chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature, Chest pain, Feeling hot, Joint swelling
Clinical narrative: Information has been received from a 76 year old female with a seizure when taking propylene and no other pertinent medical history who on 21-JUL-2008 was vaccinated with ZOSTAVAX 0.65 mL (lot # not reported). There was no concomitant medication. On 22-JUL-2008, a day after receiving the vaccine, the patient stated that she "did not feel good." It felt like she had arthritic like pain. The patient also experienced chest pain and swollen elbow. It felt as if she had fever however when she took her temperature it was fine. "Routine lab" was performed. The patient's arthritic-like pain in joints, chest pain, "did not feel good" and swollen elbow persisted. The patient sought medical attention. No further information is available.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Information has been received from a 76 year old female with a seizure when taking propylene and no other pertinent medical history who on 21-JUL-2008 was vaccinated with ZOSTAVAX 0.65 mL (lot # not reported). There was no concomitant medication. On 22-JUL-2008, a day after receiving the vaccine, the patient stated that she "did not feel good." It felt like she had arthritic like pain. The patient also experienced chest pain and swollen elbow. It felt as if she had fever however when she took her temperature it was fine. "Routine lab" was performed. The patient's arthritic-like pain in joints, chest pain, "did not feel good" and swollen elbow persisted. The patient sought medical attention. No further information is available.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash morbilliform
Clinical narrative: Information has been received from a 65 year old male with no pertinent medical history or allergies who "4 weeks ago", on approximately 01-JUL-2008 was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (Oka/Merck). Concomitant therapy included TOPROL XL and ZOLOFT. "Over this past weekend", on approximately 26-JUL-2008 the patient developed "a rash looked like measles" over his midsection and buttocks. The patient went to emergency room. No laboratory diagnostics studies were performed. The physician said that it looked like an allergic reaction and prescribed him BENADRYL and unspecified steroids. The patient was not admitted to the hospital. At the time of this report, the patient was recovering. Follow up information received from a physician indicated that the date of vaccination was 10-JUN-2008, the patient developed rash on 26-JUL-2008. The physician didn't think the rash was due to ZOSTAVAX (Oka/Merck). Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash generalised, Skin burning sensation
Clinical narrative: Information has been received from a licensed practical nurse concerning a 67 year old male with no drug allergies who on 26-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included simvastatin, ZANTAC, INDERAL LA, GLUCOPHAGE, lisinopril, ASTELIN, NIXIUM, FLONASE and PEPCID. "Within 10 days of vaccination", in approximately July 2008, the patient developed an "itching, burning" rash on both arms and legs, trunk and groin. The patient went to see a physician. No laboratory diagnostics studies were performed. The patient had been treated with triamcinolone and hydroxyzine. At the time of report, the patient was recovering. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Nausea
Clinical narrative: Information has been received from a 63 year old female with no known drug reactions/allergies and a history of Shingles about 8 years ago and a non active mycobacterium tuberculosis who on 28-JUL-2008  was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included BONIVA, ZITHROMAX  and some medications for non active mycobacterium tuberculosis. On the night of 28-JUL-2008 the patient started feeling nauseous and cold. She had no injection site reaction. The patient's nausea and cold persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 10.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 10 year old male who on 15-JUL-2008 was inadvertently vaccinated with a dose of ZOSTAVAX (Oka/Merck) (LOT# 657675/0618U) instead of VARIVAX (Oka/Merck). No adverse effects were reported. This was a human error. The responsible vaccination nurse was new. Both ZOSTAVAX (Oka/Merck) and VARIVAX (Oka/Merck) were stored in the same freezer next to each other and the nurse picked the wrong vial. The registered nurse did not have any suggestions. The patient's outcome was unknown. The patient did not seek medical attention. The registered nurse also reported the same events for patient's sibling (refer to WAE# 0807USA05679). Additional information is not expected.
Age: 5.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 5 year old patient who was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) by a human mistake at a different facility. No adverse effect reported. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Rectal haemorrhage
Clinical narrative: Information has been received from an 84 year old male with allergies to penicillin and kidney dye and a history of Shingles about 6 months ago who on approximately 22-JUL-2008 (a week ago) was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included vitamins and eye drops. A couple days ago, the patient experienced bleeding from his rectum. Subsequently, the patient recovered. The patient did not seek medical attention. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Information has been received from a physician concerning her mother, a 93 year old female with multiple unspecified medical conditions including a history of quadruple bypass surgery who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 24-JUL-2008 the patient developed progressive weakness in the legs and arms. No treatment reported. The patient's progressive weakness in the legs and arms persisted. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Injection site pruritus, Limb discomfort, Rash, Stress
Clinical narrative: Information has been received from a 60 year old female with type 2 diabetes who on 27-MAY-2008  was vaccinated with ZOSTAVAX (Oka/Merck). Within hours later of vaccination, her right arm felt uncomfortable and she had itching at and around the injection site. Also, on approximately 28-MAY-2008, within 24 to 48 hours after receiving ZOSTAVAX (Oka/Merck) a big circular rash and pimples developed on her right arm and it itched a great deal. The rash and pimples lasted for approximately ten days before they went away on approximately 06-JUN-2008. She mentioned that within 24 hours after receiving the zoster vaccine she had "a great stress in her life." She reported that she was informed that she might have cancer, which later proved to be incorrect. At the time of reporting, the patient continued to experience intermittent discomfort and "a tightness or squeezing kind of feeling" in her right arm. On 29-JUL-2008, she was seen for the same nurse who administered ZOSTAVAX (Oka/Merck) to her back in May. The nurse did not make a diagnosis but she believed this might be post herpetic neuralgia and a mild case of Shingles. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Salivary hypersecretion, Sluggishness
Clinical narrative: Information has been received from a consumer concerning her 63 year old husband who on 28-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot#659672/0294X). Concomitant therapy included vitamins (unspecified). That same date, about 6 hours after getting ZOSTAVAX (Oka/Merck), the patient got a headache lasting 30 minutes. The next morning on 29-JUL-2008, the patient experienced dizziness and salivating (no nausea). He also felt sluggish. The patient's dizziness and salivating (no nausea) and felt sluggish persisted. No further information is expected.
Age: 12.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 12 year old male who on 15-JUL-2008 was advertently vaccinated with a dose of ZOSTAVAX (Oka/Merck) (LOT# 657675/0618U) instead of VARIVAX (Oka/Merck). No adverse effects were reported. This was a human error. The responsible vaccination nurse was new. Both ZOSTAVAX (Oka/Merck) and VARIVAX (Oka/Merck) vaccines were stored in the same freezer next to each other and the nurse picked the wrong vial. The registered nurse did not have any suggestions. The patient's outcome was unknown. The patient did not seek medical attention. The registered nurse also reported the same events for patient's sibling (refer to WAE# 0807USA05537). Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Secondary transmission
Clinical narrative: Information has been received from a pharmacist student concerning a female who on an unknown date developed zoster after her husband was vaccinated with ZOSTAVAX (Oka/Merck) on 09-JUL-2008. The patient's outcome was not reported. The patient sought medical attention with a telephone call. No further information is available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Neuralgia, X-ray
Clinical narrative: Information has been received from a 59 year old female retired nurse with allergies to codeine and DEMEROL and a history of Shingles and herniated disc concerning herself who on 15-JUL-2008 was vaccinated intramuscularly with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included levotyroxine Na. After vaccination the patient woke up with severe high back pain. It was reported that the right side back pain from mid line to side began on 23-JUL-2008. She took ADVIL for the pain. On 28-JUL-2008 the patient saw an orthopedist who said it was nerve root pain and causality mentioned it almost resembled Shingles. She had a trigger point injection. On an unspecified date X-ray was performed and no results provided. At the time of this report, the patient was not recovered. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 64 year old male with no known allergy who on 07-JUL-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot number659411/0293X) subcutaneously in the left deltoid. Concomitant therapy included LUNESTA, ATACAND, XANAX, and ZOLOFT. On 16-JUL-2008, also reported as one week after vaccination, the patient experienced a zoster like rash on trunk and back and had pain around rash. The patient was treated with antivirals. Subsequently, the patient recovered from the events. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. On an unspecified date, the sample of the lesion was collected. The sample was taken from a vesicular cluster in right anterior chest and back. Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a nurse practitioner concerning her 76 year old mother who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not  reported). Two weeks after the vaccination the patient developed shingles. Unspecified medical attention was sought. Follow-up information was received which reported that the nurse practitioner did not work for the hospital for several years. No one knew of this case. Additional information has been requested.
Age: 76.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a physician concerning a 76 year old patient with a past medical history significant for temporal arteritis diagnosed in 2000, treated with a prolonged course of prednisone and diagnosis confirmed by biopsy and a intermittent stabbing frontal head pain around the supraorbital arch area which began on 27-JUL-2008 who on 29-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck). The following day, on 30-Jul-2008 the patient's pain became constant and increased in severity. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old female who in 2007 was vaccinated with ZOSTAVAX (Oka/Merck). In January 2008, the patient developed Shingles. The patient required Oxycodone for pain. Subsequently, the patient recovered from the Shingles. No further information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a nurse, concerning a male who on approximately 28-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck), 0.65 mL, SC. It was reported that on the same day the patient had a bump form at the ZOSTAVAX (Oka/Merck) injection site that was warm and hurt. At the time of the report, the patient had not recovered. The patient sought medical attention, saw the nurse. No additional AE information reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain, Temporal arteritis
Clinical narrative: Information has been received from a physician concerning a 76 year old male patient with temporal arteritis who on 29-JUL-2008 received a dose of ZOSTAVAX (Oka/Merck) subcutaneously. On 02-AUG-2008, the patient had pain related to temporal arteritis. The physician wanted to prescribed prednisone and wanted to see if there were any contraindications in giving it. The patient outcome was unknown. No further information is available.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old female with no pertinent medical history who on 29-JUL-2008 was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot #658859/0411X). Concomitant therapy included unspecified cholesterol and blood pressure medication. On 01-AUG-2008 the patient experienced an injection site reaction which was golf ball size. The area was red, itchy and warm to touch. On 04-AUG-2008 the patient went to see the pharmacy. No laboratory diagnostics studies were performed. At the time of this report, the events persisted. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a pharmacist concerning an 87 year old female with no known drug allergy and a history of breast cancer (not treated currently) and lumpectomy who on 29-JUL-2008 was vaccinated subcutaneously in left arm with the 0.65 ml first dose of with ZOSTAVAX (Oka/Merck) (lot #658859/0411X). Concomitant therapy included unspecified cholesterol and blood pressure medication. There was no illness at time of vaccination. On 01-AUG-2008 10:00 AM, the patient developed a large lump at the site of injection (golf ball size). The area was red, itchy, warm to touch and sore. Patient treated with warm compresses. On 04-AUG-2008 the patient went to see the pharmacist. Subsequently, the patient recovered from the symptoms. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Back pain, Blister, Hepatobiliary scan
Clinical narrative: Information has been received from a 62 year old female with no known drug reactions/allergies who on 25-APR-2008 was vaccinated with the 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID, ACTONEL, BENICAR and albuterol. On 29-JUL-2008 the patient developed shingles. The patient's outcome was unknown. Unspecified medical attention was sought. Additional information has been requested. Additional information has been received form a health professional concerning the 62 year old female with sulfonamide allergy, asthma, emphysema, chronic obstructive pulmonary disease, house dust allergy and mycotic allergy and a history of measles, mumps and chickenpox as a child who on 25-APR-2008 was vaccinated with ZOSTAVAX (Merck) (Lot# 659760/0159X) in the right arm. Additional concomitant therapy included ZEFTA, VERAMYST. The patient was seen in the physicians office on 29-JUL-2008 with complaints of rash, skin feeling tender, joint pain, back pain. There were 3 small vesicles at the site of orgin of pain. The patient complained of constant right sided abdominal pain that occacionaly radiates to the left and down the leg at site of pain, right side back, bottom, upper quadrant. The patient was also noted to have neuralgia/neuritis. The patient had a gall bladder ultrasound (results not reported) and a HIDA scan was ordered. On 09-OCT-2008 the patient reported her shingles were gone. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Neuritis, Pain, Pain in extremity
Clinical narrative: Information has been received from a 62 year old female with no known drug reactions/allergies who on 25-APR-2008 was vaccinated with the 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID, ACTONEL, BENICAR and albuterol. On 29-JUL-2008 the patient developed shingles. The patient's outcome was unknown. Unspecified medical attention was sought. Additional information has been requested. Additional information has been received form a health professional concerning the 62 year old female with sulfonamide allergy, asthma, emphysema, chronic obstructive pulmonary disease, house dust allergy and mycotic allergy and a history of measles, mumps and chickenpox as a child who on 25-APR-2008 was vaccinated with ZOSTAVAX (Merck) (Lot# 659760/0159X) in the right arm. Additional concomitant therapy included ZEFTA, VERAMYST. The patient was seen in the physicians office on 29-JUL-2008 with complaints of rash, skin feeling tender, joint pain, back pain. There were 3 small vesicles at the site of orgin of pain. The patient complained of constant right sided abdominal pain that occacionaly radiates to the left and down the leg at site of pain, right side back, bottom, upper quadrant. The patient was also noted to have neuralgia/neuritis. The patient had a gall bladder ultrasound (results not reported) and a HIDA scan was ordered. On 09-OCT-2008 the patient reported her shingles were gone. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Rash, Ultrasound scan
Clinical narrative: Information has been received from a 62 year old female with no known drug reactions/allergies who on 25-APR-2008 was vaccinated with the 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included SYNTHROID, ACTONEL, BENICAR and albuterol. On 29-JUL-2008 the patient developed shingles. The patient's outcome was unknown. Unspecified medical attention was sought. Additional information has been requested. Additional information has been received form a health professional concerning the 62 year old female with sulfonamide allergy, asthma, emphysema, chronic obstructive pulmonary disease, house dust allergy and mycotic allergy and a history of measles, mumps and chickenpox as a child who on 25-APR-2008 was vaccinated with ZOSTAVAX (Merck) (Lot# 659760/0159X) in the right arm. Additional concomitant therapy included ZEFTA, VERAMYST. The patient was seen in the physicians office on 29-JUL-2008 with complaints of rash, skin feeling tender, joint pain, back pain. There were 3 small vesicles at the site of orgin of pain. The patient complained of constant right sided abdominal pain that occacionaly radiates to the left and down the leg at site of pain, right side back, bottom, upper quadrant. The patient was also noted to have neuralgia/neuritis. The patient had a gall bladder ultrasound (results not reported) and a HIDA scan was ordered. On 09-OCT-2008 the patient reported her shingles were gone. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a nurse concerning a 61 year old female with penicillin, estrogen and tetanus toxoid allergy, and a history of breast lump removal who on 11-JUL-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 638210/1079U) into her left deltoid. On 02-AUG-2008 the patient developed an unspecified rash on the buttocks. The patient sought treatment at an unspecified urgent care center and was prescribed FAMVIR 500 mg three times a day and CIPRO 500 mg two times a day. On 04-AUG-2008, the patient sought treatment with the physician who administered ZOSTAVAX (Oka/Merck). The patient was placed on acyclovir. No other symptoms or treatment reported. As of 04-AUG-2008 the patient was recovering from the rash. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning an 11 year old male who on 05-AUG-2008 was vaccinated with ZOSTAVAX live (Oka/Merck) instead of VARIVAX (oka/merck) (MSD). (Dose, route, site of administration, lot number not reported). It was unknown if the patient sought medical attention. Follow-up information from the pharmacist confirmed that the patient received ZOSTAVAX (Oka/Merck) instead of VARIVAX(Oka/Merck) (MSD). Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Device malfunction, Incorrect route of drug administration, Skin haemorrhage
Clinical narrative: Information has been received from a consumer concerning her husband who on 05-AUG-2008 was vaccinated intramuscularly with a dose of zoster vaccine live (Oka/Merck). While administering the vaccine the needle fell on the ground and the patient's arm starting bleeding. The outcome was unknown. It was unknown if the patient sought medical attention or not. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Scab
Clinical narrative: Information has been received from a physician concerning an approximately 70 year old male who was vaccinated with ZOSTAVAX (Oka/Merck) SC (no lot no. provided). Subsequently the patient experienced small rash a couple of weeks after ZOSTAVAX vaccination. The physician reported that as of 06-AUG-2008, the rash was crusting over and it looks that the patient was improving. The patient sought unspecified medical attention. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Cellulitis, Debridement, Injection site erythema, Injection site infection, Injection site necrosis
Clinical narrative: Information has been received from a physician assistant concerning a 65 year old female who on 08-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) and Tdap in the same arm (left or right unspecified). In 2008, the patient developed an open infection of the arm at the injection site. As of 6-AUG-2008, the patient was being treated with BACTRIM and the injection site infection persisted. The patient sought medical attention with an office visit. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician assistant concerning a 65 year old female with allergies to codeine, ibuprofen, CYMBALTA and a history of edema while in NEURONTIN, who on 08-JUL-2008 at 11:00 AM was vaccinated with ZOSTAVAX (Oka/Merck) (lot no. 659408/0300X) subcutaneous into the upper left arm and DTP (manufacturer unknown) in the same arm. The patient had no illnesses at the time of the vaccination. On 9-JUL-2008 at 10:00 AM, the patient had a red, swollen, hot injection site necrosed that was treated as cellulitis. The wound was debrided. Packing was applied. As of 6-AUG-2008, the patient was being treated with BACTRIM. On 07-AUG-2008, the patient recovered from the open infection of the arm at the injection site and injection site necrosed. The patient sought medical attention with an office visit. No further information is available.
Age: 65.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a physician assistant concerning a 65 year old female who on 08-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) and Tdap in the same arm (left or right unspecified). In 2008, the patient developed an open infection of the arm at the injection site. As of 6-AUG-2008, the patient was being treated with BACTRIM and the injection site infection persisted. The patient sought medical attention with an office visit. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician assistant concerning a 65 year old female with allergies to codeine, ibuprofen, CYMBALTA and a history of edema while in NEURONTIN, who on 08-JUL-2008 at 11:00 AM was vaccinated with ZOSTAVAX (Oka/Merck) (lot no. 659408/0300X) subcutaneous into the upper left arm and DTP (manufacturer unknown) in the same arm. The patient had no illnesses at the time of the vaccination. On 9-JUL-2008 at 10:00 AM, the patient had a red, swollen, hot injection site necrosed that was treated as cellulitis. The wound was debrided. Packing was applied. As of 6-AUG-2008, the patient was being treated with BACTRIM. On 07-AUG-2008, the patient recovered from the open infection of the arm at the injection site and injection site necrosed. The patient sought medical attention with an office visit. No further information is available.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 70 year old female with penicillin allergy and sulfonamide allergy, hypertension, hypothyroidism, osteoporosis and dyslipidaemia who on 29-JUL-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 656394/0162U), SC, 0.5 mL, into the left deltoid. On 02-AUG-2008, the patient experienced herpes zoster. The patient was examined in the office and found to have vesicular rash in the right T1-T2 distribution, with 5 - 6 lesions extending from the right breast around to the right mid-back. The patient was prescribed topical ZOVIRAX cream. As of 06-AUG-2008 herpes zoster persisted. The physician has taken isolates from the lesions and is interested in the VZVID program. The patient was enrolled in the Varicella Zoster Virus Identification Program to Identify if VSV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain. The sample of the lesion was collected on 06-AUG-2008. The sample was taken from a papulo vascular lesion in the T1-T2 dermatone. The PCR results for the specimen from a papulo vascular lesion in the T1-T2 dermatone, identified the presence of VZV WILD TYPE STRAIN. Telephone follow-up information was received which reported that the patient's lesions were healing and she was having a lot of pain. The patient was started on LYRICA for pain and ZOVIRAX cream. The physician waited for culture results prior to treating the patient and missed treated her with VALTREX. On 19-AUG-2008, another telephone follow-up was received which reported that the positive results for VZV WILD TYPE STRAIN made sense since the patient informed that she was exposed to shingles prior to vaccination and that was the reason she was vaccinated with ZOSTAVAX (Oka/Merck). The patient was doing better. No further information is available.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a physician concerning a 62 year old female who on 21-MAr-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). On 30-MAR-2008 the patient was seen in emergency clinic for painful rash on left neck area. The patient was told that she had shingles and was treated with VALTREX. Subsequently, the patient recovered from shingles. This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Sensation of heaviness
Clinical narrative: Information has been received from a registered pharmacist concerning an over 60 years old male with left leg atrophy and a history of polio who on 04-AUG-2008 the patient felt that his legs were heavy and rubbery. The patient's symptoms persisted. It was unspecified if the patient was sought medical attention. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Information has been received from a physician assistant concerning a 56 year old male with a history of cold sores who in MAY 2008 was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) 0.65 ml SQ. Subsequently the patient experienced 2 outbreaks of cold sores. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Cough, Erythema, Headache, Influenza
Clinical narrative: Information has been received from a 65 year old female with sinus problems, reactions to steroids, antibiotics and certain vaccines, and allergies to aspirin, NAPROXEN and environmental allergy and a history of "getting sick" for 3 weeks on the flu shot (manufacturer unspecified, who on 29-JUL-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included estrogens (unspecified) (hormone replacement therapy-HRT). On 30-JUL-2008 the patient experienced sneezing, coughing, sore throat, flu symptoms, headache, arm redness, joint pain, achiness ant hurting. The patient did not seek medical attention. At time of reporting, the patient was recovering. This is one of two reports from the same source. No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Sneezing
Clinical narrative: Information has been received from a 65 year old female with sinus problems, reactions to steroids, antibiotics and certain vaccines, and allergies to aspirin, NAPROXEN and environmental allergy and a history of "getting sick" for 3 weeks on the flu shot (manufacturer unspecified, who on 29-JUL-2008 was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included estrogens (unspecified) (hormone replacement therapy-HRT). On 30-JUL-2008 the patient experienced sneezing, coughing, sore throat, flu symptoms, headache, arm redness, joint pain, achiness ant hurting. The patient did not seek medical attention. At time of reporting, the patient was recovering. This is one of two reports from the same source. No further information is available.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a nurse practitioner concerning an 40 year old female with hypertension and a history of shingles who in April 2008, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported).On approximately 29-JUL-2008, also reported as 2 weeks ago, the patient developed shingles. Unspecified medical attention was sought. The outcome of the patient was unspecified. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster ophthalmic, Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a physician concerning a 56 year old female with no known drug allergies and no pertinent medical history reported, who about 1 month ago, (approximately July 2008) was vaccinated with ZOSTAVAX vaccine(Oka/Merck). On 01-AUG-2008, the patient developed herpes zoster and had about 5 blisters on her right eyelid and forehead. The patient sought medical attention at the office. The patient has not recovered at the time of reporting. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 5 year old patient who on 07-AUG-2008 was inadvertently vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot # 659409/0899X), 0.5 mL, subcutaneously, instead of the second dose of VARIVAX vaccine (Oka/Merck). No adverse experience noted. The patient sought at the office medical attention. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a male who on 11-AUG-2008, inadvertently was vaccinated with ZOSTAVAX vaccine (Oka/Merck). 0.65 ml, subcutaneously. The registered nurse reported that the intended vaccination was VARIVAX vaccine (Oka/Merck) (MSD) and as a result of an administration error the patient received ZOSTAVAX vaccine (Oka/Merck). At the time of the report no adverse event was reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from an 81 year old retired registered nurse with arthritis and an allergy to injectable iodine who in approximately January 2008, "about 7 months ago," was vaccinated subcutaneously with a dose of ZOSTAVAX. The nurse stated that she developed pain at the injection site after her vaccination and the pain had continued to the present. The patient sought unspecified medical attention. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a consumer concerning her 80 year old husband with blood pressure high, cholesterol high and PENICILLIN allergy and a history of benign prostatic hyperplasia and kidney stone. On 31-JUL-2008, the patient was vaccinated with ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included ATENOLOL, FINASTERIDE, VYTORIN, ALLOPURINOL and  FEXOFENADINE HYDROCHLORIDE. On 31-JUL-2008 the patient started to have pain on his left arm at the injection site. On 01-AUG-2008, the injection site was very swollen and painful that lasted a couple of days. It was reported that the patient went to see his physician who took his blood pressure and told him to take IBUPROPHEN for pain and swelling. The patient reported as of 13-AUG-2008, it had been 13 days and the swelling was still there but was going down and also there was a felling of soreness at the injection site. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a consumer concerning her 80 year old husband with blood pressure high, cholesterol high, hypertension, gout, osteoarthritis and penicillin allergy and a history of benign prostatic hyperplasia and kidney stone. On 31-JUL-2008, the patient was vaccinated with a first dose ZOSTAVAX (Oka/Merck) (lot no. 658859/0411X) IM. Concomitant therapy included atenolol, finasteride (MSD), ezetimibe (+) simvastatin (MSD), allopurinol and fexofenadine hydrochloride. On 31-JUL-2008 the patient started to have pain on his left arm at the injection site. On 01-AUG-2008, the injection site was very swollen and painful that lasted a couple of days. It was reported that the patient went to see his physician who took his blood pressure and told him to take ibuprofen for pain and swelling. The patient reported as of 13-AUG-2008, it had been 13 days and the swelling was still there but was going down and also there was a feeling of soreness at the injection site. No further information is available.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 61 year old female with no pertinent medical history or allergy reaction who in November 2007, was vaccinated with ZOSTAVAX. There was no concomitant medication. In May 2008, the patient experienced shingles. As of 13-AUG-2008, the patient has not recovered. The patient did not seek medical attention. No further information is available.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Incorrect route of drug administration, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Information has been received from a 60 year old male with hypertension, kidney stones, high cholesterol, tinnitus and reactions to amoxicillin and BIAXIN, who on 20-JUN-2008 was vaccinated with a first dose of ZOSTOAVAX, IM, instead of subcutaneously. Concomitant therapy included BENICAR, spironolactone, UROCIT-K, CENTRUM SILVER, calcium (unspecified), magnesium (unspecified), omega-3 marine triglycerides, chondroitin sulfate sodium (+) glucosamine sulfate, simvastatin (manufacturer unknown), TRICOR, LEXAPRO and XANAX. The patient reported that about one-two weeks after receiving the vaccination (approximately 27-JUN-2008), he had persistent itching, slight pain, swelling, redness and a lot of tenderness and inflammation at the injection site just below his left shoulder. He though "it might be shingles," especially because his father had shingles. The lesion was 4 inches by 3 inches, but the shingles-looking area looked to be smaller than a quarter but bigger than a nickel. He still has sensitivity to clothing and a small, round redness about the size of a dime. The patient did not seek medical attention. At the time of reporting, the patient was recovered from the persistent itching, slight pain, swelling, redness and tenderness and inflammation at the injection site. The patient reported he recovered about 10 days later on approximately 09-JUL-2008. No labs or diagnostic studies were performed. This is one of two reports from the same source. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Rash vesicular
Clinical narrative: Information has been received from a 60 year old male with hypertension, kidney stones, high cholesterol, tinnitus and reactions to amoxicillin and BIAXIN, who on 20-JUN-2008 was vaccinated with a first dose of ZOSTOAVAX, IM, instead of subcutaneously. Concomitant therapy included BENICAR, spironolactone, UROCIT-K, CENTRUM SILVER, calcium (unspecified), magnesium (unspecified), omega-3 marine triglycerides, chondroitin sulfate sodium (+) glucosamine sulfate, simvastatin (manufacturer unknown), TRICOR, LEXAPRO and XANAX. The patient reported that about one-two weeks after receiving the vaccination (approximately 27-JUN-2008), he had persistent itching, slight pain, swelling, redness and a lot of tenderness and inflammation at the injection site just below his left shoulder. He though "it might be shingles," especially because his father had shingles. The lesion was 4 inches by 3 inches, but the shingles-looking area looked to be smaller than a quarter but bigger than a nickel. He still has sensitivity to clothing and a small, round redness about the size of a dime. The patient did not seek medical attention. At the time of reporting, the patient was recovered from the persistent itching, slight pain, swelling, redness and tenderness and inflammation at the injection site. The patient reported he recovered about 10 days later on approximately 09-JUL-2008. No labs or diagnostic studies were performed. This is one of two reports from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Haematology test normal, Influenza like illness, Injection site erythema, Malaise
Clinical narrative: Information has been received from a 67 year old female with high blood pressure and no drug reactions/allergies, who on a Friday in December 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included TOPROL XO TABLETS, calcium (unspecified), vitamins (unspecified) and OMEGA-3 MARINE TRIGLYCERIDES. The patient reported that on her left arm, she had redness at the injection site right after receiving the vaccine. She also reported that the next Wednesday in December 2007, she got sick, felt achy and had flu like symptoms and then a couple of days after. She started to itch really bad on her arms above the elbows, the top of her ears, on the bottom half of the scalp, her chest and back. The reporter states that she saw her primary care physician who did blood work but they all came back fine. She also saw an allergist who did blood tests and she was not allergic to anything, and then she saw a dermatologist who said she was itching from the inside out. The patient stated that they did not know if it was from the vaccine and they did not know what is causing her itching. The patient said she still itches, but the itching on her scalp went away and she can sleep a lot better. At time of reporting, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) submitted on 09/24/2008. Follow-up information was received from a licensed Piratical Nurse who reported that on 14-DEC-2007 the patient received a first dose of ZOSTAVAX (Oka/Merck) (lot # 658396/0947U) IM, into her left arm. It was reported that the patient moved and was treated there on 19-DEC-2007 for "achey and flu symptoms" which lasted 1 day. On 25-DEC-2007 a "random body itch started". Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Pruritus generalised, Sleep disorder
Clinical narrative: Information has been received from a 67 year old female with high blood pressure and no drug reactions/allergies, who on a Friday in December 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included TOPROL XO TABLETS, calcium (unspecified), vitamins (unspecified) and OMEGA-3 MARINE TRIGLYCERIDES. The patient reported that on her left arm, she had redness at the injection site right after receiving the vaccine. She also reported that the next Wednesday in December 2007, she got sick, felt achy and had flu like symptoms and then a couple of days after. She started to itch really bad on her arms above the elbows, the top of her ears, on the bottom half of the scalp, her chest and back. The reporter states that she saw her primary care physician who did blood work but they all came back fine. She also saw an allergist who did blood tests and she was not allergic to anything, and then she saw a dermatologist who said she was itching from the inside out. The patient stated that they did not know if it was from the vaccine and they did not know what is causing her itching. The patient said she still itches, but the itching on her scalp went away and she can sleep a lot better. At time of reporting, the patient was recovering. Additional information has been requested. This is in follow-up to report(s) submitted on 09/24/2008. Follow-up information was received from a licensed Piratical Nurse who reported that on 14-DEC-2007 the patient received a first dose of ZOSTAVAX (Oka/Merck) (lot # 658396/0947U) IM, into her left arm. It was reported that the patient moved and was treated there on 19-DEC-2007 for "achey and flu symptoms" which lasted 1 day. On 25-DEC-2007 a "random body itch started". Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Gait disturbance, Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a female patient who in the spring of 2007, was vaccinated with a dose of ZOSTAVAX. In approximately March 2008, the patient underwent a knee arthroscopy. Four weeks later, in April 2008, the patient developed an excruciating nerve pain which had made it difficult for the patient to walk (nerve injections had no effect on it). The patient was seen by a neurosurgeon who thought the pain was due to shingles. On approximately 25-JUL-2008, the patient developed shingles blisters which were in the location of the pain (thigh) a week or so after minor surgery (for an unspecified reason) in that area. At the time of report, the outcomes were unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with ZOSTAVAX. One week after the patient received the vaccine developed symptoms of chickenpox. On an unspecified date, the patient recovered from the symptoms of chickenpox. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes simplex serology negative, Herpes simplex serology positive, Herpes zoster, Rash vesicular
Clinical narrative: Initial and follow-up information has been received from a physician concerning a 65 year old female patient with a history of chicken pox as a toddler and herpes simplex in February, 1980, who was vaccinated with ZOSTAVAX, given at another facility. Concomitant therapy included alendronate sodium (MSD) and INDERAL. On 02-AUG-2008, the patient experienced shingles and in 04-AUG-2008, was seen in office. Vesicular rash over the right flank and right leg, of 1-2 weeks duration. There was no fever, no pain. On an unspecified date, the patient recovered from shingles. The patient contacted physician's office. The patient thought that she contracted shingles from her father-in-law who had shingles in July, it was also reported that there was no exposure to chickenpox or herpes zoster within the last five years. The patient was enrolled in the Varicella Zoster Virus Identification Program to Identify if VSV is present and if it is present to identify if it was associated with the wild-type VZV strain or with the OKA/MERCK vaccine VZV strain. On 04-AUG-2008, a blood sample was collected. No PCR was collected.
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male who in November 2007, was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot number, injection site and route not reported). In August 2008, the patient developed mild zoster. The physician drew a serum. It was unknown whether the patient sought any medical attention. Additional information has been requested. Follow up information was received which indicated that no adverse effect and no action was needed. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia facial, Skin lesion
Clinical narrative: Information has been received from a 68 year old female with type 2 diabetes mellitus and parotid cancer and a history of hall bladder removed and appendicectomy who on 31-MAR-2008 was vaccinated with one single dose of ZOSTAVAX vaccine (Oka/Merck) (injection, dose and lot number not reported). concomitant therapy included ACTONEL, PRAVACHOL, NORVASC, SYNTHROID, ACIPHEX, EZETIMIBE, SPIRONOLACTONE, INDERAL, NASONEX, SEROQUEL, MIRALAX and  ACTOS. On 03-APR-2008 "three days after receiving ZOSTAVAX vaccine (Oka/Merck), a lesion developed on the face of the patient between her eye and her nose. She also experienced "numbness of a nerve under the skin of her face which was approximately three inches over from the lesion was located. Both the lesion and the numbness lasted approximately three months. No medical attention was sought. Subsequently, the patient recovered from the adverse events. Additional information has been requested.