chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: Information has been received from a physician and a 64 year old female with osteoarthritis, coronary artery disease, high cholesterol, and allergic rhinitis and a history of hives while on therapy with celecoxib (CELEBREX) and tiredness with sulfa drugs who on 20-AUG-2007 was vaccinated with a 0.5ml first dose of Zostavax (Oka/Merck) (Lot# "076U") given IM in her right deltoid. There was no illness at the time of vaccination. Concomitant therapy included clopidogrel bisulfate (PLAVIS), aspirin, pravastatin na (PRAVACHOL), albuterol, vitamins (unspecified), glucosamine, chondroitin, flaxseed, etodolac, and fexofenadine hydrochloride (ALLEGRA). On 21-AUG-2007 the patient developed a rash on her arms and lower legs. It started off as itchiness and progressed to swelling and redness (Patient also reported as measles). On 28-AUG-2007 she developed hives. In follow-up received on 07-SEP-2007, the physician reported that on 21-AUG-2007 the patient developed a moderate local reaction consisting of pain, swelling, and warmth. On 28-AUg-2007 the patient developed a urticarial rash in sun-exposed areas. No lab studies were performed. The physician noted the patient had not had a recent exposure to chicken pox or shingles. On an unspecified date the patient recovered. The patient had no adverse event following prior vaccination. No further information was provided. There was no product quality complaint involved. Additional information is not expected.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning an 85-year-old male, who on 04-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot #658211/0884U).  Concomitant therapy included warfarin sodium (reported as "Coumedin"), pantoprazole sodium (Protonix), digoxin (reported as "Digitex"), furosemide (Lasix (furosemide)), metoprolol succinate (reported as "Topral") and doxazosin mesylate (Cardura).  On 06-SEP-2007, the patient developed a rash.  Medical attention was sought, and an unspecified antibiotic was ordered.  No outcome was reported.  No product quality complaint was involved.  Additional information received indicates that the patient has chronic atrial fibrillation and an allergy to amiodarone hydrochloride (Amiodarone).  Vaccination occurred in the left deltoid with a first dose of Zostavax (Oka/Merck) (lot #658211/0884U).  There were no other vaccines given within 4 weeks prior to vaccination.  There was no illness at the time of vaccination.  On 05-Sep-2007, (originally reported as 06-Sep-2007), the patient developed a varicelliform eruption.  He had a few scattered vesicles in various stages of development over his lower extremity and upper extremity which were pruritic.  It was not systemic or at the vaccine site.  On 06-Sep-2007, the patient was seen at the doctor's office.  No laboratory or diagnostic tests were performed.  By 10-Sep-2007, the patient had recovered.  The reporter considered rash to be an other important medical event.  Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash pruritic, Rash vesicular
Clinical narrative: Information has been received from a nurse practitioner concerning an 85-year-old male, who on 04-SEP-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot #658211/0884U).  Concomitant therapy included warfarin sodium (reported as "Coumedin"), pantoprazole sodium (Protonix), digoxin (reported as "Digitex"), furosemide (Lasix (furosemide)), metoprolol succinate (reported as "Topral") and doxazosin mesylate (Cardura).  On 06-SEP-2007, the patient developed a rash.  Medical attention was sought, and an unspecified antibiotic was ordered.  No outcome was reported.  No product quality complaint was involved.  Additional information received indicates that the patient has chronic atrial fibrillation and an allergy to amiodarone hydrochloride (Amiodarone).  Vaccination occurred in the left deltoid with a first dose of Zostavax (Oka/Merck) (lot #658211/0884U).  There were no other vaccines given within 4 weeks prior to vaccination.  There was no illness at the time of vaccination.  On 05-Sep-2007, (originally reported as 06-Sep-2007), the patient developed a varicelliform eruption.  He had a few scattered vesicles in various stages of development over his lower extremity and upper extremity which were pruritic.  It was not systemic or at the vaccine site.  On 06-Sep-2007, the patient was seen at the doctor's office.  No laboratory or diagnostic tests were performed.  By 10-Sep-2007, the patient had recovered.  The reporter considered rash to be an other important medical event.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Hypoaesthesia, Pain in extremity, Skin disorder
Clinical narrative: Information has been received from a physician concerning a 71 year old female with allergic reaction to AUGMENTIN ("patient almost died after taking a medication for congestion") who on approximately 01-SEP-2007 ("Labor Day weekend") was vaccinated with Zostavax, 0.65 ml (no lot number was provided). Concomitant therapy included PAXIL. On approximately 01-SEP-2007, after receiving vaccine, the patient experienced pain in right leg from the knee to the ankle, felt tired, had a lump, tenderness and warmth at injection site. The day after receiving the vaccine (approximately 02-SEP-2007), the patient experienced pain in left leg. She described the left leg pain as nerve pain that felt numb, but was sensitive. The patient went to the ER. The patient's outcome was reported as recovering. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Hypoaesthesia, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 71 year old female with allergic reaction to AUGMENTIN ("patient almost died after taking a medication for congestion") who on approximately 01-SEP-2007 ("Labor Day weekend") was vaccinated with Zostavax, 0.65 ml (no lot number was provided). Concomitant therapy included PAXIL. On approximately 01-SEP-2007, after receiving vaccine, the patient experienced pain in right leg from the knee to the ankle, felt tired, had a lump, tenderness and warmth at injection site. The day after receiving the vaccine (approximately 02-SEP-2007), the patient experienced pain in left leg. She described the left leg pain as nerve pain that felt numb, but was sensitive. The patient went to the ER. The patient's outcome was reported as recovering. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain in extremity
Clinical narrative: Information has been received from a physician concerning a 71 year old female with allergic reaction to AUGMENTIN ("patient almost died after taking a medication for congestion") who on approximately 01-SEP-2007 ("Labor Day weekend") was vaccinated with Zostavax, 0.65 ml (no lot number was provided). Concomitant therapy included PAXIL. On approximately 01-SEP-2007, after receiving vaccine, the patient experienced pain in right leg from the knee to the ankle, felt tired, had a lump, tenderness and warmth at injection site. The day after receiving the vaccine (approximately 02-SEP-2007), the patient experienced pain in left leg. She described the left leg pain as nerve pain that felt numb, but was sensitive. The patient went to the ER. The patient's outcome was reported as recovering. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Cold compress therapy, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 60 year old female with sulfa allergy who on 13-SEP-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (658211/0884U). Concomitant therapy included NEXIUM. On 14-SEP-2007 the patient experienced erythema and itching on the left arm. The injection site was warm to the touch and the reddened area was about 3 x 7 inches. She developed a 100 F temperature on 15-SEP-2007. The fever resolved although the reddened area persisted without being hot and itchy. The pharmacist advised the patient to apply cold compresses and BENADRYL. As of 04-OCT-2007 she had recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site warmth, Pruritus
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 60 year old female with sulfa allergy who on 13-SEP-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (658211/0884U). Concomitant therapy included NEXIUM. On 14-SEP-2007 the patient experienced erythema and itching on the left arm. The injection site was warm to the touch and the reddened area was about 3 x 7 inches. She developed a 100 F temperature on 15-SEP-2007. The fever resolved although the reddened area persisted without being hot and itchy. The pharmacist advised the patient to apply cold compresses and BENADRYL. As of 04-OCT-2007 she had recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Information has been received from a doctor of pharmacy concerning a 60 year old female with sulfa allergy who on 13-SEP-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (658211/0884U). Concomitant therapy included NEXIUM. On 14-SEP-2007 the patient experienced erythema and itching on the left arm. The injection site was warm to the touch and the reddened area was about 3 x 7 inches. She developed a 100 F temperature on 15-SEP-2007. The fever resolved although the reddened area persisted without being hot and itchy. The pharmacist advised the patient to apply cold compresses and BENADRYL. As of 04-OCT-2007 she had recovered. This is one of several reports from the same source. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Arthritis
Clinical narrative: Information has been received from a physician concerning a 65 year old female who on an unspecified date in September 2007, was vaccinated IM with a single first dose of Zostavax (Oka/Merck). Two weeks post vaccination the patient developed a nodular shingles type rash located on her left arm which also moved to her chest. The rash did not cross over onto her right side. The patient sought medical attention and was treated with valacyclovir, and the rash improved. Subsequently the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 65 year old female who on an unspecified date in September 2007, was vaccinated IM with a single first dose of Zostavax (Oka/Merck). Two weeks post vaccination the patient developed a nodular shingles type rash located on her left arm which also moved to her chest. The rash did not cross over onto her right side. The patient sought medical attention and was treated with valacyclovir, and the rash improved. Subsequently the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Influenza like illness, Pain in extremity
Clinical narrative: Information has been received from a 73 year old female with no known allergies, glaucoma, osteopenia and hyperlipidaemia who on 14-SEP-2007, was vaccinated with Zostavax (Oka/Merck) SQ. Concomitant therapy included alendronate sodium (MSD), atorvastatin calcium (LIPITOR), clopidogrel bisulfate (PLAVIX), fluoxetine HCl (PROZAC), lansoprazole (PREVACID), aspirin and dorzolamide HCl (+)/ timolol maleate (MSD). On 16-SEP-2007, the patient experienced severe pain at the injection site and she cannot elevate her arm. The contacted the physician via telephone and was instructed to place ice on her arm and take ibuprofen (ADVIL). The latter treatment had not helped. As of 18-SEP-2007, the patient had left a message with the office to return her call for further instruction as she was not recovered. In follow-up a certified medical assistant reported that this 73 year old female was given Zostavax (Oka/Merck) was given IM previously reported as SQ. She also reported that there were no concomitant medications and no pertinent medical history. She reported that on 13-SEP-2007, the patient experienced mile right arm pain at the site of the vaccination which lasted seven days. The patient had no redness and no swelling. The patient recovered on 19-SEP-2007. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Information has been received from a 73 year old female with no known allergies, glaucoma, osteopenia and hyperlipidaemia who on 14-SEP-2007, was vaccinated with Zostavax (Oka/Merck) SQ. Concomitant therapy included alendronate sodium (MSD), atorvastatin calcium (LIPITOR), clopidogrel bisulfate (PLAVIX), fluoxetine HCl (PROZAC), lansoprazole (PREVACID), aspirin and dorzolamide HCl (+)/ timolol maleate (MSD). On 16-SEP-2007, the patient experienced severe pain at the injection site and she cannot elevate her arm. The contacted the physician via telephone and was instructed to place ice on her arm and take ibuprofen (ADVIL). The latter treatment had not helped. As of 18-SEP-2007, the patient had left a message with the office to return her call for further instruction as she was not recovered. In follow-up a certified medical assistant reported that this 73 year old female was given Zostavax (Oka/Merck) was given IM previously reported as SQ. She also reported that there were no concomitant medications and no pertinent medical history. She reported that on 13-SEP-2007, the patient experienced mile right arm pain at the site of the vaccination which lasted seven days. The patient had no redness and no swelling. The patient recovered on 19-SEP-2007. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Face oedema, Herpes simplex, Herpes zoster, Skin lesion
Clinical narrative: Information has been received from a physician concerning a 76-year-old female with hypertension and "hyperlipide" and no allergies who on 27-SEP-2007 was vaccinated subcutaneous at 11:00 hours in the right deltoid with a 0.65 ml dose of Zostavax (Oka/Merck) (Lot # 658083/0885U). There were no illnesses at the time of vaccination. Concomitant therapy included levothyroxine sodium, metoprolol, hydrochlorothiazide (+) lisinopril (MSD) (was previously reported as both lisinopril (MSD) and hydrochlorothiazide (MSD), amlodipine besylate and atorvastatin calcium (LIPITOR). On 11-OCT-2007 the patient developed a vesicle papula rash with greater than 10 lesions which were distributed amongst the left mid face, left lower lip, second division left trigeminal and nose," left side of nose developed lesion, left face puffy, left lower lip lesion" following vaccination. It was noted the patient had left face weakness possibly Ramsay Hunt Syndrome. It was reported that the patient had not had any recent exposure to chickenpox or herpes zoster. The patient sought unspecified medical attention. Specimen was collected for PCR and the results are pending. At the time of the report the patient's status was recovering. A product quality complaint was not involved. The patient was enrolled in the Identification Program to identify if the VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 18-OCT-2007. The sample was taken from a vesicular lesion. The PCR results for the specimen from the vesicular lesion identified the presence of VZV Wild Type Strain. Additional information has been requested. This is a consolidation of two reports concerning the same patient.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Facial paresis, Rash papular, Swelling face, Varicella zoster virus serology positive
Clinical narrative: Information has been received from a physician concerning a 76-year-old female with hypertension and "hyperlipide" and no allergies who on 27-SEP-2007 was vaccinated subcutaneous at 11:00 hours in the right deltoid with a 0.65 ml dose of Zostavax (Oka/Merck) (Lot # 658083/0885U). There were no illnesses at the time of vaccination. Concomitant therapy included levothyroxine sodium, metoprolol, hydrochlorothiazide (+) lisinopril (MSD) (was previously reported as both lisinopril (MSD) and hydrochlorothiazide (MSD), amlodipine besylate and atorvastatin calcium (LIPITOR). On 11-OCT-2007 the patient developed a vesicle papula rash with greater than 10 lesions which were distributed amongst the left mid face, left lower lip, second division left trigeminal and nose," left side of nose developed lesion, left face puffy, left lower lip lesion" following vaccination. It was noted the patient had left face weakness possibly Ramsay Hunt Syndrome. It was reported that the patient had not had any recent exposure to chickenpox or herpes zoster. The patient sought unspecified medical attention. Specimen was collected for PCR and the results are pending. At the time of the report the patient's status was recovering. A product quality complaint was not involved. The patient was enrolled in the Identification Program to identify if the VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Oka/Merck vaccine VZV strain. The sample of the lesion was collected on 18-OCT-2007. The sample was taken from a vesicular lesion. The PCR results for the specimen from the vesicular lesion identified the presence of VZV Wild Type Strain. Additional information has been requested. This is a consolidation of two reports concerning the same patient.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning an 86 year old female with a history of shingles and drug allergies to codeine, morphine, zolpidem tartrate (Ambien) and meperidine HC1 (Demerol), who on 17-Oct-2007 was vaccinated SC with one dose of Zostavax (lot #658603/1081U).  There was no concomitant medication.  On 17-Oct-2007 the patient developed an itchy, round circular rash at the injection site.  The daughter of the patient contacted the pharmacist for medical attention.  No labs or diagnostic studies were performed.  The patient was not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist concerning an 86 year old female with a history of shingles and drug allergies to codeine, morphine, zolpidem tartrate (Ambien) and meperidine HC1 (Demerol), who on 17-Oct-2007 was vaccinated SC with one dose of Zostavax (lot #658603/1081U).  There was no concomitant medication.  On 17-Oct-2007 the patient developed an itchy, round circular rash at the injection site.  The daughter of the patient contacted the pharmacist for medical attention.  No labs or diagnostic studies were performed.  The patient was not recovered.  There was no product quality complaint.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of drug administration, Pain in extremity
Clinical narrative: Information has been received from a registered nurse concerning an approximately 61 year old female patient with no known allergies or concomitant therapy who "several months ago" was vaccinated with ZOSTAVAX (Oka/Merck) IM.  The nurse reported that another nurse and her husband were "indeed vaccinated with ZOSTAVAX (Oka/Merck) IM instead of SQ."  The nurse reported that an unspecified arm was sore for a day or two after receiving the vaccination.  Additional information is not expected.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Subsequently the patient experienced a fever and developed a blister at the injection site. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporting pharmacist indicated that the 61 year old white female with fibromyalgia, osteoarthritis and hypothyroidism and no known drug allergies who on 02-NOV-2007 at 16:30 was vaccinated SC with the first dose of zoster vaccine live (Oka/Merck) (lot# 658361/1090U) in the left arm. There was no illness at the time of vaccination. On 03-NOV-2007 starting around 11:30 the patient developed blisters. On that same day the patient experienced fever and body aches and she also developed large swelling, redness and blisters around the injection site. The patient's fever of approximately 100 continued for 3 days. The patient  was seen by the doctor on 05-NOV-2007 and then presented to the pharmacy to report the reaction. No labs or diagnostic studies were performed. The patient was treated with BENADRYL 25 mg 1 capsule in the morning and 2 capsules in the evening and SILVADENE cream to apply to the blister area(s). The blisters fully resolved in about 2 weeks approximately 17-NOV-2007. On 17-NOV-2007 the patient developed scarring in area of blister. Additional information has been requested
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Body temperature increased, Fibromyalgia, Hypothyroidism, Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Subsequently the patient experienced a fever and developed a blister at the injection site. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporting pharmacist indicated that the 61 year old white female with fibromyalgia, osteoarthritis and hypothyroidism and no known drug allergies who on 02-NOV-2007 at 16:30 was vaccinated SC with the first dose of zoster vaccine live (Oka/Merck) (lot# 658361/1090U) in the left arm. There was no illness at the time of vaccination. On 03-NOV-2007 starting around 11:30 the patient developed blisters. On that same day the patient experienced fever and body aches and she also developed large swelling, redness and blisters around the injection site. The patient's fever of approximately 100 continued for 3 days. The patient  was seen by the doctor on 05-NOV-2007 and then presented to the pharmacy to report the reaction. No labs or diagnostic studies were performed. The patient was treated with BENADRYL 25 mg 1 capsule in the morning and 2 capsules in the evening and SILVADENE cream to apply to the blister area(s). The blisters fully resolved in about 2 weeks approximately 17-NOV-2007. On 17-NOV-2007 the patient developed scarring in area of blister. Additional information has been requested
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Osteoarthritis, Pain, Pyrexia
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Subsequently the patient experienced a fever and developed a blister at the injection site. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporting pharmacist indicated that the 61 year old white female with fibromyalgia, osteoarthritis and hypothyroidism and no known drug allergies who on 02-NOV-2007 at 16:30 was vaccinated SC with the first dose of zoster vaccine live (Oka/Merck) (lot# 658361/1090U) in the left arm. There was no illness at the time of vaccination. On 03-NOV-2007 starting around 11:30 the patient developed blisters. On that same day the patient experienced fever and body aches and she also developed large swelling, redness and blisters around the injection site. The patient's fever of approximately 100 continued for 3 days. The patient  was seen by the doctor on 05-NOV-2007 and then presented to the pharmacy to report the reaction. No labs or diagnostic studies were performed. The patient was treated with BENADRYL 25 mg 1 capsule in the morning and 2 capsules in the evening and SILVADENE cream to apply to the blister area(s). The blisters fully resolved in about 2 weeks approximately 17-NOV-2007. On 17-NOV-2007 the patient developed scarring in area of blister. Additional information has been requested
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Scar
Clinical narrative: Information has been received from a pharmacist concerning a patient who was vaccinated SC with a 0.65 ml dose of ZOSTAVAX. Subsequently the patient experienced a fever and developed a blister at the injection site. The patient sought unspecified medical attention. The outcome was unknown. There was no product quality complaint. Additional information has been requested. Follow-up information from the reporting pharmacist indicated that the 61 year old white female with fibromyalgia, osteoarthritis and hypothyroidism and no known drug allergies who on 02-NOV-2007 at 16:30 was vaccinated SC with the first dose of zoster vaccine live (Oka/Merck) (lot# 658361/1090U) in the left arm. There was no illness at the time of vaccination. On 03-NOV-2007 starting around 11:30 the patient developed blisters. On that same day the patient experienced fever and body aches and she also developed large swelling, redness and blisters around the injection site. The patient's fever of approximately 100 continued for 3 days. The patient  was seen by the doctor on 05-NOV-2007 and then presented to the pharmacy to report the reaction. No labs or diagnostic studies were performed. The patient was treated with BENADRYL 25 mg 1 capsule in the morning and 2 capsules in the evening and SILVADENE cream to apply to the blister area(s). The blisters fully resolved in about 2 weeks approximately 17-NOV-2007. On 17-NOV-2007 the patient developed scarring in area of blister. Additional information has been requested
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received regarding a case in litigation.  Information has been received from a pharmacist concerning an 81 year old female with no known allergies and with hypertension, hyperlipidaemia and gastrooesophageal reflux disease and a history of chicken pox who on 19-Sep-2007 was vaccinated with a 0.65 mL dose of Zostavax SC.  Concomitant therapy included metoprolol succinate (Toprol XL Tablets), hydrochlorothiazide (+) irbesartan (Avalide), fluvastatin sodium (Lescol) and pantoprazole sodium (Protonix).  On approximately 26-Sep-2007 (reported as 1-2 weeks after receiving Zostavax, the patient developed shingles.  The patient sought medical attention: office visit.  Outcome was reported as not recovered.  The patient was treated with valacyclovir hydrochloride (Valtrex).  There was no product quality complaint.  Follow-up information was received from a questionnaire.  In the questionnaire, it was reported that the rash occurred at the site of injection or elsewhere within 42 days of the vaccination.  It was described as a vesicular rash on the trunk and buttock and possibly on the left wrist and arm.  The patient was afebrile.  There were no other systemic symptoms.  There was a history of chicken pox but there was no recent exposure to chicken pox or herpes.  The patient was reported as recovered in the questionnaire.  A direct fluorescent antibody was not done and a specimen was not collected for PCR.  Follow-up information was received from the consumer who reported that her shingles were improving.  Additional follow-up information was received from the consumer.  The consumer reported that she received the "shingles vaccine" and a week or so later came down with shingles.  The consumer stated that she was not sure of the timing as she ignored the first lesions thinking it was poison ivy or insect bites.  However, more sore, oozing, painful lesions appeared, mostly on her torso and upper thighs.  The consumer reported that "at least so far", the lesions did not appear around her eyes.  The consumer reported that she has glaucoma.  She reported that her internist diagnosed herpes zoster and that it was her physician's professional opinion that the shingles were caused by the vaccine.  The physician prescribed valacyclovir hydrochloride (Valtrex), a five day regime as a follow-up.  No further information was available.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation.  Information has been received from a pharmacist concerning an 81 year old female with no known allergies and with hypertension, hyperlipidaemia and gastrooesophageal reflux disease and a history of chicken pox who on 19-Sep-2007 was vaccinated with a 0.65 mL dose of Zostavax SC.  Concomitant therapy included metoprolol succinate (Toprol XL Tablets), hydrochlorothiazide (+) irbesartan (Avalide), fluvastatin sodium (Lescol) and pantoprazole sodium (Protonix).  On approximately 26-Sep-2007 (reported as 1-2 weeks after receiving Zostavax, the patient developed shingles.  The patient sought medical attention: office visit.  Outcome was reported as not recovered.  The patient was treated with valacyclovir hydrochloride (Valtrex).  There was no product quality complaint.  Follow-up information was received from a questionnaire.  In the questionnaire, it was reported that the rash occurred at the site of injection or elsewhere within 42 days of the vaccination.  It was described as a vesicular rash on the trunk and buttock and possibly on the left wrist and arm.  The patient was afebrile.  There were no other systemic symptoms.  There was a history of chicken pox but there was no recent exposure to chicken pox or herpes.  The patient was reported as recovered in the questionnaire.  A direct fluorescent antibody was not done and a specimen was not collected for PCR.  Follow-up information was received from the consumer who reported that her shingles were improving.  Additional follow-up information was received from the consumer.  The consumer reported that she received the "shingles vaccine" and a week or so later came down with shingles.  The consumer stated that she was not sure of the timing as she ignored the first lesions thinking it was poison ivy or insect bites.  However, more sore, oozing, painful lesions appeared, mostly on her torso and upper thighs.  The consumer reported that "at least so far", the lesions did not appear around her eyes.  The consumer reported that she has glaucoma.  She reported that her internist diagnosed herpes zoster and that it was her physician's professional opinion that the shingles were caused by the vaccine.  The physician prescribed valacyclovir hydrochloride (Valtrex), a five day regime as a follow-up.  No further information was available.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old female who in September 2007, was vaccinated with ZOSTAVAX and "now" in 2007, has shingles.  It was reported that the patient sought unspecified medical attention.  A product quality complaint was not reported.  Additional information was not available.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning an 81 year old 148 lb. female with hypertension, respiratory abnormality, allergy to PROVACHOL (muscle cramps), right carotid stenocis, glaucoma, and alcohol use (1 drink/night), with a history of sigmoidoscopy and biopsy (1997) "open coronary endarterectomy" (15-JAN-1999). colonoscopy "through stoma" (2004), urinary tract infection (2004), diagnostic dilation and curettage, and acute bronchitis (every winter), and a family history of "heart" (mother), hypertensic (sister), stroke (sister), and osteoporosis (maternal and paternal grandparents). On 19-SEP-2007, she received her first subcutaneous dose in the left arm of ZOSTAVAX vaccine (Merck) (lot# 658083/0885U) and "now" in 2007, has shingles. Concomitant medications included LESCOL XL, 80 mg. oral, tablet daily, AVALIDE 150/12.5 mg., orally, one daily in the arm, calcium (+) vitamin D, 2 tablets orally twice a day, fish oil, 1000 mg daily, TOPROL XL, 50 mg. daily, PROTONIX 40 mg, one tablet by mouth daily. It was reported that patient sought unspecified medical attention. A product quality complaint was not reported. Additional information was not available. Follow up information from the physician (6-SEP-2007), indicated that she developed lesions, oozing, painful sores, mostly on the torso and some of her legs. The patient underwent unspecified follow up with the physician who diagnosed herpes zoster. There were no relevant diagnostic or laboratory studies. Current patinet status was not reported. Additional information from medical records indicated that on 25-OCT-2007, she presented to the physician's office with itchy lesions on her abdomen for about a week that were getting dry but were oozy, very itchy and sore with no burning. Physical examination revealed crusted over lesions on her abdomen, left thigh, and right buttocks. Her blood pressure was 122/54, pulse rate of 70, and pulse oxymotry of 95%. The physician diagnosis was herpes zoster (primary encounter). Treatment included VALTREX 1 gram. orally, three times a day for one week. Current patient status was not reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning an 80 year old female who in September 2007, was vaccinated with ZOSTAVAX and "now" in 2007, has shingles.  It was reported that the patient sought unspecified medical attention.  A product quality complaint was not reported.  Additional information was not available.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007. Information has been received from a pharmacist concerning an 81 year old 148 lb. female with hypertension, respiratory abnormality, allergy to PROVACHOL (muscle cramps), right carotid stenocis, glaucoma, and alcohol use (1 drink/night), with a history of sigmoidoscopy and biopsy (1997) "open coronary endarterectomy" (15-JAN-1999). colonoscopy "through stoma" (2004), urinary tract infection (2004), diagnostic dilation and curettage, and acute bronchitis (every winter), and a family history of "heart" (mother), hypertensic (sister), stroke (sister), and osteoporosis (maternal and paternal grandparents). On 19-SEP-2007, she received her first subcutaneous dose in the left arm of ZOSTAVAX vaccine (Merck) (lot# 658083/0885U) and "now" in 2007, has shingles. Concomitant medications included LESCOL XL, 80 mg. oral, tablet daily, AVALIDE 150/12.5 mg., orally, one daily in the arm, calcium (+) vitamin D, 2 tablets orally twice a day, fish oil, 1000 mg daily, TOPROL XL, 50 mg. daily, PROTONIX 40 mg, one tablet by mouth daily. It was reported that patient sought unspecified medical attention. A product quality complaint was not reported. Additional information was not available. Follow up information from the physician (6-SEP-2007), indicated that she developed lesions, oozing, painful sores, mostly on the torso and some of her legs. The patient underwent unspecified follow up with the physician who diagnosed herpes zoster. There were no relevant diagnostic or laboratory studies. Current patinet status was not reported. Additional information from medical records indicated that on 25-OCT-2007, she presented to the physician's office with itchy lesions on her abdomen for about a week that were getting dry but were oozy, very itchy and sore with no burning. Physical examination revealed crusted over lesions on her abdomen, left thigh, and right buttocks. Her blood pressure was 122/54, pulse rate of 70, and pulse oxymotry of 95%. The physician diagnosis was herpes zoster (primary encounter). Treatment included VALTREX 1 gram. orally, three times a day for one week. Current patient status was not reported. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site papule, Limb discomfort
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male with no known drug allergies who on 05-SEP-2007 was vaccinated subcutaneously in the left deltoid with a 0.65 ml dose of Zostavax (Oka/Merck) (lot# 658083/0885U). There was no concomitant medication. On 01-OCT-2007, the patient called the pharmacist to report redness at the injection site (exact onset date not provided. No lab diagnostic studies were performed. The patient had not recovered at the time of the report. No additional information is expected.
Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Information has been received from a pharmacist concerning a 76 year old male with no known drug allergies who on 05-SEP-2007 was vaccinated subcutaneously in the left deltoid with a 0.65 ml dose of Zostavax (Oka/Merck) (lot# 658083/0885U). There was no concomitant medication. On 01-OCT-2007, the patient called the pharmacist to report redness at the injection site (exact onset date not provided. No lab diagnostic studies were performed. The patient had not recovered at the time of the report. No additional information is expected.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a pharmacist concerning a female, with no medical history and no known drug allergies, who on 09-NOV-2007 was vaccinated with a 0.65 ml subcutaneous dose of zoster vaccine live (Oka/Merck) (Lot# 658084/0888U). There was no concomitant medication. Subsequently the patient developed shingles. The patient was seen by a physician and was prescribed FAMVIR. The patient's shingles persisted. No product quality complaint was involved. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Varicella
Clinical narrative: Information has been received from a 64 year old female consumer with no pertinent medical history and an allergy to penicillin who was vaccinated on 6 NOV 2007 with Zostavax. Concomitant therapy included ZOCOR. Two days post vaccination, on 08 NOV 2007; the patient broke out with a rash all over her body. She also developed blisters which were filled with liquid. The patient said "she had approximately two to three dozen blisters, or pox marks. They are located all over her body from her scalp to her legs". The patient reported that the physician diagnosed her with chickenpox. The patient reported having had chickenpox as a child. At the time of reporting the patient was recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. No further information is expected. This is in follow-up to report (s) previously submitted on 12/21/ 2007. Information has been received from a 64 year old female consumer with no pertinent medical history and an allergy to pencillin who was vaccinated on 6 NV 2007 with ZOSTER vaccine live (Oka.Merck). Two days post vaccination, on 08 NOV 2007, the patient broke out with a rash all over her body. She also developed blisters which were filled with liquid. The patient siad "she had approximately two or three dozen blisters or pox marks. They were located all over her body from her scalp to her legs". The patient reported that the physician diagnosed her with chickem pox. The patieint reported having had chickenpox as a child. At the time of reporting the patient was recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information has been recieved forom a physician concerning a 64 year old female with no known drug allergies, seasonal allergies and a history of childhood varicella and "lipids" who was vaccinated into the left deltoid on 6 NOV 2007 with a single dose of ZOSTER vaccine live (Oka/Merck) (Lot # 658395/0966U). On 09 NOV 2007, the patient developed a papular vesicular rash with 20 lesions, on her scalp, torso and buttocks which was previously reported to have been daignosed as chickenpox. The patient had not had any recent exposure to shingles or chickenpox. At the time of reporting the patient was recovered. This is one of several reports received from the samne source.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash generalised, Varicella
Clinical narrative: Information has been received from a 64 year old female consumer with no pertinent medical history and an allergy to penicillin who was vaccinated on 6 NOV 2007 with Zostavax. Concomitant therapy included ZOCOR. Two days post vaccination, on 08 NOV 2007; the patient broke out with a rash all over her body. She also developed blisters which were filled with liquid. The patient said "she had approximately two to three dozen blisters, or pox marks. They are located all over her body from her scalp to her legs". The patient reported that the physician diagnosed her with chickenpox. The patient reported having had chickenpox as a child. At the time of reporting the patient was recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. This is one of several reports received from the same source. No further information is expected. This is in follow-up to report (s) previously submitted on 12/21/ 2007. Information has been received from a 64 year old female consumer with no pertinent medical history and an allergy to pencillin who was vaccinated on 6 NV 2007 with ZOSTER vaccine live (Oka.Merck). Two days post vaccination, on 08 NOV 2007, the patient broke out with a rash all over her body. She also developed blisters which were filled with liquid. The patient siad "she had approximately two or three dozen blisters or pox marks. They were located all over her body from her scalp to her legs". The patient reported that the physician diagnosed her with chickem pox. The patieint reported having had chickenpox as a child. At the time of reporting the patient was recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint. Follow-up information has been recieved forom a physician concerning a 64 year old female with no known drug allergies, seasonal allergies and a history of childhood varicella and "lipids" who was vaccinated into the left deltoid on 6 NOV 2007 with a single dose of ZOSTER vaccine live (Oka/Merck) (Lot # 658395/0966U). On 09 NOV 2007, the patient developed a papular vesicular rash with 20 lesions, on her scalp, torso and buttocks which was previously reported to have been daignosed as chickenpox. The patient had not had any recent exposure to shingles or chickenpox. At the time of reporting the patient was recovered. This is one of several reports received from the samne source.
Age: 9.0
Sex: F
Vaccine: HPV4
Symptoms: Bronchospasm, Dyspnoea, Pallor, Wheezing
Clinical narrative: I saw the patient 12/26/07 for new onset of moderate to severe exercise induced bronchospasm.  She has no atopic history, no history of allergies, eczema or asthma and no family history.  Symptoms developed about 6 weeks after receiving her first dose of Gardasil.  I have begun her on empiric therapy, yet am concerned her condition may have been prompted by the Gardasil.  She had her second dose, however, this past week before I became concerned about a connection between the vaccine and her bronchospasm.  I am following her very closely.    1/11/08 Reviewed office notes of 12/28-30/2007 which reveal patient experienced exercise induced bronchospasm.  Telephone conf w/parent revealed patient getting very SOB & winded w/minimal exertion despite meds & inhaler.  Referred to pediatric pulmonologist.   2/19/08 Reviewed outpatient clinics medical records which reveal patient initially seen by pulmonogy 1/3/08.  Had SOB & dyspnea w/onset of any vigorous exercise, 1st occurring 6/2007 & 8/2007 both times after biking long distance. Then in 12/2007 developed SOB w/stridor, thoat pain & chest pain while running in soccer. PCP had placed on dual inhalers w/o any improvement in s/s.  Dx w/probable vocal cord dysfunction.  Inhalers d/c & referred to laryngologist.  Seen by laryngology on 1/23/08.  Dx w/paradoxical vocal fold motion.  Referred to cardio & speech tx. FINAL DX:  paradoxical vocal fold motion.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Patient recieve both pneumo and flu vaccine in same arm.  Next day patient had red, hot, swollen back of arm, but no redness at injection site.  Patient went to instacare and was prescribed doxycycline and zyrtec and recieved an unknown shot and was feeling better in two days.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Dry skin, Headache, Pain, Pruritus, Rash
Clinical narrative: I had the flu vaccine and I had no soreness at the injection site, but the next day between the injection site and my elbow, I experienced a rash and extreme itching.  It covered an area about 3 inches in diameter.  It has continued to itch and sometimes sting in that area.  The skin in that area is hard and dry. I also had a headache the next morning and have continued to have off and on for the past two months.  I have not felt well since the injection. I have had the flu vaccine before with no adverse effects.  I feel like it was a preservative or something that the vaccine was mixed in.  I have allergies to sulfur and sulfur derivatives (even the additives to food) and penicillin.  I am allergic to shrimp.  They cause me to break out in hives.
Age: 67.0
Sex: F
Vaccine: FLUX
Symptoms: Skin induration, Skin reaction
Clinical narrative: I had the flu vaccine and I had no soreness at the injection site, but the next day between the injection site and my elbow, I experienced a rash and extreme itching.  It covered an area about 3 inches in diameter.  It has continued to itch and sometimes sting in that area.  The skin in that area is hard and dry. I also had a headache the next morning and have continued to have off and on for the past two months.  I have not felt well since the injection. I have had the flu vaccine before with no adverse effects.  I feel like it was a preservative or something that the vaccine was mixed in.  I have allergies to sulfur and sulfur derivatives (even the additives to food) and penicillin.  I am allergic to shrimp.  They cause me to break out in hives.