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 pruritus, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old white female with glaucoma and no allergies who on 24-SEP-2007 was vaccinated on left arm with a first dose of Zostavax (Oka/Merck) (Lot #658212/0887U).  Concomitant therapy included esomeprazole magnesium (Nexium), latanoprost (Xalatan), cetirizine hydrochloride (Zyrtec), omega-3 marine triglycerides, HCTZ/triamteren (Triamteren Comp), diclofenac Na (Diclofenac DR) and ethinyl estradiol/norethindrone acetate (Femhrt).  There was no illness at the time of vaccination.  On 27-SEP-2007 (previously reported as 26-SEP-2007), the patient developed soreness, warmness and itchiness at injection site on her arm.  It was reported that there was firm mass under skin that was the size of a golf ball.  The site was slightly red raised lesion with 3x3 cm.  The lesion had slight fluid clustering under the skin.  The patient was prescribed local warm compresses, acetaminophen (Tylenol) or ibuprofen (Advil) and itch cream.  At the time of report the patient had not recovered.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Additional information has been received from the registered nurse who stated that on 27-SEP-2007 the patient developed a golf ball sized lump at injection site, redness, itchy, painful to touch for 3 days.  The patient was treated with warm compress, acetaminophen (Tylenol) or ibuprofen for pain relief.  The patient recovered on an unspecified date.  No further information is expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Skin lesion
Clinical narrative: Information has been received from a registered nurse concerning a 62 year old white female with glaucoma and no allergies who on 24-SEP-2007 was vaccinated on left arm with a first dose of Zostavax (Oka/Merck) (Lot #658212/0887U).  Concomitant therapy included esomeprazole magnesium (Nexium), latanoprost (Xalatan), cetirizine hydrochloride (Zyrtec), omega-3 marine triglycerides, HCTZ/triamteren (Triamteren Comp), diclofenac Na (Diclofenac DR) and ethinyl estradiol/norethindrone acetate (Femhrt).  There was no illness at the time of vaccination.  On 27-SEP-2007 (previously reported as 26-SEP-2007), the patient developed soreness, warmness and itchiness at injection site on her arm.  It was reported that there was firm mass under skin that was the size of a golf ball.  The site was slightly red raised lesion with 3x3 cm.  The lesion had slight fluid clustering under the skin.  The patient was prescribed local warm compresses, acetaminophen (Tylenol) or ibuprofen (Advil) and itch cream.  At the time of report the patient had not recovered.  No diagnostic laboratory tests were undertaken.  A product quality complaint was not involved.  Additional information has been received from the registered nurse who stated that on 27-SEP-2007 the patient developed a golf ball sized lump at injection site, redness, itchy, painful to touch for 3 days.  The patient was treated with warm compress, acetaminophen (Tylenol) or ibuprofen for pain relief.  The patient recovered on an unspecified date.  No further information is expected.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic, Scab
Clinical narrative: Information has been received from a physician concerning a 77 year old female no drug reactions, or allergies who on 15-JUN-2007 was vaccinated with 0.65 ml zoster vaccine live (Oka/Merck). Concomitant therapy included simvastatin, for an unspecified indication. On 24-AUG-2007 the patient developed an itchy rash on her abdomen, that became "stingy" and scabbed over. The patient recovered on approximately 04 SEP 2007, "one week to ten days after the onset". No medical attention was sought. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning a patient who was vaccinated with a dose of Zostavax and then a couple weeks later developed shingles in their legs bilaterally. At the time of the report the patient's status was unknown. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site urticaria, Injection site vesicles
Clinical narrative: Information has been received from a physician concerning a male who was vaccinated "a couple of months ago" in 2007, with Zostavax (Oka/Merck).  A few days after injection, (dates not reported), he sought medical attention from an urgent care physician (not his primary physician) after he developed a welt or blister like reaction at the injection site.  It was reported that it did not look like a zoster rash or injection site like reaction.  The physician thought it could be a reaction to the vaccine itself.  The physician did not follow up with the patient.  Subsequently, current patient status was not reported.  A product quality complaint was not reported.  No further information was reported.  Additional information has been requested. 03/26/2008 Follow up information from the reporting physician reported that the patient was not his patient, was seen in urgent care, and the vaccine was given at another unspecified clinic. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Herpes simplex, Herpes simplex serology positive, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning a 60 year old female with hypertension, hypothyroidism, elevated cholesterol, allergies to penicillin and diphenhydramine (BENADRYL) with a childhood history of chicken pox, who on 17-SEP-2007, received a dose in her left arm of zoster vaccine live (Oka/Merck) (lot# 685083/0855U).  Concurrent medications included: atorvastatin calcium (LIPITOR), gabapentin (NEUROTIN), hydrochlorothiazide (+) losartan potassium (MSD), levothyroxine sodium (LEVOXINE), and nabumetone (RELAFEN). One week post vaccination on 22-SEP-2002, the patient developed less than or equal to 5 patchy lesions of a vesculiar puritic rash described as a disseminated zoster like rash on her neck, right arm and hand, left wrist and abdomen. She complained of significant itching. Her maximum temperature was 98.4 degrees. She was seen by her physician, who believe it was zoster. The patient was kept home from work due to transmission concerns. On 24-SEP-2007, a culture for herpes viral screen was obtained and sent it to a local lab. The lab results reported on 30-SEP-2007, were positive for herpes simplex and not zoster. At the time of the report the patient was recovering. No product quality complaint was reported. No further information was available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Rash vesicular, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 60 year old female with hypertension, hypothyroidism, elevated cholesterol, allergies to penicillin and diphenhydramine (BENADRYL) with a childhood history of chicken pox, who on 17-SEP-2007, received a dose in her left arm of zoster vaccine live (Oka/Merck) (lot# 685083/0855U).  Concurrent medications included: atorvastatin calcium (LIPITOR), gabapentin (NEUROTIN), hydrochlorothiazide (+) losartan potassium (MSD), levothyroxine sodium (LEVOXINE), and nabumetone (RELAFEN). One week post vaccination on 22-SEP-2002, the patient developed less than or equal to 5 patchy lesions of a vesculiar puritic rash described as a disseminated zoster like rash on her neck, right arm and hand, left wrist and abdomen. She complained of significant itching. Her maximum temperature was 98.4 degrees. She was seen by her physician, who believe it was zoster. The patient was kept home from work due to transmission concerns. On 24-SEP-2007, a culture for herpes viral screen was obtained and sent it to a local lab. The lab results reported on 30-SEP-2007, were positive for herpes simplex and not zoster. At the time of the report the patient was recovering. No product quality complaint was reported. No further information was available. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: International normalised ratio increased, Prothrombin level increased
Clinical narrative: Information has been received from a pharmacist concerning a male who on approximately 28-AUG-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  In August 2007, shortly after vaccination a PT-INR laboratory test showed an increase (11.1).  A product quality complaint was not involved.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pain, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a 71-year-old female consumer with diabetes, hypertension, depression and "bladder problems" and no known drug allergies who on 17-SEP-2007 was vaccinated subcutaneously with a 0.65 milliliter dose of Zostavax (Oka/Merck). Concomitant therapy included Metformin, atorvastatin calcium (LIPITOR), samarium Sm 153 lexidronam pentasodium (QUADRAMET) and oxybutynin. On 24-SEP-2007 the patient developed "pain in my arm around where I received the shot. It also throbs and itches a bit and may be a little swollen." Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The outcome was reported as not recovered. No product quality complaint was involved. Follow-up information received from the physician indicates that the information will be forwarded to the pharmacy that administered the vaccination. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypokinesia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a 61 year old female with type ii diabetes mellitus, hypertension, hypercholesterolaemia, asthma, glucose, statin allergies, allergies to ezetimibe and glucophage who on 12-SEP-2007 at 14:00 was vaccinated S in the right arm with a 0.65 ml single dose of Zostavax (Lot#658211/0884U). Concomitant therapy included lisinopril-HCTZ, CENTRUM, GNC TRIFLEX, vitamin E, ALLEGRA, ADVAIR, SINGULAIR, NASONEX, AVANDIA. There was no illness at the time of vaccination. On 13-SEP-2007 the patient developed injection site erythema, pain, pruritus and swelling which persisted over several days. On the fourth day after administration the patient awoke with severe pain, erythema, swelling and loss of motion in the region of the right thumb. The symptoms were treated initially with indomethacin for possible  gout, but the erythema and inflammation increased. The patient was then administered an IM dose of ROCEPHIN as well as KEFLEX 500mg four times a day for 10 days. The patient was seen three times over the course of ten days and by day four of the antibiotic therapy the patient's symptoms had greatly improved. No lab studies were performed. At the time of this report the the patient had recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This patient also had adverse experiences after therapy with ezetimibe (WAES # 0710USA00821).
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a co-worker who was a female pharmacy student that administered Zostavax (Oka/Merck) to patients at another pharmacy.  The pharmacy student developed herpes zoster, a couple of months ago in 2007.  This is one of several reports received from the same source.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Facial pain, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 70 year old female with no pre-existing allergies, birth defects or medical conditions who on 27-MAY-2007 was vaccinated in the left arm with a first dose of Zostavax (Oka/Merck).  On 31-MAY-2007 the patient experienced right facial pain.  The patient had a negative CT and MRI.  There was no illness at the time of the vaccination.  There were no adverse events following prior vaccination.  Unspecified medical attention was sought through a neurologist.  The patient was better after taking gabapentin (Neurontin).  The outcome was reported as recovering.  There was no product quality complaint.  Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Constipation, Herpes zoster, Hypertension, Inappropriate schedule of drug administration, Loss of consciousness
Clinical narrative: Information has been received from a 76-year-old female with no drug allergies, a pacemaker and a history of polio in 1943 who on 06-NOV-2006 was vaccinated with a 0.65 milliliter dose of Zostavax (Oka/Merck). Concomitant therapy included warfarin sodium (COUMADIN), verapamil and alendronate sodium (MSD). On approximately 31-MAR-2007 the patient experienced shingles. After she had the shingles, she had two episodes of syncope. She fainted once within one week after getting the shingles and then she fainted again on 18-JUN-2007. She reported that for the past year and a half, when she turns her head to the left or right, she will sometimes have "mini-blackouts". They do not involve a total loss of consciousness, such as the two incidents she had since the shingles. She also reported that she had been experiencing high blood pressure and constipation. The outcome was reported as recovering. No product quality complaint was involved. Follow up information received indicates the current physician's group did not administer the vaccination. No other information was available. Follow-up information was received from the consumer who wanted to clarify that this was not a complaint about Zostavax (Oka/Merck). While she did get shingles post vaccination she believes that the vaccine made a great impace because she felt no pain. She believes that the case of shingles that she developed was common and related to her age. Additional information is not expected.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Information has been received from a 76-year-old female with no drug allergies, a pacemaker and a history of polio in 1943 who on 06-NOV-2006 was vaccinated with a 0.65 milliliter dose of Zostavax (Oka/Merck). Concomitant therapy included warfarin sodium (COUMADIN), verapamil and alendronate sodium (MSD). On approximately 31-MAR-2007 the patient experienced shingles. After she had the shingles, she had two episodes of syncope. She fainted once within one week after getting the shingles and then she fainted again on 18-JUN-2007. She reported that for the past year and a half, when she turns her head to the left or right, she will sometimes have "mini-blackouts". They do not involve a total loss of consciousness, such as the two incidents she had since the shingles. She also reported that she had been experiencing high blood pressure and constipation. The outcome was reported as recovering. No product quality complaint was involved. Follow up information received indicates the current physician's group did not administer the vaccination. No other information was available. Follow-up information was received from the consumer who wanted to clarify that this was not a complaint about Zostavax (Oka/Merck). While she did get shingles post vaccination she believes that the vaccine made a great impace because she felt no pain. She believes that the case of shingles that she developed was common and related to her age. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a 65 year old female who on 13-SEP-2007 was vaccinated subcutaneously with Zostavax (Oka/Merck) 0.65 ml.  There was no concomitant medication.  On approximately 22-SEP-2007 the patient experienced redness and swelling from her shoulder to her elbow in the arm she received the vaccination.  She also experienced a fever.  Subsequently, the patient recovered from the events.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash maculo-papular, Urticaria
Clinical narrative: Information has been received from a medical assistant concerning a 68 year old female with hypothyroidism, osteopenia, hiatus hernia, fibromyalgia, Sjogren's syndrome and allergies to sulfamethoxazole (+) trimethoprim (Bactrim), ciprofloxacin (Cipro), cephalexin (Keflex), aspirin (+) oxycodone hydrochloride (+) oxycodone terephthalate (Percodan), tetracycline, and azithromycin (Zithromax) and tetracycline who on 21-Aug-2007 was vaccinated with zoster vaccine live (Oka/Merck) IM in the L arm (lot no. 658086/0761U).  Concomitant therapy included levothyroxine Na (Synthroid), salcatonin (Miacalcin), pantoprazole sodium (Protonix), tramadol HC1 (Ultram) and cholestyramine resin.  In 2007 the patient developed a red pimple-like rash with a discharge, that was itching and tingling around the rash on her chest, back, both arm and back of head.  On 13-Sep-2007 the patient was examined in the physician's office and she was prescribed hydroxyzine hydrochloride (Atarax) and methylprednisolone (Medrol) dose pack.  The patient was examined by a dermatologist but the results of the exam were unknown.  On 30-Sep-2007 the patient was seen in a local emergency room and the methylprednisolone pack was continued.  On 01-Oct-2007, the patient was examined in the physician's office and the rash was resolving.  The patient was advised to continue the methylprednisolone and she was also prescribed loratadine (Claritin) and diphenhydramine (Benadryl).  Follow up information was received from the physician concerning a 67 year old female, who presented to the doctor's office with complaint of a generalized rash.  Upon examination the patient was found to be well developed, well nourished, and in no acute distress, with papules on the anterior trunk, macular papular area of the left antecubital.  The patient stated that "the rash started eight days after receiving zoster vaccine live (Oka/Merck) vaccination".  The patient denied any other known trigger.  The patient was initially seen in the office (undisclosed date) with a rash of her left antecubital area and was diagnosed with contact dermatitis and prescribed medrol dose pack.  The patient stated that "two days after finishing the steroids the rash came back and flared up".  The patient was seen by a neighbor who is a dermatologist and was given a cortisone injection and other Prednisone Taper over a longer period.  Two days after completing the therapy the patient had a generalized red urticarial macular papular rash on her trunk and extremities.  The patient had gone to the emergency department for evaluation.  At the time of examination the patient was currently on day three of a 10 day steroid taper.  The rash had improved and the patient had several scattered papules on the trunk and left antecubital area.  An immunization reaction was suspected by the examining physician, and loratadine 10 mg a.m., diphenhydramine hydrochloride (Benadryl) 150 Mg HS was recommended.  The patient was instructed to follow up if further problems or no improvement.  Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Vertigo
Clinical narrative: Information has been received from a 71-year-old female with no pertinent medical history or allergies who on 16-SEP-2007 was vaccinated subcutaneous with 0.65 (unit not specified) dose of Zostavax (Oka/Merck).  Concomitant therapy included "medicine for bones" and aspirin (brand not specified).  On 29-SEP-2007 (13 days after vaccination) the patient experienced vertigo, headache and nausea.  The patient stated that she would be going to her physician on 02-OCT-2007.  No diagnostic labs were performed.  On 29-SEP-2007 the patient recovered from the adverse experience.  A product quality complaint was not involved.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash papular
Clinical narrative: Information has been received from a nurse practitioner concerning a male who on 16-MAR-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Two weeks after the vaccination, on approximately 30-MAR-2007 the patient developed a rash. The rash "waxed and weened over the summer" and in July of 2007 the patient sought medical attention with the nurse practitioner. The patient then went on a sailing trip for 2 months and came back approximately September of 2007, to see the nurse practitioner with "diffuse, red, round, coined-shaped plaques around the trunk and lower extremities". The outcome was reported as not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 90.0
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Lung disorder
Clinical narrative: Information has been received from a nurse practitioner (NP) concerning a 90-year-old immunocompromized patient with heart failure that resides in a nursing home who was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant therapy included an unspecified antibiotic.  It was reported that the patient developed shortness of breath and pulmonary problems following vaccination and required oxygen.  It was unspecified if medical attention was sought.  No further information was available at the time of this report.  No product quality complaint was involved.  Additional information has been received on 15-OCT-2007 from the director of nursing at a nursing home.  She reported that she had "no concerns with the administration of the Zostavax (Oka/Merck) at all particularly because the patient had extensive history and problems prior to receiving the vaccine".  Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Paraesthesia, Post herpetic neuralgia
Clinical narrative: Information has been received from a 56-year-old female with a medical history of seizure, a five year history of zoster and "postherpetic neuralgia (PHN)" (prior to vaccination), and an allergy to penicillin and erythromycin who in approximately November 2006 (November or December of 2006), was vaccinated with a dose of Zostavax (Oka/Merck).  The zoster and PHN prior to vaccination was in the facial and shoulder area on the left side.  Concomitant therapy included gabapentin (Neurontin) and primidone (Mysoline).  On an unspecified date the patient developed postherpetic neuralgia (PHN).  The PHN went away for 3 to 4 months after vaccination.  The patient reported a very occasional tingling during 3 to 4 month period following vaccination.  On an unspecified date the PHN has returned also on the left side of the face.  The patient is currently experiencing pain in the left ear.  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: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a 60 year old male with duoenal ulcer, high cholesterol and allergic to some antibiotics who on 15-SEP-2007 was vaccinated SC on right arm with a 0.65 ml dose of zoster vaccine live (Oka/Merck). Concomitant therapy included ezetimibe (MSD), simvastatin (MSD) and lansoprazole (PREVACID). On approximately 25-SEP2007 the patient developed pimple like red spots on right upper arm at the injection site. 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 is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Local reaction, Oedema peripheral, Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner concerning a 63 year old white female with no known drug allergies and history of shingles who in 25-JAN-2007 at approximately 10:00 AM was vaccinated IM with a dose of Zostavax (Oka/Merck) (lot #652925/0621F).  Concomitant therapy included losartan potassium (MSD), sertraline HCl (Zoloft), atenolol (Atenolol MF) and aspirin.  In January 2007, the patient developed from shoulder to elbow redness, hardness, warm to touch and tender to touch on the arm where vaccination was given.  The patient had symptoms for 2 weeks and at the time the patient had recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been received from a nurse practitioner who stated that the patient had extreme local reaction on arm.  The patient's arm was swollen and was fiery red and painful.  The patient was treated with cool compress.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had recovered.  No further information is expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm, Tenderness
Clinical narrative: Information has been received from a nurse practitioner concerning a 63 year old white female with no known drug allergies and history of shingles who in 25-JAN-2007 at approximately 10:00 AM was vaccinated IM with a dose of Zostavax (Oka/Merck) (lot #652925/0621F).  Concomitant therapy included losartan potassium (MSD), sertraline HCl (Zoloft), atenolol (Atenolol MF) and aspirin.  In January 2007, the patient developed from shoulder to elbow redness, hardness, warm to touch and tender to touch on the arm where vaccination was given.  The patient had symptoms for 2 weeks and at the time the patient had recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been received from a nurse practitioner who stated that the patient had extreme local reaction on arm.  The patient's arm was swollen and was fiery red and painful.  The patient was treated with cool compress.  No diagnostic laboratory tests were undertaken.  At the time of report the patient had recovered.  No further information is expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysaesthesia, Flushing, Hypertension, Malaise, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 58 year old female who was vaccinated with a dose of zoster vaccine live (Oka/Merck).  It was reported that after vaccination the patient experienced soreness on the back of her hand, near the thumb.  The sore was reported as painful like zoster.  The patient also had a sore on the back of her hand by the pinky finger that was there previous to her receiving vaccine.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. Follow up information was received from the physician concerning this 59 (previously reported as 58) year old white female with hypertension and type II diabetes mellitus who on an unspecified date was vaccinated with a dose of ZOSTAVAX. On 11-SEP-2007 the patient developed a rash on her face and left hand. The patient also had dysesthesia of the left hand, malaise and flushing. Medical attention was sought in the form of a doctor office visit. On 30-NOV-2007 the patient was considered recovered. No further information was provided. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin lesion, Type 2 diabetes mellitus
Clinical narrative: Information has been received from a physician concerning a 58 year old female who was vaccinated with a dose of zoster vaccine live (Oka/Merck).  It was reported that after vaccination the patient experienced soreness on the back of her hand, near the thumb.  The sore was reported as painful like zoster.  The patient also had a sore on the back of her hand by the pinky finger that was there previous to her receiving vaccine.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. Follow up information was received from the physician concerning this 59 (previously reported as 58) year old white female with hypertension and type II diabetes mellitus who on an unspecified date was vaccinated with a dose of ZOSTAVAX. On 11-SEP-2007 the patient developed a rash on her face and left hand. The patient also had dysesthesia of the left hand, malaise and flushing. Medical attention was sought in the form of a doctor office visit. On 30-NOV-2007 the patient was considered recovered. No further information was provided. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximately 70 year old male who on approximately 26-SEP-2007 was vaccinated SC with a single dose of Zostavax (Oka/Merck).  On approximately 29-SEP-2007 the patient's wife called the office and stated that the patient's arm was red and swollen several inches around the injection site.  The physician reported that the patient's wife was a nurse and stated that the patient may also have had a slight temperature.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache
Clinical narrative: Information has been received from a 74 year old female with asthma and no allergies who on 25-Sep-2007 was vaccinated SC with a 0.65 ml dose of Zostavax.  Concomitant therapy included mometasone furoate (Asmanex), albuterol sulfate (+) ipratropium bromide (Duoneb) and triamcinolone acetonide (Azmacort).  On 25-Sep-2007 the patient stated that she became dizzy after vaccination and that went away and she experienced a very dull headache that lasted about 24 hours.  No medical attention was sought.  No diagnostic laboratory tests were undertaken.  On 27-Sep-2007 the patient recovered.  A product quality complaint was not involved.  No further information is available.
Age: 8.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning an 8 year old healthy female who on 02-OCT-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck) instead of a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient was supposed to receive second dose of varicella virus vaccine live (Oka/Merck) (MSD) and received her first dose of vaccine when she was 2 years old. It was reported that the nurse was in rush and did not read the vial correctly. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been received from the registered nurse who stated that the patient was vaccinated with wrong by mistake. The doctor had checked her and there were no ill effects. Follow up information that the reporter interpreted the difference in potencies of zoster vaccine live (Oka/Merck)and varicella virus vaccine live (Oka/Merck) to be overdose and did not recall an overdose in the amount of zoster vaccine live administered. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister, Pyrexia, Rash
Clinical narrative: Information has been received from a nurse concerning an 81-year-old (born in 1926) female who on 02-OCT-2007 was vaccinated with a 0.65 ml dose of Zostavax (Oka/Merck).  On 03-OCT-2007 the patient developed a low grade fever, rash and blisters on her lips.  At the time of the report the patient was currently in the emergency room.  The patient's status at the time of the report was not recovered.  A product quality complaint was not involved.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Laboratory test, Liver function test abnormal, Malaise, Nausea
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 developed an injection site reaction that resolved on its own; and for about 1-2 weeks after the vaccination the patient complained about sickness and nausea.  The patient underwent blood work, laboratory tests (unspecified) and only a liver function test showed an elevation.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
Sex: U
Vaccine: MMRV, VARZOS
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who was vaccinated with Zostavax, right upper. Subsequently the patient received both Zostavax and Proquad at the same office visit. No symptoms or adverse reactions were reported. This is one of several reports received from the same source. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from an office manager concerning a 61 year old female who on 01-OCT-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On 02-OCT-2007 the patient developed swollen glands and on 03-OCT-2007 the patient experienced fever. Unspecified medical attention was sought. it was reported that the patient's husband was the physician in the same office. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Information has been received from a 79 year old female with no medical history or allergies who in July 2007 was vaccinated with a dose of Zostavax.  There was no concomitant  medication.  On 26-Sep-2007 the patient developed a black and blue mark and soreness at injection site.  The patient had contacted her physician but no medical attention was sought.  A product quality complaint was not involved.  No further information is expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 57-year-old female with a history of shingles (prior to vaccination) and no known allergies who in 2006 (a year ago) was vaccinated with a dose of zoster vaccine live (Oka/Merck). On an unspecified date the patient developed shingles. The patient sought unspecified medical attention. No diagnostic labs were performed. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Facial spasm, Muscle spasms
Clinical narrative: Information has been received from a consumer concerning a male with a history of shingles and no allergies who in 2007 was vaccinated with a dose of Zostavax (Oka/Merck).  It was reported that the patient experienced muscle spasms on right side of face.  No medical attention was sought.  A product quality complaint was not involved.  No further information is available.
Age: 67.0
Sex: M
Vaccine: FLUX, PPV, VARZOS
Symptoms: Body temperature increased, Injection site rash, Pyrexia
Clinical narrative: Information has been received from a registered pharmacist concerning a 67-year-old male with an allergy to codeine, hypertension, hypothyroidism and atrial fibrillation who on 01-OCT-2007 was vaccinated subcutaneous with a 0.65 ml dose of Zostavax (Oka/Merck).  Concomitant vaccines administered on 01-OCT-2007 included Pneumovax 23 (MSD) and influenza virus vaccine (unspecified).  On approximately 01-OCT-2007 (after vaccination) the patient developed a fever of 102 degrees and a rash at the injection site.  The patient sought medical attention via a phone call with their physician.  No diagnostic labs were performed.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Follow-up information received on 22-OCT-2007: The reporter felt the "adverse reaction was to the flu vaccine and not Zostavax (Oka/Merck)".  Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who in June 2007, was vaccinated SC with a dose of Zostavax.  In July 2007, the patient developed shingles.  It was reported that the patient's wife also developed shingles after vaccination with Zostavax (WAES #0710USA03384).  The physician stated that the patient had more severe case of shingles as compared to his wife.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.  This is one of several reports received from the same source.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a consumer concerning her husband who was vaccinated with zoster vaccine live (Oka/Merck). The patient developed a reaction at the injection site about 1.5" in diameter, that was red, warm, and painful. It was unknown if the patient sought medical attention. The outcome was not reported. This is one of several reports from the same source. Additional information is not expected.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse reaction, Wrong drug administered
Clinical narrative: Information has been received from a vaccine manager concerning 7 pediatric patients who were vaccinated with a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck).  It was reported that it was not a case of product confusion.  No problems were reported.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a consumer concerning her mother who was on 04-Oct-2007 vaccinated with a dose of Zostavax.  On 04-Oct-2007 the patient developed injection site redness.  The patient's injection site redness persisted.  It was unknown if medical attention was sought.  No further information was provided.  There was no product quality complaint involved.  No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Rhinorrhoea
Clinical narrative: Information has been received from a physician concerning a male who in September 2007, was vaccinated with a dose of Zostavax.  Concomitant therapy included vitamins (unspecified).  Subsequently the patient experienced malaise, sniffles and general weakness.  The patient recovered after 7 days.  No diagnostic laboratory tests were undertake.  A product quality complaint was not involved.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a physician concerning a male with no pre-existing allergies, birth defects, medical conditions, who in September 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Concomitant therapy included vitamins (unspecified). Subsequently the patient experience malaise, sniffles and general weakness. The patient recovered after 7 days. No diagnostic laboratory tests were undertaken. There was no illness at time of vaccination. There were no adverse events following prior vaccinations. There was no product quality complaint. Follow-up information indicated that "there was no problem". Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Swelling face
Clinical narrative: Information has been received from a physician concerning a 78 year old female who on 12-SEP-2007 at 14:00 was vaccinated IM with a first dose of ZOSTAVAX (lot #658208/0886U). On 12-SEP-2007, at 14:30, the patient developed facial swelling and hoarseness of voice. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information is available.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect drug dosage form administered, Wrong drug administered
Clinical narrative: Information has been received from a physician who had heard from another physician concerning a child who was vaccinated with a dose of Zostavax (Oka/Merck) instead of a dose of Varivax (Oka/Merck). It was unknown if there was any adverse event involved. A product quality complaint was not involved. Additional information has been requested.
Age: 94.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 94 year old female who on 04-OCT-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On 06-OCT-2007 the patient developed injection site itching and a 2 inch area of redness at the injection site. No further information was provided. Additional information is not expected.
Age: 7.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth, Wrong drug administered
Clinical narrative: Information has been received from a physician and a medical assistant concerning a 7 year old female who on 20-SEP-2007 was vaccinated subcutaneously in her left arm with a dose of Zostavax (Oka/Merck) (Lot #657559/0462U) instead of Varivax (Oka/Merck). The medical assistant confirmed this was staff error. No product quality complaint was involved. In follow-up, the medical assistant reported the patient did have any side effects from receiving Zostavax (Oka/Merck) and she will not be vaccinated again with Varivax (Oka/Merck). It was also reported that the patient's brother received a dose of Zostavax (Oka/Merck) (WAES# 0709USA03490) instead of Varivax (Oka/Merck). Additional information is not expected. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a physician and a medical assistant concerning a 7 year old female who on 20-SEP-2007 was vaccinated subcutaneously in her left arm with a dose of ZOSTAVAX (Lot #657559/0462U) instead of VARIVAX. The medical assistant confirmed this was staff error. No product quality complaint was involved. In follow-up, the medical assistant reported the patient did not have any side effects from receiving ZOSTAVAX and she will not be vaccinated again with VARIVAX. It was also reported that the patient's brother received a dose of ZOSTAVAX (WAES# 0709USA0349U) instead of VARIVAX. Follow-up information received by the medical assistant providing patient demographics. The patient experienced erythema, induarartion, warmth, and pain at the injection site. The site was greater than 4 inches in diameter. The patient recovered on an unknown date. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information has been received from the husband of a 65 year old female with no known drug allergies and no pertinent medical history, who in approximately September 2006 ("Fall of 2006") was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included CRESTOR and an unspecified medicine to control blood pressure. On approximately 17-SEP-2007, the patient broke out with shingles on her abdomen and lower back. This caused her a great deal of pain, and blisters developed. The patient sought medical attention. No lab/diagnostic studies were performed. As of 08-OCT-2007, the blisters were crusting over and his wife was gradually getting better. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 75 year old female with no known allergies who on 03-OCT-2007 was vaccinated with zoster vaccine live (Oka/Merck). In October 2007, the patient called the office and stated she one itchy blister behind her knee. The patient's itchy blister behind her knee persisted. Additional information has been been requested. 03/26/2008 Information has been received from a nurse concerning a 75 year old female with allergies to codeine and DEMEROL who on 03-OCT-2007 was vaccinated SC with a first dose of ZOSTAVAX (Oka/Merck) (lot # 657767/0740U). There was no illness at the time of vaccination. In October 2007, the patient called the office and stated she one itchy blister behind her knee. The patient's itchy blister behind her knee persisted. Additional information from a registered nurse indicated that the patient called the office on 08-OCT-2007 complaining of a blister on the back of her knee. On 29-OCT-2007 the nurse spoke with the patient again and she indicated that she had no further complaints, the blister lasted a couple of days then went away without treatment. It was reported that the patient recovered on 12-OCT-2007. No further information was provided. Additional information is not expected.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Injection site pain, Injection site rash, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 78 year old male who on 28-SEP-2007, was vaccinated with zoster vaccine live (Oka/Merck) (Lot# 658212/0887U). On 28-SEP-2007, the patient experienced severe painful injection site reaction and a rash at the injection site that extended to his wrist. On 05-OCtT-2007, the patient experienced shingles. The physician reported the patient did not experience any lesions/reaction at the injection site. On 09-Oct-2007, a specimen was obtained from a lesion on the patients left arm for varecella zoster virus identification that was reported as positive for wild type strain. The patient is being treated with FAMVIR. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site haematoma, Injection site swelling, Pyrexia
Clinical narrative: Information has been received from a physician who vaccinated another female physician with zoster vaccine live (Oka/Merck). Subsequently the physician developed mild hematoma and swelling at the injection site, high fever and chills. This one of several reports received from the physician. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 73-year-old female with no pertinent medical history who on 02-OCT-2007 was vaccinated subcutaneously with a 0.65 milliliter dose of zoster vaccine (Oka/Merck) (658212/0887U). There was no concomitant medication. The patient developed an injection site reaction and a "pimple on the face". The injection site reaction was described as red and the size of "a 50 cent piece." No labs were performed. The patient sought medical attention by calling the pharmacist. As of 04-OCT-2007 she was had not recovered.  Follow-up information received concerns a 73-year-old white female who on 02-Oct-2007 was vaccinated in the morning with her first dose of zoster vaccine live (Oka/Merck) at a pharmacy. There was no illness at the time of vaccination. On 10-Oct-2007 the patient recovered.  Additional information is not expected.
Age: 39.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Unevaluable event, Wrong drug administered
Clinical narrative: Information has been received from a health professional concerning a 39 year old male who was vaccinated with zoster vaccine live (Oka/Merck) instead of VARIVAX. This was an error. The reporter did not know zoster vaccine live (Oka/Merck) was in the freezer and picked up the wrong vial. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.