chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a consumer concerning herself who on 10-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck).  On 11-MAR-2009 the patient had an itchy, red and hot area (the area is 2 1/2 "x2" in size) where the injection was given.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Off label use, Pain, Therapeutic response unexpected
Clinical narrative: Information has been received from a medical assistant concerning her mother (a 63 year old female) with diabetes who had a shingles outbreak "under her right breast and was given a dose of ZOSTAVAX (Merck) 2 years ago (approximately 2007) to decrease the swelling and pain from shingles". The medical assistant stated that the patient's "pain improved and the rash went away faster from the ZOSTAVAX (Merck)". It was reported the patient's "rash lasted for a total of 4-5 days". The ZOSTAVAX (Merck) was given on the second day of the rash when her pain level was 10/10. 4 days after the vaccine was given the patient's pain was 6/10. It was also reported there was no pain or rash 14 days after vaccine was given. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration
Clinical narrative: Information has been received from a registered pharmacist concerning a female patient who on an unspecified date was vaccinated with ZOSTAVAX (Merck) SQ.  On an unspecified date the patient called because she had a "skin discoloration" at the injection site.  The patient would only speak with the pharmacist who administered the vaccine who was not at the pharmacy at the time the patient called.  The patient was expected to call the pharmacy again the next day and speak with the administering pharmacist.  The patient had sought unspecified medical attention.  The outcome of the patient's "skin discoloration" at the injection site was not reported.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Malaise, Paraesthesia
Clinical narrative: Information has been received from a 67 year old female patient with no drug reactions and "shingles 10 years ago" "1 week ago" on approximately 05-MAR-2009 was vaccinated with "one dose" of ZOSTAVAX (Merck) (lot # not available). Concomitant therapy included ALENDRONATE SODIUM (MSD). "1 week ago" on approximately 05-MAR-2009 the patient experienced redness, swelling and heat at the injection site after receiving ZOSTAVAX (Merck). Those symptoms subsided after a few days but then began experiencing a tingling sensation on one side of her body that was similar to how she felt when she had shingles 10 years ago and she did not feel well in general. The patient did not have any blisters. The patient had sought medical attention from pharmacist. The patient's adverse events persisted. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Ataxia, Balance disorder, Depression, Dysarthria, Fall
Clinical narrative: Information has been received from a veterinarian concerning her mother, a female in her eighties, who in December 2008 was vaccinated with ZOSTAVAX (Merck).  The consumer reported that almost immediately after the injection the patient experienced symptoms that were finally diagnosed as shingles (no classic lesions though).  The reported stated:  "we are dealing wit a lack of efficacy or a failure to protect or an adverse reaction to the shot itself".  The consumer reported that this all started before Christmas and the way the MDs chose to deal with the problem was with pain killers (for peripheral) nerve pain) that made patient loopy and ataxic resulting in loss of balance, slurred speech and a couple of falls.  They just continued with pain medicaments and pain patches.  The consumer reported that her mother is really depressed and was not sure how much she could take.  It was also stated that the patient's quality of life had decreased.  The outcome is unknown.  Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Quality of life decreased, Vaccination failure
Clinical narrative: Information has been received from a veterinarian concerning her mother, a female in her eighties, who in December 2008 was vaccinated with ZOSTAVAX (Merck).  The consumer reported that almost immediately after the injection the patient experienced symptoms that were finally diagnosed as shingles (no classic lesions though).  The reported stated:  "we are dealing wit a lack of efficacy or a failure to protect or an adverse reaction to the shot itself".  The consumer reported that this all started before Christmas and the way the MDs chose to deal with the problem was with pain killers (for peripheral) nerve pain) that made patient loopy and ataxic resulting in loss of balance, slurred speech and a couple of falls.  They just continued with pain medicaments and pain patches.  The consumer reported that her mother is really depressed and was not sure how much she could take.  It was also stated that the patient's quality of life had decreased.  The outcome is unknown.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with ZOSTAVAX (Merck) 0.65ml. The patient had herpes and got the vaccine and patient was doing better now. Lot number was not provided. No additional information was provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Corneal abrasion, Product quality issue
Clinical narrative: Information has been received from a nurse practitioner concerning a 50 year old nurse female who experienced eye and face exposure to ZOSTAVAX (Merck) when the dose was being withdrawn from the vial. On 13-MAR-2009 the nurse went to the urgent care center and was diagnosed with bilateral corneal abrasions. Her eyes had been flushed with water and saline. At the time of reporting, 16-MAR-2009, the nurse's eyes were "not so bad". There was a product quality complaint involved. Additional information was received on 16-MAR-2009. The nurse practitioner reported that the female nurse at her office suffered from bilateral corneal abrasions while reconstituting the product on 13-MAR-2009. As the nurse injected the diluent, the product "exploded" back into her eyes and face. The vial was completely empty after it exploded. It was first thought that the vial actually broke, but upon further inspection of the vial, it was completely intact. The nurse practitioner reported that the hole created by the syringe needle appeared to be enlarged due to the force of the pressure which must have ripped the hole. The nurse's eyes were properly irrigated following the exposure and she was doing better as of 16-MAR-2009. The emergency room physician felt the abrasions were caused by the force of the product hitting her eyes and was not from glass or metal from the vial. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a 70 year old female patient with sulfa allergy who on 31-JUL-2008 was vaccinated with a single dose of ZOSTAVAX (Merck). Concomitant therapy included TRICOR, metoprolol and PLAVIX. On 19-DEC-2008 the patient experienced shingles around her waist area. The patient mentioned that she experienced a severe pain associated with it. Unspecified blood tests were performed. The patient sought unspecified medical attention. On an unspecified date the patient recovered. Follow-up information has been received from a physician concerning the patient with no history of chickenpox who on 31-JUL-2008 was vaccinated intramuscularly in her left deltoid with a 0.5 mL dose of ZOSTAVAX (Merck) (lot # 659409/0409X). It was reported that the patient had 12 cluster lesions in the right side of her thorax. The patient's maximum temperature was 98.6 degrees. The patient experienced pain at level 8 in a 0-10 scale. She had no recent exposure to chickenpox or shingles. A direct fluorescent antibody was not done. A photo was not taken. The patient recovered. Follow up information was received from a physician who reported that on 31-JUL-2009 a 70 year old female patient was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 659409/0409X) intramuscularly into her deltoid. It was reported that on 19-DEC-2008 the patient developed herpes zoster clinically diagnosed. The patient recovered on an unspecified date. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Swelling
Clinical narrative: Information has been received from a physician concerning an approximately 64 year old female who in May 2008, was vaccinated with a dose of ZOSTAVAX (Merck0 (lot #659411/0293X) 0.65 mL. Concomitant therapy included ZYRTEC, NEXIUM, ACTIVELLA, TOPROL, CRESTOR and BENICAR. The physician reported that "this past week" the patient experienced blisters, itching and swelling and could be a case of shingles, however it was still unknown. The patient was on antibiotics. At time of reporting had not recovered. The patient sought unspecified medical attention. Follow-up information was received from the physician, who reported that patient is a retired 63 year old female with myasthenia gravis, ptosis and "problems wit the same side". The patient was vaccinated with ZOSTAVAX (Merck) on 27-MAY-2008 subcutaneously into her left arm. The physician reported that on 10-MAR-2009, the patient experienced " possible shingles episode - face". At the time of reporting, the patient recovered from the adverse experiences. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster, Influenza like illness, Pain, Pyrexia
Clinical narrative: Information has been received from a physician concerning an approximated 75 year old female with no known drugs allergies and medical history, who on 02-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck).  On 06-MAR-2009 the patient developed vesicular lesions of the right L3 dermatome distribution.  No laboratories studies performed.  The patient was examined in the office and started on VALTREX.  The patient was recovering.  Follow up information received on 26-MAR-2009 from a herpes zoster questionnaire completed by the physician, stated that the patient had a previous exposure to chickenpox when she was a child, also, the patient had an allergy to COMPAZINE.  It was also reported that the patient was 75 years old.  On 24-FEB-2009 (previously reported as 02-MAR-2009) the patient received a 0.65 mL dose of ZOSTAVAX (Merck) (lot # "01354") into the left upper arm.  Concomitant therapy included PLAVIX, MSD, LIPITOR and TOPROL.  On 26-FEB-2009 the patient developed shingles rash in the right dermatome.  Approximately one hundred lesions were identified to the patient.  The rash did not occur at the site of the injection within the 42 days after vaccination, Fever, chills and flu like syndrome were also reported.  The patient was not recently exposure to Chickenpox.  The patient had a temperature of 100 degrees C and in a scale of 1 to 10 the pain was quantify as 10.  The patient recovered.  The patient was enrolled in a 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 Merck vaccine VZV strain.  The sample of lesion was collected and sent it to the laboratory on 19-MAR-2009.  The sample was taken from a scab.  The PCR results for the specimen from the scab, identified the presence of Wild Type Strain VZV.  Follow up information received on 06-APR-2009 from the physician stated that it was a retired patient with arthritis and no illness at time of vaccination, who on 24-FEB-2009 was vaccinated with a first dose of ZOSTAVAX, (lot # 663895/0135Y), intramuscularly.  On 26-FEB-2009 the patient developed shingles in the right T11.  The patient had a skin scraping.  The patient recovered in April 2009.  No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning an approximated 75 year old female with no known drugs allergies and medical history, who on 02-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck).  On 06-MAR-2009 the patient developed vesicular lesions of the right L3 dermatome distribution.  No laboratories studies performed.  The patient was examined in the office and started on VALTREX.  The patient was recovering.  Follow up information received on 26-MAR-2009 from a herpes zoster questionnaire completed by the physician, stated that the patient had a previous exposure to chickenpox when she was a child, also, the patient had an allergy to COMPAZINE.  It was also reported that the patient was 75 years old.  On 24-FEB-2009 (previously reported as 02-MAR-2009) the patient received a 0.65 mL dose of ZOSTAVAX (Merck) (lot # "01354") into the left upper arm.  Concomitant therapy included PLAVIX, MSD, LIPITOR and TOPROL.  On 26-FEB-2009 the patient developed shingles rash in the right dermatome.  Approximately one hundred lesions were identified to the patient.  The rash did not occur at the site of the injection within the 42 days after vaccination, Fever, chills and flu like syndrome were also reported.  The patient was not recently exposure to Chickenpox.  The patient had a temperature of 100 degrees C and in a scale of 1 to 10 the pain was quantify as 10.  The patient recovered.  The patient was enrolled in a 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 Merck vaccine VZV strain.  The sample of lesion was collected and sent it to the laboratory on 19-MAR-2009.  The sample was taken from a scab.  The PCR results for the specimen from the scab, identified the presence of Wild Type Strain VZV.  Follow up information received on 06-APR-2009 from the physician stated that it was a retired patient with arthritis and no illness at time of vaccination, who on 24-FEB-2009 was vaccinated with a first dose of ZOSTAVAX, (lot # 663895/0135Y), intramuscularly.  On 26-FEB-2009 the patient developed shingles in the right T11.  The patient had a skin scraping.  The patient recovered in April 2009.  No further information is available.
Age: 56.0
Sex: F
Vaccine: RV1
Symptoms: Medical device complication, Product quality issue, Skin laceration
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of cut hand in a 56-year-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). On 23 June 2009 at 14:00, the subject received unspecified dose of ROTARIX and experienced cut hand and pharmaceutical product complaint. The reporter stated that the subject (a nurse) was cut when the ROTARIX vial shattered in her hand while preparing the vial for administrating to a patient. She put on a bandage and the cut is healing. At the time of reporting the event was improved. The healthcare professional considered the event was probably related to vaccination with ROTARIX.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 82 female with sulfa allergy and antifungal drugs allergy who on 30-DEC-2008 was vaccinated SQ with 0.65 ml of ZOSTAVAX (Merck) (lot number: 663176/1554X) at 11:00 a.m. Concomitant therapy included vitamins (unspecified) and calcium (unspecified). The patient reported that on 15-MAR-2009 that she developed shingles after getting the vaccine. The patient also reported that her shingles were not painful and she was not developing blisters yet. The patient was not recovered and did not seek medical attention. Follow-up information was received. The reporter stated that the patient's herpes zoster was confirmed at a dermatologist's office. The outcome for the patient's herpes zoster was reported as recovered on 06-APR-2009. Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site paraesthesia, Lymphadenopathy, Metabolic function test normal, Myalgia
Clinical narrative: Information has been received from a physician concerning a 61 year old female with hypertension, arthritis, imbedded rose thorn removed from left arm in August 2008 and no reported allergies, who on 11-JUL-2008 was vaccinated SQ in the left upper arm with a dose of ZOSTAVAX (Merck) (dose and lot number not provided). Concomitant therapy included lisinopril (manufacturer unknown) and CELEBREX. In October 2008, the patient developed bruising at injection site, lymphadenopathy of the left axilla. Subsequently, the patient began to notice paresthesia in the area of the injection site only when the skin of that area was touched. The patient also noticed myalgia of the left arm with use, such as raking leaves. The physician stated that the patient recovered from the bruising, lymphadenopathy, and myalgia on an unspecified date. Skin sensitivity at injection site had persisted. Lab test performed included comprehensive metabolic panel and thyroid function test with normal results. The patient sought unspecified medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Thyroid function test normal
Clinical narrative: Information has been received from a physician concerning a 61 year old female with hypertension, arthritis, imbedded rose thorn removed from left arm in August 2008 and no reported allergies, who on 11-JUL-2008 was vaccinated SQ in the left upper arm with a dose of ZOSTAVAX (Merck) (dose and lot number not provided). Concomitant therapy included lisinopril (manufacturer unknown) and CELEBREX. In October 2008, the patient developed bruising at injection site, lymphadenopathy of the left axilla. Subsequently, the patient began to notice paresthesia in the area of the injection site only when the skin of that area was touched. The patient also noticed myalgia of the left arm with use, such as raking leaves. The physician stated that the patient recovered from the bruising, lymphadenopathy, and myalgia on an unspecified date. Skin sensitivity at injection site had persisted. Lab test performed included comprehensive metabolic panel and thyroid function test with normal results. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Pain
Clinical narrative: Information has been received from a physician concerning a female patient who on 02-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 663894/0129Y) 0.65ml, subcutaneously in the left side. On approximately 02-MAR-2009 the patient experienced rash at the site injection. On 16-MAR-2009 the patient was seen in the office with shingles. The patient rated pain a 4 out of 10 (10 being the most pain). The patient had vesicles on left side of abdomen. The patient did not have any other systemic symptoms. The physician did not know if the patient was exposure to chickenpox or herpes zoster. There were no Laboratory Diagnostics Studies performed. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Underdose
Clinical narrative: Information has been received from a physician concerning a 70 male with no reported allergies, who on 20-JUN-2008 was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (route not provided) (lot number 659408/0300X). Concomitant therapy included SINGULAIR, simvastatin (unknown manufacturer), FEOSOL, aspirin, NEXIUM, verapamil, potassium (unspecified) and UROXATRAL. On 14-MAR-2009 the patient developed shingles. No lab tests were performed. Follow up information was received from an other health professional concerning the 70 year old male with quinine allergy who on 20-JUN-2008 (also report 12-JUN-2008) was vaccinated in the left deltoid with a 0.5 ml dose of ZOSTAVAX (Merck) (lot number 659408/0300X). On 16-MAR-2009 (also reported as 14-AR-2009) the patient developed Herpes zoster. The vesicles were located on the left low back. The patient's pain rated as 4 out of 10. The patient did not exposure to chickenpox or shingles recently and he had a history of chickenpox when he was 10 years old. There was no rash at the site of injection or elsewhere within 42 days of the vaccination. It was also reported that the patient was afebrile. At the time of reporting the outcome was unknown. The sample of the lesion was collected on an unspecified date. The sample was taken from vesicles on the left low back. A direct fluorescent antibody was not done. There was no specimen collected for PCR. No photo was taken. Follow up information was received from an other health professional concerning the 70 year old male with IVP dye and quinine allergy as well as a history of thrombocytopenia induced by quinine in September 2006 who on 20-JUN-2008 was vaccinated in the left deltoid with a dose of ZOSTAVAX (Merck) (lot# 659408/0300X). There was no illness at the time of vaccination. The patient recovered in March 2009. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her 66 year old husband with no known drug reactions/allergies with hypercholesterolemia and hypertension who on 08-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included Triamterene, Lisinopril, Ezetimibe (+) Simvastatin (MSD), Ibuprofen and CIALIS. On 27-FEB-2009 the patient was diagnosed with shingles (the adverse event onset was on 25-FEB-2009, even though diagnosis date was on 27-FEB-2009). The patient sought medical attention went to the office. At the time of reporting the patient was recovering. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose increased
Clinical narrative: Information has been received from an 91 year old female with atrial fibrillation, diabetes and drug reaction/allergies with cortisone shot, who " 3 months ago" on approximately 16-DEC-2008, was vaccinated with a dose of ZOSTAVAX (Merck).  Concomitant therapy included generic atorvastatin calcium (LIPITOR), metoprolol, warfarin sodium (COUMADIN), insulin and lorazepam.  The patient reported that "the same day after received ZOSTAVAX (Merck)"  her blood sugar went up.  On the same day "right away",  the patient recovered.  The patient sough medical attention with the physician.  Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye irritation, Eye pain
Clinical narrative: Information has been received from a female physician with no pertinent medical history or drug reactions or allergies and was not pregnant concerning herself. It was reported that on approximately 17-MAR-2009 ZOSTAVAX (Merck) splashed in her eye while she was reconstituting the vaccine. There was no concomitant medication. The physician felt that it was likely diluent that went in her eye, but she was injecting the diluent into the ZOSTAVAX (Merck) vial when this occurred. On 17-MAR-2009 the patient was experiencing "burning" in her eye. On 18-MAR-2009 a follow-up call was made to the physician an she reported that her eye still stung, but it was a mild stinging and could be tolerated and it was constant. Otherwise, there were no other symptoms. At the time of this report, the patient was not recovered. No lab tests were done. She did not seek medical attention. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Information has been received from a physician concerning another physician's patient who was vaccinated with a dose of ZOSTAVAX (Merck) on an unspecified date. Subsequently the patient might have developed neuropathy after administration of ZOSTAVAX (Merck) on an unspecified date. The reporter did not have any additional information. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site streaking, Injection site warmth
Clinical narrative: Information has been received from a Nurse Practitioner (N.P.) concerning a 63 year old female with hypertension, acid reflux and osteoporosis as well as penicillin allergy who on 11-MAR-2009 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot# 662855/1623X).  Concomitant therapy included alendronate sodium (NSD), atenolol, esomeprazole magnesium (NEXIUM) and "serltrazine".  The patient sought medical attention and was seen in the office on 17-MAR-2009 since she developed an injection site reaction.  There was redness, streaking and warmth starting at the injection site and working its was distally on the arm.  At the time of reporting (17-MAR-2009) the patient was not recovered.  Follow up information was received from the Nurse Practitioner (N.P.) by phone on 07-APR-2009 reporting that the patient was prescribed topical antibiotic ointment for the arm and she was getting better.  No further information is available.
Age: 64.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a registered pharmacist concerning a 64 year old male patient who on 06-MAR-2009 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck). Concomitant therapy included influenza virus vaccine (unspecified). On 08-MAR-2009 the patient experienced rash in multiple spots on her body after getting ZOSTAVAX. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a registered pharmacist concerning a 64 year old female with no medical history or a drug allergy who on 16-Mar-2009 was subcutaneously vaccinated with a 0.65 dose of ZOSTAVAX (Merck) (lot#663775/1789X) in the left deltoid area. There was no concomitant medication. On 18-Mar-2009 the patient developed a red raised area 3 inches wide at the site of injection after administration of ZOSTAVAX (Merck). She did not recover at the time of reporting. The patient contacted with physician concerning the female patient with aspirin (ASA) allergy, osteopenia, migraine, mitral valve prolapse (MVP) ,and spondylolisthesis who was vaccinated with a dose of ZOSTAVAX (Merck) at a pharmacy. The patient also was intramuscularly vaccinated with the first dose of pneumococcal vaccine (unspecified) (manufacturer unknown) at 09:20 on 24-Feb-2009. The patient did not have illness at time of vaccination. The patient developed 4-5" area at injection site that was light swelling and warm to touch. There was no pain. Subsequently, the patient recovered on unspecified dates. There was no lab test. No further information is available.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site inflammation, Palpitations
Clinical narrative: Information has been received from a 57 year old female with a history of shingles and drug allergies to penicillin, erythromycin and "vycodine" who on 16-MAR-2009 (at around 3:30 pm) was vaccinated with a dose of ZOSTAVAX (Merck). There was no concomitant medication. After a few hours, she started experiencing headache and her heart started racing. Patient added that the next day, Tuesday, she developed an inflammation on the injection site that progressed to about 5 inches in circumference. Lot# was not available. The patient noted that she received ZOSTAVAX (Merck) because she previously had shingles and she got the vaccine because she didn't want to get shingles again. At the time of reporting (19-MAR-2009) the patient was not recovered. The patient sought medical attention by visiting the physician's office. No further information is available. Correspondence attempts were unsuccessful.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Blood thyroid stimulating hormone normal, Breast pain, Burning sensation, Discomfort
Clinical narrative: Information has been received from a female consumer who on 23-FEB-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). Lot# was not reported. Concomitant therapy included PREVACID. She reported that she developed itching and burning over the feet after getting the vaccine. At the time of reporting (19-MAR-2009) the patient was not recovered. Follow up information was received from a physician concerning the 68 year old female patient with osteoporosis, tubulovillous adenoma and tubular adenoma, recent stress and anxiety related to her son's alcohol abuse and history of hiatal hernia and polyp and physical therapy for shoulder and neck pain in November 2008 who on 23-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#663638/1706X). On 18-MAR-2009 the patient was seen in the physician's office with a chief complaint of redness, swelling and itching of feet and hands for 3 weeks. Hands and feet had been itching which would not resolve by 4 days ago (14-MAR-2009). No rash had occurred, but "crawling and itching" were present. Discomfort had been 10/10 and improved with BENADRYL. No new foods, detergents or soaps were present. KEFLEX was started for bladder infection several months ago by doctor for prevention of UTI's on daily basis. However, she stopped this medicine 2 weeks ago. Significant pain was noted in right breast. She has had significant stress relating to son's disappearance last week (ongoing severe issues relating to alcohol abuse). Physical examination revealed no other abnormal symptoms. Laboratory tests were performed to check for complete blood count, lipids, liver panel, Urine, thyroid stimulating hormone. All of these tests were within normal limit. The assessment included: "recent onset of intermittent pruritus/burning hands and feet-unclear etiology", "anxiety-situational-recently worsening in view of son's alcohol abuse", "recent right breast pain". At the time of this report the outcome was unknown. Additional information has been requested. All available medical records are available upon request.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Formication, Full blood count normal, Lipids normal, Liver function test normal
Clinical narrative: Information has been received from a female consumer who on 23-FEB-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). Lot# was not reported. Concomitant therapy included PREVACID. She reported that she developed itching and burning over the feet after getting the vaccine. At the time of reporting (19-MAR-2009) the patient was not recovered. Follow up information was received from a physician concerning the 68 year old female patient with osteoporosis, tubulovillous adenoma and tubular adenoma, recent stress and anxiety related to her son's alcohol abuse and history of hiatal hernia and polyp and physical therapy for shoulder and neck pain in November 2008 who on 23-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#663638/1706X). On 18-MAR-2009 the patient was seen in the physician's office with a chief complaint of redness, swelling and itching of feet and hands for 3 weeks. Hands and feet had been itching which would not resolve by 4 days ago (14-MAR-2009). No rash had occurred, but "crawling and itching" were present. Discomfort had been 10/10 and improved with BENADRYL. No new foods, detergents or soaps were present. KEFLEX was started for bladder infection several months ago by doctor for prevention of UTI's on daily basis. However, she stopped this medicine 2 weeks ago. Significant pain was noted in right breast. She has had significant stress relating to son's disappearance last week (ongoing severe issues relating to alcohol abuse). Physical examination revealed no other abnormal symptoms. Laboratory tests were performed to check for complete blood count, lipids, liver panel, Urine, thyroid stimulating hormone. All of these tests were within normal limit. The assessment included: "recent onset of intermittent pruritus/burning hands and feet-unclear etiology", "anxiety-situational-recently worsening in view of son's alcohol abuse", "recent right breast pain". At the time of this report the outcome was unknown. Additional information has been requested. All available medical records are available upon request.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Oedema peripheral, Pruritus, Stress, Urine analysis normal
Clinical narrative: Information has been received from a female consumer who on 23-FEB-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). Lot# was not reported. Concomitant therapy included PREVACID. She reported that she developed itching and burning over the feet after getting the vaccine. At the time of reporting (19-MAR-2009) the patient was not recovered. Follow up information was received from a physician concerning the 68 year old female patient with osteoporosis, tubulovillous adenoma and tubular adenoma, recent stress and anxiety related to her son's alcohol abuse and history of hiatal hernia and polyp and physical therapy for shoulder and neck pain in November 2008 who on 23-FEB-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (lot#663638/1706X). On 18-MAR-2009 the patient was seen in the physician's office with a chief complaint of redness, swelling and itching of feet and hands for 3 weeks. Hands and feet had been itching which would not resolve by 4 days ago (14-MAR-2009). No rash had occurred, but "crawling and itching" were present. Discomfort had been 10/10 and improved with BENADRYL. No new foods, detergents or soaps were present. KEFLEX was started for bladder infection several months ago by doctor for prevention of UTI's on daily basis. However, she stopped this medicine 2 weeks ago. Significant pain was noted in right breast. She has had significant stress relating to son's disappearance last week (ongoing severe issues relating to alcohol abuse). Physical examination revealed no other abnormal symptoms. Laboratory tests were performed to check for complete blood count, lipids, liver panel, Urine, thyroid stimulating hormone. All of these tests were within normal limit. The assessment included: "recent onset of intermittent pruritus/burning hands and feet-unclear etiology", "anxiety-situational-recently worsening in view of son's alcohol abuse", "recent right breast pain". At the time of this report the outcome was unknown. Additional information has been requested. All available medical records are available upon request.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacy technician concerning a female patient who on 20-MAR-2009 was vaccinated with ZOSTAVAX (Merck). Subsequently the patient developed redness at the injection site. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 68 year old female consumer with penicillin and erythromycin allergy who in December 2008, was vaccinated with the first dose of ZOSTAVAX (Merck) (lot not reported). Concomitant therapy included ezetimie (MSD) and simvastatin (MSD). On 18-MAR-2009 the patient broke out with a case of shingles. The patient sought unspecified medical attention. As of 20-MAR-2009, the patient symptoms persisted. No further information is available.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Fatigue, Tachycardia
Clinical narrative: Information has been received from a physician concerning a 61 year old male who six days ago, on approximately 14-MAR-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (dose, route and lot number not provided). The physician reported that the patient had developed fatigue and tachycardia after receiving the vaccine. The patient was evaluated in an emergency room and was discharged. At the time of the report the patient had not recovered from the events. Lab studies performed included unspecified blood test with normal limits. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Pain, Spinal X-ray normal, X-ray normal
Clinical narrative: Information has been received from a registered nurse concerning a 69 year old female patient with asthma and allergic reaction to antibiotics (CIPRO), who on 17-FEB-2009 was vaccinated subcutaneously with one 0.5 mL dose of ZOSTAVAX (Merck) (Lot # 663673/1710X). On 20-FEB-2009, the patient complained of hot burning pain like "shingles pain" on her waist. The pain shouted up on her front and back. The patient had not rash or blisters. The patient was seen by the physician and had a x-ray (results not provided). At the time of reporting, the patient had not recovered. Follow up information received from a registered nurse concerning the 69 year old retired female (weight 136 pounds) who on 17-FEB-2009 was vaccinated subcutaneously in her left arm with a 0.65 mL first dose of ZOSTAVAX (Merck) (Lot # 663673/1710X). On 20-MAR-2009 (also reported by the registered nurse as 20-FEB-2009) the patient experienced burning pain around waist. On an unspecified date lung and spinal x ray have been negative, seemed "neuropathic", those results were sent to ortho/spine doctor. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who in 2006 was vaccinated with a dose of ZOSTAVAX (Merck) (lot not reported). In September 2008, the patient developed shingles. Subsequently, on an unspecified date, the patient recovered from shingles. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 85 year old female, who on 27-FEB-2007 was vaccinated with ZOSTAVAX (Merck). On 05-FEB-2009, the patient developed "very mild" case of shingles after receiving the vaccine. On an unspecified date, the patient recovered. The patient sought medical attention and was seen by the physician. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 82 year old male patient who on 26-SEP-2007 was vaccinated with a dose of ZOSTAVAX (Merck). On 04-FEB-2009, the patient developed shingles after receiving ZOSTAVAX (Merck). On an unspecified date, the patient recovered from shingles. The patient sought medical attention, the physician saw the patient. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth, Nausea
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old female with latex allergy and no pertinent medical history, who on 20-MAR-2009 was vaccinated with one dose of ZOSTAVAX (Lot # 663775/1789X), 0.6ml, subcutaneously. The pharmacist reported that the patient experienced an injection site reaction. The patient experienced a circular area of redness of the site of vaccine administration. The area of redness increased in size, became hard and warm to the touch on the following day 22-MAR-2009. It was noted that the area of redness had diminished. Follow-up information received from the pharmacist on 24-MAR-2009 indicated that the patient was seen by her and she still had the 4 inch diameter of faint redness at the injection site. The patient also complained of low grade fever and nausea. The patient's status at the reporting time is unknown. The physician prescribed ALLEGRA and ice pack treatments. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a 59 year old female with latex allergy and no pertinent medical history, who on 20-MAR-2009 was vaccinated with one dose of ZOSTAVAX (Lot # 663775/1789X), 0.6ml, subcutaneously. The pharmacist reported that the patient experienced an injection site reaction. The patient experienced a circular area of redness of the site of vaccine administration. The area of redness increased in size, became hard and warm to the touch on the following day 22-MAR-2009. It was noted that the area of redness had diminished. Follow-up information received from the pharmacist on 24-MAR-2009 indicated that the patient was seen by her and she still had the 4 inch diameter of faint redness at the injection site. The patient also complained of low grade fever and nausea. The patient's status at the reporting time is unknown. The physician prescribed ALLEGRA and ice pack treatments. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Information has been received from a nurse concerning an approximately in her 70's who on 17-MAR-2009 was vaccinated with ZOSTAVAX (Merck), 0.65ml, subcutaneously, lot number 663775/1789X. The nurse reported that the patient developed from large rash at the injection site, with a small bump also at the injection site. This reaction developed on 18-MAR-2009, the day after vaccination and only lasted 1 day. The rash was described as itchy and spontaneously resolved. The site was not interested in PCR analysis. The patient was recovered on 19-MAR-2009 and sought unspecified medical attention by phone. No further information available. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site streaking, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female patient with penicillin allergy who on 20-MAR-2009 was vaccinated subcutaneously in the left arm with 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot number 662857/1560X). On an unspecified date the patient experienced erythema at the injection site with induration after the administration of ZOSTAVAX (Merck). The area was tender, swollen, and warm and had a 1 inch red "pathway" radiating to the elbow. The patient sought medical attention with the pharmacist and no laboratory diagnostics studies had been performed. At the time of reporting, 13-MAR-2009, the outcome of the patient is not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female patient with penicillin allergy who on 20-MAR-2009 was vaccinated subcutaneously in the left arm with 0.65 ml of a dose of ZOSTAVAX (Merck) (Lot number 662857/1560X). On an unspecified date the patient experienced erythema at the injection site with induration after the administration of ZOSTAVAX (Merck). The area was tender, swollen, and warm and had a 1 inch red "pathway" radiating to the elbow. The patient sought medical attention with the pharmacist and no laboratory diagnostics studies had been performed. At the time of reporting, 13-MAR-2009, the outcome of the patient is not recovered. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 73 year female who in November 2006, was vaccinated subcutaneously with 0.65 ml of ZOSTAVAX (Merck) (lot no. not reported). On 20-MAR-2009 the patient experienced shingles. A blood test were performed (results not reported). The patient sought unspecified medical attention. Additional information is not expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram, Dysphagia, Lymphadenopathy
Clinical narrative: Information has been received from a 64 year old female consumer with high blood pressure and high cholesterol who on 19-FEB-2009 was vaccinated with ZOSTAVAX (Merck) (lot number not reported). Concomitant therapy included blood pressure and cholesterol medications (manufacture unspecified). On approximately 26-FEB-2009, about a week later, the patient noticed she had swelling of her lymph nodes under the left shoulder blade and under right arm and she was having trouble swallowing. The consumer stated that she had spoken with her physician and was going to had a CAT scan on 24-MAR-2009l and a biopsy on 25-MAR-2009. The consumer sought unspecified medical attention. The consumer stated that the swelling of the lymph nodes were getting worse and not recovered. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received from a nurse concerning a 70 year old female with blood pressure high, depression and history of shingles (unspecified time period) who on 14-JAN-2009 was vaccinated with ZOSTAVAX (Merck), lot number: 662971/1214X SQ. Concomitant therapy included (TEKTURNA), lovastatin (manufacturer unknown), (EFFEXOR XR), aspirin and (NAMENDA). On 23-MAR-2009 the patient developed shingles and had lesions on her left side with pain. The patient's shingles persisted. The patient was referred to unspecified dermatologist. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a Registered Nurse (R.N) concerning herself with no pertinent medical history and no known drug allergies/drug reactions, who on 17-MAR-2009 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) intradermally. There was no concomitant medication. It was reported that the patient developed a 3 inch by 1 inch lump at the site of injection. It was reported that the area was also red and sore. The patient sought unspecified medical attention. There were no laboratory diagnostic tests performed. It was reported that the patient was recovering at the time of the report. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Varicella post vaccine
Clinical narrative: Information has been received from a pharmacist concerning a male "over 60" year old who on an unspecified date was vaccinated SQ with a 0.65mL dose of ZOSTAVAX (Merck) (lot number not provided). The pharmacist reported that the patient developed chickenpox after receiving the vaccine. The reporter described it as "head to toe breakthrough varicella". The pharmacist said that this adverse event had already been reported. It was not specified if the patient sought medical attention. Additional information is not expected.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Wrong technique in drug usage process
Clinical narrative: Information has been received from registered pharmacist concerning a female patient who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck) (Lot No: 663369/1707X), in the left upper triceps. Secondary suspect vaccine included a dose of PNEUMOVAX 23 (Lot No: 661740/1408X). It was reported that the PNEUMOVAX 23 was used to reconstitute the dose of ZOSTAVAX (Merck). The registered pharmacist reported that on an unknown date, the patient's left arm was red and hurting where the injection site was given. The left arm was swollen and red around the elbow. The registered pharmacist reported that the patient mentioned that 3 weeks after ZOSTAVAX (Merck) was given she experienced these symptoms. On an unknown date the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested,