chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Oedema peripheral
Clinical narrative: Per mom states feet swollen bilat. approx 1-2 hours after 2 min shots given. Feet warm, feet swollen like balloons. Advised Dr of this at visit 10/7/08.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: Received Zostavax 0.5ml at 1230 pm.  Itchy skin on throat arrived 45 minutes after.  Patient presented to clinic with itchy around throat area, given .5ml of Benadryl.  Also noted that patient received anesthesia for excision on back which was performed prior to immunizations for Zostavax.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mole excision, Pruritus, Throat irritation
Clinical narrative: Received Zostavax 0.5ml at 1230 pm.  Itchy skin on throat arrived 45 minutes after.  Patient presented to clinic with itchy around throat area, given .5ml of Benadryl.  Also noted that patient received anesthesia for excision on back which was performed prior to immunizations for Zostavax.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Dizziness, Fatigue, Hypersomnia, Malaise
Clinical narrative: Had injection at 5:30-6:00pm.  Went to dinner at restaurant.  Had 1 glass of wine, ate dinner and had 1 more glass of wine.  Felt sick during dinner and this continued through the night and all of Friday.  Symptoms were exhausted, dizzy.  Slept all Friday, missed work.  Felt better Saturday afternoon.
Age: 36.0
Sex: F
Vaccine: HEP, HEPA, MMR, TDAP
Symptoms: Insomnia, Pain in extremity, Peripheral coldness, Tenderness
Clinical narrative: At arm sore, tender on 10/6/08.  Had trouble sleeping on at side.  By mid morning 10/7/08 was having increase in pain + by 2:30 pm it was "excruciating" at times.  10/08/08 c/o arm being cold.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Lethargy, Pyrexia
Clinical narrative: increase temps (102.6 degrees), lethargic.
Age: 53.0
Sex: F
Vaccine: HEPAB, TD, YF
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: After receiving vaccine pt stated she felt dizzy, then pt passed out.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Received ROTARIX 0.5ml IM- diluted with sterile diluent for manufacturer live virus vaccine (steril water)
Age: 9.0
Sex: F
Vaccine: DT
Symptoms: Wrong drug administered
Clinical narrative: Wrong vaccine initiated - gave pediatric DT instead of adult Td.
Age: 0.7
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Crying, Pyrexia
Clinical narrative: High fever 104-105 . Inconsolable crying for hours.
Age: 26.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 10-6-08 red hot spot at injection site- no fever- Temp 98.8 degree F oral. 1545 measure of red spot on Left arm 55mmx50mm. gave BENADRYL 25mg orally- employee already took Ibuprofen. Instruct to take another BENADRYL tonight and return tomorrow for evaluation 10/7/08 1500 employee returned area of erythema now 10cmx5cm. Sent to OCC HLTH for evaluation. Per Dr continue BENADRYL and Ibuprofen. Return tomorrow for evaluation.
Age: 1.0
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Pink bumps papules, 3mm diameter on arms/legs approximately 20 on each arm, 10 on each legs just few scattered on abd/trunk.
Age: 5.0
Sex: M
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician concerning a 5 year old patient who on 22-MAY-2008 at 18:56 was vaccinated with a dose of ZOSTAVAX. The child was healthy and was not taking any medications. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a medical assistant concerning an 18 month old male with no illness at time of vaccination who on 22-MAY-2008 at 17:15 was vaccinated subcutaneously in right anterior lateral thigh with a first dose of ZOSTAVAX in error. The patient had been back in the office several times since the event and there were no adverse experiences. The medical assistant explained that it was a case of human error. The medical assistant grabbed the wrong box out of the freezer, where both ZOSTAVAX and VARIVAX were stored. The boxes had a different appearance. She had no suggestions on how improving the packaging, etc. as the boxes already look different. It was her mistake. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning his wife who "1 year ago" in approximately May 2007, was vaccinated with ZOSTAVAX. The patient experienced shingles "1 week ago" on approximately 20-MAY-2008. There was no product quality complaint. No further information is available.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 72 year old male patient who on 24-SEP-2007 was vaccinated with a 0.65 mLdose of ZOSTAVAX. Concomitant therapy included HYDROCHLOROT, MONOPRIL, RANIDINE, simvastatin (MSD), naproxen, metoprolol tartrate,  COUMADIN, XALATAN, COMBIVENT and FLOVENT. In approximately January 2008, the patient experienced shingles. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. No diagnostic labs were performed. No product quality complaints were involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a patient who was vaccinated with ZOSTAVAX. The patient reported that she was supposed to receive VARIVAX, but was accidentally given ZOSTAVAX. Patient never had chicken pox. There was no product quality complaint. Additional information is not expected.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning a 67 year old male with hypertension and penicillin allergy who on 14-APR-2008 was vaccinated with a 0.5 mL dose of ZOSTAVAX (Lot # 659763/18750), subcutaneously. Concomitant therapy included LOVASTATIN, INDOCIN, VITAMINS (unspecified) and omega-3. The nurse practitioner reported that on 27-MAY-2008, the patient returned to the office since he developed a generalized vesicular rash. The nurse practitioner diagnosed the patient with cellulitis and gave him an antibiotic. At the time of the report the patient was recovering. Follow-up information was received from the nurse practitioner. Concomitant therapy included CEPHALEXIN and CHLORPHENIRAMINE. The patient experienced pruritic rash, possibly post ZOSTAVAX reaction with mild cellulitis secondary to scratching. The patient spruritic rash with mild cellulitis resolved without further problems. No additional information is expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 63 year old female with high cholesterol and migraine and a history of deep vein thrombosis after an ankle fracture years ago, who on 15-MAY-2008 was vaccinated in the left upper arm SQ with a 0.65 ml dose of ZOSTAVAX (Lot # 659763/1875U). Concomitant therapy included LIPITOR, multivitamins (unspecified), aspirin and calcium (unspecified).
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old female patient who "about 3 weeks ago" on approximately 06-MAY-2008 was vaccinated with a dose of ZOSTAVAX. The patient developed a rash "7 days later" on approximately 12-MAY-2008. The patient went to the emergency room (time not specified) and was diagnosed with shingles. No product quality complaint was involved.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Rash
Clinical narrative: Information has been received from a physician concerning a 61 year old male patient who in May 2007 (exact date unknown) was vaccinated with a dose of ZOSTAVAX. On 27-MAY-2008, the patient presented to the office with a rash. The physician stated that the rash was shingles and the patient is also experiencing postherpetic neuralgia (PHN). At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a clinic manager (registered nurse) concerning a 19 year old female, who at 13:30 on 27-MAY-2008 received the first dose of ZOSTAVAX (lot#: 659613/0203X) 0.65ml subcutaneoulsy in the right arm instead of the intended dose of varicella virus vaccine live (MSD). There was no product confusion involved. The incident was due to human error. On 25-JUN-2008, the patient returned and stated she had no problems post vaccination. The office has since placed the vaccines in labeled bins in the freezer. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 75 year old female with hypertension, hypercholoesterolaemia, sinus bradycardia, osteoporosis, hand osteoarthritis, gastroesophageal reflux disease, hiatus hernia, penicillin allergy and sulfa allergy and a history of colonoscopy electrocardiogram, stress cardiolite, dual energy x-ray absorptiometry (DEXA scan) who on 29-JAN-2007 was vaccinated subcutaneously in the left arm with the first dose of ZOSTAVAX (lot # 652907/1411F). Concomitant therapy included DYAZIDE, CELEXA, ACTONEL, VIACTIV SOFT CALCIUM CHEWS, multivitamin and flaxseed. On 27-JAN-2008, the patient had painful rash under her right arm. On 01-FEB-2008 the patient was diagnosed with shingles. There were mild to moderate vesiculopustular grouped lesions to the right axilla and upper back following a dermatomal pattern. The patient started valacyclovir hydrochloride tablet and calamine lotion to help dry up the lesions. Subsequently the patient recovered from shingles.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Herpes zoster, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a physician concerning a over 60 year old female with a history of shingles who on approximately 20-MAY-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). Subsequently, the patient experienced pain, hardness and swelling at injection site shortly {1-2 days} after receiving ZOSTAVAX (Merck). The latter events ceased after one week. However, the patient experienced pain in lower back about 1 week after receiving ZOSTAVAX (Merck). This was the same area where the patient developed shingles previously. The physician was requesting a culture kit to diagnose shingles. The patient's pain at injection site and in lower back persisted. Unspecified medical attention was sought by patient. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: Information has been received from a registered pharmacist concerning a 69 year old male with hypertension, high cholesterol, thyroid disorder, enlarged prostate, skin condition (type not specified) and penicillin allergy who on 28-MAY-2008 was vaccinated subcutaneously in the right upper arm with ZOSTAVAX (Merck) (Lot # 659760/0159x). Concomitant therapy included metoprolol, DIOVAN, SYNTHROID, AVODART, RETIN-A, baby aspirin and multiple vitamins. On 28-MAY-2008 the patient developed a knot on the arm a few centimeters from the injection site. There was no complaint of warmth, pain or color change at the site. The patient was recovering. The patient sought medical attention at pharmacy. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker concerning an 11 year old male who on 28-MAY-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX (Merck) instead of his second dose of VARIVAX (Merck). This was related to staff error and not product confusion. No adverse effect reported. The healthcare worker also reported the same events for patient's sister (refer to WAES# 0806USA02203). Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Oedema peripheral
Clinical narrative: Information has been received from a physician concerning a 62 year old female who on 29-MAY-2008 was vaccinated with ZOSTAVAX (Merck) (Dose and Lot# not reported). The patient was vaccinated by the intramuscular route instead of the subcutaneous route. No adverse experience was reported.   Follow up information has been received from a health professional concerning a 62 year old female who on 29-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 659760/0159X).  The health professional reported that the physician ordered ZOSTAVAX (Merck) injection. It was given intramuscularly instead of subcutaneously. The patient was notified. The patient came to office on 31-MAY-2008 and the patient presented left hand swollen. The physician though "?Gout" , not related to injection. No complaint since then.   Additional information is not expected.
Age: 22.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a pharmacist concerning a 22 year old patient who on 28-FEB-2008 was vaccinated subcutaneously with a 0.5 ml first dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). This was human error not PQC. The pharmacist stated that the first dose of prescription from the doctor for the patient was written for "ZOSTAVAX". The second dose prescription for the vaccination was listed as "Varicella". It was the discovered that the patient should have received VARIVAX (Merck) the first time. The error was on the part of the doctor initially writing the prescription. not product confusion at the time of vaccination. No adverse effects reported. Additional information has been requested.
Age: 21.0
Sex: F
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a 21 year old female who on 03-APR-2008 was inadvertently vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). No adverse effect was reported. Additional information has been requested.
Age: 0.92
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a nurse concerning a 12 month old patient who on 29-MAY-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). There was no product confusion. The incident was due to human error. The patient has not experienced any known symptoms. NO product quality complaint was involved. Additional information has been requested.
Age: 22.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a physician and medical assistant concerning a 22 year old patient who on 29-MAY-2008 was vaccinated IM with a 0.5ml of ZOSTAVAX (Merck) instead of with VARIVAX (Merck). It was reported that the patient was snot experiencing any known symptoms at the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered pharmacist concerning a 6 year old patient who was vaccinated with a dose of ZOSTAVAX (Merck) instead of VARIVAX (Merck). This happened within the past 24 hours at a hospital physician unknown. No adverse effects known. The pharmacist was not aware it was product confusion. The grandmother indicated human error. Unspecified medical attention was sought. No product quality complaint was involved. This is one of several reports received from the same source. No further information is available.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a consumer concerning her 12 month old son who on 29-MAY-2008 was vaccinated with ZOSTAVAX (Merck) instead of with VARIVAX (Merck). There was no adverse event reported. At the time of the report the patient's status was unknown. There was no product quality complaint involved.
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Information has been received from a health professional concerning a female who on approximately 02-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). On approximately 30-MAY-2008 (3-4 weeks after receiving the vaccine) the patient experienced pain in her right temporal lobe. The patient sought unspecified medical attention on an unspecified date by calling the office and the pain in her right temporal lobe persisted. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a female with not pertinent medical history who on 19-MAY-2008 was  vaccinated with ZOSTAVAX (Merck) (Lot# 659762/1874U), standard dose, once, subcutaneous. Concomitant mediation was unspecified. The patient developed small injection site rash after receiving ZOSTAVAX
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Inappropriate schedule of drug administration, Oral herpes, Paraesthesia
Clinical narrative: Information has been received from a 33 year old female with no drug reactions or allergies and a history of reoccurring shingles from October 2007 through December 2007 who on 15-DEC-2007 was vaccinated with a dose of ZOSTAVAX (Merck). There was no concomitant medication. On 15-DEC-2007, late in the afternoon, the patient had a mild outbreak of shingles but it went away quickly and she did not experienced recurrence of shingles for 6 months. On 02-JUN-2008, in the morning, the patient noticed cold sores in her whole body and her nerves are tingling. An unspecified blood test was performed (results not provided). At the time of the report, the patient's events persisted. Unspecified medical attention was sought. The patient also reported that she received VALTEX prior to receiving ZOSTAVAX (Merck) for her shingles but it was not working for her. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blood creatine phosphokinase increased, Blood uric acid increased, C-reactive protein increased, Dizziness
Clinical narrative: Information has been received from a physician and the daughter of a 73 year old female with arthritis, high blood pressure and reaction to prednisone, who on 28-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included naproxen, ACTONEL, atenolol, LASIX (furosemide), potassium (unspecified), amitriptyline hydrochloride (manufacturer unknown), ranitidine, calcium (unspecified) (+) vitamin D (unspecified) and lovastatin (manufacturer unknown).  The daughter reported that her mother received ZOSTAVAX (Oka/Merck) on her right arm and the next day, on 29-MAY-2008 she could not move her left leg.  Her hip was very painful down to her leg.  On 02-JUN-2008, the patient developed pain on the right leg.  The daughter reported that her mother went to the doctor.  The physician reported that it was equivalent to a toothache but at the left hip and leg; and that she had a headache and felt woozy with no fever.  The physician reported that the patient's CPK was 13.64, C-reactive protein was 0.2 and sedimentation rate was 13.  The patient was prescribed dexamethasone 4 mg daily.  The patient was unable to walk without taking pain pills because her leg hurt too much, and that morning the pain was worse and had spread to her back.  On 03-JUN-2008, her lovastatin (manufacturer unknown) was discontinued.  On 04-JUN-2008, her laboratory results were CPK 6.73, creatinine 1.36, slight increase in uric acid, and urine was clean.  On 06-JUN-2008, more laboratory results were pending including CPK and metabolic panels.  Dexamothasone was increased to 4mg twice daily coupled with LORTAB 5 mg every 6 hours.  At the time of the report, the patient continued to have pain at the left leg extending the hip.  Follow up information was received from the physician reporting that on 12-JUN-2008, the patient had an MRI which showed a "lesion in the lumbar spine with borderline spinal stenosis at L4-L5".  On 10-JUN-2008, the patient's CPK rate had normalized at 83 (1 week after the shot).  No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Injected limb mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: Information has been received from a physician and the daughter of a 73 year old female with arthritis, high blood pressure and reaction to prednisone, who on 28-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included naproxen, ACTONEL, atenolol, LASIX (furosemide), potassium (unspecified), amitriptyline hydrochloride (manufacturer unknown), ranitidine, calcium (unspecified) (+) vitamin D (unspecified) and lovastatin (manufacturer unknown).  The daughter reported that her mother received ZOSTAVAX (Oka/Merck) on her right arm and the next day, on 29-MAY-2008 she could not move her left leg.  Her hip was very painful down to her leg.  On 02-JUN-2008, the patient developed pain on the right leg.  The daughter reported that her mother went to the doctor.  The physician reported that it was equivalent to a toothache but at the left hip and leg; and that she had a headache and felt woozy with no fever.  The physician reported that the patient's CPK was 13.64, C-reactive protein was 0.2 and sedimentation rate was 13.  The patient was prescribed dexamethasone 4 mg daily.  The patient was unable to walk without taking pain pills because her leg hurt too much, and that morning the pain was worse and had spread to her back.  On 03-JUN-2008, her lovastatin (manufacturer unknown) was discontinued.  On 04-JUN-2008, her laboratory results were CPK 6.73, creatinine 1.36, slight increase in uric acid, and urine was clean.  On 06-JUN-2008, more laboratory results were pending including CPK and metabolic panels.  Dexamothasone was increased to 4mg twice daily coupled with LORTAB 5 mg every 6 hours.  At the time of the report, the patient continued to have pain at the left leg extending the hip.  Follow up information was received from the physician reporting that on 12-JUN-2008, the patient had an MRI which showed a "lesion in the lumbar spine with borderline spinal stenosis at L4-L5".  On 10-JUN-2008, the patient's CPK rate had normalized at 83 (1 week after the shot).  No further information is available.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate increased, Urine analysis normal
Clinical narrative: Information has been received from a physician and the daughter of a 73 year old female with arthritis, high blood pressure and reaction to prednisone, who on 28-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  Concomitant therapy included naproxen, ACTONEL, atenolol, LASIX (furosemide), potassium (unspecified), amitriptyline hydrochloride (manufacturer unknown), ranitidine, calcium (unspecified) (+) vitamin D (unspecified) and lovastatin (manufacturer unknown).  The daughter reported that her mother received ZOSTAVAX (Oka/Merck) on her right arm and the next day, on 29-MAY-2008 she could not move her left leg.  Her hip was very painful down to her leg.  On 02-JUN-2008, the patient developed pain on the right leg.  The daughter reported that her mother went to the doctor.  The physician reported that it was equivalent to a toothache but at the left hip and leg; and that she had a headache and felt woozy with no fever.  The physician reported that the patient's CPK was 13.64, C-reactive protein was 0.2 and sedimentation rate was 13.  The patient was prescribed dexamethasone 4 mg daily.  The patient was unable to walk without taking pain pills because her leg hurt too much, and that morning the pain was worse and had spread to her back.  On 03-JUN-2008, her lovastatin (manufacturer unknown) was discontinued.  On 04-JUN-2008, her laboratory results were CPK 6.73, creatinine 1.36, slight increase in uric acid, and urine was clean.  On 06-JUN-2008, more laboratory results were pending including CPK and metabolic panels.  Dexamothasone was increased to 4mg twice daily coupled with LORTAB 5 mg every 6 hours.  At the time of the report, the patient continued to have pain at the left leg extending the hip.  Follow up information was received from the physician reporting that on 12-JUN-2008, the patient had an MRI which showed a "lesion in the lumbar spine with borderline spinal stenosis at L4-L5".  On 10-JUN-2008, the patient's CPK rate had normalized at 83 (1 week after the shot).  No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated subcutaneously with a first dose of ZOSTAVAX (Oka/Merck).  On an unspecified date the patient developed shingles.  At the time of the report, it was unknown if the patient had recovered from the event.  Unspecified medical attention was sought.  Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Information has been received from a pharmacist concerning an approximately 63 year old female with no allergy to neomycin or gelatin who on 04-APR-2008 was vaccinated subcutaneously with one dose of ZOSTAVAX (Oka/Merck) (Lot #659761/0157X).  There was no concomitant medication.  On an unspecified date following vaccination the patient developed achiness in the upper arm about 8 inches surrounding the injection site.  No change in temperature or color noted.  The patient's achiness surrounding the injection site persisted.  The patient sought medical attention by speaking with the pharmacist.  Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain
Clinical narrative: Information has been received from a physician concerning a 70 year old male who on 19-MAY-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  On 24-MAY-2008 the patient developed right leg pain.  On 29-MAY-2008 he developed red "splotches" on his leg.  The patient was seen in the office on 02-JUN-2008 and diagnosed as having shingles with L3, L4, L5 nerve root involvement.  There were no vesicles.  The patient had burning pain.  The physician reported that the patient appeared to have early or late shingles (the physician could not tell which).  The patient was prescribed FAMVIR.  At the time of the report, it was unknown if the patient had recovered from the event.  Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a director of pharmacy who reported that some of their healthcare professionals had inadvertently mixed up ZOSTAVAX (Oka/Merck) and VARIVAX (Oka/Merck) with their patients.  It happened three times.  No adverse event reported.  Attempts made to obtain additional identifying information to distinguish the individual patients mentioned in the report were unsuccessful.  The pharmacist did indicate that procedures were implemented to avoid confusion in the future.  Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Arthritis, Fall, Joint range of motion decreased, Peripheral nerve infection
Clinical narrative: Information has been received from a female concerning her 79 year old mother with weakened immune system, diabetes and osteoporosis and a history of cancer 4 times and no history of drug reactions or allergies who in January or February 2008 was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml subcutaneously.  Concomitant therapy included "a lot of medications", diabetes medicines and ARIMIDEX.  "A couple weeks after the vaccination", the patient was unable to move her arms and shoulders because they "hurt very badly".  She went to her rheumatologist who said that it was a pinched nerve.  She later went to a neurologist who told her it was a "nerve virus" and an orthopedist confirmed this diagnosis.  Due to this adverse event, the patient fell in the shower and developed arthritis in both hands because she tried to break her fall with her hands.  The patient's nerve virus infection persisted.  The outcome of arthritis was not reported.  No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Radiculitis brachial
Clinical narrative: Information has been received from a female concerning her 79 year old mother with weakened immune system, diabetes and osteoporosis and a history of cancer 4 times and no history of drug reactions or allergies who in January or February 2008 was vaccinated with ZOSTAVAX (Oka/Merck) 0.65ml subcutaneously.  Concomitant therapy included "a lot of medications", diabetes medicines and ARIMIDEX.  "A couple weeks after the vaccination", the patient was unable to move her arms and shoulders because they "hurt very badly".  She went to her rheumatologist who said that it was a pinched nerve.  She later went to a neurologist who told her it was a "nerve virus" and an orthopedist confirmed this diagnosis.  Due to this adverse event, the patient fell in the shower and developed arthritis in both hands because she tried to break her fall with her hands.  The patient's nerve virus infection persisted.  The outcome of arthritis was not reported.  No further information is available.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Arthritis, Fall, Joint range of motion decreased, Peripheral nerve infection
Clinical narrative: Information has been received from a physician concerning a 79 year old female with hypertension, diabetes and allergic reaction to tetracycline and erythromycin and a history of lung neoplasm malignant (3 times), breast cancer, radiotherapy, hypothyroidism and osteopenia who in January 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). About 4 weeks later, the patient developed a partial right brachial plexitis. No laboratory or diagnostics studies was performed. The patient was seen in the physician's office and had had physical therapy and was recovering. Follow up information was received which reported that the retired patient developed a brachial plexitis at upper trunk. Unremarkable magnetic resonance imaging was performed at spine and indicated that brachial plexus and shoulder. The condition was improving. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nuclear magnetic resonance imaging normal, Radiculitis brachial
Clinical narrative: Information has been received from a physician concerning a 79 year old female with hypertension, diabetes and allergic reaction to tetracycline and erythromycin and a history of lung neoplasm malignant (3 times), breast cancer, radiotherapy, hypothyroidism and osteopenia who in January 2008, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). About 4 weeks later, the patient developed a partial right brachial plexitis. No laboratory or diagnostics studies was performed. The patient was seen in the physician's office and had had physical therapy and was recovering. Follow up information was received which reported that the retired patient developed a brachial plexitis at upper trunk. Unremarkable magnetic resonance imaging was performed at spine and indicated that brachial plexus and shoulder. The condition was improving. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who on 02-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient is currently experiencing Shingles. The patient has not experienced any known symptoms. At the time of the report, it was unknown if the patient had recovered from the event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female who was vaccinated with ZOSTER vaccine. Subsequently the patient developed shingles. The patient sought medical attention with office visit. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 70 year old female with no pertinent medical history and no history of drug reactions or allergies who on 02-JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On 03-JUN-2008 the patient reported itching, a little round pink area and a "little lump" at the injection site. On 04-JUN-2008 the
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Information has been received from a pharmacist concerning a 72 year old ale with no pertinent medical history and no history of drug reactions or allergies who on 02-JUN-2008 was vaccinated with ZOSTAVAX (Merck). On 03-JUN-2008 the patient experienced itching, a little round pink area at the injection site. At the time of the report, the patient's itching and round pink area at injection site persisted. It was unspecified if the patient sought medical attention. Additional information has been requested. This is one of several reports from the same source.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Feeling abnormal, Mouth ulceration, Oral herpes
Clinical narrative: Information has been received from a 70 year old female with borderline diabetes and no allergies who had a history of oral contact with herpes but no reaction and took GAMOGLOBULIN (manufacturer unspecified) (at 19 years of age). On 18-APR-2008 the patient was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. About 3 weeks after vaccination, on appropriately 02-MAY-2008, the patient experienced a cold sore on her mouth, "feeling very bad for awhile, very bad stomach pains", and had an ulcer in her mouth. The patient visited her druggist for information and tried ABREVA. No laboratory or diagnostic studies were performed. About 10 days after cold sore developed, the patient recovered. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Information has been received from a physician concerning a 72 year old female with no pertinent medical history or allergies who on 02-JUN-2008 was vaccinated subcutaneously with a dose of ZOSTAVAX vaccine (OKA/Merck) in the deltoid area. There was no concomitant medication. On 04-JUN-2008 the patient developed pain and redness. No other symptoms and no treatment reported. No laboratory or diagnostics studies was performed. At the time of the report, the patient's pain and redness persisted. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a RN concerning a 12 month old male who on 04-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) [lot #658839/1411U] subcutaneously instead of VARIVAX (Oka/Merck). No problems were reported. The R.N. indicated that the ZOSTAVAX (Oka/Merck) vial was in a VARIVAX (Oka/Merck) box, which led to the mix-up. She could not confirm if
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Information has been received from a female who on 27-MAY-2008 was vaccinated with a single dose of ZOSTAVAX (Oka/Merck). On 30-MAY-2008 the patient experienced a square shaped red mark approximately the size of a quarter appeared at the injection site and itching as a result of this mark. At the time of the report, the patient's red mark was still present. No further information is available.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure, Aphthous stomatitis, Device leakage, Dizziness, Pruritus
Clinical narrative: Information has been received from a registered nurse concerning herself who on 03-JUN-2008 was reconstituting ZOSTAVAX (Oka/Merck) to be administered to a patient, something happened with the syringe and some of the vaccine squirted up on her face, eye, lips and hand. The patient felt dizzy and had facial itching and a canker sore in her mouth since the eye splash. On 04-JUN-2008, the patient recovered from dizzy and facial itching. As the tine of 11-JUN-2008, the patient's canker sore in her mouth still persisted. Follow up information was from the registered nurse reported that the patient was 55 years old and had no pre-existing allergies, birth defects and medical conditions. On 03-JUN-2008 at 2:30 PM, the patient mixed the vaccine and diluent, the vaccine was inadvertently splashed to her face, eyes, lips and hands. There was no illness at time of vaccination. No laboratory diagnostics studies were performed. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Body temperature increased, Chest pain, Headache, Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 60 year old female with no allergies, hyperlipidemia, multinodular goiter and a history of chickenpox (1952) who on 20-MAY-2008 at 1700 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merk) (lot # 659759/1873U) in the left deltoid. There was no illness at the time of vaccination. Concomitant therapy included SYNTHROID and LIPITOR. On 27-MAY-2008 the patient developed pain in her chest, back, right arm and also had a headache. The pain was rated 8 out of 10. On 27-MAY-2008, the patient still had post-herpetic neuralgia. On 29-MAY-2008 the patient developed rash. Other systemic symptom included chest/back pain, headache and right arm pain. The pain was treated with VALTREX 100mg, three times a day for one week and LIDODERM patch for pain. The type of rash was vesicular erythematous, the number of lesions was multiple and the lesions distributed to right upper to right upper chest. The patient visited the physician's office. The patient had Shingles. On 06-JUN-2008 vesicle specimen was obtained. At the time of the report patient's Shingles and post-herpetic neuralgia persisted. No product quality complaint was involved. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Merck vaccine strain. The sample of the lesion was collected on 06-JUN-2008. The sample was taken form a vesicle. The result for the specimen was negative for B-Globin, no strain identified. The samples were noted to be inadequate. Follow-up information was received from a health professional which reported the patient still with some neuropathy. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008.  follow-up information was received from a health professional which reported the patient still with some post herpetic neuralgia, but it is definitely better. Follow-up information was received on 21-OCT-2008 from a health professional which reported the patient still with same symptoms no change from last report. Follow-up information was received on 08-JAN-2009 from a registered Nurse (R.N) which reported the patient still with some post herpetic neuralgia and off. Follow-up information was received on 19-MAR-2009 from a Registered Nurse (R.N) who reported that the patient still had occasional post herpetic neuropathy. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity, Polymerase chain reaction, Post herpetic neuralgia, Rash erythematous
Clinical narrative: Information has been received from a physician concerning a 60 year old female with no allergies, hyperlipidemia, multinodular goiter and a history of chickenpox (1952) who on 20-MAY-2008 at 1700 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merk) (lot # 659759/1873U) in the left deltoid. There was no illness at the time of vaccination. Concomitant therapy included SYNTHROID and LIPITOR. On 27-MAY-2008 the patient developed pain in her chest, back, right arm and also had a headache. The pain was rated 8 out of 10. On 27-MAY-2008, the patient still had post-herpetic neuralgia. On 29-MAY-2008 the patient developed rash. Other systemic symptom included chest/back pain, headache and right arm pain. The pain was treated with VALTREX 100mg, three times a day for one week and LIDODERM patch for pain. The type of rash was vesicular erythematous, the number of lesions was multiple and the lesions distributed to right upper to right upper chest. The patient visited the physician's office. The patient had Shingles. On 06-JUN-2008 vesicle specimen was obtained. At the time of the report patient's Shingles and post-herpetic neuralgia persisted. No product quality complaint was involved. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Merck vaccine strain. The sample of the lesion was collected on 06-JUN-2008. The sample was taken form a vesicle. The result for the specimen was negative for B-Globin, no strain identified. The samples were noted to be inadequate. Follow-up information was received from a health professional which reported the patient still with some neuropathy. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008.  follow-up information was received from a health professional which reported the patient still with some post herpetic neuralgia, but it is definitely better. Follow-up information was received on 21-OCT-2008 from a health professional which reported the patient still with same symptoms no change from last report. Follow-up information was received on 08-JAN-2009 from a registered Nurse (R.N) which reported the patient still with some post herpetic neuralgia and off. Follow-up information was received on 19-MAR-2009 from a Registered Nurse (R.N) who reported that the patient still had occasional post herpetic neuropathy. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a physician concerning a 60 year old female with no allergies, hyperlipidemia, multinodular goiter and a history of chickenpox (1952) who on 20-MAY-2008 at 1700 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merk) (lot # 659759/1873U) in the left deltoid. There was no illness at the time of vaccination. Concomitant therapy included SYNTHROID and LIPITOR. On 27-MAY-2008 the patient developed pain in her chest, back, right arm and also had a headache. The pain was rated 8 out of 10. On 27-MAY-2008, the patient still had post-herpetic neuralgia. On 29-MAY-2008 the patient developed rash. Other systemic symptom included chest/back pain, headache and right arm pain. The pain was treated with VALTREX 100mg, three times a day for one week and LIDODERM patch for pain. The type of rash was vesicular erythematous, the number of lesions was multiple and the lesions distributed to right upper to right upper chest. The patient visited the physician's office. The patient had Shingles. On 06-JUN-2008 vesicle specimen was obtained. At the time of the report patient's Shingles and post-herpetic neuralgia persisted. No product quality complaint was involved. The patient was enrolled in the VZVIP program: the vaccine Zoster virus identification program enables biological samples to be analyzed by PCR to identify if VZV is present and it is present to identify if it is associated with the wild type strain or with the Merck vaccine strain. The sample of the lesion was collected on 06-JUN-2008. The sample was taken form a vesicle. The result for the specimen was negative for B-Globin, no strain identified. The samples were noted to be inadequate. Follow-up information was received from a health professional which reported the patient still with some neuropathy. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2008.  follow-up information was received from a health professional which reported the patient still with some post herpetic neuralgia, but it is definitely better. Follow-up information was received on 21-OCT-2008 from a health professional which reported the patient still with same symptoms no change from last report. Follow-up information was received on 08-JAN-2009 from a registered Nurse (R.N) which reported the patient still with some post herpetic neuralgia and off. Follow-up information was received on 19-MAR-2009 from a Registered Nurse (R.N) who reported that the patient still had occasional post herpetic neuropathy. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old female who on 28-MAY-2008 was vaccinated subcutaneously with ZOSTAVAX (Oka/Merk). Concomitant therapy included NORVASC, ACTONEL, LIPITOR. On 28-MAY-2008 the patient experienced pain in the arm (unspecified arm). The patient's pain in the arm (unspecified arm) persisted. No product quality complaint was involved. Follow-up information was received from a pharmacist concerning a 76 year old retired female with tetracycline, aspirin, and barbiturates allergies who on 29-MAY-2008 at 1300 was vaccinated subcutaneously with the first dose of ZOSTAVAX (Oka/Merk) (lot # 659408/0300X). There was no illness at time of vaccination. On 04-JUN-2008, sore arm lasting one week at injection site (left arm). On 05-JUN-2008, the patient recovered. Medical attention was not sought. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash, Urticaria
Clinical narrative: Information has been received from a patient who was vaccinated with a dose of ZOSTAVAX (Merck). On 20-MAY-2008, the patient experienced rashes on left thigh and leg, as well as buttocks. The patient was in extreme pain because the rashes developed into welts and yellow blistering occurred as well. The patient went to a dermatologist and a neurologist, both of whom confirmed the fact that it was shingles and prescribed oral medication, pain killers and powders to use for soaking the areas. At the time of this report the outcome was unspecified. Follow up information was received which reported that on 30-MAY-2007 the patient was vaccinated with a dose of ZOSTAVAX (Merck). Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/24/2008. Follow-up information was received from the physician's office which reported that they "had no patient with any adverse reaction to ZOSTAVAX." There was no additional information. Additional information is not expected.