chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old female with drug hypersensitivity to DEMEROL and no pertinent medical history who on 20-SEP-2010 was vaccinated at left arm with a dose of ZOSTAVAX (Merck) (LOT# 665309/1173Y, expired date 14-FEB-2011). There was no concomitant medication. On 21-SEP-2010 the patient presented to the pharmacy with a swollen area at the site of the injection that was red and warm to the touch. The reaction was localized to the immediate area surrounding the injection site. No other areas of redness appear on her body. No lesions or hives or varicella like rash appears anywhere. The patient was also stating that since the injection she had had a feeling of generalized weakness/fatigue. No medical attention was sought. At this time of reporting, the patient was not recovered. Follow-up information was received from the registered of pharmacist who reported that the female patient with no illness at time of vaccination on 20-SEP-2010 at 17:00 was vaccinated subcutaneously into her left arm with the first dose of ZOSTAVAX (Merck) (LOT# 665309/1173Y, expired date 14-FEB-2011). On 21-SEP-2010 the patient experienced swollen area at injection site that red and warm to touch, generalized weakness and fatigue. The patient did not seek medical attention. The outcome was not reported. No further information is available.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old female with drug hypersensitivity to DEMEROL and no pertinent medical history who on 20-SEP-2010 was vaccinated at left arm with a dose of ZOSTAVAX (Merck) (LOT# 665309/1173Y, expired date 14-FEB-2011). There was no concomitant medication. On 21-SEP-2010 the patient presented to the pharmacy with a swollen area at the site of the injection that was red and warm to the touch. The reaction was localized to the immediate area surrounding the injection site. No other areas of redness appear on her body. No lesions or hives or varicella like rash appears anywhere. The patient was also stating that since the injection she had had a feeling of generalized weakness/fatigue. No medical attention was sought. At this time of reporting, the patient was not recovered. Follow-up information was received from the registered of pharmacist who reported that the female patient with no illness at time of vaccination on 20-SEP-2010 at 17:00 was vaccinated subcutaneously into her left arm with the first dose of ZOSTAVAX (Merck) (LOT# 665309/1173Y, expired date 14-FEB-2011). On 21-SEP-2010 the patient experienced swollen area at injection site that red and warm to touch, generalized weakness and fatigue. The patient did not seek medical attention. The outcome was not reported. No further information is available.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Ageusia, Diabetes mellitus inadequate control
Clinical narrative: Information has been received from a 55 year old female patient with diabetes mellitus who on 23-AUG-2010, reported as 4 weeks ago, was vaccinated with a dose of ZOSTAVAX (Merck) (route, site and lot number not reported). Concomitant therapy included vitamins (unspecified), betaine and herbs (unspecified). On 30-AUG-2009, reported as 3 weeks ago, the patient experienced loss of sense to taste. She also reported that she was having episodes of uncontrolled diabetes. There were no other adverse effects reported. The patient did not seek any medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a consumer concerning her aunt, a female patient with a history of headaches who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot number unknown). The consumer stated that her aunt's headaches became worse after receiving the ZOSTAVAX (Merck) injection. It was unknown if the patient sought medical attention. At the time of report, the patient's outcome was unknown. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received from a 65 year old female consumer who on 30-APR-2009 was vaccinated with a dose of ZOSTAVAX (Merck). In March 2010 she got an acute case of shingles. She had tried acupuncture and had been on LYRICA for several months. At the time of report she still had post therapeutic neuralgia. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash erythematous
Clinical narrative: Information has been received from a 71 year old male with type 2 diabetes and high blood pressure, who on 31-AUG-2010 was vaccinated with one time dose of ZOSTAVAX (Merck), SC. Concomitant medication included diabetes medicine. On 12-SEP-2010 the patient had a red bump the size of a nickel on his right shoulder which eventually spread to his muscle and was now the size of a half-dollar. When he was going to the physician's office he was told by the physician's assistant that it appeared to be shingles and was prescribed a medication to help cure it. The patient said he is not sure that it was in fact shingles because he did not feel confident in the physician assistant's answers, but his shoulder itched like mad. Until he was assured by his physician that he did have shingles he would not get the prescription filled. At time of reporting, the patient had not recovered. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Coronary artery bypass, Pruritus, Rash pustular, Skin lesion
Clinical narrative: Information has been received from a licensed practical nurse concerning her approximately 61 year old father with a history of myocardial infarction who on 11-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). On 18-MAY-2010, the patient had previously scheduled surgery for stents and a quadruple bypass of his heart in a hospital. On 18-MAY-2010, he broke out in a rash on his back from neck to waist bilaterally, on both sides of his back. He had serious pruritus with about 100 pustules and lesions. Diagnosis was not available at this time. It was unknown if treatment was required. The nurse reported that this did not prolong his hospital stay. The patient had been discharged from the hospital. At the time of this report, the patient was recovering. Additional information has been requested.
Age: 1.11
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Vomiting, Wrong drug administered
Clinical narrative: Information has been received from a certificated medical assistant concerning a 12 month old patient who on 08-APR-2010 was intended to receive the first dose of VARIVAX (Merck), was inadvertently administered a dose of ZOSTAVAX (Merck). No adverse effects were reported. Follow up information received from a certificated medical assistant concerning a 13 month old female who on 08-APR-2010 at 11:32 a.m. was vaccinated with a first dose of ZOSTAVAX (Merck) (reported lot # as "664628/1018Y" which is valid for VARIVAX (Merck) in the right thigh. On 11-APR-2010 at 12:00 pm, 3 days after receiving ZOSTAVAX (Merck), the patient experienced vomiting and fever lasted a week. Rash showed up 10 days after receiving the vaccine and lasted for 5 days. They followed up with the patient and no treatment was given. The patient was recovered on 24-APR-2010. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia oral, Stomatitis
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 21-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot unknown). Concomitant therapy included LAMICTAL, NEXIUM, ADVAIR, SYNTHROID, alendronate sodium (+) cholecalciferol, clonazepam and simvastatin (manufacturer unknown). On 30-SEP-2010 the patient was prescribed Z-PAK from her physician. It was reported that on 30-SEP-2010 the patient was prescribed Z-PAK from her physician. Pharmacist added that patient was just given a prescription for predisone because she had reported that the few days ago she dropped her toothbrush on the floor and rinsed it with a disinfectant cleaner and used the toothbrush, few days later she developed inflammation and developed tingling on the inside of her mouth on one side only. At the time of the report the patient had not recovered. Pharmacist stated that the patient had not started the prednisone as of 05-OCT-2010. Follow-up information was received from a registered pharmacist indicating that the female patient had some tingling on inside of mouth. The patient went to her dentist and dentist dismissed the symptoms and she was fine after that. No further information is available.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an 84 year old female consumer who in 2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included atenolol (manufacturer unspecified), lisinopril (manufacturer unspecified), "chlorchalid" and meloxicam. The patient reported that in 2008 she had a break out of shingles after having vaccine administered. Patient sought unspecified medical attention. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a healthcare worker concerning an 87 year old female patient who in approximately 15-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route no reported). The healthcare worker reported that earlier this year the patient developed shingles. The nurse could only verify that the patient was given a prescription to receive the vaccine on 15-OCT-2010. She stated that she did not have records that the patient actually received the vaccine. At the time of the report, the outcome of the patient was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a 73 year old female who on an unspecified date was injected with ZOSTAVAX (Merck) (lot number and specific route not reported). A couple of days after receiving the vaccine, the patient developed a rash around the crease of her elbow and the base of her neck, not around the injection site. The patient went to the doctor's office for medical attention. She was given a steroid cream and an antihistamine. Outcome of the event was not reported. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 74 year old male patient who about one years ago (in 2009) was vaccinated with a dose of ZOSTAVAX (Merck). Subsequently, the patient currently had shingles from his right shoulder towards his ear. The patient was receiving VALTREX. The patient contacted a physician for medical attention. The case would be considered mild by the reporter. The patient was in good health. The patient and his sister in law were both vaccinated by the same physician (WAES# 1006USA00338). This is one of several reports received from the same source. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Polymerase chain reaction
Clinical narrative: Information has been received from a physician concerning an 84 year old female with irritable bowel syndrome, Crohn's disease, hypertension, diverticulitis, microscopic colitis, osteopenic arthritis, who on 05-NOV-2008 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (SC, lot # 663194/1415X) at a local pharmacy. Concomitant therapy included corticosteroids (unspecified) for Crohn's disease. The patient developed shingles on her trunk under left breast. The diagnosis was made in the office 25-MAY-2010 upon exam. She was prescribed VALTREX, NORCO 5/325/mg, and amitriptyline for treatment. Patient was described as mildly immunocompromised due to long term corticosteroid use. The physician sent a sample away for independent PCR analysis and was awaiting the result. The patient had contacted office for medical attention. At the time of the reporting, the patient had not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Sensory loss
Clinical narrative: Information has been received from a healthcare student concerning a female "in her sixties" who "about 3 weeks ago" was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included ZOLOFT and XANAX. "About a week after receiving ZOSTAVAX (Merck)" the patient developed tingling and "prickly" sensation from her waist down. The patient also reported to the healthcare student that she was experiencing loss of sensation to her buttock and the bottom of her feet when she was sitting on the toilet. The patient had called the pharmacy for medical attention. At the time of the reporting, the patient had not recovered. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female patient with high blood pressure who "more than a year ago" was vaccinated with ZOSTAVAX (Merck) (lot number not reported). Subsequently the patient developed shingles twice since vaccination. It was unknown if medical attention was sought. The outcome of the patient was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Asthenia, Back pain, Headache, Hyperhidrosis
Clinical narrative: Information has been received from a pharmacist concerning a female who on 19-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664274/0959Y, SC). Started on 23-MAY-2010 the patient "had been in bed feeling weak, sweaty, with a backache and headache". There were no labs or diagnostic tests performed. The patient called the pharmacist for medical attention and not recovered at time of reporting. Follow up information received from a pharmacist concerning the 70 year old female with osteoarthritis, allergic reaction to alendronate, cephalosporin, penicillin, sulfa, codeine, quinolones, nonsteroidal antiinflammatory drugs and opioids, "pen" and no illnesses at time of vaccination, who on 19-MAY-2010 at 3:30 pm was vaccinated with a first dose of ZOSTAVAX (Merck) (lot # 664274/0959Y, SC) in the left arm. On 21-MAY-2010 (previously reported on 23-MAY-2010) the patient stayed in bed for a few days, feeling weak, sweaty, a backache and headache. The patient was not hospitalized. On 01-JUN-2010 the patient recovered. Additional information is not expected. The patient had a history of drug hypersensitivity while on prior therapy with alendronate (manufacturer unspecified, WAES 1007USA01397).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a 68 year old female consumer with "thyroids", high blood pressure, diabetes and household dust allergy who "4 years ago" in October 2006 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# unknown). Concomitant therapy included metformin, "thyroid pill" and "2 blood pressure pills". The patient reported that "2 weeks ago" on approximately 20-SEP-2010, she had 4 breakouts of what she believed were shingles. She stated that they looked like individual chickenpox. They were not too painful but a bruising feeling. She had two around her belly button, 4-5 around her bra and 2-3 on one shoulder. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient was recovering, her breakouts were "dried up". The patient sought medical attention. It was reported that unspecified treatment was given. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning an 80 year old female patient with penicillin allergy and a history of cancer in 1980 who on 10-SEP-2010, was vaccinated SQ with 0.65 ml dose of ZOSTAVAX (Merck) (lot# not reported). It was reported that on 16-SEP-2010, the patient went into the pharmacy to have evaluate her arm because where she had the ZOSTAVAX (Merck) injection on her arm, the area (3 inches by 2 inches in size) was dark red, inflamed, swollen and warm. The pharmacist stated that she recommended the patient put ice on the area and apply a hydrocortisone cream to the area. The pharmacist stated that the patient reported that it helped. On 01-OCT-2010, the patient returned to the pharmacy and the pharmacist stated that she looked at the patient's arm and the area was better, the site was smaller, was not as red, not as inflamed, not as swollen and not warm but was still present. Lab diagnostics studies were not performed. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Follow-up information was received from a registered pharmacist who stated that the female patient with no illness at time of vaccination was vaccinated on 10-SEP-2010 with a dose of ZOSTAVAX (Merck) (Lot# not reported). Concomitant therapy included atenolol, alendronate sodium (manufacturer unknown) and SMZ-TMP. It was reported that on 16-SEP-2010 (also reported as approximately on 14-SEP-2010), the patient experienced red, raised, hard and warm to touch. The patient was treated with ice in the arm and with hydrocortisone cream OTC. On 17-SEP-2010, the cream seemed to be helping. On 01-OCT-2010, the patient's arm was not as severe, half size and the patient was bandaged with hydrocortisone by the physician's suggestion. On 22-OCT-2010, the patient's arm was still pink, had and warm to touch. The patient did not seek medical attention by doctor because she could not afford. On 04-DEC-2010, still there light red, still a lump "but it did not bother her", the area was about "3 times wide". The patient did not want to see a doctor. There was not relevant diagnostics test. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from doctor of pharmacy concerning a 73 year old female patient with an unspecified list of allergies to medications and other products, who on 30-SEP-2010 was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (Merck) (Lot # 665311/1310Y). The pharmacist stated that on 02-OCT-2010 the patient experienced swelling, itching, and redness at the injection side. At the time of the report, the patient had not recovered. There were not laboratories performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 11.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning an 11 year old patient who on 04-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # and route no reported) instead of VARIVAX (Merck). The patient did not suffer adverse effects. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Injection site swelling, Injection site warmth, Oedema peripheral
Clinical narrative: Information has been received from a Registered Pharmacist concerning an 80 year old female patient with no pertinent medical history and no drug reactions or allergies who on 21-SEP-2010 was vaccinated SQ with a dose of ZOSTAVAX (Merck) (Lot# 664670/0151Z). The pharmacist reported that the patient developed a site reaction after vaccination with ZOSTAVAX (Merck). The reaction began "yesterday" on 22-SEP-2010 with the injection site feeling warm and "puffy". "Today" on 23-SEP-2010, the patient's arm was swollen from the elbow to shoulder, red, hot and "puffy". The pharmacist recommended ice and BENADRYL. At the time of the report, the patient had not recovered. The patient sought medical attention by calling to the pharmacy. Follow-up has been received from a pharmacist who stated that on 21-SEP-2010 the patient was vaccinated SQ in the left arm with the first dose of ZOSTAVAX (Merck) (Lot# 664275/0960Y, reported previously as Lot# 664670/0151Z) at 13:30. The pharmacist reported that on 23-SEP-2010, the patient experienced redness, warmth and slight itchy sensation lasting at least a week. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a Registered Pharmacist concerning an 80 year old female patient with no pertinent medical history and no drug reactions or allergies who on 21-SEP-2010 was vaccinated SQ with a dose of ZOSTAVAX (Merck) (Lot# 664670/0151Z). The pharmacist reported that the patient developed a site reaction after vaccination with ZOSTAVAX (Merck). The reaction began "yesterday" on 22-SEP-2010 with the injection site feeling warm and "puffy". "Today" on 23-SEP-2010, the patient's arm was swollen from the elbow to shoulder, red, hot and "puffy". The pharmacist recommended ice and BENADRYL. At the time of the report, the patient had not recovered. The patient sought medical attention by calling to the pharmacy. Follow-up has been received from a pharmacist who stated that on 21-SEP-2010 the patient was vaccinated SQ in the left arm with the first dose of ZOSTAVAX (Merck) (Lot# 664275/0960Y, reported previously as Lot# 664670/0151Z) at 13:30. The pharmacist reported that on 23-SEP-2010, the patient experienced redness, warmth and slight itchy sensation lasting at least a week. The patient did not seek medical attention. At the time of the report, the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a female patient who on approximately 26-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck). On 02-AUG-2010, the patient reported a small rash on unknown area of her body. The outcome of the patient was not reported. The patient did not seek medical attention. Follow up information has been received from the physician concerning the 60 year old female patient with right shoulder and upper back rush and scabbing at the time of vaccination and not know drug allergies who on 20-JUL-2010 was vaccinated in the arm with the first dose of ZOSTAVAX (Merck) (Lot # 665522/1765Y). Concomitant therapy include CYMBALTA, EVISTA, hydrochlorothiazide (manufacturer unknown), LIPITOR, lisinopril (manufacturer unknown), PREMARIN, PROVIGIL, trazodone HCl and VALTREX. The physician reported that less than a week after receiving the vaccination, on 04-AUG-2010, (also reported as 02-AUG-2010), the patient ultimately got shingles. At the time of the report, the patient had recovered. No further information is available.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning an 81 year old female with no medical history of shingles (even though she had taken VALTREX in 2007), with no allergies/drug reactions who on 24-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number 665431/1744Y, expiration date: 11-MAR-2011), SQ on the left arm. Concomitant therapy included gabapentin and "eye drops" (Manufacturer unknown). The pharmacist stated that the patient who received ZOSTAVAX (Merck) developed redness, swelling and two bumps at the injection site of the left arm. No laboratory diagnostics studies were performed. At the time of the report, the patient was recovering from redness, swelling and two bumps at the injection site. The patient sought medical attention by phone call. Follow up information was received from the physician who reported that on 24-JUL-2010, the 81 year old female retired patient (also reported as 82 year old) with hypertension and hypercholesterolaemia was vaccinated with the first dose of ZOSTAVAX (Merck) into her left deltoid at a pharmacy. There was no illness at time of vaccination. On 26-JUL-2010 at 11:21, the patient experienced redness, swelling at injection site, two areas of erythema each about 2-3 cm, and some diffuse induration about 4-6 cm overall. It was reported no streaking. Subsequently the patient recovered. The patient did not seek medical attention. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Rash generalised, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 60 year old female with no known drug allergies, and had pericarditis and a history of back problems who "about one month ago" (in approximately August 2010), was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). "About one week ago" (on approximately 21-SEP-2010) the patient experienced a zoster like rash located all over her body after administration of ZOSTAVAX (Merck). Patient was examined by another physician and diagnosed with zoster. She was prescribed acyclovir four times a day for 5 days. This physician would examine the patient later on the reported day. The patient was complaining of severe pruritis. There was no lab diagnostics studies performed. At this time of reporting, the patient was not recovered. Follow-up information was received from the physician who reported that the patient's condition turned due to poison ivy, and was not related to vaccination. The patient was seen by dermatologist. On 10-OCT-2010, the patient was recovered. Physician did not administer the vaccine to the patient. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient with sulfonamide and codeine allergies who on 22-MAY-2008 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The pharmacist reported that the patient developed shingles after receiving ZOSTAVAX (Merck) over 2 years ago. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by an office visit. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an approximately 64 year old male patient who on 01-MAR-2010 was vaccinated SC with a 0.65ml ("mg") dose of ZOSTAVAX (Merck) (lot # 665294/1197Y). The patient experienced shingles after being administered ZOSTAVAX (Merck). The patient sought unspecified medical attention. At the time of reporting, the patient did not recover. It was reported that the AE did not improve. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an "over 60 year old" female who on an unspecified date, was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# reported as 06957). Two days after administration, the patient developed zoster rash-like outbreak on the right side of her face. The patient also had a localized reaction of swelling and warmth at the injection site. Unspecified medical attention was sought. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash
Clinical narrative: Information has been received from a registered pharmacist concerning an 80 year old female patient with a history of shingles, no other relevant medical history and no drug reactions or allergies, who on 14-AUG-2009 was vaccinated SQ with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 664122/0628Y). Concomitant therapy included "numerous medications". The pharmacist reported that on 02-AUG-2010, the patient returned to the pharmacy. The patient stated that since "past week or two" on approximately 19-JUL-2010, she had shingles on her face. It was unknown if treatment was needed. There were no laboratory tests or diagnostic studies performed. The outcome of the patient was not reported. The patient sought unspecified medical attention. Follow up information has been received from a Registered pharmacist concerning an 80 year old female retired patient with a history of shingles and no known drug reactions or allergies, who on 14-AUG-2009 was vaccinated SQ with a dose of ZOSTAVAX (Merck). The patient had the following illness at the time of vaccination: glaucoma, hypercholesterolemia and high blood pressure. The patient said that she had a "persistent" shingles and rash. Several months after the ZOSTAVAX (Merck), it "got worse" for a short time. The patient stated that it was happened before, but this time, it was not as severe as in the past. At the time of the report the outcome of the patient was recovered on an unspecified date. No further information is available.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site pruritus
Clinical narrative: Information has been received from a pharmacy intern concerning a 78 year old female patient who on 01-SEP-2010 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number reported as 664631/0747Y valid for VARIVAX (Merck)). The pharmacy intern reported that 2 days after vaccination the patient experienced a bruise at the injection site under the skin and itching at the injection site. The pharmacy intern reported that the patient still had the reaction but it was getting better. The patient sought medical attention by contacting the pharmacy. No further information is available.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Pruritus, Rash generalised
Clinical narrative: Information has been received from a Registered pharmacist concerning an 83 year old female patient with "heart condition", quinolones allergy, penicillin allergy, MACROBID allergy and sulfonamide allergy who on 30-JUN-2010 was vaccinated SQ in the right arm with a dose of ZOSTAVAX (Merck) (Lot# 665516/1271Y) (Expiration date: 03-MAR-2010). Concomitant therapy included sotalol hydrochloride, potassium (unspecified), warfarin, furosemide and carvedilol (reported as carbadiol). The pharmacist reported that on 07-JUL-2010, the patient developed a reaction and presented to her physician with a rash all over her body especially her face and arms. She was prescribed Hydroxyzine for treatment and took one dose. The symptoms had now resolved in full, but she still had a residual itch between her fingers. Follow up information was received from the physician indicating that he did not remember any one adverse reaction and that they were not aware of any ill effects to ZOSTAVAX (Merck) for this patient. No further information is available.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old male patient who on 23-JUL-2010 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). The pharmacist reported that the patient who was vaccinated at the pharmacy, returned to the pharmacy on 29-JUL-2010, complaining of a three inch round, reddened, non-swollen area near the injection site on the patient's arm that appeared on 27-JUL-2010. No physician was treating the patient for this reaction. At the time of the report the patient was not recovered. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site irritation, Injection site reaction
Clinical narrative: Information has been received from a 75 year old female consumer with cancer, heart problems, cholesterol, high blood pressure and diabetes, who on 31-DEC-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown). Concomitant therapy included bisoprolol, allopurinol, WELCHOL, LOVAZA, losartan potassium-HCTZ (MSD), metformin, sitagliptin phosphate (MSD), warfarin, PREVACID, TRANXENE, ARIMIDEX, K-LYTE, ZAROXOLYN, "lezodipan" and "poorsimide". The consumer reported she had a half dollar size circle on the right arm, and the dot where the vaccine was administered was red and irritated. She also mentioned she thought the vaccine was administered in the wrong place. She mentioned it was administered four inches up from the elbow. There were no lab diagnostics studies performed. At the time of the report, the patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning his 74 year old wife with diabetes and no drug reactions or allergies, who on 04-AUG-2008 was vaccinated once with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# unknown). The consumer's husband reported that his wife was given ZOSTAVAX (Merck) but on 22-SEP-2010 she developed shingles anyway. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a Family Planning Nurse concerning a 47 year old male his relevant medical history, past drug history and concomitant medications were unknown, who on 03-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) 0.65 mL subcutaneously. She reported that she ordered VARIVAX (Merck) from the pharmacy and was sent ZOSTAVAX (Merck) instead which she administered to this consumer about two a hours before the report. She did not realize this inadvertently administration until she was doing her records. It was unknown if any relevant laboratory test were performed. The patient's status was unknown at the time of reporting. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress
Clinical narrative: Information has been received from a female consumer who in August 2009, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). Concomitant therapy included SYNTHROID. The consumer stated that in February 2010 she experienced shingles. The doctor believed the patient suffered only a mild episode and this was triggered to stress. The consumer was recovering from shingles. The consumer sought unspecified medical attention. Follow up information has been received from the consumer who reported that she had no further information. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who on unspecified date, was vaccinated with the first 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported) at a pharmacy. Other suspect therapy included a chemotherapy (unspecified). Several weeks later the patient developed shingles. The physician said that he was not surprised that the event happened because it was given before the patient started on chemotherapy. The physician believed that ZOSTAVAX (Merck) decreased the severity of the disease. And the physician did not consider the event to be an adverse experience. At the time of reporting, the out come of shingles was unknown. The patient sought unspecified medical attention. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). The patient stated she experienced redness and swelling at the injection site. At the time of the report the patient was recovering. It was unknown if the patient sought medical attention. No further information is available.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional disorder, Herpes zoster, Pain
Clinical narrative: Information has been received from a 78 year old female consumer with penicillin allergy who in 2007 "3 years ago, one time in 2007", was vaccinated with one dose of ZOSTAVAX (Merck) (Lot# not reported), concomitant medication included acyclovir and TYLENOL and just recently on 01-SEP-2010, was diagnosed with shingles. The consumer was currently prescribed with acyclovir and TYLENOL (unspecified manufacturer, dose and frequency for both medications). The consumer was quite upset due to the fact that she was led to believe she would never get shingles by her getting the vaccination. At the time of the report, the patient had not recovered. The patient sought medical attention. Additional information has been requested. Follow up information was received from the consumer who reported that two years ago (previously reported as 3 years) she was vaccinated with a dose of ZOSTAVAX (Merck). The consumer mentioned that for the past 7 weeks she had been suffering from shingles. The patient had paid for 3 doctor visits and numerous medications to treat this. The patient was still battling the pain and agony. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient who on 08-JUN-2009 was vaccinated with a single dose of ZOSTAVAX (Merck) (Lot number 663779/1791X), 0.65mL. The physician stated that the patient received ZOSTAVAX (Merck) and recently came down with a case of shingles. At the time of the report, the patient had not recovered for shingles. The patient sought unspecified medical attention. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 63 year old female consumer with high blood pressure, high cholesterol and allergies to DILANTIN and ZOFRAN, who in January 2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown). Concomitant therapy included LYRICA, high blood pressure medication and high cholesterol medicine. The patient reported that in February 2010, she developed shingles after getting the ZOSTAVAX (Merck). She stated she had been getting shingles twice a month. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 75 year old male consumer concerning himself with morphine allergy who on 04-MAY-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included " NEURONTIN, and many more". On 12-MAY-2010 the patient developed shingles. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. The patient's shingles persisted. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a male patient who on approximately 12-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown). The physician reported that the patient had a "blister herpes type zoster rash". Patient was not hospitalized and was seen in the physician's office on 02-AUG-2010. At the time of the report, the patient had not recovered. Additional information has been requested.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye irritation, Maternal exposure during pregnancy
Clinical narrative: Information has been received from a nurse practitioner who is also the patient and is a 28 year old female with no known drug reactions or allergies and no pertinent medical history reporting that on 29-JUL-2010, she accidentally got a small amount of ZOSTAVAX (Merck) (Lot # 664670/0151Z) that is part of the Varicella Pregnancy Registry in her left eye while she was pushing an air bubble out of syringe. Concomitant medications included prenatal vitamins. The nurse reported that her left eye was irritated but she felt it was from the flushing of her eye with water. She was pregnant. At the time of the report the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 67 year old female who on an unknown date was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (It was reported as "it's a pill). On an unknown date, the patient ended up getting shingles. Therapy with ZOSTAVAX (Merck) was discontinued. Subsequently, the patient recovered from shingles. The patient sought an unknown medical attention. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 68 year old female with cholesterol and osteoporosis and no drug reaction or allergies who in June 2007, was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included LIPITOR and BONIVA. In July 2008, the patient experienced a mild case of shingles. On 23-AUG-2010 the patient experienced a severe case of shingles. No labs/diagnostics studies were performed. The outcome of the events was not reported. The patient sought unspecified medical attention. Additional information has been requested.
Age: 15.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 15 year old patient who on approximately 29-AUG-2010 ("2 or 3 days ago'), was inadvertently vaccinated with a dose of ZOSTAVAX (Merck) instead of VARVAX (Merck). No symptoms were reported. It is unknown if the patient sought medical attention. Follow-up information received from the nurse indicating that the wrong vaccine was administered due to human error and the staff had been retrained. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a 67 year old female with penicillin allergy who on 31-AUG-2010 was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included COUMADIN, AVALIDE, NEXIUM and CRESTOR. On 01-SEP-2010 the patient experienced an injection site reaction. She had a 3 inch diameter of redness and swelling on her inner upper arm where she received the vaccine. At this time, the patient was recovering from the events. The patient sought unspecified medical attention. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a doctor of pharmacy and from a 56 year old female patient with rheumatoid arthritis who on 01-SEP-2010, was vaccinated SQ with 0.65 ml once dose of ZOSTAVAX (Merck) (Lot#: 664628/1018Y). Concomitant therapy included methotrexate. The patient stated that she was going to undergo RITUXAN procedure for arthritis in the future. The doctor of pharmacy reported that on 02-SEP-2010, the patient developed an injection site reaction after ZOSTAVAX (Merck). It began as swelling and redness along with a headache. On 03-SEP-2010, it became more red and swollen. The patient also stated that she had a "large rash that was red and inflamed around the injection site". The shot was given by the doctor of pharmacy. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow-up information was received from other health professional who stated that the 56 year old female patient with no pre-existing allergies, no birth defects and no medical conditions, no illness at time of vaccination and no adverse event following prior vaccination, was vaccinated on 26-AUG-2010 (reported previously as 01-SEP-2010), SQ in the left deltoid with the first dose of ZOSTAVAX (Merck) (lot# 664628/1018Y) at 14:30. On 27-AUG-2010 (reported previously as 02-SEP-2010) the patient developed rash extending to elbow, redness, painful, hot, fever and itchy. There was no relevant diagnostic test and laboratory data. On approximately 02-SEP-2010, the patient recovered. No further information is expected.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Information has been received from a doctor of pharmacy and from a 56 year old female patient with rheumatoid arthritis who on 01-SEP-2010, was vaccinated SQ with 0.65 ml once dose of ZOSTAVAX (Merck) (Lot#: 664628/1018Y). Concomitant therapy included methotrexate. The patient stated that she was going to undergo RITUXAN procedure for arthritis in the future. The doctor of pharmacy reported that on 02-SEP-2010, the patient developed an injection site reaction after ZOSTAVAX (Merck). It began as swelling and redness along with a headache. On 03-SEP-2010, it became more red and swollen. The patient also stated that she had a "large rash that was red and inflamed around the injection site". The shot was given by the doctor of pharmacy. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow-up information was received from other health professional who stated that the 56 year old female patient with no pre-existing allergies, no birth defects and no medical conditions, no illness at time of vaccination and no adverse event following prior vaccination, was vaccinated on 26-AUG-2010 (reported previously as 01-SEP-2010), SQ in the left deltoid with the first dose of ZOSTAVAX (Merck) (lot# 664628/1018Y) at 14:30. On 27-AUG-2010 (reported previously as 02-SEP-2010) the patient developed rash extending to elbow, redness, painful, hot, fever and itchy. There was no relevant diagnostic test and laboratory data. On approximately 02-SEP-2010, the patient recovered. No further information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Burning sensation
Clinical narrative: Information has been received from a consumer concerning his/her cousin, a 60 year old female who 4-5 weeks ago (in approximately August 2010), was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). Now, the patient was experiencing burning and pain on her back only no rash had broken out. Caller wanted to know if ZOSTAVAX (Merck) would cause this pain no additional information could be provided. The consumer didn't report his/her cousin's final outcome at this time. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a biometrician reported that a relative of her who was vaccinated with a dose of ZOSTAVAX (Merck) about two years ago and "now" had a case of shingles. At the time of report the patient's status was unspecified. Follow-up information received from the biometrician indicating that her relative who had broken through case of zoster after receiving ZOSTAVAX (Merck). Additional information has been requested.