chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: F
Vaccine: HEPA
Symptoms: Contusion, Erythema, Platelet count increased, Rash macular
Clinical narrative: 9-13-08 mother noticed red blotchy rash on arms, legs and trunk of child. Rush turned to bruising mostly on arms and legs. Examined by Dr on 09-22-08. Mother stated Dr suspected ITP. Follow up visit scheduled for Oct 1, 08
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 2 mildly indurated lesions L upper thigh  3 1/2 3cm superiorly   11/2 x 2cm inferolaterally + erythema + warm to touch zero drainage zero streak  started small on day of immunization- progressively worsening- seen 2 days after shots.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Shingles L 4 Distribution Left leg (3 other cases in practice after shingles  in vaccinated linb)
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC
Symptoms: Full blood count, Injection site rash, Laboratory test, Pyrexia
Clinical narrative: Vaccines PEDIARIX and PREVNAR administered in arm on 9-29-08. Parent reports low grade temp through night of 9-29-08. High fever started 9-3o AM on 9-30-08 max temp 103 degrees. Rash on left thigh around injection site.
Age: 1.4
Sex: M
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Erythema, Swelling
Clinical narrative: Redness, mild swelling within 24-48 hrs of vaccine - located in region of vaccination given in left thigh (PEDIARIX)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: Red spots, hot to touch, hard  >5cm.  Ibuprofen, cool compress
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Eyelid oedema, Lip swelling, Oedema peripheral, Skin discolouration
Clinical narrative: Eyelids swelling 9/286/08 pm. Top lip swole 9/27/08 am. Palms of hands started swelling and red discoloration  9/26/08 pm
Age: 36.0
Sex: M
Vaccine: RAB
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Raised, redness, warmth surrounding injection site about 1X1. Noticed it was smaller yesterday and has been getting larger. No other S/S. Infection. 7:00 - came in - assessed RXN. Likely infection/temp increased. Sent to ER/urgent care."
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Body temperature increased, Crying, Local swelling
Clinical narrative: Past vaccine given on 6/9/08 pt had T101 - local swelling, crying in consolable x 2d.
Age: 16.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: 3 days after immunization Left arm posterior distal aspect has red, itchy 5 x 9 cm area.
Age: 1.8
Sex: U
Vaccine: MMR
Symptoms: Chest X-ray abnormal, Cough, Lung infiltration, Pneumonia, Pyrexia
Clinical narrative: Pt developed pneumonia 4 days following MMR II. Fever, cough, radiographic + infiltrate. Oral Azithromycin. Improving as of 9/29/08.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: 5 hours after injection pt reported symptoms of nausea, sweating, fatigue, headache.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Biopsy skin, Body temperature increased, Herpes zoster, Pruritus, Pyrexia
Clinical narrative: Information has been received from a physician concerning a 70 year old retired female with shell and fish allergy and sulfa allergy and a history of asthma and chickenpox as a child who on 10-SEP-2007 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot # 658082/0744U) 0.65ml in left upper arm. There was no illness at time of vaccination. Concomitant therapy included MONTELUKAST SODIUM (MSD), OMEPRAZOLE, therapy unspecified and no steroids. On 12-SEP-2007 the patient developed rash on arms and upper trunk. ON 26-JUN-2008 the patient diagnosed with shingles on the upper inner left forearm T2 and T3 area. The patient's skin lesion type was vesicle. There were three large lesions which were itchy. The patient's temperature was 98.8 F. The physician stated it was classic shingles rash. The patient had no recent exposure to shingles or chicken pox. The patient's shingles was persisted. 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 Oka/Merck vaccine strain. The sample of the lesion was collected on 26-JUN-2008. The samples were taken from left lower arm were no VZV identified-negative. Follow up information has been received. The patient developed fever and several vesicles after the vaccination. On 24-JUN-2008, the patient developed a zoster like reaction on her left forearm. The patient recovered. Additional information is not expected.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician concerning a 70 year old retired female with shell and fish allergy and sulfa allergy and a history of asthma and chickenpox as a child who on 10-SEP-2007 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (lot # 658082/0744U) 0.65ml in left upper arm. There was no illness at time of vaccination. Concomitant therapy included MONTELUKAST SODIUM (MSD), OMEPRAZOLE, therapy unspecified and no steroids. On 12-SEP-2007 the patient developed rash on arms and upper trunk. ON 26-JUN-2008 the patient diagnosed with shingles on the upper inner left forearm T2 and T3 area. The patient's skin lesion type was vesicle. There were three large lesions which were itchy. The patient's temperature was 98.8 F. The physician stated it was classic shingles rash. The patient had no recent exposure to shingles or chicken pox. The patient's shingles was persisted. 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 Oka/Merck vaccine strain. The sample of the lesion was collected on 26-JUN-2008. The samples were taken from left lower arm were no VZV identified-negative. Follow up information has been received. The patient developed fever and several vesicles after the vaccination. On 24-JUN-2008, the patient developed a zoster like reaction on her left forearm. The patient recovered. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood pressure decreased, Cold sweat, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 60 year old female who on 15-MAY-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot number 659614/0161X) by subcutaneous injection in the left upper arm. Within a few moments? also reported as 10 minutes after administration, the patient became lightheaded, sweating, clammy, and then she fainted for a few seconds (she was sitting in a chair). 911 was called. The patient was transported to the emergency room. She was later released. Subsequently, the patient recovered from the events. The patient stated she did not think it was associated with the vaccine because she had not eaten the morning of vaccination and she was dehydrated from doing yard work before receiving the vaccine at noon time. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: Initial and follow-up information has been received from a pharmacist concerning a 60 year old female who on 15-MAY-2008 was vaccinated with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot number 659614/0161X) by subcutaneous injection in the left upper arm. Within a few moments? also reported as 10 minutes after administration, the patient became lightheaded, sweating, clammy, and then she fainted for a few seconds (she was sitting in a chair). 911 was called. The patient was transported to the emergency room. She was later released. Subsequently, the patient recovered from the events. The patient stated she did not think it was associated with the vaccine because she had not eaten the morning of vaccination and she was dehydrated from doing yard work before receiving the vaccine at noon time. Additional information is not expected.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 27-MAY-2008 was vaccinated subcutaneoulsy with a 0.5ml dose of  ZOSTAVAX vaccine instead of Varicella virus vaccine, due to a medical error. the patient was not experiencing any known symptoms. the nurse stated that the error was not her fault. It had nothing to do with packaging or anything else. The nurse was disturbed several times while dispensing the medications and she didn't even realize that she grabbed the wrong one until later that evening when she was doing the charts. She has since separated the two products in their freezer, in the hopes of preventing others in the office from doing it again. She also stated that the patient was in the office on 30-May-2008 and the patient looked and acted fine. The patient's siblings also had an adverse experience with ZOSTAVAX (WAES#08C6USA0771B & 0806USA07719).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a registered nurse concerning a patient who on 27-MAY-2008 was vaccinated subcutaneoulsy with a 0.5ml dose of  ZOSTAVAX vaccine instead of Varicella virus vaccine, due to a medical error. the patient was not experiencing any known symptoms. the nurse stated that the error was not her fault. It had nothing to do with packaging or anything else. The nurse was disturbed several times while dispensing the medications and she didn't even realize that she grabbed the wrong one until later that evening when she was doing the charts. She has since separated the two products in their freezer, in the hopes of preventing others in the office from doing it again. She also stated that the patient was in the office on 30-May-2008 and the patient looked and acted fine. The patient's siblings also had an adverse experience with ZOSTAVAX (WAES#08C6USA0771B & 0806USA07719).
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a physician concerning an 85 year old female with hyponatraemia, hypertension, paroxysmal atrial fibrillation, degenerative joint disease and osteoporosis who on 29-MAY-2008 was vaccinated with the first dose of ZOSTAVAX subcutaneously in the L arm (lot no. 658844/0204X). Concomitant therapy included enalapril maleate, LASIX, COUMADIN and alendronate sodium (MSD). The patient did not have any other vaccinations within 4 weeks prior to the zoster vaccine administration and had no illnesses at the time of the vaccination. The patient called the physician on 04-JUN-2008 for a systemic vascular itchy rash noted on 03-JUN-2008. At the time of this report the patient was not recovered. No further information is available.
Age: 85.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Vasculitic rash
Clinical narrative: Information has been received from a physician concerning an 85 year old female with hyponatraemia, hypertension, paroxysmal atrial fibrillation, degenerative joint disease and osteoporosis who on 29-MAY-2008 was vaccinated with the first dose of ZOSTAVAX subcutaneously in the L arm (lot no. 658844/0204X). Concomitant therapy included enalapril maleate, LASIX, COUMADIN and alendronate sodium (MSD). The patient did not have any other vaccinations within 4 weeks prior to the zoster vaccine administration and had no illnesses at the time of the vaccination. The patient called the physician on 04-JUN-2008 for a systemic vascular itchy rash noted on 03-JUN-2008. At the time of this report the patient was not recovered. No further information is available.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS, DTAP, IPV, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old male with no pre-existing allergies or medical conditions who in the morning on 20-MAY-2008 was vaccinated subcutaneously in the right arm with a 0.65 ml first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659762/1874U) instead of VARIVAX vaccine (MSD). On the same day, the patient was also vaccinated subcutaneously in the right arm with the second dose of MMR II vaccine (Wistar RA 27/3) (Lot 660208/0454X (MSD) INFANRIX (LOT# AC14BD73AA) and IPOL (LOT# L41032). There was no illness at time of involved, the incident was due to human error. Additional information is not expected.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARZOS, DTAP, IPV, MMR, VARZOS
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 year old male with no pre-existing allergies or medical conditions who in the morning on 20-MAY-2008 was vaccinated subcutaneously in the right arm with a 0.65 ml first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659762/1874U) instead of VARIVAX vaccine (MSD). On the same day, the patient was also vaccinated subcutaneously in the right arm with the second dose of MMR II vaccine (Wistar RA 27/3) (Lot 660208/0454X (MSD) INFANRIX (LOT# AC14BD73AA) and IPOL (LOT# L41032). There was no illness at time of involved, the incident was due to human error. Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discharge, Injection site pruritus, Injection site rash, Musculoskeletal pain, Neck pain
Clinical narrative: Information has been received from a nurse concerning a 68 year old patient who was vaccinated with zoster vaccine live (Oka/Merck) (lot number, injection site and route not reported). After the vaccine was given, the patient experienced a shingles rash, pain in arms and shoulders. Follow-up information was received from a physician on 23-JUN-2008 concerning a 68 year old male with no drug allergies and a history of chickenpox (onset when he was 6 year old) who on 27-MAY-2008 was vaccinated in the left arm with a dose of zoster vaccine live (Oka/Merck) (Lot #658863/1414U). There was no concomitant medication. The patient had no recent exposure to chickenpox and shingles. 48 hours post vaccination, on 29-MAY-2008, the patient developed 15 vesicular lesions and also had pruritus and pain ranked 4 out of 10 in the lateral aspect of the left upper extremity. On 20-JUN-2008 a specimen was obtained from scab for VZV identification (results pending). At the time of the report, the patient was "in process" of recovery. The patient was enrolled in Varicella Zoster Virus identification Program to identity if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was "wild". Follow-up information was received from a physician via telephone call on 08-JUL-2008. He reported that at the time of the report, the patient was about "90% recovered" from his shingles rash. The patient did not have any pain. The physician felt that the patient was "on his way to recovery". Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Pain, Pain in extremity, Pruritus
Clinical narrative: Information has been received from a nurse concerning a 68 year old patient who was vaccinated with zoster vaccine live (Oka/Merck) (lot number, injection site and route not reported). After the vaccine was given, the patient experienced a shingles rash, pain in arms and shoulders. Follow-up information was received from a physician on 23-JUN-2008 concerning a 68 year old male with no drug allergies and a history of chickenpox (onset when he was 6 year old) who on 27-MAY-2008 was vaccinated in the left arm with a dose of zoster vaccine live (Oka/Merck) (Lot #658863/1414U). There was no concomitant medication. The patient had no recent exposure to chickenpox and shingles. 48 hours post vaccination, on 29-MAY-2008, the patient developed 15 vesicular lesions and also had pruritus and pain ranked 4 out of 10 in the lateral aspect of the left upper extremity. On 20-JUN-2008 a specimen was obtained from scab for VZV identification (results pending). At the time of the report, the patient was "in process" of recovery. The patient was enrolled in Varicella Zoster Virus identification Program to identity if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was "wild". Follow-up information was received from a physician via telephone call on 08-JUL-2008. He reported that at the time of the report, the patient was about "90% recovered" from his shingles rash. The patient did not have any pain. The physician felt that the patient was "on his way to recovery". Additional information is not expected.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a nurse concerning a 68 year old patient who was vaccinated with zoster vaccine live (Oka/Merck) (lot number, injection site and route not reported). After the vaccine was given, the patient experienced a shingles rash, pain in arms and shoulders. Follow-up information was received from a physician on 23-JUN-2008 concerning a 68 year old male with no drug allergies and a history of chickenpox (onset when he was 6 year old) who on 27-MAY-2008 was vaccinated in the left arm with a dose of zoster vaccine live (Oka/Merck) (Lot #658863/1414U). There was no concomitant medication. The patient had no recent exposure to chickenpox and shingles. 48 hours post vaccination, on 29-MAY-2008, the patient developed 15 vesicular lesions and also had pruritus and pain ranked 4 out of 10 in the lateral aspect of the left upper extremity. On 20-JUN-2008 a specimen was obtained from scab for VZV identification (results pending). At the time of the report, the patient was "in process" of recovery. The patient was enrolled in Varicella Zoster Virus identification Program to identity if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. Follow-up information was received on 02-JUL-2008. The final PCR result was "wild". Follow-up information was received from a physician via telephone call on 08-JUL-2008. He reported that at the time of the report, the patient was about "90% recovered" from his shingles rash. The patient did not have any pain. The physician felt that the patient was "on his way to recovery". Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Rash macular
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female patient with a history of hip arthroplasty revision on 18-SEP-2007 who at 3:30 pm on 10-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 659410/0412x) 0.65ml subcutaneous in her left deltoid. Concomitant therapy included glucosamine, alendronate sodium (MSD) and ascorbic acid (+) beta carotene (+) copper (unspecified (+) manganese (unspecified) (+) riboflavin (+) selenium (unspecified) (+) Vitamin E (+) xanthophyll (+) zeaxanthin (+) zinc acetate (ICAPS). On 14-JUN-2008 the patient experienced a "blotch" on the stomach. The blotch was slightly itchy, elevated and 3 inches wide by 5 inches long and tapered at the end. The blotch was red and there was some fluid in the area initially but not anymore. The patient had been using an unspecified topical antibiotic ointment on the blotch that initially caused a slight burning but now it was not burning. The blotch was fading away and the patient was getting better. The patient sought medical attention by calling the pharmacist. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Burning sensation, Erythema, Pruritus, Rash macular
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female patient with a history of hip arthroplasty revision on 18-SEP-2007 who at 3:30 pm on 10-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 659410/0412x) 0.65ml subcutaneous in her left deltoid. Concomitant therapy included glucosamine, alendronate sodium (MSD) and ascorbic acid (+) beta carotene (+) copper (unspecified (+) manganese (unspecified) (+) riboflavin (+) selenium (unspecified) (+) Vitamin E (+) xanthophyll (+) zeaxanthin (+) zinc acetate (ICAPS). On 14-JUN-2008 the patient experienced a "blotch" on the stomach. The blotch was slightly itchy, elevated and 3 inches wide by 5 inches long and tapered at the end. The blotch was red and there was some fluid in the area initially but not anymore. The patient had been using an unspecified topical antibiotic ointment on the blotch that initially caused a slight burning but now it was not burning. The blotch was fading away and the patient was getting better. The patient sought medical attention by calling the pharmacist. Additional information is not expected.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old female patient with a history of hip arthroplasty revision on 18-SEP-2007 who at 3:30 pm on 10-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (Merck) (Lot # 659410/0412x) 0.65ml subcutaneous in her left deltoid. Concomitant therapy included glucosamine, alendronate sodium (MSD) and ascorbic acid (+) beta carotene (+) copper (unspecified (+) manganese (unspecified) (+) riboflavin (+) selenium (unspecified) (+) Vitamin E (+) xanthophyll (+) zeaxanthin (+) zinc acetate (ICAPS). On 14-JUN-2008 the patient experienced a "blotch" on the stomach. The blotch was slightly itchy, elevated and 3 inches wide by 5 inches long and tapered at the end. The blotch was red and there was some fluid in the area initially but not anymore. The patient had been using an unspecified topical antibiotic ointment on the blotch that initially caused a slight burning but now it was not burning. The blotch was fading away and the patient was getting better. The patient sought medical attention by calling the pharmacist. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Injection site inflammation, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmacist stated that a patient developed hives after receiving ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). The patient received the vaccine on 23-JUN-2008, and she came back to the pharmacy on 26-JUN-2008 with hives. The hives radiated to legs and waist. There were  also some hives on her chest and one small blister on her eye lid. On 28-JUN-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought: the pharmacist saw the patient. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who On 23-JUN-2008 at 4:30 pm was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left arm. On 24-JUN-2008 at 8:00 am (also reported as 26-JUN-2008, the patient developed swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. some appeared pustule like. Doctor prescribed CEPHALEXIN and CORTAID topical. On 27-JUN-2008 patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eye lid, waistline, grain with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Pharmacist told patient to return immediately to her primary care doctor for treatment. At the time of reporting the patient had not recovered. There was no illness at the time of vaccination. The events required ER/DR visit. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Pain, Pruritus, Rash generalised, Rash macular
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmacist stated that a patient developed hives after receiving ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). The patient received the vaccine on 23-JUN-2008, and she came back to the pharmacy on 26-JUN-2008 with hives. The hives radiated to legs and waist. There were  also some hives on her chest and one small blister on her eye lid. On 28-JUN-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought: the pharmacist saw the patient. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who On 23-JUN-2008 at 4:30 pm was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left arm. On 24-JUN-2008 at 8:00 am (also reported as 26-JUN-2008, the patient developed swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. some appeared pustule like. Doctor prescribed CEPHALEXIN and CORTAID topical. On 27-JUN-2008 patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eye lid, waistline, grain with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Pharmacist told patient to return immediately to her primary care doctor for treatment. At the time of reporting the patient had not recovered. There was no illness at the time of vaccination. The events required ER/DR visit. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash pustular, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmacist stated that a patient developed hives after receiving ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). The patient received the vaccine on 23-JUN-2008, and she came back to the pharmacy on 26-JUN-2008 with hives. The hives radiated to legs and waist. There were  also some hives on her chest and one small blister on her eye lid. On 28-JUN-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought: the pharmacist saw the patient. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who On 23-JUN-2008 at 4:30 pm was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left arm. On 24-JUN-2008 at 8:00 am (also reported as 26-JUN-2008, the patient developed swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. some appeared pustule like. Doctor prescribed CEPHALEXIN and CORTAID topical. On 27-JUN-2008 patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eye lid, waistline, grain with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Pharmacist told patient to return immediately to her primary care doctor for treatment. At the time of reporting the patient had not recovered. There was no illness at the time of vaccination. The events required ER/DR visit. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Culture positive, Eyelid oedema, Herpes zoster, Oedema peripheral
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmacist stated that a patient developed hives after receiving ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). The patient received the vaccine on 23-JUN-2008, and she came back to the pharmacy on 26-JUN-2008 with hives. The hives radiated to legs and waist. There were  also some hives on her chest and one small blister on her eye lid. On 28-JUN-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought: the pharmacist saw the patient. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who On 23-JUN-2008 at 4:30 pm was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left arm. On 24-JUN-2008 at 8:00 am (also reported as 26-JUN-2008, the patient developed swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. some appeared pustule like. Doctor prescribed CEPHALEXIN and CORTAID topical. On 27-JUN-2008 patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eye lid, waistline, grain with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Pharmacist told patient to return immediately to her primary care doctor for treatment. At the time of reporting the patient had not recovered. There was no illness at the time of vaccination. The events required ER/DR visit. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pruritus, Skin test positive, Skin warm
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmacist stated that a patient developed hives after receiving ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). The patient received the vaccine on 23-JUN-2008, and she came back to the pharmacy on 26-JUN-2008 with hives. The hives radiated to legs and waist. There were  also some hives on her chest and one small blister on her eye lid. On 28-JUN-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought: the pharmacist saw the patient. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who On 23-JUN-2008 at 4:30 pm was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left arm. On 24-JUN-2008 at 8:00 am (also reported as 26-JUN-2008, the patient developed swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. some appeared pustule like. Doctor prescribed CEPHALEXIN and CORTAID topical. On 27-JUN-2008 patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eye lid, waistline, grain with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Pharmacist told patient to return immediately to her primary care doctor for treatment. At the time of reporting the patient had not recovered. There was no illness at the time of vaccination. The events required ER/DR visit. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Erythema, Injection site inflammation, Injection site rash, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmacist stated that a patient developed hives after receiving ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). The patient received the vaccine on 23-JUN-2008, and she came back to the pharmacy on 26-JUN-2008 with hives. The hives radiated to legs and waist. There were  also some hives on her chest and one small blister on her eye lid. On 28-JUN-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought: the pharmacist saw the patient. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who On 23-JUN-2008 at 4:30 pm was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left arm. On 24-JUN-2008 at 8:00 am (also reported as 26-JUN-2008, the patient developed swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. some appeared pustule like. Doctor prescribed CEPHALEXIN and CORTAID topical. On 27-JUN-2008 patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eye lid, waistline, grain with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Pharmacist told patient to return immediately to her primary care doctor for treatment. At the time of reporting the patient had not recovered. There was no illness at the time of vaccination. The events required ER/DR visit. No further information is available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash generalised, Rash pustular, Urticaria
Clinical narrative: Information has been received from a pharmacist concerning a 63 year old female who on 23-JUN-2008 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). There were no concomitant medications reported. The pharmacist stated that a patient developed hives after receiving ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X). The patient received the vaccine on 23-JUN-2008, and she came back to the pharmacy on 26-JUN-2008 with hives. The hives radiated to legs and waist. There were  also some hives on her chest and one small blister on her eye lid. On 28-JUN-2008 she came back to the pharmacy and filled MEDROL dose pack. The patient told the pharmacist that she was referred to a dermatologist. Medical attention was sought: the pharmacist saw the patient. At the time of reporting, the outcome of the patient was unknown. There was no product quality complaint. Follow up information was received concerning a 63 year old female patient with no medical history, no known allergies, who On 23-JUN-2008 at 4:30 pm was vaccinated with a first dose of ZOSTAVAX vaccine (Oka/Merck) (Lot # 659411/0293X) subcutaneously on the left arm. On 24-JUN-2008 at 8:00 am (also reported as 26-JUN-2008, the patient developed swollen (softball sized) inflamed area near injection site with rash. Red inflamed rash on left and right arm, clustered on left thigh, some going up to groin area, left side hairline. some appeared pustule like. Doctor prescribed CEPHALEXIN and CORTAID topical. On 27-JUN-2008 patient returned to pharmacy with increased redness and spreading of rash to other sites, the right eye lid, waistline, grain with some that appeared pustule like. Injection site swelling had improved but pain, rash, redness had spread all over body. Pharmacist told patient to return immediately to her primary care doctor for treatment. At the time of reporting the patient had not recovered. There was no illness at the time of vaccination. The events required ER/DR visit. No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old patient who on 30-JUN-2008 was vaccinated with the first dose of ZOSTAVAX vaccine (Oka/Merck) SC (lot # 659672/0294X) at 1000. The patient came into pharmacy 2 days after vaccination was given with a bright red, softball-sized area of cellulitis. It began on 01-JUL-2008 with a small red bump at 1500, then it progressively got larger. The patient visited her doctor and was given CEPHALEXIN. The cellulitis did not go away after the CEPHALEXIN, so she went back to the doctor and received a shot of an antibiotic. After that, the cellulitis cleared up one week later. No further information is available.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis
Clinical narrative: Information has been received from a pharmacist concerning a 71 year old patient who on 30-JUN-2008 was vaccinated with the first dose of ZOSTAVAX vaccine (Oka/Merck) SC (lot # 659672/0294X) at 1000. The patient came into pharmacy 2 days after vaccination was given with a bright red, softball-sized area of cellulitis. It began on 01-JUL-2008 with a small red bump at 1500, then it progressively got larger. The patient visited her doctor and was given CEPHALEXIN. The cellulitis did not go away after the CEPHALEXIN, so she went back to the doctor and received a shot of an antibiotic. After that, the cellulitis cleared up one week later. No further information is available.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 76 year old male with an allergy to BACTRIM and a history of open heart surgery due to benign tumor of the heart and a recurrent herpetic simplex type of infection on his left buttock since 08-MAR-2007 and no illness at the time of vaccination, who at 10:32 on 09-JAN-2008 was vaccinated with the first dose of ZOSTAVAX (lot#: 658605/1089U). Concomitant therapy included COREG and LIPITOR. On 25-JAN-2008, the patient called for a prescription for cimetidine as he had developed a milder form of rash at the base of his spine. On 09-JUL-2008, the patient called again with complaints of a rash. The patient treated his rash with calamine, he stated that this lasted for 2 weeks. On 16-AUG-2008, the patient had a return episode of shingles. The patient's outcome was unknown. He had an appointment with a dermatologist on 24-SEP-2008. Follow up information received indicated that the patient had return episodes of shingles (previously reported as rash) in January 2008, July 2008 and August 2008. Additional information is not expected.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 76 year old male with an allergy to BACTRIM and a history of open heart surgery due to benign tumor of the heart and a recurrent herpetic simplex type of infection on his left buttock since 08-MAR-2007 and no illness at the time of vaccination, who at 10:32 on 09-JAN-2008 was vaccinated with the first dose of ZOSTAVAX (lot#: 658605/1089U). Concomitant therapy included COREG and LIPITOR. On 25-JAN-2008, the patient called for a prescription for cimetidine as he had developed a milder form of rash at the base of his spine. On 09-JUL-2008, the patient called again with complaints of a rash. The patient treated his rash with calamine, he stated that this lasted for 2 weeks. On 16-AUG-2008, the patient had a return episode of shingles. The patient's outcome was unknown. He had an appointment with a dermatologist on 24-SEP-2008. Follow up information received indicated that the patient had return episodes of shingles (previously reported as rash) in January 2008, July 2008 and August 2008. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Oedema peripheral, Pyrexia, Urticaria
Clinical narrative: Information has been received from a licensed practical nurse concerning a 57 year old female who on 13JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 659672/0294X). The nurse reported that on 14-JUN-2008 the patient was nauseated with vomiting and diarrhea. The patient phoned the nurse on 16-JUN-2008 and the above symptoms had resolved. The nurse also reported that on 14-JUN-2008, the patient experienced an injection site reaction with a red and warm area 3-4 inches across. No treatment noted. The patient sought medical attention by phone. No further information is available.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 57 year old female who on 13JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 659672/0294X). The nurse reported that on 14-JUN-2008 the patient was nauseated with vomiting and diarrhea. The patient phoned the nurse on 16-JUN-2008 and the above symptoms had resolved. The nurse also reported that on 14-JUN-2008, the patient experienced an injection site reaction with a red and warm area 3-4 inches across. No treatment noted. The patient sought medical attention by phone. No further information is available.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Inappropriate schedule of drug administration, Injection site erythema, Injection site reaction, Injection site warmth
Clinical narrative: Information has been received from a licensed practical nurse concerning a 57 year old female who on 13JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 659672/0294X). The nurse reported that on 14-JUN-2008 the patient was nauseated with vomiting and diarrhea. The patient phoned the nurse on 16-JUN-2008 and the above symptoms had resolved. The nurse also reported that on 14-JUN-2008, the patient experienced an injection site reaction with a red and warm area 3-4 inches across. No treatment noted. The patient sought medical attention by phone. No further information is available.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Vomiting
Clinical narrative: Information has been received from a licensed practical nurse concerning a 57 year old female who on 13JUN-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 659672/0294X). The nurse reported that on 14-JUN-2008 the patient was nauseated with vomiting and diarrhea. The patient phoned the nurse on 16-JUN-2008 and the above symptoms had resolved. The nurse also reported that on 14-JUN-2008, the patient experienced an injection site reaction with a red and warm area 3-4 inches across. No treatment noted. The patient sought medical attention by phone. No further information is available.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyskinesia, Eyelid disorder, Facial palsy, Speech disorder
Clinical narrative: Information has been received from a registered nurse concerning herself, a 67 year old female with arthritis, morphine allergy, codeine allergy and allergic to CELEBREX which caused hair fell out by the roots who on 25-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 12-JUL-2008 the patient was diagnosed with BELL's palsy which she reported was given to her by the zoster vaccine. She is currently taking MEDROL dose pack and VALTREX. The patient had lost taste, left sided drooping, drooling, eye did not close all the way. Patient had to wear left eye patch. She was very upset. No improvement has been noted with MEDROL and VALTREX. On 22-JUL-2008, the patient reported that she had new right ear pain shooting down from her ear towards her jaw. She also noted that she might be able to close her eye a little more. The patient's BELL's palsy and ear pain persisted. The patient also reported that she will receive total knee surgery soon. Unspecified medical attention was sought. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ageusia, Drooling, Ear pain, Facial palsy
Clinical narrative: Information has been received from a registered nurse concerning herself, a 67 year old female with arthritis, morphine allergy, codeine allergy and allergic to CELEBREX which caused hair fell out by the roots who on 25-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). On 12-JUL-2008 the patient was diagnosed with BELL's palsy which she reported was given to her by the zoster vaccine. She is currently taking MEDROL dose pack and VALTREX. The patient had lost taste, left sided drooping, drooling, eye did not close all the way. Patient had to wear left eye patch. She was very upset. No improvement has been noted with MEDROL and VALTREX. On 22-JUL-2008, the patient reported that she had new right ear pain shooting down from her ear towards her jaw. She also noted that she might be able to close her eye a little more. The patient's BELL's palsy and ear pain persisted. The patient also reported that she will receive total knee surgery soon. Unspecified medical attention was sought. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin test
Clinical narrative: Information has been received from a physician concerning a 62 year old male patient with oesophagitis and oesophageal reflux, who on 25-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (lot# 659404/1826U) SQ in his left upper arm. Concomitant therapy included NEXIUM and MOTRIN. On 28-JUN-2008, the patient experienced pain at the left hip and hamstring. On the fifth day, the patient developed a shingles
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 62 year old male patient with oesophagitis and oesophageal reflux, who on 25-JUN-2008 was vaccinated with a first dose of ZOSTAVAX (lot# 659404/1826U) SQ in his left upper arm. Concomitant therapy included NEXIUM and MOTRIN. On 28-JUN-2008, the patient experienced pain at the left hip and hamstring. On the fifth day, the patient developed a shingles