chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: MNQ
Symptoms: Polymerase chain reaction, Respiratory failure, Urinary tract infection
Clinical narrative: Patient diagnosed with Autoimmune Hemolytic Anemia in September 2006 complicated by EBV infection. Received vaccine prior to Splenectomy on 1-29-07. On 3-17-07 started having progressive weakness consistent with Guillan Barre Syndrome. 7/25/07-records received for DOS 3/27-4/18/07- DC DX: Guillain-Barre syndrome. Respiratory failure secondary to Guillain-Barre syndrome. Urinary tract infection. Autoimmune hemolytic anemia. Diabetes mellitus. Seen in ER with C/O low blood pressure 82/40. C/O profound weakness and dizziness for past few day. No fever, no chills no nausea, no vomiting, no diarrhea, no chest pain, no shortness of breath.  Treated with IVIG. Transferred to rehabilitation facility. 1/4/10 The patient was subsequently diagnosed with Angiaimmunodible T cell lymphormin with continued deterioration.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: was seen in Emergency Dept 3/22/07 with increased redness and warmth at injection site approx 8 x 9 cm-no lymph node involvement
Sex: M
Vaccine: HEPAB, JEV, MEN, RAB, TDAP
Symptoms: Dyspnoea, Pain, Rash
Clinical narrative: 4/9 Received JE #2/ Rabies #2/ Menomune/ Adacel and Twinrix #2 - called on 4/15/07. Left message c/o SOB, rash to upper extremities and torso, deep upper body aches from 4/11 on. Did not call till 4/15 - insisted to go to ER or MD ASAP. 4/16 Symptoms decrease.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Zostavax given on 4/11/07 woke up 4/12/07 arm with dizziness, disequilibrium and mild vertigo
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme rash-started on 4/12/07
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Body temperature increased, Coxsackie viral infection, Mouth ulceration, Rash erythematous, Rash papular
Clinical narrative: Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Blood culture negative, Body temperature increased, Coxsackie viral infection, Culture stool, Dermatitis
Clinical narrative: Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Dermatitis contact, Diarrhoea, Erythema, Foot and mouth disease, Full blood count normal
Clinical narrative: Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Fungal infection, Haematocrit decreased, Heart rate increased, Hypersensitivity, Lymphocyte count
Clinical narrative: Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Measles, Mouth ulceration, Neutrophil count, Oxygen saturation, Pallor
Clinical narrative: Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Pruritus, Pyrexia, Rash generalised, Rash macular, Rash papular
Clinical narrative: Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Rash pruritic, Respiratory rate increased, Urine analysis abnormal, Vomiting, Weight decreased
Clinical narrative: Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
Age: 1.25
Sex: M
Vaccine: MMRV, MMRV
Symptoms: White blood cell count decreased, White blood cell count normal, X-ray
Clinical narrative: Pt seen 4/12/07-Papules hands, feet-ulcers mouth Dx with Coxsackie virus, returned to DO office 4/13/07 with erythematous papules with coalescing plaques on elbows, behind ears, diaper area; rash from head to torso. Ulcers resembling Koplik spots on buccal mucosa, back of throat, low grade T-99.3, no other symptoms.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: High-pitched crying, Rash
Clinical narrative: crying >3 hours high pitch rash on flanks only.
Age: 87.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 8.5 cm x 5.5 cm indurated, reddened, swollen area noted on left deltoid. Began noticing reaction right away. Prescribed Keflex 500 mg PO QID x 7 days, tylenol, ice packs
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Bacterial infection, Insomnia, Pruritus
Clinical narrative: Pt was having severe itching causing difficulty sleeping and secondary bacterial infection.
Age: 20.0
Sex: M
Vaccine: RAB
Symptoms: Headache
Clinical narrative: On 3/31/07 pt started having headaches approx 7:30 pm-Headaches over left eye-no other s/s-duration of headache until approx 9 pm 4-5-07 (as stated by doctor)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Local redness and swelling around site. Concern caused mom to seek treatment from local clinic on Sunday
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Erythema, Rash
Clinical narrative: Rash appeared on April 12, 2007 at site of MMR injection. Dk Red rash appeared several days later. Mother had intensive pain and stiffness after receiving MMR at 15 years of age
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Anger, Blister, Confusional state, Herpes zoster, Neuralgia
Clinical narrative: Information has been received from a dermatologist concerning a female who on 15-NOV-2006 was vaccinated with a dose of Zostavax. Five days later on 20-NOV-2006, the patient developed severe acute nerve pain. The pain was so severe she thought she had a bad toothache and went to her dentist. The dentist identified her as having herpes zoster with trigeminal nerve involvement and referred her to an ophthalmologist and a dermatologist, the reporting physician. The patient had shingles like blisters in the trigeminal area; scalp, forehead, brow and tip of nose. She was prescribed valacyclovir hydrochloride (VALTREX) 1 gram PO TID for 7 days. The physician believes the patient received "Ostrava" not long prior to the breakout. he thought 1 to 2 weeks. The physician reported that the patient has been deeply distraught, confused and angered by her experience. There was no product quality complaint involved. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Trigeminal nerve disorder
Clinical narrative: Information has been received from a dermatologist concerning a female who on 15-NOV-2006 was vaccinated with a dose of Zostavax. Five days later on 20-NOV-2006, the patient developed severe acute nerve pain. The pain was so severe she thought she had a bad toothache and went to her dentist. The dentist identified her as having herpes zoster with trigeminal nerve involvement and referred her to an ophthalmologist and a dermatologist, the reporting physician. The patient had shingles like blisters in the trigeminal area; scalp, forehead, brow and tip of nose. She was prescribed valacyclovir hydrochloride (VALTREX) 1 gram PO TID for 7 days. The physician believes the patient received "Ostrava" not long prior to the breakout. he thought 1 to 2 weeks. The physician reported that the patient has been deeply distraught, confused and angered by her experience. There was no product quality complaint involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Incorrect dose administered
Clinical narrative: Information has been received from a certified medical assistant and physician concerning a 66 year old female with diabetes and hypertension who on 12, Feb 2007 was vaccinated with a 0.5 ml dose of zoster vaccine live (oka/Merck) (lot #652965/0622F). On 05, Mar 2007, the patient experienced shingles in the mouth which was diagnosed by a dentist. A sample of the lesions was unable to be obtained.  The patient had hives (date of onset not reported).  No laboratory tests were performed. There was no product quality complaint involved.  The final outcome was not reported.  No additional information is expected.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a female consumer who on 02-MAR-2007 was vaccinated with a dose of Zostavax. A few hours after vaccination the patient developed redness at the injection site. Medical attention was not sought. There were no lab studies performed. The redness was reported to be resolving without treatment. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Varicella
Clinical narrative: Information has been received from a physician concerning his wife with no known allergies or pertinent medical history, who in November 2006, was vaccinated SC with a 0.5 ml dose of Zostavax. Concomitant therapy included levothyroxine Na (SYNTHROID) and Atenolol. On approximately 12-FEB-2007 the patient developed a very mild case of chickenpox on her torso and extremities. Unspecified medical attention was sought, there were no labs tests performed. On an unspecified date the patient recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Corneal opacity, Erythema, Eye pain, Herpes zoster
Clinical narrative: Information has been received from a physician and a 72 year old male dentist with hypertension, cholesterol high and arthritis who on 09-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included DIOVA, atorvastatin calcium (LIPITOR) and VOLTAREN. On 18-FEB-2007 the patient developed a mild case of zoster which involved the left side of his face. It was reported that there was no injection site reaction, however on the evening of 18-FEB-2007 he developed soreness on the top of his head (also reported as soreness on the scalp to the touch and blisters on the scalp). The soreness progressed to the left side of his scalp, cheek and ear. The patient stated that he did not experience any real pain, only soreness. He saw his primary care physician on 21-FEB-2007 where he had unspecified blood work and x-rays performed, both tests were "negative for inflammation." Around 24-FEB-2007 or 25-FEB-2007 the patient noticed swelling over his left eyebrow area with 2 pronounced edematous areas. The 2 areas were red, raised and painful to the touch. There was an occasional ache in his left eyeball area. He saw a dermatologist on 28-FEB-2007 who said that it appeared to be zoster. Prior to the dermatologist appointment the patient had taken left over VALTREX; he had on hand (which he occasionally used for a herpes simplex infection), 2000 mg initially and 2000 mg 12 hours later for one day. The dermatologist then prescribed VALTREX 1000 mg 3 times a day. The patient saw an ophthalmologist the day after he saw the dermatologist. The ophthalmologist noted that there was no photophobia. He prescribed PRED FORTE, ALPHAGAN-P and MSD. In the following days of starting the eye drops, the patient experienced clouding of his cornea in the morning when he would initially wake up but then his vision would improve within an hour. The ophthalmologist told him to continue the drops and within a few days his eye was completely clear. As of 15-MAR-2007 the lesions remained present and crusted but no longer painful to the touch. Combing his hair and taking a shower were "annoyingly sore" for him. The VZVIP program was discussed with the patient (the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR 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 manufacturer vaccine VZV strain). The patient thought that a specimen would not yield good results. He stated that if he developed any other rash, he will discuss it with his health care provider as to whether a specimen should be sent at that time.  Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test, Pain, Pain of skin, Rash erythematous, Swelling
Clinical narrative: Information has been received from a physician and a 72 year old male dentist with hypertension, cholesterol high and arthritis who on 09-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included DIOVA, atorvastatin calcium (LIPITOR) and VOLTAREN. On 18-FEB-2007 the patient developed a mild case of zoster which involved the left side of his face. It was reported that there was no injection site reaction, however on the evening of 18-FEB-2007 he developed soreness on the top of his head (also reported as soreness on the scalp to the touch and blisters on the scalp). The soreness progressed to the left side of his scalp, cheek and ear. The patient stated that he did not experience any real pain, only soreness. He saw his primary care physician on 21-FEB-2007 where he had unspecified blood work and x-rays performed, both tests were "negative for inflammation." Around 24-FEB-2007 or 25-FEB-2007 the patient noticed swelling over his left eyebrow area with 2 pronounced edematous areas. The 2 areas were red, raised and painful to the touch. There was an occasional ache in his left eyeball area. He saw a dermatologist on 28-FEB-2007 who said that it appeared to be zoster. Prior to the dermatologist appointment the patient had taken left over VALTREX; he had on hand (which he occasionally used for a herpes simplex infection), 2000 mg initially and 2000 mg 12 hours later for one day. The dermatologist then prescribed VALTREX 1000 mg 3 times a day. The patient saw an ophthalmologist the day after he saw the dermatologist. The ophthalmologist noted that there was no photophobia. He prescribed PRED FORTE, ALPHAGAN-P and MSD. In the following days of starting the eye drops, the patient experienced clouding of his cornea in the morning when he would initially wake up but then his vision would improve within an hour. The ophthalmologist told him to continue the drops and within a few days his eye was completely clear. As of 15-MAR-2007 the lesions remained present and crusted but no longer painful to the touch. Combing his hair and taking a shower were "annoyingly sore" for him. The VZVIP program was discussed with the patient (the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR 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 manufacturer vaccine VZV strain). The patient thought that a specimen would not yield good results. He stated that if he developed any other rash, he will discuss it with his health care provider as to whether a specimen should be sent at that time.  Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: X-ray normal
Clinical narrative: Information has been received from a physician and a 72 year old male dentist with hypertension, cholesterol high and arthritis who on 09-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. Concomitant therapy included DIOVA, atorvastatin calcium (LIPITOR) and VOLTAREN. On 18-FEB-2007 the patient developed a mild case of zoster which involved the left side of his face. It was reported that there was no injection site reaction, however on the evening of 18-FEB-2007 he developed soreness on the top of his head (also reported as soreness on the scalp to the touch and blisters on the scalp). The soreness progressed to the left side of his scalp, cheek and ear. The patient stated that he did not experience any real pain, only soreness. He saw his primary care physician on 21-FEB-2007 where he had unspecified blood work and x-rays performed, both tests were "negative for inflammation." Around 24-FEB-2007 or 25-FEB-2007 the patient noticed swelling over his left eyebrow area with 2 pronounced edematous areas. The 2 areas were red, raised and painful to the touch. There was an occasional ache in his left eyeball area. He saw a dermatologist on 28-FEB-2007 who said that it appeared to be zoster. Prior to the dermatologist appointment the patient had taken left over VALTREX; he had on hand (which he occasionally used for a herpes simplex infection), 2000 mg initially and 2000 mg 12 hours later for one day. The dermatologist then prescribed VALTREX 1000 mg 3 times a day. The patient saw an ophthalmologist the day after he saw the dermatologist. The ophthalmologist noted that there was no photophobia. He prescribed PRED FORTE, ALPHAGAN-P and MSD. In the following days of starting the eye drops, the patient experienced clouding of his cornea in the morning when he would initially wake up but then his vision would improve within an hour. The ophthalmologist told him to continue the drops and within a few days his eye was completely clear. As of 15-MAR-2007 the lesions remained present and crusted but no longer painful to the touch. Combing his hair and taking a shower were "annoyingly sore" for him. The VZVIP program was discussed with the patient (the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR 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 manufacturer vaccine VZV strain). The patient thought that a specimen would not yield good results. He stated that if he developed any other rash, he will discuss it with his health care provider as to whether a specimen should be sent at that time.  Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Secondary transmission, Varicella
Clinical narrative: Information has been received from a physician concerning an 80 year old male whose 76 year old wife was vaccinated with a 0.65 nk dose of zoster vaccine live (Oka/Merck) on 16, Feb 2007. She reportedly transmitted varicella to her husband. On 26, Feb 2007, he was diagnosed with chickenpox. Unspecified medical attention was sought. The patient's current status was not reported. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a medical assistant concerning a female patient who on 27, Feb 2007 was vaccinated with a dose of roster vaccine live (Oka/Merck) (lot# 656606/0033U). Within twenty-four hours after vaccination on 27, Feb 2007, the patient developed a rash with a circumference of a few inches at or near the injection site. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister, Oral mucosal blistering, Stomatitis
Clinical narrative: Information has been received from a registered nurse concerning an 83 year old female with arthiritis, hypertension, gastrooesophageal reflux, anaemia, osteoporosis and Parkinson's disease and a history of strokes who on 09, Feb 2007 was vaccinated SC with a 0.65 ml dose of zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin, acetaminophen (TYLENOL). docusate Na (COLACE), iron (unspecified), omeprazole (PRILOSEC), amlodipine besylate (NORVASC), carbidopa/levodopa (MSD), oxybutyninC1 (DITROPAN), calcium (unspecified), hydrochlorothiazide, alendronate sodium (MSD), paroxetine HC1 (PAXIL) and potassium (unspecified). On 11, Feb 2007 the patient experienced blisters on her lips and open sores on the sides of her tongue and roof of her mouth. She was afebrile and had no history of fever blisters prior to this. She was treated with nystatin for one week which was discontinued and she was started on acyclovir (ZOVIRAX) ointment. At the time of the report, the patient was recovering. No product quality complaint was involved. Additional information has been requested. Additional information indicated that the patient developed blisters on her lips and inside her mouth. Her mouth was cleaned often, dentures were removed and ZOVIRAX cream was applied to her lips. The roof of her mouth was still sore, but physician does not believe it was from the vaccine. No laboratory tests were performed. The patieint recovered in March 2007. No further information is expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal chest pain
Clinical narrative: Information has been received from a physician's assistant concerning a male who on 01, Feb 2007 was vaccinated SC with a "single dose vial" of zoster vaccine live (Oka/Merck). Within about a week after being vaccinated approximately on 08, Feb 2007, the patient experienced "pain in the left rib area" and was diagnosed with having herpes zoster. Physician Assistant reported that the patient was treated with acyclovir 800 mg and gabapantin (NEURONTIN) 100 mg. Medical attention was sought. The patient's outcome was not reported. The product quality complaint was not involved. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Information has been received from a nurse practitioner concerning a male patient who on 01-FEB-2007 was vaccinated with SC with a dose of Zostavax. About a week later, on approximately 08-FEB-2007, the patient experienced a painful rash near the left side and underarm. Unspecified medical attention was sought. The patient was treated with famciclovir (FAMVIR) 500 mg and over the counter analgesics. A product quality complaint was not involved.  Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood test, Condition aggravated, Headache
Clinical narrative: Information has been received from a 74 year old female with pain from two previous back surgeries, unspecified heart problems, and a sulfa allergy who on 19-DEC-2006 was vaccinated with a dose of Zostavax. Concomitant therapy included valsartan (DIOVAN), atorvastatin calcium (LIPITOR), duloxetine hydrochloride (CYMBALTA), tramadol HCl (TRAMADOLOR), acetaminophen (TYLENOL ARTHRITIS PAIN), and prednisolone. Within a week of vaccination, on approximately 26-DEC-2006, the patient's typical back pain was intensified. The patient also mentioned experiencing headaches. Unspecified medical attention was sought and blood work was performed (results not provided). At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthropod bite, Blister, Chest pain, Herpes zoster, Hyperaesthesia
Clinical narrative: Information has been received from a physician concerning a 70 year old male who "about three weeks ago" on approximately 12-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. The patient presented to the clinic on 05-MAR-2007 (about three weeks after vaccination which was also reported to be as soon as he could since he just got back from a cruise), complaining of a "very painful rash on his trunk." The physician reported that the patient started to develop shingles about two days into his cruise (specific date not specified). There was no product quality complaint involved. No further information was provided. Additional information has been requested.  Information has been received from a physician and a registered nurse concerning a 71 year old male with no known allergies who on 02-JAN-2007 at 14:00 was vaccinated SC in the left arm with 0.65 ml first dose of ZOSTAVAX (Oka/Merck) (lot # 654603/1405F). Mid February the patient developed a spide-like bite on his left lower neck, two days later this progressed into lbister lesions which were painful and severely sensitive. The pain was noted to be in the left shoulder into the chest. The patient presented to the clinic on 05-MAR-2007, complaining of a "very painful rash on his trunk". The physician reported that the patient started to develop shingles about two days into his cruise. There were no labs performed. On an unspecified date the patient recovered. It was reported that the patient had no recent exposure to chicken pox or herpes zoster. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain, Rash, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 70 year old male who "about three weeks ago" on approximately 12-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax. The patient presented to the clinic on 05-MAR-2007 (about three weeks after vaccination which was also reported to be as soon as he could since he just got back from a cruise), complaining of a "very painful rash on his trunk." The physician reported that the patient started to develop shingles about two days into his cruise (specific date not specified). There was no product quality complaint involved. No further information was provided. Additional information has been requested.  Information has been received from a physician and a registered nurse concerning a 71 year old male with no known allergies who on 02-JAN-2007 at 14:00 was vaccinated SC in the left arm with 0.65 ml first dose of ZOSTAVAX (Oka/Merck) (lot # 654603/1405F). Mid February the patient developed a spide-like bite on his left lower neck, two days later this progressed into lbister lesions which were painful and severely sensitive. The pain was noted to be in the left shoulder into the chest. The patient presented to the clinic on 05-MAR-2007, complaining of a "very painful rash on his trunk". The physician reported that the patient started to develop shingles about two days into his cruise. There were no labs performed. On an unspecified date the patient recovered. It was reported that the patient had no recent exposure to chicken pox or herpes zoster. There was no product quality complaint involved. No further information was provided. Additional information is not expected.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac tamponade, Pericarditis
Clinical narrative: Information has been received from a physician concerning an 80 year old female who on an unspecified date was vaccinated with a 0.65 ml dose of Zostavax. Subsequently, about 4 weeks after vaccination the patient developed pericarditis with bloody tamponade. Unspecified medical attention was sought. At the time of the report a work up was in progress. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Incorrect route of drug administration, Rash erythematous, Serum sickness
Clinical narrative: Information has been received from a 61 year old physician with no allergies and hypertension who on 02-MAR-2007 was vaccinated IM with a dose of Zostavax. Concomitant therapy included amlodipine besylate (+) benazepril hydrochloride (LOTREL). Two days after vaccination, on 04-MAR-2007, the patient developed a serpiginous, erythematous rash that covered about two square inches of the dorsolateral area of his right hand. He "believed that it was serum sickness." He also had some arthralgia. He has been treating it was oral non-steroidal anti-inflammatory drugs and acetaminophen. His symptoms were improving but were not completely resolved. No medical attention was sought and no diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Additional information has been received from the physician who reported that no diagnosis was available and he had only had observation. No further information is expected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Discomfort, Headache, Malaise, Neck pain
Clinical narrative: Information has been received from an 81 year old male with knee problems, hypothyroidism, an allergy to amitriptyline hydrochloride (MSD), and a history of bypass surgery who on 22-FEB-2007 was vaccinated SC with a dose of Zostavax. Concomitant therapy included metoprolol succinate (TOPROL XL TABLETS), levothyroxine Na (SYNTHROID), corticotropin (ACTON), ezetimibe (MSD), atorvastatin calcium (LIPITOR), ramipril (ALTACE), esomeprazole magnesium (NEXIUM), morniflumate (FLOMAX), butenafine HCl (MENTAX), and caltipotriene (DOVONEX). On 03-MAR-2007, the patient experienced a headache, general malaise, discomfort, back pain, and neck pain. His symptoms have caused sleeping problems. Unspecified medical attention was sought. His symptoms were improving but he had not completely recovered. A product quality complaint was not involved. No further information is available.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: Information has been received from an 81 year old male with knee problems, hypothyroidism, an allergy to amitriptyline hydrochloride (MSD), and a history of bypass surgery who on 22-FEB-2007 was vaccinated SC with a dose of Zostavax. Concomitant therapy included metoprolol succinate (TOPROL XL TABLETS), levothyroxine Na (SYNTHROID), corticotropin (ACTON), ezetimibe (MSD), atorvastatin calcium (LIPITOR), ramipril (ALTACE), esomeprazole magnesium (NEXIUM), morniflumate (FLOMAX), butenafine HCl (MENTAX), and caltipotriene (DOVONEX). On 03-MAR-2007, the patient experienced a headache, general malaise, discomfort, back pain, and neck pain. His symptoms have caused sleeping problems. Unspecified medical attention was sought. His symptoms were improving but he had not completely recovered. A product quality complaint was not involved. No further information is available.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site bruising
Clinical narrative: Information has been received from an 80 year old male physician with no allergies, diabetes, and blood pressure high who on 01, Mar 2007 was vaccinated SC in the deltoid with a 0.5 , dose of zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified medications for diabetes and high blood pressure. Five days after vaccination, on 06, Mar 2007 the patient developed a black and blue mark around the injection site. Unspecified medical attention was sought and no diagnostic laboratory tests were performed. At the time of the report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a health professional concerning a patient who on an unspecified date was vaccinated with a 0.65 mL dose Zostavax. It was reported that 42 days after vaccination, the patient developed a rash. The physician "suspected that the rash might have been an outbreak of zoster." Unspecified medical attention was sought and the patient recovered. A product quality complaint was not involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise, Rash, Varicella
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female who on 28 Feb 2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck).  On 08, Mar 2007 (also reported as shortly after vaccination) the patient developed what appeared to be a chickenpox rash on her hip on the same side as vaccination. The patient was also experiencing a headache and described herself as "not feeling well". Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a pharmacist concerning a 65 year old female who on 28-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 08-MAR-2007 (also reported as shortly after vaccination) the patient developed a chickenpox rash on her hip on the same side as vaccination. The patient was also experiencing a headache and described herself as "not feeling well". Unspecified medical attention was sought. The patient was told to take TYLENOL for the pain. The patient recovered sometime the following week "after the vaccination". There was no product quality complaint involved. No further information is available.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 72 year old female who "within the last six months," in approximately 2007, was vaccinated with a dose of Zostavax. It was noted that she was vaccinated at "alternate vaccination sites." Subsequently, in approximately 2007, the patient developed shingles. Additional information has been received from the physician who reported that the patient complained of a herpes zoster outbreak post-vaccination. She was noted to have had experienced shingles prior to vaccination as well. She recovered on an unspecified date. No further information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. It was noted that the patient vaccinated at a satellite pharmacy and not at the reporter's office. Subsequently the patient developed shingles. Additional information has been received from a nurse who reported that she had no additional information regarding the event.
Age: 6.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Medication error, Rash, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning her 6 year old daughter who on 09, Mar 2007 was vaccinated IM with a 0.5 ml dose of zoster vaccine live (Oka/Merck) (lot# 652947/1411F) instead of varicella virus vaccine live (Oka/Merck) (MSD). Additional information from another registered nurse and certified medial assistant indicated that  the patient developed a rash and swelling at the injection site. The patient had redness the size of a half dollar at the injection site. the nurse reported that the staff reached for the bottle of varicella virus vaccine live (Oka/Merck) (MSD) but picked up zoster vaccine live (Oka/Merck) instead. The viala are stored near each other in the freezer. This was not product confusion, it was an error. It was reported that the patient received her first dose of varicella virus vaccine live (Oka/Merck) (MSD) on 03, Dec 2002. No product quality complaint involved. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 4/13/2007. Additional information from a registered nurse from the physician's office indicated that the patient had a local minor reaction only, slight redness at injection site for twenty-four hours. No work-up or follow-up was performed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash pruritic
Clinical narrative: Information has been received from a registered nurse, concerning a 68 year old male with hypertension, diabetes and renal insufficiency and a history of hepatitis A who on 01, Mar 2007 was vaccinated SC with one dose of zoster vaccine live (Oka/Merck) (lot# 656606/0033U). Concomitant therapy included metformin HC1 (GLUCOPHAGE), hydrochlorothiazide (+) irbeaartan (AVALIDE), metoprolol succinate (TOPROL XL TABLETS) simvastatin (ZOCOR), aspirin and alloparinol (manufacturer unknown). Subsequently the patient experienced shingles. Several days after he received the vaccine, there were blistery rashes on his right breast and under the right arm to the back, The rashes were very painful and itchy. He was given pregabalin (LYRICA) and valacyclovir hydrochloride (VALTREX) for pain. Health care professional was not interested in VZV analysis by PCR (polymerase chain reaction). As of 12, Mar 2007 the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Injection site rash, Injection site vesicles, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a female who on 09, Mar 2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Subsequently the patient's arm became swollen and red and blisters developed at the injection site. Medical attention was sought. The patient's outcome was not reported. The product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Follow up information has been received from a physician concerning a 60 year old house wife with no known history or allergies who on 08-MAR-2007 was vaccinated subcutaneously with a first dose of ZOSTAVAX vaccine (Merck) (lot # 656394/0162U). There was no illness at the time of vaccination. Subsequently on 09-MAR-2007, the patient developed a vsicular painful rasth at the site of injection and her arm became swollen and red. Medical attentionwas sough. Subswequently the patient recovered. No product complaint was involved. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 67 year old female with a medical history of restless leg syndrome, osteoarthritis GERD, fibromyalgia and allergies to LEVAQUIN, prednisone and cortisone who on 29-JAN-2007 was vaccinated with a 0.65 ml of Zostavax (lot #652947/1212F). On 16-FEB-2007 the patient experienced a very mild case of shingles. It was described a sa zoster rash with no lesions over the sternum an T5 area. The patient had a normal temperature. Medical attention was sought. Subsequently, the patient recovered from very mild case of shingles. No product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic, Skin lesion
Clinical narrative: Information has been received from a physician concerning a female (age not reported) who on 19-JAN-2007 was vaccinated with one 0.65 mL dose of Zostavax. The physician reported that the patient came into the office on 12-MAR-2007 with a break through itchy rash after being vaccinated. There was an unknown amount of lesions that appeared on her upper and lower back. The patient's status was not reported. There was no product quality complaint. Additional information has been requested.
Age: 32.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Herpes zoster
Clinical narrative: Information has been received from a 32-year-old female certified medical assistant (C.M.A) who on 02-MAR-2007, while vaccinating a client with a dose of Zostavax, was inadvertantly exposed to a small amount of Zostavax. It was reported that "while aspirating a small amount of the vaccine came out and got on her right hand". There was no concomitant medication. Within 24 hours of the exposure, on approximately 03-MAR-2007, the C.M.A. stated that she developed shingles on her right hip. Medical attention was sought and she was treated with an antiviral. As of 13-MAR-2007, she stated that she was improving and is feeling better; she has no pain and the rash on the right hip is almost gone. The C.M.A. was not interested in the VZV Identification program. No product quality complaint was involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: Information has been received from a licensed practical nurse concerning a 72 year old male with no known allergies and hypertension, hypercholesterolemia, spinal stenosis, diverticulosis and proteinuria who on 01-MAR-2007 was vaccinated in the right arm with a single dose of Zostavax (lot# 656413/1477F). Concomitant therapy included simvastatin (MSD), hydrochlorothiazide, meloxicam (MOBIC), atenolol, lisinopril (manufacturer unknown), vitamins (unspecified) and aspirin. On 14-MAR-2007 the patient was diagnosed with shingles (with an onset date reported as 13-MAR-2007). Unspecified medical attention was sought. It was reported that the patient did not have pain but that he ached. The patient had vesicular lesions in clusters at the right lower back and buttock area. The patient was treated with valacyclovir hydrochloride (VALTREX) and prednisolone as a tapering dose. The Varicella Zoster Virus Identification Program was offered to the nurse and she declined. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 4/13/2007; 6/22/2007. Information has been received from a licensed practical nurse concerning a 72 year old male with no known allergies and hypertension, hypercholesterolemia, spinal stenosis, diverticulosis, impaired fasting glucose and proteinuria who on 01-MAR-2007 was vaccinated SC in the right arm with a single first dose of ZOSTAVAX (Oka/Merck) (lot # 656413/1477F). Concomitant therapy included simvastatin (MSD), hydrochlorothiazide, MOBIC, atenolol, lisinopril (manufacturer unknown), vitamins (unspecified) and aspirin. There was no illness at the time of vaccination. On 14-MAR-2007 the patient was diagnosed with shingles at the right lumbar dermatome and right buttock (with an onset date reported as 13-MAR-2007). Unspecified medical attention was sought. It was reported that the patient did not have pain but that he ached. The patient had vesicular lesions in clusters at the right lower back and buttock area. The patient was treated with VALTREX and prednisone as a tapering dose. The Varicella Zoster Virus Identification Program was offered to the nurse and she declined. There were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information received from the licensed practical nurse indicated that the patient also has arteriosclerotic cardiovascular disease and a history of prostate cancer. The patient had no adverse events following prior vaccination. The patient's outcome was not reported. Additional information from the physician indicated that the patient recovered on an unspecified date. Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Nodule on extremity
Clinical narrative: Information has been received from a 42 year old male physician who "recently" was vaccinated "intramuscularly instead of subcutaneously" with a 0.65 mL dose of Zostavax. Subsequently the physician developed a knot on his arm as a result. Subsequently, the physician recovered. There was no product quality complaint. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse effect, Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 39 or 40 year old female who on 14-MAR-2007 was vaccinated with a dose of ZOSTAVAX vaccine (Merck) instead of a dose of VARIVAX vaccine(Merck) (MSD). No adverse reactions were reported from the nurse. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 4/15/2007. Follow-up information was received from the nurse who reported that this was product confusion in how the vaccine is packed and that they are both stored in the freezer. The nurse reported that the physician have been asked to clarify the reason for each vaccine (i.e. chickenpox, shingles) to help identify the exact vaccine that is warranted for each patient. A system has been implemented so when each vaccine arrives, "chickenpox" or "shingles" is written on the outside of the vaccine box. The nurse confirmed that no adverse reaction occurred.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site rash, Rash pruritic
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old male physician with no known allergies who on 11-MAR-2007 was vaccinated SC with a 0.5 ml dose of Zostavax (lot # 656606/0033U). Concomitant therapy included cetirizine hydrochloride (ZYRTEC), polyethylene glycol 3350 (MIRALAX), niacin (NIASPAN) and ezetimibe (+) simvastatin (MSD). Within 24 hours of vaccination the patient had a rash that started at the injection site and then became a generalised body rash which was "very itchy." It was reported to be "like an allergic (hive) type rash and not a VZV rash." Medical attention was sought, the physician gave himself a steroid injection for the itching.  There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: Information has been received from a consumer concerning his 66 year old wife with no known allergies or pertinent medical history who on 20- FEB-2006 was vaccinated SC with a single dose of Zostavax. There was no concomitant medication. On 07-MAR-2007 the patient developed eczema. Medical attention was not sought, there were no lab studies performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information is available.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Nuclear magnetic resonance imaging normal
Clinical narrative: Information has been received from a physician concerning a 75 year old male who on 17-JAN-2007 (also reported as 28-JAN-2007) was vaccinated subcutaneously with one 0.65 mL dose of Zostavax. Concomitant therapy included amlodipine besylate (NORVASC) and ezetimibe (MSD). There was no illness at the time of vaccination. On 01-FEB-2007, the patient presented to the office with "severe imbalance with tendency to fall backwards" and couldn't keep his balance. Due to the persistence of symptoms, a MRI of the brain was done on 19-FEB-2007 to rule out stroke. The MRI showed no acute stroke, results were negative. At the time of the report, the patient has improved but not to 100% yet. There was no product quality complaint. Additional information has been requested.