chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Dental operation, Mouth haemorrhage
Clinical narrative: Information has been received from a 67 year old male with no relevant medical history or allergies who had been having both cosmetic dermatology work and periodontal work done for many years. On 18-AUG-2008 the patient was vaccinated with a dose of ZOSTAVAX (lot number 659410/0412X) (injection site and route not reported). Concomitant therapy included baby aspirin. Subsequently the patient and his physician as well noticed that he had been bleeding more during both procedures. Laboratory tests included blood work (results unspecified). Unspecified medical attention was sought. The outcome of the patient's experiences was unknown. No further information is available.
Age: 8.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 8 year old patient who in August 2008, was vaccinated with a dose of ZOSTAVAX (lot no. 659763/1875U) SC, instead of the second dose of VARIVAX. The physician noted that although the VARIVAX and ZOSTAVAX vials look alike, the names of the vaccines were clearly written in large letters. This is one of several reports from the same source. Additional information has been requested.
Age: 14.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 14 year old patient who in August 2008, was vaccinated with a dose of ZOSTAVAX (lot no. 659763/1875U) SC, instead of the second dose of VARIVAX. The physician noted that although the VARIVAX and ZOSTAVAX vials look alike, the names of the vaccines were clearly written in large letters. 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
Clinical narrative: Information has been received concerning an over 60 year old female who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # not reported) just recently. Subsequently the patient experienced shingles. At the time of reporting, it was unknown if the patient recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female with history of a reaction to a flu shot (manufacturer unknown) in years past due to egg content of the vaccine, who on 20-OCT-2008 was vaccinated with a dose of ZOSTAVAX 0.5 ml, SC. After vaccination, the patient experienced nausea that had persisted. At the time of this report, the patient had not recovered. Follow up information was received from registered nurse which reported that no additional information is available.
Age: 1.1
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 13 month old patient who in August 2008, was vaccinated with ZOSTAVAX (Oka/Merck) (lot no. 659763/1875U) SC, instead of VARIVAX (Oka/Merck). The physician noted that although the VARIVAX (Oka/Merck) and ZOSTAVAX (Oka/Merck) vials look alike, the names of the vaccines were clearly written in large letters. This is one of several reports from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of drug administration, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a 56 year old female who in July 2008, was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included ACTONEL. The patient reported that "in the morning" of 28-OCT-2008 she woke up with shingles. At time of reporting, the patient stated that she was now experiencing the tingling and the itching and hadn't seen a physician yet. The patient already had shingles in May 2008 and it was in the same spot and it started the same way. She started taking VALTREX that the physician prescribed the last time she had shingles. At time of reporting, the patient had not recovered. There were no lab diagnostic studies performed. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 79 year old overweight female with hypertension who on 06-MAR-2008 was vaccinated with ZOSTAVAX (Oka/Merck), injection (lot # not provided). For the most part, the patient appeared to be healthy with no evidence of any immunodeficiency. In the beginning of October 2008, the patient experienced shingles. The patient sought medical attention and got treated in early October 2008. The outcome of the patient was unknown. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Headache, Hypersensitivity, Hypertension, Local swelling
Clinical narrative: Information has been received fro a 62 year old female with "Charcot Marie tooth", a type of muscle, never disease and drug reaction to AUGMENTIN who "a week ago last Monday" on 20-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # was not available). Concomitant therapy included DILACOR (DIGOXIN), LIPITOR, NEURONTIN, clonazepam, baclofen and isosorbide. "The following morning after receiving ZOSTAVAX (Oka/Merck)" on 21-OCT-2008 the patient experienced an allergic reaction. The patient had swelling on the face, back of the neck, mouth and chin, horrible headache, elevated blood pressure and difficulty swallowing. The patient was brought to the emergency room last Wednesday (22-OCT-2008) from 7 pm until 2 am but was not admitted in the hospital. The patient was treated with corticosteroids, anti inflammatory drug, pain medication, and BENADRYL. As of 28-OCT-2008, the patient still had swelling around her mouth and pain inside her mouth and had not recovered. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Information has been received fro a 62 year old female with "Charcot Marie tooth", a type of muscle, never disease and drug reaction to AUGMENTIN who "a week ago last Monday" on 20-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot # was not available). Concomitant therapy included DILACOR (DIGOXIN), LIPITOR, NEURONTIN, clonazepam, baclofen and isosorbide. "The following morning after receiving ZOSTAVAX (Oka/Merck)" on 21-OCT-2008 the patient experienced an allergic reaction. The patient had swelling on the face, back of the neck, mouth and chin, horrible headache, elevated blood pressure and difficulty swallowing. The patient was brought to the emergency room last Wednesday (22-OCT-2008) from 7 pm until 2 am but was not admitted in the hospital. The patient was treated with corticosteroids, anti inflammatory drug, pain medication, and BENADRYL. As of 28-OCT-2008, the patient still had swelling around her mouth and pain inside her mouth and had not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacy technician concerning a female patient who in" October 2008" was vaccinated with ZOSTAVAX (lot# 659408/0300X). "2 days after injection" "the patient's injection site became red and swollen after receiving ZOSTAVAX. The physician thought this adverse experience occurred because the lot of ZOSTAVAX was tainted with bacteria." The patient had sought medical attention. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements and research was released. No additional information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an approximately 63 year old female with a history of five different cases of the shingles who was vaccinated with single dose of ZOSTAVAX (Oka/Merck). Subsequently the patient broke out with a case of the shingles "one week later". The patient was treating herself with VALTREX. The patient sought unspecified medical attention. The patient did not have any diagnostic studies or lab work done. At time of the report the patient was recovered. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Injection site reaction, Pruritus
Clinical narrative: Information has been received from a physician concerning a female with no known medical history, who on 15-OCT-2008, was vaccinated with a dose of ZOSTER vaccine. The physician that on 17-OCT-2008, the patient experienced a severe injection site reaction, after received ZOSTER vaccine. The patient had 48 hours of extreme pain on the injection site, and then three days of red patch on her arm. The patch was red, itchy, painful, swollen and hot to the touch. The patch extended to the most of the upper arm. The patient sought medical attention and saw a physician. At the time of the report the patient was recovering. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Information has been received from a physician concerning a female with no known medical history, who on 15-OCT-2008, was vaccinated with a dose of ZOSTER vaccine. The physician that on 17-OCT-2008, the patient experienced a severe injection site reaction, after received ZOSTER vaccine. The patient had 48 hours of extreme pain on the injection site, and then three days of red patch on her arm. The patch was red, itchy, painful, swollen and hot to the touch. The patch extended to the most of the upper arm. The patient sought medical attention and saw a physician. At the time of the report the patient was recovering. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Medication error
Clinical narrative: Information has been received from a registered nurse concerning herself, a 70-year-old female, with a history of muscle weakness caused by PRAVASTATIN who on 17-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck), subcutaneously.  Concomitant therapy included AGGRENOX and VYTORIN.  The nurse reported that she received improperly stored ZOSTAVAX (Oka/Merck) and developed an injection site adverse reaction.  ZOSTAVAX (Oka/Merck) was stored in the refrigerator for 18 hours prior to the receiving the vaccination.  Within 6 hours of receiving ZOSTAVAX (Oka/Merck) the nurse developed a tender, raised, warm, red area at the injection site.  The area was described as 2 inches in diameter and raised C2BD inch in height.  As of 22-OCT-2008, the swelling had gone down and the area was still tender and red.  The red area had decreased to the size of a quarter.  At the time of reporting, the patient was recovering.  No additional information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning a female who on 11-OCT-2007 was vaccinated with ZOSTER (lot # not reported). On 17-OCT-2008, "about 1 year after" vaccination with ZOSTER, the patient experienced shingles. The patient sought medical attention. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Pain, Pyrexia, Respiratory disorder
Clinical narrative: Information has been received from a physician concerning a 72 year old female, with allergies to penicillin, sulfonamide, erythromycin ethylsuccinate, HYZAAR, with pulmonary hypertension, atrial fibrillation and cardiac failure congestive medical history, who was vaccinated with the first dose of ZOSTER (dose and injection site/route not reported) on 01-AUG-2008 AM. There was no concomitant medication. Subsequently the patient developed some respiratory pulmonary issues within a few days post vaccination. The patient also developed fever and body aches after 09:00 AM on 05-AUG-2008. The patient was given oral antibiotics and recovered. The patient sought medical attention in the office. No further information is available.
Age: 45.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Blister, Body temperature, Erythema, Herpes zoster, Pruritus
Clinical narrative: Initial information has been received from a nurse supervisor concerning a female nurse Practitioner who held a ZOSTAVAX clinic last week and administered ZOSTAVAX to numerous patients over 2-day period. As of 21-Oct-2008, it was reported that nurse practitioner was having red blotches and vesicles all over her body and was not recovered. The nurse District Health Department 4 was planning to see her physician that day. Follow-up information was received from the 45 year old nurse practitioner. She reported that she had current open wound infection in lower leg, allergy to DEMEROL, allergy to cephalosporins  and a history of chickenpox disease in 1992. On 14-Oct-2008 she administered several doses of ZOSTAVAX (lot# 658207/0883U) to people. The last doses were given at around 3:30 pm that day. She reported that she also gave one varicella vaccine. She mentioned that she had no recent exposure to chickenpox and shingles but one patient may have had shingles . concurrently, she also took TOPROL XL tablets, ORTHO-CYCLEN. On 17-Oct-2008, Friday midday, vesicles were noticed. The herpetic/ vesicles rash started on arms, most of rash located on both arms, chest and scalp. There were also lesions on both legs, abdomen, back, buttocks, perineal area, ears and hands. The maximum body temperature was 99.0. She also experienced burning skin and itching. She developed herpes zoster. The rash remained. The nurse practitioner was enrolled in the Zoster Virus Identification program to identify if VZV is present and if it is present to identify  if it is associated with the wild-type (WT) VZV strain or with the OKA/Mereck vaccine VZV strain. The sample of the lesion was collected on 22-Oct-2008. The sample was taken from a vesicle lesion on the right arm and right leg. The results revealed negative for the sample from the right leg and inadequate for the sample from the right arm. Additional information is not expected.
Age: 45.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Rash macular, Secondary transmission, Skin burning sensation, Viral DNA test negative
Clinical narrative: Initial information has been received from a nurse supervisor concerning a female nurse Practitioner who held a ZOSTAVAX clinic last week and administered ZOSTAVAX to numerous patients over 2-day period. As of 21-Oct-2008, it was reported that nurse practitioner was having red blotches and vesicles all over her body and was not recovered. The nurse District Health Department 4 was planning to see her physician that day. Follow-up information was received from the 45 year old nurse practitioner. She reported that she had current open wound infection in lower leg, allergy to DEMEROL, allergy to cephalosporins  and a history of chickenpox disease in 1992. On 14-Oct-2008 she administered several doses of ZOSTAVAX (lot# 658207/0883U) to people. The last doses were given at around 3:30 pm that day. She reported that she also gave one varicella vaccine. She mentioned that she had no recent exposure to chickenpox and shingles but one patient may have had shingles . concurrently, she also took TOPROL XL tablets, ORTHO-CYCLEN. On 17-Oct-2008, Friday midday, vesicles were noticed. The herpetic/ vesicles rash started on arms, most of rash located on both arms, chest and scalp. There were also lesions on both legs, abdomen, back, buttocks, perineal area, ears and hands. The maximum body temperature was 99.0. She also experienced burning skin and itching. She developed herpes zoster. The rash remained. The nurse practitioner was enrolled in the Zoster Virus Identification program to identify if VZV is present and if it is present to identify  if it is associated with the wild-type (WT) VZV strain or with the OKA/Mereck vaccine VZV strain. The sample of the lesion was collected on 22-Oct-2008. The sample was taken from a vesicle lesion on the right arm and right leg. The results revealed negative for the sample from the right leg and inadequate for the sample from the right arm. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who was vaccinated with a dose of ZOSTER (Oka/Merck) on an unspecified date.  Subsequently, six months after vaccination, the patient developed shingles on the face.  The shingles was reported as a mild case.  On an unspecified date, the patient recovered from shingles.  The patient sought medical attention and was seen by a physician.  Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: HIV test positive
Clinical narrative: Information has been received from a physician concerning a 64 year old female immigrant patient, who on 20-OCT-2008, was vaccinated with a dose of ZOSTER (Oka/Merck) and influenza virus vaccine (unspecified) concomitantly.  Later, it was found that the patient was HIV positive.  The patient was screened for HIV and the results were positive.  An HIV Western blot results was pending.  The patient was seen by the physician on 21-OCT-2008 and was "fine".  The patient was noted not to have past medical history or medications.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an approximately 62 year old female who on 17-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 658396/0967U) 0.65 mL, subcutaneously and then developed an injection site reaction. The injection site was described as warm and hardened on 20-OCT-2008. The patient reported that she had a similar reaction with tetanus toxoid vaccination and it lasted for 3 weeks. At the time of the report, the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested. 03/27/09 This is in follow-up to report(s) previously submitted on 12/23/2008. In follow up information received from the Pharmacist reported that the patient saw her physician regarding her injection site reaction and her symptoms resolved in a few days. The Pharmacist request that no additional forms be mail to her. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort, Chest discomfort, Influenza like illness, Pruritus, Rash
Clinical narrative: Information has been received from a male with a penicillin allergy and very healthy at the time of vaccination, who on 09-OCT-2008 was vaccinated with ZOSTAVAX (Oka/Merck), dose, therapy route and lot # were not reported. Subsequently the patient had chest tightening for 4 days. The chest tightening went away at the time of the reporting but the patient had itching in the legs, back and arms along with a rash. The patient also experienced flu-like symptoms. The patient's physician gave him a cortisone injection, and the patient had prodizone medicine and took anti itching solution. The patient reported the pills helped greatly. At the time of this report, the patient was recovering but "not yet recovered". Follow up information was received from the patient: The patient reported on 12-OCT-2008 he experienced flu-like symptoms, itching in arms and legs, rash on arms and heaviness on chest which lasted 1 day. The patient had a flu shot on 30-SEP-2008. The patient still have itch on arms and legs one month later, but the patient felt much better. Additional information has been requested. Follow-up AE information was received on 01-DEC-2008. The caller reported that he was still experiencing itchiness and would go to see his physician regarding that. No further information provided. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Body temperature increased, Herpes zoster, Pain
Clinical narrative: Information has been received from a nurse concerning a 71 year old male (this conflict to previous report which was female) with coronary artery disease, hypertension, depression, type 2 diabetes mellutis and allergies to clams and crab who in October-2008 (previous report was in April 2008), was vaccinated with ZOSTAVAX (duration and dose not reported). There was no rash at the site of injection or elsewhere within 42 days of the vaccination. Subsequently on 16-OCT-2008 (previous report was on 15-OCT-2008) the patient was diagnosed with shingles, he was noted to have 7 vesicles with clear discharge on the T8-T9 dermatomes neck and head. The patient experienced pain which was rated 8/10 (with 0 being the least and 10 being the most). The patient had no recent exposure to chickenpox or herpes zoster. At the time of report the patient had not recovered and he remained on Acyclovir. The patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 66 year old female with no pertinent medical history who in approximately October 2007, was vaccinated with ZOSTAVAX 0.6ml, SC. On approximately 01-Oct-2008 the patient started experienced pain and developed a rash on her abdomen about 1 week ago. The patient was diagnosed with shingles. The patient was being treated with LYRICA and VALTREX. As of 16-Oct-2008, the patient had not recovered. The patient sought medical attention at the doctor's office. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on 04-DEC-2007 was vaccinated with a dose of ZOSTAVAX and was just diagnosed with a mild case of shingles. Patient's age was not specified, but was indicated age for ZOSTAVAX. At time of reporting, the patient had not recovered. The patient sought unspecified medical attention. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex serology negative, Injection site erythema, Skin lesion
Clinical narrative: This is in follow-up to report (s) previously submitted on 12/21/2008. Information has been received from a licensed practical nurse concerning a 64 year old female who on 2 days ago was vaccinated subcutaneous in right arm with ZOSTAVAX (Merck) 0.65ml (LOT# 662971/1214X).  Today the patient seen at the office with 11x6 erythema and 2 1/2 x 2 centimeter lesions at the injection site, looks like a shingles break out.  The patient's adverse events persisted.  Nurse was not interested in the VZV ID program.  It was reported the patient sought medical attention: in office.  Follow up information was received from the licensed practical nurse who reported that the patient with no pre-existing allergies, birth defects and medical conditions was vaccinated in the right thigh with a first dose of ZOSTAVAX (Merc) on 14-OCT-2008.  Herpes culture was performed and the result was negative.  Additional information has been requested. Follow up information was received from the L.N.P. who reported that the patient was a 63 year old female. There was no illness at the time of vaccination. On 16-OCT-2008 the patient developed area around site red raised and central area vesicular lesions. Subsequently, the patient recovered. Follow up information was received from the L.N.P. who reported that the patient was fine and no problem at the time of this report. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Sinus congestion
Clinical narrative: Information has been received from a 64 year old female with no known pertinent medical  history or no known drug reactions / allergies, who on 06-Oct-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included SYNTHROID. The consumer reported that on 07-Oct-2008, she experienced headache, stuffy head and muscle pain in her arms and legs after receiving ZOSTAVAX. The consumer reported that her symptoms resolved on 10-Oct-2008. The patient did not seek medical attention. No further information is available since the patient declined to provide physician's information.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a male with "a reaction to a tetanus toxoid shot" where his whole arm swelled up "like a watermelon" who "2 days ago" on 14-OCT-2008 was vaccinated with ZOSTAVAX (Merck), injection and "a couple of hours after getting the vaccine", the injection site was warm, red and swelled up.  The patient was not recovered.  The patient did not seek medical attention.  No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypoaesthesia, Pain, Paraesthesia, Post herpetic neuralgia
Clinical narrative: Information has been received from a nurse practitioner and 65 year old female patient with hypothyroidism, Fibromyalgia, depression and Codeine and DERMOFLAST spray allergies who on 08-Oct-2008 was vaccinated with single dose of ZOSTAVAX. Concomitant therapy included CYMBALTA, LEXAPRO, ESTRACE, PRILOSEC, SYNTHROID, FLATORIL and RITALIN and "KOLAPEN". Around 10-Oct-2008, the patient experienced in the left side of her body, pain tingling and numbness over her shoulder blade, jaw, inside the mouth and on the left side of her head. The patient reported that at the beginning of the pain and tingling the bottom teeth on her left side were very sensitive as well. The patient stated that over the weekend, on approximately 11-Oct-2008 she had went to a walk in acute emergency clinic, and they had diagnosed her with post herpetic neuralgia and was prescribed NEUROTIN. The patient reported that her pain was improving since taking NEUROTIN but at times she just felt very tired because of the NEUROTIN. The patient reported that she went to see her physician's nurse practitioner on 17-Oct-2008 about the post herpetic neuralgia. The nurse practitioner was not interested in VZV analysis by PCR. At the time of reporting the patient was recovering. Additional information is expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a 65 year old male who is the husband of an employee of the office with no known drug allergies and no pertinent medical history reported who on 14-OCT-2008 was vaccinated with a dose of ZOSTER (Oka/Merck), intramuscularly in the left deltoid.  There was no concomitant medication.  On 14-OCT-2008, a few hours after receiving ZOSTER (Oka/Merck) the patient developed pain at the injection site.  The patient sought medical attention calling to the office.  At time of the reporting the patient had not recovered.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash vesicular
Clinical narrative: Information has been received from a health professional concerning a 62 year old female with CODEINE allergy who on 07-OCT-2008 was vaccinated S.Q. in the arm with a first dose of ZOSTAVAX (Merck) (lot # 662971/1214).  On 11-OCT-2008 the patient developed a rash at the injection site.  It was also reported that the patient developed a zoster like breakout on her forehead.  Subsequently, the patient recovered on an unspecified date.  Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female who on 11-OCT-2008 was vaccinated with one dose of ZOSTAVAX (Merck) (lot# 662971/1213) SQ.  Subsequently the patient developed a local reaction at the injection site.  The area was red and swollen about the size of 1 1/2 bandaids.  The patient was seen for follow up and it was reported that the reaction was resolving.  Follow-up information has been received from a pharmacist concerning a 70 year old female with allergy to ALENDRONATE NA (MSD, WAES 0811USA02064) who on 11-OCT-2008 was vaccinated with ZOSTAVAX (Merck) (lot# 662971/1213X) SQ into the left arm.  Concomitant therapy included influenza virus vaccine (unspecified).  On 11-OCT-2008 the patient experienced redness and swelling in injection site.  The patient's redness and swelling in injection site were slowly resolving.  The injection site was warm and still resolving on 03-NOV-2008.  Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner (N.P.) concerning a 62 year old male patient with a history of chickenpox who on 26-SEP-2008 was vaccinated with a single dose of ZOSTER (Oka/Merck).  Subsequently, the patient developed shingles on 13-OCT-2008.  The patient sought unspecified medical attention.  At the time of report, the outcome of shingles was unknown.  Follow-up information has been received from a nurse practitioner (N.P.).  Concomitant medication included COUMADIN and HYTRIN.  It was reported that the herpes ZOSTER began on 13-OCT-2008.  There was no recent exposure to chickenpox or shingles.  The patient reported pain of a 7 on a scale of 1 to 10.  No additional information was available.  Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 84 year old female with hypertension, no drug reactions/allergies who on 18-FEB-2008 was vaccinated with ZOSTER vaccine (therapy route, site unknown). Her concomitant medication was numerous medications (unspecified). She was irate that on 01-AUG-2008 she developed shingles and "never knew that efficacy in her age group is low percentage." She sought medical attention and "her physician stopped prescribing ZOSTER vaccine for the latter reason". At the time of report the patient didn't recovered. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Pain in extremity, Rash
Clinical narrative: This is in follow-up to report (s) previously submitted on 12/23/2008. Information has been received from a registered nurse concerning a 70 plus years old female with medical history unspecified who on 29-MAR-2008 was vaccinated with ZOSTER vaccine (Lot # was not provided), SC in his left arm at 11:00 AM. Concomitant therapy was unspecified. After receiving the ZOSTER vaccine, the patient experienced shingles. The patient was seen by a physician. At the time of reporting, the patient was recovering. Follow-up information was received from this registered nurse. On 08-APR-2008, after receiving the vaccine, the patient experienced rash and pain on the inside of his left thigh. He went to a "walk in clinic" and was treated with an antiviral drug for 7 days. The reporter also stated that the patient experienced great difficulty sleeping for 2 months (since approximately September 2008). The patient was treated by a physician. He went to a chiropractor and took a Tai Chi Chik Class for 8 weeks. The patient was seen by the physician. Lab and diagnostic test was unspecified. The patient recovered in July 2008. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 61 year old patient with no known drug allergies and a history of L1 compression fracture and asthma who on 05-APR-2008, was vaccinated with a dose of ZOSTER (Oka/Merck) (lot # 658863/1414U) in the left arm.  Concomitant therapy included fluticasone propionate (+) ADVAIR.  Subsequently the patient developed a case of shingles and was seen in the office on 06-OCT-2008.  The patient's outcome was not reported.  The patient was enrolled in the VARICELLA ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample of the lesion from vesicle was collected on 13-OCT-2008.  The result indicated that VZV DNA was not amplified and B-globin DNA was not amplified but also reported the specimen was inadequate.  This is one of several reports from the same source.  Additional information has been requested.
Age: 1.3
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 15 month old male who on 09-OCT-2008 was intended to receive VARIVAX, was inadvertently administered a single dose of ZOSTER vaccine (Lot number: 659407/0295X), SQ into the left thigh. On 09-OCT-2008, patient was administered the fourth dose of DTAP , IM into the right thigh (Lot number: C2955BA) There was no illness at the time of vaccination. There were no adverse symptoms or adverse reaction reported. The nurse confirmed this was due to nursing error and not product confusion. No further information provided. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning his partner, a 67 year old male patient with medical history unspecified who in approximately 2006 was vaccinated with ZOSTER vaccine (Lot# was not provided). On an unspecified date, the patient experienced shingles. The outcome of shingles was not reported. 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, Viral DNA test positive
Clinical narrative: Information has been received from a physician concerning an 84 year old female with a sulf allergy, lymphoma, hypothyroidism and a history of splenectomy, chickenpox and hysterectomy who on 05-SEP-2007 was vaccinated right side with ZOSTER (Oka/Merck) (Product Lot # 657767/0740U).  Concomitant therapy included CELEBREX, NORVASC, lovastatin (manufacturer unknown), DYAZIDE, SYNTHROID, NEXIUM and DITROPAN.  On 09-OCT-2008 the patient experienced a full blown case of shingles and was seen in the office.  No rash was reported at the injection site.  The lesions began at the level of the T8 on the back and wrapped around the body to the breast/thoracic on the left side.  The symptom was worse in afternoon.  The physician collected cultures from Herpes Simplex Virus and ZOSTER Virus.  The patient's shingles persisted.  The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  The sample was taken from lesion was collected on 09-OCT-2008.  The PCR result identified that VZV DNA was amplified and B-globin DNA was not amplied but also reported the specimen was adequate, wild type strain.  This is one of several reports from the same source.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 70 year old male consumer concerning himself with no medical history who in approximately 2006 (two years ago) was vaccinated with ZOSTER vaccine (lot# was unspecified). At the time of reporting, the patient experienced shingles. He contacted with the physician, and had no lab and diagnostic tests. At the reporting time, the patient's shingles persisted. No further information was available from the consumer. This is one of several reports received from the same source. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 75 year old female with chronic obstructive pulmonary disease and a history of chicken pox and shingles who on 19-SEP-2007 was vaccinated with a dose of ZOSTER vaccine. Concomitant medication included unspecified inhalers. On 2-OCT-2008 the patient developed 3 little eruptions on the right side of her chest. She was seen by the physician on 7-OCT-2008 and reported having pain, the physician "was surprised at the amount of pain she was reporting" and reported that the patient got shingles after receiving ZOSTER vaccine. She was prescribed acyclovir and lidocaine (LIODERM patch). At the time of the report, the outcome of AE was unknown. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Swelling face, Urine analysis, Urticaria
Clinical narrative: Information has been received from a 60 year old female with an allergy to PENICILLIN, NEOMYCIN, SULFONAMIDE and no other medical history who on 02-JUN-2008 was vaccinated with ZOSTER (Oka/Merck) (Lot # was not provided), injection in her left arm.  Concomitant therapy included CRESTOR and AVISTA.  Two weeks after receiving the vaccine, the patient experienced hives, and has had them non stop since then.  Her face has also swelled up twice in that time period.  The patient went to see a physician and a dermatologist.  And she also has basic blood test and urinalysis (results not reported).  The patient's hives and swelled face persisted.  The patient declined to provide physician's information.  No further information was given.  No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist employee concerning a female who was vaccinated with a single dose of ZOSTAVAX0.65ML, Intramuscularly. The reporter heard of a patient who on an unknown date developed Cellulitis in the arm opposite of the arm that she received the ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth, Paraesthesia
Clinical narrative: Information has been received from a patient who "2 months ago",in August 2008 was vaccinated with a dose of ZOSTER vaccine live. Subsequently the patient developed rash at site of administration which lasted 2 or 3 days. The patient wanted to consider taking flu vaccine. At the time of this report , the patient recovered. Additional information was received on 7-OCT-2009 from the patient who stated that he held a degree in chemistry. About 1 day after receiving vaccine he had a warm, tingling sensation at the injection site in a 3 by 3 inch area. The patient did not develop any further symptoms. He used ice for one day and it completely resolved. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Herpes zoster, Incorrect dose administered, Nausea
Clinical narrative: Initial follow-up information has been received from a registered nurse concerning a 84 year old female with allergy to ampicillin and medical history of chicken pox, who on 18-SEP-2008 (previously reported as 29-SEP-2008) was vaccinated with the first dose of ZOSTER, Lot #658397/1820U, 0.625 ml, subcutaneously into the left arm. Concomitant therapy included ADALAT, CELEXA and lorazepam. It was reported that on 18-SEP-2008 (previously reported as 02-OCT-2008) the patient experienced herpes zoster rash that was "very painful" with dermatome (L1) after getting ZOSTER. Patient got pain and antiviral medications. In follow-up information from the questionnaire it was reported that the patient on 18-SEP-2008 also experienced nausea,diarrhea,vomiting and abdominal discomfort. It was reported that the patient's maximum temperature "did not feel it". At the time of the report the patient had recovered. Additional information is expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Vomiting
Clinical narrative: Initial follow-up information has been received from a registered nurse concerning a 84 year old female with allergy to ampicillin and medical history of chicken pox, who on 18-SEP-2008 (previously reported as 29-SEP-2008) was vaccinated with the first dose of ZOSTER, Lot #658397/1820U, 0.625 ml, subcutaneously into the left arm. Concomitant therapy included ADALAT, CELEXA and lorazepam. It was reported that on 18-SEP-2008 (previously reported as 02-OCT-2008) the patient experienced herpes zoster rash that was "very painful" with dermatome (L1) after getting ZOSTER. Patient got pain and antiviral medications. In follow-up information from the questionnaire it was reported that the patient on 18-SEP-2008 also experienced nausea,diarrhea,vomiting and abdominal discomfort. It was reported that the patient's maximum temperature "did not feel it". At the time of the report the patient had recovered. Additional information is expected.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital rash, Herpes zoster, Paraesthesia
Clinical narrative: Information has been received from a consumer, concerning her friend, a 79 year old male with prostate cancer and no known drug allergies who on 4-SEP-2008 was vaccinated with ZOSTER (therapy route, site unknown) and then around 26-SEP-2008 the patient had tingling down the back of the leg and then a rash developed on his left groin. The patient did not see his regular physician, but he saw a neurologist who diagnosed the patient with the shingles. Concomitant therapy included triptorelin pamoate  (TRELSTAR injection), "CATHADEX". At the time of report, the patient was not recovered. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Body temperature, Herpes zoster, Pain, Pain in extremity
Clinical narrative: Information has been received from a 64 female with asthma and an allergy to imipramine hydrochloride and a history of back pain, trigeminal neuralgia, chickenpox in 10 years old and usually childhood diseases who on 02-JAN-2008, was vaccinated with ZOSTER (Oka/Merck), 0.65ml, injection in the right arm (lot # 658602/1080U).  Concomitant therapy included aspirin, KLONOPIN, ZOLOFE, ZOVIRAX, BENADRYL, QVAR and NEURONTIN.  On approximately 20-Sep-2008 the patient started to have itching on her back.  Then each day when waking up the itching circled around the left side of her trunk and then about seven days later the itching went on the inner aspect of the arm and under the arm pit.  The patient stated that the itching was mostly on her back and she had a shooting stabbing pain in her arm, where it felt like "a hot nail going into her skin."  The patient stated she did see her physician on 26-Sep-2008 but they could not do anything since there were no blisters, but told her to come back if blisters appear.  The patient stated that a couple days ago the blisters appeared on her back, left side of her trunk and on the arm and arm pit, but once the blisters appeared the itching went away.  The patient reported that she saw her physician on 01-Oct-2008 and they diagnosed her with the shingles and provided her with VALTREX.  The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated wit the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  There was no sample specimen obtained.  The physician reported this as a mild typical herpes ZOSTER rash of approximately 7-9 lesions distributed on the upper back and axilla in dermatome T2.  There was no recent exposure to chicken pox or shingles.  Other systemic symptoms included 6/10 pain, intense itching, rash and post herpetic neuralgia.  The maximum temperature of the patient was 98.5.  At the time of the report, the patient recovered from all the symptoms except for low level (3/10) post herpetic neuralgia.  Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Pruritus, Rash
Clinical narrative: Information has been received from a 64 female with asthma and an allergy to imipramine hydrochloride and a history of back pain, trigeminal neuralgia, chickenpox in 10 years old and usually childhood diseases who on 02-JAN-2008, was vaccinated with ZOSTER (Oka/Merck), 0.65ml, injection in the right arm (lot # 658602/1080U).  Concomitant therapy included aspirin, KLONOPIN, ZOLOFE, ZOVIRAX, BENADRYL, QVAR and NEURONTIN.  On approximately 20-Sep-2008 the patient started to have itching on her back.  Then each day when waking up the itching circled around the left side of her trunk and then about seven days later the itching went on the inner aspect of the arm and under the arm pit.  The patient stated that the itching was mostly on her back and she had a shooting stabbing pain in her arm, where it felt like "a hot nail going into her skin."  The patient stated she did see her physician on 26-Sep-2008 but they could not do anything since there were no blisters, but told her to come back if blisters appear.  The patient stated that a couple days ago the blisters appeared on her back, left side of her trunk and on the arm and arm pit, but once the blisters appeared the itching went away.  The patient reported that she saw her physician on 01-Oct-2008 and they diagnosed her with the shingles and provided her with VALTREX.  The patient was enrolled in the Varicella ZOSTER Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated wit the wild-type (WT) VZV strain or with the OKA/Merck vaccine VZV strain.  There was no sample specimen obtained.  The physician reported this as a mild typical herpes ZOSTER rash of approximately 7-9 lesions distributed on the upper back and axilla in dermatome T2.  There was no recent exposure to chicken pox or shingles.  Other systemic symptoms included 6/10 pain, intense itching, rash and post herpetic neuralgia.  The maximum temperature of the patient was 98.5.  At the time of the report, the patient recovered from all the symptoms except for low level (3/10) post herpetic neuralgia.  Additional information is not expected.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of drug administration, Laboratory test abnormal, Rash
Clinical narrative: Information has been received from a 53 year old female with no pertinent medical history and no known drug reaction/allergies who on 18-APR-2007 was vaccinated with a single dose of ZOSTER. Concomitant therapy included thyroid medication. On 26-SEP-2008 the patient had broken out in a rash on her abdomen, sides and back. The patient went to her physician and did blood work. She was diagnosed with the shingles. The patient's events persisted. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse concerning an 80 year old male with an allergy to tetanus vaccine, who in October 2007, was vaccinated with a dose of ZOSTER subcutaneously. In September 2008 (this week), the patient developed shingles across her lower back after administration of vaccine. The patient had "a lot of lesions". The nurse was not interested in VZV analysis by(polymerase chain reaction) PCR. The patient sought medical attention with an office visit. At the time of reporting, the patient had not recovered. This is on of two reports from the same source. Additional information is not expected.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a registered nurse concerning an 81 year old female with allergy to antibiotics, NEURONTIN, MORPHINE and iodine, who in October 2007 , was vaccinated with a dose of ZOSTER (lot no. 658207/0883U). Last week, on approximately 24-SEP-2008, the patient developed shingles on her face and head area after administration of ZOSTER. The patient reported that she is in a lot of pain. The nurse is not interested in VZV analysis by PCR. The patient sough medical attention, via telephone. At the time of the reporting, the patient was recovering. This is one of several reports received from the same source. No further information is available.