chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a female in her mid 60's who on approximately 15-AUG-2007 was vaccinated with a dose of ZOSTAVAX. On approximately 10-AUG-2008, the patient developed shingles. The patient's outcome was unknown. Medical attention was sought in the physician's office.  Follow up information was received from the physician who reported that the 72 year old patient on 19-JAN-2007 at 1:51 pm was vaccinate dwith her forst dose of ZOSTAVAX (Merck) (lot # 657559/0462U) in the left deltoid. Concomitant therapy included amlodipine, MICARDIS, and unspecified medication and simvastatin. On 08-AUG-2008 the patient developed shingles in the left breast are. At the time of this report, the patient recovered.  Additional information has been requested.  Additional ifnromation is not expected.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received from a 67 year old female consumer with a medical history of hepatitis C in 2000 and a rash while on therapy with "Lovastatin" (manufacturer unknown) ("pinkish round" pill), who before Christmas, 2007 was vaccinated with 0.65 mL of ZOSTAVAX, SQ. Concomitant therapy included hydrochlorothiazide (+) lisinopril (manufacturer unknown). In late February 2008, the patient developed a rash that looked like a poison oak rash on her leg. The doctor gave her prednisone and it "went away." About a week later it came back on both legs and spread to her elbows, her back, her shoulders and last week it spread to her face. At the time of the report, the patient not recovered. The patient sought medical attention. There was no product quality complaint. Additional information is expected.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Facial pain, Rash, Swelling face
Clinical narrative: Information has been received from a physician, concerning a 66 year old male with allergy to penicillin, hypertension and a family history of Alzheimer, congestion heart failure and hypercholesterolaemia, who on 07-MAY-2008 was vaccinated with 0.65 mL of ZOSTAVAX (Lot #659760/0159X) SQ. Concomitant therapy included IM PNEUMOVAX 23. On 18-AUG-2008, the patient went to the office with rash, pain and swelling of the right side of his face and right side of forehead. At the time of the report, the patient was not recovered. No treatment; the patient being monitored. The patient sought medical attention into office. There was no product quality complaint. Additional information is expected.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site vesicles
Clinical narrative: Information has been received from a physician, concerning a 62-63 years old patient, who approximately 07-JUL-2008 (also reported as about 6 weeks ago) was vaccinated with a dose ZOSTAVAX. The patient developed zoster lesions at the injection site. The patient recovered on an unspecified date. The patient sought medical attention on office visit. There was no product quality complaint. Additional information is expected.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a male patient over 65 years old, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Lot # was not provided). The patient experienced a herpes zoster rash. The patient developed the rash on his lumbar or his chest. The patient sought medical attention. There was no product quality complaint. Additional information is expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a physician and a 72 year old female consumer with thyroid disorder, cholesterol, acid reflux and sulfa allergy and a history of chickenpox as a child, who on 07-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Lot #658398/1087U) in her left deltoid. Concomitant therapy included LEXAPRO, "gilzedene" (unspecified) and unspecified therapies for thyroid disorder, cholesterol and acid reflux. The patient did not experience a rash at the injection site or elsewhere within 42 days of the vaccination. The patient reported that on 04-AUG-2008, she experienced pain and on 06-AUG-2008 she developed a rash and went to her physician on 07-AUG-2008. The physician reported in conflict that the patient first developed a rash on 04-AUG-2008. On 07-AUG-2008, the patient was diagnosed with shingles on the right side from her chest to her back, right trunk anterior and posterior from below the breasts to waist from T1-T11. The doctor gave VALTREX and hydrocodone, but the patient did not take hydrocodone. The patient took ibuprofen. As of 18-AUG-2008, the herpes zoster persisted. There was no product quality complaint. Additional information is expected.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with ZOSTAVAX. Two week after the patient received the vaccine developed chickenpox. On an unspecified date, the patient recovered from symptoms of chickenpox. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Liver function test, Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Information has been received from a 71 year old female with aortic aneurysm, a history of pancreatitis and history of drug reactions or allergies who "two weeks ago" (no approximately 05-AUG-2008) was ZOSTAVAX (Oka/Merck) 0.65ml IM. Concomitant therapy included pravastatin, lisinopril (manufacturer unknown), metoprolol, levothyroxine, pantoprazole and CHANTIX. "Within the last 2 weeks" (on approximately 05-AUG-2008) the patient developed muscle pain in her neck, shoulder and legs after receiving ZOSTAVAX (Oka/Merck). The patient's muscle pain persisted. Liver function tests were performed (results not reported). The patient didn't seek medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician's assistant concerning a female with a history of shingles who on approximately 12-AUG-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient developed shingles under her chin and abdomen with little or no pain after getting ZOSTAVAX (Oka/Merck). The patient was seen by doctor. No product quality complaint was involved. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 78 year old female with no pertinent medical history or drug reactions/allergies, who on 06-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) 0.65 mL. There was no concomitant medication. On approximately 27-JUN-2008 (about 3 weeks after receiving the vaccine), the patient experienced a mild case of shingles in her foot and buttock. The patient sought medical attention and saw the physician. A couple of weeks after getting shingles, the patient had recovered, no labs or diagnostics studies were performed. Additional information is not expected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood testosterone decreased, Herpes zoster, Hypothyroidism, Immediate post-injection reaction, Rash
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old male who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient experienced shingles at an unspecified time after receiving ZOSTAVAX (Oka/Merck). The patient sought medical attention and was seen by the physician. Additional information is not expected. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Initial and follow-up information has been received from a pharmacist concerning an 82 year old male with high cholesterol and history of varicella as a child, who on 08-JUN-2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # reported as 020900-invalid) 0.5 mL into his right arm. Concomitant medication included LIPITOR, aspirin and omega-3 marine triglycerides. On 01-AUG-2008, the patient experienced shingles after receiving ZOSTAVAX (Oka/Merck). The patient developed a rash and multiple lesions on his right axilla and chest. Distribution of herpes zoster lesions were found in T3 right dermatome. There was no pain in the lesions. Immediately post vaccination the patient was found to be hypothyroid with low testerone. He was good on prior testing. Patient was found to have hypothyroidism and low testosterone post zoster. There was no recent exposure to chickenpox or shingles. At time of reporting, the patient was recovered. The patient sought medical attention and was seen by the physician. Additional information is not expected.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a pharmacist concerning an 82 year old male who was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient experienced shingles at an unspecified time after receiving ZOSTAVAX (Oka/Merck). The patient sought medical attention and was seen by the physician. Additional information is not expected. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Initial and follow-up information has been received from a pharmacist concerning an 82 year old male with high cholesterol and history of varicella as a child, who on 08-JUN-2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # reported as 020900-invalid) 0.5 mL into his right arm. Concomitant medication included LIPITOR, aspirin and omega-3 marine triglycerides. On 01-AUG-2008, the patient experienced shingles after receiving ZOSTAVAX (Oka/Merck). The patient developed a rash and multiple lesions on his right axilla and chest. Distribution of herpes zoster lesions were found in T3 right dermatome. There was no pain in the lesions. Immediately post vaccination the patient was found to be hypothyroid with low testerone. He was good on prior testing. Patient was found to have hypothyroidism and low testosterone post zoster. There was no recent exposure to chickenpox or shingles. At time of reporting, the patient was recovered. The patient sought medical attention and was seen by the physician. Additional information is not expected.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer concerning her husband with fibrosis of the lungs who was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed shingles and his lidocaine patches (manufacturer unknown) and NEURONTIN put into a cream did not aid in soothing his shingles. This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck). The patient may have had a case of shingles. The physician didn't know if the patient had had the vaccine or not. Further information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Information has been received from an 81 year old female with arthritis, glaucoma and macular degeneration and a history of shingles, pain burning and murmur functional and no drug reactions/allergies who about a week ago (on approximately 13-AUG-2008) was vaccinated with ZOSTAVAX (Oka/Merck) on her left arm and did not have any pain on that side on her arm. Consumer reported that about 12 years ago she had the shingles, the first time she had the shingles she had a burning pain across her back for 6 weeks, the second time she had the shingles it was not very bad and was similar to the first time, and the third time she had the shingles she had an 8 inch band from the left arm across her breast and around the right arm and back. About two days ago on 18-AUG-2008, she started to have burning under the right arm and the burning has gotten so bad that she slept with an ice pack on it and has kept it on all day as well. At the time of the reporting, the patient had not recovered. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This is in follow-up to report (s) previously submitted on 9/24/2008. Information has been received from a 66 year old male with no allergies who on 18-AUG-2008, 2 days ago, was vaccinated with ZOSTAVAX (Oka/Merck) 0.65 ml (lot # not reported). Concomitant therapy included atenolol. On 19-AUG-2008 the patient experienced rash from elbow to wrist and behind his knees after vaccination. The patient's rash from elbow to wrist and behind his knees persisted. The patient sought medical attention. Additional information has been requested. Information has been received from a 66 year old male with hypertension, Chronic obstructive pulmonary disease, a history of chickenpox and drug allergies to CELEBREX and CLONAPIN who on 18-AUG-2008, 2 days ago, was vaccinated with ZOSTAVAX vaccine (Oka/Merck) 0.65 ml (lot # 658867/1413U) SC in left arm. Concomitant therapy included atenolol. On 19-AUG-2008 the patient experienced rash from elbow to wrist and behind his knees within 24 hours of vaccination. There was no recent exposure to chickenpox. The patient's rash from elbow to wrist and behing his knees persisted. The patient sought medical attention. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Erythema, Herpes zoster, Impaired work ability
Clinical narrative: Information has been received from a licensed practical nurse who reported that in the "last 3 months" (from approximately May, 2008) she had been administering zoster vaccine live (Oka/Merck) 0.65 ml SQ to an unspecified number of male and female patients over 60 years old. Subsequently, the nurse experienced shingles. On 07-AUG-2008 the nurse experienced pain in the right leg, buttocks and lower back. On 11-AUG-2008, the nurse went for a Doppler test because she thought something was wrong with her leg. Results of the test were unknown. On 14-AUG-2008 the nurse broke out in a rash (unspecified areas). The nurse did have some fluid filled vesicles but they have all dried up and now they looked like little red pimples, The nurse had taken VALTREX. As of 20-AUG-2008 the nurse had not recovered.  This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse who reported that in the "last 3 months" (from approximately May, 2008) she had been administering ZOSTAVAX (Merck) 0.65 ml SQ to an unspecified number of male and female patients over 60 years old. Subsequently, the nurse experienced shingles. On 29-JUL-2009, the nurse gave ZOSTAVAX (Merck) to a patient who had bleeding. The nurse wiped the patient's arm with an alcohol swab. About 2 weeks later, around the week of 11-AUG-2008 the nurse experienced pain in the right leg, buttocks and lower back. On 11-AUG-2008, the nurse went for a Doppler test because she thought something was wrong with her leg. Results of the test were unknown. On 14-AUG-2008 the nurse broke out in a rash at her buttock and back. The nurse did have some fluid filled vesicles but they have all dried up and now they looked like little red pimples. The nurse had taken VALTREX. Subsequently, the nurse recovered, though she was off of work for one week. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity, Rash, Secondary transmission, Ultrasound Doppler
Clinical narrative: Information has been received from a licensed practical nurse who reported that in the "last 3 months" (from approximately May, 2008) she had been administering zoster vaccine live (Oka/Merck) 0.65 ml SQ to an unspecified number of male and female patients over 60 years old. Subsequently, the nurse experienced shingles. On 07-AUG-2008 the nurse experienced pain in the right leg, buttocks and lower back. On 11-AUG-2008, the nurse went for a Doppler test because she thought something was wrong with her leg. Results of the test were unknown. On 14-AUG-2008 the nurse broke out in a rash (unspecified areas). The nurse did have some fluid filled vesicles but they have all dried up and now they looked like little red pimples, The nurse had taken VALTREX. As of 20-AUG-2008 the nurse had not recovered.  This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse who reported that in the "last 3 months" (from approximately May, 2008) she had been administering ZOSTAVAX (Merck) 0.65 ml SQ to an unspecified number of male and female patients over 60 years old. Subsequently, the nurse experienced shingles. On 29-JUL-2009, the nurse gave ZOSTAVAX (Merck) to a patient who had bleeding. The nurse wiped the patient's arm with an alcohol swab. About 2 weeks later, around the week of 11-AUG-2008 the nurse experienced pain in the right leg, buttocks and lower back. On 11-AUG-2008, the nurse went for a Doppler test because she thought something was wrong with her leg. Results of the test were unknown. On 14-AUG-2008 the nurse broke out in a rash at her buttock and back. The nurse did have some fluid filled vesicles but they have all dried up and now they looked like little red pimples. The nurse had taken VALTREX. Subsequently, the nurse recovered, though she was off of work for one week. Additional information is not expected.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Anaemia, Colonoscopy, Endoscopy, Herpes zoster ophthalmic, Neuralgia
Clinical narrative: Information has been received from an 85 year old female with sulfonamide allergy who in May 2007, was vaccinated with ZOSTAVAX (Oka/Merck). There was no concomitant therapy. In May 2008, a year later, the patient came down with a terrible case of shingles on her eyelids. The patient was still experiencing the nerve pain, and also became anemic and had tests done for that (colonoscopy, endoscopy). The patient also mentioned that VALTREX affected her kidneys. The patient sought medical attention. Additional information has been requested.
Age: 7.0
Sex: M
Vaccine: VARZOS
Symptoms: Wrong drug administered
Clinical narrative: This is in follow-up to report (s) previously submitted on 9/24/2008. Information has been received from a licensed practical nurse concerning a 7 year old patient who on 18-AUG-2008 was vaccinated with ZOSTAVAX (lot#: 659406/0298X) instead of VARIVAX. This was a human error. No adverse events were reported. The patient sought unspecified medical attention. Additional information has been requested. Information has been received from a licensed practical nurse concerning a 7 year old male who on 18-AUG-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck) (MSD). This was a human error. The nurse picked the wrong vaccine to give the patient. No adverse events were reported. The patient sough unspecified medical attention. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Information has been received from a 66 year old male with no pertinent medical history or allergies who about 2 months ago (in approximately June 2008), was vaccinated with a 0.65mL dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included [therapy unspecified]. The next day after getting shot (in approximately June 2008), the patient experienced warmth, pain and itchiness at injection site. At the time of the reporting, the patient had recovered (about 5 days after being vaccinated). Medical attention was not sought. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dermatitis bullous, Injection site erythema, Injection site pruritus, Injection site vesicles, Injection site warmth
Clinical narrative: Information has been received from a pharmacy intern concerning a 67 year old female with no allergies who on 25-JUL-2008 was vaccinated with ZOSTAVAX,  0.5 mL SC. Concomitant therapy included vitamin D (unspecified), fluticasone furoate and DYAZIDE. On 09-AUG-2008, 15 days after administration the patient experienced redness, itching and blisters at the injection site (4-5 inches in diameter). She was seen several times for injection site reaction and was monitored but not treated. Physician did not diagnosis the symptoms as related to ZOSTAVAX. The blisters were scabbing over and the patient was recovering. Additional information has been requested. This is in follow-up to reports previously submitted on 9/24/2008. Initial and follow-up information has been received from a physician pharmacy intern and a consumer concerning a 67 year old female writer with no allergies who on 25-JUL-2008 was vaccinated with ZOSTAVAX (Merck) 0.5ml SC. Concomitant therapy included vitamin D (unsecified), DYAZIDE. After injection, the site was warm, red and itchy. There symptoms subsided over the next week. On 09-AUG-2008, "two weeks later" (also reported as 15 days after administration) the patient noticed a small bump in the area. She thought it might be a bit- it itched. Over the next few days, more bumps appeared- all itchy- plus a general red area (same site as origanial injection over redness). The bumps began to blister and grow. She was out of town and away from her physician, but by 14-AUG-2008 the patch on her arm looked like bubble wrap with over 1/2 dozen blisters - a couple 1/2 - 3/8 inch in diameter (also reorted as 4-5 inches in diameter. She went to a walk in medical clinic. The doctor was stymied- landed the biggest blisters - gave her an antibiotic (Ampicillin IP she remeber correctly). Other bumps continued to appear and grow. She saw the physician on 19-AUG-2008 after returning home. Eventually - within a week or so - all blisters had self-drained, skin dried, fell off. No scars. The patient reported a rash that developed on her left deltoid area after she got the ZOSTAVAX (Merck). At the time the physician looked at it, it appeared to be large, bullous areas right around injection site. These areas were flat at the time, having drained their fluid. but appeared to be 2cm in diameter. The patient reported she had a small round bandaid on at the time of the injection but it was not on for extended period of time. The blistering then came after that. The physician did not sure whether this is an adverse reaction to the vaccine or whether it is an allergy to the adhesive in the bandaid. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Scab
Clinical narrative: Information has been received from a pharmacy intern concerning a 67 year old female with no allergies who on 25-JUL-2008 was vaccinated with ZOSTAVAX,  0.5 mL SC. Concomitant therapy included vitamin D (unspecified), fluticasone furoate and DYAZIDE. On 09-AUG-2008, 15 days after administration the patient experienced redness, itching and blisters at the injection site (4-5 inches in diameter). She was seen several times for injection site reaction and was monitored but not treated. Physician did not diagnosis the symptoms as related to ZOSTAVAX. The blisters were scabbing over and the patient was recovering. Additional information has been requested. This is in follow-up to reports previously submitted on 9/24/2008. Initial and follow-up information has been received from a physician pharmacy intern and a consumer concerning a 67 year old female writer with no allergies who on 25-JUL-2008 was vaccinated with ZOSTAVAX (Merck) 0.5ml SC. Concomitant therapy included vitamin D (unsecified), DYAZIDE. After injection, the site was warm, red and itchy. There symptoms subsided over the next week. On 09-AUG-2008, "two weeks later" (also reported as 15 days after administration) the patient noticed a small bump in the area. She thought it might be a bit- it itched. Over the next few days, more bumps appeared- all itchy- plus a general red area (same site as origanial injection over redness). The bumps began to blister and grow. She was out of town and away from her physician, but by 14-AUG-2008 the patch on her arm looked like bubble wrap with over 1/2 dozen blisters - a couple 1/2 - 3/8 inch in diameter (also reorted as 4-5 inches in diameter. She went to a walk in medical clinic. The doctor was stymied- landed the biggest blisters - gave her an antibiotic (Ampicillin IP she remeber correctly). Other bumps continued to appear and grow. She saw the physician on 19-AUG-2008 after returning home. Eventually - within a week or so - all blisters had self-drained, skin dried, fell off. No scars. The patient reported a rash that developed on her left deltoid area after she got the ZOSTAVAX (Merck). At the time the physician looked at it, it appeared to be large, bullous areas right around injection site. These areas were flat at the time, having drained their fluid. but appeared to be 2cm in diameter. The patient reported she had a small round bandaid on at the time of the injection but it was not on for extended period of time. The blistering then came after that. The physician did not sure whether this is an adverse reaction to the vaccine or whether it is an allergy to the adhesive in the bandaid. Additional information is not expected.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Information has been received from a physician concerning a female patient over 65 years old, who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (Lot # was not provided). The patient experienced a herpes zoster rash. The patient developed the rash on her lumbar or her neck. Additional information is expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dysaesthesia, Hyperaesthesia, Rash
Clinical narrative: Information has been received from a physician concerning a female patient over 60 year old who on an unspecified date was vaccinated with ZOSTAVAX. The patient experienced nerve root distribution on the left side 2 weeks after vaccination. The patient experienced hyperesthesia prior to eruption on the left side. The patient nerver developed blisters. The patient, 8 weeks after vaccination, developed same nerve root distribution on the right side, then shortly, after a few days, developed blisters. The patient was treated with an unspecified antiviral agent. Within 5 days, the blisters on the right side and dysesthesia on the right and left disappeared. The patient then experienced dysesthesia on the left side one week after the blisters and the dysesthesia on the right and left sides. The patient does not have diabetes. At the time of reporting the patient had not recovered. The patient sought medical attention: she contacted and unspecified dermatologist. There was no product quality complaint. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site erythema, Injection site pain, Neck pain
Clinical narrative: Information has been received from a 61 year old female consumer with sulfonamide allergy and allergy to beef and green peppers who on 08-AUG-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. On 09-AUG-2008, "one day after" vaccination, the patient experienced an intense heavy pain at injection site including redness. The patient was also experiencing flu like feeling, headache and pain in her neck and arm. At the time of this report, the patient's symptoms persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a 61 year old female consumer with sulfonamide allergy and allergy to beef and green peppers who on 08-AUG-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). There was no concomitant medication. On 09-AUG-2008, "one day after" vaccination, the patient experienced an intense heavy pain at injection site including redness. The patient was also experiencing flu like feeling, headache and pain in her neck and arm. At the time of this report, the patient's symptoms persisted. The patient did not seek medical attention. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site nodule, Rash
Clinical narrative: Information has been received from a 76 year old female with no medical history and an allergy to monosodium glutamate who on 13-AUG-2008 was vaccinated with ZOSTAVAX, 0.65 mL. Concomitant therapy included PLAVIX. On 13-AUG-2008, the patient experienced redness and small nodules at injection site. It also made a previous rash on her shoulder and chest from the latex in her bra get a little worse. She also This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a 77 year old female with no medical history and an allergy to monosodium glutamate who on 13-AUG-2008 was vaccinated with ZOSTAVAX, 0.65 mL into the left arm. Concomitant therapy included PLAVIX. On 13-AUG-2008 the patient experienced redness and small nodules at injection site. It also made a previous rash on her shoulder and chest from the latex in her bra get a little worse. In follow-up, the physician reported that on 14-AUG-2008, the vaccine made her pre-existing rash worse. The rash lasted 3 days and the patient recovered on 17-AUG-2008. She also experienced a headache. At the time of reporting, the patient was recovering. The patient sought medical attention from a physician. It was reported that in the past she had been on ZOLOFT and experienced diarrhea. There was no product quality complaint. Follow up was received from a physician concerning a female patient with allergies to sulfa, penicillin and MSG, who on 02-JUL-2008 (previously reported as 13-Aug-2008) was vaccinated with a first dose of an unspecified vaccine (MSD) (pharmacist did not know vaccine). It was reported by the physician that on 05-JUL-2008, the patient experienced an unspecified adverse event on same arm and chest. There were local and systemic allergic reactions at the time of vaccination. It was reported: "pharmacist did not know vaccine continued MSG". No further information is available.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 65 year old female with environmental allergies who in October or November 2007, was vaccinated with a 0.65 mL dose of ZOSTAVAX (lot number, injection site and route not reported). Concomitant therapy included heart medication, thyroid and simvastatin (MSD). In approximately October 2007, also reported as 2 weeks after the vaccination, the patient experienced a case of shingles. The patient This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a 65 year old female with environmental allergies who in October or November 2007, was vaccinated with a 0.65 mL dose of ZOSTAVAX (Oka/Merck) (lot number, injection site and route not reported). Concomitant therapy included heart medication, thyroid and simvastatin (MSD). In approximately October 2007, also reported as 2 weeks after the vaccination, the patient experienced a case of shingles. The patient has had 5 cases of the shingles since receiving the vaccine. The patient developed a lot of blisters underneath her arms. The patient would be seeing a neurologist to determine why the shingles kept reoccurring. Two weeks ago, the patient recovered from shingles. Additional information is not expected.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypertension, Musculoskeletal stiffness, Myalgia
Clinical narrative: Information has been received from a physician concerning a 63 year old female who on 16-AUG-2008 was vaccinated with ZOSTAVAX (lot number not provided) 0.65 mL. Concomitant therapy included aspirin. A day after receiving ZOSTAVAX, on 17-AUG-2008, the patient experienced soreness, fatigue and a headache. She had a "mild stiff neck" and high blood pressure (150/90). As of 22-AUG-2008, the patient had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician concerning a 63 year old female who on 16-AUG-2008 at 08/:21 was vaccinated with ZOSTAVAX (lot #659672/0294X) 0.65 mL. A day after receiving ZOSTAVAX (Oka/Merck), on 17-AUG-2008, the patient experienced soreness, fatigue and a headache. On 18-AUG-2008, 48 hours after receiving ZOSTAVAX (Oka/Merck), she had a "mild stiff neck", high blood pressure (150/90), achy muscles, worsening headache in left eye/temples and 2 inches diameter erythema at injection site. On approximately 30-AUG-2008, the patient had recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is not expected.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Laboratory test
Clinical narrative: Information has been received from a 61 year old male with a history of open heart surgery and no allergies who on approximately 12-AUG-2008, also reported as 2 weeks ago, was vaccinated with a 0.65 mL dose of ZOSTAVAX (lot number, injection site and route not reported). Concomitant therapy included a lot of unspecified medications for diabetes and heart disease. On approximately 14-AUG-2008, also reported as 2-3 days after vaccination, the patient experienced severe pain in his hip and can hardly walk. Therapy with ZOSTAVAX was discontinued. Unspecified medical attention was sought. The patient's event's persisted. No further information is available.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Genital rash, Genital swelling
Clinical narrative: Information has been received from a 66 year old male who in approximately November 2007, was vaccinated with ZOSTAVAX (Oka/Merck). Subsequently the patient experienced rash and swelling in genital area. The patient was seen by the physician for these adverse events. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008. In follow up the patient that the allergic reaction that he had was excessive antibiotics and has been corrected. There was no connection with the zoster vaccine live inoculation. No further information is available.
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Information has been received from a nurse, concerning a male who on sometime last week (approximately 18-AUG-2008) was vaccinated with ZOSTAVAX. There was no concomitant medication. The patient experienced generalized rash after vaccination with ZOSTAVAX. The patient sought medical attention, seen in office. There was no product quality complaint. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a consumer who read on a online blog that a male patient with Parkinson's disease on a date not reported, was vaccinated with ZOSTAVAX (Oka/Merck). The patient developed shingles two weeks after he got vaccinated with ZOSTAVAX (Oka/Merk). This is one of several reports received from the same source. No further information is available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a practice manager concerning a patient who in October 2007 was vaccinated with ZOSTAVAX (Oka/Merck) and developed shingles. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Headache, Injection site erythema, Injection site warmth, Medication error
Clinical narrative: Information has been received from a pharmacist concerning a 62 year old female with arthritis, cholesterol high and blood pressure high who on 05-AUG-2008 was vaccinated subcutaneously into the left arm with a 0.65 ml dose of ZOSTAVAX (Oka/Merck) (lot # 659323/0164X) that was reconstituted with PNEUMOVAX. The pharmacist reported that the reconstitution with PNEUMOVAX was just medication error and not product confusion. It was reported that on 06-AUG-2008 the patient developed an injection site reaction that was warm, red and was spreading down her arm (time frame unspecified). It was reported that the patient also had experienced dizziness and headache since vaccination with ZOSTAVAX (Oka/Merck) (time frame unspecified). At the time of this report, the patient was not recovered. The patient contacted the pharmacist and sought unspecified medical attention. Additional information has been requested. It was reported that this was due to mixing ZOSTAVAX (Oka/Merck) incorrectly. The patient was prescribed BENADRYL, clindamycin (antibiotic) and prednisone. On 15-AUG-2008 the patient was fullly recovered. Additional information is not expected.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Electrocardiogram abnormal
Clinical narrative: Information has been received from a physician assistant and a 58 year old male with a history of cataract operation and herniotomy and no allergies or drug reactions, who in March 2008, was vaccinated with ZOSTAVAX. There was no concomitant medication. On 14-MAR-2008, the patient reported that he got electrocardiogram test done regularly, but with the last two, electrocardiogram readings were abnormal. The patients also reported that his regular heart beat was around 80 beats or so and he through the reading about 20 beats were "weird." The patient reported that he felt fine, he had no pain and no shortness of breath, etc. The physician wanted him to come back for a stress test. The patient stated he was not sure if ZOSTAVAX is causing this effect with his electrocardiogram readings. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: Information has been received from a medical assistant concerning a female with no pertinent medical history or drug allergies or drug reactions, who in November 2007, was vaccinated with ZOSTAVAX (Oka/Merck) intramuscular. Concomitant therapy included SYNTHROID and alendronate sodium. In November 2007, the patient was given ZOSTAVAX (Oka/Merck) intramuscular instead of subcutaneous. Subsequently the patient experienced soreness at injection site. The medical assistant stated that the physician mentioned that it was a nerve irritation. No laboratory tests were performed. The patient sought medical attention with an office visit. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Information has been received from a physician concerning a 64 year old (also reported 62 year old) not immunocompromised female with high blood pressure, high cholesterol, allergies to simvastatin (MSD) (caused myalgia) and LOTENSIN, a history of varicella at 12 years old and no recent exposure to chickenpox and shingles, who on 29-JUL-2008 was vaccinated with one dose of ZOSTAVAX (LOT#: 659673/0557X) SQ in the left triceps.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ZOSTAVAX. On an unknown date, the patient developed shingles. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain in extremity, Rash, Varicella zoster serology negative
Clinical narrative: Information has been received from a physician concerning a 72 year old female with history of chickenpox in her childhood, who on 01-AUG-2008 was vaccinated with a dose of ZOSTAVAX (LOT # 658859/0411X) 06.5mL subcutaneously into her left deltoid. Concomitant therapy included alendronate sodium (MSD), atenolol and lovastatin (manufacturer unknown). On 04-AUG-2008, the patient developed shingles. The patient had 6-7 patches with vesicles on her left C-5 dermatome. On 05-AUG-2008, the patient began to experience pain in her left thumb. On 07-AUG-2008, the patient developed rash on the fingers of her left hand and spread to her arm. On 11-AUG-2008, the patient's vesicles on her left arm were diagnosed as shingles. Pain was quantified as 8, being 10 the most painful. The patient was being treated with VALTREX and ibuprofen. At th etime of reporting, the patient was recovering. There were no laboratory diagnostic studies performed. At time of reporting, the patient was recovering. Additional information is not expected.  Follow up: The patient was enrolled in the Varicella zoster virus Identification program to identify if VZV is present and if it is associated with the wild type VZV strain or with the Merck vaccine VZV strain.  The sample of the lesion was collected on 13-AUG-2008. The sample was taken from a not fluid filled vesicle lesion in her left arm. VZV DNA was not amplified. The PCR rersults for the specimen from the not fluid filled vesicle lesion, identified an inadequate specimen, negative for B-Globin, no strain I.D.  Additional information is not expected.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Rash
Clinical narrative: Information has been received from a consumer concerning her wife 76 year old with high blood pressure and no known allergies who about one year ago in approximately August 2007, was vaccinated with ZOSTAVAX. Concomitant therapy NORVASC. The husband reported that her wife developed an increase in the episodes of shingles since receiving ZOSTAVAX, about one year ago (date unspecified). To patient had a history of shingles episodes 3-4 times per year before receiving ZOSTAVAX. The patient developed an episode of shingles about 3 months after received ZOSTAVAX and had continued with episodes about every 5 weeks. The patient told the physician of the first episode but, not the subsequent shingles. The symptoms were a groin rash radiating to the buttocks that resolved in an unspecified time frame (also reported as recovering). The episodes of shingles are reported as more frequent  but less severe than the episodes prior to ZOSTAVAX. No other symptoms and treatment reported. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Information has been received from a pharmacist, concerning a female Hispanic patient, who on 31-JUL-2008 was vaccinated with ZOSTAVAX (LOT #659409/0299X). The patient developed pain and erythema at the injection site for about a week. The patient also developed a rash on the chest, neck and nose within days after vaccination. The patient did not seek medical attention from a health care professional. Additional information is expected.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician concerning a 91 year old male patient who on 20-APR-2007, was vaccinated with ZOSTAVAX. On 09-MAY-2007, the patient got shingles. The patient sought medical attention at physician's office and phone called the physician. On an unspecified date, the patient recovered from shingles. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood urine absent, Dehydration, Diet refusal, Henoch-Schonlein purpura, Joint swelling
Clinical narrative: Henoch-Schonlein Purpura developed one days after Flu vaccine we purpura lesions especially on lower abdomen, lower extremities with swelling of feet. Labs done at ER-hospital, on 10/1/08.  Rx ibuprofen when seen on 10/7/08 & Rx ZITHROMAX.
Age: 5.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Laboratory test normal, Oedema peripheral, Pain in extremity, Rash pruritic, Vasculitis
Clinical narrative: Henoch-Schonlein Purpura developed one days after Flu vaccine we purpura lesions especially on lower abdomen, lower extremities with swelling of feet. Labs done at ER-hospital, on 10/1/08.  Rx ibuprofen when seen on 10/7/08 & Rx ZITHROMAX.
Age: 5.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: Henoch-Schonlein Purpura developed one days after Flu vaccine we purpura lesions especially on lower abdomen, lower extremities with swelling of feet. Labs done at ER-hospital, on 10/1/08.  Rx ibuprofen when seen on 10/7/08 & Rx ZITHROMAX.
Age: 5.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood creatine phosphokinase normal, Blood creatinine normal, Blood potassium normal, Blood sodium normal, Blood urea normal
Clinical narrative: Henoch-Schonlein Purpura developed one days after Flu vaccine we purpura lesions especially on lower abdomen, lower extremities with swelling of feet. Labs done at ER-hospital, on 10/1/08.  Rx ibuprofen when seen on 10/7/08 & Rx ZITHROMAX.
Age: 5.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Carbon dioxide normal, Eosinophil percentage, Full blood count, Haematocrit increased, Haemoglobin increased
Clinical narrative: Henoch-Schonlein Purpura developed one days after Flu vaccine we purpura lesions especially on lower abdomen, lower extremities with swelling of feet. Labs done at ER-hospital, on 10/1/08.  Rx ibuprofen when seen on 10/7/08 & Rx ZITHROMAX.
Age: 5.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Henoch-Schonlein purpura, Lymphocyte percentage, Monocyte percentage, Neutrophil percentage, Oedema peripheral
Clinical narrative: Henoch-Schonlein Purpura developed one days after Flu vaccine we purpura lesions especially on lower abdomen, lower extremities with swelling of feet. Labs done at ER-hospital, on 10/1/08.  Rx ibuprofen when seen on 10/7/08 & Rx ZITHROMAX.
Age: 5.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Platelet count normal, Urine analysis normal, White blood cell count normal
Clinical narrative: Henoch-Schonlein Purpura developed one days after Flu vaccine we purpura lesions especially on lower abdomen, lower extremities with swelling of feet. Labs done at ER-hospital, on 10/1/08.  Rx ibuprofen when seen on 10/7/08 & Rx ZITHROMAX.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Convulsion
Clinical narrative: My daughter have experience seizures 8 times since have taken the shot, GARDASIL.
Age: 16.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Condition aggravated, Convulsion
Clinical narrative: My daughter have experience seizures 8 times since have taken the shot, GARDASIL.
Age: 4.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a public health director concerning his son, a 10 year old male who 5 year ago, who in 2003 was vaccinated with a dose of VARIVAX (Oka/Merck).  On 06-SEP-2008, the child had severe itch on left thigh that turned into open blistery sores.  The sores extended from 3 inches below the left knee up to the left hip.  At that time, child went into a hot tub and developed a severe MRSA infection of the left thigh, which the caller stated was serious.  On 08-SEP-2008, the child developed shingles in the webbing of his right hand.  The shingles traveled from right hand all the way to  under the right armpit.  The child had shingles on both sides of the body, which caller stated was unique.  The child was treated with BACTRIM, and many antibiotic ointments.  The caller stated they tried to get a scab/specimen for testing, but it was too late.  MRSA test was performed with positive result.  The child had fully recovered.  The reporter considered MRSA infection to be an other important medical event.  Additional information has been requested.