chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: Information has been received from a 62 year old female patient with blood pressure high, a history of shingles with neuralgia and no known drug allergy, who on 13-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included amlodipine. On 14-AUG-2010 the patient developed neuralgia. She spoke with a pharmacist for medical attention. The patient took one dose of BENADRYL and received some relief. No laboratory diagnostics studies were performed. The patient was not recovered at the time of reporting. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a male patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). A couple of days since he got the vaccine he had a red spot the size of a silver dollar at the injection site and it itched. He mentioned he would be contacting his doctor. The action taken and the status of the patient were unknown. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 63 year old female consumer who about three years ago in approximately 2007 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The consumer stated that on 19-JUL-2010 she developed shingles after receiving ZOSTAVAX (Merck). At the time of the report, the patient had not recovered from shingles. It was unknown if the patient sought medical attention. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Information has been received from a pharmacist concerning a male patient who was vaccinated with a dose of ZOSTAVAX (Merck) about a week and a half ago. A pharmacist mentioned that about 9-10 days later, the patient reported developing nerve pain in the neck that was a sharp shooting pain that was intermittent in nature. No laboratory tests were performed to the patient. And at the time of the report the patient's outcome was unknown. Follow-up information was received from the Doctor of pharmacy who reported that there were no more adverse reactions. Everything that occurred was discussed when he called and spoke to the representative. There was nothing else that could be documented outside of the phone conversation. No further information is available.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old female patient who on 30-JUN-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The pharmacist reported that the patient returned to the pharmacy at an unspecified time the weekend (17-JUL-2010 or 18-JUL-2010) to report that she had a chicken pox-like rash on the stomach and back and a different, very painful shingles-like rash on an unspecified foot. Pharmacist reported that the patient self-treated with BENADRYL and Hydrocortisone cream. At the time of this report, the patient was recovering from chicken pox-like rash and shingles-like rash. The patient sought medical attention. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccine breakthrough infection
Clinical narrative: Information has been received from a physician concerning a 65 year old male patient "about a year ago", in approximately 2009, was vaccinated subcutaneously with one dose of ZOSTAVAX (Merck). The physician reported that the patient got a breakthrough case of the shingles "about 6 months ago", in approximately January 2010. At the time of the report, the patient had not recovered from the event. The patient sought unspecified medical attention. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin lesion, Urticaria
Clinical narrative: Information has been received from a physician concerning a 71 year old female patient with history of chicken pox and hypertension and no recent exposure to chicken pox or shingles who on 15-JUL-2010 (also reported as 16-JUL-2010), was vaccinated with a dose of ZOSTAVAX (Merck) in her deltoid at a local pharmacy. It was reported that on 16-JUL-2010, shortly after receiving vaccine live (Merck), the patient developed a rash on her chest, back and arms, the rash was reported as urticarial rash. The patient saw the physician on 19-JUL-2010, and the physician said that the rash was two or three centimeters in size and the patient had itching as well. The patient had 7100 lesions distributed on her chest, abdomen, hands and arms. The patient was using calamine lotion but the physician provided a steroid pack on 19-JUL-2010. Additional information has been requested.
Age: 17.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a pharmacy student concerning a 17 year old patient who on 22-JUL-2010 was inadvertently vaccinated a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). No adverse event was reported. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient with penicillin allergy and sulfonamide allergy who on 20-JUL-2010 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot# 664670/0151Z, exp 28-MAR-2011) SC in left upper arm. On 22-JUL-2010 the patient woke up with swelling and redness below the injection site on her left upper arm. The patient sought unknown medical attention. At the time of report the patient's status was not recovered. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash erythematous
Clinical narrative: Information has been received from a medical resident concerning a 68 year old female patient with osteoarthritis, hyperthyroidism, hyperlipidaemia, rhinitis allergic and migraines and a history of statin induced increase in liver function tests, hysterectomy and lumpectomy three time on the right breast who in September 2009, was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included aspirin, SYNTHROID, simavastatin, multi-vitamins (unspecified), "vel patch" and "micaluer". The medical resident reported that about seven or ten days ago, on approximately 11-JUL-2010, the patient had developed shingles. The patient had a red rash on the back midway down and extending under the right breast. No lab testes were performed. The patient sought medical attention by an office visit. At the time of the report, the patient was recovering. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a physician concerning a male patient who on an unspecified date in November 2009 ("last November"), was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). Concomitant therapy included CRESTOR. In November 2009, the patient developed a generalized rash around his groin and hands since he received the ZOSTAVAX (Merck). He went to the doctor's office to seek unspecified medical attention. at the time of this report, the patient's outcome was unknown. 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 an unspecified date was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). After receiving ZOSTAVAX (Merck), "a year or 2 ago", in approximately 2008 the patient did come down with shingles, although the patient presented with limited symptomatology. It was unspecified how long after getting the "shot" the patient developed shingles. The vaccine was administered at an unspecified pharmacy. It was reported that the shingle improved after stopping therapy. The patient sought unspecified medical attention. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a 70 year old male with no allergies and hypertension, reflux, high cholesterol and benign prostatic hyperplasia who "last week", approximately on 13-JUL-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The nurse reported that the patient was given ZOSTAVAX (Merck) and 17-JUL-2010 "three days ago", the patient experienced shingles. The patient was being treated with FAMVIR. at the time of the report, the patient had not recovered from shingles. The patient sought medical attention by an office visit. Follow up information was received from other health professional concerning the retired male patient who on 13-JUL-2010 was vaccinated in the left deltoid with a dose of ZOSTAVAX (Merck) (Lot# unknown). On 17-JUL-2010, the patient experienced rash, pain, vesicular rash in the left side of chest anterior and smaller amount posterior and axilla. The patient's maximum temperature was 97.8 degrees and the level of pain was reported as 2 out of 10. At the time of the report, the patient was still symptomatic. 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 Merck vaccine strain. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injected limb mobility decreased, Pain in extremity, Rash
Clinical narrative: Information has been received from a nurse concerning a 70 year old male with no allergies and hypertension, reflux, high cholesterol and benign prostatic hyperplasia who "last week", approximately on 13-JUL-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The nurse reported that the patient was given ZOSTAVAX (Merck) and 17-JUL-2010 "three days ago", the patient experienced shingles. The patient was being treated with FAMVIR. at the time of the report, the patient had not recovered from shingles. The patient sought medical attention by an office visit. Follow up information was received from other health professional concerning the retired male patient who on 13-JUL-2010 was vaccinated in the left deltoid with a dose of ZOSTAVAX (Merck) (Lot# unknown). On 17-JUL-2010, the patient experienced rash, pain, vesicular rash in the left side of chest anterior and smaller amount posterior and axilla. The patient's maximum temperature was 97.8 degrees and the level of pain was reported as 2 out of 10. At the time of the report, the patient was still symptomatic. 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 Merck vaccine strain. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash vesicular
Clinical narrative: Information has been received from a 70 year old male patient with no drug allergies, who on 13-JUL-2010 was vaccinated with a single dose of ZOSTAVAX (Merck). Concomitant therapy included "too many" AVAPRO, terazosin hydrochloride, lansoprazole, simvastatin, UROXATRAL and AVODART. It was reported that "In 1965 I felt pain on my stomach and my physician looked at it and said that it was Shingles. He gave me something to treat it and it was over very quickly. I'm not sure if it was really Shingles because it went right away." On 20-JUL-2010, 7 days post vaccination, the patient noticed a rash on his chest and face while taking a shower. Caller also stated that his wife noticed that the rash was on his back as well and his physician diagnosed it as Shingles. The patient received unspecified medical attention. At the time of the reporting, the patient had not recovered. Follow-up information received from the patient indicating that he received the shingles vaccine on 13-JUL-2010. About 3 days later, the patient developed shingles, and also a somewhat painful left arm (the arm which received the shot) which he could not move for approximately 2 weeks. The patient subsequently took naproxen 500mg for the arm problem, which was prescribed by another doctor who the patient was seeing for an unrelated issue. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injected limb mobility decreased, Pain in extremity, Rash
Clinical narrative: Information has been received from a 70 year old male patient with no drug allergies, who on 13-JUL-2010 was vaccinated with a single dose of ZOSTAVAX (Merck). Concomitant therapy included "too many" AVAPRO, terazosin hydrochloride, lansoprazole, simvastatin, UROXATRAL and AVODART. It was reported that "In 1965 I felt pain on my stomach and my physician looked at it and said that it was Shingles. He gave me something to treat it and it was over very quickly. I'm not sure if it was really Shingles because it went right away." On 20-JUL-2010, 7 days post vaccination, the patient noticed a rash on his chest and face while taking a shower. Caller also stated that his wife noticed that the rash was on his back as well and his physician diagnosed it as Shingles. The patient received unspecified medical attention. At the time of the reporting, the patient had not recovered. Follow-up information received from the patient indicating that he received the shingles vaccine on 13-JUL-2010. About 3 days later, the patient developed shingles, and also a somewhat painful left arm (the arm which received the shot) which he could not move for approximately 2 weeks. The patient subsequently took naproxen 500mg for the arm problem, which was prescribed by another doctor who the patient was seeing for an unrelated issue. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 64 year old patient who in fall 2008, in approximately September 2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number unknown). The physician reported that in July 2010 the patient had a current shingles outbreak and he was treating the patient's shingles (Treatment unspecified). At the time of the report, the patient had not recovered from shingles. The patient sought medical attention (spoke to physician). Follow-up information has been received from a completed questionnaire from a physician concerning a retired female patient with no illness at time of vaccination, a history of chicken pox when childhood and no recent exposure to chickenpox or herpes zoster, who on 18-NOV-2008 (previously reported as September 2008) was vaccinated subcutaneously into her left arm with a dose of ZOSTAVAX (Merck) (Lot 659759/1873U). The physician stated that on 20-JUL-2010 the patient had a zoster outbreak. The lesions were in the left upper arm C5. The patient had a pain value 3 in scale 0 to 10. There was not a direct fluorescent antibody, no specimen was collected for PCR and no photos were taken of the lesion. In September 2010, the patient recovered. There were no laboratories diagnostics studies performed. No further information is available.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a 66 year old female with allergy to flu vaccine who on approximately 12-AUG-2010, "2 weeks ago", was vaccinated with ZOSTAVAX (Merck). Concomitant therapy included vitamins (unspecified). The patient said that she developed a rash on the injection site 2 days later (on approximately 14-AUG-2010) after getting ZOSTAVAX (Merck). The patient stated that her rash was approximately 1.5 inches and that it was getting bigger as time progresses. The patient was recovering at the time of reporting. It was not specified if the patient sought medical attention or not. Additional information has been requested.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pruritus, Ultrasound thyroid
Clinical narrative: Information has been received from an 85 year old female consumer with codeine, penicillin and "vioxin" allergy and a history of "on steroids about fourteen years ago" who on 18-AUG-2010 was vaccinated subcutaneously with a 0.65ml dose of ZOSTAVAX (Merck) (lot# not reported) in her upper arm. Concomitant therapy included alendronate sodium (MSD), ENAPRIL and lovastatin. On 18-AUG-2010 she began to feel soreness at the injection site. On 20-AUG-2010 she began to feel itchiness. No medical attention was sought. On 10-AUG-2010, ultrasound on thyroid was performed with no results reported. At the time of this report, the patient had not recovered. No further information is available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Paraesthesia
Clinical narrative: Information has been received from a pharmacist (R. Ph.) concerning a 60 year old male with no medical history and no drug allergies who on 07-DEC-2010 was subcutaneously vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # not reported). There was no concomitant medication. The reporter stated that on 10-JAN-2011 the patient complained of a sensation he described as "1000 pins being pushed into his back, starting at the bottom, and rising to the top, accompanied by a tingling and sweating sensation, that required me to take my coat off." At the time of reporting, the outcome of the patient was unknown. No lab diagnostics studies were performed. The patient sought medical attention by returning to pharmacy. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a patient who contracted shingles after close contact with individuals that had received ZOSTAVAX (Merck) (0.65ml, SC, one time shot). It was unknown if the patients sought medical attention. At the time of the reporting, the patients' statuses were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Exposure to vaccinated person, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a patient who contracted shingles after close contact with individuals that had received ZOSTAVAX (Merck) (0.65ml, SC, one time shot). It was unknown if the patients sought medical attention. At the time of the reporting, the patient's statuses were unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: Information has been received from a female with no drug allergies and a history of hip replacement in November 2010 who "two or three weeks ago", in approximately January 2011, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapy included SYNTHROID, LIPITOR and alendronate sodium, "2 weeks ago", on approximately 04-JAN-2011 the patient developed a hive near the injection site on her left arm. The patient did not seek medical attention. No treatment was given to the event. There were no lab diagnostics performed. On 18-JAN-2011, the patient recovered from the event. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female patient with a history of fibromyalgia who on an unspecified date was vaccinated with one dose of ZOSTAVAX (Merck) (lot # and expiration date not reported). In the evening after receiving the vaccine the patient experienced chills and zoster-like symptoms. No treatment was given to the patient (also reported as the adverse events improved on therapy). A few days after the onset date, the patient recovered from chills and zoster-like symptoms. The patient did not seek medical attention. No further information is available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash, Rash erythematous
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old male with a history of rash caused by penicillin who on 03-DEC-2010 was vaccinated with ZOSTAVAX (Merck) (lot no. 669533/1383Z, exp. 19-JAN-2012). On approximately 10-DEC-2010, reported as "a week later", the patient experienced "red dot rash without blisters" on the back of his arms and on his back, and "in prick pain" when lying in bed and while putting on a shirt. The patient sought medical attention via saw pharmacist. At the time of report, symptoms were persisted, patient did not recover. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a licensed practical nurse (L.P.N.) concerning a 66 year old female with hypertension and no drug allergies/reactions who on 27-JUN-2008 was subcutaneously vaccinated with ZOSTAVAX (Merck) (lot # 659406/0298X). Concomitant therapy included lisinopril (manufacturer unknown), loratadine (manufacturer unknown) and gabapentin. The reporter stated that the patient developed shingles twice in 2010 (the date of the first episode was unknown, the date of the second episode was 17-NOV-2010). The patient recovered from the second episode of shingles on 27-DEC-2010. TYLENOL was given for treatment of this event. No lab diagnostics studies were performed. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Information has been received from a Doctor of pharmacy concerning a 65 year old female patient with no adverse events following prior vaccination who on 17-JAN-2011, at 11:30, was vaccinated subcutaneously with the first dose of ZOSTAVAX (Merck) (Lot number 669538/1390Z) and developed localized reaction, redness and swelling which resolved without treatment. The patient did not require an emergency room/doctor visit. There were no diagnostic tests or laboratory data. At the time of the report the patient had recovered. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a registered pharmacist concerning a 62 year old female patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck). The pharmacist reported that the patient "may have developed shingles after receiving ZOSTAVAX (Merck)". The outcome of the patient was not reported. It was unknown if the patient sought medical attention. No further information is available.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pruritus generalised, Urticaria
Clinical narrative: Information has been received from a 60 year old female consumer who on 04-AUG-2010, was vaccinated with a dose of ZOSTAVAX (Merck). On 04-AUG-2010, at "about 17:00" the patient experienced itching in the middle finger of left hand, then went to hair. On 05-AUG-2010, in the morning the patient was experiencing itching "all over". The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow-up information has been received from a physician concerning the speech pathologist and teacher with allergy to levofloxacin, codeine and erythromycin, iodine hives and no illness at the time of vaccination. On 04-AUG-2010 the patient was vaccinated SQ with a first dose of ZOSTAVAX (Merck) (lot# 664671/0149Z) in her left deltoid and a first IM dose of ADACEL (lot# 03082AA) into her right deltoid. On 04-AUG-2010, one hour after receiving the two vaccines, the patient developed urticaria and generalized pruritus. She received treatment with ZYRTEC, MEDROL "dose pack" and ranitidine. At the time of the report, the outcome of urticaria was unknown. Additional information is not expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 65 year old female patient with high blood pressure, with allergic reaction to erythromycin and a history of cerebrovascular accident who on 30-JUL-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number 665532/0711Z) (Expiration date: 29-APR-2011). Concomitant therapy included MICARDIS, WELCHOL and AGGRENOX. The physician reported that a patient called the office on 02-AUG-2010 to report after receiving ZOSTAVAX (Merck), she experienced flu like symptoms, fever, chills and vomiting that started on approximately 30-JUL-2010 (over the weekend). On 02-AUG-2010 the patient recovered from flu like symptoms, fever, chills and vomiting. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 4 year old female who on 04-AUG-2010 was vaccinated subcutaneously with ZOSTAVAX (Merck) (lot number 665431/1744Y). It was reported that the patient was intended to receive the second dose of VARIVAX (Merck), and was inadvertently administered a dose of ZOSTAVAX (Merck). No adverse symptoms reported. The nurse added that the first dose of VARIVAX (Merck) was administered on 22-MAY-2007. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 67 year old female patient with asthma and hypertension and no drug allergies who on 05-AUG-2010, was vaccinated with a SC dose of ZOSTAVAX (Merck) (lot # 664672/0478Z). Concomitant therapy included PRILOSEC, hydrochlorothiazide (manufacturer unknown), metformin, sertraline HCl, clonazepam and KLOR-CON. On 06-AUG-2010, the patient experienced the "hard knot" area about the size of a half dollar at the injection site. No lab diagnostics studies were performed. The patient's "hard knot" area about the size of a half dollar at the injection site persisted. The patient would see the physician tomorrow. Follow-up information received from the physician indicating that the patient's adverse events went away. Follow-up information received from a pharmacist concerning a 67 year old female who at 3:15 PM on 05-AUG-2010 was vaccinated with the first dose of ZOSTAVAX (Merck)  (lot # 664672/0478Z) in the left deltoid. Concomitant therapy included omeprazole 20, clonazepam 1mg, etodolac 400mg, XOPENEX and ADVAIR. In the evening of 05-AUG-2010 the patient developed large knot at the injection site, swollen and itching. The patient used ice and calamine lotion for treatment. No other swelling or rash. The patient had doctor visit the next day on 06-AUG-2010. No test or action was done by the doctor. The condition resolved. No further information is available.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a 66 year old male consumer concerning himself with penicillin allergy and no other pertinent medical history who in approximately December 2006 ("end of 2006"), was vaccinated with a dose of ZOSTAVAX (Merck) (lot# not reported). There was no concomitant medication. In approximately December 2006 ("end of 2006"), the patient experienced a mild irritation at the injection site. No medical attention was sought. There were no laboratory diagnostics studies performed. The patient recovered within a couple of hours. The consumer also reported that when receiving a tetanus shot (manufacturer unspecified) he had injection site irritation that lasted for a few days. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 9 year old male patient who on 05-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number665527/0696Z, exp 21-APR-2011) instead of the second dose of VARIVAX (Merck). The staff reached for the wrong vial. This was no a PQC but human error. No adverse symptoms noted. The patient sought unspecified medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 60 year old male with benign prostatic hyperplasia and hypertension who on approximately 02?-AUG-2010 "last week" as vaccinated with ZOSTAVAX (Merck) (therapy dose, route and site unknown). On 09-AUG-2010 the patient was complaining of "burning sensation" on his rib cage. The physician stated that the patient had pain indicated as being a "6/10 on a pain scale". The patient sought medical attention. The patient did not have a rash or any blisters, but the physician believed this was a precursor to shingles. At the time of this report, the patient had not recovered. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Swelling face
Clinical narrative: Information has been received from a 79 year old female with no drug allergies and with high blood pressure and gastrooesophageal reflux (GI reflux) and a history of shingles on or about 04-JUL-2008 who in August 2008 ("approximately one month later"), was vaccinated with a SC dose of ZOSTAVAX (Merck). Concomitant therapy included aspirin, TOPROL XL tablets and PRILOSEC. In August 2008, the patient experienced raised, swollen, itchy bumps on the left side of her face from her forehead down to her left eye. The condition rarely subsided and had persisted since August 2008. No lab diagnostics studies were performed. The patient had not sought medical attention for this. Follow up information was received from a nurse practitioner who reported that on 07-JAN-2009 (previously reported as August 2008), the 80 year old female patient (previously reported as 79 year old) with malaise and weight loss at time of vaccination and allergy to codeine, DEMEROL, morphine and T/GEL, was vaccinated with the first dose of ZOSTAVAX (Merck) SC into her left deltoid (lot # 663178/1414X). The reporter was not aware the patient experienced adverse reaction. It was not reporter to the reporter. The onset of the adverse experience previously reported as "August 2008". Additional information is not available.
Age: 15.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 15 year old male patient who on 06-AUG-2010 was inadvertently vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) (lot# 664628/1018Y). It was mentioned that the patient received his first dose of VARIVAX (Merck) at one year old. He returned today (06-AUG-2010) for his second dose and inadvertently received ZOSTAVAX (Merck). No adverse effects were reported. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Hypoaesthesia, Local swelling, Oedema peripheral
Clinical narrative: Information has been received from a 76 year old female consumer who on 26-JUL-2010 was vaccinated with ZOSTAVAX (Merck). After she received the shot she began to feel hot in her legs and arms. The sensation continued to worsen, developing into numbness by the time she went to bed that night. She reported that upon awakening, her neck and face felt "puffy" and numb. She consulted with her doctor who recommended she take BENADRYL. The consumer reported only taking the BENADRYL late in the day because it "makes her sleepy." She said that her symptoms were resolving, but that her neck and face especially still felt "warm, puffy and numb." She said, "To me, I look red under my skin," but denied ever developing a rash. She denied beginning any other medications at the time of the administration. Follow-up information received from the administering facility indicating that the patient with hypertension and anxiety, was experiencing red arm and throat swollen on 29-JUL-2010 and recovered from the events on 30-JUL-2010. There were no labs or diagnostic tests performed. The reporter reported that they did not give the vaccine. Additional information was not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal oedema, Swelling face
Clinical narrative: Information has been received from a 76 year old female consumer who on 26-JUL-2010 was vaccinated with ZOSTAVAX (Merck). After she received the shot she began to feel hot in her legs and arms. The sensation continued to worsen, developing into numbness by the time she went to bed that night. She reported that upon awakening, her neck and face felt "puffy" and numb. She consulted with her doctor who recommended she take BENADRYL. The consumer reported only taking the BENADRYL late in the day because it "makes her sleepy." She said that her symptoms were resolving, but that her neck and face especially still felt "warm, puffy and numb." She said, "To me, I look red under my skin," but denied ever developing a rash. She denied beginning any other medications at the time of the administration. Follow-up information received from the administering facility indicating that the patient with hypertension and anxiety, was experiencing red arm and throat swollen on 29-JUL-2010 and recovered from the events on 30-JUL-2010. There were no labs or diagnostic tests performed. The reporter reported that they did not give the vaccine. Additional information was not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Blister, Condition aggravated, Herpes zoster, Pruritus
Clinical narrative: Information has been received from a 69 year old female patient with a history of shingles in 2007 who at the end of December 2008, was vaccinated with ZOSTAVAX (Merck) (Lot# unknown). The reporter stated that on 03-JUL-2010, she experienced a mild episode of shingles. She also reported that "recently" on 03-JUL-2010, she had been itching like crazy, she got small pimples and water like blisters. At the time of the report, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Erythema, Papule, Vaccine breakthrough infection, Varicella
Clinical narrative: Information has been received from a consumer concerning her 68 year old husband with prostate cancer who about four months ago, in approximately April 2010, was vaccinated with a dose of ZOSTAVAX (Merck). Concomitant therapy included simvastatin (MSD), finasteride (MSD), losartan potassium-HCTZ (MSD), SYNTHROID, niacin (manufacturer unknown) and vitamins (unspecified). The representative reported that about a month ago, on approximately 03-JUL-2010, her husband noticed papules on his legs and trunk, primarily his legs. The consumer believed the patient had breakthrough chickenpox. The patient went to the physician who was not sure what the issue was. The patient then went to a dermatologist who thought they were spider bites. The patient did some research and believes her husband had breakthrough chickenpox and erythema. The patient's papules started to get better then they reappeared. At the time of the report the patient was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from an over 60 year old female who at "last week" (on approximately 08-SEP-2010), was vaccinated with a dose of ZOSTAVAX (Merck) (LOT# not reported). At the point of injection soon after she developed a rash and it became extremely itchy and it was still itchy. The patient had not recovered. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Paraesthesia, Pruritus, Rash, Stomatitis
Clinical narrative: Information has been received from a physician concerning a female patient who at the end of July 2010 was vaccinated with a dose of ZOSTAVAX (Merck). A dose of ADVAIR was using prior to ZOSTAVAX (Merck) in July 2010, and cortisone shot, KENALOG and Lidocaine shots were given on 10-AUG-2010 for patient's neck and back. It was reported that a few days after receiving the cortisone shot the patient experienced sores in the mouth, tingling and rash on both legs below the knees. On 10-AUG-2010 the patient saw an orthopedic surgeon and received KENALOG and Lidocaine shots for their back and neck. Within 2 days of this the patient started to have itching and burning on their forehead and one week following this developed sores in their mouth and tingling/pins and needles sensation on both legs below the knees. The patient called and was going into the physician's office. At time of reporting, the patient had not recovered. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a certified medical assistant concerning a patient who on 07-SEP-2010 was vaccinated with ZOSTAVAX (Merck) (Lot# 665516/1271Y, dose/frequency, route unspecified). The patient was inadvertently administered ZOSTAVAX (Merck) instead of VARIVAX (Merck). No adverse effects reported. Follow up information reported that the medical assistant stated that the patient was administered ZOSTAVAX (Merck) instead of VARIVAX (Merck) due to a medical error and not product confusion, and refused to give the patient's name or DOB. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Information has been received from a female consumer who on 23-JUL-2010 was vaccinated with ZOSTAVAX (Merck) once injection. Pertinent medical history, drug reactions or allergies were unspecified by reporter. On approximately 13-SEP-2010 (reported as"now"), the patient experienced tingling and prickling feeling all over her body. At the time of reporting, the outcome of the patient was not provided. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture positive, Herpes zoster, Rash vesicular, Varicella virus test positive
Clinical narrative: Information has been received from an 80 year old female consumer who on 30-NOV-2009 was vaccinated with a 0.65ml dose of ZOSTAVAX (Merck) (Lot # and route not reported). Concomitant therapy included carvedilol, NIASPAN, simvastatin (manufacturer unknown), indapamide, warfarin, DIOVAN and SPIRIVA. The consumer reported that this past week on approximately 27-SEP-2010, she developed a case of shingles. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Follow-up information was received from the physician concerning the with patient who on 27-SEP-2010 developed a grouped vesicular cutaneous eruption on left abdomen and back stopping at midline with case of herpes zoster after receiving vaccination in winter of 2009. On 28-SEP-2010, a varicella zoster culture was performed which was positive for varicella zoster virus. Per herpes varicella zoster questionnaire received, a rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. The patient had a history of chicken pox in her childhood. It was not known if the patient was recently exposure to chicken pox or herpes zoster. A direct fluorescent antibody test was not performed and a specimen was not collected for PCR. On 10-OCT-2010, the patient recovered. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nasopharyngitis
Clinical narrative: Information has been received from a 78 year old female with blood pressure, drug reaction to amoxicillin and CIPROMAX and a history of bad case of chicken pox, who 3 years ago, in September 2007 was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (Merck). Concomitant therapy included "blood pressure pill" (unspecified). The consumer stated that "4 weeks ago" (on approximately 23-AUG-2010) she developed shingles around her waist; although she had been vaccinated with ZOSTAVAX (Merck). She stated that ever since she had developed shingles, she also had developed a cold that she "could not get rid of". The patient's shingles were healing. There were not lab diagnostic studies performed. The patient sought unspecified medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Information has been received from a registered pharmacist concerning an over 60 year old female patient who a week ago, on approximately 31-AUG-2010 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). After receiving the vaccine the injection site became red right away and then a rash developed at the injection site. At the time of the report the patient had not recovered. Patient sought unspecified medical attention. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a patient complained to a pharmacist concerning a 60 year old female patient who on approximately 19-AUG-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot Unknown). In August-2010 developed soreness, bruises, and swelling at the site. It was reported that the patient recovered from bruises and swelling, resolved but not the soreness. Patient did not seek medical attention. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Dyspnoea, Pruritus, Rash, Rash maculo-papular
Clinical narrative: Information has been received from a consumer concerning her 75 year old sister with osteoarthritis, polymyalgia and no drug reactions or allergies who on 15-SEP-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). The consumer stated that on 18-SEP-2010 "3 days later from vaccination", her sister developed a few bumps around the waist. She went to see a physician at urgent care. The physician at urgent care informed her sister that it was not shingles, the bumps were hives. No lab diagnostics were performed. The consumer stated that the physician prescribed her sister ZYRTEC. On 06-OCT-2010, the physician stated that the patient's hives had resolved on an unspecified date, but on 05-OCT-2010, the patient noticed one hive on her back at waist level. She also mentioned that the hives she had experienced had been itchy. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the consumer and a physician and a physician assistant via a medical record. It was reported that the patient with arthritis, controlled high blood pressure, mild asthma, oesophageal stricture and eggplant allergy, who did not use tobacco, drunk less than 1 drink per day and did not use illicit drugs, on 15-SEP-2010 at approximately 11:00 was vaccinated with a dose of ZOSTAVAX (Merck). The patient had no illness at the time of vaccination. Concomitant therapy included CELEBREX stopped about the same time as the vaccination, pantoprazole, losartan potassium, spironolactone, atenolol, "dirioran" and PROAIR. The patient reported that three days after vaccine, on 18-SEP-2010, the patient developed hives around waist, front and back, about 12 in all, itchy, this lasted about a week. Four days after vaccine, the patient developed a rash on hip and back; mild itchy which lasted about 1 week. The patient had occasional mild hive, 1 week, for six weeks after vaccine. The patient went away within 2 days. The patient visited an urgent care center. The physical exam was within normal limits except for skin inspection and palpitation which revealed faint maculopapular diffuse rash on back and respiratory symptoms such as short of breath. The physician reported that the patient had a non severe possible allergic reaction for 7 days which was itching. No laboratory diagnostics studies were performed. The patient was prescribed with fluids, ZYRTEC 10 mg daily for itch, hydrocortisone cream as needed and hydroxyzine 10 mg every 8 hours PRN for itch if other medication not effective. It was reported that the patient recovered from hive on 28-OCT-2010 (as well as unknown). This is one of several reports received from the same source. No further information is available.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Information has been received from a consumer concerning her 75 year old sister with osteoarthritis, polymyalgia and no drug reactions or allergies who on 15-SEP-2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot# not reported). The consumer stated that on 18-SEP-2010 "3 days later from vaccination", her sister developed a few bumps around the waist. She went to see a physician at urgent care. The physician at urgent care informed her sister that it was not shingles, the bumps were hives. No lab diagnostics were performed. The consumer stated that the physician prescribed her sister ZYRTEC. On 06-OCT-2010, the physician stated that the patient's hives had resolved on an unspecified date, but on 05-OCT-2010, the patient noticed one hive on her back at waist level. She also mentioned that the hives she had experienced had been itchy. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the consumer and a physician and a physician assistant via a medical record. It was reported that the patient with arthritis, controlled high blood pressure, mild asthma, oesophageal stricture and eggplant allergy, who did not use tobacco, drunk less than 1 drink per day and did not use illicit drugs, on 15-SEP-2010 at approximately 11:00 was vaccinated with a dose of ZOSTAVAX (Merck). The patient had no illness at the time of vaccination. Concomitant therapy included CELEBREX stopped about the same time as the vaccination, pantoprazole, losartan potassium, spironolactone, atenolol, "dirioran" and PROAIR. The patient reported that three days after vaccine, on 18-SEP-2010, the patient developed hives around waist, front and back, about 12 in all, itchy, this lasted about a week. Four days after vaccine, the patient developed a rash on hip and back; mild itchy which lasted about 1 week. The patient had occasional mild hive, 1 week, for six weeks after vaccine. The patient went away within 2 days. The patient visited an urgent care center. The physical exam was within normal limits except for skin inspection and palpitation which revealed faint maculopapular diffuse rash on back and respiratory symptoms such as short of breath. The physician reported that the patient had a non severe possible allergic reaction for 7 days which was itching. No laboratory diagnostics studies were performed. The patient was prescribed with fluids, ZYRTEC 10 mg daily for itch, hydrocortisone cream as needed and hydroxyzine 10 mg every 8 hours PRN for itch if other medication not effective. It was reported that the patient recovered from hive on 28-OCT-2010 (as well as unknown). This is one of several reports received from the same source. No further information is available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 61 year old registered nurse who on 18-SEP-2010 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # not provided) SC on back of deltoid. Within 24 hours, she developed an 8 inch by 6 inch warmth, red, raised area around the injection site. She has been treated with cortisone cream. At the time of this report, the patient had not recovered. The patient did not seek medical attention. Additional information has been requested.