chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Oral herpes, Pyrexia
Clinical narrative: Information has been received from a male physician who was vaccinated with a subcutaneous dose of Zostavax. There was no concomitant therapy. Subsequently the physician experienced a fever, GI upset and fever blister on his lip. Unspecified medical attention was sought. No product quality complaint. Subsequently, the physician recovered. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a female consumer who on 10-APR-2007 was vaccinated with one dose of Zostavax. Subsequently on 13-APR-2007 the patient developed a red swelling about 2 to 3 inches at the injection site on her arm. Medical attention was not sought. At the time of the report, the patient had not recovered. No additional information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female patient in her sixties who on approximately 10-APR-2007 was vaccinated SC in the back of the arm with a dose of Zostavax. A few hours later, the patient developed an injection site reaction, swelling, and redness at the injection site which was one half inch wide and two inches long in a rectangular shape. The patient went to her physician and no treatment was required. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Herpes zoster, Incorrect route of drug administration
Clinical narrative: Information has been received from a physician and a registered nurse concerning a 61 year old retired white female who on 19-DEC-2006 was vaccinated IM in the right deltoid with a 0.65ml first dose of Zostavax (lot # 654603/1405F). On 15-JAN-2007 and 13-MAR-2007 the patient experienced mild outbreaks of shingles. The outbreaks were reported to be in the patient's hair line on right forehead, she had hair loss with both outbreaks. Unspecified medical attention was sought. It was reported that as 13-APR-2007, the patient had not yet had to visit the ophthalmologist or be hospitalized. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a patient in their late seventies with no medical history who, on an unspecified date, was vaccinated with a 0.65 mL dose of Zostavax. There was no concomitant medication. Subsequently the patient experienced a red mark of 1 to 2.5 cm at the injection site. It became worse on the third day and was 4 by 4 cm. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a patient in their mid sixties who on an unspecified date was vaccinated with a 0.65 ml dose of Zostavax. There was no concomitant medication. Subsequently the patient experienced a two by two red, itchy, and inflamed area two days after vaccination. Unspecified medical attention was sought. No diagnostic laboratory test were performed. The patient recovered on an unspecified date. A product quality complaint was not involved. Additional information has been requested. Additional information has been received from a health care worker who reported that on 31-MAR-2007 the patient reported a red, itchy, swollen area at the injection site. It was believed to be a 3 inch by 3 inch area. It resolved on it's own on 06-APR-2007 after six days. No further information is expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Facial palsy, Facial palsy, No reaction on previous exposure to drug, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated with a 0.65 ml dose of Zostavax. Subsequently the patient developed bells palsy. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 63 year old female with allergies to ZESTRIL, losartan potassium (MSD) (WAES # 0707USA02778) NORVASC and hydrochlorithiazide (manufacturer unknown) (WAES # 0707USA02779), hypertension and hypothyroidism and a history of Bell's palsy, microscopic haematuria and cardiac murmur who on 23-MAR-2007 was vaccinated in the left deltoid with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 656606/0033U). Subsequently the patient developed Bell's palsy. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information from the physician indicated that on 30-MAR-2007 the patient developed Bell's palsy. The patient had left eye droop, left side of mouth droop and tingling left side of face. Unspecified medical attention was sought. At the time of the report the patient still had symptoms. The patient had no adverse events following prior vaccination. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a female patient in her sixties who on approximately 10-APR-2007 was vaccinated SC in the back of the arm with a dose of Zostavax. A few hours later, the patient developed an injection site reaction. She had pain, swelling, and redness at the injection site which was one half inch and two inches long in a rectangular shape. Unspecified medical attention was sought. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac stress test, Chest pain, Pain, Skin lesion
Clinical narrative: Information has been received from a 62 year old female consumer with no reported history or allergies who on 18-SEP-2006 was vaccinated with a dose of Zostavax. Concomitant therapy included Famvir. The patient had no skin reaction to the vaccine, however on 30-DEC-2006 the patient started experiencing pain in the center of her chest that was "so bad she couldn't even go to her physician's office". Two days after experiencing the pain, she started having breakouts with approximately 30 lesions in her spine area and up to the front. As of 17-APR-2007 the patient has recovered and she has had no outbreaks anymore. The only thing she was experiencing was sunburn like pain in her back. It was reported that the patient was seen by a dermatologist to verify the skin rash and for a "stressed test" (results not provided). There was no product quality complaint involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Skin lesion
Clinical narrative: Information has been received from a 67 year old female consumer with no known medical history or allergies who on 11-APR-2007 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. On 13-APR-2007 the patient developed numbness in her right hip. On 15-APR-2007 the patient developed several lesions in her groin and back area. She was seen by a physician who advised her that she had and outbreak of shingles. It was reported that the physician had unspecified "neurological"studies performed (results not provided). At the time of the report, the patient had not recovered. No product quality complaint was involved. No additional information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a male patient (age not reported) who on an unspecified date was vaccinated with Zostavax. Two days later, the patient developed shingles. The patient did not seek medical attention. No further information is available.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature, Dizziness, Malaise, Pyrexia
Clinical narrative: Information has been received from a consumer concerning a female who on an unspecified date was vaccinated with one dose of Zostavax. Subsequently the patient experienced dizziness and illness for over a month after receiving the vaccine. The patient also experienced a fever a couple months after receiving the vaccine. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from an office manager concerning a patient who was vaccinated with a dose of Zostavax. Subsequently two weeks after vaccination, the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 68 year old female who on 13-MAR-2007 was vaccinated SC with a first dose of Zostavax. Concomitant therapy included furosemide, potassium chloride, Tylenol, vitamins (unspecified), Norvasc and simvastatin (manufacturer unknown). On 15-MAR-2007, the patient developed a facial and truncal rash resembling varicella. No diagnostic laboratory tests were performed. Additional information is not expected.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Medication error
Clinical narrative: Information has been received from a 47 year old female who was vaccinated with a dose of Zostavax. The patient reported that she "almost died from a medication given for shingles." Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Nausea
Clinical narrative: Information has been received from a company representative concerning a patient who on approximately 20-MAR-2007 was vaccinated with a dose of Zostavax. Subsequently the patient experienced dizziness and nausea. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a nurse practitioner concerning herself, a 60 year old female with no pertinent medical history and no known drug reactions/allergies who on approximately 21-MAR-2007 was vaccinated with Zostavax. There was no concomitant medication. On approximately 23-MAR-2007, two days after she received one dose of the Zostavax, the patient experienced redness and itching at the injection site area. The patient sought unspecified medical attention. The symptoms lasted three days. On approximately 25-MAR-2007, the patient recovered from redness and itching at the injection site area.  Additional information has been requested. Follow-up information received from the physician office indicating that the nurse practitioner was vaccinated SC with a first dose of ZOSTAVAX on 05-APR-2007 at 17:15. The patient developed mild erythema and site pruritis. The events cleared up in 48 hours. No additional information is expected.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Information has been received from a medical assistant concerning a 72-year-old male who on 21-FEB-2007 was vaccinated with a single dose of Zostavax. On 07-MAR-2007 the patient was seen by a physician and he showed him dried and red crusted blisters on his stomach and back. He denied pain or itching. It was reported that the patient was seen for office visits on 15-MAR-2007 and 27-MAR-2007 and the patient did not mention the blisters again. No outcome was reported. No product complain was involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Mammogram normal, Nuclear magnetic resonance imaging normal, Pain
Clinical narrative: Information has been received from a physician concerning his 65 year old female office medical assistant who in January 2007, was vaccinated with Zostavax. On 05-APR-2007 at 0900 hours, the patient experienced severe pain. After the pain on her left side, it started to radiate up to her breast and shoulder. The patient had reported the pain was the most excruciating she had ever experienced. The patient was prescribed codeine and Famvir. The patient had no rash, only pain. MRI and mammogram were negative. The physician felt that the experience could be internal shingles. Subsequently, the patient recovered on 08-APR-2007. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular, Skin lesion
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a registered nurse concerning an 80 year old female with hypertension, hypokalaemia, osteoarthritis, asthma and sulfonamide allergy who on 09-APR-2007 was vaccinated SC with a 0.5 ml dose of Zostavax (Merck) (lot# 656394/0162U). Concomitant therapy included alendronate sodium, hydrochlorothiazide (manufacturer unknown), potassium (unspecified) and lisinopril (manufacturer unknown). On 16-APR-2007, the patient developed a vesicular rash. The rash covered a 5 cm area of the outer lumbar spine and the lesions crossed the midline. There was no pain. The patient questioned the registered nurse if the rash could be shingles. No lab testing was performed. Unspecified medical attention was sought. The patient was recovering. No further information is expected.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: Information has been received from a 73 year old male with an allergry to dust with no pertinent medical history who on 06-APR-2007 was vaccinated with Zostavax (Merck). Concomitant therapy included LANOXIN, PRILOSEC and "Rithinol". On approximately 08-APR-2007, the patient developed shingles on his scalp and neck. The patient presented to the emergency room where he was diagnosed with shingles. No lab testing was performed. The patient's shingles on his scalp and neck persisted. He was scheduled to see his primary physician in 2 weeks time. In follow-up the physician reported that the patient had developed herpes simplex type rash on the neck and secondary impetigo. The patient was treated with Bactrim. No lab testing was performed. Patient outcome was unknown. In follow-up the physician reported that the patient had shingles onset on 10-Apr-2007 and post herpetic neuralgia scalp. The patient's outcome was unknown. The patient was a dermatologist and the doctor diagnosed condition on "Pamvir".  Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Disability, Drug administration error, Feeling cold, Impaired work ability, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a 56 year old male physician with seasonal allergies, gastrooesophageal reflux disease, and hyperlipidaemia and a history of a "knee scope" complicated by a methicillin-resistant staphylococcal aureus infection of the left knee, pneumonia of unknown etiology in 2003, a tumor bowel resection status post colectomy, and no history of immunosuppression who on 18-APR-2007 was vaccinated with a 1.0 ml dose of Zostavax. Concomitant therapy included allergy shots in both arms every other week (last dose 17-APR-2007) in same triceps region in both arms as Zostavax, LIPITOR, omepraxole, vitamins (unspecified), glucosamine, CELEBREX, and calcium (unspecified). On 18-APR-2007, the patient was vaccinated by a nurse on his staff. The injection began in the left arm, but the needle was too small and a small amount of vaccine was injected, so the remaining vaccine was injected in the right arm using a larger needle. 'Instantly," he experienced severe pain localized to both injection sites in the upper triceps region. The pain was non radiating and persistent. The pain was so severe that the patient had to apply ice and has taken codeine and tizanidine hydrochloride, and had cancelled multiple procedures at work for 29-APR-2007. There was no rash, no fever, no radiculopathy, and no numbness. On 18-APR-2007, the patient had also experienced swelling at the injection site as well as nausea with the initial onset of pain and felt chilled while applying ice to the area. Approximately one hour following the receipt of the vaccine, his vital signs were BP 140/85, HR 61, and 02 saturation 99 percent. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007.  Additional information from the physician indicated that the vaccine caused agonizing pain.  He reported that part of the vaccine was given in each arm.  Both arms were extremely painful for 12 hours requiring ice, analgesics, NSAIDS and bedrest.  The physician reported that he was used to biweekly allergy shots and he had no previous history of pain with injection.  The physician recovered on 15-APR-2007.  The physician considered his pain with injection to be disabling.  Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Nausea, Pain
Clinical narrative: Information has been received from a 56 year old male physician with seasonal allergies, gastrooesophageal reflux disease, and hyperlipidaemia and a history of a "knee scope" complicated by a methicillin-resistant staphylococcal aureus infection of the left knee, pneumonia of unknown etiology in 2003, a tumor bowel resection status post colectomy, and no history of immunosuppression who on 18-APR-2007 was vaccinated with a 1.0 ml dose of Zostavax. Concomitant therapy included allergy shots in both arms every other week (last dose 17-APR-2007) in same triceps region in both arms as Zostavax, LIPITOR, omepraxole, vitamins (unspecified), glucosamine, CELEBREX, and calcium (unspecified). On 18-APR-2007, the patient was vaccinated by a nurse on his staff. The injection began in the left arm, but the needle was too small and a small amount of vaccine was injected, so the remaining vaccine was injected in the right arm using a larger needle. 'Instantly," he experienced severe pain localized to both injection sites in the upper triceps region. The pain was non radiating and persistent. The pain was so severe that the patient had to apply ice and has taken codeine and tizanidine hydrochloride, and had cancelled multiple procedures at work for 29-APR-2007. There was no rash, no fever, no radiculopathy, and no numbness. On 18-APR-2007, the patient had also experienced swelling at the injection site as well as nausea with the initial onset of pain and felt chilled while applying ice to the area. Approximately one hour following the receipt of the vaccine, his vital signs were BP 140/85, HR 61, and 02 saturation 99 percent. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007.  Additional information from the physician indicated that the vaccine caused agonizing pain.  He reported that part of the vaccine was given in each arm.  Both arms were extremely painful for 12 hours requiring ice, analgesics, NSAIDS and bedrest.  The physician reported that he was used to biweekly allergy shots and he had no previous history of pain with injection.  The physician recovered on 15-APR-2007.  The physician considered his pain with injection to be disabling.  Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Information has been received from a physician assistant concerning a "very elderly" patient (gender not reported) who was vaccinated subcutaneously with a 0.65 mL dose of Zostavax (Merck). Concomitantly therapy included unspecified "eye droops that contain steroids." Subsequently the patient developed a "total body rash immediately after administration" of the vaccine. It was reported that "It was not a zoster rash and was not limited to the injections site. The patient sought unspecified medical attention. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Liver function test, Neuralgia, Paraesthesia, Pruritus
Clinical narrative: Information has been received from a 79 year old female consumer with a history of "low immune system" who on 15-MAR-2007 was vaccinated with a dose of Zostavax (Merck). Concomitant therapy included "Lutrizone Cream" (therapy unspecified), "Dosaphine" (therapy unspecified), cyproheptadine hydrochloride, clonazepam, "Meglozine" (therapy unspecified) and "Thyroid medications" (therapy unspecified). Subsequently the patient "being very itchy all over her body", vaginal itch, burning, tingling and nerve pain. Unspecified medical attention was sought. An unspecified "liver test" was performed (results not reported). The patient is currently not recovered. No product quality complaint was involved. No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Vulvovaginal pruritus
Clinical narrative: Information has been received from a 79 year old female consumer with a history of "low immune system" who on 15-MAR-2007 was vaccinated with a dose of Zostavax (Merck). Concomitant therapy included "Lutrizone Cream" (therapy unspecified), "Dosaphine" (therapy unspecified), cyproheptadine hydrochloride, clonazepam, "Meglozine" (therapy unspecified) and "Thyroid medications" (therapy unspecified). Subsequently the patient "being very itchy all over her body", vaginal itch, burning, tingling and nerve pain. Unspecified medical attention was sought. An unspecified "liver test" was performed (results not reported). The patient is currently not recovered. No product quality complaint was involved. No further information is available.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site mass
Clinical narrative: Information has been received from a 63 year old male consumer with no medical history an/or drug/allergic reactions, who on 16-APR-2007 was vaccinated intramuscularly with a 0.65 mL dose of Zostavax (Merck). Concomitantly therapy included Diovan and Lipitor. On 18-APR-2007 the patient developed a "hard knot like configuration" at the injection site. No diagnostic laboratory tests were performed. Medical attention was not sought. The patient's status was reported as not recovered. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a female with a history of shingles who on approximately 29-MAR-2007 was vaccinated with Zostavax (Merck). Concomitant therapy included Famvir. On 17-APR-2007 the patient experienced shingles again. The patient's shingles persisted. Additional information has been requested.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Information has been received from a consumer concerning her 80 mother with allergies to feathers and codeine and hypertension who on 19-APR-2007 was vaccinated with a dose of Zostavax (Merck). Concomitant therapy included Synthroid and Avapro. On 20-APR-2007 the patient woke in the morning and her face was red and swollen. Medical attention was not sought. There was no product quality complaint involved. Additional information has been requested. 02/10/2010 Follow up information received. Reaction of facial swelling and itching was determined by physician to be related to new prescription medication (per pt). Patient was taken off of medication on 21-Apr-2007 and swelling and itching subsided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haematoma
Clinical narrative: Information has been received from a pharmacist concerning a female patient over 60 years old who on 17-APR-2007 was vaccinated SC with a dose of Zostavax (Merck). On 19-APR-2007 the patient developed a hematoma that started to spread down her arm down to the injection site. The patient had called the pharmacy on same date to report the event and was told to go to the local hospital. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Eye irritation
Clinical narrative: Information has been received from a medical technician concerning a female employee who on 20-APR-2007 was preparing to administer Zostavax (Merck) (lot # 656395/0162U), she pulled back on the syringe plunger and the vaccine splashed into her eyes. She complained of a burning sensation in both of her eyes, they were immediately flushed at an eyewash station and the was referred for evaluation by an ophthalmologist. The results of the evaluation were pending. There were no lab studies performed. There was no product complaint involved. No further information was provided. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: Information has been received from a physician concerning a 69 year old male who on 28-MAR-2007 was vaccinated with a dose of Zostavax (Merck), subcutaneously in the left arm (LOT#656412/1476F). Subsequently the patient experienced breakthrough of shingles at the injection site. The patient never had shingles before receiving the vaccination. Subsequently, the patient recovered from breakthrough of shingles. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema
Clinical narrative: Information has been received from a physician concerning a 64 year old female who on 23-MAR-2007 was vaccinated IM with a dose of Zostavax (Merck). Subsequently the patient experienced injection site redness which persists as of 20-APR-2007. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Follow up information indicated that the patient had no adverse event (previously reported that the patient experienced injection site redness). Nofurther information was provided. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of Zostavax (Merck). Subsequently the patient developed a small rash on her arm. Unspecified medical attention was sought and the patient improved on unspecified therapy. The rash went away after approximately 24 hours and the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female patient over 60 years old was vaccinated with 0.65 ml dose of Zostavax (Merck). Four days after vaccination, patient experienced shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a female patient in her fifties who was vaccinated with a dose of Zostavax (Merck) instead of a dose Varivax (Merck). It was noted that the vaccine was administered by a nurse. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is available.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, Injection site erythema, Injection site haematoma, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 56 year old female with allergies to different forms of "neomycins" and osteoporosis who on 17-APR-2007 was vaccinated SC on right arm with 0.65 ml dose of Zostavax. Concomitant therapy included simvastatin (MSD) and risedronate sodium (ACTONEL). On 17-APR-2007 the patient developed swollen, hot and red area at injection site. By 19-APR-2007, patient's upper arm had a hematoma "size of a softball". Patient's physician presented prescribed phenhydramine hydrochloride (BENADRYL). At the time of report, the patient was recovering and the hematoma was the "size of dime" with red area at injection site. No diagnostic laboratory tests were undertaken. A product quality complaint was not involved. Additional information has been requested. Additional information from the consumer indicated one day after vaccination, her arm became inflammed, swollen, itchy and very painfu;/ She went to the doctor and had to ice the area and took BENADRYL to stop the itching and swelling. Subsequently she recovered.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass
Clinical narrative: Information has been received from a male consumer who on 20-APR-2007 was vaccinated subcutaneously with a 0.65 ml dose of Zostavax. On 22-APR-2007 the patient experienced lump at the injection site. No product quality complaint. Patient did not seek medical attention. Outcome is unknown. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received from a male consumer with a history of shingles who in June 2006, was vaccinated with a dose of Zostavax. Concomitant therapy included famciclovir (FAMVIR). Since vaccination the patient experienced "2 outbreaks of shingles" in January 2007 and April 2007. Unspecified medical attention was sought. There was no product quality complaint involved. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female with penicillin allergy and a history of thyroid cancer 30 years ago who on 20-APR-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (Merck) (Lot # 656413/1477F). Concomitant therapy included levothyroxin. On 21-APR-2007 the patient developed redness, itching and warmth at injection site. At the time of report patient had not recovered. No diagnostic laboratory test were performed. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  Additional infromation has been received from the pharmacist who reported that the patient had recovered.  No further information is expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash pruritic
Clinical narrative: Information has been received from a medical assistant concerning a 74 year old female who on 16-APR-2007 was vaccinated with Zostavax. On 23-APR-2007, the patient experienced an itchy rash not at the injection site (not further specified). The patient had not recovered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Information has been received from a 67 year old female with no known allergies or drug reactions, a history of cancer in 1990 and no history of chicken pox as a child who on 07-FEB-2007 was vaccinated with Zostavax. Concomitant therapy included simvastatin (manufacturer unknown) and levothyroxine Na (SYNTHROID). On 11-FEB-2007, the patient experienced shingles with blisters on her head and neck, pain and a severe headache. On approximately 10-APR-2007, the patient recovered from shingles, pain and severe headache. No lab testing was performed. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Information has been received from a female consumer (age not reported) with diabetes and a history of high blood pressure who was vaccinated with a dose of Zostavax. Subsequently the patient experienced pain and headache. The patient sought unspecified medical attention. The patient recovered. There was no product quality complaint. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Lymphadenopathy, Mammogram abnormal, Ultrasound scan abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning a 62 female with a history of breast cancer and in 1998 and a right breast lump excision who on 12-APR-2007 (also reported as 11-APR-2007) was vaccinated subcutaneously in the right arm with a dose of ZOSTAVAX (Merck) (lot# 656861/0329U). Concomitant therapy included levothyroxine Na (SYNTHROID), raloxifene hydrochloride (EVISTA), alendronate sodium (MSD), olmesartan medoxomil (BENICAR), alprazolam, loratadine (CLARITIN) and bupropion HCl (WELLBUTRIN). The physician reported that the patient was vaccinated on 12-Apr-2007 (also reported as 11-APR-2007) and 17-APR-2007 the patient had a mammogram that showed swollen right axillary lymph nodes present on the same side of her vaccination. Unspecified medical attention was sought. Patient had an ultrasound which showed an enlarged right axillary node probably reactivated to recent hormone changes or secondary to vaccination with ZOSTAVAX (Merck). No product quality complaint. At the time of the report, the patient had not yet recovered. No further information is expected.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 64 year old female who on 19-APR-2007 was vaccinated with a single dose of Zostavax. It was reported that the patient visited the office on 24-APR-2007 for an unrelated issue and she reported redness and swelling at the injection site after receiving Zostavax. She did not remember exactly when it had started, but reported that it was improving each day. At the time of he report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Secondary transmission
Clinical narrative: Information has been received from a consumer concerning her 86 year old mother with a history of shingles. On 04-APR-2007 the reporter was vaccinated SC with a dose of Zostavax. On 11-APR-2007 the patient (the reporter's mother) was diagnosed with post herpetic neuralgia after coming in contact with the reporter after vaccination. It was reported that medical attention was not sought but the patient was scheduled to see her physician on 26-APR-2007. The patient's status at the time of the report was not provided. There was no product quality complaint involved. No further information was provided. No further information is available.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Paraesthesia
Clinical narrative: Information has been requested from a registered nurse concerning a 74 year old female with allergies to ofloxacin (FLOXIN) and prochlorperazine maleate (COMPAZINE) and a history of shingles (January 2007 prior to vaccination) and PPD skin test positive who on 08-MAR-2007 was vaccinated with Zostavax (Lot number 656609/0015U). Concomitant therapy included atorvastatin calcium (LIPITOR), indomethacin (MSD), baby aspirin and calcium (unspecified). In March 2007, the patient experienced burning sensation and tingling to a scarred area on her forehead above her right eyebrow. The scar was from a previous shingles outbreak in January 2007. On 19-MAR-2007, the patient was seen by a physician. The patient area on the patient's forehead was pink. On 29-MAR-2007, the patient was seen again for continued complaints of the tingling and burning sensation to the same area of the forehead. There was no breakout of rash or lesions. On 18-APR-2007, the patient was seen at the doctor's office for a tetanus injection. The nurse reported that the patient did not complain of any additional problems, and that the skin on the forehead was flesh tone. Subsequently, the patient recovered from burning sensation and tingling to a scarred area on her forehead above her right eyebrow and pink forehead. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Additional information received on 26-APR-2007 indicated that no further information was available. Additional information is not expected.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: International normalised ratio increased
Clinical narrative: Information has been received from a registered nurse concerning a 79 year old patient who on 20-APR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included COUMADIN. On 23-APR-2007 the patient had an elevated INR. The INR elevation was descried as a "panic value." Unspecified medical attention was sought. There was no product quality complaint involved. No further information was provided. Additional information has been requested. This is one of several reports from the same source.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Generalised erythema, Injection site swelling, Pruritus generalised
Clinical narrative: Information has been received from a licensed practical nurse concerning a 62 year old female with osteopenia and allergies to codeine, CELEBREX and sulfa antibiotics who on 19-APR-2007 was vaccinated with a dose of Zostavax (lot # 656609/0015U). Concomitant therapy included aspirin and calcium supplements. On 21-APR-2007 the patient developed generalized itching and redness and swelling at the injection site. Unspecified medical attention was sought. There were also lab diagnostic performed. At the time of the report the patient was recovering. There was no product quality complaint involved. No further information was provided. Additional information has been requested. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Information has been received from a female consumer with no medical history or allergies who on 06-FEB-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included lovastatin (manufacturer unknown) and lisinopril (manufacturer unknown). On approximately 09-FEB-2007 "three days after vaccination" the patient developed rashes on both legs. The patient reported that the rashes were itchy and had "red ring around i and rashes had lasted for 3 weeks and then disappeared and went back again". No diagnostic laboratory tests were undertaken. At the time of report the patient was not recovered. A product quality complaint was not involved. No further information is available.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis, Body temperature decreased, Cerumen impaction, Herpes zoster, Hypoacusis
Clinical narrative: Information has been received from a 66 year old male in October 2006, was vaccinated with Zostavax. On 09-APR-2007 the patient experienced a severe case of shingles. The patient's shingles persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007, 6/22/2007. Information has been received from a physician concerning a 66 year old male with no known medical history who in October 2006 or November 2006, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot#653965/0622F). There was no illness at the time of vaccination. Subsequently the patient experienced a 'severe case of shingles'. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information received from the patient indicated that in October 2006 he was vaccinated with ZOSTAVAX (Oka/Merck) (Lot#652965/0622F) on 09-APR-2007 (also reported as 10-APR-2007) he developed a severe case of shingles and was in a great deal of pain. Additional information indicated that the physician saw the patient on 10-APR-2007 in the office. The vaccine was administered on 23-AUG-2006 at 11:00 (previously reported as October or November 2006). The patient ws prescribed VALTREX 1 gm by mouth twice a day. On 11-APR-2007 the patient phones the office saying the valacyclovir was helping, but could he have something for pain. The VALTREX dosage was increased to 1 gm three times a day for 7 days total, VICODIN ES one tablet every 4 to 6 hours was added. The patient was also taking unspecified vitamins and ANDROGEL at that time. Further information from the physician indicated that on 05-MAY-2007 the patient had a blood pressure of 130/83, pulse of 64, and body temperature of 96 degrees F. The patient had a diffuse erythematous maculo-papular rash with lesions on the chest, back, arms, and upper abdomen. Also noted was a keloid abdominal scar. The patient complained of trouble hearing and it wa noted that the patient had bilateral cerumen impaction in the otic canals which was treated with lavage. The patient received a dose of SOLU MEDROL 125 MG im for an unspecifed allergic reaction. Unspecified inflammatory enzyme studies were performed for the arthritis. It was previously reported that on 09-MAY-2007 the patient had recovered though in theses reports it appears to be ongoing. No further information was provided. This is a consolidation of 2 reports concerning the same patient. Additional information is not expected. It has been determined that WAES #0704USA01852 is a duplicate of WAES # 074USA06020. Therefore, WAES # 0704USA01852 is being deleted from our files and the reports consolidated into WAES # 0704USA06020.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash erythematous, Rash maculo-papular, Scar, Skin lesion
Clinical narrative: Information has been received from a 66 year old male in October 2006, was vaccinated with Zostavax. On 09-APR-2007 the patient experienced a severe case of shingles. The patient's shingles persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007, 6/22/2007. Information has been received from a physician concerning a 66 year old male with no known medical history who in October 2006 or November 2006, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot#653965/0622F). There was no illness at the time of vaccination. Subsequently the patient experienced a 'severe case of shingles'. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information received from the patient indicated that in October 2006 he was vaccinated with ZOSTAVAX (Oka/Merck) (Lot#652965/0622F) on 09-APR-2007 (also reported as 10-APR-2007) he developed a severe case of shingles and was in a great deal of pain. Additional information indicated that the physician saw the patient on 10-APR-2007 in the office. The vaccine was administered on 23-AUG-2006 at 11:00 (previously reported as October or November 2006). The patient ws prescribed VALTREX 1 gm by mouth twice a day. On 11-APR-2007 the patient phones the office saying the valacyclovir was helping, but could he have something for pain. The VALTREX dosage was increased to 1 gm three times a day for 7 days total, VICODIN ES one tablet every 4 to 6 hours was added. The patient was also taking unspecified vitamins and ANDROGEL at that time. Further information from the physician indicated that on 05-MAY-2007 the patient had a blood pressure of 130/83, pulse of 64, and body temperature of 96 degrees F. The patient had a diffuse erythematous maculo-papular rash with lesions on the chest, back, arms, and upper abdomen. Also noted was a keloid abdominal scar. The patient complained of trouble hearing and it wa noted that the patient had bilateral cerumen impaction in the otic canals which was treated with lavage. The patient received a dose of SOLU MEDROL 125 MG im for an unspecifed allergic reaction. Unspecified inflammatory enzyme studies were performed for the arthritis. It was previously reported that on 09-MAY-2007 the patient had recovered though in theses reports it appears to be ongoing. No further information was provided. This is a consolidation of 2 reports concerning the same patient. Additional information is not expected. It has been determined that WAES #0704USA01852 is a duplicate of WAES # 074USA06020. Therefore, WAES # 0704USA01852 is being deleted from our files and the reports consolidated into WAES # 0704USA06020.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Urticaria
Clinical narrative: Information has been received from a registered nurse concerning a 60 year old female with no known allergies or medical history who on 24-APR-2007 was vaccinated SC with a 0.65 ml dose of Zostavax vaccine (lot # 656607/0163U). There was no concomitant medication. On 26-APR-2007 the patient developed an oval-shaped welt at the injection site. No rash was involved. The area was sore, but there were no other symptoms. Unspecified medical attention was sought. No laboratory test were performed. At the time of the report, the patient had not recovered. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007; 6/22/2007. Follow-up information indicated that the patient was instructed to take BENADRYL and apply warm compreases. subsequently the patient recovered, however the date was unknown, the registered nurse has not heard from the patient since. No additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Information has been received from a physician concerning his wife who has asthma and no history of drug reaction/allergies. She was vaccinated subcutaneously with Zostavax. Concomitant therapy included montelukast sodium and PULMICORT. Within 24 hours of receiving zoster, the patient experienced myalgia in chest area. The patient sought medical attention. No lab testing was performed. Subsequently, the patient recovered in about 24 hours. Additional information has been requested. This is one of several reports from the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with a dose of Zostavax. Subsequently the patient developed shingles. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Information has been received from a physician concerning a patient "over the age of 60" who on an unspecified date was vaccinated SC with a dose of Zostavax. Within five days of being vaccinated, the patient developed shingles. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction
Clinical narrative: Information has been received from a pharmacist concerning a female (age not reported) who was vaccinated subcutaneously with a single dose of Zostavax. The pharmacist reported that the patient experienced "dizziness" almost immediately attention. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.