chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: White blood cell count decreased
Clinical narrative: Information has been received from a physician concerning a Caucasian female patient (previously reported as 4 month old) with an unknown medical history and no known allergies who on 17 Apr 2007 was vaccinated with second oral dose (previously reported as first dose) of Rotateq (Lot # 656195/0025D). There was no illness at the time of vaccination. Concomitant vaccinations on that day included the second dose of PedvaxHIB (lot # 655079/1435F), the second dose of Pediarix (lot # AC1B092AA), and the second dose of Prevnar (lot # B08670E). Within twenty four hours of receiving Rotateq (also reported on 17 Apr 2007), the patient experienced fever of 102, loose stools, bad abdominal cramping. No blood was detected in stool. The patient was also very fussy and decreased appetite. Unspecified medical attention was sought. At the time of the report the patient was recovering. In follow up on 18 Apr 2007, in the early am (9:00am was when the physician was called), the patient had a fever up to 103.5, was fussy, has loose stool, crying unconsolable, poor appetite and everytime she eats a few sips she will start screaming pulling her legs up to her stomach. The patient did not have blood or mucous in her stool and no vomiting. The patient's white blood cell count (WBC) at the patient's mother's family doctor was 3.5. On 19 Apr 2007, the patient was recovering and he patient's temperature was down to 100.5. No further information is expected.
Age: 0.66
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Information has been received from a physician concerning an 8 month old patient who in approximately October 2006, six months ago, was vaccinated with rotavirus vaccine (human-bovine) for the first dose. The physician reported that the patient experienced vomiting and diarrhea after receiving rotavirus vaccine (human-bovine). Therapy with rotavirus vaccine (human-bovine) was discontinued. Subsequently, the patient recovered from vomiting and diarrhea. The physician reported that the patient will not finish the series. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 16  week old patient who on 09-MAR-2007, was vaccinated with the first dose of rotavirus vaccine (human-bovine) (Lot # 654392/0578F). No symptoms have been reported. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Mucous stools, Vomiting
Clinical narrative: Information has been received from a physician concerning a male who on approximately 24-MaR-2007 was vaccinated PO with the first dose of rotavirus vaccine (human-bovine) (Lot # 656193/0023U). In 2007, the patient developed a week of diarrhea mucous in stool. The patient also developed two days of vomiting. Unspecified medical attention was sought and fluids were administered. The patient recovered. Additional information has been requested.
Age: 0.7
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information had been received from a licensed visiting nurse (LVN) concerning a male who on 06-OCT-2006 was first vaccinated with rotavirus vaccine (human-bovine). The patient received the second rotavirus dose on 06-DEC-2006. On 23-APR-2007, the patient received the third rotavirus dose at age 8 months 1 day old. Additional information has been requested.
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with the first dose of rotavirus vaccine (human-bovine) beyond 12 weeks. No symptoms or problems were reported. Unspecified medical attention was sought.
Age: 0.66
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse effect
Clinical narrative: Information has been received from a physician concerning an 8 month old patient who on 18-OCT-2006 was vaccinated with the first dose of rotavirus vaccine (human-bovine). In April 2007, at eight months of age. the patient was in the office to receive the second dose of the vaccine. The patient was not experiencing any known symptoms. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a nurse practitioner concerning a 2 month old white female patient was vaccinated on the morning of 27-FEB-2007 with the first PO dose of rotavirus vaccine live. The NP reported that the vaccinated female did not experience any adverse event. The vaccinated female's maternal grandmother who was immunosuppressed and had multiple schlerois (MS) (on many medications) who had close contact, did feedings and diaper changes started with severe diarrhea several days after her granddaughter was vaccinated.  She was treated in the Emergency Room.  No cultures or other laboratory/diagnostic tests were performed.  The grandmother recovered 4-5 dsys after onset.  Concomitant therapy and medical history were reported as unknown. Subsequently, the patient experienced severe diarrhea for one week. The patient had 2 ER visits. At the time of the report, the patient was noted to be recovering. The patient's outcome was reported as recovering. There was no product quality complaint involved. Additional information is not expected.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 62 days old female who on an unspecified date was vaccinated with the first dose of rotavirus vaccine (human-bovine). Subsequently the patient experienced 12 hours worth of diarrhea. Subsequently, the patient recovered. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Body temperature increased, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Information has been received from a physician concerning an approximately 2 month old male with no allergies or past medical history who on an unspecified date was vaccinated with the first 2 ml dose of rotavirus vaccine (human-bovine) PO. There was no concomitant medication. Subsequently, the patient developed a fever of 101 degrees F, vomiting and diarrhea. The patient was seen by the physician two days after the vaccination since the symptoms were persisting. The outcome was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Diarrhoea, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a patient who in February 2007 and approximately 23-APR-2007 was vaccinated with the first and second doses of oral rotavirus vaccine (human-bovine), respectively. on 23-APR-2007, within 24 hours, of vaccination, the patient developed severe diarrhea. It was also reported the patient developed this same symptom after receiving the first dose of vaccine in February. Subsequently, the patient was recovering from the severe diarrhea. Unspecified medical attention was sought. Additional information has been requested.
Age: 0.58
Sex: U
Vaccine: RV5
Symptoms: Constipation, Decreased appetite, Diarrhoea, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 7 month old patient who on 11-APR-2007 was vaccinated with the first oral dose of rotavirus vaccine (human-bovine). On 16-APR-2007 the patient developed loose stools and a decrease in appetite. Since 16-APR-2007, the patient alternates between loose multiple stools and constipation. Prior to the vaccination, the patient was eating 6 ounces of formula every 4 hours and at the time of the report was eating 4 ounces every 6 to 8 hours. The patient was examined by the physician on 23-APR-2007 and was noted to be alert and playful. The physical examination was benign. Additional information has been requested.
Sex: F
Vaccine: HEP, IPV, RV5, TDAP
Symptoms: Diarrhoea
Clinical narrative: Information has been received from a physician concerning an approximately 10 week old female who was vaccinated with rotavirus vaccine (human-bovine) (Lot # 656194/0024U). Concomitant vaccinations included diphtheria toxoid (+) pertussia acellular vaccine (unspecified) (+) tetanus toxoid, hepatitis B virus vaccine (unknown manufacturer) and poliovirus vaccine. Subsequently, the patient experienced diarrhea for a couple of days after receiving rotavirus vaccine (human-bovine). Subsequently, the patient is fine and the diarrhea cleared on its own. The patient sought unspecified medical attention. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with third dose of  Rotateq. Subsequently, the patient received the last dose of Rotateq beyond the 32 week mark after receiving the first dose. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 4 month old birth twin whonon 09 Feb 2007, 30 Mar 2007 and 06 Apr 2007 was vaccinated with the first, second and third doses, respectively, of Rotateq. It was unknown if medical attention was sought. No symptoms were noted. This is one of several reports received from the same source. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007.  Information has been received from a physician concerning a 17-week-old male premature birth twin who on 09-FEB-2007, 30-MAR-2007 and 06-APR-2007 was vaccinated with the first, second and third doses, respectively, of ROTATEQ.  There was no illness at the time of vaccination.  No laboratory/diagnostic tests were performed as medical attention was not sought.  No symptoms were noted.  This is one of several reports received from the same source.  Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated PO with the first dose of Rotateq. The patient subsequently developed rotavirus gastroenteritis. Unspecified medical attention was sought. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Irritability
Clinical narrative: Information has been received from a physician concerning a 2-6 month old patient who was vaccinated with the first dose of Rotateq. Concomitant vaccines administered on that same day included "other vaccines". The patient subsequently became irritable. Unspecified medical attention was sought. The patient's symptoms subsequently resolved on their own after a short period of time. It was unknown if the patient completed the series. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Gastroenteritis rotavirus, Secondary transmission
Clinical narrative: Information has been received from a licensed practical nurse concerning a patient of the parents of a 21 week old female who was vaccinated with a first and second oral dose of rotavirus vaccine (human-bovine) on 20-DEC-2006 (lot # 655174/0848F) and 21-FEB-2007 (lot # 656188/1238F), respectively. Subsequently the parents developed rotavirus (date unspecified). The parents outcome were unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Induration, Pain
Clinical narrative: Information has been received from a physician concerning his 72 year old wife with thyroid problems and no known allergies who on  approximately 18-FEB-2007 was vaccinated with an IM dose of zoster vaccine live (Oka/Merck). Concomitant therapy included an unspecified thyroid medicine. On the first three days after vaccination, the patient experienced induration and soreness. She recovered within three to four days of vaccination. No laboratory tests were performed and no medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Swelling
Clinical narrative: Follow up information has been received from a physician concerning a female patient who on 28- March 2007, was vaccinated on the left arm with a single dose of 0.65 ml of zoster vaccine (Oka/Merck). On 30- March 2007, the patient experienced induration approximately 8 cm with redness at the injection site. No pain or itching. Medical attention was sought. Patient was instructed to go to ER if the condition worse. On 02-Apr-2007 the patient reported that the swelling was gone and only small amount of pink bruising noted. No product quality complaint was involved. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 month old patient who on 02-APR-2007 was vaccinated with a dose of zoster vaccine (Oka/Merck). The nurse reported that at the time of the incident, they had no measles virus vaccine (+) mumps virus vaccine (+) rubella virus vaccine (+) varicella virus vaccine (Oka/Merck upgrade process) (MSD) in there freezer. She reached into the wrong bin in the freezer and retrieved the zoster vaccine (Oka/Merck) instead of the intended measles virus vaccine (+) mumps virus vaccine (+) rubella virus vaccine (+) varicella virus vaccine (Oka/Merck upgrade process) (MSD). There was no product confusion involved and it was a nursing error. As a corrective measure, the office has separated the vaccines into different bins on different shelves of the refrigerator. The patient had no symptoms. A product quality complaint was no involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Facial neuralgia, Paraesthesia
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with one dose of zoster vaccine (Oka/Merck). Subsequently the patient developed tingling and pain in the nerves on one side of her face that went away a couple of days after vaccination. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 66 year old female with a penicillin allergy and no other pertinent medical history who on 30-MAR-2007 was vaccinated SC with a 0.65 ml dose of zoster vaccine (Oka/Merck). Concomitant therapy included alendronate sodium (MSD), sertraline HC1 (ZOLOFT) and "Tri-est". On 31-MAR-2007 the patient experienced pain in lower left arm which extended to her neck, stiffness of the neck and a slight headache. Unspecified medical attention was sought. No laboratory tests were performed. At the time of the report, the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure, Herpes zoster, Myalgia, Pruritus, Rash
Clinical narrative: Information has been received from a physician's assistant concerning a 65 year old white female with allergies to penicillin, sulfa, neomycin, FLAGYL, AVELOX and macrodantin and a history of two previous episodes of shingles (1970 and 1980) who on 13-MAR-2007 was vaccinated IM in the right deltoid with a first dose of ZOSTAVAX(Merck) (lot # "U163U"). There was no illness at the time of vaccination. Subsequently on 23-MAR-2007 the patient developed "onset rash" on her leg. On 30-MAR-2007 the patient was seen by the physician assistant to look at the rash that had been developing for the last week. The patient noticed clusters of red bumps under her right thigh. The patient reported that the muscle in the area was tender to touch but "thinks that it is related to her sciatica". The patient wondered if her past shingles has been reactivated by the vaccine, or if this is a new activation. The patient had shingles on her chest in 1970's in her vaginal area in the 1980's and has not had any shingles since then. In the past her rash was very painful with lots of blisters. This is not painful, but is itchy and no blisters were noted. The patient did apply triamcinolone cream to one of the lesions at home and no change was noted. On exam, she was alert and oriented and in no acute distress. Her blood pressure was 130/86. Her skin exam showed: on the back of her right thigh a few inches above her knee was a cluster of 10 red papules roughly 2 mm in diameter, one appears to have a flat yellow white colored vesicle, though hard to discern. She has other clusters of similar papules ranging from two papules to five papules which travel up along the back of her right thigh. Tenderness to palpation was noted over the area of her hamstring muscles and not in the area of the papule clusters. The assessment was rash, suspect activation of shingles, do not know if it is related to the vaccine or new onset shingles. The physician assistant felt that based on the duration of her symptoms that it was too late to start antiviral therapy, although a therapy could still be started. The patient declined due to her multiple allergies to antibiotics because she "didn't want to risk a potential reaction". On 03-APR-2007 the patient called the physician's office to let them known that more spots had broken out and it was painful to sit down, no blisters were noted. The patient reported she gets shooting pain every once in a while. The patient was still not interested in starting anti-viral suppressions. 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. Additional information has been received from the physician's assistant who reported that the patient had recovered. No further information is expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular
Clinical narrative: Information has been received from a physician's assistant concerning a 65 year old white female with allergies to penicillin, sulfa, neomycin, FLAGYL, AVELOX and macrodantin and a history of two previous episodes of shingles (1970 and 1980) who on 13-MAR-2007 was vaccinated IM in the right deltoid with a first dose of ZOSTAVAX(Merck) (lot # "U163U"). There was no illness at the time of vaccination. Subsequently on 23-MAR-2007 the patient developed "onset rash" on her leg. On 30-MAR-2007 the patient was seen by the physician assistant to look at the rash that had been developing for the last week. The patient noticed clusters of red bumps under her right thigh. The patient reported that the muscle in the area was tender to touch but "thinks that it is related to her sciatica". The patient wondered if her past shingles has been reactivated by the vaccine, or if this is a new activation. The patient had shingles on her chest in 1970's in her vaginal area in the 1980's and has not had any shingles since then. In the past her rash was very painful with lots of blisters. This is not painful, but is itchy and no blisters were noted. The patient did apply triamcinolone cream to one of the lesions at home and no change was noted. On exam, she was alert and oriented and in no acute distress. Her blood pressure was 130/86. Her skin exam showed: on the back of her right thigh a few inches above her knee was a cluster of 10 red papules roughly 2 mm in diameter, one appears to have a flat yellow white colored vesicle, though hard to discern. She has other clusters of similar papules ranging from two papules to five papules which travel up along the back of her right thigh. Tenderness to palpation was noted over the area of her hamstring muscles and not in the area of the papule clusters. The assessment was rash, suspect activation of shingles, do not know if it is related to the vaccine or new onset shingles. The physician assistant felt that based on the duration of her symptoms that it was too late to start antiviral therapy, although a therapy could still be started. The patient declined due to her multiple allergies to antibiotics because she "didn't want to risk a potential reaction". On 03-APR-2007 the patient called the physician's office to let them known that more spots had broken out and it was painful to sit down, no blisters were noted. The patient reported she gets shooting pain every once in a while. The patient was still not interested in starting anti-viral suppressions. 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. Additional information has been received from the physician's assistant who reported that the patient had recovered. No further information is expected.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Rash
Clinical narrative: Information has been received from a physician concerning an approximately 65 year old female who was vaccinated with a single dose of zoster vaccine (Oka/Merck). The patient experienced itching and burning associated with a rash and was diagnosed with shingles two weeks after vaccination. Amount of lesions was unknown. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received form a 67 year old female with sulfonamide allergy who on 29-MAR-2007 was vaccinated with a single dose of zoster vaccine (Oka/Merck). On 30-MAR-2007 the patient experienced injection site rash. No medical attention was sought. No diagnostic tests were performed. At the time of this report the patient was recovering from injection site rash. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse effect, Viral test negative, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 20 year old male with asthma, acne, rhinitis, and no allergies who on 04-APR-2007 was vaccinated SC with a dose of zoster vaccine (Oka/Merck) (lot # 652965/0622F) instead of a dose of varicella virus vaccine (Oka/Merck) (MSD). There was no concomitant medication. It was noted that the patient had a negative varicella titer on 22-MAR-2007. The patient picked up the zoster vaccine (Oka/Merck) from the pharmacy thinking that it was varicella virus vaccine (Oka/Merck) (MSD). The nurse did not check the vaccine prior to administration. The pharmacy informed the nurse later that zoster vaccine (Oka/Merck) and varicella virus vaccine (Oka/Merck) (MSD) are "interchangeable." Unspecified medical attention was sought. No symptoms were reported. A product quality complaint was not involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and a nurse manager concerning a female child who in approximately March 2007, was vaccinated with a dose of Zostavax (lot # 656394/0162U) instead of Varivax. Unspecified medical attention was sought. A product complaint was not involved. The nurse reported that the shipment of Zostavax normally comes in a box that is labeled for another department in their building called "adult medicine." This shipment of Zostavax came in a box labeled "pediatrics" and therefore, came to the nurse's department. It was assumed that this was their normal shipment of Varivax and was therefore dispensed to the patient. She noted that they would be following the normal Varivax schedule and the patient would be given the scheduled booster dose. This is one of several reports received from the same source. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash pruritic
Clinical narrative: Information has been received from a physician concerning a female patient who was vaccinated subcutaneously with a 0.65 ml single dose of Zostavax. Subsequently the patient returned to the office with a rash. The location or type of rash was not reported. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Initial and follow up information has been received from a physician concerning a 63 year old female patient with no known allergies and unspecified medical history, who on 20-MAR-2007 was vaccinated subcutaneously with a 0.65 ml single first dose of ZOSTAVAX (Oka/Merck) (lot # 656394/0162U). Concomitant therapy included amitriptyline hydrochloride (MSD), NEXIUM, PREMARIN, SYNTHROID and MOBIC. There was no illness at the time of vaccination. On 22-MAR-2007 the patient returned to the office with what the physician considered to be a minor reaction. The patient developed an itchy rash. The patient developed papules on her face, chest and back. The patient was treated with prednisone for one week. It was also noted "new medication added to regimen for many months". There were no other significant complaints. No lab tests were performed. One week after treatment, on approximately 29-MAR-2007 the patient recovered. No product quality complaint was involved. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a physician concerning three patients between the ages of 5 and 18 who in March 2007, was vaccinated with a dose of Zostavax instead of Varivax due to human error. The patients had no symptoms. All three patients previously received their Varivax vaccinations in the past. The reporter did not have specific patient demographics. Attempt are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blister, Body temperature normal, Erythema, Herpes zoster
Clinical narrative: Information has been received from a physician concerning an 84 year old female who on 23-MAR-2007 was vaccinated SC with one dose of Zostavax. On 04-APR-2007 the patient came back to physician's office with mild case of shingles on her lower back. It was reported that the patient was treated with Zovirax. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Additional information has been received from a physician assistant who reported that on 02-Apr-2007 developed red blistery lesions as clusters on left upper buttocks which subsequently crusted/scabbed and resolved. NO diagnostic laboratory tests were undertaken. At the time of report the patient recovered. The patient experienced no adverse events following prior vaccination. No further information is expected. 06/22/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning an 84 year old female with type II diabetes mellitus, hypertension, osteoporosis, peripheral vascular insufficiency with neuropathy, hypothyroidism, atrial fibrillation and history of chickenpox as a child who on 23-MAR-2007 at 10:00 AM was vaccinated SC on left upper arm with 0.5 ml dose of ZOSTAVAX (Oka/Merck) (Lot # 656609/0015U). The patient did not have any recent exposure to chickenpox and shingles. On 04-APR-2007 the patient came back to physician's office with mild case of shingles on her lower back. It was reported that the patient was treated with ZOVIRAX. A product quality complaint was not involved. Additional information has been received from physician assistant who reported that on 02-APR-2007 developed red blistery lesions as clusters on left upper buttocks which subsequently crusted/scabbed and resolved. No diagnostic laboratory tests were undertaken. At the time of report the patient was recovered. The rash occurred at the site of injection. On 02-APR-2007 the patient developed shingles and had body temperature of 98 degree Fahrenheit. Other systemic symptoms included weakness. The patient rated her pain a 3-4 on a scale of 0 to 10 with 10 being the highest. A direct fluorescent antibody test was not undertaken. No specimen for polymerase chain reaction test was collected. No further information is expected.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Scab, Skin lesion
Clinical narrative: Information has been received from a physician concerning an 84 year old female who on 23-MAR-2007 was vaccinated SC with one dose of Zostavax. On 04-APR-2007 the patient came back to physician's office with mild case of shingles on her lower back. It was reported that the patient was treated with Zovirax. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. Additional information has been received from a physician assistant who reported that on 02-Apr-2007 developed red blistery lesions as clusters on left upper buttocks which subsequently crusted/scabbed and resolved. NO diagnostic laboratory tests were undertaken. At the time of report the patient recovered. The patient experienced no adverse events following prior vaccination. No further information is expected. 06/22/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Information has been received from a physician concerning an 84 year old female with type II diabetes mellitus, hypertension, osteoporosis, peripheral vascular insufficiency with neuropathy, hypothyroidism, atrial fibrillation and history of chickenpox as a child who on 23-MAR-2007 at 10:00 AM was vaccinated SC on left upper arm with 0.5 ml dose of ZOSTAVAX (Oka/Merck) (Lot # 656609/0015U). The patient did not have any recent exposure to chickenpox and shingles. On 04-APR-2007 the patient came back to physician's office with mild case of shingles on her lower back. It was reported that the patient was treated with ZOVIRAX. A product quality complaint was not involved. Additional information has been received from physician assistant who reported that on 02-APR-2007 developed red blistery lesions as clusters on left upper buttocks which subsequently crusted/scabbed and resolved. No diagnostic laboratory tests were undertaken. At the time of report the patient was recovered. The rash occurred at the site of injection. On 02-APR-2007 the patient developed shingles and had body temperature of 98 degree Fahrenheit. Other systemic symptoms included weakness. The patient rated her pain a 3-4 on a scale of 0 to 10 with 10 being the highest. A direct fluorescent antibody test was not undertaken. No specimen for polymerase chain reaction test was collected. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a single dose of Zostavax (Merck). Subsequently the patient experienced irritation at the injection site. Unspecified medical attention was sought. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information received indicated that no further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
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 29 year old with sulfa allergy female who on an 29-JAN-2007 at 16:30 was vaccinated SQ in the left arm with a 0.5 ml dose of ZOSTAVAX (Lot # 656413/1477F). There was no illness at the time of vaccination.  Subsequently on 11-JAN-2007 (also reported as the day after injection) the patient experienced warmness,swelling and redness (5 cm in size) at the injection site.  The patient required a doctor visit, unspecified medical attention was obtained. There were no lab tests performed.  On 02-FEB-2007 the patient recovered.  There was no product quality complaint involved.  The patient had no adverse events following prior vaccination.  No further information was provided. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a 67 year old female consumer with hypertension and high cholesterol and a history of cancer who on 04-APR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included Synthroid, "extenddryl", Diovan, Arimidex, ezetimibe (+) simvastatin, Toprol XL Tablets, alendronate sodium, sulindac. Estring, chromium picolinate, ascorbic acid/vitamin B complex, calcium (unspecified) (+) vitamin D (unspecified), magnesium (unspecified), potassium gluconate, omega-3 marine triglycerides, minerals (unspecified) (+) vitamins (unspecified) (Centrum Silver) and "glucosoveen condroiten". On 06-APR-2007 the patient experienced injection site swelling. The site was a little tender and warm. Medical attention was not sought. At the time of the report, the patient had not recovered. There was no product quality complaint involved. There was no illness reported at the time of vaccination.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/14/2007. On 06-Apr-2007, the patient experienced injectjion site swelling. The site was a little tender and warm. It was also reported that the patient experienced minimal itching and redness at the injection site which the patient reported by phone adn was not seen in the physician's office. Medical attention was not sought. At the time of the report, the patient had recovered from the events on an unspecified date. There was no product quality complaint involved. Additional information is not expected.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hyperaesthesia
Clinical narrative: Information has been received from a physician concerning a 77 year old male with a penicillin and codeine allergy who on 30-MAR-2007 was vaccinated with a 0.65 ml dose of Zostavax (Merck-lot# 656859/0357U). Concomitant therapy included LIPITOR, ACIPHEX, LEVOXYL, ANDRODERM and vitamins (unspecified). On 06-APR-2007, the patient reported an irritated feeling on the posterior chest wall. On 07-APR-2007, the patient developed a patch of shingles on the posterior chest wall below the arm pit. The shingles were sensitive to touch. On 09-APR-2007, the patient was seen in the office and zoster was diagnosed. At the time, treatment with VALTREX 1 gram every 8 hours for 7 days and Darvocet N-100 one tablet every 4-6 hours PRN pain was prescribed. No lab testing was performed. The patient had not recovered. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/14/2007. Follow-up information received by the physician indicating that the patient developed a case of shingles 8 days post vaccine administration. No illness at the time of vaccination. No relevant diagnostic tests or laboratory data. Non-serious report.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 74 year old female who on 27-MAR-2007 was vaccinated SC with a single dose of Zostavax ( Lot # 656413/1477F). On 03-APR-2007 the patient developed shingles all over the dorsal route around T10, T11, and T12. A product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient who in October 2006 or November 2006 was vaccinated with a dose of Zostavax. Subsequently the patient experienced a "severe case of shingles". Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Information has been received from a 72 year old female, with no pertinent medical history of drug reactions/allergies who on 08-JAN-2007 was vaccinated with Zostavax. There was no concomitant medication. In late February 2007, the patient experienced a painful burning sensation around her mid torso. The patient did not have a rash. She was seen by her physician and was not diagnosed with zoster. The patient's painful burning sensation around her mid torso persisted. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 68 year old female who was vaccinated SC with 0.65 ml dose of Zostavax. On the day of vaccination, patient developed a "varicella like rash" at the injection site that was reported as "the size of softball". The patient recovered 1 week after vaccination and was reported the patient was "otherwise in good health". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. Information has been received from a physician concerning a 68 year old female with allergies to "statins and muscle relaxants" and  history of hypertension and osteoarthritis who on 22-JAN-2007 was vaccinated SC in the left arm with 0.65 ml dose of ZOSTAVX (lot # 14067). There was no illness at the time of vaccination. On the day of vaccination, patient developed a "varicella like rash" at the injection site that was reported as "the size of softball". The patieny recovered 1 week after vaccination and was reported the patient was "otherwise in good health". Unspecified medical attention was sought. A product quality complaint was not involved. Additional information indicated that on 24-JAN-2007 the patient developed a rash at the injection site which was erythematous vesiculopapular rash resembling shingles. The patient was seen for a doctor's visit and clinical exam was performed. The patient recovered one week after vaccination/ No further information is expected.
Age: 68.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Headache, Pain
Clinical narrative: Information has been received from a 68 year old female consumer with "hypersensitivity to many products" and a history of fibromyalgia in December 2006, was vaccinated SC with a dose of Zostavax. Concomitant vaccination included influenza virus vaccine (unspecified). Other concomitant therapy included Nexium and "thyroid medications". In January 2007, the patient experienced radiating pain from spinal column and headache. At the time of report the patient was not recovered from symptoms. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a 64 year old female who on 29-MAR-2007 was vaccinated with a dose of Zostavax. No pertinent medical history. There was no concomitant medication. On 31-MAR-2007 the patient experienced redness at the injection site and swelling at the injection site, size of a lemon. No labs or diagnostic tests performed. Subsequently, the patient recovered. No product quality complaint. Unspecified medical attention was sought. No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Information has been received from a nurse practioner concerning a 70 year old female, with an allergy to penicillin, who on 04-APR-2007 was vaccinated subcutaneously in the right arm with a dose of Zostavax (lot#656861/0329U). There was no illness at the time of the vaccination. On approximately 04-APR-2007 the patient experienced right arm pain, difficulty moving arm, redness at site and knot at site. The patient was treated with ADVIL, ALEVE and darvocet, with heat and ice. Unspecified medical attention was sought. No product quality complaint. The outcome is unknown. No further information is available.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Information has been received from a physician concerning a 61 year old male who on 02-APR-2007 was vaccinated with a 0.65 mL dose of Zostavax. On 10-APR-2007 the patient experienced an itchy rash. The patient sought unspecified medical attention. The patient recovered. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Erythema, Fatigue, Headache, Rash
Clinical narrative: Information has been received from a husband concerning his wife, a female with no known drug reactions/allergies who on 27-MAR-2007 was vaccinated with Zostavax by a pharmacist. On approximately 10-APR-2007, about two weeks after the vaccination, the patient experienced red rash over entire body, headaches, tiredness and horrible dreams. The patient did not seek medical attention. As of 11-APR-2007, the patient's red rash over entire body and headaches and tiredness and horrible dreams persisted. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Ear discomfort, Ear pain, Nausea, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Information has been received from a physician concerning a 60-year-old female who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included ROZEREM, CYMBALTA, BIAXIN, prednisone, clindamycin and other unspecified antibiotics. On 08-FEB-2007 the patient experienced a urinary tract infection and ringing in her ears. On 13-FEB-2007 the patient experienced clogged ears. On 19-FEB-2007 the patient experienced head congestion. On 20-FEB-2007 the patient experienced sinus pressure and jaw aching. On 20-MAR-2007 the patient experienced dizziness, nausea and fainted and was taken to the emergency room. On 21-MAR-2007 the patient went to an ear, nose and throat physician who did an MRI scan of her brain which did not show any problems. On 27-MAR-2007 the patient went to a dentist because of an abscess on her tooth. As of 11-APR-2007, the patient was still experiencing ear pain, but her status was reported as recovering. No product quality complaint was involved. Additional has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in jaw, Sinus congestion, Sinus headache, Syncope, Tinnitus
Clinical narrative: Information has been received from a physician concerning a 60-year-old female who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included ROZEREM, CYMBALTA, BIAXIN, prednisone, clindamycin and other unspecified antibiotics. On 08-FEB-2007 the patient experienced a urinary tract infection and ringing in her ears. On 13-FEB-2007 the patient experienced clogged ears. On 19-FEB-2007 the patient experienced head congestion. On 20-FEB-2007 the patient experienced sinus pressure and jaw aching. On 20-MAR-2007 the patient experienced dizziness, nausea and fainted and was taken to the emergency room. On 21-MAR-2007 the patient went to an ear, nose and throat physician who did an MRI scan of her brain which did not show any problems. On 27-MAR-2007 the patient went to a dentist because of an abscess on her tooth. As of 11-APR-2007, the patient was still experiencing ear pain, but her status was reported as recovering. No product quality complaint was involved. Additional has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Tooth abscess, Urinary tract infection
Clinical narrative: Information has been received from a physician concerning a 60-year-old female who on 30-JAN-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included ROZEREM, CYMBALTA, BIAXIN, prednisone, clindamycin and other unspecified antibiotics. On 08-FEB-2007 the patient experienced a urinary tract infection and ringing in her ears. On 13-FEB-2007 the patient experienced clogged ears. On 19-FEB-2007 the patient experienced head congestion. On 20-FEB-2007 the patient experienced sinus pressure and jaw aching. On 20-MAR-2007 the patient experienced dizziness, nausea and fainted and was taken to the emergency room. On 21-MAR-2007 the patient went to an ear, nose and throat physician who did an MRI scan of her brain which did not show any problems. On 27-MAR-2007 the patient went to a dentist because of an abscess on her tooth. As of 11-APR-2007, the patient was still experiencing ear pain, but her status was reported as recovering. No product quality complaint was involved. Additional has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex serology, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 77-year-old female with no allergies, diabetes, hypertension, hyperthyroidism and hypercholesterolaemia who on 23-MAR-2007 was vaccinated with a dose of Zostavax. Concomitant therapy included SYNTHROID, LIPITOR, LOPRESSOR and "meformin". On 09-APR-2007 the patient developed shingles. Unspecified medical attention was sought and it was reported that the physician did not want the rash analyzed. The physician reported that she drew blood blood to detect herpes simplex virus on 12-APR-2007. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Pain, Paraesthesia, Tenderness
Clinical narrative: Information has been received from a consumer concerning herself a 72 year old female with non-hodgkin's lymphoma and allergic reaction to erythromycin (nausea) who on 02-APR-2007 was vaccinated subcutaneously with a dose of Zostavax. Concomitant therapy included TOPROL XL TABLETS and PREMARIN. Two days after receiving the vaccination on 04-Apr-2007, she began to feel "achy all over". Then, a day or two later, she began to have significant pain in both of her ears and her ears were "tender to the touch". Also her skin felt "tingly" particularly on her left arm. Presently, the tingling on her skin was gone away, but she is still experiencing intermittent pain in her right ear only. The patient did not seek medical attention. No laboratory test were performed. No product quality complaint. Additional information has been requested. Follow-up information received from the physician stating that the patient has not reported any problems. No further information is available.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a 69 year old male who on approximately 03-APR-2007 was vaccinated with Zostavax. On 10-APR-2007, about a week after the vaccination, the patient was diagnosed in a physician's office with shingles. The physician reported that the patient had a rash on the trunk of his body starting from his back and going around to the front of the body. The physician reported that he prescribed Valtrex for treatment of the patient's shingles. The physician reported that the patient was vaccinated at an area pharmacy. As of 12-APR-2007, the patient's outcome was unknown. Additional information has been requested.