called the patient to check up on her.  Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Pruritus, Rash, Urticaria
Clinical narrative: Information has been received from a consumer concerning her 85 year old husband with allergy to aspirin and ACULAR and a history of colon cancer who on 22-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ACTONEL, LIPITOR and number of other medicines (unspecified). On 22-OCT-2007 the patient developed a rash on his abdomen, on back and on top of his feet and ankles. There were total of approximately 40 red welts on patient's body and it caused lot of itching. The patient took BENADRYL and had a dexamethazone injection. The rash lasted for 2 weeks. At the time of report the patient had recovered. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/26/208.  Information has been received from a consumer concerning her 85 year old husband with allergy to ASPIRIN and ACULAR and a history of colon cancer who on 22-OCT-2007 was vaccinated with a single dose of ZOSTAVAX (Merck).  Concomitant therapy included ACTONEL, LIPITOR and number of other medicines (unspecified).  On 22-OCT-2007 the patient developed a rash on his abdomen, on back and on top of his feet and ankles.  There were totatl of approximately 40 red welts on patient's body and it caused lot of itching.  The patient took BENADRYL and had a dexamethasone injection.  The rash lasted for 2 weeks.  At the time of report the patient had recovered.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Follow-up information was received from a certified medical assistant.  This 86 year old female withi allergies to ASPIRIN, ACULAR and SULFA, COPD, hypercholesterolemia and a history of prostate cancer and colon cancer was vaccinated IM in the right arm on 23-OCT-2007 (previously reported as 22-OCT-2007) with a dose of ZOSTAVAX (Merck) (lot # "08866").  There was no illness at the time of vaccination.  At 10:00 a.m. on 24-OCT-2007 (previously reported as 22-OCT-2007) the patient had an unrticarial eruption on his torso, ankle and thigh, the patient was noted to be very pruritic and uncomfortable.  Unspecified medical attention was sought.  The patient's reaction lasted 4-5 days (previously reported as 2 weeks).  The patient was reportedly recovered.  Additional information is not expected.  This is in follow-up to report(s) previously submitted on 3/26/2008; 6/24/2008. Follow up information was from the consumer who wanted to know if there was a greater chance of the vaccine not working because of the adverse event. She provided no additional adverse event information regarding her husband's experience. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered
Clinical narrative: Information has been received from a physician concerning a 70-year-old female who in August 2006, was vaccinated subcutaneous with a 0.5 ml dose of Zostavax (Oka/Merck).  There was no concomitant medication.  On 29-JAN-2008 the patient developed shingles on the back of her skull.  The patient sought unspecified medical attention.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash pustular
Clinical narrative: Information has been received from a physician concerning a 71 year old male with pemphigus who on 02-JAN-2008 was vaccinated with ZOSTAVAX.  It was originally reported as VARIVAX, but was clarified by the health care provider to have been ZOSTAVAX.  Approximately 2 1/2 weeks post vaccination (approx 20-JAN-2008) the patient developed greater than 500 generalized pruritic pustular lesions, with "questionable" impetigo sparing his face.  The rash was also indicated by the reporter to have been chicken pox.  Medical attention sought was not specified.  The health care provider indicated that the rash was biopsied.  Treatment included fuconazole (DIFLUCAN) and a six day course of a steroid pack.  The reporter indicated that as of this report, the rash was worse.  A product quality complaint was not reported.  Additional information has been requested.
Age: 1.28
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 15 month old male, with no pertinent medical history or allergies, who on 17-JAN-2008 at 10:30 am was vaccinated subcutaneous with his first dose of Zostavax (Oka/Merck) (lot # 658838/1412U) instead of a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process) (MSD).  There were no illnesses at the time of vaccination.  There were no concomitant medications.  It was reported that the error occurred because both vaccine's vials and boxes were similar in appearance.  No diagnostic labs were performed.  A product quality complaint was not involved.  Additional information is not expected.  This is one of several reports received from the same source. 06/24/2008 This is in follow-up to report(s) previously submitted on 3/26/2008. Further information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old female who was vaccinated with a dose of ZOSTAVAX.  Subsequently the patient developed shingles.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 3/26/2008. Initial and follow up information has been received from a pharmacist concerning a 72 year old female (also reported as 82) with microscopic colitis who in the AM of 19-NOV-2003 was vaccinated into the left deltoid with a first dose of 0.5 ml of ZOSTAVAX (Merck) (lot# 658082/0744U). On 24 JAN 2008 the patient developed acute shingles, with vesicles at the left neck, shoulder and C4 dermatome, greater than 20 lesions. The patient experienced pain on a scale of 1 to 10, at a level of 9 to 10. Other systemic symptoms reported included neck pain. There was no illness at the time of vaccination. There was no recent exposure to chickenpox or herpes zoster. No lab diagnostic studies were performed, and no specimen was collected for PCR. Unspecified medical attention was sought. There was no product quality complaint. At the time of reporting the patients outcome as unknown, the patient left the state shortly after onset. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure, Dizziness, Hypotension, Pulse pressure decreased
Clinical narrative: Information has been received from a registered nurse concerning a 65-year-old female with hypertension (who is being treated with unspecified meds) who on 31-JAN-2008 at 12:45 pm was vaccinated subcutaneous with her first dose of ZOSTAVAX (lot # 659326/1824U).  There were no illnesses at the time of vaccination.  On 31-JAN-2008 at 12:55 pm the patient felt lightheaded and had a low blood pressure of 78/42.  It was reported that the patient's pulse was very weak.  The nurse continued to monitor the patient and treated her by lowering her head between her knees.  The patient was also given orange juice during this episode.  Symptoms passed within 25 minutes.  Blood Pressure came up to 98/50.  It was recommended the patient make an appointment to see her doctor.  Three hours later the nurse contacted the patient's husband by phone and he reported she was well.  On the 31-JAN-2008 the patient recovered.  A product quality complaint was not involved.  Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: Information has been received from an 81 year old female with no medical history or allergies who on 21-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included COUMADIN, atenolol, ezetimibe (MSD), aspirin, "ISOSORB MONO", aspirin lysine, calcium (unspecified), vitamins (unspecified) and potassium (unspecified). On 21-JAN-2008 the patient developed a rust colored mark the size of a dime about 1 to 1.5 inches below the injection site. The patient also mentioned a 3 inch in diameter circle that was red and warm. The patient said it was hot at first but the heat decreased. Unspecified medical attention was sought. No diagnostic laboratory tests were undertaken. At the time of report the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient experienced broke out in shingles.  It was reported that the patient worked at the clinic.  On an unspecified date the patient recovered.  Unspecified medical attention was sought.  A product quality was not involved.  Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Nausea, Paraesthesia, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a 73 year old female who on 24-DEC-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck).  On approximately 11-JAN-2008 the patient developed transient, red spots that tingled.  It was reported that the spots were not blister like but appeared more like a rash.  The spots often appeared after exercise and generally disappeared after 2 days then reappear.  The spots also were reported to appear on different parts of the patient's body and not always the same location.  The patient was not seen by her physician.  No diagnosis were made.  The exact onset was unspecified but the patient was aware of the rash for at least 2 weeks.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Follow-up information received by the pharmacist indicating that the lot # of the vaccine was (658862/1415U) and it was administered on 24-Dec-2007 at 2:00 pm.  On 27-Dec-2007 at 11:00 the patient called the pharmacy to report that she was experiencing "flu-like symptoms", diarrhea and nausea.  It was unknown if the patient recovered.  On 25-Jan-2008, the patient called the pharmacy to report she was getting "transient red spots on her arms and legs that would tingle (mostly after she exercised) and then go away after a couple of days."  These particular events were originally reported with an onset of approximately 11-Jan-2008.  No further information is expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex, Oral herpes
Clinical narrative: Information has been received from a 65 year old retired female physician with no pertinent medical history, seasonal allergies and a history of herpes simplex who on 27-NOV-2007 was vaccinated intramuscularly into the arm with a "single vial dose" of ZOSTAVAX.  There was no concomitant medication.  On 01 FEB 2008 (also reported as 31-JAN-2008) the patient "broke out with a herpes simplex sore", (also reported as a "cold sore" and "fever blisters").  The physician prescribed the ZOSTAVAX for herself.  No other symptoms or treatments were reported other than unspecified topical ointments to "the cold sore".  On approximately 13 FEB 2008, after a two week duration, the patient had recovered.  There was no product quality complaint.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a female who was vaccinated with a dose of ZOSTAVAX.  Subsequently the patient developed a rash and redness at injection site.  A product quality complaint was not involved.  Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal behaviour, Asthenia, Headache, Injection site erythema, Injection site inflammation
Clinical narrative: Information has been received from a 65 year old female with sulfonamide allergy and a history of heart attack 4 years back who on 24-JAN-2008 was vaccinated on right arm with a single dose of Zostavax (Oka/Merck).  Concomitant therapy included LIPITOR and PREMARIN.  On 24-JAN-2008 3 hours after vaccination the patient's right arm was red and inflamed at injection site.  The patient also experienced weakness on her body and headaches on the right side of her head.  According to patient's husband, her behavior was rather "different" than usual.  No diagnostic laboratory tests were undertaken.  Unspecified medical attention was sought.  At the time of report the patient was recovering.  A product quality complaint was not involved.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Induration, Injection site rash, Pruritus
Clinical narrative: Information has been received from a consumer concerning her 74 year old mother with type 2 diabetes mellitus and sulfonamide allergy who on 24-JAN-2008 was vaccinated with a single dose of ZOSTAVAX.  Concomitant therapy included glipizide (GLUCOTROL), metformin HC1 (GLUCOPHAGE), escitalopram oxalate ("LEXIPRO") and "a blood pressure medicine".  On 26-JAN-2008, 2 days after vaccination the patient developed a rash at the injection site approximately 2 inches in diameter.  The rash was described as red and had caused some itching.  The rash subsequently had hardened into a lump and the patient felt heat in the area.  It was reported that the patient's symptoms did improve "in the last day or two".  No diagnostic laboratory tests were undertaken.  No medical attention was sought.  At the time of report the patient was recovering.  A product quality complaint was not involved.  No further information is expected.